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<![CDATA[ Contributing Factors for Poor HIV Treatment Response in Children With TB/HIV Coinfection ]]>
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
Email kantwi@gmail.com Email 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
Email awewura.kwara@medicine.ufl.edu Email 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
Antiretroviral-naïve to efavirenz and meet criteria for initiation or switch to efavirenz-based ART
Are available for follow-up until achievement of a study endpoint like completion of study at 6 months or discontinuation of ART.

Exclusion Criteria:

Unable to obtain informed signed consent parent(s) or legal guardian
Have AIDS-related opportunistic infections other than TB
History of acute hepatitis within 30 days of study entry
Persistent vomiting or diarrhea at time of enrolment
Hemoglobin < 6 g/dl, white blood cells < 2500/mm3, serum creatinine > 1.5 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) > 2 times upper limit of normal

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

]]>

<![CDATA[ Pharmacokinetics of Intracellular TFV-DP and FTC-TP in HIV-infected Adolescents ]]>
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
Email Kantwi@gmail.com Email 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
Email awewura.kwara@medicine.ufl.edu Email 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.
Pregnant or breast feeding.
Require therapy for other opportunistic infections other than tuberculosis (TB).

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

]]>

<![CDATA[ Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet ]]>
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
Email antwisampson@yahoo.com Email 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
Email awewura.kwara@medicine.ufl.edu Email 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.
Available for follow-up until completion of TB treatment and/or achievement of a study endpoint like discontinuation of therapy, and/or pharmacokinetic sampling.

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.
Unable to obtain informed signed consent from parent(s) or legal guardian.
Have AIDS-related opportunistic infections other than TB, history of or proven acute hepatitis within 30 days of study entry, persistent vomiting, or diarrhea.
Hemoglobin < 6 g/dl, white blood cells < 2500/mm3, serum creatinine > 1.5 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) > 2 times upper limit of normal.

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

]]>

<![CDATA[ Exercise and Overnight Motor Sequence Task ]]>
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
Based on the SCID diagnosed to have schizophrenia and related psychotic disorders
Ability to understand the nature of the study and to give written informed consent

Exclusion Criteria:

Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders
Comorbid substance dependence
Unstable psychotic symptoms
A history of brain trauma or organic brain disease
Known history of intellectual disability or special school attendance
Answered one or more "yes" in the PAR-Q and without doctors approval for exercise

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

]]>

<![CDATA[ Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk ]]>
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.
The enrollment of patients who died is allowed.

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

]]>

<![CDATA[ Recovery, Fatigability, and Proteomic Response to Aerobic Exercise Training in Healthy Individuals ]]>
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.
<![CDATA[

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
body mass index > 19 to <35 kg/m2
able to pedal leg cycle ergometer
able to comprehend and speak English

Exclusion Criteria:

diabetes mellitus
significant pulmonary dysfunction (eg. chronic obstructive lung disease; interstitial lung disease)
hypertension
anemia
stroke
cancer (other than melanoma)
cardiac, pulmonary, thyroid, autoimmune, musculoskeletal, neurological, metabolic bone, mitochondrial, hepatic, renal, and/or psychiatric disease
abnormal blood lipids
active substance abuse or cognitive impairment
chronic infection requiring antiviral or antibiotic treatment
taking any medications that may limit exercise capacity or the ability to adapt to aerobic exercise training
previously or currently on anticoagulant therapy or therapeutic hormone replacement/supplementation (excluding birth control)
pregnant
smoking

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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Am Heart J. 2009 Dec;158(6):1031-7. doi: 10.1016/j.ahj.2009.10.003. Citation Mora S, Cook N, Buring JE, Ridker PM, Lee IM. Physical activity and reduced risk of cardiovascular events: potential mediating mechanisms. Circulation. 2007 Nov 6;116(19):2110-8. doi: 10.1161/CIRCULATIONAHA.107.729939. Epub 2007 Oct 22. Citation Booth FW, Laye MJ. The future: genes, physical activity and health. Acta Physiol (Oxf). 2010 Aug;199(4):549-56. doi: 10.1111/j.1748-1716.2010.02117.x. Epub 2010 Mar 24. Citation Santos-Parker JR, Santos-Parker KS, McQueen MB, Martens CR, Seals DR. Habitual aerobic exercise and circulating proteomic patterns in healthy adults: relation to indicators of healthspan. J Appl Physiol (1985). 2018 Nov 1;125(5):1646-1659. doi: 10.1152/japplphysiol.00458.2018. Epub 2018 Sep 20. Citation Collins FS, Patrinos A, Jordan E, Chakravarti A, Gesteland R, Walters L. New goals for the U.S. Human Genome Project: 1998-2003. Science. 1998 Oct 23;282(5389):682-9. doi: 10.1126/science.282.5389.682. Citation Jameson JL, Longo DL. Precision medicine–personalized, problematic, and promising. N Engl J Med. 2015 Jun 4;372(23):2229-34. doi: 10.1056/NEJMsb1503104. Epub 2015 May 27. No abstract available. Citation Cornwall J, Elliott JM, Walton DM, Osmotherly PG. Clinical Genomics in Physical Therapy: Where to From Here? Phys Ther. 2018 Sep 1;98(9):733-736. doi: 10.1093/ptj/pzy069. No abstract available. Citation Buford TW, Roberts MD, Church TS. Toward exercise as personalized medicine. Sports Med. 2013 Mar;43(3):157-65. doi: 10.1007/s40279-013-0018-0. Citation Davidsen PK, Turan N, Egginton S, Falciani F. Multilevel functional genomics data integration as a tool for understanding physiology: a network biology perspective. J Appl Physiol (1985). 2016 Feb 1;120(3):297-309. doi: 10.1152/japplphysiol.01110.2014. Epub 2015 Nov 5. Citation Magni R, Espina BH, Liotta LA, Luchini A, Espina V. 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.

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<![CDATA[ Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery ]]>
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
Must be undergoing the procedure at Mayo Clinic in Rochester, MN
Must be greater than or equal to 40 years of age

Exclusion Criteria:

Under 40 years of age
Concomitant additional surgical procedure (e.g., CABG + valve replacement)
Patients with implantable pacemakers/defibrillators
Patients that find the device too uncomfortable to wear for 48 hours

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

]]>

<![CDATA[ Synchronous Video (Telemedicine) Consulation in the Prehospital Setting ]]>
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
Hemodynamically unstable trauma patients requiring resuscitation and airway management
Trauma patients with altered mentation requiring airway management
Acute stroke patients
Medical patients that refuse transport for medical evaluation Pediatric Intensive Care Telemedicine Program
Complex clinical situations where paramedic teams need immediate management guidance
Critically ill pediatric patients requiring evaluation/stabilization for interfacility transport
Pediatric patients requiring intervention for respiratory failure
Pediatric patients with ongoing seizures and/or neurological abnormalities
Hemodynamically unstable patients
Complex clinical situations requiring medical control guidance

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

]]>

<![CDATA[ Integrated Treatment for Youth With Mood Disorders ]]>
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;
Diagnosed with a primary depressive or bipolar disorder;
Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic.

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

]]>

<![CDATA[ Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake ]]>
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;
Male sex;
Age: 18-30
BMI: 18-25 kg/m2;
Normal physical activity levels;

Exclusion Criteria:

Not meeting all inclusion criteria
Cardiovascular diseases (determined by means of questionnaires, heart rate/blood pressure measurements)
Respiratory diseases (including asthma, bronchitis and COPD);
Unstable body weight (weight gain or loss > 5 kg in the last three months);
Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
Excessive alcohol and/or drug abuse;
Hypokalaemia;
Hb < 8.4 mmol/L;
Epilepsy;
Smoking;
Renal and/or liver insufficiency;
Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
Medication use known to hamper subject's safety during the study procedures;
Subjects who do not want to be informed about unexpected medical findings;
Subjects who do not want that their treating physician to be informed;
Inability to participate and/or complete the required measurements;
Participation in organised or structured physical exercise;
Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk;
Hyperthyroidism

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

]]>

<![CDATA[ Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health ]]>
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)
fasting insulin over 60 pmol/L or fasting glucose 5.6 – 6.9 mmol/L
at least one of the following criteria: Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL < 0,9 mmol/L; hsCRP 1-10 mg/L
non-smoking
eating fruits and vegetables less then 5 portions/day

Exclusion Criteria:

chronic disease
taking drugs or natural health products that could affect glucose or lipid metabolism
taking anti-inflammatory, antiacids
taking pre or probiotics
inflammatory bowel disease
antibiotics in the past 3 months
allergy or intolerance to cranberries or agaves
Major surgery in the past 3 months

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

]]>

<![CDATA[ Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery ]]>
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,
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
chronic obstructive pulmonary disease were not included in the study.

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

]]>

<![CDATA[ Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section ]]>
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
Email 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
Email ppopivanov@coombe.ie Email 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
18yrs
gestation >38 gestation weeks

Exclusion Criteria:

Multiple pregnancy
Previous upper GI surgery
Known disorder of gastric emptying
Hiatus Hernia
BMI >40
Diabetes Mellitus, Gestational Diabetes

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

]]>

<![CDATA[ Telehealth Powerful Tools for Caregivers Effectiveness Study ]]>
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
speak English
cognitive ability to participate in PTC classes
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

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.

]]>

<![CDATA[ Treatment of Anterior Ligament Rupture With Internal Brace Repair – A Prospective Randomised Controlled Study. ]]>
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
Rheumatoid arthritis
Other knee ligament instability
Obesity BMI >30
Morbus Bechterew

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

]]>

<![CDATA[ Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma ]]>
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
Email david.tougeron@chu-poitiers.fr Email 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
Email 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.
Histologically-proven adenocarcinoma of the ampulla of Vater which is operable or with locoregional or metastatic recurrence after excision less than 6 months previously.

Exclusion Criteria:

Patients who cannot be followed up regularly for psychological, social, family or geographical reasons.
Non-ampullary tumours.
Non-adenocarcinomatous ampullary tumours.
Ampullary adenocarcinomas which are metastatic or locally advanced from the outset and inoperable.

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

]]>

<![CDATA[ The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia ]]>
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
Email balptug@eul.edu.tr Email 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.
Feeling Fibromyalgia symptoms last 3 mounts

Exclusion Criteria:

Having physical and functional problems with FMS
Having a diagnosis of chronic pain other than FMS,
Using medicine other than simple analgesics,
History of cardiovascular or pulmonary diseases
Can not read and write in Turkish language

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.

]]>

<![CDATA[ Influence of Age on Trauma Femoral Fractures ]]>
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

]]>

<![CDATA[ A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430 ]]>
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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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
males and non-pregnant, non-lactating females
BMI 19.0-32.0
willing to abide by contraceptive requirements
normal vitals
willing to abide by study procedures and restrictions

Exclusion Criteria:

clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition
abnormal cardiac finding, or laboratory/urinalysis abnormality at screening
known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention
current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit
use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study
Recent or current history of alcohol or drug abuse
Regular use of tobacco or nicotine products
Positive serology for HBV, HCV, or HIV
history of severe adverse reaction to or known sensitivity to any drug
pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded

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
Email 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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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.
Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day)
Day 21 (+2 days) or early termination.

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

]]>

<![CDATA[ Greater China Metabolic and Bariatric Surgery Database ]]>
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

]]>

<![CDATA[ Effects of Nutritional Fat on the Growth of Intestinal E. Coli ]]>
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.
Email 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
Email benjamin.misselwitz@usz.ch Email 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
Written informed consent
Age 18 – 85 years
Working at ETH Zurich or University of Zurich and trained and experienced in handling -80°C freezers at biosafety level 2.

Exclusion Criteria:

Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and surgery for anorectal disorders)
Known diabetes mellitus, scleroderma, neurological impairment or other major diseases requiring ongoing management
Immunesuppression
Subjects with antibiotic therapy, proton pump inhibitors or laxatives within the last four weeks
Pregnancy beyond week 12. "Mutaflor" intake is safe during pregnancy; however, special regulations are required to gain access to the -80°C freezers. No pregnancy test will be performed.

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

]]>

<![CDATA[ A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer ]]>
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

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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
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin

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
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin

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
Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
Adequate organ and marrow function
Confirmation of a patient's tumour PD-L1 status
Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

Exclusion Criteria:

History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
History of another primary malignancy
History of active primary immunodeficiency
Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
Deemed unresectable NSCLC by multidisciplinary evaluation
Patients who have pre-operative radiotherapy treatment as part of their care plan
Patients who have brain metastases or spinal cord compression
Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
Known allergy or hypersensitivity to any of the study drugs or excipients
Existence of more than one primary tumour such as mixed small cell and NSCLC histology
Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
Patients with a documented test result confirming the presence of EGFRm or ALK translocation

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)

]]>

<![CDATA[ Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC) ]]>
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,
for which neoadjuvant chemotherapy is being considered
metastatic or locally advanced cancer before and after treatment with first-line chemotherapywhich may include neoadjuvant therapy

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.
Determine if the exosome concentration as well as the protein and RNA profile they contain varies after treatment.
Determine if the initial exosome concentration (at T0) is associated with a response to treatment.
Determine whether the change in exosome concentration before and after treatment is associated with a response to treatment.
Identify a protein marker or RNA associated with a treatment response (marker present at T0 or occurring during follow-up).

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
Email echaigneau@chu-besancon.fr Email ahervieu@cgfl.fr Email 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)
Then four blood samples of 32mL distributed over 6 months

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)
Then three blood samples of 32 mL distribuated over 3 months

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
Email ahervieu@cgfl.fr Email 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
Previous treatment of the disease with chemotherapy, radiotherapy or surgery is allowed if it has been completed for more than 12 months at the time of inclusion.
For metastatic or locally advanced (inoperable) sarcoma, patients for whom first-line metastatic chemotherapy is indicated.
Age ≥18 years
Affiliation to a social security scheme
Patients who signed informed consent to participate in the study

Exclusion Criteria:

Patients who meet at least one of the following criteria will not be eligible:

Patient with another synchronous tumor,
Patient with sarcoma in irradiated territory
Patient with a history of cancer other than sarcoma in the 5 years preceding the diagnosis of sarcoma
Patient unable to undergo medical follow-up for geographical, social or psychological reasons,
Person benefiting from a protection system for adults (including guardianship and trusteeship),
Serology HIV and / or HBV and / or HCV positive.
Pregnant or lactating woman.
Patients unable to understand, read and / or sign informed consent.

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

]]>

<![CDATA[ Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS ]]>
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,
Ability to provide informed consent,
Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
Disease duration of at least 4 years,
Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Exclusion Criteria:

History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
History of other central nervous system disease (excluding migraine),
Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
Current alcohol or substance abuse,
Lack of fluency in English which would invalidate cognitive testing,

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

]]>

<![CDATA[ Early Palliative Care for Patients With Haematological Malignancies ]]>
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
Email 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
Email 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
Patients from being diagnosed with acute myeloid leukemia and high-risk myelodysplastic syndrome or after the third line of therapy for high-grade lymphoma.

Exclusion Criteria:

All patients with a curative project (induction chemotherapy ou allogenic transplantation)
All patients in a terminal palliative status
Patients who don't speak French,
Patients not able to read and write
Patients who don't agree to participate in the protocol
Patients with psychiatric troubles or cognitive disorders
Patients under guardianship or curatorship, deprived of freedom or under justice protection.

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

]]>

<![CDATA[ Development and Usability Testing of a Progressive WebApp for Women With Heart Disease ]]>
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
Email monica.parry@utoronto.ca Email 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
Email monica.parry@utoronto.ca Email 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
women will be required to speak and read English

Exclusion Criteria:

severe cognitive impairment assessed using the Six-Item Screener
major co-morbid medical or psychiatric illness that could preclude their ability to participate

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.

]]>

<![CDATA[ Validation of Point of Care Liver Function Tests ]]>
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)
18 years or older

Exclusion Criteria:

Inadequate blood sample obtained from finger stick
Inconclusive liver function testing
Not all 6 liver tests completed on the same sample
Liver tests not drawn for normal method at same time as 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

]]>

<![CDATA[ Characterization of the Fungal Origins in the Autoimmune Polyendocrinopathy of Type 1 Compared With the Autoimmune Polyendocrinopathies of Type 2 ]]>
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
Email 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.
a reasonable delay of 2 weeks after the resolution of an intercurrent infectious episode is to be observed.
assent of the patient after information adapted to his age and his degree of understanding.
informed, express and written consent of the patient or of each of the holders of parental authority.
Inclusion criteria specific to group 1: 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.
Inclusion criteria specific to group 2 : 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.

Exclusion Criteria:

impossibility to receive informed information for adults, or impossibility to receive enlightened information for the holders of parental authority if minor subject
inability to participate in the entire study, refusal to sign the consent.
people in an emergency situation.
persons deprived of their liberty.
pregnant or lactating woman (pregnant women will be offered to participate in the study after delivery).

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

]]>

<![CDATA[ Social Impact of Children’s Dental Appearance ]]>
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
sufficient compliance
dividable into the two groups (with or without caries experience)

Exclusion Criteria:

missing agreement to participate in the study
insufficient compliance

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

]]>

<![CDATA[ Effect of Cross Frequency tACS on Cognitive Control ]]>
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

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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
Able to provide informed consent
Willing to comply with all study procedures and be available for the duration of the study Speak and understand English

Exclusion Criteria:

Attention Deficit Hyperactivity Disorder (currently under treatment)
Neurological disorders and conditions, including, but not limited to:
History of epilepsy
Seizures (except childhood febrile seizures and electroconvulsive therapy induced seizures) Dementia
History of stroke
Parkinson's disease
Multiple sclerosis
Cerebral aneurysm
Brain tumors
Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, malignancy)
Prior brain surgery
Any brain devices/implants, including cochlear implants and aneurysm clips
History or current traumatic brain injury
(For females) Pregnancy or breast feeding
Personal or family history of mental/psychiatric disorder (e.g., anxiety, major depressive disorder, schizophrenia, etc.)
Positive urine test for the following: Marijuana (THC), Cocaine (COC), Phencyclidine (PCP), Amphetamine (AMP), Ecstasy (MDMA), Methamphetamine (Mamp), Opiates (OPI), Oxycodone (OXY), Methadone (MTD), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Tricyclic Antidepressants (TCA), Propoxyphene (PPX)
Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

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

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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
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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
Email 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.

]]>

<![CDATA[ Skeletal Muscle Function in Interstitial Lung Disease ]]>
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.
<![CDATA[

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
Email yannick.molgat-seon@hli.ubc.ca Email 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)
A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
Appropriate candidate for pulmonary rehabilitation
6 minute walk distance 50m or more
Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air
Clinically stable for the preceding 6 weeks
Can fluently read and write in English

Inclusion Criteria for Healthy Controls:

Age 40-80 (inclusive)
Normal pulmonary function (80-120% predicted)
No lung or cardiovascular disease
Can fluently read and write in English

Exclusion Criteria for the ILD patients:

Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70)

Exclusion Criteria for Healthy Controls:

Currently smoking or previously smoked more than 10 pack-years
Any medical conditions that prevents them for exercising safely
Cardiac pacemaker or any metal or electronic inside the body

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253953517
Registered In Calendar Year 2018
Were Results Reported False
Has Single Facility False
Minimum Age Num 40
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 4
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30702349
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking Single
Subject Masked True

Responsible Parties

Sequence: 29069116
Responsible Party Type Principal Investigator
Name Jordan Guenette
Title Associate Professor
Affiliation University of British Columbia

]]>

<![CDATA[ Bone Health in Patients With Atopic Dermatitis ]]>
https://zephyrnet.com/NCT03800004
2018-07-30

https://zephyrnet.com/?p=NCT03800004
NCT03800004https://www.clinicaltrials.gov/study/NCT03800004?tab=tableKatrina PiercePierce.Katrina@mayo.edu507-266-1078This study examines the bone health in children with atopic dermatitis
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-03-01
Start Month Year July 30, 2018
Primary Completion Month Year December 2024
Verification Month Year February 2023
Verification Date 2023-02-28
Last Update Posted Date 2023-03-01

Detailed Descriptions

Sequence: 20574452
Description The goal of this study is to objectively evaluate bone health and contributing factors in children with AD. This will be compared with existing normative data. Such an objective prospective study, directly looking at bone health in children has not yet been done. This will be done using bone densitometry (DXA) and high-resolution peripheral quantitative computed tomography (HR-pQCT) for the accurate and precise measurement of bone health status. HR-pQCT is a cutting-edge technology available at only at a few academic centers in the United States that is used to measure bone strength with minimal doses of radiation. In addition, blood and urine metabolic parameters related to bone health will be analyzed, and data will be correlated with eczema severity. The results from this study will allow us to design large-scale, multi-institutional studies on bone health in this population and ultimately to guide decision making in children who may be at risk specifically regarding treatment recommendations and supportive care.

The specific aims of this project are:

To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using DXA and to compare this with normative data.
HR-pQCT data will be compared with current known data from other diseases
To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores.
To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers.

Facilities

Sequence: 198634213
Status Recruiting
Name Mayo Clinic
City Rochester
State Minnesota
Zip 55906
Country United States

Facility Contacts

Sequence: 27942023 Sequence: 27942024
Facility Id 198634213 Facility Id 198634213
Contact Type primary Contact Type backup
Name Henry Nguyen, MD Name Katrina Pierce
Email Nguyen.Henry@mayo.edu Email pierce.katrina@mayo.edu
Phone 507-284-4673 Phone 507-266-1078

Facility Investigators

Sequence: 18227991
Facility Id 198634213
Role Principal Investigator
Name Megha M Tollefson, MD

Conditions

Sequence: 51791193 Sequence: 51791192
Name Eczema Name Atopic Dermatitis
Downcase Name eczema Downcase Name atopic dermatitis

Id Information

Sequence: 39856314
Id Source org_study_id
Id Value 17-007112

Countries

Sequence: 42254742
Name United States
Removed False

Keywords

Sequence: 79244741
Name Bone Health
Downcase Name bone health

Design Outcomes

Sequence: 176155987 Sequence: 176155988 Sequence: 176155989
Outcome Type primary Outcome Type primary Outcome Type primary
Measure Correlate bone mineral density to normative data Measure Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score Measure Correlate bone age with serum markers
Time Frame 2 years Time Frame 2 years Time Frame 2 years
Description To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using dual energy x-ray absorptiometry (DXA) and High-resolution peripheral quantitative computed tomography (HR-pQCT) and to compare this with normative data. Description To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores Description To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers

Browse Conditions

Sequence: 191956395 Sequence: 191956401 Sequence: 191956394 Sequence: 191956396 Sequence: 191956397 Sequence: 191956398 Sequence: 191956399 Sequence: 191956400 Sequence: 191956402 Sequence: 191956403
Mesh Term Dermatitis Mesh Term Hypersensitivity, Immediate Mesh Term Dermatitis, Atopic Mesh Term Eczema Mesh Term Skin Diseases Mesh Term Skin Diseases, Genetic Mesh Term Genetic Diseases, Inborn Mesh Term Skin Diseases, Eczematous Mesh Term Hypersensitivity Mesh Term Immune System Diseases
Downcase Mesh Term dermatitis Downcase Mesh Term hypersensitivity, immediate Downcase Mesh Term dermatitis, atopic Downcase Mesh Term eczema Downcase Mesh Term skin diseases Downcase Mesh Term skin diseases, genetic Downcase Mesh Term genetic diseases, inborn Downcase Mesh Term skin diseases, eczematous Downcase Mesh Term hypersensitivity Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47964981 Sequence: 47964982
Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Mayo Clinic Name Pediatric Dermatology Research Alliance

Overall Officials

Sequence: 29061061 Sequence: 29061062
Role Principal Investigator Role Study Director
Name Megha M Tollefson, MD Name Henry Nguyen, MD
Affiliation Mayo Clinic Affiliation Mayo Clinic

Central Contacts

Sequence: 11932090 Sequence: 11932091
Contact Type primary Contact Type backup
Name Henry Nguyen, MD Name Katrina Pierce
Phone 507-284-4673 Phone 507-266-1078
Email Nguyen.Henry@mayo.edu Email Pierce.Katrina@mayo.edu
Role Contact Role Contact

Eligibilities

Sequence: 30542319
Sampling Method Probability Sample
Gender All
Minimum Age 5 Years
Maximum Age 17 Years
Healthy Volunteers No
Population Children with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist
Criteria Inclusion Criteria:

Children 5 to 17 years of age with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist
Duration of atopic dermatitis symptoms for a minimum of 6 months
Ability to cooperate with DXA and HR-pQCT procedure

Exclusion Criteria:

Those without a confirmed diagnosis of moderate to severe atopic dermatitis
Presence of concurrent disease that may also affect bone health, including rickets or other vitamin D deficiency, thyroid disease, renal disease, Paget's disease, osteogenesis imperfecta, inflammatory bowel disease, and other chronic inflammatory diseases
Current use of medications that may affect bone health, including bisphosphonate, Forteo, Tymlos, denosumab, thiazide, heparin, medroxyprogesterone acetate, cyclosporine, and oral tacrolimus. However, medications that are used for atopic dermatitis treatment are allowed
Pregnant or breast feeding females
Inability to cooperate with the blood draw

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254209554
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 5
Maximum Age Num 17
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3

Designs

Sequence: 30290829
Observational Model Cohort
Time Perspective Prospective

Links

Sequence: 4355635
Url https://www.mayo.edu/research/clinical-trials
Description Mayo Clinic Clinical Trials

Responsible Parties

Sequence: 28669626
Responsible Party Type Principal Investigator
Name Megha M. Tollefson, M.D.
Title Principal Investigator
Affiliation Mayo Clinic

Study References

Sequence: 51686565 Sequence: 51686566 Sequence: 51686567 Sequence: 51686568
Pmid 25353616 Pmid 19673879 Pmid 20850893 Pmid 28207767
Reference Type background Reference Type background Reference Type background Reference Type background
Citation Garg N, Silverberg JI. Association between eczema and increased fracture and bone or joint injury in adults: a US population-based study. JAMA Dermatol. 2015 Jan;151(1):33-41. doi: 10.1001/jamadermatol.2014.2098. Citation Haeck IM, Hamdy NA, Timmer-de Mik L, Lentjes EG, Verhaar HJ, Knol MJ, de Bruin-Weller MS, Bruijnzeel-Koomen CA. Low bone mineral density in adult patients with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Dec;161(6):1248-54. doi: 10.1111/j.1365-2133.2009.09327.x. Epub 2009 Jun 4. Citation van Velsen SG, Knol MJ, van Eijk RL, de Vroede MA, de Wit TC, Lam MG, Haeck IM, de Bruin-Weller MS, Bruijnzeel-Koomen CA, Pasmans SG. Bone mineral density in children with moderate to severe atopic dermatitis. J Am Acad Dermatol. 2010 Nov;63(5):824-31. doi: 10.1016/j.jaad.2009.12.015. Epub 2010 Sep 17. Citation Wu CY, Lu YY, Lu CC, Su YF, Tsai TH, Wu CH. Osteoporosis in adult patients with atopic dermatitis: A nationwide population-based study. PLoS One. 2017 Feb 16;12(2):e0171667. doi: 10.1371/journal.pone.0171667. eCollection 2017.

]]>

<![CDATA[ Vestibular Therapy in Alzheimer’s Disease ]]>
https://zephyrnet.com/NCT03799991
2021-03-01

https://zephyrnet.com/?p=NCT03799991
NCT03799991https://www.clinicaltrials.gov/study/NCT03799991?tab=tableYuri Agrawal, MDyagrawa1@jhmi.edu4105023107Nearly 2 out of 3 patients with Alzheimer’s disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-12-14
Start Month Year March 1, 2021
Primary Completion Month Year June 30, 2024
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-14

Facilities

Sequence: 200962641
Status Recruiting
Name Johns Hopkins University School of Medicine
City Baltimore
State Maryland
Zip 21287
Country United States

Facility Contacts

Sequence: 28246642
Facility Id 200962641
Contact Type primary
Name Yuri Agrawal

Facility Investigators

Sequence: 18419491
Facility Id 200962641
Role Principal Investigator
Name John Carey, MD

Conditions

Sequence: 52421116 Sequence: 52421117 Sequence: 52421118
Name Vestibular Diseases Name Vestibular Disorder Name Alzheimer Disease
Downcase Name vestibular diseases Downcase Name vestibular disorder Downcase Name alzheimer disease

Id Information

Sequence: 40335745
Id Source org_study_id
Id Value IRB00273752

Countries

Sequence: 42763393
Name United States
Removed False

Design Groups

Sequence: 55870259 Sequence: 55870260
Group Type Experimental Group Type Active Comparator
Title Vestibular therapy Title Active control
Description Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function. Description The active control regimen consists of eye movement exercises (e.g. smooth pursuit eye movements) and also general conditioning exercises (e.g. range of motion exercises, lifting light weights with the arms and legs). This regimen is "vestibular neutral" in that head movements which specifically challenge the vestibular system are avoided.

Interventions

Sequence: 52729826 Sequence: 52729827
Intervention Type Behavioral Intervention Type Behavioral
Name Vestibular physical therapy Name Active control
Description Vestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks. Description Strength and flexibility exercises that do not involve head movements.

Design Outcomes

Sequence: 178312633
Outcome Type primary
Measure Number of participant falls
Time Frame 1 year
Description Incidence of falls over a 1-year follow-up period

Browse Conditions

Sequence: 194435913 Sequence: 194435914 Sequence: 194435915 Sequence: 194435916 Sequence: 194435917 Sequence: 194435918 Sequence: 194435919 Sequence: 194435920 Sequence: 194435921 Sequence: 194435922 Sequence: 194435923 Sequence: 194435924 Sequence: 194435925
Mesh Term Vestibular Diseases Mesh Term Alzheimer Disease Mesh Term Dementia Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Tauopathies Mesh Term Neurodegenerative Diseases Mesh Term Neurocognitive Disorders Mesh Term Mental Disorders Mesh Term Labyrinth Diseases Mesh Term Ear Diseases Mesh Term Otorhinolaryngologic Diseases
Downcase Mesh Term vestibular diseases Downcase Mesh Term alzheimer disease Downcase Mesh Term dementia Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term tauopathies Downcase Mesh Term neurodegenerative diseases Downcase Mesh Term neurocognitive disorders Downcase Mesh Term mental disorders Downcase Mesh Term labyrinth diseases Downcase Mesh Term ear diseases Downcase Mesh Term otorhinolaryngologic diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48551044
Agency Class OTHER
Lead Or Collaborator lead
Name Johns Hopkins University

Overall Officials

Sequence: 29414995
Role Principal Investigator
Name Yuri Agrawal, MD
Affiliation Johns Hopkins University

Central Contacts

Sequence: 12074544
Contact Type primary
Name Yuri Agrawal, MD
Phone 4105023107
Email yagrawa1@jhmi.edu
Role Contact

Design Group Interventions

Sequence: 68489214 Sequence: 68489215
Design Group Id 55870259 Design Group Id 55870260
Intervention Id 52729826 Intervention Id 52729827

Eligibilities

Sequence: 30908871
Gender All
Minimum Age 60 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2).
Age ≥ 60 years.
Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses).
Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control.
Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control.
Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy.

Exclusion Criteria:

Diagnosis of severe AD (CDR≥3).
Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia.
Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.)
Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT.
Lack of availability to participate in 8 weeks of VT or active control.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254168668
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 60
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30654582
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Triple
Subject Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 29021238
Responsible Party Type Sponsor

Study References

Sequence: 52331765
Pmid 35918757
Reference Type derived
Citation Yesantharao LV, Rosenberg P, Oh E, Leoutsakos J, Munro CA, Agrawal Y. Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Aug 2;8(1):167. doi: 10.1186/s40814-022-01133-w.

]]>

<![CDATA[ A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects ]]>
https://zephyrnet.com/NCT03799978
2019-03-09

https://zephyrnet.com/?p=NCT03799978
NCT03799978https://www.clinicaltrials.gov/study/NCT03799978?tab=tableNANANAThis is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-04-12
Start Month Year March 9, 2019
Primary Completion Month Year March 18, 2019
Verification Month Year April 2019
Verification Date 2019-04-30
Last Update Posted Date 2019-04-12

Facilities

Sequence: 199964474
Name CEPHA s.r.o.
City Pilsen
Zip 323 00
Country Czechia

Conditions

Sequence: 52138949
Name Healthy
Downcase Name healthy

Id Information

Sequence: 40135017
Id Source org_study_id
Id Value ID-078-113

Countries

Sequence: 42542638
Name Czechia
Removed False

Design Groups

Sequence: 55559285 Sequence: 55559286
Group Type Experimental Group Type Experimental
Title Treatment A: ACT-541468 50 mg under fasted conditions Title Treatment B: ACT-541468 50 mg under fed conditions
Description Single oral dose administered on Day 1 under fasted conditions. Description Single oral dose administered on Day 1 administered after food intake.

Interventions

Sequence: 52454849
Intervention Type Drug
Name ACT-541468
Description ACT-541468 50 mg film-coated tablets

Design Outcomes

Sequence: 177263386 Sequence: 177263385 Sequence: 177263387 Sequence: 177263388 Sequence: 177263389 Sequence: 177263390 Sequence: 177263391
Outcome Type other Outcome Type primary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Pharmacokinetic endpoint: AUC0-inf Measure Pharmacokinetic endpoint: AUC0-24 Measure Pharmacokinetic endpoint: Cmax Measure Pharmacokinetic endpoint: tmax Measure Pharmacokinetic endpoint: t½ Measure Treatment-emergent adverse events Measure Serious treatment-emergent adverse events
Time Frame Multiple timepoints; duration: up to 48 hours in each treatment period Time Frame Multiple timepoints; duration: up to 48 hours in each treatment period Time Frame Multiple timepoints; duration: up to 48 hours in each treatment period Time Frame Multiple timepoints; duration: up to 48 hours in each treatment period Time Frame Multiple timepoints; duration: up to 48 hours in each treatment period Time Frame From study treatment administration up to EOT; duration: up to 48 hours in each treatment period Time Frame From study treatment administration up to EOT; duration: up to 48 hours in each treatment period
Description AUC from time zero to infinity Description Area under the plasma concentration-time curve (AUC) from time zero to 24 h Description Maximum plasma concentration Description Time to reach maximum plasma concentration Description Terminal elimination half-life

Sponsors

Sequence: 48290664
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Idorsia Pharmaceuticals Ltd.

Overall Officials

Sequence: 29268505
Role Study Director
Name Clinical Trials
Affiliation Idorsia Pharmaceuticals Ltd.

Design Group Interventions

Sequence: 68107376 Sequence: 68107377
Design Group Id 55559285 Design Group Id 55559286
Intervention Id 52454849 Intervention Id 52454849

Eligibilities

Sequence: 30747691
Gender Male
Minimum Age 18 Years
Maximum Age 45 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
Healthy male subjects aged between 18 and 45 years (inclusive) at Screening
Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
No clinically relevant findings on the physical examination at Screening

Exclusion Criteria:

History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254121761
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 0
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 45
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Other Outcomes To Measure 6

Designs

Sequence: 30493974
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)
Intervention Model Description Two way crossover

Responsible Parties

Sequence: 28860254
Responsible Party Type Sponsor

]]>

<![CDATA[ The Effect of Advanced Improvement Program (ERAS) on Postoperative Outcomes in Patients Undergoing Open Heart Surgery ]]>
https://zephyrnet.com/NCT03799965
2017-12-01

https://zephyrnet.com/?p=NCT03799965
NCT03799965https://www.clinicaltrials.gov/study/NCT03799965?tab=tableemine yurt, doctordremine@gmail.com+905054782609Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.
<![CDATA[

Studies

Study First Submitted Date 2018-12-30
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-31
Start Month Year December 1, 2017
Primary Completion Month Year January 1, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-31

Detailed Descriptions

Sequence: 20727159
Description The ERAS protocol, also known as evidence based "fast-track surgery" (FTS), is an evidence based combination of findings regarding suggestions for patient care on various levels of the perioperative period, which work in synergy for accelerating the postoperative recovery period. It has been used sucessfully for many surgical disciplines, primarily colorectal surgery, since it was first reported in 1997. However, there is a significant insufficiency of this patient oriented rehabilitation program regarding cardiovascular surgeries. This study is to compare the postoperative follow up periods of patients with ERAS protocol and patients with standard protocol who were both operated for cardiac surgery.

Following approval of the local ethics committee, 210 patients who are operated for elective cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who are not applied the ERAS protocol are evaluated in the control group (n=51). The findings regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to compare the durations of stay in the intensive care unit and in hospital; our secondary is to compare the incidences of complications of the groups. The demographic data, operative measurements, complication rates, the amounts of perioperative bleeding and drainage and the duration of stay in the intensive care unit and hospital are recorded.

Facilities

Sequence: 200159267
Status Recruiting
Name Emine yurt
City Kocaeli
State Derince
Zip 41400
Country Turkey

Facility Contacts

Sequence: 28113717 Sequence: 28113718
Facility Id 200159267 Facility Id 200159267
Contact Type primary Contact Type backup
Name ipek y duzyol, doctor Name emine yurt, doctor
Email ipekyd@hotmail.com Email dremine@gmail.com
Phone +905067922217 Phone +905054782609

Conditions

Sequence: 52185435 Sequence: 52185436
Name Enhanced Recovery After Surgery Name Open Heart Surgery
Downcase Name enhanced recovery after surgery Downcase Name open heart surgery

Id Information

Sequence: 40169040
Id Source org_study_id
Id Value KUGOKAEK 2017/369

Countries

Sequence: 42580633
Name Turkey
Removed False

Design Groups

Sequence: 55609067 Sequence: 55609068
Group Type Active Comparator Group Type Active Comparator
Title ERAS protocol are evaluated Title ERAS protocol are not evaluated
Description It is to compare the durations of stay in the intensive care unit and in hospital
It is to compare the incidences of complications of the groups
Description It is to compare the durations of stay in the intensive care unit and in hospital
It is to compare the incidences of complications of the groups

Interventions

Sequence: 52499380 Sequence: 52499381
Intervention Type Other Intervention Type Other
Name ERAS (Enhanced Recovery After Surgery ) are evaluated Name ERAS are not evaluated
Description In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence. Description In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.

Design Outcomes

Sequence: 177431890 Sequence: 177431891
Outcome Type primary Outcome Type primary
Measure durations of stay Measure complications
Time Frame 24 hours Time Frame 24 hours
Description compare the durations of stay in the intensive care unit and in hospital Description compare the incidences of complications

Sponsors

Sequence: 48332280 Sequence: 48332281
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Kocaeli Derince Education and Research Hospital Name Kocaeli University

Central Contacts

Sequence: 12012290 Sequence: 12012291
Contact Type primary Contact Type backup
Name Ipek Y duzyol, doctor Name emine yurt, doctor
Phone +905067922217 Phone +905054782609
Email ipekyd@hotmail.com Email dremine@gmail.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68168115 Sequence: 68168116
Design Group Id 55609067 Design Group Id 55609068
Intervention Id 52499380 Intervention Id 52499381

Eligibilities

Sequence: 30773549
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

over 18 years old;
Patients undergoing elective open heart surgery (cardiopulmonarybiasis, aortic and mitral valve replacement);
ASA III ;
Patients with informed consent for the study.

Exclusion Criteria:

Patients who refuse to participate in the study;
Patients under emergency conditions.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253952598
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 13
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30519680
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Double
Subject Masked True
Investigator Masked True

Responsible Parties

Sequence: 28885981
Responsible Party Type Principal Investigator
Name Ipek Yakin Duzyol
Title specialist doctor
Affiliation Kocaeli Derince Education and Research Hospital

]]>

<![CDATA[ Zoomers for the Capital Region: A Peer-Led Exercise Program for Aging Adults ]]>
https://zephyrnet.com/NCT03799952
2019-02-07

https://zephyrnet.com/?p=NCT03799952
NCT03799952https://www.clinicaltrials.gov/study/NCT03799952?tab=tableNANANAThe objective of this study is to recruit a group of older adults and study a broad set of physical health, mental health, and social outcomes when participants exercise with an older adult, peer-led exercise program.

The program to be evaluated is called Zoomers on the Go. It is a 12-week program which involves two 60-minute sessions per week and educates participants about falls, along with aerobic and resistance exercise, flexibility, and balance activities. The program is offered to older adults (age 50+) and it is delivered in their community by an older adult who is trained as a certified Zoomers group exercise leader.

Participants will be recruited, then randomized so that half of them can participate in a Zoomers class in the spring (intervention group) while half will have to wait until the fall of 2019 (control group). Pre-testing for both groups will begin around March 2019. The intervention group will participate in the program for 12 weeks, then there will be post-testing following this 12-weeks for both groups. Outcomes will be compared for the intervention and control groups, to determine if there are changes in the data pre- to post-measurements that are evident solely for the intervention group.
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Studies

Study First Submitted Date 2018-12-20
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-07-14
Start Month Year February 7, 2019
Primary Completion Month Year November 28, 2019
Verification Month Year July 2021
Verification Date 2021-07-31
Last Update Posted Date 2021-07-14
Results First Posted Date 2021-07-14

Detailed Descriptions

Sequence: 20713083
Description This study is a randomized control trial where subjects will be randomly assigned to a control or an intervention group. Participants will be recruited through general advertisements (e.g. radio, newspaper, posters), in Fredericton and surrounding areas. These participants will be volunteers, and no compensation will be provided besides having access to a free exercise program in their community. Eligibility will be determined by the research staff prior to the baseline assessment day.Eligible participants will be evaluated at an initial day of testing at either a Horizon CommunityHealth Centre or at the University of New Brunswick in the Cardiometabolic Exercise and Lifestyle Laboratory (CELLab). This first visit will involve the confirmation of eligibility, reading and signing a consent form, and the administration of the measurements discussed previously. All research staff will have received the appropriate training to deliver these fitness assessments, finger pricks, and interviews.

At the end of the baseline visit, research staff will randomly assign participants to the intervention or control group. The participant will wear a pedometer for seven consecutive days following this initial visit. The paper form for any information collected (e.g. consent form) will be stored in the CELLab at UNB in a locked cabinet. The CELLab has limited access; only staff has access through a password to the lab. All information will be linked to a participant number for which the only linkable personal information (e.g., name, age, sex) will be kept in a password protected computer and only the Principal Investigator, Co-Investigators, and Research Coordinator will have access to this information. Information will be stored for a maximum of 7 years.

Following this baseline assessment, participants in the intervention group will be assigned to an exercise program most convenient to them. This is a 12-week exercise program, offered twice a week. Full attendance is not mandatory for being a participant. This is a peer-led exercise program, meaning it is instructed by a leader of similar age. This leader has received extensive Fitness New Brunswick training to deliver a program aimed to reduce the risk of falls and help older adults safely increase their physical activity levels. This 60-minute exercise program involves aerobic and resistance exercise, as well as flexibility and balance activities. The program is currently designed to help individuals meet the physical activity guidelines. Participants' numbers will be used to register attendance from the leaders.

Following this 12-week intervention or control period, participants will repeat all the baseline assessments (including questionnaires and interviews), with an exception that they will not have to wear the pedometer in the follow up visit. The primary objective will be to determine whether participants' experiences with the program were positive or negative, and specifically identifying participants' attributions of why/how the exercise intervention positively impacted their physical and/or mental health.

Facilities

Sequence: 200013871
Name Kinesiology Building
City Fredericton
State New Brunswick
Zip E3B 5A3
Country Canada

Conditions

Sequence: 52147766 Sequence: 52147767
Name Aging Name Fall
Downcase Name aging Downcase Name fall

Id Information

Sequence: 40141580
Id Source org_study_id
Id Value 2019-01Zoom

Countries

Sequence: 42550768
Name Canada
Removed False

Design Groups

Sequence: 55568470 Sequence: 55568471
Group Type Experimental Group Type No Intervention
Title Intervention Title Control
Description Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length. Description Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks.

Interventions

Sequence: 52463575
Intervention Type Behavioral
Name Zoomers on the Go Exercise Program
Description 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.

Keywords

Sequence: 79834602 Sequence: 79834603 Sequence: 79834604
Name Older adult Name Peer-led exercise program Name Risk of falling
Downcase Name older adult Downcase Name peer-led exercise program Downcase Name risk of falling

Design Outcomes

Sequence: 177297610 Sequence: 177297611 Sequence: 177297612 Sequence: 177297613 Sequence: 177297614 Sequence: 177297615 Sequence: 177297616 Sequence: 177297617 Sequence: 177297618 Sequence: 177297619 Sequence: 177297620 Sequence: 177297621 Sequence: 177297622 Sequence: 177297623 Sequence: 177297624
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Balance Measure Walking Speed Measure Flexibility Measure Strength, Arm Curl Test Measure Strength, Chair Stand Test Measure Depression, Anxiety, Stress Measure Perceived Quality of Life Measure Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy Measure Connectedness, Sense of Belonging, and Friendships Measure The Amount of Bodily Sway When Performing Tasks and Balancing. Measure Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine Measure Measured on a Portable Biomechanical Board. Measure Systolic Blood Pressure Measure Resting Heart Rate Measure Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels
Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Following the 12 week program Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (after the 12 weeks) Time Frame Pre and post (after the 12 weeks) Time Frame Pre and post (after the 12 weeks) Time Frame Pre and post (before and after the 12 week exercise program)
Description One leg stand test (seconds) Description 6-minute test (meters walked) Description Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. Description Number of bicep curls with light weight Description Chair stand test, number of chair stand in 30 seconds Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score Description All collected information via interviews with participants Description Measured by a portable biomechanical board. Can detect sway through sensors. Description Blood draw via finger prick and analyzed with a Cardiochek machine

An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine

Description An individual's centre of mass as determined by sensors on a biomechanical board. Description Blood pressure cuff (mmHg) Description Radial pulse palpation (bpm) Description An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine

Sponsors

Sequence: 48298227 Sequence: 48298228 Sequence: 48298229 Sequence: 48298230 Sequence: 48298231
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name University of New Brunswick Name New Brunswick Health Research Foundation Name Horizon Health Network Name Universite de Moncton Name Fitness New Brunswick

Design Group Interventions

Sequence: 68119628
Design Group Id 55568470
Intervention Id 52463575

Eligibilities

Sequence: 30752360
Gender All
Minimum Age 50 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

50 years of age or older
Can exercise with minimal supervision (cleared for physical activity)
Can commit to a 12-week exercise program (2 sessions/week)

Exclusion Criteria:

Under 50 years of age
Not cleared to perform physical activity

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254174930
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 9
Were Results Reported True
Months To Report Results 12
Has Us Facility False
Has Single Facility True
Minimum Age Num 50
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 5
Number Of Secondary Outcomes To Measure 2
Number Of Other Outcomes To Measure 8

Designs

Sequence: 30498628
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Single
Intervention Model Description Randomized to a control or intervention group. The intervention group will have pre- and post-testing following 12-weeks of exercise, while the control group will have pre- and post-testing following 12-weeks of "normal" activity.
Subject Masked True

Drop Withdrawals

Sequence: 28975585 Sequence: 28975586 Sequence: 28975587 Sequence: 28975588
Result Group Id 56079277 Result Group Id 56079278 Result Group Id 56079277 Result Group Id 56079278
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Reason Program was too easy, discontinued Reason Program was too easy, discontinued Reason Lost to Follow-up Reason Lost to Follow-up
Count 1 Count 0 Count 0 Count 2

Milestones

Sequence: 40992015 Sequence: 40992016 Sequence: 40992017 Sequence: 40992018 Sequence: 40992019 Sequence: 40992020
Result Group Id 56079277 Result Group Id 56079278 Result Group Id 56079277 Result Group Id 56079278 Result Group Id 56079277 Result Group Id 56079278
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 31 Count 31 Count 30 Count 29 Count 1 Count 2

Participant Flows

Sequence: 3920076
Recruitment Details Recruitment occurred between January and March 2019. Participants were recruited through radio advertisements, newspapers, posters, and social media. Per the participants availability they were allocated to the randomization or preferred arm.
Pre Assignment Details Participants were excluded if they were not cleared by the Get Active Questionnaire and did not receive clearance from their primary physician to participate

Outcome Counts

Sequence: 73972381 Sequence: 73972382 Sequence: 73972383 Sequence: 73972384 Sequence: 73972385 Sequence: 73972386 Sequence: 73972387 Sequence: 73972388 Sequence: 73972389 Sequence: 73972390 Sequence: 73972391 Sequence: 73972392 Sequence: 73972393 Sequence: 73972394 Sequence: 73972395 Sequence: 73972396 Sequence: 73972397 Sequence: 73972398 Sequence: 73972399 Sequence: 73972400
Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793036 Outcome Id 30793036 Outcome Id 30793037 Outcome Id 30793037 Outcome Id 30793038 Outcome Id 30793038 Outcome Id 30793039 Outcome Id 30793039 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793045 Outcome Id 30793045 Outcome Id 30793047 Outcome Id 30793047 Outcome Id 30793048 Outcome Id 30793048
Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 30 Count 29 Count 30 Count 29 Count 30 Count 29 Count 30 Count 29 Count 30 Count 29 Count 30 Count 29 Count 30 Count 29 Count 30 Count 29 Count 30 Count 29 Count 30 Count 29

Provided Documents

Sequence: 2577769
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2018-11-23
Url https://ClinicalTrials.gov/ProvidedDocs/52/NCT03799952/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27934075 Sequence: 27934076 Sequence: 27934077 Sequence: 27934078 Sequence: 27934079 Sequence: 27934080
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0
Subjects At Risk 30 Subjects At Risk 30 Subjects At Risk 30 Subjects At Risk 29 Subjects At Risk 29 Subjects At Risk 29
Created At 2023-08-08 21:34:49.899586 Created At 2023-08-08 21:34:49.899586 Created At 2023-08-08 21:34:49.899586 Created At 2023-08-08 21:34:49.899586 Created At 2023-08-08 21:34:49.899586 Created At 2023-08-08 21:34:49.899586
Updated At 2023-08-08 21:34:49.899586 Updated At 2023-08-08 21:34:49.899586 Updated At 2023-08-08 21:34:49.899586 Updated At 2023-08-08 21:34:49.899586 Updated At 2023-08-08 21:34:49.899586 Updated At 2023-08-08 21:34:49.899586

Responsible Parties

Sequence: 28864902
Responsible Party Type Principal Investigator
Name Danielle Bouchard
Title Associate Professor
Affiliation University of New Brunswick

Result Agreements

Sequence: 3850820
Pi Employee No

Result Contacts

Sequence: 3850785
Organization University of New Brunswick
Name Dr. Danielle Bouchard
Phone 1 (506) 443-3908
Email danielle.bouchard@unb.ca

Outcomes

Sequence: 30793035 Sequence: 30793036 Sequence: 30793037 Sequence: 30793038 Sequence: 30793039 Sequence: 30793040 Sequence: 30793041 Sequence: 30793042 Sequence: 30793043 Sequence: 30793044 Sequence: 30793045 Sequence: 30793046 Sequence: 30793047 Sequence: 30793048 Sequence: 30793049
Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Other Pre-specified Outcome Type Other Pre-specified Outcome Type Other Pre-specified Outcome Type Other Pre-specified Outcome Type Other Pre-specified Outcome Type Other Pre-specified Outcome Type Other Pre-specified Outcome Type Other Pre-specified
Title Balance Title Walking Speed Title Flexibility Title Strength, Arm Curl Test Title Strength, Chair Stand Test Title Depression, Anxiety, Stress Title Perceived Quality of Life Title Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy Title Connectedness, Sense of Belonging, and Friendships Title The Amount of Bodily Sway When Performing Tasks and Balancing. Title Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine Title Measured on a Portable Biomechanical Board. Title Systolic Blood Pressure Title Resting Heart Rate Title Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels
Description One leg stand test (seconds) Description 6-minute test (meters walked) Description Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. Description Number of bicep curls with light weight Description Chair stand test, number of chair stand in 30 seconds Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score Description All collected information via interviews with participants Description Measured by a portable biomechanical board. Can detect sway through sensors. Description Blood draw via finger prick and analyzed with a Cardiochek machine

An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine

Description An individual's centre of mass as determined by sensors on a biomechanical board. Description Blood pressure cuff (mmHg) Description Radial pulse palpation (bpm) Description An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine
Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Change pre and post (after the 12 weeks) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Following the 12 week program Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (before and after the 12 week exercise program) Time Frame Pre and post (after the 12 weeks) Time Frame Pre and post (after the 12 weeks) Time Frame Pre and post (after the 12 weeks) Time Frame Pre and post (before and after the 12 week exercise program)
Units score on a scale Units meters Units centimeters Units reps/30 seconds Units reps/30 seconds Units score on a scale Units score on a scale Units mmol/L Units mmHg Units beats per minute
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean

Outcome Measurements

Sequence: 235564785 Sequence: 235564786 Sequence: 235564787 Sequence: 235564766 Sequence: 235564767 Sequence: 235564768 Sequence: 235564769 Sequence: 235564770 Sequence: 235564771 Sequence: 235564772 Sequence: 235564773 Sequence: 235564774 Sequence: 235564775 Sequence: 235564776 Sequence: 235564777 Sequence: 235564778 Sequence: 235564779 Sequence: 235564780 Sequence: 235564781 Sequence: 235564782 Sequence: 235564783 Sequence: 235564784 Sequence: 235564788 Sequence: 235564789 Sequence: 235564790 Sequence: 235564791 Sequence: 235564792 Sequence: 235564793 Sequence: 235564794 Sequence: 235564795 Sequence: 235564796 Sequence: 235564797 Sequence: 235564798 Sequence: 235564799 Sequence: 235564800 Sequence: 235564801 Sequence: 235564802 Sequence: 235564803 Sequence: 235564804 Sequence: 235564805 Sequence: 235564806 Sequence: 235564807 Sequence: 235564808 Sequence: 235564809 Sequence: 235564810 Sequence: 235564811 Sequence: 235564812 Sequence: 235564813 Sequence: 235564814 Sequence: 235564815 Sequence: 235564816 Sequence: 235564817 Sequence: 235564818 Sequence: 235564819 Sequence: 235564820 Sequence: 235564821 Sequence: 235564822 Sequence: 235564823 Sequence: 235564824 Sequence: 235564825 Sequence: 235564826 Sequence: 235564827 Sequence: 235564828 Sequence: 235564829 Sequence: 235564830 Sequence: 235564831 Sequence: 235564832 Sequence: 235564833 Sequence: 235564834 Sequence: 235564835 Sequence: 235564836 Sequence: 235564837 Sequence: 235564838 Sequence: 235564839 Sequence: 235564840 Sequence: 235564841 Sequence: 235564842 Sequence: 235564843 Sequence: 235564844 Sequence: 235564845
Outcome Id 30793038 Outcome Id 30793039 Outcome Id 30793039 Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793035 Outcome Id 30793036 Outcome Id 30793036 Outcome Id 30793036 Outcome Id 30793036 Outcome Id 30793037 Outcome Id 30793037 Outcome Id 30793037 Outcome Id 30793037 Outcome Id 30793038 Outcome Id 30793038 Outcome Id 30793038 Outcome Id 30793039 Outcome Id 30793039 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793040 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793041 Outcome Id 30793045 Outcome Id 30793045 Outcome Id 30793045 Outcome Id 30793045 Outcome Id 30793047 Outcome Id 30793047 Outcome Id 30793047 Outcome Id 30793047 Outcome Id 30793048 Outcome Id 30793048 Outcome Id 30793048 Outcome Id 30793048
Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280 Result Group Id 56079279 Result Group Id 56079280
Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Classification Post Classification Pre Classification Pre Classification Pre (eyes open) Classification Pre (eyes open) Classification Post (eyes open) Classification Post (eyes open) Classification Pre (eyes closed) Classification Pre (eyes closed) Classification Post (eyes closed) Classification Post (eyes closed) Classification Pre Classification Pre Classification Post Classification Post Classification Pre Classification Pre Classification Post Classification Post Classification Pre Classification Pre Classification Post Classification Post Classification Post Classification Pre Stress (0-28) Classification Pre Stress (0-28) Classification Post Stress (0-28) Classification Post Stress (0-28) Classification Pre Anxiety (0-20) Classification Pre Anxiety (0-20) Classification Post Anxiety (0-20) Classification Post Anxiety (0-20) Classification Pre Depression (0-34) Classification Pre Depression (0-34) Classification Post Depression (0-34) Classification Post Depression (0-34) Classification Pre Physical Functioning Classification Pre Physical Functioning Classification Post Physical Functioning Classification Post Physical Functioning Classification Pre Limitations due to Physical Health Classification Pre Limitations due to Physical Health Classification Post Limitations due to Physical Health Classification Post Limitations due to Physical Health Classification Pre Pain Classification Pre Pain Classification Post Pain Classification Post Pain Classification Pre General Health Classification Pre General Health Classification Post General Health Classification Post General Health Classification Pre Energy/Fatigue Classification Pre Energy/Fatigue Classification Post Energy/Fatigue Classification Post Energy/Fatigue Classification Pre Social Functioning Classification Pre Social Functioning Classification Post Social Functioning Classification Post Social Functioning Classification Pre Limitations Emotional Problems Classification Pre Limitations Emotional Problems Classification Post Limitations Emotional Problems Classification Post Limitations Emotional Problems Classification Pre Emotional Well-Being Classification Pre Emotional Well-Being Classification Post Emotional Well-Being Classification Post Emotional Well-Being Classification Pre Classification Pre Classification Post Classification Post Classification Pre Classification Pre Classification Post Classification Post Classification Pre Classification Pre Classification Post Classification Post
Title Strength, Arm Curl Test Title Strength, Chair Stand Test Title Strength, Chair Stand Test Title Balance Title Balance Title Balance Title Balance Title Balance Title Balance Title Balance Title Balance Title Walking Speed Title Walking Speed Title Walking Speed Title Walking Speed Title Flexibility Title Flexibility Title Flexibility Title Flexibility Title Strength, Arm Curl Test Title Strength, Arm Curl Test Title Strength, Arm Curl Test Title Strength, Chair Stand Test Title Strength, Chair Stand Test Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Depression, Anxiety, Stress Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Perceived Quality of Life Title Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine Title Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine Title Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine Title Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine Title Systolic Blood Pressure Title Systolic Blood Pressure Title Systolic Blood Pressure Title Systolic Blood Pressure Title Resting Heart Rate Title Resting Heart Rate Title Resting Heart Rate Title Resting Heart Rate
Description Number of bicep curls with light weight Description Chair stand test, number of chair stand in 30 seconds Description Chair stand test, number of chair stand in 30 seconds Description One leg stand test (seconds) Description One leg stand test (seconds) Description One leg stand test (seconds) Description One leg stand test (seconds) Description One leg stand test (seconds) Description One leg stand test (seconds) Description One leg stand test (seconds) Description One leg stand test (seconds) Description 6-minute test (meters walked) Description 6-minute test (meters walked) Description 6-minute test (meters walked) Description 6-minute test (meters walked) Description Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. Description Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. Description Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. Description Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. Description Number of bicep curls with light weight Description Number of bicep curls with light weight Description Number of bicep curls with light weight Description Chair stand test, number of chair stand in 30 seconds Description Chair stand test, number of chair stand in 30 seconds Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). Description Blood draw via finger prick and analyzed with a Cardiochek machine

An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine

Description Blood draw via finger prick and analyzed with a Cardiochek machine

An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine

Description Blood draw via finger prick and analyzed with a Cardiochek machine

An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine

Description Blood draw via finger prick and analyzed with a Cardiochek machine

An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine

Description Blood pressure cuff (mmHg) Description Blood pressure cuff (mmHg) Description Blood pressure cuff (mmHg) Description Blood pressure cuff (mmHg) Description Radial pulse palpation (bpm) Description Radial pulse palpation (bpm) Description Radial pulse palpation (bpm) Description Radial pulse palpation (bpm)
Units reps/30 seconds Units reps/30 seconds Units reps/30 seconds Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units meters Units meters Units meters Units meters Units centimeters Units centimeters Units centimeters Units centimeters Units reps/30 seconds Units reps/30 seconds Units reps/30 seconds Units reps/30 seconds Units reps/30 seconds Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units mmol/L Units mmol/L Units mmol/L Units mmol/L Units mmHg Units mmHg Units mmHg Units mmHg Units beats per minute Units beats per minute Units beats per minute Units beats per minute
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 17.4 Param Value 14.1 Param Value 13.6 Param Value 26.7 Param Value 27.9 Param Value 34.7 Param Value 29.7 Param Value 5.0 Param Value 4.9 Param Value 5.3 Param Value 4.4 Param Value 476 Param Value 507 Param Value 539 Param Value 504 Param Value -7.5 Param Value -5.2 Param Value -5.7 Param Value -4.7 Param Value 20.1 Param Value 17.3 Param Value 23.9 Param Value 17.9 Param Value 14.1 Param Value 6.0 Param Value 5.7 Param Value 4.1 Param Value 8.2 Param Value 3.5 Param Value 2.6 Param Value 3.2 Param Value 5.0 Param Value 4.8 Param Value 3.2 Param Value 3.2 Param Value 5.5 Param Value 78.0 Param Value 80.9 Param Value 81.2 Param Value 80.4 Param Value 78.3 Param Value 81.7 Param Value 90.8 Param Value 79.0 Param Value 73.5 Param Value 79.1 Param Value 71.9 Param Value 71.0 Param Value 71.2 Param Value 72.4 Param Value 75.5 Param Value 69.8 Param Value 63.5 Param Value 67.4 Param Value 68.7 Param Value 65.4 Param Value 90.2 Param Value 88.9 Param Value 92.1 Param Value 86.4 Param Value 84.6 Param Value 78.8 Param Value 88.9 Param Value 84.0 Param Value 80.4 Param Value 82.5 Param Value 84.7 Param Value 78.7 Param Value 5.34 Param Value 5.61 Param Value 4.70 Param Value 5.11 Param Value 123.8 Param Value 127.5 Param Value 125.7 Param Value 124.5 Param Value 68.1 Param Value 70.5 Param Value 63.0 Param Value 67.2
Param Value Num 17.4 Param Value Num 14.1 Param Value Num 13.6 Param Value Num 26.7 Param Value Num 27.9 Param Value Num 34.7 Param Value Num 29.7 Param Value Num 5.0 Param Value Num 4.9 Param Value Num 5.3 Param Value Num 4.4 Param Value Num 476.0 Param Value Num 507.0 Param Value Num 539.0 Param Value Num 504.0 Param Value Num -7.5 Param Value Num -5.2 Param Value Num -5.7 Param Value Num -4.7 Param Value Num 20.1 Param Value Num 17.3 Param Value Num 23.9 Param Value Num 17.9 Param Value Num 14.1 Param Value Num 6.0 Param Value Num 5.7 Param Value Num 4.1 Param Value Num 8.2 Param Value Num 3.5 Param Value Num 2.6 Param Value Num 3.2 Param Value Num 5.0 Param Value Num 4.8 Param Value Num 3.2 Param Value Num 3.2 Param Value Num 5.5 Param Value Num 78.0 Param Value Num 80.9 Param Value Num 81.2 Param Value Num 80.4 Param Value Num 78.3 Param Value Num 81.7 Param Value Num 90.8 Param Value Num 79.0 Param Value Num 73.5 Param Value Num 79.1 Param Value Num 71.9 Param Value Num 71.0 Param Value Num 71.2 Param Value Num 72.4 Param Value Num 75.5 Param Value Num 69.8 Param Value Num 63.5 Param Value Num 67.4 Param Value Num 68.7 Param Value Num 65.4 Param Value Num 90.2 Param Value Num 88.9 Param Value Num 92.1 Param Value Num 86.4 Param Value Num 84.6 Param Value Num 78.8 Param Value Num 88.9 Param Value Num 84.0 Param Value Num 80.4 Param Value Num 82.5 Param Value Num 84.7 Param Value Num 78.7 Param Value Num 5.34 Param Value Num 5.61 Param Value Num 4.7 Param Value Num 5.11 Param Value Num 123.8 Param Value Num 127.5 Param Value Num 125.7 Param Value Num 124.5 Param Value Num 68.1 Param Value Num 70.5 Param Value Num 63.0 Param Value Num 67.2
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 3.5 Dispersion Value 2.6 Dispersion Value 2.7 Dispersion Value 14.4 Dispersion Value 16.4 Dispersion Value 13.4 Dispersion Value 15.6 Dispersion Value 3.4 Dispersion Value 3.2 Dispersion Value 3.5 Dispersion Value 2.9 Dispersion Value 94.3 Dispersion Value 90.3 Dispersion Value 82.5 Dispersion Value 79.7 Dispersion Value 9.9 Dispersion Value 9.7 Dispersion Value 9.9 Dispersion Value 9.9 Dispersion Value 5.1 Dispersion Value 4.1 Dispersion Value 4.9 Dispersion Value 4.4 Dispersion Value 3.5 Dispersion Value 5.6 Dispersion Value 6.2 Dispersion Value 3.9 Dispersion Value 7.7 Dispersion Value 3.8 Dispersion Value 4.7 Dispersion Value 3.3 Dispersion Value 7.5 Dispersion Value 6.3 Dispersion Value 3.8 Dispersion Value 5.6 Dispersion Value 9.1 Dispersion Value 21.2 Dispersion Value 20.1 Dispersion Value 20.2 Dispersion Value 18.8 Dispersion Value 33.9 Dispersion Value 28.8 Dispersion Value 24.1 Dispersion Value 32.8 Dispersion Value 22.3 Dispersion Value 17.6 Dispersion Value 20.8 Dispersion Value 23.0 Dispersion Value 19.1 Dispersion Value 11.8 Dispersion Value 15.6 Dispersion Value 16.4 Dispersion Value 19.1 Dispersion Value 18.0 Dispersion Value 16.3 Dispersion Value 17.6 Dispersion Value 14.9 Dispersion Value 16.3 Dispersion Value 13.7 Dispersion Value 19.1 Dispersion Value 28.3 Dispersion Value 33.8 Dispersion Value 25.3 Dispersion Value 32.1 Dispersion Value 13.5 Dispersion Value 12.4 Dispersion Value 10.2 Dispersion Value 13.2 Dispersion Value 0.69 Dispersion Value 1.05 Dispersion Value 0.52 Dispersion Value 0.65 Dispersion Value 12.6 Dispersion Value 11.1 Dispersion Value 14.9 Dispersion Value 9.5 Dispersion Value 9.4 Dispersion Value 6.7 Dispersion Value 7.0 Dispersion Value 7.6
Dispersion Value Num 3.5 Dispersion Value Num 2.6 Dispersion Value Num 2.7 Dispersion Value Num 14.4 Dispersion Value Num 16.4 Dispersion Value Num 13.4 Dispersion Value Num 15.6 Dispersion Value Num 3.4 Dispersion Value Num 3.2 Dispersion Value Num 3.5 Dispersion Value Num 2.9 Dispersion Value Num 94.3 Dispersion Value Num 90.3 Dispersion Value Num 82.5 Dispersion Value Num 79.7 Dispersion Value Num 9.9 Dispersion Value Num 9.7 Dispersion Value Num 9.9 Dispersion Value Num 9.9 Dispersion Value Num 5.1 Dispersion Value Num 4.1 Dispersion Value Num 4.9 Dispersion Value Num 4.4 Dispersion Value Num 3.5 Dispersion Value Num 5.6 Dispersion Value Num 6.2 Dispersion Value Num 3.9 Dispersion Value Num 7.7 Dispersion Value Num 3.8 Dispersion Value Num 4.7 Dispersion Value Num 3.3 Dispersion Value Num 7.5 Dispersion Value Num 6.3 Dispersion Value Num 3.8 Dispersion Value Num 5.6 Dispersion Value Num 9.1 Dispersion Value Num 21.2 Dispersion Value Num 20.1 Dispersion Value Num 20.2 Dispersion Value Num 18.8 Dispersion Value Num 33.9 Dispersion Value Num 28.8 Dispersion Value Num 24.1 Dispersion Value Num 32.8 Dispersion Value Num 22.3 Dispersion Value Num 17.6 Dispersion Value Num 20.8 Dispersion Value Num 23.0 Dispersion Value Num 19.1 Dispersion Value Num 11.8 Dispersion Value Num 15.6 Dispersion Value Num 16.4 Dispersion Value Num 19.1 Dispersion Value Num 18.0 Dispersion Value Num 16.3 Dispersion Value Num 17.6 Dispersion Value Num 14.9 Dispersion Value Num 16.3 Dispersion Value Num 13.7 Dispersion Value Num 19.1 Dispersion Value Num 28.3 Dispersion Value Num 33.8 Dispersion Value Num 25.3 Dispersion Value Num 32.1 Dispersion Value Num 13.5 Dispersion Value Num 12.4 Dispersion Value Num 10.2 Dispersion Value Num 13.2 Dispersion Value Num 0.69 Dispersion Value Num 1.05 Dispersion Value Num 0.52 Dispersion Value Num 0.65 Dispersion Value Num 12.6 Dispersion Value Num 11.1 Dispersion Value Num 14.9 Dispersion Value Num 9.5 Dispersion Value Num 9.4 Dispersion Value Num 6.7 Dispersion Value Num 7.0 Dispersion Value Num 7.6

Study References

Sequence: 52040799
Pmid 33573594
Reference Type derived
Citation Bouchard DR, Olthuis JV, Bouffard-Levasseur V, Shannon C, McDonald T, Senechal M. Peer-led exercise program for ageing adults to improve physical functions – a randomized trial. Eur Rev Aging Phys Act. 2021 Feb 11;18(1):2. doi: 10.1186/s11556-021-00257-x.

Baseline Counts

Sequence: 11379728 Sequence: 11379729 Sequence: 11379730
Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 30 Count 29 Count 59

Result Groups

Sequence: 56079274 Sequence: 56079275 Sequence: 56079276 Sequence: 56079277 Sequence: 56079278 Sequence: 56079279 Sequence: 56079280 Sequence: 56079281 Sequence: 56079282
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title Intervention Title Control Title Total Title Intervention Title Control Title Intervention Title Control Title Intervention Title Control
Description Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.

Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.

Description Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. Description Total of all reporting groups Description Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.

Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.

Description Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. Description Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.

Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.

Description Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. Description Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.

Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.

Description Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks.

Baseline Measurements

Sequence: 125539998 Sequence: 125539999 Sequence: 125539989 Sequence: 125539990 Sequence: 125539991 Sequence: 125539992 Sequence: 125539993 Sequence: 125539994 Sequence: 125539995 Sequence: 125539996 Sequence: 125539997 Sequence: 125540000 Sequence: 125540001 Sequence: 125540002 Sequence: 125540003 Sequence: 125540004 Sequence: 125540005 Sequence: 125540006 Sequence: 125540007 Sequence: 125540008 Sequence: 125540009 Sequence: 125540010 Sequence: 125540011 Sequence: 125540012 Sequence: 125540013 Sequence: 125540014 Sequence: 125540015 Sequence: 125540016 Sequence: 125540017 Sequence: 125540018 Sequence: 125540019 Sequence: 125540020 Sequence: 125540021
Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276 Result Group Id 56079274 Result Group Id 56079275 Result Group Id 56079276
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Classification Canada Classification Canada Classification Canada
Category Female Category Female Category Female Category Male Category Male Category Male
Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Age, Continuous Title Age, Continuous Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Race/Ethnicity, Customized Title Region of Enrollment Title Region of Enrollment Title Region of Enrollment Title Body Mass Index (BMI) Title Body Mass Index (BMI) Title Body Mass Index (BMI) Title Occupation (Retired) Title Occupation (Retired) Title Occupation (Retired) Title Marital Status (Married) Title Marital Status (Married) Title Marital Status (Married) Title Household Income (>$100,000/year) Title Household Income (>$100,000/year) Title Household Income (>$100,000/year) Title Physical Activity Level (Steps/day) Title Physical Activity Level (Steps/day) Title Physical Activity Level (Steps/day) Title Physical Activity Level (MVPA/week) Title Physical Activity Level (MVPA/week) Title Physical Activity Level (MVPA/week)
Description Race/Ethnicity not collected Description Race/Ethnicity not collected Description Race/Ethnicity not collected
Units Participants Units Participants Units years Units years Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units participants Units participants Units kg/m^2 Units kg/m^2 Units kg/m^2 Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Steps/day Units Steps/day Units Steps/day Units Minutes of MVPA per week Units Minutes of MVPA per week Units Minutes of MVPA per week
Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number Param Type Number Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 0 Param Value 0 Param Value 66.6 Param Value 66.1 Param Value 66.4 Param Value 28 Param Value 23 Param Value 51 Param Value 2 Param Value 6 Param Value 8 Param Value 0 Param Value 30 Param Value 29 Param Value 59 Param Value 28.9 Param Value 25.8 Param Value 27.4 Param Value 19 Param Value 14 Param Value 33 Param Value 14 Param Value 20 Param Value 34 Param Value 6.0 Param Value 6.0 Param Value 12 Param Value 6349 Param Value 7221 Param Value 6762 Param Value 68 Param Value 48 Param Value 58
Param Value Num 0.0 Param Value Num 0.0 Param Value Num 66.6 Param Value Num 66.1 Param Value Num 66.4 Param Value Num 28.0 Param Value Num 23.0 Param Value Num 51.0 Param Value Num 2.0 Param Value Num 6.0 Param Value Num 8.0 Param Value Num 0.0 Param Value Num 30.0 Param Value Num 29.0 Param Value Num 59.0 Param Value Num 28.9 Param Value Num 25.8 Param Value Num 27.4 Param Value Num 19.0 Param Value Num 14.0 Param Value Num 33.0 Param Value Num 14.0 Param Value Num 20.0 Param Value Num 34.0 Param Value Num 6.0 Param Value Num 6.0 Param Value Num 12.0 Param Value Num 6349.0 Param Value Num 7221.0 Param Value Num 6762.0 Param Value Num 68.0 Param Value Num 48.0 Param Value Num 58.0
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 7.2 Dispersion Value 7.0 Dispersion Value 7.2 Dispersion Value 4.5 Dispersion Value 4.8 Dispersion Value 4.9 Dispersion Value 2903 Dispersion Value 2964 Dispersion Value 2939 Dispersion Value 68 Dispersion Value 81 Dispersion Value 74
Dispersion Value Num 7.2 Dispersion Value Num 7.0 Dispersion Value Num 7.2 Dispersion Value Num 4.5 Dispersion Value Num 4.8 Dispersion Value Num 4.9 Dispersion Value Num 2903.0 Dispersion Value Num 2964.0 Dispersion Value Num 2939.0 Dispersion Value Num 68.0 Dispersion Value Num 81.0 Dispersion Value Num 74.0
Number Analyzed 30 Number Analyzed 29 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59 Number Analyzed 30 Number Analyzed 29 Number Analyzed 59
Population Description Not collected Population Description Not collected Population Description Not collected
Calculate Percentage No Calculate Percentage No Calculate Percentage No

]]>

<![CDATA[ Chimney Trial of Parastomal Hernia Prevention ]]>
https://zephyrnet.com/NCT03799939
2019-02-05

https://zephyrnet.com/?p=NCT03799939
NCT03799939https://www.clinicaltrials.gov/study/NCT03799939?tab=tableNANANAChimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
<![CDATA[

Studies

Study First Submitted Date 2019-01-06
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-08-17
Start Month Year February 5, 2019
Primary Completion Month Year July 2022
Verification Month Year August 2021
Verification Date 2021-08-31
Last Update Posted Date 2021-08-17

Detailed Descriptions

Sequence: 20735867
Description The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.

Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.

Facilities

Sequence: 200244762 Sequence: 200244763 Sequence: 200244764 Sequence: 200244765 Sequence: 200244766 Sequence: 200244767 Sequence: 200244768
Name Helsinki University Hospital Name Keski-Suomi Central Hospital Name Oulu University Hospital Name Seinäjoki Central Hospital Name Tampere University Hospital Name Turku University Hospital Name Maziar Nikberg
City Helsinki City Jyväskylä City Oulu City Seinäjoki City Tampere City Turku City Västerås
Country Finland Country Finland Country Finland Country Finland Country Finland Country Finland Country Sweden

Conditions

Sequence: 52208319 Sequence: 52208320 Sequence: 52208321
Name Parastomal Hernia Name Rectal Adenocarcinoma Name Abdominoperineal Resection
Downcase Name parastomal hernia Downcase Name rectal adenocarcinoma Downcase Name abdominoperineal resection

Id Information

Sequence: 40186303
Id Source org_study_id
Id Value 305/2018

Countries

Sequence: 42599797 Sequence: 42599798
Name Finland Name Sweden
Removed False Removed False

Design Groups

Sequence: 55634925 Sequence: 55634926
Group Type Active Comparator Group Type No Intervention
Title Intervention group Title Control group
Description Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia. Description Participants in control group are operated with no preventive mesh.

Interventions

Sequence: 52522285
Intervention Type Device
Name Intervention group
Description Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.

Design Outcomes

Sequence: 177512082 Sequence: 177512083 Sequence: 177512084 Sequence: 177512085 Sequence: 177512086 Sequence: 177512087 Sequence: 177512088 Sequence: 177512089 Sequence: 177512090 Sequence: 177512091 Sequence: 177512092 Sequence: 177512093 Sequence: 177512094
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Incidence of parastomal hernia Measure Incidence of parastomal hernia at long term follow up Measure Surgical site infection rate Measure Complications Measure Stoma related complications Measure Reoperation rate Measure Operative time Measure Length of stay Measure Rand 36 quality of life Measure Quality of life measured by Colostomy impact score Measure Medico-economic substudy Measure Radiological substudy of stoma distance Measure Radiological substudy of adipose tissue thickness
Time Frame 12 months Time Frame 5 years Time Frame 30 days Time Frame 30 days Time Frame 5 years Time Frame 5 years Time Frame 1 day Time Frame 30 days Time Frame 5 years Time Frame 5 years Time Frame 5 years Time Frame 3 years Time Frame 3 years
Description Incidence of parastomal hernia at 12 months follow up Description Incidence of parastomal hernia during 5 years of follow up Description Surgical site infections measured by Clavien-Dindo Classification Description Complications measured by Clavien-Dindo Classification Description Stoma related complications measured by Clavien-Dindo Classification Description Need for reoperations Description Operative time Description Length of stay at the hospital Description Quality of life measured by Rand-36 quality of life questionnaire Description Quality of life measured by Colostomy impact score Description Medico-economic substudy including both short and long term costs included in both groups Description Distance of stoma from midline defined by umbilicus Description Thickness of adipose tissue on computer tomography scan on contralateral site of stoma

Browse Conditions

Sequence: 193627771 Sequence: 193627770
Mesh Term Pathological Conditions, Anatomical Mesh Term Hernia
Downcase Mesh Term pathological conditions, anatomical Downcase Mesh Term hernia
Mesh Type mesh-ancestor Mesh Type mesh-list

Sponsors

Sequence: 48353890
Agency Class OTHER
Lead Or Collaborator lead
Name University of Oulu

Overall Officials

Sequence: 29306099
Role Principal Investigator
Name Elisa Mäkäräinen-Uhlbäck, M.D.
Affiliation Oulu University Hospital

Design Group Interventions

Sequence: 68199471
Design Group Id 55634925
Intervention Id 52522285

Eligibilities

Sequence: 30787000
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

18 years or older
Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
Patient has a life expectancy of at least 12 months.
Patient must sign Informed consent before any study procedures and agrees to attend all study visits

Exclusion Criteria:

Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
Complication requiring laparotomy during post surgery treatment at surgical ward after APR
Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4-5).
Patients with concurrent or previous malignant tumors within 5 years before study enrollment
Patients with T4b tumors which impose a multi-organ resection
Rectal malignancy other than adenocarcinoma
Patient undergoing emergency procedures
Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
Metastatic disease with no possibility of curative surgery
Pregnant or suspected pregnancy
Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
Active abdominal infection at the time of surgery
Previous surgery at the colostomy site
Language barrier or other reasons why informed consent is not possible

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253989876
Number Of Facilities 7
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 12

Designs

Sequence: 30533070
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Single
Masking Description Participants are unaware of the randomization group.
Intervention Model Description Chimney trial is a prospective randomized controlled multicenter trial.
Subject Masked True

Responsible Parties

Sequence: 28899364
Responsible Party Type Principal Investigator
Name Elisa Makarainen-Uhlback
Title Principal Investigator
Affiliation University of Oulu

Study References

Sequence: 52103276
Pmid 31779699
Reference Type derived
Citation Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):652. doi: 10.1186/s13063-019-3764-y.

]]>

<![CDATA[ Exploratory Study of ZG-801 for the Treatment of Hyperkalemia ]]>
https://zephyrnet.com/NCT03799926
2019-02-18

https://zephyrnet.com/?p=NCT03799926
NCT03799926https://www.clinicaltrials.gov/study/NCT03799926?tab=tableNANANATo investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.

To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-03-25
Start Month Year February 18, 2019
Primary Completion Month Year November 6, 2019
Verification Month Year March 2021
Verification Date 2021-03-31
Last Update Posted Date 2021-03-25

Facilities

Sequence: 200108504
Name Zeria Investigative Sites
City Kanagawa
Country Japan

Conditions

Sequence: 52171317
Name Hyperkalemia
Downcase Name hyperkalemia

Id Information

Sequence: 40158677
Id Source org_study_id
Id Value ZG-801-01

Countries

Sequence: 42568976
Name Japan
Removed False

Design Groups

Sequence: 55593234 Sequence: 55593235 Sequence: 55593236 Sequence: 55593237 Sequence: 55593238 Sequence: 55593239 Sequence: 55593240 Sequence: 55593241
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title Stratum 1: 8.4 g patiromer Title Stratum 1: 16.8 g patiromer Title Stratum 1: placebo of 8.4 g patiromer Title Stratum 1: placebo of 16.8 g patiromer Title Stratum 2: 8.4 g patiromer Title Stratum 2: 16.8 g patiromer Title Stratum 3: 8.4 g patiromer Title Stratum 3: 16.8 g patiromer
Description Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Description Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Description Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Description Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Description Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline Description Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline Description Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline Description Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline

Interventions

Sequence: 52485544 Sequence: 52485545 Sequence: 52485546 Sequence: 52485547 Sequence: 52485548 Sequence: 52485549 Sequence: 52485550 Sequence: 52485551
Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name patiromer Name patiromer Name placebo Name placebo Name patiromer Name patiromer Name patiromer Name patiromer
Description Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) Description Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) Description Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) Description Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) Description Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) Description Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) Description Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3) Description Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)

Design Outcomes

Sequence: 177379077 Sequence: 177379078 Sequence: 177379079 Sequence: 177379080 Sequence: 177379081
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose Measure Change in serum potassium 4 weeks after the start of administration in each group of starting dose Measure Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose Measure Incidence of adverse events Measure Incidence of adverse drug reactions
Time Frame Baseline to week 1 Time Frame Baseline to week 4 Time Frame Week 4 Time Frame Over 52-week study period Time Frame Over 52-week study period

Browse Conditions

Sequence: 193486993 Sequence: 193486994 Sequence: 193486995
Mesh Term Hyperkalemia Mesh Term Water-Electrolyte Imbalance Mesh Term Metabolic Diseases
Downcase Mesh Term hyperkalemia Downcase Mesh Term water-electrolyte imbalance Downcase Mesh Term metabolic diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319342
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Zeria Pharmaceutical

Design Group Interventions

Sequence: 68149209 Sequence: 68149210 Sequence: 68149211 Sequence: 68149212 Sequence: 68149213 Sequence: 68149214 Sequence: 68149215 Sequence: 68149216
Design Group Id 55593234 Design Group Id 55593235 Design Group Id 55593236 Design Group Id 55593237 Design Group Id 55593238 Design Group Id 55593239 Design Group Id 55593240 Design Group Id 55593241
Intervention Id 52485544 Intervention Id 52485545 Intervention Id 52485546 Intervention Id 52485547 Intervention Id 52485548 Intervention Id 52485549 Intervention Id 52485550 Intervention Id 52485551

Eligibilities

Sequence: 30765388
Gender All
Minimum Age 20 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Males and females ages 18 – 80
Informed consent given
Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients)

Exclusion Criteria:

Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253885881
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 8
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 20
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30511554
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28877849
Responsible Party Type Sponsor

]]>

<![CDATA[ MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer ]]>
https://zephyrnet.com/NCT03799913
2019-04-10

https://zephyrnet.com/?p=NCT03799913
NCT03799913https://www.clinicaltrials.gov/study/NCT03799913?tab=tableZhigang Zhang, M.D.zzg2011@zju.edu.cn86+057189713631The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-04-10
Start Month Year April 10, 2019
Primary Completion Month Year October 2021
Verification Month Year April 2019
Verification Date 2019-04-30
Last Update Posted Date 2019-04-10

Detailed Descriptions

Sequence: 20741242
Description Primary Objectives

1.To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.

Secondary Objectives

To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.
To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.

Facilities

Sequence: 200280791
Status Recruiting
Name The Second Affiliated hospital of Zhejiang University School of Medicine
City Hangzhou
State Zhejiang
Zip 310009
Country China

Facility Contacts

Sequence: 28132913
Facility Id 200280791
Contact Type primary
Name Jianwei Zhou, M.D.
Email jianwei-zhou@163.com
Phone 0571-89713634

Browse Interventions

Sequence: 96133392 Sequence: 96133393 Sequence: 96133394 Sequence: 96133395 Sequence: 96133396 Sequence: 96133397 Sequence: 96133398 Sequence: 96133399 Sequence: 96133400 Sequence: 96133401 Sequence: 96133402
Mesh Term Cyclophosphamide Mesh Term Fludarabine Mesh Term Immunosuppressive Agents Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs Mesh Term Antirheumatic Agents Mesh Term Antineoplastic Agents, Alkylating Mesh Term Alkylating Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antineoplastic Agents Mesh Term Myeloablative Agonists
Downcase Mesh Term cyclophosphamide Downcase Mesh Term fludarabine Downcase Mesh Term immunosuppressive agents Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs Downcase Mesh Term antirheumatic agents Downcase Mesh Term antineoplastic agents, alkylating Downcase Mesh Term alkylating agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antineoplastic agents Downcase Mesh Term myeloablative agonists
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52221705
Name Ovarian Cancer
Downcase Name ovarian cancer

Id Information

Sequence: 40195753
Id Source org_study_id
Id Value MESO

Countries

Sequence: 42609743
Name China
Removed False

Design Groups

Sequence: 55650003
Group Type Experimental
Title anti-MESO CAR-T cells
Description Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients

Interventions

Sequence: 52535510 Sequence: 52535511 Sequence: 52535512
Intervention Type Biological Intervention Type Drug Intervention Type Drug
Name anti-MESO CAR-T cells Name Fludarabine Name Cyclophosphamide
Description Retroviral vector-transduced autologous T cells to express anti-MESO CARs Description 30mg/m2/d Description 300mg/m2/d

Keywords

Sequence: 79942018 Sequence: 79942019 Sequence: 79942020 Sequence: 79942021
Name CAR-T Name MESO Name Ovarian Cancer Name Relapsed and Refractory
Downcase Name car-t Downcase Name meso Downcase Name ovarian cancer Downcase Name relapsed and refractory

Design Outcomes

Sequence: 177562099 Sequence: 177562100 Sequence: 177562101 Sequence: 177562102 Sequence: 177562103
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 Measure Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm Measure Progress Free Survival (PFS) after administration Measure Duration of CAR-positive T cells in circulation Measure Detection of PD1 antibody in serum
Time Frame 1 years post infusion Time Frame 12 months post infusion Time Frame 12 months post infusion Time Frame 12 months post infusion Time Frame 12 months post infusion

Browse Conditions

Sequence: 193679156 Sequence: 193679157 Sequence: 193679158 Sequence: 193679159 Sequence: 193679160 Sequence: 193679161 Sequence: 193679162 Sequence: 193679163 Sequence: 193679164 Sequence: 193679165 Sequence: 193679166 Sequence: 193679167 Sequence: 193679168 Sequence: 193679169 Sequence: 193679170 Sequence: 193679171 Sequence: 193679172 Sequence: 193679173 Sequence: 193679174
Mesh Term Ovarian Neoplasms Mesh Term Carcinoma, Ovarian Epithelial Mesh Term Endocrine Gland Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Ovarian Diseases Mesh Term Adnexal Diseases Mesh Term Genital Diseases, Female Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Genital Neoplasms, Female Mesh Term Urogenital Neoplasms Mesh Term Genital Diseases Mesh Term Endocrine System Diseases Mesh Term Gonadal Disorders Mesh Term Carcinoma Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type
Downcase Mesh Term ovarian neoplasms Downcase Mesh Term carcinoma, ovarian epithelial Downcase Mesh Term endocrine gland neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term ovarian diseases Downcase Mesh Term adnexal diseases Downcase Mesh Term genital diseases, female Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term genital neoplasms, female Downcase Mesh Term urogenital neoplasms Downcase Mesh Term genital diseases Downcase Mesh Term endocrine system diseases Downcase Mesh Term gonadal disorders Downcase Mesh Term carcinoma Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366590 Sequence: 48366591 Sequence: 48366592
Agency Class OTHER Agency Class OTHER Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Zhejiang University Name Second Affiliated Hospital, School of Medicine, Zhejiang University Name Hrain Biotechnology Co., Ltd.

Overall Officials

Sequence: 29312998
Role Study Chair
Name Jianwei Zhou, M.D.
Affiliation Zhejiang University

Central Contacts

Sequence: 12020629
Contact Type primary
Name Zhigang Zhang, M.D.
Phone 86+057189713631
Email zzg2011@zju.edu.cn
Role Contact

Design Group Interventions

Sequence: 68217624 Sequence: 68217625 Sequence: 68217626
Design Group Id 55650003 Design Group Id 55650003 Design Group Id 55650003
Intervention Id 52535510 Intervention Id 52535511 Intervention Id 52535512

Eligibilities

Sequence: 30794811
Gender Female
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

18 to 70 Years Old, female;
Expected survival > 12 weeks;
Clinical performance status of ECOG score 0-2;
Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission);
At least one measurable tumor foci according to RECIST standard 1.1 ;
Positive Mesothelin expression in tumor tissues;
Creatinine ≤ 1.5×ULN;
ALT and AST ≤ 3×ULN;
Total bilirubin ≤ 2×ULN;
Hemoglobin≥90g/L;
Absolute counting of neutrophils≥1000uL ;
Absolute counting of lymphocytes>0.7×10^9/L;
Counting of Platelet≥75000/uL;
The venous access required for collection can be established without contraindications for leukocyte collection;
Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

Accompanied by other uncontrolled malignant tumors;
Active hepatitis B, hepatitis C, syphilis, HIV infection;
Suffering severe cardiovascular or respiratory disease;
Any other diseases could affect the outcome of this trial;
Any affairs could affect the safety of the subjects or outcome of this trial;
Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment;
There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment;
Patients who are accounted by researchers to be not appropriate for this test;
Received CAR-T treatment or other gene therapies before assignment;
Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004483
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30540851
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28907171
Responsible Party Type Principal Investigator
Name Zhigang Zhang
Title Dr
Affiliation Zhejiang University

]]>

<![CDATA[ Assessment of Abuse Potential of Rapastinel in Humans ]]>
https://zephyrnet.com/NCT03799900
2018-11-01

https://zephyrnet.com/?p=NCT03799900
NCT03799900https://www.clinicaltrials.gov/study/NCT03799900?tab=tableNANANABased on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users.
<![CDATA[

Studies

Study First Submitted Date 2018-11-15
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-05-16
Start Month Year November 1, 2018
Primary Completion Month Year March 24, 2019
Verification Month Year May 2019
Verification Date 2019-05-31
Last Update Posted Date 2019-05-16

Facilities

Sequence: 199965077
Name Vince and Associates Clinical Research Inc
City Overland Park
State Kansas
Zip 66212
Country United States

Browse Interventions

Sequence: 95996913 Sequence: 95996914 Sequence: 95996915 Sequence: 95996916 Sequence: 95996917 Sequence: 95996918 Sequence: 95996919 Sequence: 95996920 Sequence: 95996921 Sequence: 95996922 Sequence: 95996923 Sequence: 95996924 Sequence: 95996925 Sequence: 95996926
Mesh Term Ketamine Mesh Term Analgesics Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents Mesh Term Physiological Effects of Drugs Mesh Term Anesthetics, Dissociative Mesh Term Anesthetics, Intravenous Mesh Term Anesthetics, General Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Excitatory Amino Acid Antagonists Mesh Term Excitatory Amino Acid Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term ketamine Downcase Mesh Term analgesics Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term anesthetics, dissociative Downcase Mesh Term anesthetics, intravenous Downcase Mesh Term anesthetics, general Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term excitatory amino acid antagonists Downcase Mesh Term excitatory amino acid agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52139008
Name Human Abuse Potential
Downcase Name human abuse potential

Id Information

Sequence: 40135065
Id Source org_study_id
Id Value RAP-PK-12

Countries

Sequence: 42542690
Name United States
Removed False

Design Groups

Sequence: 55559347 Sequence: 55559348 Sequence: 55559349 Sequence: 55559350 Sequence: 55559351 Sequence: 55559352 Sequence: 55559353 Sequence: 55559354 Sequence: 55559355 Sequence: 55559356 Sequence: 55559357 Sequence: 55559358 Sequence: 55559359
Group Type Experimental Group Type Placebo Comparator Group Type Experimental Group Type Placebo Comparator Group Type Experimental Group Type Placebo Comparator Group Type Experimental Group Type Placebo Comparator Group Type Experimental Group Type Experimental Group Type Experimental Group Type Active Comparator Group Type Placebo Comparator
Title Part 1, Cohort 1: Ketamine Low Dose Title Part 1, Cohort 1: Placebo Title Part 1, Cohort 2: Ketamine Medium Dose Title Part 1, Cohort 2: Placebo Title Part 1, Cohort 3 (Optional): Ketamine High Dose Title Part 1, Cohort 3 (Optional): Placebo Title Part 2, Qualification Phase: Ketamine Title Part 2, Qualification Phase: Placebo Title Part 2, Treatment Phase: Rapastinel Low Dose Title Part 2, Treatment Phase: Rapastinel Medium Dose Title Part 2, Treatment Phase: Rapastinel High Dose Title Part 2, Treatment Phase: Ketamine Title Part 2, Treatment Phase: Placebo
Description Some participants will be administered a single IV dose of ketamine on Day 1. Description Some participants will be administered a single IV dose of placebo on Day 1. Description Some participants will be administered a single IV dose of ketamine on Day 1. Description Some participants will be administered a single IV dose of placebo on Day 1. Description Optional: some participants will be administered a single IV dose of ketamine on Day 1. Description Optional: some participants will be administered a single IV dose of placebo on Day 1. Description Participants will receive IV ketamine on Day 1 and placebo on Day 2 in a randomized crossover manner. Description Participants will receive IV ketamine on Day 2 and placebo on Day 1 in a randomized crossover manner. Description Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Description Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Description Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Description Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Description Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.

Interventions

Sequence: 52454912 Sequence: 52454913 Sequence: 52454914
Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Rapastinel Name Ketamine Name Placebo
Description During the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. Description Part 1

Part 2, Qualification Phase:

Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner

Part 2, Treatment Phase:

Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.

Description Part 1

Part 2, Qualification Phase:

Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner

Part 2, Treatment Phase:

Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.

Design Outcomes

Sequence: 177263647 Sequence: 177263648 Sequence: 177263649 Sequence: 177263650 Sequence: 177263651 Sequence: 177263652 Sequence: 177263653 Sequence: 177263654 Sequence: 177263655 Sequence: 177263656 Sequence: 177263657
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Maximum effect (Emax) for "At this Moment" Drug Liking visual analog scale (VAS). Measure Maximum effect (Emax) Measure Minimum effect (Emin) Measure Time to Emax (TEmax) Measure Time to Emin (TEmin) Measure Time averaged area under the effect curve (TA_AUE) Measure Maximum plasma drug concentration (Cmax) Measure Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUClast) Measure Adverse events Measure Proportion of abnormal electrocardiograms Measure Columbia-Suicide Severity Rating Scale
Time Frame Treatment Phase: Pre-dose and up to 24 hours post-dose Time Frame Treatment Phase: Pre-dose and up to 24 hours post-dose Time Frame Treatment Phase: Pre-dose and up to 24 hours post-dose Time Frame Treatment Phase: Pre-dose and up to 24 hours post-dose Time Frame Treatment Phase: Pre-dose and up to 24 hours post-dose Time Frame Treatment Phase: Hour 0 and up to 24 Hours post-dose Time Frame Treatment Phase: Pre-dose and up to 24 hours post-dose Time Frame Treatment Phase: Pre-dose and up to 24 hours post-dose Time Frame Part 1: 6 weeks, Part 2: 9 weeks Time Frame Part 1: 6 weeks, Part 2: 9 weeks Time Frame Part 1: 6 weeks, Part 2: 9 weeks
Description The drug liking VAS measures the participant's liking for the drug and is scored from 0 to 100, with 0 reflecting "Strong disliking" and 100 reflecting "Strong liking". Description The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (least severe) to 5 (most severe).

Sponsors

Sequence: 48290711
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Naurex, Inc, an affiliate of Allergan plc

Overall Officials

Sequence: 29268533
Role Study Director
Name Sheng Fang Su
Affiliation Allergan

Design Group Interventions

Sequence: 68107457 Sequence: 68107458 Sequence: 68107459 Sequence: 68107460 Sequence: 68107461 Sequence: 68107462 Sequence: 68107463 Sequence: 68107464 Sequence: 68107465 Sequence: 68107466 Sequence: 68107467 Sequence: 68107468 Sequence: 68107469
Design Group Id 55559357 Design Group Id 55559355 Design Group Id 55559356 Design Group Id 55559347 Design Group Id 55559349 Design Group Id 55559351 Design Group Id 55559353 Design Group Id 55559358 Design Group Id 55559348 Design Group Id 55559350 Design Group Id 55559352 Design Group Id 55559354 Design Group Id 55559359
Intervention Id 52454912 Intervention Id 52454912 Intervention Id 52454912 Intervention Id 52454913 Intervention Id 52454913 Intervention Id 52454913 Intervention Id 52454913 Intervention Id 52454913 Intervention Id 52454914 Intervention Id 52454914 Intervention Id 52454914 Intervention Id 52454914 Intervention Id 52454914

Eligibilities

Sequence: 30747725
Gender All
Minimum Age 18 Years
Maximum Age 55 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Participant must be a current recreational polydrug user
Have a supine systolic blood pressure (BP) ≥ 95 mm Hg and ≤ 145 mg Hg, or supine diastolic BP ≥ 50 mm Hg and ≤ 90 mm Hg at the Screening Visit.
Have negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, oxycodone and other opioids, and phencyclidine at any admission
Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits

Exclusion Criteria:

Evidence of drug or alcohol dependence (excluding nicotine and caffeine) within the past 2 years
Suicidal risk based on the opinion of the principal investigator (or appropriately trained designee)
History of violent or psychotic behavior when taking psychedelic drugs, or unwilling to take a drug that might alter perception in a controlled setting
Have taken or require concomitant treatment with any CNS depressants, or cannot safely discontinue these medications within 14 days (or 5 half-lives, whichever is longer) before study treatment administration
Previously participated in an investigational study of rapastinel.
Participation in any other clinical investigation using an experimental drug within 30 days, 5 half-lives or twice the duration of the biological effect of the study treatment (whichever is longer), prior to study treatment administration or is concurrently enrolled in any clinical trial, judged not to be scientifically or medically compatible with this study
Consumption of alcohol within 72 hours before administration of study treatment
Breastfeeding
Unable to refrain from consuming caffeine or xanthine-containing compounds such as tea, coffee, soft drinks, energy sports drinks or chocolate (more than 48 oz/day) from 48 hours before administration of study treatment.
Have consumed dietary supplements or other foods or beverages that may affect various drug metabolizing enzymes and transporters (eg, grapefruit, grapefruit juice, grapefruit-containing beverages), vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), and charbroiled meats within 14 days prior to dosing or unable to refrain from consumption during the study.
The ability to tolerate IV ketamine as judged by the Investigator, based on available safety data, as well as pharmacodynamic data.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254121861
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 4
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 55
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 10

Designs

Sequence: 30494008
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Double
Subject Masked True
Investigator Masked True

Responsible Parties

Sequence: 28860288
Responsible Party Type Sponsor

]]>

<![CDATA[ Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson’s Disease ]]>
https://zephyrnet.com/NCT03799887
2010-10-20

https://zephyrnet.com/?p=NCT03799887
NCT03799887https://www.clinicaltrials.gov/study/NCT03799887?tab=tableNANANABody weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson’s disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year October 20, 2010
Primary Completion Month Year October 20, 2010
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20727169
Description Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT. All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP), Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the beginning and end of the rehabilitation.

Facilities

Sequence: 200159378
Name Tuğba Atan
City Çorum
Zip 19100
Country Turkey

Conditions

Sequence: 52185460
Name Parkinson Disease
Downcase Name parkinson disease

Id Information

Sequence: 40169059
Id Source org_study_id
Id Value 2010-171

Countries

Sequence: 42580650
Name Turkey
Removed False

Design Groups

Sequence: 55609094 Sequence: 55609095 Sequence: 55609096
Group Type Active Comparator Group Type Experimental Group Type Experimental
Title 0% unweighed BWSTT Title 10% unweighed BWSTT Title 20% unweighed BWSTT
Description 0% unweighed Body Weight Supported Treadmill Training Description 0% unweighed Body Weight Supported Treadmill Training Description 20% unweighed Body Weight Supported Treadmill Training

Interventions

Sequence: 52499406 Sequence: 52499407 Sequence: 52499408
Intervention Type Behavioral Intervention Type Behavioral Intervention Type Behavioral
Name 0% unweighed BWSTT Name 10% unweighed BWSTT Name 20% unweighed BWSTT
Description 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.

After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).

Description 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.

After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).

Description 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.

After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).

Keywords

Sequence: 79888706 Sequence: 79888707 Sequence: 79888708 Sequence: 79888709 Sequence: 79888710
Name Parkinson's disease Name gait Name balance Name treadmill training Name fatigue
Downcase Name parkinson's disease Downcase Name gait Downcase Name balance Downcase Name treadmill training Downcase Name fatigue

Design Outcomes

Sequence: 177431970 Sequence: 177431971 Sequence: 177431972 Sequence: 177431973 Sequence: 177431974 Sequence: 177431975
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure 6 Minute Walk Test (6MWT) Measure Berg Balance Scale (BBS): Measure Unified Parkinson's Disease Rating Scale (UPDRS): Measure Nottingham Health Profile (NHP): Measure Fatigue Impact Scale (FIS): Measure Fatigue Severity Scale (FSS):
Time Frame 6 weeks Time Frame 6 weeks Time Frame 6 weeks Time Frame 6 weeks Time Frame 6 weeks Time Frame 6 weeks
Description Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response . Description It contains 14 instructions and 0 – 4 points is given for each instruction according to the performance of the patients. 0 points are given when the patient totally could not do the activity while 4 points are given when the patient completes the activity independently. Description It is used to follow the clinical status of PD. It consists of four main parts (totally 183 points): mentation, behavior and mood (UPDRS I: 16 points), activities of daily living (UPDRS II: 52 points), motor examination (UPDRS III: 92 points), treatment complications (UPDRS IV: 23 points). Description It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life. Description This scale assesses the cognitive, physical and social effects of fatigue during the last one week in a total of 40 – item questionnaire (0 = no problem, 4 = maximum problem). Description This scale assesses the severity of fatigue during the last one week in a total of 9 – item questionnaire (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 – 63, in which higher score means higher severity of fatigue .

Browse Conditions

Sequence: 193540034 Sequence: 193540035 Sequence: 193540036 Sequence: 193540037 Sequence: 193540038 Sequence: 193540039 Sequence: 193540040 Sequence: 193540041 Sequence: 193540042 Sequence: 193540043 Sequence: 193540044
Mesh Term Parkinson Disease Mesh Term Fatigue Mesh Term Body Weight Mesh Term Parkinsonian Disorders Mesh Term Basal Ganglia Diseases Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Movement Disorders Mesh Term Synucleinopathies Mesh Term Neurodegenerative Diseases
Downcase Mesh Term parkinson disease Downcase Mesh Term fatigue Downcase Mesh Term body weight Downcase Mesh Term parkinsonian disorders Downcase Mesh Term basal ganglia diseases Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term movement disorders Downcase Mesh Term synucleinopathies Downcase Mesh Term neurodegenerative diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48332315
Agency Class OTHER
Lead Or Collaborator lead
Name Hitit University

Design Group Interventions

Sequence: 68168151 Sequence: 68168152 Sequence: 68168153
Design Group Id 55609094 Design Group Id 55609095 Design Group Id 55609096
Intervention Id 52499406 Intervention Id 52499407 Intervention Id 52499408

Eligibilities

Sequence: 30773563
Gender All
Minimum Age 18 Years
Maximum Age 85 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria.
Subjects had clinically moderate to advanced severity of disease (Hoehn and Yahr stage 2 – 4).
Subjects whose medical treatment had been on stable dosage of dopaminomimetics for at least 4 weeks before the study.
Subjects ability to walk with or without assistive device.

Exclusion Criteria:

Subjects had cardiovascular, inflammatory or musculoskeletal problems that could prevent them to participate in an exercise program.
Subjects whose mini mental status examination score was less than 26.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253952660
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 0
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 85
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30519694
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Subject Masked True
Investigator Masked True

Responsible Parties

Sequence: 28885995
Responsible Party Type Principal Investigator
Name Tuğba Atan
Title Assoc. Prof.
Affiliation Hitit University

]]>

<![CDATA[ Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS) ]]>
https://zephyrnet.com/NCT03799874
2019-07-01

https://zephyrnet.com/?p=NCT03799874
NCT03799874https://www.clinicaltrials.gov/study/NCT03799874?tab=tableNANANAThis study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducted at 7 tertiary care medical centers including Weill Cornell Medicine/NewYork-Presbyterian Hospital, Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), Duke University Hospital, Durham Veterans Administration Medical Center, New York-Presbyterian Brooklyn Methodist Hospital, and Duke Regional Hospital. The purpose of this study is to evaluate the safety, tolerability, and efficacy of inhaled carbon monoxide (iCO) for the treatment of ARDS and to examine the biologic readouts of low dose iCO therapy in patients with ARDS
<![CDATA[

Studies

Study First Submitted Date 2018-12-06
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-08-23
Start Month Year July 1, 2019
Primary Completion Month Year December 2023
Verification Month Year August 2022
Verification Date 2022-08-31
Last Update Posted Date 2022-08-23

Detailed Descriptions

Sequence: 20850604
Description Acute respiratory distress syndrome (ARDS) is a devastating disease affecting military, veteran, and civilian populations. ARDS is a syndrome of severe acute lung inflammation and hypoxemic respiratory failure with an incidence of 180,000 cases annually in the United States. Despite recent advances in critical care management and lung protective ventilation strategies, ARDS morbidity and mortality remain unacceptably high. The lack of specific effective therapies for ARDS indicates a need for new treatments that target novel pathways. Carbon monoxide (CO) represents a novel therapeutic modality in ARDS based on data obtained in experimental models of ARDS over the past decade.

CO has been shown to be protective in experimental models of acute lung injury (ALI) and sepsis. Furthermore, multiple human studies have demonstrated that experimental administration of several different concentrations of CO is well tolerated and that low dose inhaled CO can be safely administered to subjects in a controlled research environment. The investigators have previously conducted a Phase I trial of low dose iCO in ARDS which demonstrated that precise administration of low dose iCO (100 and 200 ppm) is feasible, well-tolerated, and safe in patients with sepsis-induced ARDS.

The purpose of this study is to assess the safety and efficacy of low dose inhaled carbon monoxide (iCO) therapy in mechanically ventilated patients with ARDS.

Facilities

Sequence: 201277248 Sequence: 201277249 Sequence: 201277250 Sequence: 201277251 Sequence: 201277252 Sequence: 201277253 Sequence: 201277254
Name Massachusetts General Hospital Name Brigham and Women's Hospital Name Washington University Name New York-Presbyterian Brooklyn Methodist Hospital Name Weill Cornell Medical College Name Duke Regional Hospital Name Duke University Hospital
City Boston City Boston City Saint Louis City Brooklyn City New York City Durham City Durham
State Massachusetts State Massachusetts State Missouri State New York State New York State North Carolina State North Carolina
Zip 02114 Zip 02115 Zip 63130 Zip 11215 Zip 10065 Zip 27704 Zip 27710
Country United States Country United States Country United States Country United States Country United States Country United States Country United States

Browse Interventions

Sequence: 96590314 Sequence: 96590315 Sequence: 96590316 Sequence: 96590317 Sequence: 96590318 Sequence: 96590319
Mesh Term Carbon Monoxide Mesh Term Antimetabolites Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Gasotransmitters Mesh Term Neurotransmitter Agents Mesh Term Physiological Effects of Drugs
Downcase Mesh Term carbon monoxide Downcase Mesh Term antimetabolites Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term gasotransmitters Downcase Mesh Term neurotransmitter agents Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52503085
Name Acute Respiratory Distress Syndrome
Downcase Name acute respiratory distress syndrome

Id Information

Sequence: 40395925 Sequence: 40395926
Id Source org_study_id Id Source secondary_id
Id Value 2018P002051 Id Value CDMRP-PR171025, W81XWH1810667
Id Type Other Grant/Funding Number
Id Type Description United States Army Medical Research Acquisition Activity

Countries

Sequence: 42832464
Name United States
Removed False

Design Groups

Sequence: 55959192 Sequence: 55959193
Group Type Experimental Group Type Placebo Comparator
Title Inhaled Carbon Monoxide Title Medical air
Description Inhaled Carbon Monoxide at 200 ppm for up to 90 minutes daily for 3 days. Description Inhaled Medical Air for up to 90 minutes daily for 3 days.

Interventions

Sequence: 52811074 Sequence: 52811075
Intervention Type Drug Intervention Type Other
Name Inhaled Carbon Monoxide at 200 ppm Name Inhaled Medical air
Description Inhaled Carbon Monoxide at 200 ppm for 90 minutes daily for 3 days. Description Inhaled Medical Air for up to 90 minutes daily for 3 days.

Design Outcomes

Sequence: 178616982 Sequence: 178616983 Sequence: 178616984 Sequence: 178616985 Sequence: 178616986 Sequence: 178616987 Sequence: 178616988 Sequence: 178616989 Sequence: 178616990 Sequence: 178616991 Sequence: 178616992 Sequence: 178616993 Sequence: 178616994 Sequence: 178616995 Sequence: 178616996 Sequence: 178616997 Sequence: 178616998
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Primary Safety Outcome: Number of pre-specified administration-related adverse events. Measure Primary Efficacy Outcome: Change in Mitochondrial DNA (mtDNA) level from day 1 to day 5 Measure Lung injury score (LIS) on days 1-5, and on day 7 Measure PaO2/FiO2 ratio on days 1-5, and on day 7 Measure Oxygenation Index (OI) on days 1-5, and day 7 Measure Dead Space Fraction (Vd/Vt) on days 1-3, and day 7 Measure Sequential Organ Failure Assessment (SOFA) score on days 1-5, 7, 14, 28 Measure Change in biomarkers of autophagy Measure Change in biomarkers of inflammation and inflammasome activation Measure Change in lipid mediators Measure Change in biomarkers of mitochondrial quality control Measure Ventilator-free days at day 28 Measure ICU-free days at day 28 Measure Hospital-free days at day 60 Measure Hospital mortality to day 28 and 60 Measure Montreal Cognitive Assessment- MoCA-Blind Measure Hayling Sentence Completion Test
Time Frame 7 days Time Frame 5 days Time Frame 7 days Time Frame 7 days Time Frame 7 days Time Frame 7 days Time Frame 28 days Time Frame 5 days Time Frame 5 days Time Frame 5 days Time Frame 5 days Time Frame 28 days Time Frame 28 days Time Frame 60 days Time Frame 60 days Time Frame 6 months Time Frame 6 months
Description Safety of inhaled CO, defined by the incidence of pre-specified administration-related AEs (as defined below) and spontaneously reported AEs through study day 7.

Acute MI within 48 hours of study drug administration
Acute cerebrovascular accident (CVA) within 48 hours of study drug administration
New onset atrial or ventricular arrhythmia requiring DC cardioversion within 48 hours of study drug administration
Increased oxygenation requirements defined as: an increase in FiO2 of ≥ 0.2 AND increase in PEEP ≥ 5 cm H2O within 6 hours of study drug administration
Increase in COHb ≥ 10%
Increase in lactate by ≥ 2 mmol/L within 6 hours of study drug administration

Description Mitochondrial DNA (mtDNA) plasma levels will be measured by quantitative PCR of human NADH dehydrogenase 1. Description The Lung Injury Score (LIS) is a composite 4-point scoring system including the PaO2/FiO2, PEEP, quasi-static respiratory compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used. Previous randomized clinical trials in ARDS have shown that a decreased LIS correlates with improvement in lung physiology as well as important clinical outcomes including mortality and ventilator-free days (VFDs). Description PaO2/FiO2 will be measured daily on days 1-5 and on day 7 in ventilated subjects. Description The oxygenation index will be measured daily on days 1-5 and on day 7 in ventilated subjects. Oxygenation index is calculated as (FiO2 X mean airway pressure)/PaO2. Description The dead space fraction will be measured daily on days 1-3 and on day 7 in ventilated subjects. Description Organ failure will be assessed using the SOFA score. SOFA scores will be assessed daily on days 1-5, and thereafter on days 7, 14, and 28, as the SOFA score has been shown to be a reliable prognostic indicator of outcomes in critically ill patients. To calculate the Sequential Organ Failure Assessment (SOFA) score, each of the six components (Respiratory, Coagulation, Liver, Cardiovascular, Central Nervous System, Renal) is categorized from 0-4, where a higher number is worse. The SOFA score (0-24) will be calculated by summing all six components. Description Autophagy markers (eg. LC3B) will be measured in plasma daily on days 1-3 and on day 5. Description Cytokine plasma levels (eg. IL-18) will be measured by ELISA daily on days 1-3 and on day 5. Description Lipid mediators (LM) and specialized pro-resolving mediators (SPMs) will be measured in plasma using liquid chromatography-tandem mass spectrometry (LC-MS-MS) based methods daily on days 1-3 and on day 5. Description Mitochondrial quality control biomarkers (eg. Pink1, Wipi1) will be measured in peripheral blood mononuclear cells (PBMCs) daily on days 1-3 and on day 5. Description Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days. Description ICU-free days will be assessed on day 28. ICU-free days is defined as the number of days between randomization and day 28 in which the patient is in the ICU (for any part of a day). Description Hospital-free days will be assessed on day 60. Hospital-free days are days alive post hospital discharge through day 60. Patients who die on or prior to day 60 are assigned zero hospital-free days. Description Mortality will be assessed on day 28 and day 60 Description The MoCA-Blind will be administered at 6 months via telephone interview to assess 4 items examining attention, verbal learning and memory, executive functions/language, and orientation. The test is scored out of 22 with 18 and above considered normal. Description The Hayling Sentence Completion Test will be administered at 6 months via telephone interview. The Hayling Sentence Completion Test is a neuropsychological test consisting of two types of sentence completion. The first section is scored based on time taken to complete the sentence. The second section is scored based on time taken to complete a sentence as well as the quality of answer. These scores are combined and scaled according to age.

Browse Conditions

Sequence: 194752862 Sequence: 194752863 Sequence: 194752864 Sequence: 194752865 Sequence: 194752866 Sequence: 194752867 Sequence: 194752868 Sequence: 194752869 Sequence: 194752870 Sequence: 194752871 Sequence: 194752872 Sequence: 194752873
Mesh Term Respiratory Distress Syndrome Mesh Term Respiratory Distress Syndrome, Newborn Mesh Term Acute Lung Injury Mesh Term Syndrome Mesh Term Disease Mesh Term Pathologic Processes Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases Mesh Term Respiration Disorders Mesh Term Infant, Premature, Diseases Mesh Term Infant, Newborn, Diseases Mesh Term Lung Injury
Downcase Mesh Term respiratory distress syndrome Downcase Mesh Term respiratory distress syndrome, newborn Downcase Mesh Term acute lung injury Downcase Mesh Term syndrome Downcase Mesh Term disease Downcase Mesh Term pathologic processes Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term respiration disorders Downcase Mesh Term infant, premature, diseases Downcase Mesh Term infant, newborn, diseases Downcase Mesh Term lung injury
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48626627 Sequence: 48626628 Sequence: 48626629 Sequence: 48626630 Sequence: 48626631 Sequence: 48626632 Sequence: 48626633 Sequence: 48626634 Sequence: 48626635
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class FED Agency Class OTHER Agency Class UNKNOWN Agency Class FED Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Brigham and Women's Hospital Name Massachusetts General Hospital Name Weill Medical College of Cornell University Name Duke University Name Durham VA Medical Center Name New York Presbyterian Brooklyn Methodist Hospital Name Duke Regional Hospital Name U.S. Army Medical Research Acquisition Activity Name Washington University School of Medicine

Overall Officials

Sequence: 29458470
Role Principal Investigator
Name Rebecca Baron, MD
Affiliation Brigham and Women's Hospital

Design Group Interventions

Sequence: 68601127 Sequence: 68601128
Design Group Id 55959192 Design Group Id 55959193
Intervention Id 52811074 Intervention Id 52811075

Eligibilities

Sequence: 30954616
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

All intubated patients ≥ 18 years old with ARDS

ARDS is defined when all four of the following criteria are met:

A PaO2/FiO2 ratio ≤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP)
Bilateral opacities on frontal chest radiograph (not fully explained by effusions, lobar/lung collapse, or nodules) within 1 week of a known clinical insult or new or worsening respiratory symptoms
A need for positive pressure ventilation by an endotracheal or tracheal tube
Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.
ARDS onset is defined as the time the last of criteria 1-4 are met. ARDS must persist through the enrollment time window of 168 hours.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Age less than 18 years
Greater than 168 hours since ARDS onset
Pregnant or breastfeeding
Prisoner
Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
No consent/inability to obtain consent or appropriate legal representative not available
Physician refusal to allow enrollment in the trial
Moribund patient not expected to survive 24 hours
No arterial or central line/no intent to place an arterial or central line
No intent/unwillingness to follow lung protective ventilation strategy
Severe hypoxemia defined as SpO2 < 95 or PaO2 < 90 on FiO2 ≥ 0.9
Hemoglobin < 7.0 g/dL
Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization
Acute myocardial infarction (MI) or acute coronary syndrome (ACS) within the last 90 days
Coronary artery bypass graft (CABG) surgery within 30 days
Angina pectoris or use of nitrates with activities of daily living
Cardiopulmonary disease classified as NYHA class IV
Stroke (ischemic or hemorrhagic) within the prior 1 month, cardiac arrest requiring CPR within the prior 72 hours, or inability to assess mental status following cardiac arrest
Burns > 40% total body surface area (TBSA)
Severe airway inhalational injury
Use of high frequency oscillatory ventilation
Use of extracorporeal membrane oxygenation (ECMO)
Concomitant use of inhaled pulmonary vasodilator therapy (eg. nitric oxide [NO] or prostaglandins)
Diffuse alveolar hemorrhage from vasculitis
Concurrent participation in other investigational drug study

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253909900
Number Of Facilities 7
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 9
Number Of Other Outcomes To Measure 6

Designs

Sequence: 30700196
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description The study drug will be blinded to the study staff using identical tanks containing either CO or placebo air. The administering respiratory therapist (RT) and a physician study staff member will be unblinded to the treatment assignments.
Subject Masked True
Caregiver Masked True

Intervention Other Names

Sequence: 26839054
Intervention Id 52811074
Name iCO

Responsible Parties

Sequence: 29066962
Responsible Party Type Principal Investigator
Name Rebecca Baron
Title Associate Professor of Medicine
Affiliation Brigham and Women's Hospital

Study References

Sequence: 52410158 Sequence: 52410159 Sequence: 52410160 Sequence: 52410161 Sequence: 52410162 Sequence: 52410163 Sequence: 52410164 Sequence: 52410165 Sequence: 52410166 Sequence: 52410167 Sequence: 52410168 Sequence: 52410169 Sequence: 52410170 Sequence: 52410171
Pmid 24391478 Pmid 12133657 Pmid 25770182 Pmid 19465554 Pmid 26320156 Pmid 9149675 Pmid 15557136 Pmid 1194155 Pmid 5430001 Pmid 11704374 Pmid 11247913 Pmid 26186946 Pmid 30518685 Pmid 29100885
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Nakahira K, Kyung SY, Rogers AJ, Gazourian L, Youn S, Massaro AF, Quintana C, Osorio JC, Wang Z, Zhao Y, Lawler LA, Christie JD, Meyer NJ, Mc Causland FR, Waikar SS, Waxman AB, Chung RT, Bueno R, Rosas IO, Fredenburgh LE, Baron RM, Christiani DC, Hunninghake GM, Choi AM. Circulating mitochondrial DNA in patients in the ICU as a marker of mortality: derivation and validation. PLoS Med. 2013 Dec;10(12):e1001577; discussion e1001577. doi: 10.1371/journal.pmed.1001577. Epub 2013 Dec 31. Citation Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23. doi: 10.1016/S0140-6736(02)09459-X. Citation Jung SS, Moon JS, Xu JF, Ifedigbo E, Ryter SW, Choi AM, Nakahira K. Carbon monoxide negatively regulates NLRP3 inflammasome activation in macrophages. Am J Physiol Lung Cell Mol Physiol. 2015 May 15;308(10):L1058-67. doi: 10.1152/ajplung.00400.2014. Epub 2015 Mar 13. Citation Rhodes MA, Carraway MS, Piantadosi CA, Reynolds CM, Cherry AD, Wester TE, Natoli MJ, Massey EW, Moon RE, Suliman HB. Carbon monoxide, skeletal muscle oxidative stress, and mitochondrial biogenesis in humans. Am J Physiol Heart Circ Physiol. 2009 Jul;297(1):H392-9. doi: 10.1152/ajpheart.00164.2009. Epub 2009 May 22. Citation Fredenburgh LE, Kraft BD, Hess DR, Harris RS, Wolf MA, Suliman HB, Roggli VL, Davies JD, Winkler T, Stenzler A, Baron RM, Thompson BT, Choi AM, Welty-Wolf KE, Piantadosi CA. Effects of inhaled CO administration on acute lung injury in baboons with pneumococcal pneumonia. Am J Physiol Lung Cell Mol Physiol. 2015 Oct 15;309(8):L834-46. doi: 10.1152/ajplung.00240.2015. Epub 2015 Aug 28. Citation Hausberg M, Somers VK. Neural circulatory responses to carbon monoxide in healthy humans. Hypertension. 1997 May;29(5):1114-8. doi: 10.1161/01.hyp.29.5.1114. Citation Mayr FB, Spiel A, Leitner J, Marsik C, Germann P, Ullrich R, Wagner O, Jilma B. Effects of carbon monoxide inhalation during experimental endotoxemia in humans. Am J Respir Crit Care Med. 2005 Feb 15;171(4):354-60. doi: 10.1164/rccm.200404-446OC. Epub 2004 Nov 19. Citation Peterson JE, Stewart RD. Predicting the carboxyhemoglobin levels resulting from carbon monoxide exposures. J Appl Physiol. 1975 Oct;39(4):633-8. doi: 10.1152/jappl.1975.39.4.633. Citation Stewart RD, Peterson JE, Baretta ED, Bachand RT, Hosko MJ, Herrmann AA. Experimental human exposure to carbon monoxide. Arch Environ Health. 1970 Aug;21(2):154-64. doi: 10.1080/00039896.1970.10667214. No abstract available. Citation Zevin S, Saunders S, Gourlay SG, Jacob P, Benowitz NL. Cardiovascular effects of carbon monoxide and cigarette smoking. J Am Coll Cardiol. 2001 Nov 15;38(6):1633-8. doi: 10.1016/s0735-1097(01)01616-3. Citation Ren X, Dorrington KL, Robbins PA. Respiratory control in humans after 8 h of lowered arterial PO2, hemodilution, or carboxyhemoglobinemia. J Appl Physiol (1985). 2001 Apr;90(4):1189-95. doi: 10.1152/jappl.2001.90.4.1189. Citation Pecorella SR, Potter JV, Cherry AD, Peacher DF, Welty-Wolf KE, Moon RE, Piantadosi CA, Suliman HB. The HO-1/CO system regulates mitochondrial-capillary density relationships in human skeletal muscle. Am J Physiol Lung Cell Mol Physiol. 2015 Oct 15;309(8):L857-71. doi: 10.1152/ajplung.00104.2015. Epub 2015 Jul 17. Citation Fredenburgh LE, Perrella MA, Barragan-Bradford D, Hess DR, Peters E, Welty-Wolf KE, Kraft BD, Harris RS, Maurer R, Nakahira K, Oromendia C, Davies JD, Higuera A, Schiffer KT, Englert JA, Dieffenbach PB, Berlin DA, Lagambina S, Bouthot M, Sullivan AI, Nuccio PF, Kone MT, Malik MJ, Porras MAP, Finkelsztein E, Winkler T, Hurwitz S, Serhan CN, Piantadosi CA, Baron RM, Thompson BT, Choi AM. A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS. JCI Insight. 2018 Dec 6;3(23):e124039. doi: 10.1172/jci.insight.124039. Citation Rosas IO, Goldberg HJ, Collard HR, El-Chemaly S, Flaherty K, Hunninghake GM, Lasky JA, Lederer DJ, Machado R, Martinez FJ, Maurer R, Teller D, Noth I, Peters E, Raghu G, Garcia JGN, Choi AMK. A Phase II Clinical Trial of Low-Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis. Chest. 2018 Jan;153(1):94-104. doi: 10.1016/j.chest.2017.09.052. Epub 2017 Oct 31.

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<![CDATA[ Newborn Heart Rate as a Catalyst for Improved Survival ]]>
https://zephyrnet.com/NCT03799861
2018-07-05

https://zephyrnet.com/?p=NCT03799861
NCT03799861https://www.clinicaltrials.gov/study/NCT03799861?tab=tableNANANAHeart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born. The effect of a low-cost monitor for measuring HR on the problem of misclassification of stillbirths in LMICs is unknown.

Knowledge of HR during newborn resuscitation might also result in timely administration of appropriate interventions, and improvement in outcomes. Helping Babies Breathe (HBB), a resuscitation algorithm developed by the American Academy of Pediatrics (AAP), is widely accepted as the standard of care for newborn resuscitation in low-resource settings. In keeping with the International Liaison Committee on Resuscitation (ILCOR) recommendations that HR be measured during newborn resuscitation, HBB calls for HR assessment after 1 minute of positive-pressure ventilation with good chest movement (or sooner if there is a helper who can palpate/auscultate heart rate). However, given the frequent reality of a single provider attending deliveries in LMICs, as well as the currently available methods for assessing HR (i.e. palpitation or auscultation), assessment of HR is challenging to perform without delaying or stopping the provision of other life-saving interventions such as bag and mask ventilation. The effect of low-cost, continuous HR monitoring to guide resuscitation in these settings is unknown.

NeoBeat is a low-cost, battery-operated device designed by Laerdal Global Health for the measurement of newborn HR. The device can be placed rapidly on a newborn by a single provider, and within 5 seconds, displays HR digitally. A preliminary trial of NeoBeat in 349 non-breathing newborns in Tanzania detected a HR in 67% of newborns classified as stillbirths, suggesting up to two thirds of fresh stillbirths may be misclassified in similar settings.

This trial will evaluate: 1) the effectiveness of HBB in combination with NeoBeat for vital status detection on reduction of reported stillbirths, and 2) the effectiveness of HR-guided HBB on effective breathing at 3 minutes.

The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat will decrease the reported total stillbirth rate by 15% compared to standard care. The secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of newborns not breathing well at birth who are effectively breathing at 3 minutes by 50% compared to HBB with NeoBeat.
<![CDATA[

Studies

Study First Submitted Date 2018-11-09
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-03-31
Start Month Year July 5, 2018
Primary Completion Month Year July 30, 2020
Verification Month Year March 2022
Verification Date 2022-03-31
Last Update Posted Date 2022-03-31

Facilities

Sequence: 200863498 Sequence: 200863499 Sequence: 200863500
Name Binza-Delvaux Maternity Hospital Name Centre Hospital Kingasani Name Mother and Child Hospital Bumbu
City Kinshasa City Kinshasa City Kinshasa
Country Congo, The Democratic Republic of the Country Congo, The Democratic Republic of the Country Congo, The Democratic Republic of the

Conditions

Sequence: 52399526 Sequence: 52399524 Sequence: 52399525 Sequence: 52399527
Name Neonatal Bradycardia Name Stillbirth Name Neonatal Respiratory Depression Name Neonatal Resuscitation
Downcase Name neonatal bradycardia Downcase Name stillbirth Downcase Name neonatal respiratory depression Downcase Name neonatal resuscitation

Id Information

Sequence: 40320674
Id Source org_study_id
Id Value 7200AA18FA00010

Countries

Sequence: 42743900
Name Congo, The Democratic Republic of the
Removed False

Design Groups

Sequence: 55846561 Sequence: 55846562 Sequence: 55846563
Title Epoch 1: Care prior to HBB training Title Epoch 2: HBB with NeoBeat Title Epoch 3: HR-guided HBB
Description A period of demographic and birth outcome data collection for a retrospective cohort of all infants born in the three study hospitals during the 18 months prior to the start of Epoch 2, reflecting care prior to HBB training. Description Implementation of Helping Babies Breathe training in combination with NeoBeat for detection of HR in non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for prospective cohort of all infants born in the three study hospitals for a 9-month period. Description Implementation of HR-guided Helping Babies Breathe training with NeoBeat for measurement of HR throughout resuscitation of non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for a prospective cohort of all infants born in the three study hospitals for a 9-month period.

Interventions

Sequence: 52708687 Sequence: 52708688
Intervention Type Other Intervention Type Other
Name Epoch 2: HBB with NeoBeat Name Epoch 3: HR-guided HBB
Description At the beginning of Epoch 2, all birth attendants in each of the 3 maternity units will participate in a 2 day workshop in Kinshasa in French that will include instructions regarding use of NeoBeat and training in HBB 2.0. Participants will be introduced to NeoBeat, which will include practice with NeoBeat using the NeoNatalie newborn simulator. This training will be conducted in French using typical adapted training materials for this program that incorporate placement of NeoBeat at appropriate times in the algorithm, including a flipchart and NeoNatalie. Participants will complete the pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs) with the incorporation of use of NeoBeat into the OSCEs. Description At the beginning of Epoch 3, all birth attendants in each of the 3 maternity units will participate in a 1 day workshop in Kinshasa in French that will instruct them in an adapted, HR-guided HBB algorithm. This training will include simulation with NeoNatalie and NeoBeat. Participants will complete a pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs).

Keywords

Sequence: 80178385 Sequence: 80178386 Sequence: 80178387 Sequence: 80178388
Name Neonatal Resuscitation Name Stillbirth Name Neonatal Respiratory Depression Name Neonatal Bradycardia
Downcase Name neonatal resuscitation Downcase Name stillbirth Downcase Name neonatal respiratory depression Downcase Name neonatal bradycardia

Design Outcomes

Sequence: 178223249 Sequence: 178223250 Sequence: 178223251 Sequence: 178223252 Sequence: 178223253 Sequence: 178223254
Outcome Type primary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Reported Total Stillbirth Rate Measure Effective, Spontaneous Breathing at 3 Minutes Measure Fresh Stillbirth Rate Measure Macerated Stillbirth Rate Measure Neonatal Death Prior to Discharge Measure Number of Providers Adhering to Resuscitation Algorithm
Time Frame At delivery Time Frame At 3 minutes of life Time Frame At delivery Time Frame At delivery Time Frame Up to 28 days of life Time Frame At delivery
Description The total number of stillborn infants (both fresh and macerated) at the facility per 1,000 births, with stillbirth as classified by the delivery attendant. Description Breathing without the assistance of stimulation or bag and mask ventilation at a respiratory rate ≥ 40 breaths per minute with a HR ≥ 100 beats per minute at 32 minutes of life. Description Total number of non-breathing newborns without a HR at the time of birth, and without signs of maceration, as determined by the delivery attendant, per 1,000 births. Description Total number of non-breathing newborns without a HR at the time of birth, with signs of maceration, as determined by the delivery attendant, per 1,000 births. Description Death of a live born infant during the birth hospitalization, where death occurs prior to discharge or transfer from the facility of birth. Description any number of provider actions to promote resuscitation of the non-breathing newborn such as suctioning, stimulation, bag and mask ventilation and corrective measures to improve bag and mask ventilation in response to newborn respiratory condition or HR as defined in the resuscitation algorithm.

Browse Conditions

Sequence: 194354564 Sequence: 194354565 Sequence: 194354566 Sequence: 194354567 Sequence: 194354568 Sequence: 194354569 Sequence: 194354570 Sequence: 194354571 Sequence: 194354572 Sequence: 194354573 Sequence: 194354574 Sequence: 194354575 Sequence: 194354576 Sequence: 194354577 Sequence: 194354578 Sequence: 194354579
Mesh Term Respiratory Insufficiency Mesh Term Stillbirth Mesh Term Bradycardia Mesh Term Depression Mesh Term Behavioral Symptoms Mesh Term Arrhythmias, Cardiac Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases Mesh Term Pathologic Processes Mesh Term Fetal Death Mesh Term Pregnancy Complications Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Death Mesh Term Respiration Disorders Mesh Term Respiratory Tract Diseases
Downcase Mesh Term respiratory insufficiency Downcase Mesh Term stillbirth Downcase Mesh Term bradycardia Downcase Mesh Term depression Downcase Mesh Term behavioral symptoms Downcase Mesh Term arrhythmias, cardiac Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term pathologic processes Downcase Mesh Term fetal death Downcase Mesh Term pregnancy complications Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term death Downcase Mesh Term respiration disorders Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48532042 Sequence: 48532043 Sequence: 48532044 Sequence: 48532045 Sequence: 48532046 Sequence: 48532047 Sequence: 48532048
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name American Academy of Pediatrics Name Kinshasa School of Public Health Name Laerdal Global Health Name RTI International Name Thrasher Research Fund Name University of North Carolina, Chapel Hill Name Saving Lives at Birth

Overall Officials

Sequence: 29404540 Sequence: 29404541 Sequence: 29404542 Sequence: 29404543
Role Study Director Role Principal Investigator Role Study Chair Role Study Chair
Name Carl Bose, MD Name Jackie Patterson, MD, MPH Name Sara Berkelhamer, MD Name Nalini Singhal, MD
Affiliation University of North Carolina, Chapel Hill Affiliation University of North Carolina, Chapel Hill Affiliation University at Buffalo Affiliation University of Calgary

Design Group Interventions

Sequence: 68459037 Sequence: 68459038
Design Group Id 55846562 Design Group Id 55846563
Intervention Id 52708687 Intervention Id 52708688

Eligibilities

Sequence: 30896967
Sampling Method Non-Probability Sample
Gender All
Minimum Age 28 Weeks
Maximum Age 45 Weeks
Healthy Volunteers Accepts Healthy Volunteers
Population All newborns delivered at any of the following 3 maternity units in Kinshasa, DRC over 3 years: Bumbu, Kingasani and Binza-Delvaux. The first 18 months of patients enrolled in the study will be retrospective, while the subsequent 18 months will be prospective. The entire study population will include non-observed and observed deliveries. Observed deliveries will be a convenience sample of non-breathing newborns based on availability of study nurses.
Criteria Inclusion Criteria: all newborns delivered via vaginal, assisted or operative delivery at any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC), during the study period will be enrolled. All newborns will be included, regardless of:

intrauterine fetal demise
birth weight
congenital anomalies
multiple gestation
any maternal complication

Exclusion Criteria:

Newborns transferred to the maternity unit following delivery at a referral hospital or in the community
Miscarriages, or previable newborns, defined as gestational age <28 weeks (or if gestational age is unavailable, birth weight <1,000g) at the time of delivery

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254144501
Number Of Facilities 3
Registered In Calendar Year 2018
Actual Duration 25
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 28
Maximum Age Num 45
Minimum Age Unit Weeks
Maximum Age Unit Weeks
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1
Number Of Other Outcomes To Measure 4

Designs

Sequence: 30642701
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 29009316
Responsible Party Type Sponsor

]]>

<![CDATA[ A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function ]]>
https://zephyrnet.com/NCT03799848
2018-06-12

https://zephyrnet.com/?p=NCT03799848
NCT03799848https://www.clinicaltrials.gov/study/NCT03799848?tab=tableNANANAThis is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
<![CDATA[

Studies

Study First Submitted Date 2018-12-27
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-03-22
Start Month Year June 12, 2018
Primary Completion Month Year October 18, 2018
Verification Month Year March 2019
Verification Date 2019-03-31
Last Update Posted Date 2019-03-22

Detailed Descriptions

Sequence: 20721591
Description This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. The study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose.

Facilities

Sequence: 200107899 Sequence: 200107900
Name Prism Clinical Research Name American Research Corporation at the University of Texas Liver Institute
City Saint Paul City San Antonio
State Minnesota State Texas
Zip 55114 Zip 78215
Country United States Country United States

Conditions

Sequence: 52171116
Name Hepatic Impairment
Downcase Name hepatic impairment

Id Information

Sequence: 40158558
Id Source org_study_id
Id Value AKB-6548-CI-0024

Countries

Sequence: 42568862
Name United States
Removed False

Design Groups

Sequence: 55593065
Group Type Experimental
Title Vadadustat
Description Group 1: Subjects with moderately impaired hepatic function (Child-Pugh Class B) Group 2: Normal healthy volunteers Group 3: Subjects with mildly impaired hepatic function (Child-Pugh Class A)

Interventions

Sequence: 52485364
Intervention Type Drug
Name Vadadustat
Description Oral tablet

Keywords

Sequence: 79868355 Sequence: 79868356 Sequence: 79868357 Sequence: 79868358
Name Hepatic impairment Name Healthy subjects Name Child-pugh Name Vadadustat
Downcase Name hepatic impairment Downcase Name healthy subjects Downcase Name child-pugh Downcase Name vadadustat

Design Outcomes

Sequence: 177378459 Sequence: 177378460 Sequence: 177378461 Sequence: 177378462 Sequence: 177378463 Sequence: 177378464 Sequence: 177378465 Sequence: 177378466 Sequence: 177378467 Sequence: 177378468 Sequence: 177378469 Sequence: 177378470 Sequence: 177378471 Sequence: 177378472 Sequence: 177378473 Sequence: 177378474 Sequence: 177378475 Sequence: 177378476 Sequence: 177378477 Sequence: 177378478 Sequence: 177378479
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Area under the concentration-time curve from dosing to last measurable concentration (AUClast) Measure Area under the concentration-time curve from dosing to infinity (AUCinf) Measure Observed maximum concentration (Cmax). Measure Time to reach Cmax of vadadustat Measure Apparent total body clearance (CL/F) of vadadustat Measure Apparent volume of distribution (Vd/F) of vadadustat Measure Terminal half-life (t1/2) of vadadustat Measure Time to reach Tmax of vadadustat Measure Assessment of Treatment-Emergent Adverse Events (TEAEs) as reported by study subjects Measure Cmax related to free drug (Cmax, free) of Vadadustat Unbound Measure AUClast related to free drug (AUClast, free) of Vadadustat Unbound Measure AUCinf related to free drug (AUCinf, free) of Vadadustat Unbound Measure CL/F related to free drug (CL/Ffree) of Vadadustat Unbound Measure Terminal half-life (t1/2) of Vadadustat Unbound Measure The area under the concentration-time curve from dosing to last measurable concentration (AUClast) of Vadadustat metabolites Measure The area under the concentration-time curve from dosing to infinity (AUCinf) of Vadadustat metabolite Measure Time to reach Cmax of vadadustat metabolites Measure Terminal half-life (t1/2) of Vadadustat metabolites Measure Renal clearance (CLr) of Vadadustat/metabolite(s) Urine Measure Cumulative amount of drug excreted (Ae) of Vadadustat/metabolite(s) Urine Measure Cumulative fraction of drug excreted (Fe) of Vadadustat/metabolite(s) Urine
Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Up to 9 Weeks Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4 Time Frame Day 1, Day 4

Browse Conditions

Sequence: 193486247 Sequence: 193486248
Mesh Term Liver Diseases Mesh Term Digestive System Diseases
Downcase Mesh Term liver diseases Downcase Mesh Term digestive system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48319190
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Akebia Therapeutics

Overall Officials

Sequence: 29285298
Role Study Director
Name Akebia Therapeutics
Affiliation Akebia Therapeutics

Design Group Interventions

Sequence: 68148995
Design Group Id 55593065
Intervention Id 52485364

Eligibilities

Sequence: 30765285
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria (All groups):

Male or female subjects between ≥18 years and ≤70 years of age
Have a body weight ≥45 kg and body mass index (BMI) ≥18.5 kg/m2 to 40.0 kg/m2

Additional Group-Specific Inclusion Criteria:

Group 1 (Moderate Hepatic Impairment Subjects):

Presence of Moderate hepatic impairment (Child-Pugh Class B)

Group 2 (Normal Hepatic Function Subjects):

Normal hepatic function

Group 3 (Mild Hepatic Impairment Subjects):

Presence of mild hepatic impairment ( Child-Pugh Class A)

Exclusion Criteria (all groups):

Renal impairment ≥ Stage 3 (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) study equation)
Any history of active malignancy within 2 years prior to or during screening, except for treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ; any history of tuberculosis and/or prophylaxis for tuberculosis
Positive test for human immunodeficiency virus (HIV) antibody at Screening.
Hepatic or other organ or cell transplant
Subjects with alcoholic cirrhosis must be sober for a minimum of 6 months

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253878068
Number Of Facilities 2
Registered In Calendar Year 2018
Actual Duration 4
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 18

Designs

Sequence: 30511452
Intervention Model Sequential Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26673676
Intervention Id 52485364
Name AKB-6548

Responsible Parties

Sequence: 28877746
Responsible Party Type Sponsor

]]>

<![CDATA[ Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients ]]>
https://zephyrnet.com/NCT03799835
2019-01-17

https://zephyrnet.com/?p=NCT03799835
NCT03799835https://www.clinicaltrials.gov/study/NCT03799835?tab=tableMaggy Chaussonm-chausson@unicancer.fr+33185343112This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.

The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free survival.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-05-31
Start Month Year January 17, 2019
Primary Completion Month Year April 1, 2024
Verification Month Year May 2022
Verification Date 2022-05-31
Last Update Posted Date 2022-05-31

Detailed Descriptions

Sequence: 20795631
Description ALBAN study will randomize 516 patients in 45 centers in Europe (France, Belgium and Spain), according to a ratio 1:1 in the following arms of treatment:

Arm A (control arm): BCG only
Arm B (experimental arm): BCG+ atezolizumab

The are two factors of stratifications (center and CIS).

Facilities

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Status Active, not recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Recruiting Status Active, not recruiting Status Recruiting Status Recruiting Status Recruiting Status Not yet recruiting Status Recruiting Status Recruiting Status Not yet recruiting Status Not yet recruiting Status Not yet recruiting
Name Groupe Jolimont – Hôpital de Jolimont Name AZ Delta – Campus Rumbeke Name Centre Hospitalier Universitaire Angers Name Centre Hospitalier Universitaire Bordeaux Name Hôpital G. Montpied Name Clinique Claude Bernard Name CHU Grenoble Name Hôpital privé Toulon – Sainte Marguerite Name Hôpital du Kremlin-Bicêtre Name Hôpital Saint Vincent Name Hôpital privé de la Louvière Name Hôpital Saint Philibert Name Insitut Paoli Calmette Name Centre Hospitalier Universitaire Marseille Name Centre Hospitalier Universitaire Nîmes Name Hôpital européen Georges Pompidou Name Hôpital Saint Louis Name Groupe Hospitalier Paris Saint Joseph Name Hôpital Cochin Name Institut Mutualiste Montsouris Name Centre Hospitalier Universitaire Tenon Name Hôpital Diaconesses- Croix Saint Simon Name Hôpital La Pitié Salpétrière Name Centre Hospitalier Universitaire Lyon Sud Name Centre CARIO-HPCA Name Centre Hospitalier Universitaire Rennes Name Hôpitaux d'instruction des armées Begin Name Hôpital Foch Name Hôpitaux Leman Name Institut Claudius Regaud Name Centre Hospitalier Universitaire Tours Name Institut Gustave Roussy Name Hospital Universitario A Coruña Name Hospital Universitario de Jerez de la Frontera Name Hospital Universitario Ramon y Cajal Name Hospital Universitario La Paz Name Hospital General Universitario Morales Meseguer Name Hospital Universitario de Canarias
City Haine Saint Paul City Roeselare City Angers City Bordeaux City Clermont-Ferrand City Ermont City Grenoble City Hyères City Le Kremlin-Bicêtre City Lille City Lille City Lomme City Marseille City Marseille City Nîmes City Paris City Paris City Paris City Paris City Paris City Paris City Paris City Paris City Pierre-Bénite City Plérin City Rennes City Saint-Mandé City Suresnes City Thonon-les-Bains City Toulouse City Tours City Villejuif City A Coruña City Cadiz City Madrid City Madrid City Murcia City Santa Cruz De Tenerife
Zip 7100 Zip 8800 Zip 49933 Zip 33000 Zip 63003 Zip 95120 Zip 38043 Zip 83400 Zip 94270 Zip 59020 Zip 59800 Zip 59462 Zip 13009 Zip 13354 Zip 30900 Zip 75010 Zip 75010 Zip 75014 Zip 75014 Zip 75014 Zip 75020 Zip 75020 Zip 75651 Zip 69130 Zip 22198 Zip 35033 Zip 94160 Zip 92150 Zip 74200 Zip 31059 Zip 3700 Zip 94805 Zip 15006 Zip 11009 Zip 28034 Zip 28046 Zip 30008 Zip 38320
Country Belgium Country Belgium Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country France Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain

Facility Contacts

Sequence: 28213718 Sequence: 28213719 Sequence: 28213720 Sequence: 28213721 Sequence: 28213722 Sequence: 28213723 Sequence: 28213724 Sequence: 28213725 Sequence: 28213726 Sequence: 28213727 Sequence: 28213728 Sequence: 28213729 Sequence: 28213730 Sequence: 28213731 Sequence: 28213732 Sequence: 28213733 Sequence: 28213734 Sequence: 28213735 Sequence: 28213736 Sequence: 28213737 Sequence: 28213738 Sequence: 28213739 Sequence: 28213740 Sequence: 28213741 Sequence: 28213742 Sequence: 28213743 Sequence: 28213744 Sequence: 28213745 Sequence: 28213746 Sequence: 28213747 Sequence: 28213748 Sequence: 28213749 Sequence: 28213750 Sequence: 28213751 Sequence: 28213752 Sequence: 28213753 Sequence: 28213754 Sequence: 28213755 Sequence: 28213756 Sequence: 28213757 Sequence: 28213758 Sequence: 28213759 Sequence: 28213760 Sequence: 28213761 Sequence: 28213762 Sequence: 28213763 Sequence: 28213764 Sequence: 28213765 Sequence: 28213766 Sequence: 28213767 Sequence: 28213768 Sequence: 28213769 Sequence: 28213770 Sequence: 28213771 Sequence: 28213772 Sequence: 28213773 Sequence: 28213774 Sequence: 28213775 Sequence: 28213776 Sequence: 28213777
Facility Id 200760784 Facility Id 200760785 Facility Id 200760785 Facility Id 200760786 Facility Id 200760786 Facility Id 200760787 Facility Id 200760787 Facility Id 200760788 Facility Id 200760788 Facility Id 200760789 Facility Id 200760789 Facility Id 200760790 Facility Id 200760790 Facility Id 200760791 Facility Id 200760792 Facility Id 200760792 Facility Id 200760793 Facility Id 200760793 Facility Id 200760794 Facility Id 200760794 Facility Id 200760795 Facility Id 200760795 Facility Id 200760796 Facility Id 200760796 Facility Id 200760797 Facility Id 200760797 Facility Id 200760798 Facility Id 200760798 Facility Id 200760799 Facility Id 200760799 Facility Id 200760800 Facility Id 200760801 Facility Id 200760801 Facility Id 200760802 Facility Id 200760802 Facility Id 200760803 Facility Id 200760803 Facility Id 200760804 Facility Id 200760804 Facility Id 200760805 Facility Id 200760805 Facility Id 200760806 Facility Id 200760806 Facility Id 200760807 Facility Id 200760807 Facility Id 200760808 Facility Id 200760809 Facility Id 200760809 Facility Id 200760810 Facility Id 200760812 Facility Id 200760813 Facility Id 200760813 Facility Id 200760814 Facility Id 200760815 Facility Id 200760816 Facility Id 200760817 Facility Id 200760818 Facility Id 200760819 Facility Id 200760819 Facility Id 200760820
Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type primary Contact Type primary Contact Type primary Contact Type primary Contact Type backup Contact Type primary
Name Lieven Goeman, MD Name Souhil Lebdai, MD Name MD Name Grégoire Robert, MD Name Marine Gross-Goupil, MD Name Laurent Guy, MD Name MD Name Laurent Thomas, MD Name Julie Giroud, MD Name Jean-Luc Descotes, MD-PHD Name Mathieu Laramas, MD Name Mael Martin, MD Name Philippe Bernard, MD Name Jacques Irani, MD Name Jean-Louis Bonnal Name Sylvie Berger Name Pierre Colin, MD Name Olvier Romano, MD Name Jean-Louis Bonnal Name Sylvie Berger Name Géraldine Pignot, MD Name Gwenaelle Gravis, MD Name Eric LECHEVALLIER, MD Name Jean-Laurent DEVILLE, MD Name Stéphane Droupy, MD Name Nadine Houédé, MD Name Marc-Olivier Timsit, MD Name Constance Thibault, MD Name Alexandra Masson-Lecomte, MD Name Hélène Gautier, MD Name Xavier Durand Name Nicolas Barry Delongchamps, MD Name Olivier Huillard Name Rafael Sanchez-Salas, MD Name Mostefa Bennamoun, MD Name Olivier Traxer, MD Name Ahmed Khalil, MD Name Philippe Sebe, MD Name Camille Serrate, MD Name Morgan Roupret, MD-PHD Name Baptiste Abbar, MD Name Alain Ruffion, MD Name Denis Maillet, MD Name Luc Corbel Name Dominique Besson Name Romain Mathieu, MD Name Hugo Picchi, MD Name Marie Dusaud, MD-PHD Name Yann Neuzillet, MD-PHD Name Damien Pouessel, MD Name Franck Bruyère, MD Name Claude Linassier, MD Name Yohann Loriot, MD Name Sara Martinez Breijo, MD Name Álvaro Juárez Soto, MD Name Álvaro Sánchez González, MD Name Mario Álvarez Maestro, MD Name Tomás Fernández Aparicio, MD Name Marta Zafra Poves, MD Name Ana Cristina Plata Bello, MD

Browse Interventions

Sequence: 96350077 Sequence: 96350076 Sequence: 96350078 Sequence: 96350079 Sequence: 96350080 Sequence: 96350081 Sequence: 96350082 Sequence: 96350083 Sequence: 96350084
Mesh Term BCG Vaccine Mesh Term Atezolizumab Mesh Term Immune Checkpoint Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents Mesh Term Adjuvants, Immunologic Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs
Downcase Mesh Term bcg vaccine Downcase Mesh Term atezolizumab Downcase Mesh Term immune checkpoint inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents Downcase Mesh Term adjuvants, immunologic Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52361123
Name Bladder Cancer
Downcase Name bladder cancer

Id Information

Sequence: 40294592 Sequence: 40294593
Id Source org_study_id Id Source secondary_id
Id Value UC-0160/1717 Id Value 2017-004512-19
Id Type EudraCT Number

Countries

Sequence: 42717658 Sequence: 42717659 Sequence: 42717660
Name Belgium Name France Name Spain
Removed False Removed False Removed False

Design Groups

Sequence: 55804330 Sequence: 55804331
Group Type Active Comparator Group Type Experimental
Title Arm A : control arm Title Arm B: experimental arm
Description BCG therapy only

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).

Description BCG therapy + administration of atezolizumab

BCG therapy will be administered in two phases:

induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1)
maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).

Interventions

Sequence: 52671928 Sequence: 52671929
Intervention Type Drug Intervention Type Drug
Name BCG Name Atezolizumab
Description Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac® Description IV perfusion

Design Outcomes

Sequence: 178080901 Sequence: 178080902 Sequence: 178080903 Sequence: 178080904 Sequence: 178080905 Sequence: 178080906 Sequence: 178080907 Sequence: 178080908 Sequence: 178080909
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Recurrence-free survival Measure Progression-free survival Measure Disease-specific survival Measure Overall Survival Measure Disease worsening in each arm Measure Complete response in each arm Measure Complete response among patients with CIS Measure National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Measure Quality of life questionnaire (QLQ): QLQ-C30 questionnaire (EORTC)
Time Frame 2 years Time Frame From randomization to the date of progression, assessed up to 5 years Time Frame From randomization to the date of death, assessed up to 5 years Time Frame From randomization to the date of death, assessed up to 5 years Time Frame From randomization to the date of death, assessed up to 5 years Time Frame 6 weeks and 2 years after randomization Time Frame 6 weeks and 2 years after randomization Time Frame Throughout study completion, assessed up to 5 years Time Frame At randomization, every 12 weeks for years 1 and 2 after randomization, then every 24 weeks for years 3 to 5 after randomization
Description Recurrence is defined as reappearance of disease (local recurrence or occurrence of any metastasis) after the start of therapy. Description Progression- free survival defined as the time from randomization to the date of disease progression defined as increase of stage from Ta to T1 or from CIS to T1; progression to Muscle Invasive Bladder Cancer (T≥ 2) or to lymph node N+ or to distant disease M+; the date of progression being determined by the endoscopic resection (TURBT) for a local relapse or by CT scan in case of non-local relapse. Description Disease-specific survival defined as the time from randomization to the date of death from bladder cancer. Description Overall Survival defined as the time from randomization to the date of death from any cause. Description Disease worsening, defined as cystectomy or change in therapy indicative, including systemic chemotherapy or radiation therapy. The date of diagnosis (cystoscopy or CT scan) leading to cystectomy or chemotherapy will be considered as the time of disease worsening. Description Complete response is assessed by cystoscopy and cytology. Description Complete response is assessed by cystoscopy and cytology. Description The frequency, nature, and severity of adverse events graded according to NCI CTCAE v5.0 and according to the immune-related adverse event (irAE). Description This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Browse Conditions

Sequence: 194209598 Sequence: 194209599 Sequence: 194209600 Sequence: 194209601 Sequence: 194209602 Sequence: 194209603 Sequence: 194209604 Sequence: 194209605 Sequence: 194209606 Sequence: 194209607 Sequence: 194209608 Sequence: 194209609 Sequence: 194209610 Sequence: 194209611 Sequence: 194209612
Mesh Term Urinary Bladder Neoplasms Mesh Term Non-Muscle Invasive Bladder Neoplasms Mesh Term Urologic Neoplasms Mesh Term Urogenital Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Urinary Bladder Diseases Mesh Term Urologic Diseases Mesh Term Male Urogenital Diseases Mesh Term Carcinoma Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type
Downcase Mesh Term urinary bladder neoplasms Downcase Mesh Term non-muscle invasive bladder neoplasms Downcase Mesh Term urologic neoplasms Downcase Mesh Term urogenital neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term urinary bladder diseases Downcase Mesh Term urologic diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term carcinoma Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48496039 Sequence: 48496040
Agency Class OTHER Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name UNICANCER Name Hoffmann-La Roche

Overall Officials

Sequence: 29385645 Sequence: 29385646
Role Principal Investigator Role Principal Investigator
Name Morgan Roupret, MD-PHD Name Yohann Loriot, MD
Affiliation Hôpital Pitié-Salpétrière Affiliation Gustave Roussy, Cancer Campus, Grand Paris

Central Contacts

Sequence: 12056983 Sequence: 12056984
Contact Type primary Contact Type backup
Name Soazig Nénan-Le Ficher Name Maggy Chausson
Phone +33185343113 Phone +33185343112
Email s-nenan@unicancer.fr Email m-chausson@unicancer.fr
Phone Extension +33185343112
Role Contact Role Contact

Design Group Interventions

Sequence: 68408309 Sequence: 68408310 Sequence: 68408311
Design Group Id 55804330 Design Group Id 55804331 Design Group Id 55804331
Intervention Id 52671928 Intervention Id 52671928 Intervention Id 52671929

Eligibilities

Sequence: 30874885
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Signed informed consent form after the last endoscopic surgery (TURBT)
Adult man and women ( age ≥18 years)

Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the following :

T1 tumor and/or
High grade (WHO 2004) and/or
Grade 3 (WHO1973) and/or
Carcinoma in situ (CIS)
Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1

At least one additional (second) resection of the primary tumor has been performed in any of the following cases [without upstaging towards Muscle Invasive Bladder Cancer (EAU guidelines, 2017)] :

T1 tumors at physician's discretion,
incomplete initial TURB,
no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only was found)
Absence of metastasis in pelvis, abdomen, or chest, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan no more than 90 days prior to the first study treatment
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Life expectancy ≥12 weeks
Systolic blood pressure (BP) <160 mmHg and diastolic BP <95 mmHg, as documented within 7 days prior to the first study treatment (hypertension allowed provided it is controlled)

Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment:

absolute neutrophil count (ANC) ≥1500 cells/μL
white blood cell (WBC) counts >2500/μL
Lymphocyte count ≥300/μL
Platelet count ≥100,000/μL
Hemoglobin ≥9.0 g/dL
aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline phosphatase ≤2.5 × the upper limit of normal (ULN)
Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.
Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN
Calculated creatinine clearance ≥20 mL/min (Cockcroft-Gault formula)
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
Patients affiliated to the social security system
Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.

Exclusion Criteria:

Patient having received previous BCG therapy for bladder cancer
Any approved anti-cancer therapy, including systemic chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or oral contraceptives are allowed
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to day 1 of study treatment

Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following:

Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent (radiotherapy and/or prostatectomy) and without prostate-specific antigen (PSA) recurrence are eligible.
Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7 and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years) are eligible provided they meet all of the following criteria: malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.
Pregnancy or breastfeeding
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases)

Patients with a history of autoimmune-related hypothyroidism/hyperthyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan may be eligible.
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Serum albumin <2.5 g/dL
Known HIV infection

Patients with active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test prior the randomisation) or hepatitis C.

Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Known active tuberculosis
Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

Signs or symptoms of urinary infection and/or other signs and symptoms > grade 1 (NCI CTCAE v5.0) within 2 weeks prior to Cycle 1, Day 1

Patients receiving therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 are not eligible
Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.

Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months before Cycle1, Day 1, unstable arrhythmias, or unstable angina.

– Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.

Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
Prior allogeneic stem cell or solid organ transplant

Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study

– Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab).

Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1

Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial

Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study.
The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
Person deprived of their liberty or under protective custody or guardianship

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254059340
Number Of Facilities 38
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 8

Designs

Sequence: 30620677
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26769339 Sequence: 26769340 Sequence: 26769341 Sequence: 26769342
Intervention Id 52671928 Intervention Id 52671928 Intervention Id 52671929 Intervention Id 52671929
Name Bacillus Calmette Guerin (BCG) Medac® Name OncoTice Name MPDL3280A Name Tecentriq®

Responsible Parties

Sequence: 28987208
Responsible Party Type Sponsor

]]>

<![CDATA[ Oral Anticoagulation in Hemodialysis ]]>
https://zephyrnet.com/NCT03799822
2017-05-01

https://zephyrnet.com/?p=NCT03799822
NCT03799822https://www.clinicaltrials.gov/study/NCT03799822?tab=tableNANANAThe investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-11-03
Start Month Year May 1, 2017
Primary Completion Month Year September 15, 2020
Verification Month Year October 2020
Verification Date 2020-10-31
Last Update Posted Date 2020-11-03

Detailed Descriptions

Sequence: 20709988
Description The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.

Facilities

Sequence: 199965069
Name OLV Hospital
City Aalst
Zip 9300
Country Belgium

Browse Interventions

Sequence: 95996897 Sequence: 95996898 Sequence: 95996899 Sequence: 95996900 Sequence: 95996901 Sequence: 95996902 Sequence: 95996903 Sequence: 95996904 Sequence: 95996905 Sequence: 95996906 Sequence: 95996907 Sequence: 95996908 Sequence: 95996909 Sequence: 95996910 Sequence: 95996911 Sequence: 95996912
Mesh Term Vitamin K Mesh Term Rivaroxaban Mesh Term Vitamins Mesh Term Micronutrients Mesh Term Physiological Effects of Drugs Mesh Term Factor Xa Inhibitors Mesh Term Antithrombins Mesh Term Serine Proteinase Inhibitors Mesh Term Protease Inhibitors Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Anticoagulants Mesh Term Antifibrinolytic Agents Mesh Term Fibrin Modulating Agents Mesh Term Hemostatics Mesh Term Coagulants
Downcase Mesh Term vitamin k Downcase Mesh Term rivaroxaban Downcase Mesh Term vitamins Downcase Mesh Term micronutrients Downcase Mesh Term physiological effects of drugs Downcase Mesh Term factor xa inhibitors Downcase Mesh Term antithrombins Downcase Mesh Term serine proteinase inhibitors Downcase Mesh Term protease inhibitors Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term anticoagulants Downcase Mesh Term antifibrinolytic agents Downcase Mesh Term fibrin modulating agents Downcase Mesh Term hemostatics Downcase Mesh Term coagulants
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52139003
Name Atrial Fibrillation
Downcase Name atrial fibrillation

Id Information

Sequence: 40135062
Id Source org_study_id
Id Value OLV 2014/065

Countries

Sequence: 42542686
Name Belgium
Removed False

Design Groups

Sequence: 55559344 Sequence: 55559345 Sequence: 55559346
Group Type Active Comparator Group Type Experimental Group Type Experimental
Title Control Title rivaroxaban Title rivaroxaban + K2
Description Hemodialysis patients with non valvular atrial fibrillation receiving warfarin Description Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od Description Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements

Interventions

Sequence: 52454908 Sequence: 52454909 Sequence: 52454910
Intervention Type Drug Intervention Type Dietary Supplement Intervention Type Drug
Name Rivaroxaban 10 MG Oral Tablet Name MK-7 2000µg thrice weekly Name Vitamin K Antagonist – Drug
Description replacement of warfarin by rivaroxaban Description dietary supplement of vitamin K2 MK-7 2000µg thrice weekly Description treatment with a vitamin K antagonist

Keywords

Sequence: 79822817 Sequence: 79822818 Sequence: 79822819
Name hemodialysis Name rivaroxaban Name vitamin K2
Downcase Name hemodialysis Downcase Name rivaroxaban Downcase Name vitamin k2

Design Outcomes

Sequence: 177263638 Sequence: 177263639 Sequence: 177263640
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure composite of fatal and non-fatal stroke and other cardiovascular events Measure death rate Measure safety: incidence of life-threatening, major and minor bleeding
Time Frame through study completion, on average 3 years Time Frame through study completion, on average 3 years Time Frame through study completion, on average 3 years
Description composite of fatal and non-fatal stroke and other cardiovascular events Description cause of death Description incidence of life-threatening, major and minor bleeding

Browse Conditions

Sequence: 193366519 Sequence: 193366520 Sequence: 193366521 Sequence: 193366522 Sequence: 193366523
Mesh Term Atrial Fibrillation Mesh Term Arrhythmias, Cardiac Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases Mesh Term Pathologic Processes
Downcase Mesh Term atrial fibrillation Downcase Mesh Term arrhythmias, cardiac Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290708
Agency Class OTHER
Lead Or Collaborator lead
Name Onze Lieve Vrouw Hospital

Overall Officials

Sequence: 29268531
Role Principal Investigator
Name Rogier Caluwe, MD
Affiliation OLV Hospital Aalst, Belgium

Design Group Interventions

Sequence: 68107453 Sequence: 68107454 Sequence: 68107455 Sequence: 68107456
Design Group Id 55559345 Design Group Id 55559346 Design Group Id 55559346 Design Group Id 55559344
Intervention Id 52454908 Intervention Id 52454908 Intervention Id 52454909 Intervention Id 52454910

Eligibilities

Sequence: 30747722
Gender All
Minimum Age 18 Years
Maximum Age 100 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

inclusion in the trial with clinicaltrials.gov identifier NCT02610933
signed informed consent for this extension trial

Exclusion Criteria:

none

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121851
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 41
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 100
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30494005
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28860285
Responsible Party Type Principal Investigator
Name Rogier Caluwe
Title Principal Investigator
Affiliation Onze Lieve Vrouw Hospital

Study References

Sequence: 52032730
Pmid 33753537
Reference Type derived
Citation De Vriese AS, Caluwe R, Van Der Meersch H, De Boeck K, De Bacquer D. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial. J Am Soc Nephrol. 2021 Jun 1;32(6):1474-1483. doi: 10.1681/ASN.2020111566. Epub 2021 Mar 22.

]]>

<![CDATA[ Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma ]]>
https://zephyrnet.com/NCT03799809
2016-12-01

https://zephyrnet.com/?p=NCT03799809
NCT03799809https://www.clinicaltrials.gov/study/NCT03799809?tab=tableSACHIN D, MDsachinmedico@gmail.com8129840208Pulmonary aspergillomas are a common cause of recurrent hemoptysis which may be moderate to severe in 2 to 50 % of cases and may be life threatening. Surgical resection, though curative, may not be feasible in significant number of patients and also associated significant post op complications. Bronchial artery embolisation (BAE) is effective for acute control of hemoptysis, however recurrences may occur in upto a quarter of subjects over a 1 year period.

Aspergilloma is caused by a fungus hence systemic antifungals seem appropriate choice. However the fungus only partially touch the walls of the cavities containing them and rarely come into contact with the bloodstream. This is the major reason why the systemic administration of antifungal agents is ineffective in eradicating the condition.

If surgical resection is not a treatment option to control recurrent hemoptysis, instillation of antifungal agents in an aspergilloma cavity could be considered(QoE II).The instillation of antifungal directly into the cavity (intra-cavitatory) containing aspergilloma brings the drug in contact with the fungus. Thus may lead to antifungal action and shrinkage or complete disappearance of aspergilloma. This can be achieved either by percutaneous route or bronchoscopically. Percutaneous approaches have been investigated however they can sometimes cause fungal spread in thoracic space resulting in fungal empyema which should be carefully avoided. Endobronchial instillation of antifungals have been investigated and found to be safe and effective in controlling hemoptysis, however published data comprise of case reports or small case series.

Recently we have published our experience of intrabronchial voriconazole in aspergilloma among 82 patients and found to be safe and effective in hemoptysis control, with transient post procedure cough as an adverse effect with no major serious adverse events. Multiple small studies and case reports have published the safety and efficacy of voriconazole. However, a quality data in the form of randomized controlled trial (RCT) is not there. Therefore, we planned this RCT to assess the efficacy of intrabronchial voriconazole in inoperable aspergilloma.
<![CDATA[

Studies

Study First Submitted Date 2018-10-20
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year December 1, 2016
Primary Completion Month Year December 30, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20727129
Description Primary Objective : To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable symptomatic pulmonary aspergilloma.

Secondary Objectives:

To compare the percentage of patients who have complete cessation of hemoptysis after 3 months.
To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up.
To compare the severity of hemoptysis during recurrence in both groups.
To compare the change in size of aspergilloma after 3 – 6 months following last intrabronchial voriconazole instillation.
To compare the percentage of patients who need BAE during anytime till 3 – 6months.
To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and recurrent respiratory infections.

Number of Patients: 30 patients in each arm (Intrabronchial voriconazole with Standard medical therapy vs Standard medical therapy alone)

Study Design : Prospective Randomized control study

Dosages of drug – 400 mg iv preparation of Voriconazole every week for 4 sessions

Duration of follow-up – 3-6 months

Brief Methodology: Patients with aspergilloma who presented with hemoptysis will be screened for inclusion in the study. Diagnosis of aspergilloma will be based on characteristic computed tomography (CT) features with microbiological or serological evidence of Aspergillus (Aspergillus specific Ig G). The patients fulfilling the inclusion criteria will be taken informed consent and randomized into one of the two arms of intervention.

Arm 1: Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy.

Arm 2: Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician)

All subjects in arm 1 will undergo fiberoptic bronchoscopy (FOB) following standard protocol under local anesthesia with supplemental oxygen and continuous hemodynamic monitoring. After identifying the segmental/sub-segmental bronchus of interest (as identified by CT) or cavity (if visible) the study drug voriconazole, will be instilled. The bronchoscope will be kept wedged for 60 seconds to prevent back leakage of the solution and then slowly withdrawn without applying suction. The patient will be kept in right or left lateral position (depending on the side of involvement) for the next 20 minutes. Following this patients will be observed for 48 hours for cessation of hemoptysis before discharge. The procedure will be done on day 1 of each week for 4 weeks in arm 1.

All patients will receive standard medical treatment for hemoptysis including appropriate positioning, airway protection, blood product transfusions, antitussives, tranexamic acid, and antimicrobial therapy as clinically indicated. BAE shall be offered to all patients if indicated.

Mild hemoptysis shall be defined as < 50 ml in 24 hrs, moderate hemoptysis as 50-200 ml in 24 hrs and massive hemoptysis as 200-600 ml in 24 hrs or any amount causing hemodynamic compromise/threatening ventilation.

Records will be reviewed regarding demographics, primary etiology leading to fibrocavitary disease, duration and severity of hemoptysis/ other constitutional symptoms, extent of disease (unilateral, bilateral, associated pleural or parenchymal changes), simple vs complex aspergilloma. Size of index aspergilloma. The number of patients requiring emergency or hospital admission due to recurrent hemoptysis, and subsequent treatment details will be recorded.

All patients will be followed up for 3-6 months. During follow up patients will be assessed for symptoms and severity, successful cessation of hemoptysis, requirement of BAE due to persistent or increased hemoptysis, number of sessions required for symptomatic improvement/cessation of hemoptysis, hemoptysis-free interval, recurrence of hemoptysis will be noted. Pre and post procedure CT scans (low dose limited CT through aspergilloma) will be compared by an independent radiologist blinded to the clinical outcome. Size of index aspergilloma shall be determined by addition of maximum diameter of largest length and width of the visible lesion. CTs shall be compared for documenting change in the size of index aspergilloma and decrease/disappearance of the cavity. On the basis of these parameters, aspergillomas will be described as no interval change, increased or decreased aspergilloma size, or disappearance and emptying of the cavity.

Outcomes in the form of reduction/cessation of hemoptysis, decrease in size of aspergilloma, overall symptomatic improvement and mortality shall be recorded.

Facilities

Sequence: 200159067
Status Recruiting
Name All India Institute of Medical Sciences
City New Delhi
State Delhi
Zip 110029
Country India

Facility Contacts

Sequence: 28113704
Facility Id 200159067
Contact Type primary
Name Sachin D, MD
Email sachinmedico@gmail.com
Phone 8129840208

Browse Interventions

Sequence: 96074006 Sequence: 96074007 Sequence: 96074008 Sequence: 96074009 Sequence: 96074010 Sequence: 96074011 Sequence: 96074012 Sequence: 96074013 Sequence: 96074014 Sequence: 96074015 Sequence: 96074016 Sequence: 96074017
Mesh Term Voriconazole Mesh Term Antifungal Agents Mesh Term Anti-Infective Agents Mesh Term 14-alpha Demethylase Inhibitors Mesh Term Cytochrome P-450 Enzyme Inhibitors Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Steroid Synthesis Inhibitors Mesh Term Hormone Antagonists Mesh Term Hormones, Hormone Substitutes, and Hormone Antagonists Mesh Term Physiological Effects of Drugs Mesh Term Cytochrome P-450 CYP3A Inhibitors
Downcase Mesh Term voriconazole Downcase Mesh Term antifungal agents Downcase Mesh Term anti-infective agents Downcase Mesh Term 14-alpha demethylase inhibitors Downcase Mesh Term cytochrome p-450 enzyme inhibitors Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term steroid synthesis inhibitors Downcase Mesh Term hormone antagonists Downcase Mesh Term hormones, hormone substitutes, and hormone antagonists Downcase Mesh Term physiological effects of drugs Downcase Mesh Term cytochrome p-450 cyp3a inhibitors
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52185349
Name Aspergilloma
Downcase Name aspergilloma

Id Information

Sequence: 40168982
Id Source org_study_id
Id Value AIIMS SACHIN

Countries

Sequence: 42580592
Name India
Removed False

Design Groups

Sequence: 55608992 Sequence: 55608993
Group Type Active Comparator Group Type No Intervention
Title Voriconazole Title Control
Description Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy. Description Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician)

Interventions

Sequence: 52499315
Intervention Type Drug
Name Intrabronchial Voriconazole instillation
Description Efficacy of intrabronchial voriconazole instillation for inoperable pulmonary aspergilloma

Design Outcomes

Sequence: 177431653 Sequence: 177431654 Sequence: 177431655 Sequence: 177431656 Sequence: 177431657 Sequence: 177431658 Sequence: 177431659
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months. Measure To compare the percentage of patients who have complete cessation of hemoptysis after 3 months. Measure To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up. Measure To compare the severity of hemoptysis during recurrence in both groups. Measure To compare the change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. Measure To compare the percentage of patients who need BAE during anytime till 3 months. Measure To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis.
Time Frame 3 months follow up Time Frame 3 months follow up Time Frame 3 months follow up Time Frame 3 months follow up Time Frame 3 months follow up Time Frame 3 months follow up Time Frame 3 months follow up
Description Percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months. Description percentage of patients who have complete cessation of hemoptysis after 3 months. Description percentage of patients having recurrence of hemoptysis during 3 months follow up. Description severity of hemoptysis during recurrence in both groups shall be compared with visual analogue scale. Description change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. Description percentage of patients who need BAE during anytime till 3 months. Description percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis.

Sponsors

Sequence: 48332215
Agency Class OTHER
Lead Or Collaborator lead
Name All India Institute of Medical Sciences, New Delhi

Central Contacts

Sequence: 12012276
Contact Type primary
Name SACHIN D, MD
Phone 8129840208
Email sachinmedico@gmail.com
Role Contact

Design Group Interventions

Sequence: 68168032
Design Group Id 55608992
Intervention Id 52499315

Eligibilities

Sequence: 30773509
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Patients with mild to moderate hemoptysis AND inoperable aspergilloma/ those unwilling for surgery.
Who have no contra-indication of flexible fibre-optic bronchoscopy
Age > 18 yrs AND
Given the written informed consent to participate in the study.

Exclusion Criteria:

Patient who are not fit for FOB (e.g. hemodynamic instability)
Patient who have life threatening hemoptysis requiring immediate bronchial artery embolization
Patients who have underwent BAE in last 3 months
Pregnant woman

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253952452
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30519640
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28885941
Responsible Party Type Principal Investigator
Name DR SACHIN D
Title senior resident
Affiliation All India Institute of Medical Sciences, New Delhi

]]>

<![CDATA[ Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanics With Type 2 Diabetes ]]>
https://zephyrnet.com/NCT03799796
2019-01-06

https://zephyrnet.com/?p=NCT03799796
NCT03799796https://www.clinicaltrials.gov/study/NCT03799796?tab=tableNANANACurrently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.
<![CDATA[

Studies

Study First Submitted Date 2019-01-09
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-10-22
Start Month Year January 6, 2019
Primary Completion Month Year July 27, 2020
Verification Month Year October 2020
Verification Date 2020-10-31
Last Update Posted Date 2020-10-22

Detailed Descriptions

Sequence: 20716258
Description Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. FGM involves wearing an interstitial glucose sensor that is placed on the upper arm and a reader. When an individual wants to check their glucose level, they waive or scan the reader over their sensor and a glucose history, current glucose level, and projected glucose trend is displayed. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.

Little is known about the uses, benefits, and limitations of online peer support in the context of learning how to use diabetes technology, such as FGM. Hispanic, Spanish speaking individuals are at high risk for T2D and associated morbidity and mortality. Hispanics are more likely to die from diabetes compared to Caucasian counterparts. The investigators propose to address gaps in diabetes care for Hispanic individuals by conducting a pilot trial of an online peer support intervention using an online peer facilitator to augment the use of FGM. The online peer facilitator will be Hispanic and bilingual in English and Spanish with substantial knowledge of diabetes and FGM. Our intervention is culturally appropriate to address the biobehavioral and biopsychosocial needs of Hispanic individuals. The investigators anticipate the additional support provided by the online peer facilitator will encourage healthy eating habits and physical activity behaviors in Hispanic individuals with T2D. Our research team is experienced with community-based participatory research in both diabetes online peer support communities and Hispanic populations using technology to support T2D.

Examining online peer support communities to augment diabetes care in Hispanic Spanish speaking individuals is a promising, exciting, and innovative area of research that has not yet been explored. This proposed study contains several novel components. First, using online peer support communities is low-cost and easily accessible, making this intervention more translatable in the clinical setting while adding to the toolkit that already exists for diabetes care. Second, using FGM in a population not using insulin is forward thinking. Empowering people with their own glucose data, early in the course of their diabetes, may change the trajectory of diabetes management. The research team received PCORI pipeline-to-proposal funding (tiers I-III) to develop a research question via a community advisory board (CAB) in partnership with the diabetes online peer support community. The CAB included researchers, clinicians, and people with diabetes, both English and Spanish speaking. This study will address important questions identified by people affected by diabetes.

Aim 1 Explore the relationship between engagement in an online peer support intervention with clinical and behavioral outcomes in Hispanic, Spanish speaking individuals with T2D using flash glucose monitoring for 12 weeks

Method. A one group, pre-post evaluation of Hispanic, Spanish speaking individuals (N=43) recruited from a health center in Utah.

Primary outcome: Time-in-range (average glucose level and number of minutes in 70mg/dl-180mg/dl in last 10 days of the study minus average glucose level and number of minutes in 70mg/dl-180mg/dl for 10 days baseline) between baseline and 12 weeks.

Secondary outcomes: Change in A1C from baseline to 12 weeks. Online peer support engagement (measured by survey and Facebook activity), Frequency of FGM scans. Change in self-reported self-management behaviors, self-efficacy and quality of life between baseline and 12 weeks.

Hypothesis. Increased engagement in the online peer support intervention will be associated with improved clinical, behavioral and psychosocial outcomes after 12 weeks of FGM.

Aim 2. Evaluate the acceptability and feasibility of an online peer support intervention for Hispanic Spanish speaking individuals with T2D to learn how to use flash glucose monitoring to make changes to meal and activity choices.

Method. Qualitative and quantitative analysis for measures of use of and satisfaction with flash glucose sensors, eligible participant acceptance of flash glucose sensors, and dropout rates, including causes for drop out, and online peer support engagement through platform analytics. A semi-structured interview will be conducted with participants at the end of the intervention explore their experiences during engagement with the online peer support community.

Hypothesis. Online peer support engagement will be associated with satisfaction with FGM and number of daily scans.

Facilities

Sequence: 200053118
Name University of Utah College of Nursing
City Salt Lake City
State Utah
Zip 841112
Country United States

Conditions

Sequence: 52156372
Name Diabetes Mellitus, Type 2
Downcase Name diabetes mellitus, type 2

Id Information

Sequence: 40148147
Id Source org_study_id
Id Value ADC-SRR-IIS-18-23

Countries

Sequence: 42557673
Name United States
Removed False

Design Groups

Sequence: 55577805
Group Type Experimental
Title Flash Glucose Monitoring with Online Peer Support
Description Pre-Test-Post-Test

Interventions

Sequence: 52471915
Intervention Type Behavioral
Name Flash Glucose Monitoring with Online Peer Support
Description Hispanic Adults who are Spanish-Speaking with type 2 diabetes who are not using insulin will be asked to use flash glucose monitoring and to sign up for an moderated online peer support group where they can ask questions and share progress.

Keywords

Sequence: 79847961 Sequence: 79847962 Sequence: 79847963 Sequence: 79847964
Name flash glucose monitoring Name online peer support Name Hispanic Name Spanish-Speaking
Downcase Name flash glucose monitoring Downcase Name online peer support Downcase Name hispanic Downcase Name spanish-speaking

Design Outcomes

Sequence: 177327598 Sequence: 177327599 Sequence: 177327600
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Time-in-Range Measure A1C Measure Online peer support engagement
Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks
Description Average glucose level and number of minutes spent between 70-180 mg/dL Description Glycosylated hemoglobin Description Survey, Activity in online peer support group

Browse Conditions

Sequence: 193431739 Sequence: 193431740 Sequence: 193431741 Sequence: 193431742 Sequence: 193431743
Mesh Term Diabetes Mellitus Mesh Term Diabetes Mellitus, Type 2 Mesh Term Glucose Metabolism Disorders Mesh Term Metabolic Diseases Mesh Term Endocrine System Diseases
Downcase Mesh Term diabetes mellitus Downcase Mesh Term diabetes mellitus, type 2 Downcase Mesh Term glucose metabolism disorders Downcase Mesh Term metabolic diseases Downcase Mesh Term endocrine system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48305973 Sequence: 48305974
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Utah Name La Trobe University

Overall Officials

Sequence: 29277883
Role Principal Investigator
Name Michelle L Litchman, PhD, FNP-BC
Affiliation University of Utah College of Nursing

Design Group Interventions

Sequence: 68130750
Design Group Id 55577805
Intervention Id 52471915

Eligibilities

Sequence: 30757299
Gender All
Minimum Age 21 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Age ≥21 years
Self-report as Hispanic
Able to communicate in Spanish
Clinical diagnosis of T2D and HbA1c ≥8% per clinic records
Willing to wear a flash glucose monitor for 12 weeks
Access to the internet and willing to engage in an online peer support community
Willing to avoid Vitamin C 500 mg and Aspirin 325 mg or greater daily
Not using insulin

Exclusion Criteria:

Non-Spanish speaking
Using insulin
Already using a continuous glucose monitor or flash glucose monitor in previous 6 months
Participation in other diabetes clinical trials
Alcohol or drug abuse/dependency
Severe illness (physical or mental health), cognitive impairment, high dose steroids, hospitalized more than 2 times in past 12 months or other impairment that would, in the opinion of the investigators, interfere with ability to complete the study
Uncorrected hearing or vision impairment
Life expectancy <6 months

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254225709
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 18
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 21
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30503524
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26665857
Intervention Id 52471915
Name Abbott Freestyle Libre

Responsible Parties

Sequence: 28869802
Responsible Party Type Principal Investigator
Name Michelle Litchman
Title Assistant Professor
Affiliation University of Utah

Study References

Sequence: 52049347
Pmid 35200153
Reference Type derived
Citation Ng AH, Greenwood DA, Iacob E, Allen NA, Ferrer M, Rodriguez B, Litchman ML. Examining a Continuous Glucose Monitoring Plus Online Peer Support Community Intervention to Support Hispanic Adults With Type 2 Diabetes: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2022 Feb 24;11(2):e31595. doi: 10.2196/31595.

]]>

<![CDATA[ The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders ]]>
https://zephyrnet.com/NCT03799783
2018-03-01

https://zephyrnet.com/?p=NCT03799783
NCT03799783https://www.clinicaltrials.gov/study/NCT03799783?tab=tableNANANAChildren’s compliance during diagnostic or therapeutic procedures is a challenge, often requiring the use of sedative and/or analgesic drugs.

Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time, the use of any drug for sedation may affect the exam through an interference with EEG waves. Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.

The aim of this interventional study is to evaluate the effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.

Children affected by behavioral disorders and requiring sedation to perform EEG were considered. The protocol establishes to administer IV dexmedetomidine (loading dose and continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale = 2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the offset.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-02-02
Start Month Year March 1, 2018
Primary Completion Month Year February 28, 2019
Verification Month Year January 2021
Verification Date 2021-01-31
Last Update Posted Date 2021-02-02
Results First Posted Date 2021-01-15

Detailed Descriptions

Sequence: 20563345
Description Compliance during diagnostic or therapeutic procedures is a very frequent challenge in children. Procedural sedation and analgesia represents an effective answer to this problem. Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period. Whereas the majority of children carry out this procedure without sedation, patients with behavioral problems, who frequently need to rule out the presence of seizures as associated symptoms or different disease, often show an insufficient compliance. Sedative drugs usually interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.

The aim of this interventional study is to evaluate effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.

Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova and required sedation to perform EEG were considered in the study.

The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete. The loading dose can be repeated up to two times, if needed, to achieve the targeted level of Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the complete awake of the patient. The quality of the EEG pattern was also evaluated. Occurrence and type of adverse events are registered during this period. Finally, the caregivers' opinion about the quality of the sedation and the presence of any sleep disturbance at home during the next 12 hours after the procedure were considered.

Facilities

Sequence: 198529678
Name Pediatric Intensive Care Unit – Department of Woman's and Child's Health – Azienda Ospedaliera di Padova
City Padova
State PD
Country Italy

Browse Interventions

Sequence: 95247284 Sequence: 95247285 Sequence: 95247286 Sequence: 95247287 Sequence: 95247288 Sequence: 95247289 Sequence: 95247290 Sequence: 95247291 Sequence: 95247292 Sequence: 95247293 Sequence: 95247294 Sequence: 95247295 Sequence: 95247296 Sequence: 95247297
Mesh Term Dexmedetomidine Mesh Term Hypnotics and Sedatives Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Analgesics, Non-Narcotic Mesh Term Analgesics Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents Mesh Term Adrenergic alpha-2 Receptor Agonists Mesh Term Adrenergic alpha-Agonists Mesh Term Adrenergic Agonists Mesh Term Adrenergic Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term dexmedetomidine Downcase Mesh Term hypnotics and sedatives Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term analgesics, non-narcotic Downcase Mesh Term analgesics Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term adrenergic alpha-2 receptor agonists Downcase Mesh Term adrenergic alpha-agonists Downcase Mesh Term adrenergic agonists Downcase Mesh Term adrenergic agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51763891 Sequence: 51763892
Name Procedural Sedation Name Behavior Disorders
Downcase Name procedural sedation Downcase Name behavior disorders

Id Information

Sequence: 39832893
Id Source org_study_id
Id Value 4422/AO/18

Countries

Sequence: 42232503
Name Italy
Removed False

Design Groups

Sequence: 55184878
Group Type Experimental
Title Dexmedetomidine
Description 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion

Interventions

Sequence: 52085223
Intervention Type Drug
Name dexmedetomidine
Description To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete

Keywords

Sequence: 79197219 Sequence: 79197220
Name dexmedetomidine Name sedation
Downcase Name dexmedetomidine Downcase Name sedation

Design Outcomes

Sequence: 176067587 Sequence: 176067588
Outcome Type primary Outcome Type secondary
Measure Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) Measure Number of Patients With Adverse Events
Time Frame 10 minutes Time Frame during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)
Description the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. Description any adverse event potentially related with DEX-administration

Browse Conditions

Sequence: 191843053
Mesh Term Mental Disorders
Downcase Mesh Term mental disorders
Mesh Type mesh-list

Sponsors

Sequence: 47940409
Agency Class OTHER
Lead Or Collaborator lead
Name Azienda Ospedaliera di Padova

Overall Officials

Sequence: 29046343
Role Principal Investigator
Name angela amigoni, MD
Affiliation azienda Ospedaliera di Padova-Pediatric Intensive Care Unit

Design Group Interventions

Sequence: 67655734
Design Group Id 55184878
Intervention Id 52085223

Eligibilities

Sequence: 30527023
Gender All
Minimum Age 1 Month
Maximum Age 18 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

children affected by behavior disorders who underwent EEG procedure with sedation
written informed consent

Exclusion Criteria:

ASA > 2
hypersensitivity of active substance
therapy with beta blockers or digoxin, arrhythmia

Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254094507
Number Of Facilities 1
Number Of Nsae Subjects 10
Registered In Calendar Year 2019
Actual Duration 12
Were Results Reported True
Months To Report Results 21
Has Us Facility False
Has Single Facility True
Minimum Age Num 1
Maximum Age Num 18
Minimum Age Unit Month
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30275912
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Drug administration by a loading dose followed by continuous infusion during a procedure

Intervention Other Names

Sequence: 26476415
Intervention Id 52085223
Name dexdor

Milestones

Sequence: 40755998 Sequence: 40755999 Sequence: 40756000
Result Group Id 55828807 Result Group Id 55828807 Result Group Id 55828807
Ctgov Group Code FG000 Ctgov Group Code FG000 Ctgov Group Code FG000
Title STARTED Title COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study
Count 19 Count 19 Count 0

Participant Flows

Sequence: 3898056

Outcome Counts

Sequence: 73518951 Sequence: 73518952
Outcome Id 30605227 Outcome Id 30605228
Result Group Id 55828808 Result Group Id 55828808
Ctgov Group Code OG000 Ctgov Group Code OG000
Scope Measure Scope Measure
Units Participants Units Participants
Count 19 Count 19

Provided Documents

Sequence: 2566077
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2020-02-20
Url https://ClinicalTrials.gov/ProvidedDocs/83/NCT03799783/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27772330 Sequence: 27772331 Sequence: 27772332
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000
Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 10 Subjects Affected 0
Subjects At Risk 19 Subjects At Risk 19 Subjects At Risk 19
Created At 2023-08-06 14:32:18.993223 Created At 2023-08-06 14:32:18.993223 Created At 2023-08-06 14:32:18.993223
Updated At 2023-08-06 14:32:18.993223 Updated At 2023-08-06 14:32:18.993223 Updated At 2023-08-06 14:32:18.993223

Reported Events

Sequence: 524310152 Sequence: 524310153
Result Group Id 55828809 Result Group Id 55828809
Ctgov Group Code EG000 Ctgov Group Code EG000
Time Frame 90 minutes Time Frame 90 minutes
Event Type other Event Type other
Subjects Affected 6 Subjects Affected 4
Subjects At Risk 19 Subjects At Risk 19
Description Other (not including serious) adverse events Description Other (not including serious) adverse events
Event Count 6 Event Count 4
Organ System Cardiac disorders Organ System Cardiac disorders
Adverse Event Term hypotension Adverse Event Term bradycardia
Frequency Threshold 0 Frequency Threshold 0
Assessment Systematic Assessment Assessment Systematic Assessment

Responsible Parties

Sequence: 28655773
Responsible Party Type Principal Investigator
Name angela amigoni
Title Principal Investigator
Affiliation Azienda Ospedaliera di Padova

Result Agreements

Sequence: 3828800
Pi Employee Yes

Result Contacts

Sequence: 3828765
Organization University Hospital Padova
Name Angela Amigoni, MD
Phone 339 8333765
Email Angela.amigoni@aopd.veneto.it
Extension ++39

Outcomes

Sequence: 30605227 Sequence: 30605228
Outcome Type Primary Outcome Type Secondary
Title Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) Title Number of Patients With Adverse Events
Description the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. Description any adverse event potentially related with DEX-administration
Time Frame 10 minutes Time Frame during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)
Units Participants Units Participants
Param Type Count of Participants Param Type Count of Participants

Outcome Measurements

Sequence: 234052032 Sequence: 234052033
Outcome Id 30605227 Outcome Id 30605228
Result Group Id 55828808 Result Group Id 55828808
Ctgov Group Code OG000 Ctgov Group Code OG000
Title Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) Title Number of Patients With Adverse Events
Description the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. Description any adverse event potentially related with DEX-administration
Units Participants Units Participants
Param Type Count of Participants Param Type Count of Participants
Param Value 13 Param Value 10
Param Value Num 13.0 Param Value Num 10.0

Study References

Sequence: 51656827 Sequence: 51656828 Sequence: 51656829 Sequence: 51656830 Sequence: 51656831 Sequence: 51656832 Sequence: 51656833 Sequence: 51656834
Pmid 20017865 Pmid 28557732 Pmid 22536619 Pmid 27354454 Pmid 27516413 Pmid 25145661 Pmid 19589455 Pmid 16238552
Reference Type background Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result
Citation Mason KP, O'Mahony E, Zurakowski D, Libenson MH. Effects of dexmedetomidine sedation on the EEG in children. Paediatr Anaesth. 2009 Dec;19(12):1175-83. doi: 10.1111/j.1460-9592.2009.03160.x. Citation Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897. Citation National Clinical Guideline Centre (UK). Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet]. London: Royal College of Physicians (UK); 2010 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK82237/ Citation Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212. Citation Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11. Citation Keidan I, Ben-Menachem E, Tzadok M, Ben-Zeev B, Berkenstadt H. Electroencephalography for children with autistic spectrum disorder: a sedation protocol. Paediatr Anaesth. 2015 Feb;25(2):200-5. doi: 10.1111/pan.12510. Epub 2014 Aug 22. Citation Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006. Citation Zub D, Berkenbosch JW, Tobias JD. Preliminary experience with oral dexmedetomidine for procedural and anesthetic premedication. Paediatr Anaesth. 2005 Nov;15(11):932-8. doi: 10.1111/j.1460-9592.2005.01623.x.

Baseline Counts

Sequence: 11315437
Result Group Id 55828806
Ctgov Group Code BG000
Units Participants
Scope overall
Count 19

Result Groups

Sequence: 55828806 Sequence: 55828807 Sequence: 55828808 Sequence: 55828809
Ctgov Group Code BG000 Ctgov Group Code FG000 Ctgov Group Code OG000 Ctgov Group Code EG000
Result Type Baseline Result Type Participant Flow Result Type Outcome Result Type Reported Event
Title Dexmedetomidine Title Dexmedetomidine Title Dexmedetomidine Title Dexmedetomidine
Description 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion

dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete

Description 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion

dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete

Description 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion

dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete

Description 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion

dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete

Baseline Measurements

Sequence: 124860130 Sequence: 124860131 Sequence: 124860132
Result Group Id 55828806 Result Group Id 55828806 Result Group Id 55828806
Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000
Category Female Category Male
Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male
Units years Units Participants Units Participants
Param Type Mean Param Type Count of Participants Param Type Count of Participants
Param Value 7.3 Param Value 10 Param Value 9
Param Value Num 7.3 Param Value Num 10.0 Param Value Num 9.0
Dispersion Type Standard Deviation
Dispersion Value 4
Dispersion Value Num 4.0
Number Analyzed 19 Number Analyzed 19 Number Analyzed 19

]]>

<![CDATA[ ONSD and Neurotoxicity in Liver Transplant ]]>
https://zephyrnet.com/NCT03799770
2019-01-01

https://zephyrnet.com/?p=NCT03799770
NCT03799770https://www.clinicaltrials.gov/study/NCT03799770?tab=tableNANANAThis is a diagnostic test accuracy study. The investigators measure optic nerve sheath diameter (ONSD) by ultrasound on the eye during living donor liver transplantation operation at 5 minutes after reperfusion to predict the occurrence of early tacrolimus neurotoxicity after liver transplantation.

We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion.
<![CDATA[

Studies

Study First Submitted Date 2019-01-06
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-04-12
Start Month Year January 1, 2019
Primary Completion Month Year March 23, 2021
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2022-04-12

Detailed Descriptions

Sequence: 20675309
Description Neurotoxicity is mainly associated with tacrolimus and cyclosporin, amounting to 10 – 30% for CS and up to 32% for tacrolimus.(2) . Sirolimus, everolimus, and mycophenolate mofetil lack the neurotoxicity of calcineurin inhibitors (3-4).

Neurotoxicity mostly occurs in the early postoperative period increasing morbidity, mortality and hospital and intensive care stay. Neurotoxicity has variable manifestations and mainly affects the CNS. They are usually divided into minor manifestations as tremor, headache, insomnia and paraesthesia or major encephalopathy, akinetic mutism, seizures, speech disorders, polyneuropathy, myopathy, pseudobulbar palsy and even stroke. (2) The main pathogenesis of calcinurin inhibitors neurotoxicity appears to be fluid extravasation (vasogenic edema) due to disruption of blood brain barrier, not cell destruction (cytotoxic edema).(5) During liver transplant operation there are changes in the intracranial pressure and cerebral perfusion pressure especially during reperfusion that may affect the integrity of blood brain barrier. (6) There are multiple methods for monitoring of intracranial pressure invasive or non -invasive. The invasive method remains the gold standard for monitoring of intracranial pressure but there is a controversy about its use in liver transplantation as it may be complicated by bleeding and infections (7).

Also there are a multiple non-invasive methods for monitoring of ICP. Ultrasonographic measurement of the optic nerve sheath diameter (ONSD) was introduced recently as a useful noninvasive method for evaluating ICP. ONSD demonstrated a good correlation with the ICP level in many previously published studies. (8,9) Rajajee et al. found that the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm. (10) We hypothesize that the absolute value or the changes of ONSD during different stages of living donor liver transplantation operation may predict occurrence of early calcinurin inhibitor neurotoxicity (CNIN).We will investigate whether the absolute value or changes of ONSD during different stages of living donor liver transplantation operation may be a predictor of early calcinurin inhibitor neurotoxicity in the first month post liver transplantation. This is a prospective observational cohort study that will be conducted to all adult patients of both sex undergoing living donor liver transplantation operation at Gastro-Intestinal Surgical Centre (GISC), Mansoura university Hospitals, Mansoura, Egypt over the period covering more than 100 consecutive cases. After Institutional review board approval, we will secure informed consents from all included patients during the preoperative visits.

Anesthesia and surgery techniques will be done according to our center's protocol.(11)

Reperfusion:

On portal vein declamping, we will start rapid 500 ml 4% albumin infusion or packed RBCs (according to the anhepatic hemoglobin level 5 min before declamping) through 14 Gauge peripheral venous cannula in all patients.

For hypotension we will give norepinephrine and for resistant hypotension we will use adrenaline as rescue.

Technique of ONSD:

Sonographic measurement of ONSD was performed with the same manner of previous studies. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values. (8)

Immunosuppression:

All patients will receive intravenous 0.5 gm methylprednisolone at the start of the warm ischemia. After hepatic artery anastomosis and declamping, we will administer 500 mg mycophenolate mofetil through the nasogastric tube and i.v. 20 mg basiliximab.

In the ICU, patients will receive oral tacrolimus starting the day after the operation (adjusting the dose targeting serum level of 5-10 ng/ml) , mycophenolate mofetil 500 mg twice per day and basiliximab 20 mg iv 4 days after.

Facilities

Sequence: 199573623
Name Gastroenerology Surgical Center – Liver transplantation program
City Mansourah
State Dakahlia
Zip 35516
Country Egypt

Conditions

Sequence: 52049682
Name Liver Transplant; Complications
Downcase Name liver transplant; complications

Id Information

Sequence: 40062482
Id Source org_study_id
Id Value R.18.12.369 – 2018/12/16

Countries

Sequence: 42460614
Name Egypt
Removed False

Interventions

Sequence: 52361446
Intervention Type Diagnostic Test
Name Optic nerve sheath diameter by ultrasound at 5 minutes post-reperfucion
Description Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by average 4 measured values.

We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion.

Design Outcomes

Sequence: 176959503 Sequence: 176959504 Sequence: 176959505 Sequence: 176959506 Sequence: 176959507
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Early tacrolimus neurotoxicity Measure Time and presentation of neurotoxicity Measure Intensive Care Unit stay Measure Hospital Length of stay Measure Mortality
Time Frame 28 days after transplantation Time Frame 28 days after transplantation Time Frame until discharge from ICU for 1 year Time Frame until discharge from the hospital for 1 year Time Frame three months after transplant
Description definition that will be considered when neurological events (visual disturbance, altered level of consciousness, confusion, psychosis, seizure, encephalopathy, tremors and/or coma or change in the pattern of the preexisting cirrhotic neurological changes ) appeared in the absence of central pontine myelinolysis, central nervous system infection, stroke, or hemorrhage within the first 4 weeks after LT and symptoms improved after dose modification of CNI therapy Description according to the 1ry outcome definition, the time (day) and presentation (clinically) reported Description reported in days Description Measured in days Description three-month all-cause mortality

Browse Conditions

Sequence: 193001016 Sequence: 193001017 Sequence: 193001018 Sequence: 193001019
Mesh Term Neurotoxicity Syndromes Mesh Term Nervous System Diseases Mesh Term Poisoning Mesh Term Chemically-Induced Disorders
Downcase Mesh Term neurotoxicity syndromes Downcase Mesh Term nervous system diseases Downcase Mesh Term poisoning Downcase Mesh Term chemically-induced disorders
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48205598
Agency Class OTHER
Lead Or Collaborator lead
Name Mansoura University

Overall Officials

Sequence: 29214169 Sequence: 29214170
Role Principal Investigator Role Study Director
Name Mahmoud M. Elsedeiq, MD Name Amr M. Yassin, MD
Affiliation Lecturer of anaesthesia and intensive care Affiliation professor of anaesthesia and surgical intensive care

Eligibilities

Sequence: 30693802
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Population Adult (>= 18 years) recipients undergoing living donor liver transplantation
Criteria Inclusion Criteria:

All adult patients of both sex undergoing living donor liver transplantation operation

Exclusion Criteria:

History of optic neuritis
History of Arachnoid cyst of the optic nerve.
History of eye trauma
History of optic nerve trauma.
Familial amylodotic polyneuropathy
Wilson disease.
Patient planned to use immunosuppression regimen other than tacrolimus.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253904316
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 27
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30440476
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28806990
Responsible Party Type Principal Investigator
Name Amr M. Yassen
Title professor of anaesthesia and surgical intensive care
Affiliation Mansoura University

]]>

<![CDATA[ Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain ]]>
https://zephyrnet.com/NCT03799757
2016-01-31

https://zephyrnet.com/?p=NCT03799757
NCT03799757https://www.clinicaltrials.gov/study/NCT03799757?tab=tableNANANAin this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
<![CDATA[

Studies

Study First Submitted Date 2019-01-06
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year January 2016
Primary Completion Month Year November 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20741227
Description patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.

in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.

Facilities

Sequence: 200280706
Name Faculty of Medicine, Main Univeristy Hospital
City Alexandria
Country Egypt

Browse Interventions

Sequence: 96133373 Sequence: 96133374 Sequence: 96133375 Sequence: 96133376 Sequence: 96133377 Sequence: 96133378 Sequence: 96133379
Mesh Term Bupivacaine Mesh Term Anesthetics, Local Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents
Downcase Mesh Term bupivacaine Downcase Mesh Term anesthetics, local Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52221670 Sequence: 52221671
Name Pain, Postoperative Name Breast Cancer
Downcase Name pain, postoperative Downcase Name breast cancer

Id Information

Sequence: 40195726
Id Source org_study_id
Id Value malhussini001

Countries

Sequence: 42609723
Name Egypt
Removed False

Design Groups

Sequence: 55649952 Sequence: 55649953
Group Type Active Comparator Group Type Placebo Comparator
Title Bupivacaine Title Placebo
Description The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. Description The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group)

Interventions

Sequence: 52535481 Sequence: 52535482
Intervention Type Drug Intervention Type Drug
Name 40ml of 0.25% bupivacaine Name 40ml of 0.9% normal saline

Keywords

Sequence: 79941965 Sequence: 79941966 Sequence: 79941967
Name bupivacaine Name Post-mastectomy acute pain Name Wound instillation
Downcase Name bupivacaine Downcase Name post-mastectomy acute pain Downcase Name wound instillation

Design Outcomes

Sequence: 177561975 Sequence: 177561976 Sequence: 177561977
Outcome Type primary Outcome Type primary Outcome Type primary
Measure Visual analogue pain score Measure Number of demands for analgesic Measure Timing of first demand for analgesic
Time Frame first 24 hours Time Frame First 24 hours Time Frame First 24 hours
Description The intensity of pain will be assessed by the VAS score Description How many times the patient will require analgesics Description Time lapse between recovery from surgery and first demand for analgesic

Browse Conditions

Sequence: 193679043 Sequence: 193679041 Sequence: 193679042 Sequence: 193679044 Sequence: 193679045
Mesh Term Pathologic Processes Mesh Term Pain, Postoperative Mesh Term Postoperative Complications Mesh Term Pain Mesh Term Neurologic Manifestations
Downcase Mesh Term pathologic processes Downcase Mesh Term pain, postoperative Downcase Mesh Term postoperative complications Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations
Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366555
Agency Class OTHER
Lead Or Collaborator lead
Name Alexandria University

Overall Officials

Sequence: 29312982
Role Principal Investigator
Name Mahmoud A Alhussini, md
Affiliation faculty of medicine , univeristy of alexandria

Design Group Interventions

Sequence: 68217579 Sequence: 68217580
Design Group Id 55649952 Design Group Id 55649953
Intervention Id 52535481 Intervention Id 52535482

Eligibilities

Sequence: 30794789
Gender Female
Minimum Age 30 Years
Maximum Age 65 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection

Exclusion Criteria:

Male patients
Bilateral breast cancer.
Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
Patients with known psychological or mental problems.
Patients who were not exposed to axillary dissection

Gender Description only females with breast cancer who were subjected to mastectomy with axillary nodal dissection were enrolled
Gender Based True
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004454
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 34
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 30
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3

Designs

Sequence: 30540829
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking Triple
Subject Masked True
Caregiver Masked True
Investigator Masked True

Responsible Parties

Sequence: 28907149
Responsible Party Type Principal Investigator
Name Mahmoud A. Alhussini
Title lecturer surgical oncology
Affiliation Alexandria University

]]>

<![CDATA[ Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma ]]>
https://zephyrnet.com/NCT03799744
2019-03-20

https://zephyrnet.com/?p=NCT03799744
NCT03799744https://www.clinicaltrials.gov/study/NCT03799744?tab=tableNANANAThis is a Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.

VCN-01 is a genetically modified oncolytic adenovirus characterized by the presence of four independent genetic modifications on the backbone of the wild-type HAd5 adenovirus genome, encoding human PH20, that confer tumor selectivity and anti-tumor activity.

Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1.

The proposed mechanism of action (MOA) for durvalumab is interference in the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, including those that may result in tumor elimination.
<![CDATA[

Studies

Study First Submitted Date 2018-11-09
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-03-28
Start Month Year March 20, 2019
Primary Completion Month Year January 31, 2023
Verification Month Year March 2022
Verification Date 2022-03-31
Last Update Posted Date 2022-03-28

Detailed Descriptions

Sequence: 20690211
Description Research Hypothesis The presence of VCN-01 into the tumor after systemic administration will help to overcome the observed resistance to durvalumab and other PD1/PD-L1 checkpoint inhibitors.
Primary objectives To evaluate the safety and tolerability of a single intravenous injection of VCN-01 combined with durvalumab in two administration regimens (concomitant or durvalumab starting two weeks later "sequential schedule"), and to determine the recommended phase II dose (RP2D) of the combination.
Study design This is a phase I trial, multicenter, open label, and dose escalation study. Patients will be entered at each dose level, according to a planned dose escalation schedule. Absence of unacceptable toxicity at the previous dose is required for entering a patient in the subsequent level.
Number of Centers: up to 3
Number of Patients: 15-20 patients
Study Population: Patients with metastatic squamous cell carcinoma of the head and neck who have progressed during or after treatment with immune-checkpoint inhibitors.

Facilities

Sequence: 199706505 Sequence: 199706506
Name Institut Català D'Oncologia Name Hospital Universitari Vall D'Hebron
City Hospitalet de Llobregat City Barcelona
State Barcelona
Zip 08908 Zip 08035
Country Spain Country Spain

Browse Interventions

Sequence: 95880969 Sequence: 95880970 Sequence: 95880971
Mesh Term Durvalumab Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents
Downcase Mesh Term durvalumab Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52087309 Sequence: 52087310 Sequence: 52087311 Sequence: 52087312
Name Head and Neck Neoplasms Name Carcinoma, Squamous Cell of Head and Neck Name Metastasis Name Recurrence
Downcase Name head and neck neoplasms Downcase Name carcinoma, squamous cell of head and neck Downcase Name metastasis Downcase Name recurrence

Id Information

Sequence: 40091806 Sequence: 40091807
Id Source org_study_id Id Source secondary_id
Id Value ICO-VCN-H&N-2018 Id Value 2018-001095-38
Id Type EudraCT Number

Countries

Sequence: 42491726
Name Spain
Removed False

Design Groups

Sequence: 55501347 Sequence: 55501348
Group Type Experimental Group Type Experimental
Title VCN-01 and Durvalumab; concomitant. Title VCN-01 and Durvalumab; sequential
Description Combination VCN-01 (single iv dose) with Durvalumab, Concomitant schedule; Dose Escalation of VCN-01 Description Combination VCN-01 (single iv dose) with Durvalumab, Delayed schedule (14 days); Dose Escalation of VCN-01

Interventions

Sequence: 52400334 Sequence: 52400335
Intervention Type Genetic Intervention Type Biological
Name VCN-01 Name Durvalumab
Description Dose level 1: 3.3×10^12 viral particles/patient and Dose level 2: 1×10^13 viral particles/patient Description Dose: 1500 mg Q4W

Design Outcomes

Sequence: 177091026 Sequence: 177091027 Sequence: 177091028 Sequence: 177091029 Sequence: 177091030 Sequence: 177091031 Sequence: 177091032 Sequence: 177091033 Sequence: 177091034 Sequence: 177091035 Sequence: 177091036 Sequence: 177091037 Sequence: 177091038 Sequence: 177091039 Sequence: 177091040 Sequence: 177091041
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Safety by means of Adverse Events (AEs) Measure Objective response rate (ORR) Measure Progression Free Survival (PFS) Measure Maximum Plasma Concentration (Cmax ) of VCN-01 Measure Tmax of VCN-01 Measure AUC of VCN-01 Measure Apparent Half-Life (t1/2) of VCN-01 Measure Elimination rate constant of VCN-01 Measure VCN-01 viral shedding in blood Measure anti-VCN-01 antibodies Measure VCN-01 viral shedding in stool and sputum Measure Immunological changes induced by the combination of VCN-01 and durvalumab. Measure Changes in Microbiome in stool (VCN-01 and Durvalumab concomitant arm) Measure Changes in Microbiome in stool (VCN-01 and Durvalumab sequential) Measure Circulating free DNA (cfDNA) in plasma analysis (VCN-01 and Durvalumab concomitant arm) Measure Circulating free DNA (cfDNA) in plasma analysis (VCN-01 and Durvalumab sequential)
Time Frame through study completion, an average of 2 years Time Frame On Cycle 3 (+/- 3 days, each cycle is 28 days), and then every 2 cycles (± 7 days) until disease progression or withdrawal (an average of 2 years) Time Frame On Cycle 3 (+/- 3 days, each cycle is 28 days), and then every 2 cycles (± 7 days) until disease progression or withdrawal (an average of 2 years) Time Frame For both arms: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1, 2, 4, 6, 24 and 48 hours post VCN-01 administration. Time Frame VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 Time Frame VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 Time Frame VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 Time Frame VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 Time Frame VCN-01 and Durvalumab concomitant arm: On day 1: pre-dose and then, 4 hours, 24 hours and 48 hours post dose, on day 8, day 15, day 22 of cycle 1 (each cycle is 28 days), then on day1 of subsequent durvalumab cycles and at the final visit. Arm II: On day Time Frame At screening, on day 1 pre-dose (within 15 minutes prior to VCN-01 ) in both arms. In concomitant arm: at day1 of subsequent durvalumab cycles (each cycle is 28 days), and at the final visit. In sequential arm: at day15 on cycle 1, at day1 of subsequent Time Frame VCN-01 and Durvalumab concomitant arm: at day 1, 8, 15 and 22 on cycle 1 (each cycle is 28 days) And at day1 of subsequent durvalumab cycles. VCN-01 and Durvalumab sequential: at day -14, -7, 1, 8, 15 on cycle 1 and at day 1 of subsequent durvalumab Time Frame VCN-01 and Durvalumab concomitant arm: On day 1: pre-dose, at 30 minutes, 6 hours, 24 hours, 48 hours, at day 8 on cycle 1 (each cycle is 28 days), at day 1of cycle 2 and at the final visit. VCN-01 and Durvalumab sequential: On day 1, 15 minutes before Time Frame On day 1: pre-dose and 1st deposition after-dose (the first deposition occurred from day 1 to day 7), day 8, day 15, day 22 on cycle 1 (each cycle is 28 days). Time Frame On day -14 (pre-dose and 1st deposition after-dose), day -7, Day 1, day 8 and day15 on cycle 1 (each cycle is 28 days). Time Frame Pre-dose on day 1 (within 15min prior to VCN-01 infusion) and at day 8 on cycle 1, at day 1 on cycle 2, at day 1 on cycle 3 and at day 1 on cycle 4 (within 15min prior durvalumab administration) (each cycle is 28 days). Time Frame On day -14 pre-dose and 1st deposition after-dose(the first deposition occurred from day -14 to day -8), day -7, day 1, day 8 and day15 on cycle 1 (each cycle is 28 days).
Description Incidence of Adverse Events as assessed by CTCAE v4.0 Description Proportion of patients with reduction in tumor burden of a predefined amount assessed by CT or MRI Description Time from study enrollment until disease progression or death assessed by CT or MRI Description The maximum (or peak) concentration that VCN-01 achieves in plasma after its administration. Description Time to Maximum Plasma Concentration of VCN-01 Description The definite integral in a plot of drug concentration in blood plasma vs. time. Description The time it takes for half to be removed Description The rate at which VCN-01 is removed from the body. Description Determination of VCN-01 levels in peripheral blood samples Description Assessment of Blood levels of neutralizing anti-VCN-01 antibodies Description Determination of VCN-01 levels in stool and sputum Description Study of the Immunological changes induced by the combination of VCN-01 and durvalumab by assessment of blood levels of circulating Interleukin 6 and Interleukin 10 Description Analyse the microbiome in stool, prior and after VCN-01 administration Description Analyse the microbiome in stool, prior and after VCN-01 administration Description To analyse the circulating free DNA (cfDNA) in plasma obtained from samples collected prior and post VCN-01 treatment. Description To analyse the circulating free DNA (cfDNA) in plasma obtained from samples collected prior and post VCN-01 treatment.

Browse Conditions

Sequence: 193153204 Sequence: 193153194 Sequence: 193153195 Sequence: 193153196 Sequence: 193153197 Sequence: 193153198 Sequence: 193153199 Sequence: 193153200 Sequence: 193153201 Sequence: 193153202 Sequence: 193153203 Sequence: 193153205
Mesh Term Disease Attributes Mesh Term Carcinoma Mesh Term Carcinoma, Squamous Cell Mesh Term Head and Neck Neoplasms Mesh Term Squamous Cell Carcinoma of Head and Neck Mesh Term Recurrence Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Neoplasms, Squamous Cell Mesh Term Pathologic Processes Mesh Term Neoplasms by Site
Downcase Mesh Term disease attributes Downcase Mesh Term carcinoma Downcase Mesh Term carcinoma, squamous cell Downcase Mesh Term head and neck neoplasms Downcase Mesh Term squamous cell carcinoma of head and neck Downcase Mesh Term recurrence Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, squamous cell Downcase Mesh Term pathologic processes Downcase Mesh Term neoplasms by site
Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48241675 Sequence: 48241676 Sequence: 48241677 Sequence: 48241678
Agency Class OTHER Agency Class INDUSTRY Agency Class OTHER Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Institut Català d'Oncologia Name Theriva Biologics SL Name BioClever 2005 S.L. Name AstraZeneca

Design Group Interventions

Sequence: 68037155 Sequence: 68037156 Sequence: 68037157 Sequence: 68037158
Design Group Id 55501347 Design Group Id 55501348 Design Group Id 55501347 Design Group Id 55501348
Intervention Id 52400334 Intervention Id 52400334 Intervention Id 52400335 Intervention Id 52400335

Eligibilities

Sequence: 30716696
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Written informed consent and any locally-required authorization (e.g., Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures; including screening evaluations must be obtained.
Adult subjects; age ≥ 18 years at time of study entry
ECOG Performance status 0 or 1
Life expectancy above 3 months
Body weight >30kg

Adequate normal organ and marrow function as defined below (transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted):

Leukocytes ≥3000 mcL
Absolute neutrophil count ≥1500 mcL (or 1.0) x (≥ 1500 per mm3)
Platelets ≥100 000 mcL
Haemoglobin ≥9 g/dL
Total bilirubin ≤1.5 x ULN; total bilirubin ≤3×ULN in patients with documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or in the presence of liver metastases
ALT and AST ≤2.5×ULN if no demonstrable liver metastases or ≤5×ULN in the presence of liver metastases
Creatinine ≤ 1.5 x UNL or measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance (see section 4.1.).
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (see section 4.1.).
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Have histologically and/or cytologically confirmed head and neck squamous cell carcinoma from the specific sites: oral cavity, oropharynx, larynx or hypopharynx that is recurrent/Mestastasic (R/M) and not amenable to curative therapy by surgery or radiation.
For patients in R/M disease: has undergone ≥1 previous regimens of cytoreductive chemo-therapies including prior exposure to anti-PD-(L)1. Patients have progressed or be refractory to anti-PD1 or anti-PDL1 therapy. Note: anti-PD1 or Anti-PDL1 therapy with other agents is acceptable. For patients with locally advanced disease those who has progressed in the last 6 months to previous line that include anti-PD1 or anti PD-L1 in the radical treatment.
Subjects must have at least 1 lesion that is measurable using RECIST guidelines. RECIST lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy.
Subjects must consent to provide paired pretreatment and on-treatment tumor biopsies (1 pre; 2 post).
Levels of neutralizing antibodies against adenovirus ≤1/350 dilution
All patients are required to have a fibroscan assessment performed during the screening period. Patients with fibrosis value ≥9.5 kPa will not be eligible.

Exclusion Criteria:

Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) within 4 weeks (28 days) prior to the first dose of study treatment. Enrolment with a shorter period of time might be allowed upon discussion with the Study Physician/Medical Monitor according data of sufficient washout time form PK properties of the agent.
Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

Previous treatment PD1/PD-L1 inhibition (including Durvalumab) is a specific entry criterion, but patients:Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.

All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.

o Exception: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.

Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.

Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other that SCCHN in the past 3 years except for:

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Previously treated non-invasive in-situ carcinoma.
Cervical carcinoma stage 1B or less.
Non-invasive basal cell and squamous cell skin carcinoma.
Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy.
Other malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence.
Patients with other malignancies treated with curative intent and with no known active disease < 3 years and at low risk of recurrence, may be eligible upon discussion with the Medical Monitor.
Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction (within 15 minutes at 5 minutes apart).
Current or prior use of immunosuppressive medication within 28 days before the first dose of VCN-01/durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Exceptions defined in section 4.2.
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values considered not clinically significant or correctable by the investigator. The eligibility of patients who are still experiencing irreversible toxicity that is not reasonably expected to be exacerbated by the study drugs in this study (eg, hearing loss) must be reviewed and approved by the Study Physician. Patients with Grade ≥2 neuropathy or hearing loss will be evaluated on a case-by-case basis after consultation with the Study physician/Medical Monitor.
Has experienced immune-related AEs (irAEs) while receiving prior immunotherapy (including anti-CTLA4 treatment) and assessed as CTCAE grade ≥3
Has an active or prior documented autoimmune or inflammatory disorder (including but not limited to inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). (See section 4.2 for details and exceptions.)

Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.

Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.

Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent or other minor procedures are acceptable.
History of allogenic organ transplantation.
Uncontrolled intercurrent illness, including but not limited to, uncontrolled ongoing or active infection (including viral emergent infections), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. Exception: patients who are finalizing their antibiotic treatment (for example 3 days left of a total of 7 or 10) for a respiratory tract infection are allowed to be included.
History of leptomeningeal carcinomatosis
Has untreated central nervous system (CNS) metastases identified either on the baseline brain imaging obtained during the screening period or identified prior to signing the ICF. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or with stable doses of anticonvulsants and/or steroids. Steroid dose must be ≤10mg/day of prednisone or its equivalent (and anticonvulsants) for at least 14 days prior to the start of treatment.
Has a history of primary immunodeficiency
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (positive HBV surface antigen (HBsAg) result), hepatitis C (positive HCV RNA), or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to treatment. HBV carriers of those patients requiring antiviral therapy treatment of hepatitis B virus or Hepatitis C are not eligible to participate. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients with past or resolved tuberculosis are eligible.
Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control (according to the HMA CTFG guidelance) from screening to 90 days after the last dose of durvalumab.
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Viral syndrome diagnosed during the two weeks before inclusion
Patients receiving full-dose anticoagulant/antiplatelet therapy.
Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency.
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253951307
Number Of Facilities 2
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 15

Designs

Sequence: 30463233
Allocation Non-Randomized
Intervention Model Sequential Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description This is a phase I trial, multicenter, open label, and dose escalation study. Patients will be entered at each dose level, according to a planned dose escalation schedule. Absence of unacceptable toxicity at the previous dose is required for entering a patient in the subsequent level.

The investigational treatment will be a single i.v. VCN-01 dose combined with concomitant i.v. durvalumab (MEDI4736) 1500 mg Q4W (Arm I) or durvalumab starting two weeks after VCN-01 administration, "sequential schedule" (Arm II). Patient recruitment in Arm I and Arm II will be performed in parallel based on slot availability. Only one single dose of VCN-01 will be administered to each patient during the trial. Durvalumab will be administered Q4W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion.

Responsible Parties

Sequence: 28829693
Responsible Party Type Sponsor

]]>

<![CDATA[ Study for Evaluation of Murlentamab (GM102) Anti-tumoral Activity in Colorectal Cancers ]]>
https://zephyrnet.com/NCT03799731
2018-07-11

https://zephyrnet.com/?p=NCT03799731
NCT03799731https://www.clinicaltrials.gov/study/NCT03799731?tab=tableNANANAPhase 2A study, assessing the antitumor activity and the safety profile of GM102, a new compound (monoclonal antibody), administered alone or in combination with chemotherapy in patients with locally advanced or metastatic colorectal cancer. The primary objective of the study is to evaluate the antitumor activity of GM102 single agent and in combination with trifluridine/tipiracil.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-04-14
Start Month Year July 11, 2018
Primary Completion Month Year January 19, 2021
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2022-04-14

Detailed Descriptions

Sequence: 20848268
Description GM102 is a humanized low fucose monoclonal antibody with a high affinity to AMHRII receptor (fetal receptor mediating the activity of AMH, reexpressed in a variety of solid tumors). GM102 acts through engagement of immune cells (macrophages, natural killer (NK) cells) to trigger ADCC (antibody dependent cellular cytotoxicity) and phagocytosis of tumor cells.

AMRHII expression was found in 73% of primary colorectal tumors tested.

Advanced/metastatic colorectal cancer (CRC) remains an unmet need disease, with few therapeutic options beyond two or three lines of therapy.

CRC is characterized by a tumor microenvironment (TME) particularly rich in macrophages and more specifically macrophages capable of tumor phagocytosis. The pattern of the TME remains a major prognostic factor in the metastatic setting.

C201 consists in two parallel cohorts and an expansion of cohort II for patients with advanced or metastatic colorectal cancer in two different settings of the disease:

Cohort I (GM102 as a single agent) in refractory patients, having exhausted all therapeutic options. Patients will receive GM102 alone at the dose of 7 mg/kg administered by intravenous infusion at Day 1, Day 8, Day 15 and Day 22 of each 28-day cycle
Cohort II (GM102 in combination with trifluridine/tipiracil) in patients candidate to receive single agent trifluridine/tipiracil, after at least two lines of treatment for the advanced or metastatic disease. Patients will receive GM102 at the dose of 7 mg/kg administered by intravenous infusion at Day 1, Day 8, Day 15 and Day 22 and trifluridine/tipiracil at 35 mg/m² per dose twice daily orally administered on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.
Cohort II expansion (GM102 in combination with trifluridine/tipiracil) same as cohort II except a loading dose of 10 mg/kg q1w during 28-day cycle 1

Patients will be treated with GM102 (Cohort I) or GM102 and trifluridine/tipiracil (Cohort II and Cohort II expansion) until confirmed progression or toxicity.

A Trial Steering Committee (TSC) will analyze and qualify GM102 activity and toxicities and will provide recommendations on the Investigational Medicinal Product (IMP) continuation.

Facilities

Sequence: 201251996 Sequence: 201251997 Sequence: 201251998 Sequence: 201251999 Sequence: 201252000
Name Cliniques Universitaires Saint-Luc Name UZ Gasthuisberg Name UZ Leuven Name University Hopistal Olomouc Name University Hospital Motol
City Brussels City Gent City Leuven City Olomouc City Praha
Country Belgium Country Belgium Country Belgium Country Czechia Country Czechia

Browse Interventions

Sequence: 96578074 Sequence: 96578075 Sequence: 96578076 Sequence: 96578077 Sequence: 96578078
Mesh Term Trifluridine Mesh Term Antimetabolites Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antiviral Agents Mesh Term Anti-Infective Agents
Downcase Mesh Term trifluridine Downcase Mesh Term antimetabolites Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antiviral agents Downcase Mesh Term anti-infective agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52496656
Name Colorectal Cancer
Downcase Name colorectal cancer

Id Information

Sequence: 40391235
Id Source org_study_id
Id Value C201

Countries

Sequence: 42826780 Sequence: 42826781
Name Belgium Name Czechia
Removed False Removed False

Design Groups

Sequence: 55952552 Sequence: 55952553 Sequence: 55952554
Group Type Experimental Group Type Experimental Group Type Experimental
Title Cohort I: GM102 single agent Title Cohort II: GM102 + trifluridine/tipiracil Title Cohort II expansion: GM102 + trifluridine/tipiracil
Description GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22 of each 28-day cycle Description GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22, and trifluridine/tipiracil will be orally administered at the dose of 35 mg/m² twice daily on Days 1 to 5 and days 8 to 12 of each 28-day cycle Description GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22, after a loading dose of 10 mg/kg q1w during 28-day cycle 1, and trifluridine/tipiracil will be orally administered at the dose of 35 mg/m² twice daily on Days 1 to 5 and days 8 to 12 of each 28-day cycle

Interventions

Sequence: 52804814 Sequence: 52804815 Sequence: 52804816
Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name GM102 Name Trifluridine/Tipiracil Name GM102 expansion
Description GM102 7 mg/kg weekly Description Lonsurf 35 mg/m² twice daily during 10 days per cycle Description GM102 7 mg/kg weekly after a loading dose of 10 mg/kg q1w during 28-day cycle 1

Design Outcomes

Sequence: 178594437 Sequence: 178594438 Sequence: 178594439 Sequence: 178594440 Sequence: 178594441 Sequence: 178594442 Sequence: 178594443 Sequence: 178594444 Sequence: 178594445 Sequence: 178594446 Sequence: 178594447 Sequence: 178594448 Sequence: 178594449
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Overall Response Rate (ORR) Measure Progression Free Survival (PFS) at 6 months Measure Immune Overall Response Rate (iORR) Measure Clinical Benefit Rate (CBR) Measure Tumor Growth Rate (TGR) before and under treatment Measure Progression Free Survival (PFS) Measure Overall Survival (OS) Measure Incidence of Serious Adverse Event (SAE) and Treatment Emergent Adverse Event (TEAE) Measure Pharmacodynamics evaluation Measure Exposure to murlentamab Measure Exposure to trifluridine Measure Evidence of anti-murlentamab antibodies (ADA) Measure AMHRII (Anti-Mullerian Hormone type II receptor) expression
Time Frame Through study completion, an average 1 year Time Frame 6 months after the first infusion Time Frame Through study completion, an average 1 year Time Frame up to 4 months Time Frame up to 2 months Time Frame Through study completion, an average 1 year Time Frame Through study completion, an average 1 year Time Frame Through study completion, an average 1 year Time Frame Up to 2 months Time Frame At days 1 and 15 of cycles 1, 2 (each cycle is 28 days) and End of Treatment for cohort I and II, an average of one year; days 1, 8,15 and 22 of cycles 1, 2 (each cycle is 28 days) and End of Treatment for cohort II expansion, an average of one year Time Frame At days 1 and 15 of cycles 1, 2 (each cycle is 28 days) and End of Treatment, an average of one year Time Frame Baseline, beginning of every even cycle in pre-dose (each cycle is 28 days) and at the End of Treatment, an average of one year Time Frame Up to 2 months
Description ORR from the end of cycle 2 and subsequently confirmed at least 4 weeks later using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Description Proportion of patients without documented progression at 6 months Description ORR using immune Response Evaluation Criteria In Solid Tumors (iRECIST) Description CBR at 8 and 16 weeks defined as the number of non-progressors using RECIST 1.1 and iRECIST criteria Description Percentage of variation in TGR Description Time elapsed from the date of first infusion to the date of documented progression or death Description Time elapsed from the date of first infusion to the date of death Description Number of events Description Tumor Immune MicroEnvironment analysis and evolution changes: quantity/density and quality of immune cells Description PK parameters analysis Description Trifluridine plasma concentrations only for cohort II Description Presence of ADA Description AMHRII membrane expression in percentage

Browse Conditions

Sequence: 194727905 Sequence: 194727906 Sequence: 194727907 Sequence: 194727908 Sequence: 194727909 Sequence: 194727910 Sequence: 194727911 Sequence: 194727912 Sequence: 194727913 Sequence: 194727914 Sequence: 194727915
Mesh Term Colorectal Neoplasms Mesh Term Intestinal Neoplasms Mesh Term Gastrointestinal Neoplasms Mesh Term Digestive System Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Digestive System Diseases Mesh Term Gastrointestinal Diseases Mesh Term Colonic Diseases Mesh Term Intestinal Diseases Mesh Term Rectal Diseases
Downcase Mesh Term colorectal neoplasms Downcase Mesh Term intestinal neoplasms Downcase Mesh Term gastrointestinal neoplasms Downcase Mesh Term digestive system neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term digestive system diseases Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term colonic diseases Downcase Mesh Term intestinal diseases Downcase Mesh Term rectal diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48621046
Agency Class INDUSTRY
Lead Or Collaborator lead
Name GamaMabs Pharma

Overall Officials

Sequence: 29455255
Role Principal Investigator
Name Eric Van Cutsem, MD
Affiliation UZ Leuven, Belgium

Design Group Interventions

Sequence: 68592500 Sequence: 68592501 Sequence: 68592502 Sequence: 68592503 Sequence: 68592504
Design Group Id 55952552 Design Group Id 55952553 Design Group Id 55952554 Design Group Id 55952553 Design Group Id 55952554
Intervention Id 52804814 Intervention Id 52804814 Intervention Id 52804815 Intervention Id 52804815 Intervention Id 52804816

Eligibilities

Sequence: 30951203
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Histologically confirmed metastatic or locally advanced colorectal adenocarcinoma.
Having failed the previous line of treatment for locally advanced or metastatic disease and having received at least two systemic chemotherapy regimens for metastatic colorectal cancer; adjuvant regimen can be considered as one chemotherapy regimen for metastatic disease if the participant had disease recurrence within 6 months of completion.
At least one of the tumor sites amenable to core needle biopsy (may not be the site of disease for measuring antitumor response). Patient must agree to this pre-treatment biopsy and on the principle of a second biopsy under treatment; however, if eventually the second biopsy cannot be performed, patients will continue on the study and will be considered evaluable for efficacy.
Available archived CRC tumor tissue sample
At least one measurable lesion (superior or equal to 1.0 cm longest diameter or superior or equal to 1.5 cm in short axis for malignant lymph nodes) based on RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 on the screening CT-scan.
Written Informed Consent forms signed.
Willing and able to comply with the trial requirements.
Covered by healthcare insurance in accordance with local requirements.
For cohort I (single agent GM102) only: refractory patients, having exhausted all therapeutic options.
For cohort II (GM102 in combination with trifluridine/tipiracil) only: patients eligible for trifluridine/tipiracil who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-Vascular Endothelial Growth Factor (anti-VEGF) agents, regorafenib and anti-Epithelial Growth Factor Receptor (anti-EGFR) agents. Patients must have received at least 2 prior lines of standard chemotherapy for metastatic CRC.

Exclusion Criteria:

Age < 18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status superior or equal to 2.
Life expectancy < 12 weeks.
Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or anticipation of needing such procedure while receiving study treatment.
Known or symptomatic brain metastasis (other than totally resected or previously irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis.
Concurrent treatment with any other anticancer therapy (or investigational agent) or received any anticancer therapy (or investigational agent) within 4 weeks prior to first treatment.
Known severe anaphylactic or other hypersensitivity reactions to Investigational Medicinal Product (IMP) and/or its excipients.
Unresolved toxicity superior or equal to Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum induced neurotoxicity).
Serious concomitant illness, e.g. active infection requiring systemic antibiotic, antifungal or antiviral drug, or physical examination or laboratory abnormalities, that, in the opinion of the Investigator, would compromise protocol objectives.
Poor bone marrow reserve as defined by white blood cell < 3.0 x 10E9/L, neutrophils < 1.5 x 10E9/L or haemoglobin < 9.0 g/dL or platelet count < 100 x 10E9/L.
Poor organ function as defined by any one of the following: serum creatinine > 1.5 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN or > 2.5 x ULN if due to Gilbert's syndrome, AST and ALT > 2.5 x ULN in the absence of liver metastasis or > 5 x ULN in case of documented liver metastasis.
Severe New York Heart Association (NYHA) III and IV heart failure.
Pregnancy or breastfeeding.
Patient with reproductive potential who does not agree to use an accepted highly effective method of contraception – per investigator's judgment – during the study period and for at least 6 months following completion of study treatment.
Patient deprived of liberty by a judicial or administrative decision, patient admitted to a social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency situation.
Known allergy to rodents.
Patients positive to Covid-19

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253858422
Number Of Facilities 5
Registered In Calendar Year 2019
Actual Duration 30
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 11

Designs

Sequence: 30696791
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26835264
Intervention Id 52804815
Name Lonsurf

Responsible Parties

Sequence: 29063548
Responsible Party Type Sponsor

]]>

<![CDATA[ Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS ]]>
https://zephyrnet.com/NCT03799718
2019-03-13

https://zephyrnet.com/?p=NCT03799718
NCT03799718https://www.clinicaltrials.gov/study/NCT03799718?tab=tableNANANAA multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-11-14
Start Month Year March 13, 2019
Primary Completion Month Year March 11, 2021
Verification Month Year August 2021
Verification Date 2021-08-31
Last Update Posted Date 2022-11-14
Results First Posted Date 2022-11-14

Detailed Descriptions

Sequence: 20713085
Description An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy.

Facilities

Sequence: 200013922 Sequence: 200013923 Sequence: 200013924 Sequence: 200013925
Name University of Southern California Name Stanford University School of Medicine Name The Mount Sinai Hospital Name Cleveland Clinic
City Los Angeles City Redwood City City New York City Cleveland
State California State California State New York State Ohio
Zip 90033 Zip 94305 Zip 10029 Zip 44195
Country United States Country United States Country United States Country United States

Conditions

Sequence: 52147770
Name Multiple Sclerosis, Chronic Progressive
Downcase Name multiple sclerosis, chronic progressive

Id Information

Sequence: 40141583
Id Source org_study_id
Id Value BCT-101-US

Countries

Sequence: 42550783
Name United States
Removed False

Design Groups

Sequence: 55568475
Group Type Experimental
Title NurOwn (MSC-NTF cells)
Description Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

Interventions

Sequence: 52463579
Intervention Type Biological
Name NurOwn (MSC-NTF cells)
Description Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

Design Outcomes

Sequence: 177297640 Sequence: 177297641 Sequence: 177297642 Sequence: 177297643 Sequence: 177297644 Sequence: 177297645 Sequence: 177297646 Sequence: 177297647 Sequence: 177297648 Sequence: 177297649
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Number of Participants With Treatment-emergent Adverse Events Measure Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) Measure Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed Measure Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT Measure Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 Measure Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) Measure Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level Measure Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score Measure Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment Measure Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment
Time Frame Up to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 16 weeks post first treatment Time Frame From Baseline (pre-first treatment) to 16 weeks post first treatment
Description Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.

Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment.

Description 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).

The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes.

The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.

Higher values represent worse outcomes.

Description ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.

The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely.

The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes

Description The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.

The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.

Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome.

Description Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. Description The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.

It contains 12 questions that assess the impact of MS on different aspects of walking function and quality.

Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome.

Description The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.

The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome.

Description Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.

It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome.

Description Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome Description Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome

Browse Conditions

Sequence: 193399231 Sequence: 193399232 Sequence: 193399233 Sequence: 193399234 Sequence: 193399235 Sequence: 193399236 Sequence: 193399237 Sequence: 193399238 Sequence: 193399239 Sequence: 193399240 Sequence: 193399241
Mesh Term Multiple Sclerosis Mesh Term Multiple Sclerosis, Chronic Progressive Mesh Term Pathologic Processes Mesh Term Demyelinating Autoimmune Diseases, CNS Mesh Term Autoimmune Diseases of the Nervous System Mesh Term Nervous System Diseases Mesh Term Demyelinating Diseases Mesh Term Autoimmune Diseases Mesh Term Immune System Diseases Mesh Term Chronic Disease Mesh Term Disease Attributes
Downcase Mesh Term multiple sclerosis Downcase Mesh Term multiple sclerosis, chronic progressive Downcase Mesh Term pathologic processes Downcase Mesh Term demyelinating autoimmune diseases, cns Downcase Mesh Term autoimmune diseases of the nervous system Downcase Mesh Term nervous system diseases Downcase Mesh Term demyelinating diseases Downcase Mesh Term autoimmune diseases Downcase Mesh Term immune system diseases Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48298234
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Brainstorm-Cell Therapeutics

Overall Officials

Sequence: 29272860
Role Principal Investigator
Name Jeffrey Cohen, MD
Affiliation The Cleveland Clinic

Design Group Interventions

Sequence: 68119632
Design Group Id 55568475
Intervention Id 52463579

Eligibilities

Sequence: 30752363
Gender All
Minimum Age 18 Years
Maximum Age 65 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Males and females ages 18 to 65 years old, inclusive, at the Screening Visit.
Clinical diagnosis of Progressive MS (Primary and Secondary) based on the 2017 revised MacDonald Criteria and confirmation by the Investigator that the disease has entered the progressive stage for at least 6 months prior to enrollment.
No evidence of clinical MS relapse or high dose pulse corticosteroid treatment within 6 months prior to screening
Disability status at screening with an Expanded Disability Status Scale (EDSS) 3.0-6.5, inclusive.
Able to walk 25 feet in 60 seconds or less.
Stable dose of non-excluded MS Disease Modifying Therapy for at least 6 months prior to Screening Visit (Visit 1).
Women of childbearing potential shall either be surgically sterile, or must agree not to become pregnant for the duration of the study. Women must be willing to undergo a serum pregnancy test at screening, and at the conclusion of the study. Participants of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study and for at least 3 months following the last transplantation. For those women who are sexually active and using oral contraceptives, a second form of barrier contraception is required. Men must be willing to consistently use two forms of contraceptive if their partners are of childbearing age.
Capable of providing informed consent and willing and able to follow study procedures, including willingness to undergo multiple/repeated lumbar puncture.

Exclusion Criteria:

Prior stem cell therapy of any kind.
Active participation in any other MS interventional study or use of unapproved MS investigational therapy within 90 days prior to the Screening Visit (Visit 1).
Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason.
History of clinically significant autoimmune disease (excluding thyroid disease) that may confound study results, in the opinion of the Investigator and the medical monitor, myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
Any unstable clinically significant medical condition other than multiple sclerosis (e.g., within six months of Screening Visit (Visit 1), had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the investigator, would compromise the safety of participants.
Any history of malignancy within the previous 5 years, except for non-melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or reoccurrence within three years of Screening Visit (Visit 1)).
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper normal limit.
Serum creatinine value >2.0 times the upper normal limit.
Positive test for Hepatitis B (HBV; surface antigen (HBsAg) and antibodies to core antigen (IgG and IgM anti-HBc)), Hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
Current use of immunosuppressant medication or use of such medication within 6 months of study enrollment (aside from Rituximab or other approved B-cell immunotherapy). Alemtuzumab (Lemtrada), Cladribine (NDA submitted), Natalizumab (Tysabri), S1P modulators (Gilenya) are excluded for safety reasons due to the known risk of systemic autoimmune disease, malignancy, opportunistic infections, and cardiovascular toxicity associated with these therapies, as well as theoretical effects on MSC-NTF cell homing and migration, that may be associated with Natalizumab and/or S1P modulators (Gilenya).
Any history of acquired or inherited immune deficiency syndrome.
Any history of either substance abuse within the past year, or unstable psychiatric disease according to the Investigator's judgment.
Pregnant women or women currently breastfeeding.
Subjects for whom MRI is contraindicated (i.e., have a pacemaker or other metallic implanted device, or are unable to remain in the machine for period of time needed to acquire a scan.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254175113
Number Of Facilities 4
Number Of Nsae Subjects 68
Number Of Sae Subjects 2
Registered In Calendar Year 2019
Actual Duration 24
Were Results Reported True
Months To Report Results 18
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 9

Designs

Sequence: 30498631
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Open label

Drop Withdrawals

Sequence: 28975619
Result Group Id 56079294
Ctgov Group Code FG000
Period Overall Study
Reason Adverse Event
Count 2

Milestones

Sequence: 40992027 Sequence: 40992028 Sequence: 40992029
Result Group Id 56079294 Result Group Id 56079294 Result Group Id 56079294
Ctgov Group Code FG000 Ctgov Group Code FG000 Ctgov Group Code FG000
Title STARTED Title COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study
Description 20 participants underwent bone marrow aspiration. In two participants, autologous bone marrow culture failed to meet specific MSC-NTF cell product release criteria and they did not receive treatment Description Of the 20 participants enrolled, 18 were treated, 17 received all three treatments and one received two treatments.
Count 20 Count 18 Count 2
Count Units 54 Count Units 53 Count Units 1

Participant Flows

Sequence: 3920078
Pre Assignment Details Not meeting inclusion exclusion criteria
Units Analyzed Treatments

Outcome Counts

Sequence: 73972415 Sequence: 73972416 Sequence: 73972417 Sequence: 73972418 Sequence: 73972419 Sequence: 73972420 Sequence: 73972421 Sequence: 73972422 Sequence: 73972423 Sequence: 73972424
Outcome Id 30793057 Outcome Id 30793058 Outcome Id 30793059 Outcome Id 30793060 Outcome Id 30793061 Outcome Id 30793062 Outcome Id 30793063 Outcome Id 30793064 Outcome Id 30793065 Outcome Id 30793066
Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295
Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 18 Count 18 Count 18 Count 18 Count 10 Count 18 Count 18 Count 18 Count 17 Count 17

Provided Documents

Sequence: 2577770 Sequence: 2577771
Document Type Study Protocol Document Type Statistical Analysis Plan
Has Protocol True Has Protocol False
Has Icf False Has Icf False
Has Sap False Has Sap True
Document Date 2019-06-01 Document Date 2019-04-12
Url https://ClinicalTrials.gov/ProvidedDocs/18/NCT03799718/Prot_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/18/NCT03799718/SAP_001.pdf

Reported Event Totals

Sequence: 27934087 Sequence: 27934088 Sequence: 27934089
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000
Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 2 Subjects Affected 18 Subjects Affected 0
Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18
Created At 2023-08-08 21:34:52.883141 Created At 2023-08-08 21:34:52.883141 Created At 2023-08-08 21:34:52.883141
Updated At 2023-08-08 21:34:52.883141 Updated At 2023-08-08 21:34:52.883141 Updated At 2023-08-08 21:34:52.883141

Reported Events

Sequence: 528025622 Sequence: 528025623 Sequence: 528025624 Sequence: 528025625 Sequence: 528025626 Sequence: 528025627 Sequence: 528025628 Sequence: 528025629 Sequence: 528025630 Sequence: 528025631 Sequence: 528025632 Sequence: 528025633 Sequence: 528025634
Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296 Result Group Id 56079296
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000
Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks Time Frame 28 weeks
Event Type serious Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other
Subjects Affected 2 Subjects Affected 16 Subjects Affected 15 Subjects Affected 6 Subjects Affected 5 Subjects Affected 4 Subjects Affected 4 Subjects Affected 3 Subjects Affected 3 Subjects Affected 3 Subjects Affected 3 Subjects Affected 3 Subjects Affected 3
Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18
Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) Description Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit)
Event Count 2 Event Count 35 Event Count 29 Event Count 8 Event Count 5 Event Count 4 Event Count 5 Event Count 3 Event Count 4 Event Count 3 Event Count 4 Event Count 3 Event Count 4
Organ System Nervous system disorders Organ System Nervous system disorders Organ System Musculoskeletal and connective tissue disorders Organ System Infections and infestations Organ System Musculoskeletal and connective tissue disorders Organ System General disorders Organ System General disorders Organ System Musculoskeletal and connective tissue disorders Organ System Injury, poisoning and procedural complications Organ System General disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders
Adverse Event Term Arachnoiditis Adverse Event Term Headache Adverse Event Term Back pain Adverse Event Term Urinary tract infection Adverse Event Term Musculoskeletal pain Adverse Event Term Injection site pain Adverse Event Term Pyrexia Adverse Event Term Arthralgia Adverse Event Term Fall Adverse Event Term Fatigue Adverse Event Term Muscular weakness Adverse Event Term Musculoskeletal stiffness Adverse Event Term Pain in extremity
Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5 Frequency Threshold 5
Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment

Responsible Parties

Sequence: 28864905
Responsible Party Type Sponsor

Result Agreements

Sequence: 3850822
Pi Employee No
Restriction Type GT60

Result Contacts

Sequence: 3850787
Organization Brainstorm Cell therapeutics
Name Ralph Kern, MD, Chief Medical Officer
Phone 201-488-0460
Email rkern@brainstorm-cell.com

Outcomes

Sequence: 30793057 Sequence: 30793058 Sequence: 30793059 Sequence: 30793060 Sequence: 30793061 Sequence: 30793062 Sequence: 30793063 Sequence: 30793064 Sequence: 30793065 Sequence: 30793066
Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Number of Participants With Treatment-emergent Adverse Events Title Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT Title Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 Title Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) Title Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level Title Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score Title Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment Title Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment
Description Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.

Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment.

Description 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).

The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes.

The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.

Higher values represent worse outcomes.

Description ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.

The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely.

The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes

Description The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.

The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.

Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome.

Description Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. Description The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.

It contains 12 questions that assess the impact of MS on different aspects of walking function and quality.

Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome.

Description The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.

The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome.

Description Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.

It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome.

Description Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome Description Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome
Time Frame Up to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 28 weeks post-first treatment Time Frame From Baseline (pre-first treatment) to 16 weeks post first treatment Time Frame From Baseline (pre-first treatment) to 16 weeks post first treatment
Population The primary, secondary, and exploratory efficacy endpoints were analyzed using the modified intent to treat (mITT) and Efficacy Evaluable (EE) populations The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 Population The modified intent to treat (mITT) population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 Population mITT population Population The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. Population The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline.

Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3.

The participants in mITT population whose EDSS Score was >5.5 at Baseline was analyzed.

Population The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 Population The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 Population The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. Population mITT Population with data available at week 16 Population mITT population with data available at week 16
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Picograms per milliliter Units picograms per milliliter
Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Geometric Mean Param Type Geometric Mean

Outcome Measurements

Sequence: 235564904 Sequence: 235564905 Sequence: 235564906 Sequence: 235564907 Sequence: 235564908 Sequence: 235564909 Sequence: 235564910 Sequence: 235564911 Sequence: 235564912 Sequence: 235564913 Sequence: 235564914 Sequence: 235564915 Sequence: 235564916 Sequence: 235564917 Sequence: 235564918 Sequence: 235564919 Sequence: 235564920 Sequence: 235564921 Sequence: 235564922 Sequence: 235564923 Sequence: 235564924 Sequence: 235564925 Sequence: 235564926
Outcome Id 30793057 Outcome Id 30793058 Outcome Id 30793058 Outcome Id 30793058 Outcome Id 30793059 Outcome Id 30793059 Outcome Id 30793059 Outcome Id 30793060 Outcome Id 30793060 Outcome Id 30793060 Outcome Id 30793061 Outcome Id 30793061 Outcome Id 30793062 Outcome Id 30793062 Outcome Id 30793062 Outcome Id 30793063 Outcome Id 30793063 Outcome Id 30793063 Outcome Id 30793064 Outcome Id 30793064 Outcome Id 30793064 Outcome Id 30793065 Outcome Id 30793066
Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295 Result Group Id 56079295
Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Category Number of Participants with 25% or greater improvement from Baseline inT25FW speed or 9-HPT Category Number of Participants with <25% improvement from Baseline inT25FW speed or 9-HPT Category Number of Participants with missing data at week 28 Category Number of participants with 25% or more improvement Category Number of participants without 25% or more improvement Category Number of participants with missing values at week 28 Category Number of Participants with 25% or greater improvement from Baseline to Week 28 in 9-HPT Category Number of Participants with less than 25% improvement from Baseline to Week 28 in 9-HPT Category Number of participants with missing values at week 28 Category No of Participants with >5.5 in EDSS at Baseline with ≥0.5 Points Improvement from Baseline to Wk 28 Category No of Participants with >5.5 in EDSS at Baseline with <0.5 Points Improvement from Baseline to Wk 28 Category Number of Participants with ≥10 Points Improvement from Baseline to Week 28 in MSWS-12 Category Number of Participants with <10 Points Improvement from Baseline to Week 28 in MSWS-12 Category Number of Participants with missing data at week 28 Category No. of participants with ≥8 Letter improvement at Week 28 in LCLA Binocular 2.5% Contrast Level Category No. of Participants with <8 Letter Improvement at week 28 in LCLA Binocular 2.5% Contrast Level Category Number of Participants with missing data at week 28 Category Number of Participants with ≥ 3 points Improvement from Baseline to Week 28 in SDMT Score Category Number of Participants with < 3 points Improvement from Baseline to Week 28 in SDMT Score Category Number of Participants with missing data at week 28
Title Number of Participants With Treatment-emergent Adverse Events Title Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) Title Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) Title Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT Title Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT Title Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 Title Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 Title Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) Title Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) Title Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) Title Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level Title Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level Title Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level Title Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score Title Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score Title Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score Title Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment Title Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment
Description Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.

Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment.

Description 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).

The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes.

The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.

Higher values represent worse outcomes.

Description 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).

The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes.

The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.

Higher values represent worse outcomes.

Description 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).

The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes.

The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.

Higher values represent worse outcomes.

Description ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.

The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely.

The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes

Description ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.

The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely.

The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes

Description ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.

The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely.

The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes

Description The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.

The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.

Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome.

Description The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.

The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.

Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome.

Description The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.

The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.

Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome.

Description Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. Description Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. Description The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.

It contains 12 questions that assess the impact of MS on different aspects of walking function and quality.

Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome.

Description The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.

It contains 12 questions that assess the impact of MS on different aspects of walking function and quality.

Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome.

Description The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.

It contains 12 questions that assess the impact of MS on different aspects of walking function and quality.

Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome.

Description The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.

The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome.

Description The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.

The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome.

Description The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.

The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome.

Description Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.

It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome.

Description Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.

It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome.

Description Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.

It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome.

Description Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome Description Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Picograms per milliliter Units picograms per milliliter
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Geometric Mean Param Type Geometric Mean
Param Value 18 Param Value 3 Param Value 13 Param Value 2 Param Value 2 Param Value 12 Param Value 4 Param Value 2 Param Value 13 Param Value 3 Param Value 3 Param Value 7 Param Value 6 Param Value 10 Param Value 2 Param Value 4 Param Value 11 Param Value 3 Param Value 10 Param Value 5 Param Value 3 Param Value 90.17 Param Value 15.16
Param Value Num 18.0 Param Value Num 3.0 Param Value Num 13.0 Param Value Num 2.0 Param Value Num 2.0 Param Value Num 12.0 Param Value Num 4.0 Param Value Num 2.0 Param Value Num 13.0 Param Value Num 3.0 Param Value Num 3.0 Param Value Num 7.0 Param Value Num 6.0 Param Value Num 10.0 Param Value Num 2.0 Param Value Num 4.0 Param Value Num 11.0 Param Value Num 3.0 Param Value Num 10.0 Param Value Num 5.0 Param Value Num 3.0 Param Value Num 90.17 Param Value Num 15.16
Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range
Dispersion Lower Limit -9.16 Dispersion Lower Limit 0.2
Dispersion Upper Limit 124.8 Dispersion Upper Limit 19.44

Baseline Counts

Sequence: 11379734
Result Group Id 56079293
Ctgov Group Code BG000
Units Participants
Scope overall
Count 18

Result Groups

Sequence: 56079293 Sequence: 56079294 Sequence: 56079295 Sequence: 56079296
Ctgov Group Code BG000 Ctgov Group Code FG000 Ctgov Group Code OG000 Ctgov Group Code EG000
Result Type Baseline Result Type Participant Flow Result Type Outcome Result Type Reported Event
Title NurOwn (MSC-NTF Cells) Title NurOwn (MSC-NTF Cells) Title NurOwn (MSC-NTF Cells) Title NurOwn (MSC-NTF Cells)
Description Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

Description Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors NurOwn (MSC-NTF cells). Study drug was supplied in one 5 mL syringe containing 4 mL of NurOwn (MSC-NTF cells) suspension at a dose of 100-125 x106 cells for IT administration. 3 doses of NurOwn (MSC-NTF cells) were transplanted intrathecally at 8-week intervals (Day 0-1, week 8, and week 16) Description Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

Description Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

Baseline Measurements

Sequence: 125540031 Sequence: 125540032 Sequence: 125540033 Sequence: 125540034 Sequence: 125540035 Sequence: 125540036 Sequence: 125540037 Sequence: 125540038 Sequence: 125540039 Sequence: 125540040 Sequence: 125540041 Sequence: 125540042 Sequence: 125540043 Sequence: 125540044 Sequence: 125540045 Sequence: 125540046
Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293 Result Group Id 56079293
Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000
Classification United States
Category Female Category Male Category Hispanic or Latino Category Not Hispanic or Latino Category Unknown or Not Reported Category American Indian or Alaska Native Category Asian Category Native Hawaiian or Other Pacific Islander Category Black or African American Category White Category More than one race Category Unknown or Not Reported
Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Region of Enrollment Title Timed 25-foot walk speed Title Nine-Hole Peg Test (9HPT)
Description The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes Description The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses The participant is seated at a table with a container holding nine pegs and a block with 9 empty holes. On a start command, the participant picks up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.

Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. Higher values represent a worse outcome.

Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Feet/seconds Units Seconds
Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean
Param Value 47.4 Param Value 10 Param Value 8 Param Value 0 Param Value 18 Param Value 0 Param Value 0 Param Value 1 Param Value 0 Param Value 2 Param Value 15 Param Value 0 Param Value 0 Param Value 18 Param Value 2.4 Param Value 35.2
Param Value Num 47.4 Param Value Num 10.0 Param Value Num 8.0 Param Value Num 0.0 Param Value Num 18.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 2.0 Param Value Num 15.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 18.0 Param Value Num 2.4 Param Value Num 35.2
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 9.6 Dispersion Value 1.6 Dispersion Value 15.7
Dispersion Value Num 9.6 Dispersion Value Num 1.6 Dispersion Value Num 15.7
Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18 Number Analyzed 18

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<![CDATA[ Genetic Variants in Nicotinamide Adenine Dinucleotide (NAD) Synthesis Pathway ]]>
https://zephyrnet.com/NCT03799705
2019-12-01

https://zephyrnet.com/?p=NCT03799705
NCT03799705https://www.clinicaltrials.gov/study/NCT03799705?tab=tableNANANAResearchers are trying to identify versions of genes as well as factors in subjects blood associated with certain types of congenital malformations(CMs). This study will help the researchers to better understand family traits that contribute to CMs.
<![CDATA[

Studies

Study First Submitted Date 2018-08-29
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-01-12
Start Month Year December 1, 2019
Primary Completion Month Year December 29, 2022
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-01-12

Facilities

Sequence: 200307683
Name Mayo Clinic
City Rochester
State Minnesota
Zip 55905
Country United States

Conditions

Sequence: 52232513 Sequence: 52232514
Name Vacterl Association Name Congenital Malformation
Downcase Name vacterl association Downcase Name congenital malformation

Id Information

Sequence: 40203470
Id Source org_study_id
Id Value 18-001135

Countries

Sequence: 42617551
Name United States
Removed False

Design Groups

Sequence: 55662294
Title History of VACTERL or congenital malformations
Description 1) Adults with VACTERL association; 2) adults with a history of congenital malformations resembling VACTERL association; 3) gravid and non-gravid women with a history of recurrent miscarriage, their surviving offspring, and the biological father of offspring; 4) newly diagnosed VACTERL patients identified by healthcare providers.

Design Outcomes

Sequence: 177602129 Sequence: 177602130
Outcome Type primary Outcome Type primary
Measure Genetic variants Measure Targeted metabolomics
Time Frame 2 years Time Frame 2 years
Description Identification of genetic variants which may be associated with VACTERL association or other congenital malformations. Description Identification of changes in metabolic pathways which may provide functional insight into the presence of genetic variants in patients with VACTERL association

Browse Conditions

Sequence: 193720423
Mesh Term Congenital Abnormalities
Downcase Mesh Term congenital abnormalities
Mesh Type mesh-list

Sponsors

Sequence: 48376931
Agency Class OTHER
Lead Or Collaborator lead
Name Mayo Clinic

Overall Officials

Sequence: 29318892
Role Principal Investigator
Name Myra Wick, MD PhD
Affiliation Mayo Clinic

Eligibilities

Sequence: 30801282
Sampling Method Non-Probability Sample
Gender All
Minimum Age 0 Years
Maximum Age N/A
Healthy Volunteers No
Population A US population consisting of adults with VACTERL, adults and offspring with a family history of VACTERL, and women with a history of miscarriage and/or congenital malformations.
Criteria Inclusion Criteria:

Adults with confirmed or putative diagnosis of VACTERL association;
Families (mother, father, biological offspring) with a history of VACTERL-associated malformations
Gravid or non-gravid women with a history of miscarriage and/or offspring with non-VACTERL-associated malformations
Willingness to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection

Exclusion Criteria:

1) Parents of non-biological children 3) Children with congenital malformations associated with an identifiable environmental or lifestyle exposure 4) Children with congenital malformations associated with confirmed chromosomal disorders 5) Failure to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection.

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254016371
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 37
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 0
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30547302
Observational Model Family-Based
Time Perspective Other

Links

Sequence: 4392923
Url https://www.mayo.edu/research/clinical-trials
Description Mayo Clinic Clinical Trials

Responsible Parties

Sequence: 28913638
Responsible Party Type Principal Investigator
Name Myra J. Wick
Title Principal Investigator
Affiliation Mayo Clinic

]]>

<![CDATA[ Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer ]]>
https://zephyrnet.com/NCT03799692
2018-11-19

https://zephyrnet.com/?p=NCT03799692
NCT03799692https://www.clinicaltrials.gov/study/NCT03799692?tab=tableYin Liuliuyinfudan@163.com13818051895This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2 Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.

The primary objective of the trial is to evaluate of the efficacy and safety of Nanoparticle Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer.

The primary endpoint of the study is to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

The total number of patients to be included in this study is 78 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 12 months.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year November 19, 2018
Primary Completion Month Year March 30, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200107904 Sequence: 200107905
Status Recruiting Status Recruiting
Name Fudan University Shanghai Cancer Center Name Department of Breast Surgery, Cancer Hospital, Fudan University
City Shanghai City Shanghai
State Shanghai
Zip 200032 Zip 200032
Country China Country China

Facility Contacts

Sequence: 28106390 Sequence: 28106391
Facility Id 200107904 Facility Id 200107905
Contact Type primary Contact Type primary
Name Zhi-Min Shao, MD.PhD. Name Zhimin Shao
Email zhimingshao@yahoo.com Email zhimingshao@yahoo.com
Phone 13601637369 Phone 86(21)64175590
Phone Extension 88807

Facility Investigators

Sequence: 18332487 Sequence: 18332488
Facility Id 200107904 Facility Id 200107905
Role Principal Investigator Role Principal Investigator
Name Zhi-Min Shao, MD.PhD. Name Zhimin Shao

Conditions

Sequence: 52171119
Name HER-2 Negative Breast Cancer
Downcase Name her-2 negative breast cancer

Id Information

Sequence: 40158561
Id Source org_study_id
Id Value 1808189-8

Countries

Sequence: 42568865
Name China
Removed False

Design Groups

Sequence: 55593069
Group Type Experimental
Title Chemotherapy
Description Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle).

Interventions

Sequence: 52485368
Intervention Type Drug
Name Chemotherapy
Description Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15.

Drug: Carboplatin AUC=2 iv, d1, 8, 15.

Keywords

Sequence: 79868364
Name Neoadjuvant Chemotherapy
Downcase Name neoadjuvant chemotherapy

Design Outcomes

Sequence: 177378485 Sequence: 177378486 Sequence: 177378487 Sequence: 177378488
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure The primary endpoint is pathological complete remission (pCR) Measure Objective response rate (ORR) Measure Breast conserving surgery (BCS) rate Measure Adverse events (AE)
Time Frame 3 months Time Frame 3 months Time Frame 3 months Time Frame 3 months
Description Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens. Description The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases. Description Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable. Description Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.

Browse Conditions

Sequence: 193486256 Sequence: 193486257 Sequence: 193486258 Sequence: 193486259 Sequence: 193486260
Mesh Term Breast Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Breast Diseases Mesh Term Skin Diseases
Downcase Mesh Term breast neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term breast diseases Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319195
Agency Class OTHER
Lead Or Collaborator lead
Name Fudan University

Overall Officials

Sequence: 29285300
Role Principal Investigator
Name Zhimin Shao
Affiliation Fudan University

Central Contacts

Sequence: 12008851 Sequence: 12008852
Contact Type primary Contact Type backup
Name Zhimin Shao Name Yin Liu
Phone 18017312288 Phone 13818051895
Email szm@163.com Email liuyinfudan@163.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68148999
Design Group Id 55593069
Intervention Id 52485368

Eligibilities

Sequence: 30765288
Gender Female
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

1.Age: from 18 to 70 years old, female.
2.Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
3.Immunohistochemical detection of ER+, PR+, HER-2 negative (if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification) and Ki-67 expression >20% of patients;
4.At least one measurable objective lesion according to RECIST 1.1 criteria.
5.ECOG performance status of 0-1.
6.Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
7.Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
8.Has good compliance with the planned treatment, understand the study process and sign written informed consent.

Exclusion Criteria:

1.Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
2.Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
3.Severe systemic infection, or with other serious diseases.
4.Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
5.Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
6.Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
7.Have participated in other study studies within 30 days prior to the first dose of study drug.
8.Patients who, in the opinion of the Investigator, are not suitable for participation in the study.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253878248
Number Of Facilities 2
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30511455
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28877749
Responsible Party Type Principal Investigator
Name Zhimin Shao
Title professor
Affiliation Fudan University

]]>

<![CDATA[ Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer ]]>
https://zephyrnet.com/NCT03799679
2018-11-26

https://zephyrnet.com/?p=NCT03799679
NCT03799679https://www.clinicaltrials.gov/study/NCT03799679?tab=tableYin LiuNA13818051895This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.

The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.

The primary endpoint of the study is to to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..

The total number of patients to be included in this study is 60 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 19 months.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year November 26, 2018
Primary Completion Month Year November 30, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200280207
Status Recruiting
Name Cancer Hospital/ Institute, Fudan University
City Shanghai
State Shanghai
Zip 200032
Country China

Facility Contacts

Sequence: 28132832
Facility Id 200280207
Contact Type primary
Name Zhimin Shao, M.D.
Email zhimingshao@yahoo.com
Phone 862164175590
Phone Extension 8808

Browse Interventions

Sequence: 96132746
Mesh Term Antineoplastic Agents
Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list

Conditions

Sequence: 52221385
Name Triple Negative Breast Cancer
Downcase Name triple negative breast cancer

Id Information

Sequence: 40195538
Id Source org_study_id
Id Value 1808189-7

Countries

Sequence: 42609534
Name China
Removed False

Design Groups

Sequence: 55649654
Group Type Experimental
Title Chemotherapy
Description Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 days per cycle)

Interventions

Sequence: 52535179
Intervention Type Drug
Name Chemotherapeutic Agent
Description Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide.

Drug: Epirubicin 90 mg/m² given IV

Drug: Cyclophosphamide 600 mg/m² given IV

Keywords

Sequence: 79941581
Name Neoadjuvant Chemotherapy
Downcase Name neoadjuvant chemotherapy

Design Outcomes

Sequence: 177560887 Sequence: 177560888 Sequence: 177560889 Sequence: 177560890
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure The primary endpoint is pathological complete remission (pCR) Measure The second endpoint includes the objective response rate (ORR) Measure Breast conserving surgery(BCS) rate Measure Adverse events (AE)
Time Frame 2 months Time Frame 2 months Time Frame 2 months Time Frame 2 months
Description Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens. Description The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases. Description Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable. Description Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.

Browse Conditions

Sequence: 193677956 Sequence: 193677957 Sequence: 193677958 Sequence: 193677959 Sequence: 193677960 Sequence: 193677961
Mesh Term Breast Neoplasms Mesh Term Triple Negative Breast Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Breast Diseases Mesh Term Skin Diseases
Downcase Mesh Term breast neoplasms Downcase Mesh Term triple negative breast neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term breast diseases Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366296
Agency Class OTHER
Lead Or Collaborator lead
Name Fudan University

Overall Officials

Sequence: 29312849
Role Principal Investigator
Name Zhimin Shao
Affiliation Fudan University

Central Contacts

Sequence: 12020554 Sequence: 12020555
Contact Type primary Contact Type backup
Name Zhimin Shao Name Yin Liu
Phone 18017312288 Phone 13818051895
Email szm@163.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68217189
Design Group Id 55649654
Intervention Id 52535179

Eligibilities

Sequence: 30794629
Gender Female
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Age: from 18 to 70 years old, female.
Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification.
At least one measurable objective lesion according to RECIST 1.1 criteria.
ECOG performance status of 0-1.
LVEF≥55%.
Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
Has good compliance with the planned treatment, understand the study process and sign written informed consent.

Exclusion Criteria:

Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
Severe systemic infection, or with other serious diseases.
Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
Have participated in other study studies within 30 days prior to the first dose of study drug.
Patients who, in the opinion of the Investigator, are not suitable for participation in the study.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004176
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30540669
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer. Patients will treated by Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide.

Responsible Parties

Sequence: 28906989
Responsible Party Type Principal Investigator
Name Zhimin Shao
Title professor
Affiliation Fudan University

]]>

<![CDATA[ (Re)Vitalizing Pulmonary Rehabilitation for Patients With Chronic Respiratory Diseases ]]>
https://zephyrnet.com/NCT03799666
2019-01-07

https://zephyrnet.com/?p=NCT03799666
NCT03799666https://www.clinicaltrials.gov/study/NCT03799666?tab=tableNANANA3R aims to increase the access of patients with chronic respiratory diseases (CRD) to pulmonary rehabilitation (PR) in Portugal. The main goals of 3R are: i) design and implement an innovative community-based PR programme; ii) assess the cost-benefit of the community-based PR programme; iii) disseminate and perform knowledge transfer about PR across the country.

PR is an evidence-based intervention for the management of CRD and offering PR has been defined as a priority by national/international organizations. However, in Portugal PR is practically inexistent (<1% of “candidate” patients have access). Currently, PR programmes are hospital-based and directed to patients with advanced disease. One of the recommendations to enhance the implementation of PR is the development on novel models of programme delivery. It is hypothesised that community-based programs, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients, society, policy makers) may turn PR more accessible.

The plan is to implement community-based PR programs in 4 primary care centres of 2 ACES of the centre region of Portugal and assess the impact of such intervention in several domains using surrogate and patient-/family-centered outcomes. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization. Dissemination will include one conference, activities with the community, courses and an online PR toolkit. Four schools of 2 polytechnics, 2 city councils, the Health Regional Administration-Centre (ARS-Centro) and all respiratory professional and civic national associations are partners.
<![CDATA[

Studies

Study First Submitted Date 2018-12-14
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-07-08
Start Month Year January 7, 2019
Primary Completion Month Year December 30, 2019
Verification Month Year July 2020
Verification Date 2020-07-31
Last Update Posted Date 2020-07-08

Detailed Descriptions

Sequence: 20709994
Description More than 1 billion people suffer from chronic respiratory diseases worldwide and, in Europe, the total annual cost of respiratory diseases amounts to more than €380 billion. In Portugal, respiratory diseases are the 3rd leading cause of death and direct costs related to hospitalizations (in 2013 – €213 millions). Management of chronic respiratory diseases are high priorities for the National Health Service, and particularly, for the Center Health Regional Administration.

Pulmonary rehabilitation (PR) is an evidence-based intervention for the management of patients with chronic respiratory diseases (grade A). Offering PR has long been defined as a priority by several national and international organizations. Despite this firm recommendation and the knowhow on the provision of PR, in Portugal, PR is practically inexistent, with <1% of "candidate" patients having access to this standard care. Therefore, the need for a National Network on PR has been acknowledged as a priority.

It is hypothesised that community-based programmes, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients/family, society, policy makers) may turn PR more accessible. Thus, the main goal of this project is to increase the access of patients with chronic respiratory diseases, namely COPD, to PR in the center region of Portugal and disseminate this intervention nationally.

3R aims to implement and disseminate community-based PR programs in Portugal. Specifically, it will:

Implement 4 community-based PR programmes (Task 1);
Create an online platform for clinical storage and analysis of the data collected (Task 2);
Perform a cost-benefit analysis of the implemented PR programmes (Task 3);
Create a Portuguese online PR toolkit (Task 4);
Promote knowledge transfer about PR (Task 5). The plan is to implement community-based PR programmes in 4 primary care centres of 2 ACES (Baixo Vouga – BV, and Baixo-Mondego – BM) of the centre region and assess the impact of such intervention in several domains. Surrogate and patient/family centered outcome measures will be used. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization and costs. Finally, dissemination and knowledge transfer of the project will be conducted through: an international conference, activities with the community, three PR courses; the development of the Portuguese online PR toolkit to support the widespread implementation of PR in Portugal and via publications.

To bring PR from bench to Portuguese common practice, 3R brings together a strong consortium composed of 4 schools of 2 Polytechnic Institutions, 2 City Councils, Health Regional Administration – Centre and all respiratory national associations (Sociedade, Portuguesa do Pulmão – SPP, RESPIRA and Fundação Portuguesa do Pulmão – FPP). This consortium involves an experienced team with complementary backgrounds and integrates students from the several institutions during all activities. It is strongly believed that jointly this multidisciplinary team has the experience and complementary skills, as well as the means, to guarantee the success and outreach of the project.

It is estimated that 73 patients will be required to detect significant differences in patients' health-related quality of life (HRQOL), based on a previous study. Stable patients with CRD and their family members will be recruited from Primary Care Centres (PCCs) of the ACES of Baixo Vouga and Baixo Mondego (ACES-BV & BM). Family doctors from PCCs will provide a list of eligible individuals. Individuals/families will be contacted and those interested will meet with researchers to receive further information about the study and sign the informed consents. Participants will be divided in two groups: experimental (EG) and control (CG). The EG will include participants/families wanting to participate in a 12-week community-based PR programme and the CG will include those willing to collaborate in data collection but not in the PR programmes (Task 1). The PR programme will include exercise training (endurance, strength and balance training) twice a week and psychoeducational sessions every two weeks performed by a multidisciplinary team.

Data will be collected at baseline, at 12 weeks (i.e., immediately post-PR), 3 and 6 months post-PR.

Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compared. Moreover, between groups comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated.

Facilities

Sequence: 199965088
Name University of Aveiro
City Aveiro
Zip 3810-193
Country Portugal

Conditions

Sequence: 52139020
Name Chronic Respiratory Disease
Downcase Name chronic respiratory disease

Id Information

Sequence: 40135076
Id Source org_study_id
Id Value SAICT-POL/23926/2016

Countries

Sequence: 42542700
Name Portugal
Removed False

Design Groups

Sequence: 55559374 Sequence: 55559375
Group Type Experimental Group Type Active Comparator
Title Pulmonary Rehabilitation Group Title Standard Care Group
Description Patients will participate in a 12-week community-based pulmonary rehabilitation programme. Description Patients will continue to receive the standard care, which means the daily medication prescribed by the pshysician from the primary care centre team.

Interventions

Sequence: 52454925 Sequence: 52454926
Intervention Type Other Intervention Type Other
Name Pulmonary Rehabilitation Name Daily medication
Description Patients will be treated with daily medication prescribed by the physician. Additionally patients will participate in a 12-w.eek community-based pulmonary rehabilitation programme, with two exercise training sessions per week and six psycho-education sessions, managed by a multidisciplinary team, once every two weeks. Patient's families will be invited to participate in the psychoeducational component Description Patients will be treated with daily medication prescribed by the physician and will continue to receive the standard care from the primary care centre team.

Keywords

Sequence: 79822843 Sequence: 79822844 Sequence: 79822845 Sequence: 79822846
Name Pulmonary rehabilitation Name Community-based Name Chronic Respiratory Diseases Name Cost-benefit analysis
Downcase Name pulmonary rehabilitation Downcase Name community-based Downcase Name chronic respiratory diseases Downcase Name cost-benefit analysis

Design Outcomes

Sequence: 177263841 Sequence: 177263842 Sequence: 177263843 Sequence: 177263844 Sequence: 177263845 Sequence: 177263846 Sequence: 177263847 Sequence: 177263848 Sequence: 177263849 Sequence: 177263850 Sequence: 177263851 Sequence: 177263852 Sequence: 177263853 Sequence: 177263854 Sequence: 177263855 Sequence: 177263856 Sequence: 177263857 Sequence: 177263858 Sequence: 177263859 Sequence: 177263860 Sequence: 177263861 Sequence: 177263862 Sequence: 177263863 Sequence: 177263864 Sequence: 177263865
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other
Measure Change in Health Related quality-of-life: St. George Respiratory Questionnaire Measure Change in airflow obstruction Measure Change in exercise capacity Measure Change in functionality Measure Change in quadriceps muscle strength Measure Change in biceps muscle strength Measure Change in muscle cross sectional area Measure Change in upper limb muscle strength Measure Change in respiratory muscle strength Measure Change in frequency of exacerbations Measure Change in Healthcare utilization Measure Change in family adaptability/cohesion Measure Change in balance Measure Change in Physical activity Measure Change in Physical activity Measure Change in Diaphragm excursion Measure Change in Dyspnoea Measure Change in symptom's impact in patients life Measure Change in Emotional state Measure Change in Fatigue symptoms Measure Change in Fatigue Measure Change in cough-related quality of life: Leicester Cough Questionnaire Measure Change in cough and sputum symptoms Measure Digital Technology access Measure Change in Body Mass Index
Time Frame Up to 9 months Time Frame Up to 9 months Time Frame Up to 9 months Time Frame Up to 9 months Time Frame Up to 9 months Time Frame Up to 3 months Time Frame Up to 3 months Time Frame Up to 9 months Time Frame Up to 3 months Time Frame Up to 9 months Time Frame Up to 9 months Time Frame Up to 3 months Time Frame Up to 3 months Time Frame Up to 3 months Time Frame Up to 9 months Time Frame Up to 3 months Time Frame Up to 9 months Time Frame Up to 9 months Time Frame Up to 9 months Time Frame Up to 3 months Time Frame Up to 3 months Time Frame Up to 3 months Time Frame Up to 3 months Time Frame At baseline Time Frame Up to 9 months
Description St. George Respiratory Questionnaire (SGRQ) will be used to assess Health Related quality-of-life. The SGRQ is a comprehensive well-established 50-item questionnaire to measure health status in patients with chronic respiratory diseases. Scores can be provided for each domain and as a total score, ranging from 0 (no impairment) to 100 (worst possible health status). Description Forced expiratory volume in one second and forced vital capacity will be measured with a portable spirometer to assess the degree of airflow obstruction. Results will be expressed in liters and percentage of predicted. We will calculate the ratio between the forced expiratory volume in one second and the forced vital capacity. Description Exercise capacity will be tested in a 6-minute walk test, since it allows exercise prescription. The test results will be presented as the walked distance (meters). Description Functionality will be tested with the 1-minute sit-to-stand, with the results presented as number of sit-to-stand repetitions. Description Quadriceps muscle strength will be measured using a handheld dynamometer (kilogram/force). Description Biceps muscle strength will be measured using a handheld dynamometer (kilogram/force). Description Cross-sectional will be measured with ultrasound of the lower (quadriceps) and upper (biceps) limb muscles. Description Upper limb strength will be measured with Handgrip (kg) Description Respiratory muscle strength will be measured through a respiratory pressure meter to assess inspiratory and expiratory muscle strength (cm/H20) Description Number of exacerbations in the previous year, healthcare utilization, such as emergency department visits or hospital admissions, in the previous year, which are related to COPD decline Description Healthcare utilization will be assessed through the number of participants that visit emergency department and the number of visits of each participant in the previous year. The number and duration of hospital admissions in the previous year will also be assessed. Description Family function was assessed with the family adaptability and cohesion evaluation scale (FACES-IV). The FACES-IV is a 62 items subdivided in: cohesion and flexibility dimensions, and family communication and family satisfaction scales. The cohesion and flexibility dimensions provide six family scales, two balanced scales (Balanced cohesion and balanced flexibility, with percentile scores ranging from 16 to 85) and four unbalanced scales (Disengaged, Enmeshed, Rigid and Chaotic, with percentile scores ranging from 10 to 99). The six family types (Balanced, Rigidly Cohesive, Midrange, Flexibly unbalanced, chaotically unbalanced and unbalanced) can be plotted onto the Circumplex Model. The family communications and Satisfaction scales are composed of 10 items each, with percentile scores ranging from 10 to 99. In all FACES-IV subscales higher scores indicate better family cohesion, flexibility, communication or satisfaction. Description Balance will be assessed with the Brief-Best tests. Description Accelerometry will be used to assess physical activity. Description The Brief Physical Activity questionnaire will be used to assess physical activity. It a 2 items questionnaire, with scores ranging from 0 to 8. If the sum of the two items score is above or equal 4 the subject will be considered physically active. Description Ultrasound will be used to assess the diaphragm excursion, only volunteer from patients who agree to come to ESSUA and will be seen previously by a physician Description Medical Research Council scale will be used to assess functional dyspnoea related to respiratory impairment. It is a 5-point scale, rated from 0 to 4, with higher scores denoting greater breathlessness severity. Description COPD Assessment Test (CAT) will be used to assess burdensome symptoms in patients' life with 8 items (cough, sputum, dyspnoea, chest tightness, capacity of exercise and home daily activities, confidence leaving home, sleep and energy levels).he scores range from 0-40, organised in 4 categories, namely <10 low impact, 10-20 medium, 21-30 high and >30 very high impact, with 5 representing the upper limit of normal in healthy non-smokers Description Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety and depression. It is a 14 item questionnaire that can be subdivided in two subscales: anxiety and depression. Scores are provided for each subscale and range from 0 to 21, with higher scores meaning more symptoms of anxiety and depression. Description The fatigue subscale of the Checklist of Individual Strength (CIS-20) will be used to assess fatigue.The subscale of subjective fatigue is a 8-item questionnaire, with higher scores indicating higher levels of fatigue. The total scores range from 8 to 56. Description The Functional Assessment of Cancer Therapy – Fatigue subscale (FACIT-F) will be used to assess fatigue levels. It is multi-dimensional 13-item questionnaire assessing tiredness, weakness and difficulty in handling daily activities due to fatigue. Scores range from 0 to 52, with higher scores indicating less fatigue. Description Cough-related quality of life will be assessed with the Leicester Cough Questionnaire, which is a 19 items scale organised in 3 domains (physical, psychological and social). Each domain has a score ranging from 1 to 7 and the LCQ total score varies from 3 to 21. Higher scores express a better quality of life and less impact of cough. Description The Cough and Sputum Assessment Questionnaire (CASA-Q) will be used to assess cough and sputum symptoms, based on their reported frequency and severity, and their impact on daily activities. t is a 20-item questionnaire containing 4 domains: cough symptoms, cough impact, sputum symptoms and sputum impact. All items are rescored and summed, achieving a score ranging from 0 to 100 for each domain, with higher scores indicating fewer symptoms or less cough and sputum impact. Description A survey asking about the use of internet and access to computers, smartphones (combination of mobile phone, web browser and computer capabilities)/tablets and cell phones (simple devices mainly for voice calls and text messages) will be used to assess digital technology access. Confidence in using these technologies will be assessed using a numerical scale from 0 (not at all confident) to 10 (completely confident). Description Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight.

Browse Conditions

Sequence: 193366592 Sequence: 193366593
Mesh Term Respiratory Tract Diseases Mesh Term Respiration Disorders
Downcase Mesh Term respiratory tract diseases Downcase Mesh Term respiration disorders
Mesh Type mesh-list Mesh Type mesh-list

Sponsors

Sequence: 48290727 Sequence: 48290728
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Aveiro University Name Fundação para a Ciência e a Tecnologia

Overall Officials

Sequence: 29268537
Role Principal Investigator
Name Alda S. Marques, PhD
Affiliation School of Health Sciences of the University of Aveiro (ESSUA)

Design Group Interventions

Sequence: 68107484 Sequence: 68107485
Design Group Id 55559374 Design Group Id 55559375
Intervention Id 52454925 Intervention Id 52454926

Eligibilities

Sequence: 30747735
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

clinical diagnosis of a chronic respiratory disease
clinically stable in the previous month
≥ 18 years old
able to provide their own informed consent

Exclusion Criteria:

cognitive impairments
inability to understand and co-operate
history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121947
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 11
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 23
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30494018
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28860298
Responsible Party Type Principal Investigator
Name Alda Sofia Pires de Dias Marques
Title Senior Lecturer
Affiliation Aveiro University

Study References

Sequence: 52032743 Sequence: 52032744 Sequence: 52032745
Pmid 34499161 Pmid 32184112 Pmid 31151409
Reference Type derived Reference Type derived Reference Type derived
Citation Paixao C, Rebelo P, Oliveira A, Jacome C, Cruz J, Martins V, Simao P, Marques A. Responsiveness and Minimal Clinically Important Difference of the Brief-BESTest in People With COPD After Pulmonary Rehabilitation. Phys Ther. 2021 Nov 1;101(11):pzab209. doi: 10.1093/ptj/pzab209. Citation Rebelo P, Oliveira A, Andrade L, Valente C, Marques A. Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Fatigue in Patients With COPD Following Pulmonary Rehabilitation. Chest. 2020 Aug;158(2):550-561. doi: 10.1016/j.chest.2020.02.045. Epub 2020 Mar 14. Citation Marques A, Jacome C, Rebelo P, Paixao C, Oliveira A, Cruz J, Freitas C, Rua M, Loureiro H, Peguinho C, Marques F, Simoes A, Santos M, Martins P, Andre A, De Francesco S, Martins V, Brooks D, Simao P. Improving access to community-based pulmonary rehabilitation: 3R protocol for real-world settings with cost-benefit analysis. BMC Public Health. 2019 May 31;19(1):676. doi: 10.1186/s12889-019-7045-1.

]]>

<![CDATA[ A Nurse Cohort Study in Xiamen, China ]]>
https://zephyrnet.com/NCT03799653
2019-03-20

https://zephyrnet.com/?p=NCT03799653
NCT03799653https://www.clinicaltrials.gov/study/NCT03799653?tab=tableHaihua Zhu, MasterNA86592-2137278The Nurse Cohort Study Xiamen (NCSX) is an open-ended prospective cohort study with very broad research aims. The primary objectives of the NCSX is planned to examine genetic, epigenetic, biological, psychological, social, lifestyle and other environmental factors of nurses in relation to incidence and progression of the common chronic diseases, such as hypertension, ischemic heart disease, stroke, diabetes, chronic kidney disease and some cancers, which are emerging with economic development in Xiamen, China. Specifically, we intend to test whether empirically driven hypothesis and emerging risk factors mainly developed in response to observations in economically developed Western societies apply in a population living in a rapid changing lifestyle in China now.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-04-13
Start Month Year March 20, 2019
Primary Completion Month Year December 31, 2023
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2022-04-13

Detailed Descriptions

Sequence: 20695742
Description Objectives: To establish a cohort of about 10,000 registered nurses (aged 20 or over) in Xiamen, China; to describe the baseline major risk factors; to analyze their interrelationships; and to examine the risks of incidence and progression of major chronic diseases, such as hypertension, stroke, CKD and cancers, and all-cause and cause-specific mortality by different levels of the risk factors after about 5 years follow-up.

Design: A prospective cohort study. Setting: 7 public hospitals in Xiamen, China. Participants: About 10,000 registered nurses (aged 20 or over) who work in public hospitals in Xiamen, China.

Main outcome: Incidences of common chronic diseases, such as CVD, diabetes, chronic kidney disease, and cancers; progression of these diseases; all cause and specific-cause mortality.

Hypothesis: Relative risks of major risk factors. Results of the study should have strong impact on prevention and control of these diseases and promoting nurses'health in the local population.

Facilities

Sequence: 199774612
Status Recruiting
Name The First Affiliated Hospital of Xiamen University
City Xiamen
State Fujian
Zip 361003
Country China

Facility Contacts

Sequence: 28074247
Facility Id 199774612
Contact Type primary
Name Zhibin Li, Ph.D.
Email zhibinli33@hotmail.com
Phone 86592-2137364

Conditions

Sequence: 52101405
Name Hypertension
Downcase Name hypertension

Id Information

Sequence: 40103879
Id Source org_study_id
Id Value KYH2019-002

Countries

Sequence: 42506278
Name China
Removed False

Design Groups

Sequence: 55517395
Title Nurses
Description All subjects are registered nurses in Xiamen, China

Interventions

Sequence: 52415405
Intervention Type Other
Name No intervention
Description This is a prospective observational study, and there is no intervention.

Design Outcomes

Sequence: 177137644 Sequence: 177137645
Outcome Type primary Outcome Type secondary
Measure Incidence rate Measure Mortality
Time Frame 2019.1.21-2024.12.31 Time Frame 2019.1.21-2024.12.31
Description The incidence rates of common chronic diseases, such as hypertension, The stroke, CKD and cancers Description All-cause and cause-specific mortality

Browse Conditions

Sequence: 193212086 Sequence: 193212087 Sequence: 193212088
Mesh Term Hypertension Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases
Downcase Mesh Term hypertension Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48255196
Agency Class OTHER
Lead Or Collaborator lead
Name The First Affiliated Hospital of Xiamen University

Overall Officials

Sequence: 29245217
Role Study Chair
Name Weihua Li, Ph.D.
Affiliation The First Affiliated Hospital of Xiamen University

Central Contacts

Sequence: 11993860 Sequence: 11993861
Contact Type primary Contact Type backup
Name Zhibin Li, Ph.D. Name Haihua Zhu, Master
Phone 86592-2137364 Phone 86592-2137278
Email zhibinli33@hotmail.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68056445
Design Group Id 55517395
Intervention Id 52415405

Eligibilities

Sequence: 30725386
Sampling Method Probability Sample
Gender All
Minimum Age 20 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Population Registered nurses in public hospitals in Xiamen, China;
Aged 20 years or over and living in Xiamen for at least 1 year and will not move out of Xiamen for at least 5 years;
Criteria Inclusion Criteria:

Registered nurses of public hospitals in Xiamen, China;
aged 20 years or over;
Working in the public hospitals for at least 1 year;
Signed the informed consent and agreed to participate in the study;
Assuming not moved out of Xiamen for at least 5 years;

Exclusion Criteria:

who are unambulatory;
who are receiving treatment modalities, which , if omitted, may result in immediate life threatening risk such as chemotherapy or radiotherapy for cancer, or dialysis for renal failure.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253974151
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 20
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30471834
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28838265
Responsible Party Type Principal Investigator
Name Zhibin LI
Title Director
Affiliation The First Affiliated Hospital of Xiamen University

]]>

<![CDATA[ Multidirectional Yoga for Cognition ]]>
https://zephyrnet.com/NCT03799640
2018-12-05

https://zephyrnet.com/?p=NCT03799640
NCT03799640https://www.clinicaltrials.gov/study/NCT03799640?tab=tableNANANAOlder individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-09-10
Start Month Year December 5, 2018
Primary Completion Month Year August 15, 2019
Verification Month Year September 2019
Verification Date 2019-09-30
Last Update Posted Date 2019-09-10

Detailed Descriptions

Sequence: 20716261
Description Reductions in executive function are common with age. Along with these declines come reductions in simple functional patterns of daily living such as crossing a street, walking in a crowded area, or performing any functions that occurs in an open (changing) environment. This study will use a newly developed yoga program incorporating multi-directional movements, cognitive challenges and visuomotor disturbances to improve executive function and associated movements in persons over 60 years of age.

Facilities

Sequence: 200053121 Sequence: 200053122
Name Max Orovitz Laboratories Name Laboratory of Neruomuscular Research and Active Aging
City Coral Gables City Coral Gables
State Florida State Florida
Zip 33146-2416 Zip 33147
Country United States Country United States

Conditions

Sequence: 52156381 Sequence: 52156382 Sequence: 52156383
Name Standard Yoga Name Multi-directional Yoga Name Educational Control
Downcase Name standard yoga Downcase Name multi-directional yoga Downcase Name educational control

Id Information

Sequence: 40148150
Id Source org_study_id
Id Value 20180704

Countries

Sequence: 42557676
Name United States
Removed False

Design Groups

Sequence: 55577810 Sequence: 55577811 Sequence: 55577812
Group Type Experimental Group Type Experimental Group Type Experimental
Title Standard Yoga Title Multi-directional Yoga Title Educational Control
Description Yoga will be performed using linear forward and backward movements. Description The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. . Description Lectures on Health and Wellness

Interventions

Sequence: 52471920 Sequence: 52471921 Sequence: 52471922
Intervention Type Other Intervention Type Other Intervention Type Other
Name Standard Yoga Name Multi-directional Yoga Name Educational Control
Description Yoga using standard poses and linear movements Description The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. Description Lectures on health and fitness

Design Outcomes

Sequence: 177327613 Sequence: 177327608 Sequence: 177327609 Sequence: 177327610 Sequence: 177327611 Sequence: 177327612
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Timed up-and-go Measure NIH Toolbox: Picture Sequence Memory Test Measure NIH Toolbox Flanker test Measure NIH Toolbox List Sorting test Measure NIH Toolbox Pattern Comparison Processing Speed test Measure Walking Executive Function Tests
Time Frame 5 minutes Time Frame 5 minutes Time Frame 5 minutes Time Frame 5 minutes Time Frame 5 minutes Time Frame 10 minutes
Description Rising from a chair, circumventing a cone and returning to the chair. Description Measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen. Description Measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Description Measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Description Measures speed of processing. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible. Items are simple so as to purely measure processing speed. Description Walking and responding to visual cues presented on a 60 inch monitor.

Sponsors

Sequence: 48305978
Agency Class OTHER
Lead Or Collaborator lead
Name University of Miami

Overall Officials

Sequence: 29277886
Role Principal Investigator
Name Joseph Signorile, PhD
Affiliation University of Miami

Design Group Interventions

Sequence: 68130757 Sequence: 68130758 Sequence: 68130759 Sequence: 68130760 Sequence: 68130761 Sequence: 68130762
Design Group Id 55577812 Design Group Id 55577811 Design Group Id 55577812 Design Group Id 55577810 Design Group Id 55577811 Design Group Id 55577810
Intervention Id 52471920 Intervention Id 52471920 Intervention Id 52471921 Intervention Id 52471921 Intervention Id 52471922 Intervention Id 52471922

Eligibilities

Sequence: 30757302
Gender All
Minimum Age 60 Years
Maximum Age 90 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

60-90 years of age
Capable of walking 50 feet with or without a walking aid-

Exclusion Criteria:

Regularly participating in yoga or other balance training program
Currently participating in another exercise study
Unable to commit to study duration
Uncontrolled neuromuscular or cardiovascular disease that prevents participation in an exercise study
Advised not to exercise by their physician

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254225747
Number Of Facilities 2
Registered In Calendar Year 2019
Actual Duration 8
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 60
Maximum Age Num 90
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 6

Designs

Sequence: 30503527
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Masking Description Tests will not be performed by the investigators providing the interventions..
Intervention Model Description Comparison of Yoga Interventions
Investigator Masked True

Responsible Parties

Sequence: 28869805
Responsible Party Type Principal Investigator
Name Joseph Signorile
Title Professor
Affiliation University of Miami

]]>

<![CDATA[ Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa ]]>
https://zephyrnet.com/NCT03799627
2019-01-31

https://zephyrnet.com/?p=NCT03799627
NCT03799627https://www.clinicaltrials.gov/study/NCT03799627?tab=tableNANANAThis is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
<![CDATA[

Studies

Study First Submitted Date 2018-12-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-09-29
Start Month Year January 31, 2019
Primary Completion Month Year June 5, 2020
Verification Month Year September 2022
Verification Date 2022-09-30
Last Update Posted Date 2022-09-29
Results First Posted Date 2022-09-29

Detailed Descriptions

Sequence: 20730274
Description This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder parallel study), the study will include a Screening Period, a Treatment Period, and a Safety Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing excursions outside the target range.

Facilities

Sequence: 200189835 Sequence: 200189836 Sequence: 200189837 Sequence: 200189838 Sequence: 200189839 Sequence: 200189840 Sequence: 200189841 Sequence: 200189842 Sequence: 200189843 Sequence: 200189844 Sequence: 200189845 Sequence: 200189846 Sequence: 200189847 Sequence: 200189848 Sequence: 200189849 Sequence: 200189850 Sequence: 200189851 Sequence: 200189852 Sequence: 200189853 Sequence: 200189854 Sequence: 200189855 Sequence: 200189856 Sequence: 200189857 Sequence: 200189858 Sequence: 200189859 Sequence: 200189860 Sequence: 200189861 Sequence: 200189862 Sequence: 200189863 Sequence: 200189864 Sequence: 200189865 Sequence: 200189866 Sequence: 200189867 Sequence: 200189868 Sequence: 200189869 Sequence: 200189870 Sequence: 200189871 Sequence: 200189872 Sequence: 200189873 Sequence: 200189874 Sequence: 200189875
Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site #1 Name Research Site #2 Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site #1 Name Research Site #2 Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site Name Research Site
City Fresno City Granada Hills City Los Angeles City Northridge City Riverside City San Dimas City San Dimas City San Gabriel City Tarzana City Vacaville City Victorville City Denver City Bridgeport City Hartford City Coral Gables City Hollywood City Miami City Miami City Miami City Tampa City Tampa City Winter Park City Augusta City Statesboro City Roseville City Minneapolis City Minneapolis City Kansas City City Las Vegas City Bronx City Asheville City Wilmington City Canton City Oklahoma City City El Paso City Houston City San Antonio City San Antonio City Chesapeake City Norfolk City Wauwatosa
State California State California State California State California State California State California State California State California State California State California State California State Colorado State Connecticut State Connecticut State Florida State Florida State Florida State Florida State Florida State Florida State Florida State Florida State Georgia State Georgia State Michigan State Minnesota State Minnesota State Missouri State Nevada State New York State North Carolina State North Carolina State Ohio State Oklahoma State Texas State Texas State Texas State Texas State Virginia State Virginia State Wisconsin
Zip 93720 Zip 91344 Zip 90022 Zip 91324 Zip 92501 Zip 91773 Zip 91773 Zip 91776 Zip 91356 Zip 95688 Zip 92394 Zip 80230 Zip 06606 Zip 06762 Zip 33134 Zip 33024 Zip 33126 Zip 33134 Zip 33150 Zip 33607 Zip 33614 Zip 32789 Zip 30909 Zip 30458 Zip 48066 Zip 55404 Zip 55404 Zip 64111 Zip 89107 Zip 10461 Zip 28801 Zip 28401 Zip 44718 Zip 73116 Zip 79915 Zip 77004 Zip 78229 Zip 78258 Zip 23320 Zip 23510 Zip 53226
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States

Browse Interventions

Sequence: 96089741 Sequence: 96089742 Sequence: 96089743 Sequence: 96089744 Sequence: 96089745 Sequence: 96089746 Sequence: 96089747
Mesh Term Epoetin Alfa Mesh Term Glycine Mesh Term Hematinics Mesh Term Glycine Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Physiological Effects of Drugs
Downcase Mesh Term epoetin alfa Downcase Mesh Term glycine Downcase Mesh Term hematinics Downcase Mesh Term glycine agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52193549 Sequence: 52193550
Name Anemia Name Dialysis-dependent Chronic Kidney Disease
Downcase Name anemia Downcase Name dialysis-dependent chronic kidney disease

Id Information

Sequence: 40175451
Id Source org_study_id
Id Value AKB-6548-CI-0025

Countries

Sequence: 42587798
Name United States
Removed False

Design Groups

Sequence: 55618914 Sequence: 55618915 Sequence: 55618916
Group Type Experimental Group Type Experimental Group Type Active Comparator
Title Vadadustat Title Vadadustat TIW Title Epoetin Alfa
Description The initial dose of Vadadustat (300, 450, or 600 milligrams [mg]) will be based upon the dose of Epoetin Alfa dose participants had received prior to Vadadustat treatment Description Participants randomized to Vadadustat (Main and erythropoiesis-stimulating agent [ESA] hyporesponder parallel studies) who complete a once-daily dosing regimen treatment period and meet eligibility criteria for transition to three times weekly (TIW) dosing will switch to TIW dosing Description Epoetin Alfa

Interventions

Sequence: 52508185 Sequence: 52508186 Sequence: 52508187
Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Vadadustat Name Epoetin Alfa Name Vadadustat TIW
Description Vadadustat Tablets 150 mg Description Epoetin Alfa Description Oral Vadadustat

Keywords

Sequence: 79901507 Sequence: 79901508 Sequence: 79901509 Sequence: 79901510 Sequence: 79901511
Name Vadadustat Name AKB-6548 Name Anemia Name Chronic kidney disease (CKD) Name erythropoietin
Downcase Name vadadustat Downcase Name akb-6548 Downcase Name anemia Downcase Name chronic kidney disease (ckd) Downcase Name erythropoietin

Design Outcomes

Sequence: 177461945 Sequence: 177461946 Sequence: 177461947 Sequence: 177461948 Sequence: 177461949 Sequence: 177461950 Sequence: 177461951 Sequence: 177461952 Sequence: 177461953 Sequence: 177461954 Sequence: 177461955 Sequence: 177461956 Sequence: 177461957 Sequence: 177461958 Sequence: 177461959 Sequence: 177461960 Sequence: 177461961 Sequence: 177461962 Sequence: 177461963 Sequence: 177461964 Sequence: 177461965 Sequence: 177461966 Sequence: 177461967 Sequence: 177461968 Sequence: 177461969 Sequence: 177461970 Sequence: 177461971 Sequence: 177461972
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Measure Number of Participants With Treatment-emergent Adverse Events (TEAEs) Measure Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Measure Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Measure Number of Participants Classified as Hb Outliers Measure Number of Participants With Hb Values Within the Target Range at the PEP Measure Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Measure Mean Change in Hb Between Baseline and the SEP Measure Number of Participants With Hb Values Within the Target Range at the SEP Measure Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Measure Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Measure Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Measure Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Measure Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Measure Number of Participants Requiring Red Blood Cell (RBC) Transfusion Measure Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Measure Mean Change From Baseline in Reticulocyte Count Measure Mean Change From Baseline in Iron Concentration Measure Mean Change From Baseline in Ferritin Concentration Measure Mean Change From Baseline in Total Iron Binding Capacity Measure Mean Change From Baseline in Hepcidin Concentration Measure Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Measure Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Measure Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Measure Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Measure Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Measure Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Measure Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Time Frame Baseline; Week 10 to Week 12 Time Frame Up to Week 24 Time Frame Up to Week 24 Time Frame Up to Week 24 Time Frame Weeks 13 – 20 Time Frame Week 10 to Week 12 Time Frame Week 10 to Week 12; Week 18 to Week 20 Time Frame Baseline; Week 18 to Week 20 Time Frame Week 18 to Week 20 Time Frame Week 18 to Week 20 Time Frame Week 10 to Week 12 Time Frame Week 18 to Week 20 Time Frame Up to Week 20 Time Frame Up to Week 20 Time Frame Up to Week 20 Time Frame Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose) Time Frame Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20 Time Frame Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 Time Frame Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 Time Frame Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 Time Frame Baseline; Week 12 and Week 20 Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.

Browse Conditions

Sequence: 193571852 Sequence: 193571853 Sequence: 193571854 Sequence: 193571855 Sequence: 193571856 Sequence: 193571860 Sequence: 193571861 Sequence: 193571862 Sequence: 193571863 Sequence: 193571864 Sequence: 193571857 Sequence: 193571858 Sequence: 193571859
Mesh Term Kidney Diseases Mesh Term Renal Insufficiency, Chronic Mesh Term Anemia Mesh Term Hematologic Diseases Mesh Term Urologic Diseases Mesh Term Male Urogenital Diseases Mesh Term Renal Insufficiency Mesh Term Chronic Disease Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases
Downcase Mesh Term kidney diseases Downcase Mesh Term renal insufficiency, chronic Downcase Mesh Term anemia Downcase Mesh Term hematologic diseases Downcase Mesh Term urologic diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term renal insufficiency Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48340187
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Akebia Therapeutics

Overall Officials

Sequence: 29297915
Role Study Director
Name Chief Medical Officer
Affiliation Akebia Therapeutics Inc.

Design Group Interventions

Sequence: 68180082 Sequence: 68180083 Sequence: 68180084
Design Group Id 55618914 Design Group Id 55618916 Design Group Id 55618915
Intervention Id 52508185 Intervention Id 52508186 Intervention Id 52508187

Eligibilities

Sequence: 30778529
Gender All
Minimum Age 18 Years
Maximum Age 99 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

≥18 years of age, providing informed consent
Receiving chronic, outpatient in-center hemodialysis (TIW) for end-stage renal disease for at least 12 weeks prior to Screening
Maintained on intravenous Epoetin Alfa therapy for 8 weeks prior to and including Screening through Screening Visit 2 (SV2)

Eligibility in the Main study and erythropoiesis-stimulating agent (ESA) hyporesponder parallel study is based on the following mean weekly Epoetin Alfa doses:

Main study: Mean weekly Epoetin Alfa dose <300 Units per kilogram per week (U/kg/week) for 8 weeks prior to SV2;
ESA hyporesponder parallel study: Mean weekly Epoetin Alfa dose ≥300 U/kg/week for 8 weeks prior to SV2

Two Hb values measured by the central laboratory at least 4 days apart between Screening Visit 1 (SV1) and SV2 as indicated:.

Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive;
ESA hyporesponder parallel study: 2 Hb values between 8.0 and 10.0 grams per deciliter (g/dL), inclusive
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
Folate and vitamin B12 measurements ≥ lower limit of normal during Screening
Hemodialysis adequacy as indicated by single-pool Kt/Vurea ≥1.2 using the most recent historical measurement within 8 weeks prior to or during Screening
Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia)
Active bleeding or recent blood loss within 8 weeks prior to randomization
Red blood cell (RBC) transfusion within 8 weeks prior to randomization
Anticipated to discontinue hemodialysis during the study
Judged by the Investigator that the participant is likely to need rescue therapy (ESA administration or RBC transfusion) immediately after enrollment in the study
History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver)
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), or total bilirubin >1.5 x upper limit of normal (ULN) during Screening. Participants with a history of Gilbert's syndrome are not excluded.
Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of Epoetin Alfa
Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening
History of new or recurrent malignancy within 2 years prior to and during Screening or currently receiving treatment or suppressive therapy for cancer. Participants with treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ are not excluded.
History of deep vein thrombosis or pulmonary embolism within 12 weeks prior to or during Screening
History of hemosiderosis or hemochromatosis
History of prior organ transplantation (participants with a history of failed kidney transplant or corneal transplants are not excluded)
Scheduled organ transplant from a living donor and participants on the kidney transplant wait-list who are expected to receive a transplant within 6 months
History of a prior hematopoietic stem cell or bone marrow transplant (stem cell therapy for knee arthritis is not excluded)
Known hypersensitivity to Vadadustat, Epoetin Alfa, or any of their excipients
Any prior use of a hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitor or any use of an investigational medication within 30 days or 5 half-lives of the investigational medication (whichever is longer), prior to randomization

For female participants of non-childbearing potential:

inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 1 month prior to Screening;
not considered post-menopausal (no menses for >1 year with follicle stimulating hormone >40 U/Liter at Screening)

For female participants of childbearing potential:

lack of confirmation of the use of acceptable forms of contraception* for a minimum of one complete menstrual cycle prior to Screening;
positive serum pregnancy test at SV2;
unwilling to use two acceptable forms of contraception* (at least one of which must be a barrier method) starting Baseline/Day 1, throughout the Treatment Period and for 30 days after the final study drug administration
Breastfeeding during Screening or throughout the Treatment Period and for 30 days after the final study drug administration
Donation of ova starting at Screening, throughout the Treatment Period, and for 30 days after the final study drug administration
Male participants who have not had a vasectomy and do not agree to the following: use of an acceptable form of contraception* during the study and for 30 days after the last dose of the study drug; to not donate semen during the study and for at least 30 days after the last dose of Vadadustat
Participants with bilateral native nephrectomy

Any other reason, which in the opinion of the Investigator, would make the participant not suitable for participation in the study

Acceptable forms of contraception include:

Established use of oral, injected or implanted hormonal methods of contraception;
Placement of an intrauterine device or intrauterine system;
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253971225
Number Of Facilities 41
Number Of Nsae Subjects 192
Number Of Sae Subjects 96
Registered In Calendar Year 2018
Actual Duration 16
Were Results Reported True
Months To Report Results 23
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 5
Number Of Secondary Outcomes To Measure 23

Designs

Sequence: 30524632
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Randomized, Open-Label, Active-Controlled

Drop Withdrawals

Sequence: 29004199 Sequence: 29004200 Sequence: 29004201 Sequence: 29004202 Sequence: 29004203 Sequence: 29004204 Sequence: 29004205 Sequence: 29004206 Sequence: 29004207 Sequence: 29004208 Sequence: 29004209 Sequence: 29004210 Sequence: 29004211 Sequence: 29004212 Sequence: 29004213 Sequence: 29004214 Sequence: 29004215 Sequence: 29004216 Sequence: 29004217 Sequence: 29004218 Sequence: 29004219 Sequence: 29004220 Sequence: 29004221 Sequence: 29004222 Sequence: 29004223 Sequence: 29004224 Sequence: 29004225 Sequence: 29004226 Sequence: 29004227 Sequence: 29004228 Sequence: 29004229 Sequence: 29004230 Sequence: 29004231 Sequence: 29004232 Sequence: 29004233 Sequence: 29004234 Sequence: 29004235 Sequence: 29004236 Sequence: 29004237 Sequence: 29004238 Sequence: 29004239 Sequence: 29004240 Sequence: 29004241 Sequence: 29004242 Sequence: 29004243 Sequence: 29004244 Sequence: 29004245 Sequence: 29004246 Sequence: 29004247 Sequence: 29004248 Sequence: 29004249 Sequence: 29004250 Sequence: 29004251 Sequence: 29004252 Sequence: 29004253 Sequence: 29004254 Sequence: 29004255 Sequence: 29004256 Sequence: 29004257 Sequence: 29004258 Sequence: 29004259 Sequence: 29004260 Sequence: 29004261 Sequence: 29004262 Sequence: 29004263 Sequence: 29004264 Sequence: 29004265 Sequence: 29004266 Sequence: 29004267 Sequence: 29004268 Sequence: 29004269 Sequence: 29004270 Sequence: 29004271 Sequence: 29004272 Sequence: 29004273 Sequence: 29004274 Sequence: 29004275 Sequence: 29004276 Sequence: 29004277 Sequence: 29004278 Sequence: 29004279 Sequence: 29004280 Sequence: 29004281 Sequence: 29004282 Sequence: 29004283 Sequence: 29004284 Sequence: 29004285 Sequence: 29004286 Sequence: 29004287 Sequence: 29004288 Sequence: 29004289 Sequence: 29004290 Sequence: 29004291 Sequence: 29004292 Sequence: 29004293 Sequence: 29004294 Sequence: 29004295 Sequence: 29004296 Sequence: 29004297 Sequence: 29004298 Sequence: 29004299 Sequence: 29004300 Sequence: 29004301 Sequence: 29004302 Sequence: 29004303 Sequence: 29004304 Sequence: 29004305 Sequence: 29004306 Sequence: 29004307 Sequence: 29004308 Sequence: 29004309 Sequence: 29004310 Sequence: 29004311 Sequence: 29004312 Sequence: 29004313 Sequence: 29004314 Sequence: 29004315 Sequence: 29004316 Sequence: 29004317 Sequence: 29004318 Sequence: 29004319 Sequence: 29004320 Sequence: 29004321 Sequence: 29004322 Sequence: 29004323 Sequence: 29004324 Sequence: 29004325 Sequence: 29004326 Sequence: 29004327 Sequence: 29004328 Sequence: 29004329 Sequence: 29004330 Sequence: 29004331 Sequence: 29004332 Sequence: 29004333 Sequence: 29004334 Sequence: 29004335 Sequence: 29004336 Sequence: 29004337 Sequence: 29004338 Sequence: 29004339 Sequence: 29004340 Sequence: 29004341 Sequence: 29004342 Sequence: 29004343 Sequence: 29004344 Sequence: 29004345 Sequence: 29004346 Sequence: 29004347 Sequence: 29004348 Sequence: 29004349 Sequence: 29004350 Sequence: 29004351 Sequence: 29004352 Sequence: 29004353 Sequence: 29004354 Sequence: 29004355 Sequence: 29004356 Sequence: 29004357 Sequence: 29004358 Sequence: 29004359 Sequence: 29004360
Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540
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Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Lack of Efficacy Reason Lack of Efficacy Reason Lack of Efficacy Reason Lack of Efficacy Reason Lack of Efficacy Reason Lack of Efficacy Reason Lack of Efficacy Reason Lack of Efficacy Reason Lack of Efficacy Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Death Reason Death Reason Death Reason Death Reason Death Reason Death Reason Death Reason Death Reason Death Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Study Drug Put on Hold Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Due to Urgent Safety Measures Letter Reason Kidney Transplantation Reason Kidney Transplantation Reason Kidney Transplantation Reason Kidney Transplantation Reason Kidney Transplantation Reason Kidney Transplantation Reason Kidney Transplantation Reason Kidney Transplantation Reason Kidney Transplantation Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Participant Was on Rescue Epogen Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Placed on Dose Hold Until End of Treatment Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Met Exclusion Criteria Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Investigational Product Noncompliance Reason Participant Relocation Reason Participant Relocation Reason Participant Relocation Reason Participant Relocation Reason Participant Relocation Reason Participant Relocation Reason Participant Relocation Reason Participant Relocation Reason Participant Relocation Reason Eurofin Issue Reason Eurofin Issue Reason Eurofin Issue Reason Eurofin Issue Reason Eurofin Issue Reason Eurofin Issue Reason Eurofin Issue Reason Eurofin Issue Reason Eurofin Issue Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Noncompliance with Site Instructions Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Participant's Last Dose Prior to End of Treatment Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values Reason Changes In Hemoglobin Values
Count 1 Count 2 Count 0 Count 0 Count 2 Count 5 Count 0 Count 2 Count 0 Count 2 Count 2 Count 0 Count 0 Count 2 Count 2 Count 0 Count 0 Count 0 Count 1 Count 1 Count 0 Count 2 Count 0 Count 3 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 1 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 2 Count 0 Count 2 Count 1 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 1 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 1 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 1 Count 2 Count 1 Count 0 Count 0 Count 2 Count 1 Count 0 Count 1

Intervention Other Names

Sequence: 26684156 Sequence: 26684157 Sequence: 26684158
Intervention Id 52508185 Intervention Id 52508186 Intervention Id 52508186
Name AKB-6548 Name Procrit Name Epogen

Milestones

Sequence: 41027678 Sequence: 41027679 Sequence: 41027680 Sequence: 41027681 Sequence: 41027682 Sequence: 41027683 Sequence: 41027684 Sequence: 41027685 Sequence: 41027686 Sequence: 41027687 Sequence: 41027688 Sequence: 41027689 Sequence: 41027690 Sequence: 41027691 Sequence: 41027692 Sequence: 41027693 Sequence: 41027694 Sequence: 41027695 Sequence: 41027696 Sequence: 41027697 Sequence: 41027698 Sequence: 41027699 Sequence: 41027700 Sequence: 41027701 Sequence: 41027702 Sequence: 41027703 Sequence: 41027704
Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540 Result Group Id 56112532 Result Group Id 56112533 Result Group Id 56112534 Result Group Id 56112535 Result Group Id 56112536 Result Group Id 56112537 Result Group Id 56112538 Result Group Id 56112539 Result Group Id 56112540
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG006 Ctgov Group Code FG007 Ctgov Group Code FG008 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG006 Ctgov Group Code FG007 Ctgov Group Code FG008 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG006 Ctgov Group Code FG007 Ctgov Group Code FG008
Title STARTED Title STARTED Title STARTED Title STARTED Title STARTED Title STARTED Title STARTED Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 27 Count 23 Count 22 Count 8 Count 12 Count 8 Count 10 Count 3 Count 2 Count 8 Count 11 Count 1 Count 10 Count 9 Count 13 Count 3 Count 2 Count 3

Participant Flows

Sequence: 3922864
Pre Assignment Details A total of 540 participants were screened, of which 175 participants were enrolled and randomized into the 2 parts of this study (Main Study; n=165; Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study: n=10). A total of 365 participants failed screening. Participants were randomized to either a Vadadustat or Epoetin Alfa treatment group, and randomization was stratified by mean weekly Epoetin Alfa dose calculated over a period of 8 weeks prior to Screening Visit 2.

Outcome Counts

Sequence: 74039013 Sequence: 74039014 Sequence: 74039015 Sequence: 74039016 Sequence: 74039017 Sequence: 74039018 Sequence: 74039019 Sequence: 74039020 Sequence: 74039021 Sequence: 74039022 Sequence: 74039023 Sequence: 74039024 Sequence: 74039025 Sequence: 74039026 Sequence: 74039027 Sequence: 74039028 Sequence: 74039029 Sequence: 74039030 Sequence: 74039031 Sequence: 74039032 Sequence: 74039033 Sequence: 74039034 Sequence: 74039035 Sequence: 74039036 Sequence: 74039037 Sequence: 74039038 Sequence: 74039039 Sequence: 74039040 Sequence: 74039041 Sequence: 74039042 Sequence: 74039043 Sequence: 74039044 Sequence: 74039045 Sequence: 74039046 Sequence: 74039047 Sequence: 74039048 Sequence: 74039049 Sequence: 74039050 Sequence: 74039051 Sequence: 74039052 Sequence: 74039053 Sequence: 74039054 Sequence: 74039055 Sequence: 74039056 Sequence: 74039057 Sequence: 74039058 Sequence: 74039059 Sequence: 74039060 Sequence: 74039061 Sequence: 74039062 Sequence: 74039063 Sequence: 74039064 Sequence: 74039065 Sequence: 74039066 Sequence: 74039067 Sequence: 74039068 Sequence: 74039069 Sequence: 74039070 Sequence: 74039071 Sequence: 74039072 Sequence: 74039073 Sequence: 74039074 Sequence: 74039075 Sequence: 74039076 Sequence: 74039077 Sequence: 74039078 Sequence: 74039079 Sequence: 74039080 Sequence: 74039081 Sequence: 74039082 Sequence: 74039083 Sequence: 74039084 Sequence: 74039085 Sequence: 74039086 Sequence: 74039087 Sequence: 74039088 Sequence: 74039089 Sequence: 74039090 Sequence: 74039091 Sequence: 74039092 Sequence: 74039093 Sequence: 74039094 Sequence: 74039095 Sequence: 74039096 Sequence: 74039097 Sequence: 74039098 Sequence: 74039099 Sequence: 74039100 Sequence: 74039101 Sequence: 74039102 Sequence: 74039103 Sequence: 74039104 Sequence: 74039105 Sequence: 74039106 Sequence: 74039107 Sequence: 74039108 Sequence: 74039109 Sequence: 74039110 Sequence: 74039111 Sequence: 74039112 Sequence: 74039113 Sequence: 74039114 Sequence: 74039115 Sequence: 74039116 Sequence: 74039117 Sequence: 74039118 Sequence: 74039119 Sequence: 74039120 Sequence: 74039121 Sequence: 74039122 Sequence: 74039123 Sequence: 74039124 Sequence: 74039125 Sequence: 74039126 Sequence: 74039127 Sequence: 74039128 Sequence: 74039129 Sequence: 74039130 Sequence: 74039131 Sequence: 74039132 Sequence: 74039133 Sequence: 74039134 Sequence: 74039135 Sequence: 74039136 Sequence: 74039137 Sequence: 74039138 Sequence: 74039139 Sequence: 74039140 Sequence: 74039141 Sequence: 74039142 Sequence: 74039143 Sequence: 74039144 Sequence: 74039145 Sequence: 74039146 Sequence: 74039147 Sequence: 74039148 Sequence: 74039149 Sequence: 74039150 Sequence: 74039151 Sequence: 74039152 Sequence: 74039153 Sequence: 74039154 Sequence: 74039155 Sequence: 74039156 Sequence: 74039157 Sequence: 74039158 Sequence: 74039159 Sequence: 74039160 Sequence: 74039161 Sequence: 74039162 Sequence: 74039163 Sequence: 74039164 Sequence: 74039165 Sequence: 74039166 Sequence: 74039167 Sequence: 74039168 Sequence: 74039169 Sequence: 74039170 Sequence: 74039171 Sequence: 74039172 Sequence: 74039173 Sequence: 74039174 Sequence: 74039175 Sequence: 74039176 Sequence: 74039177 Sequence: 74039178 Sequence: 74039179 Sequence: 74039180 Sequence: 74039181 Sequence: 74039182 Sequence: 74039183 Sequence: 74039184 Sequence: 74039185 Sequence: 74039186 Sequence: 74039187 Sequence: 74039188 Sequence: 74039189 Sequence: 74039190 Sequence: 74039191 Sequence: 74039192 Sequence: 74039193 Sequence: 74039194 Sequence: 74039195 Sequence: 74039196 Sequence: 74039197 Sequence: 74039198 Sequence: 74039199 Sequence: 74039200 Sequence: 74039201 Sequence: 74039202 Sequence: 74039203 Sequence: 74039204 Sequence: 74039205 Sequence: 74039206 Sequence: 74039207 Sequence: 74039208 Sequence: 74039209 Sequence: 74039210 Sequence: 74039211 Sequence: 74039212 Sequence: 74039213 Sequence: 74039214 Sequence: 74039215 Sequence: 74039216 Sequence: 74039217 Sequence: 74039218 Sequence: 74039219 Sequence: 74039220 Sequence: 74039221 Sequence: 74039222 Sequence: 74039223 Sequence: 74039224 Sequence: 74039225 Sequence: 74039226 Sequence: 74039227 Sequence: 74039228 Sequence: 74039229 Sequence: 74039230 Sequence: 74039231 Sequence: 74039232 Sequence: 74039233 Sequence: 74039234
Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820443 Outcome Id 30820443 Outcome Id 30820443 Outcome Id 30820443 Outcome Id 30820443 Outcome Id 30820443 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820444 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820445 Outcome Id 30820446 Outcome Id 30820446 Outcome Id 30820446 Outcome Id 30820446 Outcome Id 30820446 Outcome Id 30820446 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820447 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820448 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464
Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112551 Result Group Id 56112552 Result Group Id 56112553 Result Group Id 56112554 Result Group Id 56112555 Result Group Id 56112556 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112551 Result Group Id 56112552 Result Group Id 56112553 Result Group Id 56112554 Result Group Id 56112555 Result Group Id 56112557 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112558 Result Group Id 56112559 Result Group Id 56112560 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112561 Result Group Id 56112562 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112568 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 34 Count 35 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 34 Count 35 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 34 Count 35 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 30 Count 27 Count 23 Count 10 Count 16 Count 13 Count 12 Count 3 Count 5 Count 30 Count 30 Count 23 Count 12 Count 18 Count 14 Count 12 Count 4 Count 5 Count 1 Count 4 Count 7 Count 5 Count 17 Count 0 Count 26 Count 24 Count 23 Count 7 Count 14 Count 10 Count 12 Count 3 Count 4 Count 26 Count 24 Count 23 Count 7 Count 14 Count 10 Count 12 Count 3 Count 4 Count 1 Count 4 Count 7 Count 5 Count 17 Count 0 Count 30 Count 30 Count 23 Count 12 Count 18 Count 14 Count 12 Count 4 Count 5 Count 26 Count 24 Count 23 Count 7 Count 14 Count 10 Count 12 Count 3 Count 4 Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 33 Count 30 Count 15 Count 21 Count 15 Count 5 Count 30 Count 32 Count 21 Count 18 Count 20 Count 21 Count 11 Count 5 Count 5 Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 34 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 35 Count 34 Count 21 Count 17 Count 21 Count 21 Count 13 Count 5 Count 5 Count 32 Count 30 Count 14 Count 21 Count 17 Count 5 Count 29 Count 28 Count 13 Count 21 Count 13 Count 5 Count 17 Count 17 Count 8 Count 8 Count 6 Count 2 Count 32 Count 30 Count 14 Count 21 Count 17 Count 5 Count 17 Count 17 Count 8 Count 8 Count 6 Count 2 Count 29 Count 28 Count 13 Count 21 Count 13 Count 5 Count 16 Count 15 Count 8 Count 8 Count 6 Count 2

Provided Documents

Sequence: 2581571 Sequence: 2581572
Document Type Study Protocol Document Type Statistical Analysis Plan
Has Protocol True Has Protocol False
Has Icf False Has Icf False
Has Sap False Has Sap True
Document Date 2018-06-27 Document Date 2020-07-02
Url https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/Prot_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/SAP_001.pdf

Reported Event Totals

Sequence: 27955798 Sequence: 27955799 Sequence: 27955800 Sequence: 27955801 Sequence: 27955802 Sequence: 27955803 Sequence: 27955804 Sequence: 27955805 Sequence: 27955806 Sequence: 27955807 Sequence: 27955808 Sequence: 27955809 Sequence: 27955810 Sequence: 27955811 Sequence: 27955812 Sequence: 27955813 Sequence: 27955814 Sequence: 27955815 Sequence: 27955816 Sequence: 27955817 Sequence: 27955818 Sequence: 27955819 Sequence: 27955820 Sequence: 27955821 Sequence: 27955822 Sequence: 27955823 Sequence: 27955824
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG002 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG003 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG004 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG005 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG006 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG007 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG008 Ctgov Group Code EG008
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 9 Subjects Affected 11 Subjects Affected 0 Subjects Affected 7 Subjects Affected 20 Subjects Affected 0 Subjects Affected 5 Subjects Affected 10 Subjects Affected 0 Subjects Affected 8 Subjects Affected 9 Subjects Affected 1 Subjects Affected 6 Subjects Affected 9 Subjects Affected 1 Subjects Affected 10 Subjects Affected 10 Subjects Affected 1 Subjects Affected 5 Subjects Affected 8 Subjects Affected 1 Subjects Affected 4 Subjects Affected 4 Subjects Affected 0 Subjects Affected 3 Subjects Affected 2 Subjects Affected 0
Subjects At Risk 34 Subjects At Risk 34 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 35 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 23 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 13 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 5
Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012 Created At 2023-08-09 03:55:44.020012
Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012 Updated At 2023-08-09 03:55:44.020012

Reported Events

Sequence: 528504815 Sequence: 528504736 Sequence: 528504737 Sequence: 528504738 Sequence: 528504816 Sequence: 528504817 Sequence: 528504818 Sequence: 528504819 Sequence: 528504739 Sequence: 528504820 Sequence: 528504740 Sequence: 528504741 Sequence: 528504742 Sequence: 528504743 Sequence: 528504733 Sequence: 528504734 Sequence: 528504735 Sequence: 528504744 Sequence: 528504745 Sequence: 528504746 Sequence: 528504747 Sequence: 528504748 Sequence: 528504749 Sequence: 528504750 Sequence: 528504751 Sequence: 528504752 Sequence: 528504753 Sequence: 528504754 Sequence: 528504755 Sequence: 528504756 Sequence: 528504757 Sequence: 528504758 Sequence: 528504759 Sequence: 528504760 Sequence: 528504761 Sequence: 528504762 Sequence: 528504763 Sequence: 528504764 Sequence: 528504765 Sequence: 528504766 Sequence: 528504767 Sequence: 528504768 Sequence: 528504769 Sequence: 528504770 Sequence: 528504771 Sequence: 528504772 Sequence: 528504773 Sequence: 528504774 Sequence: 528504775 Sequence: 528504776 Sequence: 528504777 Sequence: 528504778 Sequence: 528504779 Sequence: 528504780 Sequence: 528504781 Sequence: 528504782 Sequence: 528504783 Sequence: 528504784 Sequence: 528504785 Sequence: 528504786 Sequence: 528504787 Sequence: 528504788 Sequence: 528504789 Sequence: 528504790 Sequence: 528504791 Sequence: 528504792 Sequence: 528504793 Sequence: 528504794 Sequence: 528504795 Sequence: 528504796 Sequence: 528504797 Sequence: 528504798 Sequence: 528504799 Sequence: 528504800 Sequence: 528504801 Sequence: 528504802 Sequence: 528504803 Sequence: 528504804 Sequence: 528504805 Sequence: 528504806 Sequence: 528504807 Sequence: 528504808 Sequence: 528504809 Sequence: 528504810 Sequence: 528504811 Sequence: 528504812 Sequence: 528504813 Sequence: 528504814 Sequence: 528504821 Sequence: 528504822 Sequence: 528504823 Sequence: 528504824 Sequence: 528504825 Sequence: 528504826 Sequence: 528504827 Sequence: 528504828 Sequence: 528504829 Sequence: 528504830 Sequence: 528504831 Sequence: 528504832 Sequence: 528504833 Sequence: 528504834 Sequence: 528504835 Sequence: 528504836 Sequence: 528504837 Sequence: 528504838 Sequence: 528504839 Sequence: 528504840 Sequence: 528504841 Sequence: 528504842 Sequence: 528504843 Sequence: 528504844 Sequence: 528504845 Sequence: 528504846 Sequence: 528504847 Sequence: 528504848 Sequence: 528504849 Sequence: 528504850 Sequence: 528504851 Sequence: 528504852 Sequence: 528504853 Sequence: 528504854 Sequence: 528504855 Sequence: 528504856 Sequence: 528504857 Sequence: 528504858 Sequence: 528504859 Sequence: 528504860 Sequence: 528504861 Sequence: 528504862 Sequence: 528504863 Sequence: 528504864 Sequence: 528504865 Sequence: 528504866 Sequence: 528504867 Sequence: 528504868 Sequence: 528504869 Sequence: 528504870 Sequence: 528504871 Sequence: 528504872 Sequence: 528504873 Sequence: 528504874 Sequence: 528504875 Sequence: 528504876 Sequence: 528504877 Sequence: 528504878 Sequence: 528504879 Sequence: 528504880 Sequence: 528504881 Sequence: 528504882 Sequence: 528504883 Sequence: 528504884 Sequence: 528504885 Sequence: 528504886 Sequence: 528504887 Sequence: 528504888 Sequence: 528504889 Sequence: 528504890 Sequence: 528504891 Sequence: 528504892 Sequence: 528504893 Sequence: 528504894 Sequence: 528504895 Sequence: 528504896 Sequence: 528504897 Sequence: 528504898 Sequence: 528504899 Sequence: 528504900 Sequence: 528504901 Sequence: 528504902 Sequence: 528504903 Sequence: 528504904 Sequence: 528504905 Sequence: 528504906 Sequence: 528504907 Sequence: 528504908 Sequence: 528504909 Sequence: 528504910 Sequence: 528504911 Sequence: 528504912 Sequence: 528504913 Sequence: 528504914 Sequence: 528504915 Sequence: 528504916 Sequence: 528504917 Sequence: 528504918 Sequence: 528504919 Sequence: 528504920 Sequence: 528504921 Sequence: 528504922 Sequence: 528504923 Sequence: 528504924 Sequence: 528504925 Sequence: 528504926 Sequence: 528504927 Sequence: 528504928 Sequence: 528504929 Sequence: 528504930 Sequence: 528504931 Sequence: 528504932 Sequence: 528504933 Sequence: 528504934 Sequence: 528504935 Sequence: 528504936 Sequence: 528504937 Sequence: 528504938 Sequence: 528504939 Sequence: 528504940 Sequence: 528504941 Sequence: 528504942 Sequence: 528504943 Sequence: 528504944 Sequence: 528504945 Sequence: 528504946 Sequence: 528504947 Sequence: 528504948 Sequence: 528504949 Sequence: 528504950 Sequence: 528504951 Sequence: 528504952 Sequence: 528504953 Sequence: 528504954 Sequence: 528504955 Sequence: 528504956 Sequence: 528504957 Sequence: 528504958 Sequence: 528504959 Sequence: 528504960 Sequence: 528504961 Sequence: 528504962 Sequence: 528504963 Sequence: 528504964 Sequence: 528504965 Sequence: 528504966 Sequence: 528504967 Sequence: 528504968 Sequence: 528504969 Sequence: 528504970 Sequence: 528504971 Sequence: 528504972 Sequence: 528504973 Sequence: 528504974 Sequence: 528504975 Sequence: 528504976 Sequence: 528504977 Sequence: 528504978 Sequence: 528504979 Sequence: 528504980 Sequence: 528504981 Sequence: 528504982 Sequence: 528504983 Sequence: 528504984 Sequence: 528504985 Sequence: 528504986 Sequence: 528504987 Sequence: 528504988 Sequence: 528504989 Sequence: 528504990 Sequence: 528504991 Sequence: 528504992 Sequence: 528504993 Sequence: 528504994 Sequence: 528504995 Sequence: 528504996 Sequence: 528504997 Sequence: 528504998 Sequence: 528504999 Sequence: 528505000 Sequence: 528505001 Sequence: 528505002 Sequence: 528505003 Sequence: 528505004 Sequence: 528505005 Sequence: 528505006 Sequence: 528505007 Sequence: 528505008 Sequence: 528505009 Sequence: 528505010 Sequence: 528505011 Sequence: 528505012 Sequence: 528505013 Sequence: 528505014 Sequence: 528505015 Sequence: 528505016 Sequence: 528505017 Sequence: 528505018 Sequence: 528505019 Sequence: 528505020 Sequence: 528505021 Sequence: 528505022 Sequence: 528505023 Sequence: 528505024 Sequence: 528505025 Sequence: 528505026 Sequence: 528505027 Sequence: 528505028 Sequence: 528505029 Sequence: 528505030 Sequence: 528505031 Sequence: 528505032 Sequence: 528505033 Sequence: 528505034 Sequence: 528505035 Sequence: 528505036 Sequence: 528505037 Sequence: 528505038 Sequence: 528505039 Sequence: 528505040 Sequence: 528505041 Sequence: 528505042 Sequence: 528505043 Sequence: 528505044 Sequence: 528505045 Sequence: 528505046 Sequence: 528505047 Sequence: 528505048 Sequence: 528505049 Sequence: 528505050 Sequence: 528505051 Sequence: 528505052 Sequence: 528505053 Sequence: 528505054 Sequence: 528505055 Sequence: 528505056 Sequence: 528505057 Sequence: 528505058 Sequence: 528505059 Sequence: 528505060 Sequence: 528505061 Sequence: 528505062 Sequence: 528505063 Sequence: 528505064 Sequence: 528505065 Sequence: 528505066 Sequence: 528505067 Sequence: 528505068 Sequence: 528505069 Sequence: 528505070 Sequence: 528505071 Sequence: 528505072 Sequence: 528505073 Sequence: 528505074 Sequence: 528505075 Sequence: 528505076 Sequence: 528505077 Sequence: 528505078 Sequence: 528505079 Sequence: 528505080 Sequence: 528505081 Sequence: 528505082 Sequence: 528505083 Sequence: 528505084 Sequence: 528505085 Sequence: 528505086 Sequence: 528505087 Sequence: 528505088 Sequence: 528505089 Sequence: 528505090 Sequence: 528505091 Sequence: 528505092 Sequence: 528505093 Sequence: 528505094 Sequence: 528505095 Sequence: 528505096 Sequence: 528505097 Sequence: 528505098 Sequence: 528505099 Sequence: 528505100 Sequence: 528505101 Sequence: 528505102 Sequence: 528505103 Sequence: 528505104 Sequence: 528505105 Sequence: 528505106 Sequence: 528505107 Sequence: 528505108 Sequence: 528505109 Sequence: 528505110 Sequence: 528505111 Sequence: 528505112 Sequence: 528505113 Sequence: 528505114 Sequence: 528505115 Sequence: 528505116 Sequence: 528505117 Sequence: 528505118 Sequence: 528505119 Sequence: 528505120 Sequence: 528505121 Sequence: 528505122 Sequence: 528505123 Sequence: 528505124 Sequence: 528505125 Sequence: 528505126 Sequence: 528505127 Sequence: 528505128 Sequence: 528505129 Sequence: 528505130 Sequence: 528505131 Sequence: 528505132 Sequence: 528505133 Sequence: 528505134 Sequence: 528505135 Sequence: 528505136 Sequence: 528505137 Sequence: 528505138 Sequence: 528505139 Sequence: 528505140 Sequence: 528505141 Sequence: 528505142 Sequence: 528505143 Sequence: 528505144 Sequence: 528505145 Sequence: 528505146 Sequence: 528505147 Sequence: 528505148 Sequence: 528505149 Sequence: 528505150 Sequence: 528505151 Sequence: 528505152 Sequence: 528505153 Sequence: 528505154 Sequence: 528505155 Sequence: 528505156 Sequence: 528505157 Sequence: 528505158 Sequence: 528505159 Sequence: 528505160 Sequence: 528505161 Sequence: 528505162 Sequence: 528505163 Sequence: 528505164 Sequence: 528505165 Sequence: 528505166 Sequence: 528505167 Sequence: 528505168 Sequence: 528505169 Sequence: 528505170 Sequence: 528505171 Sequence: 528505172 Sequence: 528505173 Sequence: 528505174 Sequence: 528505175 Sequence: 528505176 Sequence: 528505177 Sequence: 528505178 Sequence: 528505179 Sequence: 528505180 Sequence: 528505181 Sequence: 528505182 Sequence: 528505183 Sequence: 528505184 Sequence: 528505185 Sequence: 528505186 Sequence: 528505187 Sequence: 528505188 Sequence: 528505189 Sequence: 528505190 Sequence: 528505191 Sequence: 528505192 Sequence: 528505193 Sequence: 528505194 Sequence: 528505195 Sequence: 528505196 Sequence: 528505197 Sequence: 528505198 Sequence: 528505199 Sequence: 528505200 Sequence: 528505201 Sequence: 528505202 Sequence: 528505203 Sequence: 528505204 Sequence: 528505205 Sequence: 528505206 Sequence: 528505207 Sequence: 528505208 Sequence: 528505209 Sequence: 528505210 Sequence: 528505211 Sequence: 528505212 Sequence: 528505213 Sequence: 528505214 Sequence: 528505215 Sequence: 528505216 Sequence: 528505217 Sequence: 528505218 Sequence: 528505219 Sequence: 528505220 Sequence: 528505221 Sequence: 528505222 Sequence: 528505223 Sequence: 528505224 Sequence: 528505225 Sequence: 528505226 Sequence: 528505227 Sequence: 528505228 Sequence: 528505229 Sequence: 528505230 Sequence: 528505231 Sequence: 528505232 Sequence: 528505233 Sequence: 528505234 Sequence: 528505235 Sequence: 528505236 Sequence: 528505237 Sequence: 528505238 Sequence: 528505239 Sequence: 528505240 Sequence: 528505241 Sequence: 528505242 Sequence: 528505243 Sequence: 528505244 Sequence: 528505245 Sequence: 528505246 Sequence: 528505247 Sequence: 528505248 Sequence: 528505249 Sequence: 528505250 Sequence: 528505251 Sequence: 528505252 Sequence: 528505253 Sequence: 528505254 Sequence: 528505255 Sequence: 528505256 Sequence: 528505257 Sequence: 528505258 Sequence: 528505259 Sequence: 528505260 Sequence: 528505261 Sequence: 528505262 Sequence: 528505263 Sequence: 528505264 Sequence: 528505265 Sequence: 528505266 Sequence: 528505267 Sequence: 528505268 Sequence: 528505269 Sequence: 528505270 Sequence: 528505271 Sequence: 528505272 Sequence: 528505273 Sequence: 528505274 Sequence: 528505275 Sequence: 528505276 Sequence: 528505277 Sequence: 528505278 Sequence: 528505279 Sequence: 528505280 Sequence: 528505281 Sequence: 528505282 Sequence: 528505283 Sequence: 528505284 Sequence: 528505285 Sequence: 528505286 Sequence: 528505287 Sequence: 528505288 Sequence: 528505289 Sequence: 528505290 Sequence: 528505291 Sequence: 528505292 Sequence: 528505293 Sequence: 528505294 Sequence: 528505295 Sequence: 528505296 Sequence: 528505297 Sequence: 528505298 Sequence: 528505299 Sequence: 528505300 Sequence: 528505301 Sequence: 528505302 Sequence: 528505303 Sequence: 528505304 Sequence: 528505305 Sequence: 528505306 Sequence: 528505307 Sequence: 528505308 Sequence: 528505309 Sequence: 528505310 Sequence: 528505311 Sequence: 528505312 Sequence: 528505313 Sequence: 528505314 Sequence: 528505315 Sequence: 528505316 Sequence: 528505317 Sequence: 528505318 Sequence: 528505319 Sequence: 528505320 Sequence: 528505321 Sequence: 528505322 Sequence: 528505323 Sequence: 528505324 Sequence: 528505325 Sequence: 528505326 Sequence: 528505327 Sequence: 528505328 Sequence: 528505329 Sequence: 528505330 Sequence: 528505331 Sequence: 528505332 Sequence: 528505333 Sequence: 528505334 Sequence: 528505335 Sequence: 528505336 Sequence: 528505337 Sequence: 528505338 Sequence: 528505339 Sequence: 528505340 Sequence: 528505341 Sequence: 528505342 Sequence: 528505343 Sequence: 528505344 Sequence: 528505345 Sequence: 528505346 Sequence: 528505347 Sequence: 528505348 Sequence: 528505349 Sequence: 528505350 Sequence: 528505351 Sequence: 528505352 Sequence: 528505353 Sequence: 528505354 Sequence: 528505355 Sequence: 528505356 Sequence: 528505357 Sequence: 528505358 Sequence: 528505359 Sequence: 528505360 Sequence: 528505361 Sequence: 528505362 Sequence: 528505363 Sequence: 528505364 Sequence: 528505365 Sequence: 528505366 Sequence: 528505367 Sequence: 528505368 Sequence: 528505369 Sequence: 528505370 Sequence: 528505371 Sequence: 528505372 Sequence: 528505373 Sequence: 528505374 Sequence: 528505375 Sequence: 528505376 Sequence: 528505377 Sequence: 528505378 Sequence: 528505379 Sequence: 528505380 Sequence: 528505381 Sequence: 528505382 Sequence: 528505383 Sequence: 528505384 Sequence: 528505385 Sequence: 528505386 Sequence: 528505387 Sequence: 528505388 Sequence: 528505389 Sequence: 528505390 Sequence: 528505391 Sequence: 528505392 Sequence: 528505393 Sequence: 528505394 Sequence: 528505395 Sequence: 528505396 Sequence: 528505397 Sequence: 528505398 Sequence: 528505399 Sequence: 528505400 Sequence: 528505401 Sequence: 528505402 Sequence: 528505403 Sequence: 528505404 Sequence: 528505405 Sequence: 528505406 Sequence: 528505407 Sequence: 528505408 Sequence: 528505409 Sequence: 528505410 Sequence: 528505411 Sequence: 528505412 Sequence: 528505413 Sequence: 528505414 Sequence: 528505415 Sequence: 528505416 Sequence: 528505417 Sequence: 528505418 Sequence: 528505419 Sequence: 528505420 Sequence: 528505421 Sequence: 528505422 Sequence: 528505423 Sequence: 528505424 Sequence: 528505425 Sequence: 528505426 Sequence: 528505427 Sequence: 528505428 Sequence: 528505429 Sequence: 528505430 Sequence: 528505431 Sequence: 528505432 Sequence: 528505433 Sequence: 528505434 Sequence: 528505435 Sequence: 528505436 Sequence: 528505437 Sequence: 528505438 Sequence: 528505439 Sequence: 528505440 Sequence: 528505441 Sequence: 528505442 Sequence: 528505443 Sequence: 528505444 Sequence: 528505445 Sequence: 528505446 Sequence: 528505447 Sequence: 528505448 Sequence: 528505449 Sequence: 528505450 Sequence: 528505451 Sequence: 528505452 Sequence: 528505453 Sequence: 528505454 Sequence: 528505455 Sequence: 528505456 Sequence: 528505457 Sequence: 528505458 Sequence: 528505459 Sequence: 528505460 Sequence: 528505461 Sequence: 528505462 Sequence: 528505463 Sequence: 528505464 Sequence: 528505465 Sequence: 528505466 Sequence: 528505467 Sequence: 528505468 Sequence: 528505469 Sequence: 528505470 Sequence: 528505471 Sequence: 528505472 Sequence: 528505473 Sequence: 528505474 Sequence: 528505475 Sequence: 528505476 Sequence: 528505477 Sequence: 528505478 Sequence: 528505479 Sequence: 528505480 Sequence: 528505481 Sequence: 528505482 Sequence: 528505483 Sequence: 528505484 Sequence: 528505485 Sequence: 528505486 Sequence: 528505487 Sequence: 528505488 Sequence: 528505489 Sequence: 528505490 Sequence: 528505491 Sequence: 528505492 Sequence: 528505493 Sequence: 528505494 Sequence: 528505495 Sequence: 528505496 Sequence: 528505497 Sequence: 528505498 Sequence: 528505499 Sequence: 528505500 Sequence: 528505501 Sequence: 528505502 Sequence: 528505503 Sequence: 528505504 Sequence: 528505505 Sequence: 528505506 Sequence: 528505507 Sequence: 528505508 Sequence: 528505509 Sequence: 528505510 Sequence: 528505511 Sequence: 528505512 Sequence: 528505513 Sequence: 528505514 Sequence: 528505515 Sequence: 528505516 Sequence: 528505517 Sequence: 528505518 Sequence: 528505519 Sequence: 528505520 Sequence: 528505521 Sequence: 528505522 Sequence: 528505523 Sequence: 528505524 Sequence: 528505525 Sequence: 528505526 Sequence: 528505527 Sequence: 528505528 Sequence: 528505529 Sequence: 528505530 Sequence: 528505531 Sequence: 528505532 Sequence: 528505533 Sequence: 528505534 Sequence: 528505535 Sequence: 528505536 Sequence: 528505537 Sequence: 528505538 Sequence: 528505539 Sequence: 528505540 Sequence: 528505541 Sequence: 528505542 Sequence: 528505543 Sequence: 528505544 Sequence: 528505545 Sequence: 528505546 Sequence: 528505547 Sequence: 528505548 Sequence: 528505549 Sequence: 528505550 Sequence: 528505551 Sequence: 528505552 Sequence: 528505553 Sequence: 528505554 Sequence: 528505555 Sequence: 528505556 Sequence: 528505557 Sequence: 528505558 Sequence: 528505559 Sequence: 528505560 Sequence: 528505561 Sequence: 528505562 Sequence: 528505563 Sequence: 528505564 Sequence: 528505565 Sequence: 528505566 Sequence: 528505567 Sequence: 528505568 Sequence: 528505569 Sequence: 528505570 Sequence: 528505571 Sequence: 528505572 Sequence: 528505573 Sequence: 528505574 Sequence: 528505575 Sequence: 528505576 Sequence: 528505577 Sequence: 528505578 Sequence: 528505579 Sequence: 528505580 Sequence: 528505581 Sequence: 528505582 Sequence: 528505583 Sequence: 528505584 Sequence: 528505585 Sequence: 528505586 Sequence: 528505587 Sequence: 528505588 Sequence: 528505589 Sequence: 528505590 Sequence: 528505591 Sequence: 528505592 Sequence: 528505593 Sequence: 528505594 Sequence: 528505595 Sequence: 528505596 Sequence: 528505597 Sequence: 528505598 Sequence: 528505599 Sequence: 528505600 Sequence: 528505601 Sequence: 528505602 Sequence: 528505603 Sequence: 528505604 Sequence: 528505605 Sequence: 528505606 Sequence: 528505607 Sequence: 528505608 Sequence: 528505609 Sequence: 528505610 Sequence: 528505611 Sequence: 528505612 Sequence: 528505613 Sequence: 528505614 Sequence: 528505615 Sequence: 528505616 Sequence: 528505617 Sequence: 528505618 Sequence: 528505619 Sequence: 528505620 Sequence: 528505621 Sequence: 528505622 Sequence: 528505623 Sequence: 528505624 Sequence: 528505625 Sequence: 528505626 Sequence: 528505627 Sequence: 528505628 Sequence: 528505629 Sequence: 528505630 Sequence: 528505631 Sequence: 528505632 Sequence: 528505633 Sequence: 528505634 Sequence: 528505635 Sequence: 528505636 Sequence: 528505637 Sequence: 528505638 Sequence: 528505639 Sequence: 528505640 Sequence: 528505641 Sequence: 528505642 Sequence: 528505643 Sequence: 528505644 Sequence: 528505645 Sequence: 528505646 Sequence: 528505647 Sequence: 528505648 Sequence: 528505649 Sequence: 528505650 Sequence: 528505651 Sequence: 528505652 Sequence: 528505653 Sequence: 528505654 Sequence: 528505655 Sequence: 528505656 Sequence: 528505657 Sequence: 528505658 Sequence: 528505659 Sequence: 528505660 Sequence: 528505661 Sequence: 528505662 Sequence: 528505663 Sequence: 528505664 Sequence: 528505665 Sequence: 528505666 Sequence: 528505667 Sequence: 528505668 Sequence: 528505669 Sequence: 528505670 Sequence: 528505671 Sequence: 528505672 Sequence: 528505673 Sequence: 528505674 Sequence: 528505675 Sequence: 528505676 Sequence: 528505677 Sequence: 528505678 Sequence: 528505679 Sequence: 528505680 Sequence: 528505681 Sequence: 528505682 Sequence: 528505683 Sequence: 528505684 Sequence: 528505685 Sequence: 528505686 Sequence: 528505687 Sequence: 528505688 Sequence: 528505689 Sequence: 528505690 Sequence: 528505691 Sequence: 528505692 Sequence: 528505693 Sequence: 528505694 Sequence: 528505695 Sequence: 528505696 Sequence: 528505697 Sequence: 528505698 Sequence: 528505699 Sequence: 528505700 Sequence: 528505701 Sequence: 528505702 Sequence: 528505703 Sequence: 528505704 Sequence: 528505705 Sequence: 528505706 Sequence: 528505707 Sequence: 528505708 Sequence: 528505709 Sequence: 528505710 Sequence: 528505711 Sequence: 528505712 Sequence: 528505713 Sequence: 528505714 Sequence: 528505715 Sequence: 528505716 Sequence: 528505717 Sequence: 528505718 Sequence: 528505719 Sequence: 528505720 Sequence: 528505721 Sequence: 528505722 Sequence: 528505723 Sequence: 528505724 Sequence: 528505725 Sequence: 528505726 Sequence: 528505727 Sequence: 528505728 Sequence: 528505729 Sequence: 528505730 Sequence: 528505731 Sequence: 528505732 Sequence: 528505733 Sequence: 528505734 Sequence: 528505735 Sequence: 528505736 Sequence: 528505737 Sequence: 528505738 Sequence: 528505739 Sequence: 528505740 Sequence: 528505741 Sequence: 528505742 Sequence: 528505743 Sequence: 528505744 Sequence: 528505745 Sequence: 528505746 Sequence: 528505747 Sequence: 528505748 Sequence: 528505749 Sequence: 528505750 Sequence: 528505751 Sequence: 528505752 Sequence: 528505753 Sequence: 528505754 Sequence: 528505755 Sequence: 528505756 Sequence: 528505757 Sequence: 528505758 Sequence: 528505759 Sequence: 528505760 Sequence: 528505761 Sequence: 528505762 Sequence: 528505763 Sequence: 528505764 Sequence: 528505765 Sequence: 528505766 Sequence: 528505767 Sequence: 528505768 Sequence: 528505769 Sequence: 528505770 Sequence: 528505771 Sequence: 528505772 Sequence: 528505773 Sequence: 528505774 Sequence: 528505775 Sequence: 528505776 Sequence: 528505777 Sequence: 528505778 Sequence: 528505779 Sequence: 528505780 Sequence: 528505781 Sequence: 528505782 Sequence: 528505783 Sequence: 528505784 Sequence: 528505785 Sequence: 528505786 Sequence: 528505787 Sequence: 528505788 Sequence: 528505789 Sequence: 528505790 Sequence: 528505791 Sequence: 528505792 Sequence: 528505793 Sequence: 528505794 Sequence: 528505795 Sequence: 528505796 Sequence: 528505797 Sequence: 528505798 Sequence: 528505799 Sequence: 528505800 Sequence: 528505801 Sequence: 528505802 Sequence: 528505803 Sequence: 528505804 Sequence: 528505805 Sequence: 528505806 Sequence: 528505807 Sequence: 528505808 Sequence: 528505809 Sequence: 528505810 Sequence: 528505811 Sequence: 528505812 Sequence: 528505813 Sequence: 528505814 Sequence: 528505815 Sequence: 528505816 Sequence: 528505817 Sequence: 528505818 Sequence: 528505819 Sequence: 528505820 Sequence: 528505821 Sequence: 528505822 Sequence: 528505823 Sequence: 528505824 Sequence: 528505825 Sequence: 528505826 Sequence: 528505827 Sequence: 528505828 Sequence: 528505829 Sequence: 528505830 Sequence: 528505831 Sequence: 528505832 Sequence: 528505833 Sequence: 528505834 Sequence: 528505835 Sequence: 528505836 Sequence: 528505837 Sequence: 528505838 Sequence: 528505839 Sequence: 528505840 Sequence: 528505841 Sequence: 528505842 Sequence: 528505843 Sequence: 528505844 Sequence: 528505845 Sequence: 528505846 Sequence: 528505847 Sequence: 528505848 Sequence: 528505849 Sequence: 528505850 Sequence: 528505851 Sequence: 528505852 Sequence: 528505853 Sequence: 528505854 Sequence: 528505855 Sequence: 528505856 Sequence: 528505857 Sequence: 528505858 Sequence: 528505859 Sequence: 528505860 Sequence: 528505861 Sequence: 528505862 Sequence: 528505863 Sequence: 528505864 Sequence: 528505865 Sequence: 528505866 Sequence: 528505867 Sequence: 528505868 Sequence: 528505869 Sequence: 528505870 Sequence: 528505871 Sequence: 528505872 Sequence: 528505873 Sequence: 528505874 Sequence: 528505875 Sequence: 528505876 Sequence: 528505877 Sequence: 528505878 Sequence: 528505879 Sequence: 528505880 Sequence: 528505881 Sequence: 528505882 Sequence: 528505883 Sequence: 528505884 Sequence: 528505885 Sequence: 528505886 Sequence: 528505887 Sequence: 528505888 Sequence: 528505889 Sequence: 528505890 Sequence: 528505891 Sequence: 528505892 Sequence: 528505893 Sequence: 528505894 Sequence: 528505895 Sequence: 528505896 Sequence: 528505897 Sequence: 528505898 Sequence: 528505899 Sequence: 528505900 Sequence: 528505901 Sequence: 528505902 Sequence: 528505903 Sequence: 528505904 Sequence: 528505905 Sequence: 528505906 Sequence: 528505907 Sequence: 528505908 Sequence: 528505909 Sequence: 528505910 Sequence: 528505911 Sequence: 528505912 Sequence: 528505913 Sequence: 528505914 Sequence: 528505915 Sequence: 528505916 Sequence: 528505917 Sequence: 528505918 Sequence: 528505919 Sequence: 528505920 Sequence: 528505921 Sequence: 528505922 Sequence: 528505923 Sequence: 528505924 Sequence: 528505925 Sequence: 528505926 Sequence: 528505927 Sequence: 528505928 Sequence: 528505929 Sequence: 528505930 Sequence: 528505931 Sequence: 528505932 Sequence: 528505933 Sequence: 528505934 Sequence: 528505935 Sequence: 528505936 Sequence: 528505937 Sequence: 528505938 Sequence: 528505939 Sequence: 528505940 Sequence: 528505941 Sequence: 528505942 Sequence: 528505943 Sequence: 528505944 Sequence: 528505945 Sequence: 528505946 Sequence: 528505947 Sequence: 528505948 Sequence: 528505949 Sequence: 528505950 Sequence: 528505951 Sequence: 528505952 Sequence: 528505953 Sequence: 528505954 Sequence: 528505955 Sequence: 528505956 Sequence: 528505957 Sequence: 528505958 Sequence: 528505959 Sequence: 528505960 Sequence: 528505961 Sequence: 528505962 Sequence: 528505963 Sequence: 528505964 Sequence: 528505965 Sequence: 528505966 Sequence: 528505967 Sequence: 528505968 Sequence: 528505969 Sequence: 528505970 Sequence: 528505971 Sequence: 528505972 Sequence: 528505973 Sequence: 528505974 Sequence: 528505975 Sequence: 528505976 Sequence: 528505977 Sequence: 528505978 Sequence: 528505979 Sequence: 528505980 Sequence: 528505981 Sequence: 528505982 Sequence: 528505983 Sequence: 528505984 Sequence: 528505985 Sequence: 528505986 Sequence: 528505987 Sequence: 528505988 Sequence: 528505989 Sequence: 528505990 Sequence: 528505991 Sequence: 528505992 Sequence: 528505993 Sequence: 528505994 Sequence: 528505995 Sequence: 528505996 Sequence: 528505997 Sequence: 528505998 Sequence: 528505999 Sequence: 528506000 Sequence: 528506001 Sequence: 528506002 Sequence: 528506003 Sequence: 528506004 Sequence: 528506005 Sequence: 528506006 Sequence: 528506007 Sequence: 528506008 Sequence: 528506009 Sequence: 528506010 Sequence: 528506011 Sequence: 528506012 Sequence: 528506013 Sequence: 528506014 Sequence: 528506015 Sequence: 528506016 Sequence: 528506017 Sequence: 528506018 Sequence: 528506019 Sequence: 528506020 Sequence: 528506021 Sequence: 528506022 Sequence: 528506023 Sequence: 528506024 Sequence: 528506025 Sequence: 528506026 Sequence: 528506027 Sequence: 528506028 Sequence: 528506029 Sequence: 528506030 Sequence: 528506031 Sequence: 528506032 Sequence: 528506033 Sequence: 528506034 Sequence: 528506035 Sequence: 528506036 Sequence: 528506037 Sequence: 528506038 Sequence: 528506039 Sequence: 528506040 Sequence: 528506041 Sequence: 528506042 Sequence: 528506043 Sequence: 528506044 Sequence: 528506045 Sequence: 528506046 Sequence: 528506047 Sequence: 528506048 Sequence: 528506049 Sequence: 528506050 Sequence: 528506051 Sequence: 528506052 Sequence: 528506053 Sequence: 528506054 Sequence: 528506055 Sequence: 528506056 Sequence: 528506057 Sequence: 528506058 Sequence: 528506059 Sequence: 528506060 Sequence: 528506061 Sequence: 528506062 Sequence: 528506063 Sequence: 528506064 Sequence: 528506065 Sequence: 528506066 Sequence: 528506067 Sequence: 528506068 Sequence: 528506069 Sequence: 528506070 Sequence: 528506071 Sequence: 528506072 Sequence: 528506073 Sequence: 528506074 Sequence: 528506075 Sequence: 528506076 Sequence: 528506077 Sequence: 528506078 Sequence: 528506079 Sequence: 528506080 Sequence: 528506081 Sequence: 528506082 Sequence: 528506083 Sequence: 528506084 Sequence: 528506085 Sequence: 528506086 Sequence: 528506087 Sequence: 528506088 Sequence: 528506089 Sequence: 528506090 Sequence: 528506091 Sequence: 528506092 Sequence: 528506093 Sequence: 528506094 Sequence: 528506095 Sequence: 528506096 Sequence: 528506097 Sequence: 528506098 Sequence: 528506099 Sequence: 528506100 Sequence: 528506101 Sequence: 528506102 Sequence: 528506103 Sequence: 528506104 Sequence: 528506105 Sequence: 528506106 Sequence: 528506107 Sequence: 528506108 Sequence: 528506109 Sequence: 528506110 Sequence: 528506111 Sequence: 528506112 Sequence: 528506113 Sequence: 528506114 Sequence: 528506115 Sequence: 528506116 Sequence: 528506117 Sequence: 528506118 Sequence: 528506119 Sequence: 528506120 Sequence: 528506121 Sequence: 528506122 Sequence: 528506123 Sequence: 528506124 Sequence: 528506125 Sequence: 528506126 Sequence: 528506127
Result Group Id 56112570 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 Result Group Id 56112575 Result Group Id 56112576 Result Group Id 56112577 Result Group Id 56112569 Result Group Id 56112570 Result Group Id 56112571 Result Group Id 56112572 Result Group Id 56112573 Result Group Id 56112574 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Ctgov Group Code EG001 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008
Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) Time Frame Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
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Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5 Subjects At Risk 34 Subjects At Risk 35 Subjects At Risk 23 Subjects At Risk 18 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 13 Subjects At Risk 5 Subjects At Risk 5
Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Description TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
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Organ System Cardiac disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Blood and lymphatic system disorders Organ System Cardiac disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Eye disorders Organ System Eye disorders Organ System Eye disorders Organ System Eye disorders Organ System Eye disorders Organ System Eye disorders Organ System Eye disorders Organ System Eye disorders Organ System Eye disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders
Adverse Event Term Tachycardia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Tachycardia Adverse Event Term Tachycardia Adverse Event Term Tachycardia Adverse Event Term Tachycardia Adverse Event Term Anaemia Adverse Event Term Tachycardia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute coronary syndrome Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute left ventricular failure Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Acute myocardial infarction Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Atrial flutter Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac arrest Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Cardiac failure Adverse Event Term Tachycardia Adverse Event Term Tachycardia Adverse Event Term Tachycardia Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrointestinal haemorrhage Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated inguinal hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Incarcerated umbilical hernia Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Pancreatitis Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Catheter site thrombosis Adverse Event Term Death Adverse Event Term Death Adverse Event Term Death Adverse Event Term Death Adverse Event Term Death Adverse Event Term Death Adverse Event Term Death Adverse Event Term Death Adverse Event Term Death Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Non-cardiac chest pain Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Cholecystitis acute Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Liver injury Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Gangrene Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Osteomyelitis Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Pneumonia bacterial Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Staphylococcal bacteraemia Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula site complication Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Arteriovenous graft thrombosis Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Facial bones fracture Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Humerus fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Rib fracture Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Subdural haematoma Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Vascular pseudoaneurysm Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Hypoglycaemia Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Intervertebral disc protrusion Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Osteoarthritis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Facial paralysis Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Hypertensive encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Metabolic encephalopathy Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Seizure Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Subarachnoid haemorrhage Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Transient ischaemic attack Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Haematuria Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Subcapsular renal haematoma Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Nipple pain Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Uterine mass Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Acute pulmonary oedema Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Pulmonary embolism Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Petechiae Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Pancreas transplant Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Accelerated hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive crisis Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypertensive urgency Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Hypotension Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Subclavian artery stenosis Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Nephrogenic anaemia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Thrombocytopenia Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Arteriosclerosis coronary artery Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Bundle branch block right Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Diastolic dysfunction Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Left atrial enlargement Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Mitral valve incompetence Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Right atrial enlargement Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Sinus tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Supraventricular tachycardia Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Systolic dysfunction Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Tinnitus Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Cataract Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal discomfort Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Haematemesis Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Toothache Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Vomiting Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Asthenia Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Fatigue Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pain Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Ulcer haemorrhage Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Acarodermatitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Clostridium difficile infection Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Localised infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nail infection Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Pneumonia Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Urosepsis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Arteriovenous fistula thrombosis Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Contusion Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Fall Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Graft thrombosis Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Joint injury Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Transfusion reaction Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular access complication Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Vascular pseudoaneurysm ruptured Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Weight decreased Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Fluid overload Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hyperkalaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Hypovolaemia Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Type 2 diabetes mellitus Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Intervertebral disc degeneration Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Muscle spasms Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Loss of consciousness Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Presyncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Mental status changes Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Costovertebral angle tenderness Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary retention Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Urinary tract obstruction Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Uterine haemorrhage Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Acute respiratory failure Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Chronic obstructive pulmonary disease Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Epistaxis Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Hypoxia Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pleural effusion Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary hypertension Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Pulmonary oedema Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Diabetic foot Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Pruritus Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Uraemic pruritus Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Deep vein thrombosis Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Haematoma Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypertension Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Hypovolaemic shock Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Shock haemorrhagic Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification Adverse Event Term Vascular calcification
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab 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MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0
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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 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: 28890942
Responsible Party Type Sponsor

Result Agreements

Sequence: 3853608
Pi Employee No

Result Contacts

Sequence: 3853573
Organization Akebia Therapeutics, Inc
Name Akebia Therapeutics, Inc
Phone 617-844-6128
Email trials@akebia.com

Outcomes

Sequence: 30820453 Sequence: 30820437 Sequence: 30820438 Sequence: 30820439 Sequence: 30820440 Sequence: 30820441 Sequence: 30820442 Sequence: 30820443 Sequence: 30820444 Sequence: 30820445 Sequence: 30820446 Sequence: 30820447 Sequence: 30820448 Sequence: 30820449 Sequence: 30820450 Sequence: 30820451 Sequence: 30820452 Sequence: 30820454 Sequence: 30820455 Sequence: 30820456 Sequence: 30820457 Sequence: 30820458 Sequence: 30820459 Sequence: 30820460 Sequence: 30820461 Sequence: 30820462 Sequence: 30820463 Sequence: 30820464
Outcome Type Secondary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Mean Change From Baseline in Reticulocyte Count Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants Classified as Hb Outliers Title Number of Participants With Hb Values Within the Target Range at the PEP Title Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Title Mean Change in Hb Between Baseline and the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Hepcidin Concentration Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.
Time Frame Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20 Time Frame Baseline; Week 10 to Week 12 Time Frame Up to Week 24 Time Frame Up to Week 24 Time Frame Up to Week 24 Time Frame Weeks 13 – 20 Time Frame Week 10 to Week 12 Time Frame Week 10 to Week 12; Week 18 to Week 20 Time Frame Baseline; Week 18 to Week 20 Time Frame Week 18 to Week 20 Time Frame Week 18 to Week 20 Time Frame Week 10 to Week 12 Time Frame Week 18 to Week 20 Time Frame Up to Week 20 Time Frame Up to Week 20 Time Frame Up to Week 20 Time Frame Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose) Time Frame Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 Time Frame Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 Time Frame Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 Time Frame Baseline; Week 12 and Week 20 Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose Time Frame Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment. Population Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Population Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Population Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. Population Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB > 12.0 g/dL, HB > 13.0 g/dL and HB > 14.0 g/dL are mutually exclusive. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Population Randomized Population. Analysis of this population was based on the randomized treatment. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. Population PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. Population PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. Population PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. Population PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. Population PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. Population PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. Population PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Units 10^3 cells/microliter (µL) Units grams per deciliter (g/dL) Units Participants Units Participants Units Participants Units Participants Units Participants Units g/dL Units g/dL Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Milliunits per milliliter Units micrograms per deciliter (µg/dL) Units micrograms per liter (µg/L) Units µg/dL Units nanograms per milliliter (ng/mL) Units Micrograms per milliliter (μg/mL) Units hours*µg/mL Units Hours Units Hours Units 1/hour Units liters per hour Units Liters
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Geometric Coefficient of Variation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation
Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Geometric Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Median Param Type Median Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean

Outcome Measurements

Sequence: 235800598 Sequence: 235800699 Sequence: 235800539 Sequence: 235800700 Sequence: 235800674 Sequence: 235800531 Sequence: 235800532 Sequence: 235800533 Sequence: 235800534 Sequence: 235800535 Sequence: 235800536 Sequence: 235800537 Sequence: 235800538 Sequence: 235800540 Sequence: 235800541 Sequence: 235800542 Sequence: 235800543 Sequence: 235800544 Sequence: 235800545 Sequence: 235800546 Sequence: 235800547 Sequence: 235800548 Sequence: 235800549 Sequence: 235800550 Sequence: 235800558 Sequence: 235800551 Sequence: 235800552 Sequence: 235800553 Sequence: 235800554 Sequence: 235800555 Sequence: 235800556 Sequence: 235800557 Sequence: 235800559 Sequence: 235800560 Sequence: 235800561 Sequence: 235800562 Sequence: 235800563 Sequence: 235800564 Sequence: 235800565 Sequence: 235800566 Sequence: 235800567 Sequence: 235800568 Sequence: 235800569 Sequence: 235800570 Sequence: 235800571 Sequence: 235800572 Sequence: 235800573 Sequence: 235800574 Sequence: 235800575 Sequence: 235800576 Sequence: 235800577 Sequence: 235800578 Sequence: 235800579 Sequence: 235800580 Sequence: 235800581 Sequence: 235800582 Sequence: 235800583 Sequence: 235800584 Sequence: 235800585 Sequence: 235800586 Sequence: 235800587 Sequence: 235800588 Sequence: 235800589 Sequence: 235800590 Sequence: 235800591 Sequence: 235800592 Sequence: 235800593 Sequence: 235800594 Sequence: 235800595 Sequence: 235800596 Sequence: 235800597 Sequence: 235800675 Sequence: 235800599 Sequence: 235800600 Sequence: 235800601 Sequence: 235800602 Sequence: 235800603 Sequence: 235800604 Sequence: 235800605 Sequence: 235800606 Sequence: 235800607 Sequence: 235800608 Sequence: 235800609 Sequence: 235800610 Sequence: 235800611 Sequence: 235800612 Sequence: 235800613 Sequence: 235800614 Sequence: 235800615 Sequence: 235800616 Sequence: 235800617 Sequence: 235800618 Sequence: 235800619 Sequence: 235800620 Sequence: 235800621 Sequence: 235800622 Sequence: 235800623 Sequence: 235800624 Sequence: 235800625 Sequence: 235800626 Sequence: 235800627 Sequence: 235800628 Sequence: 235800629 Sequence: 235800630 Sequence: 235800631 Sequence: 235800632 Sequence: 235800633 Sequence: 235800634 Sequence: 235800635 Sequence: 235800636 Sequence: 235800637 Sequence: 235800638 Sequence: 235800639 Sequence: 235800676 Sequence: 235800640 Sequence: 235800641 Sequence: 235800642 Sequence: 235800643 Sequence: 235800644 Sequence: 235800645 Sequence: 235800646 Sequence: 235800647 Sequence: 235800648 Sequence: 235800649 Sequence: 235800650 Sequence: 235800651 Sequence: 235800652 Sequence: 235800653 Sequence: 235800654 Sequence: 235800655 Sequence: 235800656 Sequence: 235800657 Sequence: 235800658 Sequence: 235800659 Sequence: 235800660 Sequence: 235800661 Sequence: 235800662 Sequence: 235800663 Sequence: 235800664 Sequence: 235800665 Sequence: 235800666 Sequence: 235800667 Sequence: 235800668 Sequence: 235800669 Sequence: 235800670 Sequence: 235800671 Sequence: 235800672 Sequence: 235800673 Sequence: 235800677 Sequence: 235800678 Sequence: 235800679 Sequence: 235800680 Sequence: 235800681 Sequence: 235800682 Sequence: 235800683 Sequence: 235800684 Sequence: 235800685 Sequence: 235800686 Sequence: 235800687 Sequence: 235800688 Sequence: 235800689 Sequence: 235800690 Sequence: 235800691 Sequence: 235800692 Sequence: 235800693 Sequence: 235800694 Sequence: 235800695 Sequence: 235800696 Sequence: 235800697 Sequence: 235800698 Sequence: 235800701 Sequence: 235800702 Sequence: 235800703 Sequence: 235800704 Sequence: 235800705 Sequence: 235800706 Sequence: 235800707 Sequence: 235800708 Sequence: 235800709 Sequence: 235800710 Sequence: 235800711 Sequence: 235800712 Sequence: 235800713 Sequence: 235800714 Sequence: 235800715 Sequence: 235800716 Sequence: 235800717 Sequence: 235800718 Sequence: 235800719 Sequence: 235800720 Sequence: 235800721 Sequence: 235800722 Sequence: 235800723 Sequence: 235800724 Sequence: 235800725 Sequence: 235800726 Sequence: 235800727 Sequence: 235800728 Sequence: 235800729 Sequence: 235800730 Sequence: 235800731 Sequence: 235800732 Sequence: 235800733 Sequence: 235800734 Sequence: 235800735 Sequence: 235800736 Sequence: 235800737 Sequence: 235800738 Sequence: 235800739 Sequence: 235800740 Sequence: 235800741 Sequence: 235800742 Sequence: 235800743 Sequence: 235800744 Sequence: 235800745 Sequence: 235800746 Sequence: 235800747 Sequence: 235800748 Sequence: 235800749 Sequence: 235800750 Sequence: 235800751 Sequence: 235800752 Sequence: 235800753 Sequence: 235800754 Sequence: 235800755 Sequence: 235800756 Sequence: 235800757 Sequence: 235800758 Sequence: 235800759 Sequence: 235800760 Sequence: 235800761 Sequence: 235800762 Sequence: 235800763 Sequence: 235800764 Sequence: 235800765 Sequence: 235800766 Sequence: 235800767 Sequence: 235800768 Sequence: 235800769 Sequence: 235800770 Sequence: 235800771 Sequence: 235800772 Sequence: 235800773 Sequence: 235800774 Sequence: 235800775 Sequence: 235800776 Sequence: 235800777 Sequence: 235800778 Sequence: 235800779 Sequence: 235800780 Sequence: 235800781 Sequence: 235800782 Sequence: 235800783 Sequence: 235800784 Sequence: 235801049 Sequence: 235800785 Sequence: 235800786 Sequence: 235800787 Sequence: 235800788 Sequence: 235800789 Sequence: 235800790 Sequence: 235800791 Sequence: 235800792 Sequence: 235800793 Sequence: 235800794 Sequence: 235800795 Sequence: 235800796 Sequence: 235800797 Sequence: 235800798 Sequence: 235800799 Sequence: 235800800 Sequence: 235800801 Sequence: 235800802 Sequence: 235800803 Sequence: 235800804 Sequence: 235800805 Sequence: 235800806 Sequence: 235800807 Sequence: 235800808 Sequence: 235800809 Sequence: 235800810 Sequence: 235800811 Sequence: 235800812 Sequence: 235800813 Sequence: 235800814 Sequence: 235800815 Sequence: 235800816 Sequence: 235800817 Sequence: 235800818 Sequence: 235800819 Sequence: 235800820 Sequence: 235800821 Sequence: 235800822 Sequence: 235800823 Sequence: 235800824 Sequence: 235800825 Sequence: 235800826 Sequence: 235800827 Sequence: 235800828 Sequence: 235800829 Sequence: 235800830 Sequence: 235800831 Sequence: 235800832 Sequence: 235800833 Sequence: 235800834 Sequence: 235800835 Sequence: 235800836 Sequence: 235800837 Sequence: 235800838 Sequence: 235800839 Sequence: 235800840 Sequence: 235800841 Sequence: 235800842 Sequence: 235800843 Sequence: 235800844 Sequence: 235800845 Sequence: 235800846 Sequence: 235800847 Sequence: 235800848 Sequence: 235800849 Sequence: 235800850 Sequence: 235800851 Sequence: 235800852 Sequence: 235800853 Sequence: 235800854 Sequence: 235800855 Sequence: 235800856 Sequence: 235800857 Sequence: 235800858 Sequence: 235800859 Sequence: 235800860 Sequence: 235800861 Sequence: 235800862 Sequence: 235800863 Sequence: 235800864 Sequence: 235800865 Sequence: 235800866 Sequence: 235800867 Sequence: 235800868 Sequence: 235800869 Sequence: 235800870 Sequence: 235800871 Sequence: 235800872 Sequence: 235800873 Sequence: 235800874 Sequence: 235800875 Sequence: 235800876 Sequence: 235800877 Sequence: 235800878 Sequence: 235800879 Sequence: 235800880 Sequence: 235800881 Sequence: 235800882 Sequence: 235800883 Sequence: 235800884 Sequence: 235800885 Sequence: 235800886 Sequence: 235800887 Sequence: 235800888 Sequence: 235800889 Sequence: 235800890 Sequence: 235800891 Sequence: 235800892 Sequence: 235800893 Sequence: 235800894 Sequence: 235800895 Sequence: 235800896 Sequence: 235800897 Sequence: 235800898 Sequence: 235800899 Sequence: 235800900 Sequence: 235800901 Sequence: 235800902 Sequence: 235800903 Sequence: 235800904 Sequence: 235801050 Sequence: 235800905 Sequence: 235800906 Sequence: 235800907 Sequence: 235800908 Sequence: 235800909 Sequence: 235800910 Sequence: 235800911 Sequence: 235800912 Sequence: 235800913 Sequence: 235800914 Sequence: 235800915 Sequence: 235800916 Sequence: 235800917 Sequence: 235800918 Sequence: 235800919 Sequence: 235801051 Sequence: 235800920 Sequence: 235800921 Sequence: 235800922 Sequence: 235800923 Sequence: 235800924 Sequence: 235800925 Sequence: 235800926 Sequence: 235800927 Sequence: 235800928 Sequence: 235800929 Sequence: 235800930 Sequence: 235800931 Sequence: 235800932 Sequence: 235800933 Sequence: 235800934 Sequence: 235800935 Sequence: 235800936 Sequence: 235800937 Sequence: 235800938 Sequence: 235800939 Sequence: 235800940 Sequence: 235800941 Sequence: 235800942 Sequence: 235800943 Sequence: 235800944 Sequence: 235800945 Sequence: 235800946 Sequence: 235800947 Sequence: 235800948 Sequence: 235800949 Sequence: 235800950 Sequence: 235800951 Sequence: 235800952 Sequence: 235800953 Sequence: 235800954 Sequence: 235800955 Sequence: 235800956 Sequence: 235800957 Sequence: 235800976 Sequence: 235800958 Sequence: 235800959 Sequence: 235800960 Sequence: 235800961 Sequence: 235801047 Sequence: 235800962 Sequence: 235800963 Sequence: 235800964 Sequence: 235800965 Sequence: 235800966 Sequence: 235800967 Sequence: 235800968 Sequence: 235800969 Sequence: 235800970 Sequence: 235800971 Sequence: 235800972 Sequence: 235800973 Sequence: 235800974 Sequence: 235800975 Sequence: 235800977 Sequence: 235800978 Sequence: 235800979 Sequence: 235800980 Sequence: 235800981 Sequence: 235800982 Sequence: 235800983 Sequence: 235800984 Sequence: 235800985 Sequence: 235800986 Sequence: 235800987 Sequence: 235800988 Sequence: 235800989 Sequence: 235800990 Sequence: 235800991 Sequence: 235800992 Sequence: 235800993 Sequence: 235800994 Sequence: 235800995 Sequence: 235800996 Sequence: 235800997 Sequence: 235800998 Sequence: 235800999 Sequence: 235801000 Sequence: 235801001 Sequence: 235801002 Sequence: 235801003 Sequence: 235801004 Sequence: 235801005 Sequence: 235801006 Sequence: 235801007 Sequence: 235801008 Sequence: 235801009 Sequence: 235801010 Sequence: 235801011 Sequence: 235801012 Sequence: 235801013 Sequence: 235801014 Sequence: 235801015 Sequence: 235801016 Sequence: 235801017 Sequence: 235801018 Sequence: 235801019 Sequence: 235801020 Sequence: 235801021 Sequence: 235801022 Sequence: 235801023 Sequence: 235801024 Sequence: 235801025 Sequence: 235801026 Sequence: 235801027 Sequence: 235801028 Sequence: 235801048 Sequence: 235801029 Sequence: 235801030 Sequence: 235801031 Sequence: 235801032 Sequence: 235801033 Sequence: 235801034 Sequence: 235801035 Sequence: 235801036 Sequence: 235801037 Sequence: 235801038 Sequence: 235801039 Sequence: 235801040 Sequence: 235801041 Sequence: 235801042 Sequence: 235801043 Sequence: 235801044 Sequence: 235801045 Sequence: 235801046 Sequence: 235801052 Sequence: 235801053 Sequence: 235801054 Sequence: 235801055 Sequence: 235801056 Sequence: 235801057 Sequence: 235801058 Sequence: 235801059 Sequence: 235801060 Sequence: 235801061 Sequence: 235801062 Sequence: 235801063 Sequence: 235801064 Sequence: 235801065 Sequence: 235801066 Sequence: 235801067 Sequence: 235801068 Sequence: 235801069 Sequence: 235801070 Sequence: 235801071 Sequence: 235801072 Sequence: 235801073 Sequence: 235801074 Sequence: 235801075 Sequence: 235801076 Sequence: 235801077 Sequence: 235801078 Sequence: 235801079 Sequence: 235801080 Sequence: 235801081 Sequence: 235801082 Sequence: 235801083 Sequence: 235801084 Sequence: 235801085 Sequence: 235801086 Sequence: 235801087 Sequence: 235801088 Sequence: 235801089 Sequence: 235801105 Sequence: 235801090 Sequence: 235801091 Sequence: 235801092 Sequence: 235801093 Sequence: 235801094 Sequence: 235801095 Sequence: 235801096 Sequence: 235801097 Sequence: 235801098 Sequence: 235801099 Sequence: 235801100 Sequence: 235801101 Sequence: 235801102 Sequence: 235801103 Sequence: 235801104 Sequence: 235801106 Sequence: 235801107 Sequence: 235801108 Sequence: 235801109 Sequence: 235801110 Sequence: 235801111 Sequence: 235801112 Sequence: 235801113 Sequence: 235801114 Sequence: 235801115 Sequence: 235801116 Sequence: 235801117 Sequence: 235801118 Sequence: 235801119 Sequence: 235801120 Sequence: 235801121 Sequence: 235801122 Sequence: 235801123 Sequence: 235801124 Sequence: 235801125 Sequence: 235801126 Sequence: 235801127
Outcome Id 30820441 Outcome Id 30820451 Outcome Id 30820437 Outcome Id 30820451 Outcome Id 30820448 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820437 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820439 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820438 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820439 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820440 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820448 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820441 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 Outcome Id 30820442 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Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820449 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820450 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820451 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820452 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820460 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820453 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820454 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820460 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820455 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820460 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820457 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820460 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820456 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820457 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820458 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820460 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820459 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820460 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820461 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820463 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820462 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820463 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464 Outcome Id 30820464
Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112549 Result Group Id 56112547 Result Group Id 56112561 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112541 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112562 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112551 Result Group Id 56112552 Result Group Id 56112553 Result Group Id 56112554 Result Group Id 56112555 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112541 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112551 Result Group Id 56112552 Result Group Id 56112553 Result Group Id 56112554 Result Group Id 56112555 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112558 Result Group Id 56112559 Result Group Id 56112560 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112550 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112548 Result Group Id 56112549 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112563 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112564 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112566 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112567 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112568 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112568 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112543 Result Group Id 56112544 Result Group Id 56112545 Result Group Id 56112546 Result Group Id 56112547 Result Group Id 56112548 Result Group Id 56112568 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112541 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112565 Result Group Id 56112542 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112566 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112542 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565 Result Group Id 56112566 Result Group Id 56112541 Result Group Id 56112542 Result Group Id 56112563 Result Group Id 56112564 Result Group Id 56112565
Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG008 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG008 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG002 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG003 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG005 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG000 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG004 Ctgov Group Code OG001 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG005 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG001 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004
Classification Hb >14.0 g/dL Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Change from Baseline at PEP Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >12.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >13.0 g/dL Classification Hb >14.0 g/dL Classification Hb >14.0 g/dL Classification Hb >14.0 g/dL Classification Hb >14.0 g/dL Classification Hb >14.0 g/dL Classification Hb >14.0 g/dL Classification Hb >14.0 g/dL Classification Hb >14.0 g/dL Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Hb increase >1.0 g/dL within any 2-week interval Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 13 Classification Week 13 Classification Week 13 Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 13 Classification Week 13 Classification Week 11 Classification Week 13 Classification Week 13 Classification Week 13 Classification Week 13 Classification Week 13 Classification Week 13 Classification Week 13 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 11 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Baseline Classification Baseline Classification Week 11 Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 4 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 8 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Baseline Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 16 Classification Week 1 +1 (Day 8) Classification Week 16 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Baseline Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 12 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 20 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 13 Classification Week 13 Classification Week 13 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 13 Classification Week 13 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 13 Classification Week 13 Classification Week 13 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 13 Classification Week 13 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 1 +1 (Day 8) Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11 Classification Week 11
Title Number of Participants Classified as Hb Outliers Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants Classified as Hb Outliers Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Number of Participants With Hb Values Within the Target Range at the PEP Title Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Title Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Title Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Title Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Title Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Title Mean Change in Hb Between Baseline and the SEP Title Mean Change in Hb Between Baseline and the SEP Title Mean Change in Hb Between Baseline and the SEP Title Mean Change in Hb Between Baseline and the SEP Title Mean Change in Hb Between Baseline and the SEP Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Mean Change in Hb Between Baseline and the SEP Title Mean Change in Hb Between Baseline and the SEP Title Mean Change in Hb Between Baseline and the SEP Title Mean Change in Hb Between Baseline and the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP Title Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Title Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Title Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Title Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Title Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Number of Participants Requiring Red Blood Cell (RBC) Transfusion Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Reticulocyte Count Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Iron Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Ferritin Concentration Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Total Iron Binding Capacity Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Mean Change From Baseline in Hepcidin Concentration Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose Title Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. Description Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. Description Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.
Units Participants Units Participants Units grams per deciliter (g/dL) Units Participants Units Participants Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units grams per deciliter (g/dL) Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units 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cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units Hours Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units 10^3 cells/microliter (µL) Units micrograms per deciliter (µg/dL) 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deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per deciliter (µg/dL) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units micrograms per liter (µg/L) Units 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Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units nanograms per milliliter (ng/mL) Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units Hours Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units µg/dL Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units nanograms per milliliter (ng/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units Micrograms per milliliter (μg/mL) Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units Hours Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units hours*µg/mL Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units Hours Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units liters per hour Units 1/hour Units 1/hour Units 1/hour Units 1/hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units liters per hour Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters Units Liters
Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Median Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Median Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Median Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Median Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Median Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean Param Type Geometric Mean
Param Value 0 Param Value 2 Param Value 9.620 Param Value 0 Param Value 1 Param Value 10.223 Param Value 10.059 Param Value 10.165 Param Value 9.778 Param Value 10.288 Param Value 10.095 Param Value 9.950 Param Value 9.530 Param Value -0.371 Param Value 0.072 Param Value 0.160 Param Value -0.911 Param Value -0.284 Param Value -0.418 Param Value 0.268 Param Value -0.671 Param Value -0.290 Param Value 18 Param Value 27 Param Value 0 Param Value 13 Param Value 12 Param Value 14 Param Value 13 Param Value 9 Param Value 5 Param Value 3 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 2 Param Value 2 Param Value 3 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 2 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 2 Param Value 2 Param Value 0 Param Value 1 Param Value 1 Param Value 3 Param Value 1 Param Value 1 Param Value 1 Param Value 4 Param Value 8 Param Value 4 Param Value 4 Param Value 2 Param Value 3 Param Value 6 Param Value 0 Param Value 2 Param Value 12 Param Value 13 Param Value 15 Param Value 1 Param Value 4 Param Value 4 Param Value 6 Param Value 0 Param Value 0 Param Value -0.050 Param Value -1.021 Param Value -0.360 Param Value -0.103 Param Value -0.422 Param Value -0.197 Param Value -0.186 Param Value 0.070 Param Value 0.114 Param Value -0.421 Param Value 23 Param Value -0.545 Param Value 0.343 Param Value -0.283 Param Value -0.400 Param Value 6 Param Value 7 Param Value 9 Param Value 2 Param Value 3 Param Value 2 Param Value 6 Param Value 1 Param Value 1 Param Value 0 Param Value 2 Param Value 2 Param Value 3 Param Value 7 Param Value 14 Param Value 19 Param Value 18 Param Value 1 Param Value 6 Param Value 6 Param Value 8 Param Value 0 Param Value 1 Param Value 10 Param Value 11 Param Value 14 Param Value 3 Param Value 5 Param Value 2 Param Value 8 Param Value 21 Param Value 16 Param Value 10 Param Value 14 Param Value 18 Param Value 10 Param Value 4 Param Value 5 Param Value 2 Param Value 8 Param Value 3 Param Value 5 Param Value 5 Param Value 3 Param Value 1 Param Value 3 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 3 Param Value 1 Param Value 1 Param Value 1 Param Value 7.33 Param Value 9.53 Param Value 9.93 Param Value 8.77 Param Value 6.98 Param Value 8.03 Param Value 12.1 Param Value 17.5 Param Value 15.3 Param Value 14.1 Param Value 20.2 Param Value 12.9 Param Value 15.6 Param Value 18.9 Param Value 16.1 Param Value 18.0 Param Value 17.4 Param Value 9.49 Param Value 14.2 Param Value 14.9 Param Value 19.4 Param Value 20.6 Param Value 17.3 Param Value 15.7 Param Value 39.2 Param Value 10.5 Param Value 51.9 Param Value 47.2 Param Value 48.8 Param Value 59.3 Param Value 48.4 Param Value 51.5 Param Value 62.6 Param Value 77.6 Param Value 83.0 Param Value 3.1 Param Value 6.9 Param Value 1.0 Param Value -18.1 Param Value -3.9 Param Value -6.6 Param Value 20.4 Param Value -35.8 Param Value -25.2 Param Value 14.6 Param Value 14.9 Param Value 0.8 Param Value -5.6 Param Value 2.9 Param Value 6.1 Param Value 22.5 Param Value -26.8 Param Value 17.5 Param Value 14.0 Param Value 23.9 Param Value 23.1 Param Value 9.1 Param Value 20.4 Param Value 23.1 Param Value 14.0 Param Value -3.3 Param Value -21.8 Param Value 11.7 Param Value 20.2 Param Value 21.0 Param Value 26.2 Param Value 32.5 Param Value 9.2 Param Value 3.9 Param Value -6.7 Param Value -27.2 Param Value 16.1 Param Value 16.3 Param Value 22.2 Param Value 47.7 Param Value 20.3 Param Value 26.9 Param Value 4.6 Param Value 3.8 Param Value -17.3 Param Value 16.7 Param Value 12.1 Param Value 10.4 Param Value 16.4 Param Value 46.3 Param Value 15.9 Param Value 10.5 Param Value 0.1 Param Value 2.0 Param Value 16.3 Param Value 13.9 Param Value 19.6 Param Value 8.3 Param Value -2.2 Param Value 9.7 Param Value 0.2 Param Value 26.6 Param Value -31.5 Param Value 4.0 Param Value 14.5 Param Value 13.2 Param Value 23.8 Param Value 10.3 Param Value 16.4 Param Value 10.9 Param Value 38.5 Param Value -3.3 Param Value 40.0 Param Value 87.4 Param Value 93.9 Param Value 90.1 Param Value 57.7 Param Value 80.9 Param Value 73.1 Param Value 65.7 Param Value 81.6 Param Value 58.4 Param Value -8.0 Param Value -11.2 Param Value -18.3 Param Value 3.3 Param Value 9.6 Param Value 1.7 Param Value -6.6 Param Value 8.6 Param Value 3.8 Param Value -5.5 Param Value -15.0 Param Value -8.6 Param Value 4.5 Param Value -5.9 Param Value 11.7 Param Value -12.6 Param Value 0.3 Param Value 2.0 Param Value -2.7 Param Value -22.2 Param Value -26.0 Param Value -2.8 Param Value -0.4 Param Value -5.1 Param Value -16.1 Param Value -2.5 Param Value -12.6 Param Value -22.8 Param Value -18.3 Param Value -17.9 Param Value -0.7 Param Value 5.2 Param Value -4.6 Param Value -13.9 Param Value 19.5 Param Value -12.0 Param Value -14.2 Param Value -9.5 Param Value -16.6 Param Value 28.7 Param Value -3.1 Param Value 13.4 Param Value -8.4 Param Value -15.3 Param Value -10.3 Param Value 939.3 Param Value 1043.6 Param Value 919.3 Param Value 910.2 Param Value 745.2 Param Value 739.5 Param Value 723.6 Param Value 1182.2 Param Value 449.6 Param Value -30.1 Param Value -101.9 Param Value -23.7 Param Value 41.4 Param Value 152.9 Param Value 45.5 Param Value -145.6 Param Value 34.8 Param Value -61.5 Param Value -120.8 Param Value -185.4 Param Value 24.9 Param Value 29.4 Param Value -5.6 Param Value -87.8 Param Value -78.3 Param Value 111.3 Param Value 397.8 Param Value -118.5 Param Value -194.8 Param Value -42.4 Param Value -68.0 Param Value -23.8 Param Value -30.1 Param Value -195.3 Param Value -0.5 Param Value -35.0 Param Value -92.0 Param Value -70.9 Param Value 99.5 Param Value -144.0 Param Value 27.8 Param Value 6.49 Param Value -97.2 Param Value -81.8 Param Value 80.0 Param Value 62.3 Param Value -113.6 Param Value -166.6 Param Value 26.5 Param Value -199.4 Param Value 4.8 Param Value -51.6 Param Value -104.8 Param Value 249.0 Param Value 607.0 Param Value 237.8 Param Value 230.7 Param Value 3.95 Param Value 234.8 Param Value 210.1 Param Value 235.7 Param Value 223.6 Param Value 218.2 Param Value 211.0 Param Value 225.6 Param Value 35.9 Param Value 27.7 Param Value -13.4 Param Value 27.6 Param Value 41.0 Param Value 48.2 Param Value -0.5 Param Value 44.2 Param Value 7.8 Param Value 30.3 Param Value 37.0 Param Value -1.1 Param Value 26.3 Param Value 49.4 Param Value 58.8 Param Value -7.4 Param Value 56.0 Param Value -24.8 Param Value 42.4 Param Value 37.2 Param Value -9.9 Param Value 25.1 Param Value 41.0 Param Value 54.5 Param Value -3.8 Param Value 58.0 Param Value -0.6 Param Value 35.0 Param Value 27.8 Param Value -3.0 Param Value 55.3 Param Value 215.608 Param Value 53.1 Param Value 60.9 Param Value -13.7 Param Value 42.5 Param Value 11.7 Param Value -2.5 Param Value 38.0 Param Value 44.9 Param Value -9.5 Param Value 51.7 Param Value 68.4 Param Value 67.9 Param Value -5.4 Param Value 66.7 Param Value -6.0 Param Value 194.870 Param Value 208.816 Param Value 259.161 Param Value 185.852 Param Value 160.760 Param Value 143.519 Param Value 239.958 Param Value 74.748 Param Value -50.565 Param Value -53.675 Param Value -66.646 Param Value -55.283 Param Value -34.868 Param Value -74.797 Param Value -62.787 Param Value -128.587 Param Value -1.062 Param Value -86.025 Param Value -38.627 Param Value -83.685 Param Value -93.412 Param Value -83.012 Param Value -43.701 Param Value -80.680 Param Value -152.243 Param Value -9.023 Param Value 26.0 Param Value 40.8 Param Value 26.5 Param Value 47.0 Param Value 56.5 Param Value 44.2 Param Value 20.1 Param Value 37.6 Param Value 23.8 Param Value 44.2 Param Value 60.1 Param Value 31.6 Param Value 28.6 Param Value 24.4 Param Value 32.4 Param Value 38.1 Param Value 41.2 Param Value 30.6 Param Value 11.5 Param Value 60.2 Param Value 338 Param Value 518 Param Value 342 Param Value 605 Param Value 786 Param Value 464 Param Value 289 Param Value 465 Param Value 310 Param Value 566 Param Value 6.73 Param Value 847 Param Value 388 Param Value 344 Param Value 338 Param Value 402 Param Value 450 Param Value 588 Param Value 8.53 Param Value 10.5 Param Value 12.5 Param Value 10.3 Param Value 11.0 Param Value 9.01 Param Value 8.82 Param Value 8.83 Param Value 10.1 Param Value 12.4 Param Value 14.6 Param Value 5.65 Param Value 11.0 Param Value 5.01 Param Value 2.08 Param Value 2.72 Param Value 3.48 Param Value 3.50 Param Value 2.00 Param Value 3.28 Param Value 3.28 Param Value 2.11 Param Value 3.33 Param Value 3.30 Param Value 2.17 Param Value 3.42 Param Value 3.23 Param Value 3.50 Param Value 3.50 Param Value 2.03 Param Value 2.11 Param Value 1.98 Param Value 4.25 Param Value 2.04 Param Value 0.0797 Param Value 0.0665 Param Value 0.0560 Param Value 0.0681 Param Value 0.0608 Param Value 0.0771 Param Value 0.0720 Param Value 0.0615 Param Value 0.0714 Param Value 0.0469 Param Value 0.0469 Param Value 0.0594 Param Value 0.0925 Param Value 0.0687 Param Value 0.124 Param Value 1.55 Param Value 0.175 Param Value 0.116 Param Value 0.0632 Param Value 0.138 Param Value 0.888 Param Value 0.869 Param Value 0.877 Param Value 0.744 Param Value 0.763 Param Value 1.29 Param Value 1.04 Param Value 0.967 Param Value 0.968 Param Value 0.795 Param Value 0.708 Param Value 0.872 Param Value 1.33 Param Value 0.747 Param Value 1.00 Param Value 1.02 Param Value 10.9 Param Value 14.3 Param Value 13.7 Param Value 12.1 Param Value 13.8 Param Value 15.8 Param Value 12.5 Param Value 13.7 Param Value 17.4 Param Value 15.3 Param Value 15.6 Param Value 12.4 Param Value 10.2 Param Value 10.7 Param Value 10.1 Param Value 8.24 Param Value 8.76
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Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Full Range Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Full Range Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Full Range Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Full Range Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Full Range Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Full Range Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation Dispersion Type Geometric Coefficient of Variation
Dispersion Value 0.6925 Dispersion Value 0.5805 Dispersion Value 0.6769 Dispersion Value 0.6806 Dispersion Value 0.6832 Dispersion Value 0.5445 Dispersion Value 0.7150 Dispersion Value 0.7950 Dispersion Value 0.2864 Dispersion Value 0.8920 Dispersion Value 1.1353 Dispersion Value 0.7519 Dispersion Value 1.3515 Dispersion Value 1.0383 Dispersion Value 1.2752 Dispersion Value 1.0087 Dispersion Value 0.7643 Dispersion Value 1.7730 Dispersion Value NA Dispersion Value 1.0961 Dispersion Value 0.4894 Dispersion Value 1.9225 Dispersion Value 1.1708 Dispersion Value 1.1597 Dispersion Value 0.8703 Dispersion Value 0.9545 Dispersion Value 1.0242 Dispersion Value 0.8370 Dispersion Value 0.9771 Dispersion Value 0.8897 Dispersion Value 0.7371 Dispersion Value 1.0157 Dispersion Value 57.3 Dispersion Value 54.0 Dispersion Value 83.6 Dispersion Value 48.2 Dispersion Value 61.6 Dispersion Value 53.2 Dispersion Value 94.3 Dispersion Value 97.0 Dispersion Value 72.6 Dispersion Value 86.4 Dispersion Value 90.8 Dispersion Value 54.2 Dispersion Value 76.3 Dispersion Value 98.2 Dispersion Value 76.0 Dispersion Value 49.8 Dispersion Value 104.8 Dispersion Value 37.1 Dispersion Value 55.9 Dispersion Value 106.2 Dispersion Value 78.0 Dispersion Value 169.6 Dispersion Value 53.4 Dispersion Value 107.2 Dispersion Value NA Dispersion Value 47.1 Dispersion Value 27.57 Dispersion Value 17.81 Dispersion Value 27.27 Dispersion Value 42.02 Dispersion Value 33.45 Dispersion Value 25.14 Dispersion Value 25.88 Dispersion Value 51.04 Dispersion Value 45.34 Dispersion Value 24.09 Dispersion Value 30.60 Dispersion Value 22.42 Dispersion Value 24.81 Dispersion Value 28.51 Dispersion Value 33.80 Dispersion Value 48.64 Dispersion Value 45.06 Dispersion Value 29.73 Dispersion Value 32.25 Dispersion Value 29.45 Dispersion Value 40.68 Dispersion Value 37.38 Dispersion Value 39.68 Dispersion Value 33.24 Dispersion Value 50.53 Dispersion Value 55.44 Dispersion Value 26.21 Dispersion Value 31.40 Dispersion Value 39.26 Dispersion Value 38.98 Dispersion Value 46.38 Dispersion Value 49.42 Dispersion Value 20.33 Dispersion Value 54.60 Dispersion Value 67.56 Dispersion Value 69.36 Dispersion Value 25.06 Dispersion Value 25.80 Dispersion Value 35.12 Dispersion Value 26.2 Dispersion Value 70.42 Dispersion Value 41.30 Dispersion Value 46.15 Dispersion Value 76.89 Dispersion Value 71.36 Dispersion Value 32.60 Dispersion Value 34.27 Dispersion Value 26.72 Dispersion Value 66.66 Dispersion Value 44.30 Dispersion Value 52.64 Dispersion Value 39.53 Dispersion Value 52.72 Dispersion Value 67.06 Dispersion Value 27.07 Dispersion Value 43.12 Dispersion Value 26.53 Dispersion Value 57.25 Dispersion Value 43.79 Dispersion Value 28.80 Dispersion Value 46.05 Dispersion Value 83.44 Dispersion Value 11.93 Dispersion Value 35.40 Dispersion Value 37.61 Dispersion Value 34.16 Dispersion Value 57.32 Dispersion Value 30.17 Dispersion Value 22.08 Dispersion Value 55.82 Dispersion Value 86.97 Dispersion Value 16.21 Dispersion Value 25.74 Dispersion Value 24.50 Dispersion Value 26.49 Dispersion Value 41.33 Dispersion Value 35.54 Dispersion Value 29.81 Dispersion Value 44.11 Dispersion Value 52.58 Dispersion Value 7.07 Dispersion Value 38.46 Dispersion Value 36.56 Dispersion Value 35.09 Dispersion Value 26.71 Dispersion Value 36.94 Dispersion Value 22.23 Dispersion Value 23.93 Dispersion Value 37.01 Dispersion Value 18.77 Dispersion Value 34.49 Dispersion Value 33.59 Dispersion Value 22.83 Dispersion Value 35.23 Dispersion Value 29.67 Dispersion Value 23.37 Dispersion Value 32.86 Dispersion Value 17.36 Dispersion Value 25.79 Dispersion Value 45.04 Dispersion Value 40.51 Dispersion Value 44.30 Dispersion Value 24.06 Dispersion Value 36.91 Dispersion Value 40.33 Dispersion Value 26.55 Dispersion Value 11.09 Dispersion Value 20.33 Dispersion Value 38.24 Dispersion Value 43.14 Dispersion Value 33.03 Dispersion Value 40.49 Dispersion Value 40.20 Dispersion Value 27.54 Dispersion Value 22.88 Dispersion Value 43.94 Dispersion Value 28.99 Dispersion Value 39.39 Dispersion Value 39.85 Dispersion Value 53.89 Dispersion Value 10.26 Dispersion Value 30.27 Dispersion Value 30.31 Dispersion Value 44.05 Dispersion Value 53.03 Dispersion Value 24.06 Dispersion Value 41.11 Dispersion Value 27.87 Dispersion Value 46.49 Dispersion Value 67.73 Dispersion Value 32.43 Dispersion Value 16.03 Dispersion Value 28.94 Dispersion Value 43.19 Dispersion Value 21.57 Dispersion Value 478.64 Dispersion Value 359.10 Dispersion Value 298.27 Dispersion Value 408.03 Dispersion Value 362.98 Dispersion Value 329.66 Dispersion Value 484.29 Dispersion Value 508.67 Dispersion Value 423.44 Dispersion Value 185.45 Dispersion Value 204.51 Dispersion Value 274.39 Dispersion Value 335.00 Dispersion Value 347.97 Dispersion Value 320.50 Dispersion Value 211.10 Dispersion Value 470.43 Dispersion Value 17.37 Dispersion Value 273.28 Dispersion Value 298.19 Dispersion Value 334.28 Dispersion Value 361.29 Dispersion Value 255.10 Dispersion Value 285.30 Dispersion Value 254.98 Dispersion Value 609.61 Dispersion Value 453.76 Dispersion Value 220.40 Dispersion Value 288.47 Dispersion Value 356.19 Dispersion Value 275.11 Dispersion Value 303.39 Dispersion Value 386.24 Dispersion Value 304.63 Dispersion Value 237.99 Dispersion Value 157.46 Dispersion Value 309.88 Dispersion Value 288.34 Dispersion Value 567.19 Dispersion Value 358.78 Dispersion Value 244.67 Dispersion Value 188.15 Dispersion Value 447.01 Dispersion Value 243.24 Dispersion Value 186.15 Dispersion Value 327.06 Dispersion Value 298.67 Dispersion Value 497.52 Dispersion Value 370.32 Dispersion Value 331.76 Dispersion Value 253.07 Dispersion Value 347.53 Dispersion Value 636.33 Dispersion Value 607.0 Dispersion Value 39.28 Dispersion Value 39.09 Dispersion Value 44.76 Dispersion Value 33.33 Dispersion Value 38.80 Dispersion Value 34.31 Dispersion Value 33.80 Dispersion Value 42.99 Dispersion Value 98.15 Dispersion Value 27.11 Dispersion Value 33.58 Dispersion Value 26.02 Dispersion Value 28.49 Dispersion Value 26.22 Dispersion Value 37.78 Dispersion Value 21.44 Dispersion Value 53.58 Dispersion Value 14.38 Dispersion Value 28.42 Dispersion Value 40.99 Dispersion Value 18.38 Dispersion Value 23.98 Dispersion Value 27.34 Dispersion Value 24.54 Dispersion Value 19.26 Dispersion Value 58.15 Dispersion Value 58.79 Dispersion Value 27.10 Dispersion Value 43.09 Dispersion Value 25.85 Dispersion Value 33.90 Dispersion Value 39.05 Dispersion Value 44.05 Dispersion Value 25.42 Dispersion Value 14.45 Dispersion Value 15.32 Dispersion Value 43.00 Dispersion Value 35.16 Dispersion Value 25.44 Dispersion Value 28.63 Dispersion Value 130.7350 Dispersion Value 58.33 Dispersion Value 70.50 Dispersion Value 31.46 Dispersion Value 62.93 Dispersion Value 18.52 Dispersion Value 28.15 Dispersion Value 30.71 Dispersion Value 29.29 Dispersion Value 37.50 Dispersion Value 43.40 Dispersion Value 58.44 Dispersion Value 29.78 Dispersion Value 35.22 Dispersion Value 21.79 Dispersion Value 113.9348 Dispersion Value 85.1667 Dispersion Value 134.9995 Dispersion Value 105.6611 Dispersion Value 102.6261 Dispersion Value 124.6749 Dispersion Value 151.3859 Dispersion Value 40.2119 Dispersion Value 57.6474 Dispersion Value 92.1185 Dispersion Value 152.3178 Dispersion Value 77.1648 Dispersion Value 89.7176 Dispersion Value 126.1667 Dispersion Value 96.1842 Dispersion Value 262.6300 Dispersion Value 30.4842 Dispersion Value 100.4382 Dispersion Value 75.0555 Dispersion Value 95.7049 Dispersion Value 115.2839 Dispersion Value 98.7521 Dispersion Value 80.8411 Dispersion Value 125.2481 Dispersion Value 218.9284 Dispersion Value 80.4001 Dispersion Value 87.9 Dispersion Value 54.8 Dispersion Value 59.3 Dispersion Value 38.2 Dispersion Value 39.2 Dispersion Value 73.1 Dispersion Value 174.4 Dispersion Value 78.9 Dispersion Value 69.0 Dispersion Value 29.6 Dispersion Value 41.6 Dispersion Value 151.6 Dispersion Value 49.3 Dispersion Value 350.6 Dispersion Value 26.9 Dispersion Value 99.0 Dispersion Value 77.7 Dispersion Value 102.7 Dispersion Value NA Dispersion Value 9.2 Dispersion Value 63.8 Dispersion Value 71.1 Dispersion Value 81.7 Dispersion Value 54.5 Dispersion Value 36.6 Dispersion Value 80.9 Dispersion Value 76.6 Dispersion Value 80.8 Dispersion Value 94.7 Dispersion Value 41.1 Dispersion Value 54.8 Dispersion Value 112.4 Dispersion Value 53.5 Dispersion Value 282.0 Dispersion Value 70.8 Dispersion Value 68.2 Dispersion Value 52.5 Dispersion Value 38.7 Dispersion Value 50.5 Dispersion Value 41.6 Dispersion Value 32.7 Dispersion Value 46.9 Dispersion Value 8.9 Dispersion Value 44.2 Dispersion Value 70.0 Dispersion Value 53.9 Dispersion Value 72.2 Dispersion Value 74.4 Dispersion Value 4.5 Dispersion Value 65.5 Dispersion Value 26.5 Dispersion Value 92.0 Dispersion Value 112.4 Dispersion Value NA Dispersion Value 15.9 Dispersion Value NA Dispersion Value NA Dispersion Value 63.8 Dispersion Value 71.1 Dispersion Value 81.7 Dispersion Value 54.5 Dispersion Value 36.6 Dispersion Value 80.9 Dispersion Value 76.6 Dispersion Value 80.8 Dispersion Value 94.7 Dispersion Value 41.1 Dispersion Value 54.8 Dispersion Value 53.5 Dispersion Value 282.0 Dispersion Value 70.8 Dispersion Value 68.2 Dispersion Value 52.5 Dispersion Value 36.2 Dispersion Value 53.4 Dispersion Value 69.7 Dispersion Value 38.6 Dispersion Value 16.7 Dispersion Value 56.9 Dispersion Value 36.6 Dispersion Value 41.0 Dispersion Value 50.4 Dispersion Value 67.4 Dispersion Value 27.2 Dispersion Value 35.8 Dispersion Value 28.7 Dispersion Value 37.6 Dispersion Value 10.3 Dispersion Value NA Dispersion Value 18.9
Dispersion Value Num 0.6925 Dispersion Value Num 0.5805 Dispersion Value Num 0.6769 Dispersion Value Num 0.6806 Dispersion Value Num 0.6832 Dispersion Value Num 0.5445 Dispersion Value Num 0.715 Dispersion Value Num 0.795 Dispersion Value Num 0.2864 Dispersion Value Num 0.892 Dispersion Value Num 1.1353 Dispersion Value Num 0.7519 Dispersion Value Num 1.3515 Dispersion Value Num 1.0383 Dispersion Value Num 1.2752 Dispersion Value Num 1.0087 Dispersion Value Num 0.7643 Dispersion Value Num 1.773 Dispersion Value Num 1.0961 Dispersion Value Num 0.4894 Dispersion Value Num 1.9225 Dispersion Value Num 1.1708 Dispersion Value Num 1.1597 Dispersion Value Num 0.8703 Dispersion Value Num 0.9545 Dispersion Value Num 1.0242 Dispersion Value Num 0.837 Dispersion Value Num 0.9771 Dispersion Value Num 0.8897 Dispersion Value Num 0.7371 Dispersion Value Num 1.0157 Dispersion Value Num 57.3 Dispersion Value Num 54.0 Dispersion Value Num 83.6 Dispersion Value Num 48.2 Dispersion Value Num 61.6 Dispersion Value Num 53.2 Dispersion Value Num 94.3 Dispersion Value Num 97.0 Dispersion Value Num 72.6 Dispersion Value Num 86.4 Dispersion Value Num 90.8 Dispersion Value Num 54.2 Dispersion Value Num 76.3 Dispersion Value Num 98.2 Dispersion Value Num 76.0 Dispersion Value Num 49.8 Dispersion Value Num 104.8 Dispersion Value Num 37.1 Dispersion Value Num 55.9 Dispersion Value Num 106.2 Dispersion Value Num 78.0 Dispersion Value Num 169.6 Dispersion Value Num 53.4 Dispersion Value Num 107.2 Dispersion Value Num 47.1 Dispersion Value Num 27.57 Dispersion Value Num 17.81 Dispersion Value Num 27.27 Dispersion Value Num 42.02 Dispersion Value Num 33.45 Dispersion Value Num 25.14 Dispersion Value Num 25.88 Dispersion Value Num 51.04 Dispersion Value Num 45.34 Dispersion Value Num 24.09 Dispersion Value Num 30.6 Dispersion Value Num 22.42 Dispersion Value Num 24.81 Dispersion Value Num 28.51 Dispersion Value Num 33.8 Dispersion Value Num 48.64 Dispersion Value Num 45.06 Dispersion Value Num 29.73 Dispersion Value Num 32.25 Dispersion Value Num 29.45 Dispersion Value Num 40.68 Dispersion Value Num 37.38 Dispersion Value Num 39.68 Dispersion Value Num 33.24 Dispersion Value Num 50.53 Dispersion Value Num 55.44 Dispersion Value Num 26.21 Dispersion Value Num 31.4 Dispersion Value Num 39.26 Dispersion Value Num 38.98 Dispersion Value Num 46.38 Dispersion Value Num 49.42 Dispersion Value Num 20.33 Dispersion Value Num 54.6 Dispersion Value Num 67.56 Dispersion Value Num 69.36 Dispersion Value Num 25.06 Dispersion Value Num 25.8 Dispersion Value Num 35.12 Dispersion Value Num 26.2 Dispersion Value Num 70.42 Dispersion Value Num 41.3 Dispersion Value Num 46.15 Dispersion Value Num 76.89 Dispersion Value Num 71.36 Dispersion Value Num 32.6 Dispersion Value Num 34.27 Dispersion Value Num 26.72 Dispersion Value Num 66.66 Dispersion Value Num 44.3 Dispersion Value Num 52.64 Dispersion Value Num 39.53 Dispersion Value Num 52.72 Dispersion Value Num 67.06 Dispersion Value Num 27.07 Dispersion Value Num 43.12 Dispersion Value Num 26.53 Dispersion Value Num 57.25 Dispersion Value Num 43.79 Dispersion Value Num 28.8 Dispersion Value Num 46.05 Dispersion Value Num 83.44 Dispersion Value Num 11.93 Dispersion Value Num 35.4 Dispersion Value Num 37.61 Dispersion Value Num 34.16 Dispersion Value Num 57.32 Dispersion Value Num 30.17 Dispersion Value Num 22.08 Dispersion Value Num 55.82 Dispersion Value Num 86.97 Dispersion Value Num 16.21 Dispersion Value Num 25.74 Dispersion Value Num 24.5 Dispersion Value Num 26.49 Dispersion Value Num 41.33 Dispersion Value Num 35.54 Dispersion Value Num 29.81 Dispersion Value Num 44.11 Dispersion Value Num 52.58 Dispersion Value Num 7.07 Dispersion Value Num 38.46 Dispersion Value Num 36.56 Dispersion Value Num 35.09 Dispersion Value Num 26.71 Dispersion Value Num 36.94 Dispersion Value Num 22.23 Dispersion Value Num 23.93 Dispersion Value Num 37.01 Dispersion Value Num 18.77 Dispersion Value Num 34.49 Dispersion Value Num 33.59 Dispersion Value Num 22.83 Dispersion Value Num 35.23 Dispersion Value Num 29.67 Dispersion Value Num 23.37 Dispersion Value Num 32.86 Dispersion Value Num 17.36 Dispersion Value Num 25.79 Dispersion Value Num 45.04 Dispersion Value Num 40.51 Dispersion Value Num 44.3 Dispersion Value Num 24.06 Dispersion Value Num 36.91 Dispersion Value Num 40.33 Dispersion Value Num 26.55 Dispersion Value Num 11.09 Dispersion Value Num 20.33 Dispersion Value Num 38.24 Dispersion Value Num 43.14 Dispersion Value Num 33.03 Dispersion Value Num 40.49 Dispersion Value Num 40.2 Dispersion Value Num 27.54 Dispersion Value Num 22.88 Dispersion Value Num 43.94 Dispersion Value Num 28.99 Dispersion Value Num 39.39 Dispersion Value Num 39.85 Dispersion Value Num 53.89 Dispersion Value Num 10.26 Dispersion Value Num 30.27 Dispersion Value Num 30.31 Dispersion Value Num 44.05 Dispersion Value Num 53.03 Dispersion Value Num 24.06 Dispersion Value Num 41.11 Dispersion Value Num 27.87 Dispersion Value Num 46.49 Dispersion Value Num 67.73 Dispersion Value Num 32.43 Dispersion Value Num 16.03 Dispersion Value Num 28.94 Dispersion Value Num 43.19 Dispersion Value Num 21.57 Dispersion Value Num 478.64 Dispersion Value Num 359.1 Dispersion Value Num 298.27 Dispersion Value Num 408.03 Dispersion Value Num 362.98 Dispersion Value Num 329.66 Dispersion Value Num 484.29 Dispersion Value Num 508.67 Dispersion Value Num 423.44 Dispersion Value Num 185.45 Dispersion Value Num 204.51 Dispersion Value Num 274.39 Dispersion Value Num 335.0 Dispersion Value Num 347.97 Dispersion Value Num 320.5 Dispersion Value Num 211.1 Dispersion Value Num 470.43 Dispersion Value Num 17.37 Dispersion Value Num 273.28 Dispersion Value Num 298.19 Dispersion Value Num 334.28 Dispersion Value Num 361.29 Dispersion Value Num 255.1 Dispersion Value Num 285.3 Dispersion Value Num 254.98 Dispersion Value Num 609.61 Dispersion Value Num 453.76 Dispersion Value Num 220.4 Dispersion Value Num 288.47 Dispersion Value Num 356.19 Dispersion Value Num 275.11 Dispersion Value Num 303.39 Dispersion Value Num 386.24 Dispersion Value Num 304.63 Dispersion Value Num 237.99 Dispersion Value Num 157.46 Dispersion Value Num 309.88 Dispersion Value Num 288.34 Dispersion Value Num 567.19 Dispersion Value Num 358.78 Dispersion Value Num 244.67 Dispersion Value Num 188.15 Dispersion Value Num 447.01 Dispersion Value Num 243.24 Dispersion Value Num 186.15 Dispersion Value Num 327.06 Dispersion Value Num 298.67 Dispersion Value Num 497.52 Dispersion Value Num 370.32 Dispersion Value Num 331.76 Dispersion Value Num 253.07 Dispersion Value Num 347.53 Dispersion Value Num 636.33 Dispersion Value Num 607.0 Dispersion Value Num 39.28 Dispersion Value Num 39.09 Dispersion Value Num 44.76 Dispersion Value Num 33.33 Dispersion Value Num 38.8 Dispersion Value Num 34.31 Dispersion Value Num 33.8 Dispersion Value Num 42.99 Dispersion Value Num 98.15 Dispersion Value Num 27.11 Dispersion Value Num 33.58 Dispersion Value Num 26.02 Dispersion Value Num 28.49 Dispersion Value Num 26.22 Dispersion Value Num 37.78 Dispersion Value Num 21.44 Dispersion Value Num 53.58 Dispersion Value Num 14.38 Dispersion Value Num 28.42 Dispersion Value Num 40.99 Dispersion Value Num 18.38 Dispersion Value Num 23.98 Dispersion Value Num 27.34 Dispersion Value Num 24.54 Dispersion Value Num 19.26 Dispersion Value Num 58.15 Dispersion Value Num 58.79 Dispersion Value Num 27.1 Dispersion Value Num 43.09 Dispersion Value Num 25.85 Dispersion Value Num 33.9 Dispersion Value Num 39.05 Dispersion Value Num 44.05 Dispersion Value Num 25.42 Dispersion Value Num 14.45 Dispersion Value Num 15.32 Dispersion Value Num 43.0 Dispersion Value Num 35.16 Dispersion Value Num 25.44 Dispersion Value Num 28.63 Dispersion Value Num 130.735 Dispersion Value Num 58.33 Dispersion Value Num 70.5 Dispersion Value Num 31.46 Dispersion Value Num 62.93 Dispersion Value Num 18.52 Dispersion Value Num 28.15 Dispersion Value Num 30.71 Dispersion Value Num 29.29 Dispersion Value Num 37.5 Dispersion Value Num 43.4 Dispersion Value Num 58.44 Dispersion Value Num 29.78 Dispersion Value Num 35.22 Dispersion Value Num 21.79 Dispersion Value Num 113.9348 Dispersion Value Num 85.1667 Dispersion Value Num 134.9995 Dispersion Value Num 105.6611 Dispersion Value Num 102.6261 Dispersion Value Num 124.6749 Dispersion Value Num 151.3859 Dispersion Value Num 40.2119 Dispersion Value Num 57.6474 Dispersion Value Num 92.1185 Dispersion Value Num 152.3178 Dispersion Value Num 77.1648 Dispersion Value Num 89.7176 Dispersion Value Num 126.1667 Dispersion Value Num 96.1842 Dispersion Value Num 262.63 Dispersion Value Num 30.4842 Dispersion Value Num 100.4382 Dispersion Value Num 75.0555 Dispersion Value Num 95.7049 Dispersion Value Num 115.2839 Dispersion Value Num 98.7521 Dispersion Value Num 80.8411 Dispersion Value Num 125.2481 Dispersion Value Num 218.9284 Dispersion Value Num 80.4001 Dispersion Value Num 87.9 Dispersion Value Num 54.8 Dispersion Value Num 59.3 Dispersion Value Num 38.2 Dispersion Value Num 39.2 Dispersion Value Num 73.1 Dispersion Value Num 174.4 Dispersion Value Num 78.9 Dispersion Value Num 69.0 Dispersion Value Num 29.6 Dispersion Value Num 41.6 Dispersion Value Num 151.6 Dispersion Value Num 49.3 Dispersion Value Num 350.6 Dispersion Value Num 26.9 Dispersion Value Num 99.0 Dispersion Value Num 77.7 Dispersion Value Num 102.7 Dispersion Value Num 9.2 Dispersion Value Num 63.8 Dispersion Value Num 71.1 Dispersion Value Num 81.7 Dispersion Value Num 54.5 Dispersion Value Num 36.6 Dispersion Value Num 80.9 Dispersion Value Num 76.6 Dispersion Value Num 80.8 Dispersion Value Num 94.7 Dispersion Value Num 41.1 Dispersion Value Num 54.8 Dispersion Value Num 112.4 Dispersion Value Num 53.5 Dispersion Value Num 282.0 Dispersion Value Num 70.8 Dispersion Value Num 68.2 Dispersion Value Num 52.5 Dispersion Value Num 38.7 Dispersion Value Num 50.5 Dispersion Value Num 41.6 Dispersion Value Num 32.7 Dispersion Value Num 46.9 Dispersion Value Num 8.9 Dispersion Value Num 44.2 Dispersion Value Num 70.0 Dispersion Value Num 53.9 Dispersion Value Num 72.2 Dispersion Value Num 74.4 Dispersion Value Num 4.5 Dispersion Value Num 65.5 Dispersion Value Num 26.5 Dispersion Value Num 92.0 Dispersion Value Num 112.4 Dispersion Value Num 15.9 Dispersion Value Num 63.8 Dispersion Value Num 71.1 Dispersion Value Num 81.7 Dispersion Value Num 54.5 Dispersion Value Num 36.6 Dispersion Value Num 80.9 Dispersion Value Num 76.6 Dispersion Value Num 80.8 Dispersion Value Num 94.7 Dispersion Value Num 41.1 Dispersion Value Num 54.8 Dispersion Value Num 53.5 Dispersion Value Num 282.0 Dispersion Value Num 70.8 Dispersion Value Num 68.2 Dispersion Value Num 52.5 Dispersion Value Num 36.2 Dispersion Value Num 53.4 Dispersion Value Num 69.7 Dispersion Value Num 38.6 Dispersion Value Num 16.7 Dispersion Value Num 56.9 Dispersion Value Num 36.6 Dispersion Value Num 41.0 Dispersion Value Num 50.4 Dispersion Value Num 67.4 Dispersion Value Num 27.2 Dispersion Value Num 35.8 Dispersion Value Num 28.7 Dispersion Value Num 37.6 Dispersion Value Num 10.3 Dispersion Value Num 18.9
Dispersion Lower Limit 6.46 Dispersion Lower Limit 3.22 Dispersion Lower Limit 3.95 Dispersion Lower Limit 11.3 Dispersion Lower Limit 3.55 Dispersion Lower Limit 5.36 Dispersion Lower Limit 3.26 Dispersion Lower Limit 7.33 Dispersion Lower Limit 6.33 Dispersion Lower Limit 6.51 Dispersion Lower Limit 8.45 Dispersion Lower Limit 5.8 Dispersion Lower Limit 4.98 Dispersion Lower Limit 4.79 Dispersion Lower Limit 5.73 Dispersion Lower Limit 5.61 Dispersion Lower Limit 5.26 Dispersion Lower Limit 11.0 Dispersion Lower Limit 5.01 Dispersion Lower Limit 0.0 Dispersion Lower Limit 1.83 Dispersion Lower Limit 1.92 Dispersion Lower Limit 1.58 Dispersion Lower Limit 1.75 Dispersion Lower Limit 1.83 Dispersion Lower Limit 1.75 Dispersion Lower Limit 0.0 Dispersion Lower Limit 1.8 Dispersion Lower Limit 0.0 Dispersion Lower Limit 1.75 Dispersion Lower Limit 1.8 Dispersion Lower Limit 0.0 Dispersion Lower Limit 1.75 Dispersion Lower Limit 2.0 Dispersion Lower Limit 1.75 Dispersion Lower Limit 1.8 Dispersion Lower Limit 1.75 Dispersion Lower Limit 4.25 Dispersion Lower Limit 1.97
Dispersion Upper Limit 13.8 Dispersion Upper Limit 9.75 Dispersion Upper Limit 3.95 Dispersion Upper Limit 12.0 Dispersion Upper Limit 22.1 Dispersion Upper Limit 26.6 Dispersion Upper Limit 21.1 Dispersion Upper Limit 20.7 Dispersion Upper Limit 18.3 Dispersion Upper Limit 18.0 Dispersion Upper Limit 9.58 Dispersion Upper Limit 22.9 Dispersion Upper Limit 70.0 Dispersion Upper Limit 17.9 Dispersion Upper Limit 47.8 Dispersion Upper Limit 31.3 Dispersion Upper Limit 7.12 Dispersion Upper Limit 11.0 Dispersion Upper Limit 5.01 Dispersion Upper Limit 11.5 Dispersion Upper Limit 5.03 Dispersion Upper Limit 10.5 Dispersion Upper Limit 9.0 Dispersion Upper Limit 5.03 Dispersion Upper Limit 4.5 Dispersion Upper Limit 6.75 Dispersion Upper Limit 5.23 Dispersion Upper Limit 5.0 Dispersion Upper Limit 5.0 Dispersion Upper Limit 5.05 Dispersion Upper Limit 4.5 Dispersion Upper Limit 4.5 Dispersion Upper Limit 10.83 Dispersion Upper Limit 4.67 Dispersion Upper Limit 3.63 Dispersion Upper Limit 5.0 Dispersion Upper Limit 5.0 Dispersion Upper Limit 4.25 Dispersion Upper Limit 2.12
Explanation Of Na Standard deviation cannot be calculated due to only one participant with data Explanation Of Na Dispersion data are not available for a single participant. Explanation Of Na Dispersion data are not available for a single participant Explanation Of Na Dispersion data are not available for a single participant Explanation Of Na Dispersion data are not available for a single participant Explanation Of Na Dispersion data are not available for a single participant Explanation Of Na Dispersion data are not available for a single participant

Study References

Sequence: 52087708
Pmid 36005278
Reference Type derived
Citation Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Baseline Counts

Sequence: 11388349 Sequence: 11388350 Sequence: 11388351 Sequence: 11388352 Sequence: 11388353 Sequence: 11388354 Sequence: 11388355 Sequence: 11388356 Sequence: 11388357 Sequence: 11388358
Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall Scope overall Scope overall Scope overall Scope overall Scope overall Scope overall Scope overall
Count 35 Count 34 Count 23 Count 18 Count 21 Count 21 Count 13 Count 5 Count 5 Count 175

Result Groups

Sequence: 56112522 Sequence: 56112523 Sequence: 56112524 Sequence: 56112525 Sequence: 56112526 Sequence: 56112527 Sequence: 56112528 Sequence: 56112529 Sequence: 56112530 Sequence: 56112531 Sequence: 56112554 Sequence: 56112532 Sequence: 56112533 Sequence: 56112534 Sequence: 56112535 Sequence: 56112536 Sequence: 56112537 Sequence: 56112538 Sequence: 56112539 Sequence: 56112540 Sequence: 56112541 Sequence: 56112542 Sequence: 56112543 Sequence: 56112544 Sequence: 56112545 Sequence: 56112546 Sequence: 56112547 Sequence: 56112548 Sequence: 56112549 Sequence: 56112550 Sequence: 56112551 Sequence: 56112552 Sequence: 56112553 Sequence: 56112555 Sequence: 56112556 Sequence: 56112557 Sequence: 56112558 Sequence: 56112559 Sequence: 56112560 Sequence: 56112561 Sequence: 56112562 Sequence: 56112563 Sequence: 56112564 Sequence: 56112565 Sequence: 56112566 Sequence: 56112567 Sequence: 56112568 Sequence: 56112569 Sequence: 56112570 Sequence: 56112571 Sequence: 56112572 Sequence: 56112573 Sequence: 56112574 Sequence: 56112575 Sequence: 56112576 Sequence: 56112577
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code OG003 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG006 Ctgov Group Code FG007 Ctgov Group Code FG008 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG006 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG007 Ctgov Group Code OG008 Ctgov Group Code OG002 Ctgov Group Code OG003 Ctgov Group Code OG004 Ctgov Group Code OG005 Ctgov Group Code OG008 Ctgov Group Code OG008 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG003 Ctgov Group Code EG004 Ctgov Group Code EG005 Ctgov Group Code EG006 Ctgov Group Code EG007 Ctgov Group Code EG008
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Outcome Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event Result Type Reported Event Result Type Reported Event Result Type Reported Event Result Type Reported Event Result Type Reported Event Result Type Reported Event Result Type Reported Event
Title Low Dose of Epoetin Alfa: Vadadustat 300 mg Title Low Dose of Epoetin Alfa: Vadadustat 450 mg Title Low Dose of Epoetin Alfa: Epoetin Alfa Title High Dose of Epoetin Alfa: Vadadustat 300 mg Title High Dose of Epoetin Alfa: Vadadustat 450 mg Title High Dose of Epoetin Alfa: Vadadustat 600 mg Title High Dose of Epoetin Alfa: Epoetin Alfa Title ESA Hyporesponder: Vadadustat 600 mg Title ESA Hyporesponder: Epoetin Alfa Title Total Title Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen) Title Low Dose of Epoetin Alfa: Vadadustat 300 mg Title Low Dose of Epoetin Alfa: Vadadustat 450 mg Title Low Dose of Epoetin Alfa: Epoetin Alfa Title High Dose of Epoetin Alfa: Vadadustat 300 mg Title High Dose of Epoetin Alfa: Vadadustat 450 mg Title High Dose of Epoetin Alfa: Vadadustat 600 mg Title High Dose of Epoetin Alfa: Epoetin Alfa Title ESA Hyporesponder: Vadadustat 600 mg Title ESA Hyporesponder: Epoetin Alfa Title Low Dose of Epoetin Alfa: Vadadustat 300 mg Title Low Dose of Epoetin Alfa: Vadadustat 450 mg Title Low Dose of Epoetin Alfa: Epoetin Alfa Title High Dose of Epoetin Alfa: Vadadustat 300 mg Title High Dose of Epoetin Alfa: Vadadustat 450 mg Title High Dose of Epoetin Alfa: Vadadustat 600 mg Title High Dose of Epoetin Alfa: Epoetin Alfa Title ESA Hyporesponder: Vadadustat 600 mg Title ESA Hyporesponder: Epoetin Alfa Title Low Dose of Epoetin Alfa: Epoetin Alfa Title Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen) Title Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen) Title Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen) Title Vadadustat Total (TIW Dosing Regimen) Title ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen) Title ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen) Title Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 300 mg Title Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 450 mg Title Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Epoetin Alfa Title ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg Title ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa Title High Dose of Epoetin Alfa: Vadadustat 300 mg Title High Dose of Epoetin Alfa: Vadadustat 450 mg Title High Dose of Epoetin Alfa: Vadadustat 600 mg Title ESA Hyporesponder: Vadadustat 600 mg Title ESA Hyporesponder: Epoetin Alfa Title ESA Hyporesponder: Epoetin Alfa Title Low Dose of Epoetin Alfa: Vadadustat 300 mg Title Low Dose of Epoetin Alfa: Vadadustat 450 mg Title Low Dose of Epoetin Alfa: Epoetin Alfa Title High Dose of Epoetin Alfa: Vadadustat 300 mg Title High Dose of Epoetin Alfa: Vadadustat 450 mg Title High Dose of Epoetin Alfa: Vadadustat 600 mg Title High Dose of Epoetin Alfa: Epoetin Alfa Title ESA Hyporesponder: Vadadustat 600 mg Title ESA Hyporesponder: Epoetin Alfa
Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description Total of all reporting groups Description After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [600 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. Description After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 300 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [150 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 450 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [300 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 600 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [450 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 1 tablet greater (150 mg) than final dose in QD dosing regimen. Vadadustat Total comprises all participants who switched from Vadadustat QD to TIW dosing regimen in the Main Study (i.e., combined arm for starting doses of 300mg, 450 mg, 600 mg and 750 mg). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. Description In the erythropoiesis-stimulating agent (ESA) hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with an oral dose of Vadadustat 600 mg tablet per day. Description In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive Description In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.(US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive" Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. Description In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. Description In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.

Baseline Measurements

Sequence: 125654974 Sequence: 125654975 Sequence: 125654976 Sequence: 125654977 Sequence: 125654978 Sequence: 125654979 Sequence: 125654980 Sequence: 125654981 Sequence: 125654982 Sequence: 125654983 Sequence: 125654984 Sequence: 125654985 Sequence: 125654986 Sequence: 125654987 Sequence: 125654988 Sequence: 125654989 Sequence: 125654990 Sequence: 125654991 Sequence: 125654992 Sequence: 125654993 Sequence: 125654994 Sequence: 125654995 Sequence: 125654996 Sequence: 125654997 Sequence: 125654998 Sequence: 125654999 Sequence: 125655000 Sequence: 125655001 Sequence: 125655002 Sequence: 125655003 Sequence: 125655004 Sequence: 125655005 Sequence: 125655006 Sequence: 125655007 Sequence: 125655008 Sequence: 125655009 Sequence: 125655010 Sequence: 125655011 Sequence: 125655012 Sequence: 125655013 Sequence: 125655014 Sequence: 125655015 Sequence: 125655016 Sequence: 125655017 Sequence: 125655018 Sequence: 125655019 Sequence: 125655020 Sequence: 125655021 Sequence: 125655022 Sequence: 125655023 Sequence: 125655024 Sequence: 125655025 Sequence: 125655026 Sequence: 125655027 Sequence: 125655028 Sequence: 125655029 Sequence: 125655030 Sequence: 125655031 Sequence: 125655032 Sequence: 125655033 Sequence: 125655034 Sequence: 125655035 Sequence: 125655036 Sequence: 125655037 Sequence: 125655038 Sequence: 125655039 Sequence: 125655040 Sequence: 125655041 Sequence: 125655042 Sequence: 125655043 Sequence: 125655044 Sequence: 125655045 Sequence: 125655046 Sequence: 125655047 Sequence: 125655048 Sequence: 125655049 Sequence: 125655050 Sequence: 125655051 Sequence: 125655052 Sequence: 125655053 Sequence: 125655054 Sequence: 125655055 Sequence: 125655056 Sequence: 125655057 Sequence: 125655058 Sequence: 125655059 Sequence: 125655060 Sequence: 125655061 Sequence: 125655062 Sequence: 125655063 Sequence: 125655064 Sequence: 125655065 Sequence: 125655066 Sequence: 125655067 Sequence: 125655068 Sequence: 125655069 Sequence: 125655070 Sequence: 125655071 Sequence: 125655072 Sequence: 125655073 Sequence: 125655074 Sequence: 125655075 Sequence: 125655076 Sequence: 125655077 Sequence: 125655078 Sequence: 125655079 Sequence: 125655080 Sequence: 125655081 Sequence: 125655082 Sequence: 125655083
Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531 Result Group Id 56112522 Result Group Id 56112523 Result Group Id 56112524 Result Group Id 56112525 Result Group Id 56112526 Result Group Id 56112527 Result Group Id 56112528 Result Group Id 56112529 Result Group Id 56112530 Result Group Id 56112531
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG007 Ctgov Group Code BG008 Ctgov Group Code BG009
Classification <65 years Classification <65 years Classification <65 years Classification <65 years Classification <65 years Classification <65 years Classification <65 years Classification <65 years Classification <65 years Classification <65 years Classification >=65 years Classification >=65 years Classification >=65 years Classification >=65 years Classification >=65 years Classification >=65 years Classification >=65 years Classification >=65 years Classification >=65 years Classification >=65 years
Category Female Category Female Category Female Category Female Category Female Category Female Category Female Category Female Category Female Category Female Category Male Category Male Category Male Category Male Category Male Category Male Category Male Category Male Category Male Category Male Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category Asian Category Asian Category Asian Category Asian Category Asian Category Asian Category Asian Category Asian Category Asian Category Asian Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Black or African American Category Black or African American Category Black or African American Category Black or African American Category Black or African American Category Black or African American Category Black or African American Category Black or African American Category Black or African American Category Black or African American Category White Category White Category White Category White Category White Category White Category White Category White Category White Category White Category More than one race Category More than one race Category More than one race Category More than one race Category More than one race Category More than one race Category More than one race Category More than one race Category More than one race Category More than one race Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported
Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Age, Customized Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB)
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 20 Param Value 22 Param Value 15 Param Value 11 Param Value 18 Param Value 13 Param Value 7 Param Value 4 Param Value 3 Param Value 113 Param Value 15 Param Value 12 Param Value 8 Param Value 7 Param Value 3 Param Value 8 Param Value 6 Param Value 1 Param Value 2 Param Value 62 Param Value 14 Param Value 13 Param Value 4 Param Value 7 Param Value 7 Param Value 9 Param Value 6 Param Value 4 Param Value 3 Param Value 67 Param Value 21 Param Value 21 Param Value 19 Param Value 11 Param Value 14 Param Value 12 Param Value 7 Param Value 1 Param Value 2 Param Value 108 Param Value 0 Param Value 1 Param Value 0 Param Value 2 Param Value 0 Param Value 1 Param Value 0 Param Value 0 Param Value 0 Param Value 4 Param Value 2 Param Value 1 Param Value 1 Param Value 1 Param Value 1 Param Value 1 Param Value 1 Param Value 0 Param Value 1 Param Value 9 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 2 Param Value 4 Param Value 18 Param Value 19 Param Value 7 Param Value 8 Param Value 13 Param Value 14 Param Value 6 Param Value 2 Param Value 2 Param Value 89 Param Value 10 Param Value 9 Param Value 13 Param Value 5 Param Value 6 Param Value 5 Param Value 5 Param Value 3 Param Value 0 Param Value 56 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 4 Param Value 4 Param Value 1 Param Value 2 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 0 Param Value 13
Param Value Num 20.0 Param Value Num 22.0 Param Value Num 15.0 Param Value Num 11.0 Param Value Num 18.0 Param Value Num 13.0 Param Value Num 7.0 Param Value Num 4.0 Param Value Num 3.0 Param Value Num 113.0 Param Value Num 15.0 Param Value Num 12.0 Param Value Num 8.0 Param Value Num 7.0 Param Value Num 3.0 Param Value Num 8.0 Param Value Num 6.0 Param Value Num 1.0 Param Value Num 2.0 Param Value Num 62.0 Param Value Num 14.0 Param Value Num 13.0 Param Value Num 4.0 Param Value Num 7.0 Param Value Num 7.0 Param Value Num 9.0 Param Value Num 6.0 Param Value Num 4.0 Param Value Num 3.0 Param Value Num 67.0 Param Value Num 21.0 Param Value Num 21.0 Param Value Num 19.0 Param Value Num 11.0 Param Value Num 14.0 Param Value Num 12.0 Param Value Num 7.0 Param Value Num 1.0 Param Value Num 2.0 Param Value Num 108.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 2.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 4.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 9.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 2.0 Param Value Num 4.0 Param Value Num 18.0 Param Value Num 19.0 Param Value Num 7.0 Param Value Num 8.0 Param Value Num 13.0 Param Value Num 14.0 Param Value Num 6.0 Param Value Num 2.0 Param Value Num 2.0 Param Value Num 89.0 Param Value Num 10.0 Param Value Num 9.0 Param Value Num 13.0 Param Value Num 5.0 Param Value Num 6.0 Param Value Num 5.0 Param Value Num 5.0 Param Value Num 3.0 Param Value Num 0.0 Param Value Num 56.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 4.0 Param Value Num 4.0 Param Value Num 1.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 13.0
Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175 Number Analyzed 35 Number Analyzed 34 Number Analyzed 23 Number Analyzed 18 Number Analyzed 21 Number Analyzed 21 Number Analyzed 13 Number Analyzed 5 Number Analyzed 5 Number Analyzed 175

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<![CDATA[ Vibration Impact on Parkinson’s Tremor ]]>
https://zephyrnet.com/NCT03799614
2019-02-26

https://zephyrnet.com/?p=NCT03799614
NCT03799614https://www.clinicaltrials.gov/study/NCT03799614?tab=tableNANANAThe primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject’s arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson’s disease (PD).
<![CDATA[

Studies

Study First Submitted Date 2018-12-19
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-12-17
Start Month Year February 26, 2019
Primary Completion Month Year November 27, 2019
Verification Month Year November 2020
Verification Date 2020-11-30
Last Update Posted Date 2020-12-17
Results First Posted Date 2020-12-17

Detailed Descriptions

Sequence: 20573952
Description Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.

Facilities

Sequence: 198630695
Name Virginia Commonwealth University
City Richmond
State Virginia
Zip 23298
Country United States

Conditions

Sequence: 51790013
Name Parkinson Disease
Downcase Name parkinson disease

Id Information

Sequence: 39855187
Id Source org_study_id
Id Value HM20012404

Countries

Sequence: 42254026
Name United States
Removed False

Design Groups

Sequence: 55210666 Sequence: 55210667
Group Type Experimental Group Type Experimental
Title Lower dose vibration Title Higher dose vibration
Description RMBand lower dose vibration Description RMBand higher dose vibration

Interventions

Sequence: 52112621 Sequence: 52112622
Intervention Type Device Intervention Type Device
Name RMBand lower dose Name RMBand higher dose
Description Light-weight portable device that delivers low dose vibration to the arm Description Light-weight portable device that delivers higher dose vibration to the arm

Design Outcomes

Sequence: 176153634 Sequence: 176153635 Sequence: 176153636 Sequence: 176153637
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Measure Clinical Rating for Tremor Measure Objective Measurement of Tremor Frequency (Hz) Measure Objective Measurement of Tremor Amplitude (mm).
Time Frame This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. Time Frame Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . Time Frame Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. Time Frame Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment.

Browse Conditions

Sequence: 191950703 Sequence: 191950704 Sequence: 191950705 Sequence: 191950706 Sequence: 191950707 Sequence: 191950708 Sequence: 191950709 Sequence: 191950710 Sequence: 191950711
Mesh Term Parkinson Disease Mesh Term Parkinsonian Disorders Mesh Term Basal Ganglia Diseases Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Movement Disorders Mesh Term Synucleinopathies Mesh Term Neurodegenerative Diseases
Downcase Mesh Term parkinson disease Downcase Mesh Term parkinsonian disorders Downcase Mesh Term basal ganglia diseases Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term movement disorders Downcase Mesh Term synucleinopathies Downcase Mesh Term neurodegenerative diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47964007
Agency Class OTHER
Lead Or Collaborator lead
Name Virginia Commonwealth University

Overall Officials

Sequence: 29060523
Role Principal Investigator
Name Ingrid Pretzer-Aboff, PhD, RN
Affiliation Virginia Commonwealth University

Design Group Interventions

Sequence: 67689829 Sequence: 67689830
Design Group Id 55210666 Design Group Id 55210667
Intervention Id 52112621 Intervention Id 52112622

Eligibilities

Sequence: 30541670
Gender All
Minimum Age 21 Years
Maximum Age 95 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Parkinson's disease (PD) as diagnosed by a movement disorder specialist
Tremor caused by their Parkinson's disease
Ability to provide informed consent

Exclusion Criteria:

Known diagnosis of Parkinson Plus Syndrome
Dementia
Other known non-PD cause of tremor
Other known non-PD cause of limb dysfunction
Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
Non-English speaker
Prisoners
Pregnant women

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254206584
Number Of Facilities 1
Number Of Nsae Subjects 1
Registered In Calendar Year 2018
Actual Duration 9
Were Results Reported True
Months To Report Results 11
Has Us Facility True
Has Single Facility True
Minimum Age Num 21
Maximum Age Num 95
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 4

Designs

Sequence: 30290204
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Triple
Subject Masked True
Investigator Masked True
Outcomes Assessor Masked True

Milestones

Sequence: 40799723 Sequence: 40799724 Sequence: 40799725 Sequence: 40799726 Sequence: 40799727 Sequence: 40799728
Result Group Id 55879876 Result Group Id 55879877 Result Group Id 55879876 Result Group Id 55879877 Result Group Id 55879876 Result Group Id 55879877
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 15 Count 15 Count 15 Count 15 Count 0 Count 0

Participant Flows

Sequence: 3902853

Outcome Counts

Sequence: 73593018 Sequence: 73593019 Sequence: 73593020 Sequence: 73593021 Sequence: 73593022 Sequence: 73593023 Sequence: 73593024 Sequence: 73593025
Outcome Id 30636650 Outcome Id 30636650 Outcome Id 30636651 Outcome Id 30636651 Outcome Id 30636652 Outcome Id 30636652 Outcome Id 30636653 Outcome Id 30636653
Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879880 Result Group Id 55879881 Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879882 Result Group Id 55879879
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 15 Count 15 Count 15 Count 15 Count 15 Count 15 Count 15 Count 15

Provided Documents

Sequence: 2568501 Sequence: 2568502
Document Type Informed Consent Form Document Type Study Protocol and Statistical Analysis Plan
Has Protocol False Has Protocol True
Has Icf True Has Icf False
Has Sap False Has Sap True
Document Date 2018-10-01 Document Date 2018-10-01
Url https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/ICF_001.pdf Url https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/Prot_SAP_002.pdf

Reported Event Totals

Sequence: 27805369 Sequence: 27805370 Sequence: 27805371 Sequence: 27805372 Sequence: 27805373 Sequence: 27805374
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1
Subjects At Risk 15 Subjects At Risk 15 Subjects At Risk 15 Subjects At Risk 15 Subjects At Risk 15 Subjects At Risk 15
Created At 2023-08-06 18:18:13.636944 Created At 2023-08-06 18:18:13.636944 Created At 2023-08-06 18:18:13.636944 Created At 2023-08-06 18:18:13.636944 Created At 2023-08-06 18:18:13.636944 Created At 2023-08-06 18:18:13.636944
Updated At 2023-08-06 18:18:13.636944 Updated At 2023-08-06 18:18:13.636944 Updated At 2023-08-06 18:18:13.636944 Updated At 2023-08-06 18:18:13.636944 Updated At 2023-08-06 18:18:13.636944 Updated At 2023-08-06 18:18:13.636944

Reported Events

Sequence: 524777665 Sequence: 524777666
Result Group Id 55879883 Result Group Id 55879884
Ctgov Group Code EG000 Ctgov Group Code EG001
Time Frame two hours, during time of study activities Time Frame two hours, during time of study activities
Event Type other Event Type other
Subjects Affected 0 Subjects Affected 1
Subjects At Risk 15 Subjects At Risk 15
Event Count 0 Event Count 1
Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders
Adverse Event Term muscle tightness Adverse Event Term muscle tightness
Frequency Threshold 0 Frequency Threshold 0
Assessment Non-systematic Assessment Assessment Non-systematic Assessment

Responsible Parties

Sequence: 28669164
Responsible Party Type Sponsor

Result Agreements

Sequence: 3833597
Pi Employee No
Restriction Type GT60

Result Contacts

Sequence: 3833562
Organization Virginia Commonwealth University
Name Dr. Ingrid Pretzer-Aboff
Phone 804-828-3340
Email iaboff@vcu.edu

Outcomes

Sequence: 30636650 Sequence: 30636651 Sequence: 30636652 Sequence: 30636653
Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary
Title Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Title Clinical Rating for Tremor Title Objective Measurement of Tremor Frequency (Hz) Title Objective Measurement of Tremor Amplitude (mm).
Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment.
Time Frame This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. Time Frame Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . Time Frame Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. Time Frame Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
Units score on a scale Units score on a scale Units hertz Units millimeters
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Param Type Mean Param Type Mean Param Type Mean Param Type Mean

Outcome Measurements

Sequence: 234242622 Sequence: 234242623 Sequence: 234242624 Sequence: 234242625 Sequence: 234242626 Sequence: 234242627 Sequence: 234242628 Sequence: 234242629 Sequence: 234242633 Sequence: 234242630 Sequence: 234242631 Sequence: 234242632 Sequence: 234242634 Sequence: 234242635 Sequence: 234242636 Sequence: 234242637 Sequence: 234242638 Sequence: 234242639 Sequence: 234242640 Sequence: 234242641 Sequence: 234242642 Sequence: 234242643 Sequence: 234242644 Sequence: 234242645
Outcome Id 30636650 Outcome Id 30636650 Outcome Id 30636650 Outcome Id 30636650 Outcome Id 30636650 Outcome Id 30636650 Outcome Id 30636651 Outcome Id 30636651 Outcome Id 30636651 Outcome Id 30636651 Outcome Id 30636651 Outcome Id 30636651 Outcome Id 30636652 Outcome Id 30636652 Outcome Id 30636652 Outcome Id 30636652 Outcome Id 30636652 Outcome Id 30636652 Outcome Id 30636653 Outcome Id 30636653 Outcome Id 30636653 Outcome Id 30636653 Outcome Id 30636653 Outcome Id 30636653
Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879880 Result Group Id 55879881 Result Group Id 55879881 Result Group Id 55879880 Result Group Id 55879881 Result Group Id 55879880 Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879878 Result Group Id 55879879 Result Group Id 55879882 Result Group Id 55879879 Result Group Id 55879882 Result Group Id 55879879 Result Group Id 55879882 Result Group Id 55879879
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Classification Baseline Classification Baseline Classification During vibration treatment Classification During vibration treatment Classification Post vibration treatment Classification Post vibration treatment Classification Baseline Classification Baseline Classification Post vibration Classification During vibration Classification During vibration Classification Post vibration Classification Baseline Classification Baseline Classification During Vibration Classification During Vibration Classification Post Vibration Classification Post Vibration Classification Baseline Classification Baseline Classification During vibration Classification During vibration Classification Post vibration Classification Post vibration
Title Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Title Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Title Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Title Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Title Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Title Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Title Clinical Rating for Tremor Title Clinical Rating for Tremor Title Clinical Rating for Tremor Title Clinical Rating for Tremor Title Clinical Rating for Tremor Title Clinical Rating for Tremor Title Objective Measurement of Tremor Frequency (Hz) Title Objective Measurement of Tremor Frequency (Hz) Title Objective Measurement of Tremor Frequency (Hz) Title Objective Measurement of Tremor Frequency (Hz) Title Objective Measurement of Tremor Frequency (Hz) Title Objective Measurement of Tremor Frequency (Hz) Title Objective Measurement of Tremor Amplitude (mm). Title Objective Measurement of Tremor Amplitude (mm). Title Objective Measurement of Tremor Amplitude (mm). Title Objective Measurement of Tremor Amplitude (mm). Title Objective Measurement of Tremor Amplitude (mm). Title Objective Measurement of Tremor Amplitude (mm).
Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.

Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.

Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment. Description This is a device that will objectively measure tremor amplitude pre, during, and post treatment.
Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units hertz Units hertz Units hertz Units hertz Units hertz Units hertz Units millimeters Units millimeters Units millimeters Units millimeters Units millimeters Units millimeters
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 32.67 Param Value 27.4 Param Value 33.67 Param Value 27.33 Param Value 32.67 Param Value 28.6 Param Value 15.47 Param Value 13.87 Param Value 14.13 Param Value 15.87 Param Value 13.20 Param Value 14.53 Param Value 4.77 Param Value 4.51 Param Value 4.79 Param Value 3.99 Param Value 3.36 Param Value 4.64 Param Value 0.71 Param Value 0.43 Param Value 0.76 Param Value 0.44 Param Value 0.70 Param Value 0.52
Param Value Num 32.67 Param Value Num 27.4 Param Value Num 33.67 Param Value Num 27.33 Param Value Num 32.67 Param Value Num 28.6 Param Value Num 15.47 Param Value Num 13.87 Param Value Num 14.13 Param Value Num 15.87 Param Value Num 13.2 Param Value Num 14.53 Param Value Num 4.77 Param Value Num 4.51 Param Value Num 4.79 Param Value Num 3.99 Param Value Num 3.36 Param Value Num 4.64 Param Value Num 0.71 Param Value Num 0.43 Param Value Num 0.76 Param Value Num 0.44 Param Value Num 0.7 Param Value Num 0.52
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 12.88 Dispersion Value 11.25 Dispersion Value 14.31 Dispersion Value 11.14 Dispersion Value 13.67 Dispersion Value 10.39 Dispersion Value 7.94 Dispersion Value 4.03 Dispersion Value 5.63 Dispersion Value 8.55 Dispersion Value 4.03 Dispersion Value 7.98 Dispersion Value 1.57 Dispersion Value 1.31 Dispersion Value 1.13 Dispersion Value 1.12 Dispersion Value 0.87 Dispersion Value 1.48 Dispersion Value 0.82 Dispersion Value 0.41 Dispersion Value 0.72 Dispersion Value 0.31 Dispersion Value 0.75 Dispersion Value 0.47
Dispersion Value Num 12.88 Dispersion Value Num 11.25 Dispersion Value Num 14.31 Dispersion Value Num 11.14 Dispersion Value Num 13.67 Dispersion Value Num 10.39 Dispersion Value Num 7.94 Dispersion Value Num 4.03 Dispersion Value Num 5.63 Dispersion Value Num 8.55 Dispersion Value Num 4.03 Dispersion Value Num 7.98 Dispersion Value Num 1.57 Dispersion Value Num 1.31 Dispersion Value Num 1.13 Dispersion Value Num 1.12 Dispersion Value Num 0.87 Dispersion Value Num 1.48 Dispersion Value Num 0.82 Dispersion Value Num 0.41 Dispersion Value Num 0.72 Dispersion Value Num 0.31 Dispersion Value Num 0.75 Dispersion Value Num 0.47

Baseline Counts

Sequence: 11328791 Sequence: 11328792 Sequence: 11328793
Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 15 Count 15 Count 30

Result Groups

Sequence: 55879875 Sequence: 55879876 Sequence: 55879873 Sequence: 55879874 Sequence: 55879877 Sequence: 55879878 Sequence: 55879879 Sequence: 55879880 Sequence: 55879881 Sequence: 55879882 Sequence: 55879883 Sequence: 55879884
Ctgov Group Code BG002 Ctgov Group Code FG000 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Participant Flow Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title Total Title Low Dose Vibration Title Lower Dose Vibration Title Higher Dose Vibration Title High Dose Vibration Title Low Dose Vibration Title Higher Dose Vibration Title Lower Dose Vibration Title Higher Dose Vibration Title Low Dose Vibration Amplitude Title Lower Dose Vibration Title Higher Dose Vibration
Description Total of all reporting groups Description RMBand lower dose vibration

RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm

Description RMBand lower dose vibration

RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm

Description RMBand higher dose vibration

RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm

Description RMBand higher dose vibration

RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm

Description RMBand low dose vibration

RMBand: Light-weight portable device that delivers low dose vibration to the arm

Description RMBand high dose vibration

RMBand: Light-weight portable device that delivers higher dose vibration to the arm

Description RMBand lower dose vibration

RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm

Description RMBand higher dose vibration

RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm

Description RMBand low dose vibration

RMBand: Light-weight portable device that delivers low dose vibration to the arm,reported in mm.

Description RMBand lower dose vibration

RMBand lower dose: Light-weight portable device that delivers low dose vibration (frequency of 80 Hz) to the arm

Description RMBand higher dose vibration

RMBand higher dose: Light-weight portable device that delivers higher dose (frequency of 160 Hz) vibration to the arm

Baseline Measurements

Sequence: 124996019 Sequence: 124996020 Sequence: 124996021 Sequence: 124996022 Sequence: 124996023 Sequence: 124996024 Sequence: 124996025 Sequence: 124996026 Sequence: 124996027 Sequence: 124996028 Sequence: 124996029 Sequence: 124996030 Sequence: 124996031 Sequence: 124996032 Sequence: 124996033 Sequence: 124996034 Sequence: 124996035 Sequence: 124996036 Sequence: 124996037 Sequence: 124996038 Sequence: 124996039 Sequence: 124996040 Sequence: 124996041 Sequence: 124996042 Sequence: 124996043 Sequence: 124996044 Sequence: 124996045 Sequence: 124996046 Sequence: 124996047 Sequence: 124996048 Sequence: 124996049 Sequence: 124996050 Sequence: 124996051 Sequence: 124996052 Sequence: 124996053 Sequence: 124996054 Sequence: 124996055 Sequence: 124996056 Sequence: 124996057
Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875 Result Group Id 55879873 Result Group Id 55879874 Result Group Id 55879875
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Classification United States Classification United States Classification United States
Category Female Category Female Category Female Category Male Category Male Category Male Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category Asian Category Asian Category Asian Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Black or African American Category Black or African American Category Black or African American Category White Category White Category White Category More than one race Category More than one race Category More than one race Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported
Title Age, Continuous Title Age, Continuous Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Region of Enrollment Title Region of Enrollment Title Region of Enrollment Title Clinical Rating Scale for Tremor, total score Title Clinical Rating Scale for Tremor, total score Title Clinical Rating Scale for Tremor, total score Title MDS UPDRS II – IV total Title MDS UPDRS II – IV total Title MDS UPDRS II – IV total
Description Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. Description Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. Description Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V.
Units years Units years Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units participants Units participants Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale
Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number Param Type Number Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 67.3 Param Value 67.6 Param Value 67.4 Param Value 4 Param Value 8 Param Value 12 Param Value 11 Param Value 7 Param Value 18 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 1 Param Value 1 Param Value 15 Param Value 14 Param Value 29 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 15 Param Value 15 Param Value 30 Param Value 21.13 Param Value 18.07 Param Value 19.6 Param Value 44.26 Param Value 38.47 Param Value 41.37
Param Value Num 67.3 Param Value Num 67.6 Param Value Num 67.4 Param Value Num 4.0 Param Value Num 8.0 Param Value Num 12.0 Param Value Num 11.0 Param Value Num 7.0 Param Value Num 18.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 15.0 Param Value Num 14.0 Param Value Num 29.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 15.0 Param Value Num 15.0 Param Value Num 30.0 Param Value Num 21.13 Param Value Num 18.07 Param Value Num 19.6 Param Value Num 44.26 Param Value Num 38.47 Param Value Num 41.37
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 6.7 Dispersion Value 8.4 Dispersion Value 7.63 Dispersion Value 10.69 Dispersion Value 5.22 Dispersion Value 8.55 Dispersion Value 16.41 Dispersion Value 14.08 Dispersion Value 15.56
Dispersion Value Num 6.7 Dispersion Value Num 8.4 Dispersion Value Num 7.63 Dispersion Value Num 10.69 Dispersion Value Num 5.22 Dispersion Value Num 8.55 Dispersion Value Num 16.41 Dispersion Value Num 14.08 Dispersion Value Num 15.56
Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30 Number Analyzed 15 Number Analyzed 15 Number Analyzed 30

]]>

<![CDATA[ Docetaxel Combined With Carboplatin Plus Anlotinib as First Line Treatment in NSCLC ]]>
https://zephyrnet.com/NCT03799601
2019-03-01

https://zephyrnet.com/?p=NCT03799601
NCT03799601https://www.clinicaltrials.gov/study/NCT03799601?tab=tableXianglin Yuan, MD.xlyuan@tjh.tjmu.cn0086-13667241722Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit. The purpose of this trail is to establish whether advanced non-squamous NSCLC patients could benefit from the combination treatment of docetaxel, carboplatin and anlotinib as the first-line and maintenance treatment.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year March 1, 2019
Primary Completion Month Year December 1, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20741248
Description First-line patients (or postoperative recurrence) with locally advanced or metastatic NSCLC were enrolled in this trail. The patients (clinical stage ⅢB/Ⅳ, with no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene) were confirmed by histological or cytological diagnosis. The primary endpoint is PFS; secondary endpoint includes OS, DCR and ORR. The study was single-arm, conducted at 8 centers in China mainland. The primary end point was PFS (time from enrollment to first RECIST1.1-defined PD or death). 45 patients were planned for enrollment. This estimate was based on 80% power, with a two-sided 5% significance level. We analyzed PFS and OS using Kaplan-Meier methodology. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Facilities

Sequence: 200280799
Name Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology,
City Wuhan
State Hubei
Zip 430000
Country China

Facility Contacts

Sequence: 28132917
Facility Id 200280799
Contact Type primary
Name Xianglin Yuan, MD.
Email xlyuan@tjh.tjmu.cn
Phone 0086-13667241722

Browse Interventions

Sequence: 96133426 Sequence: 96133427 Sequence: 96133428 Sequence: 96133429 Sequence: 96133430 Sequence: 96133431 Sequence: 96133432
Mesh Term Carboplatin Mesh Term Docetaxel Mesh Term Antineoplastic Agents Mesh Term Tubulin Modulators Mesh Term Antimitotic Agents Mesh Term Mitosis Modulators Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term carboplatin Downcase Mesh Term docetaxel Downcase Mesh Term antineoplastic agents Downcase Mesh Term tubulin modulators Downcase Mesh Term antimitotic agents Downcase Mesh Term mitosis modulators Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52221717
Name NSCLC
Downcase Name nsclc

Id Information

Sequence: 40195766
Id Source org_study_id
Id Value TJCC-LC-20190108

Countries

Sequence: 42609750
Name China
Removed False

Design Groups

Sequence: 55650014
Group Type Experimental
Title combination of docetaxel, carboplatin and anlotinib

Interventions

Sequence: 52535521 Sequence: 52535522 Sequence: 52535523
Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Anlotinib Name Docetaxel Name Carboplatin
Description Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit. Description a chemotherapy medication used to treat a number of types of cancer.This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer.It may be used by itself or along with other chemotherapy medication.It is given by slow injection into a vein. Description Carboplatin is used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It may be used for some types of testicular cancer but cisplatin is generally more effective.

Keywords

Sequence: 79942038 Sequence: 79942039 Sequence: 79942040 Sequence: 79942041
Name Anlotinib Name Docetaxel Name Carboplatin Name NSCLC
Downcase Name anlotinib Downcase Name docetaxel Downcase Name carboplatin Downcase Name nsclc

Design Outcomes

Sequence: 177562120 Sequence: 177562121 Sequence: 177562122 Sequence: 177562123
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure progression-free survival Measure Overall Survival Measure Disease Control Rate Measure Overall Response Rate
Time Frame Estimated about 24 months. Time Frame Estimated about 24 months. Time Frame Estimated about 24 months. Time Frame Estimated about 24 months.
Description Clinical response of treatment according to RESIST v1.1 criteria (PFS, progression-free survival) Description Clinical response of treatment according to RESIST v1.1 criteria (OS, overall survival) Description Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate) Description Clinical response of treatment according to RESIST v1.1 criteria (ORR, Overall Response Rate)

Browse Conditions

Sequence: 193679203 Sequence: 193679204 Sequence: 193679205 Sequence: 193679206 Sequence: 193679207 Sequence: 193679208 Sequence: 193679209 Sequence: 193679210 Sequence: 193679211 Sequence: 193679212
Mesh Term Carcinoma, Non-Small-Cell Lung Mesh Term Carcinoma, Bronchogenic Mesh Term Bronchial Neoplasms Mesh Term Lung Neoplasms Mesh Term Respiratory Tract Neoplasms Mesh Term Thoracic Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases
Downcase Mesh Term carcinoma, non-small-cell lung Downcase Mesh Term carcinoma, bronchogenic Downcase Mesh Term bronchial neoplasms Downcase Mesh Term lung neoplasms Downcase Mesh Term respiratory tract neoplasms Downcase Mesh Term thoracic neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366604 Sequence: 48366605
Agency Class OTHER Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Tongji Hospital Name Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Overall Officials

Sequence: 29313003
Role Study Chair
Name Xianglin Yuan, MD.
Affiliation Tongji Hospital

Central Contacts

Sequence: 12020631
Contact Type primary
Name Xianglin Yuan, MD.
Phone 0086-13667241722
Email xlyuan@tjh.tjmu.cn
Role Contact

Design Group Interventions

Sequence: 68217635 Sequence: 68217636 Sequence: 68217637
Design Group Id 55650014 Design Group Id 55650014 Design Group Id 55650014
Intervention Id 52535521 Intervention Id 52535522 Intervention Id 52535523

Eligibilities

Sequence: 30794819
Gender All
Minimum Age 18 Years
Maximum Age 75 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

≥18 years of age on the day of signing informed consent and with good compliance and agree to accept follow-up of disease progression and adverse events.
Patients with histologic or cytologic confirmation of advanced or metastatic Non squamous NSCLC with stage IIIB or IV disease.(For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment)
There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm.
Life expectancy ≥6 months
a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
With normal marrow, liver ,renal and coagulation function:
The blood routine examination need to be standard (no blood transfusion and blood products within 14 days, no g-csf and other hematopoietic stimulating factor correction)
The main organs function are normally, the following criteria are met:(1)Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): HB≥90 g/L; ANC ≥ 1.5×10^9/L; PLT ≥80×10^9/L;(2)Biochemical examinations must meet the following criteria: TBIL<1.5×ULN; ALT and AST < 2.5×ULN, and for patients with liver metastases < 5×ULN; Serum Cr ≤ 1.25×ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Gault formula);

Women of child-bearing age should take appropriate contraceptive measures and should not breastfeed from screening to 3 months after stopping the study and treatment.Before starting administration, the pregnancy test was negative, or one of the following criteria was met to prove that there was no risk of pregnancy:

Postmenopause is defined as amenorrhea at least 12 months after age 50 and cessation of all exogenous hormone replacement therapy;
Postmenopausal women under the age of 50 May also be considered postmenopausal if their amenorrhea is 12 months or more after the cessation of all exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the reference value range of laboratory postmenopausal;
Have undergone irreversible sterilization surgery, including hysterectomy, bilateral ovectomy or bilateral salpingectomy, except for bilateral tubal ligation.
For men, consent is required to use appropriate methods of contraception or to be surgically sterilized during the trial and 8 weeks after the last administration of the trial drug.

Exclusion Criteria:

Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer), Lung sarcomatoid carcinoma;
Had histologically confirmed lung squamous cell carcinoma, or adenosquamous carcinoma;
Patients with pathological fracture in bone metastasis induced by non-small-cell lung cancer;
Tumor histology or cytology confirmed EGFR mutagenesis [EGFR sensitive mutations include 18 exon point mutations (G719X), 19 exon deletions, 20 exon S768I mutations and 21 exon point mutations (L858R and L861Q)] and ALK gene rearrangement positivity, include EGFR/ALK status cannot be determined for various reasons;
Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor; Medical history and combined history:
Active brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms in 28 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms and metastases in midbrain, pons, cerebellum, medulla oblongata, or spinal cord, brain metastases and local radiotherapy after two weeks to allow group);
The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks;
Had malignant tumors except NSCLC within 5 years before enrollment(except for patients with carcinoma in situ of the cervix , basal cell or squamous cell skin cancer who have undergone a curative treatment, local prostate cancer after radical resection, ductal carcinoma in situ or papillary thyroid cancer after radical resection);
Abnormal blood coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; Note: Under the condition of prothrombin time international normalized ratio (INR) ≤ 1.5, low-dose heparin (adult daily dose of 0.6 million to 12,000 U) or low-dose aspirin (daily dosage ≤ 100 mg) is allowed for preventive purposes;
Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;
The effects of surgery or trauma have been eliminated for less than 14 days before enrollment in subjects who have undergone major surgery or have severe trauma;
Severe acute or chronic infections requiring systemic treatment; Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%;
There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma;
Respiratory syndrome (≥CTC AE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment; Long-term unhealed wounds or fractures;
Decompensated diabetes or other ailments treated with high doses of glucocorticoids;
Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
Clinically significant hemoptysis (daily hemoptysis greater than 50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis;
Events of venous/venous thrombosis occurring within the first 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;

Physical examination and laboratory findings:

A known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS);
Untreated active hepatitis (hepatitis b: HBsAg positive and HBV DNA more than 1 x 103 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection;
Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004493
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30540859
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26697011
Intervention Id 52535521
Name Anlotinib Hydrochloride

Responsible Parties

Sequence: 28907179
Responsible Party Type Sponsor

]]>

<![CDATA[ Transmitted Lung Pressures With Biphasic Chest Cuirass ]]>
https://zephyrnet.com/NCT03799588
2019-01-08

https://zephyrnet.com/?p=NCT03799588
NCT03799588https://www.clinicaltrials.gov/study/NCT03799588?tab=tableNANANAThis study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-03-08
Start Month Year January 8, 2019
Primary Completion Month Year January 31, 2022
Verification Month Year March 2022
Verification Date 2022-03-31
Last Update Posted Date 2022-03-08

Detailed Descriptions

Sequence: 20576911
Description Conventional mechanical ventilation is known as positive pressure ventilation (PPV) because the machine delivers positive pressure directly into the airways to ventilate and expand the lungs. In a healthy lung, inflation occurs when the pressure inside the lung is greater than the pressure outside the lung. This transpulmonary pressure is the difference between the pressure inside the lung (in the alveolus) and the pressure just outside the lung (the pleural cavity). Since positive pressure ventilation delivers pressure directly into the airways, the transpulmonary pressure is increased by making the lung pressure more positive. This is markedly different than physiologic breathing and carries an increased risk of ventilator-associated lung injury1. In the setting of sick lungs, where the pressure required to open collapsed areas of lung may be more than areas of healthy lung, this higher pressure can in turn cause damage to the areas of healthy lung. The known effects of this ventilator-associated lung injury from positive pressure ventilation can be avoided with the use of negative pressure ventilation. In negative pressure ventilation (NPV), the transpulmonary pressure is increased by making the pleural pressure more negative. This is achieved by using a plastic shell that covers the chest and generates negative pressure between the plastic shell and the chest. This pressure is distributed more evenly across a large surface of the chest wall and results in more uniform lung expansion. As a result, NPV results in better oxygen delivery and less lung injury than positive pressure ventilation2.

However, despite the extensive use of NPV in other countries, there is little data available regarding the transpulmonary pressure that these machines can generate; i.e. how well does negative pressure in the plastic shell transmit to the pleural cavity to expand the lung. There is a large amount of data supporting the use of biphasic cuirass ventilation to minimize lung damage3 and improve hemodynamics4-9, but no studies have been done to date that look at the transpulmonary pressure and how it differs depending on age and size. It is still unclear what optimal pressure is required via the chest cuirass to expand and ventilate the lungs via. It is also unknown what maximum pressures can be used before the lung becomes overinflated and complications arise.

This study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.

Facilities

Sequence: 198653046
Name Oishei Children's Hospital
City Buffalo
State New York
Zip 14203
Country United States

Conditions

Sequence: 51797600
Name Lung Diseases
Downcase Name lung diseases

Id Information

Sequence: 39861467
Id Source org_study_id
Id Value STUDY00002374

Countries

Sequence: 42259143
Name United States
Removed False

Design Groups

Sequence: 55217086
Group Type Experimental
Title Biphasic Chest Cuirass Arm
Description This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass.

Interventions

Sequence: 52119692
Intervention Type Device
Name Biphasic Chest Cuirass
Description Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.

Keywords

Sequence: 79254888 Sequence: 79254889 Sequence: 79254890
Name Pediatrics Name biphasic chest cuirass Name transpulmonary pressure
Downcase Name pediatrics Downcase Name biphasic chest cuirass Downcase Name transpulmonary pressure

Design Outcomes

Sequence: 176174171
Outcome Type primary
Measure Transpulmonary Pressure Deliverance
Time Frame 1 year
Description Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.

Browse Conditions

Sequence: 191981778 Sequence: 191981777
Mesh Term Respiratory Tract Diseases Mesh Term Lung Diseases
Downcase Mesh Term respiratory tract diseases Downcase Mesh Term lung diseases
Mesh Type mesh-ancestor Mesh Type mesh-list

Sponsors

Sequence: 47970753
Agency Class OTHER
Lead Or Collaborator lead
Name State University of New York at Buffalo

Overall Officials

Sequence: 29064571
Role Principal Investigator
Name Bree C Kramer, DO
Affiliation University at Buffalo

Design Group Interventions

Sequence: 67697337
Design Group Id 55217086
Intervention Id 52119692

Eligibilities

Sequence: 30545892
Gender Male
Minimum Age 6 Months
Maximum Age 5 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Are between the age of 6 months and 5 years
Undergo circumcision, hypospadias repair, or orchidopexy in the operating room of the John R. Oishei Children's Hospital

Exclusion Criteria:

Previous history of chronic lung disease or cyanotic heart disease or
Patients with significant chest wall abnormalities or other abnormalities that preclude proper placement of the biphasic chest cuirass.

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254224131
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 6
Maximum Age Num 5
Minimum Age Unit Months
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30294295
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)
Intervention Model Description After routine intubation for elective urologic procedures in the OR, the patient will be placed on a biphasic chest cuirass after anesthesia induction. A esophageal manometer will then be placed to measure transpulmonary pressures. The patient will be switched off the anesthesia ventilator and the biphasic chest cuirass will begin negative pressure ventilation. During this time, the patient will continue to receive inhalation anesthetic gas. After 30 minutes, the biphasic chest cuirass will terminate and the patient will again receive positive pressure ventilation via the anesthesia ventilator.

Responsible Parties

Sequence: 28672847
Responsible Party Type Principal Investigator
Name Bree Cyrene Kramer
Title Assistant Clinical Professor of Pediatrics
Affiliation State University of New York at Buffalo

Study References

Sequence: 51693049 Sequence: 51693050
Pmid 9142069 Pmid 7653758
Reference Type background Reference Type background
Citation Scholz SE, Knothe C, Thiel A, Hempelmann G. Improved oxygen delivery by positive pressure ventilation with continuous negative external chest pressure. Lancet. 1997 May 3;349(9061):1295-6. doi: 10.1016/S0140-6736(05)62507-X. No abstract available. Citation Petros AJ, Fernando SS, Shenoy VS, al-Saady NM. The Hayek oscillator. Nomograms for tidal volume and minute ventilation using external high frequency oscillation. Anaesthesia. 1995 Jul;50(7):601-6. doi: 10.1111/j.1365-2044.1995.tb15112.x.

]]>

<![CDATA[ Internal Limiting Membrane and Macular Hole ]]>
https://zephyrnet.com/NCT03799575
2019-01-02

https://zephyrnet.com/?p=NCT03799575
NCT03799575https://www.clinicaltrials.gov/study/NCT03799575?tab=tableAndreia L Pinto, MSCandreia.lucia.pinto@gmail.com+351969721099Observational study of Internal Limiting Membrane peeled in macular Hole surgery and studied by Transmission electronic Microscopy (TEM) and Optical Coherence Tomography (OCT) findings in closed holes.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year January 2, 2019
Primary Completion Month Year July 2, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20727133
Description A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.

Surgeries are performed under local or general anesthesia, pars plana vitrectomy with internal limiting membrane peeling, fluid gas exchange and face down position.

Two samples of discarded ILM peeled in Macular hole surgery is studied in Laboratory.

Laboratory Analysis Two samples of ILM per patient are harvested, one will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. Both samples from same patient will follow the protocol available at dx.doi.org/10.17504/protocols.io.qjiduke.

Image acquisition Six electron-micrographs will be acquired for each fragment, using a Hitachi H-7000 electron microscope equipped with a megaview III digital camera. Fields of interest will be randomly selected, and acquisition of 15,000x magnification images.

Histology and immunohistochemistry ILM samples will be stained with anti-GFAP antibody (anti-glial fibrillary acidic protein), to detect this protein in glial cells.

Results:

Only successful macular hole closure will be considered, BCVA will be compared before and after surgery and related to OCT findings. ILM findings in TEM analysis will be compared with and without enriched medium.

Facilities

Sequence: 200159071
Status Recruiting
Name Hospital Santa Maria
City Lisbon
State Lisboa
Zip 1649-035
Country Portugal

Facility Contacts

Sequence: 28113707
Facility Id 200159071
Contact Type primary
Name Mun Y Faria, MD
Email munfaria1@gmail.com
Phone +351966026791

Conditions

Sequence: 52185355
Name C11.768.740
Downcase Name c11.768.740

Id Information

Sequence: 40168986
Id Source org_study_id
Id Value MD26339

Countries

Sequence: 42580596
Name Portugal
Removed False

Design Groups

Sequence: 55609000 Sequence: 55609001
Title A Title B
Description Two samples of ILM per patient are harvested, group A will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. Description Group B sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.

Interventions

Sequence: 52499322
Intervention Type Behavioral
Name Transmission Electron Microscopy analysis
Description Morphology of two vitreal side of Internal Limiting Membrane in contact

Design Outcomes

Sequence: 177431667
Outcome Type primary
Measure Fibrosis in vitreal sides of Internal Limiting Membranes
Time Frame 12 months
Description Fibrilliary process between two vitreal sides of Internal Limiting Membranes in contact, after incubation in enriched medium

Browse Conditions

Sequence: 193539667 Sequence: 193539668 Sequence: 193539669
Mesh Term Retinal Perforations Mesh Term Retinal Diseases Mesh Term Eye Diseases
Downcase Mesh Term retinal perforations Downcase Mesh Term retinal diseases Downcase Mesh Term eye diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48332219
Agency Class OTHER
Lead Or Collaborator lead
Name Hospital de Santa Maria, Portugal

Overall Officials

Sequence: 29292920
Role Principal Investigator
Name Mun Y Faria, MD
Affiliation Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT

Central Contacts

Sequence: 12012279 Sequence: 12012280
Contact Type primary Contact Type backup
Name Nuno P Ferreira, MD Name Andreia L Pinto, MSC
Phone +351918503467 Phone +351969721099
Email ngcpferreira@gmail.com Email andreia.lucia.pinto@gmail.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68168041 Sequence: 68168042
Design Group Id 55609000 Design Group Id 55609001
Intervention Id 52499322 Intervention Id 52499322

Eligibilities

Sequence: 30773513
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 90 Years
Healthy Volunteers No
Population A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.

Inclusion criteria

Full Thickness Macular Hole
Male or female aged 18 years or older
Visual symptoms due to IMH
Intraocular pressure inferior to 21 mmHG
Signed informed consent form

Criteria Inclusion Criteria:

All macular holes were staged based on recent OCT based classification and only full thickness macular hole, grade 2 to 4 IMH are considered for study.

Exclusion Criteria:

Excluding criteria are maculopathy other than IMH, surgeries of recurrence of IMH, other retinal diseases, or an axial length greater than 26.0 mm. Mean follow-up will be at least 12 months after surgery.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253952460
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 90
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30519644
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28885945
Responsible Party Type Principal Investigator
Name Mun Yueh de Faria
Title MD
Affiliation Hospital de Santa Maria, Portugal

Study References

Sequence: 52078780
Pmid 31191990
Reference Type derived
Citation Faria MY, Sousa DC, Almeida BC, Pinto AL, Ferreira NP. Morphology of Peeled Internal Limiting Membrane in Macular Hole Surgery. J Ophthalmol. 2019 May 2;2019:1345683. doi: 10.1155/2019/1345683. eCollection 2019.

]]>

<![CDATA[ Neurosteroids for PTSD in Veterans ]]>
https://zephyrnet.com/NCT03799562
2019-05-01

https://zephyrnet.com/?p=NCT03799562
NCT03799562https://www.clinicaltrials.gov/study/NCT03799562?tab=tableChristine E Marx, MD MAchristine.marx@va.gov(919) 286-0411This study seeks to determine if pregnenolone can improve symptoms of PTSD and other symptoms that commonly occur with PTSD in Iraq/Afghanistan-era Veterans. The total study duration is 10 weeks. Eligible Veterans with PTSD will receive either pregnenolone or placebo throughout the study duration and will complete mental and physical health assessments at each study visit. Eligible participants will attend 6 in-person study visits and receive several short “check-in” phone calls.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-12-13
Start Month Year May 1, 2019
Primary Completion Month Year December 1, 2024
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-13

Detailed Descriptions

Sequence: 20818827
Description BACKGROUND: There is an acute and urgent need to develop new and effective posttraumatic stress disorder (PTSD) pharmacotherapies, as there are currently only two FDA-approved medications for the treatment of PTSD (both of which are from the same drug class and have shown only moderate effect sizes in FDA registration trials). Many Veterans with PTSD thus remain symptomatic despite the availability of these treatments, increasing the likelihood of receiving pharmacological treatment interventions for which there is little or no empirical evidence. Multiple national and VA working groups focusing on PTSD have identified the critical need to address the paucity of PTSD pharmacotherapies, and have strongly recommended more randomized clinical trials to evaluate possible effective pharmacological treatments. Both preclinical and clinical data suggest that reductions in neurosteroids are involved in the pathophysiology of PTSD, and that ameliorating these deficits could potentially be clinically therapeutic – the proposed investigation targeting a neurosteroid intervention for the treatment of PTSD could thus be a promising research avenue. The investigators therefore propose to conduct a randomized clinical trial (RCT) to determine the efficacy of a neurosteroid intervention (pregnenolone) for PTSD and commonly co-occurring disorders in Iraq/Afghanistan-era Veterans, an understudied cohort that may be less treatment-refractory.

METHODS: This study will be a 10-week randomized, placebo-controlled, double-blind clinical trial of pregnenolone or matching placebo in Veterans with PTSD. The trial will include a 2-week single-blind placebo lead-in phase followed by 8 weeks of study medication (placebo or pregnenolone). Forty-five subjects meeting DSM-5 criteria for PTSD (as measured by a CAPS-5 score of 30) will be randomized to receive pregnenolone, and 45 subjects meeting DSM-5 criteria for PTSD will be randomized to receive placebo. The primary outcome for this RCT will be changes in total CAPS-5 score at Visit 6 for this modified intent-to-treat sample. Secondary clinical outcomes for this RCT include changes in pain intensity and functional interference, as measured by the Brief Pain Inventory, Short Form (BPI-SF) and depression symptoms by the Hamilton-Depression Rating Scale (HAM-D). Blood samples will be collected for serum analysis at all study visits and frozen in a -80 degree freezer. Upon completion of the study, samples will be thawed and analyzed using Gas Chromatography/Mass Spectrometry for neurosteroid analyses and inflammatory markers will be quantified. Genetic analyses will be conducted to determine therapeutic response.

PREDICTED RESULTS: The investigators hypothesize that treatment with pregnenolone will be efficacious in Iraq/Afghanistan-era Veterans with PTSD, and will significantly reduce PTSD symptoms as assessed by the CAPS-5 (primary endpoint) compared to placebo. Secondary endpoints will include the assessment of conditions that frequently co-occur with PTSD; specifically, the investigators hypothesize that pregnenolone will also demonstrate efficacy for co-occurring chronic pain symptoms and depression symptoms. The investigators hypothesize that increases in pregnenolone and other neurosteroids (and decreases in inflammatory markers) will predict improvements in PTSD, depression, and chronic pain symptoms. The investigators also hypothesize that neurosteroids are dysregulated in PTSD, and that specific SNPs of genes coding for neurosteroidogenic enzymes will be associated with therapeutic response.

Facilities

Sequence: 200953723
Status Recruiting
Name Durham VA Medical Center, Durham, NC
City Durham
State North Carolina
Zip 27705
Country United States

Facility Contacts

Sequence: 28246269 Sequence: 28246270
Facility Id 200953723 Facility Id 200953723
Contact Type primary Contact Type backup
Name Virginia J Rhodes Name John D Whited, MD MHS
Email Virginia.Rhodes@va.gov Email john.whited@va.gov
Phone 919-286-0411 Phone (919) 286-0411
Phone Extension 177632 Phone Extension 176926

Facility Investigators

Sequence: 18419314
Facility Id 200953723
Role Principal Investigator
Name Jennifer C Naylor, PhD

Conditions

Sequence: 52419868
Name Posttraumatic Stress Disorder
Downcase Name posttraumatic stress disorder

Id Information

Sequence: 40334795 Sequence: 40334796
Id Source org_study_id Id Source secondary_id
Id Value MHBB-004-18S Id Value I01CX001784-01
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/I01CX001784-01

Countries

Sequence: 42761961
Name United States
Removed False

Design Groups

Sequence: 55868892 Sequence: 55868891
Group Type Placebo Comparator Group Type Experimental
Title Placebo Title Pregnenolone
Description Same as pregnenolone (active study medication), except placebo dispensed. Description Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial

Interventions

Sequence: 52728479 Sequence: 52728480
Intervention Type Drug Intervention Type Drug
Name Pregnenolone Name Placebo
Description Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. Placebo will be identical to the pregnenolone arm, except placebo will be dispensed. Description Same as pregnenolone (active study medication), except placebo dispensed.

Keywords

Sequence: 80204244 Sequence: 80204245 Sequence: 80204246 Sequence: 80204247 Sequence: 80204248
Name Depression Name Pain Name Clinical Trial Name Veteran Name Supplement
Downcase Name depression Downcase Name pain Downcase Name clinical trial Downcase Name veteran Downcase Name supplement

Design Outcomes

Sequence: 178306993 Sequence: 178306994 Sequence: 178306995
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Change in Clinician Administered PTSD Scale for DSM-5 (Visit 6-Baseline) Measure Change in Brief Pain Inventory, Short Form (Visit 6-Baseline) Measure Change in Hamilton-Depression Inventory (Visit 6-Baseline)
Time Frame Through study completion, an average of 5 years Time Frame Through study completion, an average of 5 years Time Frame Through study completion, an average of 5 years
Description The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make a diagnosis of PTSD and assess PTSD symptoms. It assesses the intensity and frequency of PTSD symptoms. Scores range from 0-80; higher score indicates greater severity. Description The Brief Pain Inventory, Short Form (BPI-SF) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Description The HAM-D measures the severity of depressive symptoms. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.

Browse Conditions

Sequence: 194431101 Sequence: 194431102 Sequence: 194431103 Sequence: 194431104
Mesh Term Stress Disorders, Post-Traumatic Mesh Term Stress Disorders, Traumatic Mesh Term Trauma and Stressor Related Disorders Mesh Term Mental Disorders
Downcase Mesh Term stress disorders, post-traumatic Downcase Mesh Term stress disorders, traumatic Downcase Mesh Term trauma and stressor related disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48549974
Agency Class FED
Lead Or Collaborator lead
Name VA Office of Research and Development

Overall Officials

Sequence: 29414361
Role Principal Investigator
Name Jennifer C Naylor, PhD
Affiliation Durham VA Medical Center, Durham, NC

Central Contacts

Sequence: 12074310 Sequence: 12074311
Contact Type primary Contact Type backup
Name Jennifer C Naylor, PhD Name Christine E Marx, MD MA
Phone (919) 286-0411 Phone (919) 286-0411
Email jennifer.naylor2@va.gov Email christine.marx@va.gov
Phone Extension 7722 Phone Extension 5112
Role Contact Role Contact

Design Group Interventions

Sequence: 68487288 Sequence: 68487289
Design Group Id 55868891 Design Group Id 55868892
Intervention Id 52728479 Intervention Id 52728480

Eligibilities

Sequence: 30908192
Gender All
Minimum Age 18 Years
Maximum Age 65 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3

Females will be required to use a medically and study approved contraceptive or otherwise not be of child-bearing potential

Birth control methods must be non-hormonal
No anticipated need to alter psychiatric medications for duration of study involvement
Ability to participate fully in the informed consent process

Exclusion Criteria:

History of allergy to pregnenolone
Medical disorders that may preclude safe administration of pregnenolone or exacerbate PTSD symptoms

Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern

Prior suicide attempt history or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted

Serious unstable medical illness, such as:

history of cerebrovascular accident
prostate
uterine or breast cancer
others (at the discretion of the PI and medical oversight team)
Medical conditions not well controlled will be excluded, at the discretion of the PI and Medical Team

Standard pharmacological interventions for PTSD will not be exclusionary, including, but not limited to:

antidepressant medications such as SSRIs, SNRIs, tricyclics, bupropion, mirtazapine, venlafaxine, and nefazodone
mood stabilizers such as carbamazepine, divalproex, lamotrigine, topiramate
atypical antipsychotics, and other agents including prazosin
However, there may be no changes in psychotropic medications for PTSD 4 weeks prior to study randomization
Benzodiazepine use
Current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than mild TBI (assessed at screening)

Initiation or change in psychotherapy within 3 months of randomization

i.e., psychotherapy must be stable for 3 months prior to study start
Participants on hormonal therapies such as finasteride or hormonal birth control
Female participants who are pregnant or breast-feeding

As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry

Mild Alcohol Use Disorder is not exclusionary, at the judgment of the PI and her medical team

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254167606
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30653904
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Masking Description This is a randomized, double-blind, placebo-controlled trial. All roles will be masked with the exception of the research pharmacist.
Intervention Model Description Participants will be randomized to receive the active study medication (pregnenolone) or placebo.
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 29020559
Responsible Party Type Sponsor

]]>

<![CDATA[ [Trial of device that is not approved or cleared by the U.S. FDA] ]]>
https://zephyrnet.com/NCT03799549
None

https://zephyrnet.com/?p=NCT03799549
NCT03799549https://www.clinicaltrials.gov/study/NCT03799549?tab=tableNANANA[Trial of device that is not approved or cleared by the U.S. FDA]
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-04-12
Last Update Posted Date 2019-04-12

Id Information

Sequence: 40266151
Id Source org_study_id
Id Value SK-0118

Sponsors

Sequence: 48460040
Lead Or Collaborator lead
Name [Redacted]

Calculated Values

Sequence: 254272071
Registered In Calendar Year 2019
Were Results Reported False
Has Single Facility False

Responsible Parties

Sequence: 28964691
Organization [Redacted]
Old Name Title [Redacted]

]]>

<![CDATA[ Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions ]]>
https://zephyrnet.com/NCT03799536
2019-01-09

https://zephyrnet.com/?p=NCT03799536
NCT03799536https://www.clinicaltrials.gov/study/NCT03799536?tab=tableNANANAThis is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-06-07
Start Month Year January 9, 2019
Primary Completion Month Year February 4, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-06-07

Detailed Descriptions

Sequence: 20721593
Description The objective of this study is to establish if two formulations of sotalol are bioequivalent. The test formulation is Sotalol Tablets, 160 mg (Pharmtechnology LLC, Belarus). The reference formulation is Sotalex®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany). 36 healthy adult volunteers of both genders with age ranging from 18 to 55 years old will receive a single tablet (160 mg of sotalol) of the test and the reference products with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list. In the first period, 18 subjects will receive the test product and 18 subjects the reference product.In the second period subjects will receive the products in the opposite order. Subjects will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples were collected before dosing and 0,5 ; 1; 1,5; 2 ; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing (total number: 19). The washout period will be 14 days. A validated HPLC/MS/MS method will be used to determine plasma concentrations of analyte (sotalol). ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for the analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t.

Facilities

Sequence: 200107909
Name National Anti-Doping Laboratory
City Settl.Lesnoy
State Minsk Region
Zip 223040
Country Belarus

Browse Interventions

Sequence: 96050076 Sequence: 96050077 Sequence: 96050078 Sequence: 96050079 Sequence: 96050080 Sequence: 96050081 Sequence: 96050082 Sequence: 96050083 Sequence: 96050084 Sequence: 96050085 Sequence: 96050086
Mesh Term Sotalol Mesh Term Adrenergic beta-Antagonists Mesh Term Adrenergic Antagonists Mesh Term Adrenergic Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Physiological Effects of Drugs Mesh Term Anti-Arrhythmia Agents Mesh Term Sympatholytics Mesh Term Autonomic Agents Mesh Term Peripheral Nervous System Agents
Downcase Mesh Term sotalol Downcase Mesh Term adrenergic beta-antagonists Downcase Mesh Term adrenergic antagonists Downcase Mesh Term adrenergic agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term physiological effects of drugs Downcase Mesh Term anti-arrhythmia agents Downcase Mesh Term sympatholytics Downcase Mesh Term autonomic agents Downcase Mesh Term peripheral nervous system agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52171123
Name Bioequivalence
Downcase Name bioequivalence

Id Information

Sequence: 40158566
Id Source org_study_id
Id Value BE-SOTL-160- 2018

Countries

Sequence: 42568869
Name Belarus
Removed False

Design Groups

Sequence: 55593071 Sequence: 55593072
Group Type Experimental Group Type Active Comparator
Title Sequence AB Title Sequence BA
Description Subjects assigned to sequence AB will receive a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 1 and a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Description Subjects assigned to sequence BA will receive a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 1 and a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.

Interventions

Sequence: 52485371 Sequence: 52485372
Intervention Type Drug Intervention Type Drug
Name Sotalol Name Sotalex
Description Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus Description Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH & Co. KGaA, Germany

Keywords

Sequence: 79868375 Sequence: 79868376 Sequence: 79868377
Name Bioequivalence Name Sotalol Name Sotalex
Downcase Name bioequivalence Downcase Name sotalol Downcase Name sotalex

Design Outcomes

Sequence: 177378503 Sequence: 177378496 Sequence: 177378497 Sequence: 177378498 Sequence: 177378499 Sequence: 177378500 Sequence: 177378501 Sequence: 177378502
Outcome Type secondary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol Measure Cmax of sotalol for the test and the reference products Measure AUC0-t of sotalol for the test and the reference products Measure AUC0-∞ of sotalol for the test and the reference products Measure Tmax of sotalol for the test and the reference products Measure T1/2 of sotalol for the test and the reference products Measure Kel of sotalol for the test and the reference products Measure AUCresid of sotalol for the test and the reference products
Time Frame 28 days Time Frame Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing Time Frame Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing Time Frame Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing Time Frame Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing Time Frame Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing Time Frame Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing Time Frame Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing
Description An AE is defined as any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have a causal relationship with the treatment. The data from participants who had taken at least one investigational product was analyzed. Description Maximum concentration in plasma among observed concentrations at pre-specified time points Description Area under the plasma concentration versus time curve from time 0 to the last measured concentration Description Area under the plasma concentration versus time curve from time 0 to to infinite time Description Time to maximum measured plasma concentration Description Elimination or terminal half-life Description Elimination rate constant Description Residual area

Sponsors

Sequence: 48319201 Sequence: 48319202
Agency Class INDUSTRY Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Pharmtechnology LLC Name National Anti-Doping Labaratory

Overall Officials

Sequence: 29285302
Role Principal Investigator
Name Anastasia Teteryukova, MD
Affiliation National Anti-Doping Labaratory

Design Group Interventions

Sequence: 68149001 Sequence: 68149002
Design Group Id 55593071 Design Group Id 55593072
Intervention Id 52485371 Intervention Id 52485372

Eligibilities

Sequence: 30765292
Gender All
Minimum Age 18 Years
Maximum Age 55 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Caucasian men or women aged between 18 to 55 years
Body mass index 18.5-30 kg/m²
Subjects who have no signs of disease during the screening, and whose screening is conducted within 21 days after the registration in the trial
Subjects whose laboratory blood and urine values are within the normal range orof deviations are considered by researchers to be clinically insignificant
Non-smokers or ex-smokers (defined as completely quitting smoking for at least three months prior to being included in the test)
No known history of alcohol abuse
No known history of abuse of drugs (benzodiazepines, opioids, cocaine, barbiturates, amphetamine, etc.)
Willingness to comply with the protocol requirements regarding the restriction of the consumption of products containing xanthine (coffee, tea, chocolate, cola, etc.) for at least 48 hours and products containing tobacco, alcohol-containing products and beverages, grapefruit and/or its juice, food containing poppy at least 72 hours prior taking the investigational medicinal products and over the course of the study, as well as requirements regarding the intake of food, fluids and physical activity imposed by the study
Healthy subject according to medical history, physical examination and assessment of basic vital signs
No significant abnormalities on 12-lead ECG
No significant abnormalities on the chest x-ray obtained within 12 months prior the start of the study
Consent of women of childbearing age and male participants to use medically confirmed barrier methods of contraception (from the date of screening to the completion of the study), or surgical sterilization in history, or women in postmenopause (at least 24 months) or hysterectomy in history . If women use hormonal contraceptives,they should stop them at least 60 days prior the planned beginning of the study
The subject's voluntary willingness to provide written informed consent
The ability, at disceretion of the researcher, to follow all the requirements of the protocol
The ability, at judgment of the researcher, to follow all the requirements of the protocol

Exclusion Criteria:

Known history of allergy
Known contraindications to the use of investigational products or hypersensitivity to the active substance or components of drugs
Use of drugs with enzymatic-modifying activity, within 28 days prior the beginning of the study
Use any over-the-counter or prescription drugs (including vitamins, minerals, herbal remedies, and dietary supplements) within 14 days prior the administration of investigational products and over the course of the study
Intense physical exercises within 24 hours prior to the administration of investigational products
Any medical or surgical interventions that can disrupt the function of the hematopoietic system, the gastrointestinal tract (with the exception of appendectomy), the liver, urinary system and other body systems
Any chronic diseases or conditions of the urinary, cardiovascular, neuroendocrine, immune, central nervous systems, hematopoietic system, gastrointestinal tract, liver, organs of vision and other systems of the body and diabetes in medical history, mental illness in an active phase or the history
The presence of any hereditary disease
Participation in any clinical trials within 90 days prior the beginning of the current clincial study
Oncological diseaes in medical history
Any blood donation within 90 days prior the beginning of the current clincial study
Acute infectious diseases within 28 days prior the beginning of the current clincial study as well as positive testing for HIV, hepatitis B and C, and syphilis
Positive test for alcohol
Positive urinary screen test for drugs of abuse
Swallowing problems in mediical history
Positive urinary pregnancy test
Breast-feeding
Known history of venous access difficulties
Vegetarian diet
Sitting systolic blood pressure < 110 mm Hg or > 140 mm Hg and/or sitting diastolic blood pressure < 70 mm Hg or > 90 mm Hg.Heart rate <50 or >100 beats per minute at screening check-in
Values of the standard laboratory and instrumental tests outside of normal limits and are judged as clinically significant by investigators or require additional examination and interpretation.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253878332
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 0
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 55
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30511459
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Single
Masking Description The subjects and the investigator will not be blinded towards the identity of the study products. However, analysts will be blinded towards identity of the study products administered.
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26673677 Sequence: 26673678
Intervention Id 52485371 Intervention Id 52485372
Name the test product Name the reference product

Responsible Parties

Sequence: 28877753
Responsible Party Type Sponsor

]]>

<![CDATA[ Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy ]]>
https://zephyrnet.com/NCT03799523
2019-01-16

https://zephyrnet.com/?p=NCT03799523
NCT03799523https://www.clinicaltrials.gov/study/NCT03799523?tab=tableNANANAThe first goal of this project is to validate the superiority of semi-permanent marks used in conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out the use of permanent tattoos for the investigator’s patients. The secondary goal of this project is to validate the superiority of specialized light-based surface imaging for daily radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for breast cancer.
<![CDATA[

Studies

Study First Submitted Date 2018-11-19
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-01-25
Start Month Year January 16, 2019
Primary Completion Month Year December 2023
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-01-25

Detailed Descriptions

Sequence: 20815550
Description This study uses surface imaging for breast patients to standardize or normalize planning position & minimize variability of port films thus reducing systematic error. The primary objective of this study is to demonstrate the superiority of using surface imaging to combine an ideally gated treatment planning CT and verification images timed to the breathing cycle, quantified as the total within-subject variation of the measured location relative to current methods of radiation delivery not using this approach. The secondary objective is to demonstrate the superiority of specialized light-based surface imaging for daily radiation set-up without tattoos compared to standard-of-care methods with regard to the total within-subject variation of the measured location determined by weekly port films during a course of radiation for breast cancer.

Facilities

Sequence: 200889880
Name UT Health San Antonio Mays Cancer Center
City San Antonio
State Texas
Zip 78229
Country United States

Conditions

Sequence: 52410820
Name Breast Cancer
Downcase Name breast cancer

Id Information

Sequence: 40327860 Sequence: 40327861
Id Source org_study_id Id Source secondary_id
Id Value CTMS# 18-0135 Id Value 18-769H
Id Type Other Identifier
Id Type Description UT Health Science Center Institutional Review Board

Countries

Sequence: 42751098
Name United States
Removed False

Design Groups

Sequence: 55858392
Group Type Experimental
Title Subjects undergoing breast radiotherapy
Description At the time of CT simulation study participants will receive temporary skin markings to be covered in clear medical grade tape. Light-based surface imaging will be used to determine alignment between the patient and the radiation machine. Radiation treatment will proceed as standard of care.

Interventions

Sequence: 52718720 Sequence: 52718721
Intervention Type Other Intervention Type Other
Name Temporary skin markings Name Surface imaging
Description To use temporary markings in lieu of localization tattoos. Description To use light-based surface imaging for patient positioning during radiation treatment.

Design Outcomes

Sequence: 178265296
Outcome Type primary
Measure Position measurement from Port films.
Time Frame Once weekly for 3 weeks up to 5 weeks
Description Distance measured (centimeters) from the planned position of radiotherapy to the actual position of radiotherapy on weekly port films. Port films are x-rays of the treatment field which are done to ensure that the patient and the radiation machine are properly aligned to each other. Weekly port films will be obtained for the duration of radiation treatment, which will be from three to five weeks in length.

Sponsors

Sequence: 48542077
Agency Class OTHER
Lead Or Collaborator lead
Name The University of Texas Health Science Center at San Antonio

Overall Officials

Sequence: 29409518
Role Principal Investigator
Name Eva Galvan, MD
Affiliation Principal Investigator

Design Group Interventions

Sequence: 68472889 Sequence: 68472890
Design Group Id 55858392 Design Group Id 55858392
Intervention Id 52718720 Intervention Id 52718721

Eligibilities

Sequence: 30903191
Gender Female
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Age ≥ 18 years
Biologically female
Ability to provide informed written consent in either English or Spanish
Surgical pathology and staging scans must demonstrate Ductal carcinoma in situ (DCIS) or invasive breast cancer, Stages 0, 1, 2, and 3
Patient will undergo adjuvant radiation therapy as a part of multimodality breast cancer treatment with plans for tangent field radiation treatment with or without loco-regional lymph node targeting, based on the clinical judgement of the treating physician
Willingness to maintain temporary skin markings for a part of their of radiation therapy duration
Absence of any conditions that may affect ability to have either tattoos or skin markings, as discussed in Exclusion Criteria

Exclusion Criteria:

Age < 18 years
Biologically non-female
Inability or unwillingness of subject to give written informed consent
Patients found at presentation to have very locally-advanced cancer (e.g. inflammatory breast cancer) or metastatic breast cancer (Stage 4)
Patients that will be treated with a deep-inspiration breath hold technique (typically younger patients being treated for left-sided tumors)
Current pregnancy, as this is a contraindication to receiving radiation therapy
History of prior radiotherapy to the chest wall or torso
Known allergy / sensitivity to standard medical marking tattoo ink (by design non-toxic, low-allergy), skin marking paint, or medical tape (e.g. Tegaderm)
Active drug or alcohol use or dependence evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254158531
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30648908
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29015552
Responsible Party Type Sponsor

]]>

<![CDATA[ Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children ]]>
https://zephyrnet.com/NCT03799510
2018-12-13

https://zephyrnet.com/?p=NCT03799510
NCT03799510https://www.clinicaltrials.gov/study/NCT03799510?tab=tableNANANAThe clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-12-09
Start Month Year December 13, 2018
Primary Completion Month Year July 1, 2019
Verification Month Year December 2019
Verification Date 2019-12-31
Last Update Posted Date 2019-12-09

Detailed Descriptions

Sequence: 20709967
Description A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel arms, two of them formed by groups of healthy or infected school children, both receiving three (3) injections at D0, W4 (Week 4), W8; both groups receiving 50 μg Sm14 vaccine candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated infected school children.

Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP) conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.

Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection.

Blood analysis: Liver function tests – renal function tests – blood counts, at W-1 before inclusion, and at W9 and W21 during the follow-up.

Blood samples for immune response analysis at D0, W12 and W21.

Facilities

Sequence: 199964475
Name Biomedical Research Center EPLS
City Saint Louis
Zip BP226
Country Senegal

Conditions

Sequence: 52138950
Name Schistosomiasis
Downcase Name schistosomiasis

Id Information

Sequence: 40135018
Id Source org_study_id
Id Value Sm14 Phase 2b – Sn

Countries

Sequence: 42542639
Name Senegal
Removed False

Design Groups

Sequence: 55559287 Sequence: 55559288 Sequence: 55559289
Group Type Experimental Group Type Experimental Group Type No Intervention
Title Group 1 Title Group 2 Title Group 3
Description Healthy school children with no infectious history of Schistosomiasis receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20). Description School children with an infectious history of S. haematobium and-or S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20). Description School children with an infectious history of S. haematobium and S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) not receiving vaccine. Control group.

Interventions

Sequence: 52454850 Sequence: 52454851
Intervention Type Biological Intervention Type Drug
Name Sm14 Name GLA-SE solution
Description Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week). Description The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.

Keywords

Sequence: 79822738 Sequence: 79822739 Sequence: 79822740 Sequence: 79822741 Sequence: 79822742 Sequence: 79822743 Sequence: 79822744
Name Schistosomiasis Name Recombinant vaccine Name rSm14 Name GLA-SE Name Fatty acid-binding protein (FABP) Name Phase II Clinical Trial Name Senegal
Downcase Name schistosomiasis Downcase Name recombinant vaccine Downcase Name rsm14 Downcase Name gla-se Downcase Name fatty acid-binding protein (fabp) Downcase Name phase ii clinical trial Downcase Name senegal

Design Outcomes

Sequence: 177263392 Sequence: 177263393 Sequence: 177263394 Sequence: 177263395 Sequence: 177263396 Sequence: 177263397 Sequence: 177263398 Sequence: 177263399 Sequence: 177263400
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Number of Participants with Adverse Events as a Measure of Safety and Tolerability Measure Number of Participants with Adverse Events as a Measure of Safety and Tolerability Measure Number of Participants with Adverse Events as a Measure of Safety and Tolerability Measure Number of Participants with Adverse Events as a Measure of Safety and Tolerability Measure Number of Participants with Adverse Events as a Measure of Safety and Tolerability Measure Number of Participants with Adverse Events as a Measure of Safety and Tolerability Measure Qualitative and quantitative assessment of the Immunogenicity Measure Qualitative and quantitative assessment of the Immunogenicity Measure Qualitative and quantitative assessment of the Immunogenicity
Time Frame within 2 days of the administration of the first dose (Day 0) Time Frame Day 30-Day 32: within 2 days of the administration of the second dose (Week 4) Time Frame Days 60-67 : within 7 days of the administration of the third dose (Week 8) Time Frame Day 90: three months after the first injection (Week 12) Time Frame Day 120: four months after the first injection (Week 16) Time Frame Day 150: five months after the first injection (Week 21) Time Frame The Day of first Sm14 vaccine administration (Day 0) Time Frame At the 30th day after the third Sm14 vaccine administration (Week 12) Time Frame At the 90th day after the third Sm14 vaccine administration (Week 21)
Description Local signs and symptoms included Pain, Swelling and Inflammation at the injection site, heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.

General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances.

Description Local signs and symptoms included Pain, Swelling and Inflammation at the injection site, Heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.

General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances.

Description Local signs and symptoms included Pain, Swelling and Inflammation at the injection site. Heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.

General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. Laboratory tests (blood count, liver and kidney biological functions).

Description Injection local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. Description Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection.

Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances.

Description Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection.

Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances.

Description Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 and vaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).

Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA).

Description Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 and vaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).

Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA).

Description Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 andvaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).

Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA).

Browse Conditions

Sequence: 193366325 Sequence: 193366326 Sequence: 193366327 Sequence: 193366328 Sequence: 193366329 Sequence: 193366330
Mesh Term Schistosomiasis Mesh Term Trematode Infections Mesh Term Helminthiasis Mesh Term Parasitic Diseases Mesh Term Infections Mesh Term Vector Borne Diseases
Downcase Mesh Term schistosomiasis Downcase Mesh Term trematode infections Downcase Mesh Term helminthiasis Downcase Mesh Term parasitic diseases Downcase Mesh Term infections Downcase Mesh Term vector borne diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290665 Sequence: 48290666 Sequence: 48290667 Sequence: 48290668
Agency Class OTHER Agency Class UNKNOWN Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Oswaldo Cruz Foundation Name Orygen Biotecnologia SA Name Biomedical Research Center EPLS Name Access to Advanced Health Institute (AAHI)

Overall Officials

Sequence: 29268506 Sequence: 29268507 Sequence: 29268508 Sequence: 29268509
Role Study Chair Role Principal Investigator Role Study Director Role Study Director
Name Miriam Tendler, MD, PhD Name Modou DIOP, MD Name Gilles RIVEAU, PharmD, PhD Name Anne-Marie SCHACHT, CRA
Affiliation Oswaldo Cruz Foundation Affiliation Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS) Affiliation Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS). Affiliation Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS).

Design Group Interventions

Sequence: 68107378 Sequence: 68107379 Sequence: 68107380 Sequence: 68107381
Design Group Id 55559287 Design Group Id 55559288 Design Group Id 55559287 Design Group Id 55559288
Intervention Id 52454850 Intervention Id 52454850 Intervention Id 52454851 Intervention Id 52454851

Eligibilities

Sequence: 30747692
Gender All
Minimum Age 8 Years
Maximum Age 11 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

School children, of public schools in villages of Saint Louis region (Senegal), female or male, 8 to 11 years old (inclusive) at the time of inclusion.
Residence in the area during the period of the study.
Free of obvious/severe health problems except schistosomiasis, as established by clinical examination.
Written informed consent to participate obtained from subject's parents or legal guardian.
Free of obvious/severe health problems except schistosomiasis, established by blood analysis, i.e. hematological exams, liver and renal function tests.
Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-2 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium
Children of Group 1: not infected, no schistosomiasis history and living in area/village free of Sm and Sh transmission.
Children Groups 2 & 3: infected with mansoni or/and haematobium schistosomiasis.

Exclusion Criteria:

School child who does not respond to one of the inclusion criteria
Child under 20kg of body weight
Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or planned use during the study period.
Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs.
Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease.
Knowledge of non-infectious chronic disease
Known acute disease.
Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254121779
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 6
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 8
Maximum Age Num 11
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 6
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30493975
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking None (Open Label)
Masking Description No masking

Intervention Other Names

Sequence: 26655388 Sequence: 26655389 Sequence: 26655390 Sequence: 26655391
Intervention Id 52454850 Intervention Id 52454851 Intervention Id 52454851 Intervention Id 52454851
Name rSm14 Name • Glucopyranosyl Lipid A in Stable Emulsion Name • Glucopyranosyl Lipid Adjuvant-Stable Emulsion Name • Toll-like Receptor 4 Agonist GLA-SE

Responsible Parties

Sequence: 28860255
Responsible Party Type Sponsor

Study References

Sequence: 52032531 Sequence: 52032532 Sequence: 52032533 Sequence: 52032534 Sequence: 52032535 Sequence: 52032536
Pmid 2022660 Pmid 19150418 Pmid 21298114 Pmid 26571311 Pmid 23284726 Pmid 30469320
Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result
Citation Moser D, Tendler M, Griffiths G, Klinkert MQ. A 14-kDa Schistosoma mansoni polypeptide is homologous to a gene family of fatty acid binding proteins. J Biol Chem. 1991 May 5;266(13):8447-54. Citation Ramos CR, Spisni A, Oyama S Jr, Sforca ML, Ramos HR, Vilar MM, Alves AC, Figueredo RC, Tendler M, Zanchin NI, Pertinhez TA, Ho PL. Stability improvement of the fatty acid binding protein Sm14 from S. mansoni by Cys replacement: structural and functional characterization of a vaccine candidate. Biochim Biophys Acta. 2009 Apr;1794(4):655-62. doi: 10.1016/j.bbapap.2008.12.010. Epub 2008 Dec 25. Citation Coler RN, Bertholet S, Moutaftsi M, Guderian JA, Windish HP, Baldwin SL, Laughlin EM, Duthie MS, Fox CB, Carter D, Friede M, Vedvick TS, Reed SG. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One. 2011 Jan 26;6(1):e16333. doi: 10.1371/journal.pone.0016333. Citation Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10. Citation Lambert SL, Yang CF, Liu Z, Sweetwood R, Zhao J, Cheng L, Jin H, Woo J. Molecular and cellular response profiles induced by the TLR4 agonist-based adjuvant Glucopyranosyl Lipid A. PLoS One. 2012;7(12):e51618. doi: 10.1371/journal.pone.0051618. Epub 2012 Dec 28. Citation Tendler M, Almeida MS, Vilar MM, Pinto PM, Limaverde-Sousa G. Current Status of the Sm14/GLA-SE Schistosomiasis Vaccine: Overcoming Barriers and Paradigms towards the First Anti-Parasitic Human(itarian) Vaccine. Trop Med Infect Dis. 2018 Nov 21;3(4):121. doi: 10.3390/tropicalmed3040121. Erratum In: Trop Med Infect Dis. 2019 Jan 19;4(1):

]]>

<![CDATA[ Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental ]]>
https://zephyrnet.com/NCT03799497
2013-06-07

https://zephyrnet.com/?p=NCT03799497
NCT03799497https://www.clinicaltrials.gov/study/NCT03799497?tab=tableNANANABody Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-09-16
Start Month Year June 7, 2013
Primary Completion Month Year June 7, 2020
Verification Month Year September 2020
Verification Date 2020-09-30
Last Update Posted Date 2020-09-16

Detailed Descriptions

Sequence: 20762935
Description Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network.

Facilities

Sequence: 200458210
Name CHRU,Hôpital Fontan 2
City Lille
Country France

Conditions

Sequence: 52277473
Name Anorexia Nervosa
Downcase Name anorexia nervosa

Id Information

Sequence: 40235475 Sequence: 40235476
Id Source org_study_id Id Source secondary_id
Id Value 2009_48 Id Value 2010-A00545-34
Id Type Other Identifier
Id Type Description ID-RCB number, ANSM

Countries

Sequence: 42653071
Name France
Removed False

Design Groups

Sequence: 55711604 Sequence: 55711605
Title Patients suffering from Anorexia Nervosa Title Control group
Description Subjects with a diagnostic of anorexia nervosa disorder Description Healthy subjects with no psychiatric disorder

Keywords

Sequence: 80018988 Sequence: 80018989 Sequence: 80018990
Name Anorexia nervosa Name functional MRI (fMRI) Name self body-shape recognition
Downcase Name anorexia nervosa Downcase Name functional mri (fmri) Downcase Name self body-shape recognition

Design Outcomes

Sequence: 177770721
Outcome Type primary
Measure Measure of the activation brain areas in self body-recognition network
Time Frame 15 days
Description Level of activation areas in the self body-recognition network measured during fMRI

Browse Conditions

Sequence: 193892826 Sequence: 193892827 Sequence: 193892828 Sequence: 193892829 Sequence: 193892830
Mesh Term Anorexia Mesh Term Anorexia Nervosa Mesh Term Signs and Symptoms, Digestive Mesh Term Feeding and Eating Disorders Mesh Term Mental Disorders
Downcase Mesh Term anorexia Downcase Mesh Term anorexia nervosa Downcase Mesh Term signs and symptoms, digestive Downcase Mesh Term feeding and eating disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48418656
Agency Class OTHER
Lead Or Collaborator lead
Name University Hospital, Lille

Overall Officials

Sequence: 29342626
Role Principal Investigator
Name Olivier Cottencin, MD, PhD
Affiliation University Hospital, Lille

Eligibilities

Sequence: 30827042
Sampling Method Non-Probability Sample
Gender Female
Minimum Age 15 Years
Maximum Age 45 Years
Healthy Volunteers Accepts Healthy Volunteers
Population Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched by age and study level
Criteria Inclusion Criteria:

Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
With medical insurance
With normal vision
Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder

Exclusion Criteria:

Pregnant or breast-feeding women
With antecedent or current neurologic disease
With antecedent or current ophthalmologic disease
Contraindication for IRMf

Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254123737
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 85
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 15
Maximum Age Num 45
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30572972
Observational Model Case-Control
Time Perspective Prospective

Responsible Parties

Sequence: 28939394
Responsible Party Type Sponsor

]]>

<![CDATA[ Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment ]]>
https://zephyrnet.com/NCT03799484
2019-01-04

https://zephyrnet.com/?p=NCT03799484
NCT03799484https://www.clinicaltrials.gov/study/NCT03799484?tab=tableNANANAThe purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.
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Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-06-18
Start Month Year January 4, 2019
Primary Completion Month Year June 14, 2019
Verification Month Year June 2020
Verification Date 2020-06-30
Last Update Posted Date 2020-06-18
Results First Posted Date 2020-06-18

Detailed Descriptions

Sequence: 20562940
Description This is a prospective, randomized, double-masked, comparative study in patients who present at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).

The objective of this study is to determine whether there is a difference in clinical effect (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 % prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum ointment on the other prior to BTX-A administration for the treatment of forehead rhytides.

Primary outcome variable is change of eyebrow excursion on each side of the forehead from baseline to each follow-up visit.

Secondary outcome variables

Duration of effect, defined as the elapsed time from injection to the end of botulinum, such that return of baseline frontalis function, i.e. within 2 mm of baseline value
Perception of pain immediately after injection at each side
Patient satisfaction for each side
Patient's perception of difference in efficacy

Facilities

Sequence: 198527942
Name Robert Cizik Eye Clinic
City Houston
State Texas
Zip 77030
Country United States

Browse Interventions

Sequence: 95244644 Sequence: 95244645 Sequence: 95244646 Sequence: 95244647 Sequence: 95244648 Sequence: 95244649 Sequence: 95244650 Sequence: 95244651 Sequence: 95244652 Sequence: 95244653 Sequence: 95244654 Sequence: 95244655 Sequence: 95244656 Sequence: 95244657 Sequence: 95244658 Sequence: 95244659 Sequence: 95244660 Sequence: 95244661 Sequence: 95244662 Sequence: 95244663 Sequence: 95244664 Sequence: 95244665 Sequence: 95244666
Mesh Term Lidocaine Mesh Term Prilocaine Mesh Term Petrolatum Mesh Term Botulinum Toxins Mesh Term Botulinum Toxins, Type A Mesh Term abobotulinumtoxinA Mesh Term Anesthetics, Local Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents Mesh Term Anti-Arrhythmia Agents Mesh Term Voltage-Gated Sodium Channel Blockers Mesh Term Sodium Channel Blockers Mesh Term Membrane Transport Modulators Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Acetylcholine Release Inhibitors Mesh Term Cholinergic Agents Mesh Term Neurotransmitter Agents Mesh Term Neuromuscular Agents Mesh Term Emollients Mesh Term Dermatologic Agents
Downcase Mesh Term lidocaine Downcase Mesh Term prilocaine Downcase Mesh Term petrolatum Downcase Mesh Term botulinum toxins Downcase Mesh Term botulinum toxins, type a Downcase Mesh Term abobotulinumtoxina Downcase Mesh Term anesthetics, local Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term anti-arrhythmia agents Downcase Mesh Term voltage-gated sodium channel blockers Downcase Mesh Term sodium channel blockers Downcase Mesh Term membrane transport modulators Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term acetylcholine release inhibitors Downcase Mesh Term cholinergic agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term neuromuscular agents Downcase Mesh Term emollients Downcase Mesh Term dermatologic agents
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51763013 Sequence: 51763014
Name Forehead Rhytides Name Forehead Wrinkles
Downcase Name forehead rhytides Downcase Name forehead wrinkles

Id Information

Sequence: 39832114
Id Source org_study_id
Id Value HSC-MS-18-0908

Countries

Sequence: 42231927
Name United States
Removed False

Design Groups

Sequence: 55184009 Sequence: 55184010
Group Type Other Group Type Other
Title Topical Anesthesia Title Petrolatum
Description 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection Description Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection

Interventions

Sequence: 52084252 Sequence: 52084253 Sequence: 52084254
Intervention Type Drug Intervention Type Drug Intervention Type Device
Name Botulinum toxin type A Name 2.5% lidocaine/2.5% prilocaine Name petrolatum ointment
Description Botulinum toxin type A will be administered to both sides Description 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead Description petrolatum ointment will be applied to one side of the forehead

Keywords

Sequence: 79195454 Sequence: 79195455
Name Rhytides Name Forehead Wrinkles
Downcase Name rhytides Downcase Name forehead wrinkles

Design Outcomes

Sequence: 176065007 Sequence: 176064999 Sequence: 176065000 Sequence: 176065001 Sequence: 176065002 Sequence: 176065003 Sequence: 176065004 Sequence: 176065005 Sequence: 176065006 Sequence: 176065008 Sequence: 176065009 Sequence: 176065010 Sequence: 176065011 Sequence: 176065012 Sequence: 176065013 Sequence: 176065014 Sequence: 176065015 Sequence: 176065016
Outcome Type secondary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Measure Eyebrow Excursion Measure Eyebrow Excursion Measure Eyebrow Excursion Measure Eyebrow Excursion Measure Duration of Botulinum Toxin Type A Effect Measure Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale Measure Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Measure Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Measure Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Measure Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Measure Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Measure Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Measure Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Measure Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Measure Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face Measure Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face Measure Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
Time Frame Week 16 Time Frame Baseline Time Frame Week 2 Time Frame Week 6 Time Frame week 16 Time Frame week 16 Time Frame Immediately after botox injection Time Frame Week 2 Time Frame Week 6 Time Frame Week 2 Time Frame Week 6 Time Frame Week 16 Time Frame Week 2 Time Frame Week 6 Time Frame Week 16 Time Frame Week 2 Time Frame Week 6 Time Frame Week 16
Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. Description A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face.

Sponsors

Sequence: 47939525 Sequence: 47939526
Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name The University of Texas Health Science Center, Houston Name Robert Cizik Eye Clinic

Overall Officials

Sequence: 29045814
Role Principal Investigator
Name Karina Richani-Reverol, MD
Affiliation The University of Texas Health Science Center, Houston

Design Group Interventions

Sequence: 67654565 Sequence: 67654566 Sequence: 67654567 Sequence: 67654568
Design Group Id 55184010 Design Group Id 55184009 Design Group Id 55184009 Design Group Id 55184010
Intervention Id 52084252 Intervention Id 52084252 Intervention Id 52084253 Intervention Id 52084254

Eligibilities

Sequence: 30526478
Gender All
Minimum Age 18 Years
Maximum Age 65 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

18 to 65 years of age
Presence of horizontal forehead rhytides
Good eyebrow excursion (greater than or equal to 5 mm)
Able to understand and sign an informed consent form that has been approved by the Committee for the Protection of Human Subjects

Exclusion Criteria:

Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months
Known allergy to botulinum toxin
Known history of sensitivity to local anesthetics of the amide type
Existing disorder of neuromuscular transmission
Usage of medication with effect on neuromuscular function
Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile), who are pregnant or nursing or intend to become pregnant during the time of the study
Significant brow asymmetry (> 5mm)
Unable to follow-up for the duration of the study (16 weeks)

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254093111
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 5
Were Results Reported True
Months To Report Results 11
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 4
Number Of Secondary Outcomes To Measure 14

Designs

Sequence: 30275385
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Double
Masking Description Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.
Subject Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26476003 Sequence: 26476004 Sequence: 26476005
Intervention Id 52084252 Intervention Id 52084253 Intervention Id 52084254
Name BTX-A Name EMLA Name Aquaphor

Milestones

Sequence: 40753554 Sequence: 40753555 Sequence: 40753556
Result Group Id 55825946 Result Group Id 55825946 Result Group Id 55825946
Ctgov Group Code FG000 Ctgov Group Code FG000 Ctgov Group Code FG000
Title STARTED Title COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study
Count 14 Count 14 Count 0

Participant Flows

Sequence: 3897729

Outcome Counts

Sequence: 73515605 Sequence: 73515606 Sequence: 73515607 Sequence: 73515608 Sequence: 73515609 Sequence: 73515610 Sequence: 73515611 Sequence: 73515612 Sequence: 73515613 Sequence: 73515614 Sequence: 73515615 Sequence: 73515616 Sequence: 73515617 Sequence: 73515618 Sequence: 73515619 Sequence: 73515620 Sequence: 73515621 Sequence: 73515622 Sequence: 73515623 Sequence: 73515624 Sequence: 73515625 Sequence: 73515626 Sequence: 73515627 Sequence: 73515628 Sequence: 73515629 Sequence: 73515630 Sequence: 73515631 Sequence: 73515632 Sequence: 73515633 Sequence: 73515634 Sequence: 73515635 Sequence: 73515636 Sequence: 73515637 Sequence: 73515638 Sequence: 73515639 Sequence: 73515640
Outcome Id 30603527 Outcome Id 30603527 Outcome Id 30603527 Outcome Id 30603527 Outcome Id 30603528 Outcome Id 30603528 Outcome Id 30603528 Outcome Id 30603528 Outcome Id 30603529 Outcome Id 30603529 Outcome Id 30603529 Outcome Id 30603529 Outcome Id 30603530 Outcome Id 30603530 Outcome Id 30603530 Outcome Id 30603530 Outcome Id 30603531 Outcome Id 30603531 Outcome Id 30603531 Outcome Id 30603531 Outcome Id 30603532 Outcome Id 30603532 Outcome Id 30603532 Outcome Id 30603532 Outcome Id 30603533 Outcome Id 30603534 Outcome Id 30603535 Outcome Id 30603536 Outcome Id 30603537 Outcome Id 30603538 Outcome Id 30603539 Outcome Id 30603540 Outcome Id 30603541 Outcome Id 30603542 Outcome Id 30603543 Outcome Id 30603544
Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units side of forehead (either left or right) Units side of forehead (either left or right) Units Participants Units Participants Units side of forehead (either left or right) Units side of forehead (either left or right) Units Participants Units Participants Units side of forehead (either left or right) Units side of forehead (either left or right) Units Participants Units Participants Units side of forehead (either left or right) Units side of forehead (either left or right) Units Participants Units Participants Units side of forehead (either left or right) Units side of forehead (either left or right) Units Participants Units Participants Units side of forehead (either left or right) Units side of forehead (either left or right) Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14 Count 14

Provided Documents

Sequence: 2565770
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2018-11-30
Url https://ClinicalTrials.gov/ProvidedDocs/84/NCT03799484/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27770422 Sequence: 27770423 Sequence: 27770424 Sequence: 27770425 Sequence: 27770426 Sequence: 27770427
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0
Subjects At Risk 14 Subjects At Risk 14 Subjects At Risk 14 Subjects At Risk 14 Subjects At Risk 14 Subjects At Risk 14
Created At 2023-08-06 14:23:58.045603 Created At 2023-08-06 14:23:58.045603 Created At 2023-08-06 14:23:58.045603 Created At 2023-08-06 14:23:58.045603 Created At 2023-08-06 14:23:58.045603 Created At 2023-08-06 14:23:58.045603
Updated At 2023-08-06 14:23:58.045603 Updated At 2023-08-06 14:23:58.045603 Updated At 2023-08-06 14:23:58.045603 Updated At 2023-08-06 14:23:58.045603 Updated At 2023-08-06 14:23:58.045603 Updated At 2023-08-06 14:23:58.045603

Responsible Parties

Sequence: 28655291
Responsible Party Type Principal Investigator
Name Karina Richani-Reverol
Title Clinical Assistant Professor
Affiliation The University of Texas Health Science Center, Houston

Result Agreements

Sequence: 3828473
Pi Employee Yes

Result Contacts

Sequence: 3828438
Organization The University of Texas Health Science Center at Houston
Name Karina Richani-Reverol, MD
Phone (713) 559-5200
Email Karina.RichaniReverol@uth.tmc.edu

Outcomes

Sequence: 30603528 Sequence: 30603527 Sequence: 30603529 Sequence: 30603530 Sequence: 30603531 Sequence: 30603532 Sequence: 30603533 Sequence: 30603534 Sequence: 30603535 Sequence: 30603536 Sequence: 30603537 Sequence: 30603538 Sequence: 30603539 Sequence: 30603540 Sequence: 30603541 Sequence: 30603542 Sequence: 30603543 Sequence: 30603544
Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Duration of Botulinum Toxin Type A Effect Title Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face Title Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face Title Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. Description A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face.
Time Frame Week 2 Time Frame Baseline Time Frame Week 6 Time Frame week 16 Time Frame week 16 Time Frame Immediately after botox injection Time Frame Week 2 Time Frame Week 6 Time Frame Week 16 Time Frame Week 2 Time Frame Week 6 Time Frame Week 16 Time Frame Week 2 Time Frame Week 6 Time Frame Week 16 Time Frame Week 2 Time Frame Week 6 Time Frame Week 16
Units millimeters Units millimeters Units millimeters Units millimeters Units weeks Units units on a scale Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Units Analyzed side of forehead (either left or right) Units Analyzed side of forehead (either left or right) Units Analyzed side of forehead (either left or right) Units Analyzed side of forehead (either left or right) Units Analyzed side of forehead (either left or right) Units Analyzed side of forehead (either left or right)
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Error Dispersion Type Standard Deviation
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants

Outcome Measurements

Sequence: 234047580 Sequence: 234047581 Sequence: 234047582 Sequence: 234047583 Sequence: 234047584 Sequence: 234047585 Sequence: 234047586 Sequence: 234047587 Sequence: 234047588 Sequence: 234047589 Sequence: 234047590 Sequence: 234047591 Sequence: 234047592 Sequence: 234047593 Sequence: 234047594 Sequence: 234047595 Sequence: 234047596 Sequence: 234047597 Sequence: 234047598 Sequence: 234047599 Sequence: 234047600 Sequence: 234047601 Sequence: 234047602 Sequence: 234047603 Sequence: 234047604 Sequence: 234047605 Sequence: 234047606 Sequence: 234047607 Sequence: 234047608 Sequence: 234047609 Sequence: 234047610 Sequence: 234047611 Sequence: 234047612 Sequence: 234047613 Sequence: 234047614 Sequence: 234047615 Sequence: 234047616 Sequence: 234047617 Sequence: 234047618 Sequence: 234047619 Sequence: 234047620 Sequence: 234047621 Sequence: 234047622 Sequence: 234047623 Sequence: 234047624 Sequence: 234047625 Sequence: 234047626 Sequence: 234047627 Sequence: 234047628 Sequence: 234047629 Sequence: 234047630 Sequence: 234047631 Sequence: 234047632 Sequence: 234047633 Sequence: 234047634 Sequence: 234047635 Sequence: 234047636 Sequence: 234047637 Sequence: 234047638 Sequence: 234047639
Outcome Id 30603527 Outcome Id 30603527 Outcome Id 30603528 Outcome Id 30603528 Outcome Id 30603529 Outcome Id 30603529 Outcome Id 30603530 Outcome Id 30603530 Outcome Id 30603531 Outcome Id 30603531 Outcome Id 30603532 Outcome Id 30603532 Outcome Id 30603533 Outcome Id 30603533 Outcome Id 30603533 Outcome Id 30603533 Outcome Id 30603533 Outcome Id 30603534 Outcome Id 30603534 Outcome Id 30603534 Outcome Id 30603534 Outcome Id 30603534 Outcome Id 30603535 Outcome Id 30603535 Outcome Id 30603535 Outcome Id 30603535 Outcome Id 30603535 Outcome Id 30603536 Outcome Id 30603536 Outcome Id 30603536 Outcome Id 30603536 Outcome Id 30603536 Outcome Id 30603537 Outcome Id 30603537 Outcome Id 30603537 Outcome Id 30603537 Outcome Id 30603537 Outcome Id 30603538 Outcome Id 30603538 Outcome Id 30603538 Outcome Id 30603538 Outcome Id 30603538 Outcome Id 30603539 Outcome Id 30603539 Outcome Id 30603539 Outcome Id 30603539 Outcome Id 30603539 Outcome Id 30603540 Outcome Id 30603540 Outcome Id 30603540 Outcome Id 30603540 Outcome Id 30603540 Outcome Id 30603541 Outcome Id 30603541 Outcome Id 30603541 Outcome Id 30603541 Outcome Id 30603541 Outcome Id 30603542 Outcome Id 30603543 Outcome Id 30603544
Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825947 Result Group Id 55825948 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949 Result Group Id 55825949
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied Category very satisfied Category satisfied Category neutral Category dissatisfied Category very dissatisfied
Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Eyebrow Excursion Title Duration of Botulinum Toxin Type A Effect Title Duration of Botulinum Toxin Type A Effect Title Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale Title Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey Title Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face Title Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face Title Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. Description Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. Description Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. Description A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. Description A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face. Description Participants will be asked if there is a noticeable difference between the 2 sides of their face.
Units millimeters Units millimeters Units millimeters Units millimeters Units millimeters Units millimeters Units millimeters Units millimeters Units weeks Units weeks Units units on a scale Units units on a scale Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 10.57 Param Value 10.57 Param Value 3.46 Param Value 3.43 Param Value 5.96 Param Value 5.68 Param Value 8.21 Param Value 8.07 Param Value 14.2857 Param Value 15.2857 Param Value 2.43 Param Value 3.96 Param Value 8 Param Value 6 Param Value 0 Param Value 0 Param Value 0 Param Value 7 Param Value 6 Param Value 1 Param Value 0 Param Value 0 Param Value 8 Param Value 2 Param Value 1 Param Value 3 Param Value 0 Param Value 8 Param Value 6 Param Value 0 Param Value 0 Param Value 0 Param Value 7 Param Value 5 Param Value 2 Param Value 0 Param Value 0 Param Value 8 Param Value 2 Param Value 1 Param Value 3 Param Value 0 Param Value 8 Param Value 6 Param Value 0 Param Value 0 Param Value 0 Param Value 6 Param Value 7 Param Value 1 Param Value 0 Param Value 0 Param Value 8 Param Value 2 Param Value 1 Param Value 3 Param Value 0 Param Value 3 Param Value 2 Param Value 0
Param Value Num 10.57 Param Value Num 10.57 Param Value Num 3.46 Param Value Num 3.43 Param Value Num 5.96 Param Value Num 5.68 Param Value Num 8.21 Param Value Num 8.07 Param Value Num 14.2857 Param Value Num 15.2857 Param Value Num 2.43 Param Value Num 3.96 Param Value Num 8.0 Param Value Num 6.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 7.0 Param Value Num 6.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 8.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 3.0 Param Value Num 0.0 Param Value Num 8.0 Param Value Num 6.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 7.0 Param Value Num 5.0 Param Value Num 2.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 8.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 3.0 Param Value Num 0.0 Param Value Num 8.0 Param Value Num 6.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 6.0 Param Value Num 7.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 8.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 3.0 Param Value Num 0.0 Param Value Num 3.0 Param Value Num 2.0 Param Value Num 0.0
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 3.3 Dispersion Value 3.16 Dispersion Value 2.76 Dispersion Value 2.93 Dispersion Value 2.62 Dispersion Value 2.55 Dispersion Value 2.89 Dispersion Value 2.97 Dispersion Value 1.2317 Dispersion Value 0.7301 Dispersion Value 1.55 Dispersion Value 1.74
Dispersion Value Num 3.3 Dispersion Value Num 3.16 Dispersion Value Num 2.76 Dispersion Value Num 2.93 Dispersion Value Num 2.62 Dispersion Value Num 2.55 Dispersion Value Num 2.89 Dispersion Value Num 2.97 Dispersion Value Num 1.2317 Dispersion Value Num 0.7301 Dispersion Value Num 1.55 Dispersion Value Num 1.74

Study References

Sequence: 51655904 Sequence: 51655905 Sequence: 51655906 Sequence: 51655907 Sequence: 51655908 Sequence: 51655909 Sequence: 51655910 Sequence: 51655911 Sequence: 51655912 Sequence: 51655913 Sequence: 51655914 Sequence: 51655915 Sequence: 51655916 Sequence: 51655917 Sequence: 51655918 Sequence: 51655919
Pmid 7365644 Pmid 9834738 Pmid 9279643 Pmid 15598005 Pmid 7824641 Pmid 2748749 Pmid 17117100 Pmid 24699554 Pmid 29016544 Pmid 27617615 Pmid 21120257 Pmid 19454924 Pmid 25705950 Pmid 15507786 Pmid 17376126 Pmid 15710113
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. J Pediatr Ophthalmol Strabismus. 1980 Jan-Feb;17(1):21-5. doi: 10.3928/0191-3913-19800101-06. Citation Carruthers A, Carruthers J. Clinical indications and injection technique for the cosmetic use of botulinum A exotoxin. Dermatol Surg. 1998 Nov;24(11):1189-94. doi: 10.1111/j.1524-4725.1998.tb04097.x. Citation Carter SR, Seiff SR. Cosmetic botulinum toxin injections. Int Ophthalmol Clin. 1997 Summer;37(3):69-79. doi: 10.1097/00004397-199703730-00006. No abstract available. Citation Charles PD. Botulinum neurotoxin serotype A: a clinical update on non-cosmetic uses. Am J Health Syst Pharm. 2004 Nov 15;61(22 Suppl 6):S11-23. doi: 10.1093/ajhp/61.suppl_6.S11. Citation Carruthers A, Carruthers J. Aesthetic indications for botulinum toxin injections. Plast Reconstr Surg. 1995 Feb;95(2):427-8. doi: 10.1097/00006534-199502000-00049. No abstract available. Citation Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg. 1989 Aug;84(2):353-5. Citation Sami MS, Soparkar CN, Patrinely JR, Hollier LM, Hollier LH. Efficacy of botulinum toxin type a after topical anesthesia. Ophthalmic Plast Reconstr Surg. 2006 Nov-Dec;22(6):448-52. doi: 10.1097/01.iop.0000248989.33572.3c. Citation Gordin EA, Luginbuhl AL, Ortlip T, Heffelfinger RN, Krein H. Subcutaneous vs intramuscular botulinum toxin: split-face randomized study. JAMA Facial Plast Surg. 2014 May-Jun;16(3):193-8. doi: 10.1001/jamafacial.2013.2458. Citation Li Y, Dong W, Wang M, Xu N. Investigation of the Efficacy and Safety of Topical Vibration Anesthesia to Reduce Pain From Cosmetic Botulinum Toxin A Injections in Chinese Patients: A Multicenter, Randomized, Self-Controlled Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S329-S335. doi: 10.1097/DSS.0000000000001349. Citation Shi LL, Sargen MR, Chen SC, Arbiser JL, Pollack BP. Effective local anesthesia for onabotulinumtoxin A injections to treat hyperhidrosis associated with traumatic amputation. Dermatol Online J. 2016 Jun 15;22(6):13030/qt38b203d0. Citation Baumann LS, Grunebaum L, Elsaie ML, Murdock J, Jablonka E, Figueras K, Bell M. Safety and efficacy of a rapid-acting topical 4% lidocaine gel in a unique drug delivery system. J Drugs Dermatol. 2010 Dec;9(12):1500-4. Citation Weiss RA, Lavin PT. Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. Ophthalmic Plast Reconstr Surg. 2009 May-Jun;25(3):173-7. doi: 10.1097/IOP.0b013e3181a145ca. Citation Alam M, Bolotin D, Carruthers J, Hexsel D, Lawrence N, Minkis K, Ross EV. Consensus statement regarding storage and reuse of previously reconstituted neuromodulators. Dermatol Surg. 2015 Mar;41(3):321-6. doi: 10.1097/DSS.0000000000000303. Citation Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3. Citation Ito H, Ito H, Nakano S, Kusaka H. Low-dose subcutaneous injection of botulinum toxin type A for facial synkinesis and hyperlacrimation. Acta Neurol Scand. 2007 Apr;115(4):271-4. doi: 10.1111/j.1600-0404.2006.00746.x. Citation Tzou CH, Giovanoli P, Ploner M, Frey M. Are there ethnic differences of facial movements between Europeans and Asians? Br J Plast Surg. 2005 Mar;58(2):183-95. doi: 10.1016/j.bjps.2004.10.014.

Baseline Counts

Sequence: 11314641
Result Group Id 55825945
Ctgov Group Code BG000
Units Participants
Scope overall
Count 14

Result Groups

Sequence: 55825945 Sequence: 55825946 Sequence: 55825947 Sequence: 55825948 Sequence: 55825949 Sequence: 55825950 Sequence: 55825951
Ctgov Group Code BG000 Ctgov Group Code FG000 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title All Participants Title All Participants Title Topical Anesthesia Title Petrolatum Title All Participants Title Topical Anesthesia Title Petrolatum
Description 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. Description 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. Description 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection

Botulinum toxin type A: Botulinum toxin type A will be administered to both sides

2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead

Description Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection

Botulinum toxin type A: Botulinum toxin type A will be administered to both sides

petrolatum ointment: petrolatum ointment will be applied to one side of the forehead

Description 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. Description 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection

Botulinum toxin type A: Botulinum toxin type A will be administered to both sides

2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead

Description Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection

Botulinum toxin type A: Botulinum toxin type A will be administered to both sides

petrolatum ointment: petrolatum ointment will be applied to one side of the forehead

Baseline Measurements

Sequence: 124852627 Sequence: 124852628 Sequence: 124852629 Sequence: 124852630 Sequence: 124852631 Sequence: 124852632 Sequence: 124852633 Sequence: 124852634
Result Group Id 55825945 Result Group Id 55825945 Result Group Id 55825945 Result Group Id 55825945 Result Group Id 55825945 Result Group Id 55825945 Result Group Id 55825945 Result Group Id 55825945
Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000
Classification Asian Classification Hispanic Classification White Classification United States
Category Female Category Male
Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Region of Enrollment Title Distance between both lateral canthi
Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units millimeters
Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean
Param Value 35.5 Param Value 9 Param Value 5 Param Value 1 Param Value 6 Param Value 7 Param Value 14 Param Value 98.29
Param Value Num 35.5 Param Value Num 9.0 Param Value Num 5.0 Param Value Num 1.0 Param Value Num 6.0 Param Value Num 7.0 Param Value Num 14.0 Param Value Num 98.29
Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 6.7 Dispersion Value 3.43
Dispersion Value Num 6.7 Dispersion Value Num 3.43
Number Analyzed 14 Number Analyzed 14 Number Analyzed 14 Number Analyzed 14 Number Analyzed 14 Number Analyzed 14 Number Analyzed 14 Number Analyzed 14

]]>

<![CDATA[ Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease ]]>
https://zephyrnet.com/NCT03799471
2019-02-26

https://zephyrnet.com/?p=NCT03799471
NCT03799471https://www.clinicaltrials.gov/study/NCT03799471?tab=tableNANANAThis study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (IBD) and experiences of ongoing musculoskeletal (MSK) pain. Previous results and current literature suggest that MSK pain in IBD may be influenced by hypersensitivity of the central nervous system, termed central sensitization. However, specific mechanisms contributing to pain experiences are unknown. Therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and IBD features to sensory profiles. This study hypothesizes that IBD patients with MSK pain will demonstrate altered sensory function, and IBD/psychosocial features will be associated with altered sensory functioning and worse pain experiences.
<![CDATA[

Studies

Study First Submitted Date 2019-01-06
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-08-28
Start Month Year February 26, 2019
Primary Completion Month Year July 19, 2019
Verification Month Year August 2019
Verification Date 2019-08-31
Last Update Posted Date 2019-08-28

Facilities

Sequence: 200594632
Name Dartmouth-Hitchcock Medical Center
City Lebanon
State New Hampshire
Zip 03756-0001
Country United States

Conditions

Sequence: 52321373 Sequence: 52321374 Sequence: 52321375
Name Inflammatory Bowel Diseases Name Chronic Pain Name Central Sensitization
Downcase Name inflammatory bowel diseases Downcase Name chronic pain Downcase Name central sensitization

Id Information

Sequence: 40266105
Id Source org_study_id
Id Value W19040

Countries

Sequence: 42685623
Name United States
Removed False

Design Groups

Sequence: 55760298 Sequence: 55760299 Sequence: 55760300
Title IBD with MSK pain Title IBD without MSK pain Title Healthy Controls
Description IBD patients with self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, MSK pain features, co-morbidity, and IBD features Description IBD patients without self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, co-morbidity, and IBD features Description Healthy controls. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, and co-morbidity.

Keywords

Sequence: 80075943 Sequence: 80075944
Name chronic musculoskeletal pain Name central hypersensitivity
Downcase Name chronic musculoskeletal pain Downcase Name central hypersensitivity

Design Outcomes

Sequence: 177934246 Sequence: 177934247 Sequence: 177934248 Sequence: 177934249 Sequence: 177934250 Sequence: 177934251 Sequence: 177934252 Sequence: 177934253 Sequence: 177934254 Sequence: 177934255 Sequence: 177934256 Sequence: 177934257 Sequence: 177934258 Sequence: 177934259 Sequence: 177934260 Sequence: 177934261 Sequence: 177934262 Sequence: 177934263 Sequence: 177934264 Sequence: 177934265
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other
Measure Pain pressure threshold (PPT) Measure Conditioned pain modulation (CPM) Measure Temporal summation (TS) Measure Central sensitization inventory (CSI) Measure Abdominal pain: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a short form Measure Abdominal pain intensity: numeric rating scale Measure Health-related quality of life (HRQOL) – EQ-5D Measure Situational Catastrophizing Questionnaire (SCQ) Measure Positive and Negative Affective Schedule (PANAS) Measure 10-item Perceived Stress Scale (PSS-10) Measure Hospital Anxiety and Depression Scale (HADS) Measure Total comorbidity score Measure MSK pain location Measure MSK pain – PROMIS Pain Interference 4a Measure MSK pain intensity – numeric rating scale Measure Health-related quality of life (EQ-5D) Measure IBD type Measure IBD duration Measure Vibration detection threshold (VDT) Measure Semmes-Weinstein monofilament examination (SWME)
Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline Time Frame Baseline
Description PPT will be assessed using an electronic handheld algometer (Wagner Force One™ FDIX) in: 1) low back (local), and 2) contralateral tibialis anterior. Individuals in "IBD with MSK pain" group will undergo an additional PPT assessment related to the region identified as their "main" area of MSK pain.

PPT will be assessed by a series of 3 ascending stimulus intensities given as a slowly increasing ramp (50 kilopascal (kPa/s)) from 0 to a maximum pressure of 1000 kPa. Pressure corresponding to the moment when participants identify that the sensation of pressure alone changing to one of pressure and pain, will be recorded for each trial. PPT for each region will be described as the mean of three trials in kPa. Decreased values indicates hypersensitivity of the nervous system.

Description CPM in the present study includes: PPT of tibialis anterior (test stimulus) and cold pressor test (CPT) to the contralateral hand (conditioning stimulus).

PPT will be performed and recorded as descried above prior to and immediately following CPT.

CPT: Hand will be submerged in an ice bath with the temperature maintained below 3°C for a maximum of 2 minutes. Participants will withdraw their hand when the pain perceived becomes intolerable or 2 minute maximum is reached. Participants will give a numeric pain rating (0-100) at the time of hand removal. Total immersion time (minutes:seconds) and pain rating will be recorded for CPT.

CPM (primary outcome) will be defined as the absolute numerical difference of PPT after minus before the CPT, with positive values indicating successful pain modulation.

Description Mechanical TS in the present study will be assessed by a wind-up-ratio (WUR) of the volar aspect of the non-dominant arm using a Semmes-Weinstein monofilament (no. 6.45). The perceived intensity of a single stimulus will be compared with that of a series of 10 repetitive stimuli of the same physical intensity. Participants will be asked to give a pain rating for the single stimulus and a pain rating for the series of 10 stimuli as a whole, using a '0-100' numerical rating scale. This procedure will be repeated for three trials, with 1 minute between trials, and performed at different areas of the volar forearm for each trial. The mean pain rating of the 10 series divided by the mean pain rating of the single stimuli will be calculated as WUR. Higher scores indicate greater mechanical TS, indicating an increase in central sensitivity or facilitation. Description CSI is a self-report questionnaire indicating the presence of symptoms related to central sensitization syndromes. CSI consists of 25 statements where each statement is evaluated using a 5 point like scale with Never (0), Rarely (1), Sometimes (2), Often (3), and Always (4). This results in a cumulative score of 100. Scores equal to or greater than 40 indicate the likelihood of central sensitization. Description Positive findings for abdominal pain interference, include: mild (50-59), moderate (60-69), or severe (≥70). Description Numeric rating scales recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10). Description The EQ-5D questionnaire descriptive system comprises five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each one with five possible levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5); as well as a visual analogue scale ranging from 0 to 100 with higher scores indicating 'best health'. Description SCQ asks participants to reflect on any pain experienced during CPM testing, and to indicate the degree to which they experienced each of 13 thoughts or feelings during this experience, on 5-point Likert scales ranging from (0) not at all to (4) all the time. Total scores range from 0 to 24, with higher score representing greater pain catastrophizing. Description This questionnaire includes words describing 10 positive and 10 negative emotions, and requires participants to indicate on a Likert scale (1-5) the extent for which they felt each emotion during the previous week, with higher sub-scores represent greater negative or positive affect styles, respectively. Description The PSS-10 evaluates the degree to which individuals believe their life has been unpredictable, uncontrollable, and overloaded during the previous month, using a Likert scale (0-4) for each item, with higher scores representing greater perceived stress. Description Scores for each subscale range from 0 to 21, with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. Description Total comorbidity scores will be calculated as numerical disease counts using health conditions identified on the Self-Administered Comorbidity Questionnaire, a 20-item extraintestinal manifestation (EIM) checklist developed from multiple EIM investigations, and conditions identified on the central sensitization inventory (CSI) (part B). Scores range from 0 to 39 with higher scores indicating greater comorbidity. Description Pain location will be recorded regionally (n=47) using a body diagram. Individuals with generalized pain will be categorically (yes/no) distinguished from those with regional pain using the modified widespread pain criterion which requires having pain in 4 out of 5 pain regions (4 quadrants plus axial pain). Description Positive findings for the PROMIS Pain Interference 4a, include: mild (50-59), moderate (60-69), or severe (≥70). Description Numeric rating scales for pain intensity will be recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10) Description EQ-5D is a standardized instrument for measuring of health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each scored on a 5-point Likert scales ranging from (0) no problem to (4) severe. The EQ VAS records the patient's self-rated health on a 0 to 100 vertical visual analogue scale, with higher scores representing better health-related quality of life. Description IBD subtype recorded from medical charts as Crohn's disease, ulcerative colitis, or unspecified IBD. Description Time from initial IBD diagnosis – recorded from medical charts in years. Description VDT will be assessed using a Rydel-Seiffer graded tuning fork (64 Hz, 8/8 scale) placed over bony prominences (styloid process of the ulna and medial malleolus), bilaterally. Participants will verbally indicate the moment they can no longer feel the sensation of vibration, and the value (1-8) will be recorded. VDT of each site will be described as the mean of three trials. Lower scores indicate decreased thresholds and possible peripheral neuropathy. Description SWME of the upper limb will be performed using a 4.56 (4 g) monofilament at six locations divided over the palm and fingers, bilaterally. SWME of the lower limb will be performed using a 5.07 (10 g) monofilament at the pulp of the great toe, as well as the first, third, and fifth metatarsal heads, bilaterally. Participants will confirm (recorded as yes/no) application of the stimulus at each location. Incorrect response at any location indicates possible peripheral neuropathy.

Browse Conditions

Sequence: 194058662 Sequence: 194058663 Sequence: 194058664 Sequence: 194058665 Sequence: 194058666 Sequence: 194058670 Sequence: 194058671 Sequence: 194058672 Sequence: 194058667 Sequence: 194058668 Sequence: 194058669
Mesh Term Musculoskeletal Pain Mesh Term Intestinal Diseases Mesh Term Inflammatory Bowel Diseases Mesh Term Chronic Pain Mesh Term Pain Mesh Term Gastroenteritis Mesh Term Muscular Diseases Mesh Term Musculoskeletal Diseases Mesh Term Neurologic Manifestations Mesh Term Gastrointestinal Diseases Mesh Term Digestive System Diseases
Downcase Mesh Term musculoskeletal pain Downcase Mesh Term intestinal diseases Downcase Mesh Term inflammatory bowel diseases Downcase Mesh Term chronic pain Downcase Mesh Term pain Downcase Mesh Term gastroenteritis Downcase Mesh Term muscular diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term neurologic manifestations Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term digestive system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48459975 Sequence: 48459976
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Dartmouth-Hitchcock Medical Center Name University of Otago

Overall Officials

Sequence: 29365316
Role Principal Investigator
Name Corey A Siegel, MD
Affiliation Dartmouth-Hitchcock Medical Center

Eligibilities

Sequence: 30852310
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Population Dartmouth-Hitchcock Medical Center – IBD Center patient database.
Criteria Inclusion Criteria:

Adults (18 years of age or older)
Clinical diagnosis of IBD or healthy control

Exclusion Criteria: Participants with IBD (with and without MSK pain) will be excluded if they report any of the following:

pregnancy
current history of drug or alcohol abuse
any condition resulting in altered sensation such as: nerve injuries, neurological conditions (e.g. stroke, multiple sclerosis, and Parkinson's disease)
surgery within the last 3 months

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254271951
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 4
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 15
Number Of Other Outcomes To Measure 2

Designs

Sequence: 30598162
Observational Model Case-Control
Time Perspective Cross-Sectional

Responsible Parties

Sequence: 28964651
Responsible Party Type Principal Investigator
Name Corey Siegel
Title Section Chief, Gastroenterology and Hepatology
Affiliation Dartmouth-Hitchcock Medical Center

Study References

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Positive emotional style predicts resistance to illness after experimental exposure to rhinovirus or influenza a virus. Psychosom Med. 2006 Nov-Dec;68(6):809-15. doi: 10.1097/01.psy.0000245867.92364.3c. Epub 2006 Nov 13. Citation Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. Citation Edwards RR, Smith MT, Stonerock G, Haythornthwaite JA. Pain-related catastrophizing in healthy women is associated with greater temporal summation of and reduced habituation to thermal pain. Clin J Pain. 2006 Oct;22(8):730-7. doi: 10.1097/01.ajp.0000210914.72794.bc. Citation Buchholz I, Janssen MF, Kohlmann T, Feng YS. A Systematic Review of Studies Comparing the Measurement Properties of the Three-Level and Five-Level Versions of the EQ-5D. Pharmacoeconomics. 2018 Jun;36(6):645-661. doi: 10.1007/s40273-018-0642-5. Citation Schoepfer AM, Vavricka S, Zahnd-Straumann N, Straumann A, Beglinger C. Monitoring inflammatory bowel disease activity: clinical activity is judged to be more relevant than endoscopic severity or biomarkers. J Crohns Colitis. 2012 May;6(4):412-8. doi: 10.1016/j.crohns.2011.09.008. Epub 2011 Oct 14. Citation Siegel CA, Whitman CB, Spiegel BMR, Feagan B, Sands B, Loftus EV Jr, Panaccione R, D'Haens G, Bernstein CN, Gearry R, Ng SC, Mantzaris GJ, Sartor B, Silverberg MS, Riddell R, Koutroubakis IE, O'Morain C, Lakatos PL, McGovern DPB, Halfvarson J, Reinisch W, Rogler G, Kruis W, Tysk C, Schreiber S, Danese S, Sandborn W, Griffiths A, Moum B, Gasche C, Pallone F, Travis S, Panes J, Colombel JF, Hanauer S, Peyrin-Biroulet L. Development of an index to define overall disease severity in IBD. Gut. 2018 Feb;67(2):244-254. doi: 10.1136/gutjnl-2016-312648. Epub 2016 Oct 25. Citation Peyrin-Biroulet L, Panes J, Sandborn WJ, Vermeire S, Danese S, Feagan BG, Colombel JF, Hanauer SB, Rycroft B. Defining Disease Severity in Inflammatory Bowel Diseases: Current and Future Directions. Clin Gastroenterol Hepatol. 2016 Mar;14(3):348-354.e17. doi: 10.1016/j.cgh.2015.06.001. Epub 2015 Jun 11. Citation Jensen MP, Tome-Pires C, de la Vega R, Galan S, Sole E, Miro J. What Determines Whether a Pain is Rated as Mild, Moderate, or Severe? The Importance of Pain Beliefs and Pain Interference. Clin J Pain. 2017 May;33(5):414-421. doi: 10.1097/AJP.0000000000000429. Citation Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research. J Appl Meas. 2010;11(3):304-14. Citation Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x. Citation Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30. Citation Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13. Citation Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27. Citation Whitton TL, Johnson RW, Lovell AT. Use of the Rydel-Seiffer graduated tuning fork in the assessment of vibration threshold in postherpetic neuralgia patients and healthy controls. Eur J Pain. 2005 Apr;9(2):167-71. doi: 10.1016/j.ejpain.2004.05.001. Citation Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11. Erratum In: Pain. 2006 Nov;125(1-2):197. Citation Feng Y, Schlosser FJ, Sumpio BE. The Semmes Weinstein monofilament examination as a screening tool for diabetic peripheral neuropathy. J Vasc Surg. 2009 Sep;50(3):675-82, 682.e1. doi: 10.1016/j.jvs.2009.05.017. Epub 2009 Jul 30. Citation Olaleye D, Perkins BA, Bril V. Evaluation of three screening tests and a risk assessment model for diagnosing peripheral neuropathy in the diabetes clinic. Diabetes Res Clin Pract. 2001 Nov;54(2):115-28. doi: 10.1016/s0168-8227(01)00278-9. Citation Schreuders TA, Selles RW, van Ginneken BT, Janssen WG, Stam HJ. Sensory evaluation of the hands in patients with Charcot-Marie-Tooth disease using Semmes-Weinstein monofilaments. J Hand Ther. 2008 Jan-Mar;21(1):28-34; quiz 35. doi: 10.1197/j.jht.2007.07.020. Citation Alqarni AM, Manlapaz D, Baxter D, Tumilty S, Mani R. Test Procedures to Assess Somatosensory Abnormalities in Individuals with Peripheral Joint Pain: A Systematic Review of Psychometric Properties. Pain Pract. 2018 Sep;18(7):895-924. doi: 10.1111/papr.12680. Epub 2018 Mar 6. Citation Neziri AY, Scaramozzino P, Andersen OK, Dickenson AH, Arendt-Nielsen L, Curatolo M. Reference values of mechanical and thermal pain tests in a pain-free population. Eur J Pain. 2011 Apr;15(4):376-83. doi: 10.1016/j.ejpain.2010.08.011. Epub 2010 Oct 6. Citation Neziri AY, Limacher A, Juni P, Radanov BP, Andersen OK, Arendt-Nielsen L, Curatolo M. Ranking of tests for pain hypersensitivity according to their discriminative ability in chronic neck pain. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):308-20. doi: 10.1097/AAP.0b013e318295a3ea. Citation Mlekusch S, Neziri AY, Limacher A, Juni P, Arendt-Nielsen L, Curatolo M. Conditioned Pain Modulation in Patients With Acute and Chronic Low Back Pain. Clin J Pain. 2016 Feb;32(2):116-21. doi: 10.1097/AJP.0000000000000238. Citation Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20. Citation LeResche L, Turner JA, Saunders K, Shortreed SM, Von Korff M. Psychophysical tests as predictors of back pain chronicity in primary care. J Pain. 2013 Dec;14(12):1663-70. doi: 10.1016/j.jpain.2013.08.008. Citation Vuilleumier PH, Biurrun Manresa JA, Ghamri Y, Mlekusch S, Siegenthaler A, Arendt-Nielsen L, Curatolo M. Reliability of Quantitative Sensory Tests in a Low Back Pain Population. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):665-73. doi: 10.1097/AAP.0000000000000289. Citation Meeus M, Roussel NA, Truijen S, Nijs J. Reduced pressure pain thresholds in response to exercise in chronic fatigue syndrome but not in chronic low back pain: an experimental study. J Rehabil Med. 2010 Oct;42(9):884-90. doi: 10.2340/16501977-0595. Citation Gerhardt A, Eich W, Janke S, Leisner S, Treede RD, Tesarz J. Chronic Widespread Back Pain is Distinct From Chronic Local Back Pain: Evidence From Quantitative Sensory Testing, Pain Drawings, and Psychometrics. Clin J Pain. 2016 Jul;32(7):568-79. doi: 10.1097/AJP.0000000000000300. Citation Marcuzzi A, Wrigley PJ, Dean CM, Adams R, Hush JM. The long-term reliability of static and dynamic quantitative sensory testing in healthy individuals. Pain. 2017 Jul;158(7):1217-1223. doi: 10.1097/j.pain.0000000000000901.

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<![CDATA[ High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury ]]>
https://zephyrnet.com/NCT03799458
2018-07-11

https://zephyrnet.com/?p=NCT03799458
NCT03799458https://www.clinicaltrials.gov/study/NCT03799458?tab=tableNANANAAim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as shown by reliable changes in the activity of the cognitive control network (CCN) and sensory system network (SSN) following stimulation; Aim 2: this intervention will result in long-term improvements in measures of executive function, depression/anxiety, and quality of life.
<![CDATA[

Studies

Study First Submitted Date 2018-12-12
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-06-05
Start Month Year July 11, 2018
Primary Completion Month Year April 30, 2023
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-05

Detailed Descriptions

Sequence: 20701809
Description Experimental Design and Methods Participants: 120 subjects will be recruited for this study from the NM VA Health Care System and community, 40 healthy controls subjects for an imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered injury at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. All participants will be 18-59 years of age.

Recruitment: Human participants (ages 18-59) will be invited to come to the University of New Mexico (UNM) to ask questions prior to providing consent. They will be provided with consent forms that describe the study procedures and potential risks.

Once informed consent is obtained and the appropriate forms signed, the participant will be assigned a unique research subject identifier (URSI) number, and from that point forward all research data will only be labeled with the URSI number. The key linking identifiers of participants to the URSI will be maintained on a separate database that will be stored behind locked doors, in a locked filing cabinet in a secure area. All participants may then undergo demographic data collection, neuropsychological assessments sensory evaluation, at UNM. They may also undergo MEG and MRI at the Mind Research Network (MRN), located in the same building.

Demographic Data: As part of the initial assessment, basic demographic data regarding the subject may be noted down, including age, gender, socioeconomic status, educational attainment, handedness, use of common stimulants such as caffeine, and brain injury severity. They may also be asked if they are willing to allow their medical record to be accessed, for the purposes of confirming details about any traumatic brain injury (TBI) as well as obtaining results of neuroimaging studies done at the time of injury or afterward. This will include medical, surgical, neurological and psychiatric history, results of lab tests, brain scans, electroencephalography tests, medication lists, information from doctor's visits and hospital visits.

Neuropsychological testing procedures: All neuropsychological testing will be administered in the Center for Brain Recovery and Repair Core by trained study personnel under direct supervision of core directors. The following domains and tests will be administered: Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (Examiner); Digit Span; Delis-Kaplan Executive Function Systems (DKEFS) Trail-making Test Conditions 2 and 4; Hopkins Verbal Learning Test (HVLT); Frontal Systems Behavior Scale (FrSBe); Test of Memory Malingering (TOMM); Wechsler Test of Adult Reading (WTAR); Digit Symbol Coding; Handedness; Socioeconomic Status (SES); Patient's Global Impression of Change (PGIC); Glasgow Outcome Scale-Extended (GOSE).

Sensory Assessment: Hearing, balance, and vision will be assessed using Common Data Element (CDE) instruments, including the Hearing Handicap Assessment, the Test for Visual Discomfort, the modified Balance Error Scoring System. Oculomotor control will be assessed using virtual reality goggles (Oculus) with implanted eye trackers (iScan).

Magnetoencephalography: Magnetoencephalography (MEG) may be done after neuropsychological testing. The participant will sit in the MEG scanner to record brain magnetic fields. MEG setup takes between 10 and 30 minutes, and subsequent recording takes one hour. During MEG assessments participants will complete numerous tasks. Each task is designed to parse different cognitive mechanisms that contribute to sensory performance. In perceptual tasks, participants will discriminate tone pitches amongst novel distracting tones (Auditory Orienting Task; AOT). For eye movement tasks, participants are asked look either towards or away from a visual stimulus (Pro- and Anti-saccades).

Magnetic resonance imaging (MRI): MRI scan(s) will be obtained for integration with MEG, as needed for analyses. Total scan time, including participant setup and removal, is expected to take 1 hour. Participants may lie down on a table and be placed into a long donut-shaped magnet. During the scan, participants will be asked to rest quietly or to fixate on a dot on a screen in front of them, or to perform a memory task. No contrast will be used. Any female over 18 who thinks she may be pregnant will complete a urine pregnancy screen before the MRI scan.

Following initial testing, the participants in the stimulation arm of the study will receive 10 consecutive weekday sessions of high-definition transcranial direct current stimulation. 2 milliamperes active or sham anodal current will be delivered to the left dorsolateral prefrontal cortex for 30 minutes. During this time, participants will perform vision therapy tasks through a virtual reality headset, or a computer-based working memory task. Skin sensations will be assessed every 10 minutes.

Post stimulation testing: the next available weekday following completion of the study protocol, subjects will return to UNM to repeat the demographic, neuropsychological, sensory, and imaging assessments.

Long term followup: At 1 month, 3 months and 6 months after stimulation, subjects will be contacted via telephone or meet in person, and will be administered the Beck Depression Inventory (BDI-II), Posttraumatic Stress Disorder Checklist-Military (PCL-M), the Neurobehavioral Symptom Inventory (NSI), and Patient Global Impression of Change (PGIC) quality of life assessment tools utilized before and immediately after, after stimulation. Veterans will undergo these study followup visits at NMVAHCS, and civilians at UNM.

Facilities

Sequence: 199846146
Name University of New Mexico Health Sciences Center
City Albuquerque
State New Mexico
Zip 87106
Country United States

Conditions

Sequence: 52116838
Name Mild Traumatic Brain Injury
Downcase Name mild traumatic brain injury

Id Information

Sequence: 40116755
Id Source org_study_id
Id Value CDMRP-PT160096

Countries

Sequence: 42520729
Name United States
Removed False

Design Groups

Sequence: 55534787 Sequence: 55534788 Sequence: 55534789
Group Type Active Comparator Group Type Sham Comparator Group Type No Intervention
Title Active Stimulation Title Sham Stimulation Title Imaging Only
Description Active HD-tDCS will be delivered while subjects perform sensory training tasks. Description Sham HD-tDCS will be delivered while subjects perform sensory training tasks. Description 40 subjects will undergo initial testing only as a healthy control group.

Interventions

Sequence: 52431833 Sequence: 52431834
Intervention Type Device Intervention Type Device
Name Active High-definition transcranial direct current stimulation (HD-tDCS) Name Sham High-definition transcranial direct current stimulation (HD-tDCS)
Description Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates. Description Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates

Design Outcomes

Sequence: 177188508 Sequence: 177188509
Outcome Type primary Outcome Type secondary
Measure Postconcussive sensory symptoms Measure Magnetoencephalography peak activation
Time Frame 2 week visit Time Frame 2 week visit
Description Somatic sub scale score from the Neurobehavioral Symptom Inventory (NSI) (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe) Description Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography

Browse Conditions

Sequence: 193275585 Sequence: 193275586 Sequence: 193275587 Sequence: 193275588 Sequence: 193275589 Sequence: 193275590 Sequence: 193275591 Sequence: 193275592 Sequence: 193275593 Sequence: 193275594 Sequence: 193275584
Mesh Term Brain Injuries, Traumatic Mesh Term Brain Concussion Mesh Term Wounds and Injuries Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Craniocerebral Trauma Mesh Term Trauma, Nervous System Mesh Term Head Injuries, Closed Mesh Term Wounds, Nonpenetrating Mesh Term Brain Injuries
Downcase Mesh Term brain injuries, traumatic Downcase Mesh Term brain concussion Downcase Mesh Term wounds and injuries Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term craniocerebral trauma Downcase Mesh Term trauma, nervous system Downcase Mesh Term head injuries, closed Downcase Mesh Term wounds, nonpenetrating Downcase Mesh Term brain injuries
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-list

Sponsors

Sequence: 48269942 Sequence: 48269943 Sequence: 48269944 Sequence: 48269945 Sequence: 48269946 Sequence: 48269947
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name University of New Mexico Name Biomedical Research Institute of New Mexico Name New Jersey Institute of Technology Name University of Miami Name The Mind Research Network Name The City College of New York

Design Group Interventions

Sequence: 68077502 Sequence: 68077503
Design Group Id 55534787 Design Group Id 55534788
Intervention Id 52431833 Intervention Id 52431834

Eligibilities

Sequence: 30734726
Gender All
Minimum Age 18 Years
Maximum Age 59 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

are US Veteran or Active Duty Military personnel aged 18-59,
have suffered a mild TBI (alteration in neurological functioning < 24 hours, loss of consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if available) of between 13 and 15 acutely, and less than 24 hours of post-traumatic amnesia (PTA));
were injured between 3 months and 15 years ago;
have post-traumatic sensory symptoms as evidenced by endorsing at least 2 out of 12 sensory symptoms on the Neurobehavioral Symptom Inventory (NSI), a measure of post-traumatic symptoms from the NIH Common Data Elements (CDE) to a severity of "3" or higher,
are fluent in English,
have been on stable doses of any psychotropic medications for the past 2 months.
The imaging-only group will have the same inclusion and exclusion criteria except they will not have had a head injury.

Exclusion Criteria:

any history of moderate or severe TBI;
a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, to as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
history of psychosis, so as to reduce risk of psychiatric decompensation;
history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on cognition and plasticity;
any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current;
presence of any implanted electrical device (e.g. pacemaker), to reduce risk of device malfunction;
recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study;
any condition that would prevent the subject from completing the protocol; 9) appointment of a legal representative, as assessed via direct inquiry of the subject and a designated trusted other, to avoid coercion of a vulnerable population;

10) any significant blindness, to screen out peripheral sensory damage; 11) any significant deafness beyond mild hearing loss, to screen out peripheral sensory damage; 12) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 13) any contraindication to MRI; 14) membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254011363
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 58
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 59
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30481094
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Triple
Masking Description Active and sham HD-tDCS will be delivered with the same device, and participants and research technician are blinded to the condition.
Intervention Model Description 120 subjects will be recruited for this study: 40 healthy controls subjects for the imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered mild TBI at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. The 80 mTBI subjects will be randomized to either active stimulation (40) or sham stimulation (40).
Subject Masked True
Caregiver Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28847447
Responsible Party Type Sponsor

]]>

<![CDATA[ Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma ]]>
https://zephyrnet.com/NCT03799445
2019-07-25

https://zephyrnet.com/?p=NCT03799445
NCT03799445https://www.clinicaltrials.gov/study/NCT03799445?tab=tableMaura Gillisonmgillison@mdanderson.org713-792-6363This phase II trial studies the side effects and best dose of ipilimumab, nivolumab, and radiation therapy and how well they work in treating patients with advanced human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ipilimumab, nivolumab, and radiation therapy may work better in treating patients with HPV positive oropharyngeal squamous cell carcinoma.
<![CDATA[

Studies

Study First Submitted Date 2018-12-13
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-04-20
Start Month Year July 25, 2019
Primary Completion Month Year December 31, 2023
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-20

Detailed Descriptions

Sequence: 20839691
Description PRIMARY OBJECTIVES:

I. To evaluate the safety, tolerability and feasibility of ipilimumab and nivolumab when administered concurrently with reduced-field radiotherapy (intensity-modulated radiation therapy [IMRT]).

II. To evaluate the clinical complete response rate to ipilimumab, nivolumab and IMRT with reduced field at six months as indicated by fluorodeoxyglucose – positron emission tomography/computed tomography (FDG-PET/CT) post completion of radiation therapy (RT).

III. To evaluate the 2-year progression-free survival (PFS) rate of subjects with low-intermediate volume, local-regionally advanced, human papilloma virus (HPV)-positive squamous cell carcinoma of the head and neck (SCCHN) treated with ipilimumab, nivolumab and reduced-field IMRT.

SECONDARY OBJECTIVES:

I. To evaluate overall response rate to six weeks of induction immunotherapy (IO).

II. To evaluate the frequency of pharyngeal dysphasia as measured by Dynamic Imaging (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]) grade on modified barium swallow (MBS) and patient-reported symptoms (MD Anderson Dysphagia Inventory [MDADI]) at 6 month, 1 and 2 years after radiotherapy ([IMRT].

III. To measure acute and chronic toxicities per Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (CTCAE PRO).

IV. To measure acute toxicity profiles at the end of radiation therapy and IO and at 6 months.

V. To measure late toxicity profiles at 1 and 2 years. VI. To determine local and regional control at 6 and 12 months. VII. To determine patterns of failure (local-regional relapse vs. distant) at 1 and 2 years.

VIII. To determine overall survival (OS) at 1 and 2 years.

CORRELATIVE OBJECTIVES:

I. To evaluate associations between total mutational load, interferon (INF) gamma score, T cell clonality at diagnosis with clinical response to induction, combination CTLA-4 PD-1 checkpoint blockade.

II. To evaluate changes in the tumor immune microenvironment (CD8 + INF gamma score, T cell clonality, in tumor biopsy specimens pre and post induction immunotherapy (IO).

III. To evaluate dynamic changes in and clearance of oral HPV and cell-free deoxyribonucleic acid (cfDNA) viral load during therapy and to investigate associations with PFS and OS.

EXPLORATORY OBJECTIVES:

I. To evaluate changes in peripheral blood lymphocyte phenotypes and serum cytokine profiles before and after induction IO.

II. To evaluate changes in the T cell receptor repertoire in tumor-infiltrating lymphocyte (TIL) and the peripheral blood in tumor biopsy specimens pre and post induction IO.

III. To determine the negative and positive predictive values (NPV and PPV) of FDG-PET/CT 12-14 weeks after end of RT for 1 year and 2 year PFS and OS.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Facilities

Sequence: 201189730
Status Recruiting
Name M D Anderson Cancer Center
City Houston
State Texas
Zip 77030
Country United States

Facility Contacts

Sequence: 28265827
Facility Id 201189730
Contact Type primary
Name Maura L. Gillison
Phone 713-792-6363

Facility Investigators

Sequence: 18429847
Facility Id 201189730
Role Principal Investigator
Name Maura L. Gillison

Browse Interventions

Sequence: 96542851 Sequence: 96542852 Sequence: 96542853 Sequence: 96542854 Sequence: 96542855 Sequence: 96542856
Mesh Term Nivolumab Mesh Term Ipilimumab Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents Mesh Term Immune Checkpoint Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term nivolumab Downcase Mesh Term ipilimumab Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents Downcase Mesh Term immune checkpoint inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52473688 Sequence: 52473689 Sequence: 52473690 Sequence: 52473691 Sequence: 52473692 Sequence: 52473693 Sequence: 52473694 Sequence: 52473695 Sequence: 52473696 Sequence: 52473697 Sequence: 52473698
Name Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Name Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Name Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma Name Oropharyngeal Basaloid Carcinoma Name Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Name Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Name Posterior Tongue Squamous Cell Carcinoma Name Soft Palate Squamous Cell Carcinoma Name Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 Name Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 Name Tonsillar Squamous Cell Carcinoma
Downcase Name clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 Downcase Name clinical stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 Downcase Name human papillomavirus positive oropharyngeal squamous cell carcinoma Downcase Name oropharyngeal basaloid carcinoma Downcase Name pathologic stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 Downcase Name pathologic stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 Downcase Name posterior tongue squamous cell carcinoma Downcase Name soft palate squamous cell carcinoma Downcase Name stage iii oropharyngeal squamous cell carcinoma ajcc v7 Downcase Name stage iva oropharyngeal squamous cell carcinoma ajcc v7 Downcase Name tonsillar squamous cell carcinoma

Id Information

Sequence: 40375496 Sequence: 40375497 Sequence: 40375498
Id Source org_study_id Id Source secondary_id Id Source secondary_id
Id Value 2018-0381 Id Value NCI-2018-03260 Id Value 2018-0381
Id Type Registry Identifier Id Type Other Identifier
Id Type Description CTRP (Clinical Trial Reporting Program) Id Type Description M D Anderson Cancer Center

Countries

Sequence: 42811279
Name United States
Removed False

Design Groups

Sequence: 55929314
Group Type Experimental
Title Treatment (nivolumab, ipilimumab, IMRT)
Description Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.

Interventions

Sequence: 52783865 Sequence: 52783866 Sequence: 52783867 Sequence: 52783868 Sequence: 52783869
Intervention Type Radiation Intervention Type Biological Intervention Type Biological Intervention Type Other Intervention Type Other
Name Intensity-Modulated Radiation Therapy Name Ipilimumab Name Nivolumab Name Quality-of-Life Assessment Name Questionnaire Administration
Description Undergo IMRT Description Given IV Description Given IV Description Ancillary studies Description Ancillary studies

Design Outcomes

Sequence: 178513931 Sequence: 178513932 Sequence: 178513933 Sequence: 178513934 Sequence: 178513935 Sequence: 178513936 Sequence: 178513937 Sequence: 178513938 Sequence: 178513939 Sequence: 178513940 Sequence: 178513941 Sequence: 178513942 Sequence: 178513943
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Dose limiting toxicity (DLT) (safety lead-in) Measure Complete response rate (Phase II) Measure Progression-free survival (PFS) (Phase II) Measure Number of patients who experience a >= grade 3 treatment-related adverse event (safety lead-in) Measure Number of patients who tolerated protocol therapy (safety lead-in) Measure Number of patients who achieve a clinical complete response (safety lead-in) Measure Incidence of acute and chronic adverse events (Phase II) Measure Acute toxicity profiles (Phase II) Measure Number of patients who experience >= grade 3 treatment-related adverse event (Phase II) Measure Late toxicity profiles (Phase II) Measure Patient-reported swallowing outcomes (Phase II) Measure Patterns of failure (local-regional relapse versus [vs] distant) (Phase II) Measure Overall survival (Phase II)
Time Frame Up to 28 days post-completion of radiation therapy Time Frame At 6 months Time Frame From start of therapy to progression or disease or death from any cause, assessed up to 2 years Time Frame Up to 28 days post-completion of radiation therapy Time Frame Up to 12 weeks (end of cycle 2) Time Frame Up to 28 weeks after radiation therapy Time Frame Up to 3 months from the end of intensity-modulated radiation therapy (IMRT) Time Frame At the end of radiation therapy, end of IO, and 6 months Time Frame At the end of radiation therapy, end of IO, and 6 months Time Frame At 1 and 2 years Time Frame At 1 and 2 years Time Frame At 1 and 2 years Time Frame At 1 and 2 years
Description Defined as any >= grade 3 adverse event (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4) that is related to immunotherapy (IO) that does not resolve to grade 1 or less within 28 days. Description The number of patients who tolerated protocol therapy, including completion of radiotherapy without a treatment break and who were administered immunotherapy (IO) will be assessed. Description Incidence of adverse events (acute and chronic toxicities) will be assessed per CTCAE Patient Reported Outcome (PRO). Description Will be assessed by CTCAE v 4. Description Will be assessed per CTCAE v 4.

Browse Conditions

Sequence: 194642944 Sequence: 194642945 Sequence: 194642946 Sequence: 194642947 Sequence: 194642948 Sequence: 194642949 Sequence: 194642950 Sequence: 194642951 Sequence: 194642952 Sequence: 194642953 Sequence: 194642954 Sequence: 194642955 Sequence: 194642956 Sequence: 194642957 Sequence: 194642958
Mesh Term Carcinoma Mesh Term Carcinoma, Squamous Cell Mesh Term Squamous Cell Carcinoma of Head and Neck Mesh Term Oropharyngeal Neoplasms Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Neoplasms, Squamous Cell Mesh Term Head and Neck Neoplasms Mesh Term Neoplasms by Site Mesh Term Pharyngeal Neoplasms Mesh Term Otorhinolaryngologic Neoplasms Mesh Term Pharyngeal Diseases Mesh Term Stomatognathic Diseases Mesh Term Otorhinolaryngologic Diseases
Downcase Mesh Term carcinoma Downcase Mesh Term carcinoma, squamous cell Downcase Mesh Term squamous cell carcinoma of head and neck Downcase Mesh Term oropharyngeal neoplasms Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, squamous cell Downcase Mesh Term head and neck neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term pharyngeal neoplasms Downcase Mesh Term otorhinolaryngologic neoplasms Downcase Mesh Term pharyngeal diseases Downcase Mesh Term stomatognathic diseases Downcase Mesh Term otorhinolaryngologic diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48600519 Sequence: 48600520
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name M.D. Anderson Cancer Center Name National Cancer Institute (NCI)

Overall Officials

Sequence: 29444061
Role Principal Investigator
Name Maura L Gillison
Affiliation M.D. Anderson Cancer Center

Central Contacts

Sequence: 12086171
Contact Type primary
Name Maura Gillison
Phone 713-792-6363
Email mgillison@mdanderson.org
Role Contact

Design Group Interventions

Sequence: 68564033 Sequence: 68564034 Sequence: 68564035 Sequence: 68564036 Sequence: 68564037
Design Group Id 55929314 Design Group Id 55929314 Design Group Id 55929314 Design Group Id 55929314 Design Group Id 55929314
Intervention Id 52783865 Intervention Id 52783866 Intervention Id 52783867 Intervention Id 52783868 Intervention Id 52783869

Eligibilities

Sequence: 30938913
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Histologically or cytologically newly confirmed diagnosis of squamous cell carcinoma (including the histological variants of papillary or basaloid) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
Clinical American Joint Committee on Cancer (AJCC) 7th edition stage T1N2a-N2CM0, T2N1-N2CM0, T3N0-N2CM0, equivalent to AJCC 8th edition stage 1 and 2 (T1 N2, T2 N1-N2, T3 N0-N2) excluding T1N0-N1 and T2N0 (Brian O'Sullivan et al. 2016)
Tumor positive for p16 immunohistochemistry (IHC) (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells) and HPV DNA in situ hybridization or HPV messenger ribonucleic acid (mRNA) RNAScope. Repeat samples may be required if adequate diagnostic tissue is unavailable for testing
Zubrod Performance Status of 0-1
Patients must have radiographically evident measurable disease at the primary site or at nodal stations per response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]) 1.1 documented by diagnostic quality CT or magnetic resonance imaging (MRI) of the neck with contrast within 28 days prior to registration; a FDG-PET/CT of the neck performed for the purposes of radiation planning is acceptable as a substitute if the CT is of diagnostic quality
Diagnostic quality cross sectional imaging of the thorax within 28 days prior to registration. A 18-FDG-PET/CT or conventional CT are acceptable
FDG-PET/CT of the neck is required within 28 days prior to registration for comparison to post treatment FDG-PET/CT. Note: Repeat imaging for variability within 96 hours of this time frame should be allowed to avoid unnecessary re-imaging and its financial and potential physical consequences for patients
History and physical exam within 1 month prior to registration
Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) by radiation oncologist, medical oncologist or ear, nose, throat (ENT)/head and neck surgeons within 28 days prior to registration
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 2 weeks prior to registration)
Platelets >= 100,000 cells/mm^3 (within 2 weeks prior to registration)
Hemoglobin >= 8.0 g/dl (within 2 weeks prior to registration); Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable
Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula (within 2 weeks prior to registration)
Bilirubin < 2 mg/dl (within 2 weeks prior to registration)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal (within 2 weeks prior to registration)
Sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), albumin, amylase, lipase, thyroid stimulating hormone (TSH) within 2 weeks prior to registration
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
Seronegative for active hepatitis-B or hepatitis-C infection and seronegative for human immunodeficiency virus (HIV)
Mandatory submission of hematoxylin and eosin (H&E) and paraffin-embedded tumor block or unstained slides

Exclusion Criteria:

Cancers of the oral cavity (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive
Carcinoma of the neck of unknown primary site origin (even if p16 positive)
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
Simultaneous primary cancers or separate bilateral primary tumor sites
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; patients who have received PD-1/PD-L1 or CTLA4 therapy for a previous malignancy are not eligible
Prior RT to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active co-morbidity defined as any of the following: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; a diagnosis of immunodeficiency or use of any form of systemic immunosuppressive therapy. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor
Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Steroid premedications for contrast allergy allowed
Has evidence of active, non-infectious pneumonitis
Has received a live vaccine within 30 days of planned start of study therapy
Pregnancy or breast-feeding; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
History of severe hypersensitivity or contraindication to CT or PET contrast material uncontrolled with pre-medications (steroids, antihistamines)

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254254490
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 10

Designs

Sequence: 30684531
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26823847 Sequence: 26823848 Sequence: 26823849 Sequence: 26823850 Sequence: 26823851 Sequence: 26823852 Sequence: 26823853 Sequence: 26823854 Sequence: 26823855 Sequence: 26823856 Sequence: 26823857 Sequence: 26823858 Sequence: 26823859 Sequence: 26823860
Intervention Id 52783865 Intervention Id 52783865 Intervention Id 52783865 Intervention Id 52783866 Intervention Id 52783866 Intervention Id 52783866 Intervention Id 52783866 Intervention Id 52783866 Intervention Id 52783867 Intervention Id 52783867 Intervention Id 52783867 Intervention Id 52783867 Intervention Id 52783867 Intervention Id 52783868
Name IMRT Name Intensity Modulated RT Name Intensity-Modulated Radiotherapy Name Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody Name BMS-734016 Name MDX-010 Name MDX-CTLA4 Name Yervoy Name BMS-936558 Name MDX-1106 Name NIVO Name ONO-4538 Name Opdivo Name Quality of Life Assessment

Links

Sequence: 4411106
Url http://www.mdanderson.org
Description MD Anderson Cancer Center Website

Responsible Parties

Sequence: 29051261
Responsible Party Type Sponsor

]]>

<![CDATA[ Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies ]]>
https://zephyrnet.com/NCT03799432
2019-07-08

https://zephyrnet.com/?p=NCT03799432
NCT03799432https://www.clinicaltrials.gov/study/NCT03799432?tab=tableNANANAThe purpose of this study is to partner with the North Carolina Child Treatment Program (NC CTP) and the SAMHSA-funded National Child Traumatic Stress Network (NCTSN) to develop and pilot the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). The COAST-IS intervention will involve coaching organizational leaders and therapists to use Intervention Mapping to select and tailor strategies. Intervention Mapping is a multistep process that is inherently ecological and incorporates theory, evidence, and stakeholder perspectives to ensure that intervention components effectively address key determinants of change. After collaboratively developing COAST-IS in Year 1, the investigators will conduct a randomized pilot trial of the intervention within an NC CTP learning collaborative, randomly assigning eight organizations to the learning collaborative-only condition or the learning collaborative plus COAST-IS condition. Participants will include organizational leaders (e.g., CEOs/Directors, Clinical Directors, Supervisors) and therapists (e.g., Licensed Clinical Social Workers, Licensed Psychologists, Licensed Professional Counselors). The investigators will evaluate COAST-IS in the following aims: 1) to assess the acceptability, appropriateness, feasibility, and utility of COAST-IS; 2) to evaluate organizational stakeholders’ fidelity to the core elements of Intervention Mapping; and 3) to demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. This work is significant because it will yield a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. Ultimately, COAST-IS may have the potential to improve implementation and sustainment of a wide-range of EBPs in mental health and other health sectors.
<![CDATA[

Studies

Study First Submitted Date 2018-12-09
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-04-27
Start Month Year July 8, 2019
Primary Completion Month Year December 31, 2020
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2022-04-27

Facilities

Sequence: 201296264
Name North Carolina Child Treatment Program
City Durham
State North Carolina
Zip 27701
Country United States

Conditions

Sequence: 52511142 Sequence: 52511143
Name Psychological Trauma Name Mental Health
Downcase Name psychological trauma Downcase Name mental health

Id Information

Sequence: 40401616 Sequence: 40401617
Id Source org_study_id Id Source secondary_id
Id Value 17-0978 Id Value 1K01MH113806-01
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/1K01MH113806-01

Countries

Sequence: 42837787
Name United States
Removed False

Design Groups

Sequence: 55967529 Sequence: 55967530
Group Type Experimental Group Type Active Comparator
Title TF-CBT Learning collaborative + COAST-IS Title TF-CBT Learning collaborative
Description In addition to participating in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls, organizations will receive additional training and tailored implementation support. Description Organizations will participate in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls.

Interventions

Sequence: 52818778 Sequence: 52818779
Intervention Type Other Intervention Type Other
Name COAST-IS Name TF-CBT Learning Collaborative
Description COAST-IS has been designed to equip organizations with the knowledge, motivation, and skill needed to thoughtfully match implementation strategies to identified determinants by applying intervention mapping. The COAST-IS intervention will include four different modes of delivery: 1) dissemination of educational materials; 2) five web-based interactive education sessions on the need for tailoring implementation strategies and the application of intervention mapping; 3) site visits to discuss change objectives necessary to successfully implement trauma-focused cognitive behavioral therapy; and 4) organizational coaching related to using an intervention mapping approach. Description The learning collaborative model was adapted from the Breakthrough Series Collaborative model. Leadership of the collaboratives includes experts in evidence-based practices, implementation, and quality improvement. Main components include: 1) three face-to-face learning sessions (2-days each) that provide clinical training; 2) post-learning session action periods structured to facilitate therapists' application of learned skills; 3) a secure website to facilitate faculty-to-participant and peer-to-peer learning and document use of quality improvement methods; 4) fidelity monitoring and coaching; 5) a senior leader track supporting organizational change; 6) monthly outcomes monitoring; and 7) sustainability planning.

Keywords

Sequence: 80329878 Sequence: 80329879 Sequence: 80329880 Sequence: 80329881
Name Implementation Science Name Cognitive Behavioral Therapy Name Children Name Youth
Downcase Name implementation science Downcase Name cognitive behavioral therapy Downcase Name children Downcase Name youth

Design Outcomes

Sequence: 178643283 Sequence: 178643284 Sequence: 178643285 Sequence: 178643286 Sequence: 178643287 Sequence: 178643288 Sequence: 178643289 Sequence: 178643290 Sequence: 178643291 Sequence: 178643292 Sequence: 178643293 Sequence: 178643294 Sequence: 178643295 Sequence: 178643296 Sequence: 178643297
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Evaluate the acceptability of COAST-IS Measure Evaluate the appropriateness of COAST-IS Measure Evaluate the feasibility of COAST-IS Measure Evaluate the perceived utility of COAST-IS Measure Fidelity to COAST-IS Measure Fidelity to TF-CBT Measure Fidelity to TF-CBT Measure Organizational Readiness for Implementing Change (ORIC) Measure Evidence-based Practice Attitudes Scales (EBPAS) Measure Inner Setting of the Consolidated Framework for Implementation Research Measure Scale for Implementation Climate Measure Psychological Safety Scale (PSS) Measure Implementation Leadership Scale (ILS) Measure Implementation Citizenship Behavior Scale (ICBS) Measure Prior Experiences with Implementation
Time Frame 1 year Time Frame 1 year Time Frame 1 year Time Frame 1 year Time Frame 1 year Time Frame 6 months Time Frame 1 year Time Frame Baseline, 1 year Time Frame Baseline, 1 year Time Frame Baseline, 1 year Time Frame Baseline, 1 year Time Frame Baseline, 1 year Time Frame Baseline, 1 year Time Frame Baseline, 1 year Time Frame Baseline, 1 year
Description This will be assessed with the 4-item measure: Acceptability of Intervention. This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater acceptability. Description This will be assessed with the 4-item measure: Intervention Appropriateness.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater appropriateness. Description This will be assessed with the 4-item measure: Feasibility of Intervention.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater feasibility. Description Semi-structured interview will focus on the perceived utility of COAST-IS. Description Fidelity to COAST-IS will be measured with a fidelity assessment tool adapted from the Stages of Implementation Completion measure, which assesses organizations' progression through eight stages of implementation (engagement through competency [conceptualized as the start of sustainment]). Description Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session. Description Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session. Description The 12 items comprising the ORIC measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether members of an organization, collectively, are (1) committed to implementing a new practice or process and (2) believe that they have the capacity to do so. For these two subscales and the overall ORIC scale, organizations receive scores between 1 and 5 (higher scores are considered more positive). Description The 15 items comprising the EBPAS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure articulates practitioner willingness to adopt new interventions as a function of four factors: (1) appeal of the new intervention, (2) organizational requirements, (3) practitioner openness, and (4) divergence (perceived incompatibility with practice or limited usefulness of research-based interventions). For these four subscales and the overall EBPAS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). Description This questionnaire assesses factors related to the inner setting of organizations that are believed to be important in influencing the implementation of interventions. Thirty items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure three factors: (1) culture, (2) learning climate, and (3) available resources. Organizations receive scores between 1 and 5 for each of these factors (higher scores are considered more positive). Description The six items comprising this measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether organizations are primed for implementation via three factors: the extent to which employees believe implementation is (1) expected, (2) supported, and (3) rewarded. For these three subscales and the overall ICS scale, organizations receive scores between 1 and 5 (higher scores are considered more positive). Description The seven items comprising the PSS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses how much the environment of a work team makes members feel they can safely engage in learning behavior (e.g., seeking feedback, discussing errors, asking questions, experimenting) without great risk of losing face. Organizations receive a score between 1 and 7 for this scale (higher scores are considered more positive). Description The 12 items comprising the ILS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether leadership is proactive, knowledgeable, supportive, and perseverant based on specific actions leaders take in promoting implementation. For these four subscales and the overall ILS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). Description The six items comprising the ICBS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses two critical employee behaviors that go beyond what is required to support the implementation of evidence-based practices: (1) helping their peers with implementation-related activities and (2) keeping informed about issues related to evidence-based practice and implementation efforts. For these two subscales and the overall ICBS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). Description This questionnaire assesses employees' experiences and judgments toward previous innovation implementation, which may affect their implementation behavior regarding future innovations. Sixteen items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure four subscales: (1) perceived intensity of previous innovations, (2) perceived failure of previous innovations, (3) innovation-targeted helplessness, and (4) innovation fatigue. Organizations receive scores between 1 and 5 for each of these subscales (higher scores are considered more negative).

Browse Conditions

Sequence: 194782684 Sequence: 194782685 Sequence: 194782686 Sequence: 194782687
Mesh Term Psychological Trauma Mesh Term Stress Disorders, Traumatic Mesh Term Trauma and Stressor Related Disorders Mesh Term Mental Disorders
Downcase Mesh Term psychological trauma Downcase Mesh Term stress disorders, traumatic Downcase Mesh Term trauma and stressor related disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48633725 Sequence: 48633726 Sequence: 48633727 Sequence: 48633728 Sequence: 48633729
Agency Class OTHER Agency Class NIH Agency Class UNKNOWN Agency Class NETWORK Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Washington University School of Medicine Name National Institute of Mental Health (NIMH) Name North Carolina Child Treatment Program Name National Child Traumatic Stress Network Name UCLA-Duke National Center for Child Traumatic Stress

Overall Officials

Sequence: 29462751
Role Principal Investigator
Name Byron J Powell, PhD
Affiliation Washington University School of Medicine

Design Group Interventions

Sequence: 68611695 Sequence: 68611696 Sequence: 68611697
Design Group Id 55967529 Design Group Id 55967530 Design Group Id 55967529
Intervention Id 52818778 Intervention Id 52818779 Intervention Id 52818779

Eligibilities

Sequence: 30958980
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Employed at an organization participating in a North Carolina Child Treatment Program TF-CBT learning collaborative
Working as an organizational leader (e.g., senior leaders and clinical supervisors) or therapist
Direct involvement in the organization's implementation of TF-CBT
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253975780
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 18
Were Results Reported False
Has Us Facility True
Has Single Facility True
Number Of Primary Outcomes To Measure 5
Number Of Secondary Outcomes To Measure 2
Number Of Other Outcomes To Measure 8

Designs

Sequence: 30704547
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Health Services Research
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29071273
Responsible Party Type Sponsor

Study References

Sequence: 52416722
Pmid 32391524
Reference Type derived
Citation Powell BJ, Haley AD, Patel SV, Amaya-Jackson L, Glienke B, Blythe M, Lengnick-Hall R, McCrary S, Beidas RS, Lewis CC, Aarons GA, Wells KB, Saldana L, McKay MM, Weinberger M. Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). Implement Sci Commun. 2020;1:9. doi: 10.1186/s43058-020-00009-5. Epub 2020 Feb 25.

]]>

<![CDATA[ Cognitive Bias Modification for OCD ]]>
https://zephyrnet.com/NCT03799419
2019-04-01

https://zephyrnet.com/?p=NCT03799419
NCT03799419https://www.clinicaltrials.gov/study/NCT03799419?tab=tableMartha Falkensteinmfalkenstein@mclean.harvard.edu617-855-4424This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT.

Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-03-15
Start Month Year April 1, 2019
Primary Completion Month Year September 2024
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-15

Facilities

Sequence: 198942328
Status Recruiting
Name McLean Hospital
City Belmont
State Massachusetts
Zip 02478
Country United States

Facility Contacts

Sequence: 27982637
Facility Id 198942328
Contact Type primary
Name Martha Falkenstein
Email mfalkenstein@mclean.harvard.edu
Phone 617-855-4424

Conditions

Sequence: 51881526 Sequence: 51881527
Name Obsessive-Compulsive Disorder Name Obsessive-compulsive Disorders and Symptoms
Downcase Name obsessive-compulsive disorder Downcase Name obsessive-compulsive disorders and symptoms

Id Information

Sequence: 39929117
Id Source org_study_id
Id Value 2017P002864

Countries

Sequence: 42322966
Name United States
Removed False

Design Groups

Sequence: 55301063 Sequence: 55301064 Sequence: 55301065 Sequence: 55301066
Group Type Experimental Group Type Sham Comparator Group Type Experimental Group Type Sham Comparator
Title Cognitive bias modification with treatment as usual Title Psychoeducation with treatment as usual Title Approach avoidance training with treatment as usual Title Inactive sham approach avoidance training
Description Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias Description Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation Description Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies Description Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training

Interventions

Sequence: 52199460 Sequence: 52199461 Sequence: 52199462 Sequence: 52199463
Intervention Type Behavioral Intervention Type Behavioral Intervention Type Behavioral Intervention Type Behavioral
Name Cognitive bias modification for interpretation bias Name Psychoeducation Name Approach avoidance training Name Inactive sham approach avoidance training
Description Eight sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity. Description Eight sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles. Description Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, & Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach). Description Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training.

Keywords

Sequence: 79401306 Sequence: 79401307 Sequence: 79401308
Name cognitive bias modification Name interpretation bias Name approach avoidance
Downcase Name cognitive bias modification Downcase Name interpretation bias Downcase Name approach avoidance

Design Outcomes

Sequence: 176414902 Sequence: 176414899 Sequence: 176414900 Sequence: 176414901 Sequence: 176414903 Sequence: 176414904 Sequence: 176414905 Sequence: 176414906 Sequence: 176414907 Sequence: 176414908
Outcome Type secondary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in Suicide Implicit Association Test Measure Change in Average Score on Obsessive Beliefs Questionnaire Measure Change in Average Score on Yale-Brown Obsessive Compulsive Scale Measure Change in Columbia-Suicide Severity Rating Scale Measure Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity. Measure Credibility/Expectancy Questionnaire Measure Exit Interview Measure Change in Behavioral Approach Test Measure Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales Measure Dimensional Obsessive-Compulsive Scale
Time Frame Weeks 0, 2, and 4 Time Frame Weeks 0, 2, 4, and 8 Time Frame Weeks 0, 4, and 8 Time Frame Weeks 0, 4, and 8 Time Frame Weeks 0, 1, 2, 3, and 4 Time Frame Week 0 Time Frame Week 4 Time Frame Weeks 0, 2, and 4 Time Frame Weeks 0, 2, 4, and 8 Time Frame Weeks 0, 2, 4, and 8
Description Computerized task which assesses implicit thoughts about self-injury, death, and suicide. Description Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity. Description Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity. Description An interviewer-rated assessment of retrospective suicidality as well as recent suicidal ideation and behavior. Minimum total score 0, maximum total score 5, higher total scores indicate more suicidal ideation and/or behavior. Description Self-report measure of suicidality Description Measure of treatment expectancy and rationale credibility in our study. The items are rated on 9-point scales, with a total score range of 3 to 27. Greater scores indicate greater expectations and perceptions of treatment credibility. Description This interview will be conducted by a member of the study staff to obtain participant feedback on satisfaction and how the intervention might be improved. Description Behavioral Approach Test (BAT) will be administered as a measure of OCD-related avoidance, based on previously validated procedures (Cougle et al., 2007; Amir, Kuckertz, & Najmi, 2013). Participants rate peak anxiety 0-100 for each step of approaching feared stimuli.

Three different types of BAT will be implemented in order to measure avoidance with multiple types of contaminants, each with six steps on a hierarchy to be completed sequentially, providing a rating of anxiety 0-100 for each step.

Description 24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed. Description (DOCS; Abramowitz et al., 2010) participants with contamination fears will be identified by their DOCS contamination subscale score; the DOCS is part of the admission measures in the OCD Institute's main study protocol. Additionally, we will examine these scores as an outcome measure for contamination-related obsessions and compulsions. It includes 20 items and is rated 0-4.

Browse Conditions

Sequence: 192315455 Sequence: 192315456 Sequence: 192315457 Sequence: 192315458 Sequence: 192315459
Mesh Term Compulsive Personality Disorder Mesh Term Obsessive-Compulsive Disorder Mesh Term Personality Disorders Mesh Term Mental Disorders Mesh Term Anxiety Disorders
Downcase Mesh Term compulsive personality disorder Downcase Mesh Term obsessive-compulsive disorder Downcase Mesh Term personality disorders Downcase Mesh Term mental disorders Downcase Mesh Term anxiety disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48048244
Agency Class OTHER
Lead Or Collaborator lead
Name Mclean Hospital

Central Contacts

Sequence: 11947809
Contact Type primary
Name Martha Falkenstein
Phone 617-855-4424
Email mfalkenstein@mclean.harvard.edu
Role Contact

Design Group Interventions

Sequence: 67795305 Sequence: 67795306 Sequence: 67795307 Sequence: 67795308
Design Group Id 55301063 Design Group Id 55301064 Design Group Id 55301065 Design Group Id 55301066
Intervention Id 52199460 Intervention Id 52199461 Intervention Id 52199462 Intervention Id 52199463

Eligibilities

Sequence: 30594239
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Currently receiving treatment at the McLean Hospital OCD Institute
For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs Questionnaire-44 upon admission to the OCD Institute
For AAT condition only: endorse score of at least 7 on the DOCS subscale #1 (contamination subscale) upon admission to the OCD Institute
Able to complete a computer task for 20 minutes
Consent to main OCD Institute study protocol

Exclusion Criteria:

Currently undergoing electroconvulsive therapy (ECT)
Current symptoms of acute mania or psychosis
A reported diagnosis at admission of a psychotic disorder
History of traumatic brain injury

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253885480
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 9

Designs

Sequence: 30341874
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking Triple
Subject Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28718372
Responsible Party Type Principal Investigator
Name Martha J Falkenstein
Title Staff Psychologist
Affiliation Mclean Hospital

]]>

<![CDATA[ Vitamin D Supplementation for Acute Bronchiolitis ]]>
https://zephyrnet.com/NCT03799406
2016-10-01

https://zephyrnet.com/?p=NCT03799406
NCT03799406https://www.clinicaltrials.gov/study/NCT03799406?tab=tableNANANAThis study was conducted to evaluate the effect of oral vitamin D supplementation on the clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among infants who required hospital-based care for bronchiolitis is associated with the severity of the acute episode.
<![CDATA[

Studies

Study First Submitted Date 2018-12-29
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-11
Start Month Year October 1, 2016
Primary Completion Month Year March 1, 2017
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-11

Detailed Descriptions

Sequence: 20716264
Description This is a double blind randomized controlled trial which was conducted on 60 infants who required hospital-based care for acute bronchiolitis. The patients were recruited in the period from October 2018 to January 2019. Informed consents were obtained from all caregivers, and approved by Institutional Research Board of our University.

The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea, coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for bronchiolitis, since it is repeatable and can reliably be used in research and clinical practice

Sample size:

Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80% to detect a clinical significance (α error) of 0.05 between interventional groups, we calculated a sample size of 30 patients in each treatment group.

Randomization and Enrollment:

Patients were randomized to receive vitamin D3 treatment [100 IU/Kg/day in acute bronchiolitis] (vitamin D group) or placebo (placebo group) all through the period of admission as a previous cohort observational study has postulated that vitamin D daily dose close to 100 IU/kg body weight is favorable for infants up to age 12 months. Both groups were equal in number. Both vitamin D3 and placebo were in drop form and were identical in shape and nearly the same taste and color. The assignments were kept in sealed envelopes till data analysis. The randomization and allocation process were done by a higher nursing staff blinded to the study. Throughout the study, the medical staff, and parents were blind to assignments.

All patients were hospitalized and received treatment. The treatment consisted of intravenous fluids, oxygenation, and antipyretics if needed, and nebulized hypertonic saline. Nebulized adrenaline or salbutamol was added in severe cases according to the decision of a senior pediatrician. The validated clinical score for acute bronchiolitis were taken after a period of adjustment of at least 5 min and with the child quiet, not crying, without fever, and breathing room air. Respiratory rate were determined by observation of the thoracic movement over a full minute. The degree of accessory muscle use was based on the degree of intercostal or subcostal retraction. Physical examination as well as clinical severity score was recorded for each case at admission and every 12 hours, and at discharge. On discharge, all caregivers of breastfed, partially breastfed and bottle fed infants were advised to continue vitamin D supplementation at dose 400 IU per day

All patients were submitted to careful history taking, complete clinical examination and the following laboratory investigations.

Complete blood count
Basal serum vitamin D3 (The 25-hydroxy vitamin D): was done before enrollment of patients in the randomized trial.

Venous blood samples were collected from every subject by sterile venipuncture using disposable syringes. Each sample was then distributed as follows:

One ml of blood was disposed into a plastic tube containing EDTA solution for performing complete blood count using electronic cell counter (sysmex kx-21,Japon).
|Two ml blood was delivered into plain tube and centrifuged to obtain a clear non hemolyzed serum which was used for performing 25 (OH) vitamin D assays. The specimens were stored at – 20 until the time of the analysis. The serum 25 (OH) D levels were measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method.

Facilities

Sequence: 200053145
Name Mansoura University Children's Hospital
City Mansourah
Country Egypt

Browse Interventions

Sequence: 96027720 Sequence: 96027721 Sequence: 96027722 Sequence: 96027723 Sequence: 96027724 Sequence: 96027725 Sequence: 96027726
Mesh Term Vitamin D Mesh Term Cholecalciferol Mesh Term Vitamins Mesh Term Micronutrients Mesh Term Physiological Effects of Drugs Mesh Term Bone Density Conservation Agents Mesh Term Calcium-Regulating Hormones and Agents
Downcase Mesh Term vitamin d Downcase Mesh Term cholecalciferol Downcase Mesh Term vitamins Downcase Mesh Term micronutrients Downcase Mesh Term physiological effects of drugs Downcase Mesh Term bone density conservation agents Downcase Mesh Term calcium-regulating hormones and agents
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52156391
Name Bronchiolitis
Downcase Name bronchiolitis

Id Information

Sequence: 40148157
Id Source org_study_id
Id Value MS/16.01.38

Countries

Sequence: 42557682
Name Egypt
Removed False

Design Groups

Sequence: 55577820 Sequence: 55577821
Group Type Active Comparator Group Type Placebo Comparator
Title Intervention group Title Placebo group
Description cholecalciferol at dose of 100 IU/Kg/day Description placebo

Interventions

Sequence: 52471929 Sequence: 52471930
Intervention Type Drug Intervention Type Other
Name Cholecalciferol Name Placebo
Description Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis Description Placebo supplementation during acute episode of bronchiolitis

Keywords

Sequence: 79847977 Sequence: 79847978 Sequence: 79847979 Sequence: 79847980 Sequence: 79847981
Name Acute bronchiolitis Name Vitamin D Name Modified Tal score Name Randomized Name Controlled trial
Downcase Name acute bronchiolitis Downcase Name vitamin d Downcase Name modified tal score Downcase Name randomized Downcase Name controlled trial

Design Outcomes

Sequence: 177327651
Outcome Type primary
Measure length of hospital stay
Time Frame 3 to 5 days
Description Length of hospital stay in days

Browse Conditions

Sequence: 193431809 Sequence: 193431802 Sequence: 193431803 Sequence: 193431804 Sequence: 193431805 Sequence: 193431806 Sequence: 193431807 Sequence: 193431808
Mesh Term Lung Diseases Mesh Term Bronchiolitis Mesh Term Bronchitis Mesh Term Respiratory Tract Infections Mesh Term Infections Mesh Term Bronchial Diseases Mesh Term Respiratory Tract Diseases Mesh Term Lung Diseases, Obstructive
Downcase Mesh Term lung diseases Downcase Mesh Term bronchiolitis Downcase Mesh Term bronchitis Downcase Mesh Term respiratory tract infections Downcase Mesh Term infections Downcase Mesh Term bronchial diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term lung diseases, obstructive
Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48305984
Agency Class OTHER
Lead Or Collaborator lead
Name Mansoura University

Overall Officials

Sequence: 29277890
Role Principal Investigator
Name amal osman, M.D.
Affiliation Mansoura University

Design Group Interventions

Sequence: 68130769 Sequence: 68130770
Design Group Id 55577820 Design Group Id 55577821
Intervention Id 52471929 Intervention Id 52471930

Eligibilities

Sequence: 30757308
Gender All
Minimum Age 1 Month
Maximum Age 24 Months
Healthy Volunteers No
Criteria Inclusion Criteria:

Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and presented with any of the following:

Persistent resting oxygen saturation below 92% in room air.
Marked tachypnea.
Intercostal retractions indicating respiratory distress.
Inability to maintain oral hydration.
Parent unable to care for child at home.

Exclusion Criteria:

Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition.
Patients receiving any micronutrient supplementation or therapies containing vitamin D for 4 weeks prior to the study period.
Infants with previous episodes of wheezing or a physician's diagnosis of asthma.
Patients with acute bronchiolitis having very severe clinical score.

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254226290
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 5
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 1
Maximum Age Num 24
Minimum Age Unit Month
Maximum Age Unit Months
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30503533
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26665860
Intervention Id 52471929
Name Vitamin D

Responsible Parties

Sequence: 28869811
Responsible Party Type Principal Investigator
Name Amal Osman
Title Lecturer of Pediatrics, Mansoura University
Affiliation Mansoura University

Study References

Sequence: 52049362
Pmid 33305842
Reference Type derived
Citation Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

]]>

<![CDATA[ Buckle Me Up!: A Digital Emergency Department Discharge Intervention for Child Car Safety ]]>
https://zephyrnet.com/NCT03799393
2017-08-01

https://zephyrnet.com/?p=NCT03799393
NCT03799393https://www.clinicaltrials.gov/study/NCT03799393?tab=tableNANANAThis study explores the utility of a tablet computer-based, individually-tailored application called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of of children age 0-21 years old in the Emergency Department. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention – CIAS, a tablet-based computer program. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups.
<![CDATA[

Studies

Study First Submitted Date 2018-12-24
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-12-09
Start Month Year August 1, 2017
Primary Completion Month Year February 28, 2019
Verification Month Year December 2021
Verification Date 2021-12-31
Last Update Posted Date 2021-12-09

Detailed Descriptions

Sequence: 20792333
Description This study explores the utility of a tablet computer-based, individually-tailored technology called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of a convenience sample of 200 children age 0-21 years old who present to the Hasbro Children's Hospital Emergency Department by car and have access to a smartphone and/or email. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention – CIAS, a computer program that allows families to interact with a tablet computer to receive educational information customized to the patient. Children 13 years old and above will answer questions themselves instead of having their parent/guardian answer for them. Both group will be offered information for the Lifespan Injury Prevention Center's Kohl's Car Seat Program. Both groups will complete a questionnaire on the usefulness of their discharge education. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups.

Facilities

Sequence: 200729942
Name Hasbro Children's Hospital Emergency Department
City Providence
State Rhode Island
Zip 02903
Country United States

Conditions

Sequence: 52352795 Sequence: 52352796 Sequence: 52352797
Name Safety Issues Name Injuries Name Car Accident
Downcase Name safety issues Downcase Name injuries Downcase Name car accident

Id Information

Sequence: 40288731
Id Source org_study_id
Id Value 2012-17

Countries

Sequence: 42710615
Name United States
Removed False

Design Groups

Sequence: 55795171 Sequence: 55795172
Group Type Active Comparator Group Type Experimental
Title Control Group Title Experimental/CIAS Group
Description The control group will receive a brief tablet-based questionnaire followed by standard, paper discharge instructions on car safety. Children ≥13 years old and above will answer questions themselves. They will complete a questionnaire on the usefulness of their discharge education.

One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.

Description The Experimental/CIAS Group will receive a brief tablet-based questionnaire followed by the intervention – CIAS, an interactive tablet computer program that gives educational information customized to the patient's age and size. Children ≥13 years old will answer questions and interact with the program themselves. They will complete a questionnaire on the usefulness of their discharge education.

One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.

Interventions

Sequence: 52663852 Sequence: 52663851
Intervention Type Behavioral Intervention Type Behavioral
Name Standard Printed Discharge Instructions Name CIAS (Computer Intervention Authoring Software)
Description Patients/families will receive standard, printed discharge instructions. This is a 5 page general document from our Injury Prevention Center that describes appropriate car restraint safety for all age groups, not specific to the child enrolled. Description This is a digital application that allows families to interact with a tablet computer to receive educational information customized to the patient's age and size. allows authors to develop screening, assessment, and intervention tools for patients without requiring new programming. The CIAS intervention is programmed using tailored branching logic to allow a custom path through the intervention based on the respondent's answers. Delivery of the intervention uses a two-dimensional avatar narrator character that mimics the conversational structure of person-delivered brief interventions.

Keywords

Sequence: 80118423 Sequence: 80118424 Sequence: 80118425 Sequence: 80118426 Sequence: 80118427
Name injury prevention Name car safety Name car seats Name booster seats Name car restraints
Downcase Name injury prevention Downcase Name car safety Downcase Name car seats Downcase Name booster seats Downcase Name car restraints

Design Outcomes

Sequence: 178048746 Sequence: 178048747 Sequence: 178048748 Sequence: 178048749 Sequence: 178048750 Sequence: 178048751 Sequence: 178048752 Sequence: 178048753
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Demonstration of age-appropriate car restraint knowledge Measure Change in car restraint knowledge Measure Actions taken related to car restraints Measure Rate of difference types of actions taken related to car restraints Measure Satisfaction with discharge education – CIAS Measure Parental confidence in type of car restraint Measure Parental confidence in car restraint installation Measure Parental confidence in buckling the car restraint
Time Frame one week after enrollment Time Frame one week after enrollment Time Frame one week after enrollment Time Frame one week after enrollment Time Frame during intervention/enrollment Time Frame one week after enrollment Time Frame one week after enrollment Time Frame one week after enrollment
Description Rate of correct response to a post-intervention follow-up survey question regarding age appropriate car restraint for child in control group vs. intervention group. Description Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention Description Rate of parental self-report of actions taken related to changing use of car restraints on post-intervention follow-up survey. This will be a binary variable (NO action taken vs. YES action taken). Description Rates of each specific type of actions taken will also be compared between control and intervention groups (e.g. percentage of subjects who purchased a new car restraint device in each group, percentage of patients that had car seat installation checked at a fire department in each group, etc). Description For intervention group only – parent/patient satisfaction with education given on discharge based on score on Technology Posttrial Impressions Questionnaire. We will examine 13 individual components scored on an ordinal scale 1 to 5 (poor, fair, good, very good, excellent). Mean total score will be calculated. Description Change in parental confidence that child is in the correct type of car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:

How confident are you that your child is in the right type of car restraint?

1- not at all confident 2- 3- 4- 5- very confident

Description Change in parental confidence that car restraint is correctly installed, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:

How confident are you that your car restraint is installed correctly?

1- not at all confident 2- 3- 4- 5- very confident

Description Change in parental confidence that the child is correctly buckled in the car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:

How confident are you that your child is correctly buckled into the car restraint?

1- not at all confident 2- 3- 4- 5- very confident

Browse Conditions

Sequence: 194177447 Sequence: 194177448 Sequence: 194177449
Mesh Term Emergencies Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term emergencies Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48488244
Agency Class OTHER
Lead Or Collaborator lead
Name Lifespan

Overall Officials

Sequence: 29381423
Role Study Director
Name Susan Duffy, MD, MPH
Affiliation Associate Professor

Design Group Interventions

Sequence: 68396841 Sequence: 68396842
Design Group Id 55795172 Design Group Id 55795171
Intervention Id 52663851 Intervention Id 52663852

Eligibilities

Sequence: 30870131
Gender All
Minimum Age N/A
Maximum Age 21 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

– Children age 0-21 years presenting to the children's emergency department for any chief complaint whose parent/guardian owns or has access to a car that the child rides in (or for adolescents 16 years or older, have access to a car themselves).

Exclusion Criteria:

No access to email or a smart phone
Adolescents with significant developmental delay
Adolescents who are critically injured
No parent/guardian present at time of enrollment

Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254027863
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 19
Were Results Reported False
Has Us Facility True
Has Single Facility True
Maximum Age Num 21
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30615929
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Single
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28982467
Responsible Party Type Principal Investigator
Name Almaz Dessie
Title Principal Investigator
Affiliation Lifespan

]]>

<![CDATA[ DRIHNC – Dehydration Reduction in Head & Neck Cancer ]]>
https://zephyrnet.com/NCT03799380
2019-11-05

https://zephyrnet.com/?p=NCT03799380
NCT03799380https://www.clinicaltrials.gov/study/NCT03799380?tab=tableNANANAThe purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head & neck (H&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-11-03
Start Month Year November 5, 2019
Primary Completion Month Year May 5, 2021
Verification Month Year November 2021
Verification Date 2021-11-30
Last Update Posted Date 2021-11-03

Detailed Descriptions

Sequence: 20837991
Description Among patients with cancer of the H&N or esophagus, complications related to dehydration are fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even inpatient admission. By instructing participants to drink a reasonable amount of a common electrolyte-rich energy drink from the initiation of treatment through its completion, the hypothesis will be tested that this inexpensive and easily administered preventative strategy can significantly decrease the rate of ACC and ED visits.

The objectives of this study are to decrease the frequency of ACC visits during the course of radiation therapy and decrease the frequency of ED visits during the course of radiation therapy. The study team also seeks to decrease the incidence of orthostatic vital signs during the course of radiation therapy and decrease the number of days of missed treatments due to radiation toxicity during the course of radiation therapy.

In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course of radiation, along with standard of care nutritional support from dietitians. The randomized Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional support. Group 2 will receive standard of care nutritional support plus the study agent, Gatorade G2.

Facilities

Sequence: 201176072
Name Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City Cleveland
State Ohio
Zip 44106
Country United States

Conditions

Sequence: 52469404 Sequence: 52469405 Sequence: 52469406
Name Dehydration Name Head & Neck Cancer Name Esophageal Cancer
Downcase Name dehydration Downcase Name head & neck cancer Downcase Name esophageal cancer

Id Information

Sequence: 40372466
Id Source org_study_id
Id Value CASE8318

Countries

Sequence: 42807918
Name United States
Removed False

Design Groups

Sequence: 55924638 Sequence: 55924639
Group Type Active Comparator Group Type Experimental
Title Control – Standard of Care Title Experimental – Gatorade
Description Standard of care nutritional support Description Standard of care nutritional support with the addition of daily Gatorade G2

Interventions

Sequence: 52779740 Sequence: 52779741
Intervention Type Dietary Supplement Intervention Type Dietary Supplement
Name Gatorade G2 Name Standard of care nutritional support
Description Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks) Description Standard of care nutritional support

Design Outcomes

Sequence: 178498165 Sequence: 178498166 Sequence: 178498163 Sequence: 178498164
Outcome Type secondary Outcome Type secondary Outcome Type primary Outcome Type primary
Measure Incidence of orthostatic vital signs Measure Missed days of radiation +/- chemotherapy/immunotherapy treatment Measure ACC visits Measure ED visits
Time Frame Up to 11 weeks after start of treatment Time Frame Up to 7 weeks after start of treatment Time Frame Up to 11 weeks after start of treatment Time Frame Up to 11 weeks after start of treatment
Description Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits. Description Number of missed days of radiation treatment among H&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment. Description ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation. Description Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation.

Browse Conditions

Sequence: 194626385 Sequence: 194626386 Sequence: 194626387 Sequence: 194626388 Sequence: 194626389 Sequence: 194626390 Sequence: 194626391 Sequence: 194626392 Sequence: 194626393 Sequence: 194626394 Sequence: 194626395 Sequence: 194626396 Sequence: 194626397
Mesh Term Head and Neck Neoplasms Mesh Term Esophageal Neoplasms Mesh Term Dehydration Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Gastrointestinal Neoplasms Mesh Term Digestive System Neoplasms Mesh Term Digestive System Diseases Mesh Term Esophageal Diseases Mesh Term Gastrointestinal Diseases Mesh Term Water-Electrolyte Imbalance Mesh Term Metabolic Diseases Mesh Term Pathologic Processes
Downcase Mesh Term head and neck neoplasms Downcase Mesh Term esophageal neoplasms Downcase Mesh Term dehydration Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term gastrointestinal neoplasms Downcase Mesh Term digestive system neoplasms Downcase Mesh Term digestive system diseases Downcase Mesh Term esophageal diseases Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term water-electrolyte imbalance Downcase Mesh Term metabolic diseases Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48596466
Agency Class OTHER
Lead Or Collaborator lead
Name Case Comprehensive Cancer Center

Overall Officials

Sequence: 29441657
Role Principal Investigator
Name Elisha Fredman, MD
Affiliation University Hospitals Cleveland Medical Center

Design Group Interventions

Sequence: 68558422 Sequence: 68558423
Design Group Id 55924639 Design Group Id 55924638
Intervention Id 52779740 Intervention Id 52779741

Eligibilities

Sequence: 30936492
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

– Subjects must have histologically confirmed primary invasive cancer of the H&N (Nasopharynx/Nasal Cavity, Oral cavity, Oropharynx, Larynx, Hypopharynx) or Esophagus.

Histologies: squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, sinonasal undifferentiated carcinoma Stages: Any stage that necessitates radiation therapy (either definitive, neoadjuvant or adjuvant) as per standard practice guidelines (NCCN, ASTRO)

Subjects must have received no prior radiation therapy to the head, neck, thorax or abdomen in the last 1 year (with the exception of scalp squamous cell or basal cell carcinoma.
ECOG Performance status 0-2.
Life expectancy of ≥ 3 months, in the opinion of and as documented by the investigator.
Subjects must have organ and marrow function based on lab values deemed acceptable to proceed with radiation therapy. No additional or specific lab value cutoffs are required for this protocol given the nature of the intervention. General guidelines are provided below.
Hemoglobin ≥ 7 g/dl
Absolute neutrophil count ≥ 500/mcL
Platelet count ≥ 50,000/mcL
Total bilirubin within normal institutional limits
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
HIV-positive subjects on combination antiretroviral therapy are eligible.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment.

Prior radiation therapy to the head, neck, thorax or abdomen in the last year, with the exception of scalp squamous cell or basal cell carcinoma.
Patients with active, uncontrolled, symptomatic volume overload congestive heart failure.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254222790
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 18
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30682117
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29048843
Responsible Party Type Sponsor

]]>

<![CDATA[ The Feasibility of Drug Delivery to Infants During Breastfeeding ]]>
https://zephyrnet.com/NCT03799367
2018-07-09

https://zephyrnet.com/?p=NCT03799367
NCT03799367https://www.clinicaltrials.gov/study/NCT03799367?tab=tableNANANAParents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water. To overcome these challenges and encourage breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery system that makes it possible to give medicine and nutrients to babies during breastfeeding. It consists of a silicone nipple shield that allows the release of medicine/nutrients into human milk during the feed. Presentations of a prototype to parents and staff at the Rosie Hospital was very positive, and encouraged this clinical study. This study aims to give a vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.
<![CDATA[

Studies

Study First Submitted Date 2018-07-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year July 9, 2018
Primary Completion Month Year December 31, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200617878
Name addenbrookes Hospital
City Cambridge
Country United Kingdom

Conditions

Sequence: 52328196 Sequence: 52328197 Sequence: 52328198 Sequence: 52328199
Name Medication Systems Name Breast Feeding Name Milk, Human Name Infant, Newborn
Downcase Name medication systems Downcase Name breast feeding Downcase Name milk, human Downcase Name infant, newborn

Id Information

Sequence: 40271016
Id Source org_study_id
Id Value 18/LO/0551

Countries

Sequence: 42691058
Name United Kingdom
Removed False

Interventions

Sequence: 52639205
Intervention Type Device
Name Drug delivery during breastfeeding
Description This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.

Design Outcomes

Sequence: 177959668 Sequence: 177959669
Outcome Type primary Outcome Type secondary
Measure Detection of the change in vitamin B12 concentration in the infants' blood 6-8 hours following vitamin B12 delivery from a nipple shield device during breastfeeding Measure Qualitative assessment of impact on maternal expectation, experience and acceptability
Time Frame Blood sampling base line and 6-8 hours post feed Time Frame Interviews will be conducted prior to and post interventional feed and will last about 30-50 min.
Description Two infant blood samples will be taken – one base line and one post intervention Description Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding

Sponsors

Sequence: 48466339 Sequence: 48466340
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Cambridge University Hospitals NHS Foundation Trust Name University of Cambridge

Eligibilities

Sequence: 30856276
Gender All
Minimum Age 7 Days
Maximum Age 12 Months
Healthy Volunteers No
Criteria Inclusion Criteria:

No known allergy or hypersensitivity against any ingredient used in the study Infant aged up to 12 months Confident breastfeeder (exclusively or non-exclusively)

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

Not confident at breastfeeding
Infant not feeding properly
Allergy or hypersensitivity against any ingredient of the commercially available Methylcobalamin Vitamin B12 Tablets (Just Vitamins Ltd, UK) used in the study (infant or mother)
Medical conditions that could negatively influence swallowing, and thus breastfeeding

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254312995
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 5
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 7
Maximum Age Num 12
Minimum Age Unit Days
Maximum Age Unit Months
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30602115
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Device Feasibility
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28968630
Responsible Party Type Principal Investigator
Name Kathryn Beardsall
Title University Lecturer, University of Cambridge
Affiliation Cambridge University Hospitals NHS Foundation Trust

Study References

Sequence: 52232544
Pmid 35245341
Reference Type derived
Citation Maier T, Peirce P, Baird L, Whitehouse SL, Slater NKH, Beardsall K. Drug delivery from a solid formulation during breastfeeding-A feasibility study with mothers and infants. PLoS One. 2022 Mar 4;17(3):e0264747. doi: 10.1371/journal.pone.0264747. eCollection 2022.

]]>

<![CDATA[ Study on Impact of Maximal Strength Training in Patients With COPD ]]>
https://zephyrnet.com/NCT03799354
2019-09-18

https://zephyrnet.com/?p=NCT03799354
NCT03799354https://www.clinicaltrials.gov/study/NCT03799354?tab=tablePaola Baiardi, Mathpaola.baiardi@icsmaugeri.it0039+0382+592In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.

Maximal Strength Training (MST) is a kind of RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.

When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.

Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
<![CDATA[

Studies

Study First Submitted Date 2018-12-04
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-08-11
Start Month Year September 18, 2019
Primary Completion Month Year June 15, 2023
Verification Month Year December 2021
Verification Date 2021-12-31
Last Update Posted Date 2022-08-11

Detailed Descriptions

Sequence: 20822172
Description Exercise intolerance is a cardinal problem existing in patients with Chronic Obstructive Pulmonary Disease (COPD). Moreover, skeletal muscle dysfunction is a common extra-pulmonary manifestation, leading to fatigue, decrease in activity of daily living (ADL) performance and quality of life and increase of risk of falls, mainly in older patients. In the context of pulmonary rehabilitation, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.

As concern the RT programs, metanalysis in COPD describe that training have been mainly performed with the lower limbs and the training intensities are heterogeneous, generally ranging from 40% to 70% of 1-Repetition Maximum (1-RM).

Maximal Strength Training (MST) is a RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.

When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.

Although the mechanisms at the base of MST effect on the mechanical efficiency have not been completely clarified, there is evidence that changes in the relationships between power and speed bring to a longer relaxation phase inside the cycle of job, improving the recovery between contractions.

In this field, only a small cohort study of COPD patients was conducted describing that MST can meaningfully improve the strength and the RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. Nevertheless, this study has been conducted only in a small cohort (twelve patients) of patients with COPD and further studies are necessary to define the impact on the different components that determine the effort intolerance.

The main aim of this physiological pilot randomized controlled trail will be to test the feasibility and the efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).

Facilities

Sequence: 201025529
Status Recruiting
Name ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane
City Lumezzane
State Brescia
Zip 25065
Country Italy

Facility Contacts

Sequence: 28249728 Sequence: 28249729
Facility Id 201025529 Facility Id 201025529
Contact Type primary Contact Type backup
Name Mara Paneroni, MSc, PT Name Michele Vitacca, MD
Email mara.paneroni@icsmaugeri.it Email michele.vitacca@icsmaugeri.it
Phone 0039+030+8253 Phone 0039+030+8253
Phone Extension 122 Phone Extension 182

Conditions

Sequence: 52429186
Name Chronic Obstructive Pulmonary Disease
Downcase Name chronic obstructive pulmonary disease

Id Information

Sequence: 40342075
Id Source org_study_id
Id Value ICS Maugeri CE 2241

Countries

Sequence: 42773619
Name Italy
Removed False

Design Groups

Sequence: 55879528 Sequence: 55879529
Group Type Experimental Group Type Active Comparator
Title Treatment Group Title Control group
Description Maximal strenght training (MST) plus endurance training (ET) Description Endurance training (ET)

Interventions

Sequence: 52738550 Sequence: 52738551
Intervention Type Other Intervention Type Other
Name Maximal strenght training (MST) plus endurance training (ET) Name Endurance training (ET)
Description Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of:

MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength training will be performed on a seated horizontal leg press.
ET – A cycling session will follow the MST and last 40 minutes at constant-load, starting from a load intensity corresponding to patient specific AT. The intensity will be gradually increased with a symptom-based progression.

Description Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-down will be provided. Heart rate (HR), blood pressure, oxygen pulsoxymetry, and symptoms by Borg CR10 scale will be monitored at the beginning and end of each session.

Out of the training-days, both groups will continue their normal daily living with modest regular activity, as recommended by their physician.

Keywords

Sequence: 80217494 Sequence: 80217495 Sequence: 80217496
Name rehabilitation Name resistive training Name exercise
Downcase Name rehabilitation Downcase Name resistive training Downcase Name exercise

Design Outcomes

Sequence: 178349218 Sequence: 178349219 Sequence: 178349220 Sequence: 178349221 Sequence: 178349222 Sequence: 178349223 Sequence: 178349224 Sequence: 178349225 Sequence: 178349226 Sequence: 178349227 Sequence: 178349228 Sequence: 178349229 Sequence: 178349230 Sequence: 178349231 Sequence: 178349232 Sequence: 178349233 Sequence: 178349234 Sequence: 178349235 Sequence: 178349236 Sequence: 178349237 Sequence: 178349238
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in walking efficiency Measure Change in Leg Strength by 1-Repetition Maximum on leg press Measure Change in maximal Rate of Force Development (RFD) Measure Change in maximal effort tolerance Measure Change in Constant Load Effort tolerance Measure Change in Fatigue (physiological evaluation) Measure Change in Fatigue (qualitative evaluation) Measure Change in Muscle volume Measure Change in Dyspnea Measure Concentration of CRP Measure Change in Low grade Inflammation Measure Concentration of Tumor necrosis factor alpha Measure Concentration of Interleukin-6 Measure Muscular proteolyses by 3-MeH concentration Measure Change in Balance (qualitative measure) Measure Change in quality of life Measure Patient Satisfaction: Likert Scale Measure Change in Falls Measure Hospitalizations Measure Mortality Measure Change in Balance (quantitative measure)
Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame baseline and 8 weeks Time Frame at 8 weeks Time Frame baseline and 8 months Time Frame baseline and 8 months Time Frame baseline and 8 months Time Frame baseline and 8 weeks
Description The text will be executed using a portable metabolimeter detecting oxygen consumption (VO2).

After a 10 min of warm up on a treadmill, the patient will walk 5 min at submaximal steady state walking at 4.5 km/h at 5% incline.

Using the average of VO2 of the last minute of walking, the walking efficiency will be defined as percentage of change as follows: external work accomplished/ energy expenditure x 100.

Description 1-Repetition Maximum (1RM) will be evaluated. 1RM will be measured on a horizontal leg press at a knee angle of 90°. 1RM will be recorded as the heaviest lifted load achieved, applying rest periods of ~4 min between test lifts and increments of 5 kg between each trial until failure. Description Immediately after the maximal test 1-RM (see above), using the same apparatus, maximal rate of Force Development (RFD) will be assessed using a force platform and applying a load corresponding to 75% of the participant's pre-test 1RM. The subjects will be instructed to execute the lift as rapidly as possible in the concentric phase. RFD will be analyzed as the time difference between 10% and 90% of Peak force. Description It will be evaluated by VO2 consumption on maximal cardiopulmonary exercise test (CPET) on cycloergometer Description It will be evaluated by evaluated by time of execution of Cardiopulmonary Constant-Load Endurance Test Description To define peripheral and central component of fatigue, before and after CLET, the investigators will test the difference on force produced during a single twitch superimposed on the Maximal Voluntary Contraction (MVC) and the force produced by the electrically evoked Resting Twitch (RT) produced, at rest, 5 seconds after the MVC. Description Fatigue Severity Scale (scale measuring fatigue, 9-item scale ranging from 7 = absence of fatigue to 63= maximal presence of fatigue) Description Sagittal ultrasound images of the Vastus Lateralis (VL) muscle will be recorded with an 8-12 MHz linear transducer. Images will be obtained with a 90° flexion of hip and knee, at 50% of femur length. The pennation angle (hp) of the VL fascicles will be measured as the angle between the VL muscle fascicles and the deep aponeurosis of the insertion. Description Barthel Index Dyspnea (scale measuring dyspnea during basal ADL, 10-item scale ranging from 0 = absence of dyspnea to 100 = maximal dyspnea) Description C reactive protein [CRP] (mg/dl) Description Evaluation of neutrophils/ lymphocytes ratio Description TNF-alpha (pg/ml) Description IL6 (pg/ml) Description Evaluation of urinary 3 Methyl-Histine (3-MeH) (micromol/ml) Description BERG scale ( scale measuring balance, composed by 14 balance related tasks, ranging from 0 = worse balance to 56= best balance) Description EuroQol 5-D (scale measuring quality of life, composed by 2 sessions: one of 5 questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with multiple choice ranging from 0 = no problem to 25= very low quality of life and one using Visual Analogic Scale (VAS) to quantify the health status ranging from 0 = worst health condition to 100 = best health condition. The two scale sessions are considered separately. Description Likert Scale 0-4 ( 0=completely unsatisfied, 4= very satisfied). Description Evaluation of the rate of falls Description Evaluation of the rate of hospitalizations Description Evaluation of deaths (number) Description The fall risk (FR) assessment will be evaluated by Balance Board.

Browse Conditions

Sequence: 194467913 Sequence: 194467914 Sequence: 194467915 Sequence: 194467916 Sequence: 194467917 Sequence: 194467918 Sequence: 194467919
Mesh Term Lung Diseases, Obstructive Mesh Term Pulmonary Disease, Chronic Obstructive Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases Mesh Term Chronic Disease Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term lung diseases, obstructive Downcase Mesh Term pulmonary disease, chronic obstructive Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48558168 Sequence: 48558169
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Istituti Clinici Scientifici Maugeri SpA Name Universita di Verona

Overall Officials

Sequence: 29419480
Role Principal Investigator
Name Mara Paneroni, MSc, PT
Affiliation Istituti Clinici Scientifici Maugeri

Central Contacts

Sequence: 12076270 Sequence: 12076271
Contact Type primary Contact Type backup
Name Mara Paneroni, MSc, PT Name Paola Baiardi, Math
Phone 0039+030+8253 Phone 0039+0382+592
Email mara.paneroni@icsmaugeri.it Email paola.baiardi@icsmaugeri.it
Phone Extension 122 Phone Extension 599
Role Contact Role Contact

Design Group Interventions

Sequence: 68501762 Sequence: 68501763
Design Group Id 55879528 Design Group Id 55879529
Intervention Id 52738550 Intervention Id 52738551

Eligibilities

Sequence: 30913340
Gender All
Minimum Age 50 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) < 70%, and FEV1 < 50% of predicted
stable clinical condition

Exclusion Criteria:

pulmonary diseases other than COPD
type II diabetes or other metabolic diseases
malign disease
a respiratory tract infection within the last 4 wks
long oxygen therapy use.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254176376
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 50
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 20

Designs

Sequence: 30659035
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)
Intervention Model Description Pilot randomized controlled trial

Responsible Parties

Sequence: 29025709
Responsible Party Type Sponsor

Study References

Sequence: 52339669 Sequence: 52339670 Sequence: 52339671 Sequence: 52339672
Pmid 24787074 Pmid 10378915 Pmid 17277584 Pmid 19804581
Reference Type background Reference Type background Reference Type background Reference Type background
Citation Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST. Citation Hoff J, Helgerud J, Wisloff U. Maximal strength training improves work economy in trained female cross-country skiers. Med Sci Sports Exerc. 1999 Jun;31(6):870-7. doi: 10.1097/00005768-199906000-00016. Citation Hoff J, Tjonna AE, Steinshamn S, Hoydal M, Richardson RS, Helgerud J. Maximal strength training of the legs in COPD: a therapy for mechanical inefficiency. Med Sci Sports Exerc. 2007 Feb;39(2):220-6. doi: 10.1249/01.mss.0000246989.48729.39. Citation Wang E, Helgerud J, Loe H, Indseth K, Kaehler N, Hoff J. Maximal strength training improves walking performance in peripheral arterial disease patients. Scand J Med Sci Sports. 2010 Oct;20(5):764-70. doi: 10.1111/j.1600-0838.2009.01014.x.

]]>

<![CDATA[ Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project ]]>
https://zephyrnet.com/NCT03799341
2019-11-13

https://zephyrnet.com/?p=NCT03799341
NCT03799341https://www.clinicaltrials.gov/study/NCT03799341?tab=tableStuart R Steinhauer, PhDStuart.Steinhauer@va.gov(412) 360-2397The proposed work will investigate changes in brain signaling and cognitive functioning that support recovery from addiction, as well as use of pretreatment neurocognitive functioning to inform substance use treatment planning. Substance use disorders are prevalent amongst Veterans. Cocaine addiction, in particular, has been shown to complicate treatment of other high priority behavioral health problems in the Veteran population (e.g., PTSD, opioid addiction). While there are currently no approved medications to support recovery from cocaine addiction, research indicates that Contingency Management (CM) – a behavioral intervention for cocaine users – can be effective. However, individual responses are variable and long-term benefits are limited. This CDA will test a new model of how CM works by examining brain-based predictors and indicators of treatment response. Results will have immediate implications for measurement-based implementation of existing CM variants within the VA, supporting access to the version of CM that is best aligned with each Veteran’s needs.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-03-06
Start Month Year November 13, 2019
Primary Completion Month Year December 31, 2023
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-06

Detailed Descriptions

Sequence: 20685817
Description Electrophysiological methods, including event-related potential and functional connectivity approaches, have potential to clarify mechanisms of substance use treatment response and characterize individual differences therein. Veterans are disproportionately affected by disorders of addiction, of which cocaine use disorder (CUD) is particularly problematic due to high relapse rates and the absence of approved pharmacotherapy options. Behavioral interventions for CUD have therefore become an important focus and Contingency Management (CM) has emerged as the best-supported approach. CM involves reinforcing cocaine abstinence (established through objective testing) with reliable, short-term reward, such as chances to win prizes (i.e., Prize-Based CM or PBCM). Given robust empirical support, nationwide dissemination of PBCM has been supported by a VHA initiative since 2011. However, PBCM response rates are variable and long-term benefits are limited – problems magnified by the cost of implementation with respect to staffing and prizes. Measurement-based approaches to PBCM implementation have promise to improve the effectiveness and efficiency of CM programming but have not yet been investigated within the VA or considered in relation to promising neuromarkers. Importantly, two versions of PBCM are already utilized at VA sites and may differentially benefit individuals with distinct neurocognitive profiles. Specifically, VA PBCM programs employ either abstract (voucher prize) or concrete (tangible prize) incentives, the latter of which may more effectively incentivize abstinence in Veterans with poor future-oriented thinking and planning ability. While selection between existing PBCM variants currently reflects practical considerations only, pretreatment neurocognitive functioning could meaningfully and realistically inform clinical decision-making in this regard.

This project aims to advance measurement-based implementation of CM by testing a novel neurocognitive model with immediate implications for the use of abstract versus concrete PBCM incentives within the VA. Specifically, the future-minded decision-making (FMDM) model posits that CM scaffolds future-oriented goal representation and self-control to support abstinence during in the moment use-related decision-making. For individuals with greater FMDM impairment, concrete, readily-accessible incentives may be more effective than abstract voucher-based rewards (which require future-oriented thinking and planning to acquire value). To test this model, neurocognitive substrates of FMDM will be examined as predictors of differential treatment response in voucher (VoucherPBCM) versus tangible prize (TangiblePBCM) versions of PBCM. Treatment-related change in neural and cognitive-behavioral correlates of FMDM will also be evaluated in PBCM-adherent versus non-adherent subgroups. Veterans with CUD will be allocated to VoucherPBCM or TangiblePBCM conditions and followed for a 12-week treatment interval. Pre- and post-treatment electroencephalography (EEG) and cognitive-behavioral assessments will be used to measure FMDM-related constructs (working memory, self-control, future-oriented decision-making, future reward representation) and related neuromarkers. These measures will be investigated as predictors of differential treatment response in VoucherPBCM versus TangiblePBCM, as well as maintenance of gains during a post-treatment follow-up period. Change in FMDM-related neural and cognitive measures over the course of treatment will also be evaluated for evidence of neuroadaptation (e.g., changes in functional connectivity) and enhancement of FMDM function through PBCM. Taken together, results of the current research project will represent a first step toward precision implementation of CM within the VA.

Facilities

Sequence: 199669286
Status Recruiting
Name VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City Pittsburgh
State Pennsylvania
Zip 15240
Country United States

Facility Contacts

Sequence: 28064311 Sequence: 28064312
Facility Id 199669286 Facility Id 199669286
Contact Type primary Contact Type backup
Name Sarah E Forster, PhD Name Stuart R Steinhauer, PhD
Email Sarah.Forster2@va.gov Email Stuart.Steinhauer@va.gov
Phone 412-360-2365 Phone (412) 360-2397

Facility Investigators

Sequence: 18305269
Facility Id 199669286
Role Principal Investigator
Name Sarah E. Forster, PhD

Conditions

Sequence: 52075941
Name Cocaine Use Disorder
Downcase Name cocaine use disorder

Id Information

Sequence: 40082978 Sequence: 40082979
Id Source org_study_id Id Source secondary_id
Id Value NURA-002-18S Id Value CX001807-01A1
Id Type Other Grant/Funding Number
Id Type Description VA CSR&D

Countries

Sequence: 42482393
Name United States
Removed False

Design Groups

Sequence: 55489107 Sequence: 55489108
Group Type Experimental Group Type Experimental
Title Tangible Prize-Based Contingency Management (TangiblePBCM) Title Voucher Prize-Based Contingency Management (VoucherPBCM)
Description For participants assigned to TangiblePBCM, prize draws resulting in one or more small, large, or jumbo wins will result in access to a prize cabinet stocked with small, medium, large, and jumbo financial incentive items. Medium incentive items are included for selection in the event that a patient draws several small prize slips on the same day and are considered equivalent to 4 small prizes. Selection of specific prize items will be informed by patient preference and items will be restocked at least every 2 weeks. The prize cabinet will be open during TangiblePBCM sessions such that prize items are readily visible. Selection of prizes, maintenance of the prize cabinet, and policies regarding prize redemption will follow published guidance on administration of TangiblePBCM within the context of research protocols. Description For participants assigned to VoucherPBCM, prize draws resulting in one or more small, large, or jumbo wins will be reinforced with VA Canteen vouchers in the specified incentive range (i.e., small, large, or jumbo).

Interventions

Sequence: 52388954 Sequence: 52388955
Intervention Type Behavioral Intervention Type Behavioral
Name Prize-Based Contingency Management Name Treatment As Usual Outpatient Substance Use Treatment
Description Participants assigned to Prize-based Contingency

Management (PBCM) conditions will receive PBCM as an adjunct to TAU. PBCM will involve twice weekly one-on-one sessions with a provider for 12-weeks. During each session, a urine specimen provided by the patient will be tested for cocaine using a point-of-care dip-test. Results of point-of-care testing will be shared with the patient and negative results will be reinforced with draws from a fish bowl containing 500 paper slips, 250 of which award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients will be reinforced with a single prize draw for their first negative specimen; an additional prize draw will be added for each consecutive negative result (up to 8

prize draws per session). Abstinence-contingent prize draws will be reset to one upon either a positive test result or unexcused, missed appointment.

Description All participants will receive treatment as usual outpatient substance use services during the 12-week treatment interval. TAU will specifically entail recommended participation in at least two outpatient group and/or individual psychotherapy encounters per week within the Center for Treatment of Addictive Disorders (CTAD) at VA Pittsburgh Healthcare System. Participants will additionally continue any previously prescribed pharmacotherapy for substance use and/or other mental health conditions, if applicable.

Keywords

Sequence: 79711704 Sequence: 79711705 Sequence: 79711706 Sequence: 79711707 Sequence: 79711708 Sequence: 79711709 Sequence: 79711710 Sequence: 79711711 Sequence: 79711712 Sequence: 79711713 Sequence: 79711714
Name Cocaine-Related Disorders Name Contingency Management Name Reward Name Choice Behavior Name Executive Function Name Precision Medicine Name Evidence-Based Practice Name Prospective Thinking Name Electroencephalography Name Event-Related Potentials Name Functional Connectivity
Downcase Name cocaine-related disorders Downcase Name contingency management Downcase Name reward Downcase Name choice behavior Downcase Name executive function Downcase Name precision medicine Downcase Name evidence-based practice Downcase Name prospective thinking Downcase Name electroencephalography Downcase Name event-related potentials Downcase Name functional connectivity

Design Outcomes

Sequence: 177054177 Sequence: 177054178 Sequence: 177054179 Sequence: 177054180 Sequence: 177054181 Sequence: 177054182 Sequence: 177054183 Sequence: 177054184 Sequence: 177054185 Sequence: 177054186 Sequence: 177054187 Sequence: 177054188
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure % Cocaine-Negative Urine Specimens Measure Longest Duration of Cocaine Abstinence Measure % Contingency Management (CM) Sessions Attended (CM Groups Only) Measure Total Non-CM Treatment Encounters Measure % Self-Reported Cocaine-Abstinent Days During Treatment Measure % Self-Reported Drug- and Alcohol-Abstinent Days During Treatment Measure % Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only) Measure % Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only) Measure Pre- to Post-Treatment Change in Theta Synchronization Measure Pre- to Post-Treatment Change in Executive Working Memory Measure Pre- to Post-Treatment Change in Episodic Future Thinking Effect (Delay Discounting) Measure Pre- to Post-Treatment Change Spontaneous Eyeblink Rate
Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 6 Month Post-Treatment Interval Time Frame 6 Month Post-Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval Time Frame 12-Week Treatment Interval
Description Proportion of urine specimens provided during the 12-week treatment interval that test negative for cocaine. Description Longest period of objectively verified abstinence from cocaine during treatment. Description Proportion of CM treatment sessions attended. Description Number of non-CM treatment encounters during treatment (documented in chart and/or self-reported) Description Proportion of self-reported cocaine-abstinent days during the 12-week treatment interval. Description Proportion of self-reported drug- and alcohol-abstinent days during the 12-week treatment interval. Description Proportion of self-reported stimulant-abstinent days during the 6 month post-treatment interval. Description Proportion of self-reported drug- and alcohol-abstinent days during the 6 month post-treatment interval. Description Treatment-related change in theta synchronization between anterior cingulate cortex and lateral prefrontal cortex during high conflict events in the Parametric Conflict Flankers task. Description Treatment-related change in Brown-Peterson working memory scores. We will specifically use a modified Brown-Peterson test (Auditory Consonant Trigrams) for which both age- and Veteran-specific norms exist. Summary scores for this measure (including 9-, 18-, and 36-second delay conditions) can range from 0-45, with higher scores indicating improved executive working memory performance. Description Treatment-related change in the difference in delay discounting slopes (ln(k)) estimated for discounting conditions with and without personally meaningful event tags. Description Treatment-related change in spontaneous eyeblink rate at rest.

Sponsors

Sequence: 48231043
Agency Class FED
Lead Or Collaborator lead
Name VA Office of Research and Development

Overall Officials

Sequence: 29229791
Role Principal Investigator
Name Sarah E. Forster, PhD
Affiliation VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Central Contacts

Sequence: 11988926 Sequence: 11988927
Contact Type primary Contact Type backup
Name Sarah E Forster, PhD Name Stuart R Steinhauer, PhD
Phone (412) 360-2365 Phone (412) 360-2397
Email Sarah.Forster2@va.gov Email Stuart.Steinhauer@va.gov
Role Contact Role Contact

Design Group Interventions

Sequence: 68022635 Sequence: 68022636 Sequence: 68022637 Sequence: 68022638
Design Group Id 55489107 Design Group Id 55489108 Design Group Id 55489107 Design Group Id 55489108
Intervention Id 52388954 Intervention Id 52388954 Intervention Id 52388955 Intervention Id 52388955

Eligibilities

Sequence: 30709974
Gender All
Minimum Age 18 Years
Maximum Age 75 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Military Veterans
DSM-5 Criteria for Cocaine Use Disorder (Mild, Moderate, or Severe)
Cocaine Use Within Past 60 Days
Stated Goal of Cocaine Abstinence or Reduced Cocaine Use
Normal or Corrected-to-Normal Vision
Average or Corrected Hearing

Exclusion Criteria:

History of Severe Traumatic Brain Injury, Seizure Disorder, or other Neurological Illness
Severe or Unstable Medical or Psychiatric Condition
Pregnant or Lactating Women
Moderate-to-Severe Neurocognitive Impairment per Medical Record, SLUMS < 21, or Mini MoCA < 11
In Ongoing Residential Treatment or Imminently Expected to Enter Residential Treatment During the Study Interval at Time of Screening

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253935080
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 6
Number Of Other Outcomes To Measure 4

Designs

Sequence: 30456565
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Participants will be randomly assigned to receive: (1) 12 weeks of TangiblePBCM (n = 70) or (2) 12 weeks of VoucherPBCM (n = 70). CM recipients will also be followed for 6 months post treatment. The proposed design enables evaluation of CM outcome predictors within 140 CM recipients – both with respect to initial treatment response and longer term (6 month) outcomes. All participants will receive a Baseline Assessment prior to the 12 Week Treatment interval, as well as a Follow-up Assessment at the conclusion of this period. Data from Baseline and Follow-up Assessments will enable longitudinal analysis of treatment-related change in EEG and cognitive-behavioral measures in TangiblePBCM and VoucherPBCM in treatment adherent versus treatment non-adherent subgroups.

Responsible Parties

Sequence: 28823039
Responsible Party Type Sponsor

]]>

<![CDATA[ Low Dose Multi-OIT for Food Allergy (LoMo) ]]>
https://zephyrnet.com/NCT03799328
2019-05-23

https://zephyrnet.com/?p=NCT03799328
NCT03799328https://www.clinicaltrials.gov/study/NCT03799328?tab=tableNANANAOral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies.

Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects.

The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and
<![CDATA[

Studies

Study First Submitted Date 2018-11-20
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-05-06
Start Month Year May 23, 2019
Primary Completion Month Year January 2025
Verification Month Year May 2022
Verification Date 2022-05-31
Last Update Posted Date 2022-05-06

Detailed Descriptions

Sequence: 20562430
Description This is a single-arm, open label, study of the intervention of low dose multiple-nut OIT in nut allergic children.

After meeting eligibility criteria, participants will have a food challenge to 2-5 nuts.

If the oral food challenge is positive, participants will be enrolled in the study to multiple nut OIT. A blood draw and quality of life (QOL) survey will occur at baseline.

Participants will have dose escalation visits of the multiple nut OIT every 2 months to a target dose of 30mg of each nut protein. A blood draw and QOL survey will occur at 6 months.

Participants will then continue with daily ingestion of the 30mg of each nut protein for 1 year with visits every 3 months.

After 18 months from the start of the study, another oral food challenge will be given to participants to assess the change in the maximum tolerated dose of nuts. A blood draw will assess changes in the immune parameters. A QOL survey will occur at 18 months to assess changes in QOL.

Facilities

Sequence: 198524681
Name Hospital for Sick Children
City Toronto
State Ontario
Zip M5G1X8
Country Canada

Conditions

Sequence: 51761827
Name Food Allergy
Downcase Name food allergy

Id Information

Sequence: 39831227
Id Source org_study_id
Id Value 1000060633

Countries

Sequence: 42230995
Name Canada
Removed False

Design Groups

Sequence: 55182572
Group Type Experimental
Title multi-OIT
Description Low dose OIT with multiple allergens

Interventions

Sequence: 52082940
Intervention Type Other
Name multi-OIT
Description low dose OIT to multiple foods

Design Outcomes

Sequence: 176059986 Sequence: 176059987 Sequence: 176059988 Sequence: 176059989 Sequence: 176059990 Sequence: 176059991 Sequence: 176059992 Sequence: 176059993 Sequence: 176059994 Sequence: 176059995 Sequence: 176059996 Sequence: 176059997 Sequence: 176059998 Sequence: 176059999 Sequence: 176060000
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner Measure Immunological change in IgG4 Measure Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale Measure Immunological change in IgG4 Measure Desensitization to allergic food as assessed by maximum tolerated dose Measure Desensitization to allergic food as assessed by maximum tolerated dose Measure Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT Measure Feasibility analysis as assessed by drop-out rate Measure Incidence of Treatment-Emergent Adverse Events: Safety analysis as assessed by use of epinephrine Measure Quality of life scale Measure Change in allergen specific IgE, and components Measure Basophil activation test Measure Skin prick test (SPT) reactivity to the individual nut extracts Measure High content functional immune profiling via mass cytometry and single cell sorting Measure Number of participants with treatment related adverse effects
Time Frame month 0, month 18 Time Frame month 0, month 18 Time Frame month 0, month 18 Time Frame pre-study, month 18 Time Frame month 18 Time Frame month 0, month 18 Time Frame month 18 Time Frame month 18 Time Frame month 18 Time Frame month 0, month 18 Time Frame month 0, month 18 Time Frame month 0, month 18 Time Frame month 0, month 18 Time Frame pre-study, month 18 Time Frame month 0, month 18
Description Change in how much nuts the participant can eat without an allergic reaction after the low dose OIT assessed as dichotomous did the participant reach 5 times the baseline eliciting dose Description Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end Description A continuous variable amount tolerated at baseline vs at end Description Change in IgG4 from measures from historical data to 18 month of study. Some patients will have historical IgG4 values to compare Description Did they reach 300mg (cumulative) on the 18 month exit oral food challenge Description Did they reach 140mg (cumulative) on the 18 month exit oral food challenge Description Proportion who achieve maintenance doses of their allergen mix (descriptive) Description Proportion who drop-out of the study (descriptive) Description Administration of epinephrine; (descriptive); Description Change in quality of life at 18m of children compared to baseline assessment (using validated questionnaire: Food allergy quality of life questionnaires (FAQLQ) FAQLQ Parental form (PF) for ages 0-12 OR the FAQLQ-teenager form (TF) using total score. The FAQLQ total and domain scores range from 1-7 with higher scores indicative of worse health related quality of life with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, Food Anxiety, Allergen Avoidance, and Risk of Accidental Exposure. Description Change in allergen specific IgE, and components via microarray Description Basophil activation test Description The size of the skin prick test will be compared Description Compare the change in the immune pattern Description Diaries will be analyzed for allergic symptoms and tabulated

Browse Conditions

Sequence: 191834671 Sequence: 191834672 Sequence: 191834673 Sequence: 191834674
Mesh Term Hypersensitivity Mesh Term Food Hypersensitivity Mesh Term Immune System Diseases Mesh Term Hypersensitivity, Immediate
Downcase Mesh Term hypersensitivity Downcase Mesh Term food hypersensitivity Downcase Mesh Term immune system diseases Downcase Mesh Term hypersensitivity, immediate
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47938447
Agency Class OTHER
Lead Or Collaborator lead
Name The Hospital for Sick Children

Overall Officials

Sequence: 29045136
Role Principal Investigator
Name Julia Upton
Affiliation The Hospital for Sick Children

Design Group Interventions

Sequence: 67652690
Design Group Id 55182572
Intervention Id 52082940

Eligibilities

Sequence: 30525763
Gender All
Minimum Age 6 Months
Maximum Age 15 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Relevant allergy to 2-5 nuts
Serum immunoglobulin E (IgE) >0.35 kilounits/L (kU/L) (determined by UniCAP within the past 12 months) and/or a SPT to nut >3 mm compared to control
Positive oral food challenge (OFC) to less than 300mg of a nut in the nut mix at baseline (cumulative 444mg).

Exclusion Criteria:

History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
use of omalizumab or other non-traditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
history of eosinophilic gastrointestinal disease, uncontrolled asthma as defined by Global Initiative for Asthma (GINA)
use of beta-blockers(oral)
use of angiotensin-converting enzyme inhibitors (ACE)
fails to tolerate 4mg of peanut after the first desensitization day
Other significant medical conditions that in the opinion of the investigator prevent participation in the study,
Previous intubation due to allergies or asthma,
Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines,
Patients with problems related to compliance or following study instructions, Inability to come to hospital every for dose escalation
Pregnancy
Non-fluency in English because participants may need to communicate with us after hours and be able to describe symptoms and concerns and follow instructions to treat anaphylaxis

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254091700
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 6
Maximum Age Num 15
Minimum Age Unit Months
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 4
Number Of Other Outcomes To Measure 9

Designs

Sequence: 30274672
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Provided Documents

Sequence: 2565148
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2018-11-13
Url https://ClinicalTrials.gov/ProvidedDocs/28/NCT03799328/Prot_SAP_000.pdf

Responsible Parties

Sequence: 28654595
Responsible Party Type Principal Investigator
Name Julia Upton
Title Principal Investigator
Affiliation The Hospital for Sick Children

]]>

<![CDATA[ Jail-Based Use of Smoking Cessation Treatment Study ]]>
https://zephyrnet.com/NCT03799315
2019-01-14

https://zephyrnet.com/?p=NCT03799315
NCT03799315https://www.clinicaltrials.gov/study/NCT03799315?tab=tableNANANASmoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study’s findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.
<![CDATA[

Studies

Study First Submitted Date 2019-01-04
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-09-14
Start Month Year January 14, 2019
Primary Completion Month Year March 16, 2020
Verification Month Year September 2020
Verification Date 2020-09-30
Last Update Posted Date 2020-09-14

Detailed Descriptions

Sequence: 20735760
Description Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power > .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models.

Facilities

Sequence: 200244169
Name Hennepin Healthcare Research Institute
City Minneapolis
State Minnesota
Zip 55415
Country United States

Browse Interventions

Sequence: 96113049 Sequence: 96113050 Sequence: 96113051 Sequence: 96113052 Sequence: 96113053 Sequence: 96113054 Sequence: 96113055 Sequence: 96113056 Sequence: 96113057 Sequence: 96113058
Mesh Term Nicotine Mesh Term Ganglionic Stimulants Mesh Term Autonomic Agents Mesh Term Peripheral Nervous System Agents Mesh Term Physiological Effects of Drugs Mesh Term Nicotinic Agonists Mesh Term Cholinergic Agonists Mesh Term Cholinergic Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term nicotine Downcase Mesh Term ganglionic stimulants Downcase Mesh Term autonomic agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term nicotinic agonists Downcase Mesh Term cholinergic agonists Downcase Mesh Term cholinergic agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52208079
Name Tobacco Use
Downcase Name tobacco use

Id Information

Sequence: 40186125
Id Source org_study_id
Id Value RC-2018-0013

Countries

Sequence: 42599618
Name United States
Removed False

Design Groups

Sequence: 55634631 Sequence: 55634632
Group Type Experimental Group Type No Intervention
Title Jail-Based Use of Smoking Cessation Treatment (JUST) Title Enhanced Treatment As Usual (TAU)
Description Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail. Description Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking.

Interventions

Sequence: 52522046 Sequence: 52522047
Intervention Type Drug Intervention Type Behavioral
Name Nicotine Replacement Therapy Name Counseling
Description All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges. Description All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.

Keywords

Sequence: 79922895 Sequence: 79922896 Sequence: 79922897 Sequence: 79922898 Sequence: 79922899
Name Incarceration Name Smoking Name Counseling Name Nicotine Replacement Name Disparities
Downcase Name incarceration Downcase Name smoking Downcase Name counseling Downcase Name nicotine replacement Downcase Name disparities

Design Outcomes

Sequence: 177511092 Sequence: 177511093 Sequence: 177511094 Sequence: 177511095 Sequence: 177511096 Sequence: 177511097 Sequence: 177511098 Sequence: 177511099 Sequence: 177511100
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Bioverified 7-day point prevalence abstinence from smoking Measure Time to Lapse Measure Time to Relapse Measure Bio-verified 7-day point prevalence abstinence from smoking Measure Health-related quality of life Measure Depressive symptoms Measure Self-Reported Affect Measure Health care utilization Measure Substance abuse
Time Frame Over 3 weeks Time Frame 1 week, 3 weeks, 12 weeks Time Frame 3 weeks, 12 weeks Time Frame Over 12 weeks Time Frame 1 week, 3 weeks, 12 weeks Time Frame 1 week, 3 weeks, 12 weeks Time Frame 1 week, 3 weeks, 12 weeks Time Frame 1 week, 3 weeks, 12 weeks Time Frame 1 week, 3 weeks, 12 weeks
Description Bioverified 7-day point prevalence abstinence from smoking Description Days to first lapse (i.e., any cigarette use, even a puff) Description Days to first relapse Description Bioverified 7-day point prevalence abstinence from smoking Description Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health. Description The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms. Description 10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect. Description Self-reported hospitalizations and use of the emergency department Description Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.

Sponsors

Sequence: 48353668 Sequence: 48353669 Sequence: 48353670
Agency Class OTHER Agency Class UNKNOWN Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Hennepin Healthcare Research Institute Name Hennepin County Adult Detention Center Name Brown University

Design Group Interventions

Sequence: 68199155 Sequence: 68199156
Design Group Id 55634631 Design Group Id 55634631
Intervention Id 52522046 Intervention Id 52522047

Eligibilities

Sequence: 30786852
Gender All
Minimum Age 18 Years
Maximum Age 64 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Use of ≥ 1 cigarette per day prior to incarceration
Expected release from the Hennepin Adult Detention Center to the community within 90 days
Age 18-64
English fluency
Lives within 20 minutes of Hennepin County Medical Center and has no plans to move away from area for 4 months
Willing to attempt quitting or reducing smoking at discharge
Has a telephone
Cleared for nicotine lozenge safety by jail health care provider and willing to use at discharge

Exclusion Criteria:

Active tuberculosis
Current mental health crisis (i.e., currently experiencing significant mania, psychosis, or suicidality)
Unable to ambulate independently
Acute medical condition that would impair participant's ability to follow-up for assessments
Expected discharge to a control institutional setting (e.g., locked state mental health facility or prison)
Active pregnancy
Heart attack within the last two weeks

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253989600
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 14
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 64
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 8

Designs

Sequence: 30532922
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28899216
Responsible Party Type Principal Investigator
Name Tyler Winkelman
Title Clinician-Investigator
Affiliation Hennepin Healthcare Research Institute

Study References

Sequence: 52103034 Sequence: 52103035 Sequence: 52103036 Sequence: 52103037 Sequence: 52103038 Sequence: 52103039 Sequence: 52103040 Sequence: 52103041 Sequence: 52103042 Sequence: 52103043 Sequence: 52103044 Sequence: 52103045 Sequence: 52103046 Sequence: 52103047 Sequence: 52103048 Sequence: 52103049 Sequence: 52103050 Sequence: 52103051 Sequence: 52103052 Sequence: 52103053 Sequence: 52103054 Sequence: 52103055 Sequence: 52103056 Sequence: 52103057
Pmid 27832052 Pmid 30635028 Pmid 28116579 Pmid 25097186 Pmid 27638837 Pmid 28323472 Pmid 29309230 Pmid 24817280 Pmid 21974746 Pmid 23567902 Pmid 11716663 Pmid 22160762 Pmid 12915172 Pmid 26069036 Pmid 28415979 Pmid 27798322 Pmid 21802731 Pmid 18381994 Pmid 20509891 Pmid 34228127
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type derived
Citation Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults – United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2. Citation Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y. Citation Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23. Citation Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542. Citation Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613. Citation Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5. Citation Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21. Citation Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991. Citation Frank JW, Linder JA, Becker WC, Fiellin DA, Wang EA. Increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1226-33. doi: 10.1007/s11606-014-2877-y. Epub 2014 May 10. Citation Clarke JG, Martin RA, Stein L, Lopes CE, Mello J, Friedmann P, Bock B. Working Inside for Smoking Elimination (Project W.I.S.E.) study design and rationale to prevent return to smoking after release from a smoke free prison. BMC Public Health. 2011 Oct 5;11:767. doi: 10.1186/1471-2458-11-767. Citation Clarke JG, Stein LA, Martin RA, Martin SA, Parker D, Lopes CE, McGovern AR, Simon R, Roberts M, Friedman P, Bock B. Forced smoking abstinence: not enough for smoking cessation. JAMA Intern Med. 2013 May 13;173(9):789-94. doi: 10.1001/jamainternmed.2013.197. Citation Mulder I, Tijhuis M, Smit HA, Kromhout D. Smoking cessation and quality of life: the effect of amount of smoking and time since quitting. Prev Med. 2001 Dec;33(6):653-60. doi: 10.1006/pmed.2001.0941. Citation Piper ME, Kenford S, Fiore MC, Baker TB. Smoking cessation and quality of life: changes in life satisfaction over 3 years following a quit attempt. Ann Behav Med. 2012 Apr;43(2):262-70. doi: 10.1007/s12160-011-9329-2. Citation Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addict Behav. 2003 Sep;28(7):1323-31. doi: 10.1016/s0306-4603(02)00259-9. Citation Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res. 2016 May;18(5):993-1001. doi: 10.1093/ntr/ntv127. Epub 2015 Jun 11. Citation Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7. Citation A randomised controlled study of the Health Intervention "SNAP" in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking. Trial Review. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371923. Published October 10, 2017. Accessed December 29, 2017. Citation de Andrade D, Kinner SA. Systematic review of health and behavioural outcomes of smoking cessation interventions in prisons. Tob Control. 2016 Sep;26(5):495-501. doi: 10.1136/tobaccocontrol-2016-053297. Epub 2016 Oct 18. Citation Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; 2008. https://bphc.hrsa.gov/buckets/treatingtobacco.pdf. Accessed October 17, 2017. Citation Prisoner Research FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-andpolicy/ guidance/faq/prisoner-research/index.html. Accessed December 18, 2017. Citation Binswanger IA, Nowels C, Corsi KF, Long J, Booth RE, Kutner J, Steiner JF. "From the prison door right to the sidewalk, everything went downhill," a qualitative study of the health experiences of recently released inmates. Int J Law Psychiatry. 2011 Jul-Aug;34(4):249-55. doi: 10.1016/j.ijlp.2011.07.002. Epub 2011 Jul 29. Citation Wang EA, White MC, Jamison R, Goldenson J, Estes M, Tulsky JP. Discharge planning and continuity of health care: findings from the San Francisco County Jail. Am J Public Health. 2008 Dec;98(12):2182-4. doi: 10.2105/AJPH.2007.119669. Epub 2008 Apr 1. Citation Wang EA, Green J. Incarceration as a key variable in racial disparities of asthma prevalence. BMC Public Health. 2010 May 28;10:290. doi: 10.1186/1471-2458-10-290. Citation Winkelman TNA, Ford BR, Dunsiger S, Chrastek M, Cameron S, Strother E, Bock BC, Busch AM. Feasibility and Acceptability of a Smoking Cessation Program for Individuals Released From an Urban, Pretrial Jail: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2115687. doi: 10.1001/jamanetworkopen.2021.15687.

]]>

<![CDATA[ Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model ]]>
https://zephyrnet.com/NCT03799302
2018-08-01

https://zephyrnet.com/?p=NCT03799302
NCT03799302https://www.clinicaltrials.gov/study/NCT03799302?tab=tableTed Donahuetedd@oslc.org541-285-2711This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize “technology-based approaches” for “implementing large-scale change.” Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.
<![CDATA[

Studies

Study First Submitted Date 2018-12-13
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-07-22
Start Month Year August 1, 2018
Primary Completion Month Year January 2023
Verification Month Year July 2022
Verification Date 2022-07-31
Last Update Posted Date 2022-07-22

Facilities

Sequence: 199189122
Status Recruiting
Name Oregon Social Learning Center
City Eugene
State Oregon
Zip 97401
Country United States

Facility Contacts

Sequence: 28003923 Sequence: 28003924
Facility Id 199189122 Facility Id 199189122
Contact Type primary Contact Type backup
Name Courtenay Padgett Name Lisa Saldana, PhD
Email courtp@oslc.org Email lisas@oslc.org
Phone 541-485-2711 Phone 541-485-2711

Facility Investigators

Sequence: 18267812
Facility Id 199189122
Role Principal Investigator
Name Lisa Saldana, PhD

Conditions

Sequence: 51953393
Name Evidence Based Practice
Downcase Name evidence based practice

Id Information

Sequence: 39989609
Id Source org_study_id
Id Value R01DA044745
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/R01DA044745

Countries

Sequence: 42380514
Name United States
Removed False

Design Groups

Sequence: 55353391 Sequence: 55353392
Group Type No Intervention Group Type Experimental
Title Standard Consultation Title SIC Coaching Consultation
Description Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors Description In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP.

Interventions

Sequence: 52265626
Intervention Type Behavioral
Name SIC Coaching
Description Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.

Design Outcomes

Sequence: 176606146
Outcome Type primary
Measure Stages of Implementation Completion (SIC)
Time Frame Baseline through month 60
Description The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability).

Sponsors

Sequence: 48115544
Agency Class OTHER
Lead Or Collaborator lead
Name Oregon Social Learning Center

Overall Officials

Sequence: 29160890
Role Principal Investigator
Name Lisa Saldana, PHD
Affiliation Oregon Social Learning Center

Central Contacts

Sequence: 11959552 Sequence: 11959553
Contact Type primary Contact Type backup
Name Lisa Saldana Name Ted Donahue
Phone 541-485-2711 Phone 541-285-2711
Email lisas@oslc.org Email tedd@oslc.org
Role Contact Role Contact

Design Group Interventions

Sequence: 67857640
Design Group Id 55353392
Intervention Id 52265626

Eligibilities

Sequence: 30637058
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project

Exclusion Criteria:

none

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254132236
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30383992
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28750727
Responsible Party Type Principal Investigator
Name Lisa Saldana
Title Principal Investigator
Affiliation Oregon Social Learning Center

]]>

<![CDATA[ Approaches for Improving Long-term Weight Loss ]]>
https://zephyrnet.com/NCT03799289
2019-01-03

https://zephyrnet.com/?p=NCT03799289
NCT03799289https://www.clinicaltrials.gov/study/NCT03799289?tab=tableNANANAThe purpose of this study is to examine two approaches for improving long-term weight loss success. All participants will receive a 12-week, in-person standard behavioral weight loss program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary education instruction (determined via randomization procedures). Assessments of weight, physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and 6 months.
<![CDATA[

Studies

Study First Submitted Date 2018-12-05
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-10-28
Start Month Year January 3, 2019
Primary Completion Month Year June 18, 2020
Verification Month Year June 2021
Verification Date 2021-06-30
Last Update Posted Date 2021-10-28
Results First Posted Date 2021-10-28

Detailed Descriptions

Sequence: 20559316
Description Behavioral weight loss (WL) programs result in clinically significant weight losses; however rates of long-term WL maintenance are poor. Previous studies suggest that long-term WL success may require an enhanced ability to overcome physiological and hedonic urges to eat and an improved capacity for dealing with life stressors, negative mood states, and food cravings. Thus interventions which target stress reduction and reduce the tendency to use food as a coping strategy for aversive experiences may offer a protective effect against dietary lapses; thereby improving long-term WL outcomes. Yoga is a mind-body intervention which reduces stress and improves overall physical and psychological well-being and offers promise for strengthening the psychological skill set needed for maintaining important weight-related behaviors long-term. The physical and cognitive skills practiced within yoga target multiple underlying psychological processes (e.g., mindfulness, distress tolerance) which could reduce emotional eating, improve dietary choices, and enhance one's ability to tolerate food cravings or hedonic urges to eat. While yoga is an effective treatment approach for other chronic health conditions, it has not been examined as a potential intervention for improving long-term WL outcomes. Within the context of the obesity field, yoga has been viewed as a mode of exercise and not necessarily as a mind-body intervention approach (as is the case in other fields). Thus, given the lower caloric expenditure of yoga in comparison to many forms of aerobic exercise, the effect of yoga on important weight- related processes and behaviors has not been examined.

The primary aims of this study are to examine the feasibility and acceptability of implementing yoga within a weight management program. Secondary aims focus on examining the impact of yoga, relative to a cooking/dietary education intervention (matched for contact time) on important psychological constructs (perceived stress, mindfulness, and distress tolerance) and weight. Sixty women with overweight or obesity will be randomly assigned to a 12-week standard behavioral WL program, followed by either 12 weeks of group-based yoga or 12 weeks of cooking/dietary information classes. Both groups will be instructed to self-monitor and achieve the dietary and aerobic exercise goals throughout the 24-week program. Primary assessments will occur at baseline and weeks 12 and 24.

Facilities

Sequence: 198498215
Name Weight Control and Diabetes Research Center
City Providence
State Rhode Island
Zip 02903
Country United States

Conditions

Sequence: 51754237
Name Obesity
Downcase Name obesity

Id Information

Sequence: 39825469 Sequence: 39825470
Id Source org_study_id Id Source secondary_id
Id Value 2096-18 Id Value R03DK115978-01A1
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/R03DK115978-01A1

Countries

Sequence: 42225517
Name United States
Removed False

Design Groups

Sequence: 55175384 Sequence: 55175385
Group Type Experimental Group Type Active Comparator
Title Iyengar Yoga Title Cooking/dietary education
Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Description Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

Interventions

Sequence: 52075617 Sequence: 52075618
Intervention Type Behavioral Intervention Type Behavioral
Name Behavioral weight loss followed by yoga instruction Name Behavioral weight loss followed by cooking/dietary education instruction
Description 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Description 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention

Keywords

Sequence: 79182957 Sequence: 79182958 Sequence: 79182959 Sequence: 79182960 Sequence: 79182961
Name Obesity Name Weight loss Name physical activity Name yoga Name exercise
Downcase Name obesity Downcase Name weight loss Downcase Name physical activity Downcase Name yoga Downcase Name exercise

Design Outcomes

Sequence: 176033855 Sequence: 176033856 Sequence: 176033857 Sequence: 176033858 Sequence: 176033859 Sequence: 176033860 Sequence: 176033861 Sequence: 176033862 Sequence: 176033863 Sequence: 176033864 Sequence: 176033865
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Program Satisfaction Ratings Measure Intervention Session Attendance Measure Feasibility of the Intervention (Retention) Measure Changes in Perceived Stress (Measured Via the Perceived Stress Scale) Measure Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale Measure Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale Measure Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale Measure Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale Measure Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale Measure Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) Measure Change in Weight
Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks
Description Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) Description Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). Description Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment Description Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. Description The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. Description Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.

Browse Conditions

Sequence: 191805387 Sequence: 191805388 Sequence: 191805389
Mesh Term Weight Loss Mesh Term Body Weight Mesh Term Body Weight Changes
Downcase Mesh Term weight loss Downcase Mesh Term body weight Downcase Mesh Term body weight changes
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47931499 Sequence: 47931500
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name The Miriam Hospital Name National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Officials

Sequence: 29041257
Role Principal Investigator
Name Jessica Unick, PhD
Affiliation The Miriam Hospital's Weight Control & Diabetes Research Center

Design Group Interventions

Sequence: 67643575 Sequence: 67643576
Design Group Id 55175384 Design Group Id 55175385
Intervention Id 52075617 Intervention Id 52075618

Eligibilities

Sequence: 30521601
Gender Female
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

BMI 25-40 kg/m2
Female

Exclusion Criteria:

Presence of any condition that would limit one's ability to exercise or lose weight safely
Recent weight loss
Current or recent enrollment in a weight loss or mindfulness-based treatment program
Women who are pregnant or planning on becoming pregnant
History of a serious psychiatric disorder
Recent cancer diagnosis (<1 year)
Does not own a smartphone

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254081799
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 17
Were Results Reported True
Months To Report Results 14
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 8

Designs

Sequence: 30270614
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Milestones

Sequence: 40739741 Sequence: 40739742 Sequence: 40739743 Sequence: 40739744 Sequence: 40739745 Sequence: 40739746 Sequence: 40739747 Sequence: 40739748 Sequence: 40739749 Sequence: 40739750 Sequence: 40739751 Sequence: 40739752
Result Group Id 55809366 Result Group Id 55809367 Result Group Id 55809366 Result Group Id 55809367 Result Group Id 55809366 Result Group Id 55809367 Result Group Id 55809366 Result Group Id 55809367 Result Group Id 55809366 Result Group Id 55809367 Result Group Id 55809366 Result Group Id 55809367
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Initial Weight Loss Program (Weeks 1-12) Period Initial Weight Loss Program (Weeks 1-12) Period Initial Weight Loss Program (Weeks 1-12) Period Initial Weight Loss Program (Weeks 1-12) Period Initial Weight Loss Program (Weeks 1-12) Period Initial Weight Loss Program (Weeks 1-12) Period Maintenance Intervention (Weeks 13-24) Period Maintenance Intervention (Weeks 13-24) Period Maintenance Intervention (Weeks 13-24) Period Maintenance Intervention (Weeks 13-24) Period Maintenance Intervention (Weeks 13-24) Period Maintenance Intervention (Weeks 13-24)
Count 30 Count 30 Count 24 Count 27 Count 6 Count 3 Count 24 Count 27 Count 24 Count 27 Count 0 Count 0

Participant Flows

Sequence: 3896129

Outcome Counts

Sequence: 73491903 Sequence: 73491904 Sequence: 73491905 Sequence: 73491906 Sequence: 73491907 Sequence: 73491908 Sequence: 73491909 Sequence: 73491910 Sequence: 73491911 Sequence: 73491912 Sequence: 73491913 Sequence: 73491914 Sequence: 73491915 Sequence: 73491916 Sequence: 73491917 Sequence: 73491918 Sequence: 73491919 Sequence: 73491920 Sequence: 73491921 Sequence: 73491922 Sequence: 73491923 Sequence: 73491924
Outcome Id 30592640 Outcome Id 30592640 Outcome Id 30592641 Outcome Id 30592641 Outcome Id 30592642 Outcome Id 30592642 Outcome Id 30592643 Outcome Id 30592643 Outcome Id 30592644 Outcome Id 30592644 Outcome Id 30592645 Outcome Id 30592645 Outcome Id 30592646 Outcome Id 30592646 Outcome Id 30592647 Outcome Id 30592647 Outcome Id 30592648 Outcome Id 30592648 Outcome Id 30592649 Outcome Id 30592649 Outcome Id 30592650 Outcome Id 30592650
Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27 Count 24 Count 27

Provided Documents

Sequence: 2564033 Sequence: 2564034
Document Type Study Protocol and Statistical Analysis Plan Document Type Informed Consent Form
Has Protocol True Has Protocol False
Has Icf False Has Icf True
Has Sap True Has Sap False
Document Date 2020-05-16 Document Date 2019-05-03
Url https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/Prot_SAP_002.pdf Url https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/ICF_000.pdf

Reported Event Totals

Sequence: 27759742 Sequence: 27759743 Sequence: 27759744 Sequence: 27759745 Sequence: 27759746 Sequence: 27759747
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0
Subjects At Risk 24 Subjects At Risk 24 Subjects At Risk 24 Subjects At Risk 27 Subjects At Risk 27 Subjects At Risk 27
Created At 2023-08-06 13:09:20.552364 Created At 2023-08-06 13:09:20.552364 Created At 2023-08-06 13:09:20.552364 Created At 2023-08-06 13:09:20.552364 Created At 2023-08-06 13:09:20.552364 Created At 2023-08-06 13:09:20.552364
Updated At 2023-08-06 13:09:20.552364 Updated At 2023-08-06 13:09:20.552364 Updated At 2023-08-06 13:09:20.552364 Updated At 2023-08-06 13:09:20.552364 Updated At 2023-08-06 13:09:20.552364 Updated At 2023-08-06 13:09:20.552364

Responsible Parties

Sequence: 28650760
Responsible Party Type Sponsor

Result Agreements

Sequence: 3826873
Pi Employee No

Result Contacts

Sequence: 3826838
Organization The Miriam Hospital
Name Jessica Unick, PD (Principal Investigator)
Phone 401-793-8966
Email junick@lifespan.org

Outcomes

Sequence: 30592640 Sequence: 30592641 Sequence: 30592642 Sequence: 30592643 Sequence: 30592644 Sequence: 30592645 Sequence: 30592646 Sequence: 30592647 Sequence: 30592648 Sequence: 30592649 Sequence: 30592650
Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Program Satisfaction Ratings Title Intervention Session Attendance Title Feasibility of the Intervention (Retention) Title Changes in Perceived Stress (Measured Via the Perceived Stress Scale) Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale Title Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) Title Change in Weight
Description Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) Description Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). Description Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment Description Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. Description The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. Description Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.
Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks Time Frame Change from 12 to 24 weeks
Units units on a scale Units percentage of sessions attended Units Participants Units units on a scale Units units on a scale Units Change on a scale Units units on a scale Units Change on a scale Units units on a scale Units units on a scale Units Percent weight change
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Param Type Mean Param Type Mean Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean

Outcome Measurements

Sequence: 233985906 Sequence: 233985907 Sequence: 233985908 Sequence: 233985909 Sequence: 233985910 Sequence: 233985911 Sequence: 233985912 Sequence: 233985913 Sequence: 233985924 Sequence: 233985914 Sequence: 233985915 Sequence: 233985916 Sequence: 233985917 Sequence: 233985918 Sequence: 233985919 Sequence: 233985920 Sequence: 233985921 Sequence: 233985922 Sequence: 233985923 Sequence: 233985925 Sequence: 233985926 Sequence: 233985927
Outcome Id 30592640 Outcome Id 30592640 Outcome Id 30592641 Outcome Id 30592641 Outcome Id 30592642 Outcome Id 30592642 Outcome Id 30592643 Outcome Id 30592643 Outcome Id 30592649 Outcome Id 30592644 Outcome Id 30592644 Outcome Id 30592645 Outcome Id 30592645 Outcome Id 30592646 Outcome Id 30592646 Outcome Id 30592647 Outcome Id 30592647 Outcome Id 30592648 Outcome Id 30592648 Outcome Id 30592649 Outcome Id 30592650 Outcome Id 30592650
Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369 Result Group Id 55809369 Result Group Id 55809368 Result Group Id 55809369
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Title Program Satisfaction Ratings Title Program Satisfaction Ratings Title Intervention Session Attendance Title Intervention Session Attendance Title Feasibility of the Intervention (Retention) Title Feasibility of the Intervention (Retention) Title Changes in Perceived Stress (Measured Via the Perceived Stress Scale) Title Changes in Perceived Stress (Measured Via the Perceived Stress Scale) Title Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale Title Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) Title Change in Weight Title Change in Weight
Description Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) Description Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) Description Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). Description Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). Description Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment Description Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment Description Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. Description Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. Description The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. Description The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. Description The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. Description Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. Description Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.
Units units on a scale Units units on a scale Units percentage of sessions attended Units percentage of sessions attended Units Participants Units Participants Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units Change on a scale Units Change on a scale Units units on a scale Units units on a scale Units Change on a scale Units Change on a scale Units units on a scale Units units on a scale Units units on a scale Units Percent weight change Units Percent weight change
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 7.6 Param Value 8.3 Param Value 75.4 Param Value 75.9 Param Value 24 Param Value 27 Param Value 0.01 Param Value -0.06 Param Value 0.02 Param Value 1.7 Param Value 0.9 Param Value -0.17 Param Value -0.9 Param Value -0.29 Param Value 0.04 Param Value 0.46 Param Value 0.74 Param Value 0.33 Param Value -1.67 Param Value -0.06 Param Value -0.33 Param Value -0.38
Param Value Num 7.6 Param Value Num 8.3 Param Value Num 75.4 Param Value Num 75.9 Param Value Num 24.0 Param Value Num 27.0 Param Value Num 0.01 Param Value Num -0.06 Param Value Num 0.02 Param Value Num 1.7 Param Value Num 0.9 Param Value Num -0.17 Param Value Num -0.9 Param Value Num -0.29 Param Value Num 0.04 Param Value Num 0.46 Param Value Num 0.74 Param Value Num 0.33 Param Value Num -1.67 Param Value Num -0.06 Param Value Num -0.33 Param Value Num -0.38
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 2.9 Dispersion Value 2.4 Dispersion Value 24.6 Dispersion Value 27.1 Dispersion Value 0.51 Dispersion Value 0.60 Dispersion Value 0.51 Dispersion Value 5.9 Dispersion Value 3.7 Dispersion Value 5.1 Dispersion Value 3.9 Dispersion Value 3.06 Dispersion Value 5.03 Dispersion Value 4.34 Dispersion Value 4.59 Dispersion Value 3.17 Dispersion Value 3.82 Dispersion Value 0.60 Dispersion Value 2.91 Dispersion Value 4.03
Dispersion Value Num 2.9 Dispersion Value Num 2.4 Dispersion Value Num 24.6 Dispersion Value Num 27.1 Dispersion Value Num 0.51 Dispersion Value Num 0.6 Dispersion Value Num 0.51 Dispersion Value Num 5.9 Dispersion Value Num 3.7 Dispersion Value Num 5.1 Dispersion Value Num 3.9 Dispersion Value Num 3.06 Dispersion Value Num 5.03 Dispersion Value Num 4.34 Dispersion Value Num 4.59 Dispersion Value Num 3.17 Dispersion Value Num 3.82 Dispersion Value Num 0.6 Dispersion Value Num 2.91 Dispersion Value Num 4.03

Baseline Counts

Sequence: 11310350 Sequence: 11310351 Sequence: 11310352
Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 24 Count 27 Count 51

Result Groups

Sequence: 55809363 Sequence: 55809364 Sequence: 55809365 Sequence: 55809366 Sequence: 55809367 Sequence: 55809368 Sequence: 55809369 Sequence: 55809370 Sequence: 55809371
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title Iyengar Yoga Title Cooking/Dietary Education Title Total Title Iyengar Yoga Title Cooking/Dietary Education Title Iyengar Yoga Title Cooking/Dietary Education Title Iyengar Yoga Title Cooking/Dietary Education
Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.

Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention

Description Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention

Description Total of all reporting groups Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.

Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention

Description Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention

Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.

Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention

Description Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention

Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.

Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention

Description Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention

Baseline Measurements

Sequence: 124801200 Sequence: 124801201 Sequence: 124801202 Sequence: 124801173 Sequence: 124801174 Sequence: 124801175 Sequence: 124801176 Sequence: 124801177 Sequence: 124801178 Sequence: 124801179 Sequence: 124801180 Sequence: 124801181 Sequence: 124801182 Sequence: 124801183 Sequence: 124801184 Sequence: 124801185 Sequence: 124801186 Sequence: 124801187 Sequence: 124801188 Sequence: 124801189 Sequence: 124801190 Sequence: 124801191 Sequence: 124801192 Sequence: 124801193 Sequence: 124801194 Sequence: 124801195 Sequence: 124801196 Sequence: 124801197 Sequence: 124801198 Sequence: 124801199 Sequence: 124801203 Sequence: 124801204 Sequence: 124801205 Sequence: 124801206 Sequence: 124801207 Sequence: 124801208 Sequence: 124801209 Sequence: 124801210 Sequence: 124801211 Sequence: 124801212 Sequence: 124801213 Sequence: 124801214 Sequence: 124801215 Sequence: 124801216 Sequence: 124801217 Sequence: 124801218 Sequence: 124801219 Sequence: 124801220
Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365 Result Group Id 55809363 Result Group Id 55809364 Result Group Id 55809365
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Classification United States Classification United States Classification United States
Category Black or African American Category Black or African American Category Black or African American Category Female Category Female Category Female Category Male Category Male Category Male Category Hispanic or Latino Category Hispanic or Latino Category Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category Asian Category Asian Category Asian Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category White Category White Category White Category More than one race Category More than one race Category More than one race Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported
Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Age, Continuous Title Age, Continuous Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Region of Enrollment Title Region of Enrollment Title Region of Enrollment Title Body mass index (BMI) at baseline (pre weight loss) Title Body mass index (BMI) at baseline (pre weight loss) Title Body mass index (BMI) at baseline (pre weight loss) Title Body mass index (BMI) at 12 weeks (post weight loss intervention) Title Body mass index (BMI) at 12 weeks (post weight loss intervention) Title Body mass index (BMI) at 12 weeks (post weight loss intervention)
Description Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss Description Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss Description Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss
Units Participants Units Participants Units Participants Units years Units years Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units participants Units participants Units kg /m^2 Units kg /m^2 Units kg /m^2 Units kg/m^2 Units kg/m^2 Units kg/m^2
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number Param Type Number Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 1 Param Value 1 Param Value 2 Param Value 48.7 Param Value 49.1 Param Value 48.7 Param Value 24 Param Value 27 Param Value 51 Param Value 0 Param Value 0 Param Value 0 Param Value 4 Param Value 2 Param Value 6 Param Value 20 Param Value 25 Param Value 45 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 0 Param Value 0 Param Value 19 Param Value 23 Param Value 42 Param Value 3 Param Value 3 Param Value 6 Param Value 0 Param Value 0 Param Value 0 Param Value 24 Param Value 27 Param Value 51 Param Value 34.6 Param Value 34.5 Param Value 34.6 Param Value 33.1 Param Value 31.8 Param Value 32.4
Param Value Num 1.0 Param Value Num 1.0 Param Value Num 2.0 Param Value Num 48.7 Param Value Num 49.1 Param Value Num 48.7 Param Value Num 24.0 Param Value Num 27.0 Param Value Num 51.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 4.0 Param Value Num 2.0 Param Value Num 6.0 Param Value Num 20.0 Param Value Num 25.0 Param Value Num 45.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 19.0 Param Value Num 23.0 Param Value Num 42.0 Param Value Num 3.0 Param Value Num 3.0 Param Value Num 6.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 24.0 Param Value Num 27.0 Param Value Num 51.0 Param Value Num 34.6 Param Value Num 34.5 Param Value Num 34.6 Param Value Num 33.1 Param Value Num 31.8 Param Value Num 32.4
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 9.9 Dispersion Value 9.5 Dispersion Value 9.6 Dispersion Value 4.1 Dispersion Value 3.5 Dispersion Value 3.8 Dispersion Value 4.5 Dispersion Value 3.7 Dispersion Value 4.1
Dispersion Value Num 9.9 Dispersion Value Num 9.5 Dispersion Value Num 9.6 Dispersion Value Num 4.1 Dispersion Value Num 3.5 Dispersion Value Num 3.8 Dispersion Value Num 4.5 Dispersion Value Num 3.7 Dispersion Value Num 4.1
Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51 Number Analyzed 24 Number Analyzed 27 Number Analyzed 51

]]>

<![CDATA[ Optimisation of Care in Vulnerable HIV Infected Individuals ]]>
https://zephyrnet.com/NCT03799276
2019-01-15

https://zephyrnet.com/?p=NCT03799276
NCT03799276https://www.clinicaltrials.gov/study/NCT03799276?tab=tableSophie Seang, MDsophie.seang@aphp.fr33142164183Antiretroviral therapy is currently the only way to control HIV disease progression in HIV infected subjects and to prevent transmission. However a sustained virological control through antiretroviral therapy is requested for these objectives. There is currently 8-10% of patients who failed therapy for many reasons other than virological resistance including social unstability, psychiatric disorders, migrant status, drug or alcohol addictions. Because many of these vulnerabilities can be managed and patients helped for following adequately cares and treatments, study team designed the OPTICARE Program to help reduce impact of the patients’ vulnerabilities.

The OPTICARE study is designed as a prospective implementation interventional study which aims to improve retention in care among vulnerable HIV infected patients over 48 weeks.

The OPTICARE program is a support program dedicated to patients either lost to follow up or in highly fraility situation that will offer an individualized care management to fill their gaps towards optimized care and control of viral replication. Our aim is, in patients virally failing in relation with poor adherence to care and treatment to test first part whether tracking proactively lost to follow up patients or detecting frail individuals at risk of lost to care is effective and secondly to evaluate the efficacy, the feasibility and the acceptability of an intervention tailored to each individual to get them to treatment success with viral suppression. In our context, a randomized approach would not be seen as ethical or possible in an environment where investigators need to evaluate such intervention as a pilot approach. Investigators therefore enrolled patients in a cohort population study OPTICARE program aim to actively identify vulnerable HIV+ population and promote optimal access to health care to this population using retention in care program in order to enable long term HIV infection control.

The primary objective is to assess the feasability and the effectiveness of the OPTICARE program. The OPTICARE program aims to propose an individualized care to vulnerable HIV infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success (UNAIDS/Third 90% goal) within a one-year period.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-05-12
Start Month Year January 15, 2019
Primary Completion Month Year June 15, 2022
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-12

Detailed Descriptions

Sequence: 20665983
Description The OPTICARE program is an individualized program proposed to vulnerable HIV infected patients according to a baseline evaluation of the clinical, social, psychological and cultural aspects.

Once enrolled in the OPTICARE program, each patient will benefit of:

A comprehensive and complete check up personal interview, through a daily visit, with a physician, an educational nurse, a social worker and a cultural mediator (if needed), in order to identify mains issues
A specific follow up will be set up with obligatory visits at week 4, week 12, week 24, week 36 and week 48 to assess the evolution of the previously identified issues. If needed, additional visits will be set up.
Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program.
Each patient will be accompanied by a tutoring nurse who will be in direct contact with the patient.

Regarding the specific needs, each patient may benefit of:

a personal assistance to complete administrative procedures (update health insurance, assistance to fill administrative papers, provide a budget for photo ID, transport tickets)
a personalized medical follow up with regular phone calls, home visits (if the patient agrees), assistance in taking HIV medication (set up pillbox, therapeutic education)
a close psychological and social support (connection with HIV organizations, participation to monthly support group)
a specific assistance related to dependence issues (connection with addiction organization, sex therapist consultation)

A multidisciplinary team (physician, educational nurse, psychotherapist, social worker and cultural mediator) will proactively assist the patient (home visits, recall) during a one year follow up.

The program is initially proposed to the patient. In case of non-acceptance, the patient can further join the program after 3 months.

Patients who do not accept the OPTICARE program will be followed up in standard of care according to French HIV management guidelines. (https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts/). All administratives and social procedures will be given to the social district.

Facilities

Sequence: 199484753
Status Recruiting
Name Yasmine Dudoit
City Paris
Zip 75013
Country France

Facility Contacts

Sequence: 28039724 Sequence: 28039725
Facility Id 199484753 Facility Id 199484753
Contact Type primary Contact Type backup
Name Yasmine Dudoit Name Sophie Seang, MD
Email yasmine.dudoit@aphp.fr Email sophie.seang@aphp.fr
Phone 330142164181 Phone 33142164183

Conditions

Sequence: 52026073
Name HIV Infections
Downcase Name hiv infections

Id Information

Sequence: 40044816
Id Source org_study_id
Id Value CREPATS 08

Countries

Sequence: 42442144
Name France
Removed False

Design Groups

Sequence: 55433550
Group Type Experimental
Title Opticare study
Description Phase I: Identification and Selection of study population The first step will include an active search by OPTICARE team for vulnerable and lost to follow up patients

Phase II: Implementation of the individualized follow-up program The patients who agree to participate to the program will be defined as the OPTICARE population.

Interventions

Sequence: 52338401
Intervention Type Other
Name Opticare study
Description Each patient will be evaluated by

An HIV physician
A nurse
A social worker
A psychological therapist
A cultural mediator/member of patients community if needed for migrants

Following these interviews and visits, a multisciplinary team will define for each patient an individualized OPTICARE program based on the following items: clinical, psychological/psychiatric, social status and follow up visits will be planned with the patient.

Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program, to assess the clinical status and ART adherence.

Patients will have their medical, biological and social status assessed through visits at W4, W12, W24, W36 (medical and social status only) and W 48 with all members of the OPTICARE team.

Design Outcomes

Sequence: 176876087
Outcome Type primary
Measure Measure of plasma viral load to assess the effectiveness of the OPTICARE Program to attend HIV plasma viral load < 50 cp/ml at week 48
Time Frame 12 months
Description Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)

Browse Conditions

Sequence: 192910405 Sequence: 192910406 Sequence: 192910407 Sequence: 192910408 Sequence: 192910409 Sequence: 192910410 Sequence: 192910411 Sequence: 192910412 Sequence: 192910413 Sequence: 192910414 Sequence: 192910415 Sequence: 192910416 Sequence: 192910417 Sequence: 192910418
Mesh Term HIV Infections Mesh Term Blood-Borne Infections Mesh Term Communicable Diseases Mesh Term Infections Mesh Term Sexually Transmitted Diseases, Viral Mesh Term Sexually Transmitted Diseases Mesh Term Lentivirus Infections Mesh Term Retroviridae Infections Mesh Term RNA Virus Infections Mesh Term Virus Diseases Mesh Term Genital Diseases Mesh Term Urogenital Diseases Mesh Term Immunologic Deficiency Syndromes Mesh Term Immune System Diseases
Downcase Mesh Term hiv infections Downcase Mesh Term blood-borne infections Downcase Mesh Term communicable diseases Downcase Mesh Term infections Downcase Mesh Term sexually transmitted diseases, viral Downcase Mesh Term sexually transmitted diseases Downcase Mesh Term lentivirus infections Downcase Mesh Term retroviridae infections Downcase Mesh Term rna virus infections Downcase Mesh Term virus diseases Downcase Mesh Term genital diseases Downcase Mesh Term urogenital diseases Downcase Mesh Term immunologic deficiency syndromes Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48183685 Sequence: 48183686 Sequence: 48183687
Agency Class OTHER Agency Class INDUSTRY Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida Name ViiV Healthcare Name Institut de Sante Publique, d'Epidemiologie et de Developpement

Overall Officials

Sequence: 29201525
Role Principal Investigator
Name Sophie Seang, MD
Affiliation Pitie Salpetriere Hospital

Central Contacts

Sequence: 11977103 Sequence: 11977104
Contact Type primary Contact Type backup
Name Yasmine Dudoit Name Sophie Seang, MD
Phone 33142164181 Phone 33142164183
Email yasmine.dudoit@aphp.fr Email sophie.seang@aphp.fr
Role Contact Role Contact

Design Group Interventions

Sequence: 67955894
Design Group Id 55433550
Intervention Id 52338401

Eligibilities

Sequence: 30680162
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Patients Lost to follow-up defined as a patient with no clinical visit:

In the 12 months period for patients > 250/mm3 CD4 cells or
In the 6 months period for patients < 250/mm3 CD4 cells or
In the 3 months period following a new HIV + diagnosis or an AIDS defining illnesses

AND with HIV plasma viral load > 400 cp/ml (following French HIV guidelines)

HIV+ patients with virological failure defined as HIV plasma viral load (pVL) > 400 cp/ml (2 determinations with at least two weeks apart)
HIV+ patients presenting with an AIDS defining (<3 months) event in a context of lost to care prior to the event

HIV+ patients newly diagnosed with virological failure 6 months after ART initiation (virological failure defined by two HIV plasma viral load > 50cp/ml following French HIV guidelines *) and with one of the following vulnerable risk factors :

Social frailty (lack of health insurance, homeless, accommodation by family/friends, post incarceration)
Migrants with a first arrival in France in the last 6 months
Women in postpartum period (3 months after delivery)
Psychiatric disease
Intravenous drug users, alcohol consumers (women > 40g/day or > 2 standard drinks /day; men > 60g/day ou > 3 standard drinks/day)

A standard glass is defined by a quantity of pure alcohol of 10 grams, corresponding to approximately 10 cl of wine, 25 cl of beer at 5% vol, or 3 cl of alcohol at 40% vol. (https://www.sfalcoologie.asso.fr/download/RBP2014-SFA-Mesusage-AA.pdf)

Exclusion Criteria:

Patients unwilling to participate.
Patients with HIV plasma viral load < 50 cp/ml

https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253878348
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 41
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30426905
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28793431
Responsible Party Type Sponsor

]]>

<![CDATA[ A Six Minute Walking Test Based Index as an Outcome Predictor in COPD Subjects. (Chronic Obstructive Pulmonary Disease) ]]>
https://zephyrnet.com/NCT03799263
2019-02-01

https://zephyrnet.com/?p=NCT03799263
NCT03799263https://www.clinicaltrials.gov/study/NCT03799263?tab=tableNANANAThe six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. The investigators wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-03-03
Start Month Year February 1, 2019
Primary Completion Month Year January 31, 2021
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-03

Detailed Descriptions

Sequence: 20685819
Description Rationale: the six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. In COPD patients the 6MWT is a marker of severity, influenced by the severity of airway obstruction as well as of comorbidities. This test has been shown as a predictor of survival and need of hospitalization. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. However, besides the pathological conditions, this result is influenced by the individual demographic and anthropometrics characteristics. The Minimal Clinically Important Difference in COPD subjects is reported to be 30 meters (m.). A decrease greater than 30 m., as compared to the previous year, is a predictor of death risk. During the test some physiological variables should be monitored such as heart rate (HR), and pulse oxymetry (SpO2). An oxyhemoglobin desaturation >4% or a SpO2 <90% during the test, are also predictors of increased risk of death or hospitalization. In addition, also the difference between the HR at baseline and that after one minute after the end of the test (recovery heart rate: HRR) seems to be a predictor of survival and COPD exacerbation rates. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. We wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.

Objectives:

Primary Objective: To develop and validate a multidimensional index in COPD subjects with different grades of severity as assessed by the Global Initiative for Chronic Obstructive Lung disease as a predictor of 24 month exacerbation rate.

Secondary Objectives: To evaluate the predictive value of 24 month mortality. To evaluate the relationship of this index and other accepted clinical predictors.

Facilities

Sequence: 199669288
Name Maugeri Foundation
City Tradate
State VA
Zip 21049
Country Italy

Conditions

Sequence: 52075944 Sequence: 52075945 Sequence: 52075946 Sequence: 52075947
Name COPD Name Mortality Name Disease Exacerbation Name Exercise Capacity
Downcase Name copd Downcase Name mortality Downcase Name disease exacerbation Downcase Name exercise capacity

Id Information

Sequence: 40082981
Id Source org_study_id
Id Value 2019001

Countries

Sequence: 42482395
Name Italy
Removed False

Interventions

Sequence: 52388957
Intervention Type Procedure
Name evaluation group
Description Recordings Pneumologic assessment Severity grades (I-IV: old GOLD and A-D: new GOLD) Smoke History Drug therapy Comorbidities 6MWT performed within previous 10-14 months, if available. Measurements Standard exams usually performed at Rehab Center Lung Function tests and diffusing capacity of the lung for carbon monoxide Arterial Blood Gases Dyspnoea Health Status and Health Related Quality of Life Daily activity Lower limb muscle strength Exercise capacity

Design Outcomes

Sequence: 177054200 Sequence: 177054201 Sequence: 177054202 Sequence: 177054203
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure COPD Exacerbation Measure Mortality Measure hospitalizations Measure symptoms and anthropometrics characteristics correlation
Time Frame 24 month Time Frame 24 month Time Frame 24 month Time Frame 24 month
Description number of patients with acute exacerbations (treated with antibiotics or steroids) Description number of patients died Description number of patients hospitalized for COPD Description Index correlation capacity with dyspnoea (Medical Research Council questionnaire, Barthel Dyspnoea), body weight (kilogram), heart frequency (HR), distance walked (6MWT)

Browse Conditions

Sequence: 193107893 Sequence: 193107894 Sequence: 193107895
Mesh Term Disease Progression Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term disease progression Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48231045 Sequence: 48231046
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Maugeri Foundation Name Università degli Studi di Sassari

Overall Officials

Sequence: 29229793
Role Study Director
Name Antonio Spanevello, Prof
Affiliation Maugeri Foundation

Eligibilities

Sequence: 30709976
Sampling Method Non-Probability Sample
Gender All
Minimum Age 45 Years
Maximum Age 85 Years
Population Stable COPD patients assessed for Pulmonary Rehabilitation
Criteria Inclusion Criteria:

COPD diagnosis and grades of severity as assessed by the "old" (I to IV) and "new" (A to D) GOLD guidelines (23)
Under inhaler therapy for ≥30 days according to guidelines (23)
Smokers or o ex-smokers, smoke history ≥10 pack/years (p/y)
Informed Consent Signature.

Exclusion Criteria:

Associated Comorbidities with short term severe prognosis
Actual Cardiac Arrythmias
Pace-maker
Other associated respiratory diseases
Chronic Heart Failure New York Heart Association classes III, IV.
Use of drugs influencing the heart rate
Changes in drug therapy in the previous 30 days
Use of systemic steroids or antibiotics in the previous 30 days
Unscheduled visits or admission to the Emergency Room for symptoms worsening in the previous 30 days
Pneumonia during the previous 60 days
Myocardial Infarction in the previous 4 months
Subjective and objective inability to perform the 6MWT
Inability to carry the oxygen cylinder.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253935084
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 24
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 45
Maximum Age Num 85
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30456567
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28823041
Responsible Party Type Principal Investigator
Name elisabetta zampogna
Title Dr
Affiliation Maugeri Foundation

Study References

Sequence: 51971733 Sequence: 51971734 Sequence: 51971735 Sequence: 51971736 Sequence: 51971737 Sequence: 51971738
Pmid 6805625 Pmid 20471236 Pmid 12091180 Pmid 12917227 Pmid 28624883 Pmid 18550610
Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result
Citation Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available. Citation Spruit MA, Watkins ML, Edwards LD, Vestbo J, Calverley PM, Pinto-Plata V, Celli BR, Tal-Singer R, Wouters EF; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Determinants of poor 6-min walking distance in patients with COPD: the ECLIPSE cohort. Respir Med. 2010 Jun;104(6):849-57. doi: 10.1016/j.rmed.2009.12.007. Epub 2010 May 14. Citation ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. Citation Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13. Citation Rodriguez DA, Kortianou EA, Alison JA, Casas A, Giavedoni S, Barberan-Garcia A, Arbillaga A, Vilaro J, Gimeno-Santos E, Vogiatzis I, Rabinovich R, Roca J. Heart Rate Recovery After 6-min Walking Test Predicts Acute Exacerbation in COPD. Lung. 2017 Aug;195(4):463-467. doi: 10.1007/s00408-017-0027-0. Epub 2017 Jun 17. Citation Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schunemann HJ. Interpretation of treatment changes in 6-minute walk distance in patients with COPD. Eur Respir J. 2008 Sep;32(3):637-43. doi: 10.1183/09031936.00140507. Epub 2008 Jun 11.

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<![CDATA[ Fluid Management in the Post Anesthesia Care Unit ]]>
https://zephyrnet.com/NCT03799250
2019-06-30

https://zephyrnet.com/?p=NCT03799250
NCT03799250https://www.clinicaltrials.gov/study/NCT03799250?tab=tableBinyamin Zeribibenjzr@gmail.comNAFluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct evaluation of the dynamic fluid status of patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic therapy (GDHT) trials and has become a widely used approach in intraoperative fluid management.

While there are numerous studies on the intraoperative outcome of GDHT, research on the immediate postoperative outcome of GDHT therapy use is scarce.

In this study the investigators aim to evaluate the efficacy of bolus-based fluid management guided by common clinical parameters in postoperative period in post-anesthesia care unit.

In this randomized clinical trial all patients will be randomized to one of the following groups:

The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.

The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.

Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.

Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-09-25
Start Month Year June 30, 2019
Primary Completion Month Year December 2020
Verification Month Year December 2018
Verification Date 2018-12-31
Last Update Posted Date 2019-09-25

Detailed Descriptions

Sequence: 20716267
Description Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study protocol will be explained, questions answered and informed consent form will be signed by one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic visit, the process will take place in the entrance to the surgery room. Following surgery, patients will be assessed for eligibility and randomized to one of the study arms.

The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.

Study Arm:

The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.

Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record.

Blood products will be administered according to departmental guidelines and clinician decision unrelated to participation in the study.

Patients will be extubated, either in the operating room or postoperatively, when they fulfilled standard clinical criteria (adequate protective reflexes, adequate oxygenation, and stable hemodynamics), according to clinical indication unrelated to the participation in the study.

Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.

Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.

Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study.

Data Collection:

For each participating patient the following data will be collected and recorded:

Demographic data
Medical history including regular medications
Hemodynamic data including heart rate, automatic non-invasive blood pressure measurements, temperature as well pulse oximetry as routine procedures will be recorded and stored by Metavision system
Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake, anesthetic complications.
Laboratory values
Length of stay in PACU
Length of stay in hospital
Post-operative pulmonary complications
Acute kidney injury

Facilities

Sequence: 200053165
Status Recruiting
Name Rabin Medical Center
City Petah tikva
Country Israel

Facility Contacts

Sequence: 28097472
Facility Id 200053165
Contact Type primary
Name nadav sheffy, md
Email nadavs1@gmail.com
Phone 972522246447

Facility Investigators

Sequence: 18326398
Facility Id 200053165
Role Principal Investigator
Name nadav sheffy, md

Conditions

Sequence: 52156396
Name Ringer's Lactate
Downcase Name ringer's lactate

Id Information

Sequence: 40148163
Id Source org_study_id
Id Value 824-18

Countries

Sequence: 42557689
Name Israel
Removed False

Design Groups

Sequence: 55577830 Sequence: 55577831
Group Type Experimental Group Type Active Comparator
Title Goal Directed Hemodynamic Therapy Title Control Group
Description The GDT (Goal Directed Therapy) group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.

Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record.

Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.

Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.

Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study.

Description The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU (Post Anesthesia Care Unit) stay.

Interventions

Sequence: 52471939 Sequence: 52471940
Intervention Type Drug Intervention Type Other
Name Ringer lactate Name standard care
Description Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU Description standard care

Design Outcomes

Sequence: 177327660 Sequence: 177327661 Sequence: 177327662 Sequence: 177327663 Sequence: 177327664 Sequence: 177327665
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention Measure The total amount of fluid infused. Measure Length of stay in PACU Measure Length of stay in hospital Measure Post-operative pulmonary complications Measure Acute kidney injury
Time Frame 1 week post surgery Time Frame 1 week post operative Time Frame 8 hours after surgery Time Frame 1 month after surgery Time Frame 1 week after surgery Time Frame 1 week after surgery
Description Postoperative complication rates according to the EPCO classification

Sponsors

Sequence: 48305990
Agency Class OTHER
Lead Or Collaborator lead
Name Rabin Medical Center

Overall Officials

Sequence: 29277893 Sequence: 29277894
Role Principal Investigator Role Study Chair
Name Nadav O Sheffy, MD Name Leonid O Eidelman, MD
Affiliation Rabin Medical Center Affiliation Rabin Medical Center

Central Contacts

Sequence: 12004724 Sequence: 12004725
Contact Type primary Contact Type backup
Name Nadav Sheffy, MD Name Binyamin Zeribi
Phone 972522246447
Email nadavs1@gmail.com Email benjzr@gmail.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68130780 Sequence: 68130781
Design Group Id 55577830 Design Group Id 55577831
Intervention Id 52471939 Intervention Id 52471940

Eligibilities

Sequence: 30757313
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Patient undergoing general surgery, vascular surgery or urological surgery and who are expected to stay in the PACU for more than 8 hours.
Above 18 years old
Not requiring dialysis treatment
Not requiring advanced monitoring (arterial waveform analysis or cardiac output monitoring)
Eligible for signing an informed consent prior to surgery

Exclusion Criteria:

– Pregnancy
Inability to obtain an informed consent
Massive transfusion in OR (more than 5 blood products)
Colloids infusion needed
The requirement for greater than 0.1mcg/kg/min of noradrenaline at arrival to PACU

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254226389
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30503538
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28869816
Responsible Party Type Sponsor

Study References

Sequence: 52049364 Sequence: 52049365 Sequence: 52049366 Sequence: 52049367 Sequence: 52049368 Sequence: 52049369 Sequence: 52049370 Sequence: 52049371 Sequence: 52049372 Sequence: 52049373 Sequence: 52049374 Sequence: 52049375 Sequence: 52049376 Sequence: 52049377 Sequence: 52049378
Pmid 23672779 Pmid 16356219 Pmid 25104915 Pmid 28558654 Pmid 12357146 Pmid 26829494 Pmid 29576114 Pmid 29742967 Pmid 17115398 Pmid 28880931 Pmid 21873370 Pmid 20613538 Pmid 9510275 Pmid 25058504 Pmid 15273542
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Cecconi M, Corredor C, Arulkumaran N, Abuella G, Ball J, Grounds RM, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy-what is the evidence in surgical patients? The effect on different risk groups. Crit Care. 2013 Mar 5;17(2):209. doi: 10.1186/cc11823. Citation Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8. Citation Della Rocca G, Vetrugno L, Tripi G, Deana C, Barbariol F, Pompei L. Liberal or restricted fluid administration: are we ready for a proposal of a restricted intraoperative approach? BMC Anesthesiol. 2014 Aug 1;14:62. doi: 10.1186/1471-2253-14-62. eCollection 2014. Citation Malbouisson LMS, Silva JM Jr, Carmona MJC, Lopes MR, Assuncao MS, Valiatti JLDS, Simoes CM, Auler JOC Jr. A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery. BMC Anesthesiol. 2017 May 30;17(1):70. doi: 10.1186/s12871-017-0356-9. Citation Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012. Citation Hand WR, Stoll WD, McEvoy MD, McSwain JR, Sealy CD, Skoner JM, Hornig JD, Tennant PA, Wolf B, Day TA. Intraoperative goal-directed hemodynamic management in free tissue transfer for head and neck cancer. Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E1974-80. doi: 10.1002/hed.24362. Epub 2016 Feb 1. Citation Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3. Citation Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9. Citation Sanders GM. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection (Br J Surg) 2006; 93; 1069-1076. Br J Surg. 2006 Dec;93(12):1563. doi: 10.1002/bjs.5683. No abstract available. Citation Weinberg L, Ianno D, Churilov L, Chao I, Scurrah N, Rachbuch C, Banting J, Muralidharan V, Story D, Bellomo R, Christophi C, Nikfarjam M. Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial. PLoS One. 2017 Sep 7;12(9):e0183313. doi: 10.1371/journal.pone.0183313. eCollection 2017. Citation Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26. Citation Van der Linden PJ, Dierick A, Wilmin S, Bellens B, De Hert SG. A randomized controlled trial comparing an intraoperative goal-directed strategy with routine clinical practice in patients undergoing peripheral arterial surgery. Eur J Anaesthesiol. 2010 Sep;27(9):788-93. doi: 10.1097/EJA.0b013e32833cb2dd. Citation Valentine RJ, Duke ML, Inman MH, Grayburn PA, Hagino RT, Kakish HB, Clagett GP. Effectiveness of pulmonary artery catheters in aortic surgery: a randomized trial. J Vasc Surg. 1998 Feb;27(2):203-11; discussion 211-2. doi: 10.1016/s0741-5214(98)70351-9. Citation Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118. Citation Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

]]>

<![CDATA[ Combating Dengue With Innovative, Paradigm-shift-Strategies: Early Dengue Surveillance in Adult Aedes Mosquitoes ]]>
https://zephyrnet.com/NCT03799237
2018-10-01

https://zephyrnet.com/?p=NCT03799237
NCT03799237https://www.clinicaltrials.gov/study/NCT03799237?tab=tableSivaneswari Selvarajoo, BScsivaneswariselvarajoo@gmail.com+60108968645During dengue outbreaks, the Ministry of Health Malaysia employs various methods to control the spread of disease, including killing the larvae of Aedes mosquitoes, fogging, together with educating and disseminating information about the dengue outbreak, to the community. However, this is too late. Research has shown that when an outbreak has occurred, the viral infection has already spread among the community. Therefore, this current trial aims to educate the public (via questionnaire survey and interactions with the residential managements, mainly), detect dengue-infected mosquitoes, inform the communities of the presence of dengue-infected mosquitoes, followed by approaching and educating them to take precautionary measures before the outbreak happens. Trapping (using gravid oviposition sticky (GOS) traps) and detecting dengue virus non-structural 1 (NS1) antigen (using dengue NS1 kit) in the Aedes mosquitoes will be a more reliable way to alert the community before a potential dengue outbreak in their housing area. The community will receive information of presence of infected mosquitoes and probable dengue infections before dengue cases are reported. This will be an ideal time for clean-ups and for search and destroy activities. With this shift in approach and the use of newer techniques, it is hoped that deaths and epidemics due to dengue will be reduced.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year October 1, 2018
Primary Completion Month Year March 31, 2020
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20735757
Description This cluster randomised controlled trial will be conducted to provide evidence on the efficacy of an integrated active vector surveillance and preventive strategy in the community. It aims to demonstrate effectiveness of a new proactive paradigm in reducing dengue epidemics. The main hypotheses are 1) This new paradigm (GOS trap and dengue NS1 kit for detection of dengue in Aedes) will reduce dengue epidemics compared to the usual current vector surveillance/control carried out by the Ministry of Health. 2) Community will be more receptive to this new surveillance activity as they will receive information of dengue transmissions before dengue cases are reported.

The study sites at PJU10, Damansara Damai, Petaling Jaya, Selangor, Malaysia are

Intervention arm: Harmoni Apartment, Impian Apartment, Park Avenue Condominium, and Suria Shop Apartment
Control arm: Permai Apartment, Lestari Apartment, Indah Apartment, and Vista Shop Apartment

Activities to be carried out include:

A. Questionnaire survey and blood taking for dengue seroprevalence among residents from both arms When people in the community are gathered at an identified, suitable area, the Knowledge, Attitude and Practice (KAP) questionnaires will be distributed for them to answer. After the questionnaire survey, about 3 ml of venous blood would be taken by trained personnel for dengue IgG and IgM serology.

B. Placement of the GOS mosquito trap in the intervention arm The GOS mosquito traps will be placed in the intervention arm and serviced weekly. The trapped Aedes mosquitoes would be checked for dengue virus via dengue NS1 rapid diagnostic test kit.

The GOS mosquito traps will also be placed randomly in the control arm once per month for entomological survey.

C. If a dengue-positive mosquito is found, flyers and banners will be distributed and hung to inform the residents of the presence of dengue transmission in the apartment block/apartment. Alternatively, the residents may also be approached house-to-house or an educational booth set up at strategic locations in the apartment to warn and educate the residents.

D. The KAP questionnaire survey will be carried out again 3 months before the completion of the trial in the intervention arm to gauge the communities' perception of this intervention.

Facilities

Sequence: 200244156
Status Recruiting
Name Petaling Jaya City Council
City Petaling Jaya
State Selangor
Country Malaysia

Facility Contacts

Sequence: 28127966
Facility Id 200244156
Contact Type primary
Name Poo Soon Ong, Master

Conditions

Sequence: 52208074
Name Dengue
Downcase Name dengue

Id Information

Sequence: 40186121 Sequence: 40186122
Id Source org_study_id Id Source secondary_id
Id Value GOSNS1-1 Id Value MO013-2017
Id Type Other Grant/Funding Number
Id Type Description Malaysia Ministry of Education

Countries

Sequence: 42599613
Name Malaysia
Removed False

Design Groups

Sequence: 55634627 Sequence: 55634628
Group Type Experimental Group Type No Intervention
Title GOS trap and dengue NS1 antigen kit Title Control
Description Gravid Oviposition Sticky (GOS) traps will be placed to trap adult Aedes mosquitoes and changed weekly. NS1 will be used to detect dengue in trapped Aedes mosquitoes. When dengue NS1 positive mosquitoes are found, community will be alerted via flyers, banners and other means. Routine Aedes/dengue control and surveillance will be carried out as usual as per the current Ministry of Health guidelines. Description The GOS traps will be placed randomly in the control arm once per month for entomological survey. Routine Aedes control and surveillance will be carried out as per the current Ministry of Health guidelines. Dengue control measure will be initiated by the health authorities when human cases are reported from this arm.

Interventions

Sequence: 52522043
Intervention Type Other
Name GOS trap and dengue NS1 antigen kit
Description The GOS trap lure and sticky surfaces to trap gravid Aedes mosquitoes. Three GOS traps will be placed on every 3 floors of the residential blocks. The traps will be changed weekly. Trapped Aedes mosquitoes will be identified to species. The mosquitoes will then be dissected, to remove the abdomen from the thorax. Five to seven abdomens of the same mosquito species will be pooled and tested for dengue NS1 antigen using the SD Biosensor Standard Q dengue NS1 antigen test kit. If the pool is tested positive for dengue NS1, the head and thorax of the respective abdomens will be subjected to the same procedure for dengue NS1 antigen test, individually. This may allow us to identify a focus where there could be dengue-infected individuals. Flyers/Posters will be disseminated besides, house-to-house approach to inform the residents of the findings and apartment blocks where these mosquitoes were found. The apartment management will also make use of social media disseminate this information.

Keywords

Sequence: 79922882 Sequence: 79922883 Sequence: 79922884 Sequence: 79922885 Sequence: 79922886
Name Dengue Name Adult Aedes Name GOS trap Name Dengue NS1 antigen test Name Early dengue detection and surveillance
Downcase Name dengue Downcase Name adult aedes Downcase Name gos trap Downcase Name dengue ns1 antigen test Downcase Name early dengue detection and surveillance

Design Outcomes

Sequence: 177511066 Sequence: 177511067 Sequence: 177511068 Sequence: 177511069
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Change in number of weekly notified dengue cases in intervention arm Measure Change in the duration of dengue outbreaks in intervention arm Measure Change in adult Aedes density in the intervention arm Measure Change in level of dengue Knowledge, Attitude and Practice in the intervention arm
Time Frame Assess weekly, through study completion, 1 and a half years Time Frame Through study completion, an average of 1 and a half years Time Frame Assess weekly, through study completion, within 1 and half years. Time Frame 6 months after recruitment for pre-trial questionnaire survey. 3 months after recruitment for post-trial questionnaire survey, through study completion, 1 and a half years
Description The number of notified dengue cases in the study sites will be obtained from the District Health Office Description The duration of dengue outbreaks in the study sites will be obtained from the District Health Office. Description Based on the weekly trap index Description The mean of the percentage score of the population for each domain (knowledge & attitude/practises) will be determined for the pre- and post-test. Then, paired t-test will be performed to determine the presence of significant changes in both means (An increase in score percentage indicate a better outcome). Additionally, an individual percentage score of 80% and above indicates indicates good knowledge/attitude/practice.

Browse Conditions

Sequence: 193626881 Sequence: 193626882 Sequence: 193626883 Sequence: 193626884 Sequence: 193626885 Sequence: 193626886 Sequence: 193626887 Sequence: 193626888 Sequence: 193626889
Mesh Term Dengue Mesh Term Arbovirus Infections Mesh Term Vector Borne Diseases Mesh Term Infections Mesh Term Virus Diseases Mesh Term Flavivirus Infections Mesh Term Flaviviridae Infections Mesh Term RNA Virus Infections Mesh Term Hemorrhagic Fevers, Viral
Downcase Mesh Term dengue Downcase Mesh Term arbovirus infections Downcase Mesh Term vector borne diseases Downcase Mesh Term infections Downcase Mesh Term virus diseases Downcase Mesh Term flavivirus infections Downcase Mesh Term flaviviridae infections Downcase Mesh Term rna virus infections Downcase Mesh Term hemorrhagic fevers, viral
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48353659 Sequence: 48353660 Sequence: 48353661
Agency Class OTHER Agency Class UNKNOWN Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Jonathan Liew Wee Kent Name Petaling Jaya City Council, Malaysia Name Selangor State Health Department, Malaysia

Overall Officials

Sequence: 29305961 Sequence: 29305962
Role Principal Investigator Role Study Director
Name Jonathan WK Liew, PhD Name Indra Vythilingam, PhD
Affiliation University of Malaya Affiliation University of Malaya

Central Contacts

Sequence: 12017205 Sequence: 12017206
Contact Type primary Contact Type backup
Name Jonathan WK Liew, PhD Name Sivaneswari Selvarajoo, BSc
Phone +60178858375 Phone +60108968645
Email jonathanliew@um.edu.my Email sivaneswariselvarajoo@gmail.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68199152
Design Group Id 55634627
Intervention Id 52522043

Eligibilities

Sequence: 30786849
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Age 18 years and above, including pregnant women and healthy individuals
Reside in the study sites
Work at the study sites for at least 40 hours per week
Able to give consent
Willing to participate in blood taking

Exclusion Criteria:

Age below 18 years
Unable to give consent
Not willing to undergo venepuncture or finger-prick

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253989595
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30532919
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking None (Open Label)
Intervention Model Description Cluster Randomized Controlled Trial

Provided Documents

Sequence: 2582458 Sequence: 2582459
Document Type Informed Consent Form Document Type Study Protocol and Statistical Analysis Plan
Has Protocol False Has Protocol True
Has Icf True Has Icf False
Has Sap False Has Sap True
Document Date 2019-01-02 Document Date 2019-01-04
Url https://ClinicalTrials.gov/ProvidedDocs/37/NCT03799237/ICF_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/37/NCT03799237/Prot_SAP_001.pdf

Responsible Parties

Sequence: 28899213
Responsible Party Type Sponsor-Investigator
Name Jonathan Liew Wee Kent
Title Postdoctoral Research Fellow
Affiliation University of Malaya

Study References

Sequence: 52103019 Sequence: 52103020 Sequence: 52103021 Sequence: 52103022 Sequence: 52103023 Sequence: 52103024 Sequence: 52103025 Sequence: 52103026
Pmid 28327173 Pmid 25600599 Pmid 29125255 Pmid 21175947 Pmid 17607465 Pmid 23478581 Pmid 26094839 Pmid 31477185
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type derived
Citation Lau SM, Chua TH, Sulaiman WY, Joanne S, Lim YA, Sekaran SD, Chinna K, Venugopalan B, Vythilingam I. A new paradigm for Aedes spp. surveillance using gravid ovipositing sticky trap and NS1 antigen test kit. Parasit Vectors. 2017 Mar 21;10(1):151. doi: 10.1186/s13071-017-2091-y. Citation Klungthong C, Manasatienkij W, Phonpakobsin T, Chinnawirotpisan P, Rodpradit P, Hussem K, Thaisomboonsuk B, Ong-ajchaowlerd P, Nisalak A, Kalayanarooj S, Buddhari D, Gibbons RV, Jarman RG, Yoon IK, Fernandez S. Monitoring and improving the sensitivity of dengue nested RT-PCR used in longitudinal surveillance in Thailand. J Clin Virol. 2015 Feb;63:25-31. doi: 10.1016/j.jcv.2014.12.009. Epub 2014 Dec 12. Citation Roslan MA, Ngui R, Vythilingam I, Sulaiman WYW. Evaluation of sticky traps for adult Aedes mosquitoes in Malaysia: a potential monitoring and surveillance tool for the efficacy of control strategies. J Vector Ecol. 2017 Dec;42(2):298-307. doi: 10.1111/jvec.12270. Citation Chadee DD, Ritchie SA. Efficacy of sticky and standard ovitraps for Aedes aegypti in Trinidad, West Indies. J Vector Ecol. 2010 Dec;35(2):395-400. doi: 10.1111/j.1948-7134.2010.00098.x. Citation Gama RA, Silva EM, Silva IM, Resende MC, Eiras AE. Evaluation of the sticky MosquiTRAP for detecting Aedes (Stegomyia) aegypti (L.) (Diptera: Culicidae) during the dry season in Belo Horizonte, Minas Gerais, Brazil. Neotrop Entomol. 2007 Mar-Apr;36(2):294-302. doi: 10.1590/s1519-566×2007000200018. Citation Lee C, Vythilingam I, Chong CS, Abdul Razak MA, Tan CH, Liew C, Pok KY, Ng LC. Gravitraps for management of dengue clusters in Singapore. Am J Trop Med Hyg. 2013 May;88(5):888-892. doi: 10.4269/ajtmh.12-0329. Epub 2013 Mar 11. Citation Lau SM, Vythilingam I, Doss JI, Sekaran SD, Chua TH, Wan Sulaiman WY, Chinna K, Lim YA, Venugopalan B. Surveillance of adult Aedes mosquitoes in Selangor, Malaysia. Trop Med Int Health. 2015 Oct;20(10):1271-80. doi: 10.1111/tmi.12555. Epub 2015 Jul 14. Citation Liew JWK, Selvarajoo S, Tan W, Ahmad Zaki R, Vythilingam I. Gravid oviposition sticky trap and dengue non-structural 1 antigen test for early surveillance of dengue in multi-storey dwellings: study protocol of a cluster randomized controlled trial. Infect Dis Poverty. 2019 Sep 3;8(1):71. doi: 10.1186/s40249-019-0584-y.

]]>

<![CDATA[ Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia ]]>
https://zephyrnet.com/NCT03799224
2018-12-01

https://zephyrnet.com/?p=NCT03799224
NCT03799224https://www.clinicaltrials.gov/study/NCT03799224?tab=tableChen-Hua Yanyanchenhua@vip.sina.com+86 010 88326666Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with relapse or refractory AL were at very high risk of relapse post allo-HSCT, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. It was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in recurrent and refractory AL patients.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-05-29
Start Month Year December 1, 2018
Primary Completion Month Year December 31, 2021
Verification Month Year May 2019
Verification Date 2019-05-31
Last Update Posted Date 2019-05-29

Detailed Descriptions

Sequence: 20721625
Description Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG (thymoglobulin; Sang Stat, France) consisting of cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg·m-2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.

BM(bone marrow) samples from patients were obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation.

Facilities

Sequence: 200108113
Status Recruiting
Name Peking University Institute of Hematology,Beijing
City Beijing
State Beijing
Zip 100044
Country China

Facility Contacts

Sequence: 28106410 Sequence: 28106411
Facility Id 200108113 Facility Id 200108113
Contact Type primary Contact Type backup
Name Chen-hua Yan, MD Name Jing Liu, MD
Email yanchenhua@vip.sina.com Email liujing0245@bjmu.edu.cn
Phone 86 010 88326666 Phone 86 010 88326666

Facility Investigators

Sequence: 18332492
Facility Id 200108113
Role Principal Investigator
Name Xiao-Jun Huang, MD

Browse Interventions

Sequence: 96050229 Sequence: 96050230 Sequence: 96050231 Sequence: 96050232 Sequence: 96050233 Sequence: 96050234
Mesh Term Decitabine Mesh Term Antimetabolites, Antineoplastic Mesh Term Antimetabolites Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antineoplastic Agents Mesh Term Enzyme Inhibitors
Downcase Mesh Term decitabine Downcase Mesh Term antimetabolites, antineoplastic Downcase Mesh Term antimetabolites Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antineoplastic agents Downcase Mesh Term enzyme inhibitors
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52171218 Sequence: 52171219 Sequence: 52171220
Name Stem Cell Transplant Complications Name Relapse Leukemia Name Refractory Leukemia
Downcase Name stem cell transplant complications Downcase Name relapse leukemia Downcase Name refractory leukemia

Id Information

Sequence: 40158622
Id Source org_study_id
Id Value decitabine pre-HSCT for R/R AL

Countries

Sequence: 42568933
Name China
Removed False

Design Groups

Sequence: 55593155 Sequence: 55593156
Group Type Experimental Group Type Experimental
Title Decitabine plus mBU/CY for HLA-mismatched HSCT Title Decitabine plus mBU/CY for matched sibling transplant
Description Decitabine plus mBU/CY as precondition regimen for recurrent and refractory acute leukemia at the time of HLA-mismatched HSCT

Details:

The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was decitabine plus modified BU/CY and ATG,consisting of decitabine 100mg·m-2·d-1 q12h on days-12 and -11,cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg/m2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2

Description Decitabine plus mBU/CY as precondition regimen for High Risk Acute Leukemia With MRD (minimal residual disease) at the time of matched sibling transplant.

Details:

In matched sibling transplantations, patients received decitabine 100mg·m-2·d-1 q12h on days-12 and -11,hydroxycarbamide (80 mg/kg) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg/m2), orally once on day -3.

Interventions

Sequence: 52485463 Sequence: 52485464 Sequence: 52485465
Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Decitabine Name mBU/CY and ATG Name mBU/CY
Description Decitabine 200mg.m-2.d-1 intravenously on days -12 and -11 Description Ara-C 4 g·m-2·d-1 intravenously on days -10 to -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3 ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2 Description hydroxycarbamide (80 mg·kg-1) orally on day -10 Ara-C (2 g·m-2·d-1) on day -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3

Keywords

Sequence: 79868505 Sequence: 79868506 Sequence: 79868507 Sequence: 79868508
Name recurrent acute leukemia Name refractory acute leukemia Name preconditioning regimen Name allogeneic stem cell transplantation
Downcase Name recurrent acute leukemia Downcase Name refractory acute leukemia Downcase Name preconditioning regimen Downcase Name allogeneic stem cell transplantation

Design Outcomes

Sequence: 177378813 Sequence: 177378814 Sequence: 177378815 Sequence: 177378816 Sequence: 177378817 Sequence: 177378818 Sequence: 177378819 Sequence: 177378820 Sequence: 177378821 Sequence: 177378822
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure 1 year cumulative incidence of relapse Measure 2 year cumulative incidence of relapse Measure Non-relapse mortality Measure 1 year overall survival Measure 5 years overall survival Measure 1 year leukemia free survival Measure 5 years leukemia free survival Measure engraftment Measure Acute graft versus host disease Measure Chronic graft versus host disease
Time Frame 1 year post allo-HSCT Time Frame 2 years post allo-HSCT Time Frame 1 year post allo-HSCT Time Frame 1 year post allo-HSCT Time Frame 5 years post allo-HSCT] 1 year leukemia free survival Time Frame 1 year post allo-HSCT Time Frame 5 years post allo-HSCT Time Frame 100 days post allo-HSCT Time Frame 100 days post allo-HSCT Time Frame 1 years post allo-HSCT
Description The cumulative incidence of relapse at 1 year post allo-HSCT Description The cumulative incidence of relapse at 2 years post allo-HSCT Description The cumulative incidence of non-relapse mortality at 1 year post allo-HSCT Description The overall survival at 1 year post allo-HSCT Description The overall survival at 5 years post allo-HSCT Description The leukemia free survival at 1 years post allo-HSCT Description The leukemia free survival at 5 years post allo-HSCT Description The total neutrophil and platelet engraftment rate Description The cumulative incidence of grade II-IV acute graft versus host disease Description The cumulative incidence of intermediate to severe chronic graft versus host disease

Browse Conditions

Sequence: 193486661 Sequence: 193486662 Sequence: 193486663 Sequence: 193486664 Sequence: 193486665 Sequence: 193486666
Mesh Term Leukemia Mesh Term Recurrence Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term leukemia Downcase Mesh Term recurrence Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319267
Agency Class OTHER
Lead Or Collaborator lead
Name Peking University People's Hospital

Overall Officials

Sequence: 29285342
Role Study Chair
Name Xiao-Jun Huang
Affiliation Peking University People's Hospital

Central Contacts

Sequence: 12008870 Sequence: 12008871
Contact Type primary Contact Type backup
Name Xiao-Jun Huang Name Chen-Hua Yan
Phone +86 010 88326666 Phone +86 010 88326666
Email yanchenhua@vip.sina.com Email yanchenhua@vip.sina.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68149111 Sequence: 68149112 Sequence: 68149113 Sequence: 68149114
Design Group Id 55593155 Design Group Id 55593156 Design Group Id 55593155 Design Group Id 55593156
Intervention Id 52485463 Intervention Id 52485463 Intervention Id 52485464 Intervention Id 52485465

Eligibilities

Sequence: 30765341
Gender All
Minimum Age 18 Years
Maximum Age 55 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

patients with relapsed acute leukemia
patients with acute leukemia in the third(or more)complete remission (CR3) status

Exclusion Criteria:

pregnancy women
uncontrolled severe infection

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253883255
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 55
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 8

Designs

Sequence: 30511508
Allocation Non-Randomized
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.BM samples from patients would be obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 year after transplantation.

Responsible Parties

Sequence: 28877802
Responsible Party Type Principal Investigator
Name Xiaojun Huang,MD
Title Director of the Hematology Department
Affiliation Peking University People's Hospital

]]>

<![CDATA[ Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine ]]>
https://zephyrnet.com/NCT03799211
2018-06-04

https://zephyrnet.com/?p=NCT03799211
NCT03799211https://www.clinicaltrials.gov/study/NCT03799211?tab=tableNANANAMigraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients’ reasons for making/not making the appointment.
<![CDATA[

Studies

Study First Submitted Date 2018-12-31
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-07-23
Start Month Year June 4, 2018
Primary Completion Month Year January 1, 2019
Verification Month Year July 2020
Verification Date 2020-07-31
Last Update Posted Date 2020-07-23
Results First Posted Date 2020-07-23

Facilities

Sequence: 200233720
Name NYU Langone
City New York
State New York
Zip 10016
Country United States

Conditions

Sequence: 52204174
Name Migraine
Downcase Name migraine

Id Information

Sequence: 40183286
Id Source org_study_id
Id Value 16-00937

Countries

Sequence: 42596886
Name United States
Removed False

Design Groups

Sequence: 55630429 Sequence: 55630430
Group Type Experimental Group Type Active Comparator
Title Motivational Interviewing Title Usual Care

Interventions

Sequence: 52518367 Sequence: 52518368
Intervention Type Behavioral Intervention Type Behavioral
Name Motivational Interviewing Name Treatment as Usual
Description Phone call using motivational interviewing technique Description will receive a regular study phone call after three months

Design Outcomes

Sequence: 177498710 Sequence: 177498711 Sequence: 177498712 Sequence: 177498713 Sequence: 177498714 Sequence: 177498715
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Percentage of Patients Who Made an Appointment for Behavioral Therapy Measure Percentage of Participants Who Attended Appointments Measure Percentage of Participants Who Initiated Appointments Measure Mean Reported Importance of Managing Migraine Measure Mean Reported Confidence in Managing Migraines Measure Mean Reported Confidence in Behavioral Therapy
Time Frame 3-6 Months Time Frame 3-6 Months Time Frame Month 3-4 post-recruitment Time Frame First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) Time Frame First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) Time Frame First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Description Of those who initiated behavioral therapy, percentage who attended appointments Description Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. Description Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. Description Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.

Browse Conditions

Sequence: 193612179 Sequence: 193612180 Sequence: 193612181 Sequence: 193612182 Sequence: 193612183 Sequence: 193612184
Mesh Term Migraine Disorders Mesh Term Headache Disorders, Primary Mesh Term Headache Disorders Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases
Downcase Mesh Term migraine disorders Downcase Mesh Term headache disorders, primary Downcase Mesh Term headache disorders Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48350097
Agency Class OTHER
Lead Or Collaborator lead
Name NYU Langone Health

Overall Officials

Sequence: 29303713
Role Principal Investigator
Name Mia Minen, MD
Affiliation NYU Langone

Design Group Interventions

Sequence: 68194259 Sequence: 68194260
Design Group Id 55630429 Design Group Id 55630430
Intervention Id 52518367 Intervention Id 52518368

Eligibilities

Sequence: 30784602
Gender All
Minimum Age 16 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Migraine diagnosis age 16+
English speaking

Exclusion Criteria:

Unable to read the questionnaire, no phone number

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253985177
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 7
Were Results Reported True
Months To Report Results 18
Has Us Facility True
Has Single Facility True
Minimum Age Num 16
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30530683
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Drop Withdrawals

Sequence: 29007649 Sequence: 29007650 Sequence: 29007651 Sequence: 29007652
Result Group Id 56116378 Result Group Id 56116379 Result Group Id 56116378 Result Group Id 56116379
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Reason Lost to Follow-up Reason Lost to Follow-up Reason Withdrawal by Subject Reason Withdrawal by Subject
Count 2 Count 13 Count 2 Count 0

Milestones

Sequence: 41031649 Sequence: 41031650 Sequence: 41031651 Sequence: 41031652 Sequence: 41031653 Sequence: 41031654
Result Group Id 56116378 Result Group Id 56116379 Result Group Id 56116378 Result Group Id 56116379 Result Group Id 56116378 Result Group Id 56116379
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 36 Count 40 Count 32 Count 27 Count 4 Count 13

Participant Flows

Sequence: 3923169

Outcome Counts

Sequence: 74046062 Sequence: 74046063 Sequence: 74046064 Sequence: 74046065 Sequence: 74046066 Sequence: 74046067 Sequence: 74046068 Sequence: 74046069 Sequence: 74046070 Sequence: 74046071 Sequence: 74046072 Sequence: 74046073
Outcome Id 30823261 Outcome Id 30823261 Outcome Id 30823262 Outcome Id 30823262 Outcome Id 30823263 Outcome Id 30823263 Outcome Id 30823264 Outcome Id 30823264 Outcome Id 30823265 Outcome Id 30823265 Outcome Id 30823266 Outcome Id 30823266
Result Group Id 56116380 Result Group Id 56116381 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 32 Count 27 Count 27 Count 32 Count 27 Count 32 Count 27 Count 32 Count 27 Count 32 Count 27 Count 32

Provided Documents

Sequence: 2582162
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2019-12-23
Url https://ClinicalTrials.gov/ProvidedDocs/11/NCT03799211/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27958312 Sequence: 27958313 Sequence: 27958314 Sequence: 27958315 Sequence: 27958316 Sequence: 27958317
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0
Subjects At Risk 0 Subjects At Risk 0 Subjects At Risk 0 Subjects At Risk 0 Subjects At Risk 0 Subjects At Risk 0
Created At 2023-08-09 06:44:03.854711 Created At 2023-08-09 06:44:03.854711 Created At 2023-08-09 06:44:03.854711 Created At 2023-08-09 06:44:03.854711 Created At 2023-08-09 06:44:03.854711 Created At 2023-08-09 06:44:03.854711
Updated At 2023-08-09 06:44:03.854711 Updated At 2023-08-09 06:44:03.854711 Updated At 2023-08-09 06:44:03.854711 Updated At 2023-08-09 06:44:03.854711 Updated At 2023-08-09 06:44:03.854711 Updated At 2023-08-09 06:44:03.854711

Responsible Parties

Sequence: 28896984
Responsible Party Type Sponsor

Result Agreements

Sequence: 3853913
Pi Employee Yes

Result Contacts

Sequence: 3853878
Organization NYU Langone Health
Name Mia Minen, MD, MPH
Phone 212-263-7744
Email Mia.Minen@nyulangone.org

Outcomes

Sequence: 30823261 Sequence: 30823262 Sequence: 30823263 Sequence: 30823264 Sequence: 30823265 Sequence: 30823266
Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Percentage of Patients Who Made an Appointment for Behavioral Therapy Title Percentage of Participants Who Attended Appointments Title Percentage of Participants Who Initiated Appointments Title Mean Reported Importance of Managing Migraine Title Mean Reported Confidence in Managing Migraines Title Mean Reported Confidence in Behavioral Therapy
Description Of those who initiated behavioral therapy, percentage who attended appointments Description Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. Description Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. Description Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.
Time Frame 3-6 Months Time Frame 3-6 Months Time Frame Month 3-4 post-recruitment Time Frame First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) Time Frame First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) Time Frame First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Units percentage of participants Units percentage of participants Units percentage of participants Units units on a scale Units score on a scale Units score on a scale
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Param Type Number Param Type Number Param Type Number Param Type Mean Param Type Mean Param Type Mean

Outcome Measurements

Sequence: 235818943 Sequence: 235818944 Sequence: 235818945 Sequence: 235818946 Sequence: 235818947 Sequence: 235818948 Sequence: 235818933 Sequence: 235818934 Sequence: 235818935 Sequence: 235818936 Sequence: 235818937 Sequence: 235818938 Sequence: 235818939 Sequence: 235818940 Sequence: 235818941 Sequence: 235818942 Sequence: 235818949 Sequence: 235818950
Outcome Id 30823265 Outcome Id 30823265 Outcome Id 30823265 Outcome Id 30823265 Outcome Id 30823266 Outcome Id 30823266 Outcome Id 30823261 Outcome Id 30823261 Outcome Id 30823262 Outcome Id 30823262 Outcome Id 30823263 Outcome Id 30823263 Outcome Id 30823264 Outcome Id 30823264 Outcome Id 30823264 Outcome Id 30823264 Outcome Id 30823266 Outcome Id 30823266
Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116380 Result Group Id 56116381 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383 Result Group Id 56116382 Result Group Id 56116383
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Classification First Follow-Up Call Classification First Follow-Up Call Classification Last Follow-Up Call Classification Last Follow-Up Call Classification First Follow-Up Call Classification First Follow-Up Call Classification First Follow-Up Call Classification First Follow-Up Call Classification Last Follow-Up Call Classification Last Follow-Up Call Classification Last Follow-Up Call Classification Last Follow-Up Call
Title Mean Reported Confidence in Managing Migraines Title Mean Reported Confidence in Managing Migraines Title Mean Reported Confidence in Managing Migraines Title Mean Reported Confidence in Managing Migraines Title Mean Reported Confidence in Behavioral Therapy Title Mean Reported Confidence in Behavioral Therapy Title Percentage of Patients Who Made an Appointment for Behavioral Therapy Title Percentage of Patients Who Made an Appointment for Behavioral Therapy Title Percentage of Participants Who Attended Appointments Title Percentage of Participants Who Attended Appointments Title Percentage of Participants Who Initiated Appointments Title Percentage of Participants Who Initiated Appointments Title Mean Reported Importance of Managing Migraine Title Mean Reported Importance of Managing Migraine Title Mean Reported Importance of Managing Migraine Title Mean Reported Importance of Managing Migraine Title Mean Reported Confidence in Behavioral Therapy Title Mean Reported Confidence in Behavioral Therapy
Description Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. Description Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. Description Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. Description Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. Description Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. Description Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. Description Of those who initiated behavioral therapy, percentage who attended appointments Description Of those who initiated behavioral therapy, percentage who attended appointments Description Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. Description Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. Description Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. Description Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. Description Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. Description Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.
Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units percentage of participants Units percentage of participants Units percentage of participants Units percentage of participants Units percentage of participants Units percentage of participants Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units score on a scale Units score on a scale
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value NA Param Value 6.26 Param Value 6.59 Param Value 6.62 Param Value NA Param Value 4.83 Param Value 37.5 Param Value 22.2 Param Value 22.2 Param Value 21.9 Param Value 40.7 Param Value 68.8 Param Value NA Param Value 9.16 Param Value 9.19 Param Value 9.22 Param Value 5.35 Param Value 5.04
Param Value Num 6.26 Param Value Num 6.59 Param Value Num 6.62 Param Value Num 4.83 Param Value Num 37.5 Param Value Num 22.2 Param Value Num 22.2 Param Value Num 21.9 Param Value Num 40.7 Param Value Num 68.8 Param Value Num 9.16 Param Value Num 9.19 Param Value Num 9.22 Param Value Num 5.35 Param Value Num 5.04
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value NA Dispersion Value 2.27 Dispersion Value 2.26 Dispersion Value 2.50 Dispersion Value NA Dispersion Value 2.47 Dispersion Value NA Dispersion Value 1.27 Dispersion Value 1.3 Dispersion Value 1.18 Dispersion Value 2.59 Dispersion Value 1.95
Dispersion Value Num 2.27 Dispersion Value Num 2.26 Dispersion Value Num 2.5 Dispersion Value Num 2.47 Dispersion Value Num 1.27 Dispersion Value Num 1.3 Dispersion Value Num 1.18 Dispersion Value Num 2.59 Dispersion Value Num 1.95
Explanation Of Na Only one follow-up call was conducted for this arm Explanation Of Na Only one follow-up call was conducted for this arm Explanation Of Na Only one follow-up call was conducted for this arm

Baseline Counts

Sequence: 11389330 Sequence: 11389331 Sequence: 11389332
Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 36 Count 40 Count 76

Result Groups

Sequence: 56116375 Sequence: 56116376 Sequence: 56116377 Sequence: 56116378 Sequence: 56116379 Sequence: 56116380 Sequence: 56116381 Sequence: 56116382 Sequence: 56116383 Sequence: 56116384 Sequence: 56116385
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title Motivational Interviewing Title Usual Care Title Total Title Motivational Interviewing Title Usual Care Title Motivational Interviewing Title Usual Care Title Usual Care Title Motivational Interviewing Title Motivational Interviewing Title Usual Care
Description Motivational Interviewing: Phone call using motivational interviewing technique Description Treatment as Usual: will receive a regular study phone call after three months Description Total of all reporting groups Description Motivational Interviewing: Phone call using motivational interviewing technique Description Treatment as Usual: will receive a regular study phone call after three months Description Motivational Interviewing: Phone call using motivational interviewing technique Description Treatment as Usual: will receive a regular study phone call after three months Description Treatment as Usual: will receive a regular study phone call after three months Description Motivational Interviewing: Phone call using motivational interviewing technique Description Motivational Interviewing: Phone call using motivational interviewing technique Description Treatment as Usual: will receive a regular study phone call after three months

Baseline Measurements

Sequence: 125670055 Sequence: 125670033 Sequence: 125670034 Sequence: 125670035 Sequence: 125670036 Sequence: 125670037 Sequence: 125670038 Sequence: 125670039 Sequence: 125670040 Sequence: 125670041 Sequence: 125670042 Sequence: 125670043 Sequence: 125670044 Sequence: 125670045 Sequence: 125670046 Sequence: 125670047 Sequence: 125670048 Sequence: 125670049 Sequence: 125670050 Sequence: 125670051 Sequence: 125670052 Sequence: 125670053 Sequence: 125670054 Sequence: 125670056 Sequence: 125670057 Sequence: 125670058 Sequence: 125670059 Sequence: 125670060 Sequence: 125670061 Sequence: 125670062 Sequence: 125670063 Sequence: 125670064 Sequence: 125670065 Sequence: 125670066 Sequence: 125670067 Sequence: 125670068 Sequence: 125670069 Sequence: 125670070 Sequence: 125670071 Sequence: 125670072 Sequence: 125670073 Sequence: 125670074
Result Group Id 56116376 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377 Result Group Id 56116375 Result Group Id 56116376 Result Group Id 56116377
Ctgov Group Code BG001 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Classification United States Classification United States Classification United States
Category Asian Category Female Category Female Category Female Category Male Category Male Category Male Category Hispanic or Latino Category Hispanic or Latino Category Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category Asian Category Asian Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Black or African American Category Black or African American Category Black or African American Category White Category White Category White Category More than one race Category More than one race Category More than one race Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported
Title Race (NIH/OMB) Title Age, Continuous Title Age, Continuous Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Region of Enrollment Title Region of Enrollment Title Region of Enrollment
Units Participants Units years Units years Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units participants Units participants
Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number Param Type Number
Param Value 0 Param Value 40.4 Param Value 38.1 Param Value 39.3 Param Value 32 Param Value 39 Param Value 71 Param Value 4 Param Value 1 Param Value 5 Param Value 6 Param Value 4 Param Value 10 Param Value 30 Param Value 36 Param Value 66 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 3 Param Value 3 Param Value 0 Param Value 0 Param Value 0 Param Value 2 Param Value 1 Param Value 3 Param Value 26 Param Value 33 Param Value 59 Param Value 0 Param Value 0 Param Value 0 Param Value 5 Param Value 6 Param Value 11 Param Value 36 Param Value 40 Param Value 76
Param Value Num 0.0 Param Value Num 40.4 Param Value Num 38.1 Param Value Num 39.3 Param Value Num 32.0 Param Value Num 39.0 Param Value Num 71.0 Param Value Num 4.0 Param Value Num 1.0 Param Value Num 5.0 Param Value Num 6.0 Param Value Num 4.0 Param Value Num 10.0 Param Value Num 30.0 Param Value Num 36.0 Param Value Num 66.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 3.0 Param Value Num 3.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 3.0 Param Value Num 26.0 Param Value Num 33.0 Param Value Num 59.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 5.0 Param Value Num 6.0 Param Value Num 11.0 Param Value Num 36.0 Param Value Num 40.0 Param Value Num 76.0
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 12.3 Dispersion Value 12.1 Dispersion Value 12.2
Dispersion Value Num 12.3 Dispersion Value Num 12.1 Dispersion Value Num 12.2
Number Analyzed 40 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76 Number Analyzed 36 Number Analyzed 40 Number Analyzed 76

]]>

<![CDATA[ Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity ]]>
https://zephyrnet.com/NCT03799198
2019-01-07

https://zephyrnet.com/?p=NCT03799198
NCT03799198https://www.clinicaltrials.gov/study/NCT03799198?tab=tableNANANAResearchers are doing this study to compare the effects of drugs approved for long-term weight loss combined with an employer-based weight management program with the effects of the weight management program without drugs for weight loss. If participants agree to be in this study, they will join the Cleveland Clinic Integrated Medical Weight Management Program (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss. Participants have an equal chance of being in either of the treatment groups. The total study duration for the individual participants will be approximately one year.
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Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-11-14
Start Month Year January 7, 2019
Primary Completion Month Year May 22, 2020
Verification Month Year November 2022
Verification Date 2022-11-30
Last Update Posted Date 2022-11-14
Results First Posted Date 2021-06-18

Facilities

Sequence: 199947291
Name Novo Nordisk Investigational Site
City Cleveland
State Ohio
Zip 44195
Country United States

Conditions

Sequence: 52133459
Name Obesity
Downcase Name obesity

Id Information

Sequence: 40130936 Sequence: 40130937
Id Source org_study_id Id Source secondary_id
Id Value NN8022-4432 Id Value U1111-1218-8104
Id Type Other Identifier
Id Type Description World Health Organization (WHO)

Countries

Sequence: 42538538
Name United States
Removed False

Design Groups

Sequence: 55553236 Sequence: 55553237
Group Type Experimental Group Type Active Comparator
Title WMP + Rx Title WMP alone
Description Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately one year. After discussing with the study doctor, participants will receive one of the following listed 5 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) lorcaserin or lorcaserin extended-release, 3) phentermine/topiramate extended-release, 4) naltrexone/bupropion extended-release and 5) liraglutide 3.0 mg. Description Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year.

Interventions

Sequence: 52449619 Sequence: 52449620
Intervention Type Other Intervention Type Drug
Name Weight Management Program (WMP) Name Medication for chronic weight management (Rx)
Description As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic. Description Following listed 5 drugs will be administered as prescribed by the study doctor:

1) Orlistat (Xenical® pills, per os [p.o.; by mouth]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously [under the skin]).

Design Outcomes

Sequence: 177246914 Sequence: 177246915 Sequence: 177246916 Sequence: 177246917 Sequence: 177246918 Sequence: 177246919 Sequence: 177246920 Sequence: 177246921 Sequence: 177246922 Sequence: 177246923 Sequence: 177246924 Sequence: 177246925 Sequence: 177246926 Sequence: 177246927 Sequence: 177246928 Sequence: 177246929
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in Body Weight Measure Participants Achieving 5% or More Reduction in Body Weight Measure Participants Achieving 10% or More Reduction in Body Weight Measure Number of Shared Medical Appointments (SMAs) Attended Measure Participants Attending 9 or More SMAs Measure Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management Measure Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days Measure Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) Measure Change in 'Time Management' as Measured by WLQ-8 Measure Change in 'Physical Tasks' as Measured by WLQ-8 Measure Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 Measure Change in 'Output Tasks' as Measured by WLQ-8 Measure Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) Measure Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP Measure Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP Measure Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP
Time Frame Month 0, month 12 Time Frame Month 12 Time Frame Month 12 Time Frame Months 0-12 Time Frame Months 0-12 Time Frame Months 0-12 Time Frame Months 0-12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12
Description Percentage change in body weight from baseline (month 0) to month 12 is presented. Description The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. Description The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. Description Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. Description Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. Description Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx. Description Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.

Browse Conditions

Sequence: 193345553 Sequence: 193345554 Sequence: 193345555 Sequence: 193345556 Sequence: 193345557
Mesh Term Obesity Mesh Term Overweight Mesh Term Overnutrition Mesh Term Nutrition Disorders Mesh Term Body Weight
Downcase Mesh Term obesity Downcase Mesh Term overweight Downcase Mesh Term overnutrition Downcase Mesh Term nutrition disorders Downcase Mesh Term body weight
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48285506
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Novo Nordisk A/S

Overall Officials

Sequence: 29265149
Role Study Director
Name Clinical Reporting Anchor and Disclosure (1452)
Affiliation Novo Nordisk A/S

Design Group Interventions

Sequence: 68100615 Sequence: 68100616 Sequence: 68100617
Design Group Id 55553236 Design Group Id 55553237 Design Group Id 55553236
Intervention Id 52449619 Intervention Id 52449619 Intervention Id 52449620

Eligibilities

Sequence: 30744449
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study
Male or female, age more than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) more than or equal 30 kg/m^2
Enrolled in Cleveland Clinic Employee Health Plan, and expecting to be covered by the Cleveland Clinic Employee Health Plan for the duration of the study

Exclusion Criteria:

Contraindications to all of the medications approved by the FDA for chronic weight management according to the label
Previous participation in this study. Participation is defined as signed informed consent
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Participation in another clinical trial within 30 days before screening
Treatment with any medication with the intention of weight loss within 90 days before screening
Previous or current participation in Cleveland Clinic's Integrated Medical Weight Management Program
History of (or plans during the study period for) bariatric surgery, or use of minimally-invasive weight loss devices (i.e. Intragastric balloons, lap bands) not removed within 1 year prior to screening
History of type 1 or type 2 diabetes mellitus
Hemoglobin A1c (HbA1c) more than or equal to 6.5% at screening or within 90 days prior to randomization
Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254096827
Number Of Facilities 1
Number Of Sae Subjects 23
Registered In Calendar Year 2019
Actual Duration 16
Were Results Reported True
Months To Report Results 11
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 15

Designs

Sequence: 30490746
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Drop Withdrawals

Sequence: 28962950 Sequence: 28962951 Sequence: 28962952 Sequence: 28962953
Result Group Id 56067797 Result Group Id 56067798 Result Group Id 56067797 Result Group Id 56067798
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Reason Lost to Follow-up Reason Lost to Follow-up Reason Death Reason Death
Count 4 Count 8 Count 0 Count 1

Milestones

Sequence: 40980557 Sequence: 40980558 Sequence: 40980559 Sequence: 40980560 Sequence: 40980561 Sequence: 40980562 Sequence: 40980563 Sequence: 40980564
Result Group Id 56067797 Result Group Id 56067798 Result Group Id 56067797 Result Group Id 56067798 Result Group Id 56067797 Result Group Id 56067798 Result Group Id 56067797 Result Group Id 56067798
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title Full Analysis Set (FAS) Title Full Analysis Set (FAS) Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 100 Count 100 Count 100 Count 100 Count 96 Count 91 Count 4 Count 9

Outcome Analyses

Sequence: 16556339
Outcome Id 30783824
Non Inferiority Type Superiority
Param Type Treatment Difference
Param Value -3.5
Dispersion Type Standard Error of the Mean
Dispersion Value 1.02
P Value Modifier <
P Value 0.001
Ci N Sides 2-Sided
Ci Percent 95.0
Ci Lower Limit -5.51
Ci Upper Limit -1.5
Method ANCOVA
Groups Description Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.

Outcome Analysis Groups

Sequence: 32109410 Sequence: 32109411
Outcome Analysis Id 16556339 Outcome Analysis Id 16556339
Result Group Id 56067799 Result Group Id 56067800
Ctgov Group Code OG000 Ctgov Group Code OG001

Participant Flows

Sequence: 3919108
Recruitment Details The trial was conducted at a single site in the United States.
Pre Assignment Details Participants were randomized in a 1:1 manner to receive either Cleveland Clinic's Integrated Medical Weight Management Program (WMP) with medication for chronic weight management (WMP + Rx) or Cleveland Clinic's Integrated Medical WMP alone (WMP).

Outcome Counts

Sequence: 73950351 Sequence: 73950352 Sequence: 73950353 Sequence: 73950354 Sequence: 73950355 Sequence: 73950356 Sequence: 73950357 Sequence: 73950358 Sequence: 73950359 Sequence: 73950360 Sequence: 73950361 Sequence: 73950362 Sequence: 73950363 Sequence: 73950364 Sequence: 73950365 Sequence: 73950366 Sequence: 73950367 Sequence: 73950368 Sequence: 73950369 Sequence: 73950370 Sequence: 73950371 Sequence: 73950372 Sequence: 73950373 Sequence: 73950374 Sequence: 73950375 Sequence: 73950376 Sequence: 73950377 Sequence: 73950378 Sequence: 73950379 Sequence: 73950380
Outcome Id 30783824 Outcome Id 30783824 Outcome Id 30783825 Outcome Id 30783825 Outcome Id 30783826 Outcome Id 30783826 Outcome Id 30783827 Outcome Id 30783827 Outcome Id 30783828 Outcome Id 30783828 Outcome Id 30783829 Outcome Id 30783830 Outcome Id 30783831 Outcome Id 30783831 Outcome Id 30783832 Outcome Id 30783832 Outcome Id 30783833 Outcome Id 30783833 Outcome Id 30783834 Outcome Id 30783834 Outcome Id 30783835 Outcome Id 30783835 Outcome Id 30783836 Outcome Id 30783836 Outcome Id 30783837 Outcome Id 30783837 Outcome Id 30783838 Outcome Id 30783838 Outcome Id 30783839 Outcome Id 30783839
Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067799 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 100 Count 98 Count 98 Count 95 Count 99 Count 98 Count 98 Count 97 Count 97 Count 98 Count 95 Count 95 Count 95 Count 95 Count 95 Count 95 Count 100 Count 100

Provided Documents

Sequence: 2576849 Sequence: 2576850
Document Type Study Protocol Document Type Statistical Analysis Plan
Has Protocol True Has Protocol False
Has Icf False Has Icf False
Has Sap False Has Sap True
Document Date 2018-10-10 Document Date 2020-05-18
Url https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/Prot_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/SAP_001.pdf

Reported Event Totals

Sequence: 27926830 Sequence: 27926831 Sequence: 27926832 Sequence: 27926833 Sequence: 27926834 Sequence: 27926835
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 8 Subjects Affected 0 Subjects Affected 0 Subjects Affected 11 Subjects Affected 0 Subjects Affected 1
Subjects At Risk 100 Subjects At Risk 0 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 0 Subjects At Risk 100
Created At 2023-08-08 19:39:46.931925 Created At 2023-08-08 19:39:46.931925 Created At 2023-08-08 19:39:46.931925 Created At 2023-08-08 19:39:46.931925 Created At 2023-08-08 19:39:46.931925 Created At 2023-08-08 19:39:46.931925
Updated At 2023-08-08 19:39:46.931925 Updated At 2023-08-08 19:39:46.931925 Updated At 2023-08-08 19:39:46.931925 Updated At 2023-08-08 19:39:46.931925 Updated At 2023-08-08 19:39:46.931925 Updated At 2023-08-08 19:39:46.931925

Reported Events

Sequence: 527811605 Sequence: 527811585 Sequence: 527811586 Sequence: 527811587 Sequence: 527811588 Sequence: 527811589 Sequence: 527811590 Sequence: 527811591 Sequence: 527811592 Sequence: 527811606 Sequence: 527811593 Sequence: 527811594 Sequence: 527811595 Sequence: 527811596 Sequence: 527811597 Sequence: 527811598 Sequence: 527811599 Sequence: 527811600 Sequence: 527811601 Sequence: 527811602 Sequence: 527811603 Sequence: 527811604 Sequence: 527811607 Sequence: 527811608 Sequence: 527811609 Sequence: 527811610 Sequence: 527811611 Sequence: 527811612 Sequence: 527811613 Sequence: 527811614 Sequence: 527811615 Sequence: 527811616 Sequence: 527811617 Sequence: 527811618 Sequence: 527811619 Sequence: 527811620 Sequence: 527811621 Sequence: 527811622 Sequence: 527811623 Sequence: 527811624 Sequence: 527811625 Sequence: 527811626 Sequence: 527811627 Sequence: 527811628 Sequence: 527811629 Sequence: 527811630
Result Group Id 56067801 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802 Result Group Id 56067801 Result Group Id 56067802
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12 Time Frame Months 0 – 12
Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious
Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0
Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100 Subjects At Risk 100
Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. Description All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Event Count 0 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 1 Event Count 0 Event Count 0 Event Count 1 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 1 Event Count 0 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 1 Event Count 0 Event Count 0 Event Count 1 Event Count 1 Event Count 0
Organ System Blood and lymphatic system disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Blood and lymphatic system disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System General disorders Organ System General disorders Organ System Hepatobiliary disorders Organ System Hepatobiliary disorders Organ System Infections and infestations Organ System Infections and infestations Organ System Neoplasms benign, malignant and unspecified (incl cysts and polyps) Organ System Neoplasms benign, malignant and unspecified (incl cysts and polyps) Organ System Nervous system disorders Organ System Nervous system disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Reproductive system and breast disorders Organ System Reproductive system and breast disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Social circumstances Organ System Social circumstances Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Vascular disorders Organ System Vascular disorders
Adverse Event Term Plasma Cell Myeloma Adverse Event Term Atrial Fibrillation Adverse Event Term Atrial Fibrillation Adverse Event Term Atrial Tachycardia Adverse Event Term Atrial Tachycardia Adverse Event Term Congestive Cardiomyopathy Adverse Event Term Congestive Cardiomyopathy Adverse Event Term Appendicitis Adverse Event Term Appendicitis Adverse Event Term Plasma Cell Myeloma Adverse Event Term Gastroenteritis Salmonella Adverse Event Term Gastroenteritis Salmonella Adverse Event Term Procedural Vomiting Adverse Event Term Procedural Vomiting Adverse Event Term Dehydration Adverse Event Term Dehydration Adverse Event Term Malnutrition Adverse Event Term Malnutrition Adverse Event Term Arthralgia Adverse Event Term Arthralgia Adverse Event Term Intervertebral Disc Protrusion Adverse Event Term Intervertebral Disc Protrusion Adverse Event Term Non-Cardiac Chest Pain Adverse Event Term Non-Cardiac Chest Pain Adverse Event Term Cholelithiasis Adverse Event Term Cholelithiasis Adverse Event Term Pyelonephritis Adverse Event Term Pyelonephritis Adverse Event Term Parathyroid Tumour Benign Adverse Event Term Parathyroid Tumour Benign Adverse Event Term Syncope Adverse Event Term Syncope Adverse Event Term Depression Suicidal Adverse Event Term Depression Suicidal Adverse Event Term Ovarian Mass Adverse Event Term Ovarian Mass Adverse Event Term Respiratory Failure Adverse Event Term Respiratory Failure Adverse Event Term Skin Lesion Adverse Event Term Skin Lesion Adverse Event Term Organ Donor Adverse Event Term Organ Donor Adverse Event Term Gastric Bypass Adverse Event Term Gastric Bypass Adverse Event Term Dizziness Adverse Event Term Dizziness
Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0
Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1 Vocab 20.1
Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment Assessment Systematic Assessment

Responsible Parties

Sequence: 28857047
Responsible Party Type Sponsor

Result Agreements

Sequence: 3849852
Pi Employee No
Restriction Type OTHER
Other Details At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Restrictive Agreement At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.

Result Contacts

Sequence: 3849817
Organization Novo Nordisk A/S
Name Clinical Transparency and Medical Writing Office (1452)
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com

Outcomes

Sequence: 30783824 Sequence: 30783825 Sequence: 30783826 Sequence: 30783827 Sequence: 30783828 Sequence: 30783829 Sequence: 30783830 Sequence: 30783831 Sequence: 30783832 Sequence: 30783833 Sequence: 30783834 Sequence: 30783835 Sequence: 30783837 Sequence: 30783836 Sequence: 30783838 Sequence: 30783839
Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Change in Body Weight Title Participants Achieving 5% or More Reduction in Body Weight Title Participants Achieving 10% or More Reduction in Body Weight Title Number of Shared Medical Appointments (SMAs) Attended Title Participants Attending 9 or More SMAs Title Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management Title Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days Title Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) Title Change in 'Time Management' as Measured by WLQ-8 Title Change in 'Physical Tasks' as Measured by WLQ-8 Title Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 Title Change in 'Output Tasks' as Measured by WLQ-8 Title Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP Title Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) Title Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP Title Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP
Description Percentage change in body weight from baseline (month 0) to month 12 is presented. Description The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. Description The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. Description Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. Description Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. Description Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx. Description Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Time Frame Month 0, month 12 Time Frame Month 12 Time Frame Month 12 Time Frame Months 0-12 Time Frame Months 0-12 Time Frame Months 0-12 Time Frame Months 0-12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12 Time Frame Month 0, month 12
Population The FAS comprised of all randomized participants. Population The FAS comprised of all randomized participants. Population The FAS comprised of all randomized participants. Population The FAS comprised of all randomized participants. Population The FAS comprised of all randomized participants. Population The FAS comprised of all randomized participants. Population The FAS comprised of all randomized participants. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. Population The FAS comprised of all randomized participants.
Units Percent change of body weight Units Percentage of participants Units Percentage of participants Units SMAs Units Participants Units Proportion of days Units Participants Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale
Dispersion Type Standard Error Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error
Param Type Least Squares Mean Param Type Number Param Type Number Param Type Mean Param Type Count of Participants Param Type Mean Param Type Count of Participants Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean

Outcome Measurements

Sequence: 235487856 Sequence: 235487857 Sequence: 235487858 Sequence: 235487859 Sequence: 235487860 Sequence: 235487861 Sequence: 235487862 Sequence: 235487863 Sequence: 235487864 Sequence: 235487865 Sequence: 235487866 Sequence: 235487867 Sequence: 235487868 Sequence: 235487869 Sequence: 235487870 Sequence: 235487871 Sequence: 235487872 Sequence: 235487873 Sequence: 235487874 Sequence: 235487875 Sequence: 235487876 Sequence: 235487877 Sequence: 235487878 Sequence: 235487879 Sequence: 235487880 Sequence: 235487881 Sequence: 235487882 Sequence: 235487883 Sequence: 235487884 Sequence: 235487885
Outcome Id 30783824 Outcome Id 30783824 Outcome Id 30783825 Outcome Id 30783825 Outcome Id 30783826 Outcome Id 30783826 Outcome Id 30783827 Outcome Id 30783827 Outcome Id 30783828 Outcome Id 30783828 Outcome Id 30783829 Outcome Id 30783830 Outcome Id 30783831 Outcome Id 30783831 Outcome Id 30783832 Outcome Id 30783832 Outcome Id 30783833 Outcome Id 30783833 Outcome Id 30783834 Outcome Id 30783834 Outcome Id 30783835 Outcome Id 30783835 Outcome Id 30783836 Outcome Id 30783836 Outcome Id 30783837 Outcome Id 30783837 Outcome Id 30783838 Outcome Id 30783838 Outcome Id 30783839 Outcome Id 30783839
Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067799 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800 Result Group Id 56067799 Result Group Id 56067800
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Title Change in Body Weight Title Change in Body Weight Title Participants Achieving 5% or More Reduction in Body Weight Title Participants Achieving 5% or More Reduction in Body Weight Title Participants Achieving 10% or More Reduction in Body Weight Title Participants Achieving 10% or More Reduction in Body Weight Title Number of Shared Medical Appointments (SMAs) Attended Title Number of Shared Medical Appointments (SMAs) Attended Title Participants Attending 9 or More SMAs Title Participants Attending 9 or More SMAs Title Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management Title Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days Title Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) Title Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) Title Change in 'Time Management' as Measured by WLQ-8 Title Change in 'Time Management' as Measured by WLQ-8 Title Change in 'Physical Tasks' as Measured by WLQ-8 Title Change in 'Physical Tasks' as Measured by WLQ-8 Title Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 Title Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 Title Change in 'Output Tasks' as Measured by WLQ-8 Title Change in 'Output Tasks' as Measured by WLQ-8 Title Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) Title Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) Title Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP Title Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP Title Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP Title Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP Title Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP Title Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP
Description Percentage change in body weight from baseline (month 0) to month 12 is presented. Description Percentage change in body weight from baseline (month 0) to month 12 is presented. Description The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. Description The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. Description The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. Description The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. Description Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. Description Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. Description Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. Description Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. Description Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx. Description Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. Description The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. Description The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Units Percent change of body weight Units Percent change of body weight Units Percentage of participants Units Percentage of participants Units Percentage of participants Units Percentage of participants Units SMAs Units SMAs Units Participants Units Participants Units Proportion of days Units Participants Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale Units Score on a scale
Param Type Least Squares Mean Param Type Least Squares Mean Param Type Number Param Type Number Param Type Number Param Type Number Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Count of Participants Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean
Param Value -7.69 Param Value -4.19 Param Value 62.5 Param Value 44.8 Param Value 34.7 Param Value 22.4 Param Value 9.7 Param Value 7.4 Param Value 79 Param Value 51 Param Value 66.48 Param Value 43 Param Value -0.06 Param Value -0.03 Param Value -0.10 Param Value -0.19 Param Value -0.09 Param Value -0.05 Param Value -0.06 Param Value -0.03 Param Value 0.07 Param Value 0.12 Param Value -0.43 Param Value -0.48 Param Value -1.88 Param Value -1.94 Param Value -1.84 Param Value -1.89 Param Value -9.95 Param Value -7.20
Param Value Num -7.69 Param Value Num -4.19 Param Value Num 62.5 Param Value Num 44.8 Param Value Num 34.7 Param Value Num 22.4 Param Value Num 9.7 Param Value Num 7.4 Param Value Num 79.0 Param Value Num 51.0 Param Value Num 66.48 Param Value Num 43.0 Param Value Num -0.06 Param Value Num -0.03 Param Value Num -0.1 Param Value Num -0.19 Param Value Num -0.09 Param Value Num -0.05 Param Value Num -0.06 Param Value Num -0.03 Param Value Num 0.07 Param Value Num 0.12 Param Value Num -0.43 Param Value Num -0.48 Param Value Num -1.88 Param Value Num -1.94 Param Value Num -1.84 Param Value Num -1.89 Param Value Num -9.95 Param Value Num -7.2
Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error
Dispersion Value 0.72 Dispersion Value 0.73 Dispersion Value 2.98 Dispersion Value 3.90 Dispersion Value 27.096 Dispersion Value 0.06 Dispersion Value 0.06 Dispersion Value 0.07 Dispersion Value 0.07 Dispersion Value 0.11 Dispersion Value 0.11 Dispersion Value 0.09 Dispersion Value 0.09 Dispersion Value 0.10 Dispersion Value 0.11 Dispersion Value 0.17 Dispersion Value 0.19 Dispersion Value 1.62 Dispersion Value 1.82 Dispersion Value 1.62 Dispersion Value 1.82 Dispersion Value 2.53 Dispersion Value 2.69
Dispersion Value Num 0.72 Dispersion Value Num 0.73 Dispersion Value Num 2.98 Dispersion Value Num 3.9 Dispersion Value Num 27.096 Dispersion Value Num 0.06 Dispersion Value Num 0.06 Dispersion Value Num 0.07 Dispersion Value Num 0.07 Dispersion Value Num 0.11 Dispersion Value Num 0.11 Dispersion Value Num 0.09 Dispersion Value Num 0.09 Dispersion Value Num 0.1 Dispersion Value Num 0.11 Dispersion Value Num 0.17 Dispersion Value Num 0.19 Dispersion Value Num 1.62 Dispersion Value Num 1.82 Dispersion Value Num 1.62 Dispersion Value Num 1.82 Dispersion Value Num 2.53 Dispersion Value Num 2.69

Study References

Sequence: 52027283
Pmid 34255049
Reference Type derived
Citation Pantalone KM, Smolarz BG, Ramasamy A, Baz Hecht M, Harty BJ, Rogen B, Griebeler ML, Borukh E, Young JB, Burguera B. Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116595. doi: 10.1001/jamanetworkopen.2021.16595.

Baseline Counts

Sequence: 11376893 Sequence: 11376894 Sequence: 11376895
Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 100 Count 100 Count 200

Result Groups

Sequence: 56067796 Sequence: 56067794 Sequence: 56067795 Sequence: 56067797 Sequence: 56067798 Sequence: 56067799 Sequence: 56067800 Sequence: 56067801 Sequence: 56067802
Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title Total Title Weight Management Program (WMP) + Rx Title Weight Management Program (WMP) Title Weight Management Program (WMP) + Rx Title Weight Management Program (WMP) Title Weight Management Program (WMP) + Rx Title Weight Management Program (WMP) Title Weight Management Program (WMP) + Rx Title Weight Management Program (WMP)
Description Total of all reporting groups Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. Description Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.

Baseline Measurements

Sequence: 125504758 Sequence: 125504759 Sequence: 125504760 Sequence: 125504761 Sequence: 125504762 Sequence: 125504763 Sequence: 125504764 Sequence: 125504765 Sequence: 125504766 Sequence: 125504767 Sequence: 125504768 Sequence: 125504769 Sequence: 125504770 Sequence: 125504771 Sequence: 125504772 Sequence: 125504773 Sequence: 125504774 Sequence: 125504775 Sequence: 125504776 Sequence: 125504777 Sequence: 125504778 Sequence: 125504779 Sequence: 125504780 Sequence: 125504781 Sequence: 125504782 Sequence: 125504783 Sequence: 125504784 Sequence: 125504785 Sequence: 125504786 Sequence: 125504787
Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796 Result Group Id 56067794 Result Group Id 56067795 Result Group Id 56067796
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Category Female Category Female Category Female Category Male Category Male Category Male Category Hispanic or Latino Category Hispanic or Latino Category Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category White Category White Category White Category Black or African American Category Black or African American Category Black or African American Category Asian/White Category Asian/White Category Asian/White Category India Category India Category India
Title Age, Continuous Title Age, Continuous Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized
Description Race Description Race Description Race Description Race Description Race Description Race Description Race Description Race Description Race Description Race Description Race Description Race
Units years Units years Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 51.0 Param Value 49.1 Param Value 50.0 Param Value 88 Param Value 89 Param Value 177 Param Value 12 Param Value 11 Param Value 23 Param Value 4 Param Value 0 Param Value 4 Param Value 96 Param Value 100 Param Value 196 Param Value 0 Param Value 0 Param Value 0 Param Value 80 Param Value 66 Param Value 146 Param Value 19 Param Value 33 Param Value 52 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 1
Param Value Num 51.0 Param Value Num 49.1 Param Value Num 50.0 Param Value Num 88.0 Param Value Num 89.0 Param Value Num 177.0 Param Value Num 12.0 Param Value Num 11.0 Param Value Num 23.0 Param Value Num 4.0 Param Value Num 0.0 Param Value Num 4.0 Param Value Num 96.0 Param Value Num 100.0 Param Value Num 196.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 80.0 Param Value Num 66.0 Param Value Num 146.0 Param Value Num 19.0 Param Value Num 33.0 Param Value Num 52.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 1.0
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 10.43 Dispersion Value 10.11 Dispersion Value 10.29
Dispersion Value Num 10.43 Dispersion Value Num 10.11 Dispersion Value Num 10.29
Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200 Number Analyzed 100 Number Analyzed 100 Number Analyzed 200

]]>

<![CDATA[ Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population ]]>
https://zephyrnet.com/NCT03799185
2016-01-04

https://zephyrnet.com/?p=NCT03799185
NCT03799185https://www.clinicaltrials.gov/study/NCT03799185?tab=tableNANANAATERA Survey is a national cross sectional observational study, aiming to determine the prevalence of dyslipidemia and other conventional risk factors for CHD (Coronary Heart Disease), the relationship between environmental and lifestyle factors with dyslipidemia, the perception and the knowledge of cardiovascular risk factors by the population, and above all, to strengthen the national strategy for primary and secondary prevention against coronary heart disease.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-01-22
Start Month Year January 4, 2016
Primary Completion Month Year August 31, 2019
Verification Month Year January 2020
Verification Date 2020-01-31
Last Update Posted Date 2020-01-22

Detailed Descriptions

Sequence: 20762920
Description ATERA Survey is carried on in a random sampling including 10 000 men and women from the seven regions of Tunisia (Great Tunis, North East, North West, central East, Central West, South East and South West. The screening is being assessed using surveys covering socioeconomic, nutritional and anthropometric measures in addition to biological assessments.

The target population is being recruited by random sampling drown by the National Institute of Statistics (Tunisia). The estimated number of participants at the end of recruitment amount to 10 000. The frame sampling uses a two stage cluster sampling (district and household).

Interview with each eligible participant will be conducted mainly during assessment visit and after consenting the subject, it will be notified all the demographic, behavioral history, family history, cardiovascular risk factors and medical history. During the assessment visit, Physical examination/anthropometry data and Diet survey will be filled up by the investigator.

Data capture will be performed by the DACIMA Clinical Suite according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)

Facilities

Sequence: 200458031
Name ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
City Tunis
Zip 1007
Country Tunisia

Conditions

Sequence: 52277442 Sequence: 52277443 Sequence: 52277444 Sequence: 52277445
Name Dyslipidemias Name Atherosclerosis Name Households Name Survey, Family Life
Downcase Name dyslipidemias Downcase Name atherosclerosis Downcase Name households Downcase Name survey, family life

Id Information

Sequence: 40235451
Id Source org_study_id
Id Value ID5726367

Countries

Sequence: 42653026
Name Tunisia
Removed False

Keywords

Sequence: 80018939 Sequence: 80018940 Sequence: 80018941 Sequence: 80018942 Sequence: 80018943 Sequence: 80018944 Sequence: 80018945 Sequence: 80018946 Sequence: 80018947 Sequence: 80018948 Sequence: 80018949
Name Coronary Heart Disease Name Hypercholesterolemia Name Triglycerides High Name LDL Hyperlipoproteinemia Name HDL Low Name Diabetes Name Cardiovascular Diseases Name Hypertension Name Risk Factor, Cardiovascular Name Diet Habit Name Smoking
Downcase Name coronary heart disease Downcase Name hypercholesterolemia Downcase Name triglycerides high Downcase Name ldl hyperlipoproteinemia Downcase Name hdl low Downcase Name diabetes Downcase Name cardiovascular diseases Downcase Name hypertension Downcase Name risk factor, cardiovascular Downcase Name diet habit Downcase Name smoking

Design Outcomes

Sequence: 177770615 Sequence: 177770616 Sequence: 177770617
Outcome Type primary Outcome Type secondary Outcome Type other
Measure Prevalence of dyslipidemia Measure Prevalence of cardiovascular associated risk factors Measure Dietary assessment
Time Frame At inclusion Time Frame At inclusion Time Frame Up to 1 month
Description Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia Description Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking) Description Frequency of diet daily intake (fat, sugar, proteins, fiber)

Browse Conditions

Sequence: 193892697 Sequence: 193892698 Sequence: 193892699 Sequence: 193892700 Sequence: 193892701 Sequence: 193892702 Sequence: 193892703 Sequence: 193892704
Mesh Term Atherosclerosis Mesh Term Dyslipidemias Mesh Term Arteriosclerosis Mesh Term Arterial Occlusive Diseases Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases Mesh Term Lipid Metabolism Disorders Mesh Term Metabolic Diseases
Downcase Mesh Term atherosclerosis Downcase Mesh Term dyslipidemias Downcase Mesh Term arteriosclerosis Downcase Mesh Term arterial occlusive diseases Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term lipid metabolism disorders Downcase Mesh Term metabolic diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48418622 Sequence: 48418623 Sequence: 48418624 Sequence: 48418625 Sequence: 48418626 Sequence: 48418627 Sequence: 48418628 Sequence: 48418629 Sequence: 48418630
Agency Class OTHER Agency Class UNKNOWN Agency Class UNKNOWN Agency Class UNKNOWN Agency Class UNKNOWN Agency Class OTHER_GOV Agency Class UNKNOWN Agency Class UNKNOWN Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose Name Biochimie Clinique LR99ES11 Name Department of Biochemistry, La Rabta Hospital, Tunisia. Name Ministry of Health, Tunisia Name Ministry of Interior, Tunisia Name Direction des Soins de Santé de Base Name National Institute of Statistics Name National Institute of Public Health of Tunisia Name Dacima Consulting

Overall Officials

Sequence: 29342601 Sequence: 29342602
Role Study Chair Role Study Chair
Name Amani Kallel, PhD Name Riadh Jemaa, PhD
Affiliation Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose Affiliation Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

Eligibilities

Sequence: 30827021
Sampling Method Probability Sample
Gender All
Minimum Age 25 Years
Maximum Age 75 Years
Healthy Volunteers Accepts Healthy Volunteers
Population All subjects aged between 25 and 75 years who accept to participate at the study
Criteria Inclusion Criteria:

All subjects

Exclusion Criteria:

Prescribed treatment for cancer
Organ transplantation
Known auto-immune disease
Severe liver disease
Chronic renal failure
Pregnant women

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254123693
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 44
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 25
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30572951
Observational Model Family-Based
Time Perspective Cross-Sectional

Links

Sequence: 4396489
Url http://atera1.org
Description ATERA official Website

Responsible Parties

Sequence: 28939373
Responsible Party Type Sponsor

]]>

<![CDATA[ Echinocandins Versus Azoles for Candidemia Treatment ]]>
https://zephyrnet.com/NCT03799172
2018-11-01

https://zephyrnet.com/?p=NCT03799172
NCT03799172https://www.clinicaltrials.gov/study/NCT03799172?tab=tableNANANACandidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-03-04
Start Month Year November 1, 2018
Primary Completion Month Year February 1, 2019
Verification Month Year March 2020
Verification Date 2020-03-31
Last Update Posted Date 2020-03-04

Facilities

Sequence: 200053151
Name Hospices Civils de Lyon, Hôpital de la Croix-Rousse
City Lyon
Zip 69004
Country France

Browse Interventions

Sequence: 96027727 Sequence: 96027728 Sequence: 96027729
Mesh Term Echinocandins Mesh Term Antifungal Agents Mesh Term Anti-Infective Agents
Downcase Mesh Term echinocandins Downcase Mesh Term antifungal agents Downcase Mesh Term anti-infective agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52156393
Name Candidemia
Downcase Name candidemia

Id Information

Sequence: 40148159
Id Source org_study_id
Id Value CRC_GHN_2019_001

Countries

Sequence: 42557685
Name France
Removed False

Design Groups

Sequence: 55577824 Sequence: 55577825
Title Echinocandin group Title Triazole group
Description Echinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia Description Triazole group is the group of patients who received triazoles as first-line therapy for candidemia

Interventions

Sequence: 52471933 Sequence: 52471934
Intervention Type Drug Intervention Type Drug
Name Echinocandin treatment Name Triazole treatment
Description Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care Description Patients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care.

Candidemia was defined as at least one blood culture positive for Candida.

Design Outcomes

Sequence: 177327653 Sequence: 177327654
Outcome Type primary Outcome Type secondary
Measure Comparison of all cause hospital mortality on day 90 between echinocandins and azoles Measure Comparison of treatment success on day 30 between echinocandins and azoles.
Time Frame Mortality on day 90 after antifungal initiation Time Frame Treatment success on day 30 after antifungal initiation
Description Comparison of all cause hospital mortality on day 90 between echinocandins and azoles Description Treatment success is defined as a complete response if the following two criteria were full-filled: survival and resolution of all attributable symptoms and signs of disease, and mycological success (documented clearance of pathogen from the blood).

Browse Conditions

Sequence: 193431817 Sequence: 193431818 Sequence: 193431819 Sequence: 193431820 Sequence: 193431821 Sequence: 193431822 Sequence: 193431823 Sequence: 193431824 Sequence: 193431825 Sequence: 193431826 Sequence: 193431827 Sequence: 193431828
Mesh Term Candidemia Mesh Term Candidiasis, Invasive Mesh Term Candidiasis Mesh Term Mycoses Mesh Term Bacterial Infections and Mycoses Mesh Term Infections Mesh Term Invasive Fungal Infections Mesh Term Fungemia Mesh Term Sepsis Mesh Term Systemic Inflammatory Response Syndrome Mesh Term Inflammation Mesh Term Pathologic Processes
Downcase Mesh Term candidemia Downcase Mesh Term candidiasis, invasive Downcase Mesh Term candidiasis Downcase Mesh Term mycoses Downcase Mesh Term bacterial infections and mycoses Downcase Mesh Term infections Downcase Mesh Term invasive fungal infections Downcase Mesh Term fungemia Downcase Mesh Term sepsis Downcase Mesh Term systemic inflammatory response syndrome Downcase Mesh Term inflammation Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48305986
Agency Class OTHER
Lead Or Collaborator lead
Name Hospices Civils de Lyon

Design Group Interventions

Sequence: 68130773 Sequence: 68130774
Design Group Id 55577824 Design Group Id 55577825
Intervention Id 52471933 Intervention Id 52471934

Eligibilities

Sequence: 30757310
Sampling Method Non-Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population Patients with a diagnosis of candidemia during their ICU stay
Criteria Inclusion Criteria:

Patients who had a diagnosis of candidemia during ICU stay and were treated with echinocandins or azoles

Exclusion Criteria:

Patients with neutropenia
Patients without antifungal treatment
Patients who received antifungal therapy for more than two days before candidemia diagnosis
Patients receiving liposomal amphotericin b or multiple antifungal agents as first-line therapy
Patients who received less than 4 days of antifungal therapy after candidemia diagnosis

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254226293
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 3
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30503535
Observational Model Cohort
Time Perspective Retrospective

Responsible Parties

Sequence: 28869813
Responsible Party Type Sponsor

]]>

<![CDATA[ Renal Arterial Resistive Index Versus Novel Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury ]]>
https://zephyrnet.com/NCT03799159
2019-05-15

https://zephyrnet.com/?p=NCT03799159
NCT03799159https://www.clinicaltrials.gov/study/NCT03799159?tab=tableNANANAPopulations at high risk of Sepsis-Associated Acute Kidney Injury (SA-AKI) have been identified. Sources of sepsis, in particular, bloodstream infection, abdominal and genitourinary sepsis, and infective endocarditis, are associated with a higher likelihood of developing AKI. Similar to the poor outcome of patients with sepsis, delayed administration of appropriate antimicrobial therapy was shown to be an independent predictor of the development of AKI. Incremental delays in antimicrobial delivery after the onset of hypotension showed a direct relationship with the development of AKI. The need for sensitive, simple and time-applicable biomarker to predict AKI development after renal insult is urgent.

Serum creatinine (sCr) and urea are used routinely for the diagnosis of AKI. However, these parameters are not accurate for the diagnosis of AKI. Cystatin C. (CysC) is suggested to be a good biomarker because of its constant rate of production, almost filtered by glomeruli (99%), has no significant protein binding and not secreted by renal tubule. Neutrophil gelatinase-associated lipocalin (NGAL) is recently identified and extensively investigated as a most promising early marker of AKI. Urinary NGAL is not only effective in detection of AKI but also its degree of expression might distinguish among AKI, prerenal azotemia and chronic kidney disease, and it is detectable before the accumulation of serum creatinine.

Ultrasonography (US) is used routinely to assess renal morphology. Renal Resistive Index (RRI) is a non-invasive Doppler-measured parameter that is directly correlated with intra-renal arterial resistance. RRI is defined as [(peak systolic velocity – end diastolic velocity)/ peak systolic velocity]. It theoretically ranges from 0 to 1 and it is normally lower than 0.7 with age differences. RRI calculation was found to be useful as an early indicator of the vascular resistance changes and in the determination of the optimal systemic hemodynamics required for renal perfusion.

The aim of this study is to compare the ability of arterial renal resistive index (RRI), serum and urinary neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C (CysC) in early diagnosis and predicting the persistence of acute kidney injury in septic patients.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-03-02
Start Month Year May 15, 2019
Primary Completion Month Year February 28, 2021
Verification Month Year February 2021
Verification Date 2021-02-28
Last Update Posted Date 2021-03-02

Detailed Descriptions

Sequence: 20780355
Description All included patients in this study will be assessed for the following:

Data Collection

Complete history taking (age, sex, illness, medications, etc.).
Complete physical examination (Glasgow coma scale (GCS), temperature, blood pressure, urine output, heart rate, respiratory rate and chest auscultation).
SOFA score, APACHE II score, and Quick SOFA (qSOFA).
Routine laboratory investigations and Coagulation profile.
C-reactive protein (CRP), and Serum lactate.
Complete sepsis workup (chest x-ray, urine analysis, abdomen and pelvis ultrasound, microbiological cultures) to identify the source of sepsis.

Renal Biomarkers

– Serum and urinary samples will be collected directly at time of enrollment (within 2 hours from admission). It will be assayed for serum creatinine, serum neutrophil gelatinase-associated lipocalin (NGAL), urinary NGAL and serum Cystatin C (CysC). Then, it will be repeated at day 3.

Ultrasound evaluation of kidneys and renal Doppler

In each patient, both kidneys will be examined with real-time ultrasound (US) with a 3.75-MHz transducer (ACUSON X 300). Pulsed Doppler US evaluation of the intrarenal arteries will be obtained at the same respective scanning frequencies. The color Doppler functions are set for a study focused on interlobar arteries, that is, the highest gains possible, the use of the lowest filters and a low pulse repetition frequency (PRF) of 1-1.5 kHz that must be preferred while always limiting the aliasing phenomenon.
The renal resistance index (RRI, [peak systolic frequency shift-minimum diastolic frequency shift]/ peak systolic frequency shift) will be calculated from calibrated software. (26) All measurements will be performed by the same examiner.
The renal resistive index (RRI) will be measured at time of enrollment (within 2 hours from admission) and 24 hours after admission.
Treatment All patients will receive the standard treatment for management of sepsis on the guidelines of SCC (sepsis-3). The protocol of treatment will not be changed during the study time.
Follow up – All patients will be followed up using urine output (UOP), serum creatinine, KDIGO (Kidney Disease Improving Global Outcomes) classification, the use of vasopressors and need for renal replacement therapy (RRT).

Facilities

Sequence: 200594685
Name Alexandria Main University Hospital
City Alexandria
Zip 21563
Country Egypt

Conditions

Sequence: 52321396 Sequence: 52321394 Sequence: 52321395
Name Acute Kidney Injury Name Sepsis Name Septic Shock
Downcase Name acute kidney injury Downcase Name sepsis Downcase Name septic shock

Id Information

Sequence: 40266127
Id Source org_study_id
Id Value RRIBIOSAKI

Countries

Sequence: 42685642
Name Egypt
Removed False

Keywords

Sequence: 80075987 Sequence: 80075988 Sequence: 80075989 Sequence: 80075990 Sequence: 80075991
Name Sepsis Name Acute Kidney Injury Name Ultrasound Name Resistive Index Name Biomarkers
Downcase Name sepsis Downcase Name acute kidney injury Downcase Name ultrasound Downcase Name resistive index Downcase Name biomarkers

Design Outcomes

Sequence: 177934359 Sequence: 177934360 Sequence: 177934361 Sequence: 177934362
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary
Measure Acute Kidney Injury Measure Transient Acute Kidney Injury Measure Persistent Acute Kidney Injury Measure Mortality
Time Frame 7 days from inclusion Time Frame 7 days from inclusion Time Frame 7 days from inclusion Time Frame 28 days from inclusion
Description AKI is defined according to KDIGO (Kidney Disease Improving Global Outcomes) Description Transient AKI is defined as AKI with a cause of renal hypoperfusion and recovery within 3 days after inclusion. Recovery from AKI is defined as urine output normalization and/or serum creatinine decrease by 50% and/or serum creatinine normalization to its measured or estimated baseline level. Description Persistent AKI is defined as persistent serum creatinine rise or oliguria after 3 days. Description All cause 28-days mortality

Browse Conditions

Sequence: 194058765 Sequence: 194058766 Sequence: 194058767 Sequence: 194058768 Sequence: 194058769 Sequence: 194058770 Sequence: 194058771 Sequence: 194058772 Sequence: 194058773 Sequence: 194058774 Sequence: 194058775 Sequence: 194058776 Sequence: 194058777 Sequence: 194058778 Sequence: 194058779
Mesh Term Sepsis Mesh Term Toxemia Mesh Term Acute Kidney Injury Mesh Term Wounds and Injuries Mesh Term Infections Mesh Term Systemic Inflammatory Response Syndrome Mesh Term Inflammation Mesh Term Pathologic Processes Mesh Term Renal Insufficiency Mesh Term Kidney Diseases Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases
Downcase Mesh Term sepsis Downcase Mesh Term toxemia Downcase Mesh Term acute kidney injury Downcase Mesh Term wounds and injuries Downcase Mesh Term infections Downcase Mesh Term systemic inflammatory response syndrome Downcase Mesh Term inflammation Downcase Mesh Term pathologic processes Downcase Mesh Term renal insufficiency Downcase Mesh Term kidney diseases Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48460004
Agency Class OTHER
Lead Or Collaborator lead
Name Islam Elsayed Mohamed Ahmed

Overall Officials

Sequence: 29365332 Sequence: 29365333 Sequence: 29365334 Sequence: 29365335 Sequence: 29365336 Sequence: 29365337
Role Principal Investigator Role Study Director Role Study Director Role Study Chair Role Study Chair Role Study Chair
Name Ibrahim Ibrahim, MSc Name Taysser Zaitoun, MD Name Mohamed Megahed, MD Name Hisham Elghonemy, MD Name Doaa Emara, MD Name Islam Ahmed, PharmD
Affiliation Assistant Lecturer of Critical Care Medicine, Kafr Elsheikh University Affiliation Professor of Critical Care Medicine, Alexandria University Affiliation Professor of Critical Care Medicine, Alexandria University Affiliation Lecturer of Nephrology, Alexandria University Affiliation Lecturer of Radiodiagnosis, Alexandria University Affiliation Clinical Pharmacy Specialist, Alexandria University

Eligibilities

Sequence: 30852326
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Population – Critically ill patients recently admitted with sepsis.
Criteria Inclusion Criteria:

Adult patients (aged above 18 years) recently admitted with sepsis

Exclusion Criteria:

Pregnant Females
Patients with renal transplant.
Patients with End Stage Renal Disease (ESRD).
Patients with Chronic Kidney Disease (CKD) known with history, laboratory or ultrasonographic evaluation with chronic nephropathic changes.
Patients with renal artery stenosis.
Patients with obstructive uropathy.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254272000
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 21
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30598178
Observational Model Case-Only
Time Perspective Prospective

Responsible Parties

Sequence: 28964667
Responsible Party Type Sponsor-Investigator
Name Islam Elsayed Mohamed Ahmed
Title Critical Care Clinical Pharmacy Specialist
Affiliation Alexandria University

Study References

Sequence: 52225870 Sequence: 52225871 Sequence: 52225872 Sequence: 52225873 Sequence: 52225874 Sequence: 52225875 Sequence: 52225876 Sequence: 52225877 Sequence: 52225878 Sequence: 52225879 Sequence: 52225880 Sequence: 52225881 Sequence: 52225882
Pmid 18402655 Pmid 17699448 Pmid 19066848 Pmid 23042202 Pmid 24627874 Pmid 21601330 Pmid 15711640 Pmid 15811456 Pmid 18519927 Pmid 25895828 Pmid 19474273 Pmid 23001447 Pmid 21921613
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Bagshaw SM, George C, Bellomo R; ANZICS Database Management Committee. Early acute kidney injury and sepsis: a multicentre evaluation. Crit Care. 2008;12(2):R47. doi: 10.1186/cc6863. Epub 2008 Apr 10. Citation Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Septic acute kidney injury in critically ill patients: clinical characteristics and outcomes. Clin J Am Soc Nephrol. 2007 May;2(3):431-9. doi: 10.2215/CJN.03681106. Epub 2007 Mar 21. Citation Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9. Citation Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c. Citation Merrikhi A, Gheissari A, Mousazadeh H. Urine and serum neutrophil gelatinase-associated lipocalin cut-off point for the prediction of acute kidney injury. Adv Biomed Res. 2014 Jan 27;3:66. doi: 10.4103/2277-9175.125847. eCollection 2014. Citation Zhang Z, Lu B, Sheng X, Jin N. Cystatin C in prediction of acute kidney injury: a systemic review and meta-analysis. Am J Kidney Dis. 2011 Sep;58(3):356-65. doi: 10.1053/j.ajkd.2011.02.389. Epub 2011 May 20. Erratum In: Am J Kidney Dis. 2012 Apr;59(4):590-2. Citation Mori K, Lee HT, Rapoport D, Drexler IR, Foster K, Yang J, Schmidt-Ott KM, Chen X, Li JY, Weiss S, Mishra J, Cheema FH, Markowitz G, Suganami T, Sawai K, Mukoyama M, Kunis C, D'Agati V, Devarajan P, Barasch J. Endocytic delivery of lipocalin-siderophore-iron complex rescues the kidney from ischemia-reperfusion injury. J Clin Invest. 2005 Mar;115(3):610-21. doi: 10.1172/JCI23056. Citation Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X. Citation Nickolas TL, O'Rourke MJ, Yang J, Sise ME, Canetta PA, Barasch N, Buchen C, Khan F, Mori K, Giglio J, Devarajan P, Barasch J. Sensitivity and specificity of a single emergency department measurement of urinary neutrophil gelatinase-associated lipocalin for diagnosing acute kidney injury. Ann Intern Med. 2008 Jun 3;148(11):810-9. doi: 10.7326/0003-4819-148-11-200806030-00003. Citation Zwiers AJ, de Wildt SN, van Rosmalen J, de Rijke YB, Buijs EA, Tibboel D, Cransberg K. Urinary neutrophil gelatinase-associated lipocalin identifies critically ill young children with acute kidney injury following intensive care admission: a prospective cohort study. Crit Care. 2015 Apr 21;19(1):181. doi: 10.1186/s13054-015-0910-0. Citation Haase-Fielitz A, Bellomo R, Devarajan P, Bennett M, Story D, Matalanis G, Frei U, Dragun D, Haase M. The predictive performance of plasma neutrophil gelatinase-associated lipocalin (NGAL) increases with grade of acute kidney injury. Nephrol Dial Transplant. 2009 Nov;24(11):3349-54. doi: 10.1093/ndt/gfp234. Epub 2009 May 27. Citation Schnell D, Darmon M. Renal Doppler to assess renal perfusion in the critically ill: a reappraisal. Intensive Care Med. 2012 Nov;38(11):1751-60. doi: 10.1007/s00134-012-2692-z. Epub 2012 Sep 22. Citation Bougle A, Duranteau J. Pathophysiology of sepsis-induced acute kidney injury: the role of global renal blood flow and renal vascular resistance. Contrib Nephrol. 2011;174:89-97. doi: 10.1159/000329243. Epub 2011 Sep 9.

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<![CDATA[ Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Older Adults ]]>
https://zephyrnet.com/NCT03799146
2018-01-15

https://zephyrnet.com/?p=NCT03799146
NCT03799146https://www.clinicaltrials.gov/study/NCT03799146?tab=tableNANANAThe aim of this study is to investigate whether and how ‘MyPlan 2.0’ helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-12-06
Start Month Year January 15, 2018
Primary Completion Month Year August 15, 2018
Verification Month Year December 2021
Verification Date 2021-12-31
Last Update Posted Date 2021-12-06

Detailed Descriptions

Sequence: 20767536
Description The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group. Both groups will be tested during three testing waves: pretest, posttest and follow-up test. Only the intervention group will be given acces to 'MyPlan 2.0'.

'MyPlan 2.0' consists of a website and mobile application targeting physical activity and sedentary behaviour. The intervention has a duration of five weeks.

Facilities

Sequence: 200488504
Name Department of Movement and Sports Sciences
City Ghent
Zip 9000
Country Belgium

Conditions

Sequence: 52289132
Name Overweight
Downcase Name overweight

Id Information

Sequence: 40243618
Id Source org_study_id
Id Value MyPlan2.0_older_adults_50

Countries

Sequence: 42661452
Name Belgium
Removed False

Design Groups

Sequence: 55724643 Sequence: 55724644
Group Type Experimental Group Type Experimental
Title Intervention group Title Waiting List control group
Description Participants will receive the e- and mHealth intervention 'MyPlan 2.0'. Description Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.

Interventions

Sequence: 52600814 Sequence: 52600815
Intervention Type Behavioral Intervention Type Other
Name MyPlan 2.0 Name Waiting List
Description MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring. Description Waiting List control group

Keywords

Sequence: 80034884 Sequence: 80034885 Sequence: 80034886 Sequence: 80034887 Sequence: 80034888 Sequence: 80034889
Name physical activity Name sedentary behaviour Name eHealth Name mHealth Name self-regulation Name behaviour change techniques
Downcase Name physical activity Downcase Name sedentary behaviour Downcase Name ehealth Downcase Name mhealth Downcase Name self-regulation Downcase Name behaviour change techniques

Design Outcomes

Sequence: 177811906 Sequence: 177811907 Sequence: 177811908 Sequence: 177811909 Sequence: 177811910 Sequence: 177811911 Sequence: 177811912 Sequence: 177811913 Sequence: 177811914 Sequence: 177811915
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in objective total, light and moderate-to-vigorous physical activity (PA) Measure Change in objective sedentary behaviour Measure Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA. Measure Change in self-reported sedentary behaviour Measure Change in self-efficacy Measure Change in outcome expectancies Measure Change in risk perception Measure Change in intention Measure Change in action planning Measure Change in coping planning
Time Frame Pretest, posttest (6 weeks) and follow-up (6 months) Time Frame Pretest, posttest (6 weeks) and follow-up (6 months) Time Frame Pretest, posttest (6 weeks) and follow-up (6 months) Time Frame Pretest, posttest (6 weeks) and follow-up (6 months) Time Frame Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) Time Frame Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months Time Frame Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months Time Frame Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months Time Frame Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months Time Frame Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months
Description Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers Description Change in amount of total sitting time, measured via accelerometers Description Change in amount of total, light and moderate-to-vigorous PA well as total work-related, transport-related, household-related and leisure time PA will be measured via the International Physical Activity Questionnaire (IPAQ). The IPAQ measures physical activity in four domains: work, transport, household and leisure time. Higher scores indicate higher levels of physical activity. For each scale the minimum value is 0. We will use the method described by Dubuy et al. (2013) to truncate the data. Description Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire. The total score is calculated by summing all 10 items.The minimum value is 0 and the maximum value is 24 hours. However, data will be truncated at 16 hours. Description Change in amount of self-efficacy to change behaviour, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score. Description Outcome expectancies regarding the behaviour change, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score. Description Risk perception about the behaviour, measured via 4 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the four items will be considered the final score Description Amount of intention to change the behaviour, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. Description Amount of action planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. Description Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score.

Browse Conditions

Sequence: 193937413 Sequence: 193937414 Sequence: 193937415 Sequence: 193937416
Mesh Term Overweight Mesh Term Overnutrition Mesh Term Nutrition Disorders Mesh Term Body Weight
Downcase Mesh Term overweight Downcase Mesh Term overnutrition Downcase Mesh Term nutrition disorders Downcase Mesh Term body weight
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48429630
Agency Class OTHER
Lead Or Collaborator lead
Name University Ghent

Overall Officials

Sequence: 29348815 Sequence: 29348816
Role Principal Investigator Role Principal Investigator
Name Ilse De Bourdeaudhuij Name Geert Crombez
Affiliation University Ghent Affiliation University Ghent

Design Group Interventions

Sequence: 68307708 Sequence: 68307709
Design Group Id 55724643 Design Group Id 55724644
Intervention Id 52600814 Intervention Id 52600815

Eligibilities

Sequence: 30833833
Gender All
Minimum Age 50 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Have access to internet
Being computer literate

Exclusion Criteria:

non Dutch speaking

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254145952
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 7
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 50
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 4
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30579746
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Randomized controlled trial with two groups: intervention group and waiting-list control group

Responsible Parties

Sequence: 28946164
Responsible Party Type Sponsor

Study References

Sequence: 52189221
Pmid 31376274
Reference Type derived
Citation Poppe L, De Bourdeaudhuij I, Verloigne M, Shadid S, Van Cauwenberg J, Compernolle S, Crombez G. Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials. J Med Internet Res. 2019 Aug 2;21(8):e13363. doi: 10.2196/13363.

]]>

<![CDATA[ Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery ]]>
https://zephyrnet.com/NCT03799133
2018-09-26

https://zephyrnet.com/?p=NCT03799133
NCT03799133https://www.clinicaltrials.gov/study/NCT03799133?tab=tableNANANAEvaluate the safety and effectiveness of the XL trend measured by Florence (Critical Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients post-operated of elective cardiovascular surgery.

Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing cardiac surgery.
<![CDATA[

Studies

Study First Submitted Date 2018-12-20
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-01-23
Start Month Year September 26, 2018
Primary Completion Month Year December 28, 2019
Verification Month Year January 2020
Verification Date 2020-01-31
Last Update Posted Date 2020-01-23

Detailed Descriptions

Sequence: 20741133
Description A maximum of 35 patients with age greater or equal to 18 years with elective surgery (valvular surgery, revascularization, or a combination of both) that comply with the inclusion/exclusion criteria of this protocol will be enrolled.

Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed venous saturation.

The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.

Facilities

Sequence: 200280495
Name Instituto Nacional de Cardiología Ignacio Chávez
City Tlalpan
State Ciudad De México
Zip 14080
Country Mexico

Conditions

Sequence: 52221433 Sequence: 52221434 Sequence: 52221435
Name Cardiac Failure Name Ventricular Dysfunction Name Valvular Heart Disease
Downcase Name cardiac failure Downcase Name ventricular dysfunction Downcase Name valvular heart disease

Id Information

Sequence: 40195566 Sequence: 40195567
Id Source org_study_id Id Source secondary_id
Id Value ISM_VC_01_17 Id Value 17-1025
Id Type Other Identifier
Id Type Description Instituto Nacional de Cardiología Ignacio Chávez

Countries

Sequence: 42609602
Name Mexico
Removed False

Design Groups

Sequence: 55649708
Group Type Experimental
Title Patients with Florence device
Description Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.

Interventions

Sequence: 52535237
Intervention Type Device
Name Florence device
Description The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.

Keywords

Sequence: 79941628 Sequence: 79941629 Sequence: 79941630 Sequence: 79941631 Sequence: 79941632 Sequence: 79941633 Sequence: 79941634
Name gastric reactance Name elective cardiac surgery Name morbimortality Name APACHE II Name STS Name SOFA Name EUROSCORE II
Downcase Name gastric reactance Downcase Name elective cardiac surgery Downcase Name morbimortality Downcase Name apache ii Downcase Name sts Downcase Name sofa Downcase Name euroscore ii

Design Outcomes

Sequence: 177561164 Sequence: 177561165 Sequence: 177561166 Sequence: 177561167 Sequence: 177561168 Sequence: 177561169
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Correlation between gastric reactance (XL) and morbimortality and risk predictors Measure Sensibility and specificity of the collected variables Measure Adverse events tracing with the use of Florence catheter Measure Correlations between XL measurements and medication Measure Correlations between laboratory parameters and XL Measure Usability of Florence device in a real environment.
Time Frame 72 hours Time Frame 72 hours Time Frame 30 days Time Frame 72 hours Time Frame 72 hours Time Frame 72 hours
Description Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting the risk scales, hemodynamic variables, lactate and mixed venous oxygen saturation, morbidity and mortality with central gastric reactance (XL). Description ROC curves will be calculated to determine sensibility and specificity of the variables. Description Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety. Description Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with amines, proton-pump inhibitors, and anesthesia medications. Description Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters. Description Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.

Browse Conditions

Sequence: 193678116 Sequence: 193678117 Sequence: 193678118 Sequence: 193678119 Sequence: 193678120
Mesh Term Heart Diseases Mesh Term Ventricular Dysfunction Mesh Term Heart Valve Diseases Mesh Term Heart Failure Mesh Term Cardiovascular Diseases
Downcase Mesh Term heart diseases Downcase Mesh Term ventricular dysfunction Downcase Mesh Term heart valve diseases Downcase Mesh Term heart failure Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48366338 Sequence: 48366339 Sequence: 48366340 Sequence: 48366341 Sequence: 48366342
Agency Class INDUSTRY Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Critical Perfusion Inc. Name Instituto Nacional de Cardiologia Ignacio Chavez Name National Council of Science and Technology, Mexico Name Gerbera Capital Name Alandra Medical SAPI de CV

Overall Officials

Sequence: 29312866 Sequence: 29312867
Role Principal Investigator Role Study Director
Name Rolando J. Álvarez Álvarez, MD Name Montserrat Godínez, MSc
Affiliation Instituto Nacional de Cardiologia Ignacio Chavez Affiliation Alandra Medical SAPI de CV

Design Group Interventions

Sequence: 68217256
Design Group Id 55649708
Intervention Id 52535237

Eligibilities

Sequence: 30794656
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Women and men within an age equal or greater than 18 years old.
Subjects scheduled to an elective cardiac surgery for valvular surgery, revascularization or a combination of both.
Subjects compliant with the indication to be placed a floating pulmonary artery catheter.
Marks results previous to surgery: STS mortality risk equal or greater than 6% of the day before or Euro Score II with a mortality risk equal or greater than 6% or left ventricle ejection fraction (LVEF/FEVI) less than 45% (patients with cardiac failure or right ventricle dysfunction or a combination of both), tricuspid annular plane systolic excursion (TAPSE) less than 17 mm, peak systolic velocity of tricuspid lateral ring measured by Tissue Doppler (LVOT/TSVI) less than 0.1 m/s; patient with elective surgery of: aortic and mitral valve replacement or aortic and mitral valve replacement + tricuspid valve plasty or aortic valve replacement + mitral valve plasty or mitral valve replacement + tricuspid valve plasty or aortic, mitral and tricuspid valve replacement or aortic valve replacement + tricuspid valve plasty or double valve replacement (any combination) + revascularization or aortic valve replacement + revascularization + mitral valve plasty.
Subject is not enrolled in another investigational protocol.
Informed consent has been signed of acceptance by the subject before study procedures.
Subject in sinus rhythm before surgery.

Exclusion Criteria:

Subjects with records of recent digestive tube bleeding (last 30 days).
Paraplegic or hemiplegic subjects.
Subjects with congenital background (interauricular communication, ventricular atrial channel, coarctation of the aorta, persistent arterial duct, pulmonary stenosis, ventricular septal defect, tetralogy of fallot, total or partial anomalous pulmonary venous drainage, transposition of the great vessels, tricuspid atresia, arterial trunk, etc).
Maxillofacial malformation.
Catheter placement failure.
Known pregnancy or discovered pregnancy after admission (before surgery).
Woman in breastfeeding period.
Subjects not compliant with clinical indication of nasogastric catheter placement or contraindicated to place a nasogastric catheter.
Subjects with an implanted pacemaker or permanent defibrillator.
Medication supply that impedes contact between Florence catheter and the gastric mucosa (barrier effect) like sucralfate, aluminum hydroxide, bismuth subsalicylate, magaldrate, etc.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004215
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 15
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30540696
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Screening
Time Perspective
Masking None (Open Label)
Intervention Model Description Eligible patients will be placed the Florence catheter.

Intervention Other Names

Sequence: 26696902 Sequence: 26696903
Intervention Id 52535237 Intervention Id 52535237
Name ISMO Name Gastric Impedance Spectrometer System

Links

Sequence: 4392139 Sequence: 4392140 Sequence: 4392141 Sequence: 4392142 Sequence: 4392143 Sequence: 4392144 Sequence: 4392145 Sequence: 4392146 Sequence: 4392147 Sequence: 4392148 Sequence: 4392149 Sequence: 4392150 Sequence: 4392151 Sequence: 4392152 Sequence: 4392153 Sequence: 4392154 Sequence: 4392155 Sequence: 4392156 Sequence: 4392157 Sequence: 4392158 Sequence: 4392159 Sequence: 4392160 Sequence: 4392161 Sequence: 4392162 Sequence: 4392163 Sequence: 4392164 Sequence: 4392165 Sequence: 4392166 Sequence: 4392167 Sequence: 4392168 Sequence: 4392169 Sequence: 4392170 Sequence: 4392171 Sequence: 4392172 Sequence: 4392173 Sequence: 4392174 Sequence: 4392175 Sequence: 4392176 Sequence: 4392177 Sequence: 4392178 Sequence: 4392179 Sequence: 4392180 Sequence: 4392181 Sequence: 4392182 Sequence: 4392183 Sequence: 4392184 Sequence: 4392185 Sequence: 4392186 Sequence: 4392187 Sequence: 4392188 Sequence: 4392189
Url http://www.who.int/mediacentre/factsheets/fs317/es/ Url http://www.medigraphic.com/pdfs/cardio/h-2016/hs163a.pdf Url http://www.ncbi.nlm.nih.gov/pubmed/24055446 Url http://www.ncbi.nlm.nih.gov/pubmed/23361625 Url https://www.ncbi.nlm.nih.gov/pubmed/17285286 Url https://www.ncbi.nlm.nih.gov/pubmed/15681577 Url https://www.ncbi.nlm.nih.gov/pubmed/22611136 Url https://www.ncbi.nlm.nih.gov/pubmed/11445675 Url https://www.ncbi.nlm.nih.gov/pubmed/14997295 Url https://www.ncbi.nlm.nih.gov/pubmed/17323051 Url https://www.ncbi.nlm.nih.gov/pubmed/17414725 Url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968574/ Url https://www.ncbi.nlm.nih.gov/pubmed/16046651 Url https://www.ncbi.nlm.nih.gov/pubmed/12161222 Url https://www.ncbi.nlm.nih.gov/pubmed/17828438 Url https://www.ncbi.nlm.nih.gov/pubmed/11874305 Url https://www.ncbi.nlm.nih.gov/pubmed/12352031 Url https://www.ncbi.nlm.nih.gov/pubmed/20966436 Url https://jamanetwork.com/journals/jamasurgery/article-abstract/591550 Url https://www.ncbi.nlm.nih.gov/pubmed/24694282 Url https://www.ncbi.nlm.nih.gov/pubmed/25417158 Url https://www.ncbi.nlm.nih.gov/pubmed/23370829 Url https://www.ncbi.nlm.nih.gov/pubmed/17577136 Url https://www.ncbi.nlm.nih.gov/pubmed/27016162 Url https://www.ncbi.nlm.nih.gov/pubmed/17933153 Url https://www.ncbi.nlm.nih.gov/pubmed/8528108 Url http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.516.4685&rep=rep1&type=pdf Url https://www.ncbi.nlm.nih.gov/pubmed/2662632 Url https://ieeexplore.ieee.org/document/4067112 Url https://www.ncbi.nlm.nih.gov/pubmed/9196884 Url https://ieeexplore.ieee.org/document/415187 Url https://ieeexplore.ieee.org/document/758768 Url https://www.ncbi.nlm.nih.gov/pubmed/15798229 Url https://www.ncbi.nlm.nih.gov/pubmed/2651001 Url https://www.ncbi.nlm.nih.gov/pubmed/11713146 Url https://www.ncbi.nlm.nih.gov/pubmed/8087035 Url https://www.ncbi.nlm.nih.gov/pubmed/27687052 Url https://www.ncbi.nlm.nih.gov/pubmed/22378855 Url http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0188-21982014000100010&nrm=iso Url http://www.iccueducation.org.uk/uploads/2/3/1/0/23109338/sofa_score.pdf Url https://www.ncbi.nlm.nih.gov/pubmed/9824069 Url https://www.ncbi.nlm.nih.gov/pubmed/10470572 Url https://www.ncbi.nlm.nih.gov/pubmed/10990106 Url https://www.ncbi.nlm.nih.gov/pubmed/11594901 Url https://www.ncbi.nlm.nih.gov/pubmed/3928249 Url https://www.ncbi.nlm.nih.gov/pubmed/6851607 Url https://www.ncbi.nlm.nih.gov/pubmed/8087584 Url https://www.ncbi.nlm.nih.gov/pubmed/19559823 Url https://www.ncbi.nlm.nih.gov/pubmed/19559822 Url https://www.ncbi.nlm.nih.gov/pubmed/19559824 Url https://www.ncbi.nlm.nih.gov/pubmed/23522221
Description WHO Cardiovascular illness; 2015 Description Arias AS, Serrano MEB, Altamirano BD, Ortega MG, Gonzalez GG. Cardiovascular illness: first cause of morbility in a third level hospital. Cardiology Mexican Journal; 2016 Description Mittal R, Coopersmith CM. Redefining the gut as the motor of critical illness. Trends in molecular medicine. 2014 Apr;20:214-223 Description Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Critical care medicine. 2013 Feb;41:580-637 Description Antonelli M, Levy M, Andrews PJD, Chastre J, Hudson LD, Manthous C, et al. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive care medicine. 2007 Apr;33:575-590 Description Nieminen MS, Boehm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, et al. Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Description McMurray JJV, Adamopoulos S, Anker SD, Auricchio A, Boehm M, Dickstein K, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure2012 Description Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Critical care medicine. 2001 Jul;29:1303-1310 Description Brun-Buisson C, Meshaka P, Pinton P, Vallet B, Group ES. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive care medicine. 2004 Apr;30:580-588 Description Engel C, Brunkhorst FM, Bone HG, Brunkhorst R, Gerlach H, Grond S, et al. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive care medicine. 2007 Apr;33:606-618 Description Esteban A, Frutos-Vivar F, Ferguson ND, Penuelas O, Lorente JA, Gordo F, et al. Sepsis incidence and outcome: contrasting the intensive care unit with the hospital ward. Critical care medicine. 2007 May;35:1284-1289 Description Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, et al.. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); 2016 Description Babaev A, Frederick PD, Pasta DJ, Every N, Sichrovsky T, Hochman JS, et al. Trends in management and outcomes of patients with acute myocardial infarction complicated by cardiogenic shock. JAMA. 2005 Jul;294:448-454 Description Steg PG, Goldberg RJ, Gore JM, Fox KAA, Eagle KA, Flather MD, et al. Baseline characteristics, management practices, and in-hospital outcomes of patients hospitalized with acute coronary syndromes in the Global Registry of Acute Coronary Events (GRACE). Description Koek HL, Kardaun JWPF, Gevers E, de Bruin A, Reitsma JB, Grobbee DE, et al. Acute myocardial infarction incidence and hospital mortality: routinely collected national data versus linkage of national registers. European Journal of Epidemiology. 2007 Description Roger VL, Jacobsen SJ, Weston SA, Goraya TY, Killian J, Reeder GS, et al. Trends in the incidence and survival of patients with hospitalized myocardial infarction, Olmsted County, Minnesota, 1979 to 1994. Annals of internal medicine. 2002 Mar;136:341-348 Description Geppert A, Steiner A, Zorn G, Delle-Karth G, Koreny M, Haumer M, et al. Multiple organ failure in patients with cardiogenic shock is associated with high plasma levels of interleukin-6. Critical care medicine. 2002 Sep;30:1987-1994 Description Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesthesia and analgesia. 2011 Jun;112:1392-1402 Description Carrico CJ, Meakins JL, Marshall JC, Fry D, Maier RV. Multiple-organ-failure syndrome. Archives of surgery (Chicago, Ill : 1960). 1986 Feb;121:196-208 Description Helander HF, Fändriks L. Surface area of the digestive tract – revisited. Scandinavian journal of gastroenterology. 2014 Jun;49:681-689 Description Thome JJC, Yudanin N, Ohmura Y, Kubota M, Grinshpun B, Sathaliyawala T, et al. Spatial map of human T cell compartmentalization and maintenance over decades of life. Cell. 2014 Nov; 159:814-828 Description Reintam B, Poeze M, Malbrain ML, Björck M, Oudemans-van Straaten H. Starkopf J, et al. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Medicine. 2013 Description Clark JA, Coopersmith CM. Intestinal crosstalk: a new paradigm for understanding the gut as the "motor" of critical illness. Shock (Augusta, Ga). 2007 Oct; 28:384-393 Description Klingensmith NJ, Coopersmith CM. The Gut as the Motor of Multiple Organ Dysfunction in Critical Illness; 2016 Description van Haren FMP, Sleigh JW, Pickkers P, Van der Hoeven JG. Gastrointestinal perfusion in septic shock. Anaesth Intensive Care. 2007 Oct;35(5):679-694 Description McAdams ET, Jossinet J. Tissue impedance: a historical overview. Physiol Meas. 1995 Aug;16(3 Suppl A):A1-13. Historical Article Journal Article Description Ivorra A. Bioimpedance monitoring for physicians: an overview; 2003 Description Kim DW. Detection of physiological events by impedance. Yonsei Med J. 1989;30(1):1-11 Description Grimnes S, Martinsen OG. Comments on "Algorithm for Tissue Ischemia Estimation Based on Electrical Impedance Spectroscopy". IEEE Transactions on Biomedical Engineering. 2007 Feb;54(2):344-344 Description Rigaud B, Morucci JP, Chauveau N. Bioelectrical impedance techniques in medicine. Part I: Bioimpedance measurement. Second section: impedance spectrometry. Crit Rev Biomed Eng. 1996;24(4-6):257-351 Description Kun S, Peura RA. Tissue ischemia detection using impedance spectroscopy. In: Engineering in Medicine and Biology Society, 1994. Engineering Advances: New Opportunities for Biomedical Engineers. Proceedings of the 16th Annual International Conference Description Ristic B, Kun S, Peura RA. Muscle tissue ischemia monitoring using impedance spectroscopy: quantitative results of animal studies. In: Engineering in Medicine and Biology Society, 1997. Proceedings of the 19th Annual International Conference of the IEEE. Description Ivorra A, Genesca M, Sola A, Palacios L, Villa R, Hotter G, et al. Bioimpedance dispersion width as a parameter to monitor living tissues. Physiol Meas. 2005 Apr;26(2):S165-73. Comparative Study Journal Article Research Support, Non-U.S. Gov't Description Foster KR, Schwan HP. Dielectric properties of tissues and biological materials: a critical review. Critical reviews in biomedical engineering. 1989;17:25-104 Description Rackow EC, O'Neil P, Astiz ME, Carpati CM. Sublingual capnometry and indexes of tissue perfusion in patients with circulatory failure. Chest. 2001 Nov;120:1633-1638 Description Rigaud B, Hamzaoui L, Chauveau N, Granie M, Scotto Di Rinaldi JP, Morucci JP. Tissue characterization by impedance: a multifrequency approach. Physiol Meas. 1994 May;15 Suppl 2a:A13-20 Description Sullivan PG, Wallach JD, Ioannidis JPA. Meta-Analysis Comparing Established Risk Prediction Models (EuroSCORE II, STS Score, and ACEF Score) for Perioperative Mortality During Cardiac Surgery. The American journal of cardiology. 2016 Nov;118:1574-1582 Description Nashef SAM, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, et al. EuroSCORE II. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2012 Apr;41:734-44; discussion 744-5 Description A GVO. EuroSCORE II: Como se usa en la practica actual. Revista Mexicana de Cardiologia. 2014 03;25:50 – 51 Description Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Societ Description Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, et al. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related Description Moreno R, Vincent JL, Matos R, Mendoca A, Cantraine F, Thijs L, et al. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems Description de Mendonca A, Vincent JL, Suter PM, Moreno R, Dearden NM, Antonelli M, et al. Acute renal failure in the ICU: risk factors and outcome evaluated by the SOFA score. Intensive care medicine. 2000 Jul;26:915-921 Description Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct;286:1754-1758 Description Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical care medicine. 1985 Oct;13:818-829 Description NIH. Consensus Development Conference on critical care medicine. Critical care medicine. 1983 Jun;11:466-469 Description Chalfin DB, Fein AM. Critical care medicine in managed competition and a managed care environment. New horizons (Baltimore, Md). 1994 Aug;2:275-282 Description O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2-isolated valve surgery. The Annals of thoracic surgery. 2009 Jul;88:S23-S42 Description Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1-coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S2-22 Description Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3-valve plus coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S43-S62 Description Rankin JS, He X, O'Brien SM, Jacobs JP, Welke KF, Filardo G, et al. The Society of Thoracic Surgeons risk model for operative mortality after multiple valve surgery. The Annals of thoracic surgery. 2013 Apr;95:1484-1490

Responsible Parties

Sequence: 28907016
Responsible Party Type Sponsor

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<![CDATA[ Daily Versus Twice Per Day Tamsulosin for Ureteral Stent Symptoms ]]>
https://zephyrnet.com/NCT03799120
2019-02-18

https://zephyrnet.com/?p=NCT03799120
NCT03799120https://www.clinicaltrials.gov/study/NCT03799120?tab=tableNANANAA single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.
<![CDATA[

Studies

Study First Submitted Date 2019-01-04
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-02-25
Start Month Year February 18, 2019
Primary Completion Month Year December 2021
Verification Month Year February 2019
Verification Date 2019-02-28
Last Update Posted Date 2019-02-25

Detailed Descriptions

Sequence: 20709968
Description Ureteral stents are commonly used to maintain patency of the ureter and are placed for several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been associated with significant discomfort and dissatisfaction among patients.5 Bosio and colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over 90% of patients reported that this pain interfered with their everyday life.

The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures several domains relating to stent pain including general health, urinary issues, pain, work performance, sexual matters, and quality of life with stent in situ. The USSQ has been validated and translated and is currently a widely used measure.

While commonly used for treatment of benign prostatic hyperplasia, several studies have evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores and 7.2 in body pain scores). To date, randomized controlled trials have used one of two types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for lower urinary tract symptoms for patients with an indwelling stent. No study to date, however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on stent-related symptoms. The objective of this study is to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort.

Facilities

Sequence: 199964476
Name Gundersen Health System
City La Crosse
State Wisconsin
Zip 54601
Country United States

Browse Interventions

Sequence: 95996816 Sequence: 95996817 Sequence: 95996818 Sequence: 95996819 Sequence: 95996820 Sequence: 95996821 Sequence: 95996822 Sequence: 95996823 Sequence: 95996824
Mesh Term Tamsulosin Mesh Term Adrenergic alpha-1 Receptor Antagonists Mesh Term Adrenergic alpha-Antagonists Mesh Term Adrenergic Antagonists Mesh Term Adrenergic Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Physiological Effects of Drugs Mesh Term Urological Agents
Downcase Mesh Term tamsulosin Downcase Mesh Term adrenergic alpha-1 receptor antagonists Downcase Mesh Term adrenergic alpha-antagonists Downcase Mesh Term adrenergic antagonists Downcase Mesh Term adrenergic agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term physiological effects of drugs Downcase Mesh Term urological agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52138951
Name Ureteral Diseases
Downcase Name ureteral diseases

Id Information

Sequence: 40135019
Id Source org_study_id
Id Value 2-18-11-001

Countries

Sequence: 42542640
Name United States
Removed False

Design Groups

Sequence: 55559290 Sequence: 55559291
Group Type Placebo Comparator Group Type Experimental
Title tamsulosin QD + Placebo Title tamsulosin BID
Description 0.4 mg tamsulosin QD + Placebo QD Description 0.4 mg tamsulosin BID

Interventions

Sequence: 52454852 Sequence: 52454853
Intervention Type Drug Intervention Type Other
Name Tamsulosin BID Name Placebo
Description comparison of once daily versus twice daily tamsulosin Description Placebo

Design Outcomes

Sequence: 177263401
Outcome Type primary
Measure Ureteric Stent Symptoms Questionnaire
Time Frame 1 week post-stent placement
Description Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.

Browse Conditions

Sequence: 193366332 Sequence: 193366333 Sequence: 193366334 Sequence: 193366335 Sequence: 193366336 Sequence: 193366331
Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases Mesh Term Ureteral Diseases
Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term ureteral diseases
Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-list

Sponsors

Sequence: 48290669
Agency Class OTHER
Lead Or Collaborator lead
Name Gundersen Lutheran Medical Foundation

Overall Officials

Sequence: 29268510
Role Principal Investigator
Name Matthew Ferroni, MD
Affiliation Gundersen Health System

Design Group Interventions

Sequence: 68107382 Sequence: 68107383 Sequence: 68107384
Design Group Id 55559291 Design Group Id 55559290 Design Group Id 55559290
Intervention Id 52454852 Intervention Id 52454852 Intervention Id 52454853

Eligibilities

Sequence: 30747693
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Patients between the ages of 18 and 70 years old.
Planning to undergo ureteroscopy with ureteral stent placement at our site.
Able to read and understand an English language survey (USSQ).

Exclusion Criteria:

Patients who are unable to provide informed consent.
Patients who are already taking an alpha-blocker.
Patients with hypersensitivity or known adverse side effects of tamsulosin or its ingredients and those who are not candidates for tamsulosin per attending Urologist discretion.
Patients with a preexisting bladder condition including UTI within 30 days of the procedure.
Patients with hepatitis C on boceprevir.
Patients who have medical conditions known to be associated with chronic pain, those taking medications for chronic pain such as gabapentin or a chronic opioid per the judgement of the PI, or those with a pain contract on file.
Women who are pregnant or planning to become pregnant.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121786
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30493976
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking Triple
Subject Masked True
Caregiver Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28860256
Responsible Party Type Principal Investigator
Name Kara Kallies
Title Academic Researcher / study coordinator
Affiliation Gundersen Lutheran Medical Foundation

Study References

Sequence: 52032537 Sequence: 52032538 Sequence: 52032539 Sequence: 52032540 Sequence: 52032541
Pmid 27125392 Pmid 29923014 Pmid 12576846 Pmid 21453351 Pmid 27809592
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23. Citation Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19. Citation Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d. Citation Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31. Citation Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29.

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<![CDATA[ Developmental Epidemiological Study of Children Born Through Reproductive Technology ]]>
https://zephyrnet.com/NCT03799107
2017-07-14

https://zephyrnet.com/?p=NCT03799107
NCT03799107https://www.clinicaltrials.gov/study/NCT03799107?tab=tableNANANADESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. There are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.
<![CDATA[

Studies

Study First Submitted Date 2018-11-15
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-12-01
Start Month Year July 14, 2017
Primary Completion Month Year December 1, 2023
Verification Month Year November 2022
Verification Date 2022-11-30
Last Update Posted Date 2022-12-01

Detailed Descriptions

Sequence: 20769367
Description Over the past 30 years, much of the research and clinical effort in the field of ART had to do with improving outcome in terms of successful pregnancy. However, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. Short-term health complications, in particular birth defects,have been well-described. However, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. When underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. This exemplifies the problems with much of the currently available research regarding childhood outcomes following ART. While the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist.

In order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. The proposed Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT) is aimed to carefully address these important characteristics.

Facilities

Sequence: 200500712
Name University of California, San Francisco
City San Francisco
State California
Zip 94115
Country United States

Conditions

Sequence: 52293891 Sequence: 52293892 Sequence: 52293893 Sequence: 52293894 Sequence: 52293895 Sequence: 52293896
Name Infertility Name Infertility, Female Name Infertility, Male Name Infertility Primary Name Infertility Secondary Name Infertility Unexplained
Downcase Name infertility Downcase Name infertility, female Downcase Name infertility, male Downcase Name infertility primary Downcase Name infertility secondary Downcase Name infertility unexplained

Id Information

Sequence: 40246923
Id Source org_study_id
Id Value IRB 16-20474

Countries

Sequence: 42664612
Name United States
Removed False

Design Groups

Sequence: 55729869 Sequence: 55729870
Title Retrospective Title Prospective
Description Children born with assistance Description People who have sought evaluation/treatment for infertility

Design Outcomes

Sequence: 177829867 Sequence: 177829868 Sequence: 177829859 Sequence: 177829860 Sequence: 177829861 Sequence: 177829862 Sequence: 177829863 Sequence: 177829864 Sequence: 177829865 Sequence: 177829866
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Metabolic testing of child – non-HDL cholesterol Measure Metabolic testing of child – Alanine Aminotransferase Measure Metabolic testing of child – fasting glucose Measure Metabolic testing of child – fasting insulin Measure Metabolic testing of child – uric acid Measure Metabolic testing of child – total cholesterol Measure Metabolic testing of child – HDL cholesterol Measure Metabolic testing of child – LDL cholesterol Measure Metabolic testing of child – Triglycerides Measure Metabolic testing of child – cholesterol ratio
Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit Time Frame 1 day at study visit
Description Non-HDL cholesterol mg/dL Description Alanine Aminotransferase (ALT) U/L Description Fasting glucose mg/dL Description Fasting insulin uIU/mL Description uric acid mg/dL Description Cholesterol, Total mg/dL Description HDL cholesterol mg/dL Description LDL cholesterol mg/dL Description Triglycerides mg/dL Description CHOL/HDLC ratio

Browse Conditions

Sequence: 193955209 Sequence: 193955210 Sequence: 193955211 Sequence: 193955212 Sequence: 193955213 Sequence: 193955214 Sequence: 193955215 Sequence: 193955216 Sequence: 193955217 Sequence: 193955218
Mesh Term Infertility Mesh Term Infertility, Female Mesh Term Infertility, Male Mesh Term Genital Diseases Mesh Term Urogenital Diseases Mesh Term Genital Diseases, Female Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Genital Diseases, Male Mesh Term Male Urogenital Diseases
Downcase Mesh Term infertility Downcase Mesh Term infertility, female Downcase Mesh Term infertility, male Downcase Mesh Term genital diseases Downcase Mesh Term urogenital diseases Downcase Mesh Term genital diseases, female Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term genital diseases, male Downcase Mesh Term male urogenital diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48434205
Agency Class OTHER
Lead Or Collaborator lead
Name University of California, San Francisco

Eligibilities

Sequence: 30836566
Sampling Method Non-Probability Sample
Gender All
Minimum Age 4 Years
Maximum Age N/A
Healthy Volunteers No
Population Retrospective:

– children conceived by parent(s) who sought evaluation/treatment for infertility

Prospective:

– people seeking evaluation/treatment for infertility

Criteria Retrospective arm

Inclusion criteria:

– children conceived by parent(s) who sought evaluation/treatment for infertility

Exclusion criteria:

– Children with chronic medical illnesses that prevent a study visit

Prospective arm

Inclusion criteria:

– seeking evaluation/treatment for infertility

Exclusion criteria:

– none

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254157169
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 4
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 10

Designs

Sequence: 30582467
Observational Model Cohort
Time Perspective Other

Responsible Parties

Sequence: 28948901
Responsible Party Type Sponsor

]]>

<![CDATA[ Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations ]]>
https://zephyrnet.com/NCT03799094
2018-12-05

https://zephyrnet.com/?p=NCT03799094
NCT03799094https://www.clinicaltrials.gov/study/NCT03799094?tab=tableJunwen Ou, PhDoujunwen66@163.com86-13556021810This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year December 5, 2018
Primary Completion Month Year December 31, 2020
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20716265
Description The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated.

This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process.

Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.

Facilities

Sequence: 200053152
Status Recruiting
Name Clifford Hospital
City Guangzhou
Zip 511495
Country China

Facility Contacts

Sequence: 28097471
Facility Id 200053152
Contact Type primary
Name Junwen Ou, PhD
Email oujunwen66@163.com
Phone 86-13556021810

Facility Investigators

Sequence: 18326397
Facility Id 200053152
Role Principal Investigator
Name Junwen Ou, PhD

Browse Interventions

Sequence: 96027730 Sequence: 96027731 Sequence: 96027732 Sequence: 96027733 Sequence: 96027734 Sequence: 96027735 Sequence: 96027736 Sequence: 96027737 Sequence: 96027738 Sequence: 96027739
Mesh Term Ascorbic Acid Mesh Term Tyrosine Protein Kinase Inhibitors Mesh Term Vitamins Mesh Term Micronutrients Mesh Term Physiological Effects of Drugs Mesh Term Antioxidants Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Protective Agents Mesh Term Protein Kinase Inhibitors Mesh Term Enzyme Inhibitors
Downcase Mesh Term ascorbic acid Downcase Mesh Term tyrosine protein kinase inhibitors Downcase Mesh Term vitamins Downcase Mesh Term micronutrients Downcase Mesh Term physiological effects of drugs Downcase Mesh Term antioxidants Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term protective agents Downcase Mesh Term protein kinase inhibitors Downcase Mesh Term enzyme inhibitors
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52156394
Name Carcinoma, Non-Small-Cell Lung
Downcase Name carcinoma, non-small-cell lung

Id Information

Sequence: 40148160
Id Source org_study_id
Id Value 2/2018-19

Countries

Sequence: 42557686
Name China
Removed False

Design Groups

Sequence: 55577826 Sequence: 55577827
Group Type Experimental Group Type Experimental
Title Experimental group Title Control group
Description 75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor. Description 75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)

Interventions

Sequence: 52471935 Sequence: 52471936
Intervention Type Drug Intervention Type Drug
Name Vitamin C Name Tyrosine kinase inhibitor
Description Participants will receive intravenous vitamin C therapy at the indicated dose. Description Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.

Keywords

Sequence: 79847982 Sequence: 79847983 Sequence: 79847984 Sequence: 79847985 Sequence: 79847986
Name tyrosine kinase inhibitor Name Vitamin C Name non-small cell lung cancer Name progression-free survival Name overall survival
Downcase Name tyrosine kinase inhibitor Downcase Name vitamin c Downcase Name non-small cell lung cancer Downcase Name progression-free survival Downcase Name overall survival

Design Outcomes

Sequence: 177327655 Sequence: 177327656 Sequence: 177327657
Outcome Type primary Outcome Type secondary Outcome Type other
Measure Progression free survival Measure Overall survival Measure Changes in Health Related Quality of Life: European Organisation for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30
Time Frame From the start date of treatment until the date of first documented progression or death, assessed up to 2 years Time Frame From the start date of treatment until the date of death from any cause, assessed up to 2 years. Time Frame From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
Description From the start of treatment until the patient has tumor progression or death Description The length of time from the start of treatment for a disease until death Description Using QLQ-C30: Function subscales, (include physical, role, emotional, cognitive, social, global) (averaged, 0-100, higher value represent a better outcome); Symptoms subscales (include fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) (averaged, 0-100, lower value represent a better outcome). Given at basal, 1, 2, 3, 6, 12 months.

Browse Conditions

Sequence: 193431829 Sequence: 193431830 Sequence: 193431831 Sequence: 193431832 Sequence: 193431833 Sequence: 193431834 Sequence: 193431835 Sequence: 193431836 Sequence: 193431837 Sequence: 193431838
Mesh Term Carcinoma, Non-Small-Cell Lung Mesh Term Carcinoma, Bronchogenic Mesh Term Bronchial Neoplasms Mesh Term Lung Neoplasms Mesh Term Respiratory Tract Neoplasms Mesh Term Thoracic Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases
Downcase Mesh Term carcinoma, non-small-cell lung Downcase Mesh Term carcinoma, bronchogenic Downcase Mesh Term bronchial neoplasms Downcase Mesh Term lung neoplasms Downcase Mesh Term respiratory tract neoplasms Downcase Mesh Term thoracic neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48305987
Agency Class OTHER
Lead Or Collaborator lead
Name Clifford Hospital, Guangzhou, China

Overall Officials

Sequence: 29277891
Role Study Chair
Name Junwen Ou, PhD
Affiliation Clifford Hospital

Central Contacts

Sequence: 12004723
Contact Type primary
Name Junwen Ou, PhD
Phone 86-13556021810
Email oujunwen66@163.com
Role Contact

Design Group Interventions

Sequence: 68130775 Sequence: 68130776 Sequence: 68130777
Design Group Id 55577826 Design Group Id 55577827 Design Group Id 55577826
Intervention Id 52471935 Intervention Id 52471936 Intervention Id 52471936

Eligibilities

Sequence: 30757311
Gender All
Minimum Age 18 Years
Maximum Age 75 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21.
18 years old to 75 years old.
During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time.
Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2.
Expected survival over 3 months.
Household registration is Guangdong Province.

Exclusion Criteria:

Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication).
Patients who are allergic to vitamin C.
Patients with HIV and other infectious diseases.
Patients who are taking anticoagulants and have coagulopathy;
Combine dysfunction of important organs such as heart, lung, liver and kidney;
Patients with impaired renal function (serum creatinine content > 1.2 mg/dL)
Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)> 2 times normal reference value.
Pregnant or lactating female.
Smoking and alcohol abuse patients;
Anti-infective treatment is required for systemic or localized serious infections;
Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h));
Wilson's disease.
Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.
Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery;
History of surgery of visceral organs within 6 weeks before the study.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254226296
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30503536
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26665861
Intervention Id 52471935
Name Sodium Ascorbate

Provided Documents

Sequence: 2578356 Sequence: 2578357
Document Type Study Protocol and Statistical Analysis Plan Document Type Informed Consent Form
Has Protocol True Has Protocol False
Has Icf False Has Icf True
Has Sap True Has Sap False
Document Date 2018-11-14 Document Date 2018-11-14
Url https://ClinicalTrials.gov/ProvidedDocs/94/NCT03799094/Prot_SAP_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/94/NCT03799094/ICF_001.pdf

Responsible Parties

Sequence: 28869814
Responsible Party Type Sponsor

]]>

<![CDATA[ Use of Fetoscopy in Missed Abortion ]]>
https://zephyrnet.com/NCT03799081
2019-01-31

https://zephyrnet.com/?p=NCT03799081
NCT03799081https://www.clinicaltrials.gov/study/NCT03799081?tab=tableEmiliya Ilizirov, MDemiliyailizirova@gmal.com972-532323246The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.
<![CDATA[

Studies

Study First Submitted Date 2018-11-05
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year January 2019
Primary Completion Month Year January 2021
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200244222
Name Hille Yaffe Medical Center
City Hadera
Zip 38100
Country Israel

Facility Contacts

Sequence: 28128012
Facility Id 200244222
Contact Type primary
Name Emiliya Ilizirov, MD
Email emiliyailizirova@gmail.com

Conditions

Sequence: 52208099
Name Abortion, Missed
Downcase Name abortion, missed

Id Information

Sequence: 40186142
Id Source org_study_id
Id Value HYMC-00056-18

Countries

Sequence: 42599637
Name Israel
Removed False

Design Groups

Sequence: 55634661
Group Type Other
Title Fetoscopy in missed abortion
Description Women who have decided to undergo fetoscopy in missed abortion

Interventions

Sequence: 52522069
Intervention Type Procedure
Name Fetoscopy
Description Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope

Design Outcomes

Sequence: 177511202 Sequence: 177511203 Sequence: 177511204
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Macroscopic anatomic malformations in missed abortions Measure Minimize intrauterine adhesions through observation Measure Prevention of retained conception products
Time Frame Two years Time Frame Two years Time Frame Two years
Description The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope Description To minimize intrauterine adhesions that might occur after curettage through the ability to visualize the womb and pregnancy site through a hysteroscope before the surgical procedure so that inadvertent intrauterine adhesions are minimized. After one year, if pregnancy is not achieved (due to intrauterine adhesions that cause infertility), a follow-up hysteroscopy will be performed and intrauterine adhesions can be visualized if they have occurred. Description Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb

Browse Conditions

Sequence: 193626995 Sequence: 193626996 Sequence: 193626997 Sequence: 193626998 Sequence: 193626999
Mesh Term Abortion, Missed Mesh Term Abortion, Spontaneous Mesh Term Pregnancy Complications Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases
Downcase Mesh Term abortion, missed Downcase Mesh Term abortion, spontaneous Downcase Mesh Term pregnancy complications Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48353691
Agency Class OTHER_GOV
Lead Or Collaborator lead
Name Hillel Yaffe Medical Center

Overall Officials

Sequence: 29305976
Role Principal Investigator
Name Sergio Haimovich, MD, PhD
Affiliation Hillel Yaffe Medical Center

Central Contacts

Sequence: 12017213
Contact Type primary
Name Emiliya Ilizirov, MD
Phone 972-532323246
Email emiliyailizirova@gmal.com
Role Contact

Design Group Interventions

Sequence: 68199184
Design Group Id 55634661
Intervention Id 52522069

Eligibilities

Sequence: 30786866
Gender Female
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Women diagnosed with missed abortion during the first trimester of pregnancy

Exclusion Criteria:

Women diagnosed with missed abortion after the first trimester of pregnancy
Any contraindication for hysteroscopy

Gender Based True
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253989621
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30532936
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Diagnostic
Time Perspective
Masking None (Open Label)
Intervention Model Description Women who have undergone a missed abortion in the first trimester who want a surgical treatment option

Responsible Parties

Sequence: 28899230
Responsible Party Type Sponsor

]]>

<![CDATA[ Suprazygomatic Nerve Block vs Surgical Site Infiltration in Cleft Palate Repair ]]>
https://zephyrnet.com/NCT03799068
2018-10-01

https://zephyrnet.com/?p=NCT03799068
NCT03799068https://www.clinicaltrials.gov/study/NCT03799068?tab=tableNANANAThe aim of this study is to evaluate the efficacy and duration of effect of bupivacaine given preoperatively as a bilateral suprazygomatic maxillary nerve block and to compare it with peri-incisional infiltration with the same agent for perioperative analgesia in children undergoing cleft palate repair.
<![CDATA[

Studies

Study First Submitted Date 2018-11-27
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year October 1, 2018
Primary Completion Month Year March 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20721629
Description Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births, Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract infections. The surgical procedure can be complicated by airway obstruction and respiratory complications. CP is painful in the first 24-48 h following surgery.

Different treatment modalities have been used for reducing or ameliorating the pain following cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory drugs (NSAIDs), surgical site infiltration and various nerve blocks However, the analgesic drugs may provide inadequate analgesia and have side effects such as respiratory depression and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted interest in nerve blocking techniques for operative analgesia. These became established in paediatric anaesthetic practice with the accumulating evidence of advantages such as postoperative pain relief, reduced use of potent narcotics, rapid return of alertness, early feeding and moving about, and early discharge in day care surgery.

The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of the face through the foramen rotundum, and then passes forward and laterally through the pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of the orbit by the infra- orbital foramen. This sensory nerve supplies innervation of the lower eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate.

Maxillary nerve block through the infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve block has lead to complications such as orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury In adults, approach to the suprazygomatic MN block (SMB) seems to minimize the risks of the infrazygomatic route providing effective anaesthesia of the entire sensory territory of the MN and its terminal branches.

Bupivacaine, a long-acting amide local anaesthetic has been used widely in infants, particularly for infiltration of wound-edges and nerve blocking.

Pre-incisional infiltration of local anaesthetics has been used both in adults and children in a variety of surgeries with variable results. submucosal infiltration performed by the surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic approach has demonstrated beneficial effects in adults for trigeminal neuralgia.

Facilities

Sequence: 200108117
Name Assiut university hospital
City Assiut
Zip 71515
Country Egypt

Conditions

Sequence: 52171227 Sequence: 52171228
Name Cleft Palate Children Name Block
Downcase Name cleft palate children Downcase Name block

Id Information

Sequence: 40158626
Id Source org_study_id
Id Value Cleft Palate

Countries

Sequence: 42568937
Name Egypt
Removed False

Design Groups

Sequence: 55593162 Sequence: 55593163
Group Type Active Comparator Group Type Active Comparator
Title suprazygomatic maxillary nerve block Title surgical site infiltraion
Description the group were given a bilateral suprazygomatic maxillary nerve block with 0.125% bupivacaine, 2 ml on each side, the total dose of bupivacaine not exceeding 2 mg/kg. Description the group were given peri-incisional infiltration with 0.125% bupivacaine, 2 ml on each side. In all cases the block was given by the anaesthetist and the infiltration by the surgeon.

Interventions

Sequence: 52485469 Sequence: 52485470
Intervention Type Other Intervention Type Other
Name suprazygomatic maxillary nerve block Name surgical site infiltration
Description bilateral Suprazygomatic maxillary nerve block is performed before surgery in anaesthetized children, after aseptic preparation of the skin. The patient is in supine position with the head in neutral position. The puncture site is at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal process. A 24G needle is attached to a syringe containing the local anaesthetic. It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa is 35 to 45 mm. Loss of resistance after passing through the temporalis muscle assisted in determining the puncture depth. After a negative blood aspiration test, the calculated dose of the local anaesthetic is injected on each side. Description peri-incisional infiltration of bupivacaine around the incision site given by the surgeon on an anesthetized patient before the incision is done.

Keywords

Sequence: 79868530 Sequence: 79868531
Name bupivacaine Name suprazygomatic nerve block
Downcase Name bupivacaine Downcase Name suprazygomatic nerve block

Design Outcomes

Sequence: 177378837
Outcome Type primary
Measure Pain assessment
Time Frame 24 hours postoperative
Description By Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) in Young Children (1-7 years) is a behavioral scale for evaluating postoperative pain in young children.

Cry No crying +1 Moaning,crying +2 Screaming+3

Facial expression: Smiling +1 Composed, neutral +2 Grimace +3

Verbal responses Positive statements +1 Negative statement +2 Suffering from pain +3

Torso Neutral/resting +1 Shifting, shivering, upright +2 Restrained +3

Legs Neutral position+1 Squirming/kicking, drawn up, tensed legs +2 Restrained +3 Cheops score of 4 or less indicates no pain. Rescue analgesic consisting of paracetamol 10-15 mg/kg will be given rectally when CHEOPS is > 4.

Browse Conditions

Sequence: 193486680 Sequence: 193486681 Sequence: 193486682 Sequence: 193486683 Sequence: 193486684 Sequence: 193486685 Sequence: 193486686 Sequence: 193486687 Sequence: 193486688 Sequence: 193486689 Sequence: 193486690 Sequence: 193486691
Mesh Term Cleft Palate Mesh Term Jaw Abnormalities Mesh Term Jaw Diseases Mesh Term Musculoskeletal Diseases Mesh Term Maxillofacial Abnormalities Mesh Term Craniofacial Abnormalities Mesh Term Musculoskeletal Abnormalities Mesh Term Stomatognathic Diseases Mesh Term Mouth Abnormalities Mesh Term Mouth Diseases Mesh Term Stomatognathic System Abnormalities Mesh Term Congenital Abnormalities
Downcase Mesh Term cleft palate Downcase Mesh Term jaw abnormalities Downcase Mesh Term jaw diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term maxillofacial abnormalities Downcase Mesh Term craniofacial abnormalities Downcase Mesh Term musculoskeletal abnormalities Downcase Mesh Term stomatognathic diseases Downcase Mesh Term mouth abnormalities Downcase Mesh Term mouth diseases Downcase Mesh Term stomatognathic system abnormalities Downcase Mesh Term congenital abnormalities
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319286
Agency Class OTHER
Lead Or Collaborator lead
Name Assiut University

Design Group Interventions

Sequence: 68149118 Sequence: 68149119
Design Group Id 55593162 Design Group Id 55593163
Intervention Id 52485469 Intervention Id 52485470

Eligibilities

Sequence: 30765345
Gender All
Minimum Age 1 Year
Maximum Age 5 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

ASA grade I-III.
Aged from1-5 years
Undergoing cleft palate repair.

Exclusion Criteria:

Patient's refusal.
Allergy to local anaesthetics.
Trigeminal neuralgia.
Bleeding diathesis.
Inflammation or infection over injection site.

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 253883355
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 1
Maximum Age Num 5
Minimum Age Unit Year
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30511512
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Subject Masked True

Responsible Parties

Sequence: 28877806
Responsible Party Type Principal Investigator
Name Maha Nasser Abdellatif Elshimy
Title Clinical physician
Affiliation Assiut University

]]>

<![CDATA[ Ultrasonography vs Conventional Methods for Prediction of Difficult Airway in Adult Patients ]]>
https://zephyrnet.com/NCT03799055
2019-06-10

https://zephyrnet.com/?p=NCT03799055
NCT03799055https://www.clinicaltrials.gov/study/NCT03799055?tab=tableNANANAThe aim of this study to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-04-22
Start Month Year June 10, 2019
Primary Completion Month Year December 29, 2019
Verification Month Year April 2020
Verification Date 2020-04-30
Last Update Posted Date 2020-04-22

Facilities

Sequence: 200617894
Name Benha University Hospital
City Banhā
State Banha
Zip 13518
Country Egypt

Conditions

Sequence: 52328229
Name Difficult Intubation
Downcase Name difficult intubation

Id Information

Sequence: 40271035
Id Source org_study_id
Id Value Us in difficult airway

Countries

Sequence: 42691070
Name Egypt
Removed False

Design Groups

Sequence: 55768046 Sequence: 55768047
Title easy intubation Title difficult intubation
Description Cormack _Lehane : 1&2 Description Cormack _Lehane : 3&4

Design Outcomes

Sequence: 177959709
Outcome Type primary
Measure Prediction of difficult airway
Time Frame Preoperative
Description Assess which method is better for prediction of difficult airway DES or conventional

Sponsors

Sequence: 48466358
Agency Class OTHER
Lead Or Collaborator lead
Name Benha University

Overall Officials

Sequence: 29368827
Role Study Director
Name Faculty Of Medicine
Affiliation faculty of medicine

Eligibilities

Sequence: 30856288
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers Accepts Healthy Volunteers
Population Patients at Benha University Surgical Hospital scheduled for elective surgical procedures requiring endotracheal tube
Criteria Inclusion Criteria:

American Society of Anaesthesia class 1,2and 3.
elective surgical procedure requiring endotracheal intubation.
Age 18_60 years old.
BMI less than 40kg/meter square.

Exclusion Criteria:

patients refusal.
Unable to give consent.
Preexisting airway malformations or pathology.
History of difficult intubation.
Pregnancy.
Patients with tracheostomy tube.
BMI more than 40 kg/meter square.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254313007
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 6
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30602127
Observational Model Other
Time Perspective Prospective

Responsible Parties

Sequence: 28968642
Responsible Party Type Principal Investigator
Name Baher Said Elshahat Mohamed Abdelhady
Title Principal investigator
Affiliation Benha University

]]>

<![CDATA[ The Use of Virtual Reality (VR) and the Change in Emotion in Hong Kong Elders ]]>
https://zephyrnet.com/NCT03799042
2018-08-01

https://zephyrnet.com/?p=NCT03799042
NCT03799042https://www.clinicaltrials.gov/study/NCT03799042?tab=tableNANANAVirtual Reality (VR) is a technology that combines virtual technology and real-world scenario. In recent years, more and more neuroscience and psychology scientists utilised VR technology in their research. In Hong Kong, many of the community-dwelling elders are immobile. Long-term homestay may negatively affect the emotional state. Measuring the emotional change after administration of VR may prove it as an alternative tool for emotion intervention.

The primary objective is to compare the improvement in the emotional changes between intergeneration interaction and the use of VR technology.

The secondary objective is to evaluate the side effect after using VR technology.

This is a randomized, open label-controlled trial with a crossover design. The subject will be randomized in a ratio of 1:1 into two different intervention groups, the VR group and the Intergeneration Interaction group. After 2 weeks of washout period, the VR group will receive Intergeneration Interaction and vice versa. The intervention phases last approximately 2 hours. The change in the emotional state will be assessed using the Positive and Negative Affect Scale. Any adverse event that causes by the VR will be recorded using the Simulator Sickness Questionnaire(SSQ).

This trial is the first study in Hong Kong to investigate the change of emotional state after the administration of VR technology, targeting community-dwelling elders in Hong Kong.
<![CDATA[

Studies

Study First Submitted Date 2018-08-10
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year August 1, 2018
Primary Completion Month Year September 30, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 199965042
Name Caritas Elderly Centre – Sai Kung
City Hong Kong
State HK
Country Hong Kong

Conditions

Sequence: 52138964 Sequence: 52138965
Name Virtual Reality Name Emotions
Downcase Name virtual reality Downcase Name emotions

Id Information

Sequence: 40135030
Id Source org_study_id
Id Value CUHKHKT0818

Countries

Sequence: 42542665
Name Hong Kong
Removed False

Design Groups

Sequence: 55559302 Sequence: 55559303
Group Type Experimental Group Type Active Comparator
Title Vitural Reality Title Inter-generation interaction
Description Virtual Reality 3D glass Description Elders-teenager interaction

Interventions

Sequence: 52454863 Sequence: 52454864
Intervention Type Device Intervention Type Behavioral
Name Virtual Reality Name Inter-generation interaction
Description Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong. Description Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong

Design Outcomes

Sequence: 177263517 Sequence: 177263518 Sequence: 177263519 Sequence: 177263520
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Positive and Negative Affect Schedule (PANAS) Measure Simulator Sickness Questionnaire Measure Positive and Negative Affect Schedule (PANAS) Measure Simulator Sickness Questionnaire
Time Frame Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.) Time Frame Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.) Time Frame Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline) Time Frame Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
Description Measure the difference in mean score between the two intervention groups. The Positive and Negative Affect Schedule (PANAS) is consist of 20 emotions. Positive Affect Score consists of 10 positive emotions, while Negative Affect Score consists of 10 negative emotions. Positive Affect Score ranges from 10 to 50, a score of 30 indicates a higher level of positive emotion. Negative Affect Score ranges from 10 to 50, a score of 15 indicates a higher level of negative emotion. Total PANAS score is 100, added up by both Positive Affect Score and Negative Affect Score. Description Measure the difference in mean score between the two intervention groups. The Simulator Sickness Questionnaire (SSQ) is consist of 16 symptoms. Each symptom includes four level, none (0 marks), slight(1mark), moderate (2 marks) and severe(3). Three subscore are included, Nausea-related subscore (Symptom 1,6,7,8,9,15,16), Oculomotor-related subscore (Symptom 1,2,3,4,5,9,11), and Disorientation-related subscore (5,8,10,11,12,13,14). Adding Nausea subscore, oculomotor subscore, and disorientation subscore and multiply by 3.74. Total score larger than 15 indicated a significant level of adverse reaction. Description Measure the changes from baseline to first intervention Description Measure the changes from baseline to first intervention

Sponsors

Sequence: 48290677
Agency Class OTHER
Lead Or Collaborator lead
Name Chinese University of Hong Kong

Overall Officials

Sequence: 29268516
Role Principal Investigator
Name Kelvin KF Tsoi, BSc, PhD
Affiliation Chinese University of Hong Kong

Design Group Interventions

Sequence: 68107396 Sequence: 68107397
Design Group Id 55559302 Design Group Id 55559303
Intervention Id 52454863 Intervention Id 52454864

Eligibilities

Sequence: 30747700
Gender All
Minimum Age 50 Years
Maximum Age 99 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Native Cantonese Speaker

Exclusion Criteria:

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121794
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 2
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 50
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30493983
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28860263
Responsible Party Type Principal Investigator
Name Kelvin KF Tsoi
Title Associate Professor
Affiliation Chinese University of Hong Kong

]]>

<![CDATA[ Effects of a Cognitive Training Program With Game Elements Among ADHD ]]>
https://zephyrnet.com/NCT03799029
2019-02-20

https://zephyrnet.com/?p=NCT03799029
NCT03799029https://www.clinicaltrials.gov/study/NCT03799029?tab=tableChantal Martin Soelch, Prchantal.martinsoelch@unifr.ch+41 26 300 7687This study examines the impact of cognitive training among participants with ADHD in Switzerland
<![CDATA[

Studies

Study First Submitted Date 2018-05-28
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year February 20, 2019
Primary Completion Month Year June 1, 2021
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20727138
Description The main aim of the experimental study is to investigate cognitive functioning, behavioral and neural levels in ADHD, both before and after cognitive training where there has been the addition of motivation elements. Near and far transfers effects of this new program are evaluated. For far transfers, ambulatory assessment is used to improve ecological validity. Neural activity has rarely been examined in cognitive training with ADHD participants, and that is why this study also includes FMRI measures. Long-term effects, defined as three and six months following the completion of cognitive training, are also investigated. This study focuses on children, adolescents and adults with ADHD. Indeed, cognitive training effects have been rarely studied over the lifespan.

Facilities

Sequence: 200159077
Name Dentz Amélie
City Montréal
State Quebec
Zip 2000
Country Canada

Conditions

Sequence: 52185366
Name ADHD
Downcase Name adhd

Id Information

Sequence: 40168994
Id Source org_study_id
Id Value University of Fribourg

Countries

Sequence: 42580602
Name Canada
Removed False

Design Groups

Sequence: 55609009 Sequence: 55609010 Sequence: 55609011
Group Type Active Comparator Group Type Experimental Group Type No Intervention
Title active control group low-intensity Title experimental training group cognitive training Title control healthy participants
Description Low intensity version of the same cognitive training program Exercice are realized at home using a computer 25 sessions of 30-45 minutes are realized five days per week during 5 weeks Description a multifactorial cognitive program that tackles working memory, attention, inhibition, planification and reasoning Exercice are realized at home using a computer 25 sessions of 30-45 minutes are realized five days per week during 5 weeks Description Just a control group including healthy participants No intervention

Interventions

Sequence: 52499330
Intervention Type Other
Name Cognitive training
Description Participants will train at home during 25 sessions (about 45 minutes each) over a maximum of 5 weeks. Investigators will verify compliance via Internet and call participants and their legal guardians once a week. A reward system will be established with participants. Five sessions of metacognition (1 hour each) are added.

Keywords

Sequence: 79888564 Sequence: 79888565 Sequence: 79888566
Name Cognitive training Name treatment Name ADHD
Downcase Name cognitive training Downcase Name treatment Downcase Name adhd

Design Outcomes

Sequence: 177431700 Sequence: 177431701 Sequence: 177431702 Sequence: 177431703 Sequence: 177431704 Sequence: 177431705 Sequence: 177431706 Sequence: 177431707 Sequence: 177431708
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure ADHD symptoms for adults Measure ADHD symptoms for children Measure Impulsivity Measure executive function Measure Reward Measure Reward Measure Memory Measure Memory Measure Neural activity
Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 training 4. Six months after cognitive training Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 training 4. Six months after cognitive training Time Frame Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4
Description The Conners' Adult ADHD Rating Scales (CAARS) higher values represent worse outcome The Conners' Adult ADHD Rating Scales (CAARS) is used to assess ADHD symptoms among adults (Conners et al., 1999) depending on the DSM-IV-TR (APA, 2000). This short version includes 26 items and 4 possible ratings from from 0 (not at all) to 3 (very much). This scale comprises four factors: (1) inattention, memory problems, (2) hyperactivity, restlessness, (3) impulsivity, emotional lability, (4) problems with self-concept and one ADHD index. score are summed. Range 0 to 100. Description The Conners Scale, 3rd edition higher values represent a worse outcome Questionnaire is rated by the legal guardian. This questionnaire assesses ADHD symptoms.Score are summed. Score range 0 to 100. Description The Impulsivity Behavior Scale (UPPS) higher values represent a worse outcome. score are summed short version contains 20 items measuring the following five dimensions of impulsivity: positive urgency, negative urgency, lack of perseverance, lack of premeditation and sensation seeking. This scale is based on Cyder and Smith (2007) and Whiteside and Lynam (2001) theory of impulsivity. Range 0 to 50. Description The Behavior Rating Inventory of Executive Function higher values represent a worse outcome Score are summed. This questionnaire measures executive functionning in everyday life. The BRIEF includes 75 questions and eight sub-domains: Inhibit Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials and Monitor. Score range 0 to 100 Description Subjects will perform a reward under stress task adapted from the spatial delayed response task from (Glahn et al., 2002) measure reward (Martin-Soelch, C., et al.,2009: Gaillac et al., 2016). Reaction time is calculated.

The sensitivity to Punishment and Sensitivity to Reward questionnaire for Children, adolescents (SPSRQ-C) (Colder and O'Connor 2004) and adults (SPSRQ, Torrubia, Ávila, Moltó, & Caseras, 2001) are used. These questionnaires are based on Gray's reinforcement sensitivity theory of personality (1981, 1987, 2000). Reward task higher values represent a better outcome. Score range 0 to 110.

Description The sensitivity to Punishment and Sensitivity to Reward questionnaire for Children, adolescents (SPSRQ-C) (Colder and O'Connor 2004) and adults (SPSRQ, Torrubia, Ávila, Moltó, & Caseras, 2001) are used. These questionnaires are based on Gray's reinforcement sensitivity theory of personality (1981, 1987, 2000). Reward task higher values represent a better outcome. Score range 0 to 110. Description WISC-IV higher values represent a better outcome. The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) Score are standardized from 0 to 20 for subtest and summed from 0 to 150.

The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) and the Weschler adult intelligent scale measure verbal memory. Score are standardized from 0 to 20 for subtest and summed from 0 to 150.

Description WAIS-IV higher values represent a better outcome .the Weschler adult intelligent scale to (WAIS-IV; Wechsler, 2008). Score are standardized from 0 to 20 for subtest and summed from 0 to 150.

The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) and the Weschler adult intelligent scale measure verbal memory. Score are standardized from 0 to 20 for subtest and summed from 0 to 150.

Description The fMRI measure include. Resting-state functional MRI.Task-free. Subjects are instructed to just lie quietly in the scanner and to think of nothing in particular and let their mind wander.- binding potential (ΔBP) is measured.

Browse Conditions

Sequence: 193539712 Sequence: 193539713 Sequence: 193539714 Sequence: 193539711
Mesh Term Attention Deficit and Disruptive Behavior Disorders Mesh Term Neurodevelopmental Disorders Mesh Term Mental Disorders Mesh Term Attention Deficit Disorder with Hyperactivity
Downcase Mesh Term attention deficit and disruptive behavior disorders Downcase Mesh Term neurodevelopmental disorders Downcase Mesh Term mental disorders Downcase Mesh Term attention deficit disorder with hyperactivity
Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-list

Sponsors

Sequence: 48332227 Sequence: 48332228
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Fribourg Name Paris West University Nanterre La Défense

Overall Officials

Sequence: 29292926 Sequence: 29292927
Role Principal Investigator Role Principal Investigator
Name Amélie Dentz, Ph.D Name Martin Soelch Chantal, PR
Affiliation University of Fribourg Affiliation University of Fribourg

Central Contacts

Sequence: 12012282 Sequence: 12012283
Contact Type primary Contact Type backup
Name amelie dentz, Ph.D Name Chantal Martin Soelch, Pr
Phone 0676951881 Phone +41 26 300 7687
Email ameliedentz@hotmail.com Email chantal.martinsoelch@unifr.ch
Role Contact Role Contact

Design Group Interventions

Sequence: 68168052 Sequence: 68168053
Design Group Id 55609009 Design Group Id 55609010
Intervention Id 52499330 Intervention Id 52499330

Eligibilities

Sequence: 30773519
Gender All
Minimum Age 6 Years
Maximum Age 65 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Participants fulfilling all of the following inclusion criteria are eligible for the study for the patients'group:

Age between 6 and 65 years' old
ADHD diagnostic by a specialist
IQ-score higher than 80 for adult according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
Treatment with or without medication for ADHD
Computer and Internet connexion at home
Informed consent from participants and the legal guardian of the minors (under 14 years old) involved – as documented by signature (Appendix Informed Consent Form).

Participants fulfilling all of the following inclusion criteria are eligible for the study for the control group of healthy participants:

Age between 6 and 65 years' old
No ADHD diagnostic by a specialist
IQ-score higher than 80 for adult according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
No medication treatment for ADHD
Informed consent from participants and the legal guardian of the minors involved – as documented by signature (Appendix Informed Consent Form).

Exclusion Criteria:

Exclusion criteria

The exclusion criteria for the participants in the patient's group are:

Age younger than 6 and older than 65 years' old
No diagnosis of ADHD
IQ-score lower than 80 points according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
No computer and Internet access at home
No written consent from participants and from the legal guardians of minors involved as less than 14 years old.

(7) FMRI exclusion: claustrophobia, Pregnancy known or suspected,metallic implants in their bodies (e.g: pacemakers, aneurism clips, metal Prosthetic, cochlear implant) (8) In case of suicidal risk, the participant is encouraged to consult the medical staff (9) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (10) Participation in another study on cognitive training (11) Previous enrolment into the current study (12) Enrolment of the investigator, his/her family members, employees and other dependent persons

The exclusion criteria for the participants in the control group of healthy participants are:

Age younger than 6 and older than 65 years' old
Diagnosis of ADHD or other mental disorders
IQ-score lower than 80 points according to (WAIS-IV; Wechsler, 2008) and for children and adolescents according to (WISC-IV; Wechsler, 2003)
No written consent from participants and from the legal guardians of minors involved (for participants under 14 years old)
FMRI exclusion: claustrophobia, Pregnancy known or suspected, metallic implants in their bodies (e.g: pacemakers, aneurism clips, metal Prosthetic, cochlear implant)
In case of suicidal risk, the participant is encouraged to consult the medical staff.
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Previous enrolment into the current study
Enrolment of the investigator, his/her family members, employees and other dependent persons

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253952483
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 6
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 7

Designs

Sequence: 30519650
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description Participant are blind on their group assignation. Investigator are blind on group assignation
Intervention Model Description will compare the ADHD group with a control group including healthy participants .The experimental study uses a pseudo-randomized, double-blind, controlled multi-center design.Participants will be assigned to an experimental group (cognitive training ) or in a control active group.
Subject Masked True
Investigator Masked True

Responsible Parties

Sequence: 28885951
Responsible Party Type Principal Investigator
Name Amelie Dentz
Title principal investigator Ph.D
Affiliation University of Fribourg

Study References

Sequence: 52078781 Sequence: 52078782
Pmid 27875585 Pmid 24438534
Reference Type background Reference Type result
Citation Spencer-Smith M, Klingberg T. Correction: Benefits of a Working Memory Training Program for Inattention in Daily Life: A Systematic Review and Meta-Analysis. PLoS One. 2016 Nov 22;11(11):e0167373. doi: 10.1371/journal.pone.0167373. eCollection 2016. Citation Gathercole SE. Commentary: Working memory training and ADHD – where does its potential lie? Reflections on Chacko et al. (2014). J Child Psychol Psychiatry. 2014 Mar;55(3):256-7. doi: 10.1111/jcpp.12196. Epub 2014 Jan 20.

]]>

<![CDATA[ An Observational Study on Incidence, Natural History and Treatment Patterns of Venous Thromboembolism in Taiwan ]]>
https://zephyrnet.com/NCT03799016
2016-12-15

https://zephyrnet.com/?p=NCT03799016
NCT03799016https://www.clinicaltrials.gov/study/NCT03799016?tab=tableNANANAThe research question addressed by this study is primarily on the clinical epidemiology of VTE in Taiwan. The study aims to estimate the incidence of VTE and describe natural history of VTE, including long term clinical outcomes in adult Taiwanese population, utilizing population-based electronic health data in Taiwan.
<![CDATA[

Studies

Study First Submitted Date 2018-10-25
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year December 15, 2016
Primary Completion Month Year July 1, 2017
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200352050
City Taipei
Country Taiwan

Conditions

Sequence: 52244445
Name Venous Thromboembolism
Downcase Name venous thromboembolism

Id Information

Sequence: 40212161
Id Source org_study_id
Id Value 18787

Countries

Sequence: 42627117
Name Taiwan
Removed False

Design Outcomes

Sequence: 177648648 Sequence: 177648649 Sequence: 177648650 Sequence: 177648651 Sequence: 177648652 Sequence: 177648653 Sequence: 177648654
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Incident VTE Measure Potential risk factors that occurred before the incident VTE events Measure Usage patterns of anticoagulants among incident VTE patients were evaluated during incident VTE hospital admission and after discharge Measure All-cause mortality Measure Major bleeding Measure Recurrent VTE Measure Adherence of oral anticoagulant treatment was also evaluated with the calculation of MPR within 6 months and 12 months after discharge.
Time Frame 4 years Time Frame 4 years Time Frame 4 years Time Frame 4 years Time Frame 4 years Time Frame 4 years Time Frame Up to 6 and 12 month
Description Incident VTE cases were those who had a first VTE diagnosis after 1 January 2005 and with at least 5 years of look-back period. Those with a first VTE diagnosis less than 5 years of look-period were considered as undetermined VTE cases. Description Events during the 3 months before the first VTE recurrence will be described. Potential risk factors that will be evaluated include age, gender, and treatment regimen for VTE, adherence to treatment regimen, concomitant medications, and comorbidity. The analysis will be stratified by the nature of the first VTE (provoked and unprovoked). Due to the unknown number of repeated recurrence and complex clinical nature of patients with multiple VTE recurrence, risk factors for multiple recurrences will be evaluated at a less detailed level than that for the first recurrence. Description All deaths before 31 December 2014 among the incident VTE patients were identified through the mortality records. Patients were followed from incident VTE index date, and the patients were censored on 31 December 2014 or termination of NHI coverage without further medical or mortality records. If the patient died during the same hospitalization during the incident VTE, the death date was defined as the discharge date of that specific hospitalization. Description Major bleeding (intracranial bleed and gastrointestinal bleed) was the major morbidity of interest and incident VTE patients were followed from incident VTE index date till 31 December 2014, death or termination of NHI coverage without any further medical records. Patients died during the incident VTE hospitalization were excluded for major bleeding follow up. Description Recurrent VTE events after the incident VTE diagnosis were evaluated during the follow-up period through 31 December 2014 or until the patient died or NHI coverage terminated without any further medical records after the termination. The same VTE operational definitions according to different algorithm in incident VTE were consistently applied in recurrent VTE.

Browse Conditions

Sequence: 193766196 Sequence: 193766197 Sequence: 193766198 Sequence: 193766199 Sequence: 193766200
Mesh Term Thromboembolism Mesh Term Venous Thromboembolism Mesh Term Embolism and Thrombosis Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases
Downcase Mesh Term thromboembolism Downcase Mesh Term venous thromboembolism Downcase Mesh Term embolism and thrombosis Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48388131
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Bayer

Overall Officials

Sequence: 29325245
Role Study Director
Name Bayer Study Director
Affiliation Bayer

Eligibilities

Sequence: 30808193
Sampling Method Non-Probability Sample
Gender All
Minimum Age 20 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

The source population was the adult population in Taiwan. The legal age for definition as an adult (without additional research ethics review requirement) in Taiwan is 20; therefore all National Health Insurance (NHI) enrollees age 20 or older at any time during the study period were evaluated for VTE.

Exclusion Criteria:

Person-time before an eligible subject turned 20 were not evaluated.
Study subjects having inconsistent data on gender and unrealistic date of birth (birth year before 1890 and after 2015) were identified and excluded from the analysis.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254032302
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 6
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 20
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 7

Designs

Sequence: 30554190
Observational Model Cohort
Time Perspective Retrospective

Links

Sequence: 4393856
Url https://clinicaltrials.bayer.com/
Description Click here to learn more about Bayer clinical study results.

Responsible Parties

Sequence: 28920553
Responsible Party Type Sponsor

]]>

<![CDATA[ A Study of ASP1951 in Subjects With Advanced Solid Tumors ]]>
https://zephyrnet.com/NCT03799003
2019-01-14

https://zephyrnet.com/?p=NCT03799003
NCT03799003https://www.clinicaltrials.gov/study/NCT03799003?tab=tableNANANAThe primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-08-04
Start Month Year January 14, 2019
Primary Completion Month Year July 6, 2023
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-08-04

Detailed Descriptions

Sequence: 20787083
Description This is a dose-escalation and expansion study of ASP1951. The study consists of 3 periods for monotherapy and combination therapy: screening, treatment and follow up, followed by an optional Re-treatment period for participants that qualify.

The monotherapy escalation cohorts will evaluate escalating dose levels of ASP1951 in participants with locally advanced (unresectable) or metastatic solid tumor malignancies including but not limited to squamous cell carcinoma of the head and neck (SCCHN), colorectal cancer, metastatic castration-resistant prostate cancer (mCRPC) and cervical cancer.

The combination escalation cohorts will evaluate escalating dose levels of ASP1951 in combination with a fixed dose of pembrolizumab.

For dose expansion, the tumor-specific cohorts will include participants with squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC) (all PD-L1 status), NSCLC PDL1 high, and cervical cancer, as well as participants with any tumor types that respond to study drug treatment during dose escalation.

Participants may reinitiate study drug treatment in the optional Re-treatment period after confirmation that the participant meets all the re-treatment eligibility criteria.

After discontinuation of study drug, all participants will complete an end-of-treatment visit, along with 30-day and 90 day safety follow-up visits from the last dose of study drug.

Facilities

Sequence: 200650001 Sequence: 200650002 Sequence: 200650003 Sequence: 200650004 Sequence: 200650005 Sequence: 200650006 Sequence: 200650007 Sequence: 200650008 Sequence: 200650009 Sequence: 200650010 Sequence: 200650011 Sequence: 200650012 Sequence: 200650013 Sequence: 200650014 Sequence: 200650015 Sequence: 200650016 Sequence: 200650017 Sequence: 200650018 Sequence: 200650019 Sequence: 200650020 Sequence: 200650021 Sequence: 200650022 Sequence: 200650023 Sequence: 200650024 Sequence: 200650025 Sequence: 200650026 Sequence: 200650027 Sequence: 200650028 Sequence: 200650029 Sequence: 200650030 Sequence: 200650031 Sequence: 200650032
Name Arizona Clinical Research Cent Name University of California Name University of Florida, Davis C Name Emory University Name Augusta University Name Northwestern University Name Rush University Medical Center Name University of Iowa Hospitals Name Henry Ford Health System Name Nebraska Cancer Specialists Name Comprehensive Cancer Nevada Name Rutgers Cancer Institute Name Icahn school of Medicine at Mount Sinai Name Columbia University Medical Center Name Duke University Medical Center Name Hollings Cancer Center Name South Texas Accelerated Research Therapeutics, LLC Name Huntsman Cancer Institute Name Virginia Cancer Specialists Name Multicare Regional Cancer Center Tacoma Name Site CA15002 Name Site CA15005 Name Site CA15004 Name Site KR82002 Name Site KR82005 Name Site KR82001 Name Site KR82003 Name Site KR82004 Name Site KR82006 Name Site KR82007 Name Site TW88603 Name Site TW88604
City Tucson City Sacramento City Gainesville City Atlanta City Augusta City Chicago City Chicago City Iowa City City Detroit City Omaha City Las Vegas City New Brunswick City New York City New York City Durham City Charleston City San Antonio City Salt Lake City City Fairfax City Tacoma City Montreal City Montreal City Ontario City Chungcheongbukdo City Daegu City Gyeonggi-do City Seoul City Seoul City Seoul City Seoul City Taichung City Taipei
State Arizona State California State Florida State Georgia State Georgia State Illinois State Illinois State Iowa State Michigan State Nebraska State Nevada State New Jersey State New York State New York State North Carolina State South Carolina State Texas State Utah State Virginia State Washington
Zip 85715 Zip 95817 Zip 326102 Zip 30322 Zip 30912 Zip 60611 Zip 60612 Zip 52242 Zip 48202 Zip 68130 Zip 89169 Zip 08903 Zip 10029 Zip 10032 Zip 27705 Zip 29425 Zip 78229 Zip 84112 Zip 22031 Zip 98405
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country Canada Country Canada Country Canada Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Taiwan Country Taiwan

Browse Interventions

Sequence: 96313809 Sequence: 96313810 Sequence: 96313811 Sequence: 96313812 Sequence: 96313813
Mesh Term Pembrolizumab Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents Mesh Term Immune Checkpoint Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term pembrolizumab Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents Downcase Mesh Term immune checkpoint inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52338617
Name Advanced Solid Tumors
Downcase Name advanced solid tumors

Id Information

Sequence: 40278245 Sequence: 40278246 Sequence: 40278247
Id Source org_study_id Id Source secondary_id Id Source secondary_id
Id Value 1951-CL-0101 Id Value 2019-002287-27 Id Value KEYNOTE KN-B02
Id Type EudraCT Number Id Type Other Identifier
Id Type Description Merck

Countries

Sequence: 42698485 Sequence: 42698486 Sequence: 42698487 Sequence: 42698488
Name United States Name Canada Name Korea, Republic of Name Taiwan
Removed False Removed False Removed False Removed False

Design Groups

Sequence: 55779600 Sequence: 55779601 Sequence: 55779602 Sequence: 55779603 Sequence: 55779604 Sequence: 55779605
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title ASP1951 Monotherapy Escalation Title ASP1951 Monotherapy Expansion Title ASP1951 Optional Monotherapy Retreatment Period Title ASP1951 plus pembrolizumab Combination Escalation Title ASP1951 plus pembrolizumab Combination Expansion Title ASP1951 plus pembrolizumab Optional Retreatment Period
Description The monotherapy escalation cohort will evaluate escalating dose levels of ASP1951.Dose escalation to the next level will be made based on the Bayesian Continual Reassessment Method (CRM). Description If a confirmed response (partial Response (PR) or complete response (CR)) occurs in a monotherapy or combination escalation cohort, a tumor-specific expansion cohort may be opened in that tumor type, at the dose level in which the confirmed response was observed and at all subsequent dose levels once each dose level has been deemed tolerable. Description Participants may reinitiate study drug treatment after confirmation that the participant meets all the re-treatment eligibility criteria. Description The combination escalation cohort will evaluate escalating dose levels of ASP1951 in combination with a fixed dose of pembrolizumab. Dose escalation to the next level will be made based on the Bayesian Continual Reassessment Method (CRM). Description If a confirmed response (partial Response (PR) or complete response (CR)) occurs in the combination escalation cohort, a tumor-specific expansion cohort may be opened in that tumor type, at the dose level in which the confirmed response was observed and at all subsequent dose levels once each dose level has been deemed tolerable. Once the high dose RP2D and schedule of ASP1951 in combination with pembrolizumab has been determined, expansion cohorts may be opened to enroll participants with NSCLC (all PD-L1 status), NSCLC PD-L1 high, SCCHN and cervical cancer (if any of these tumor specific expansion cohorts are not already opened). Also, low dose cohorts of ASP1951 in combination will be opened in NSCLC (all PD-L1 status), SCCHN and cervical cancer for further evaluation of response and safety and establishing a possible low dose RP2D based on clinical and biomarker activity. Description Participants may reinitiate study drug treatment after confirmation that the participant meets all the re-treatment eligibility criteria.

Interventions

Sequence: 52649263 Sequence: 52649264
Intervention Type Drug Intervention Type Drug
Name ASP1951 Name pembrolizumab
Description Intravenously (IV) Description Intravenously (IV)

Keywords

Sequence: 80099535 Sequence: 80099536 Sequence: 80099537 Sequence: 80099538 Sequence: 80099539 Sequence: 80099540 Sequence: 80099541 Sequence: 80099542 Sequence: 80099543 Sequence: 80099544 Sequence: 80099545
Name ASP1951 Name cervical cancer Name Oncology Name squamous cell carcinoma of the head and neck (SCCHN) Name metastatic castration-resistant prostate cancer (mCRPC) Name melanoma Name Tumors Name pembrolizumab Name colorectal cancer Name Advanced (unresectable) or metastatic solid tumor malignancies Name Advanced solid tumors
Downcase Name asp1951 Downcase Name cervical cancer Downcase Name oncology Downcase Name squamous cell carcinoma of the head and neck (scchn) Downcase Name metastatic castration-resistant prostate cancer (mcrpc) Downcase Name melanoma Downcase Name tumors Downcase Name pembrolizumab Downcase Name colorectal cancer Downcase Name advanced (unresectable) or metastatic solid tumor malignancies Downcase Name advanced solid tumors

Design Outcomes

Sequence: 177997504 Sequence: 177997486 Sequence: 177997487 Sequence: 177997488 Sequence: 177997489 Sequence: 177997505 Sequence: 177997490 Sequence: 177997491 Sequence: 177997492 Sequence: 177997493 Sequence: 177997494 Sequence: 177997495 Sequence: 177997496 Sequence: 177997497 Sequence: 177997498 Sequence: 177997499 Sequence: 177997500 Sequence: 177997501 Sequence: 177997502 Sequence: 177997503 Sequence: 177997506 Sequence: 177997507 Sequence: 177997508 Sequence: 177997509 Sequence: 177997510 Sequence: 177997511 Sequence: 177997512 Sequence: 177997513 Sequence: 177997514 Sequence: 177997515 Sequence: 177997516 Sequence: 177997517 Sequence: 177997518 Sequence: 177997519 Sequence: 177997520 Sequence: 177997521 Sequence: 177997522 Sequence: 177997523
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Pharmacokinetics (PK) of ASP1951 in serum: tlast Measure Safety and tolerability assessed by Dose Limiting Toxicity (DLT) Measure Safety and tolerability assessed by adverse events (AEs) Measure Safety and tolerability assessed by immune-related AEs (irAEs) Measure Safety and tolerability assessed by infusion-related reactions (IRRs) Measure Pharmacokinetics (PK) of ASP1951 in serum: CL Measure Safety and tolerability assessed by serious adverse events (SAEs) Measure Number of participants with laboratory value abnormalities and/or adverse events related to treatment Measure Safety and tolerability assessed by 12- lead electrocardiogram (ECG) Measure Number of participants with vital signs abnormalities and/or adverse events related to treatment Measure Number of participants with Physical Exam abnormalities and/or adverse events related to treatment Measure Safety and tolerability assessed by ECOG performance status Measure Pharmacokinetics (PK) of ASP1951 in serum: AUClast Measure Pharmacokinetics (PK) of ASP1951 in serum: AUCinf Measure Pharmacokinetics (PK) of ASP1951 in serum: AUCinf%extrap Measure Pharmacokinetics (PK) of ASP1951 in serum: AUCtau Measure Pharmacokinetics (PK) of ASP1951 in serum: Cmax Measure Pharmacokinetics (PK) of ASP1951 in serum: Ctrough Measure Pharmacokinetics (PK) of ASP1951 in serum: tmax Measure Pharmacokinetics (PK) of ASP1951 in serum: t 1/2 Measure Pharmacokinetics (PK) of ASP1951 in serum: Vz Measure Pharmacokinetics (PK) of ASP1951 in serum: Vss Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUClast Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf%extrap Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCtau Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Cmax Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Ctrough Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tmax Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: t 1/2 Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tlast Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: CL Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vz Measure Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vss Measure Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 and modified RECIST 1.1 for immune-based therapeutics (iRECIST) Measure Duration of Response (DOR) per RECIST V1.1 and iRECIST Measure Persistence of response after discontinuation per RECIST V1.1 and iRECIST Measure Disease Control Rate (DCR) per RECIST V1.1 and iRECIST
Time Frame Up to 10 weeks Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 10 weeks Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 48 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 48 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 10 weeks Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years
Description Initial monotherapy escalation treatment only. Time of last measurable concentration (tlast) will be recorded from the pharmacokinetic (PK) serum samples collected. Description A DLT is defined as any of the prespecified Adverse Events (AEs) (graded using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03) that the investigator (or sponsor) cannot clearly attribute to a cause other than study drug. Description Initial and retreatment. An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AEs will be coded using the medical dictionary for regulatory activities (MedDRA) and graded using NCI-CTCAE 4.03. Description Initial and retreatment. Most frequent immune-related AEs include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies (hypophysitis, hypothyroidism, hyperthyroidism, adrenal insufficiency and Type 1 diabetes mellitus). In the event a participant is diagnosed with an irAE, then it should be reported as an AE. Description Initial and retreatment. IRRs are considered AEs of special interest. In the event a participant is diagnosed with an IRR, then it should be reported as an AE. Description Initial monotherapy escalation treatment only. Total clearance after intravenous dosing (CL) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial and retreatment. An AE is considered "serious" if it results in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE). Hospitalization for treatment/observation/examination caused by AE is to be considered as serious; and other medically important events. Description Initial and retreatment. Number of participants with potentially clinically significant laboratory values. Description Initial and retreatment. ECGs should be obtained after the participant has rested in supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes. Any clinically significant adverse changes on the ECG will be reported as AEs. Description Initial and retreatment. Number of participants with potentially clinically significant vital sign values. Description Initial and retreatment. Number of participants with potentially clinically significant physical exam values. Description Initial and retreatment. The Eastern Cooperative Oncology Group (ECOG) scale will be used to assess performance status. Grades range from 0 (fully active) to 4 (completely disabled). Negative change scores indicate an improvement. Positive scores indicate a decline in performance. Description Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf %extrap) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing to the start of next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation and retreatment. Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Volume of distribution after intravenous dosing during the terminal elimination phase (Vz) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial monotherapy escalation treatment only. Volume of distribution at steady state after intravenous dosing (Vss) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf %extrap) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing to the start of next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation and retreatment. Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Time of last measurable concentration (tlast) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Total clearance after intravenous dosing (CL) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Volume of distribution after intravenous dosing during the terminal elimination phase (Vz) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial combination escalation treatment only. Volume of distribution at steady state after intravenous dosing (Vss) will be recorded from the pharmacokinetic (PK) serum samples collected. Description Initial and retreatment. ORR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed complete response (CR) or partial response (PR). Description Initial and retreatment. DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression/death or date of censoring. Description Initial and retreatment. Persistence of response is defined as the time from the date of treatment discontinuation to the date of radiographical progression or date of censoring. Description Initial and retreatment. DCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR, PR or stable disease (SD).

Browse Conditions

Sequence: 194123954
Mesh Term Neoplasms
Downcase Mesh Term neoplasms
Mesh Type mesh-list

Sponsors

Sequence: 48475873 Sequence: 48475874
Agency Class INDUSTRY Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Astellas Pharma Global Development, Inc. Name Merck Sharp & Dohme LLC

Overall Officials

Sequence: 29374185
Role Study Director
Name Medical Monitor
Affiliation Astellas Pharma Global Development, Inc.

Design Group Interventions

Sequence: 68376194 Sequence: 68376195 Sequence: 68376196 Sequence: 68376197 Sequence: 68376198 Sequence: 68376199 Sequence: 68376200 Sequence: 68376201 Sequence: 68376202
Design Group Id 55779600 Design Group Id 55779601 Design Group Id 55779602 Design Group Id 55779603 Design Group Id 55779604 Design Group Id 55779605 Design Group Id 55779603 Design Group Id 55779604 Design Group Id 55779605
Intervention Id 52649263 Intervention Id 52649263 Intervention Id 52649263 Intervention Id 52649263 Intervention Id 52649263 Intervention Id 52649263 Intervention Id 52649264 Intervention Id 52649264 Intervention Id 52649264

Eligibilities

Sequence: 30862288
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy as well as the following:

Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit the subject's specific tumor type. OR
Subject in an expansion cohort has received at least 1 standard therapy for the subject's specific tumor type.

[Taiwan only]: Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit in the opinion of the treating investigator for his/her specific tumor type. Note: Subjects in the combination expansion cohort with tumor types that pembrolizumab is not approved for can only enroll if their standard treatment is ineffective, unsuitable per investigator's judgment or if the subject is unwilling to receive the standard therapy.

Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5-half-lives, whichever is shorter, prior to initiation of study drug administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor therapy until 4 days prior to the start of study drug administration.
Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to study drug administration. Subjects must have recovered from all radiation related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to noncentral nervous system [CNS] disease.
Subject's AEs (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 2 weeks prior to start of study treatment.

Subject with metastatic castration-resistant prostate cancer (mCRPC) (positive bone scan and/or soft tissue disease documented by computed tomography [CT]/magnetic resonance imaging [MRI]) meets both of the following:

Subject has serum testosterone ≤ 50 ng/dL at Screening.
Subject has had a bilateral orchiectomy or plans to continue androgen deprivation therapy (ADT) for the duration of study treatment.
Subject has adequate organ function prior to start of study treatment. If a subject has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion. Subjects can be on stable dose of erythropoietin (≥ approximately 3 months).

A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:

Not a woman of childbearing potential (WOCBP); OR
WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
Female subject must agree not to breastfeed starting at Screening and throughout the study treatment, and for 6 months after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study treatment, and for 6 months after the final study drug administration.
A male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
Subject agrees not to participate in another interventional study while receiving study drug (Subjects who are currently in the follow-up period of an interventional clinical trial are allowed).

Additional Inclusion Criteria for Subjects in the Expansion Cohorts:

Subject has at least 1 measureable lesion per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Subjects with mC RPC who do not have measurable lesions must have at least 1 of the following:

Progression with 2 or more new bone lesions; or
Prostate-specific antigen (PSA) progression (defined as a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination) within 6 weeks prior to study drug administration and a PSA value at the screening visit ≥ 2 ng/mL.
Subject consents to provide available tumor specimen in a tissue block or unstained serial slides obtained within 56 days prior to first dose of study treatment. Note: This does not apply to subjects with mCRPC who do not have measurable disease.
Subject is an appropriate candidate for tumor biopsy and consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period as indicated in the Schedule of Assessments. Note: This does not apply to subjects with mCRPC who do not have measurable disease.

Subject meets one of the following:

Subject has the tumor type for which a confirmed response was observed in a monotherapy or combination therapy cohort; or
Subject has SCCHN and a combination therapy expansion cohort is opened due to achieving the predicted efficacious exposure or
High dose RP2D combination therapy expansion cohorts are opened and subject has NSCLC (all PD-L1 status), NSCLC PD-L1 high*, SCCHN, or cervical cancer; or

Low dose RP2D combination therapy expansion cohorts are opened and subject has NSCLC (all PD-L1 status), SCCHN and cervical cancer.

NSCLC with PD-L1 high expressing tumor (tumor proportion score ≥ 50%) as determined by 22C3 PD-L1 immunohistochemistry assay at a local/central laboratory during the screening period. Note: Local 22C3 PD-L1 IHC assay results available within 60 days prior study drug administration may be used for evaluating this entry criterion.

Additional Inclusion Criteria for Re-treatment:

Subject stopped initial treatment with ASP1951 or ASP1951 in combination with pembrolizumab after attaining a confirmed CR, PR or SD.
Subject experienced an investigator-determined iCPD after stopping their initial treatment with ASP1951 or ASP1951 in combination with pembrolizumab.
Subject did not receive any prohibited anti-cancer treatment since the last dose of ASP1951 or ASP1951 in combination with pembrolizumab.
Subject did not experience a toxicity that met treatment discontinuation criteria during the initial treatment with ASP1951 or ASP1951 in combination with pembrolizumab or pembrolizumab alone.

Exclusion Criteria:

Subject weighs < 45 kg.
Subject has received investigational therapy (other than an investigational EGFR TKI in a subject with EGFR activating mutations or ALK inhibitor in a subject with an ALK mutation) within 21 days or 5-half-lives, whichever is shorter, prior to start of study drug.
Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone) are allowed.
Subject has symptomatic CNS metastases or subject has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Subjects with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone, > 2 mg per day of dexamethasone, or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
Subject has leptomeningeal disease as a manifestation of the current malignancy.
Subject has an active autoimmune disease that has required systemic treatment in the past 2 years. Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, and skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.
Subject was discontinued from prior immunomodulatory therapy due to a grade ≥ 3 toxicity that was mechanistically related (e.g., immune related) to the agent.
Subject has known history of serious hypersensitivity reaction (≥ grade 3) to a known ingredient of ASP1951 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.
Subject with positive Hepatitis B virus (HBV) antibodies and surface antigen (indicating acute HBV or chronic HBV) or Hepatitis C ([HCV]; ribonucleic acid [RNA] detected by qualitative or quantitative assay). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody testing. HBV antibodies are not required in subjects with negative HBV surface antigen.
Subject has received a live vaccine against infectious diseases within 4 weeks prior to initiation of study treatment.
Subject has a history of drug-induced pneumonitis (interstitial lung disease), a history of (non-infectious) pneumonitis that required steroids, radiation pneumonitis or currently has pneumonitis.
Subject has an infection requiring systemic therapy within 2 weeks prior to study drug administration.
Subject has received a prior allogeneic bone marrow or solid organ transplant.
Subject is expected to require another form of antineoplastic therapy while on study treatment.
Subject has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Subject has received prior treatment with an anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) antibody.
Subject has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.
Subject has any condition which makes the subject unsuitable for study participation.
Subject has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
Subject has known history of coronavirus disease 2019 (COVID-19) positive polymerase chain reaction (PCR) test within 4 weeks prior to start of study treatment.

Additional Exclusion Criterion for Subjects in Expansion Cohorts:

Subject has a prior malignancy, other than the current malignancy for which the subject is seeking treatment, active (i.e., requiring treatment of intervention) within the previous 2 years except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.

Additional Exclusion Criteria for Re-treatment:

Subjects who have completed 45 weeks in monotherapy or 57 weeks in combination therapy follow-up with disease control are not eligible for re-treatment.
Subject currently has an ongoing AE related to ASP1951 or ASP1951 in combination with pembrolizumab that meets the criteria for treatment interruption or discontinuation.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253920823
Number Of Facilities 32
Registered In Calendar Year 2019
Actual Duration 54
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 34
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30608114
Allocation Non-Randomized
Intervention Model Sequential Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28974648
Responsible Party Type Sponsor

Ipd Information Types

Sequence: 3347577 Sequence: 3347578 Sequence: 3347579
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Clinical Study Report (CSR)

]]>

<![CDATA[ Reduce Speed Limits From 90km/h to 80 km/h on French Roads: Impact on Mortality ]]>
https://zephyrnet.com/NCT03798990
2015-01-31

https://zephyrnet.com/?p=NCT03798990
NCT03798990https://www.clinicaltrials.gov/study/NCT03798990?tab=tableDavid Chupindavid.chupin@cerema.fr33 4 72 14 31 52On the first July 2018, the French government lowered the maximum authorized speeds on two-way roads without a central separator from 90 km/h to 80 km/h. The network concerned represents approximately 400 000 km of roads outside the built-up area, accounting for 55% of road deaths.

The objective of the measure is to reduce the number of deaths on the roads concerned by encouraging the reduction of the average speed practiced by drivers.

The analysis deals with a comparison of the number of killed persons on the network concerned, before and after the reduction of the speed limits. The “before” period is 2015-2017. The “after” period is from July 2018 to June 2019.

The data used are extracted from the national bodily injury accident file (BAAC). The police fills this file for each road accidents occurring on a road open to public traffic and causing at least one victim (i.e., one user requiring medical care and involving at least one vehicle).
<![CDATA[

Studies

Study First Submitted Date 2018-12-21
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year January 2015
Primary Completion Month Year July 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20721631
Description This measure was intended general and concerns a type of roads in its entirety. The rest of the road network is too heterogeneous (urban, highways …), leading to an accidentology very far in terms of severity, users concerned and families of accidents to allow the establishment of control groups that would not be affected by a reduction in the speed limit. As a result, the principle of an assessment of "before-and-after" effects has been retained.

Facilities

Sequence: 200108119
Status Recruiting
Name Cerema
City Lyon
Country France

Facility Contacts

Sequence: 28106416
Facility Id 200108119
Contact Type primary
Name David Chupin

Conditions

Sequence: 52171231 Sequence: 52171232
Name Health Risks Name Death
Downcase Name health risks Downcase Name death

Id Information

Sequence: 40158628
Id Source org_study_id
Id Value 2018-12

Countries

Sequence: 42568939
Name France
Removed False

Design Groups

Sequence: 55593166
Title users of French roads
Description all road users circulating on French roads outside over-seas

Keywords

Sequence: 79868533 Sequence: 79868534
Name Speed Name Road safety
Downcase Name speed Downcase Name road safety

Design Outcomes

Sequence: 177378844 Sequence: 177378845
Outcome Type primary Outcome Type secondary
Measure Evolution of the number of fatalities in road accidents before and after the implementation of the measure Measure Sub-groups analysis of road fatalities, by type of road users, before and after the implementation of the measure
Time Frame before period: 2015-2017 / after period: July 2018- June 2019 Time Frame before period: 2015-2017 / after period: July 2018- June 2019
Description the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 ("after" the measure) compared to the number of fatalities during the period 2015-2017 ("before" the measure) Description For each type of road users, the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 ("after" the measure) compared to the number of fatalities during the period 2015-2017 ("before" the measure)

Sponsors

Sequence: 48319288
Agency Class OTHER
Lead Or Collaborator lead
Name Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement

Overall Officials

Sequence: 29285347
Role Study Director
Name Marine Millot, PhD
Affiliation Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement

Central Contacts

Sequence: 12008877
Contact Type primary
Name David Chupin
Phone 33 4 72 14 31 52
Email david.chupin@cerema.fr
Role Contact

Eligibilities

Sequence: 30765347
Sampling Method Non-Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Population All the population who circulate on French non-motorway non-urban roads during the period of the study may be potentially concerned
Criteria Inclusion Criteria:

people who circulate on French non-motorway non-urban roads during the period of the study
any person who dies in a road accident on this network during the period of the study, who either dies instantly or within 30 days of the accident, due to the consequences of the accident

Exclusion Criteria:

all persons involved in an accident on a private road
all persons involved in a road accident without a motor vehicle

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253883417
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30511514
Observational Model Ecologic or Community
Time Perspective Other

Responsible Parties

Sequence: 28877808
Responsible Party Type Sponsor

]]>

<![CDATA[ Preclinical Validation of New Anti-melanoma Compounds ]]>
https://zephyrnet.com/NCT03798977
2018-02-01

https://zephyrnet.com/?p=NCT03798977
NCT03798977https://www.clinicaltrials.gov/study/NCT03798977?tab=tableHenri MONTAUDIE, Drmontaudie.h@chu-nice.fr492036083This research program is in keeping with the chemistry/biology/clinical interface and gathers 4 teams with complementary expertise in these respective fields. It will allow deciphering the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will use melanoma cell lines and primary cells from patients to validate these compounds in collaboration with clinical team 2 and 4. In conclusion, the investigators expect to establish the proof of concept that this new class of bioactive molecules (first in class) we developed in collaboration with Team 3 have the potential to go to the clinic for the treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of restoring the sensitivity of these melanoma cells.
<![CDATA[

Studies

Study First Submitted Date 2018-12-27
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year February 1, 2018
Primary Completion Month Year December 2019
Verification Month Year December 2018
Verification Date 2018-12-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200280524
Status Recruiting
Name Nice hospital
City Nice
Zip 06000
Country France

Facility Contacts

Sequence: 28132850
Facility Id 200280524
Contact Type primary
Name Thierry Passeron, Pr
Email passeron.t@chu-nice.fr
Phone 492036488
Phone Extension 33

Conditions

Sequence: 52221464
Name Melanoma
Downcase Name melanoma

Id Information

Sequence: 40195586
Id Source org_study_id
Id Value 17-PRTK-01

Countries

Sequence: 42609621
Name France
Removed False

Keywords

Sequence: 79941662 Sequence: 79941663 Sequence: 79941664 Sequence: 79941665
Name Skin metastasis Name Resistance Name Endoplasmic reticulum stress Name Metastasis
Downcase Name skin metastasis Downcase Name resistance Downcase Name endoplasmic reticulum stress Downcase Name metastasis

Design Outcomes

Sequence: 177561265
Outcome Type primary
Measure BRAF mutation
Time Frame 24 months
Description The status of the BRAF mutation will be expressed through laboratory analysis of the samples collected, i.e. positive or negative.

Browse Conditions

Sequence: 193678217 Sequence: 193678218 Sequence: 193678219 Sequence: 193678220 Sequence: 193678221 Sequence: 193678222 Sequence: 193678223 Sequence: 193678224
Mesh Term Melanoma Mesh Term Neuroendocrine Tumors Mesh Term Neuroectodermal Tumors Mesh Term Neoplasms, Germ Cell and Embryonal Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Neoplasms, Nerve Tissue Mesh Term Nevi and Melanomas
Downcase Mesh Term melanoma Downcase Mesh Term neuroendocrine tumors Downcase Mesh Term neuroectodermal tumors Downcase Mesh Term neoplasms, germ cell and embryonal Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, nerve tissue Downcase Mesh Term nevi and melanomas
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366367
Agency Class OTHER
Lead Or Collaborator lead
Name Centre Hospitalier Universitaire de Nice

Central Contacts

Sequence: 12020576 Sequence: 12020577
Contact Type primary Contact Type backup
Name Thierry PASSERON, Pr Name Henri MONTAUDIE, Dr
Phone 492036488 Phone 492036083
Email passeron.t@chu-nice.fr Email montaudie.h@chu-nice.fr
Phone Extension +33 Phone Extension +33
Role Contact Role Contact

Eligibilities

Sequence: 30794672
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population Patient with metastatic melanoma
Criteria Inclusion Criteria:

Patient with metastatic melanoma
Not opposition of the patient will have been looked for

Exclusion Criteria:

Primary resistance,
Absence of resistance,
Patient already included in other trials

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004259
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30540712
Observational Model Other
Time Perspective Cross-Sectional

Responsible Parties

Sequence: 28907032
Responsible Party Type Sponsor

]]>

<![CDATA[ The Expression Heparanase in Term and Preterm Placentas ]]>
https://zephyrnet.com/NCT03798964
2019-01-23

https://zephyrnet.com/?p=NCT03798964
NCT03798964https://www.clinicaltrials.gov/study/NCT03798964?tab=tableNANANAHeparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).

This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) .

The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-06-28
Start Month Year January 23, 2019
Primary Completion Month Year November 24, 2020
Verification Month Year June 2022
Verification Date 2022-06-30
Last Update Posted Date 2022-06-28

Facilities

Sequence: 199635900
Name Hille Yaffe Medical Center
City Hadera
Zip 38100
Country Israel

Conditions

Sequence: 52068890
Name Preterm Birth
Downcase Name preterm birth

Id Information

Sequence: 40077199
Id Source org_study_id
Id Value HYMC-0119-18

Countries

Sequence: 42475381
Name Israel
Removed False

Design Groups

Sequence: 55480736 Sequence: 55480737 Sequence: 55480738
Title Elective term cesarean Title Term vaginal delivery Title Preterm vaginal delivery
Description Low-risk women undergoing elective term cesarean section Description Low-risk women undergoing term vaginal delivery Description Women undergoing preterm vaginal delivery

Interventions

Sequence: 52381274
Intervention Type Other
Name Placental analysis
Description Analysis of placenta to determine expression of heparanase

Design Outcomes

Sequence: 177027080
Outcome Type primary
Measure Heparanase expression
Time Frame Six months
Description Heparanase expression in the human placenta following delivery will be evaluated by western blot analysis in the three groups and will be compared to determine differences in the levels.

Browse Conditions

Sequence: 193078196 Sequence: 193078197 Sequence: 193078198 Sequence: 193078199 Sequence: 193078200 Sequence: 193078201
Mesh Term Premature Birth Mesh Term Obstetric Labor, Premature Mesh Term Obstetric Labor Complications Mesh Term Pregnancy Complications Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases
Downcase Mesh Term premature birth Downcase Mesh Term obstetric labor, premature Downcase Mesh Term obstetric labor complications Downcase Mesh Term pregnancy complications Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48224000
Agency Class OTHER_GOV
Lead Or Collaborator lead
Name Hillel Yaffe Medical Center

Overall Officials

Sequence: 29225271
Role Principal Investigator
Name Rinat Gabbay-Benziv, MD
Affiliation Hillel Yaffe Medical Center

Design Group Interventions

Sequence: 68012521 Sequence: 68012522 Sequence: 68012523
Design Group Id 55480736 Design Group Id 55480738 Design Group Id 55480737
Intervention Id 52381274 Intervention Id 52381274 Intervention Id 52381274

Eligibilities

Sequence: 30705493
Sampling Method Non-Probability Sample
Gender Female
Minimum Age 18 Years
Maximum Age 40 Years
Healthy Volunteers No
Population Pregnant women attending our obstetrical unit
Criteria Inclusion Criteria:

Singleton pregnancy

Exclusion Criteria:

High-risk patients
Multiple pregnancy
Significant maternal illness
Significant fetal anomaly

Gender Based True
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253924934
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 22
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 40
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30452105
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28818583
Responsible Party Type Sponsor

]]>

<![CDATA[ Prehabilitation in Esophageal Surgery (PRESS) ]]>
https://zephyrnet.com/NCT03798951
2019-06-05

https://zephyrnet.com/?p=NCT03798951
NCT03798951https://www.clinicaltrials.gov/study/NCT03798951?tab=tableStefano Turi, MDturi.stefano@hsr.it+39022643Despite important clinical improvements, esophageal cancer surgery is still associated to a high rate of postoperative complications. Recent ERAS (Enhanced Recovery After Surgery) Society guidelines underline the possible role of prehabilitations’ programs in reducing postoperative morbidity. In this trial, 200 patients, scheduled for esophageal cancer resection, will be randomly assigned to two groups (100 patients for each group). In both groups, patients will perform a basal evaluation with a physiotherapist, a nutritionist and a psychologist. In the treatment group, each patient will receive a tailored prehabilitative program and, during the 4 weeks before surgery, will be monitored constantly by each single specialist. A preoperative revaluation (the day before surgery) and follow up visits at 3 and 6 months will be performed for all patients. The incidence of postoperative complications, the length of hospital stay, and the reach of discharge criteria will be registered.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-12-27
Start Month Year June 5, 2019
Primary Completion Month Year January 2025
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-27

Detailed Descriptions

Sequence: 20738804
Description Multi-modal prehabilitation programs reported positive results in patients undergoing colonic resection. These protocols are, generally, based on physiotherapist, nutritional and psychological implementation programs. Nevertheless, the conflicting results obtained in previous trials demonstrate how many elements have still to be clarified and that, probably, the pre-habilitation interventions must be tailored, as much as possible, on the peculiar characteristics of each single patient, modifying the approach as a function of the clinical specific response. All these considerations suggest a strong basis for tailored interventions in patients undergoing esophageal surgery, highlighting at the same time, as concluded in a recent review, the need of further studies to better define specific peri-operative strategies. This study will be a randomized, not blind, monocentric trial, that will be conducted at Ospedale San Raffaele, Milano, Italia, between January 2018 and January 2021 (three years). 200 patients will be randomly assigned to two different groups. All the patients, included in the study, will receive a preliminary evaluation performed by different professional figures.

Physiotherapist evaluation:

All the patients of both groups will be classified according to specific tests in order to establish their basal condition. Spirometry examination, 6-minute walking test, time up and go test, steep ramp test

strength tests (target muscles will be the quadriceps and the handgrip muscles:

in both cases a specific dynamometer will be utilized) and Modified Iowa Level

of Assistance Scale (MILAS) evaluation will be performed.

The experimental group will follow a home-based prehabilitation program for four weeks; this will be tailored on the patient on the bases of the first functional evaluation and the identified needs. On day 1 the patients will attend a hospital session and will be instructed by a physiotherapist on exercises and program to follow. The patients will then receive instruction support in order to better follow and adjust the program at home. Patients will also record what they do on a diary.

The physiotherapist will make phone calls in order to supervise patients' adherence to the program and help them in adjusting it.

Prehabilitation program will comprise aerobic exercise (cyclette or treadmill, 3 times a week) and IMT (inspiration muscle training, IMT respironics Philips, daily). In adjunction to these ones, further exercises will be prescribed on the bases of the functional assessment and the identification of deficits in any functional capacity assessed and will include two of the following: airway clearance (two sessions 10' a day for 7 days a week), skeletal muscles strengthening (3 days a week), stretching (three times a week), transfer and mobility training.

The control group will follow the actual procedure usually administered prior to surgery: this comprises inspiration exercises through a spirometer incentive without any monitoring and some recommendations aimed at staying active during the preoperative period.

Nutritional evaluation:

All patients will undergo a comprehensive nutritional assessment at baseline, 4 weeks prior to surgery, the day before or the day of surgery and 3 and 6 months after surgery. At baseline, a complete medical and nutrition history will be collected, and physical examination will be performed. Anthropometric parameters including body weight (kg) and height (cm), waist and hip circumference will be measured, and body mass index (kg/m2) calculated. The Malnutrition Universal Screening Tool (MUST) will be used to screen patients for nutrition risk. Standard biochemical markers of malnutrition and inflammation, including albumin, prealbumin, retinol-binding protein, total lymphocyte count, transferrin and C-reactive protein will be measured in all patients. The Prognostic Nutritional Index (PNI) will also be calculated using serum albumin concentration and total lymphocyte count. Single frequency-bio-impedance analysis (SF-BIA) will be used to estimate total body water (TBW), fat free mass (FFM) and BIA-derived phase angle. Basal energy expenditure (BEE) will be estimated using the Harris-Benedict equation. Energy and protein needs (ranging from 1 to 1.5 g/kg/day) will be established according to age, BEE, disease and degree of protein depletion. At baseline, all patients will receive nutrition counselling to help manage symptoms and encourage the intake of energy-enriched foods and fluids that are better tolerated, as per the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on nutrition in cancer patients. Patients in the treatment group will be provided with a dietary plan based on their energy and protein needs. Patients will be monitored by a follow-up phone call at two weeks after the baseline visit. Furthermore, patients in the treatment group will receive an immune-enhancing formula (7.6% protein, 18.9% carbohydrate, 3.9% fat) enriched with arginine, RNA, ω3 fatty acids and soluble fibre (partially hydrolysed guar gum, PHGG) 5 days before surgery (237 ml TID). Patients in the control group will receive nutritional counselling at baseline and will be managed according to standard protocols in use at our Institution.

Psychologist evaluation:

All the patients will perform a psychological interview and specific assessment tests to define their: quality of life (SF-36 and EORTC), specific disorders anxiety and depression Hads (Hospital anxiety and Depression Scale) and coping strategies (MAC mental Adjustment to Cancer). The assessment test will be performed at the recruitment of the patients, the day before surgery and 3 and 6 months after surgery. In the treatment group, periodical re-evaluations, trough phone calls, will be performed to support patients in their adjustment path to surgery. It will be, also, necessary to sustain them to accept possible changes and pressures deriving from prehabilitative programs. Treated patients will also receive a post-operative evaluation to define possible symptoms and adaptive reactions, developed to overcome the physiologic and metabolic modifications deriving from surgery.

The intra and post-operative treatment will be developed according to the same principles of ERAS in both groups. The authors will record all post-operative complications; the length of hospital stays and the reach of the criteria for the discharge (free solid intake, adequate pain control with oral analgesics, autonomous mobilization, restarting of bowel function and no evidence of possible post-surgical complications). Postoperative complications will be defined and registered according Calvien- Dindo classification criteria. The primary outcome of our study will be the reduction of post-operative complications, from 70% to 50%. Secondary outcomes will be a reduction in the length of hospital stay and a faster return to the pre-operative physical conditions, through a comparison with the basal evaluation, in the treatment group. Patients will be evaluated the day before surgery, during hospital stay and trough a follow-up visit at 3 and 6 months after surgery.

Facilities

Sequence: 200263386
Status Recruiting
Name IRCCS San Raffaele Scientific Institute
City Milan
State MI
Zip 20132
Country Italy

Facility Contacts

Sequence: 28130569
Facility Id 200263386
Contact Type primary
Name Giovanni Landoni
Email landoni.giovanni@hsr.it

Facility Investigators

Sequence: 18345055 Sequence: 18345056
Facility Id 200263386 Facility Id 200263386
Role Sub-Investigator Role Principal Investigator
Name Stefano Turi, MD Name Riccardo Rosati, Prof

Conditions

Sequence: 52215749
Name Esophageal Cancer Surgery
Downcase Name esophageal cancer surgery

Id Information

Sequence: 40191425
Id Source org_study_id
Id Value PRESS 152/INT/2018

Countries

Sequence: 42604989
Name Italy
Removed False

Design Groups

Sequence: 55643218 Sequence: 55643219
Group Type Experimental Group Type No Intervention
Title Prehabilitation program Title Control
Description The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient. The program will have a duration of, at least, 4 weeks. Description The patients included in this group will, also, receive a basal evaluation by a physiotherapist, a nutritionist and a psychologist. These patients will not receive a tailored prehabilitation program and will be revaluated the day before surgery.

Interventions

Sequence: 52529415
Intervention Type Other
Name Prehabilitation
Description The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient.

The program will have a duration of, at least, 4 weeks.

Keywords

Sequence: 79933375 Sequence: 79933376 Sequence: 79933377
Name Esophageal cancer surgery Name Prehabilitation Name Enhanced recovery after surgery
Downcase Name esophageal cancer surgery Downcase Name prehabilitation Downcase Name enhanced recovery after surgery

Design Outcomes

Sequence: 177539242
Outcome Type primary
Measure Post-operative complications
Time Frame Hospital discharge (10-15 days)
Description Reduction of incidence of post-operative complications, registered according to Clavien-Dindo's Classification criteria

Browse Conditions

Sequence: 193656271 Sequence: 193656272 Sequence: 193656273 Sequence: 193656274 Sequence: 193656275 Sequence: 193656276 Sequence: 193656277 Sequence: 193656278 Sequence: 193656279
Mesh Term Esophageal Neoplasms Mesh Term Gastrointestinal Neoplasms Mesh Term Digestive System Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Head and Neck Neoplasms Mesh Term Digestive System Diseases Mesh Term Esophageal Diseases Mesh Term Gastrointestinal Diseases
Downcase Mesh Term esophageal neoplasms Downcase Mesh Term gastrointestinal neoplasms Downcase Mesh Term digestive system neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term head and neck neoplasms Downcase Mesh Term digestive system diseases Downcase Mesh Term esophageal diseases Downcase Mesh Term gastrointestinal diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48360904 Sequence: 48360905 Sequence: 48360906 Sequence: 48360907 Sequence: 48360908
Agency Class OTHER Agency Class UNKNOWN Agency Class UNKNOWN Agency Class UNKNOWN Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Università Vita-Salute San Raffaele Name Stefano Turi Name Luigi Beretta Name Paolo Parise Name Riccardo Rosati

Central Contacts

Sequence: 12019029 Sequence: 12019030
Contact Type primary Contact Type backup
Name Riccardo Rosati, Prof Name Stefano Turi, MD
Phone +39022643 Phone +39022643
Email rosati.riccardo@hsr.it Email turi.stefano@hsr.it
Phone Extension 2270 Phone Extension 2656
Role Contact Role Contact

Design Group Interventions

Sequence: 68209212
Design Group Id 55643218
Intervention Id 52529415

Eligibilities

Sequence: 30791246
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Written informed consent;
Patients scheduled for Esophageal cancer resection with Ivor-lewis technique;
Previous CT/RT neoadjuvant treatment;
Possibility to perform a prehabilitation treatment of, at least, 4 weeks.

Exclusion Criteria:

Patient refusal
Comorbid medical, physical, and mental conditions that contraindicate exercise or oral nutrition.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253998224
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30537301
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28903608
Responsible Party Type Principal Investigator
Name Giovanni Landoni
Title MD, Asociate Professor
Affiliation Università Vita-Salute San Raffaele

Study References

Sequence: 52111321 Sequence: 52111322 Sequence: 52111323 Sequence: 52111324 Sequence: 52111325 Sequence: 52111326
Pmid 30276441 Pmid 30193337 Pmid 29754828 Pmid 15533269 Pmid 23884382 Pmid 27637832
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Low DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4. Citation Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645. Citation Minnella EM, Carli F. Prehabilitation and functional recovery for colorectal cancer patients. Eur J Surg Oncol. 2018 Jul;44(7):919-926. doi: 10.1016/j.ejso.2018.04.016. Epub 2018 Apr 30. Citation Stratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. doi: 10.1079/bjn20041258. Citation Mohri Y, Inoue Y, Tanaka K, Hiro J, Uchida K, Kusunoki M. Prognostic nutritional index predicts postoperative outcome in colorectal cancer. World J Surg. 2013 Nov;37(11):2688-92. doi: 10.1007/s00268-013-2156-9. Citation Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.

]]>

<![CDATA[ Effects of Plant-Based Diet on Peripheral Arterial Disease ]]>
https://zephyrnet.com/NCT03798938
2019-01-10

https://zephyrnet.com/?p=NCT03798938
NCT03798938https://www.clinicaltrials.gov/study/NCT03798938?tab=tableNANANACardiovascular disease (CVD), a condition predominantly caused by atherosclerosis, is the leading cause of morbidity and mortality in the investigator’s society. Peripheral arterial disease (PAD), a subset of CVD, occurs when the atherosclerosis progresses to compromise the lower extremity circulation resulting in ischemic symptoms. Although atherosclerosis has been generally regarded as a disease of developed or affluent countries, recent evidence showed a progressive rise in the prevalence of CVD in developing countries where an epidemiological shift of disease prevalence patterns from infectious illnesses to atherosclerotic disease has occurred. Management of CVD, particularly with an emphasis of disease prevention, will undoubtedly play an increasing vital role in the health care system around the world.

Endothelial dysfunction, as reflected by the impaired arterial vasodilatory capacity, represents one of the pathogenic mechanisms linking atherosclerosis and cardiovascular mortality. The ability of arteries to dilate in response to stimuli is a significant indicator of underlying vascular endothelial function and associated CVD. Factors modulating vasodilatory response include the release of vasoactive compounds such as nitric oxide (NO) from the endothelium and vascular compliance. In healthy individuals, a major mechanism responsible for vasodilation is the hyperemic-stimulated release of NO from the endothelium, resulting in vascular smooth muscle relaxation with subsequent vasodilation.

Vascular endothelial function can be assessed using a non-invasive technique to determine brachial artery reactivity whereby a high-resolution ultrasound is used to measure changes in brachial artery diameter to endogenous production of endothelium-derived NO via flow-mediated dilation (FMD). Therefore, reduced FMD has been described as a reliable indicator of vascular endothelial dysfunction as well as presence of underlying CVD risk factors and related diseases. Recent studies have similarly shown that arterial pulse-wave velocity (PWV), which is a non-invasive evaluation of arterial stiffness, is a reliable indicator of vascular function. While numerous studies have documented the benefit of dietary intervention in the reduction of CVD related sequelae, limited data is available regarding whether the beneficial effect of dietary intervention are reflected in vascular endothelial function. The present study was therefore conducted to assess the effects of plant-based diet (PBD) on vascular endothelial function as assessed by FMD and PWV in patients with peripheral arterial disease (PAD).
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year January 10, 2019
Primary Completion Month Year June 10, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20750432
Description Patients with peripheral arterial disease (PAD) will be included in the study. Inclusion criteria for PAD included an ankle brachial index (ABI) of 0.90 or less at baseline. Those with an ABI greater than 0.90 at baseline were eligible if a non-invasive vascular ultrasound demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or medical records documented prior revascularization of lower extremities.9 Additionally, subjects must be willing and able to maintain an on-line food journal using smartphone-based dietary apps. Once enrolled, all participants underwent baseline evaluation, after which they were enrolled in either dietary advice for plant-based diet (PBD group) or no specific dietary advice (control group). The dietary intervention was continued for four months, at the end of which a follow up evaluation was performed.

Facilities

Sequence: 200352057
Name University Vascular Associates
City Alhambra
State California
Zip 90212
Country United States

Conditions

Sequence: 52244448
Name Peripheral Arterial Disease
Downcase Name peripheral arterial disease

Id Information

Sequence: 40212165
Id Source org_study_id
Id Value 01012019

Countries

Sequence: 42627120
Name United States
Removed False

Interventions

Sequence: 52557927
Intervention Type Other
Name plant-based diet
Description subjects will be placed in plant-based diet and the effect of plant-based diet to the endothelial function will be monitored

Design Outcomes

Sequence: 177648664
Outcome Type primary
Measure endothelial function
Time Frame 10 minutes
Description brachial artery reactivity test, flow-mediated vasodilation

Browse Conditions

Sequence: 193766203 Sequence: 193766204 Sequence: 193766205 Sequence: 193766206 Sequence: 193766207 Sequence: 193766208 Sequence: 193766209
Mesh Term Peripheral Arterial Disease Mesh Term Peripheral Vascular Diseases Mesh Term Atherosclerosis Mesh Term Arteriosclerosis Mesh Term Arterial Occlusive Diseases Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases
Downcase Mesh Term peripheral arterial disease Downcase Mesh Term peripheral vascular diseases Downcase Mesh Term atherosclerosis Downcase Mesh Term arteriosclerosis Downcase Mesh Term arterial occlusive diseases Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48388134
Agency Class OTHER
Lead Or Collaborator lead
Name Vascular Institute of Texas

Eligibilities

Sequence: 30808196
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers Accepts Healthy Volunteers
Population peripheral arterial disease as defined by an ankle brachial index (ABI) of 0.90 or less at baseline. Those with an ABI greater than 0.90 at baseline will be eligible if a non-invasive vascular ultrasound demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or medical records documented prior revascularization of lower extremities
Criteria Inclusion Criteria:

peripheral arterial disease

Exclusion Criteria:

none

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254032387
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30554193
Observational Model Cohort
Time Perspective Cross-Sectional

Responsible Parties

Sequence: 28920556
Responsible Party Type Sponsor

]]>

<![CDATA[ mNGS for Detection of Pathogens for Pulmonary Infection ]]>
https://zephyrnet.com/NCT03798925
2018-08-19

https://zephyrnet.com/?p=NCT03798925
NCT03798925https://www.clinicaltrials.gov/study/NCT03798925?tab=tableNANANAPulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.
<![CDATA[

Studies

Study First Submitted Date 2018-12-29
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year August 19, 2018
Primary Completion Month Year February 2019
Verification Month Year December 2018
Verification Date 2018-12-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200244224
Status Recruiting
Name Sir Run Run Shaw Hospital
City Hangzhou
State Zhejiang
Zip 310016
Country China

Facility Contacts

Sequence: 28128013
Facility Id 200244224
Contact Type primary
Name Ying-zhi Fang
Phone +86 571 86006987

Facility Investigators

Sequence: 18343592
Facility Id 200244224
Role Principal Investigator
Name Yun-song Yu, M.D.

Conditions

Sequence: 52208101
Name Pulmonary Infection
Downcase Name pulmonary infection

Id Information

Sequence: 40186144
Id Source org_study_id
Id Value SRRSH-mNGS-respiratory

Countries

Sequence: 42599639
Name China
Removed False

Interventions

Sequence: 52522071
Intervention Type Other
Name None Intervention
Description It is observational study

Design Outcomes

Sequence: 177511206
Outcome Type primary
Measure microbiological diagnosis (pathogen of pulmonary infection)
Time Frame through study completion, up to 6 months
Description the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations.

Browse Conditions

Sequence: 193627007 Sequence: 193627006 Sequence: 193627008 Sequence: 193627009
Mesh Term Communicable Diseases Mesh Term Infections Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term communicable diseases Downcase Mesh Term infections Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48353693
Agency Class OTHER
Lead Or Collaborator lead
Name Sir Run Run Shaw Hospital

Eligibilities

Sequence: 30786868
Sampling Method Non-Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained
Criteria Inclusion Criteria:

Pulmonary infection as the primary diagnosis
Bronchoalveolar lavage fluid can be obtained

Exclusion Criteria:

when the primary diagnosis is tumor or connective tissue diseases
microbiological diagnosis is confirmed before bronchoalveolar lavage
not enough bronchoalveolar lavage fluid for mNGS

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253989623
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30532938
Observational Model Case-Only
Time Perspective Other

Responsible Parties

Sequence: 28899232
Responsible Party Type Principal Investigator
Name Jian-cang Zhou M.D.
Title Department of Infectious Diseases
Affiliation Sir Run Run Shaw Hospital

]]>

<![CDATA[ A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform ]]>
https://zephyrnet.com/NCT03798912
2019-07-09

https://zephyrnet.com/?p=NCT03798912
NCT03798912https://www.clinicaltrials.gov/study/NCT03798912?tab=tableNANANAThe objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
<![CDATA[

Studies

Study First Submitted Date 2018-12-13
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-10-08
Start Month Year July 9, 2019
Primary Completion Month Year February 17, 2020
Verification Month Year October 2020
Verification Date 2020-10-31
Last Update Posted Date 2020-10-08

Detailed Descriptions

Sequence: 20721632
Description The RaniPill device is capsule-like ingestible device, which injects a microneedle containing a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human) open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®) will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg of octreotide. The bioavailability of octreotide will be determined by serial blood sampling in Groups A and B. Performance of the RaniPill will be evaluated in all groups.

Facilities

Sequence: 200108122
Name Nucleus Network
City Melbourne
Country Australia

Browse Interventions

Sequence: 96050235 Sequence: 96050236 Sequence: 96050237 Sequence: 96050238
Mesh Term Octreotide Mesh Term Gastrointestinal Agents Mesh Term Antineoplastic Agents, Hormonal Mesh Term Antineoplastic Agents
Downcase Mesh Term octreotide Downcase Mesh Term gastrointestinal agents Downcase Mesh Term antineoplastic agents, hormonal Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52171236
Name Healthy Volunteers
Downcase Name healthy volunteers

Id Information

Sequence: 40158631
Id Source org_study_id
Id Value TST-0114

Countries

Sequence: 42568942
Name Australia
Removed False

Design Groups

Sequence: 55593171 Sequence: 55593172 Sequence: 55593173 Sequence: 55593174
Group Type Active Comparator Group Type Experimental Group Type Experimental Group Type Experimental
Title Intravenous octreotide group Title RaniPill A group Title RaniPill B group Title RaniPill C group
Description Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis Description In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis Description In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis Description In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug

Interventions

Sequence: 52485476
Intervention Type Combination Product
Name RaniPill capsule containing octreotide
Description Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.

Keywords

Sequence: 79868542
Name RaniPill capsule, drug delivery, octreotide, pharmacokinetic
Downcase Name ranipill capsule, drug delivery, octreotide, pharmacokinetic

Design Outcomes

Sequence: 177378852 Sequence: 177378853 Sequence: 177378854
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Incidence and kind of adverse events possibly related to the RaniPill capsule Measure Pharmacokinetic profile of octreotide delivered by the RaniPill capsule Measure Confirmation of the excretion of all RaniPill device components
Time Frame Up to 30 days after ingestion of the device Time Frame 4 to 8 hours Time Frame up to 7 days
Description All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, injuries to the gastrointestinal tract and abnormal changes in blood tests results will be monitored and recorded Description Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill Description Stool examinations to verify that all components of the RaniPill capsule have been defecated

Sponsors

Sequence: 48319291
Agency Class INDUSTRY
Lead Or Collaborator lead
Name RANI Therapeutics

Overall Officials

Sequence: 29285349
Role Study Director
Name Arvinder K Dhalla, PhD
Affiliation RANI Therapeutics

Design Group Interventions

Sequence: 68149127 Sequence: 68149128 Sequence: 68149129 Sequence: 68149130
Design Group Id 55593171 Design Group Id 55593172 Design Group Id 55593173 Design Group Id 55593174
Intervention Id 52485476 Intervention Id 52485476 Intervention Id 52485476 Intervention Id 52485476

Eligibilities

Sequence: 30765350
Gender All
Minimum Age 18 Years
Maximum Age 55 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Signed and dated informed consent form
Willing to comply with all study procedures and available for the entire duration of the study
Age between 18 and 55 years
BMI 17 – 32 kg/m2
In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per investigator's judgment;
Women of reproductive potential must use, between study day and the final study visit, a highly effective contraceptive, as defined in the Informed Consent Document, and have a negative urine pregnancy test at the time of screening, as well as on the day of study.

Exclusion Criteria:

Unable to swallow an intact 000 capsule with water
History of gastrointestinal surgery or illness, including diarrhea, constipation or other manifestations suggestive of abnormal digestion
Use of an antacid, proton pump inhibitor or histamine H2 receptor antagonist within 5 days of study day
Barium ingestion within 30 days of study day
Allergy or sensitivity to contrast media, iodine, barium sulfate, or latex
History chronic disease other than mild to moderate systemic hypertension
Menstruation on day of dosing
Pregnancy or lactating state
Participation in an investigational or marketed drug trial within 30 days of the screening visit
Low likelihood, in the investigator's judgment, to complete the study as required per study plan;
Any other history which, in the investigator's judgment, makes the subject ineligible or exposes the subject to a risk;
History of allergic reactions to a component of the RaniPill device or any allergic history other than common food (i.e. shellfish) or insect (i.e. bees) allergies;
Febrile illness within 5 days;
History of drug or alcohol abuse or any other factor that, in the investigator's opinion, may interfere with the subject's ability to cooperate and comply with the study procedures.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253883527
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 7
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 55
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30511517
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Healthy men and women volunteers

Responsible Parties

Sequence: 28877811
Responsible Party Type Sponsor

]]>

<![CDATA[ Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma ]]>
https://zephyrnet.com/NCT03798899
2018-05-14

https://zephyrnet.com/?p=NCT03798899
NCT03798899https://www.clinicaltrials.gov/study/NCT03798899?tab=tableNANANAA phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma
<![CDATA[

Studies

Study First Submitted Date 2018-11-09
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year May 14, 2018
Primary Completion Month Year December 20, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20741149
Description On admission, the patient pain score will be measured using a numerical scale (NRS-11) to verify the eligibility of the patient in the study (NRS ≥ 4).

At the time of randomisation, the patient's pain score will be measured using a VAS in order to verify the patient's eligibility for randomisation (VAS ≥ 40).

Admissible patients will be randomised by IWRS (Interactive Web Response System) to receive:

Either Penthrox® + SoC
Or placebo + SoC (Figure 1). Randomisation will be stratified by sex, site and according to the baseline pain score (NRS 4-5 for a moderate-intensity pain versus NS 6-10 for a severe-intensity pain).

The IWRS system will be based on the fact of including 50% patients with moderate pain and 50% patients with severe pain.

Close weekly monitoring of this ratio will be set up. The decision to no longer include patients in one of the study subgroups according to pain, if necessary, or to change this ratio, will be made by the Study Sponsor and in agreement with the study investigator-coordinator and the study scientific committee. A minimum of 150 patients will be included in the severe pain subgroup (EN 6-10).

The treatment (preparation of two inhalers, the second only being given to the patient on request) will only be administered once intermittently or continuously to patients on admission to the study (D0, T0).

The pain score will be assessed using the VAS every 5 minutes up to 20 minutes, then at 30, 60, 90, and 120 minutes after the start of study treatment (T0). Patients will be assessed until their discharge from the emergency departments (hospitalization, transfer home, transfer to the operating room) or up to 120 minutes after the initial administration.

A telephone interview will take place 14 (± 2) days after the first treatment administration to assess the medium-term safety of the product.

Facilities

Sequence: 200280546 Sequence: 200280547 Sequence: 200280548 Sequence: 200280549 Sequence: 200280550 Sequence: 200280551 Sequence: 200280552 Sequence: 200280553
Name CH Annecy Genevois Name GH Carnelle Porte de l'Oise Name Hôpital Avicenne – APHP Name CHRU Lille Name Hôpital Edouard Herriot Name Hospice civil de Lyon Name CH René Dubos Name CHU Purpan
City Annecy City Beaumont-sur-Oise City Bobigny City Lille City Lyon City Pierre Bénite City Pontoise City Toulouse
Zip 74374 Zip 95260 Zip 93000 Zip 59037 Zip 69437 Zip 69495 Zip 95300 Zip 31059
Country France Country France Country France Country France Country France Country France Country France Country France

Browse Interventions

Sequence: 96132959 Sequence: 96132960 Sequence: 96132961 Sequence: 96132962 Sequence: 96132963 Sequence: 96132964
Mesh Term Methoxyflurane Mesh Term Anesthetics, Inhalation Mesh Term Anesthetics, General Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs
Downcase Mesh Term methoxyflurane Downcase Mesh Term anesthetics, inhalation Downcase Mesh Term anesthetics, general Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52221481
Name Pain, Acute
Downcase Name pain, acute

Id Information

Sequence: 40195596 Sequence: 40195597
Id Source org_study_id Id Source secondary_id
Id Value MR311-4501 Id Value 2017-004469-28
Id Type EudraCT Number

Countries

Sequence: 42609631
Name France
Removed False

Design Groups

Sequence: 55649755 Sequence: 55649756
Group Type Experimental Group Type Placebo Comparator
Title Penthrox® (Methoxyflurane) Title Normal Saline
Description Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.

Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).

Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.

Description Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.

Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).

Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.

Interventions

Sequence: 52535292 Sequence: 52535293
Intervention Type Drug Intervention Type Drug
Name Methoxyflurane Name Normal Saline
Description PENTHROX 3mL inhalation vapour, liquid Description Placebo

Design Outcomes

Sequence: 177561320 Sequence: 177561321 Sequence: 177561322 Sequence: 177561323 Sequence: 177561324 Sequence: 177561325 Sequence: 177561327 Sequence: 177561326 Sequence: 177561328 Sequence: 177561329 Sequence: 177561330 Sequence: 177561331 Sequence: 177561332 Sequence: 177561333 Sequence: 177561334 Sequence: 177561335 Sequence: 177561336 Sequence: 177561337 Sequence: 177561338 Sequence: 177561339 Sequence: 177561340 Sequence: 177561341 Sequence: 177561342 Sequence: 177561343
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief Measure Duration between the start of study treatment (T0) and pain relief reported by the patient Measure Absolute Pain Intensity Difference (PID) measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 Measure Relative Pain Intensity Difference measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 Measure Pain relief defined by pain intensity < 40 mm on the PI-VAS scale at 5, 10, 15, 20 and 30 minutes after T0 Measure Response defined by pain reduction of 20 mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 Measure Summed Pain Intensity Difference (SPID) measured on the PI-VAS at 5, 10, 15, 20 and 30 minutes Measure Response defined by pain reduction of 30% mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 Measure Proportion of patients attaining an SPID of at least 33% Measure Quantity of opioids received (in milligrams of morphine) Measure Description of the Standard of Care and concomitant analgesic treatments Measure Sedation score (Ramsay scale) Measure Patient satisfaction score (Likert 0-5 scale) Measure Physician satisfaction scale (Likert 0-5 scale) Measure Nurse satisfaction scale (Likert 0-5 scale) Measure Length of stay (LOS) in emergency Measure Assess the time until medical decision to discharge Measure Incidence of adverse events (AE) not associated with the underlying trauma and occurring during treatment Measure Change in blood pressure Measure Change in oxygen saturation Measure Change in respiration rate Measure Change in heart rate Measure Incidence of tachycardia, hypotension, hypertension and respiratory depression Measure Incidence of premature withdrawal of patients for safety or tolerability reasons
Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame baseline to 5, 10, 15, 20 and 30 minutes Time Frame baseline to 5, 10, 15, 20 and 30 minutes Time Frame baseline to 5, 10, 15, 20 and 30 minutes Time Frame baseline to 5, 10, 15, 20 and 30 minutes Time Frame baseline to 30 minutes Time Frame baseline to 5, 10, 15, 20 and 30 minutes Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours Time Frame baseline to 30 minutes Time Frame baseline to 30 minutes Time Frame baseline to 30 minutes Time Frame baseline to 30 minutes Time Frame through study completion, maximum of 2 hours Time Frame through study completion, maximum of 2 hours
Description Measured on Pain intensity visual analogue scale (PI-VAS) 0-100 where 100 is the highest pain Description Pain measured on PI-VAS, 0-100 where 100 is the highest pain Description PID for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study. Pain measured on PI-VAS, 0-100 where 100 is the highest pain Description Relative pain intensity difference for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study divided by the VAS score at T0. Pain measured on PI-VAS, 0-100 where 100 is the highest pain Description Pain measured on PI-VAS, 0-100 where 100 is the highest pain Description Pain measured on PI-VAS, 0-100 where 100 is the highest pain Description SPID will be calculated by using the pain intensity difference (PID) at each of these assessment times provided in the study. SPID is the sum of the PID at each study assessment time, weighted by using the time elapsed since the previous assessment, and approaches the area under the curve for the PID over time. Relative to the VAS score, the SPID measurement has the advantage of considering individual differences at the level of initial pain intensity (baseline) as well as time. Description Pain measured on PI-VAS, 0-100 where 100 is the highest pain Description The proportion of patients attaining an SPID of at least 33% of the maximum possible SPID will be calculated (maximum possible SPID is the the value that would be obtained if the patient was pain free (VAS=0) for the entire study period); this will be considered as corresponding to the responder rate. A % SPID of 33% was previously established as being a clinically significant measurement in pain results. Description Descriptions from the World Health Organization (http://www.who.int/cancer/palliative/painladder/en/): Type of drug, doses, administration periods, and treatment duration Description Measured using the Ramsay sedation scale Description Satisfaction is rated by patient as Poor, Fair, Good, Very Good or Excellent Description Satisfaction is rated by Physician as Poor, Fair, Good, Very Good or Excellent Description Satisfaction is rated by Nurse as Poor, Fair, Good, Very Good or Excellent Description The Blood Systolic and Diastolic pressure (mmHg) will be measured at baseline and 30 minutes. The difference between the values will be calculated. Description Oxygen saturation (%) will be measured at baseline and 30 minutes. The difference between the values will be calculated. Description Respiration rate (breaths/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated. Description Heart rate (beats/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated.

Browse Conditions

Sequence: 193678270 Sequence: 193678271 Sequence: 193678272 Sequence: 193678273 Sequence: 193678274 Sequence: 193678275
Mesh Term Emergencies Mesh Term Acute Pain Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Pain Mesh Term Neurologic Manifestations
Downcase Mesh Term emergencies Downcase Mesh Term acute pain Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366378 Sequence: 48366379 Sequence: 48366380
Agency Class INDUSTRY Agency Class UNKNOWN Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Mundipharma SAS Name AXONAL Name Exystat

Overall Officials

Sequence: 29312894
Role Principal Investigator
Name A Ricard-Hibon, Dr
Affiliation CHG Pontoise / SAMU 95

Design Group Interventions

Sequence: 68217336 Sequence: 68217337
Design Group Id 55649755 Design Group Id 55649756
Intervention Id 52535292 Intervention Id 52535293

Eligibilities

Sequence: 30794681
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Men and women aged 18 or older
Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study
Patients admitted to the emergency department due to a trauma
Patients having a pain score ≥ 4 measured using a numerical scale (NRS) at the time of admission to emergency departments.
Patients having a pain score ≥ 40 measured using the VAS at the time of randomisation.

Exclusion Criteria:

Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit;
Impaired consciousness according to the investigator regardless of the cause, including head trauma or drug or alcohol consumption;
Acute medicinal or alcohol intoxication, according to the investigator;
Pregnant woman or woman at risk of pregnancy and not using highly effective contraception methods or known lactation;
Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed;
Treatment with nitrous oxide within 5 hours before presentation at the emergency department;
Use of analgesics for chronic pain;
Prior use of Penthrox®;
Use of an investigational product one month before presentation at the emergency department;
Hypersensitivity to Penthrox® or any other fluoridated anesthetic;
History of signs of hepatic lesions after use of methoxyflurane or after anaesthesia by a halogenated hydrocarbon;
Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition or patient or family history of serious adverse reactions;
Clinical evidence of respiratory depression according to the investigator;
Clinical evidence of cardiovascular instability according to the investigator;
Clinical renal or hepatic damage, according to the investigator, pre-existing or known;
Presence of any other clinical condition that can, according to the investigator's opinion, have an impact on the patient's ability to participate in the study or the results of the study.
Individuals protected by law

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004278
Number Of Facilities 8
Registered In Calendar Year 2018
Actual Duration 7
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 23

Designs

Sequence: 30540721
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26696928
Intervention Id 52535292
Name Penthrox®

Responsible Parties

Sequence: 28907041
Responsible Party Type Sponsor

]]>

<![CDATA[ Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos ]]>
https://zephyrnet.com/NCT03798886
2018-01-01

https://zephyrnet.com/?p=NCT03798886
NCT03798886https://www.clinicaltrials.gov/study/NCT03798886?tab=tableNANANAThere has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-03-13
Start Month Year January 1, 2018
Primary Completion Month Year December 1, 2019
Verification Month Year March 2019
Verification Date 2019-03-31
Last Update Posted Date 2019-03-13

Detailed Descriptions

Sequence: 20709973
Description There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer, with reports from observational studies and randomized controlled trials suggesting that:

The endometrium in stimulated cycles is not optimal for implantation
Pregnancy rates are increased following FET
Perinatal outcomes are less affected after FET
Preimplantation genetic screening We will follow only natural and modified natural cycles patients. Spontaneous ovulation will documented with hormonal and sonographic monitoring. Hormonal monitoring are including estradiol and luteinizing hormone (LH). Sonographic monitoring is including follicule diameter (16-20 mm). At modified natural cycles we will use hCG triggering for ovulation approximately 16-20 mm diameter.

We will compare success rate between natural and modified natural cycles

Facilities

Sequence: 199965043
Name Acibadem MAA University Atakent Hospital
City Istanbul
Zip 34457
Country Turkey

Conditions

Sequence: 52138966
Name Infertility, Female
Downcase Name infertility, female

Id Information

Sequence: 40135031
Id Source org_study_id
Id Value ATADEK-2018/20

Countries

Sequence: 42542666
Name Turkey
Removed False

Design Groups

Sequence: 55559304 Sequence: 55559305
Title Natural frozen embryo transfer group Title modified natural embryo transfer group
Description In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used. Description In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used.

Interventions

Sequence: 52454865 Sequence: 52454866 Sequence: 52454867
Intervention Type Other Intervention Type Other Intervention Type Other
Name natural cycle Name modified natural cycle Name embryo transfer
Description When follicle is ready for ovulation, we will use this injection by intra-dermal route Description we will use that drug in the natural modified transfer group after embryo transfer Description we will do transfer when the endometrium is ready

Keywords

Sequence: 79822767
Name Frozen embryo replacement, IVF success, ovarian stimulation
Downcase Name frozen embryo replacement, ivf success, ovarian stimulation

Design Outcomes

Sequence: 177263521 Sequence: 177263522 Sequence: 177263523 Sequence: 177263524
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure birth Measure pregnancy rate Measure clinical pregnancy rate Measure abortion rate
Time Frame bigger than 24 weeks pregnancy Time Frame 10th day after embryo transfer Time Frame 8 weeks Time Frame 8 weeks
Description live birth Description hcg blood test Description positive fetal cardiac activity Description abortion after visualization of fetal cardiac activity

Browse Conditions

Sequence: 193366379 Sequence: 193366380 Sequence: 193366381 Sequence: 193366382 Sequence: 193366383 Sequence: 193366384 Sequence: 193366385
Mesh Term Infertility Mesh Term Infertility, Female Mesh Term Genital Diseases Mesh Term Urogenital Diseases Mesh Term Genital Diseases, Female Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications
Downcase Mesh Term infertility Downcase Mesh Term infertility, female Downcase Mesh Term genital diseases Downcase Mesh Term urogenital diseases Downcase Mesh Term genital diseases, female Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290678
Agency Class OTHER
Lead Or Collaborator lead
Name Acibadem University

Overall Officials

Sequence: 29268517 Sequence: 29268518 Sequence: 29268519 Sequence: 29268520
Role Study Director Role Study Chair Role Study Chair Role Study Chair
Name Turgut Aydın Name Elif Ganime Aydeniz Name Emine Karabük Name Burak Yücel
Affiliation acıbadem university atakent hospital Affiliation acıbadem university atakent hospital Affiliation acıbadem university atakent hospital Affiliation Kanuni Sultan SüleymanHospital

Design Group Interventions

Sequence: 68107398 Sequence: 68107399 Sequence: 68107400 Sequence: 68107401 Sequence: 68107402 Sequence: 68107403
Design Group Id 55559304 Design Group Id 55559305 Design Group Id 55559304 Design Group Id 55559305 Design Group Id 55559304 Design Group Id 55559305
Intervention Id 52454865 Intervention Id 52454865 Intervention Id 52454866 Intervention Id 52454866 Intervention Id 52454867 Intervention Id 52454867

Eligibilities

Sequence: 30747701
Sampling Method Probability Sample
Gender Female
Minimum Age 18 Years
Maximum Age 40 Years
Healthy Volunteers Accepts Healthy Volunteers
Population This study will bw carried out as a prospective randomized clinical trial on regular menstruating patients arriving for transfer of frozen embryo to the center in a single IVF center. Results will collected and recorded daily during the study. With 80% power analysis minimum number of patients 0.05% significance level is 240.

Study will be designed in 1 year.

Criteria Inclusion Criteria:

Patient who are admitted to the IVF center and who will be transferred to frozen embryos.
Infertile women under 40 years of age who accepted this study.
Unexplained infertilite couple.
All ovulatory patient.
Male factor.
Tubal factor.

Exclusion Criteria:

Patients who made intrauterin surgery.
Over 40 years of age women.
Patients with preimplantation genetic diagnosis.
Anovulatory patient.

Gender Description woman who is infertile at reproductive age
Gender Based True
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254121795
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 40
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30493984
Observational Model Other
Time Perspective Prospective

Intervention Other Names

Sequence: 26655392 Sequence: 26655393 Sequence: 26655394
Intervention Id 52454865 Intervention Id 52454866 Intervention Id 52454867
Name natural LH surge Name recombinant hcg Name frozen embryo transfer

Responsible Parties

Sequence: 28860264
Responsible Party Type Sponsor

Study References

Sequence: 52032689 Sequence: 52032690 Sequence: 52032691 Sequence: 52032692
Pmid 21840758 Pmid 23820515 Pmid 25069504 Pmid 20097333
Reference Type background Reference Type background Reference Type result Reference Type result
Citation Weissman A, Horowitz E, Ravhon A, Steinfeld Z, Mutzafi R, Golan A, Levran D. Spontaneous ovulation versus HCG triggering for timing natural-cycle frozen-thawed embryo transfer: a randomized study. Reprod Biomed Online. 2011 Oct;23(4):484-9. doi: 10.1016/j.rbmo.2011.06.004. Epub 2011 Jun 15. Citation Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2. Erratum In: Hum Reprod Update. 2017 Mar 1;23(2):255-261. Citation Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27. Citation Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.

]]>

<![CDATA[ Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35 ]]>
https://zephyrnet.com/NCT03798873
2019-02-13

https://zephyrnet.com/?p=NCT03798873
NCT03798873https://www.clinicaltrials.gov/study/NCT03798873?tab=tableRachel Trope, MSrtrope@wtmgmt.com7038070037To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing an individual’s level of pain, mood, self-stigma and comfort with the use of a compression garment. Additionally, to assess the impact of the compression garment on activity, strength, posture and movement of an individual with a BMI ≥35 over the period of one year.
<![CDATA[

Studies

Study First Submitted Date 2018-12-13
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-02-19
Start Month Year February 13, 2019
Primary Completion Month Year July 2020
Verification Month Year February 2019
Verification Date 2019-02-28
Last Update Posted Date 2019-02-19

Detailed Descriptions

Sequence: 20727140
Description Individuals suffering with obesity often experience daily pain and discomfort which limits movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep, self-esteem and ultimately overall quality of life. Many individuals who experience weight gain have an abdominal or central distribution of weight which affects body mechanics leading to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain impedes mobility often incorporating depression and low motivation in an endless cycle. Furthermore, as individuals are losing weight, they often suffer from excess skin which also aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.

The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing the participant's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additional assessments include impact of the compression garment on activity, strength, posture and movement as well as potential impact of the use of this garment on weight loss and change in laboratory measures of metabolic health.

Facilities

Sequence: 200159080
Status Recruiting
Name Washington Center for Weight Management and Research, Inc.
City Shirlington
State Virginia
Zip 22206
Country United States

Facility Contacts

Sequence: 28113709 Sequence: 28113710
Facility Id 200159080 Facility Id 200159080
Contact Type primary Contact Type backup
Name Michelle Vaughan, MBA Name Rachel Trope, MS
Email mvaughan@wtmgmt.com Email rtrope@wtmgmt.com
Phone 703-807-0037 Phone 7038070037

Facility Investigators

Sequence: 18336337 Sequence: 18336338 Sequence: 18336339
Facility Id 200159080 Facility Id 200159080 Facility Id 200159080
Role Principal Investigator Role Sub-Investigator Role Sub-Investigator
Name Domenica Rubino, MD Name Rachel Trope, MS Name Mike Reing, MS

Conditions

Sequence: 52185369 Sequence: 52185370 Sequence: 52185371 Sequence: 52185372 Sequence: 52185373 Sequence: 52185374 Sequence: 52185375 Sequence: 52185376 Sequence: 52185377 Sequence: 52185378 Sequence: 52185379
Name Obesity Name Obesity, Abdominal Name Mobility Limitation Name Quality of Life Name Back Pain Name Pain, Chronic Name Weight Change, Body Name Inactivity Name Exercise Name Body Composition Name Redundant Skin
Downcase Name obesity Downcase Name obesity, abdominal Downcase Name mobility limitation Downcase Name quality of life Downcase Name back pain Downcase Name pain, chronic Downcase Name weight change, body Downcase Name inactivity Downcase Name exercise Downcase Name body composition Downcase Name redundant skin

Id Information

Sequence: 40168996
Id Source org_study_id
Id Value FeelWell2018

Countries

Sequence: 42580604
Name United States
Removed False

Design Groups

Sequence: 55609014 Sequence: 55609015
Group Type Experimental Group Type Other
Title FeelWell™ Compression garment use with increase mobility Title Increase mobility
Description Subjects are randomized to wear custom-fitted FeelWell™ Compression garment daily during regular and exercise activities.

Subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity.

Description For the control group, subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. The control group will not be assigned a compression garment during the trial.

Interventions

Sequence: 52499332 Sequence: 52499333
Intervention Type Device Intervention Type Behavioral
Name FeelWell™ Compression garment Name Increase Mobility
Description Registered FDA class I device:

The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back.

Description Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity

Keywords

Sequence: 79888573 Sequence: 79888574 Sequence: 79888575 Sequence: 79888576 Sequence: 79888577
Name Compression garment Name Physical therapy Name Obesity Name Movement Name Abdominal binder
Downcase Name compression garment Downcase Name physical therapy Downcase Name obesity Downcase Name movement Downcase Name abdominal binder

Design Outcomes

Sequence: 177431729 Sequence: 177431730 Sequence: 177431731 Sequence: 177431732 Sequence: 177431733 Sequence: 177431734 Sequence: 177431735 Sequence: 177431736 Sequence: 177431737 Sequence: 177431738
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure 6- minute walk test- distance walked Measure 6- minute walk test- Perceived exertion Measure SF-36 physical component sub-score Measure 30 Second Chair Stand Measure Brief Pain Inventory-Interference sub-score Measure Steps per day measured by accelerometer Measure Weight Self Stigma questionnaire Measure Lean body mass Measure Fat mass Measure Bone density
Time Frame baseline, 1, 3, 6 and 12 months Time Frame baseline, 1, 3, 6 and 12 months Time Frame baseline, 3, 6 and 12 months Time Frame baseline, 1, 3, 6 and 12 months Time Frame baseline, 1, 3, 6 and 12 months Time Frame baseline, 6 months and 1 year Time Frame baseline, 1, 3, 6 and 12 months Time Frame baseline, 12 months Time Frame baseline, 12 months Time Frame baseline, 12 months
Description 6-min walk test is a sub-maximal exercise test measuring the total distance walked by a subject in a period of 6 minutes to assess functional capacity of a subject's cardio-respiratory systems and reflects their ability to perform Activities of Daily Living. Total distance walked will be measured and change recorded from baseline. Description The Borg Rate of Perceived Exertion scale of 1-10 will be used for the subject to record their exertion level from 1 (no exertion)-10 (maximal exertion) and change will be noted from baseline. Description SF-36 consists of 8 sub-scales of health-related quality of life measuring various aspects of functioning. The summary score for physical component includes physical functioning, physical role, bodily pain and general health scores. This sub-score is reported on a scale from 0-100 with higher numbers indicating better physical functioning. Description A test of leg strength and endurance. The number of times a patient stands from a sitting position in 30 seconds is recorded. Description A measure of pain and the interference of such pain on daily function. A sub-score on a scale of 0 (no interference)- 10 (maximal interference) will be recorded. The mean score of the 7 items will be recorded. Description The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial. Description A questionnaire designed to explore both internalized self stigma (internalized self-devaluation) and enacted stigma (directly experienced stigma) on function will be administered. The scale is comprised of 12 questions, and the subject responds on a scale from 1-5 with a greater score indicating greater experienced stigma. Description Using DXA (Dual-energy X-ray Absorptiometry), lean body mass (LBM) or fat-free mass will be measured at baseline and at end of study. Percent change will be reported. Description Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported. Description Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.

Browse Conditions

Sequence: 193539727 Sequence: 193539728 Sequence: 193539729 Sequence: 193539730 Sequence: 193539731 Sequence: 193539732 Sequence: 193539733 Sequence: 193539734 Sequence: 193539735 Sequence: 193539736 Sequence: 193539737
Mesh Term Obesity Mesh Term Obesity, Abdominal Mesh Term Chronic Pain Mesh Term Body Weight Changes Mesh Term Mobility Limitation Mesh Term Overweight Mesh Term Overnutrition Mesh Term Nutrition Disorders Mesh Term Body Weight Mesh Term Pain Mesh Term Neurologic Manifestations
Downcase Mesh Term obesity Downcase Mesh Term obesity, abdominal Downcase Mesh Term chronic pain Downcase Mesh Term body weight changes Downcase Mesh Term mobility limitation Downcase Mesh Term overweight Downcase Mesh Term overnutrition Downcase Mesh Term nutrition disorders Downcase Mesh Term body weight Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48332230 Sequence: 48332231
Agency Class INDUSTRY Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Feelwell Compression Name Washington Center for Weight Management and Research, Inc.

Overall Officials

Sequence: 29292930
Role Principal Investigator
Name Domenica Rubino, MD
Affiliation Washington Center for Weight Management and Research

Central Contacts

Sequence: 12012284 Sequence: 12012285
Contact Type primary Contact Type backup
Name Domenica Rubino, MD Name Rachel Trope, MS
Phone 17038070037 Phone 7038070037
Email mvaughan@wtmgmt.com Email rtrope@wtmgmt.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68168056 Sequence: 68168057 Sequence: 68168058
Design Group Id 55609014 Design Group Id 55609014 Design Group Id 55609015
Intervention Id 52499332 Intervention Id 52499333 Intervention Id 52499333

Eligibilities

Sequence: 30773521
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Male or female, over 18 years old.
Subjects with a BMI of ≥ 35.
Subjects in any stage of weight loss or maintenance.

Exclusion Criteria:

Inability to put on or have help in putting on garment.
Inability to participate in movement and exercise intervention.
Panniculus grade >3 at baseline or other body habitus that limits mobility.
Duke Activity Status Index (DASI) score < 3.62
Medical condition limiting participation in trial or basic mobility.
Current participation in a physical therapy program.
Unwillingness to participate fully in trial.
Participation in another trial at the same time.
Patient Health Questionnaire (PHQ)-9≥15.
Current or expected pregnancy
Investigator's discretion

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253952512
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 7
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30519652
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description Test group treated with the FeelWell™ Compression garment and control group without compression garment. All subjects will receive the same intervention working with exercise physiologist and physical therapist in order to improve mobility.

Responsible Parties

Sequence: 28885953
Responsible Party Type Sponsor

Study References

Sequence: 52078783 Sequence: 52078784 Sequence: 52078785 Sequence: 52078786 Sequence: 52078787
Pmid 12091180 Pmid 16229997 Pmid 25175697 Pmid 29158251 Pmid 28886865
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. Citation Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S. Six minute walk distance in healthy subjects aged 55-75 years. Respir Med. 2006 Apr;100(4):658-65. doi: 10.1016/j.rmed.2005.08.003. Epub 2005 Oct 17. Citation Grodin JL, Hammadah M, Fan Y, Hazen SL, Tang WH. Prognostic value of estimating functional capacity with the use of the duke activity status index in stable patients with chronic heart failure. J Card Fail. 2015 Jan;21(1):44-50. doi: 10.1016/j.cardfail.2014.08.013. Epub 2014 Aug 28. Citation Jakicic JM, Rogers RJ, Davis KK, Collins KA. Role of Physical Activity and Exercise in Treating Patients with Overweight and Obesity. Clin Chem. 2018 Jan;64(1):99-107. doi: 10.1373/clinchem.2017.272443. Epub 2017 Nov 20. Citation Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21.

Ipd Information Types

Sequence: 3335313 Sequence: 3335314 Sequence: 3335315 Sequence: 3335316 Sequence: 3335317
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Informed Consent Form (ICF) Name Clinical Study Report (CSR) Name Analytic Code

]]>

<![CDATA[ Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation ]]>
https://zephyrnet.com/NCT03798860
2018-10-01

https://zephyrnet.com/?p=NCT03798860
NCT03798860https://www.clinicaltrials.gov/study/NCT03798860?tab=tableSusanne Freytfreyt.susanne@mh-hannover.de+49 511-532-3450Single-arm, prospective observational study
<![CDATA[

Studies

Study First Submitted Date 2018-09-26
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-03-02
Start Month Year October 1, 2018
Primary Completion Month Year July 2024
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-02

Detailed Descriptions

Sequence: 20564028
Description This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.

Facilities

Sequence: 198534388
Status Recruiting
Name Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
City Hannover
Country Germany

Facility Contacts

Sequence: 27933745
Facility Id 198534388
Contact Type primary
Name Susanne Freyt
Email freyt.susanne@mh-hannover.de
Phone +49 511-532-3450

Facility Investigators

Sequence: 18223508
Facility Id 198534388
Role Principal Investigator
Name Fabio Ius, Dr.

Conditions

Sequence: 51765551 Sequence: 51765552
Name Lung Transplantation Name Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies
Downcase Name lung transplantation Downcase Name donor-specific anti-human leukocyte antigen(hla) antibodies

Id Information

Sequence: 39834520
Id Source org_study_id
Id Value DSA-2018

Countries

Sequence: 42233572
Name Germany
Removed False

Interventions

Sequence: 52086937
Intervention Type Diagnostic Test
Name blood samples
Description For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.

Design Outcomes

Sequence: 176070992 Sequence: 176070993 Sequence: 176070994
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Donor-specific Antibodies Clearance Measure Graft survival Measure Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)
Time Frame 6, 12, 18, 24 months Time Frame 1, 3, 5 years Time Frame 1, 3, 5 years
Description The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end. Description Graft survival is defined as freedom from mortality and re-transplantation

Sponsors

Sequence: 47941787
Agency Class OTHER
Lead Or Collaborator lead
Name Hannover Medical School

Overall Officials

Sequence: 29047169
Role Principal Investigator
Name Fabio Ius, Dr.
Affiliation Hannover Medical School

Central Contacts

Sequence: 11927299 Sequence: 11927300
Contact Type primary Contact Type backup
Name Fabio Ius, Dr. Name Susanne Freyt
Phone +49 511-532-2125 Phone +49 511-532-3450
Email Ius.Fabio@mh-hannover.de Email freyt.susanne@mh-hannover.de
Role Contact Role Contact

Eligibilities

Sequence: 30527958
Sampling Method Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population All patients after lung transplantation with detection of donor-specific antibodies
Criteria Inclusion Criteria:

all patients after lung transplantation with detection of donor-specific antibodies

Exclusion Criteria:

none

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254097212
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30276802
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28656387
Responsible Party Type Sponsor

]]>

<![CDATA[ Safety and Performance of Journey II XR Total Knee System ]]>
https://zephyrnet.com/NCT03798847
2018-11-01

https://zephyrnet.com/?p=NCT03798847
NCT03798847https://www.clinicaltrials.gov/study/NCT03798847?tab=tableNANANAThe objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
<![CDATA[

Studies

Study First Submitted Date 2018-11-27
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-07-14
Start Month Year November 1, 2018
Primary Completion Month Year September 10, 2020
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-14

Facilities

Sequence: 198409859 Sequence: 198409860 Sequence: 198409861 Sequence: 198409862 Sequence: 198409863 Sequence: 198409864 Sequence: 198409865 Sequence: 198409866 Sequence: 198409867 Sequence: 198409868 Sequence: 198409869 Sequence: 198409870
Name Orthopedic Institute of the West Name Rush Copley Orthopaedics Name Jerry Orthopaedic Institute Name Reno Orthopedic Clinic Name Orthopaedic Center of New Jersey Name Hospital for Joint Diseases Orthopaedics Institute Name Regenerative Orthopedic Center (ROC) Name Oregon Health & Science University Name San Antonio Orthopaedic Specialists Name Anderson Orthopaedic Clinic Name Scott Orthopedic Center Name Aurora Medical Center
City Phoenix City Aurora City Port Huron City Reno City Somerset City New York City Oregon City City Portland City San Antonio City Alexandria City Huntington City Kenosha
State Arizona State Illinois State Michigan State Nevada State New Jersey State New York State Oregon State Oregon State Texas State Virginia State West Virginia State Wisconsin
Zip 85054 Zip 60504 Zip 48060 Zip 89503 Zip 08873 Zip 10003 Zip 97045 Zip 97239 Zip 78258 Zip 22306 Zip 25702 Zip 53142
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States

Conditions

Sequence: 51728843
Name Journey II XR Total Knee System
Downcase Name journey ii xr total knee system

Id Information

Sequence: 39806932
Id Source org_study_id
Id Value JIIXR.PMCF.2018.13

Countries

Sequence: 42205856
Name United States
Removed False

Interventions

Sequence: 52050546
Intervention Type Device
Name Journey II XR TKA
Description Journey II XR Total Knee System

Keywords

Sequence: 79147520
Name Journey II XR Total Knee System
Downcase Name journey ii xr total knee system

Design Outcomes

Sequence: 175940758 Sequence: 175940759 Sequence: 175940760 Sequence: 175940761 Sequence: 175940762 Sequence: 175940763 Sequence: 175940764 Sequence: 175940765 Sequence: 175940766 Sequence: 175940767 Sequence: 175940768
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Revision of one or more study device components Measure Adverse Events Measure Health care utilization: Hospitalization Measure Health care utilization: Hospitalization Measure Health care utilization: Rehabilitation Measure Health care utilization: Outpatient visits Measure Health Care Utilization: Re-operations Measure Quality of Life: EQ-5D-3L Measure Quality of Life: KSS Measure Return to Work Measure Technical Difficulties Encountered During Device Implantation
Time Frame 12 weeks follow up Time Frame 12 weeks follow up Time Frame implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years Time Frame Implantation through study completion, approximately 3 years
Description Measure of the number of revision cases Description All collected and reported AEs Description Length of hospital stay for primary (index) surgery Description Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay) Description number of sessions and duration of rehabilitation in weeks Description Number and type of outpatient visits Description Number of re-operations and revisions Description EuroQol Five Dimensions Questionnaire Description 2011 Knee Society Score Description Changes in employment status will be recorded with the date on which the change occurred and the change status. Description Number of technical difficulties encountered with the device

Sponsors

Sequence: 47908586
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Smith & Nephew, Inc.

Eligibilities

Sequence: 30507529
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication
Criteria Inclusion Criteria:

Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
The TKA occurred at least 12 weeks prior to enrollment.

Exclusion Criteria:

– None

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254054594
Number Of Facilities 12
Registered In Calendar Year 2018
Actual Duration 22
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 10

Designs

Sequence: 30256607
Observational Model Other
Time Perspective Retrospective

Responsible Parties

Sequence: 28637104
Responsible Party Type Sponsor

]]>

<![CDATA[ Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy ]]>
https://zephyrnet.com/NCT03798834
2018-11-17

https://zephyrnet.com/?p=NCT03798834
NCT03798834https://www.clinicaltrials.gov/study/NCT03798834?tab=tableNANANAThe fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.

The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ”pops” due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-09-22
Start Month Year November 17, 2018
Primary Completion Month Year February 1, 2019
Verification Month Year September 2020
Verification Date 2020-09-30
Last Update Posted Date 2020-09-22

Detailed Descriptions

Sequence: 20721637
Description This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.

Facilities

Sequence: 200108131
Name Mansoura University
City Mansourah
State DK
Zip 050
Country Egypt

Browse Interventions

Sequence: 96050239 Sequence: 96050240 Sequence: 96050241
Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs
Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52171244
Name Chronic Lower Limb Ischemia
Downcase Name chronic lower limb ischemia

Id Information

Sequence: 40158638
Id Source org_study_id
Id Value R/17.07.111

Countries

Sequence: 42568948
Name Egypt
Removed False

Design Groups

Sequence: 55593181 Sequence: 55593182
Group Type Experimental Group Type Placebo Comparator
Title Fascia iliaca block (FIB) Title Spinal anesthesia
Description ultrasound-guided Fascia iliaca block Description Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Interventions

Sequence: 52485482 Sequence: 52485483
Intervention Type Drug Intervention Type Other
Name Fascia iliaca block (FIB) Name Spinal anesthesia
Description ultrasound-guided Fascia iliaca block Description Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Design Outcomes

Sequence: 177378876 Sequence: 177378872 Sequence: 177378873 Sequence: 177378874 Sequence: 177378875 Sequence: 177378870 Sequence: 177378871
Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type primary Outcome Type secondary
Measure bradycardia Measure Heart rate Measure mean arterial pressure (MAP Measure hypotension Measure Any observed adverse effects Measure The proportion of the patients who did not require conversion to general anesthesia Measure Postoperative pain
Time Frame For 24 hours from the block Time Frame For 6 hours after the intervention Time Frame For 6 hours after the intervention Time Frame For 24 hours from the block Time Frame over the 24 hours postoperative Time Frame for 30 minutes Time Frame For 24 hours after the intervention
Description Incidents if bradycardia Description changes in Heart rate Description changes in mean arterial pressure (MAP Description Incidents of hypotension Description ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding Description The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)

Browse Conditions

Sequence: 193486753 Sequence: 193486754
Mesh Term Ischemia Mesh Term Pathologic Processes
Downcase Mesh Term ischemia Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48319298
Agency Class OTHER
Lead Or Collaborator lead
Name Mansoura University

Overall Officials

Sequence: 29285354
Role Study Chair
Name Reem A Elsharkawy, MD
Affiliation Lecturer of Anesthesia and Surgical Intensive Care

Design Group Interventions

Sequence: 68149137 Sequence: 68149138
Design Group Id 55593181 Design Group Id 55593182
Intervention Id 52485482 Intervention Id 52485483

Eligibilities

Sequence: 30765356
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

ASA physical status I or II.

Exclusion Criteria:

Patients with previous same lower limb surgery
Neuromuscular disease
Severe cardiovascular disease
Any contraindications to regional anesthesia
patient refusal
coagulation abnormality
Known allergy to local anesthetics
Infection at the injection site

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253883940
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 2
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30511523
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking Single
Subject Masked True

Responsible Parties

Sequence: 28877817
Responsible Party Type Sponsor

]]>

<![CDATA[ The Antioxidant Efficacy of a Product Probiotic in Research ]]>
https://zephyrnet.com/NCT03798821
2018-01-08

https://zephyrnet.com/?p=NCT03798821
NCT03798821https://www.clinicaltrials.gov/study/NCT03798821?tab=tableNANANADetermine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration.
<![CDATA[

Studies

Study First Submitted Date 2018-03-15
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year January 8, 2018
Primary Completion Month Year July 30, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20741157
Description The effectiveness of a probiotic for oxidative stress after eight weeks of the product to study will be checked. the sample will be formed by cyclists that will submit to a baseline exercise and after the product is taken.

Facilities

Sequence: 200280563
Name Catholic University of Murcia
City Murcia
Zip 30107
Country Spain

Browse Interventions

Sequence: 96132970 Sequence: 96132971 Sequence: 96132972 Sequence: 96132973 Sequence: 96132974 Sequence: 96132975
Mesh Term Sulfalene Mesh Term Anti-Infective Agents Mesh Term Anti-Infective Agents, Urinary Mesh Term Antimalarials Mesh Term Antiprotozoal Agents Mesh Term Antiparasitic Agents
Downcase Mesh Term sulfalene Downcase Mesh Term anti-infective agents Downcase Mesh Term anti-infective agents, urinary Downcase Mesh Term antimalarials Downcase Mesh Term antiprotozoal agents Downcase Mesh Term antiparasitic agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52221496
Name Oxidative Stress
Downcase Name oxidative stress

Id Information

Sequence: 40195608
Id Source org_study_id
Id Value UCAM-CFE-0003

Countries

Sequence: 42609639
Name Spain
Removed False

Design Groups

Sequence: 55649773 Sequence: 55649774
Group Type Experimental Group Type Placebo Comparator
Title Experimental Title Comparator
Description One capsule a day will be consumed. At breakfast for the six weeks. Description One capsule a day will be consumed. At breakfast for the six weeks.

Interventions

Sequence: 52535307 Sequence: 52535308 Sequence: 52535309
Intervention Type Dietary Supplement Intervention Type Dietary Supplement Intervention Type Dietary Supplement
Name Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG) Name Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG) Name maltodextrin and sucrose (PLACEBO)
Description six weeks of consumption Description six weeks of consumption Description six weeks of consumption

Design Outcomes

Sequence: 177561386 Sequence: 177561387 Sequence: 177561388 Sequence: 177561389 Sequence: 177561390 Sequence: 177561391 Sequence: 177561392 Sequence: 177561393 Sequence: 177561394
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Oxidative damage to lipids Measure Oxidative damage to DNA Measure Oxidative damage to proteins. Measure Oxidative damage to lipids Measure Blood analysis Measure Blood analysis Measure Blood analysis Measure Blood analysis Measure Blood analysis
Time Frame Oxidative lipid damage will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Oxidative damage to DNA will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Oxidative damage to protein will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Oxidative damage to lipids will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. Time Frame Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product.
Description It will be measured by isoprostanes in urine 24 hours. Description Analysis of 8-oxo 2'-deoxyguanosine in 24-hour urine. Description Analysis of serum carbonyl groups Description analysis of malondialdehyde in plasma Description serum carbonyls. It is measured in nmol / mg proteins Description Malondialdehyde in plasma Description Oxidized LDL. Description Antioxidant capacity. Description glutathione metabolism. It is measured in nmol / mg proteins

Sponsors

Sequence: 48366396
Agency Class OTHER
Lead Or Collaborator lead
Name Universidad Católica San Antonio de Murcia

Design Group Interventions

Sequence: 68217353 Sequence: 68217354 Sequence: 68217355
Design Group Id 55649773 Design Group Id 55649773 Design Group Id 55649774
Intervention Id 52535307 Intervention Id 52535308 Intervention Id 52535309

Eligibilities

Sequence: 30794691
Gender Male
Minimum Age 18 Years
Maximum Age 45 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Age: between 18 and 45 years
Sex: male, of Caucasian race, selected from the general population.
Subjects that perform aerobic physical exercise between 2 and 4 times a week.
Volunteers capable of understanding the clinical study, willing to grant consent informed in writing and to comply with the procedures and requirements of the study

Exclusion Criteria:

Subjects with a history of any chronic disease.
History of bronchial asthma or chronic obstructive pulmonary disease, disease Reactive airways such as bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease.
Sinus bradycardia, second or third degree of atrioventricular block, insufficiency manifest cardiac or cardiogenic shock.
History of allergic hypersensitivity or poor tolerance to any component of the products under study.
Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.
Subjects diagnosed and / or under treatment for arterial hypertension.
Smoking subjects (> 10 cigarettes a day).
Subjects with body mass index greater than 35 Kg / m2 (BMI> 30).
Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study.
Subjects whose condition does not make them eligible for the study according to the researcher's criteria.

Gender Based True
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254004306
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 6
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 45
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 8

Designs

Sequence: 30540731
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Triple
Subject Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28907051
Responsible Party Type Principal Investigator
Name Francisco Javier López Román
Title Principal Investigator
Affiliation Universidad Católica San Antonio de Murcia

Study References

Sequence: 52118171
Pmid 33671691
Reference Type derived
Citation Sanchez Macarro M, Avila-Gandia V, Perez-Pinero S, Canovas F, Garcia-Munoz AM, Abellan-Ruiz MS, Victoria-Montesinos D, Luque-Rubia AJ, Climent E, Genoves S, Ramon D, Chenoll E, Lopez-Roman FJ. Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise. Antioxidants (Basel). 2021 Feb 22;10(2):323. doi: 10.3390/antiox10020323.

]]>

<![CDATA[ Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children ]]>
https://zephyrnet.com/NCT03798808
2016-02-01

https://zephyrnet.com/?p=NCT03798808
NCT03798808https://www.clinicaltrials.gov/study/NCT03798808?tab=tableNANANAConsidering the high prevalence of childhood obesity worldwide, effective interventions are needed . Parental involvement in interventions and the use of web-based modalities appear to be promising approaches. The aim of the study was to evaluate the efficacy of an innovative family and Web-based nutrition intervention called “Family Nutriathlon” on consumption of vegetables and fruit and dairy products and/or alternatives and on diet quality among children and their parents.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-11
Start Month Year February 1, 2016
Primary Completion Month Year March 1, 2017
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-11

Detailed Descriptions

Sequence: 20709974
Description Forty-three families, with at least one child with a BMI >85th percentile, participated in either the intervention (n=24) or control group (n=19) over an 8-week period. Families in the intervention (Family Nutriathlon) will participated in a nutrition challenge that aimed to increase their consumption and variety of fruits and vegetables and dairy products by recording their daily intakes using a Web-based platform. Families in the control group received recommendations based on general nutrition guidelines. Three follow-ups with a dietitian once every two weeks via Skype to assess progress were scheduled. A three-day food record was completed at baseline (week 0), immediately after (week 8) and 6 months after the intervention. A two-way repeated measures analysis of variance was used to assess changes in consumption of fruits and vegetables and dairy products, diet quality and dietary intakes between groups and over time.

Conditions

Sequence: 52138967
Name Diet Habit
Downcase Name diet habit

Id Information

Sequence: 40135032
Id Source org_study_id
Id Value NUTRIATHLON-2015-259 R-2

Design Groups

Sequence: 55559306 Sequence: 55559307
Group Type Experimental Group Type No Intervention
Title Family Nutriathlon group Title Control group
Description Web-based nutrition program (encouraging consumption of fruits, vegetables and dairy products through an online platform) Description General nutrition guidelines (e.g. following Canada's Food Guide)

Interventions

Sequence: 52454868
Intervention Type Other
Name Consumption of fruits, vegetables and dairy products
Description Family Nutriathlon was an eight-week, family-based nutrition program where children and their parents were encouraged to reach individual and team goals with respect to the quantity and variety of fruit, vegetable and dairy product consumption.

Keywords

Sequence: 79822768
Name vegetables, fruits, dairy, children, habits
Downcase Name vegetables, fruits, dairy, children, habits

Design Outcomes

Sequence: 177263525 Sequence: 177263526
Outcome Type primary Outcome Type secondary
Measure Dietary intakes and diet quality Measure Anthropometric measurements
Time Frame 8 weeks Time Frame Weeks 0, 9 and 18-36 (follow-up)
Description Fruit, vegetable and dairy product consumption and diet quality as measured by the Nutrient-Rich Foods Index Description Body weight, height and body mass index

Sponsors

Sequence: 48290679
Agency Class OTHER
Lead Or Collaborator lead
Name Laval University

Design Group Interventions

Sequence: 68107404
Design Group Id 55559306
Intervention Id 52454868

Eligibilities

Sequence: 30747702
Gender All
Minimum Age 8 Years
Maximum Age 16 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria All inclusion/exclusion criterion were the same between the two projects (including the intervention) except for the inclusion of a child living with obesity or overweight.

Children were aged between 8 and 16 years, but there was no age limit for parents.

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254121796
Registered In Calendar Year 2019
Actual Duration 13
Were Results Reported False
Has Single Facility False
Minimum Age Num 8
Maximum Age Num 16
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30493985
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Investigator Masked True

Responsible Parties

Sequence: 28860265
Responsible Party Type Principal Investigator
Name Vicky Drapeau
Title Professor
Affiliation Laval University

]]>

<![CDATA[ Radiomics for Tumor Grading of Soft Tissue Sarcomas. ]]>
https://zephyrnet.com/NCT03798795
2017-10-01

https://zephyrnet.com/?p=NCT03798795
NCT03798795https://www.clinicaltrials.gov/study/NCT03798795?tab=tableNANANARadiomics is defined as a quantitative high-throughput analysis of imaging data combined with model development aiming to predict biological correlates or clinical endpoints. The investigators of this study hypothesize that radiomic features may correlate with pathology-defined tumor grading in soft tissue sarcoma patients. The aim of this study is to develop a predictive radiomics model for tumor grading determination.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-04-10
Start Month Year October 1, 2017
Primary Completion Month Year March 31, 2018
Verification Month Year April 2019
Verification Date 2019-04-30
Last Update Posted Date 2019-04-10

Detailed Descriptions

Sequence: 20762921
Description Soft tissue sarcomas (STS) constitute an overall rare malignant entity comprising 1% of all cancers with a yearly incidence rate of 3.8 per 100.000 inhabitants. Therapy decisions are made using clinical and pathological determinants defined by the American Joint Committee on Cancer (AJCC). It involves the TNM staging system that classifies STS by their tumor size (measured as maximal diameter), pathological tumor grading defined by the French Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) and the occurrence of nodal or distant metastases.

For the guidance of therapy, the most important factor constitutes tumor grading. In "low-grade" sarcomas (G1), surgical resection is often sufficient for durable tumor control. In "high risk" STS, however, resection of the tumor is combined with radiotherapy improving locoregional control and eventually survival.

Currently, invasive biopsies followed by pathological work-up are necessary to determine tumor grading. However, bioptic specimens are always restricted to small tumor subvolume.

Medical imaging-based analyses constitutes an alternative tool to characterize tissue. Recent developments in quantitative image analysis and data science have led to the evolvement of "Radiomics". It is defined as an algorithm-based large-scale quantitative analysis of imaging features. It should be considered as a two-step process with (1) extraction of relevant imaging features, and (2) incorporating these features into a mathematical model to ultimately predict patient or tumor-specific outcomes. In previous scientific studies, radiomic models have been associated with survival, tumor progression, and molecular changes including genetic mutations or expression profiles as shown in multiple malignant entities. In addition, radiomic models were able to predict tumor grading e.g. for gliomas, meningiomas, hepatocellular carcinoma or pancreatic neuroendocrine tumors. In contrast to pathology, quantitative image analysis (radiomics) has the principal advantage of analyzing the whole tumor.

In this study, the investigators are aiming to correlate radiomic features with tumor grading of STS. The ultimate goal is to develop a prediction model to non-invasively classify tumor grading. In a first step, the focus will be laid on differentiating "low-grade" and "high-grade" STS. In a second step, "high-grade" STS will be divided into G2 and G3 tumors.

To this end, the investigators will retrospectively analyze a patient cohort of 138 patients (139 tumors) with known tumor grading and available pre-therapeutic MRI-scans. As secondary endpoint overall survival will be determined for all patients. An independent patient cohort from the University of Washington (139 patients) will be used for external validation of the developed models.

Facilities

Sequence: 200458041
Name Klinik für RadioOnkologie Strahlentherapie
City Munich
State Bavaria
Zip 81675
Country Germany

Conditions

Sequence: 52277447
Name Sarcoma, Soft Tissue
Downcase Name sarcoma, soft tissue

Id Information

Sequence: 40235454
Id Source org_study_id
Id Value Sarcoma_Grading_Radiomics

Countries

Sequence: 42653031
Name Germany
Removed False

Design Outcomes

Sequence: 177770623 Sequence: 177770624
Outcome Type primary Outcome Type secondary
Measure Pathological tumor grading Measure Overall Survival
Time Frame Baseline Time Frame From initial pathologic diagnosis to the time point of death or the time point of censoring up to 100 months.
Description Defined by the French Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) Description Overall Survival

Browse Conditions

Sequence: 193892720 Sequence: 193892721 Sequence: 193892722 Sequence: 193892723
Mesh Term Sarcoma Mesh Term Neoplasms, Connective and Soft Tissue Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms
Downcase Mesh Term sarcoma Downcase Mesh Term neoplasms, connective and soft tissue Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48418632 Sequence: 48418633
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Technical University of Munich Name University of Washington

Overall Officials

Sequence: 29342604
Role Principal Investigator
Name Stephanie E Combs, MD
Affiliation Technical University of Munich

Eligibilities

Sequence: 30827023
Sampling Method Non-Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population Patients with histologically proven soft tissue sarcomas with known FNCLCC tumor grading determined by biopsy prior to therapy.
Criteria Inclusion Criteria:

Histologically proven soft tissue sarcoma
Available pre-therapeutic MRI with a contrast-enhanced T1 weight fat saturated sequence +/- fat saturated T2 sequences (e.g. STIR)

Exclusion Criteria:

Indeterminate tumor grading
Osteosarcoma
Ewing Sarcoma
Endoprothesis-dependent MRI artifacts
Previous radiotherapy or chemotherapy
Lack of a contrast-enhanced T1 weight fat saturated MRI sequence

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254123702
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 6
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30572953
Observational Model Cohort
Time Perspective Retrospective

Responsible Parties

Sequence: 28939375
Responsible Party Type Sponsor

Study References

Sequence: 52177362 Sequence: 52177363 Sequence: 52177364
Pmid 30397175 Pmid 24892406 Pmid 31522983
Reference Type background Reference Type background Reference Type derived
Citation Liang W, Yang P, Huang R, Xu L, Wang J, Liu W, Zhang L, Wan D, Huang Q, Lu Y, Kuang Y, Niu T. A Combined Nomogram Model to Preoperatively Predict Histologic Grade in Pancreatic Neuroendocrine Tumors. Clin Cancer Res. 2019 Jan 15;25(2):584-594. doi: 10.1158/1078-0432.CCR-18-1305. Epub 2018 Nov 5. Citation Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006. Erratum In: Nat Commun. 2014;5:4644. Cavalho, Sara [corrected to Carvalho, Sara]. Citation Peeken JC, Spraker MB, Knebel C, Dapper H, Pfeiffer D, Devecka M, Thamer A, Shouman MA, Ott A, von Eisenhart-Rothe R, Nusslin F, Mayr NA, Nyflot MJ, Combs SE. Tumor grading of soft tissue sarcomas using MRI-based radiomics. EBioMedicine. 2019 Oct;48:332-340. doi: 10.1016/j.ebiom.2019.08.059. Epub 2019 Sep 12.

]]>

<![CDATA[ Ross for Valve Replacement in AduLts Trial ]]>
https://zephyrnet.com/NCT03798782
2019-04-29

https://zephyrnet.com/?p=NCT03798782
NCT03798782https://www.clinicaltrials.gov/study/NCT03798782?tab=tableNANANAThis study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure versus conventional aortic valve replacement using a biologic or mechanical heart valve. The Ross procedure replaces a patient’s diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span.
<![CDATA[

Studies

Study First Submitted Date 2018-12-18
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-02-24
Start Month Year April 29, 2019
Primary Completion Month Year October 1, 2022
Verification Month Year February 2023
Verification Date 2023-02-28
Last Update Posted Date 2023-02-24

Detailed Descriptions

Sequence: 20549475
Description Heart valves help control blood flow through the heart and, if diseased, may need to be replaced. After having a heart valve replaced, patients have a higher risk of death than people who have not had a valve replaced. In young adult patients, replacing the aortic heart valve with a mechanical valve halves their life-span compared to other people their age. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span. An operation, called the Ross procedure, replaces a patient's diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. The Ross procedure aims to improve valve durability with less clotting, avoiding use of blood thinners. Patients and physicians need a large, high-quality study comparing the Ross procedure and standard valve replacement to know if either approach is better.

The investigators will perform a 3-year feasibility study in seven sites, in Canada and abroad, to test the study design and ability to do a larger, conclusive study comparing the impact of the Ross procedure to standard valve replacement on survival without valve-related life-threatening complications. Patients will be randomized, like flipping a coin, to receive the Ross or standard valve surgery. The goals are 1) to evaluate if the investigators can recruit 6 patients per site per year, 2) to test if the assigned procedure is performed in over 90% of study patients, and 3) to see how many mechanical vs. tissue valves are used in the standard valve group. Patients eligible but not enrolled in the trial will be asked if the investigators can collect some data on how they do after their surgery. If the investigators show the study is feasible, they will proceed to the full study and will include the feasibility patients in the full study.

Facilities

Sequence: 198413911
Name Hamilton General Hospital
City Hamilton
State Ontario
Zip L8L 2X2
Country Canada

Conditions

Sequence: 51729101
Name Aortic Valve Disease
Downcase Name aortic valve disease

Id Information

Sequence: 39807126
Id Source org_study_id
Id Value REVIVAL-2018

Countries

Sequence: 42206284
Name Canada
Removed False

Design Groups

Sequence: 55149161 Sequence: 55149162
Group Type Experimental Group Type Active Comparator
Title Ross procedure Title Conventional aortic valve replacement
Description The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. Description The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.

Interventions

Sequence: 52050747 Sequence: 52050748
Intervention Type Procedure Intervention Type Procedure
Name Ross procedure Name Conventional aortic valve replacement
Description The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. Identified Ross experts will perform all Ross procedures. Description The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.

Keywords

Sequence: 79147984 Sequence: 79147985 Sequence: 79147986
Name Cardiac surgery Name Aortic valve replacement Name Ross procedure
Downcase Name cardiac surgery Downcase Name aortic valve replacement Downcase Name ross procedure

Design Outcomes

Sequence: 175941658 Sequence: 175941659 Sequence: 175941660 Sequence: 175941661 Sequence: 175941662 Sequence: 175941663 Sequence: 175941664 Sequence: 175941665 Sequence: 175941666 Sequence: 175941667 Sequence: 175941668 Sequence: 175941669 Sequence: 175941670 Sequence: 175941671 Sequence: 175941672 Sequence: 175941673 Sequence: 175941674 Sequence: 175941675 Sequence: 175941676 Sequence: 175941677 Sequence: 175941678 Sequence: 175941679
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Full trial primary outcome – The rate of survival free of a composite of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention) Measure Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial Measure The rate of compliance with allocation in the pilot trial to determine the feasibility of a full trial Measure Measure the proportions of type of conventional valve used in the pilot trial Measure The rate of perioperative and non-perioperative major bleeding over the duration of patient follow-up Measure The rate of stroke or systemic thromboembolism over the duration of patient follow-up Measure The rate of valve thrombosis per VARC criteria over the duration of patient follow-up Measure The rate of operated-on valve reintervention over the duration of patient follow-up Measure Rate of mortality within 30 days post-operatively Measure Measure health related quality of life using the 36-Item Short Form Survey (SF-36) questionnaire over the duration of patient follow-up Measure The rate of operated-valve endocarditis over the duration of patient follow-up Measure The rate of aortic valve re-intervention over the duration of patient follow-up Measure The rate of pulmonary valve re-intervention over the duration of patient follow-up Measure Mean aortic valve gradient Measure Mean pulmonic valve gradient Measure Severity of aortic valve regurgitation Measure Severity of pulmonic valve regurgitation Measure Rate of myocardial infarction Measure Rate of acute renal failure by Acute Kidney Injury Network classification Measure Rate of need for acute renal replacement therapy Measure Rate of surgical re-exploration of the mediastinum for bleeding Measure Rate of deep mediastinal wound infection
Time Frame Through trial completion, estimated to be 10 years Time Frame Through completion of the pilot trial, estimated to be 3 years Time Frame Through completion of the pilot trial, estimated to be 3 years Time Frame Through completion of the pilot trial, estimated to be 3 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame 30 days Time Frame Annually through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame Through trial completion, estimated to be 10 years Time Frame 30 days postoperatively Time Frame 30 days postoperatively Time Frame 30 days postoperatively Time Frame 30 days postoperatively Time Frame 30 days postoperatively
Description The primary outcome is the rate of survival free of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention) over duration of follow-up. Assessment of this composite over time is particularly important, as the Ross procedure may show initial benefit secondary to thromboembolic and bleeding reduction, however should the technique show high late rates of reoperation as suggested in some observational literature, the effect magnitude may change significantly over time. Description The outcome measures of the pilot trial, in order of importance, are:

To evaluate the capacity to enroll a mean of 6 patients per centre per year.

Description To determine the rate of compliance with randomization allocation. Description To validate the proportion of mechanical (at least 65%) versus biological (at most 35%) valves in the conventional arm. Description Perioperative (index surgery only) Intraoperative: After administration of protamine, delay of chest closure for bleeding > 500 mL/hr requiring packing and transfusion of more than 3 units red blood cells /whole blood.

Upon leaving OR to 48hrs postop (modified BARC type 4)

Intracranial bleeding within 48hrs
Reoperation after sternum closure for purpose of controlling bleeding or relief of tamponade
Transfusion of ≥ 5 units packed red blood cells /whole blood in the 48hr period
Chest tube output ≥ 2L in the first 24hr

Non-perioperative Per the International Society of Thrombosis and Hemostasis (ISTH) major bleeding definition.

Description Stroke is acute focal brain dysfunction due to a vascular cause lasting ≥ 24 hrs in the absence of brain imaging or requires evidence of acute stroke on brain imaging (if there is a stroke documented by CT or MRI or at autopsy, the duration of symptoms/signs may be < 24 hours). Stroke is divided into 3 types: ischemic stroke, hemorrhagic stroke, and undetermined stroke. If death occurs within 24 hours, the neurological deficit must persist up to the time of death.

Systemic arterial embolism is an abrupt vascular insufficiency associated with evidence of arterial occlusion in the absence of other likely mechanisms. Clinical signs/symptoms must be consistent with embolic arterial occlusion, there must be clear evidence of abrupt occlusion of a systemic artery, with at least one type of supporting evidence (surgical report indicating evidence of arterial embolism, pathological specimens related to embolism removal, imaging evidence consistent with arterial embolism, or autopsy report).

Description Valve thrombosis is defined as any thrombus not caused by infection attached to or near an operated valve that occludes part of the blood flow path, interferes with valve function, or is large enough to warrant treatment. Valve thrombus found at autopsy in a patient whose cause of death was not valve related or found at operation for and unrelated indication is to be counted as valve thrombosis. Description Rate of valve reintervention Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve. Description Rate of mortality within 30 days post-operatively Description The SF-36 is a health related quality of life questionnaire that measure eight health domains and each survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. The domains are physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The questionnaire is calibrated such that scored values of 50 represent the norm and higher scored values according to the scoring key represent a more favourable health state. A baseline score will be obtained prior to the patient's surgery and the SF-36 will be administered annually thereafter over the duration of patient follow-up. Description Defined as any infection involving a valve on which an operation has been performed. The diagnosis is based on one or more of the following: 1) reoperation with evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histologic or bacteriologic studies; 2) autopsy findings of abscess, pus, or vegetation involving an operated-on valve; or 3) the meeting of Duke criteria for endocarditis. Description Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve in the aortic position. Description Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve in the pulmonary position. Description Measured through echocardiography Description Measured through echocardiography Description Measured through echocardiography, categorized as mild, moderate, or severe Description Measured through echocardiography, categorized as mild, moderate, or severe Description Myocardial infarction (Fourth universal definition)

Occurring after 48 hrs post-operative, clinical evidence of acute myocardial injury with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of:

Symptoms of myocardial ischemia
New ischemic ECG changes
Development of pathological Q waves
Imaging evidence of new loss of viable myocardium or a new regional wall motion abnormality in a pattern consistent with an ischemic etiology; indication of a coronary thrombus by angiography or autopsy.

Description Acute renal failure By AKIN classification – An abrupt (within 48 hours) reduction in kidney function currently defined as an absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours). Description The rate of patients requiring new renal replacement therapy within 30 days of surgery. Description Surgical re-exploration of the mediastinum for bleeding Description Deep mediastinal wound infection

Browse Conditions

Sequence: 191708275 Sequence: 191708276 Sequence: 191708277 Sequence: 191708278
Mesh Term Aortic Valve Disease Mesh Term Heart Valve Diseases Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases
Downcase Mesh Term aortic valve disease Downcase Mesh Term heart valve diseases Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47908759 Sequence: 47908760
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Population Health Research Institute Name Hamilton Health Sciences Corporation

Overall Officials

Sequence: 29028038
Role Principal Investigator
Name Richard Whitlock, MD, PhD
Affiliation Population Health Research Institute

Design Group Interventions

Sequence: 67610602 Sequence: 67610603
Design Group Id 55149161 Design Group Id 55149162
Intervention Id 52050747 Intervention Id 52050748

Eligibilities

Sequence: 30507631
Gender All
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Age 18-60 years
Undergoing clinically indicated aortic valve replacement
Provided written informed consent

Exclusion Criteria:

Previous valve replacement not in the aortic position
Patients undergoing concomitant CABG or other valve procedure during aortic valve replacement
Known connective tissue disease
Severe (grade 3 or 4) right or left ventricular dysfunction
Pulmonary valve dysfunction or anomaly not compatible with the Ross procedure (as determined by the consulting cardiac surgeon)
Life expectancy less than 5 years (as determined by the consulting cardiac surgeon)
Documented severe aortic insufficiency not solely due to leaflet issue
Previous intervention on the pulmonary valve

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254054785
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 41
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 4
Number Of Secondary Outcomes To Measure 13
Number Of Other Outcomes To Measure 5

Designs

Sequence: 30256709
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Single
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28637206
Responsible Party Type Principal Investigator
Name Richard Whitlock
Title Associate Professor
Affiliation McMaster University

Study References

Sequence: 51620023
Pmid 34531204
Reference Type derived
Citation Whitlock R, Belley-Cote E, Rega F, Chu MWA, McClure GR, Hronyecz H, Verbrugghe P, Devereaux PJ, Bangdiwala S, Eikelboom J, Brady K, Sharifulin R, Bogachev-Prokophiev A, Stoica S. Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial. BMJ Open. 2021 Sep 16;11(9):e046198. doi: 10.1136/bmjopen-2020-046198.

]]>

<![CDATA[ Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX ]]>
https://zephyrnet.com/NCT03798769
2019-01-31

https://zephyrnet.com/?p=NCT03798769
NCT03798769https://www.clinicaltrials.gov/study/NCT03798769?tab=tableNANANAThe goal of this research is to study an intervention, which the investigators call “Supportive Oncology Care at Home,” that entails both remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs, and body weight) and a Medically Home care model (e.g. triggers for phone calls and visits to patients’ homes to address and manage any concerning issues identified). Specifically, the investigators will conduct a single arm pilot study (N=20) in patients with pancreatic cancer who sign consent for parent trial of neoadjuvant FOLFIRINOX (18-179) receiving preoperative FOLFIRINOX to assess the feasibility and acceptability of Supportive Oncology Care at Home.
<![CDATA[

Studies

Study First Submitted Date 2018-12-27
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-11-22
Start Month Year January 31, 2019
Primary Completion Month Year June 1, 2022
Verification Month Year November 2022
Verification Date 2022-11-30
Last Update Posted Date 2022-11-22

Detailed Descriptions

Sequence: 20730278
Description Preoperative treatment can cause significant morbidity and often result in hospitalizations. Patients receiving preoperative FOLFIRINOX often experience numerous side effects, including nausea, vomiting, diarrhea, fatigue, fever, neuropathy, and loss of appetite. Frequently, patients require hospital admissions to help address uncontrolled symptoms related to their cancer and side effects related to the treatment,

Interventions targeting patients' symptoms and delivering care to patients at their homes have the potential to improve patient outcomes. Studies show that interventions targeting patients' symptoms can improve symptom management, enhance quality of life (QOL), and prevent hospitalizations.

Medically Home interventions have shown the potential to enhance patient outcomes. The Medically Home model of care is an alternative to a hospital admission for acute care and treatment of a clinical condition. Medically Home interventions entail providing medical care to acutely ill patients in their home. In addition, research in the general medicine literature has demonstrated that interventions involving remote patient monitoring with 'triggers' for visits to patients' homes for worrisome symptoms can enhance care outcomes.

Although this research demonstrates promising results, these studies have not been conducted among patients with cancer. Notably, the prior work involving home monitoring with visits as needed has lacked patient-reported outcomes, such as symptom monitoring. Thus, efforts are needed to develop and test interventions containing both symptom monitoring and the potential for home visits when necessary in a population of patients with cancer.

Facilities

Sequence: 200189881
Name Ryan Nipp
City Boston
State Massachusetts
Zip 02114
Country United States

Conditions

Sequence: 52193556
Name Pancreas Cancer
Downcase Name pancreas cancer

Id Information

Sequence: 40175456
Id Source org_study_id
Id Value 18-532

Countries

Sequence: 42587803
Name United States
Removed False

Design Groups

Sequence: 55618925
Group Type Experimental
Title Supportive Oncology Care at Home
Description The Supportive Oncology Care at Home intervention entails the following:

patient-reported symptoms, vital sign, and weight monitoring with appropriate triggers for phone calls and home visits by Medically Home based on a clinician-derived algorithm
scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy;
regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.

Interventions

Sequence: 52508198
Intervention Type Other
Name Supportive Oncology Care at Home
Description Entails the following:

patient-reported symptoms, vital sign, and weight monitoring with appropriate triggers to phone calls and home visits by Medically Home based on a clinician-derived algorithm;
scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy;
regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.

Keywords

Sequence: 79901536
Name Pancreas Cancer
Downcase Name pancreas cancer

Design Outcomes

Sequence: 177462003 Sequence: 177461995 Sequence: 177461996 Sequence: 177461997 Sequence: 177461998 Sequence: 177461999 Sequence: 177462000 Sequence: 177462001 Sequence: 177462002 Sequence: 177462004 Sequence: 177462005 Sequence: 177462006 Sequence: 177462007 Sequence: 177462008 Sequence: 177462009 Sequence: 177462010 Sequence: 177462011 Sequence: 177462012 Sequence: 177462013 Sequence: 177462014 Sequence: 177462015 Sequence: 177462016 Sequence: 177462017 Sequence: 177462018 Sequence: 177462019 Sequence: 177462020 Sequence: 177462021 Sequence: 177462022 Sequence: 177462023 Sequence: 177462024 Sequence: 177462025 Sequence: 177462026 Sequence: 177462027 Sequence: 177462028 Sequence: 177462029 Sequence: 177462030
Outcome Type secondary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Patient acceptability Measure Rates of study enrollment Measure Rates of completion Measure Rates of completion of daily symptom monitoring Measure Rates of completion of daily vital signs Measure Rates of completion of weekly body weight Measure Number of home visits required Measure Number of phone calls required Measure Number of emails required Measure Family caregiver acceptability Measure Clinician acceptability Measure Number of emergency department visits Measure Number of urgent visits Measure Number of hospital admissions Measure Change in symptom burden longitudinally throughout the study Measure Change in psychological distress Measure Change in quality of life longitudinally throughout the study Measure Number of cycles of FOLFIRINOX received Measure Number of treatment delays Measure Cumulative dose of FOLFIRINOX received Measure Proportion of patients requiring a hospital admission Measure Number of hospital admissions Measure Proportion of patients requiring an emergency department visit Measure Number of emergency department visits Measure Proportion of patients requiring an urgent care visit Measure Number of urgent care visits Measure Proportion of patients requiring a hospital admission or emergency department visit Measure Number of hospital admissions or emergency department visits Measure Proportion of patients requiring a treatment delay Measure Proportion of days in hospital or emergency department Measure Proportion of days in hospital, emergency department, or urgent care Measure Number of cycles of chemotherapy completed Measure Numbers of treatment delays Measure Dose intensity Measure Overall survival Measure Progression free survival
Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 Years Time Frame 2 Years Time Frame 2 Years Time Frame 2 years Time Frame 2 years Time Frame 2 Years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years Time Frame 2 years
Description Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study. Description Proportion of patients who agree to participate in the study and sign informed consent. Description Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment. Description Proportion of participants completing daily symptom monitoring throughout the study Description Proportion of participants completing daily reporting of vital signs throughout the study Description Proportion of participants completing weekly reporting of body weight throughout the study Description Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home Description Number of phone calls required per patient as well as average duration of these calls Description Number of emails from Medically Home to the primary oncology team Description Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study. Description Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study. Description The number of emergency department [ED] visits and the proportion of patients needing an emergency department [ED] visit Description The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic Description The number of hospital admissions and the proportion of patients needing a hospital admission Description Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised [ESAS-r], range 0-10 for each symptom with higher scores indicating worse symptom burden) throughout the study. Description Change in psychological distress (assessed using the Patient Health Questionnaire-4 [PHQ-4], range 0-12 with higher scores indicating greater distress, and subscales for depression/anxiety ranging 0-6 with higher scores indicating greater distress) throughout the study. Description Change in quality of life (assessed using the Functional Assessment of Cancer Therapy-General [FACT-G], with range of 0-108 and higher scores indicating better quality of life) throughout the study. Description Describe the number of cycles of FOLFIRINOX chemotherapy received by patients Description Describe the number of treatment delays for patients Description Describe the cumulative dose of FOLFIRINOX received Description Compare difference in proportion of patients with hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in number of hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in proportion of patients with emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in number of emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in proportion of patients with urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in number of urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in proportion of patients with a hospital admission or emergency department visit between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in number of hospital admissions or emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in proportion of patients with a treatment delay between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in proportion of days in hospital or emergency department between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in proportion of days in hospital, emergency department, or urgent care between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in number of cycles of chemotherapy completed between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in number of treatment delays between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in chemotherapy dose intensity between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in overall survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home Description Compare difference in progression free survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home

Browse Conditions

Sequence: 193571877 Sequence: 193571878 Sequence: 193571879 Sequence: 193571880 Sequence: 193571881 Sequence: 193571882 Sequence: 193571883 Sequence: 193571884
Mesh Term Pancreatic Neoplasms Mesh Term Digestive System Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Endocrine Gland Neoplasms Mesh Term Digestive System Diseases Mesh Term Pancreatic Diseases Mesh Term Endocrine System Diseases
Downcase Mesh Term pancreatic neoplasms Downcase Mesh Term digestive system neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term endocrine gland neoplasms Downcase Mesh Term digestive system diseases Downcase Mesh Term pancreatic diseases Downcase Mesh Term endocrine system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48340195 Sequence: 48340196
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Massachusetts General Hospital Name Stand Up To Cancer

Overall Officials

Sequence: 29297920
Role Principal Investigator
Name Ryan Nipp, MD, MPH
Affiliation Massachusetts General Hospital

Design Group Interventions

Sequence: 68180096
Design Group Id 55618925
Intervention Id 52508198

Eligibilities

Sequence: 30778534
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Age 18 or older
Within three weeks of signing consent for parent trial of neoadjuvant FOLFIRINOX
Planning to receive care at Massachusetts General Hospital
Ability to read and respond to questions in English
Residing within 50 miles of Massachusetts General Hospital

Exclusion Criteria:

-Uncontrolled psychiatric illness or impaired cognition

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253971231
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 40
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 18
Number Of Other Outcomes To Measure 16

Designs

Sequence: 30524637
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28890947
Responsible Party Type Principal Investigator
Name Ryan Nipp
Title Primary Investigator
Affiliation Massachusetts General Hospital

Study References

Sequence: 52087716
Pmid 35830625
Reference Type derived
Citation Nipp RD, Gaufberg E, Vyas C, Azoba C, Qian CL, Jaggers J, Weekes CD, Allen JN, Roeland EJ, Parikh AR, Miller L, Wo JY, Smith MH, Brown PMC, Shulman E, Fernandez-Del Castillo C, Kimmelman AC, Ting D, Hong TS, Greer JA, Ryan DP, Temel JS, El-Jawahri A. Supportive Oncology Care at Home Intervention for Patients With Pancreatic Cancer. JCO Oncol Pract. 2022 Oct;18(10):e1587-e1593. doi: 10.1200/OP.22.00088. Epub 2022 Jul 13.

Ipd Information Types

Sequence: 3335812 Sequence: 3335813
Name Study Protocol Name Statistical Analysis Plan (SAP)

]]>

<![CDATA[ Automated Check-in Data Collection Study ]]>
https://zephyrnet.com/NCT03798756
2019-01-14

https://zephyrnet.com/?p=NCT03798756
NCT03798756https://www.clinicaltrials.gov/study/NCT03798756?tab=tableNANANAThe aim of this study is to examine patient acceptability, for providing brief research information, whilst self-completing an automated check-in screen prior to any general practice consultation.
<![CDATA[

Studies

Study First Submitted Date 2018-09-14
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-04-19
Start Month Year January 14, 2019
Primary Completion Month Year April 14, 2019
Verification Month Year March 2021
Verification Date 2021-03-31
Last Update Posted Date 2021-04-19
Results First Posted Date 2021-04-19

Detailed Descriptions

Sequence: 20754946
Description The Automated Check-in Data Collection (AC DC) Study, is a pilot feasibility study, observing patients consulting in general practice and completing an automated check-in screen prior to their booked appointment, to confirm their attendance. Participants will be recruited over three weeks from approximately 11 participating general practices.

The primary objective of the study is to assess patient acceptability for answering brief research questions in the general practice waiting room, using an automated check-in screen. This will be measured by observing the percentage of completed automated check-in screens with entered research data.

Secondary objectives will assess check-in completion of self-reported pain and willingness to be contacted about future research studies of relevance. Reported severity of bodily pain experienced over the last 4 weeks and the proportion of patients agreeing to be contacted about future research studies of relevance, will be observed.

Facilities

Sequence: 200390365
Name New Cross Hospital
City Wolverhampton
Zip WV10 0QP
Country United Kingdom

Conditions

Sequence: 52256650
Name Primary Care
Downcase Name primary care

Id Information

Sequence: 40220877
Id Source org_study_id
Id Value RG-0275-18 V1.0

Countries

Sequence: 42636502
Name United Kingdom
Removed False

Design Outcomes

Sequence: 177692558 Sequence: 177692559 Sequence: 177692560
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Self-reported Bodily Pain Measure Bodily Pain Response Measure Consent to Contact Response
Time Frame Through study completion at 1st visit (Day 1) Time Frame Through study completion at 1st visit (Day 1) Time Frame Through study completion at 1st visit (Day 1)
Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description Proportion of participants answering the bodily pain research question using an automated check-in screen. Description Proportion of participants answering the consent to contact research question using an automated check-in screen.

Sponsors

Sequence: 48399214
Agency Class OTHER
Lead Or Collaborator lead
Name Keele University

Overall Officials

Sequence: 29331629
Role Study Director
Name Christian D Mallen
Affiliation University of Keele

Eligibilities

Sequence: 30815056
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Population All patients of age 18 and over, who can read and respond in English and with a booked appointment, consulting with any Health Care Professional (HCP) at their general practice, during the recruitment period will be eligible to participate. All patients are required to confirm their attendance at the general practice by using the automated check-in screen. If the patient completing the automated check-in screen is 18 years of age or over, the additional two research questions will appear for completion.
Criteria Inclusion Criteria:

Patients 18 years of age or over attending participating general practices for a consultation with any healthcare professional.
Patients registered with the participating general practice during the specified recruitment period.
Patients able to read and respond in English.

Exclusion Criteria:

• Patients under the age of 18 attending the general practice for a consultation with a healthcare professional.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254076406
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 3
Were Results Reported True
Months To Report Results 22
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30561019
Observational Model Cohort
Time Perspective Prospective

Milestones

Sequence: 41075729 Sequence: 41075730 Sequence: 41075731
Result Group Id 56156932 Result Group Id 56156932 Result Group Id 56156932
Ctgov Group Code FG000 Ctgov Group Code FG000 Ctgov Group Code FG000
Title STARTED Title COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study
Count 9274 Count 9274 Count 0

Participant Flows

Sequence: 3926520

Outcome Counts

Sequence: 74126858 Sequence: 74126859 Sequence: 74126860
Outcome Id 30855932 Outcome Id 30855933 Outcome Id 30855934
Result Group Id 56156933 Result Group Id 56156934 Result Group Id 56156933
Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants
Count 9274 Count 9274 Count 9274

Provided Documents

Sequence: 2587837
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2018-11-05
Url https://ClinicalTrials.gov/ProvidedDocs/56/NCT03798756/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27985117 Sequence: 27985118 Sequence: 27985119
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000
Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0
Subjects At Risk 0 Subjects At Risk 0 Subjects At Risk 0
Created At 2023-08-09 14:43:35.046965 Created At 2023-08-09 14:43:35.046965 Created At 2023-08-09 14:43:35.046965
Updated At 2023-08-09 14:43:35.046965 Updated At 2023-08-09 14:43:35.046965 Updated At 2023-08-09 14:43:35.046965

Responsible Parties

Sequence: 28927423
Responsible Party Type Sponsor

Result Agreements

Sequence: 3857264
Pi Employee Yes

Result Contacts

Sequence: 3857229
Organization Keele University
Name Mrs Sarah Lawton
Phone 01782 734887
Email s.a.lawton@keele.ac.uk

Outcomes

Sequence: 30855932 Sequence: 30855933 Sequence: 30855934
Outcome Type Primary Outcome Type Secondary Outcome Type Secondary
Title Self-reported Bodily Pain Title Bodily Pain Response Title Consent to Contact Response
Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description Proportion of participants answering the bodily pain research question using an automated check-in screen. Description Proportion of participants answering the consent to contact research question using an automated check-in screen.
Time Frame Through study completion at 1st visit (Day 1) Time Frame Through study completion at 1st visit (Day 1) Time Frame Through study completion at 1st visit (Day 1)
Units Participants Units Participants Units Participants
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants

Outcome Measurements

Sequence: 236078567 Sequence: 236078568 Sequence: 236078569 Sequence: 236078570 Sequence: 236078571 Sequence: 236078572 Sequence: 236078573 Sequence: 236078574 Sequence: 236078575
Outcome Id 30855932 Outcome Id 30855932 Outcome Id 30855932 Outcome Id 30855932 Outcome Id 30855932 Outcome Id 30855932 Outcome Id 30855932 Outcome Id 30855933 Outcome Id 30855934
Result Group Id 56156933 Result Group Id 56156933 Result Group Id 56156933 Result Group Id 56156933 Result Group Id 56156933 Result Group Id 56156933 Result Group Id 56156933 Result Group Id 56156934 Result Group Id 56156933
Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Category None Category Very mild Category Mild Category Moderate Category Severe Category Very Severe Category Not documented
Title Self-reported Bodily Pain Title Self-reported Bodily Pain Title Self-reported Bodily Pain Title Self-reported Bodily Pain Title Self-reported Bodily Pain Title Self-reported Bodily Pain Title Self-reported Bodily Pain Title Bodily Pain Response Title Consent to Contact Response
Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. Description Proportion of participants answering the bodily pain research question using an automated check-in screen. Description Proportion of participants answering the consent to contact research question using an automated check-in screen.
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 2937 Param Value 1061 Param Value 1446 Param Value 2344 Param Value 1125 Param Value 9 Param Value 352 Param Value 8922 Param Value 8285
Param Value Num 2937.0 Param Value Num 1061.0 Param Value Num 1446.0 Param Value Num 2344.0 Param Value Num 1125.0 Param Value Num 9.0 Param Value Num 352.0 Param Value Num 8922.0 Param Value Num 8285.0

Baseline Counts

Sequence: 11399690
Result Group Id 56156931
Ctgov Group Code BG000
Units Participants
Scope overall
Count 9274

Result Groups

Sequence: 56156931 Sequence: 56156932 Sequence: 56156933 Sequence: 56156934 Sequence: 56156935
Ctgov Group Code BG000 Ctgov Group Code FG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code EG000
Result Type Baseline Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Reported Event
Title Cohort Title Cohort Title Bodily Pain Title Cohort Title Cohort
Description This was a Cohort, there were no arms. It was an entire group. Description Automated check-in Description To assess patient acceptability of answering a research question on bodily pain, in the general practice waiting room using an automated check-in screen. Description Automated check-in Description All those patients checking-in for a pre-booked consultation using an automated check-in screen and answering at least one research question

Baseline Measurements

Sequence: 125816605 Sequence: 125816606 Sequence: 125816607 Sequence: 125816608 Sequence: 125816609 Sequence: 125816610 Sequence: 125816611
Result Group Id 56156931 Result Group Id 56156931 Result Group Id 56156931 Result Group Id 56156931 Result Group Id 56156931 Result Group Id 56156931 Result Group Id 56156931
Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000
Classification United Kingdom
Category <=18 years Category Between 18 and 65 years Category >=65 years Category Female Category Male
Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Sex: Female, Male Title Sex: Female, Male Title Region of Enrollment Title Patients checking in for a consultation, answering a research question, using check-in sceen
Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units Participants
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Count of Participants
Param Value 0 Param Value 5982 Param Value 3292 Param Value 5653 Param Value 3621 Param Value 9274 Param Value 9274
Param Value Num 0.0 Param Value Num 5982.0 Param Value Num 3292.0 Param Value Num 5653.0 Param Value Num 3621.0 Param Value Num 9274.0 Param Value Num 9274.0
Number Analyzed 9274 Number Analyzed 9274 Number Analyzed 9274 Number Analyzed 9274 Number Analyzed 9274 Number Analyzed 9274 Number Analyzed 9274

]]>

<![CDATA[ Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study ]]>
https://zephyrnet.com/NCT03798743
2019-01-01

https://zephyrnet.com/?p=NCT03798743
NCT03798743https://www.clinicaltrials.gov/study/NCT03798743?tab=tableNANANAThe study aim to Evaluate the combination of ididilimumab and docetaxel alone in the treatment of previous platinum-containing double-drug chemotherapy according to RECIST 1.1Objective remission rate of advanced or metastatic non-small cell lung cancer with negative, driving gene negative (EGFR, ALK, ROS1); (ORR).
<![CDATA[

Studies

Study First Submitted Date 2019-01-05
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-03-02
Start Month Year January 1, 2019
Primary Completion Month Year December 30, 2021
Verification Month Year March 2022
Verification Date 2022-03-31
Last Update Posted Date 2022-03-02

Detailed Descriptions

Sequence: 20790132
Description This study is a single case of syndilizumab plus docetaxel monotherapy in a Chinese-negative late-stage or metastatic non-small cell lung cancer (NSCLC) failed platinum-containing dual-drug chemotherapy. Center, single arm phase II study. In this study, 30 patients with advanced or metastatic non-small cell lung cancer who had failed platinum-containing dual-drug chemotherapy were treated with rituximab plus docetaxel every 3 weeks until disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other cessation of treatment as prescribed by the program, whichever occurs first. The primary end point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review Board (IRRC). The longest treatment time for ididibizumab is 24 months. An interim analysis will be conducted during the course of the study. The results and reports will be provided to the Independent Data Audit Committee (IDMC), which determines whether the trial is valid based on the valid cut-off value of the trial and whether the study data can be submitted in advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and the sponsor. The responsibilities and related procedures of IDMC members will be defined in the IDMC charter.

Facilities

Sequence: 200680789
Name Hunan Provincal Tumor Hospital
City Changsha
State Hunan
Zip 410013
Country China

Browse Interventions

Sequence: 96327338 Sequence: 96327339 Sequence: 96327340 Sequence: 96327341 Sequence: 96327342 Sequence: 96327343
Mesh Term Docetaxel Mesh Term Antineoplastic Agents Mesh Term Tubulin Modulators Mesh Term Antimitotic Agents Mesh Term Mitosis Modulators Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term docetaxel Downcase Mesh Term antineoplastic agents Downcase Mesh Term tubulin modulators Downcase Mesh Term antimitotic agents Downcase Mesh Term mitosis modulators Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52346402
Name Non-small Cell Lung Cancer
Downcase Name non-small cell lung cancer

Id Information

Sequence: 40284229
Id Source org_study_id
Id Value SUCCESS

Countries

Sequence: 42705271
Name China
Removed False

Design Groups

Sequence: 55788743
Group Type Experimental
Title Sintilimab Combined With Docetaxel
Description Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer

Interventions

Sequence: 52657519
Intervention Type Drug
Name Sintilimab Combined With Docetaxel
Description Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w

Keywords

Sequence: 80110991 Sequence: 80110992 Sequence: 80110993
Name Non-small Cell Lung Cancer Name Sintilimab Name Docetaxel
Downcase Name non-small cell lung cancer Downcase Name sintilimab Downcase Name docetaxel

Design Outcomes

Sequence: 178026315 Sequence: 178026316 Sequence: 178026317 Sequence: 178026318 Sequence: 178026319 Sequence: 178026320
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure ORR (Overall response rate) Measure PFS (progression free survival time) Measure OS (overall survival time) Measure DOR (duration of response) Measure DCR (disease control rate) Measure TTR (time to response)
Time Frame Approximately 1 years Time Frame Approximately 1 years Time Frame Approximately 1 years Time Frame Approximately 1 years Time Frame Approximately 1 years Time Frame Approximately 1 years
Description Evaluation of objective response rates in patients with advanced or metastatic non-small cell lung cancer who failed to receive platinum-based dual-drug chemotherapy in response to RECIST 1.1 and in combination with docetaxel and docetaxel Description Assessment of the disease-free progression of the subject according to RECIST 1.1 Description Assess the overall survival of the subject according to RECIST 1.1 Description Assessment of subject's duration of remission according to RECIST 1.1 Description Assessment of subject's disease control rate according to RECIST 1.1 Description Assessment of subject's objective response time according to RECIST 1.1

Browse Conditions

Sequence: 194154796 Sequence: 194154797 Sequence: 194154798 Sequence: 194154799 Sequence: 194154800 Sequence: 194154801 Sequence: 194154802 Sequence: 194154803 Sequence: 194154804 Sequence: 194154805
Mesh Term Lung Neoplasms Mesh Term Carcinoma, Non-Small-Cell Lung Mesh Term Respiratory Tract Neoplasms Mesh Term Thoracic Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases Mesh Term Carcinoma, Bronchogenic Mesh Term Bronchial Neoplasms
Downcase Mesh Term lung neoplasms Downcase Mesh Term carcinoma, non-small-cell lung Downcase Mesh Term respiratory tract neoplasms Downcase Mesh Term thoracic neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term carcinoma, bronchogenic Downcase Mesh Term bronchial neoplasms
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48483096
Agency Class OTHER
Lead Or Collaborator lead
Name Hunan Province Tumor Hospital

Overall Officials

Sequence: 29378430
Role Principal Investigator
Name Yongchang Zhang, MD
Affiliation Hunan Cancer Hospital

Design Group Interventions

Sequence: 68387504
Design Group Id 55788743
Intervention Id 52657519

Eligibilities

Sequence: 30866920
Gender All
Minimum Age 18 Years
Maximum Age 75 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Sign written informed consent before any trial-related processes are implemented
Age ≥ 18 years old and ≤ 75 years old
Life expectancy exceeds 3 months
The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard
Histological or cytological diagnosis of NSCLC and stage IIIB/IV stage tumors (according to the International Association for the Study of Lung Cancer)Chest tumor staging manual 8th edition judgment) or in multimodal treatment (radiotherapy, surgical resection or radical chemoradiotherapy local treatment)Subjects with relapse or disease progression after treatment for locally advanced disease.

Subjects must have previously been treated with a platinum-containing dual chemotherapy (carboplatin or cisplatin) regimen for advanced or metastatic tumorsisease progression occurred during or after the period.

i) receiving maintenance therapy (referring to treatment with no progress after treatment with a platinum-containing dual chemotherapy regimen) and progress Subjects are eligible for inclusion. Ii) treatment of locally advanced disease with platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy, and completion of treatment Subjects with tumor recurrence or metastasis within 6 months after treatment are eligible.selected.

Iii) administration of platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy for treatment of locally advanced disease >6 months laterTumor recurrence, and later progressed during or after treatment of a recurrent tumor with a platinum-based regimen Subjects are eligible for inclusion.

Patients confirmed by histological specimens who are not eligible for EGFR, ALK or ROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK, ROS1 gene rearrangement);
The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1
Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin≥90g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];
Good liver function, defined as total bilirubin level ≤ normal upper limit (ULN); patients without liver metastases, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 1.5 times ULN, alkaline phosphatase ≤ 2.5 times ULN For patients with recorded liver metastases, AST and ALT levels ≤ 5 times ULN;

Exclusion Criteria:

Small cell lung cancer
Currently participating in interventional clinical research treatment, or receiving other research medications within 4 weeks prior to the first dose or Used research equipment;
Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulus or association a drug that inhibits T cell receptors (eg, CTLA-4, OX-40, CD137);
Systemic systemic treatment of Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use of pleural effusion) with anti-lung cancer indications within 2 weeks prior to the first dose, or before the first dose Major surgical treatment within 3 weeks;
Pulmonary radiation therapy >30 Gy within 6 months prior to first dose
Completed palliative radiotherapy within 7 days prior to the first dose

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253996042
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 36
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30612734
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26757161
Intervention Id 52657519
Name SCD

Responsible Parties

Sequence: 28979268
Responsible Party Type Principal Investigator
Name Yongchang Zhang
Title Professor
Affiliation Hunan Province Tumor Hospital

Study References

Sequence: 52251261
Pmid 36064386
Reference Type derived
Citation Zhang Y, Song L, Zeng L, Xiong Y, Liu L, Zhou C, Yang H, Wang Z, Xia Q, Jiang W, Xu Q, Yang N. Sintilimab plus docetaxel as second-line therapy of advanced non-small cell lung cancer without targetable mutations: a phase II efficacy and biomarker study. BMC Cancer. 2022 Sep 5;22(1):952. doi: 10.1186/s12885-022-10045-0.

]]>

<![CDATA[ Investigation of the Perception of Protein Fortified Foods and Beverages ]]>
https://zephyrnet.com/NCT03798730
2019-01-07

https://zephyrnet.com/?p=NCT03798730
NCT03798730https://www.clinicaltrials.gov/study/NCT03798730?tab=tableNANANAThis study aims to investigate whether protein fortification of foods and beverages causes mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.
<![CDATA[

Studies

Study First Submitted Date 2018-12-18
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-02-12
Start Month Year January 7, 2019
Primary Completion Month Year July 10, 2019
Verification Month Year February 2020
Verification Date 2020-02-29
Last Update Posted Date 2020-02-12

Detailed Descriptions

Sequence: 20709975
Description To investigate, by using protein fortified foods and beverages, whether mucoadhesion to the oral cavity is greater for older adults compared to younger adults and determine whether it is related to salivary flow rate.
To determine whether protein fortification of foods and beverages causes mouthdrying and whether perception and acceptance are influenced by age and individual differences in saliva flow.

These aims will be investigated using two different models: a liquid model using whey protein and a solid model using protein fortified biscuits and cakes.

Facilities

Sequence: 199965044
Name Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading
City Reading
State Berkshire
Zip R66 6UR
Country United Kingdom

Conditions

Sequence: 52138968 Sequence: 52138969 Sequence: 52138970
Name Individual Difference Name Food Sensitivity Name Food Preferences
Downcase Name individual difference Downcase Name food sensitivity Downcase Name food preferences

Id Information

Sequence: 40135033
Id Source org_study_id
Id Value UREC 18/46

Countries

Sequence: 42542667
Name United Kingdom
Removed False

Design Groups

Sequence: 55559308 Sequence: 55559309
Group Type Experimental Group Type Experimental
Title Solid Model Title Liquid Model
Description Cake

-Control Vanilla Cake and Protein Fortified Vanilla Cake

Biscuit -Control Lemon Biscuit and Protein Fortified Lemon Biscuit

Description Whey Protein Beverages

Native sample (protein unheated)
Denatured whey protein (protein heated to denature)

Interventions

Sequence: 52454869 Sequence: 52454870
Intervention Type Behavioral Intervention Type Behavioral
Name Solid Model Name Liquid Model
Description Cake and biscuit will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods of rating drying and discrimination tests "which is the stronger in drying") Description Intervention Description: To study the effect of protein denaturation on perception of whey protein beverages using sensory methods (rating drying as well as discrimination tests "which is the stronger in drying"). Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein beverages.

Keywords

Sequence: 79822769 Sequence: 79822770 Sequence: 79822771 Sequence: 79822772 Sequence: 79822773
Name Older Adults Name Oral Nutritional Supplements Name Saliva Flow Name Mucoadhesion Name Mouthdrying
Downcase Name older adults Downcase Name oral nutritional supplements Downcase Name saliva flow Downcase Name mucoadhesion Downcase Name mouthdrying

Design Outcomes

Sequence: 177263527 Sequence: 177263528 Sequence: 177263529 Sequence: 177263531 Sequence: 177263530 Sequence: 177263532
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion) Measure Mouthdrying from cake Measure Mouthdrying from biscuits Measure Saliva Collection Measure Mouthdrying from whey protein Measure Questionnaire
Time Frame Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year. Time Frame At one time point (visit 3) reported at 1 year. Time Frame At one time point (visit 2) reported at 1 year. Time Frame Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.) Time Frame At one time point (visit 1) reported at 1 year. Time Frame At one time point (visit 1) reported at 1 year.
Description Participants drink whey protein beverages (unheated and heated protein) then after different time points post swallowing (15 seconds to 5 minutes) expectorated saliva is collected to analyse protein for the extent of mucoadhesion) Description Perceived mouth drying from protein fortified vanilla cake and control vanilla cake using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying") Description Perceived mouth drying from protein fortified lemon biscuits and control lemon biscuit using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying") Description Salivary flow rates from unstimulated and stimulated saliva samples. Description Perceived mouth drying from whey protein beverages (unheated and heated whey protein) using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying") Description Dental status and mouth behaviour categorisation via a questionnaire. Category data (ie participants check boxes that apply). The dental status questionnaire is adapted from the WHO oral health questionnaire, it indicates where a participant has poor dental status. The mouth behaviour questionnaire is a validated questionnaire (JMBM, trademarked), we are investigating whether it relates to perception of protein fortified foods.

Browse Conditions

Sequence: 193366386 Sequence: 193366387
Mesh Term Hypersensitivity Mesh Term Immune System Diseases
Downcase Mesh Term hypersensitivity Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48290680
Agency Class OTHER
Lead Or Collaborator lead
Name University of Reading

Overall Officials

Sequence: 29268521
Role Principal Investigator
Name Lisa Methven
Affiliation University of Reading

Design Group Interventions

Sequence: 68107405 Sequence: 68107406
Design Group Id 55559308 Design Group Id 55559309
Intervention Id 52454869 Intervention Id 52454870

Eligibilities

Sequence: 30747703
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Age 18-30 years or over 65 years
Self reported as healthy (no specific disease states)

Exclusion Criteria:

Cognitively impaired
Allergies or intolerances that include coeliac disease, lactose or gluten intolerance
Diabetic
Had oral surgery
Had stroke
Smoker

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121797
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 6
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30493986
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Single
Masking Description All samples provided to the participant are labelled with 3 digit random codes
Intervention Model Description This study involves both a crossover design where each participant tastes both the control product (not fortified) and the protein fortified product with an appropriate break between the two sessions. It is also both a within and between groups design as the responses from the older participants will be compared to the younger participants. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 3 study visits and all foods will be presented with random blinding codes.
Subject Masked True

Responsible Parties

Sequence: 28860266
Responsible Party Type Principal Investigator
Name Lisa Methven
Title Professor in Food and Sensory Science
Affiliation University of Reading

Study References

Sequence: 52032695 Sequence: 52032696 Sequence: 52032697 Sequence: 52032693 Sequence: 52032694 Sequence: 52032698
Pmid 26456531 Pmid 12859786 Pmid 20861088 Pmid 28260840 Pmid 24092277 Pmid 24440265
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Affoo RH, Foley N, Garrick R, Siqueira WL, Martin RE. Meta-Analysis of Salivary Flow Rates in Young and Older Adults. J Am Geriatr Soc. 2015 Oct;63(10):2142-51. doi: 10.1111/jgs.13652. Epub 2015 Oct 12. Citation Gosney M. Are we wasting our money on food supplements in elder care wards? J Adv Nurs. 2003 Aug;43(3):275-80. doi: 10.1046/j.1365-2648.2003.02710.x. Citation Kennedy O, Law C, Methven L, Mottram D, Gosney M. Investigating age-related changes in taste and affects on sensory perceptions of oral nutritional supplements. Age Ageing. 2010 Nov;39(6):733-8. doi: 10.1093/ageing/afq104. Epub 2010 Sep 22. Citation Bull SP, Hong Y, Khutoryanskiy VV, Parker JK, Faka M, Methven L. Whey protein mouth drying influenced by thermal denaturation. Food Qual Prefer. 2017 Mar;56(Pt B):233-240. doi: 10.1016/j.foodqual.2016.03.008. Citation Withers CA, Cook MT, Methven L, Gosney MA, Khutoryanskiy VV. Investigation of milk proteins binding to the oral mucosa. Food Funct. 2013 Nov;4(11):1668-74. doi: 10.1039/c3fo60291e. Citation Withers CA, Lewis MJ, Gosney MA, Methven L. Potential sources of mouth drying in beverages fortified with dairy proteins: A comparison of casein- and whey-rich ingredients. J Dairy Sci. 2014 Mar;97(3):1233-47. doi: 10.3168/jds.2013-7273. Epub 2014 Jan 17.

]]>

<![CDATA[ To Bathe or Not to Bathe ]]>
https://zephyrnet.com/NCT03798717
2019-02-20

https://zephyrnet.com/?p=NCT03798717
NCT03798717https://www.clinicaltrials.gov/study/NCT03798717?tab=tableNANANAType 2 diabetes mellitus (T2DM) is characterised by chronic high blood sugar concentration (hyperglycaemia) and insulin resistance leading to a reduction in insulin sensitivity. These hyperglycaemic excursions can seriously impact metabolic, micro and macrovascular health. The total cost of the direct and indirect care of individuals with diabetes (~90% T2DM) in the UK (United Kingdom) is £23.7 billion, equating to ~20% of the annual national health service (NHS) budget, with this projected to become unsustainable. Low-cost interventions to improve glycaemic control in these individuals are therefore warranted. Current interventions include pharmaceuticals, exercise and calorie restrictive diets. Pharmaceutical interventions carry a high financial cost, while exercise and diet programmes have a low adherence rate in individuals with T2DM.

Heat therapy offers one potential low cost therapy. Immersion in a hot tub for 30 mins.day-1 for 10 days has been shown to reduce fasting plasma [glucose] and HbA1c in individuals with T2DM, which may be explained by acute (e.g. muscle) and chronic (e.g. reduced inflammatory status and increased heat shock proteins (HSP)) adaptations, although experimental evidence for these hypothesis are sparse. Other potential benefits include improved glycaemic control, insulin sensitivity, elevated resting metabolic rate and improved micro- and macrovascular function.

The aim of the present study is to determine whether acute hot water immersion can improve glucose tolerance in individuals with T2DM and whether it is more beneficial to undertake this before or after a OGTT (oral glucose tolerance test).
<![CDATA[

Studies

Study First Submitted Date 2018-12-20
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-07-21
Start Month Year February 20, 2019
Primary Completion Month Year March 9, 2020
Verification Month Year July 2021
Verification Date 2021-07-31
Last Update Posted Date 2021-07-21
Results First Posted Date 2021-07-19

Detailed Descriptions

Sequence: 20724573
Description Visit 1 (consent, screening and familiarisation) During visit 1, participants will give their informed consent, followed by a health screening questionnaire. In addition to the health screening questionnaire, medical history and a blood sample will be collected and analysed for a full blood count, glycated haemoglobin (HbA1c), liver and kidney function. Finally, a resting electrocardiogram (ECG) will also be recorded and then examined for irregularities, where a clinical decision will be made on further participation to the study by consultants at QA (Queen Alexandra) hospital. Participants will then be shown the rest of the equipment and taken through the procedure for the next 3 visits and, if the participant is happy to continue the study, the next visit will be organised.

Visit 2, 3 and 4 Participants will arrive at the laboratory at ~9 am for conditions 1 and 2 and 8 am for condition 3. Prior to a 15 min resting period (supine) before any measures are taken participants will be asked to insert a rectal thermistor (participants will be given clear instructions using the investigator's SoPs (standard operating procedure)). Condition 1, 2 and 3 will be balanced and participants randomly allocated to begin the study in either visit 2, 3 or 4 using a blinded member of the team.

For all visits (see figure 2), participants will lie in a semi recumbent position in minimal clothing (bathing shorts and a t-shirt) for the entirety of the visit. Initially, participants will be cannulated (Versatus winged and ported IV cannula, Terumo, Japan) and blood samples drawn for analysis of osmolality (Lithium Heparin (LH) tubes BD (Becton, Dickinson and Company), USA) plasma [glucose] (Fluoride/Oxalate tubes, BD, USA), [insulin] (Ethylenediaminetetraacetic acid (EDTA) K2, BD, USA), and [eHSP70 (extracellular heat shock protein 70)] (EDTA K2, BD, USA) at baseline and every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) (Rapilose OGTT solution, Penlan healthcare, Japan) will commence in a thermoneutral room (~ 23oC). A maximum of 18 mL of blood being drawn at each time point (max 126 mL per visit). To maintain the patency of the cannula and to reduce the risk of infection, after every sample is taken, 5 mL of saline will be flushed through the cannula. Then before every sample is taken, 2.5 mL of blood will be drawn out of the cannula to ensure any remaining saline will not interfere with the samples and data interpretation (additional 17.5mL per visit). During the OGTT, HR (heart rate) (via electrocardiogram) will be measured continuously, whilst blood pressure (M5-1, Omron, Japan), deep body temperature (rectal probe) and resting metabolic rate (indirect calorimetry) (Quark CPET (cardiopulmonary exercise test), Cosmed, Italy) will be assessed every 30 min.

Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear. Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min (see figure 2 for a schematic).

Facilities

Sequence: 200141289
Name Department of Sport and Exercise Science
City Portsmouth
State Hampshire
Zip PO1 2ER
Country United Kingdom

Conditions

Sequence: 52178903
Name Diabetes Mellitus, Type 2
Downcase Name diabetes mellitus, type 2

Id Information

Sequence: 40164254
Id Source org_study_id
Id Value 003AS

Countries

Sequence: 42575663
Name United Kingdom
Removed False

Design Groups

Sequence: 55601789 Sequence: 55601790 Sequence: 55601791
Group Type No Intervention Group Type Experimental Group Type Experimental
Title Control Title Pre OGTT Title Post OGTT
Description Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. Description Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear. Description Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.

Interventions

Sequence: 52493074
Intervention Type Diagnostic Test
Name Heating
Description Warm water immersion

Design Outcomes

Sequence: 177409859 Sequence: 177409860 Sequence: 177409861 Sequence: 177409862 Sequence: 177409863 Sequence: 177409864 Sequence: 177409865
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Mean AUC (Area Under the Curve) Plasma [Glucose] Measure Change in Plasma [Insulin] Measure Mean Insulin Sensitivity Measure Change in Fuel Utilisation Measure Change in Cardiovascular Status Measure Change in eHSP70 (Extracellular Heat Shock Protein 70) Measure Change in Inflammatory Status
Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks
Description Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). Description Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? Description Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. Description Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? Description Does heart rate (variability) change during or after an acute bout of warm water therapy? Description Does eHSP increases during and following an acute bout of warm water therapy? Description Does inflammatory status (IL-6 & IL-10) change during or after an acute bout of warm water therapy?

Browse Conditions

Sequence: 193515886 Sequence: 193515887 Sequence: 193515888 Sequence: 193515889 Sequence: 193515890
Mesh Term Diabetes Mellitus Mesh Term Diabetes Mellitus, Type 2 Mesh Term Glucose Metabolism Disorders Mesh Term Metabolic Diseases Mesh Term Endocrine System Diseases
Downcase Mesh Term diabetes mellitus Downcase Mesh Term diabetes mellitus, type 2 Downcase Mesh Term glucose metabolism disorders Downcase Mesh Term metabolic diseases Downcase Mesh Term endocrine system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48326163 Sequence: 48326164
Agency Class OTHER Agency Class OTHER_GOV
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Portsmouth Name Portsmouth Hospitals NHS Trust

Design Group Interventions

Sequence: 68159872 Sequence: 68159873
Design Group Id 55601791 Design Group Id 55601790
Intervention Id 52493074 Intervention Id 52493074

Eligibilities

Sequence: 30769672
Gender All
Minimum Age 35 Years
Maximum Age N/A
Healthy Volunteers No
Criteria The participants must meet all of the following criteria to be considered eligible for the study:

Male or female (either post-menopausal or in the early-follicular phase (3-5 days after the onset of menstruation) of the menstrual cycle), aged 35 years or above.
Diagnosed with T2DM as defined by the WHO (World Health Organisation).
Participant is willing and able to give informed consent for participation in the study.
Participant is able to understand and fully cooperate with the study protocol.

Exclusion Criteria

The participant may not enter / be withdrawn from the study if any of the following apply:

Severe peripheral neuropathy (to the point to which they cannot sense temperature)
Uncontrolled hypertension (≥180 systolic / 100 diastolic mmHg)
Taking any medication which may interfere with data interpretation or safety
Who have had a myocardial infarction or cerebro-vascular event
Any cardiac abnormalities which restrict hard exercise
Current smokers or who have stopped within 3 months
Participant is unable to understand and/or fully cooperate with the study protocol
Any other serious medical condition which would interfere with data interpretation or safety will be excluded from participation.
Any skin conditions including ulcerations

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253936836
Number Of Facilities 1
Number Of Nsae Subjects 3
Registered In Calendar Year 2018
Actual Duration 12
Were Results Reported True
Months To Report Results 13
Has Us Facility False
Has Single Facility True
Minimum Age Num 35
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30515826
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Drop Withdrawals

Sequence: 28993690 Sequence: 28993691 Sequence: 28993692 Sequence: 28993693 Sequence: 28993694 Sequence: 28993695 Sequence: 28993696 Sequence: 28993697 Sequence: 28993698 Sequence: 28993699 Sequence: 28993700 Sequence: 28993701 Sequence: 28993702 Sequence: 28993703 Sequence: 28993704 Sequence: 28993705 Sequence: 28993706 Sequence: 28993707 Sequence: 28993708 Sequence: 28993709 Sequence: 28993710 Sequence: 28993711 Sequence: 28993712 Sequence: 28993713 Sequence: 28993714 Sequence: 28993715 Sequence: 28993716 Sequence: 28993717 Sequence: 28993718 Sequence: 28993719 Sequence: 28993720 Sequence: 28993721 Sequence: 28993722 Sequence: 28993723 Sequence: 28993724 Sequence: 28993725
Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812 Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812 Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812 Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812 Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812 Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Reason Failed Screening Reason Failed Screening Reason Failed Screening Reason Failed Screening Reason Failed Screening Reason Failed Screening Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Physician Decision Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Lost to Follow-up Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason Adverse Event Reason COVID-19 (coronavirus disease) Lockdown Reason COVID-19 (coronavirus disease) Lockdown Reason COVID-19 (coronavirus disease) Lockdown Reason COVID-19 (coronavirus disease) Lockdown Reason COVID-19 (coronavirus disease) Lockdown Reason COVID-19 (coronavirus disease) Lockdown
Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 1 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 1 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 1 Count 0

Intervention Other Names

Sequence: 26678029
Intervention Id 52493074
Name Bath

Milestones

Sequence: 41014439 Sequence: 41014440 Sequence: 41014441 Sequence: 41014442 Sequence: 41014443 Sequence: 41014444 Sequence: 41014445 Sequence: 41014446 Sequence: 41014447 Sequence: 41014448 Sequence: 41014449 Sequence: 41014450 Sequence: 41014451 Sequence: 41014452 Sequence: 41014453 Sequence: 41014454 Sequence: 41014455 Sequence: 41014456
Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812 Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812 Result Group Id 56100807 Result Group Id 56100808 Result Group Id 56100809 Result Group Id 56100810 Result Group Id 56100811 Result Group Id 56100812
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005
Title STARTED Title STARTED Title STARTED Title STARTED Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 4 Count 3 Count 3 Count 4 Count 3 Count 3 Count 2 Count 2 Count 2 Count 2 Count 2 Count 2 Count 2 Count 1 Count 1 Count 2 Count 1 Count 1

Participant Flows

Sequence: 3921905
Recruitment Details 440 individuals were screened for eligibility (200 clinical letters, 40 from day events and 200 from local diabetes education group). 420 declined and 0 were excluded. Once participants were randomly allocated to arm sequence 5 withdrew before starting. Three in-between experimental visits. Twelve completed the study and data analysed.
Pre Assignment Details Participants were excluded from the study before assignment to groups if they did not pass screening criteria. Balanced randomisation of order in which individuals completed each arm (cross-over) was carried out. Therefore there was an equal number of individuals completing all combinations of arms.

Outcome Counts

Sequence: 74016528 Sequence: 74016529 Sequence: 74016530 Sequence: 74016531 Sequence: 74016532 Sequence: 74016533 Sequence: 74016534 Sequence: 74016535 Sequence: 74016536 Sequence: 74016537 Sequence: 74016538 Sequence: 74016539 Sequence: 74016540 Sequence: 74016541 Sequence: 74016542 Sequence: 74016543 Sequence: 74016544 Sequence: 74016545 Sequence: 74016546 Sequence: 74016547 Sequence: 74016548
Outcome Id 30811310 Outcome Id 30811310 Outcome Id 30811310 Outcome Id 30811311 Outcome Id 30811311 Outcome Id 30811311 Outcome Id 30811312 Outcome Id 30811312 Outcome Id 30811312 Outcome Id 30811313 Outcome Id 30811313 Outcome Id 30811313 Outcome Id 30811314 Outcome Id 30811314 Outcome Id 30811314 Outcome Id 30811315 Outcome Id 30811315 Outcome Id 30811315 Outcome Id 30811316 Outcome Id 30811316 Outcome Id 30811316
Result Group Id 56100813 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100813 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100813 Result Group Id 56100814 Result Group Id 56100815
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 12 Count 12 Count 12 Count 12 Count 12 Count 12 Count 12 Count 12 Count 12 Count 12 Count 12 Count 12 Count 0 Count 0 Count 0 Count 8 Count 8 Count 8 Count 0 Count 0 Count 0

Provided Documents

Sequence: 2580331
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2019-04-05
Url https://ClinicalTrials.gov/ProvidedDocs/17/NCT03798717/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27948250 Sequence: 27948251 Sequence: 27948252 Sequence: 27948253 Sequence: 27948254 Sequence: 27948255 Sequence: 27948256 Sequence: 27948257 Sequence: 27948258
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG002 Ctgov Group Code EG002
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 2 Subjects Affected 0
Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12
Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404 Created At 2023-08-09 01:48:56.292404
Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404 Updated At 2023-08-09 01:48:56.292404

Reported Events

Sequence: 528319393 Sequence: 528319394 Sequence: 528319395 Sequence: 528319396 Sequence: 528319397 Sequence: 528319398
Result Group Id 56100817 Result Group Id 56100818 Result Group Id 56100819 Result Group Id 56100817 Result Group Id 56100818 Result Group Id 56100819
Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002
Time Frame 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. Time Frame 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. Time Frame 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. Time Frame 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. Time Frame 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. Time Frame 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks.
Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other
Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 2
Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12
Description Safety population included all participants who underwent the OGTT and passive heating. Description Safety population included all participants who underwent the OGTT and passive heating. Description Safety population included all participants who underwent the OGTT and passive heating. Description Safety population included all participants who underwent the OGTT and passive heating. Description Safety population included all participants who underwent the OGTT and passive heating. Description Safety population included all participants who underwent the OGTT and passive heating.
Event Count 0 Event Count 1 Event Count 0 Event Count 0 Event Count 0 Event Count 2
Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Surgical and medical procedures Organ System Investigations Organ System Investigations Organ System Investigations
Adverse Event Term Pain on cannulation Adverse Event Term Pain on cannulation Adverse Event Term Pain on cannulation Adverse Event Term Vasovagal syncope Adverse Event Term Vasovagal syncope Adverse Event Term Vasovagal syncope
Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0
Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment

Responsible Parties

Sequence: 28882133
Responsible Party Type Principal Investigator
Name Ant Shepherd
Title Senior Lecturer
Affiliation University of Portsmouth

Result Agreements

Sequence: 3852649
Pi Employee Yes

Result Contacts

Sequence: 3852614
Organization University of Portsmouth
Name Dr. Ant Shepherd
Phone 02392845289
Email ant.shepherd@port.ac.uk

Outcomes

Sequence: 30811316 Sequence: 30811310 Sequence: 30811311 Sequence: 30811315 Sequence: 30811312 Sequence: 30811313 Sequence: 30811314
Outcome Type Secondary Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Change in Inflammatory Status Title Mean AUC (Area Under the Curve) Plasma [Glucose] Title Change in Plasma [Insulin] Title Change in eHSP70 (Extracellular Heat Shock Protein 70) Title Mean Insulin Sensitivity Title Change in Fuel Utilisation Title Change in Cardiovascular Status
Description Does inflammatory status (IL-6 & IL-10) change during or after an acute bout of warm water therapy? Description Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). Description Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? Description Does eHSP increases during and following an acute bout of warm water therapy? Description Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. Description Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? Description Does heart rate (variability) change during or after an acute bout of warm water therapy?
Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks Time Frame Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks
Population 0 participants analysed due to lack of funds as a result of the COVID-19 pandemic. Data for this has not been collected and will not be in the future. Population Individuals with T2DM (type 2 diabetes mellitus) Population Individuals with T2DM Population Individuals with T2DM Population Individuals with T2DM Population Individuals with T2DM Population 0 participants analysed due to immersion for passive heating causing too much noise in the data for it to be valid.
Units AU Units µU/mL Units pg/mL Units AU Units kcal
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean

Outcome Measurements

Sequence: 235724863 Sequence: 235724864 Sequence: 235724865 Sequence: 235724866 Sequence: 235724867 Sequence: 235724868 Sequence: 235724869 Sequence: 235724870 Sequence: 235724871 Sequence: 235724872 Sequence: 235724873 Sequence: 235724874 Sequence: 235724875 Sequence: 235724876 Sequence: 235724877
Outcome Id 30811310 Outcome Id 30811310 Outcome Id 30811310 Outcome Id 30811311 Outcome Id 30811311 Outcome Id 30811311 Outcome Id 30811312 Outcome Id 30811312 Outcome Id 30811312 Outcome Id 30811313 Outcome Id 30811313 Outcome Id 30811313 Outcome Id 30811315 Outcome Id 30811315 Outcome Id 30811315
Result Group Id 56100813 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815 Result Group Id 56100816 Result Group Id 56100814 Result Group Id 56100815
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002
Title Mean AUC (Area Under the Curve) Plasma [Glucose] Title Mean AUC (Area Under the Curve) Plasma [Glucose] Title Mean AUC (Area Under the Curve) Plasma [Glucose] Title Change in Plasma [Insulin] Title Change in Plasma [Insulin] Title Change in Plasma [Insulin] Title Mean Insulin Sensitivity Title Mean Insulin Sensitivity Title Mean Insulin Sensitivity Title Change in Fuel Utilisation Title Change in Fuel Utilisation Title Change in Fuel Utilisation Title Change in eHSP70 (Extracellular Heat Shock Protein 70) Title Change in eHSP70 (Extracellular Heat Shock Protein 70) Title Change in eHSP70 (Extracellular Heat Shock Protein 70)
Description Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). Description Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). Description Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). Description Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? Description Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? Description Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? Description Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. Description Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. Description Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. Description Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? Description Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? Description Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? Description Does eHSP increases during and following an acute bout of warm water therapy? Description Does eHSP increases during and following an acute bout of warm water therapy? Description Does eHSP increases during and following an acute bout of warm water therapy?
Units AU Units AU Units AU Units µU/mL Units µU/mL Units µU/mL Units AU Units AU Units AU Units kcal Units kcal Units kcal Units pg/mL Units pg/mL Units pg/mL
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 1677 Param Value 1797 Param Value 1662 Param Value 75.18 Param Value 48.79 Param Value 79.86 Param Value 52.00 Param Value 47.45 Param Value 56.51 Param Value 263 Param Value 278 Param Value 304 Param Value 324 Param Value 507 Param Value 364
Param Value Num 1677.0 Param Value Num 1797.0 Param Value Num 1662.0 Param Value Num 75.18 Param Value Num 48.79 Param Value Num 79.86 Param Value Num 52.0 Param Value Num 47.45 Param Value Num 56.51 Param Value Num 263.0 Param Value Num 278.0 Param Value Num 304.0 Param Value Num 324.0 Param Value Num 507.0 Param Value Num 364.0
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 386 Dispersion Value 340 Dispersion Value 364 Dispersion Value 68.94 Dispersion Value 35.11 Dispersion Value 63.91 Dispersion Value 11.56 Dispersion Value 13.86 Dispersion Value 13.85 Dispersion Value 33 Dispersion Value 40 Dispersion Value 38 Dispersion Value 154 Dispersion Value 112 Dispersion Value 81
Dispersion Value Num 386.0 Dispersion Value Num 340.0 Dispersion Value Num 364.0 Dispersion Value Num 68.94 Dispersion Value Num 35.11 Dispersion Value Num 63.91 Dispersion Value Num 11.56 Dispersion Value Num 13.86 Dispersion Value Num 13.85 Dispersion Value Num 33.0 Dispersion Value Num 40.0 Dispersion Value Num 38.0 Dispersion Value Num 154.0 Dispersion Value Num 112.0 Dispersion Value Num 81.0

Baseline Counts

Sequence: 11385352 Sequence: 11385353 Sequence: 11385354 Sequence: 11385355 Sequence: 11385356 Sequence: 11385357 Sequence: 11385358
Result Group Id 56100800 Result Group Id 56100801 Result Group Id 56100802 Result Group Id 56100803 Result Group Id 56100804 Result Group Id 56100805 Result Group Id 56100806
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall Scope overall Scope overall Scope overall Scope overall
Count 4 Count 3 Count 3 Count 4 Count 3 Count 3 Count 20

Result Groups

Sequence: 56100802 Sequence: 56100803 Sequence: 56100800 Sequence: 56100801 Sequence: 56100804 Sequence: 56100805 Sequence: 56100806 Sequence: 56100807 Sequence: 56100808 Sequence: 56100809 Sequence: 56100810 Sequence: 56100811 Sequence: 56100812 Sequence: 56100813 Sequence: 56100814 Sequence: 56100815 Sequence: 56100816 Sequence: 56100817 Sequence: 56100818 Sequence: 56100819
Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG002 Ctgov Group Code FG003 Ctgov Group Code FG004 Ctgov Group Code FG005 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG002 Ctgov Group Code OG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG002
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event Result Type Reported Event
Title Pre OGTT – Control – Post OGTT Title Pre OGTT – Post OGTT – Control Title Control – Pre OGTT – Post OGTT Title Control – Post OGTT – Pre OGTT Title Post OGTT – Control – Pre OGTT Title Post OGTT – Pre OGTT – Control Title Total Title Control – Pre OGTT – Post OGTT Title Control – Post OGTT – Pre OGTT Title Pre OGTT – Control – Post OGTT Title Pre OGTT – Post OGTT – Control Title Post OGTT – Control – Pre OGTT Title Post OGTT – Pre OGTT – Control Title Control Title Pre OGTT Title Post OGTT Title Control Title Control Title Pre OGTT Title Post OGTT
Description Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Description Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Description Participants first underwent a 3 h OGTT with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Description Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Description Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Description Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Description Total of all reporting groups Description Participants first underwent a 3 h OGTT (oral glucose tolerance test) with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Description Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Description Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Description Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Description Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Description Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Description Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. Description Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.

Heating: Warm water immersion

Description Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.

Heating: Warm water immersion

Description Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. Description Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. Description Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.

Heating: Warm water immersion

Description Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.

Heating: Warm water immersion

Baseline Measurements

Sequence: 125616062 Sequence: 125616063 Sequence: 125616064 Sequence: 125616065 Sequence: 125616066 Sequence: 125616067 Sequence: 125616068 Sequence: 125616069 Sequence: 125616070 Sequence: 125616071 Sequence: 125616072 Sequence: 125616073 Sequence: 125616074 Sequence: 125616075 Sequence: 125616076 Sequence: 125616077 Sequence: 125616078 Sequence: 125616079 Sequence: 125616080 Sequence: 125616081 Sequence: 125616082 Sequence: 125616083 Sequence: 125616084 Sequence: 125616085 Sequence: 125616086 Sequence: 125616087 Sequence: 125616088 Sequence: 125616089 Sequence: 125616090 Sequence: 125616091 Sequence: 125616092 Sequence: 125616093 Sequence: 125616094 Sequence: 125616095 Sequence: 125616096 Sequence: 125616097
Result Group Id 56100800 Result Group Id 56100801 Result Group Id 56100802 Result Group Id 56100803 Result Group Id 56100804 Result Group Id 56100805 Result Group Id 56100806 Result Group Id 56100800 Result Group Id 56100801 Result Group Id 56100802 Result Group Id 56100803 Result Group Id 56100804 Result Group Id 56100805 Result Group Id 56100806 Result Group Id 56100800 Result Group Id 56100801 Result Group Id 56100802 Result Group Id 56100803 Result Group Id 56100804 Result Group Id 56100805 Result Group Id 56100806 Result Group Id 56100800 Result Group Id 56100801 Result Group Id 56100802 Result Group Id 56100803 Result Group Id 56100804 Result Group Id 56100805 Result Group Id 56100806 Result Group Id 56100800 Result Group Id 56100801 Result Group Id 56100802 Result Group Id 56100803 Result Group Id 56100804 Result Group Id 56100805 Result Group Id 56100806 Result Group Id 56100806
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG003 Ctgov Group Code BG004 Ctgov Group Code BG005 Ctgov Group Code BG006 Ctgov Group Code BG006
Category <=18 years Category <=18 years Category <=18 years Category <=18 years Category <=18 years Category <=18 years Category <=18 years Category Between 18 and 65 years Category Between 18 and 65 years Category Between 18 and 65 years Category Between 18 and 65 years Category Between 18 and 65 years Category Between 18 and 65 years Category Between 18 and 65 years Category >=65 years Category >=65 years Category >=65 years Category >=65 years Category >=65 years Category >=65 years Category >=65 years Category Female Category Female Category Female Category Female Category Female Category Female Category Female Category Male Category Male Category Male Category Male Category Male Category Male Category Male
Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Race and Ethnicity Not Collected
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 2 Param Value 1 Param Value 1 Param Value 2 Param Value 1 Param Value 2 Param Value 9 Param Value 2 Param Value 2 Param Value 2 Param Value 2 Param Value 2 Param Value 1 Param Value 11 Param Value 1 Param Value 1 Param Value 1 Param Value 1 Param Value 0 Param Value 1 Param Value 5 Param Value 3 Param Value 2 Param Value 2 Param Value 3 Param Value 3 Param Value 2 Param Value 15 Param Value 0
Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 2.0 Param Value Num 9.0 Param Value Num 2.0 Param Value Num 2.0 Param Value Num 2.0 Param Value Num 2.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 11.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 5.0 Param Value Num 3.0 Param Value Num 2.0 Param Value Num 2.0 Param Value Num 3.0 Param Value Num 3.0 Param Value Num 2.0 Param Value Num 15.0 Param Value Num 0.0
Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 20 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 20 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 20 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 20 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 4 Number Analyzed 3 Number Analyzed 3 Number Analyzed 20 Number Analyzed 20
Population Description Race and Ethnicity were not collected from any participant.

]]>

<![CDATA[ Comparison of IFA and LIAISON® for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years ]]>
https://zephyrnet.com/NCT03798704
2019-01-29

https://zephyrnet.com/?p=NCT03798704
NCT03798704https://www.clinicaltrials.gov/study/NCT03798704?tab=tableNANANAThe aim of this study is to compare two different serological tests, IFA and LIAISON, for detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early disseminated Lyme borreliosis.
<![CDATA[

Studies

Study First Submitted Date 2018-12-17
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-04-30
Start Month Year January 29, 2019
Primary Completion Month Year December 31, 2020
Verification Month Year April 2021
Verification Date 2021-04-30
Last Update Posted Date 2021-04-30

Detailed Descriptions

Sequence: 20750439
Description Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick – borne multisystem infectious disease caused by Borrelia burgdorferi sensu lato.

Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and microbiological confirmation of borrelial infection is not required for diagnosis.

Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis, indicating the need for laboratory demonstration of borrelial infection which is mainly accomplished with serological tests.

For detection of borrelial antibodies several methods are used, such as immunofluorescent assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized and have limited sensitivity and specificity.

The aim of this study is to specify and compare the sensitivity of IFA and LIAISON serological tests in early disseminated LB in children in Slovenia.

The secondary aim is to determine the influence of early antibiotic treatment of early disseminated LB on serological results in children with LB in Slovenia and to compare the serological results in children who are treated with antibiotics immediately and those who are treated later in the course of the study.

Facilities

Sequence: 200352070
Name University clinical center
City Ljubljana
Country Slovenia

Conditions

Sequence: 52244470
Name Lyme Disease
Downcase Name lyme disease

Id Information

Sequence: 40212178
Id Source org_study_id
Id Value Arnez 0120-134/2018

Countries

Sequence: 42627132
Name Slovenia
Removed False

Interventions

Sequence: 52557944
Intervention Type Diagnostic Test
Name IFA, LIAISON
Description Comparison of two diagnostic serological tests – IFA and LIAISON.

Keywords

Sequence: 79972573 Sequence: 79972574 Sequence: 79972575 Sequence: 79972576 Sequence: 79972577
Name Lyme disease Name IFA Name LIAISON Name children Name Slovenia
Downcase Name lyme disease Downcase Name ifa Downcase Name liaison Downcase Name children Downcase Name slovenia

Design Outcomes

Sequence: 177648746
Outcome Type primary
Measure Sensitivity IFA vs. LIAISON
Time Frame 2 years
Description LIAISON test (E/ml) is expected to be more sensitive than IFA (titer) in detection of Borrelial antibodies in children with early disseminated LB. In all patients both asseys (LIAISON and IFA) are going to be done from the same samples. The difference in the proportion of positive tests between the two assays will be statisticaly analyzed for IgM and IgG antibodies of each patient group. P values < 0,05 will be interpreted as statistically significant.

IFA: Titres >256 in serum and >4 in CSF will be considered positive. LIAISON values in serum: the values of IgM and IgG in serum <18 in <10 E/ml will be considered as negative, 18-22 and 10-15 E/ml will be considerd as border values and >22 in >15 E/ml will be considered as positive.

LIAISON in cerebral fluid: the values of IgM in IgG in cerebral fluid <2,5 and <4,5 E/ml will be considered as negative, values 2,5-3,5 and 4,5-5,5 E/ml will be considered as border values and >2,5 in >5,5 E/ml will be considered as positive.

Browse Conditions

Sequence: 193766272 Sequence: 193766273 Sequence: 193766274 Sequence: 193766275 Sequence: 193766276 Sequence: 193766277 Sequence: 193766278 Sequence: 193766279 Sequence: 193766280
Mesh Term Lyme Disease Mesh Term Gram-Negative Bacterial Infections Mesh Term Bacterial Infections Mesh Term Bacterial Infections and Mycoses Mesh Term Infections Mesh Term Borrelia Infections Mesh Term Spirochaetales Infections Mesh Term Tick-Borne Diseases Mesh Term Vector Borne Diseases
Downcase Mesh Term lyme disease Downcase Mesh Term gram-negative bacterial infections Downcase Mesh Term bacterial infections Downcase Mesh Term bacterial infections and mycoses Downcase Mesh Term infections Downcase Mesh Term borrelia infections Downcase Mesh Term spirochaetales infections Downcase Mesh Term tick-borne diseases Downcase Mesh Term vector borne diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48388154
Agency Class OTHER
Lead Or Collaborator lead
Name University Medical Centre Ljubljana

Eligibilities

Sequence: 30808209
Sampling Method Non-Probability Sample
Gender All
Minimum Age N/A
Maximum Age 18 Years
Healthy Volunteers No
Population Younger then 18 years
Criteria Children younger than 18 years with early disseminated Lyme disease:

multiple erythema migrans
peripheral facial nerve palsy
lymphocytic meningitis

Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254032419
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 23
Were Results Reported False
Has Us Facility False
Has Single Facility True
Maximum Age Num 18
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30554206
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28920569
Responsible Party Type Principal Investigator
Name Maja Arnez
Title izr. prof. dr. Maja Arnez, dr. med
Affiliation University Medical Centre Ljubljana

]]>

<![CDATA[ Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab ]]>
https://zephyrnet.com/NCT03798691
2019-05-28

https://zephyrnet.com/?p=NCT03798691
NCT03798691https://www.clinicaltrials.gov/study/NCT03798691?tab=tableNANANAInflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract(1) affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles.

Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-07-11
Start Month Year May 28, 2019
Primary Completion Month Year September 2023
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-11

Detailed Descriptions

Sequence: 20647896
Description The purpose of this study is to determine the immunogenicity of the herpes zoster subunit vaccine in inflammatory bowel disease patients on vedolizumab compared to those on anti-tumor necrosis factor (TNF) monotherapy.

The study will evaluate humoral and cell mediated immunity in patients with IBD on vedolizumab who receive the two-dose herpes zoster vaccine. The investigators will evaluate short term, one month after second vaccination dose and sustained immunogenicity at 6 and 12 months post vaccination.

The central hypothesis of this proposal is that IBD patients on vedolizumab should be able to mount a normal vaccine response comparable to those on anti-TNF monotherapy who might benefit from a third dose of the subunit vaccine as has been evaluated in HIV and transplant populations. The hypothesis is that IBD patients on vedolizumab will be able to mount a superior response to those on anti-TNF therapy. A recent study showed that hepatitis B vaccine immunogenicity was not affected by vedolizumab.

The study population will include adult patients aged 50 or older with IBD(diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at University of Wisconsin Hospital and Clinics or Boston Medical Center. There is no randomization or use of placebo in this study. Two study groups (each containing 15 subjects) will be established Group A: Patients with IBD on anti-TNF monotherapy and Group B patients with IBD on vedolizumab monotherapy.

Methods: Eligible patients with IBD will be recruited from the University of Wisconsin Hospital and Clinics or from Center for Digestive Diseases at Boston Medical Center.

Facilities

Sequence: 199300710
Name University of Wisconsin Digestive Health Center
City Madison
State Wisconsin
Zip 53705
Country United States

Browse Interventions

Sequence: 95682476 Sequence: 95682477 Sequence: 95682478
Mesh Term Vaccines Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs
Downcase Mesh Term vaccines Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51980449 Sequence: 51980450 Sequence: 51980451 Sequence: 51980452
Name Inflammatory Bowel Diseases Name Crohn Disease Name Ulcerative Colitis Name Herpes Zoster
Downcase Name inflammatory bowel diseases Downcase Name crohn disease Downcase Name ulcerative colitis Downcase Name herpes zoster

Id Information

Sequence: 40010000 Sequence: 40010001 Sequence: 40010002 Sequence: 40010003
Id Source org_study_id Id Source secondary_id Id Source secondary_id Id Source secondary_id
Id Value 2018-1037 Id Value SMPH/MEDICINE/GASTROENT Id Value A534250 Id Value Protocol Version 9/22/2021
Id Type Other Identifier Id Type Other Identifier Id Type Other Identifier
Id Type Description UW Madison Id Type Description UW Madison Id Type Description UW Madison

Countries

Sequence: 42403985
Name United States
Removed False

Design Groups

Sequence: 55382227 Sequence: 55382228
Group Type Active Comparator Group Type Active Comparator
Title Anti-TNF monotherapy Title Vedolizumab
Description Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. Description Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.

Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.

Interventions

Sequence: 52291549
Intervention Type Biological
Name Shingrix
Description Biological: SHINGRIX

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older.

SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL.

Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.

Design Outcomes

Sequence: 176703110 Sequence: 176703111 Sequence: 176703112 Sequence: 176703113 Sequence: 176703114 Sequence: 176703115
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in cell mediated immunity Measure Percent of participants with sustained cell mediated immunity measured via ELISPOT after immunization. Measure Percent of participants with a change in antibody concentration post immunization Measure Percent of participants with a change in antibody concentration that is sustained at 6 months Measure Incidence of Vaccine related adverse effects Measure Incidence of change in disease activity post immunization
Time Frame It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization. Time Frame Baseline to 6 months post-immunization 2nd dose of vaccine. Time Frame pre-immunization to one month 2nd dose post-immunization Time Frame Baseline to 6 months post-immunization Time Frame This will be done at months 1, 2 and 3. Time Frame at the baseline visit and one month after receipt of each vaccine
Description The primary objective will be the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to one month after receiving second dose of vaccine. Description Sustained change in CMI at 6 months will be assessed after receiving a second dose of booster vaccine post-immunization. CMI will be measured via ELISPOT Description A secondary outcome will be the change in varicella zoster virus (VZV) antibody concentration comparing pre-immunization to post immunization antibody concentration. Description Sustained change in VZV antibody concentration at 6 months after receiving a second dose of booster vaccine post-immunization will be assessed. Description To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects. Description The Simple Clinical Colitis Activity Index (SCCAI) will be used to measure disease activity. It is a questionnaire with six subscore topics with scores defined by UC signs and symptoms from 0 to 4 for a range of scores from 0 to 17. Total scores are interpreted as: Remission = score of 0 to 4 points, Mild Activity = score of 5 to 7 points, Moderate Activity = Score of 8 to 16 points, and Severe Activity = Score of > 16 points.

Browse Conditions

Sequence: 192731834 Sequence: 192731835 Sequence: 192731836 Sequence: 192731837 Sequence: 192731838 Sequence: 192731839 Sequence: 192731840 Sequence: 192731841 Sequence: 192731842 Sequence: 192731843 Sequence: 192731844 Sequence: 192731849 Sequence: 192731845 Sequence: 192731846 Sequence: 192731847 Sequence: 192731848
Mesh Term Herpes Simplex Mesh Term Herpes Zoster Mesh Term Crohn Disease Mesh Term Intestinal Diseases Mesh Term Inflammatory Bowel Diseases Mesh Term Gastroenteritis Mesh Term Gastrointestinal Diseases Mesh Term Digestive System Diseases Mesh Term Herpesviridae Infections Mesh Term DNA Virus Infections Mesh Term Virus Diseases Mesh Term Varicella Zoster Virus Infection Mesh Term Infections Mesh Term Skin Diseases, Viral Mesh Term Skin Diseases, Infectious Mesh Term Skin Diseases
Downcase Mesh Term herpes simplex Downcase Mesh Term herpes zoster Downcase Mesh Term crohn disease Downcase Mesh Term intestinal diseases Downcase Mesh Term inflammatory bowel diseases Downcase Mesh Term gastroenteritis Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term digestive system diseases Downcase Mesh Term herpesviridae infections Downcase Mesh Term dna virus infections Downcase Mesh Term virus diseases Downcase Mesh Term varicella zoster virus infection Downcase Mesh Term infections Downcase Mesh Term skin diseases, viral Downcase Mesh Term skin diseases, infectious Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48140363 Sequence: 48140364
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Wisconsin, Madison Name Boston Medical Center

Design Group Interventions

Sequence: 67892032 Sequence: 67892033
Design Group Id 55382227 Design Group Id 55382228
Intervention Id 52291549 Intervention Id 52291549

Eligibilities

Sequence: 30653071
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Patient is between the ages of 18-70 years, inclusive.
History of primary varicella infection (chicken pox) Confirmed by a previous history of positive varicella zoster virus (VZV) Immunoglobulin G antibody or history of chicken pox
Patient has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
Patient is receiving one of the following treatments for their IBD Group A: Anti-TNF monotherapy (adalimumab, certolizumab, golimumab, infliximab) Group B: Vedolizumab monotherapy
Patient has been on stable treatment for IBD for at least three months.

Exclusion Criteria:

Previous receipt of any HZ vaccine
Allergy to zoster vaccine or a component of it
Other underlying chronic medical condition that could affect immunogenicity to vaccines (rheumatoid arthritis, etc.)
History of herpes zoster or post herpetic neuralgia within the past year.
Patient cannot or will not provide written informed consent.
Patient is being administered immunomodulators currently or within the past three months
Patient has been taking any dose of oral or intravenous steroids within 30 days prior to immunization.
Patient has received polyclonal immunoglobulin therapy or blood products within the last year.
Patient is pregnant per self-reporting or older than age 70 years
Unable to provide appropriate informed consent due to being illiterate or impairment in decision-making capacity.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254257430
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30399927
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26571341
Intervention Id 52291549
Name Recombinant zoster vaccine

Responsible Parties

Sequence: 28766431
Responsible Party Type Sponsor

]]>

<![CDATA[ CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma ]]>
https://zephyrnet.com/NCT03798678
2018-12-26

https://zephyrnet.com/?p=NCT03798678
NCT03798678https://www.clinicaltrials.gov/study/NCT03798678?tab=tableNANANAThis phase I trial studies the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 HCl, carfilzomib, and dexamethasone may work better in treating patients with multiple myeloma.
<![CDATA[

Studies

Study First Submitted Date 2019-01-09
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-06-07
Start Month Year December 26, 2018
Primary Completion Month Year January 30, 2024
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-06-07

Detailed Descriptions

Sequence: 20821318
Description PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of glutaminase inhibitor CB-839 hydrochloride (CB-839 HCl) in combination with carfilzomib and dexamethasone.

SECONDARY OBJECTIVES:

I. Evaluate the safety and tolerability of CB-839 HCl in combination with carfilzomib and dexamethasone.

II. To determine the overall response rate (ORR) associated with the combination of CB-839 HCl with carfilzomib and dexamethasone.

CORRELATIVE RESEARCH OBJECTIVES:

I. Evaluate plasma pharmacokinetic (PK) profiles of CB-839 HCl and carfilzomib when used in combination.

II. To perform molecular profiling assays on malignant and normal tissues, including, but not limited to, whole exome sequencing (WES), messenger ribonucleic acid (RNA) sequencing (RNAseq), circulating cell free (cf) deoxyribonucleic acid (DNA) analysis, flow cytometry assessments, immunohistochemical (IHC) staining, and metabolomics-based assessments in order to identify potential predictive and prognostic biomarkers, and identify resistance mechanisms using genomic DNA, RNA, flow cytometry, IHC, and metabolomics-based assessment platforms.

III. To contribute genetic analysis data from de-identified biospecimens to Genomic Data Commons (GDC), a well annotated cancer molecular and clinical data repository, for current and future research.

IV. To bank CD138+ multiple myeloma (MM) cells from the bone marrow, and blood (for cfDNA analysis) obtained from patients at the Experimental Therapeutics Clinical Trials Network (ETCTN) Biorepository at Nationwide Children's Hospital.

OUTLINE: This is a dose escalation study of glutaminase inhibitor CB-839 hydrochloride.

Patients receive glutaminase inhibitor CB-839 hydrochloride orally (PO) every 12 hours on days 1-28, dexamethasone PO on days 1, 2, 8, 9, 15, 16, and 23, and carfilzomib intravenously (IV) over 10 minutes on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then periodically for up to 1 year.

Facilities

Sequence: 201015882 Sequence: 201015883 Sequence: 201015884 Sequence: 201015885 Sequence: 201015886
Name Yale University Name Moffitt Cancer Center Name Mayo Clinic in Rochester Name Rutgers Cancer Institute of New Jersey Name Ohio State University Comprehensive Cancer Center
City New Haven City Tampa City Rochester City New Brunswick City Columbus
State Connecticut State Florida State Minnesota State New Jersey State Ohio
Zip 06520 Zip 33612 Zip 55905 Zip 08903 Zip 43210
Country United States Country United States Country United States Country United States Country United States

Browse Interventions

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Mesh Term Protease Inhibitors Mesh Term Dexamethasone Mesh Term Dexamethasone acetate Mesh Term Ichthammol Mesh Term BB 1101 Mesh Term Anti-Inflammatory Agents Mesh Term Antiemetics Mesh Term Autonomic Agents Mesh Term Peripheral Nervous System Agents Mesh Term Physiological Effects of Drugs Mesh Term Gastrointestinal Agents Mesh Term Glucocorticoids Mesh Term Hormones Mesh Term Hormones, Hormone Substitutes, and Hormone Antagonists Mesh Term Antineoplastic Agents, Hormonal Mesh Term Antineoplastic Agents Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Dermatologic Agents
Downcase Mesh Term protease inhibitors Downcase Mesh Term dexamethasone Downcase Mesh Term dexamethasone acetate Downcase Mesh Term ichthammol Downcase Mesh Term bb 1101 Downcase Mesh Term anti-inflammatory agents Downcase Mesh Term antiemetics Downcase Mesh Term autonomic agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term gastrointestinal agents Downcase Mesh Term glucocorticoids Downcase Mesh Term hormones Downcase Mesh Term hormones, hormone substitutes, and hormone antagonists Downcase Mesh Term antineoplastic agents, hormonal Downcase Mesh Term antineoplastic agents Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term dermatologic agents
Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52427050 Sequence: 52427051
Name Recurrent Multiple Myeloma Name Refractory Multiple Myeloma
Downcase Name recurrent multiple myeloma Downcase Name refractory multiple myeloma

Id Information

Sequence: 40340431 Sequence: 40340432 Sequence: 40340433 Sequence: 40340434 Sequence: 40340435
Id Source org_study_id Id Source secondary_id Id Source secondary_id Id Source secondary_id Id Source secondary_id
Id Value NCI-2019-00111 Id Value NCI-2019-00111 Id Value 10219 Id Value 10219 Id Value UM1CA186686
Id Type Registry Identifier Id Type Other Identifier Id Type Other Identifier Id Type U.S. NIH Grant/Contract
Id Type Description CTRP (Clinical Trial Reporting Program) Id Type Description Mayo Clinic Cancer Center LAO Id Type Description CTEP
Id Link https://reporter.nih.gov/quickSearch/UM1CA186686

Countries

Sequence: 42771624
Name United States
Removed False

Design Groups

Sequence: 55877194
Group Type Experimental
Title Treatment (CB-839 HCI, dexamethasone, carfilzomib)
Description Patients receive glutaminase inhibitor CB-839 Patients receive glutaminase inhibitor CB-839 hydrochloride PO every 12 hours on days 1-28, dexamethasone PO on days 1, 2, 8, 9, 15, 16, and 23, and carfilzomib IV over 10 minutes on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

Interventions

Sequence: 52736356 Sequence: 52736357 Sequence: 52736358
Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Carfilzomib Name Dexamethasone Name Telaglenastat Hydrochloride
Description Given IV Description Given PO Description Given PO

Design Outcomes

Sequence: 178340804 Sequence: 178340805 Sequence: 178340806 Sequence: 178340807
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type other
Measure Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) Measure Incidence of adverse events Measure Overall response rate (ORR) Measure Pharmacokinetic (PK) profiles and pharmacodynamic effect
Time Frame Up to 28 days Time Frame Up to 30 days after study treatment Time Frame Up to 1 year Time Frame Days 1 and 15 of cycle 1
Description MTD will be determined by dose limiting toxicity (DLT). MTD is defined as the dose level below the lowest dose that induces DLT in at least 2 patients (out of 6). The highest dose is defined as the RP2D. A standard cohort 3+3 design will be used. Description Incidence of adverse events will be graded according to Common Terminology Criteria for Adverse Events version 5.0. The number and severity of all AEs (overall and by dose-level) will be tabulated and summarized in this patient population. These data will be summarized with and without regard to the relationship to the treatment (i.e., ignoring the relationship data and after sub-setting the data to only events that are at least possibly related to study drug). Description The ORR will be defined as the percentage of patients that achieve at least a partial response (as their best response). Properties of the binomial distribution will be used in order to construct an exact 95% confidence interval around this proportion. Description PK and pharmacodynamic data will be examined in an exploratory manner.

Browse Conditions

Sequence: 194459587 Sequence: 194459588 Sequence: 194459589 Sequence: 194459590 Sequence: 194459591 Sequence: 194459592 Sequence: 194459593 Sequence: 194459594 Sequence: 194459595 Sequence: 194459596 Sequence: 194459597 Sequence: 194459598 Sequence: 194459599 Sequence: 194459600
Mesh Term Multiple Myeloma Mesh Term Neoplasms, Plasma Cell Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Hemostatic Disorders Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases Mesh Term Paraproteinemias Mesh Term Blood Protein Disorders Mesh Term Hematologic Diseases Mesh Term Hemorrhagic Disorders Mesh Term Lymphoproliferative Disorders Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases
Downcase Mesh Term multiple myeloma Downcase Mesh Term neoplasms, plasma cell Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term hemostatic disorders Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term paraproteinemias Downcase Mesh Term blood protein disorders Downcase Mesh Term hematologic diseases Downcase Mesh Term hemorrhagic disorders Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48556202
Agency Class NIH
Lead Or Collaborator lead
Name National Cancer Institute (NCI)

Overall Officials

Sequence: 29418330
Role Principal Investigator
Name Wilson I Gonsalves
Affiliation Mayo Clinic Cancer Center LAO

Design Group Interventions

Sequence: 68498718 Sequence: 68498719 Sequence: 68498720
Design Group Id 55877194 Design Group Id 55877194 Design Group Id 55877194
Intervention Id 52736356 Intervention Id 52736357 Intervention Id 52736358

Eligibilities

Sequence: 30912118
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Patients must have relapsed and/or refractory myeloma and be experiencing disease relapse

Patients must have measurable disease by International Myeloma Working Group (IMWG) criteria (any of the following):

Serum M-protein >= 0.5 g/dL or for IgA myeloma, an elevated IgA level by quantitative IgA nephelometry
Urine M-protein >= 200 mg in a 24-hour collection
Serum free light chain level >= 10 mg/dL with an abnormal free light chain ratio
Measurable plasmacytoma by cross sectional imaging (computed tomography [CT], magnetic resonance imaging [MRI] or [18F]-fluorodeoxyglucose positron emission tomography with CT [FDG PET/CT])
20% or more light chain restricted, clonal plasma cells in the bone marrow
At least two prior lines of therapy and all patients should have at least been exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,000 cells/mm3 without growth factors (within 14 days of enrollment)
Hemoglobin >= 8 g/dL (within 14 days of enrollment)
Platelets >= 50,000 cells/mm3 (>= 30,000 cells/mm3 if bone marrow plasma cells >= 50% at enrollment)
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
Creatinine =< institutional ULN OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Willingness to undergo interim bone marrow biopsy/aspiration for clinical purposes

Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

The effects of CB-839 HCl on the developing human fetus are unknown. For this reason and because carfilzomib caused embryo-fetal toxicity in pregnant rabbits at doses lower than the recommended dose, women of child-bearing potential and men must agree to use two effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone administration
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who are refractory or intolerant to carfilzomib (prior carfilzomib exposure accepted)

Patients who have received recent prior chemotherapy with:

Alkylators (e.g., melphalan, cyclophosphamide) and anthracyclines =< 14 days prior to registration,
High dose corticosteroids and immunomodulatory drugs (thalidomide or lenalidomide) =< 7 days prior to registration, or
Monoclonal antibodies =< 14 days prior to registration
Patients who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1 except peripheral neuropathy)
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to CB-839 HCl, carfilzomib, or dexamethasone
Patients with uncontrolled intercurrent illness

Any of the following:

Pregnant women or women of reproductive ability who are unwilling to use two effective methods of contraception from the time of signing the informed consent form through 4 months after the last dose of study drug
Nursing women

And men who are unwilling to use birth control while taking the drug and for 4 months after stopping treatment

Pregnant women are excluded from this study because carfilzomib is a PI with the potential for abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with CB-839 HCl, carfilzomib, and dexamethasone, breastfeeding should be discontinued if the mother is treated with this drug combination
Adverse cardiac history (unstable angina, myocardial infarction less than 4 months, New York Heart Association [NYHA] class III or IV congestive heart failure [CHF], ejection fraction [EF] < 40%, uncontrolled arrhythmias)
Concomitant high dose corticosteroids other than what is part of treatment protocol (concurrent use of corticosteroids). EXCEPTION: Patients may be on chronic steroids (maximum dose 10 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, e.g., adrenal insufficiency, rheumatoid arthritis, etc

Central nervous system (CNS) involvement

Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs
Concurrent amyloid light-chain (AL) amyloidosis
Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
Patient has >= grade 3 peripheral neuropathy or grade 2 with pain on clinical examination during the screening period
Major surgery within 14 days before study registration

On concurrent treatment with an HIV protease inhibitor

Human immunodeficiency virus (HIV) protease inhibitors can affect the unfolded protein response in myeloma cells as well as the activity of PIs
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of CB-839 HCl including difficulty swallowing, refractory vomiting, gastric resection or bypass, or duodenal/jejunal resection

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254174421
Number Of Facilities 5
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30657818
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26798662 Sequence: 26798663 Sequence: 26798664 Sequence: 26798665 Sequence: 26798666 Sequence: 26798667 Sequence: 26798668 Sequence: 26798669 Sequence: 26798670 Sequence: 26798671 Sequence: 26798672 Sequence: 26798673 Sequence: 26798674 Sequence: 26798675 Sequence: 26798676 Sequence: 26798677 Sequence: 26798678 Sequence: 26798679 Sequence: 26798680 Sequence: 26798681 Sequence: 26798682 Sequence: 26798683 Sequence: 26798684 Sequence: 26798685 Sequence: 26798686 Sequence: 26798687 Sequence: 26798688 Sequence: 26798689 Sequence: 26798690 Sequence: 26798691 Sequence: 26798692 Sequence: 26798693 Sequence: 26798694 Sequence: 26798695 Sequence: 26798696 Sequence: 26798697 Sequence: 26798698 Sequence: 26798699 Sequence: 26798700 Sequence: 26798701 Sequence: 26798702 Sequence: 26798703 Sequence: 26798704 Sequence: 26798705 Sequence: 26798706 Sequence: 26798707 Sequence: 26798708 Sequence: 26798709 Sequence: 26798710 Sequence: 26798711 Sequence: 26798712 Sequence: 26798713 Sequence: 26798714 Sequence: 26798715 Sequence: 26798716 Sequence: 26798717 Sequence: 26798718 Sequence: 26798719 Sequence: 26798720 Sequence: 26798721 Sequence: 26798722 Sequence: 26798723 Sequence: 26798724 Sequence: 26798725 Sequence: 26798726 Sequence: 26798727 Sequence: 26798728 Sequence: 26798729
Intervention Id 52736356 Intervention Id 52736356 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736357 Intervention Id 52736358 Intervention Id 52736358
Name Kyprolis Name PR-171 Name Aacidexam Name Adexone Name Aknichthol Dexa Name Alba-Dex Name Alin Name Alin Depot Name Alin Oftalmico Name Amplidermis Name Anemul mono Name Auricularum Name Auxiloson Name Baycadron Name Baycuten Name Baycuten N Name Cortidexason Name Cortisumman Name Decacort Name Decadrol Name Decadron Name Decadron DP Name Decalix Name Decameth Name Decasone R.p. Name Dectancyl Name Dekacort Name Deltafluorene Name Deronil Name Desamethasone Name Desameton Name Dexa-Mamallet Name Dexa-Rhinosan Name Dexa-Scheroson Name Dexa-sine Name Dexacortal Name Dexacortin Name Dexafarma Name Dexafluorene Name Dexalocal Name Dexamecortin Name Dexameth Name Dexamethasone Intensol Name Dexamethasonum Name Dexamonozon Name Dexapos Name Dexinoral Name Dexone Name Dinormon Name Dxevo Name Fluorodelta Name Fortecortin Name Gammacorten Name Hemady Name Hexadecadrol Name Hexadrol Name Lokalison-F Name Loverine Name Methylfluorprednisolone Name Millicorten Name Mymethasone Name Orgadrone Name Spersadex Name TaperDex Name Visumetazone Name ZoDex Name CB-839 HCl Name Glutaminase Inhibitor CB-839 Hydrochloride

Responsible Parties

Sequence: 29024487
Responsible Party Type Sponsor

]]>

<![CDATA[ A Real World Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Solid Tumors ]]>
https://zephyrnet.com/NCT03798665
2018-07-06

https://zephyrnet.com/?p=NCT03798665
NCT03798665https://www.clinicaltrials.gov/study/NCT03798665?tab=tableXian Bang Tantbx-n9mB@126.com13458406996Prospective, multicenter, non-interventional registration studies were used in this project . Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.
<![CDATA[

Studies

Study First Submitted Date 2019-01-08
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year July 6, 2018
Primary Completion Month Year July 6, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200280564
Status Recruiting
Name Affiliated Hospital of North Sichuan Medical College
City Nanchong
State Sichuan
Country China

Facility Contacts

Sequence: 28132853
Facility Id 200280564
Contact Type primary
Name Xian Bang Tan
Email tbx-n9mB@126.com
Phone 13458406996

Conditions

Sequence: 52221498
Name Neutropenia
Downcase Name neutropenia

Id Information

Sequence: 40195610
Id Source org_study_id
Id Value CB-RWS

Countries

Sequence: 42609640
Name China
Removed False

Interventions

Sequence: 52535312
Intervention Type Drug
Name Pegfilgrastim(PEG-rhG-CSF)
Description From the first chemotherapy cycle using PEG-rhG-CSF (which can be any chemotherapy cycle of the patient), record the use of PEG-rhG-CSF in this cycle and each subsequent chemotherapy cycle, including dosage, administration time and dosing frequency

Design Outcomes

Sequence: 177561396 Sequence: 177561397 Sequence: 177561398
Outcome Type primary Outcome Type primary Outcome Type primary
Measure Dosage of PEG-rhG-CSF in chemotherapy Measure Administration time of PEG-rhG-CSF in chemotherapy Measure dosing frequency of PEG-rhG-CSF in chemotherapy
Time Frame 1 YEAR Time Frame 1 YEAR Time Frame 1 YEAR

Browse Conditions

Sequence: 193678340 Sequence: 193678341 Sequence: 193678342 Sequence: 193678343 Sequence: 193678344
Mesh Term Neutropenia Mesh Term Agranulocytosis Mesh Term Leukopenia Mesh Term Leukocyte Disorders Mesh Term Hematologic Diseases
Downcase Mesh Term neutropenia Downcase Mesh Term agranulocytosis Downcase Mesh Term leukopenia Downcase Mesh Term leukocyte disorders Downcase Mesh Term hematologic diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366398
Agency Class OTHER
Lead Or Collaborator lead
Name Affiliated Hospital of North Sichuan Medical College

Central Contacts

Sequence: 12020585
Contact Type primary
Name Xian Bang Tan
Phone 13458406996
Email tbx-n9mB@126.com
Role Contact

Eligibilities

Sequence: 30794693
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Population Age ≥ 18 years old;
Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients;
The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient);
Subjects volunteered to participate in this clinical trial and signed informed consent.
Criteria Inclusion Criteria:

Age ≥ 18 years old;
Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients;
The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient);
Subjects volunteered to participate in this clinical trial and signed informed consent.

Exclusion Criteria:

PEG-rhG-CSF was used in the current chemotherapy cycle;
Have received hematopoietic stem cell transplantation or bone marrow transplantation;
Other drug clinical trials are currently underway.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004308
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3

Designs

Sequence: 30540733
Observational Model Other
Time Perspective Prospective

Responsible Parties

Sequence: 28907053
Responsible Party Type Principal Investigator
Name DaiYuan Ma
Title Director of Cancer Center Affiliation: Affiliated Hospital of North Sichuan Medical College
Affiliation Affiliated Hospital of North Sichuan Medical College

]]>

<![CDATA[ Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR – Pilot Study ]]>
https://zephyrnet.com/NCT03798652
2019-03-03

https://zephyrnet.com/?p=NCT03798652
NCT03798652https://www.clinicaltrials.gov/study/NCT03798652?tab=tableRussell Franks, DrRussell.Franks@kcl.ac.ukNAThe study will investigate whether a new high resolution heart Magnetic Resonance Imaging scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging alone in predicting functional recovery following revascularisation.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-08-19
Start Month Year March 3, 2019
Primary Completion Month Year December 31, 2021
Verification Month Year November 2018
Verification Date 2018-11-30
Last Update Posted Date 2019-08-19

Detailed Descriptions

Sequence: 20709976
Description Coronary artery disease, where the heart's blood supply is restricted by narrowings or blockages, is the commonest cause of heart failure. This condition is called ischaemic cardiomyopathy. In some patients, treating these narrowings/ blockages with by-pass surgery or stents, known as "revascularisation", helps improve the pumping strength of the heart but it is currently difficult to predict which patients will benefit. The best test the investigators currently have to predict who will benefit from revascularisation is an Magnetic Resonance Imaging scan of the heart which looks for how much the heart has been scarred. Hearts with no scar usually improve after revascularisation and hearts with lots of scar usually do not. However, lots of patients fall into the middle and have moderate amounts of scar. The Magnetic Resonance Imaging scan isn't good at predicting if this group of patients will benefit from revascularisation. Revascularisation procedures, including heart by-passes, are not without risk and often require time in intensive care, several days in hospital and a long recovery period at home. If the investigators can develop a better test which is more accurate at predicting whether hearts with moderate scar will improve then they will be able to provide better care for patients by ensuring only those patients who will get benefit from revascularisation are put through the procedure.

This study will investigate whether a new high-resolution heart Magnetic Resonance Imaging scan, which looks at not only levels of scar but also the quality of blood supply, is more accurate than current MRI scans at predicting heart recovery after revascularisation in patients with moderate amounts of scar.

Facilities

Sequence: 199965045
Status Recruiting
Name King's College London
City London
Zip SE1 7EH
Country United Kingdom

Facility Contacts

Sequence: 28086640 Sequence: 28086641
Facility Id 199965045 Facility Id 199965045
Contact Type primary Contact Type backup
Name Amedeo Chiribiri, Dr Name Russell Franks, Dr
Email Amedeo.Chiribiri@kcl.ac.uk Email russell.franks@kcl.ac.uk
Phone +44 (0)2071887188 Phone +44 (0)2071887188

Conditions

Sequence: 52138971 Sequence: 52138972 Sequence: 52138973
Name Cardiovascular Diseases Name Ischemic Cardiomyopathy Name Cardiac Ischemia
Downcase Name cardiovascular diseases Downcase Name ischemic cardiomyopathy Downcase Name cardiac ischemia

Id Information

Sequence: 40135034
Id Source org_study_id
Id Value 247309

Countries

Sequence: 42542668
Name United Kingdom
Removed False

Design Groups

Sequence: 55559310
Title Patients referred for CABG
Description Patients with known coronary artery disease referred for isolated surgical revascularisation, who will be invited to attend our facility for a research CMR scan, a research 3D transthoracic echocardiogram and a 6 minute walk test

Interventions

Sequence: 52454871 Sequence: 52454872 Sequence: 52454873
Intervention Type Device Intervention Type Device Intervention Type Other
Name Research CMR scan Name Research 3D transthoracic echocardiogram Name 6-minute walk test
Description CMR scanning at a 3Tesla scanner at King's College London Description The scan is required to assess left ventricular systolic function Description Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Keywords

Sequence: 79822774 Sequence: 79822775
Name Perfusion Name Viability
Downcase Name perfusion Downcase Name viability

Design Outcomes

Sequence: 177263533 Sequence: 177263534 Sequence: 177263535 Sequence: 177263536 Sequence: 177263537
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other
Measure Recovery of the regional systolic function Measure Recovery of overall Left Ventricular ejection fraction Measure Change in Left Ventricular end diastolic volume Measure Composite of all cause death hospitalisation for heart failure Measure 6- minute walk test
Time Frame 12 months Time Frame 12 months Time Frame 12 months Time Frame 12 months Time Frame 12 months
Description Recovery will be defined as a reduction in average resting wall motion score equal or more than 1. The region of interest will be defined as the segments of myocardium subentended by the revascularised coronary stenosis.

Segments will be considered to have been revascularised if surgical by-pass to the diseased coronary artery subtending the segment is considered successful by the surgical team at the time of surgery.

Browse Conditions

Sequence: 193366388 Sequence: 193366389 Sequence: 193366390 Sequence: 193366391 Sequence: 193366392 Sequence: 193366393 Sequence: 193366394 Sequence: 193366395 Sequence: 193366396 Sequence: 193366397 Sequence: 193366398
Mesh Term Cardiovascular Diseases Mesh Term Cardiomyopathies Mesh Term Myocardial Ischemia Mesh Term Coronary Artery Disease Mesh Term Ischemia Mesh Term Pathologic Processes Mesh Term Heart Diseases Mesh Term Vascular Diseases Mesh Term Coronary Disease Mesh Term Arteriosclerosis Mesh Term Arterial Occlusive Diseases
Downcase Mesh Term cardiovascular diseases Downcase Mesh Term cardiomyopathies Downcase Mesh Term myocardial ischemia Downcase Mesh Term coronary artery disease Downcase Mesh Term ischemia Downcase Mesh Term pathologic processes Downcase Mesh Term heart diseases Downcase Mesh Term vascular diseases Downcase Mesh Term coronary disease Downcase Mesh Term arteriosclerosis Downcase Mesh Term arterial occlusive diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290681
Agency Class OTHER
Lead Or Collaborator lead
Name King's College London

Overall Officials

Sequence: 29268522
Role Principal Investigator
Name Amedeo Chiribiri, Dr
Affiliation King's College London

Central Contacts

Sequence: 12000481 Sequence: 12000482
Contact Type primary Contact Type backup
Name Amedeo Chiribiri, Dr Name Russell Franks, Dr
Phone +44 (0)2071887188
Email Amedeo.Chiribiri@kcl.ac.uk Email Russell.Franks@kcl.ac.uk
Role Contact Role Contact

Design Group Interventions

Sequence: 68107407 Sequence: 68107408 Sequence: 68107409
Design Group Id 55559310 Design Group Id 55559310 Design Group Id 55559310
Intervention Id 52454871 Intervention Id 52454872 Intervention Id 52454873

Eligibilities

Sequence: 30747704
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population The patient will all the above inclusion criteria and none of the exclusion criteria will be identified from:

Referrals for cardiac MRI scans at King's College London;
Referrals for cardiac catheterisation at St. Thomas' Hospital;
Outpatient clinic referrals to St. Thomas's Hospital cardiovascular services;
Cardiovascular multi-disciolinary team meetings

Criteria Inclusion Criteria:

Known coronary artery disease referred for isolated surgical revascularisation;
Wall motion abnormalities at rest in at least two adjacents segments on standard AHA model supplied by a diseased coronary artery;
LV EF <45%.

Exclusion Criteria:

Contraindications to CMR, adenosine and low-dose dobutamine;
GFR <30 ml/min
Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Ballon Pump/left ventricular assist device therapy < 72 hours prior to enrolment;
Sustained Ventricular Tachycardia/Ventricular Fibrillation<72 hours prior to enrolment;
Implantable Cardioverter Defibrilator;
Pregnancy;
Age<18 years
Previous established diagnosis of non ischaemic cardiomyopathy;
Severe concomitant valvular disease;
Recente acute coronary syndrome(<4 weeks prior to enrolment).

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121798
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2
Number Of Other Outcomes To Measure 2

Designs

Sequence: 30493987
Observational Model Cohort
Time Perspective Other

Responsible Parties

Sequence: 28860267
Responsible Party Type Sponsor

]]>

<![CDATA[ Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer ]]>
https://zephyrnet.com/NCT03798639
2019-01-07

https://zephyrnet.com/?p=NCT03798639
NCT03798639https://www.clinicaltrials.gov/study/NCT03798639?tab=tableNANANAThis phase I trial studies the side effects and how well nivolumab works when given together with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-04-21
Start Month Year January 7, 2019
Primary Completion Month Year December 31, 2023
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-21

Detailed Descriptions

Sequence: 20639468
Description PRIMARY OBJECTIVES:

I. To assess the tolerability of two different experimental immunotherapy regimens in the adjuvant setting in patients with Merkel cell carcinoma (MCC).

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability profile of each of the treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

II. To assess the efficacy of each of the treatment arms according to recurrence-free survival (RFS) at one and half years, defined as the time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), whichever occurs first.

III. To assess the efficacy of each of the treatment arms according to overall survival (OS) at three years, defined from the time of randomization and the date of death, compared to historical registry control.

EXPLORATORY OBJECTIVES:

I. To explore potential biomarkers, next generation T cell receptor (TCR) sequencing will be performed to identify and longitudinally track individual T cell clones thus granting a comprehensive insight into immunological changes that occur within the tumor and peripheral blood throughout the course of the disease.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

Facilities

Sequence: 199205021
Name Ohio State University Comprehensive Cancer Center
City Columbus
State Ohio
Zip 43210
Country United States

Browse Interventions

Sequence: 95645035 Sequence: 95645036 Sequence: 95645037 Sequence: 95645038 Sequence: 95645039 Sequence: 95645040
Mesh Term Nivolumab Mesh Term Ipilimumab Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents Mesh Term Immune Checkpoint Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term nivolumab Downcase Mesh Term ipilimumab Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents Downcase Mesh Term immune checkpoint inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51958098 Sequence: 51958099 Sequence: 51958100
Name Merkel Cell Carcinoma Name Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8 Name Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8
Downcase Name merkel cell carcinoma Downcase Name pathologic stage iiia merkel cell carcinoma ajcc v8 Downcase Name pathologic stage iiib merkel cell carcinoma ajcc v8

Id Information

Sequence: 39993159 Sequence: 39993160
Id Source org_study_id Id Source secondary_id
Id Value OSU-18231 Id Value NCI-2018-03329
Id Type Registry Identifier
Id Type Description CTRP (Clinical Trial Reporting Program)

Countries

Sequence: 42384127
Name United States
Removed False

Design Groups

Sequence: 55358680 Sequence: 55358681
Group Type Experimental Group Type Active Comparator
Title Arm I (nivolumab, radiation therapy) Title Arm II (nivolumab, ipilimumab)
Description Patients receive nivolumab IV over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Description Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity.

Interventions

Sequence: 52270402 Sequence: 52270403 Sequence: 52270404
Intervention Type Biological Intervention Type Biological Intervention Type Radiation
Name Ipilimumab Name Nivolumab Name Radiation Therapy
Description Given IV Description Given IV Description Receive radiation therapy

Design Outcomes

Sequence: 176623894 Sequence: 176623895 Sequence: 176623896 Sequence: 176623897 Sequence: 176623898
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other
Measure Percentage of patients completing 12 months of treatment Measure Recurrence-free survival (RFS) one and half years Measure Overall survival at three years Measure Incidence of adverse events (AEs) Measure T cell analysis
Time Frame Up to 12 months Time Frame Time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), assessed up to one and half years. Time Frame Time from randomization to the date of death, assessed up to 3 years Time Frame Up to 3 years post treatment Time Frame Baseline up to 3 years post treatment
Description Will be estimated along with the 95% confidence interval for each arm based on the binomial distribution. Description Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and overall survival (OS), for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated. Description Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and OS, for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated. Description Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Side effects will be summarized by each treatment group. Description TT cell analysis will be performed using peripheral blood at regular time points during the study period

Browse Conditions

Sequence: 192642160 Sequence: 192642161 Sequence: 192642162 Sequence: 192642163 Sequence: 192642164 Sequence: 192642165 Sequence: 192642166 Sequence: 192642167 Sequence: 192642168 Sequence: 192642169 Sequence: 192642170 Sequence: 192642171 Sequence: 192642172 Sequence: 192642173 Sequence: 192642174 Sequence: 192642175
Mesh Term Carcinoma, Merkel Cell Mesh Term Carcinoma Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Polyomavirus Infections Mesh Term DNA Virus Infections Mesh Term Virus Diseases Mesh Term Infections Mesh Term Tumor Virus Infections Mesh Term Carcinoma, Neuroendocrine Mesh Term Neuroendocrine Tumors Mesh Term Neuroectodermal Tumors Mesh Term Neoplasms, Germ Cell and Embryonal Mesh Term Adenocarcinoma Mesh Term Neoplasms, Nerve Tissue
Downcase Mesh Term carcinoma, merkel cell Downcase Mesh Term carcinoma Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term polyomavirus infections Downcase Mesh Term dna virus infections Downcase Mesh Term virus diseases Downcase Mesh Term infections Downcase Mesh Term tumor virus infections Downcase Mesh Term carcinoma, neuroendocrine Downcase Mesh Term neuroendocrine tumors Downcase Mesh Term neuroectodermal tumors Downcase Mesh Term neoplasms, germ cell and embryonal Downcase Mesh Term adenocarcinoma Downcase Mesh Term neoplasms, nerve tissue
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48120030
Agency Class OTHER
Lead Or Collaborator lead
Name Claire Verschraegen

Overall Officials

Sequence: 29163571
Role Principal Investigator
Name Claire Verschraegen, MD
Affiliation Ohio State University Comprehensive Cancer Center

Design Group Interventions

Sequence: 67864119 Sequence: 67864120 Sequence: 67864121 Sequence: 67864122
Design Group Id 55358681 Design Group Id 55358680 Design Group Id 55358681 Design Group Id 55358680
Intervention Id 52270402 Intervention Id 52270403 Intervention Id 52270403 Intervention Id 52270404

Eligibilities

Sequence: 30639974
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Be willing and able to understand and give written informed consent and comply with all study related procedures
All patients should undergo definitive surgical resection, including when possible sentinel lymph node dissection
Patients must have recovered after any recent surgery and be ambulatory
Have node positive disease (stage pIIIA or pIIIB) +/- extracapsular extension

Have node negative disease and any of the following high risk features

Tumor size >= 2 cm
Margins =< 1-2 cm and re-resection is not possible
Evidence of perineural or lymphovascular invasion
Human immunodeficiency virus (HIV) patients with undetectable viral load and CD4+ T-cell counts >= 350 cells/uL
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Absolute neutrophil count (ANC) >= 1,500/mcL (performed within 16 days of treatment initiation)
Platelets >= 100,000/mcL in the absence of transfusion support within 7 days of determining eligibility (performed within 16 days of treatment initiation)
Hemoglobin >= 8 g/dL (performed within 16 days of treatment initiation)

Serum creatinine =< 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance >= 40 mL/min creatinine clearance (performed within 16 days of treatment initiation) (Glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl])

Creatinine clearance should be calculated per institutional standard
Serum total bilirubin =< 1.5 x ULN OR Except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 x ULN (performed within 16 days of treatment initiation)
Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN (performed within 16 days of treatment initiation)
Female subject of childbearing potential should have a negative urine or serum pregnancy at screening and within 24 hours prior to receiving the first dose of study medication and then every 4 weeks while on treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Subjects should agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy. Males must refrain from donating sperm during study participation and for 7 months after the last dose of study medication. Female subject should agree to use an adequate method of contraception starting with the first dose of study therapy through 5 months after the last dose of study therapy

Exclusion Criteria:

Has known distant metastatic MCC
Has a known history of active TB (Bacillus tuberculosis)
Hypersensitivity to any study agents
Have received prior immunotherapy with any PD-1/PDL-1 inhibitors or CTLA-4 antibodies at any time in the past
Has had prior chemotherapy or radiation therapy for treatment of MCC
Has a clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy or radiotherapy, such as serious autoimmune disease, hypersensitivity to investigational product or any component in its formulations, per Food and Drug Administration (FDA) prescription notice

Subjects with prior history of non-Merkel cell carcinoma malignancies are excluded except

Adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia (CLL) or other indolent malignancies not requiring therapy (ie. active surveillance)
Adequately treated malignancies and patient has been in complete remission for at least two years
Patients with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence
Patients with prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligible
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization will be excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease
Has an active infection requiring intravenous systemic therapy
Solid organ transplant recipients and patients with concurrent hematological malignancies including thymomas, leukemias (other than CLL) and lymphomas actively undergoing treatment or completed < 5 years prior
Clinically significant cardiovascular disease with uncontrolled arrhythmia, New York Association class 3 or 4 congestive heart failure, history of myocardial infarction within 6 months, or prolonged corrected QT (QTc) > 500 msec
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254175841
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30386893
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26561913 Sequence: 26561914 Sequence: 26561915 Sequence: 26561916 Sequence: 26561917 Sequence: 26561918 Sequence: 26561919 Sequence: 26561920 Sequence: 26561921 Sequence: 26561922 Sequence: 26561923 Sequence: 26561924 Sequence: 26561925 Sequence: 26561926 Sequence: 26561927 Sequence: 26561928 Sequence: 26561929 Sequence: 26561930 Sequence: 26561931
Intervention Id 52270402 Intervention Id 52270402 Intervention Id 52270402 Intervention Id 52270402 Intervention Id 52270402 Intervention Id 52270403 Intervention Id 52270403 Intervention Id 52270403 Intervention Id 52270403 Intervention Id 52270403 Intervention Id 52270404 Intervention Id 52270404 Intervention Id 52270404 Intervention Id 52270404 Intervention Id 52270404 Intervention Id 52270404 Intervention Id 52270404 Intervention Id 52270404 Intervention Id 52270404
Name Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody Name BMS-734016 Name MDX-010 Name MDX-CTLA4 Name Yervoy Name BMS-936558 Name MDX-1106 Name NIVO Name ONO-4538 Name Opdivo Name Cancer Radiotherapy Name Irradiate Name Irradiated Name irradiation Name Radiation Name Radiotherapeutics Name RADIOTHERAPY Name RT Name Therapy, Radiation

Links

Sequence: 4369037
Url http://cancer.osu.edu
Description The Jamesline

Responsible Parties

Sequence: 28753495
Responsible Party Type Sponsor-Investigator
Name Claire Verschraegen
Title Principal Investigator
Affiliation Ohio State University Comprehensive Cancer Center

]]>

<![CDATA[ Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers ]]>
https://zephyrnet.com/NCT03798626
2019-05-22

https://zephyrnet.com/?p=NCT03798626
NCT03798626https://www.clinicaltrials.gov/study/NCT03798626?tab=tableNANANAThis study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-08-08
Start Month Year May 22, 2019
Primary Completion Month Year March 1, 2023
Verification Month Year August 2023
Verification Date 2023-08-31
Last Update Posted Date 2023-08-08

Facilities

Sequence: 200019886 Sequence: 200019887 Sequence: 200019888 Sequence: 200019889 Sequence: 200019890 Sequence: 200019891 Sequence: 200019892 Sequence: 200019893 Sequence: 200019894 Sequence: 200019895 Sequence: 200019896 Sequence: 200019897 Sequence: 200019898 Sequence: 200019899 Sequence: 200019900 Sequence: 200019901 Sequence: 200019902 Sequence: 200019903 Sequence: 200019904 Sequence: 200019905 Sequence: 200019906 Sequence: 200019907 Sequence: 200019908 Sequence: 200019909 Sequence: 200019910 Sequence: 200019911 Sequence: 200019912 Sequence: 200019913 Sequence: 200019914 Sequence: 200019915 Sequence: 200019916 Sequence: 200019917 Sequence: 200019918 Sequence: 200019919
Name UCLA Medical Center UCLA Oncology Clinic Name Washington University School Siteman Cancer Center Name Sarah Cannon Research Institute Drug Ship – 4 Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site Name Novartis Investigative Site
City Los Angeles City Saint Louis City Nashville City Melbourne City Edegem City Bruxelles City Leuven City Calgary City Toronto City Santiago City Brno City Dresden City Frankfurt City Ulm City Ramat Gan City Tel Aviv City Milano City Rozzano City Nagoya City Kashiwa City Osaka-city City Sunto Gun City Bunkyo-ku City Seoul City Singapore City Sevilla City Hospitalet de LLobregat City Valencia City Madrid City Madrid City Madrid City Tainan City London City Manchester
State California State Missouri State Tennessee State Victoria State Antwerpen State Alberta State Ontario State Czech Republic State MI State MI State Aichi State Chiba State Osaka State Shizuoka State Tokyo State Andalucia State Catalunya State Comunidad Valenciana
Zip 90095 Zip 63110 Zip 37203 Zip 3000 Zip 2650 Zip 1000 Zip 3000 Zip T2N 4N2 Zip M5G 1Z6 Zip 8330074 Zip 656 53 Zip 01307 Zip 60488 Zip 89081 Zip 52621 Zip 6423906 Zip 20162 Zip 20089 Zip 464 8681 Zip 277 8577 Zip 541-8567 Zip 411 8777 Zip 113-8603 Zip 05505 Zip 119074 Zip 41013 Zip 08907 Zip 46010 Zip 28009 Zip 28034 Zip 28050 Zip 70403 Zip SW3 6JJ Zip M20 4BX
Country United States Country United States Country United States Country Australia Country Belgium Country Belgium Country Belgium Country Canada Country Canada Country Chile Country Czechia Country Germany Country Germany Country Germany Country Israel Country Israel Country Italy Country Italy Country Japan Country Japan Country Japan Country Japan Country Japan Country Korea, Republic of Country Singapore Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain Country Taiwan Country United Kingdom Country United Kingdom

Browse Interventions

Sequence: 96013570 Sequence: 96013571 Sequence: 96013572 Sequence: 96013573 Sequence: 96013574 Sequence: 96013575 Sequence: 96013576 Sequence: 96013577 Sequence: 96013578 Sequence: 96013579 Sequence: 96013580 Sequence: 96013581 Sequence: 96013582 Sequence: 96013583 Sequence: 96013584 Sequence: 96013585 Sequence: 96013586 Sequence: 96013587 Sequence: 96013588 Sequence: 96013589 Sequence: 96013590 Sequence: 96013591 Sequence: 96013592 Sequence: 96013593 Sequence: 96013594 Sequence: 96013595 Sequence: 96013596 Sequence: 96013597 Sequence: 96013598 Sequence: 96013599 Sequence: 96013600 Sequence: 96013601
Mesh Term Leucovorin Mesh Term Paclitaxel Mesh Term Bevacizumab Mesh Term Fluorouracil Mesh Term Oxaliplatin Mesh Term Irinotecan Mesh Term Ramucirumab Mesh Term Levoleucovorin Mesh Term Antineoplastic Agents, Phytogenic Mesh Term Antineoplastic Agents Mesh Term Tubulin Modulators Mesh Term Antimitotic Agents Mesh Term Mitosis Modulators Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antineoplastic Agents, Immunological Mesh Term Angiogenesis Inhibitors Mesh Term Angiogenesis Modulating Agents Mesh Term Growth Substances Mesh Term Physiological Effects of Drugs Mesh Term Growth Inhibitors Mesh Term Antimetabolites Mesh Term Antimetabolites, Antineoplastic Mesh Term Immunosuppressive Agents Mesh Term Immunologic Factors Mesh Term Topoisomerase I Inhibitors Mesh Term Topoisomerase Inhibitors Mesh Term Enzyme Inhibitors Mesh Term Antidotes Mesh Term Protective Agents Mesh Term Vitamin B Complex Mesh Term Vitamins Mesh Term Micronutrients
Downcase Mesh Term leucovorin Downcase Mesh Term paclitaxel Downcase Mesh Term bevacizumab Downcase Mesh Term fluorouracil Downcase Mesh Term oxaliplatin Downcase Mesh Term irinotecan Downcase Mesh Term ramucirumab Downcase Mesh Term levoleucovorin Downcase Mesh Term antineoplastic agents, phytogenic Downcase Mesh Term antineoplastic agents Downcase Mesh Term tubulin modulators Downcase Mesh Term antimitotic agents Downcase Mesh Term mitosis modulators Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term angiogenesis inhibitors Downcase Mesh Term angiogenesis modulating agents Downcase Mesh Term growth substances Downcase Mesh Term physiological effects of drugs Downcase Mesh Term growth inhibitors Downcase Mesh Term antimetabolites Downcase Mesh Term antimetabolites, antineoplastic Downcase Mesh Term immunosuppressive agents Downcase Mesh Term immunologic factors Downcase Mesh Term topoisomerase i inhibitors Downcase Mesh Term topoisomerase inhibitors Downcase Mesh Term enzyme inhibitors Downcase Mesh Term antidotes Downcase Mesh Term protective agents Downcase Mesh Term vitamin b complex Downcase Mesh Term vitamins Downcase Mesh Term micronutrients
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52148477 Sequence: 52148478 Sequence: 52148479
Name Colorectal Cancer Name Gastroesophageal Cancer Name Renal Cell Carcinoma
Downcase Name colorectal cancer Downcase Name gastroesophageal cancer Downcase Name renal cell carcinoma

Id Information

Sequence: 40142135 Sequence: 40142136
Id Source org_study_id Id Source secondary_id
Id Value CVPM087A2101 Id Value 2018-003952-19
Id Type EudraCT Number

Countries

Sequence: 42551316 Sequence: 42551317 Sequence: 42551318 Sequence: 42551319 Sequence: 42551320 Sequence: 42551321 Sequence: 42551322 Sequence: 42551323 Sequence: 42551324 Sequence: 42551325 Sequence: 42551326 Sequence: 42551327 Sequence: 42551328 Sequence: 42551329 Sequence: 42551330 Sequence: 42551331 Sequence: 42551332 Sequence: 42551333
Name United States Name Australia Name Belgium Name Canada Name Chile Name Czechia Name Germany Name Israel Name Italy Name Japan Name Korea, Republic of Name Singapore Name Spain Name Taiwan Name United Kingdom Name Argentina Name Austria Name Hong Kong
Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed True Removed True Removed True

Design Groups

Sequence: 55569215 Sequence: 55569212 Sequence: 55569213 Sequence: 55569214
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title Cohort D: 2nd or 3rd line renal cell carcinoma Title Cohort A: 1st line colorectal cancer Title Cohort B: 2nd line colorectal cancer Title Cohort C: 2nd line gastroesophageal cancer
Description Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib Description Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab Description Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab Description Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab

Interventions

Sequence: 52464299 Sequence: 52464300 Sequence: 52464301 Sequence: 52464302 Sequence: 52464303 Sequence: 52464304 Sequence: 52464305
Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Gevokizumab Name Bevacizumab Name Modified FOLFOX6 Name FOLFIRI Name Ramucirumab Name Paclitaxel Name Cabozantinib
Description 60 mg/mL concentration; administered intravenously (IV) Description 25 mg/mL concentration; administered IV Description Oxaliplatin [5 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV] Description Irinotecan [20 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV] Description 10 mg/mL concentration; administered IV Description 6 mg/mL concentration; administered IV Description 60 mg tablet; administered orally

Keywords

Sequence: 79835564 Sequence: 79835558 Sequence: 79835559 Sequence: 79835560 Sequence: 79835561 Sequence: 79835562 Sequence: 79835563 Sequence: 79835565 Sequence: 79835566 Sequence: 79835567 Sequence: 79835568 Sequence: 79835569 Sequence: 79835570 Sequence: 79835571
Name FOLFIRI Name colorectal cancer Name gastroesophageal cancer Name renal cell carcinoma Name gevokizumab Name bevacizumab Name modified FOLFOX6 Name ramucirumab Name paclitaxel Name cabozantinib Name CRC Name GEC Name RCC Name VPM087
Downcase Name folfiri Downcase Name colorectal cancer Downcase Name gastroesophageal cancer Downcase Name renal cell carcinoma Downcase Name gevokizumab Downcase Name bevacizumab Downcase Name modified folfox6 Downcase Name ramucirumab Downcase Name paclitaxel Downcase Name cabozantinib Downcase Name crc Downcase Name gec Downcase Name rcc Downcase Name vpm087

Design Outcomes

Sequence: 177300759 Sequence: 177300760 Sequence: 177300761 Sequence: 177300762 Sequence: 177300763 Sequence: 177300764 Sequence: 177300765 Sequence: 177300766 Sequence: 177300767 Sequence: 177300768 Sequence: 177300769 Sequence: 177300770 Sequence: 177300771 Sequence: 177300772 Sequence: 177300773 Sequence: 177300774 Sequence: 177300775 Sequence: 177300776 Sequence: 177300777 Sequence: 177300778 Sequence: 177300779
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Part 1a (Dose finding): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy Measure Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs) [Cohort C and Cohort D] Measure Part 1b (Safety run-in): Number of DLTs [Cohort A and Cohort B] Measure Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort A subjects at RDE level] Measure Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort B subjects at RDE level] Measure Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort C subjects at RDE level] Measure Overall response rate (ORR) per investigator assessment using RECIST v1.1 Measure Duration of response (DOR) per investigator assessment using RECIST v1.1 Measure Disease Control Rate (DCR) per investigator assessment using RECIST v1.1 Measure Overall survival (OS) Measure PFS by baseline hs-CRP category using RECIST 1.1 [Cohort A and B at RDE level] Measure PFS for subjects from Part 1b at doses other than RDE level (Cohort A and Cohort B) Measure Serum concentration of gevokizumab, as monotherapy and in the combination regimens Measure Serum concentration of bevacizumab Measure Serum concentration of ramucirumab Measure Serum concentration of irinotecan Measure Serum concentration of paclitaxel Measure Serum concentration of cabozantinib Measure Number of patients with anti-drug antibodies for gevokizumab in the combination regimens Measure Number of patients with anti-drug antibodies for bevacizumab in the combination regimens Measure Number of patients with anti-drug antibodies for ramucirumab in the combination regimens
Time Frame Baseline, Day 15 Time Frame First 4 weeks of combination treatment Time Frame First 6 weeks of combination treatment Time Frame At 15 months Time Frame At 9 months Time Frame At 6 months Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 3 months Time Frame Up to 3 months Time Frame Up to 3 months Time Frame Up to 5 years Time Frame Up to 5 years Time Frame Up to 5 years
Description Log scale change of hs-CRP at Day 15 from baseline Description DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria. Description DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria. Description PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1. Description PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1. Description PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1. Description ORR is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), according to RECIST 1.1 Description Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria Description DCR is defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD), according to RECIST 1.1. Description OS is defined as the time from date of first dose of study treatment to date of death due to any cause. Description PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause. Description PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause. Description To characterize the pharmacokinetics of gevokizumab therapy Description To characterize the pharmacokinetics of bevacizumab therapy Description To characterize the pharmacokinetics of ramucirumab therapy Description To characterize the pharmacokinetics of irinotecan therapy Description To characterize the pharmacokinetics of paclitaxel therapy Description To characterize the pharmacokinetics of cabozantinib therapy Description Incidence of immunogenicity for gevokizumab Description Incidence of immunogenicity for bevacizumab Description Incidence of immunogenicity for ramucirumab

Browse Conditions

Sequence: 193401960 Sequence: 193401961 Sequence: 193401962 Sequence: 193401963 Sequence: 193401964 Sequence: 193401965 Sequence: 193401966 Sequence: 193401967 Sequence: 193401968 Sequence: 193401969 Sequence: 193401970 Sequence: 193401971 Sequence: 193401972 Sequence: 193401973 Sequence: 193401974 Sequence: 193401975 Sequence: 193401976 Sequence: 193401977 Sequence: 193401978 Sequence: 193401979 Sequence: 193401980 Sequence: 193401981 Sequence: 193401982 Sequence: 193401983 Sequence: 193401984
Mesh Term Carcinoma Mesh Term Colorectal Neoplasms Mesh Term Carcinoma, Renal Cell Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Intestinal Neoplasms Mesh Term Gastrointestinal Neoplasms Mesh Term Digestive System Neoplasms Mesh Term Neoplasms by Site Mesh Term Digestive System Diseases Mesh Term Gastrointestinal Diseases Mesh Term Colonic Diseases Mesh Term Intestinal Diseases Mesh Term Rectal Diseases Mesh Term Adenocarcinoma Mesh Term Kidney Neoplasms Mesh Term Urologic Neoplasms Mesh Term Urogenital Neoplasms Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Kidney Diseases Mesh Term Urologic Diseases Mesh Term Male Urogenital Diseases
Downcase Mesh Term carcinoma Downcase Mesh Term colorectal neoplasms Downcase Mesh Term carcinoma, renal cell Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term intestinal neoplasms Downcase Mesh Term gastrointestinal neoplasms Downcase Mesh Term digestive system neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term digestive system diseases Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term colonic diseases Downcase Mesh Term intestinal diseases Downcase Mesh Term rectal diseases Downcase Mesh Term adenocarcinoma Downcase Mesh Term kidney neoplasms Downcase Mesh Term urologic neoplasms Downcase Mesh Term urogenital neoplasms Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term kidney diseases Downcase Mesh Term urologic diseases Downcase Mesh Term male urogenital diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48298867
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Novartis Pharmaceuticals

Overall Officials

Sequence: 29273185
Role Study Director
Name Novartis Pharmaceuticals
Affiliation Novartis Pharmaceuticals

Design Group Interventions

Sequence: 68120666 Sequence: 68120667 Sequence: 68120668 Sequence: 68120669 Sequence: 68120670 Sequence: 68120671 Sequence: 68120672 Sequence: 68120673 Sequence: 68120674 Sequence: 68120675 Sequence: 68120676
Design Group Id 55569212 Design Group Id 55569213 Design Group Id 55569214 Design Group Id 55569215 Design Group Id 55569212 Design Group Id 55569213 Design Group Id 55569212 Design Group Id 55569213 Design Group Id 55569214 Design Group Id 55569214 Design Group Id 55569215
Intervention Id 52464299 Intervention Id 52464299 Intervention Id 52464299 Intervention Id 52464299 Intervention Id 52464300 Intervention Id 52464300 Intervention Id 52464301 Intervention Id 52464302 Intervention Id 52464303 Intervention Id 52464304 Intervention Id 52464305

Eligibilities

Sequence: 30752754
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy.
Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1.

For Cohort A:

– First line metastatic colorectal cancer.

For Cohort B:

– Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.

For Cohort C:

– Second line metastatic gastroesophageal cancer that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet.

For Cohort D:

– Second or third line metastatic renal cell carcinoma with a clear-cell component and has received one or two lines of treatment for metastatic disease that included an anti-angiogenic agent for at least 4 weeks with radiologic progression on that treatment.

For subjects starting from Part 1a in Cohorts A and B:

Serum hs-CRP at screening ≥ 10 mg/L.
Not requiring immediate initiation of anti-cancer therapy per investigator's best judgement.

For subjects starting from Part 2 in Cohort C:

– Serum hs-CRP at screening ≥ 10 mg/L.

Exclusion Criteria:

For All Cohorts:

Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol.
Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
Suspected or proven immunocompromised state, or infections (as defined in the protocol).
Conditions that have a high risk of clinically significant bleeding after administration of anti-VEGF agents.
Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease.

For Cohort D:

Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib.

Other protocol-defined inclusion/exclusion criteria may apply

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254186897
Number Of Facilities 34
Registered In Calendar Year 2019
Actual Duration 45
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 6
Number Of Secondary Outcomes To Measure 15

Designs

Sequence: 30499020
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26662278 Sequence: 26662279 Sequence: 26662280
Intervention Id 52464299 Intervention Id 52464301 Intervention Id 52464302
Name VPM087 Name oxaliplatin, leucovorin, 5-fluorouracil Name irinotecan, leucovorin, 5-fluorouracil

Responsible Parties

Sequence: 28865296
Responsible Party Type Sponsor

]]>

<![CDATA[ Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study ]]>
https://zephyrnet.com/NCT03798613
2018-12-21

https://zephyrnet.com/?p=NCT03798613
NCT03798613https://www.clinicaltrials.gov/study/NCT03798613?tab=tableNANANAThe objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4 series watch in identifying atrial fibrillation when it is present.
<![CDATA[

Studies

Study First Submitted Date 2018-12-21
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-04-09
Start Month Year December 21, 2018
Primary Completion Month Year March 29, 2019
Verification Month Year April 2019
Verification Date 2019-04-30
Last Update Posted Date 2019-04-09

Detailed Descriptions

Sequence: 20735788
Description The study will assess the accuracy of the Apple watch 4 series watch when worn by post-operative cardiac surgery patients after they have transferred from the ICU to the cardiac telemetry unit.

During testing each subject will wear:

An Apple Watch 4 series watch for no more than 5 minutes.
Standard continuous telemetry monitor

The location of the watch (left or right wrist) will be randomly assigned.

Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series watch while at the same point in time obtaining tracings from a standard telemetry monitor.

ECGs from the Apple Watch 4 will be collected by asking the patient to place his/ her finger on the digital crown of the Apple Watch 4 for 30 seconds. The rhythm displayed by the Apple Watch 4 will be viewed on the Apple health app (available on the iPhone 8) and will be saved for subsequent viewing and analysis.

Each enrolled patient will have a minimum of three assessments of heart rhythm per day for at least two days, generating a minimum of six data points per patient.

After conclusion of the study for each subject, the ECG's from the health app pertaining to that subject will be reviewed by a board certified cardiologist as will the telemetry tracings.

In order to obtain tracings of new onset post-operative atrial fibrillation. 50% of the subjects enrolled will be in sinus rhythm and 50% will be in atrial fibrillation at the time of enrollment.

Facilities

Sequence: 200244328
Name Cleveland Clinic
City Cleveland
State Ohio
Zip 44195
Country United States

Conditions

Sequence: 52208145 Sequence: 52208146
Name Heart Rate Fast Name Heart Rate Low
Downcase Name heart rate fast Downcase Name heart rate low

Id Information

Sequence: 40186173
Id Source org_study_id
Id Value 18-1397

Countries

Sequence: 42599667
Name United States
Removed False

Design Groups

Sequence: 55634699 Sequence: 55634700
Group Type Active Comparator Group Type Active Comparator
Title Apple Watch 4 Series Device Title Continuous Telemetry
Description Apple watch 4 series heart rate monitoring device Description Standard continuous telemetry monitoring device

Interventions

Sequence: 52522102 Sequence: 52522103
Intervention Type Device Intervention Type Device
Name Apple Watch 4 Series Device Name Continuous Telemetry Monitor
Description tracings from the apple watch 4 series watch Description tracings from the continuous telemetry monitor

Keywords

Sequence: 79922995 Sequence: 79922996 Sequence: 79922997 Sequence: 79922998
Name Post-op Atrial Fibrillation Name Heart Rhythm Name Accuracy Name Apple Watch
Downcase Name post-op atrial fibrillation Downcase Name heart rhythm Downcase Name accuracy Downcase Name apple watch

Design Outcomes

Sequence: 177511440 Sequence: 177511441
Outcome Type primary Outcome Type secondary
Measure Heart rate accuracy compared to telemetry Measure Heart rhythm accuracy compared to telemetry
Time Frame 5 minutes Time Frame 5 minutes
Description Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient. Description Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.

Browse Conditions

Sequence: 193627141 Sequence: 193627142 Sequence: 193627143 Sequence: 193627144 Sequence: 193627145 Sequence: 193627146 Sequence: 193627147
Mesh Term Tachycardia Mesh Term Bradycardia Mesh Term Arrhythmias, Cardiac Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases Mesh Term Cardiac Conduction System Disease Mesh Term Pathologic Processes
Downcase Mesh Term tachycardia Downcase Mesh Term bradycardia Downcase Mesh Term arrhythmias, cardiac Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term cardiac conduction system disease Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48353726 Sequence: 48353727
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name The Cleveland Clinic Name Case Western Reserve University

Overall Officials

Sequence: 29305997
Role Principal Investigator
Name Marc Gillinov, MD
Affiliation The Cleveland Clinic

Design Group Interventions

Sequence: 68199224 Sequence: 68199225
Design Group Id 55634699 Design Group Id 55634700
Intervention Id 52522102 Intervention Id 52522103

Eligibilities

Sequence: 30786889
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Age > 18 years
Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus

Exclusion Criteria:

Presence of a cardiac pacemaker
Use of a radial artery graft for coronary artery bypass grafting
Tattoos located on the skin of the wrist or forearm where the Apple Watch 4 will be placed

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253989648
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 3
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30532959
Allocation Non-Randomized
Intervention Model Factorial Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28899253
Responsible Party Type Principal Investigator
Name Marc Gillinov, MD
Title Principal Investigator
Affiliation The Cleveland Clinic

]]>

<![CDATA[ Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment’s Optimization ]]>
https://zephyrnet.com/NCT03798600
2016-01-01

https://zephyrnet.com/?p=NCT03798600
NCT03798600https://www.clinicaltrials.gov/study/NCT03798600?tab=tableNANANAPK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.

Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.
<![CDATA[

Studies

Study First Submitted Date 2019-01-04
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-17
Start Month Year January 1, 2016
Primary Completion Month Year December 31, 2017
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-17

Detailed Descriptions

Sequence: 20721643
Description Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.

Browse Interventions

Sequence: 96050267 Sequence: 96050268 Sequence: 96050269 Sequence: 96050270 Sequence: 96050271
Mesh Term Caspofungin Mesh Term Antifungal Agents Mesh Term Anti-Infective Agents Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term caspofungin Downcase Mesh Term antifungal agents Downcase Mesh Term anti-infective agents Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52171253 Sequence: 52171254
Name Critical Illness Name Infection
Downcase Name critical illness Downcase Name infection

Id Information

Sequence: 40158647
Id Source org_study_id
Id Value CEAVC, 32366/2015; OSS.15.114

Design Groups

Sequence: 55593194
Title Critically ill patients
Description 20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.

Inclusion Criteria:

Adult ICU patients (>18 yrs) with severe sepsis or septic shock undergoing caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).

Exclusion criteria:

Concomitant ciclosporin or rifampicin therapy. Pregnancy Continuous renal replacement therapy Severe Liver failure (Child Pugh score > 6)

Interventions

Sequence: 52485497
Intervention Type Drug
Name Caspofungin
Description In accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people < 80 kg body weight). No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions.

Keywords

Sequence: 79868564 Sequence: 79868565 Sequence: 79868566
Name Caspofungin Name pharmacokinetic Name pharmacodynamic
Downcase Name caspofungin Downcase Name pharmacokinetic Downcase Name pharmacodynamic

Design Outcomes

Sequence: 177378907 Sequence: 177378908 Sequence: 177378909 Sequence: 177378910 Sequence: 177378911 Sequence: 177378912 Sequence: 177378913 Sequence: 177378914 Sequence: 177378915 Sequence: 177378916 Sequence: 177378917 Sequence: 177378918 Sequence: 177378919 Sequence: 177378920
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Cmax/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin Measure Alterations of Cmax/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin Measure Alterations of AUC/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin Measure Alterations of AUC/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin Measure Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU). Measure Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
Time Frame first 24 hours after loading dose Time Frame first 24 hours after loading dose Time Frame at day 4 after loading dose Time Frame first 24 hours after loading dose Time Frame at day 4 after loading dose Time Frame first 24 hours after loading dose Time Frame at day 4 after loading dose Time Frame first 24 hours after loading dose Time Frame at day 4 after loading dose Time Frame first 24 hours after loading dose Time Frame at day 4 after loading dose Time Frame first 24 hours after loading dose Time Frame at day 4 after loading dose Time Frame at day 4 after loading dose
Description The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers. Description The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. Description The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. Description The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. Description The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. Description The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers. Description The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.

Browse Conditions

Sequence: 193486791 Sequence: 193486792 Sequence: 193486793
Mesh Term Critical Illness Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term critical illness Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319307
Agency Class OTHER
Lead Or Collaborator lead
Name Careggi Hospital

Overall Officials

Sequence: 29285358
Role Principal Investigator
Name Gianluca Villa, MD
Affiliation Azienda Careggi

Design Group Interventions

Sequence: 68149151
Design Group Id 55593194
Intervention Id 52485497

Eligibilities

Sequence: 30765362
Sampling Method Non-Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population 20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.
Criteria Inclusion Criteria:

Adult ICU patients (>18 yrs)
Severe sepsis or septic shock
Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).

Exclusion Criteria:

Concomitant ciclosporin or rifampicin therapy.
Pregnancy
Continuous renal replacement therapy
Severe Liver failure (Child Pugh score > 6)

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253884472
Registered In Calendar Year 2019
Actual Duration 24
Were Results Reported False
Has Single Facility False
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 13

Designs

Sequence: 30511529
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28877823
Responsible Party Type Principal Investigator
Name Gianluca Villa
Title Principal investigator
Affiliation Careggi Hospital

Study References

Sequence: 52063298
Pmid 32202224
Reference Type derived
Citation Adembri C, Villa G, Rosi E, Tofani L, Fallani S, De Gaudio AR, Novelli A. Caspofungin PK in critically ill patients after the first and fourth doses: suggestions for therapeutic drug monitoring? J Chemother. 2020 May;32(3):124-131. doi: 10.1080/1120009X.2020.1737783. Epub 2020 Mar 23.

]]>

<![CDATA[ Inhibition of SENP1 for the Suppression of OS Growth and Metastasis ]]>
https://zephyrnet.com/NCT03798587
2020-01-31

https://zephyrnet.com/?p=NCT03798587
NCT03798587https://www.clinicaltrials.gov/study/NCT03798587?tab=tableElena Cittera, MScelena.cittera@grupposandonato.it+39 026621The aim of this project is to test a new powerful PNA-based SENP1 inhibitor, previously characterized in an in vitro model of OS cell lines.

The most effective PNA, conjugated with a cell-permeable CPP, which is able to inhibit OS cells viability and invasiveness in both normoxia and hypoxia through SENP1-mediated inhibition of HIF1α, ZEB1, and Akt, will be investigated for its ability to penetrate and silence SENP1 expression in ex vivo human OS tissues.

Primary aim:

To determine the ability of PNA-CPP to penetrate into an ex vivo tridimensional tissue of OS, derived from wasted biological material obtained during OS eradication surgery, and to exert its biological function of inhibiting SENP1 within the tissue.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-11-22
Start Month Year January 2020
Primary Completion Month Year December 2020
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-11-22

Detailed Descriptions

Sequence: 20741167
Description Background:

Osteosarcoma (OS) is the most common type of primary malignant bone tumor in children and adolescents. The overall survival rate is dramatically reduced by the development of metastases, often pulmonary. Solid malignant tumors, such as OS, often develop a hypoxic microenvironment, which contributes to tumor growth, metastasis, treatment failure, and patient mortality. Adaptation to hypoxia, as well as to other environmental conditions, is often associated with modifications in the post-transcriptional regulation of key effectors. Among these, SUMOylation is carried out by small ubiquitin-like modifier (SUMO) proteins and is dynamically reversed (deSUMOylation) by Sentrin/SUMO-specific proteases (SENPs). SENP1, the best characterized SENP, is upregulated in multiple tumors being involved in tumorigenesis and tumor progression. Through deSUMOylation, SENP1 acts as a molecular hub that stabilizes and activates key regulator factors, such as hypoxia-inducible factor 1α (HIF1α), zinc finger E-box binding homeobox 1 (ZEB1), and Akt, responsible for tumor cells adaptation to hypoxic microenvironment, induction of cell proliferation, invasion and migration, and inhibition of apoptosis, thus contributing to tumor progression and metastasis.

HIF1α is the master transcriptional regulator for cellular adaptation and survival under hypoxic conditions, and contributes to enhance the cell metastatic potential. SENP1-mediated HIF1α deSUMOylation prevents HIF1α degradation by proteasome, thus activating the HIF1α signaling pathway. SENP1 is overexpressed in OS cells under hypoxic condition and siRNA-mediated silencing of SENP1 decreases tumor cell viability, promotes cell apoptosis, reduces invasiveness, and inhibits the epithelial-mesenchymal transition (EMT).

ZEB1 is involved in tumorigenesis, progression, invasion and metastases in several tumors (e.g. glioblastoma, prostate, lung, liver, and colorectal). ZEB1 silencing in OS cells leads to a reduced caspase-3 activity, NF-κB and iNOS inhibition, overall reduced cell proliferation and increased apoptosis. SENP1 knockdown in hepatocellular carcinoma (HCC) cells decreases ZEB1 and inhibits EMT].

Akt hyper-activation is essential for the onset and progression of tumors, including OS. In astroglioma cells siRNA-mediated inhibition of SENP1 is associated to Akt hypophosphorylation accompanied by the inhibition of its downstream targets Bcl-xL and cyclinD1 and p21 upregulation, leading to cell-cycle arrest and increased apoptosis.

Altogether, these studies suggest that SENP1 acts as a hub whose inhibition reflects on multiple targets some of which, i.e. HIF1α, ZEB1, Akt, are key factors in tumor progression and metastasis in both normoxia and hypoxia. While it is known the effect of SENP1 on HIF1α in OS, it is reasonable to assume that SENP1 might mediate ZEB1 downregulation and Akt inactivation also in OS. Thus, novel SENP1 inhibition strategies are potentially effective therapeutic approaches to block OS growth and metastasis.

SENP1 inhibition can be achieved by gene silencing mediated by siRNAs. However, naked siRNAs are highly unstable and liposome-based delivery systems are poorly efficient and cytotoxic both in vitro and in vivo. A promising approach for inhibition of SENP1 expression is gene silencing mediated by peptide nucleic acids (PNA), nucleobase oligomers with the phosphate backbone replaced by a pseudopeptide backbone of repeated units of N-(2-aminoethyl) glycine. Because of their unnatural backbone, PNAs are definitively resistant to both nuclease and protease activities, form a more specific and stable binding with the complementary DNA or RNA, allowing an efficient and persistent silencing effect. Although PNA cell permeability is very poor, it can be effectively enhanced by their conjugation with cell-penetrating peptides (CPP). In the last years, PNA have emerged as really promising tools for cancer diagnosis and therapy, and, above all, as effective candidates for stable gene silencing in gene therapy.

Rational and preliminary study:

3 different PNA sequences targeting different SENP1 mRNA regions will be designed and tested. PNAs will be conjugated to an octa-arginine (R8) CPP that efficiently mediate the intracellular delivery of PNAs. The uptake will be studied with a scrambled-sequence R8- and fluorescein (Fl)-conjugated PNA (scrPNA-R8-Fl).

An in vitro characterization of the ability of the designed PNA-CPP to penetrate intracellular and to silence the target SENP1 will be performed in cell lines of OS.

To study the PNA-R8 uptake in OS cells, different OS cell lines (SaOS-2, MG-63, U2OS) with different invasive potential and all expressing SENP1, and primary human osteoblasts (hOb) as negative control for SENP1 expression, will be used. Following incubation with scrPNA-R8-Fl at different concentrations the uptake will be determined at consecutive time-points by flow cytometry, while the cytoplasmic localization will be confirmed by fluorescence microscopy. A scrPNA-Fl not conjugated to R8 will function as a negative control, as it is not expected to enter the cell. Cytotoxicity of scrPNA-R8 will be assayed by Alamar Blue Cell Viability assay. The silencing effectiveness of the different anti-SENP1 PNA-R8 conjugates (senpPNA-R8) will be assayed in all cell lines in both normoxia and hypoxia (1% O2, 5% CO2, and 94% N2). The senpPNA-R8-mediated SENP1 silencing efficiency will be assessed by RT-qPCR and western-blot (WB). scrPNA-R8 will serve as negative control, while cells transfected with siRNA targeting SENP1 will serve as positive control. In this part the most efficient silencing senpPNA-R8 compound will be selected.

The senpPNA-R8-mediated downregulation of HIF1α, and potentially of ZEB1 expression and Akt phosphorylation inhibitions, as consequence of SENP1 inhibition in OS cells, will be assayed by WB. Thus, reduced cell viability, migration and invasion, induction of apoptosis, and EMT inhibition will be assayed, and compared to the effects in hOb. Cell viability will be determined by Alamar Blue assay, whereas apoptosis will be assayed by flow cytometry by staining of Annexin V and with propidium iodide. The residual migration and invasion ability will be assessed by wound-healing assay and transwell invasion assay, respectively. Downregulation of vimentin and N-cadherin and upregulation of E-cadherin, EMT markers and of the downstream targets of ZEB1 (caspase-3, NF-κB) and Akt, (cyclinD1 and Bcl-xL) will be determined by WB.

The in vitro characterization of the penetration and silencing ability of the designed PNA-CPP in OS cell lines is the preliminary step of the study. An ex vivo analysis of the ability of the PNA-CPP to penetrate into a 3D tissue and silence the target SENP in an OS tissue explant from patients will follow.

Aims of the study:

The aim of this project is to test a new powerful PNA-based SENP1 inhibitor, previously characterized in an in vitro model of OS cell lines.

The most effective PNA, conjugated with a cell-permeable CPP, which is able to inhibit OS cells viability and invasiveness in both normoxia and hypoxia through SENP1-mediated inhibition of HIF1α, ZEB1, and Akt, will be investigated for its ability to penetrate and silence SENP1 expression in ex vivo human OS tissues.

Primary aim:

To determine the ability of PNA-CPP to penetrate into an ex vivo tridimensional tissue of OS, derived from wasted biological material obtained during OS eradication surgery, and to exert its biological function of inhibiting SENP1 within the tissue.

Study design:

For this study, wasted biological material derived from osteosarcoma eradication surgery will be collected which comprise only a small proportion of the removed tumor mass other than that used for histological and molecular diagnosis.

15 patients with primary OS will be recruited. The target group will comprise patients hospitalized at IRCCS Istituto Ortopedico Galeazzi who will be subjected to surgical eradication of primary OS.

The study will be presented to patients with age ≥18 years that can be recruited also in the IRCCS Istituto Ortopedico Galeazzi BioBanca protocol (ethical committee approval n. 29/INT/2017) by the surgeon. These patients will sign two Informed Consents: one for the BioBanca and one for the PNA-OS study.

Patients with age <18 years will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca. These patients will be considered eligible for the study if the legal tutor will sign the Informed Consents relative to the PNA-OS study.

Also samples of OS already existing in the BioBanca as frozen samples preserved in liquid nitrogen at BioRep Service-Provider (BioRep S.r.l. Via Olgettina 60, 20132, Milano), will be used. Every reasonable effort will be done to call these patients to sign a specific informed consent relative to this study.

Since several practical issues (e.g. unsuitableness or low amount of biological material) can occur, we envision the possibility to recruit additional patients until the achievement of 15 complete samples.

The Study will start after approval of Ethical Committee and the estimated duration is 36 months, divided as following:

Timing for enrolment: 24 month
Data analysis: 12 month

Experimental design:

Ex vivo analysis of the PNA-R8 silencing ability in osteosarcoma samples. We will investigate whether senpPNA-R8 is able to penetrate into a tridimensional OS tissue and to exert its silencing effect.

15 OS samples will be collected either in the context of the IRCCS Galeazzi BioBanca (ethical committee approval n. 29/INT/2017) or from newly recruited patients, in collaboration with the C.C.O.O.R.R. equip.

Only wasted biological material derived from surgery will be used without any additional harm to the patients other than the surgery itself and the study does not involve any diagnostic aim or genetic profiling of the samples collected.

OS samples, already existing in the BioBanca as frozen samples preserved in liquid nitrogen at BioRep Service-Provider (BioRep S.r.l. Via Olgettina 60, 20132, Milano), will be used to determine the initial expression levels of SENP1 in OS by RT-qPCR. For this, samples will be homogenized, total RNA will be extracted and RT-qPCR will be performed assaying for SENP1 expression levels.

The remaining samples out of 15, freshly collected, will be preserved in physiological solution until usage. The OS samples will be cut in 3 mm3 pieces, placed in a 24-multiwell culture plate, and cultivated ex vivo as organotypic OS cultures in both normoxia and hypoxia-induced microenvironment under orbital rotation [21-23]. Organotypic tumor tissue maintain the complexity of the original tissue with tumor cells being surrounded by their original microenvironment rather than artificial matrices and this system is particularly advantageous for ex vivo drug screening, for studying drug uptake and molecular processes. OS cultures will be treated with senpPNA-R8, and SENP1 expression in naïve and PNA-treated samples will be determined by RT-qPCR and immunohistochemistry in paraffin-embedded sections. The ability of the PNA-R8 to penetrate within the hypoxic core of the OS samples will be assessed: after incubation with scrPNA-R8-Fl, sections will be immediately frozen (-80°C), processed and analyzed by immunofluorescence.

Samples will be analyzed and stored at Laboratorio di Biochimica Sperimentale e Biologia Molecolare at the Istituto Ortopedico Galeazzi for the whole duration of the study. At the end of the study every residual material will be destroyed.

Facilities

Sequence: 200280592
Name IRCCS Istituto Ortopedico Galeazzi
City Milano
Zip 20161
Country Italy

Facility Contacts

Sequence: 28132856 Sequence: 28132857
Facility Id 200280592 Facility Id 200280592
Contact Type primary Contact Type backup
Name Marta Sofia Gomarasca, PhD Name Elena Cittera, MSc
Email marta.gomarasca@grupposandonato.it Email elena.cittera@grupposandonato.it
Phone 0039022261 Phone 0039022261
Phone Extension 4068 Phone Extension 4057

Conditions

Sequence: 52221522
Name Primary Osteosarcoma of Bone
Downcase Name primary osteosarcoma of bone

Id Information

Sequence: 40195625
Id Source org_study_id
Id Value PNA-OS

Countries

Sequence: 42609655
Name Italy
Removed False

Design Groups

Sequence: 55649813
Title OS patients
Description Patients with age ≥18 years that were/can be recruited within the IRCCS Istituto Ortopedico Galeazzi BioBanca (ethical committee approval n. 29/INT/2017).

Patients with age <18 years: will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca.

The target group corresponds to patients hospitalized at Istituto Ortopedico Galeazzi, undergoing surgical eradication of primary osteosarcoma.

Patients will be considered eligible for enrollment in the study if able to sign the consent to the procedure after appropriate information from the reference surgeon or signed by parents or legal guardian after appropriate information from the reference surgeon (if age <18).

Inclusion Criteria:

Indication for primary OS eradication surgery
Patients hospitalized in Istituto Ortopedico Galeazzi

Exclusion criteria:

-Patients not able to sign the Informed Consent.

Design Outcomes

Sequence: 177561481 Sequence: 177561482
Outcome Type primary Outcome Type primary
Measure Determination of SENP1 expression in OS samples Measure Ex vivo analysis of the PNA-R8 silencing ability in osteosarcoma samples.
Time Frame 8 months Time Frame 16 months
Description OS samples, already existing in the BioBanca as frozen samples preserved in liquid nitrogen at BioRep Service-Provider (BioRep S.r.l. Via Olgettina 60, 20132, Milano), will be used to determine the initial expression levels of SENP1 in OS by RT-qPCR. For this, samples will be homogenized, total RNA will be extracted and RT-qPCR will be performed assaying for SENP1 expression levels. Description Freshly collected OS samples will be preserved in physiological solution until usage. The OS samples will be cut in 3 mm3 pieces, placed in a 24-multiwell culture plate, and cultivated ex vivo as organotypic OS cultures in both normoxia and hypoxia-induced microenvironment under orbital rotation. OS cultures will be treated with senpPNA-R8, and SENP1 expression in naïve and PNA-treated samples will be determined by RT-qPCR and immunohistochemistry in paraffin-embedded sections. The ability of the PNA-R8 to penetrate within the hypoxic core of the OS samples will be assessed: after incubation with scrPNA-R8-Fl, sections will be immediately frozen (-80°C), processed and analyzed by immunofluorescence.

Browse Conditions

Sequence: 193678423 Sequence: 193678424 Sequence: 193678425 Sequence: 193678426 Sequence: 193678427 Sequence: 193678428 Sequence: 193678429
Mesh Term Osteosarcoma Mesh Term Neoplasms Mesh Term Neoplasms, Bone Tissue Mesh Term Neoplasms, Connective Tissue Mesh Term Neoplasms, Connective and Soft Tissue Mesh Term Neoplasms by Histologic Type Mesh Term Sarcoma
Downcase Mesh Term osteosarcoma Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, bone tissue Downcase Mesh Term neoplasms, connective tissue Downcase Mesh Term neoplasms, connective and soft tissue Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term sarcoma
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366424
Agency Class OTHER
Lead Or Collaborator lead
Name Istituto Ortopedico Galeazzi

Central Contacts

Sequence: 12020588 Sequence: 12020589
Contact Type primary Contact Type backup
Name Marta Sofia Gomarasca, PhD Name Elena Cittera, MSc
Phone +39 026621 Phone +39 026621
Email marta.gomarasca@grupposandonato.it Email elena.cittera@grupposandonato.it
Phone Extension 4068 Phone Extension 4057
Role Contact Role Contact

Eligibilities

Sequence: 30794708
Sampling Method Non-Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population 15 patients with primary OS.

Patients with age ≥18 years that were/can be recruited within the IRCCS Istituto Ortopedico Galeazzi BioBanca (ethical committee approval n. 29/INT/2017).

Patients with age <18 years: will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca.

The target group corresponds to patients hospitalized at Istituto Ortopedico Galeazzi, undergoing surgical eradication of primary osteosarcoma.

Patients with age ≥18 will be considered eligible for enrollment in the study if able to sign the consent to the procedure after appropriate information from the reference surgeon.

Patients with age <18 will be considered eligible for enrollment in the study if able to provide the consent to the procedure (donation of waste material) signed by parents or legal guardian after appropriate information from the reference surgeon.

Criteria Inclusion Criteria:

Indication for primary OS eradication surgery
Patients hospitalized in Istituto Ortopedico Galeazzi

Patients with age ≥18 years: were/can be recruited within the IRCCS Istituto Ortopedico Galeazzi BioBanca (ethical committee approval n. 29/INT/2017).

Patients with age <18 years: will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca.

Exclusion Criteria:

Patients not able to sign the Informed Consent.

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254004324
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30540748
Observational Model Cohort
Time Perspective Other

Responsible Parties

Sequence: 28907068
Responsible Party Type Sponsor

Study References

Sequence: 52118201 Sequence: 52118202 Sequence: 52118203 Sequence: 52118204 Sequence: 52118205 Sequence: 52118206 Sequence: 52118207 Sequence: 52118208 Sequence: 52118209 Sequence: 52118210 Sequence: 52118211 Sequence: 52118212 Sequence: 52118213 Sequence: 52118214 Sequence: 52118215 Sequence: 52118216 Sequence: 52118217 Sequence: 52118218 Sequence: 52118219 Sequence: 52118220 Sequence: 52118221 Sequence: 52118222
Pmid 27366153 Pmid 26424695 Pmid 23740838 Pmid 25444927 Pmid 22138131 Pmid 28258134 Pmid 26695141 Pmid 27693211 Pmid 18809331 Pmid 28796315 Pmid 22213004 Pmid 28387915 Pmid 23884910 Pmid 22455499 Pmid 28414202 Pmid 19812898 Pmid 29734750 Pmid 28670958 Pmid 28670477 Pmid 26860465 Pmid 27111283 Pmid 16603054
Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result
Citation Abarrategi A, Tornin J, Martinez-Cruzado L, Hamilton A, Martinez-Campos E, Rodrigo JP, Gonzalez MV, Baldini N, Garcia-Castro J, Rodriguez R. Osteosarcoma: Cells-of-Origin, Cancer Stem Cells, and Targeted Therapies. Stem Cells Int. 2016;2016:3631764. doi: 10.1155/2016/3631764. Epub 2016 Jun 5. Citation Cao J, Wang Y, Dong R, Lin G, Zhang N, Wang J, Lin N, Gu Y, Ding L, Ying M, He Q, Yang B. Hypoxia-Induced WSB1 Promotes the Metastatic Potential of Osteosarcoma Cells. Cancer Res. 2015 Nov 15;75(22):4839-51. doi: 10.1158/0008-5472.CAN-15-0711. Epub 2015 Sep 30. Erratum In: Cancer Res. 2020 Jun 1;80(11):2421. Citation Philip B, Ito K, Moreno-Sanchez R, Ralph SJ. HIF expression and the role of hypoxic microenvironments within primary tumours as protective sites driving cancer stem cell renewal and metastatic progression. Carcinogenesis. 2013 Aug;34(8):1699-707. doi: 10.1093/carcin/bgt209. Epub 2013 Jun 5. Citation Guan G, Zhang Y, Lu Y, Liu L, Shi D, Wen Y, Yang L, Ma Q, Liu T, Zhu X, Qiu X, Zhou Y. The HIF-1alpha/CXCR4 pathway supports hypoxia-induced metastasis of human osteosarcoma cells. Cancer Lett. 2015 Feb 1;357(1):254-264. doi: 10.1016/j.canlet.2014.11.034. Epub 2014 Nov 18. Citation Bettermann K, Benesch M, Weis S, Haybaeck J. SUMOylation in carcinogenesis. Cancer Lett. 2012 Mar 28;316(2):113-25. doi: 10.1016/j.canlet.2011.10.036. Epub 2011 Nov 2. Citation Cui CP, Wong CC, Kai AK, Ho DW, Lau EY, Tsui YM, Chan LK, Cheung TT, Chok KS, Chan ACY, Lo RC, Lee JM, Lee TK, Ng IOL. SENP1 promotes hypoxia-induced cancer stemness by HIF-1alpha deSUMOylation and SENP1/HIF-1alpha positive feedback loop. Gut. 2017 Dec;66(12):2149-2159. doi: 10.1136/gutjnl-2016-313264. Epub 2017 Mar 3. Citation Zhang W, Sun H, Shi X, Wang H, Cui C, Xiao F, Wu C, Guo X, Wang L. SENP1 regulates hepatocyte growth factor-induced migration and epithelial-mesenchymal transition of hepatocellular carcinoma. Tumour Biol. 2016 Jun;37(6):7741-8. doi: 10.1007/s13277-015-4406-y. Epub 2015 Dec 22. Citation Xia W, Tian H, Cai X, Kong H, Fu W, Xing W, Wang Y, Zou M, Hu Y, Xu D. Inhibition of SUMO-specific protease 1 induces apoptosis of astroglioma cells by regulating NF-kappaB/Akt pathways. Gene. 2016 Dec 31;595(2):175-179. doi: 10.1016/j.gene.2016.09.040. Epub 2016 Sep 28. Citation Yee Koh M, Spivak-Kroizman TR, Powis G. HIF-1 regulation: not so easy come, easy go. Trends Biochem Sci. 2008 Nov;33(11):526-34. doi: 10.1016/j.tibs.2008.08.002. Epub 2008 Sep 21. Citation Wang X, Liang X, Liang H, Wang B. SENP1/HIF-1alpha feedback loop modulates hypoxia-induced cell proliferation, invasion, and EMT in human osteosarcoma cells. J Cell Biochem. 2018 Feb;119(2):1819-1826. doi: 10.1002/jcb.26342. Epub 2017 Sep 27. Citation Shen A, Zhang Y, Yang H, Xu R, Huang G. Overexpression of ZEB1 relates to metastasis and invasion in osteosarcoma. J Surg Oncol. 2012 Jun 15;105(8):830-4. doi: 10.1002/jso.23012. Epub 2011 Dec 27. Citation Xu XM, Liu W, Cao ZH, Liu MX. Effects of ZEB1 on regulating osteosarcoma cells via NF-kappaB/iNOS. Eur Rev Med Pharmacol Sci. 2017 Mar;21(6):1184-1190. Citation Li R, Wei J, Jiang C, Liu D, Deng L, Zhang K, Wang P. Akt SUMOylation regulates cell proliferation and tumorigenesis. Cancer Res. 2013 Sep 15;73(18):5742-53. doi: 10.1158/0008-5472.CAN-13-0538. Epub 2013 Jul 24. Citation Hoyer J, Neundorf I. Peptide vectors for the nonviral delivery of nucleic acids. Acc Chem Res. 2012 Jul 17;45(7):1048-56. doi: 10.1021/ar2002304. Epub 2012 Mar 28. Citation Wu JC, Meng QC, Ren HM, Wang HT, Wu J, Wang Q. Recent advances in peptide nucleic acid for cancer bionanotechnology. Acta Pharmacol Sin. 2017 Jun;38(6):798-805. doi: 10.1038/aps.2017.33. Epub 2017 Apr 17. Citation Oh SY, Ju Y, Park H. A highly effective and long-lasting inhibition of miRNAs with PNA-based antisense oligonucleotides. Mol Cells. 2009 Oct 31;28(4):341-5. doi: 10.1007/s10059-009-0134-8. Epub 2009 Sep 30. Citation McClorey G, Banerjee S. Cell-Penetrating Peptides to Enhance Delivery of Oligonucleotide-Based Therapeutics. Biomedicines. 2018 May 5;6(2):51. doi: 10.3390/biomedicines6020051. Citation Song C, Liu W, Li J. USP17 is upregulated in osteosarcoma and promotes cell proliferation, metastasis, and epithelial-mesenchymal transition through stabilizing SMAD4. Tumour Biol. 2017 Jul;39(7):1010428317717138. doi: 10.1177/1010428317717138. Citation Meijer TG, Naipal KA, Jager A, van Gent DC. Ex vivo tumor culture systems for functional drug testing and therapy response prediction. Future Sci OA. 2017 Mar 27;3(2):FSO190. doi: 10.4155/fsoa-2017-0003. eCollection 2017 Jun. Citation Naipal KA, Verkaik NS, Sanchez H, van Deurzen CH, den Bakker MA, Hoeijmakers JH, Kanaar R, Vreeswijk MP, Jager A, van Gent DC. Tumor slice culture system to assess drug response of primary breast cancer. BMC Cancer. 2016 Feb 9;16:78. doi: 10.1186/s12885-016-2119-2. Citation Muff R, Botter SM, Husmann K, Tchinda J, Selvam P, Seeli-Maduz F, Fuchs B. Explant culture of sarcoma patients' tissue. Lab Invest. 2016 Jul;96(7):752-62. doi: 10.1038/labinvest.2016.49. Epub 2016 Apr 25. Citation van der Kuip H, Murdter TE, Sonnenberg M, McClellan M, Gutzeit S, Gerteis A, Simon W, Fritz P, Aulitzky WE. Short term culture of breast cancer tissues to study the activity of the anticancer drug taxol in an intact tumor environment. BMC Cancer. 2006 Apr 7;6:86. doi: 10.1186/1471-2407-6-86.

]]>

<![CDATA[ The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults ]]>
https://zephyrnet.com/NCT03798574
2016-03-01

https://zephyrnet.com/?p=NCT03798574
NCT03798574https://www.clinicaltrials.gov/study/NCT03798574?tab=tableNANANASurvivors of invasive meningococcal disease (IMD) experience a range of mild to severe sequelae that impact upon their quality of life. The majority of studies to date have focused on the impact of IMD on childhood and very little is known about the impact of the disease on adolescents and young people.

The aim of this study is to assess the physical, neurocognitive, economic and societal impact of IMD on adolescents and young adult Australian survivors.

Hypothesis:

Adolescents and young adult survivors who are 2 to 10 years post IMD have significantly poorer outcomes including intellectual functioning and quality of life when compared to healthy controls.
IMD imposes a significant financial burden upon individuals, families and society.
Serogroup B disease is associated with an increased risk of sequelae when compared to non-B serogroup IMD.

Study design:

This a multi-centre, case-control mixed-methods study. Survivors of IMD (retrospective and prospective cases) and non-IMD healthy controls will be invited to participate in the study.

Retrospective IMD cases admitted in the previous 10 years will be identified through each of the participating hospitals (paediatric and adult hospitals). During the course of the study prospective recruitment of IMD cases will also occur at participating hospitals. Meningococcal foundations/groups will also be approached and asked to advertise and conduct a mail out to their members to inform them about the study.

Healthy controls will be prospectively recruited by “snowballing technique” whereby enrolled IMD cases will be asked to distribute a study information sheet to their healthy friends/acquaintances who are approximately the same age. Control participants may also be identified from databases at each participating site or through community advertising.

Enrolled cases will undergo a neurocognitive, psychological and physical examination 2 – 10 years post IMD admission. A subset of IMD cases will be invited to participate in a semi-structured interview. Controls will also undergo neurocognitive, psychological and physical examination.
<![CDATA[

Studies

Study First Submitted Date 2018-12-23
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-03-09
Start Month Year March 1, 2016
Primary Completion Month Year December 31, 2022
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-09

Facilities

Sequence: 200123960 Sequence: 200123961 Sequence: 200123962 Sequence: 200123963
Name The Children's Hospital at Westmead Name Women's and Children's Hosptial Name Monash Children's Hospital, Melbourne Name Perth Children's Hospital
City Westmead City Adelaide City Clayton City Nedlands
State New South Wales State South Australia State Victoria State Western Australia
Zip 2145 Zip 5006 Zip 3168 Zip 6009
Country Australia Country Australia Country Australia Country Australia

Conditions

Sequence: 52175909 Sequence: 52175910 Sequence: 52175911
Name Meningococcal Infections Name Neisseria Meningitis Sepsis Name Neisseria Infection
Downcase Name meningococcal infections Downcase Name neisseria meningitis sepsis Downcase Name neisseria infection

Id Information

Sequence: 40161847
Id Source org_study_id
Id Value HREC/14/WCHN/024

Countries

Sequence: 42572549
Name Australia
Removed False

Design Groups

Sequence: 55598336 Sequence: 55598337
Title IMD Case Title Control
Description No intervention Description No intervention

Design Outcomes

Sequence: 177397492 Sequence: 177397493 Sequence: 177397494 Sequence: 177397495 Sequence: 177397496 Sequence: 177397497 Sequence: 177397498 Sequence: 177397499 Sequence: 177397500 Sequence: 177397501 Sequence: 177397502 Sequence: 177397503 Sequence: 177397504 Sequence: 177397505 Sequence: 177397506 Sequence: 177397507
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Difference in intellectual functioning between cases and controls Measure Difference in quality of life between cases and controls Measure Difference in academic achievement between cases and controls. Measure Difference in memory (verbal and visual) between cases and controls. Measure Difference in executive functioning between cases and controls. Measure Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire Measure Difference in the frequency of psychiatric disorders between cases and controls. Measure Difference in psychological functioning between cases and controls. Measure Difference in behavioral ratings between cases and controls Measure Difference in health and disability functioning between cases and controls Measure Difference in hearing threshold levels between cases and controls Measure Difference in health status between cases and controls Measure To estimate the lifetime costs associated with survival following IMD Measure Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD Measure Carer's experience assessed through the Carer Experience Scale Measure Carer's experience assessed through ICEpop CAPability questionnaires
Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame From time of admission up to time of follow up (2 to 10 years post IMD admission) Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission Time Frame Between 2 to 10 years post IMD admission
Description Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale – Fourth Edition (WAIS-IV) Description Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report. Description Measured by Wechsler Individual Achievement Test – Second Edition (WIAT-II) Description Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2) Description Measured by Delis-Kaplan Executive Function System (D-KEFS) Description Assessed through BRIEF self-report questionnaire (parent and/or self-report) Description Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0) Description Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report) Description Measured by Conners Rating Scales (parent and/or self-report) Description Measured by the International Classification of Functioning, Disability and Health (ICF) tool. Description Measured by pure tone audiometry. Description The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost. Description IMD cases only: Lifetime dollar costs. Description A subset of IMD cases will participate in a semi-structured interview. Description For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete the Carer Experience Scale. Description For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete ICEpop CAPability questionnaire.

Browse Conditions

Sequence: 193504492 Sequence: 193504493 Sequence: 193504494 Sequence: 193504495 Sequence: 193504496 Sequence: 193504497 Sequence: 193504498 Sequence: 193504499 Sequence: 193504500 Sequence: 193504501 Sequence: 193504502 Sequence: 193504503
Mesh Term Infections Mesh Term Communicable Diseases Mesh Term Meningococcal Infections Mesh Term Meningitis Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Neuroinflammatory Diseases Mesh Term Nervous System Diseases Mesh Term Neisseriaceae Infections Mesh Term Gram-Negative Bacterial Infections Mesh Term Bacterial Infections Mesh Term Bacterial Infections and Mycoses
Downcase Mesh Term infections Downcase Mesh Term communicable diseases Downcase Mesh Term meningococcal infections Downcase Mesh Term meningitis Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term neuroinflammatory diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term neisseriaceae infections Downcase Mesh Term gram-negative bacterial infections Downcase Mesh Term bacterial infections Downcase Mesh Term bacterial infections and mycoses
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48323435
Agency Class OTHER
Lead Or Collaborator lead
Name University of Adelaide

Overall Officials

Sequence: 29287670
Role Principal Investigator
Name Helen Marshall
Affiliation University of Adelaide

Eligibilities

Sequence: 30767977
Sampling Method Non-Probability Sample
Gender All
Minimum Age 15 Years
Maximum Age 24 Years
Healthy Volunteers Accepts Healthy Volunteers
Population Population sample from participating Australian hospitals in Adelaide, Melbourne, Perth, and Sydney.
Criteria Inclusion Criteria:

Patients aged 15 to 24 years 11 months at time of IMD admission
Hospitalised IMD case from 1st January 2006 -with serogroup B or non-B IMD, confirmed by culture or polymerase chain reaction (PCR) in blood or CSF.
Healthy controls aged 17 to 34 years 11 months at the time of assessment.

Exclusion Criteria:

Individuals who are not fluent with the English language.
Control participants with a history of meningitis, encephalitis, or meningococcal disease, intellectual disability, intracranial pathology (eg. traumatic brain injury) that may impact on cognitive functioning, or significant vision and/or hearing loss that may impact on the validity or reliability of the neurocognitive assessment.

Adult True
Child True
Older Adult False

Calculated Values

Sequence: 253927719
Number Of Facilities 4
Registered In Calendar Year 2018
Actual Duration 83
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 15
Maximum Age Num 24
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 14

Designs

Sequence: 30514137
Observational Model Case-Control
Time Perspective Other

Responsible Parties

Sequence: 28880438
Responsible Party Type Principal Investigator
Name Helen Marshall
Title Professor
Affiliation University of Adelaide

Study References

Sequence: 52068413
Pmid 31888931
Reference Type derived
Citation Marshall H, McMillan M, Wang B, Booy R, Afzali H, Buttery J, Blyth CC, Richmond P, Shaw D, Gordon D, Barton B. AMEND study protocol: a case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults. BMJ Open. 2019 Dec 29;9(12):e032583. doi: 10.1136/bmjopen-2019-032583.

]]>

<![CDATA[ Study to Evaluate ASN008 Topical Gel (TG) ]]>
https://zephyrnet.com/NCT03798561
2019-01-14

https://zephyrnet.com/?p=NCT03798561
NCT03798561https://www.clinicaltrials.gov/study/NCT03798561?tab=tableNANANAThis is an ascending dose escalation study to test the safety, tolerability and preliminary efficacy of ASN008 TG in first-in-human subjects
<![CDATA[

Studies

Study First Submitted Date 2019-01-04
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-05-09
Start Month Year January 14, 2019
Primary Completion Month Year March 20, 2020
Verification Month Year May 2020
Verification Date 2020-05-31
Last Update Posted Date 2023-05-09

Detailed Descriptions

Sequence: 20777531
Description This is a two part, randomized, blinded, vehicle-controlled study to determine a safe and tolerable dose of ASN008 TG. Part A will asses a single ascending dose of ASN008 TG in cohorts of healthy volunteers, while Part B will assess multiple ascending doses of TG, to be determined (TBD) based on Part A safety and tolerability, in patients with mild-to-moderate dermatitis. Results from Part A and B will characterize safety, tolerability and pharmacokinetics. Part B patients will be assessed for changes in pruritus based on a numerical rating scale (NRS) of pruritus at baseline and on Day 15.

Facilities

Sequence: 200571965 Sequence: 200571966 Sequence: 200571967 Sequence: 200571968 Sequence: 200571969
Name Certified Research Associates Name Dermatology Consulting Services, PLLC Name Progressive Clinical Research Name Spaulding Research Clinic, Inc Name Innovaderm Recherches Inc
City Cortland City High Point City San Antonio City West Bend City Montréal
State New York State North Carolina State Texas State Wisconsin State Quebec
Zip 13045 Zip 27262 Zip 78213 Zip 53095 Zip H2K4L5
Country United States Country United States Country United States Country United States Country Canada

Conditions

Sequence: 52314340 Sequence: 52314341 Sequence: 52314342
Name Dermatitis, Atopic Name Pruritus Name Dermatitis Eczema
Downcase Name dermatitis, atopic Downcase Name pruritus Downcase Name dermatitis eczema

Id Information

Sequence: 40261132
Id Source org_study_id
Id Value ASN008-101

Countries

Sequence: 42680531 Sequence: 42680532
Name United States Name Canada
Removed False Removed False

Design Groups

Sequence: 55752712 Sequence: 55752713 Sequence: 55752714 Sequence: 55752715 Sequence: 55752716 Sequence: 55752717 Sequence: 55752718
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title 82 µg/cm2 ASN008 TG or Placebo Title 164 µg/cm2 ASN008 TG or Placebo Title 328 µg/cm2 ASN008 TG or Placebo Title 492 µg/cm2 ASN008 TG or Placebo Title ASN008 TG TBD Cohort 1 or Placebo Title ASN008 TG TBD Cohort 2 or Placebo Title ASN008 TG TBD Cohort 3 or Placebo
Description PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2) Description PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2) Description Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2) Description Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2) Description Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3) Description Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3) Description Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3)

Interventions

Sequence: 52625618 Sequence: 52625619
Intervention Type Drug Intervention Type Drug
Name ASN008 TG Name Placebo TG
Description ASN008 TG Description Placebo TG

Design Outcomes

Sequence: 177907810 Sequence: 177907811 Sequence: 177907812 Sequence: 177907813 Sequence: 177907814 Sequence: 177907815 Sequence: 177907816
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B) Measure Calculate area under the plasma concentration versus time curve (Part A and B) Measure Calculate the Pharmacokinetic Half-life (Part A and B) Measure Calculate the Pharmacokinetic maximum concentration (Part A and B) Measure Change from baseline in pruritus NRS in AD subjects (Part B) Measure Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B) Measure Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)
Time Frame Part A: 14 days; Part B: 22 days Time Frame 7 days and 16 days Time Frame 7 days and 16 days Time Frame 7 days and 16 days Time Frame 22 days Time Frame 22 days Time Frame 22 Days
Description Analyze incidence of treatment-emergent adverse events (TEAE) Description A plot of the concentration of ASN008 in plasma over time Description Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50% Description Maximum concentration of ASN008 achieved after dosing Description Numeric Rating Scale ranging from 0 to 10; 0 indicates no itching; 10 indicates worst possible itching; Rating of pruritis based degree, duration, direction, disability, and distribution Description Measurement of area and severity of atopic dermatitis based on composite score 0 to 72 encompassing degree of erythema, induration, excoriation and lichenification; each scored from 0 to 3 with 0 indicating none and 3 indicating severe Description 5 point morphological assessment of overall disease severity scored from 0 to 4 with 0 indicating clear (no inflammation) and 4 indicating severe (marked erythema)

Browse Conditions

Sequence: 194031813 Sequence: 194031814 Sequence: 194031815 Sequence: 194031816 Sequence: 194031817 Sequence: 194031818 Sequence: 194031819 Sequence: 194031820 Sequence: 194031821 Sequence: 194031822 Sequence: 194031823
Mesh Term Dermatitis, Atopic Mesh Term Dermatitis Mesh Term Pruritus Mesh Term Skin Diseases Mesh Term Skin Diseases, Eczematous Mesh Term Skin Manifestations Mesh Term Skin Diseases, Genetic Mesh Term Genetic Diseases, Inborn Mesh Term Hypersensitivity, Immediate Mesh Term Hypersensitivity Mesh Term Immune System Diseases
Downcase Mesh Term dermatitis, atopic Downcase Mesh Term dermatitis Downcase Mesh Term pruritus Downcase Mesh Term skin diseases Downcase Mesh Term skin diseases, eczematous Downcase Mesh Term skin manifestations Downcase Mesh Term skin diseases, genetic Downcase Mesh Term genetic diseases, inborn Downcase Mesh Term hypersensitivity, immediate Downcase Mesh Term hypersensitivity Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48453245
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Asana BioSciences

Overall Officials

Sequence: 29361673
Role Study Director
Name Niranjan Rao, PhD
Affiliation Asana BioSciences

Design Group Interventions

Sequence: 68342282 Sequence: 68342283 Sequence: 68342284 Sequence: 68342285 Sequence: 68342286 Sequence: 68342287 Sequence: 68342288 Sequence: 68342289 Sequence: 68342290 Sequence: 68342291 Sequence: 68342292 Sequence: 68342293 Sequence: 68342294 Sequence: 68342295
Design Group Id 55752713 Design Group Id 55752714 Design Group Id 55752715 Design Group Id 55752712 Design Group Id 55752716 Design Group Id 55752717 Design Group Id 55752718 Design Group Id 55752713 Design Group Id 55752714 Design Group Id 55752715 Design Group Id 55752712 Design Group Id 55752716 Design Group Id 55752717 Design Group Id 55752718
Intervention Id 52625618 Intervention Id 52625618 Intervention Id 52625618 Intervention Id 52625618 Intervention Id 52625618 Intervention Id 52625618 Intervention Id 52625618 Intervention Id 52625619 Intervention Id 52625619 Intervention Id 52625619 Intervention Id 52625619 Intervention Id 52625619 Intervention Id 52625619 Intervention Id 52625619

Eligibilities

Sequence: 30848297
Gender All
Minimum Age 18 Years
Maximum Age 65 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Part A – Healthy Volunteers:

Written informed consent obtained prior to any required study-related procedure
Healthy female or male subject aged 18 to 65
Willing to use medically effective methods of birth control
Females of reproductive potential must have a negative serum pregnancy test at screening and negative serum or urine pregnancy test prior to first study drug application on Day 1
Non-smoker (no nicotine products for at least 6 months prior to screening)
BMI ≥18.5 kg/m2 and ≤32.0 kg/m2 with minimum weight of 60 kg

Part B- Subjects with AD:

Written informed consent obtained prior to any required study-related procedure
Confirmed diagnosis of active atopic dermatitis (AD)
History of AD for at least 6 months prior to Day 1 with an investigator global assessment ≥3 and body surface area covered with 1-10% AD
Pruritus score (NRS)≥ 5 at screening and NRS ≥7 on Day 1

Exclusion Criteria:

Both Part A and Part B:

Pregnant or breast-feeding women
Skin disease that may interfere with study assessments
Febrile illness within 6 days prior to Day 1, history of cancer within 5 years of Day 1, major surgery within 8 weeks prior to Day1, known immunodeficiencies, positive for hepatitis B or C or HIV infection
Significant medical/surgical history or condition or current physical/laboratory/ECG/ vitals signs abnormality that might compromise the subject
Corrected QT duration ≥450 milliseconds or other significant ECG abnormality
Received marketed or investigational biological agent within 12 weeks prior to Day 1 or JAK inhibitor or nonbiological product or device within 4 weeks of Day 1 or within 8 weeks of Day 1 if investigational product used or any drug/ substance that is a strong inhibitor or inducer of CYP3A4 or CYP2D6
Suspected hypersensitivity/allergy to lidocaine
Significant drug or alcohol abuse or mental illness in 2 years prior to Day 1

Part A Only- Healthy Volunteers:

-Used medications or skin emollients within 2 weeks prior to Day 1 unless approved by investigator and sponsor

Part B Only – Subjects with AD:

Has infected atopic dermatitis
Used dupilumab 12 weeks prior to Day 1
Used doxepin, hydroxyzine or diphenhydramine, urea containing topical products within 1 week prior to Day 1
Used systemic antibiotics or topical medicated treatment or other systemic treatments that could affect AD 2 weeks prior to Day 1
Received any UV-B phototherapy, excimer laser treatment or psoralen-UV-A treatment within 4 weeks prior to Day 1

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254230253
Number Of Facilities 5
Registered In Calendar Year 2019
Actual Duration 14
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30594156
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded
Intervention Model Description Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.
Subject Masked True
Investigator Masked True

Responsible Parties

Sequence: 28960629
Responsible Party Type Sponsor

Study References

Sequence: 52217526
Pmid 32616515
Reference Type derived
Citation Ramachandran R, Thompson SK, Malkmus S, Mieda T, Lin JH, Gupta S, Yaksh TL. Topical Application of ASN008, a Permanently Charged Sodium Channel Blocker, Shows Robust Efficacy, a Rapid Onset, and Long Duration of Action in a Mouse Model of Pruritus. J Pharmacol Exp Ther. 2020 Sep;374(3):521-528. doi: 10.1124/jpet.120.265074. Epub 2020 Jul 2.

]]>

<![CDATA[ Brief CBT for Patients Undergoing TAVR ]]>
https://zephyrnet.com/NCT03798548
2015-01-15

https://zephyrnet.com/?p=NCT03798548
NCT03798548https://www.clinicaltrials.gov/study/NCT03798548?tab=tableNANANAAdult patients scheduled to undergo TAVR were randomized to receive brief bedside cognitive behavioral therapy for depression/anxiety or treatment as usual.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year January 15, 2015
Primary Completion Month Year March 31, 2017
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20716274
Description Depression and anxiety are common symptoms in patients undergoing cardiac surgery and associated with increased cardiac morbidity and decreased functional status. Cognitive behavioral therapy (CBT) has been shown to be an effective intervention to treat these symptoms after cardiac surgery, but has not yet been studied in patients undergoing less invasive cardiac procedures such as Transcatheter Aortic Valve Replacement (TAVR). This study will examine the effect of CBT on symptoms of anxiety and depression in patients undergoing TAVR.

The CBT protocol was loosely structured on the Managing Depression and Anxiety using Education and Skills (MADES) protocol described in Dao and colleagues (2011). The current intervention was designed to address the needs of individuals who may develop anxiety or depression symptoms post-TAVR. The CBT intervention consisted of four 30 to 60-minute bedside treatment sessions with a trained clinician while the participant was hospitalized for TAVR.

Main outcome measures were self-reported symptoms of depression and anxiety as measured by the Beck Depression Inventory-II and State Trait Anxiety Inventory Form Y1. Secondary outcomes included health related quality of life and hospital length of stay.

Conditions

Sequence: 52156415
Name Depression, Anxiety
Downcase Name depression, anxiety

Id Information

Sequence: 40148173
Id Source org_study_id
Id Value 32178

Design Groups

Sequence: 55577845 Sequence: 55577846
Group Type Experimental Group Type No Intervention
Title Brief Bedside CBT Title Treatment As Usual

Interventions

Sequence: 52471955
Intervention Type Behavioral
Name Brief Bedside CBT
Description 4 sessions of CBT including psychoeducation about TAVR and how mood can impact recovery in cardiac patients, discussion of patients' expectations and any concerns. Teaching and practice of cognitive restructuring and behavioral goal setting techniques for a healthy recovery.

Keywords

Sequence: 79848006 Sequence: 79848007 Sequence: 79848008
Name CBT Name Brief Therapy Name Bedside Intervention
Downcase Name cbt Downcase Name brief therapy Downcase Name bedside intervention

Design Outcomes

Sequence: 177327727 Sequence: 177327728 Sequence: 177327729 Sequence: 177327730
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change from Baseline Score on Beck Depression Inventory II (BDI-II) Measure Change from Baseline Score on State Trait Anxiety Inventory Form YI (STAI-YI) Measure Change from Baseline Score on Minnesota Living With Heart Failure Questionnaire (MLHFQ) Measure Change from Baseline Score on 12-Item Short Form Health Survey (SF12v2)
Time Frame An average of 3 days post TAVR Procedure, 1-Month Follow Up Time Frame An average of 3 days post TAVR Procedure, 1-Month Follow Up Time Frame 1-Month Follow Up Time Frame 1-Month Follow Up
Description 21-item self-report questionnaire with good reliability and validity in assessing symptoms of depression. Total score range 0-63 with higher scores indicating a worse outcome. Total BDI-II scores are interpreted as follows, 0-13: minimal, 14-19: mild, 20-28: moderate, 29-63: severe. In this study, a score of 14 or greater, and 20 or greater, were used define subpopulations with significant symptoms of depression on the BDI-II. Description 20-item self-report questionnaire with good internal consistency and construct validity in assessing symptoms of anxiety. Total score range 20-80 with higher scores indicating a worse outcome. The recommended cutoff score for clinically significant anxiety is 39 but a recent validity study of anxiety disorders in cardiac patients found ≥ 40 as an optimal cutoff score for screening the presence of an anxiety disorder. In this study, a score of 40 or greater, and 46 or greater, were used to define subpopulations with significant symptoms of anxiety on the STAI-Y1. Description 21-item self-report questionnaire designed to measure the effects of heart failure and treatments for heart failure on and individual's quality of life. Total score range 0-105. The total score is considered a measurement of heart failure severity as indicated by its adverse effect on the respondent's life over the past month. In this study, the MLHFQ total score was used as a continuous measure of heart failure related quality of life. Higher scores indicate a worse outcome. Description An abbreviated version of the 36-item Short Form Health Survey, which is a well-established measure assessing dimensions of mental and physical health. In this study, PCS and MCS summary scores were used as continuous measures of health-related quality of life. Scoring procedures involve computer-based scoring algorithms to calculate two summary scores, the physical component summary score (PCS) and mental component summary score (MCS), on a scale from 0 to 100 with a mean of 50 ± 10 that is normally distributed according to the adult U.S. population. Higher scores indicate a better outcome.

Browse Conditions

Sequence: 193431891 Sequence: 193431892
Mesh Term Depression Mesh Term Behavioral Symptoms
Downcase Mesh Term depression Downcase Mesh Term behavioral symptoms
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48306001
Agency Class OTHER
Lead Or Collaborator lead
Name Stanford University

Design Group Interventions

Sequence: 68130801
Design Group Id 55577845
Intervention Id 52471955

Eligibilities

Sequence: 30757321
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Adults 18 years of age and older
Voluntary participation
Informed consent obtained
Patients with severe aortic stenosis and high surgical risk who are undergoing TAVR

Exclusion Criteria:

Current psychiatric instability (eg., suicidality, schizophrenia, bipolar disorder, active alcoholism or substance abuse)
Severe cognitive impairment, i.e. dementia
Life threatening co-morbidities
Inability to provide consent

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254223917
Registered In Calendar Year 2019
Actual Duration 26
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30503546
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Double
Intervention Model Description Brief Bedside CBT versus Treatment As Usual
Investigator Masked True
Outcomes Assessor Masked True

Links

Sequence: 4386994
Url https://www.jtcvs.org/article/S0022-5223(11)00402-8/fulltext
Description Link to Dao et al 2011

Responsible Parties

Sequence: 28869824
Responsible Party Type Principal Investigator
Name William Fearon
Title Professor of Medicine
Affiliation Stanford University

Study References

Sequence: 52049382
Pmid 21621227
Reference Type background
Citation Dao TK, Youssef NA, Armsworth M, Wear E, Papathopoulos KN, Gopaldas R. Randomized controlled trial of brief cognitive behavioral intervention for depression and anxiety symptoms preoperatively in patients undergoing coronary artery bypass graft surgery. J Thorac Cardiovasc Surg. 2011 Sep;142(3):e109-15. doi: 10.1016/j.jtcvs.2011.02.046. Epub 2011 May 28.

]]>

<![CDATA[ First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy ]]>
https://zephyrnet.com/NCT03798535
2018-12-19

https://zephyrnet.com/?p=NCT03798535
NCT03798535https://www.clinicaltrials.gov/study/NCT03798535?tab=tableNANANAThis is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab.

The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.
<![CDATA[

Studies

Study First Submitted Date 2018-12-21
Study First Posted Date 2019-01-10
Last Update Posted Date 2023-05-30
Start Month Year December 19, 2018
Primary Completion Month Year December 20, 2023
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-30

Detailed Descriptions

Sequence: 20703091
Description This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain

Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment.

First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of stage III unresectable NSCLC and the durvalumab start date (index date).
The second chart extraction will be triggered at time of estimated maturity of PFS data to provide an accurate measure of the PFS outcome.
The third chart extraction will be triggered at time of estimated maturity of OS data to provide an accurate measure of the OS outcome• The fourth and fifth chart extractions will occur approximately 3-years and 5-years after enrolment
The dates for the second through fifth chart abstractions may be adjusted, pending data availability. The estimated PFS and OS maturity will be calculated from the actual patient index dates (date of first dose of durvalumab) and any available data on PFS and OS observed in the first extraction together with the distribution of PFS and OS observed in the PACIFIC trial.

Facilities

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Conditions

Sequence: 52120158
Name NSCLC
Downcase Name nsclc

Id Information

Sequence: 40119354
Id Source org_study_id
Id Value D4194R00005

Countries

Sequence: 42523597 Sequence: 42523598 Sequence: 42523599 Sequence: 42523600 Sequence: 42523601 Sequence: 42523602 Sequence: 42523603 Sequence: 42523604 Sequence: 42523605 Sequence: 42523606
Name Australia Name Belgium Name France Name Germany Name Israel Name Italy Name Netherlands Name Norway Name Switzerland Name United Kingdom
Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False

Design Outcomes

Sequence: 177201070 Sequence: 177201071
Outcome Type primary Outcome Type primary
Measure To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS) Measure To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS)
Time Frame PFS is assessed as PFS rates at 12 months and 18 months, and as PFS median for a period of time of 5 years. From Index date (first dose of durvalumab) to progression or death whichever came first, assessed up to 5 years. Time Frame OS is assessed as OS rates at 2, 3 and 5 years, and as OS median for a period of time of 5 years. From Index date (first dose of durvalumab) to death or end of follow up, whichever came first, assessed during 5 years.
Description PFS defined as time from the index date (date of the first dose of durvalumab) to the date of investigator-determined disease progression or death (if no progression) or the end of follow-up Description OS following durvalumab regimen received from the index date to death or end of follow-up.

Browse Conditions

Sequence: 193288645 Sequence: 193288646 Sequence: 193288647 Sequence: 193288648 Sequence: 193288649 Sequence: 193288650 Sequence: 193288651 Sequence: 193288652 Sequence: 193288653 Sequence: 193288654
Mesh Term Carcinoma, Non-Small-Cell Lung Mesh Term Carcinoma, Bronchogenic Mesh Term Bronchial Neoplasms Mesh Term Lung Neoplasms Mesh Term Respiratory Tract Neoplasms Mesh Term Thoracic Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases
Downcase Mesh Term carcinoma, non-small-cell lung Downcase Mesh Term carcinoma, bronchogenic Downcase Mesh Term bronchial neoplasms Downcase Mesh Term lung neoplasms Downcase Mesh Term respiratory tract neoplasms Downcase Mesh Term thoracic neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48273086
Agency Class INDUSTRY
Lead Or Collaborator lead
Name AstraZeneca

Eligibilities

Sequence: 30736638
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 130 Years
Healthy Volunteers No
Population Patient selection criteria: Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain. Data will be collected from those patients who have received at least one dose of durvalumab between September 2017 through 21 DEC 2018. Patients may participate in other clinical trials during this follow-up period.

Patients must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. There is no fixed maximum duration for durvalumab treatment and it continues until the physician determines that it is in the patient's best interest to stop therapy.

Criteria Inclusion Criteria:

Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
Age ≥ 18 years at time of study entry or adult according to each country regulations for age of majority
Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8)
Patients must have been enrolled in one of the durvalumab EAPs Patients must have been treated with at least one dose of durvalumab within the EAP prior to the study entry and between start of EAP in the country, from September 2017 or later up to end of EAP enrolment or MA + three months (estimated as maximum to 30 December 2018) (whichever occurs earlier).

Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met.

Exclusion Criteria:

-Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254020505
Number Of Facilities 254
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 130
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30482996
Observational Model Cohort
Time Perspective Other

Responsible Parties

Sequence: 28849349
Responsible Party Type Sponsor

]]>

<![CDATA[ Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery ]]>
https://zephyrnet.com/NCT03798522
2019-02-01

https://zephyrnet.com/?p=NCT03798522
NCT03798522https://www.clinicaltrials.gov/study/NCT03798522?tab=tableNANANAbilateral continuous erector spinae plane blockade may represent a valuable alternatives to thoracіc epidurals analgaesіa in treatment of thoracic neuropathic pain.

There were 3 cases reported in 2017 suggested that the erector spinae plane block provides visceral abdominal analgesia in bariatric surgery and at end of the report they recommended further clinical investigation. The investigators hypothesіzed that performing the erector spinae plane (ESP) block at T7 would provide effective abdominal analgaesіa іn patients undergone laparoscopic bariatric surgery. The investigators aimed to compare the analgesic effect of erector spinae plane block and opioid based general anesthesia for laparoscopic bariatric surgeries.
<![CDATA[

Studies

Study First Submitted Date 2018-12-27
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-01-14
Start Month Year February 1, 2019
Primary Completion Month Year August 30, 2019
Verification Month Year January 2020
Verification Date 2020-01-31
Last Update Posted Date 2020-01-14

Detailed Descriptions

Sequence: 20721644
Description The investigators hypothesized that, erector spinae plane block will provide good analgesia for patients undergoing laparoscopic bariatric surgery with less complication compared to opioid based general anesthesia. The visual analogue scale (VAS) will be explained clearly to all participants before conduction of anesthesia. All the drugs will be calculated according to the ideal body weight (IBW).A low-frequency (2-5 MHz) curved array ultrasound probe (Mindray®, China) will be used. In the 1st group: bilateral ultrasound-guided erector spinae plane block will be performed under complete aseptic conditions in the lateral position at T7 vertebrae and before induction of general anesthesia. An 8-cm echogenic 22-G block needle will be inserted in-plane. A total of 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will then be injected into the erector spinae plane. This procedure will be repeated on the contralateral side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine). In the 2nd group: the investigator will give intravenous nalbuphine in a dose of 2mg /kg according to ideal body weight after induction of general anesthesia. All participants will be given 1 gram of intravenous paracetamol (15 mg/Kg), together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.

Intraoperatively, any increase in heart rate and/or arterial blood pressure 10 min after intubation by more than 20% of baseline values in response to surgical stimulus or thereafter throughout the whole operation will be managed by intravenous administration of fentanyl 0.5 µg/Kg. VAS score will be assessed 30 min after extubation and when the VAS score exceeded 4/10, rescue analgesia in the form of IV nalbuphine 5 mg will be administered. Another dose of rescue analgesia can be given in the post anesthesia care unit (PACU) if the VAS still more than 4 after 60 min of extubation. If still high, Ketorolac 60 mg will be given by intravenous infusion.

Facilities

Sequence: 200108200
Name Hany Mohammed El-Hadi Shoukat Mohammed
City Giza
Zip 12211
Country Egypt

Browse Interventions

Sequence: 96050272 Sequence: 96050273 Sequence: 96050274 Sequence: 96050275 Sequence: 96050276 Sequence: 96050277 Sequence: 96050278 Sequence: 96050279
Mesh Term Nalbuphine Mesh Term Analgesics, Opioid Mesh Term Narcotics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Analgesics Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents
Downcase Mesh Term nalbuphine Downcase Mesh Term analgesics, opioid Downcase Mesh Term narcotics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term analgesics Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52171255 Sequence: 52171256 Sequence: 52171257
Name Bariatric Surgery Candidate Name Morbid Obesity Name Visceral Pain
Downcase Name bariatric surgery candidate Downcase Name morbid obesity Downcase Name visceral pain

Id Information

Sequence: 40158648
Id Source org_study_id
Id Value N-42-2018

Countries

Sequence: 42568954
Name Egypt
Removed False

Design Groups

Sequence: 55593195 Sequence: 55593196
Group Type Experimental Group Type Active Comparator
Title erector spinae plane block group (ESPB) n=14 Title general anesthesia group (GA) n= 14
Description Bilateral ultrasound guided erector spinae plane block will be performed in the lateral position at T7 vertebrae and before induction of GA. 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will be injected in-plane into the ESP. This procedure will be repeated on the other side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine) and then GA will be conducted . Description these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA

Interventions

Sequence: 52485498 Sequence: 52485499
Intervention Type Procedure Intervention Type Drug
Name bilateral ultrasound guided erector spinae plane block Name Nalbuphine
Description ESPB on both sides at T7 before GA Description in nalbuphine for analgesia after GA

Keywords

Sequence: 79868567 Sequence: 79868568 Sequence: 79868569
Name ultrasound guided regional blocks Name laparoscopic surgery Name erector spinae plane block
Downcase Name ultrasound guided regional blocks Downcase Name laparoscopic surgery Downcase Name erector spinae plane block

Design Outcomes

Sequence: 177378921 Sequence: 177378922 Sequence: 177378923 Sequence: 177378924 Sequence: 177378925 Sequence: 177378926 Sequence: 177378927 Sequence: 177378928 Sequence: 177378929 Sequence: 177378930 Sequence: 177378931 Sequence: 177378932 Sequence: 177378933 Sequence: 177378934 Sequence: 177378935 Sequence: 177378936
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure The duration of analgesic effect in minutes Measure mean arterial blood pressure changes Measure Nalbuphine consumption Measure visual analogue scale (VAS) for assessment of postoperative pain Measure Block failure rate Measure Resumption of peristalsis Measure incidence of adverse effects Measure Incidence of shoulder pain Measure length of hospital stay Measure heart rate Measure Failure rate of the ESP block Measure demographic data Measure duration of surgery Measure weight Measure height Measure body mass index (BMI)
Time Frame defined as the time n minutes between finishing the block technique in ESPB group or after administration of nalbuphine in GA-group, and the request of first dose of postoperative analgesics) when VAS is more than 4 during the 1st 8 hours postoperatively Time Frame intraoperative and post extubation in the 1st hour Time Frame total dose given post operatively up to 1 hour postoperatively Time Frame at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery Time Frame in the first hour postoperatively Time Frame postoperatively up to 48 hours postoperatively Time Frame postoperative up to 48 hours Time Frame postoperativey up to 24 hours Time Frame postoperative up to 28 days postoperatively Time Frame intraoperatively and throughout one hour postextubation Time Frame in the first hour postoperatively Time Frame during 30 minutes preoperatively Time Frame from skin incision up to skin closure Time Frame during 30 minutes preoperatively Time Frame during 30 minutes preoperatively Time Frame uring 30 minutes preoperatively
Description The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS Description mean arterial blood pressure will be assessed and measured in mmHg non invasively Description in mg Description in numbers, normal scale ranges from 0 to 10 with 0 means no pain and 10 means worst pain imaginable. if VAS score exceeded 4/10; this will be considered insufficient analgesia and participant will be given rescue analgesia Description patient required more than two 5mg doses of nalbuphine Description in hours Description postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation Description percent Description in days Description heart rate in beat per minute will be measured Description the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine Description age, sex, ASA class, co-morbidities Description in minutes Description kilograms Description meter Description weight in kilograms divided by square height in meter

Browse Conditions

Sequence: 193486794 Sequence: 193486795 Sequence: 193486796 Sequence: 193486797 Sequence: 193486798 Sequence: 193486799 Sequence: 193486800 Sequence: 193486801 Sequence: 193486802 Sequence: 193486803
Mesh Term Obesity, Morbid Mesh Term Visceral Pain Mesh Term Obesity Mesh Term Overweight Mesh Term Overnutrition Mesh Term Nutrition Disorders Mesh Term Body Weight Mesh Term Nociceptive Pain Mesh Term Pain Mesh Term Neurologic Manifestations
Downcase Mesh Term obesity, morbid Downcase Mesh Term visceral pain Downcase Mesh Term obesity Downcase Mesh Term overweight Downcase Mesh Term overnutrition Downcase Mesh Term nutrition disorders Downcase Mesh Term body weight Downcase Mesh Term nociceptive pain Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319308
Agency Class OTHER
Lead Or Collaborator lead
Name Cairo University

Design Group Interventions

Sequence: 68149152 Sequence: 68149153
Design Group Id 55593195 Design Group Id 55593196
Intervention Id 52485498 Intervention Id 52485499

Eligibilities

Sequence: 30765363
Gender All
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Patient age >18 <60
Obese patients 40˂ Body mass index(BMI) ˂50
Both sexes
American Society of Anesthesiologists(ASA) physical status classes II and III
Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries

Exclusion Criteria:

Refusal of regional block
Patients with neurological, psychological disorders or those lacking cooperation
Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL)
Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
Patients who are allergic to amide local anesthetics.
Cases converted to open surgery will also be excluded from the study

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253884488
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 7
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 10
Number Of Other Outcomes To Measure 5

Designs

Sequence: 30511530
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Single
Intervention Model Description erector spinae plane block group (ESPB)
general anesthesia group (GA)
Subject Masked True

Intervention Other Names

Sequence: 26673744 Sequence: 26673745
Intervention Id 52485498 Intervention Id 52485499
Name ESPB Name GA

Responsible Parties

Sequence: 28877824
Responsible Party Type Principal Investigator
Name Hany Mohammed El-Hadi Shoukat Mohammed
Title lecturer of anesthesia, pain management and surgical ICU
Affiliation Cairo University

Ipd Information Types

Sequence: 3334121 Sequence: 3334122
Name Study Protocol Name Statistical Analysis Plan (SAP)

]]>

<![CDATA[ Human CD19 Targeted T Cells Injection Therapy for Relapsed and Refractory CD19-positive Leukemia ]]>
https://zephyrnet.com/NCT03798509
2019-03-13

https://zephyrnet.com/?p=NCT03798509
NCT03798509https://www.clinicaltrials.gov/study/NCT03798509?tab=tableHongliang Fang, doctorfanghongliang@dashengbio.com021-58552006To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-08-31
Start Month Year March 13, 2019
Primary Completion Month Year January 2022
Verification Month Year August 2021
Verification Date 2021-08-31
Last Update Posted Date 2021-08-31

Detailed Descriptions

Sequence: 20741170
Description Participants with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, electrocardiograph and blood draws. Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.

Facilities

Sequence: 200280595
Status Recruiting
Name Shanghai General Hospital
City Shanghai
State Shanghai
Zip 200080
Country China

Facility Contacts

Sequence: 28132858
Facility Id 200280595
Contact Type primary
Name Xianmin Song, Professor
Email shongxm@139.com
Phone 021-63240090
Phone Extension 3173

Conditions

Sequence: 52221525 Sequence: 52221526
Name CD19-positive Name Acute Lymphoblastic Leukemia
Downcase Name cd19-positive Downcase Name acute lymphoblastic leukemia

Id Information

Sequence: 40195629
Id Source org_study_id
Id Value HRAIN01-ALL01

Countries

Sequence: 42609658
Name China
Removed False

Design Groups

Sequence: 55649818
Group Type Experimental
Title Human CD19 targeted T Cells Injection

Interventions

Sequence: 52535341
Intervention Type Drug
Name Human CD19 targeted T Cells Injection
Description Autologous genetically modified anti-CD19 CAR transduced T cells

Keywords

Sequence: 79941759 Sequence: 79941760 Sequence: 79941761 Sequence: 79941762 Sequence: 79941763
Name CD19 Name CAR-T Name leukemia Name Relapsed /Refractory Name B-ALL
Downcase Name cd19 Downcase Name car-t Downcase Name leukemia Downcase Name relapsed /refractory Downcase Name b-all

Design Outcomes

Sequence: 177561495 Sequence: 177561496 Sequence: 177561497 Sequence: 177561498 Sequence: 177561499 Sequence: 177561500 Sequence: 177561501 Sequence: 177561502
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure DLT Measure Duration of CAR-positive T cells in circulation Measure The concentration of CD19-positive B cells in peripheral blood. Measure Overall response rate (ORR) after administration Measure Duration of remission (DOR) after administration Measure Progress Free Survival (PFS) after administration Measure Overall Survival (OS)after administration Measure The immunogenicity of Human CD19 targeted T Cells Injection. (the detection of human anti-mouse antibody)
Time Frame 28 days post infusion Time Frame 2 years post infusion Time Frame 2 years post infusion Time Frame 90 days post infusion Time Frame 2 years post infusion Time Frame 2 years post infusion Time Frame 2 years post infusion Time Frame 2 years post infusion

Browse Conditions

Sequence: 193678453 Sequence: 193678454 Sequence: 193678455 Sequence: 193678456 Sequence: 193678457 Sequence: 193678458 Sequence: 193678459 Sequence: 193678460 Sequence: 193678461
Mesh Term Leukemia Mesh Term Precursor Cell Lymphoblastic Leukemia-Lymphoma Mesh Term Leukemia, Lymphoid Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Lymphoproliferative Disorders Mesh Term Lymphatic Diseases Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases
Downcase Mesh Term leukemia Downcase Mesh Term precursor cell lymphoblastic leukemia-lymphoma Downcase Mesh Term leukemia, lymphoid Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term lymphatic diseases Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366429 Sequence: 48366430
Agency Class INDUSTRY Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Hrain Biotechnology Co., Ltd. Name Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Central Contacts

Sequence: 12020590
Contact Type primary
Name Hongliang Fang, doctor
Phone 021-58552006
Email fanghongliang@dashengbio.com
Role Contact

Design Group Interventions

Sequence: 68217409
Design Group Id 55649818
Intervention Id 52535341

Eligibilities

Sequence: 30794711
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

18 to 70 Years Old, Male and female;
Expected survival > 12 weeks;
ECOG score 0-1;

Bone marrow examination clearly diagnosed as CD19 positive B-cell acute lymphoblastic leukemia and who met one of the following conditions:

Those who failed to achieve CR after at least 2 courses of standard chemotherapy or had early relapse after complete remission (<12 months) or late relapse after complete remission (≥ 12 months) and failed to achieve CR after 1 course of standard chemotherapy;
For Ph+ ALL: in addition to receiving at least 2 courses of standard chemotherapy, at least two TKIs should be treated with no complete remission or relapse after complete remission (Patients who cannot tolerate TKI therapy or have TKI treatment contraindications or have T315i mutation are excluded);
Those who relapse after stem cell transplantation are not affected by previous treatments;
The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;

Liver, kidney and cardiopulmonary functions meet the following requirements:

Creatinine is in the normal range;
Left ventricular ejection fraction >50%;
Baseline oxygen saturation>92%;
Total bilirubin ≤ 2×ULN; ALT and AST ≤2.5 × ULN;
Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

Graft-versus-host disease (GVHD), or need to use immunosuppressants;
Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
Received CAR-T treatment or other gene therapies before enrollment;
Patients with symptoms of central nervous system;
Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
The investigators consider other conditions unsuitable for enrollment.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004327
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 7

Designs

Sequence: 30540751
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28907071
Responsible Party Type Sponsor

]]>

<![CDATA[ Anatomical and Biomechanical Study About Stability in Galeazzi´s Fracture ]]>
https://zephyrnet.com/NCT03798496
2018-12-18

https://zephyrnet.com/?p=NCT03798496
NCT03798496https://www.clinicaltrials.gov/study/NCT03798496?tab=tableNANANAMost Galeazzi fractures can be treated adequately with open reduction and internal fixation (ORIF) of the radius alone, but some will remain unstable at the DRUJ and require repair of the TFCC.The purpose of this anatomical and biomechanical study was to define and measure DRUJ dislocation, displacement and instability associated with the sequential sectioning of the different bands in the interosseous membrane (IOM) and TFCC in the simulation of a Galeazzi fracture.
<![CDATA[

Studies

Study First Submitted Date 2018-12-19
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-07-13
Start Month Year December 18, 2018
Primary Completion Month Year January 31, 2021
Verification Month Year July 2021
Verification Date 2021-07-31
Last Update Posted Date 2021-07-13

Detailed Descriptions

Sequence: 20709980
Description Instability of the DRUJ is a common clinical problem associated with Galeazzi fracture. Stability of the DRUJ is primarily provided by both the bony anatomy of the sigmoid notch of the radius and ulnar head and the soft tissues surrounding the joint. The interosseous membrane plays an important role in DRUJ stability but the TFCC is the major soft tissue stabilizer of the DRUJ. The Central Band works as a restraint on the radius from proximal migration in cooperation with the radial head and the TFCC and also works as a load transmitter between the radius and ulnar to redistribute load. Some investigators suggested that the distal membranous portion and DOB stabilizes the DRUJ when TFCC is disrupted. Watanabe et al. (2005) insisted on the importance of DOB, which constrained volar and dorsal instability of the radius at the DRUJ in all forearm rotation positions. The purpose of this anatomical and biomechanical study was to define and measure DRUJ dislocation in the simulation of a Galeazzi fracture.

Facilities

Sequence: 199965051
Name Hospital de la Santa Creu i Sant Pau
City Barcelona
Zip 08025
Country Spain

Conditions

Sequence: 52138979
Name Galeazzi's Fracture
Downcase Name galeazzi's fracture

Id Information

Sequence: 40135041
Id Source org_study_id
Id Value IIBSP-GAL-2018-75

Countries

Sequence: 42542672
Name Spain
Removed False

Interventions

Sequence: 52454878
Intervention Type Procedure
Name Open reduction and internal fixation
Description Open reduction of the Galeazzi fracture dislocation with a plate.

Design Outcomes

Sequence: 177263571 Sequence: 177263572
Outcome Type primary Outcome Type primary
Measure Displacement in distal radius fracture Measure Stability in the DRU joint
Time Frame 12 months Time Frame 12 months
Description The investigators will mesure the degree of displacement (mm) in a simulate distal radius fracture with a biomechanical device named Medmesin with a especific computer software that applies newtons (from 0 to 100N) in the radius in each especimen. Description Dislocation of the ulnar in the wrist. In the retrospective clinical reports the investigators evaluate the x-rays before and after the surgery and the radioulnar ratio in the CT scan (congruency method, Mino criteria and the epicenter method).

Browse Conditions

Sequence: 193366415 Sequence: 193366416 Sequence: 193366417 Sequence: 193366418 Sequence: 193366419
Mesh Term Fractures, Bone Mesh Term Radius Fractures Mesh Term Wounds and Injuries Mesh Term Forearm Injuries Mesh Term Arm Injuries
Downcase Mesh Term fractures, bone Downcase Mesh Term radius fractures Downcase Mesh Term wounds and injuries Downcase Mesh Term forearm injuries Downcase Mesh Term arm injuries
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290688
Agency Class OTHER
Lead Or Collaborator lead
Name Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Overall Officials

Sequence: 29268526
Role Principal Investigator
Name Claudia Lamas, Ph D
Affiliation Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Eligibilities

Sequence: 30747708
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 85 Years
Healthy Volunteers No
Population Anatomical and biomechanical study: Twelve specimens from the Human Anatomy Department.

Clinical study: Review of reports (X-rays) about patients with Galeazzi fracture-dislocation treated with ORIF.

Criteria Inclusion Criteria:

Adults patients(18-85 years old) with Galeazzi fracture-dislocation treated with open reduction and internal fixation (ORIF).

Exclusion Criteria:

Children
Other types of forearms fractures

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121821
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 25
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 85
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30493991
Observational Model Cohort
Time Perspective Other

Intervention Other Names

Sequence: 26655395
Intervention Id 52454878
Name DRUJ reduction with Kirschner wire

Responsible Parties

Sequence: 28860271
Responsible Party Type Sponsor

Study References

Sequence: 52032712 Sequence: 52032713 Sequence: 52032714 Sequence: 52032715 Sequence: 52032716 Sequence: 52032717 Sequence: 52032718 Sequence: 52032719 Sequence: 52032720 Sequence: 52032721
Pmid 25703865 Pmid 21872404 Pmid 24315636 Pmid 22721462 Pmid 19211201 Pmid 8463602 Pmid 24436838 Pmid 26518322 Pmid 28428910 Pmid 22100813
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Farr LD, Werner FW, McGrattan ML, Zwerling SR, Harley BJ. Anatomy and biomechanics of the forearm interosseous membrane. J Hand Surg Am. 2015 Jun;40(6):1145-51.e2. doi: 10.1016/j.jhsa.2014.12.025. Epub 2015 Feb 20. Citation Kitamura T, Moritomo H, Arimitsu S, Berglund LJ, Zhao KD, An KN, Rizzo M. The biomechanical effect of the distal interosseous membrane on distal radioulnar joint stability: a preliminary anatomic study. J Hand Surg Am. 2011 Oct;36(10):1626-30. doi: 10.1016/j.jhsa.2011.07.016. Epub 2011 Aug 26. Citation Loeffler BJ, Green JB, Zelouf DS. Forearm instability. J Hand Surg Am. 2014 Jan;39(1):156-67. doi: 10.1016/j.jhsa.2013.07.010. Epub 2013 Dec 6. Citation Moritomo H. The distal interosseous membrane: current concepts in wrist anatomy and biomechanics. J Hand Surg Am. 2012 Jul;37(7):1501-7. doi: 10.1016/j.jhsa.2012.04.037. Citation Noda K, Goto A, Murase T, Sugamoto K, Yoshikawa H, Moritomo H. Interosseous membrane of the forearm: an anatomical study of ligament attachment locations. J Hand Surg Am. 2009 Mar;34(3):415-22. doi: 10.1016/j.jhsa.2008.10.025. Epub 2009 Feb 11. Citation Petersen MS, Adams BD. Biomechanical evaluation of distal radioulnar reconstructions. J Hand Surg Am. 1993 Mar;18(2):328-34. doi: 10.1016/0363-5023(93)90370-I. Citation Riggenbach MD, Conrad BP, Wright TW, Dell PC. Distal oblique bundle reconstruction and distal radioulnar joint instability. J Wrist Surg. 2013 Nov;2(4):330-6. doi: 10.1055/s-0033-1358546. Citation Riggenbach MD, Wright TW, Dell PC. Reconstruction of the Distal Oblique Bundle of the Interosseous Membrane: A Technique to Restore Distal Radioulnar Joint Stability. J Hand Surg Am. 2015 Nov;40(11):2279-82. doi: 10.1016/j.jhsa.2015.08.019. Citation Werner FW, LeVasseur MR, Harley BJ, Anderson A. Role of the Interosseous Membrane in Preventing Distal Radioulnar Gapping. J Wrist Surg. 2017 May;6(2):97-101. doi: 10.1055/s-0036-1584545. Epub 2016 Jun 20. Citation Werner FW, Taormina JL, Sutton LG, Harley BJ. Structural properties of 6 forearm ligaments. J Hand Surg Am. 2011 Dec;36(12):1981-7. doi: 10.1016/j.jhsa.2011.09.026. Epub 2011 Nov 17.

]]>

<![CDATA[ INDividualised EXercise for Kneecap Dislocations ]]>
https://zephyrnet.com/NCT03798483
2019-01-24

https://zephyrnet.com/?p=NCT03798483
NCT03798483https://www.clinicaltrials.gov/study/NCT03798483?tab=tableNANANAThis study is a feasibility study. It will assess areas of uncertainty relating to the implementation of an individualised exercise programme for patients with a recent kneecap dislocation. This will help determine if a future larger study is feasible, and inform the design and conduct of future research that would aim to optimise outcomes after a kneecap dislocation.
<![CDATA[

Studies

Study First Submitted Date 2018-12-11
Study First Posted Date 2019-01-10
Last Update Posted Date 2021-02-01
Start Month Year January 24, 2019
Primary Completion Month Year October 8, 2019
Verification Month Year December 2018
Verification Date 2018-12-31
Last Update Posted Date 2021-02-01
Results First Posted Date 2021-02-01

Detailed Descriptions

Sequence: 20724609
Description The investigators aim to recruit 15 adult participants with a recent, first-time or recurrent kneecap dislocation, from an acute hospital. Participants will receive up to 6 physiotherapy sessions over 3 months. The investigator's exercise programme aims to improve leg muscle strength and facilitate a return to the participant's usual activities. This may include activities such as hopping and changing direction which differentiates it from other programmes. Participants will be required to perform the exercise programme 3 times a week independently. Strategies to increase adherence to the exercise programme will also be used. This study is part of a Masters in Clinical Research funded by the National Institute for Health Research

Facilities

Sequence: 200141486
Name John Radcliffe Hospital
City Oxford
Zip OX3 9DU
Country United Kingdom

Conditions

Sequence: 52178978 Sequence: 52178979
Name Patella Dislocation Name Patella Dislocation Recurrent
Downcase Name patella dislocation Downcase Name patella dislocation recurrent

Id Information

Sequence: 40164322 Sequence: 40164323
Id Source org_study_id Id Source secondary_id
Id Value MRes/18-19/04/2 Id Value 251913
Id Type Other Identifier
Id Type Description Health Research Authority – IRAS ID

Countries

Sequence: 42575730
Name United Kingdom
Removed False

Design Groups

Sequence: 55601887
Group Type Experimental
Title Individualized exercise
Description Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist

Interventions

Sequence: 52493164
Intervention Type Other
Name Individualised exercise
Description The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.

Design Outcomes

Sequence: 177410072 Sequence: 177410073 Sequence: 177410074 Sequence: 177410075 Sequence: 177410076 Sequence: 177410077 Sequence: 177410078 Sequence: 177410079 Sequence: 177410080 Sequence: 177410081 Sequence: 177410082 Sequence: 177410083 Sequence: 177410084 Sequence: 177410085 Sequence: 177410086 Sequence: 177410087 Sequence: 177410088 Sequence: 177410089
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Eligibility Rate Measure Recruitment Rate Measure Attrition Measure Acceptability [Participant Satisfaction]: Questionnaire Measure Adherence Measure Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] Measure Acceptability of Outcome Data Collection Measure Number of Treatment Related Adverse Events Experienced by Participants Measure Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Measure Tegner Activity Scale Questionnaire Measure Lyhsolm Knee Scoring Scale Questionnaire Measure Quality of Life Using the EQ-5D-5L Questionnaire Measure Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] Measure Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] Measure Assess Delivery of the Intervention [Duration of Intervention] Measure Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Measure Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] Measure Assess Delivery of the Intervention [Initial Injury Management]
Time Frame 15 weeks Time Frame 15 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame Through 12 weeks after first physiotherapy session Time Frame Baseline Time Frame 12 weeks Time Frame 12 Weeks Time Frame 12 weeks Time Frame From date of injury until date of the first physiotherapy session, assessed up to 6 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks
Description Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria Description Percentage of eligible participants who consented to participate in the study Description Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Percentage (0-100%) of scheduled physiotherapy sessions attended Description Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. Description Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction Description This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire. Description It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire. Description This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. Description Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention Description Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants Description Treatment logs will be analysed to assess the duration (days) of the study intervention Description Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team

Browse Conditions

Sequence: 193516248 Sequence: 193516249 Sequence: 193516250 Sequence: 193516251 Sequence: 193516252 Sequence: 193516253 Sequence: 193516254
Mesh Term Joint Dislocations Mesh Term Patellar Dislocation Mesh Term Joint Diseases Mesh Term Musculoskeletal Diseases Mesh Term Wounds and Injuries Mesh Term Knee Injuries Mesh Term Leg Injuries
Downcase Mesh Term joint dislocations Downcase Mesh Term patellar dislocation Downcase Mesh Term joint diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term wounds and injuries Downcase Mesh Term knee injuries Downcase Mesh Term leg injuries
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48326279 Sequence: 48326280
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name City, University of London Name Oxford University Hospitals NHS Trust

Overall Officials

Sequence: 29289214
Role Principal Investigator
Name Mark Haddad, PhD
Affiliation City, University of London

Design Group Interventions

Sequence: 68159982
Design Group Id 55601887
Intervention Id 52493164

Eligibilities

Sequence: 30769727
Gender All
Minimum Age 16 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

First time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team.

Exclusion Criteria:

Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention
> 4 weeks from injury to presentation to acute care (ED or trauma services)
Unable to give written informed consent
Previous surgery on the affected knee
Presence of fracture on plain radiograph including osteochondral fractures
Medial patellar dislocation
Considered inappropriate for referral to physiotherapy (by member of trauma and orthopaedic team assessing the patient)
History of severe neuromuscular or congenital disorders
Patients referred for orthopaedic opinion who are subsequently listed for surgery prior to completion of the study intervention
Unable to understand written or spoken English
Unable to attend physiotherapy sessions at the John Radcliffe trauma outpatient physiotherapy department

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253937151
Number Of Facilities 1
Number Of Nsae Subjects 2
Registered In Calendar Year 2018
Actual Duration 8
Were Results Reported True
Months To Report Results 13
Has Us Facility False
Has Single Facility True
Minimum Age Num 16
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 6
Number Of Secondary Outcomes To Measure 12

Designs

Sequence: 30515881
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Drop Withdrawals

Sequence: 28993726
Result Group Id 56100821
Ctgov Group Code FG000
Period Overall Study
Reason Lost to Follow-up
Count 2

Milestones

Sequence: 41014457 Sequence: 41014458 Sequence: 41014459 Sequence: 41014460
Result Group Id 56100821 Result Group Id 56100821 Result Group Id 56100821 Result Group Id 56100821
Ctgov Group Code FG000 Ctgov Group Code FG000 Ctgov Group Code FG000 Ctgov Group Code FG000
Title STARTED Title Returned All Follow-up Outcome Data Title COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 15 Count 11 Count 13 Count 2
Milestone Description Completed participants were participants that returned Lysholm Knee Scoring Scale data. 2 participants returned Lysholm Knee Scoring Scale outcome data only.

Participant Flows

Sequence: 3921906

Outcome Counts

Sequence: 74016549 Sequence: 74016550 Sequence: 74016551 Sequence: 74016552 Sequence: 74016553 Sequence: 74016554 Sequence: 74016555 Sequence: 74016556 Sequence: 74016557 Sequence: 74016558 Sequence: 74016559 Sequence: 74016560 Sequence: 74016561 Sequence: 74016562 Sequence: 74016563 Sequence: 74016564 Sequence: 74016565 Sequence: 74016566 Sequence: 74016567 Sequence: 74016568
Outcome Id 30811317 Outcome Id 30811318 Outcome Id 30811319 Outcome Id 30811320 Outcome Id 30811321 Outcome Id 30811321 Outcome Id 30811322 Outcome Id 30811323 Outcome Id 30811324 Outcome Id 30811325 Outcome Id 30811326 Outcome Id 30811327 Outcome Id 30811328 Outcome Id 30811329 Outcome Id 30811330 Outcome Id 30811331 Outcome Id 30811332 Outcome Id 30811333 Outcome Id 30811333 Outcome Id 30811334
Result Group Id 56100822 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100824 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100824 Result Group Id 56100823 Result Group Id 56100825 Result Group Id 56100822 Result Group Id 56100824 Result Group Id 56100826 Result Group Id 56100824 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823
Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Scheduled physiotherapy sessions Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Prescribed leg resistance exercise Units Participants
Count 22 Count 15 Count 15 Count 11 Count 15 Count 66 Count 11 Count 15 Count 15 Count 15 Count 11 Count 13 Count 11 Count 15 Count 15 Count 15 Count 15 Count 15 Count 93 Count 15

Provided Documents

Sequence: 2580332
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2018-12-17
Url https://ClinicalTrials.gov/ProvidedDocs/83/NCT03798483/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27948259 Sequence: 27948260 Sequence: 27948261
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000
Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 2 Subjects Affected 0
Subjects At Risk 15 Subjects At Risk 15 Subjects At Risk 15
Created At 2023-08-09 01:49:36.032676 Created At 2023-08-09 01:49:36.032676 Created At 2023-08-09 01:49:36.032676
Updated At 2023-08-09 01:49:36.032676 Updated At 2023-08-09 01:49:36.032676 Updated At 2023-08-09 01:49:36.032676

Reported Events

Sequence: 528319399 Sequence: 528319400
Result Group Id 56100827 Result Group Id 56100827
Ctgov Group Code EG000 Ctgov Group Code EG000
Time Frame through 3 months after the first physiotherapy session Time Frame through 3 months after the first physiotherapy session
Event Type other Event Type other
Subjects Affected 1 Subjects Affected 1
Subjects At Risk 15 Subjects At Risk 15
Event Count 3 Event Count 1
Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders
Adverse Event Term Knee pain or swelling after completing prescribed exercise that last >1 week Adverse Event Term Recurrent patellar dislocation
Frequency Threshold 0 Frequency Threshold 0
Assessment Systematic Assessment Assessment Non-systematic Assessment

Responsible Parties

Sequence: 28882189
Responsible Party Type Sponsor

Result Agreements

Sequence: 3852650
Pi Employee No

Result Contacts

Sequence: 3852615
Organization Oxford University hospital foundation trust
Name Colin Forde
Phone +441865221540
Email Colin.Forde@ouh.nhs.uk

Outcomes

Sequence: 30811317 Sequence: 30811318 Sequence: 30811319 Sequence: 30811320 Sequence: 30811321 Sequence: 30811322 Sequence: 30811323 Sequence: 30811324 Sequence: 30811325 Sequence: 30811326 Sequence: 30811327 Sequence: 30811328 Sequence: 30811329 Sequence: 30811330 Sequence: 30811331 Sequence: 30811332 Sequence: 30811333 Sequence: 30811334
Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Eligibility Rate Title Recruitment Rate Title Attrition Title Acceptability [Participant Satisfaction]: Questionnaire Title Adherence Title Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] Title Acceptability of Outcome Data Collection Title Number of Treatment Related Adverse Events Experienced by Participants Title Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Title Tegner Activity Scale Questionnaire Title Lyhsolm Knee Scoring Scale Questionnaire Title Quality of Life Using the EQ-5D-5L Questionnaire Title Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] Title Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] Title Assess Delivery of the Intervention [Duration of Intervention] Title Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Initial Injury Management]
Description Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria Description Percentage of eligible participants who consented to participate in the study Description Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Percentage (0-100%) of scheduled physiotherapy sessions attended Description Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. Description Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction Description This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire. Description It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire. Description This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. Description Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention Description Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants Description Treatment logs will be analysed to assess the duration (days) of the study intervention Description Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team
Time Frame 15 weeks Time Frame 15 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame Through 12 weeks after first physiotherapy session Time Frame Baseline Time Frame 12 weeks Time Frame 12 Weeks Time Frame 12 weeks Time Frame From date of injury until date of the first physiotherapy session, assessed up to 6 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks
Population These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment Population 11/15 participants completed and returned data for this outcome Population 15 participants completed baseline patient-reported outcome measures and 11 participants completed all patient-reported outcome measures at 3-month follow-up and returned by post. Analysed data refers only to these participants.

Lysholm Knee Scoring Scale outcome data was obtained for 2 participants by phone at 3-month follow-up, so they are not included in analysed data

Population 15 participants were assessed for all the clinical findings below, except for the patella apprehension test which was only assessed in 13 participants.
Units Participants Units Participants Units Participants Units units on a scale Units Scheduled physiotherapy sessions Units Participants Units percentage of questions Units Participants Units percentage Units units on a scale Units units on a scale Units units on a scale Units Days Units physiotherapy sessions Units Days Units participants Units Prescribed leg resistance exercise Units Participants
Units Analyzed Scheduled physiotherapy sessions Units Analyzed Prescribed leg resistance exercise
Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Median Param Type Count of Units Param Type Count of Participants Param Type Number Param Type Count of Participants Param Type Number Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Number Param Type Count of Units Param Type Count of Participants

Outcome Measurements

Sequence: 235724878 Sequence: 235724901 Sequence: 235724910 Sequence: 235724879 Sequence: 235724880 Sequence: 235724881 Sequence: 235724882 Sequence: 235724883 Sequence: 235724884 Sequence: 235724885 Sequence: 235724886 Sequence: 235724887 Sequence: 235724888 Sequence: 235724889 Sequence: 235724890 Sequence: 235724891 Sequence: 235724892 Sequence: 235724893 Sequence: 235724894 Sequence: 235724895 Sequence: 235724896 Sequence: 235724897 Sequence: 235724898 Sequence: 235724899 Sequence: 235724900 Sequence: 235724902 Sequence: 235724903 Sequence: 235724904 Sequence: 235724905 Sequence: 235724906 Sequence: 235724907 Sequence: 235724908 Sequence: 235724909 Sequence: 235724911 Sequence: 235724912 Sequence: 235724913 Sequence: 235724914 Sequence: 235724915 Sequence: 235724916 Sequence: 235724917 Sequence: 235724918 Sequence: 235724919 Sequence: 235724920 Sequence: 235724921 Sequence: 235724922 Sequence: 235724923 Sequence: 235724924 Sequence: 235724925 Sequence: 235724926 Sequence: 235724927 Sequence: 235724928 Sequence: 235724929 Sequence: 235724930 Sequence: 235724931 Sequence: 235724932 Sequence: 235724933
Outcome Id 30811317 Outcome Id 30811323 Outcome Id 30811327 Outcome Id 30811318 Outcome Id 30811319 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811320 Outcome Id 30811321 Outcome Id 30811322 Outcome Id 30811322 Outcome Id 30811322 Outcome Id 30811323 Outcome Id 30811323 Outcome Id 30811323 Outcome Id 30811323 Outcome Id 30811323 Outcome Id 30811324 Outcome Id 30811324 Outcome Id 30811324 Outcome Id 30811325 Outcome Id 30811325 Outcome Id 30811325 Outcome Id 30811325 Outcome Id 30811326 Outcome Id 30811328 Outcome Id 30811328 Outcome Id 30811329 Outcome Id 30811330 Outcome Id 30811331 Outcome Id 30811332 Outcome Id 30811332 Outcome Id 30811332 Outcome Id 30811332 Outcome Id 30811332 Outcome Id 30811333 Outcome Id 30811333 Outcome Id 30811333 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334 Outcome Id 30811334
Result Group Id 56100822 Result Group Id 56100823 Result Group Id 56100826 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100823 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100825 Result Group Id 56100825 Result Group Id 56100825 Result Group Id 56100822 Result Group Id 56100822 Result Group Id 56100822 Result Group Id 56100822 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100824 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823 Result Group Id 56100823
Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000
Classification Follow-up EQ-5D-5L Classification How satisfied are you with the effect of your physiotherapy treatment? Classification How satisfied are you with your involvement in decision making about your physiotherapy treatment? Classification How satisfied were you with up to six physiotherapy sessions over three months after your injury? Classification How satisfied were you with the written information you were given describing the study? Classification How satisfied were you with the written information you were given about your injury? Classification How satisfied are you overall with the physiotherapy care you received after your injury? Classification How confident are you that you can return to all your normal activities? Classification How did doing your exercises fit into your weekly routine? Classification How confident are you that you were doing your exercises the way your physiotherapist showed you? Classification How confident are you that you understood how tiring the muscle strengthening exercises should feel? Classification How likely are you to continue your exercises now your physiotherapy is finished? Classification Baseline Lysholm Knee Scoring Scale Classification Baseline Tegner Activity Scale Classification Baseline EQ-5D-5L Classification Follow-up Lysholm Knee Scoring Scale Classification Follow-up Tegner Activity Scale Classification Medial patellofemoral ligament tenderness Classification convincing history of a lateral patellar dislocation Classification visible knee joint effusion or haemarthrosis Classification positive patella apprehension test, Classification Index score Classification Health on a Visual Analogue Scale Classification Knee flexibility exercise Classification Trunk and leg control exercise Classification Leg resistance exercise Classification Running exercise Classification Bespoke exercise Classification Prescribed sets between 1-3 Classification Prescribed repetitions between 8-12 Classification Prescribed frequency 3 or more per week Classification Lateral butress splint Classification Cricket pad splint Classification Hinged knee brace Classification Full weight-bearing Classification Two elbow crutches Classification No walking aids Classification Knee range of movement exercises Classification Non-weight bearing knee strengthening exercise Classification Gait practice, balance exercises Classification Weight-bearing knee strengthening, strengthening of unijured joints
Category 'Always' Category 'Often' Category 'Sometimes' Category knee pain or swelling after completing prescribed exercises that lasted >1 week Category Recurrent patella dislocation Category No treatment related adverse event
Title Eligibility Rate Title Acceptability of Outcome Data Collection Title Lyhsolm Knee Scoring Scale Questionnaire Title Recruitment Rate Title Attrition Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Acceptability [Participant Satisfaction]: Questionnaire Title Adherence Title Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] Title Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] Title Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] Title Acceptability of Outcome Data Collection Title Acceptability of Outcome Data Collection Title Acceptability of Outcome Data Collection Title Acceptability of Outcome Data Collection Title Acceptability of Outcome Data Collection Title Number of Treatment Related Adverse Events Experienced by Participants Title Number of Treatment Related Adverse Events Experienced by Participants Title Number of Treatment Related Adverse Events Experienced by Participants Title Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Title Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Title Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Title Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria Title Tegner Activity Scale Questionnaire Title Quality of Life Using the EQ-5D-5L Questionnaire Title Quality of Life Using the EQ-5D-5L Questionnaire Title Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] Title Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] Title Assess Delivery of the Intervention [Duration of Intervention] Title Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management] Title Assess Delivery of the Intervention [Initial Injury Management]
Description Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire. Description Percentage of eligible participants who consented to participate in the study Description Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. Description Percentage (0-100%) of scheduled physiotherapy sessions attended Description Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) Description Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) Description Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up Description The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. Description The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. Description The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. Description Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction Description Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction Description Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction Description Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction Description This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire. Description This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. Description This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. Description Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention Description Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants Description Treatment logs will be analysed to assess the duration (days) of the study intervention Description Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team Description Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team
Units Participants Units percentage of questions Units units on a scale Units Participants Units Participants Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units Scheduled physiotherapy sessions Units Participants Units Participants Units Participants Units percentage of questions Units percentage of questions Units percentage of questions Units percentage of questions Units percentage of questions Units Participants Units Participants Units Participants Units percentage Units percentage Units percentage Units percentage Units units on a scale Units units on a scale Units units on a scale Units Days Units physiotherapy sessions Units Days Units participants Units participants Units participants Units participants Units participants Units Prescribed leg resistance exercise Units Prescribed leg resistance exercise Units Prescribed leg resistance exercise Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Count of Participants Param Type Number Param Type Median Param Type Count of Participants Param Type Count of Participants Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Count of Units Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number Param Type Number Param Type Number Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Median Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Count of Units Param Type Count of Units Param Type Count of Units Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 15 Param Value 100 Param Value 90 Param Value 15 Param Value 2 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 1 Param Value 1 Param Value 1 Param Value 1 Param Value 56 Param Value 4 Param Value 5 Param Value 2 Param Value 100 Param Value 100 Param Value 100 Param Value 100 Param Value 100 Param Value 1 Param Value 1 Param Value 13 Param Value 100 Param Value 93.3 Param Value 66.7 Param Value 100 Param Value 6 Param Value 0.84 Param Value 90 Param Value 21 Param Value 3 Param Value 50 Param Value 13 Param Value 14 Param Value 15 Param Value 5 Param Value 5 Param Value 90 Param Value 89 Param Value 91 Param Value 12 Param Value 2 Param Value 1 Param Value 15 Param Value 7 Param Value 8 Param Value 7 Param Value 4 Param Value 2 Param Value 1
Param Value Num 15.0 Param Value Num 100.0 Param Value Num 90.0 Param Value Num 15.0 Param Value Num 2.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 56.0 Param Value Num 4.0 Param Value Num 5.0 Param Value Num 2.0 Param Value Num 100.0 Param Value Num 100.0 Param Value Num 100.0 Param Value Num 100.0 Param Value Num 100.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 13.0 Param Value Num 100.0 Param Value Num 93.3 Param Value Num 66.7 Param Value Num 100.0 Param Value Num 6.0 Param Value Num 0.84 Param Value Num 90.0 Param Value Num 21.0 Param Value Num 3.0 Param Value Num 50.0 Param Value Num 13.0 Param Value Num 14.0 Param Value Num 15.0 Param Value Num 5.0 Param Value Num 5.0 Param Value Num 90.0 Param Value Num 89.0 Param Value Num 91.0 Param Value Num 12.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 15.0 Param Value Num 7.0 Param Value Num 8.0 Param Value Num 7.0 Param Value Num 4.0 Param Value Num 2.0 Param Value Num 1.0
Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range
Dispersion Lower Limit 76.5 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 0.0 Dispersion Lower Limit 3.0 Dispersion Lower Limit 0.8 Dispersion Lower Limit 85.0 Dispersion Lower Limit 15.0 Dispersion Lower Limit 3.0 Dispersion Lower Limit 37.0
Dispersion Upper Limit 95.0 Dispersion Upper Limit 0.0 Dispersion Upper Limit 0.0 Dispersion Upper Limit 0.0 Dispersion Upper Limit 0.0 Dispersion Upper Limit 1.0 Dispersion Upper Limit 0.0 Dispersion Upper Limit 1.0 Dispersion Upper Limit 2.0 Dispersion Upper Limit 1.0 Dispersion Upper Limit 1.0 Dispersion Upper Limit 1.0 Dispersion Upper Limit 7.0 Dispersion Upper Limit 1.0 Dispersion Upper Limit 95.0 Dispersion Upper Limit 27.0 Dispersion Upper Limit 5.0 Dispersion Upper Limit 79.0

Study References

Sequence: 52071450
Pmid 34749823
Reference Type derived
Citation Forde C, Haddad M, Hirani SP, Keene DJ. Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study. Pilot Feasibility Stud. 2021 Nov 8;7(1):197. doi: 10.1186/s40814-021-00932-x.

Baseline Counts

Sequence: 11385359
Result Group Id 56100820
Ctgov Group Code BG000
Units Participants
Scope overall
Count 15

Result Groups

Sequence: 56100820 Sequence: 56100821 Sequence: 56100822 Sequence: 56100823 Sequence: 56100824 Sequence: 56100825 Sequence: 56100826 Sequence: 56100827
Ctgov Group Code BG000 Ctgov Group Code FG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code EG000
Result Type Baseline Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Reported Event
Title Individualized Exercise Title Individualized Exercise Title Patients With a Diagnosed Lateral Patellar Dislocation Title Individualized Exercise Title Participants Who Completed and Returned Follow-up Outcome Data Title Individualized Exercise Title Patients Who Returned Lysholm Knee Scoring Scale Outcome Data Title Individualized Exercise
Description Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist

Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.

Description Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist

Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.

Description Patients with a clinically diagnosed lateral patellar dislocation Description Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist

Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.

Description 11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants Description Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist

Individualised exercise: The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.

Description 13 participants returned Lysholm Knee Scoring Scale data, for 2 of these participants outcome data was obtained by phone Description Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist

Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used.

Baseline Measurements

Sequence: 125616098 Sequence: 125616099 Sequence: 125616100 Sequence: 125616101 Sequence: 125616102 Sequence: 125616103 Sequence: 125616104 Sequence: 125616105 Sequence: 125616106 Sequence: 125616107 Sequence: 125616108 Sequence: 125616109 Sequence: 125616110 Sequence: 125616111 Sequence: 125616112 Sequence: 125616113 Sequence: 125616114 Sequence: 125616115 Sequence: 125616116 Sequence: 125616117 Sequence: 125616118 Sequence: 125616119 Sequence: 125616120 Sequence: 125616121 Sequence: 125616122 Sequence: 125616123 Sequence: 125616124
Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820 Result Group Id 56100820
Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000 Ctgov Group Code BG000
Classification Ethnicity Classification Ethnicity Classification Ethnicity Classification United Kingdom
Category Female Category Male Category White British Category White Other Category Other Category Secondary education Category Higher professional or University education Category Employed Category Student Category 0 Category 1 Category 2 Category 3 Category 4 Category 5-6 Category 0 Category 1 Category 2 Category >10
Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Region of Enrollment Title Height Title Weight Title Education Title Education Title Employment status Title Employment status Title Duration from injury to eligibility assessment Title Previous ipsilateral patellar dislocation Title Number of previous ipsilateral patellar dislocations Title Number of previous ipsilateral patellar dislocations Title Number of previous ipsilateral patellar dislocations Title Number of previous ipsilateral patellar dislocations Title Number of previous ipsilateral patellar dislocations Title Number of previous ipsilateral patellar dislocations Title Previous contralateral patellar dislocation Title Number of previous contralateral patellar dislocations (number of participants) Title Number of previous contralateral patellar dislocations (number of participants) Title Number of previous contralateral patellar dislocations (number of participants) Title Number of previous contralateral patellar dislocations (number of participants) Title Family history of patellar dislocation
Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units meters Units Kilograms Units Participants Units Participants Units Participants Units Participants Units days Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Median Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Median Param Type Median Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 22 Param Value 7 Param Value 8 Param Value 13 Param Value 1 Param Value 1 Param Value 15 Param Value 1.75 Param Value 69.9 Param Value 9 Param Value 6 Param Value 12 Param Value 3 Param Value 2 Param Value 5 Param Value 10 Param Value 1 Param Value 1 Param Value 1 Param Value 1 Param Value 1 Param Value 3 Param Value 12 Param Value 1 Param Value 1 Param Value 1 Param Value 1
Param Value Num 22.0 Param Value Num 7.0 Param Value Num 8.0 Param Value Num 13.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 15.0 Param Value Num 1.75 Param Value Num 69.9 Param Value Num 9.0 Param Value Num 6.0 Param Value Num 12.0 Param Value Num 3.0 Param Value Num 2.0 Param Value Num 5.0 Param Value Num 10.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 3.0 Param Value Num 12.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 1.0
Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range Dispersion Type Inter-Quartile Range
Dispersion Lower Limit 19.0 Dispersion Lower Limit 1.62 Dispersion Lower Limit 64.0 Dispersion Lower Limit 1.0
Dispersion Upper Limit 28.0 Dispersion Upper Limit 1.8 Dispersion Upper Limit 85.0 Dispersion Upper Limit 9.0
Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15 Number Analyzed 15

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<![CDATA[ FAVOR Opioid Recovery Coaching Evaluation ]]>
https://zephyrnet.com/NCT03798470
2018-01-01

https://zephyrnet.com/?p=NCT03798470
NCT03798470https://www.clinicaltrials.gov/study/NCT03798470?tab=tableNANANAThe Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.

These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.
<![CDATA[

Studies

Study First Submitted Date 2018-12-24
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-02-19
Start Month Year January 1, 2018
Primary Completion Month Year December 31, 2018
Verification Month Year February 2019
Verification Date 2019-02-28
Last Update Posted Date 2019-02-19

Detailed Descriptions

Sequence: 20716275
Description The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.

Facilities

Sequence: 200053181
Name Greenville Health System
City Greenville
State South Carolina
Zip 29605
Country United States

Conditions

Sequence: 52156416 Sequence: 52156417 Sequence: 52156418
Name Opiate Abuse Name Opiate Overdose Name Opioid-use Disorder
Downcase Name opiate abuse Downcase Name opiate overdose Downcase Name opioid-use disorder

Id Information

Sequence: 40148174
Id Source org_study_id
Id Value Pro00073004

Countries

Sequence: 42557695
Name United States
Removed False

Design Groups

Sequence: 55577847
Group Type Experimental
Title Cohort
Description Intervention with FAVOR peer recovery coaching. Patients identified in the ED as opioid overdose and enrolled in the current study.

Interventions

Sequence: 52471956
Intervention Type Behavioral
Name Peer Addiction Counseling
Description After identification, a 24/7 on-call FRC was paged and met with the patient in the ED. The patients were offered recovery services at the bedside by the FRC. The research team members offered voluntary participation and obtained informed consent to enrolling a longitudinal study looking into the success of his intervention. Patients did not need to participate to be eligible for counseling and resources from AVOR. The FRCs counselled and engaged the patient along with the family to offer a variety of services including active recovery coaching, group treatment modalities, family support services and transportation. After he initial encounter in the ED, the FAVOR team re-engaged the participant by phone or in person the next day and gradually increasing intervals thereafter.

Keywords

Sequence: 79848009 Sequence: 79848010
Name opioid Name overdose
Downcase Name opioid Downcase Name overdose

Design Outcomes

Sequence: 177327731 Sequence: 177327732
Outcome Type primary Outcome Type secondary
Measure Percentage of patients with active involvement in recovery Measure All-cause Mortality
Time Frame One year Time Frame One year
Description Defined as: Patients who have had phone, email, or in-person contact with their FAVOR recovery coach after discharge from the Emergency Department. Description Number of participants with death from any cause within the study period.

Browse Conditions

Sequence: 193431893 Sequence: 193431894 Sequence: 193431895 Sequence: 193431896 Sequence: 193431897 Sequence: 193431898 Sequence: 193431899
Mesh Term Opioid-Related Disorders Mesh Term Drug Overdose Mesh Term Opiate Overdose Mesh Term Narcotic-Related Disorders Mesh Term Substance-Related Disorders Mesh Term Chemically-Induced Disorders Mesh Term Mental Disorders
Downcase Mesh Term opioid-related disorders Downcase Mesh Term drug overdose Downcase Mesh Term opiate overdose Downcase Mesh Term narcotic-related disorders Downcase Mesh Term substance-related disorders Downcase Mesh Term chemically-induced disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48306002 Sequence: 48306003 Sequence: 48306004
Agency Class OTHER Agency Class UNKNOWN Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Prisma Health-Upstate Name FAVOR (Faces and Voices of Recovery) OF GREENVILLE Name South Carolina Department of Alcohol and Other Drug Abuse Services

Overall Officials

Sequence: 29277901
Role Principal Investigator
Name Christopher Carey, MD
Affiliation Greenville Health System Emergency Medicine

Design Group Interventions

Sequence: 68130802
Design Group Id 55577847
Intervention Id 52471956

Eligibilities

Sequence: 30757322
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Patients presenting to the ED with opioid overdose or withdrawal

Exclusion Criteria:

Age <18
Known pregnant female
Prisoners

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254223918
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 12
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30503547
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26665871
Intervention Id 52471956
Name FAVOR counseling

Responsible Parties

Sequence: 28869825
Responsible Party Type Principal Investigator
Name Sarah Fabiano
Title Emergency Medicine Physician
Affiliation Prisma Health-Upstate

]]>

<![CDATA[ Incidence and Prognostic Implication of Acute CV Events in Patients Hospitalized for CAP in Internal Medicine Units. ]]>
https://zephyrnet.com/NCT03798457
2016-10-01

https://zephyrnet.com/?p=NCT03798457
NCT03798457https://www.clinicaltrials.gov/study/NCT03798457?tab=tableNANANAFADOI-ICECAP is a observational, prospective, multicenter study involving 20-25 nationwide Units of Internal Medicine. The study foresees the participation of 26 Internal Medicine Operative Units, and for each of them a prospective registration of data relative to at least 50 patients admitted with CAP (in total, at least 1300 evaluable subjects) is foreseen.
<![CDATA[

Studies

Study First Submitted Date 2018-12-28
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year October 1, 2016
Primary Completion Month Year February 28, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20735810
Description Phase 1 – Patients enrollment (October 2016 – February 2018) Each Investigator have recorded data concerning 50 patients. It will be collected general characteristics of patients, clinical parameters and conditions, diagnostic imaging and blood tests,

Phase 2 – Database review and validation (April 2018 – October 2018) The data collected will be analysed to process the endpoints.

Conditions

Sequence: 52208194
Name Cardiovascular Events
Downcase Name cardiovascular events

Id Information

Sequence: 40186209
Id Source org_study_id
Id Value FADOI.06.2015

Design Groups

Sequence: 55634769
Title Patients with CAP hospitalized in IM
Description Data of Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units will be collected for this study; no intervention is planned for this study

Interventions

Sequence: 52522161
Intervention Type Other
Name No intervention
Description In this study there is no intervention

Keywords

Sequence: 79923080
Name Community-acquired pneumonia (CAP)
Downcase Name community-acquired pneumonia (cap)

Design Outcomes

Sequence: 177511706 Sequence: 177511707 Sequence: 177511708 Sequence: 177511709 Sequence: 177511710 Sequence: 177511711
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Incidence of CV events Measure Mortality Measure Impact of acute CV events Measure Impact of CV events Measure Risk factor Measure Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia
Time Frame 17 months Time Frame 18 months Time Frame 18 months Time Frame 18 months Time Frame 18 months Time Frame 18 months
Description To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event). Description To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization Description To assess the impact of acute CV events occurred during hospitalization on the risk of hospital readmission within 30 days Description To assess the impact of CV events on the length of hospitalization Description To evaluate risk factors for the occurrence of acute CV events Description To evaluate the incidence of CV complications in the group of patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia

Sponsors

Sequence: 48353770
Agency Class OTHER
Lead Or Collaborator lead
Name Fadoi Foundation, Italy

Overall Officials

Sequence: 29306021
Role Study Director
Name Gualberto Gussoni, MD
Affiliation Fadoi Foundation

Design Group Interventions

Sequence: 68199314
Design Group Id 55634769
Intervention Id 52522161

Eligibilities

Sequence: 30786920
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units
Criteria Inclusion Criteria:

Age > 18 years

Diagnosis of pneumonia defined by the presence on chest X-ray or CT-scan of lung of new infiltration associated with at least two of the following clinical features:

fever > 37.8°C
typical symptoms (dyspnea, productive cough, pain)
typical clinical signs on chest examination (crepitation, bronchial breathing, pleural effusion)
leukocytosis

Exclusion Criteria:

patients with Hospital-Acquired Pneumonia (HAP) (i.e. those patients with pneumonia acquired in hospital more than 48 hours after admission)
patients with tuberculosis in active phase
patients with cystic fibrosis
patients who refuse to participate in the study and/or to give the written informed consent.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253989695
Registered In Calendar Year 2018
Actual Duration 17
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30532990
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28899284
Responsible Party Type Sponsor

Study References

Sequence: 52103133
Pmid 33494707
Reference Type derived
Citation Pieralli F, Vannucchi V, Nozzoli C, Augello G, Dentali F, De Marzi G, Uomo G, Risaliti F, Morbidoni L, Mazzone A, Santini C, Tirotta D, Corradi F, Gerloni R, Gnerre P, Gussoni G, Valerio A, Campanini M, Manfellotto D, Fontanella A; FADOI-ICECAP Study Group. Acute cardiovascular events in patients with community acquired pneumonia: results from the observational prospective FADOI-ICECAP study. BMC Infect Dis. 2021 Jan 25;21(1):116. doi: 10.1186/s12879-021-05781-w. Erratum In: BMC Infect Dis. 2021 Feb 19;21(1):195.

]]>

<![CDATA[ Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women ]]>
https://zephyrnet.com/NCT03798444
2017-09-01

https://zephyrnet.com/?p=NCT03798444
NCT03798444https://www.clinicaltrials.gov/study/NCT03798444?tab=tableNANANAThis is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women
<![CDATA[

Studies

Study First Submitted Date 2018-11-20
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year September 1, 2017
Primary Completion Month Year September 30, 2017
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Detailed Descriptions

Sequence: 20721648
Description Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs All participants were interviewed using a standard questionnaire. Body weight and height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic information, including current age, age at the start of menopause, years since menopause (YSM), weight, and their tallest recalled height. The current measured height subtracted from the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. For the kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was defined as the horizontal distance from the participant's tragus to the wall . All RPD and anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on X-ray.

Facilities

Sequence: 200108209
Name The 2nd Xiangya Hospital, Central South University
City Changsha
State Hunan
Zip 410011
Country China

Conditions

Sequence: 52171262
Name Osteoporosis Fracture
Downcase Name osteoporosis fracture

Id Information

Sequence: 40158653
Id Source org_study_id
Id Value CRong

Countries

Sequence: 42568958
Name China
Removed False

Design Groups

Sequence: 55593200 Sequence: 55593201
Title Bone mineral denstiy Title Vertebral fractures
Description BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry in all subjects.Accroding to The World Health Organization, we defined osteoporosis as a T-score ≤-2.5,and the non osteoporosis as T-score>-2.5. Description VFs were assessed using lateral spine imaging from T4 to L4 on X-ray. A visual semi-quantitative method was used, with fractures defined as a vertebral height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra.

Interventions

Sequence: 52485504 Sequence: 52485505
Intervention Type Radiation Intervention Type Radiation
Name dual energy X-ray absorptiometry Name lateral spine imaging from T4 to L4 on X-ray
Description BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. The lumbar spine, left femoral neck, or total hip of T-score ≤-2.5 as the osteoporosis Description VFs were assessed using lateral spine imaging from T4 to L4 on X-ray .A visual semi-quantitative method was used, with fractures defined as a vertebral Vertebral fractures should be diagnose if height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra

Keywords

Sequence: 79868575 Sequence: 79868576 Sequence: 79868577
Name Height loss, Kyphosis Name Osteoporosis, Vertebral fracture Name Postmenopausal women
Downcase Name height loss, kyphosis Downcase Name osteoporosis, vertebral fracture Downcase Name postmenopausal women

Design Outcomes

Sequence: 177378953 Sequence: 177378954 Sequence: 177378955 Sequence: 177378956 Sequence: 177378957 Sequence: 177378958 Sequence: 177378959
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Height Measure Weight Measure Rib to pelvis distance Measure Wall-occiput distance Measure 7th cervical vertebra-wall distance Measure Wall-tragus-distance Measure Historical height loss
Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks Time Frame 4 weeks
Description Subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. Height were measured to the closest 0.5 cm, Description Body weight was measured with subjects wearing light clothing and no shoes Description The rib to pelvis distance, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. Measured in increments of 0.1 cm by two trained physicians. Description Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. Measured in increments of 0.1 cm by two trained physicians. Description Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance. Measured in increments of 0.1 cm by two trained physicians. Description Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown.Wall-tragus-distance was defined as the horizontal distance from the participant's tragus to the wall. Measured in increments of 0.1 cm by two trained physicians. Description The current measured height subtracted from the tallest recalled height was subjects' historical height loss

Browse Conditions

Sequence: 193486816 Sequence: 193486817 Sequence: 193486818 Sequence: 193486819 Sequence: 193486820 Sequence: 193486821 Sequence: 193486822 Sequence: 193486823 Sequence: 193486824 Sequence: 193486825 Sequence: 193486826
Mesh Term Osteoporosis Mesh Term Fractures, Bone Mesh Term Spinal Fractures Mesh Term Osteoporotic Fractures Mesh Term Wounds and Injuries Mesh Term Bone Diseases, Metabolic Mesh Term Bone Diseases Mesh Term Musculoskeletal Diseases Mesh Term Metabolic Diseases Mesh Term Spinal Injuries Mesh Term Back Injuries
Downcase Mesh Term osteoporosis Downcase Mesh Term fractures, bone Downcase Mesh Term spinal fractures Downcase Mesh Term osteoporotic fractures Downcase Mesh Term wounds and injuries Downcase Mesh Term bone diseases, metabolic Downcase Mesh Term bone diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term metabolic diseases Downcase Mesh Term spinal injuries Downcase Mesh Term back injuries
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319314
Agency Class OTHER
Lead Or Collaborator lead
Name Central South University

Overall Officials

Sequence: 29285363
Role Principal Investigator
Name sheng zhifeng, MD
Affiliation Central south of university

Design Group Interventions

Sequence: 68149157 Sequence: 68149158
Design Group Id 55593200 Design Group Id 55593201
Intervention Id 52485504 Intervention Id 52485505

Eligibilities

Sequence: 30765367
Sampling Method Probability Sample
Gender Female
Minimum Age 50 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Population Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017.
Criteria Inclusion Criteria:

Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual cycles for at least one year)

Exclusion Criteria:

Morphological abnormalities or skeletal distortions

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253884711
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 0
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 50
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 7

Designs

Sequence: 30511534
Observational Model Case-Control
Time Perspective Cross-Sectional

Provided Documents

Sequence: 2579104
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2016-03-28
Url https://ClinicalTrials.gov/ProvidedDocs/44/NCT03798444/Prot_SAP_000.pdf

Responsible Parties

Sequence: 28877828
Responsible Party Type Principal Investigator
Name ChenRong
Title Principal Investigator
Affiliation Central South University

Study References

Sequence: 52063341 Sequence: 52063342 Sequence: 52063343 Sequence: 52063344 Sequence: 52063345 Sequence: 52063346
Pmid 24122280 Pmid 16143833 Pmid 12935830 Pmid 24627138 Pmid 29532182 Pmid 2108749
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Yoh K, Kuwabara A, Tanaka K. Detective value of historical height loss and current height/knee height ratio for prevalent vertebral fracture in Japanese postmenopausal women. J Bone Miner Metab. 2014 Sep;32(5):533-8. doi: 10.1007/s00774-013-0525-y. Citation Siminoski K, Warshawski RS, Jen H, Lee K. The accuracy of historical height loss for the detection of vertebral fractures in postmenopausal women. Osteoporos Int. 2006 Feb;17(2):290-6. doi: 10.1007/s00198-005-2017-y. Epub 2005 Sep 6. Citation Siminoski K, Warshawski RS, Jen H, Lee KC. Accuracy of physical examination using the rib-pelvis distance for detection of lumbar vertebral fractures. Am J Med. 2003 Aug 15;115(3):233-6. doi: 10.1016/s0002-9343(03)00299-7. No abstract available. Citation Mizukami S, Abe Y, Tsujimoto R, Arima K, Kanagae M, Chiba G, Aoyagi K. Accuracy of spinal curvature assessed by a computer-assisted device and anthropometric indicators in discriminating vertebral fractures among individuals with back pain. Osteoporos Int. 2014 Jun;25(6):1727-34. doi: 10.1007/s00198-014-2680-y. Epub 2014 Mar 14. Citation Suwannarat P, Amatachaya P, Sooknuan T, Tochaeng P, Kramkrathok K, Thaweewannakij T, Manimmanakorn N, Amatachaya S. Hyperkyphotic measures using distance from the wall: validity, reliability, and distance from the wall to indicate the risk for thoracic hyperkyphosis and vertebral fracture. Arch Osteoporos. 2018 Mar 12;13(1):25. doi: 10.1007/s11657-018-0433-9. Citation Ralston SH, Urquhart GD, Brzeski M, Sturrock RD. Prevalence of vertebral compression fractures due to osteoporosis in ankylosing spondylitis. BMJ. 1990 Mar 3;300(6724):563-5. doi: 10.1136/bmj.300.6724.563.

]]>

<![CDATA[ MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment ]]>
https://zephyrnet.com/NCT03798431
2018-12-11

https://zephyrnet.com/?p=NCT03798431
NCT03798431https://www.clinicaltrials.gov/study/NCT03798431?tab=tableNANANAThe goal of this pilot study is to test the Mindful Recovery OBOT Care Continuum (M-ROCC) model in primary care office-based opioid treatment (OBOT). M-ROCC features integration of evidence-based mindfulness training with weekly group-based opioid treatment. Primary outcomes include (1) Feasibility measured by implementation of the curriculum into two CHA primary care sites and attendance at weekly sessions; (2) Acceptance via self-report and qualitative interviews. Secondary outcomes include anxiety reduction.
<![CDATA[

Studies

Study First Submitted Date 2018-12-10
Study First Posted Date 2019-01-10
Last Update Posted Date 2020-11-13
Start Month Year December 11, 2018
Primary Completion Month Year February 3, 2020
Verification Month Year November 2020
Verification Date 2020-11-30
Last Update Posted Date 2020-11-13

Detailed Descriptions

Sequence: 20741188
Description The primary objective of this study is to conduct a single-arm pilot study in order to refine a Mindfulness-Based Intervention for the Opioid Use Disorder (OUD) treatment in primary care, called the Mindful Recovery OUD Care Continuum (M-ROCC). Study investigators will conduct qualitative interviews, assess opioid use, preliminary pre/post measures for participants participating in the pilot study. Additional aims of the pilot study is manual refinement and pilot testing assessment batteries to prepare for a multi-site RCT.

The study will focus on demonstrating feasibility and acceptability of the M-ROCC continuum.

Facilities

Sequence: 200280615
Name Cambridge Health Alliance
City Somerville
State Massachusetts
Zip 02143
Country United States

Conditions

Sequence: 52221565 Sequence: 52221566 Sequence: 52221567 Sequence: 52221568
Name Opioid-use Disorder Name Anxiety Name Depression Name Stress Related Disorder
Downcase Name opioid-use disorder Downcase Name anxiety Downcase Name depression Downcase Name stress related disorder

Id Information

Sequence: 40195652 Sequence: 40195653
Id Source org_study_id Id Source secondary_id
Id Value CHA-IRB-1094/08/18 Id Value R21AT010125
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/R21AT010125

Countries

Sequence: 42609676
Name United States
Removed False

Design Groups

Sequence: 55649851
Group Type Experimental
Title M-ROCC
Description Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed with the clinical needs of OUD patients on buprenorphine and logistic needs of primary care OBOT clinicians in mind. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then ongoing mindful recovery support.

Interventions

Sequence: 52535370
Intervention Type Behavioral
Name M-ROCC
Description LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder.
MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 8 weeks & 120 minutes/wk.
MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for grads of LDM for 50 mins/wk.

After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness.

Design Outcomes

Sequence: 177561593 Sequence: 177561594 Sequence: 177561595 Sequence: 177561596 Sequence: 177561597 Sequence: 177561598 Sequence: 177561599 Sequence: 177561600 Sequence: 177561601 Sequence: 177561602 Sequence: 177561603 Sequence: 177561604 Sequence: 177561605 Sequence: 177561606 Sequence: 177561607
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Likelihood of recommending program to a friend Measure Number of weekly sessions attended Measure Anxiety PROMIS-SF 8a Measure Number of biochemically-confirmed illicit opioid abstinent weeks Measure PROMIS-SF 8a (PROMIS-ASF) Pain Interference Measure Number of biochemically-confirmed cocaine abstinent weeks Measure Brief Experiential Avoidance Questionnaire (BEAQ) Measure Patient Reported Outcomes Measurement Information System – Depression Short Form (PROMIS-DSF) Measure Five Facet Mindfulness Questionnaire (FFMQ) Measure Difficulties in Emotion Regulation (DERS) Scale Measure Perceived Stress Scale (PSS) Scale Measure Self-Compassion Scale-Short Form (SCS-SF) Measure Multidimensional Assessment of Interoceptive Awareness (MAIA) Measure Sustained Attention to Response Task (SART) Measure Hypothetical Delay Discounting Task (HDT)
Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24 Time Frame Week 24
Description Percentage of participants who would recommend the program to a friend (score of 4 or 5 on a Likert scale (1-5)) Description Percentage of attendance out of 24 weekly group sessions during the 6 month study period. Description The Patient Reported Outcomes Measurement Information System – Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). With use of the PROMIS Assessment Center Scoring Service, a T score is generated from subject responses. A sample item includes "My worries overwhelmed me." Description Number of 2-week time periods with no self-reported illicit opioid use and biochemically-confirmed abstinence from illicit opioid use during a 24-week period. Urine toxicology will be administered every two weeks for 24 weeks and weekly self-report about illicit opioid use will be collected weekly. Description The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. each question has five response options ranging in value from one to five (for pediatrics and parent proxy it is 0 to 4). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 6-item form, the lowest possible raw score is 6; the highest possible raw score is 30. A higher PROMIS T-score represents higher consequences of pain. Description Number of 2-week time periods with no self-reported cocaine use and biochemically-confirmed abstinence from cocaine use during a 24-week period. Description The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item scale developed to assess a broad range of experiential avoidance (EA) content. Answers are based on a 6-point Likert scale. Total score is sum of individual items (range is 15 – 90). Higher score indicates higher levels of experiential avoidance. Description The Patient Reported Outcomes Measurement Information System – Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Description is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: "observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience." An example item is "I pay attention to how my emotions affect my thoughts and behavior." Subjects rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true), with higher scores indicating higher experience of mindfulness. Total score is sum of all facets (range is 39 – 195). Subscales range from 7 – 40. Description The DERS is a 36-item self-report scale designed to assess emotional dysregulation. The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses ("When I'm upset, I become embarrassed for feeling that way"), difficulties engaging in goal directed behavior ("When I'm upset, I have difficulty thinking about anything else"), impulse control difficulties ("When I'm upset, I lose control over my behaviors"), lack of emotional awareness ("When I'm upset, I take time to figure out what I'm really feeling (reverse-scored)", limited access to emotion regulation strategies ("When I'm upset, it takes me a long time to feel better"), and lack of emotional clarity ("I have no idea how I am feeling"). Answers are selected from a 1-5 Likert scale. Total score is sum of each subscale. Subscales are scored by summing individual subscale items. Total score ranges from 36 to 180 and subscale scores range from 5 to 40. Description The PSS Scale uses 14 items to measure the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). An example question is, "In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?" Positively stated items are reverse scored before all scale items are summed to yield a total score. Total score ranges from 0 to 56. Description The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored. Total score is calculated by taking the mean of all scores and ranges from 1 to 5. Description The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness. The 6 point Likert scale (ranging from 0-5) assesses 8 aspects of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Subscales are averaged, and a higher total score represents a better outcome. Total average score can also be reported. Total and subscale scores range from 0 to 5. Description Participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer. Description This is a brief delay discounting task performed on a computer that presents a series of 5 discrete choice questions between delayed larger reward and smaller sooner reward in dollars.

Browse Conditions

Sequence: 193678635 Sequence: 193678636 Sequence: 193678637 Sequence: 193678638 Sequence: 193678639 Sequence: 193678640
Mesh Term Opioid-Related Disorders Mesh Term Anxiety Disorders Mesh Term Mental Disorders Mesh Term Narcotic-Related Disorders Mesh Term Substance-Related Disorders Mesh Term Chemically-Induced Disorders
Downcase Mesh Term opioid-related disorders Downcase Mesh Term anxiety disorders Downcase Mesh Term mental disorders Downcase Mesh Term narcotic-related disorders Downcase Mesh Term substance-related disorders Downcase Mesh Term chemically-induced disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366459 Sequence: 48366460
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Cambridge Health Alliance Name National Center for Complementary and Integrative Health (NCCIH)

Overall Officials

Sequence: 29312934
Role Principal Investigator
Name Zev Schuman-Olivier, MD
Affiliation Study Principal Investigator

Design Group Interventions

Sequence: 68217441
Design Group Id 55649851
Intervention Id 52535370

Eligibilities

Sequence: 30794732
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

18 years or older
Current CHA patient with a CHA primary care provider
Diagnosis of opioid use disorder prescribed buprenorphine/naloxone
Sufficient English fluency to understand procedures and questionnaires
<90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, AND alcohol (excluding cannabis/nicotine)
Ability to provide informed consent.

Exclusion Criteria:

Psychosis
Mania
Thought disorder
Schizophrenia or Schizoaffective disorder
Acute suicidality with plan
Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments.
Current participation in another CHA research study
Expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004354
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 13
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4
Number Of Other Outcomes To Measure 10

Designs

Sequence: 30540772
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description There will be no randomization for this pilot study.

Provided Documents

Sequence: 2584037
Document Type Informed Consent Form
Has Protocol False
Has Icf True
Has Sap False
Document Date 2019-05-15
Url https://ClinicalTrials.gov/ProvidedDocs/31/NCT03798431/ICF_000.pdf

Responsible Parties

Sequence: 28907092
Responsible Party Type Sponsor

]]>

<![CDATA[ Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases ]]>
https://zephyrnet.com/NCT03798418
2019-02-01

https://zephyrnet.com/?p=NCT03798418
NCT03798418https://www.clinicaltrials.gov/study/NCT03798418?tab=tableNANANAThe objective of this study is to investigate the effects of therapeutic exercise and nutrition intervention for sarcopenia and risk of falls in patients with major chronic diseases. The outcomes will be analyzed regarding muscle strength, quality, and volume, etc., balance and gait, bone density, body composition, fall and quality of life after the intervention.
<![CDATA[

Studies

Study First Submitted Date 2018-12-28
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-11-01
Start Month Year February 1, 2019
Primary Completion Month Year September 30, 2022
Verification Month Year October 2022
Verification Date 2022-10-31
Last Update Posted Date 2022-11-01

Detailed Descriptions

Sequence: 20709708
Description The main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney disease and cancer, have been regarded as the fall high-risk patients. These patients are considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and other reasons. Sarcopenia can be diagnosed and intervened effectively to delay the vicious cycle of health. Past studies have pointed out that in addition to drug intervention, treatment for sarcopenia must be accompanied by appropriate exercise and nutritional intervention (such as protein supplements, vitamin D) in order to achieve the best prevention and treatment.

Facilities

Sequence: 199962368
Name Changhua Christian Hospital
City Changhua
Zip 500
Country Taiwan

Conditions

Sequence: 52138278 Sequence: 52138279 Sequence: 52138280 Sequence: 52138281
Name Stroke Name Osteoporosis Name Chronic Kidney Diseases Name Cancer
Downcase Name stroke Downcase Name osteoporosis Downcase Name chronic kidney diseases Downcase Name cancer

Id Information

Sequence: 40134522
Id Source org_study_id
Id Value CCH-170208

Countries

Sequence: 42542162
Name Taiwan
Removed False

Design Groups

Sequence: 55558584 Sequence: 55558585
Group Type Active Comparator Group Type Experimental
Title exercise group Title exercise combine diet counseling group
Description elastic band strengthening exercise Description elastic band strengthening exercise combined diet counseling.

Interventions

Sequence: 52454245 Sequence: 52454246
Intervention Type Behavioral Intervention Type Dietary Supplement
Name elastic band strengthening exercise Name diet counseling
Description 2-3days per week(150min per week) Description each patients in this group will receive4-5times diet counseling

Keywords

Sequence: 79821792 Sequence: 79821793 Sequence: 79821794 Sequence: 79821795 Sequence: 79821796 Sequence: 79821797 Sequence: 79821798
Name Sarcopenia Name stroke Name osteoporosis Name chronic kidney disease Name cancer Name balance and gait Name fall
Downcase Name sarcopenia Downcase Name stroke Downcase Name osteoporosis Downcase Name chronic kidney disease Downcase Name cancer Downcase Name balance and gait Downcase Name fall

Design Outcomes

Sequence: 177261232 Sequence: 177261233 Sequence: 177261234 Sequence: 177261235 Sequence: 177261236 Sequence: 177261237 Sequence: 177261238 Sequence: 177261239 Sequence: 177261240 Sequence: 177261241 Sequence: 177261242 Sequence: 177261243 Sequence: 177261244 Sequence: 177261245 Sequence: 177261246 Sequence: 177261247 Sequence: 177261248 Sequence: 177261249 Sequence: 177261250 Sequence: 177261251 Sequence: 177261252 Sequence: 177261253 Sequence: 177261254 Sequence: 177261255 Sequence: 177261256 Sequence: 177261257 Sequence: 177261258 Sequence: 177261259 Sequence: 177261260 Sequence: 177261261 Sequence: 177261262 Sequence: 177261263 Sequence: 177261264
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change of walking speed Measure Change of grip force Measure Change of postural sway displacement Measure Change of postural sway velocity Measure Change of postural sway area Measure Change of step time Measure Change of stance time Measure Change of swing time Measure Change of single support time Measure Change of double support time Measure Change of step length Measure Change of stance length Measure Change of muscle thickness Measure Change of muscle fiber length Measure Change of muscle fiber orientation angle Measure Change of muscle cross section area Measure Change of physiological cost index (PCI) Measure Change of international Quality of Life Assessment Short Form -36 (SF-36) Measure Change of amplitude of Muscle activity Measure Change of concentration of CRP (C-Reactive Protein) Measure Change of concentration of ALB (Serum albumin) Measure Change of concentration of Glomerular Filtration Rate (GFR) Measure Change of concentration of Hemoglobin (Hb) Measure Change of concentration of Glucose SPOT Measure Change of concentration of Cholesterol Measure Change of concentration of Triglyceride Measure Change of concentration of Transferrin Measure Change of Berg balance test (BBS) Measure Change of Fugl-Meyer Assessment (FMA) Measure Change of Body Mass Index (BMI) Measure Change of Mini-mental state examination (MMSE) Measure Change of Modified Ashworth scale (MAS) Measure Change of Muscle tone
Time Frame baseline: before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame Time Frame: before intervention; follow-up: 3 months after intervention Time Frame Time Frame: before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention Time Frame before intervention; follow-up: 3 months after intervention
Description distance: 6m, patients can walk with foor orthosis and assistive devices Description Use a grip force meter (kg) to test both hands for test 3 times Description Use computerized dynography to measure the postural sway displacement (mm) Description Use computerized dynography to measure the postural sway velocity (mm/s) Description Use computerized dynography to measure the postural sway area (mm^2) Description Use computerized dynography to measure spatial gait parameter: step time (ms) Description Use computerized dynography to measure spatial gait parameter: stance time (ms) Description Use computerized dynography to measure spatial gait parameter: swing time (ms) Description Use computerized dynography to measure spatial gait parameter: single support time (ms) Description Use computerized dynography to measure spatial gait parameter: double support time (ms) Description Use computerized dynography to measure spatial gait parameter: step distance (mm) Description Use computerized dynography to measure spatial gait parameter: stance distance (mm) Description Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. Description Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. Description Use ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. Description Use ultrasound to assess muscles morphological parameter: cross-sectional area (mm^2).

Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.

Description Heart rate (HR: beats/min) and walking speed (m/s) have been previously shown to be linearly related to oxygen uptake at sub-maximal exercise levels. Combination of these two parameters yields a single value in beats per meter, the physiological cost index (PCI). This is calculated as Working HR – Resting HR (beats/min) / Walking speed (m/s) Description including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.

Scoring: answers to each question are scored which are then summed and transformed to a 0 – 100 scale.

The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Description use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters. Description The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation. Description The concentration of ALB in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema. Description The concentration of GFR in the blood test. The glomerular filtration rate is the best test to measure the patient's level of kidney function and determine the stage of kidney disease. It can calculate it from the results of the blood creatinine test. Description The concentration of Hb in the blood test. Description The concentration of Glucose SPOT in the blood test. TheSpot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation Description The concentration of Cholesterol in the blood test. Description The concentration of Triglyceride in the blood test. Description The concentration of Transferrin in the blood test. Description including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.

The item scores are summed, minimum score =0, maximum score = 56

Description Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (UE maximum score = 66; LE maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44) Description (body weight) kg/(height) m*(height)m Description It is an 11-question measure that tests five areas of cognitive function:

orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.

Description measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone

Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension

Description measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.

Browse Conditions

Sequence: 193363936 Sequence: 193363937 Sequence: 193363938 Sequence: 193363939 Sequence: 193363940 Sequence: 193363941 Sequence: 193363942 Sequence: 193363943 Sequence: 193363944 Sequence: 193363945 Sequence: 193363946 Sequence: 193363947 Sequence: 193363948 Sequence: 193363949 Sequence: 193363950 Sequence: 193363951 Sequence: 193363952 Sequence: 193363953 Sequence: 193363954 Sequence: 193363955 Sequence: 193363956 Sequence: 193363957 Sequence: 193363958
Mesh Term Osteoporosis Mesh Term Sarcopenia Mesh Term Kidney Diseases Mesh Term Renal Insufficiency, Chronic Mesh Term Chronic Disease Mesh Term Nervous System Diseases Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases Mesh Term Renal Insufficiency Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Bone Diseases, Metabolic Mesh Term Bone Diseases Mesh Term Musculoskeletal Diseases Mesh Term Metabolic Diseases Mesh Term Muscular Atrophy Mesh Term Neuromuscular Manifestations Mesh Term Neurologic Manifestations Mesh Term Atrophy Mesh Term Pathological Conditions, Anatomical
Downcase Mesh Term osteoporosis Downcase Mesh Term sarcopenia Downcase Mesh Term kidney diseases Downcase Mesh Term renal insufficiency, chronic Downcase Mesh Term chronic disease Downcase Mesh Term nervous system diseases Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term renal insufficiency Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term bone diseases, metabolic Downcase Mesh Term bone diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term metabolic diseases Downcase Mesh Term muscular atrophy Downcase Mesh Term neuromuscular manifestations Downcase Mesh Term neurologic manifestations Downcase Mesh Term atrophy Downcase Mesh Term pathological conditions, anatomical
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290031
Agency Class OTHER
Lead Or Collaborator lead
Name Changhua Christian Hospital

Overall Officials

Sequence: 29268078
Role Study Director
Name Tasen Wei, Doctor
Affiliation Changhua Christian Hospital

Design Group Interventions

Sequence: 68106596 Sequence: 68106597 Sequence: 68106598
Design Group Id 55558585 Design Group Id 55558584 Design Group Id 55558585
Intervention Id 52454245 Intervention Id 52454245 Intervention Id 52454246

Eligibilities

Sequence: 30747318
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

55-85 years old
3-6 months after onset
walk independently for at least 10m

Exclusion Criteria:

lower limb Brunnstrom stage >5
combine other neuropathy diseases
significant deformity of lower limb include: Modified Ashworth scale(MAS) >3; contracture, fracture, chronic joint pain.
joint arthroplasty
unstable vital sign
can not cooperate study

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254118833
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 44
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 19
Number Of Secondary Outcomes To Measure 14

Designs

Sequence: 30493603
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Double
Subject Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26655066 Sequence: 26655067
Intervention Id 52454245 Intervention Id 52454246
Name thera-band strengthening exercise Name nutrition counseling

Responsible Parties

Sequence: 28859884
Responsible Party Type Principal Investigator
Name Ta-Sen Wei,MD
Title Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor
Affiliation Changhua Christian Hospital

Study References

Sequence: 52031717 Sequence: 52031718 Sequence: 52031719 Sequence: 52031720 Sequence: 52031721 Sequence: 52031722 Sequence: 52031723
Pmid 24785098 Pmid 11518445 Pmid 11833018 Pmid 25852886 Pmid 17699348 Pmid 24415363 Pmid 19588334
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin Nutr. 2014 Oct;33(5):737-48. doi: 10.1016/j.clnu.2014.03.007. Epub 2014 Mar 29. Citation Stapleton T, Ashburn A, Stack E. A pilot study of attention deficits, balance control and falls in the subacute stage following stroke. Clin Rehabil. 2001 Aug;15(4):437-44. doi: 10.1191/026921501678310243. Citation Hyndman D, Ashburn A, Stack E. Fall events among people with stroke living in the community: circumstances of falls and characteristics of fallers. Arch Phys Med Rehabil. 2002 Feb;83(2):165-70. doi: 10.1053/apmr.2002.28030. Citation Kutner NG, Zhang R, Huang Y, Wasse H. Falls among hemodialysis patients: potential opportunities for prevention? Clin Kidney J. 2014 Jun;7(3):257-63. doi: 10.1093/ckj/sfu034. Epub 2014 Apr 15. Citation Cook WL, Tomlinson G, Donaldson M, Markowitz SN, Naglie G, Sobolev B, Jassal SV. Falls and fall-related injuries in older dialysis patients. Clin J Am Soc Nephrol. 2006 Nov;1(6):1197-204. doi: 10.2215/CJN.01650506. Epub 2006 Aug 30. Citation Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25. Citation Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.

]]>

<![CDATA[ Reactive vs. Proactive Pain Control in IBD ]]>
https://zephyrnet.com/NCT03798405
2019-01-01

https://zephyrnet.com/?p=NCT03798405
NCT03798405https://www.clinicaltrials.gov/study/NCT03798405?tab=tableNANANAThe investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution’s Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional “reactive” analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.

Aims:

Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.

Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.

Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.
<![CDATA[

Studies

Study First Submitted Date 2018-12-04
Study First Posted Date 2019-01-10
Last Update Posted Date 2022-07-22
Start Month Year January 1, 2019
Primary Completion Month Year July 1, 2022
Verification Month Year July 2022
Verification Date 2022-07-31
Last Update Posted Date 2022-07-22

Detailed Descriptions

Sequence: 20637546
Description Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay.

Facilities

Sequence: 199189124
Name Cedars-Sinai Medical Center
City Los Angeles
State California
Zip 90048
Country United States

Browse Interventions

Sequence: 95637274 Sequence: 95637275 Sequence: 95637276 Sequence: 95637277 Sequence: 95637278 Sequence: 95637279
Mesh Term Analgesics Mesh Term Narcotics Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents Mesh Term Physiological Effects of Drugs Mesh Term Central Nervous System Depressants
Downcase Mesh Term analgesics Downcase Mesh Term narcotics Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term central nervous system depressants
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51953395 Sequence: 51953396 Sequence: 51953397 Sequence: 51953398 Sequence: 51953399
Name Inflammatory Bowel Diseases Name Pain Name Opioid Use Name Crohn Disease Name Ulcerative Colitis
Downcase Name inflammatory bowel diseases Downcase Name pain Downcase Name opioid use Downcase Name crohn disease Downcase Name ulcerative colitis

Id Information

Sequence: 39989611
Id Source org_study_id
Id Value Pro00050742

Countries

Sequence: 42380516
Name United States
Removed False

Design Groups

Sequence: 55353393 Sequence: 55353394
Group Type Experimental Group Type No Intervention
Title Proactive Title Reactive (Control Group)
Description Proactive Analgesic Inpatient Narcotic-Sparing:

Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol".

Description Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group.

Interventions

Sequence: 52265628
Intervention Type Behavioral
Name Proactive Analgesic Inpatient Narcotic-Sparing
Description Medications suggested to the physician with enhanced ease of ordering.

Keywords

Sequence: 79528858 Sequence: 79528859 Sequence: 79528860
Name Pain Name Inflammatory Bowel Disease Name Opioids
Downcase Name pain Downcase Name inflammatory bowel disease Downcase Name opioids

Design Outcomes

Sequence: 176606148 Sequence: 176606149 Sequence: 176606150 Sequence: 176606151
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Patient-Reported Pain Scores Measure Healthcare Utilization Measure Functional Activity Measure Opioid-Consumption
Time Frame Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days. Time Frame From hospital admission until hospital discharge, typically 7 days. Time Frame From hospital admission until hospital discharge, typically 7 days. Time Frame From hospital admission until hospital discharge, typically 7 days.
Description Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain)) Description Hospital length of stay (in days) Description FitBit activity (number of steps per day) Description Milligram morphine-equivalents consumed per day

Browse Conditions

Sequence: 192623033 Sequence: 192623034 Sequence: 192623035 Sequence: 192623036 Sequence: 192623037 Sequence: 192623038
Mesh Term Crohn Disease Mesh Term Intestinal Diseases Mesh Term Inflammatory Bowel Diseases Mesh Term Gastroenteritis Mesh Term Gastrointestinal Diseases Mesh Term Digestive System Diseases
Downcase Mesh Term crohn disease Downcase Mesh Term intestinal diseases Downcase Mesh Term inflammatory bowel diseases Downcase Mesh Term gastroenteritis Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term digestive system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48115546
Agency Class OTHER
Lead Or Collaborator lead
Name Cedars-Sinai Medical Center

Overall Officials

Sequence: 29160892 Sequence: 29160893
Role Principal Investigator Role Study Director
Name Gil Y Melmed, MD, MS Name Sameer K Berry, MD, MBA
Affiliation Cedars-Sinai Medical Center Affiliation Cedars-Sinai Medical Center

Design Group Interventions

Sequence: 67857641
Design Group Id 55353393
Intervention Id 52265628

Eligibilities

Sequence: 30637060
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Adults with confirmed IBD diagnosis
Admitted for primary IBD-related sign or symptom

Exclusion Criteria:

Admitted for primary non-IBD complaint
Surgery in the last 30 days
Alternative (non-IBD) GI diagnosis determined
Age <18
Pregnancy

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254132239
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 42
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30383994
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Health Services Research
Time Perspective
Masking Double
Masking Description The primary investigators will be blinded, as will the computer programmers who collect the data.
Intervention Model Description Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score > 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline – all patients will receive a FitBit exercise tracker.
Investigator Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26560204
Intervention Id 52265628
Name P.A.I.N.-Sparing Bundle

Responsible Parties

Sequence: 28750728
Responsible Party Type Principal Investigator
Name Gil Melmed
Title co-Director, Inflammatory Bowel Disease Center, Principal Investigator
Affiliation Cedars-Sinai Medical Center

]]>

<![CDATA[ Self-pressurised Air-Q With Blocker Versus Baska Mask in Low Risk Female Patients Undergoing Ambulatory Surgery. ]]>
https://zephyrnet.com/NCT03798392
2019-02-28

https://zephyrnet.com/?p=NCT03798392
NCT03798392https://www.clinicaltrials.gov/study/NCT03798392?tab=tableAbeer Ahmed, MDabeer_ahmed@kasralainy.edu.eg01005244590Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries. Supraglottic airway devices with non-inflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal complications.

Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation, the cuff seals the esophageal opening into the stomach, preventing any regurgitation of stomach contents. Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker has a communication orifice at the junction of the peri-glotic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation.

The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. It was revealed that the baska mask is relatively easy to insert, provided a high-quality seal with the glotic aperture and the incidence of throat discomfort appeared low.

To our knowledge, and after searching in previous literature, no previous studies have compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with non-inflatable cuff.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-10
Last Update Posted Date 2019-01-10
Start Month Year February 2019
Primary Completion Month Year May 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-10

Facilities

Sequence: 200053182
Status Recruiting
Name Kasr Alainy Faculty of Medicine – Cairo university
City Cairo
Zip 00225
Country Egypt

Facility Contacts

Sequence: 28097486
Facility Id 200053182
Contact Type primary
Name Abeer Ahmed, Assistant Professor

Browse Interventions

Sequence: 96027777 Sequence: 96027778 Sequence: 96027779
Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs
Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52156419
Name Supraglottic Airway Devices
Downcase Name supraglottic airway devices

Id Information

Sequence: 40148175
Id Source org_study_id
Id Value N-24- 2018

Countries

Sequence: 42557696
Name Egypt
Removed False

Design Groups

Sequence: 55577848 Sequence: 55577849
Group Type Active Comparator Group Type Active Comparator
Title SP group Title Baska group

Interventions

Sequence: 52471957 Sequence: 52471958
Intervention Type Device Intervention Type Device
Name Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion Name Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion
Description comparing the airway seal pressure 10 min after insertion of each devices . Description comparing the airway seal pressure 10 min after insertion of each devices .

Design Outcomes

Sequence: 177327733
Outcome Type primary
Measure airway seal pressure 10 minutes after insertion
Time Frame 10 minutes after the device insertion.

Sponsors

Sequence: 48306005
Agency Class OTHER
Lead Or Collaborator lead
Name Cairo University

Central Contacts

Sequence: 12004730
Contact Type primary
Name Abeer Ahmed, MD
Phone 01005244590
Email abeer_ahmed@kasralainy.edu.eg
Role Contact

Design Group Interventions

Sequence: 68130803 Sequence: 68130804
Design Group Id 55577848 Design Group Id 55577849
Intervention Id 52471957 Intervention Id 52471958

Eligibilities

Sequence: 30757323
Gender Female
Minimum Age 18 Years
Maximum Age 50 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Female patients between the age group of 18 and 50 years,
ASA class I and II,
undergoing elective surgeries,
with Ganzouri airway score less than 4

Exclusion Criteria:

ASA III – V patients.
Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.
Patients with respiratory or pharyngeal pathology.
Patients allergic to any drugs in the protocol.
Obese patients with body mass index ≥ 40.
Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease, hiatus hernia or previous upper gastrointestinal tract surgery.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254223928
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 50
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30503548
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Single
Subject Masked True

Intervention Other Names

Sequence: 26665872 Sequence: 26665873
Intervention Id 52471957 Intervention Id 52471958
Name airway management under general anesthesia Name airway management under general anesthesia

Responsible Parties

Sequence: 28869826
Responsible Party Type Principal Investigator
Name Abeer Ahmed, MD
Title Assistant Professor of Anesthesia, SICU and pain management – kasr Aiainy Faculty of Medicine – Cairo University
Affiliation Cairo University

]]>

<![CDATA[ Exercises for Patients Who Were Receiving Chemotherapy ]]>
https://zephyrnet.com/NCT03798379
2015-10-01

https://zephyrnet.com/?p=NCT03798379
NCT03798379https://www.clinicaltrials.gov/study/NCT03798379?tab=tableNANANATo evaluate the effect of lower extremity strengthening and balance exercises on balance, quality of life and neuropathic pain of the cancer patients receiving neurotoxic chemotherapy.
<![CDATA[

Studies

Study First Submitted Date 2019-01-04
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year October 1, 2015
Primary Completion Month Year July 1, 2016
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-09

Detailed Descriptions

Sequence: 20735811
Description Cancer-related mortality rates decreased considerably thanks to novel treatment methods and new agents over the last two decades. Although chemotherapy (CT) is an effective treatment type in reducing the size of the tumor and eliminating metastases, it may harm many different organs and systems due to short & long-term side effects. Peripheral neuropathy (PN) is regarded as a neurological and clinical side effect for cancer patients. PN may arise as a paraneoplastic symptom but more commonly occurs with neurotoxic CT agents. Short & long-term side effects that may damage sensory, motor, and autonomic neurons. This damage to the small-fiber sensory nerves causes a change in the sense of touch, pain, and warmth, while the damage to the large-fiber nerves causes a change in the sense of vibration and proprioception. Motor nerve damage affects voluntary movement, muscle tone, and coordination, and damage to the autonomic nervous system affects intestinal motility and blood pressure over smooth muscles. Despite the fact that studies on PN treatment have generally focused on pharmacological agents reducing pain or treating selected side effects, no agent that may be preventive for chemotherapy induced Peripheral Neuropathy (CIPN) due to neurotoxic chemotherapy has been recommended in the review of the American Society of Clinical Oncology.

Side effects due to CT such as anorexia, nausea, vomiting, mucositis, diarrhea, anemia or PN may lead to impairment in the quality of life of the patient and may significantly reduce the level of physical activity. Neurotoxic and ototoxic effects may cause ataxia, paresthesia and dysesthesia, leading to gait, and balance disorders. CIPN has been associated with balance disorder, loss of function and reduced quality of life in the literature. It may result in loss of balance, difficulty in ambulation, increase in the frequency of collapse and accordingly increase in injuries. Despite the fact that medical treatments used in CIPN are often helpful in the treatment of neuropathic pain, no effect has been observed on muscle strength, gait, and balance. It is believed that muscle strength and balance exercises, such as aerobic exercises, can provide mitochondria with oxygen and glucose by increasing blood supply, thereby contributing to energy production and reducing symptoms. Current data suggest that exercise is applicable, safe, and beneficial for this group of patients. Balance exercises at an early stage may prevent or delay the onset of sensory and motor symptoms. Although exercise is accepted as a supportive treatment, which should be addressed more seriously for a patient population with PN, there is not enough information in the literature on timing, frequency, and mode of administration of the treatment program that will be carried out in this specific group of patients.

The aim of this study is to investigate the effects of therapeutic exercise program including concurrently initiated strengthening, balance and aerobic exercises on the symptoms, balance status and quality of life of the group of patients who have a limited physical activity, a risk of developing PN following the treatment, and will have a long-term bed rest and compare with the group of patients not receiving any exercise program in the same treatment period.

Facilities

Sequence: 200244562
Name Marmara University Pendik Training and Research Hospital
City Istanbul
Zip 34000
Country Turkey

Conditions

Sequence: 52208196
Name Chemotherapy-induced Peripheral Neuropathy
Downcase Name chemotherapy-induced peripheral neuropathy

Id Information

Sequence: 40186212
Id Source org_study_id
Id Value 09.2015.278

Countries

Sequence: 42599716
Name Turkey
Removed False

Design Groups

Sequence: 55634772 Sequence: 55634773
Group Type Active Comparator Group Type No Intervention
Title Exercise group Title Control group
Description Eligible patients who were planned to receive neurotoxic chemotherapy Description Patients eligible for the study and received the 3rd cycle of chemotherapy

Interventions

Sequence: 52522168
Intervention Type Other
Name Exercise
Description Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient.

Keywords

Sequence: 79923089 Sequence: 79923090 Sequence: 79923091 Sequence: 79923092
Name cancer Name chemotherapy Name peripheral neuropathy Name exercise
Downcase Name cancer Downcase Name chemotherapy Downcase Name peripheral neuropathy Downcase Name exercise

Design Outcomes

Sequence: 177511715 Sequence: 177511716 Sequence: 177511717 Sequence: 177511718
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Balance assessment Measure Berg balance scale Measure PainDETECT: questionnaire Measure The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Time Frame 3 months Time Frame 3 months Time Frame 3 months Time Frame 3 months
Description NeuroCom Balance Master® device (Natus Medical, San Carlos, California, USA) is a balance evaluation device measuring the position of the center of gravity, postural control along with static and dynamic stability. Description Berg balance scale used in the evaluation of balance based on performance is a 14-item measure in which patient is required to perform different activities.14 different activities are scored between 0 (worst) and 4 (best) according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of patient is good. Description The presence of neuropathic pain was evaluated with the painDETECT questionnaire. The maximum score is 35 and a high score indicates the severity of neuropathic pain. When the PD-Q score is more than 13, it is indicated the presence of neuropathic pain component. Description It is a questionnaire developed by the European Organization for Research and Treatment of Cancer and used to assess the quality of life of cancer patients participating in clinical trials and includes a variety of components. Patients' higher points of functional scale and general health status scale and lower points of symptom scale scores indicate a high QoL.

Browse Conditions

Sequence: 193627337 Sequence: 193627338 Sequence: 193627339
Mesh Term Peripheral Nervous System Diseases Mesh Term Neuromuscular Diseases Mesh Term Nervous System Diseases
Downcase Mesh Term peripheral nervous system diseases Downcase Mesh Term neuromuscular diseases Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48353772
Agency Class OTHER
Lead Or Collaborator lead
Name Hitit University

Design Group Interventions

Sequence: 68199325
Design Group Id 55634772
Intervention Id 52522168

Eligibilities

Sequence: 30786922
Gender All
Minimum Age 20 Years
Maximum Age 75 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

the ability to understand the informed consent form, and the signing the informed consent form after being informed in detail,
planned to have ≥3 cycles of neurotoxic chemotherapy (paclitaxel, docetaxel from taxane class agents, and cisplatin, oxaliplatin or carboplatin from platin group),
expected to have a survival of ≥6 months,
to have an Eastern Cooperative Oncology Group performance level between 0-2,
to have a full manual muscle strength.

Exclusion Criteria:

Previously diagnosed peripheral neuropathy (Diabetic peripheral neuropathy, entrapment neuropathies etc.)
Patients receiving medical treatment due to neuropathic pain (pregabalin, gabapentin, duloxetine etc.)
Pre-existing neurological disease
Pre-existing diabetes mellitus (>3 years or insulin use)
Alcoholism
HIV infection
Presence of peripheral vascular disease
Vitamin D or vitamin B12 deficiency
Non-ambulatory or refuse to practice exercise program
Visual or vestibular system impairment
Patients with central nervous system involvement or metastasis

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253989697
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 9
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 20
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30532992
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking Single
Masking Description Non randomized, single blind, prospective
Intervention Model Description Parallel Assignment
Subject Masked True

Responsible Parties

Sequence: 28899286
Responsible Party Type Principal Investigator
Name Yeliz Bahar Ozdemir
Title Principal investigator
Affiliation Hitit University

Study References

Sequence: 52103135 Sequence: 52103136 Sequence: 52103137 Sequence: 52103138 Sequence: 52103139 Sequence: 52103140
Pmid 28963591 Pmid 24478323 Pmid 25261162 Pmid 27243828 Pmid 19417586 Pmid 29424607
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30. Citation Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568. Citation Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23. Citation Cammisuli S, Cavazzi E, Baldissarro E, Leandri M. Rehabilitation of balance disturbances due to chemotherapy-induced peripheral neuropathy: a pilot study. Eur J Phys Rehabil Med. 2016 Aug;52(4):479-88. Epub 2016 May 31. Citation Nurgalieva Z, Xia R, Liu CC, Burau K, Hardy D, Du XL. Risk of chemotherapy-induced peripheral neuropathy in large population-based cohorts of elderly patients with breast, ovarian, and lung cancer. Am J Ther. 2010 Mar-Apr;17(2):148-58. doi: 10.1097/MJT.0b013e3181a3e50b. Citation Hershman DL, Lacchetti C, Loprinzi CL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2014 Nov;10(6):e421-e424. doi: 10.1200/JOP.2014.001776. No abstract available.

]]>

<![CDATA[ A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis ]]>
https://zephyrnet.com/NCT03798366
2019-01-14

https://zephyrnet.com/?p=NCT03798366
NCT03798366https://www.clinicaltrials.gov/study/NCT03798366?tab=tableNANANAThe main purpose of the study is to see if GLPG1690 helps (together with the standard of care treatment) in the treatment of the skin and other areas affected by systemic sclerosis.

Another aim is to find out how safe/well tolerated GLPG1690 will be and whether there are any side effects. The study will also look at other things, including whether the study drug affects disease progression and also if it changes any aspect of the quality of life.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-09
Last Update Posted Date 2021-05-04
Start Month Year January 14, 2019
Primary Completion Month Year May 21, 2020
Verification Month Year April 2021
Verification Date 2021-04-30
Last Update Posted Date 2021-05-04
Results First Posted Date 2021-05-04

Facilities

Sequence: 200061805 Sequence: 200061806 Sequence: 200061807 Sequence: 200061808 Sequence: 200061809 Sequence: 200061810 Sequence: 200061811 Sequence: 200061812 Sequence: 200061813 Sequence: 200061814 Sequence: 200061815 Sequence: 200061816 Sequence: 200061817 Sequence: 200061818 Sequence: 200061819 Sequence: 200061820 Sequence: 200061821 Sequence: 200061822
Name Pacific Arthritis Care Center Name UCLA Rheumatology Name RASF Clinical Research Center Name Massachusetts General Hospital Name University of Michigan Name Metroplex Clinical Research Center Name UT Physicians Center for Autoimmunity Name UZ Gent Name UZ Leuven Name Charité – Universitätsmedizin Berlin Name Universitätsklinikum Frankfurt Name Azienda Ospedaliero Name Ospedale San Raffaele S.r.l. – PPDS Name Hospital Universitario Vall d'Hebron – PPDS Name Hospital Universitario 12 de Octubre Name Hospital Nuestra Señora de Valme Name University Hospital Aintree Name Royal Free Hospital
City Los Angeles City Los Angeles City Boca Raton City Boston City Ann Arbor City Dallas City Houston City Gent City Leuven City Berlin City Frankfurt City Firenze City Milano City Barcelona City Madrid City Sevilla City Liverpool City London
State California State California State Florida State Massachusetts State Michigan State Texas State Texas
Zip 90045 Zip 90095 Zip 33486 Zip 02114 Zip 48109 Zip 75231 Zip 77030 Zip 9000 Zip 3000 Zip 10117 Zip 60590 Zip 50439 Zip 20132 Zip L9 7AL Zip NW32QG
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country Belgium Country Belgium Country Germany Country Germany Country Italy Country Italy Country Spain Country Spain Country Spain Country United Kingdom Country United Kingdom

Conditions

Sequence: 52158829
Name Systemic Sclerosis
Downcase Name systemic sclerosis

Id Information

Sequence: 40150021 Sequence: 40150022
Id Source org_study_id Id Source secondary_id
Id Value GLPG1690-CL-204 Id Value 2018-001817-33
Id Type EudraCT Number

Countries

Sequence: 42559608 Sequence: 42559609 Sequence: 42559610 Sequence: 42559611 Sequence: 42559612 Sequence: 42559613
Name United States Name Belgium Name Germany Name Italy Name Spain Name United Kingdom
Removed False Removed False Removed False Removed False Removed False Removed False

Design Groups

Sequence: 55580709 Sequence: 55580710
Group Type Experimental Group Type Placebo Comparator
Title GLPG1690 600 mg Title Placebo
Description Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks. Description Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.

Interventions

Sequence: 52474400 Sequence: 52474401
Intervention Type Drug Intervention Type Drug
Name GLPG1690 Name Placebo
Description Film-coated tablets of GLPG1690 for oral use. Description Film-coated tablets of GLPG1690 matching placebo for oral use.

Design Outcomes

Sequence: 177336088 Sequence: 177336089 Sequence: 177336090 Sequence: 177336091 Sequence: 177336092
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary
Measure Change From Baseline in mRSS at Week 4 Measure Change From Baseline in mRSS at Week 8 Measure Change From Baseline in mRSS at Week 16 Measure Change From Baseline in mRSS at Week 24 Measure Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time Frame Baseline, Week 4 Time Frame Baseline, Week 8 Time Frame Baseline, Week 16 Time Frame Baseline, Week 24 Time Frame Baseline up to end of the study (36 weeks)
Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant.

Browse Conditions

Sequence: 193441369 Sequence: 193441370 Sequence: 193441371 Sequence: 193441372 Sequence: 193441373 Sequence: 193441374
Mesh Term Scleroderma, Systemic Mesh Term Scleroderma, Diffuse Mesh Term Sclerosis Mesh Term Pathologic Processes Mesh Term Connective Tissue Diseases Mesh Term Skin Diseases
Downcase Mesh Term scleroderma, systemic Downcase Mesh Term scleroderma, diffuse Downcase Mesh Term sclerosis Downcase Mesh Term pathologic processes Downcase Mesh Term connective tissue diseases Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48308403
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Galapagos NV

Overall Officials

Sequence: 29279265
Role Study Director
Name Galapagos Study Director
Affiliation Galapagos NV

Design Group Interventions

Sequence: 68134096 Sequence: 68134097
Design Group Id 55580709 Design Group Id 55580710
Intervention Id 52474400 Intervention Id 52474401

Eligibilities

Sequence: 30758779
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
Male and female participants ≥18 years at the time of consent who meet the American College of Rheumatology (ACR)/EULAR 2013 diagnostic criteria for systemic sclerosis with diffuse cutaneous involvement (according to LeRoy's criteria) and ≤5 years since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon.
Modified Rodnan Skin Score (mRSS) >10 at screening.
Active disease at screening, as defined by: Worsening of skin thickening (≥2 mRSS points) as assessed by mRSS measured at screening versus a previous mRSS assessment made within 6 months prior to screening, or new areas of skin involvement within 6 months prior to screening as documented by physician note, or new-onset systemic sclerosis with symptoms or signs other than Raynaud's phenomenon within 2 years prior to screening, or ≥1 tendon friction rub (palpated in the finger flexors or extensors, wrist flexors or extensors, olecranon bursa, shoulders, knees, anterior or posterior ankles with active motion).
Participant must be able and willing to comply with restrictions on prior and concomitant medication as described in the protocol
Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit.
Female participants of childbearing potential or male participants with female partners of childbearing potential must be willing to comply with the contraceptive methods described in the protocol prior to the first dose of the investigational medicinal product (IMP), during the clinical study, and for at least 90 days after the last dose of the IMP for male participants and 30 days after the last dose of the IMP for female participants.
A body mass index (BMI) between 18-35 kg/m^2, inclusive, at screening.
Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered non-clinically significant in the opinion of the investigator.

Exclusion Criteria:

Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
Breastfeeding female or participant intending to become pregnant or breastfeed.
History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired).
Positive blood testing for hepatitis B surface antigen or hepatitis C virus (antibody, confirmed by hepatitis C virus ribonucleic acid [RNA] positivity). Note: Participants with a resolved hepatitis A at least 3 months prior to screening can be screened.
History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer medically managed through active surveillance or watchful waiting, and squamous cell carcinoma of the skin if fully resected and ductal carcinoma in situ).
Clinically significant abnormalities, in the opinion of the investigator, detected on ECG at screening of either rhythm or conduction, QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms, or a known long QT syndrome.
Unstable cardiovascular, pulmonary, or other disease (other than systemic sclerosis-related), in the opinion of the investigator, within 6 months prior to the baseline visit (e.g. coronary heart disease, heart failure, stroke).
Severe pulmonary disease with forced vital capacity (FVC) ≤45% of predicted within 6 months prior to the baseline visit.
Chronic or ongoing active infectious disease, including tuberculosis (requiring hospitalization or systemic treatment within 4 weeks prior to the baseline visit).
Abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT), and/or bilirubin, and/or alkaline phosphatase >2x upper limit of normal (ULN). Retesting is allowed once.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254251149
Number Of Facilities 18
Number Of Nsae Subjects 146
Number Of Sae Subjects 5
Registered In Calendar Year 2019
Actual Duration 16
Were Results Reported True
Months To Report Results 10
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 4
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30504996
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Drop Withdrawals

Sequence: 28983575 Sequence: 28983576
Result Group Id 56087617 Result Group Id 56087618
Ctgov Group Code FG000 Ctgov Group Code FG001
Period Overall Study Period Overall Study
Reason Lost to Follow-up Reason Lost to Follow-up
Count 0 Count 1

Milestones

Sequence: 41000861 Sequence: 41000862 Sequence: 41000863 Sequence: 41000864 Sequence: 41000865 Sequence: 41000866
Result Group Id 56087617 Result Group Id 56087618 Result Group Id 56087617 Result Group Id 56087618 Result Group Id 56087617 Result Group Id 56087618
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 21 Count 12 Count 21 Count 11 Count 0 Count 1

Outcome Analyses

Sequence: 16566219 Sequence: 16566220 Sequence: 16566221 Sequence: 16566222
Outcome Id 30800457 Outcome Id 30800458 Outcome Id 30800459 Outcome Id 30800460
Non Inferiority Type Superiority Non Inferiority Type Superiority Non Inferiority Type Superiority Non Inferiority Type Superiority
Param Type Least square (LS) mean difference Param Type LS mean difference Param Type LS mean difference Param Type LS mean difference
Param Value -0.5 Param Value -0.7 Param Value -2.1 Param Value -2.8
Dispersion Type Standard Error of the Mean Dispersion Type Standard Error of the Mean Dispersion Type Standard Error of the Mean Dispersion Type Standard Error of the Mean
Dispersion Value 1.29 Dispersion Value 1.31 Dispersion Value 1.35 Dispersion Value 1.36
P Value Modifier P Value Modifier P Value Modifier P Value Modifier
P Value 0.6757 P Value 0.6079 P Value 0.1298 P Value 0.0411
Ci N Sides 2-Sided Ci N Sides 2-Sided Ci N Sides 2-Sided Ci N Sides 2-Sided
Ci Percent 95.0 Ci Percent 95.0 Ci Percent 95.0 Ci Percent 95.0
Ci Lower Limit -3.1 Ci Lower Limit -3.3 Ci Lower Limit -4.8 Ci Lower Limit -5.6
Ci Upper Limit 2.0 Ci Upper Limit 1.9 Ci Upper Limit 0.6 Ci Upper Limit -0.1
Method Mixed Models Analysis Method Mixed Models Analysis Method Mixed Models Analysis Method Mixed Models Analysis
Estimate Description A negative difference indicates a greater improvement in the GLPG1690 treatment group. Estimate Description A negative difference indicates a greater improvement in the GLPG1690 treatment group. Estimate Description A negative difference indicates a greater improvement in the GLPG1690 treatment group. Estimate Description A negative difference indicates a greater improvement in the GLPG1690 treatment group.
Groups Description Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. Groups Description Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. Groups Description Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. Groups Description Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.

Outcome Analysis Groups

Sequence: 32128576 Sequence: 32128577 Sequence: 32128578 Sequence: 32128579 Sequence: 32128580 Sequence: 32128581 Sequence: 32128582 Sequence: 32128583
Outcome Analysis Id 16566219 Outcome Analysis Id 16566219 Outcome Analysis Id 16566220 Outcome Analysis Id 16566220 Outcome Analysis Id 16566221 Outcome Analysis Id 16566221 Outcome Analysis Id 16566222 Outcome Analysis Id 16566222
Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001

Participant Flows

Sequence: 3920805
Recruitment Details Participants were enrolled at study sites in Belgium, the United States, United Kingdom, Spain, and Italy. The first participant was screened on 14 Jan 2019. The last study visit occurred on 22 Jun 2020.
Pre Assignment Details A total of 40 participants were screened, of whom 33 participants were randomized and treated.

Outcome Counts

Sequence: 73990087 Sequence: 73990088 Sequence: 73990089 Sequence: 73990090 Sequence: 73990091 Sequence: 73990092 Sequence: 73990093 Sequence: 73990094 Sequence: 73990095 Sequence: 73990096
Outcome Id 30800457 Outcome Id 30800457 Outcome Id 30800458 Outcome Id 30800458 Outcome Id 30800459 Outcome Id 30800459 Outcome Id 30800460 Outcome Id 30800460 Outcome Id 30800461 Outcome Id 30800461
Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 21 Count 12 Count 21 Count 12 Count 21 Count 12 Count 21 Count 12 Count 21 Count 12

Provided Documents

Sequence: 2578521 Sequence: 2578522
Document Type Study Protocol Document Type Statistical Analysis Plan
Has Protocol True Has Protocol False
Has Icf False Has Icf False
Has Sap False Has Sap True
Document Date 2020-04-28 Document Date 2020-08-05
Url https://ClinicalTrials.gov/ProvidedDocs/66/NCT03798366/Prot_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/66/NCT03798366/SAP_001.pdf

Reported Event Totals

Sequence: 27939424 Sequence: 27939425 Sequence: 27939426 Sequence: 27939427 Sequence: 27939428 Sequence: 27939429
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 2 Subjects Affected 20 Subjects Affected 0 Subjects Affected 1 Subjects Affected 11 Subjects Affected 0
Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 12
Created At 2023-08-08 23:06:40.239151 Created At 2023-08-08 23:06:40.239151 Created At 2023-08-08 23:06:40.239151 Created At 2023-08-08 23:06:40.239151 Created At 2023-08-08 23:06:40.239151 Created At 2023-08-08 23:06:40.239151
Updated At 2023-08-08 23:06:40.239151 Updated At 2023-08-08 23:06:40.239151 Updated At 2023-08-08 23:06:40.239151 Updated At 2023-08-08 23:06:40.239151 Updated At 2023-08-08 23:06:40.239151 Updated At 2023-08-08 23:06:40.239151

Reported Events

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Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622 Result Group Id 56087621 Result Group Id 56087622
Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to 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end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks) Time Frame Baseline up to end of the study (36 weeks)
Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type serious Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other Event Type other
Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 7 Subjects Affected 2 Subjects Affected 2 Subjects Affected 0 Subjects Affected 2 Subjects Affected 0 Subjects Affected 1 Subjects Affected 2 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 2 Subjects Affected 2 Subjects Affected 2 Subjects Affected 1 Subjects Affected 3 Subjects Affected 0 Subjects Affected 2 Subjects Affected 0 Subjects Affected 2 Subjects Affected 0 Subjects Affected 2 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 5 Subjects Affected 2 Subjects Affected 3 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 4 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 2 Subjects Affected 0 Subjects Affected 2 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 3 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 3 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 2 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 2 Subjects Affected 0 Subjects Affected 2 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 2 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0
Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12 Subjects At Risk 21 Subjects At Risk 12
Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed. Description Participants in the safety analysis set were analyzed.
Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Infections and infestations Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Gastrointestinal disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Nervous system disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Skin and subcutaneous tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Musculoskeletal and connective tissue disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Respiratory, thoracic and mediastinal disorders Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System Injury, poisoning and procedural complications Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System General disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Metabolism and nutrition disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Cardiac disorders Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Investigations Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Psychiatric disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Renal and urinary disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Vascular disorders Organ System Blood and lymphatic system disorders Organ System Blood and lymphatic system disorders Organ System Ear and labyrinth disorders Organ System Ear and labyrinth disorders Organ System Eye disorders Organ System Eye disorders
Adverse Event Term Conjunctivitis Adverse Event Term Conjunctivitis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis Adverse Event Term Gastroenteritis viral Adverse Event Term Gastroenteritis viral Adverse Event Term Herpes zoster Adverse Event Term Herpes zoster Adverse Event Term Hordeolum Adverse Event Term Hordeolum Adverse Event Term Nasopharyngitis Adverse Event Term Nasopharyngitis Adverse Event Term Oral herpes Adverse Event Term Oral herpes Adverse Event Term Otitis media Adverse Event Term Otitis media Adverse Event Term Sinusitis Adverse Event Term Sinusitis Adverse Event Term Suspected COVID-19 Adverse Event Term Suspected COVID-19 Adverse Event Term Diarrhoea Adverse Event Term Diarrhoea Adverse Event Term Abdominal distension Adverse Event Term Abdominal distension Adverse Event Term Dyspepsia Adverse Event Term Dyspepsia Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Sepsis Adverse Event Term Sepsis Adverse Event Term Device related infection Adverse Event Term Device related infection Adverse Event Term Pharyngitis Adverse Event Term Pharyngitis Adverse Event Term Foreign body in gastrointestinal tract Adverse Event Term Foreign body in gastrointestinal tract Adverse Event Term Upper respiratory tract infection Adverse Event Term Upper respiratory tract infection Adverse Event Term Rhinitis Adverse Event Term Rhinitis Adverse Event Term Urinary tract infection Adverse Event Term Urinary tract infection Adverse Event Term Cellulitis Adverse Event Term Cellulitis Adverse Event Term Influenza Adverse Event Term Influenza Adverse Event Term Pharyngitis Adverse Event Term Pharyngitis Adverse Event Term Bronchitis Adverse Event Term Bronchitis Adverse Event Term Gastrooesophageal reflux disease Adverse Event Term Oesophagitis Adverse Event Term Oesophagitis Adverse Event Term Abdominal pain Adverse Event Term Abdominal pain Adverse Event Term Aphthous ulcer Adverse Event Term Aphthous ulcer Adverse Event Term Constipation Adverse Event Term Constipation Adverse Event Term Eructation Adverse Event Term Eructation Adverse Event Term Gastric antral vascular ectasia Adverse Event Term Gastric antral vascular ectasia Adverse Event Term Gastrointestinal inflammation Adverse Event Term Gastrointestinal inflammation Adverse Event Term Gingival recession Adverse Event Term Gingival recession Adverse Event Term Nausea Adverse Event Term Nausea Adverse Event Term Headache Adverse Event Term Headache Adverse Event Term Dizziness Adverse Event Term Dizziness Adverse Event Term Dyskinesia Adverse Event Term Dyskinesia Adverse Event Term Memory impairment Adverse Event Term Memory impairment Adverse Event Term Migraine Adverse Event Term Migraine Adverse Event Term Skin lesion Adverse Event Term Skin lesion Adverse Event Term Digital pitting scar Adverse Event Term Digital pitting scar Adverse Event Term Hyperhidrosis Adverse Event Term Hyperhidrosis Adverse Event Term Skin ulcer Adverse Event Term Skin ulcer Adverse Event Term Acne Adverse Event Term Acne Adverse Event Term Hair growth abnormal Adverse Event Term Hair growth abnormal Adverse Event Term Hypertrichosis Adverse Event Term Hypertrichosis Adverse Event Term Night sweats Adverse Event Term Night sweats Adverse Event Term Rash Adverse Event Term Rash Adverse Event Term Rash erythematous Adverse Event Term Rash erythematous Adverse Event Term Rash macular Adverse Event Term Rash macular Adverse Event Term Arthralgia Adverse Event Term Arthralgia Adverse Event Term Back pain Adverse Event Term Back pain Adverse Event Term Bone disorder Adverse Event Term Bone disorder Adverse Event Term Fibromyalgia Adverse Event Term Fibromyalgia Adverse Event Term Muscular weakness Adverse Event Term Muscular weakness Adverse Event Term Musculoskeletal pain Adverse Event Term Musculoskeletal pain Adverse Event Term Myalgia Adverse Event Term Myalgia Adverse Event Term Osteolysis Adverse Event Term Osteolysis Adverse Event Term Pain in extremity Adverse Event Term Pain in extremity Adverse Event Term Scleroderma Adverse Event Term Scleroderma Adverse Event Term Synovitis Adverse Event Term Synovitis Adverse Event Term Tendonitis Adverse Event Term Tendonitis Adverse Event Term Tenosynovitis stenosans Adverse Event Term Tenosynovitis stenosans Adverse Event Term Cough Adverse Event Term Cough Adverse Event Term Rhinorrhoea Adverse Event Term Rhinorrhoea Adverse Event Term Dyspnoea Adverse Event Term Dyspnoea Adverse Event Term Interstitial lung disease Adverse Event Term Interstitial lung disease Adverse Event Term Nasal congestion Adverse Event Term Nasal congestion Adverse Event Term Oropharyngeal pain Adverse Event Term Oropharyngeal pain Adverse Event Term Sinus congestion Adverse Event Term Sinus congestion Adverse Event Term Ligament sprain Adverse Event Term Ligament sprain Adverse Event Term Limb injury Adverse Event Term Limb injury Adverse Event Term Procedural pain Adverse Event Term Procedural pain Adverse Event Term Skin abrasion Adverse Event Term Skin abrasion Adverse Event Term Tendon injury Adverse Event Term Tendon injury Adverse Event Term Vascular injury Adverse Event Term Vascular injury Adverse Event Term Peripheral swelling Adverse Event Term Peripheral swelling Adverse Event Term Discomfort Adverse Event Term Discomfort Adverse Event Term Malaise Adverse Event Term Malaise Adverse Event Term Pyrexia Adverse Event Term Pyrexia Adverse Event Term Decreased appetite Adverse Event Term Decreased appetite Adverse Event Term Dyslipidaemia Adverse Event Term Dyslipidaemia Adverse Event Term Iron deficiency Adverse Event Term Iron deficiency Adverse Event Term Lactose intolerance Adverse Event Term Lactose intolerance Adverse Event Term Vitamin D deficiency Adverse Event Term Vitamin D deficiency Adverse Event Term Palpitations Adverse Event Term Palpitations Adverse Event Term Bundle branch block left Adverse Event Term Bundle branch block left Adverse Event Term Alanine aminotransferase increased Adverse Event Term Alanine aminotransferase increased Adverse Event Term Weight increased Adverse Event Term Weight increased Adverse Event Term Aspartate aminotransferase increased Adverse Event Term Aspartate aminotransferase increased Adverse Event Term Blood lactate dehydrogenase increased Adverse Event Term Blood lactate dehydrogenase increased Adverse Event Term Insomnia Adverse Event Term Insomnia Adverse Event Term Anger Adverse Event Term Anger Adverse Event Term Pollakiuria Adverse Event Term Pollakiuria Adverse Event Term Urinary incontinence Adverse Event Term Urinary incontinence Adverse Event Term Hot flush Adverse Event Term Hot flush Adverse Event Term Raynaud's phenomenon Adverse Event Term Raynaud's phenomenon Adverse Event Term Anaemia Adverse Event Term Anaemia Adverse Event Term Vertigo Adverse Event Term Vertigo Adverse Event Term Vision blurred Adverse Event Term Vision blurred
Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0 Frequency Threshold 0
Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0 Vocab MedDRA 23.0
Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment Assessment Non-systematic Assessment

Responsible Parties

Sequence: 28871276
Responsible Party Type Sponsor

Result Agreements

Sequence: 3851549
Pi Employee No
Restriction Type OTHER
Other Details The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
Restrictive Agreement The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.

Result Contacts

Sequence: 3851514
Organization Galapagos NV
Name Galapagos Medical Information
Phone +32 15 342 900
Email medicalinfo@glpg.com

Outcomes

Sequence: 30800457 Sequence: 30800458 Sequence: 30800459 Sequence: 30800460 Sequence: 30800461
Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Primary Outcome Type Secondary
Title Change From Baseline in mRSS at Week 4 Title Change From Baseline in mRSS at Week 8 Title Change From Baseline in mRSS at Week 16 Title Change From Baseline in mRSS at Week 24 Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant.
Time Frame Baseline, Week 4 Time Frame Baseline, Week 8 Time Frame Baseline, Week 16 Time Frame Baseline, Week 24 Time Frame Baseline up to end of the study (36 weeks)
Population Participants in the FAS were analyzed. Population Participants in the FAS were analyzed. Population Participants in the FAS were analyzed. Population Participants in the FAS were analyzed. Population Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.
Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units Participants
Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error
Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Count of Participants

Outcome Measurements

Sequence: 235627210 Sequence: 235627211 Sequence: 235627212 Sequence: 235627213 Sequence: 235627214 Sequence: 235627215 Sequence: 235627216 Sequence: 235627217 Sequence: 235627218 Sequence: 235627219 Sequence: 235627220 Sequence: 235627221
Outcome Id 30800457 Outcome Id 30800457 Outcome Id 30800458 Outcome Id 30800458 Outcome Id 30800459 Outcome Id 30800459 Outcome Id 30800460 Outcome Id 30800460 Outcome Id 30800461 Outcome Id 30800461 Outcome Id 30800461 Outcome Id 30800461
Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620 Result Group Id 56087619 Result Group Id 56087620
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Classification TEAEs Classification TEAEs Classification Serious TEAEs Classification Serious TEAEs
Title Change From Baseline in mRSS at Week 4 Title Change From Baseline in mRSS at Week 4 Title Change From Baseline in mRSS at Week 8 Title Change From Baseline in mRSS at Week 8 Title Change From Baseline in mRSS at Week 16 Title Change From Baseline in mRSS at Week 16 Title Change From Baseline in mRSS at Week 24 Title Change From Baseline in mRSS at Week 24 Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. Description An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. Description An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. Description An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant.
Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units units on a scale Units Participants Units Participants Units Participants Units Participants
Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Least Squares Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value -2.2 Param Value -1.6 Param Value -3.2 Param Value -2.5 Param Value -6.8 Param Value -4.8 Param Value -8.9 Param Value -6.0 Param Value 20 Param Value 11 Param Value 2 Param Value 1
Param Value Num -2.2 Param Value Num -1.6 Param Value Num -3.2 Param Value Num -2.5 Param Value Num -6.8 Param Value Num -4.8 Param Value Num -8.9 Param Value Num -6.0 Param Value Num 20.0 Param Value Num 11.0 Param Value Num 2.0 Param Value Num 1.0
Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error Dispersion Type Standard Error
Dispersion Value 0.85 Dispersion Value 1.04 Dispersion Value 0.85 Dispersion Value 1.07 Dispersion Value 0.85 Dispersion Value 1.12 Dispersion Value 0.87 Dispersion Value 1.11
Dispersion Value Num 0.85 Dispersion Value Num 1.04 Dispersion Value Num 0.85 Dispersion Value Num 1.07 Dispersion Value Num 0.85 Dispersion Value Num 1.12 Dispersion Value Num 0.87 Dispersion Value Num 1.11

Baseline Counts

Sequence: 11381948 Sequence: 11381949 Sequence: 11381950
Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 21 Count 12 Count 33

Result Groups

Sequence: 56087614 Sequence: 56087615 Sequence: 56087616 Sequence: 56087617 Sequence: 56087618 Sequence: 56087619 Sequence: 56087620 Sequence: 56087621 Sequence: 56087622
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title GLPG1690 600 mg Title Placebo Title Total Title GLPG1690 600 mg Title Placebo Title GLPG1690 600 mg Title Placebo Title GLPG1690 600 mg Title Placebo
Description Participants received GLPG1690 600 mg, orally once daily for 24 weeks. Description Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. Description Total of all reporting groups Description Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks. Description Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. Description Participants received GLPG1690 600 mg, orally once daily for 24 weeks. Description Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. Description Participants received GLPG1690 600 mg, orally once daily for 24 weeks. Description Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.

Baseline Measurements

Sequence: 125567185 Sequence: 125567186 Sequence: 125567187 Sequence: 125567188 Sequence: 125567189 Sequence: 125567190 Sequence: 125567191 Sequence: 125567192 Sequence: 125567193 Sequence: 125567194 Sequence: 125567195 Sequence: 125567196 Sequence: 125567197 Sequence: 125567198 Sequence: 125567199 Sequence: 125567200 Sequence: 125567201 Sequence: 125567202 Sequence: 125567203 Sequence: 125567204 Sequence: 125567205 Sequence: 125567206 Sequence: 125567207 Sequence: 125567208 Sequence: 125567209 Sequence: 125567210 Sequence: 125567211 Sequence: 125567212 Sequence: 125567213 Sequence: 125567214 Sequence: 125567215 Sequence: 125567216 Sequence: 125567217 Sequence: 125567218 Sequence: 125567219 Sequence: 125567220 Sequence: 125567221 Sequence: 125567222 Sequence: 125567223 Sequence: 125567224 Sequence: 125567225 Sequence: 125567226
Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616 Result Group Id 56087614 Result Group Id 56087615 Result Group Id 56087616
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Category Female Category Female Category Female Category Male Category Male Category Male Category Hispanic or Latino Category Hispanic or Latino Category Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Not Hispanic or Latino Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported Category American Indian or Alaska Native Category American Indian or Alaska Native Category American Indian or Alaska Native Category Asian Category Asian Category Asian Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Native Hawaiian or Other Pacific Islander Category Black or African American Category Black or African American Category Black or African American Category White Category White Category White Category More than one race Category More than one race Category More than one race Category Unknown or Not Reported Category Unknown or Not Reported Category Unknown or Not Reported
Title Age, Continuous Title Age, Continuous Title Age, Continuous Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Ethnicity (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Race (NIH/OMB) Title Modified Rodnan Skin Score (mRSS) Title Modified Rodnan Skin Score (mRSS) Title Modified Rodnan Skin Score (mRSS)
Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. Description The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
Units years Units years Units years Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units units on a scale Units units on a scale Units units on a scale
Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean
Param Value 50.4 Param Value 47.3 Param Value 49.3 Param Value 15 Param Value 8 Param Value 23 Param Value 6 Param Value 4 Param Value 10 Param Value 1 Param Value 1 Param Value 2 Param Value 20 Param Value 10 Param Value 30 Param Value 0 Param Value 1 Param Value 1 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 1 Param Value 1 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 21 Param Value 11 Param Value 32 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 27.0 Param Value 22.5 Param Value 25.3
Param Value Num 50.4 Param Value Num 47.3 Param Value Num 49.3 Param Value Num 15.0 Param Value Num 8.0 Param Value Num 23.0 Param Value Num 6.0 Param Value Num 4.0 Param Value Num 10.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 2.0 Param Value Num 20.0 Param Value Num 10.0 Param Value Num 30.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 21.0 Param Value Num 11.0 Param Value Num 32.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 27.0 Param Value Num 22.5 Param Value Num 25.3
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 13.58 Dispersion Value 17.99 Dispersion Value 15.13 Dispersion Value 8.84 Dispersion Value 6.24 Dispersion Value 8.18
Dispersion Value Num 13.58 Dispersion Value Num 17.99 Dispersion Value Num 15.13 Dispersion Value Num 8.84 Dispersion Value Num 6.24 Dispersion Value Num 8.18
Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33 Number Analyzed 21 Number Analyzed 12 Number Analyzed 33

]]>

<![CDATA[ Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue ]]>
https://zephyrnet.com/NCT03798353
2019-05-13

https://zephyrnet.com/?p=NCT03798353
NCT03798353https://www.clinicaltrials.gov/study/NCT03798353?tab=tableNANANAMyocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today, there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and in more advanced stages the only therapy that completely restores cardiac function is heart transplantation.

Mesenchymal stem cells are multipotent cells found from embryonic mesoderm and found in all tissues. In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. Our approach is based on a decellularized matrix that carries the cells directly over myocardial infarction.
<![CDATA[

Studies

Study First Submitted Date 2018-12-21
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-12-02
Start Month Year May 13, 2019
Primary Completion Month Year September 27, 2022
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-02

Detailed Descriptions

Sequence: 20809621
Description Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and, in more advanced stages, the only therapy that completely restores cardiac function is heart transplantation.

Experimental studies are evaluating new therapeutic approaches based on tissue engineering for myocardial regeneration. Cardiac tissue engineering attempts to create functional tissue constructs that can restore the structure and function of damaged myocardium.

Mesenchymal stem cells (MSCs) are multipotent cells that develop from embryonic mesoderm and are found in all structural tissues of the body.

In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. The investigators approach is based on a decellularized matrix that carries the cells directly over myocardial infarction.

Among the different types of MSC currently available, the investigators propose the use of those derived from the connective tissue surrounding the great vessels (2 arteries and one vein) of the umbilical cord called Wharton's gelatin (MSC, WJ) whose immunomodulatory properties are described extensively in the literature. These MSC, WJ cells have a PEI approved by the Spanish Agency for Medicines and Healthcare Products (AEMPS) (PEI 16-017) that guarantees an optimal manufacturing process for a clinical trial.

Facilities

Sequence: 200855707
Name Hospital Universitari Germans Trias i Pujol
City Badalona
State Barcelona
Zip 08916
Country Spain

Conditions

Sequence: 52395730
Name Myocardial Infarction
Downcase Name myocardial infarction

Id Information

Sequence: 40318197 Sequence: 40318198
Id Source org_study_id Id Source secondary_id
Id Value ICOR-2016-02 Id Value 2018-001964-49
Id Type EudraCT Number

Countries

Sequence: 42741522
Name Spain
Removed False

Design Groups

Sequence: 55842445 Sequence: 55842446
Group Type Experimental Group Type Active Comparator
Title Experimental group Title Control group
Description The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.

In addition, the matrix-cell (PeriCord) construct will be placed on the ischemic area of the non-candidate revascularization area and will be fixed using surgical glue.

PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix .

Description The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed.

Interventions

Sequence: 52705255 Sequence: 52705256
Intervention Type Combination Product Intervention Type Procedure
Name PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix. Name Surgery by sternotomy
Description A matrix-cell construct (PeriCord) will be placed on the ischemic area of the non-candidate revascularization area during a surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. Description The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed only the by-pass.

Keywords

Sequence: 80173548 Sequence: 80173549 Sequence: 80173550 Sequence: 80173551 Sequence: 80173552 Sequence: 80173553
Name Cardiac repair Name Wharton jelly mesenchymal stem cells Name Chronic myocardial infarction Name Tissue engineering Name Cell therapy Name Clinical trial
Downcase Name cardiac repair Downcase Name wharton jelly mesenchymal stem cells Downcase Name chronic myocardial infarction Downcase Name tissue engineering Downcase Name cell therapy Downcase Name clinical trial

Design Outcomes

Sequence: 178209045 Sequence: 178209046 Sequence: 178209047 Sequence: 178209048 Sequence: 178209049 Sequence: 178209050 Sequence: 178209051 Sequence: 178209052 Sequence: 178209053 Sequence: 178209054 Sequence: 178209055 Sequence: 178209056
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other
Measure Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation. Measure Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation. Measure Death rate or rehospitalization due to cardiovascular causes Measure Rate of relevant arrhythmias in Holter of 24 hours Measure Relevant changes in N-terminal B-type natriuretic peptide (NT-proBNP) and High sensitivity troponin I (hsTnI) levels Measure Changes in the necrotic myocardial mass ratio Measure Changes of regional contractility Measure Changes in ejection fraction of the left ventricle Measure changes in left and right ventricular geometric remodeling Measure Changes in the score on the quality of life test Short Form 36 Healthy Survey (SF-36). Measure Changes in the score on the quality of life Kansas City Cardiomyopathy Questionnaire (KCCQ) test in cases of participants with heart failure will be used. Measure monocyte populations and cytokines and chemokines levels
Time Frame at 12 months of follow-up Time Frame At 1 week, 3 and 6 months Time Frame At 1 week, 3 , 6and 12 months Time Frame At 1 week, 3 and 12 months Time Frame At 1 week, 3 and 12 months Time Frame At 3 and 12 months Time Frame At 3 and 12 months Time Frame At 3 and 12 months Time Frame At 3 and 12 months Time Frame At 3 and 12 months Time Frame At 3 and 12 months Time Frame At screening, day 3 and day 5
Description Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment. Description Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment Description Death rate or rehospitalization due to cardiovascular causes at week, 3, 6 and 12 months. Description Rate of relevant arrhythmias in Holter of 24 hours a week, 3 and 12 months. Description Relevant changes in NT-proBNP and hsTnI levels at week, 3 and 12 months. Description Changes in the necrotic myocardial mass ratio due to gadolinium retention at 3 and 12 months. Description change of regional contractility by nuclear magnetic resonance (NMR) at 3 and 12 months. Description Changes in ejection fraction of the left at 3 and 12 months Description changes in left and right ventricular geometric remodeling at 3 and 12 months Description Changes in the score on the quality of life test SF-36 will be used at 3 and 12 months. The mínimum value is 0 and the máximum value is 100. Higher scores mean a better outcome. Description Changes in the score on the quality of life test KCCQ in cases of participants with heart failure will be used at 3 and 12 months. The test is composed of 23 items. The options for the answers are Likert scales of 1 to 5, 6 or 7 points and the score of each of its dimensions has a theoretical range from 0 to 100, 100 being the best outcome. Description changes in the monocyte populations and cytokines and chemokines levels between the two groups in order to analyze if the PeriCord could improve these variables

Browse Conditions

Sequence: 194339368 Sequence: 194339369 Sequence: 194339370 Sequence: 194339371 Sequence: 194339372 Sequence: 194339373 Sequence: 194339374 Sequence: 194339375 Sequence: 194339376
Mesh Term Myocardial Infarction Mesh Term Infarction Mesh Term Ischemia Mesh Term Pathologic Processes Mesh Term Necrosis Mesh Term Myocardial Ischemia Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases Mesh Term Vascular Diseases
Downcase Mesh Term myocardial infarction Downcase Mesh Term infarction Downcase Mesh Term ischemia Downcase Mesh Term pathologic processes Downcase Mesh Term necrosis Downcase Mesh Term myocardial ischemia Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term vascular diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48528073 Sequence: 48528074
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Fundació Institut Germans Trias i Pujol Name Germans Trias i Pujol Hospital

Overall Officials

Sequence: 29402712
Role Principal Investigator
Name Antoni Bayes-Genís, MD, PhD,FESC
Affiliation Institut del Cor, HUGTiP, IGTP

Design Group Interventions

Sequence: 68454189 Sequence: 68454190
Design Group Id 55842445 Design Group Id 55842446
Intervention Id 52705255 Intervention Id 52705256

Eligibilities

Sequence: 30894786
Gender All
Minimum Age 18 Years
Maximum Age 99 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Myocardial infarction of ≥50% of transmurally due to MR
Candidate for coronary by-pass through that or another territory
Age ≥18 years
Signature of informed consent
Wave Q present in the ECG
Followed by the cardiology service of Germans Trial i Pujol hospital

Exclusion Criteria:

Severe valvular disease with indication of surgical repair
Candidate for ventricular remodeling
Contraindication for MR (creatinine clearance less than 30 ml / min / 1.73m2, metallic implant carriers, claustrophobia)
Extracardiac disease with estimated life expectancy less than 1 year
Neoplastic disease detected in the last five years or without complete remission
Severe renal or hepatic insufficiency
Abnormal laboratory values, not explainable at the time of inclusion, and that at the discretion of the investigator contraindicate the patient's participation in the study
Patients with a previous cardiac intervention
Women who are pregnant or breast-feeding.
Women of childbearing age who are heterosexually active and who do not use an effective contraceptive method from 14 days before the inclusion in the study and at least up to 12 weeks after the end of the study.
Simultaneous participation in another clinical trial or treatment with another product in investigational phase in the 30 days prior to inclusion in the study.
Negation of the patient to be followed by a period that exceeds the clinical trial itself (long-term follow-up in the second and third year).

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254139394
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 41
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 10
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30640526
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description The randomization will be known exclusively by the cardiac surgery team and the study coordinator, and it will be blind to the patient and to the rest of the investigators team: clinical cardiologist who performs the follow-up, team that performs image tests, core lab that evaluates the imaging tests and the equipment that statistically analyzes the data.
Intervention Model Description – Experimental group: The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.

In addition, the matrix-cell construct will be placed on the ischemic area of the non-candidate revascularization area and will be fixed using surgical glue.

– Control group: The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed.

Subject Masked True
Investigator Masked True

Responsible Parties

Sequence: 29007130
Responsible Party Type Sponsor

]]>

<![CDATA[ Vibratory Perturbation-based Pinch Task Training for Stroke Patients ]]>
https://zephyrnet.com/NCT03798340
2016-03-24

https://zephyrnet.com/?p=NCT03798340
NCT03798340https://www.clinicaltrials.gov/study/NCT03798340?tab=tableNANANAThe investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-30
Start Month Year March 24, 2016
Primary Completion Month Year October 4, 2016
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-30

Facilities

Sequence: 199965052
Name National Cheng-Kung University Hospital
City Tainan
Zip 704
Country Taiwan

Conditions

Sequence: 52138980
Name Stroke Rehabilitation
Downcase Name stroke rehabilitation

Id Information

Sequence: 40135042
Id Source org_study_id
Id Value A-ER-104-206

Countries

Sequence: 42542673
Name Taiwan
Removed False

Design Groups

Sequence: 55559316 Sequence: 55559317
Group Type Experimental Group Type Active Comparator
Title Vibratory perturbed task-specific movement training Title Traditional task-oriented facilitation
Description Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training Description Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.

Interventions

Sequence: 52454879 Sequence: 52454880 Sequence: 52454881
Intervention Type Other Intervention Type Other Intervention Type Other
Name Vibratory perturbed task-specific movement training Name Traditional task-oriented facilitation Name Sensorimotor training
Description The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min. Description Reach-to-grasp training and hand release training Description Targeted to goals that are relevant to the sensorimotor facilitation of the patient

Keywords

Sequence: 79822787 Sequence: 79822788 Sequence: 79822789 Sequence: 79822790
Name stroke Name perturbation-based training Name task-specific motor training Name recovery of function
Downcase Name stroke Downcase Name perturbation-based training Downcase Name task-specific motor training Downcase Name recovery of function

Design Outcomes

Sequence: 177263573 Sequence: 177263574 Sequence: 177263575 Sequence: 177263576 Sequence: 177263577
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Change in the result of Fugl-Meyer assessment for UE motor function Measure Change in the result of Modified Ashworth scale (MAS) Measure Change in the result of Box and blocks test Measure Change in the result of Semmes-Weinstein monofilament (SWM) test Measure Change in the result of Motor Activity Log
Time Frame baseline, endpoint (6 weeks) and follow up (18 weeks) Time Frame baseline, endpoint (6 weeks) and follow up (18 weeks) Time Frame baseline, endpoint (6 weeks) and follow up (18 weeks) Time Frame baseline, endpoint (6 weeks) and follow up (18 weeks) Time Frame baseline, endpoint (6 weeks) and follow up (18 weeks)
Description Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity. Description Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension. Description The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. Description The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome. Description MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.

Browse Conditions

Sequence: 193366420 Sequence: 193366421 Sequence: 193366422 Sequence: 193366423 Sequence: 193366424 Sequence: 193366425 Sequence: 193366426
Mesh Term Stroke Mesh Term Cerebrovascular Disorders Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases
Downcase Mesh Term stroke Downcase Mesh Term cerebrovascular disorders Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290689
Agency Class OTHER
Lead Or Collaborator lead
Name National Cheng-Kung University Hospital

Design Group Interventions

Sequence: 68107414 Sequence: 68107415 Sequence: 68107416 Sequence: 68107417
Design Group Id 55559316 Design Group Id 55559317 Design Group Id 55559317 Design Group Id 55559316
Intervention Id 52454879 Intervention Id 52454880 Intervention Id 52454881 Intervention Id 52454881

Eligibilities

Sequence: 30747709
Gender All
Minimum Age 20 Years
Maximum Age 80 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Clinical diagnosis of unilateral cerebral infarction or hemorrhage
Be able to perform a pinch task with the thumb and index finger
With premorbid right-handedness

Exclusion Criteria:

Subject has a uncontrolled hypertension
Subject has major cognitive-perceptual deficits
Subject has other brain disease

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121824
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 6
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 20
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 5

Designs

Sequence: 30493992
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28860272
Responsible Party Type Sponsor

Study References

Sequence: 52032722
Pmid 33278364
Reference Type derived
Citation Hsu HY, Kuan TS, Tsai CL, Wu PT, Kuo YL, Su FC, Kuo LC. Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):811-818. doi: 10.1016/j.apmr.2020.11.004. Epub 2020 Dec 2.

]]>

<![CDATA[ Palliative Care at Home for Dementia ]]>
https://zephyrnet.com/NCT03798327
2018-11-01

https://zephyrnet.com/?p=NCT03798327
NCT03798327https://www.clinicaltrials.gov/study/NCT03798327?tab=tableNANANAThe proposed project is a randomized controlled trial of a new home-based palliative care program for adults with advanced dementia and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for 6 months.

Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-08-01
Start Month Year November 1, 2018
Primary Completion Month Year April 29, 2022
Verification Month Year July 2022
Verification Date 2022-07-31
Last Update Posted Date 2022-08-01

Detailed Descriptions

Sequence: 20827258
Description The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.

Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Visits will combine a combination of video-teleconferencing technology and in person visits. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.

Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.

Facilities

Sequence: 201087032 Sequence: 201087033 Sequence: 201087034 Sequence: 201087035
Name Mount Sinai Beth Israel Name Mount Sinai West Name Mount Sinai St. Luke's Name Icahn School of Medicine at Mount Sinai
City New York City New York City New York City New York
State New York State New York State New York State New York
Zip 10003 Zip 10019 Zip 10025 Zip 10029
Country United States Country United States Country United States Country United States

Conditions

Sequence: 52442604
Name Dementia
Downcase Name dementia

Id Information

Sequence: 40352652 Sequence: 40352653
Id Source org_study_id Id Source secondary_id
Id Value GCO 17-02787 Id Value R56AG067045-01
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/R56AG067045-01

Countries

Sequence: 42786455
Name United States
Removed False

Design Groups

Sequence: 55894594 Sequence: 55894595
Group Type Experimental Group Type No Intervention
Title Home Palliative Care Title Control Arm
Description Randomized to Intervention Arm Description Usual Care – Patients will be cared for by the physician who treats their dementia and other illnesses.

Interventions

Sequence: 52752593
Intervention Type Behavioral
Name Home Palliative Care
Description Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.

Keywords

Sequence: 80236887 Sequence: 80236888
Name Palliative Care Name Home-Based Care
Downcase Name palliative care Downcase Name home-based care

Design Outcomes

Sequence: 178400246 Sequence: 178400247 Sequence: 178400248 Sequence: 178400249 Sequence: 178400250 Sequence: 178400251 Sequence: 178400252 Sequence: 178400253 Sequence: 178400254 Sequence: 178400255
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Symptom Management at the End of Life for Dementia scale Measure Patient Quality of Life – Alzheimer's Disease scale Measure Number of Complete of Advance Directives Measure Preference Consistent Care Measure Caregiver Zaria Burden Inventory Measure Caregiver FAMCARE-10 Measure Caregiver PHQ-9 Measure Number of hospital admissions Measure Number of emergency department visits Measure Number of outpatient appointments
Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months
Description This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator

Scale: Symptom Management at the End of Life for Dementia – Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms

Description This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator.

Scale: Quality of Life – Alzheimer's Disease; Likert scale, 13 items, each 1-4, (52 total possible score) lower is worse quality of life

Description The Study Team will examine the patient's chart for completion of advanced directives

Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no).

Description The Study Team will examine if the care patients receive is concordant with the care they wanted to receive.

Scale: Simple chart review of whether care received matches stated preferences (yes/no)

Description Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point scale range from 0 (never) to 4 (always)

Scale: Zarit Burden Inventory – Likert scale 0-4,total score = 0-88, higher score is more burden

Description FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator.

Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction

Description PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

Scale: Patient Health Questionnaire – 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months]

Description healthcare utilization Description healthcare utilization Description healthcare utilization

Browse Conditions

Sequence: 194522412 Sequence: 194522413 Sequence: 194522414 Sequence: 194522415 Sequence: 194522416 Sequence: 194522417
Mesh Term Dementia Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Neurocognitive Disorders Mesh Term Mental Disorders
Downcase Mesh Term dementia Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term neurocognitive disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48570861 Sequence: 48570862
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Icahn School of Medicine at Mount Sinai Name National Institute on Aging (NIA)

Overall Officials

Sequence: 29426952
Role Study Director
Name Nathan Goldstein, MD
Affiliation Icahn School of Medicine at Mount Sinai

Design Group Interventions

Sequence: 68521087
Design Group Id 55894594
Intervention Id 52752593

Eligibilities

Sequence: 30920984
Gender All
Minimum Age 65 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Presence of advanced dementia
Subject has a Mount Sinai physician who authorizes their participation in the study and receipt of the program
Subject is resident in Manhattan outside of a long term care facility and is not receiving hospice 5.
Subject has evidence of capacity to benefit from enrollment in palliative care program
Subject is conversant in English or Spanish
Subject has capacity to consent or has a caregiver who can provide consent for the patient

Exclusion Criteria:

Subject has no usual physician within Mount Sinai
Subject's usual physician doesn't provide authorization to patient participation
Subject resident outside of Manhattan or in long term care facility or receiving hospice
Subject is not conversant in English or Spanish
Subject cannot provide consent or has no caregiver who can provide consent

Adult False
Child False
Older Adult True

Calculated Values

Sequence: 254190324
Number Of Facilities 4
Registered In Calendar Year 2019
Actual Duration 42
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 65
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 9

Designs

Sequence: 30666656
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Health Services Research
Time Perspective
Masking Single
Masking Description Single blind control
Outcomes Assessor Masked True

Responsible Parties

Sequence: 29033353
Responsible Party Type Principal Investigator
Name Nathan Goldstein
Title Professor, Geriatrics and Palliative Medicine
Affiliation Icahn School of Medicine at Mount Sinai

]]>

<![CDATA[ Nivolumab and Pomalidomide in Treating Patients With Relapsed or Refractory Central Nervous System Diffuse Large B Cell Lymphoma or Primary Vitreoretinal Diffuse Large B Cell Lymphoma ]]>
https://zephyrnet.com/NCT03798314
2019-01-30

https://zephyrnet.com/?p=NCT03798314
NCT03798314https://www.clinicaltrials.gov/study/NCT03798314?tab=tableNANANAThis phase I trials studies side effects and best dose of pomalidomide when given together with nivolumab in treating patients with primary central nervous system diffuse large B cell lymphoma or primary vitreoretinal diffuse large B cell lymphoma that has come back or that has not responded to treatment. Immunotherapy with monoclonal antibodies, such as pomalidomide and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-01-06
Start Month Year January 30, 2019
Primary Completion Month Year December 30, 2020
Verification Month Year September 2021
Verification Date 2021-09-30
Last Update Posted Date 2023-01-06

Detailed Descriptions

Sequence: 20697134
Description PRIMARY OBJECTIVES:

I. To establish the maximum tolerated dose (MTD) of pomalidomide which can be safely combined with the fixed dose schedule of nivolumab in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and primary vitreoretinal lymphoma (PVRL). (Phase I)

SECONDARY OBJECTIVES:

I. To evaluate the overall response rate (ORR) and progression free survival (PFS) of nivolumab and pomalidomide combination in patients with relapsed/refractory PCNSL and PVRL.

OUTLINE: This is dose-escalation study of pomalidomide.

Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and pomalidomide orally (PO) on days 1-14. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 weeks, then every 3 months for 4 years.

Facilities

Sequence: 199787881 Sequence: 199787882
Name Mayo Clinic in Florida Name Mayo Clinic
City Jacksonville City Rochester
State Florida State Minnesota
Zip 32224-9980 Zip 55905
Country United States Country United States

Browse Interventions

Sequence: 95919626 Sequence: 95919627 Sequence: 95919628 Sequence: 95919629 Sequence: 95919630 Sequence: 95919631 Sequence: 95919632 Sequence: 95919633 Sequence: 95919634 Sequence: 95919635 Sequence: 95919636 Sequence: 95919637
Mesh Term Nivolumab Mesh Term Pomalidomide Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents Mesh Term Immune Checkpoint Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs Mesh Term Angiogenesis Inhibitors Mesh Term Angiogenesis Modulating Agents Mesh Term Growth Substances Mesh Term Growth Inhibitors
Downcase Mesh Term nivolumab Downcase Mesh Term pomalidomide Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents Downcase Mesh Term immune checkpoint inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs Downcase Mesh Term angiogenesis inhibitors Downcase Mesh Term angiogenesis modulating agents Downcase Mesh Term growth substances Downcase Mesh Term growth inhibitors
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52104846 Sequence: 52104847 Sequence: 52104848 Sequence: 52104849
Name Recurrent Nervous System Lymphoma Name Recurrent Primary Vitreoretinal DLBCL Name Refractory Nervous System Lymphoma Name Refractory Primary Vitreoretinal DLBCL
Downcase Name recurrent nervous system lymphoma Downcase Name recurrent primary vitreoretinal dlbcl Downcase Name refractory nervous system lymphoma Downcase Name refractory primary vitreoretinal dlbcl

Id Information

Sequence: 40106696 Sequence: 40106697 Sequence: 40106698
Id Source org_study_id Id Source secondary_id Id Source secondary_id
Id Value MC178A Id Value NCI-2018-03661 Id Value MC178A
Id Type Registry Identifier Id Type Other Identifier
Id Type Description CTRP (Clinical Trial Reporting Program) Id Type Description Mayo Clinic in Arizona

Countries

Sequence: 42509357
Name United States
Removed False

Design Groups

Sequence: 55521251
Group Type Experimental
Title Treatment (nivolumab and pomalidomide)
Description Patients receive nivolumab IV over 30 minutes on day 1 and pomalidomide PO on days 1-14. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity.

Interventions

Sequence: 52418956 Sequence: 52418957
Intervention Type Biological Intervention Type Drug
Name Nivolumab Name Pomalidomide
Description Given IV Description Given PO

Design Outcomes

Sequence: 177148513 Sequence: 177148514 Sequence: 177148515 Sequence: 177148516 Sequence: 177148517 Sequence: 177148518
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Maximum-tolerated dose (MTD) of pomalidomide Measure Incidence of adverse events Measure Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment Measure Overall response rate (ORR) Measure Progression-free survival (PFS) Measure Incidence of adverse events
Time Frame Up to 28 days Time Frame Up to 12 weeks following end of treatment. Time Frame Up to 12 weeks following end of treatment Time Frame Up to 4 years Time Frame From registration to progression or death due to primary central nervous system lymphoma (PCNSL) or primary vitreoretinal lymphoma (PVRL), assessed up to 4 years Time Frame Up to 12 weeks following treatment
Description The MTD in this study will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). Description Will be evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number and severity of all adverse events will be tabulated and summarized in this patient population both overall and by dose level. The grade 3+ adverse events will also be described and summarized in a similar fashion. Description The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. Description Will be estimated by the number of patients with an objective status of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. Description Will be estimated using the method of Kaplan-Meier. Description Will be assessed by CTCAE version 5.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

Browse Conditions

Sequence: 193226354 Sequence: 193226355 Sequence: 193226356 Sequence: 193226357 Sequence: 193226358 Sequence: 193226359 Sequence: 193226360 Sequence: 193226361 Sequence: 193226362 Sequence: 193226363
Mesh Term Lymphoma Mesh Term Recurrence Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Lymphoproliferative Disorders Mesh Term Lymphatic Diseases Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term lymphoma Downcase Mesh Term recurrence Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term lymphatic diseases Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48258571 Sequence: 48258572
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Mayo Clinic Name National Cancer Institute (NCI)

Overall Officials

Sequence: 29247342
Role Principal Investigator
Name Han Tun
Affiliation Mayo Clinic

Design Group Interventions

Sequence: 68060901 Sequence: 68060902
Design Group Id 55521251 Design Group Id 55521251
Intervention Id 52418956 Intervention Id 52418957

Eligibilities

Sequence: 30727490
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Patient must have one of the following:

Relapsed or refractory primary central nervous system (CNS) diffuse large B cell lymphoma (PCNSDLBCL) with a brain lesion >= 1 cm, or with cerebrospinal fluid (CSF) relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy

NOTE: Tissue biopsy is not absolutely necessary for brain tumor unless clinical and radiologic findings strongly suggest other etiologies as per treating physician. Initial diagnosis must be made by tissue biopsy OR

Relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma (DLBCL) with a CNS lesion >= 1 cm, or with CSF relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy. Relapsed PVRL must have progressed or failed at least one systemic regimen

NOTE: Intraocular treatments are not regarded as systemic therapy
NOTE: If recurrence in ocular or leptomeningeal space, the patient will need a positive ocular tissue biopsy and CSF biopsy. Tissue biopsy requirement of the CNS lesion is as outlined in bullet above
Patient progressed after or did not respond to at least 1 line of systemic therapy (e.g., high-dose methotrexate, high-dose methotrexate based regimen, high dose cytarabine, etc)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3
Absolute neutrophil count (ANC) >= 1500/mm^3 (within =< 14 days prior to registration)
Platelet count >= 100,000/mm^3 (within =< 14 days prior to registration)
Hemoglobin >= 9.0 g/dL (within =< 14 days prior to registration)
Direct bilirubin < 1.5 x upper limit of normal (ULN) (or total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert?s Syndrome) (within =< 14 days prior to registration)
Aspartate transaminase (AST) =< 3 x ULN (within =< 14 days prior to registration)
Creatinine =< 1.5 x ULN OR calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula (within =< 14 days prior to registration)
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of anticoagulants (within =< 14 days prior to registration)

Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/ml, =< 14 days prior to registration and within 24 hours of starting pomalidomide. In addition, must either commit to continue abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. WOCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a WOCBP even if they have had a vasectomy. In addition, women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of nivolumab. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of nivolumab. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure

A woman of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Able to take aspirin (81 or 325 mg) daily or an anticoagulant (as determined by treating physician) as prophylactic anticoagulation
Provide written informed consent
Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Willingness to undergo biopsy procedures, if deemed necessary by treating physician
Willing to be registered into a mandatory POMALYST REMS program, and willing and able to comply with the requirements of the POMALYST REMS program

Exclusion Criteria:

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)

Other active malignancy =< 3 years prior to registration

EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
NOTE: If there is a history of prior malignancy, they must not have received immune checkpoint inhibitors or immunomodulatory therapy (IMiD) for their cancer
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

Use of corticosteroid in the absence of cerebral edema

NOTE: If a corticosteroid is used, it should be used at the lowest dose possible for the shortest possible duration. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of treatment assignment are excluded
EXCEPTIONS: Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
Therapy with myelosuppressive chemotherapy or biologic therapy =< 21 days prior to registration with incomplete recovery of blood counts
Persistent toxicities >= grade 3 from prior chemotherapy or biological therapy regardless of interval since last treatment
History of thromboembolic episodes =< 3 months prior to registration

Active hepatitis B or C with uncontrolled disease

NOTE: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B core IgM antibody (HBcIgM Ab), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV) Ab screen (Scrn) w/Reflex testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV infection
Inability to swallow or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) that would preclude use of oral medications
Major surgery =< 4 weeks prior to registration or have not recovered from side effects of such therapy
New York Heart Association classification III or IV

Patient received radiation alone previously

NOTE: Radiation therapy would not be regarded as a systemic therapy
EXCEPTION: Patients who have received systemic therapy followed by radiation would be eligible
PCNSL with systemic disease
Inability to undergo or have a magnetic resonance imaging (MRI) performed

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253979906
Number Of Facilities 2
Registered In Calendar Year 2019
Actual Duration 23
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30473917
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26635870 Sequence: 26635871 Sequence: 26635872 Sequence: 26635873 Sequence: 26635874 Sequence: 26635875 Sequence: 26635876 Sequence: 26635877 Sequence: 26635878 Sequence: 26635879
Intervention Id 52418956 Intervention Id 52418956 Intervention Id 52418956 Intervention Id 52418956 Intervention Id 52418956 Intervention Id 52418957 Intervention Id 52418957 Intervention Id 52418957 Intervention Id 52418957 Intervention Id 52418957
Name BMS-936558 Name MDX-1106 Name NIVO Name ONO-4538 Name Opdivo Name 4-Aminothalidomide Name Actimid Name CC-4047 Name Imnovid Name Pomalyst

Responsible Parties

Sequence: 28840337
Responsible Party Type Sponsor

]]>

<![CDATA[ Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells ]]>
https://zephyrnet.com/NCT03798301
2020-02-06

https://zephyrnet.com/?p=NCT03798301
NCT03798301https://www.clinicaltrials.gov/study/NCT03798301?tab=tableCancer Connectclinicaltrials@cancer.wisc.edu800-622-8922The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections.

The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).

Participants will be followed for one year.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-01-31
Start Month Year February 6, 2020
Primary Completion Month Year September 2025
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-01-31

Facilities

Sequence: 200615769
Status Recruiting
Name University of Wisconsin Carbone Cancer Center
City Madison
State Wisconsin
Zip 53705
Country United States

Facility Contacts

Sequence: 28187139
Facility Id 200615769
Contact Type primary
Name Jenny Weiland
Email jlweiland@pediatrics.wisc.edu
Phone 608-890-8070

Facility Investigators

Sequence: 18380300
Facility Id 200615769
Role Principal Investigator
Name Kenneth DeSantes, MD

Conditions

Sequence: 52327634 Sequence: 52327635 Sequence: 52327636 Sequence: 52327637
Name CMV Infection Name Cytomegalovirus Infections Name CMV Viremia Name Opportunistic Infections
Downcase Name cmv infection Downcase Name cytomegalovirus infections Downcase Name cmv viremia Downcase Name opportunistic infections

Id Information

Sequence: 40270580 Sequence: 40270581 Sequence: 40270582 Sequence: 40270583 Sequence: 40270584 Sequence: 40270585
Id Source org_study_id Id Source secondary_id Id Source secondary_id Id Source secondary_id Id Source secondary_id Id Source secondary_id
Id Value UW18073 Id Value 2018-1278 Id Value NCI-2019-00245 Id Value A536755 Id Value SMPHPEDIATRICSHEM-ONCOL Id Value Protocol Version: 7/15/2022
Id Type Other Identifier Id Type Registry Identifier Id Type Other Identifier Id Type Other Identifier Id Type Other Identifier
Id Type Description Institutional Review Board Id Type Description NCI CTRP Id Type Description UW Madison Id Type Description UW Madison Id Type Description UW Madison

Countries

Sequence: 42690596
Name United States
Removed False

Design Groups

Sequence: 55767382
Group Type Experimental
Title Treatment Arm
Description Suspension of CMV-specific T-cells in 10 mL of 0.9% NaCl with 2% HSA. Single dose max. 25,000 T cells/kg body weight (BW) of the recipient delivered via IV bolus injection.

Interventions

Sequence: 52638665
Intervention Type Biological
Name CMV-specific T-cells
Description Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMVspecific CD4+ and CD8+ T-cells

Keywords

Sequence: 80084263 Sequence: 80084264 Sequence: 80084265 Sequence: 80084266
Name Immunocompromised Name Allogeneic Stem Cell Transplantation Name Hematopoietic stem cell transplantation (HSCT) Name T-cell
Downcase Name immunocompromised Downcase Name allogeneic stem cell transplantation Downcase Name hematopoietic stem cell transplantation (hsct) Downcase Name t-cell

Design Outcomes

Sequence: 177957408 Sequence: 177957409 Sequence: 177957410 Sequence: 177957411 Sequence: 177957412 Sequence: 177957413 Sequence: 177957414 Sequence: 177957415 Sequence: 177957416 Sequence: 177957417 Sequence: 177957418 Sequence: 177957419 Sequence: 177957420 Sequence: 177957421 Sequence: 177957422 Sequence: 177957423
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer Measure Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST Measure Feasibility: Successful production of CMV-VST from donors Measure Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion Measure Safety: Number of Subjects who experience newly occurring acute GVHD grade 1 Measure Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD Measure Safety: Number of subjects experiencing chronic GVHD Measure The number of severe infusion-related adverse events or severe non-hematological adverse events Measure Safety: Time to Occurrence of GVHD Measure Efficacy: Percentage of Participants with a ≥1 log decrease in CMV viral load Measure Efficacy: Time to ≥1 log change in viral load Measure Efficacy: Number of Participants with CMV Clearance Measure Efficacy: Time to CMV Clearance Measure Efficacy: Number of Participants with Reduction or Clearance of Clinical Symptoms Measure Efficacy: Number of CMV Reactivations Following Initial Viral Clearance Measure Efficacy: Overall Survival
Time Frame up to 21 days from enrollement Time Frame up to 21 days from enrollment Time Frame up to 21 weeks from enrollment Time Frame up to 4 hours after CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 28 days from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 12 weeks from CMV-VST infusion Time Frame up to 52 weeks from CMV-VST infusion Time Frame up to 52 weeks
Description The feasibility of this intervention will in part be accomplished by measuring the number of dropped out participants before T-Cell Transfer. Description The feasibility of this intervention will in part be accomplished by measuring the amount of time from participant enrollment to administration of Cytomegalovirus-Viral Specific T-Cells (CMV-VST). Description The feasibility of this intervention will be assessed by quantifying the number of successful productions of Cytomegalovirus-Viral Specific T-Cells (CMV-VST) on an intent to treat basis. Description Incidence assessed by monitoring vital signs and specific adverse events Description Incidence of subjects who experience newly occurring acute GVHD grade 1 Description Incidence of newly occurring acute GVHD grade ≥ 2 or increase in grade of pre-existing acute GVHD Description Incidence of chronic GVHD Description Incidence of infusion-related adverse events ≥ grade 3 and non-hematological adverse events ≥ grade 4 after CMV-VST, which are not due to pre-existing infection or original malignancy or pre-existing condition Description Time to occurrence of acute GVHD of any grade or to occurrence of chronic GVHD will be evaluated using the Kaplan-Meier method to assess incidence and severity of acute or chronic GVHD from day of T-cell transfer. The first day of GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that GVHD grade, acute or chronic. Overall cumulative incidence curves will be computed along with the 95% confidence intervals until Week 12 after T-cell transfer with death considered as a competing risk. Description Evaluation of efficacy will in part be measured by percentage of participants with a ≥1 log decrease in CMV viral load at Week 12. Description Evaluation of efficacy will in part be measured by time to ≥1 log change in viral load in days. Description Evaluation of efficacy will in part be measured by the number of patients with CMV clearance, defined as negative Polymerase Chain Reaction (PCR) from Day 7 to Week 12 after T-cell transfer. Description Evaluation of efficacy will in part be measured by the time to CMV clearance (defined as negative PCR) from Day 0 to first day of two subsequent negative CMV PCR studies. Description Evaluation of efficacy will in part be measured by the number of participants with reduction or clearance of clinical symptoms of underlying CMV infection from Day 7 to Week 12 after T-cell transfer as compared to Day 0. Description Evaluation of efficacy will in part be measured by the number of CMV reactivations following initial viral clearance until Week 52. Description Evaluation of efficacy will in part be measured by the overall survival. Overall survival rate (OS): time from T-cell transfer (Day 0) to death or last follow-up throughout the study from Day 1 to Week 52.

Browse Conditions

Sequence: 194082368 Sequence: 194082369 Sequence: 194082370 Sequence: 194082371 Sequence: 194082372 Sequence: 194082373 Sequence: 194082374 Sequence: 194082375 Sequence: 194082376 Sequence: 194082377 Sequence: 194082378 Sequence: 194082379 Sequence: 194082380
Mesh Term Infections Mesh Term Communicable Diseases Mesh Term Cytomegalovirus Infections Mesh Term Opportunistic Infections Mesh Term Viremia Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Herpesviridae Infections Mesh Term DNA Virus Infections Mesh Term Virus Diseases Mesh Term Sepsis Mesh Term Systemic Inflammatory Response Syndrome Mesh Term Inflammation
Downcase Mesh Term infections Downcase Mesh Term communicable diseases Downcase Mesh Term cytomegalovirus infections Downcase Mesh Term opportunistic infections Downcase Mesh Term viremia Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term herpesviridae infections Downcase Mesh Term dna virus infections Downcase Mesh Term virus diseases Downcase Mesh Term sepsis Downcase Mesh Term systemic inflammatory response syndrome Downcase Mesh Term inflammation
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48465786 Sequence: 48465787
Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Wisconsin, Madison Name University of Wisconsin Carbone Cancer Center (UWCCC)

Overall Officials

Sequence: 29368470 Sequence: 29368471
Role Principal Investigator Role Study Director
Name Kenneth DeSantes, MD Name Jacques Galipeau, MD
Affiliation University of Wisconsin, Madison Affiliation University of Wisconsin, Madison

Central Contacts

Sequence: 12048021
Contact Type primary
Name Cancer Connect
Phone 800-622-8922
Email clinicaltrials@cancer.wisc.edu
Role Contact

Design Group Interventions

Sequence: 68360812
Design Group Id 55767382
Intervention Id 52638665

Eligibilities

Sequence: 30855937
Gender All
Minimum Age 1 Month
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Adult or pediatric patient suffering from CMV reactivation/infections following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).

CMV reactivation/viremia defined as positive (>500 copies/ml) CMV qPCR and/or
Presence of symptoms secondary to CMV infection or evidence of invasive CMV infection (e.g. pneumonitis, colitis) AND

Patients must have ONE OF THE FOLLOWING CRITERIA:

Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold), or
New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or
Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet, or
Known resistance to ganciclovir and/or foscarnet based on molecular testing.
Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time of T-cell transfer.
Written informed consent given by patient or legal representative.
Minimum patient age 1 month.
Minimum weight 7 lbs.
Female patients of childbearing age with negative pregnancy tests.
Patient Karnofsky/Lansky Performance Status >30%.
Donor eligible based on FACT infectious screening requirements.

Exclusion Criteria:

Patient with acute GVHD > grade 2 or active moderate or severe chronic GVHD at time of T-cell transfer
Patient receiving steroids (>1.0 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer
Patient received allogeneic HSCT less than 28 days prior to T-cell transfer
Patient treated with donor lymphocyte infusion (DLI) within 28 days prior to T-cell transfer
Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days.
Patient with organ dysfunction or failure as determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% (Appendix 5)
Patients with CMV retinitis
Concomitant enrollment in another clinical trial with endpoints interfering with this study
Any medical condition which could compromise participation in the study according to the investigator's assessment
Known HIV infection
Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control during study treatment. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry.
Patients unwilling or unable to comply with the protocol or unable to give informed consent.

Donor Eligibility:

The original donor will be the first choice as source of T cells. If the original donor is not available for donation (such as NMDP donor, cord blood unit, or related donor not available) of peripheral mononuclear cells or does not meet all donor eligibility criteria (including donor selection criteria based on University of Wisconsin – Madison Standard Operating Procedures for the selection of allogeneic donors), alternative related donors will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (≥ 3/6 HLA loci).

All donors must be ≥ 18 years old, available, CMV IgG positive, eligible and capable of undergoing a single standard 2 blood volume leukapheresis. If original HSCT donor is not available, CMV IgG negative or ineligible, a CMV IgG positive fully matched or haploidentical family donor will be used.
Related donors must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this).
Donors must be CMV IgG seropositive.
Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator Peptide Pools of CMV pp65 before undergoing leukapheresis.
Donor must meet the criteria for donor selection defined in the Standard Operating Procedures of the University of Wisconsin Hospitals and Clinics Stem Cell Transplant Program and in FACT standards.

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254312639
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 1
Minimum Age Unit Month
Number Of Primary Outcomes To Measure 9
Number Of Secondary Outcomes To Measure 7

Designs

Sequence: 30601778
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description single-center, open-label, single-arm, pilot study

Links

Sequence: 4400263
Url https://cancer.wisc.edu/
Description University of Wisconsin Carbone Cancer Center

Responsible Parties

Sequence: 28968291
Responsible Party Type Sponsor

]]>

<![CDATA[ Randomised Controlled Trial for the selfBACK Project ]]>
https://zephyrnet.com/NCT03798288
2019-03-08

https://zephyrnet.com/?p=NCT03798288
NCT03798288https://www.clinicaltrials.gov/study/NCT03798288?tab=tableNANANAThe intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-02-17
Start Month Year March 8, 2019
Primary Completion Month Year May 6, 2020
Verification Month Year February 2023
Verification Date 2023-02-28
Last Update Posted Date 2023-02-17

Detailed Descriptions

Sequence: 20702262
Description The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain.

The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants.

The weekly plan includes three categories of content;

information/education
recommended daily number of steps
recommended strength and flexibility exercises

Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.

Facilities

Sequence: 199852480 Sequence: 199852481
Name Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark Name Norwegian University of Science and Technology
City Odense City Trondheim
Zip 5230
Country Denmark Country Norway

Conditions

Sequence: 52117974
Name Low Back Pain
Downcase Name low back pain

Id Information

Sequence: 40117742
Id Source org_study_id
Id Value 18/17955CDJ

Countries

Sequence: 42521789 Sequence: 42521790
Name Denmark Name Norway
Removed False Removed False

Design Groups

Sequence: 55536107 Sequence: 55536108
Group Type Experimental Group Type Active Comparator
Title Usual care + selfBACK Title Usual care
Description The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants.

The weekly plan includes three categories of content;

information/education
recommended daily number of steps
recommended strength and flexibility exercises

Description Any diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal.

Interventions

Sequence: 52433102 Sequence: 52433103
Intervention Type Behavioral Intervention Type Other
Name selfBACK Name Usual care
Description Participants will use the selfBACK system and app in addition to receiving usual care Description Participants will receive usual care

Keywords

Sequence: 79786498 Sequence: 79786499 Sequence: 79786500
Name Digital Decision Support System Name App Name Self-management
Downcase Name digital decision support system Downcase Name app Downcase Name self-management

Design Outcomes

Sequence: 177192240 Sequence: 177192231 Sequence: 177192232 Sequence: 177192233 Sequence: 177192234 Sequence: 177192235 Sequence: 177192236 Sequence: 177192237 Sequence: 177192238 Sequence: 177192239 Sequence: 177192241 Sequence: 177192242 Sequence: 177192243 Sequence: 177192244 Sequence: 177192245 Sequence: 177192246 Sequence: 177192247 Sequence: 177192248 Sequence: 177192249 Sequence: 177192250
Outcome Type other Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other Outcome Type other
Measure Activity limitation Measure Roland Morris Disability Questionnaire Measure Pain Self-Efficacy Questionnaire Measure The Fear Avoidance Belief Questionnaire Measure Pain intensity Measure Brief Illness Perception Questionnaire Measure Saltin-Grimby Physical Activity Level Scale Measure Patients Global Perceived Effect Measure Workability Measure Health-related Quality of Life Measure Sleep Measure Perceived Stress Scale Measure Patient Health Questionnaire-8 Measure Patient Specific Functional Scale Measure Pain duration and frequency Measure Virtual Care Climate Questionnaire Measure User ratings Measure Tailoring variables Measure Physical activity Measure Exercise volume
Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame change from baseline to 3 months Time Frame 4 months Time Frame 4 months Time Frame weekly for 9 months Time Frame weekly for 9 months Time Frame weekly for 9 months
Description Activity Limitation evaluates if LBP has limited work and leisure time activities. The questionnaire consists of two single items with response options "yes" and "no". Description The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering "yes" or "no" to a series of descriptions of functional abilities with higher scores indicating higher level of disability. Description The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain. The PSEQ is a 10-item questionnaire scored on an ordinal scale ranging from zero [completely disagree] to six [completely agree]. Description The FABQ is a 5-item questionnaire, where the participants score their beliefs about their LBP on an ordinal scale ranging from zero [completely disagree] to six [completely agree] Description Pain intensity measured as average and worst LBP within the past week. Measured on a 0 – 10 Numerical Rating Scale with 0 being no pain and 10 being worst pain imaginable. Description The questionnaire evaluates the participants' illness perception in an 8-item questionnaire. Items are scored on an ordinal scale ranging from zero [no problems] to 10 [worst severity]. Description Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active Description A single item question for Patient's Global Perceived Effect will be asked at follow-up, where participants are asked to rate improvement or deterioration of their LBP compared to before the intervention Description Workability is measured by a single-item and rated on an 11-point NRS scale ranging from zero [completely unable to work] to 10 [work ability at its best]. Description The EuroQoL 5-dimension (EQ-5D) questionnaire is used to asses quality of life within each of the five dimension (i.e., mobility, self-care, activities, pain/discomfort and anxiety/depression). Description Sleep is assessed by self-report using four items concerning problems with falling asleep, waking up repeatedly, waking up too early, and feeling sleepy during the day. Description a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress Description the questionnaire is an 8-item questionnaire used to evaluate the participants' depressive symptoms. Items are scored on a 4-point Likert scale scoring frequency of experiencing symptoms of depression. Description Participants rate their function on up to two self-selected activities, are asked to rate if they are unable to do or are having difficulty with the their ability to perform self-selected activities regarded as important by the participants themselves Description Pain duration measures patients' self-reported length of current pain episode. Pain medication measures the frequency of the non-prescription pain medication use for LBP. Description The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting. Description Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system Description Participants in the intervention are on a weekly basis asked a set of tailoring questions. These are tracked over the intervention period. The tailoring questions include items on lob back pain (NRS for pain intensity), function, fear-avoidance, workability, sleep, pain self-efficacy, stress, symptoms of depression, and barriers for self-management.

Note. not all questions are asked on a weekly basis

Description The patients' weekly recommended step count goal, and the actual achieved step count per. day Description The patients report back their completed exercise volume as number of sets and repetitions for their suggested exercises, when they perform them

Browse Conditions

Sequence: 193280414 Sequence: 193280415 Sequence: 193280416 Sequence: 193280417
Mesh Term Back Pain Mesh Term Low Back Pain Mesh Term Pain Mesh Term Neurologic Manifestations
Downcase Mesh Term back pain Downcase Mesh Term low back pain Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48271093 Sequence: 48271094 Sequence: 48271095 Sequence: 48271096 Sequence: 48271097
Agency Class OTHER Agency Class OTHER Agency Class OTHER_GOV Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name University of Southern Denmark Name Norwegian University of Science and Technology Name National Research Centre for the Working Environment, Denmark Name University of Glasgow Name Robert Gordon University

Overall Officials

Sequence: 29255396
Role Principal Investigator
Name Karen Søgaard, PhD
Affiliation University of Southern Denmark

Design Group Interventions

Sequence: 68079195 Sequence: 68079196 Sequence: 68079197
Design Group Id 55536107 Design Group Id 55536108 Design Group Id 55536107
Intervention Id 52433102 Intervention Id 52433103 Intervention Id 52433103

Eligibilities

Sequence: 30735430
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks
LBP of any duration
Mild-to severe pain-related disability rated as 6 or above on the Roland Morris Disability Questionnaire
Age: ≥18 years
Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data)
Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser.

Exclusion Criteria:

Not interested,
Unable to speak, read or understand the national language (Danish/ Norwegian),
Cognitive impairments or learning disabilities limiting participation,
Mental or physical illness or condition limiting participation,
Inability to take part in exercise/physical activity,
Fibromyalgia (diagnosed by a health care professional),
Pregnancy,
Previous back surgery
Ongoing participation in other research trials for LBP management.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254014477
Number Of Facilities 2
Registered In Calendar Year 2019
Actual Duration 14
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6
Number Of Other Outcomes To Measure 13

Designs

Sequence: 30481790
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Masking Description The analysis of the data will be performed blindly.
Intervention Model Description The study design is a multi-center randomised controlled trial with 2 parallel arms
Investigator Masked True

Links

Sequence: 4383456
Url http://www.selfback.eu
Description project webpage

Provided Documents

Sequence: 2576398 Sequence: 2576399
Document Type Study Protocol Document Type Statistical Analysis Plan
Has Protocol True Has Protocol False
Has Icf False Has Icf False
Has Sap False Has Sap True
Document Date 2019-02-20 Document Date 2023-02-08
Url https://ClinicalTrials.gov/ProvidedDocs/88/NCT03798288/Prot_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/88/NCT03798288/SAP_002.pdf

Responsible Parties

Sequence: 28848140
Responsible Party Type Sponsor

Study References

Sequence: 52012667 Sequence: 52012668 Sequence: 52012669 Sequence: 52012670 Sequence: 52012671
Pmid 30030208 Pmid 35130898 Pmid 34338710 Pmid 33118959 Pmid 31793897
Reference Type background Reference Type derived Reference Type derived Reference Type derived Reference Type derived
Citation Mork PJ, Bach K; selfBACK Consortium. A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project. JMIR Res Protoc. 2018 Jul 20;7(7):e167. doi: 10.2196/resprot.9379. Erratum In: JMIR Res Protoc. 2019 Jan 03;8(1):e12180. Citation Overas CK, Nilsen TIL, Nicholl BI, Rughani G, Wood K, Sogaard K, Mair FS, Hartvigsen J. Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. BMC Med. 2022 Feb 8;20(1):53. doi: 10.1186/s12916-022-02237-z. Citation Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097. Citation Rasmussen CDN, Svendsen MJ, Wood K, Nicholl BI, Mair FS, Sandal LF, Mork PJ, Sogaard K, Bach K, Stochkendahl MJ. App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation. JMIR Res Protoc. 2020 Oct 29;9(10):e20308. doi: 10.2196/20308. Citation Sandal LF, Stochkendahl MJ, Svendsen MJ, Wood K, Overas CK, Nordstoga AL, Villumsen M, Rasmussen CDN, Nicholl B, Cooper K, Kjaer P, Mair FS, Sjogaard G, Nilsen TIL, Hartvigsen J, Bach K, Mork PJ, Sogaard K. An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e14720. doi: 10.2196/14720.

]]>

<![CDATA[ Coffee Consumption and Pregnancy ]]>
https://zephyrnet.com/NCT03798275
2018-01-01

https://zephyrnet.com/?p=NCT03798275
NCT03798275https://www.clinicaltrials.gov/study/NCT03798275?tab=tableNANANACoffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood flow and amniotic fluid index (AFI) in the third trimester of pregnancy
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year January 1, 2018
Primary Completion Month Year August 1, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-09

Detailed Descriptions

Sequence: 20741194
Description This cross-sectional study occurred in a tertiary center with volunteer pregnant women who agreed to drink coffee. In healthy pregnant women with isolated borderline oligohydramnios, AFI and fetal renal artery blood flow indices were evaluated before and after coffee consumption. Sixty three patients for the borderline oligohydramnios group (the study group) were included in this study. These patients were compared with 63 healthy pregnant women who had normal amniotic fluid volume (the control group)

Facilities

Sequence: 200280620
Name Yusuf Madendağ
City Kayseri̇
Zip 38090
Country Turkey

Conditions

Sequence: 52221576 Sequence: 52221577
Name Coffee Name Pregnancy
Downcase Name coffee Downcase Name pregnancy

Id Information

Sequence: 40195661
Id Source org_study_id
Id Value 2017/489

Countries

Sequence: 42609681
Name Turkey
Removed False

Design Groups

Sequence: 55649866 Sequence: 55649867
Group Type Active Comparator Group Type No Intervention
Title the study group Title the control group
Description healthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee Description healthy pregnant women with normal amniotic volume

Interventions

Sequence: 52535386
Intervention Type Dietary Supplement
Name coffee
Description 2 g Nescafe Clasico contains approximately 65 mg caffeine

Keywords

Sequence: 79941819 Sequence: 79941820 Sequence: 79941821 Sequence: 79941822
Name amniotic fluid index Name caffeine Name coffee Name oligohydramnios
Downcase Name amniotic fluid index Downcase Name caffeine Downcase Name coffee Downcase Name oligohydramnios

Design Outcomes

Sequence: 177561649 Sequence: 177561650
Outcome Type primary Outcome Type primary
Measure amniotic fluid index Measure fetal renal artery doppler indices
Time Frame two hours Time Frame two hours

Sponsors

Sequence: 48366472
Agency Class OTHER_GOV
Lead Or Collaborator lead
Name Kayseri Education and Research Hospital

Overall Officials

Sequence: 29312940
Role Principal Investigator
Name YUSUF MADENDAĞ
Affiliation Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi

Design Group Interventions

Sequence: 68217463
Design Group Id 55649866
Intervention Id 52535386

Eligibilities

Sequence: 30794739
Gender Female
Minimum Age 18 Years
Maximum Age 35 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations

Exclusion Criteria:

abnormal amniotic fluid volume (AFV), any intake of nutrient or fluid within the 4 hours previous to ultrasonographic examination [10], abnormal Doppler blood flow, hypertension, preeclampsia, chromosomal anomaly, intrauterine growth restriction, fetal anomaly, collagen vascular disease, ruptured fetal membranes, and multiple pregnancies.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254004377
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 7
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 35
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30540779
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Triple
Subject Masked True
Caregiver Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28907099
Responsible Party Type Principal Investigator
Name Yusuf MADENDAG
Title obstetrics and gynecology
Affiliation Kayseri Education and Research Hospital

]]>

<![CDATA[ Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects ]]>
https://zephyrnet.com/NCT03798262
2017-02-16

https://zephyrnet.com/?p=NCT03798262
NCT03798262https://www.clinicaltrials.gov/study/NCT03798262?tab=tableNANANAThe investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms and gut peptide levels in healthy volunteers (HV).
<![CDATA[

Studies

Study First Submitted Date 2018-10-11
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year February 16, 2017
Primary Completion Month Year April 2, 2018
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-09

Facilities

Sequence: 199965058 Sequence: 199965059
Name Jan Tack Name TARGID
City Leuven City Leuven
Zip 3000 Zip 3000
Country Belgium Country Belgium

Conditions

Sequence: 52138988
Name Healthy Volunteers, Gluten
Downcase Name healthy volunteers, gluten

Id Information

Sequence: 40135053
Id Source org_study_id
Id Value S58915

Countries

Sequence: 42542678
Name Belgium
Removed False

Design Groups

Sequence: 55559324 Sequence: 55559325
Group Type Active Comparator Group Type Placebo Comparator
Title Gluten Title Placebo
Description Patients receive 16 g of gluten acutely and afterwards 2 glutenfree muffins with 8 g of gluten for 5 days sub-acutely Description Patients receive 16 g of whey protein acutely and afterwards 2 glutenfree muffins for 5 days sub-acutely

Interventions

Sequence: 52454893 Sequence: 52454894
Intervention Type Other Intervention Type Other
Name Gluten Name Placebo
Description Tereos Description Whey protein from Nestlé Healthy Science

Design Outcomes

Sequence: 177263589 Sequence: 177263590 Sequence: 177263591 Sequence: 177263592 Sequence: 177263593 Sequence: 177263594 Sequence: 177263595 Sequence: 177263596 Sequence: 177263597
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Positive and Negative Affect Schedule Measure The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Profile of Mood State. Measure The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in HV measured on the visual analogue scale for gastrointestinal symptoms Measure The effect of gluten acutely and sub-acutely on intestinal permeability (using the lactulose mannitol ratio) Measure Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in blood samples Measure Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in blood samples Measure Effect of acute and sub-acute gluten administration on Lipopolysaccharide levels in blood samples Measure Effect of acute and sub-acute gluten administration on gut microbiota composition (stool samples) Measure Effect of acute and sub-acute gluten administration on cortisol awakening response (saliva samples)
Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 36), after test visit 4 (at day 41) Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 36), after test visit 4 (at day 41) Time Frame During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Time Frame During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Time Frame During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Time Frame After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40 Time Frame Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41)
Description Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely'. Measured at day 0, day 15, day 20, day 36 and day 41. Description Change from baseline. Scores are measured on the Visual Analogue Scale. The scale is ranged 0 – 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 20, day 36 and day 41. Description Scores are measured on the Visual Analogue Scale. With '0' no complaints and '10' a lot of complaints (change from baseline). Description Investigate change in intestinal permeability after gluten administration. In the urine we can measure the ratio lactulose/mannitol. This can be measured using High Performance Liquid Chromatography Description Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41. Description Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41. Description Change in lipopolysaccharide levels measured at day 0, day 21 and day 41. Description Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli; measured in stool samples. Analyses will provide an overall view of the gut microbiota composition. Description Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.

Sponsors

Sequence: 48290697
Agency Class OTHER
Lead Or Collaborator lead
Name Universitaire Ziekenhuizen KU Leuven

Design Group Interventions

Sequence: 68107433 Sequence: 68107434
Design Group Id 55559324 Design Group Id 55559325
Intervention Id 52454893 Intervention Id 52454894

Eligibilities

Sequence: 30747713
Gender All
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Body Mass Index (BMI) of 20 – 25 kg/m2
Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

Medical

Coeliac disease (excluded either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten containing diet in individuals expressing the HLA-DQ2 (human leukocyte antigen) or HLA-DQ8 haplotype)
Abdominal or thoracic surgery. Exception: appendectomy
Gastrointestinal, endocrine or neurological diseases
Cardiovascular, respiratory, renal or urinary diseases
Hypertension
Diagnosed food or drug allergies
Psychiatric disorders
Eating disorders
Depressive disorders
Anxiety disorders
Psychotic disorders
Restraint or emotional eating
Dieters, especially no gluten-free diet or a diet low on gluten
Medication on a regular basis, exception: oral contraception
Smoking
History of cannabis use or any other drug of abuse for at least 12 months prior to the study
Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
Pregnant or breastfeeding women

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254121841
Number Of Facilities 2
Registered In Calendar Year 2018
Actual Duration 13
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 7

Designs

Sequence: 30493996
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking Single
Intervention Model Description single-blinded, randomised controlled, cross-over study
Subject Masked True

Responsible Parties

Sequence: 28860276
Responsible Party Type Principal Investigator
Name Prof Dr Jan Tack
Title Principal Investigator
Affiliation Universitaire Ziekenhuizen KU Leuven

]]>

<![CDATA[ Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity ]]>
https://zephyrnet.com/NCT03798249
2017-05-11

https://zephyrnet.com/?p=NCT03798249
NCT03798249https://www.clinicaltrials.gov/study/NCT03798249?tab=tableNANANAThe investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in NCGS patients.
<![CDATA[

Studies

Study First Submitted Date 2018-10-11
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year May 11, 2017
Primary Completion Month Year January 2022
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-09

Facilities

Sequence: 200159095 Sequence: 200159096
Status Recruiting Status Recruiting
Name TARGID Name Jan Tack
City Leuven City Leuven
State Vlaams-Brabant
Zip 3000
Country Belgium Country Belgium

Facility Contacts

Sequence: 28113712 Sequence: 28113713
Facility Id 200159095 Facility Id 200159096
Contact Type primary Contact Type primary
Name Annelies Geeraerts Name Jan Tack
Email Annelies.Geeraerts@kuleuven.be Email jan.tack@med.kuleuven.be
Phone 016377034 Phone 498797124

Conditions

Sequence: 52185410 Sequence: 52185411
Name NCGS Name Gluten
Downcase Name ncgs Downcase Name gluten

Id Information

Sequence: 40169012
Id Source org_study_id
Id Value S60127

Countries

Sequence: 42580614
Name Belgium
Removed False

Design Groups

Sequence: 55609033 Sequence: 55609034
Group Type Active Comparator Group Type Placebo Comparator
Title Gluten Title Placebo
Description Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days Description Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days

Interventions

Sequence: 52499351 Sequence: 52499352
Intervention Type Other Intervention Type Other
Name Gluten Name Placebo
Description Tereos Description Nestlé Health Science

Design Outcomes

Sequence: 177431775 Sequence: 177431776 Sequence: 177431777 Sequence: 177431778 Sequence: 177431779 Sequence: 177431780 Sequence: 177431781 Sequence: 177431782 Sequence: 177431783
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule Measure The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State Measure The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms Measure Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio) Measure Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample Measure Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample Measure Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample Measure Effect of acute and sub-acute gluten administration on gut microbiota composition Measure Effect of acute and sub-acute gluten administration on cortisol awakening response
Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) Time Frame At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) Time Frame During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Time Frame During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Time Frame During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Time Frame After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40 Time Frame Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41)
Description Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely' Description Scores are measured on the Visual Analogue Scale. Change from baseline. The scale is ranged 0 – 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 21, day 36 and day 41. Description With '0' no complaints and '10' a lot of complaints (change from baseline). Measured on the Visual Analogue Scale. Measured at day 0, day 15, day 21, day 36 and day 41. Description Change in intestinal permeability after gluten administration. In the urine we can measure the ratio lactulose/mannitol. This can be measured using High Performance Liquid Chromatography at day 0, day 15, day 21, day 36 and day 41. Description Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41 Description Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41 Description Change in lipopolysaccharide levels measured at day 0, day 21 and day 41 Description Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli (stool samples) Description Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.

Browse Conditions

Sequence: 193539810 Sequence: 193539811
Mesh Term Hypersensitivity Mesh Term Immune System Diseases
Downcase Mesh Term hypersensitivity Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48332246
Agency Class OTHER
Lead Or Collaborator lead
Name Universitaire Ziekenhuizen KU Leuven

Design Group Interventions

Sequence: 68168081 Sequence: 68168082
Design Group Id 55609033 Design Group Id 55609034
Intervention Id 52499351 Intervention Id 52499352

Eligibilities

Sequence: 30773531
Gender All
Minimum Age 18 Years
Maximum Age 60 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Non-coeliac gluten sensitivity patients

Previous symptoms of IBS fulfilling Rome III criteria that self reportedly improved with a gluten-free diet
Symptoms currently well controlled on a gluten-free diet
Adherence to the gluten-free diet for at least 6 weeks prior to recruitment
Coeliac disease excluded (either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten-containing diet in individuals expressing the HLA-DQ2 or HLA-DQ8 haplotype)
IgA anti-tissue-transglutaminase or IgG anti-deaminated gliadin peptide positive
Body Mass Index (BMI) of 20 – 25 kg/m2
Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

Medical

Coeliac disease
Abdominal or thoracic surgery. Exception: appendectomy
Gastrointestinal, endocrine or neurological diseases
Cardiovascular, respiratory, renal or urinary diseases
Hypertension
Food or drug allergies

Psychiatric disorders

Eating disorders
Depressive disorders
Anxiety disorders
Psychotic disorders
Restraint or emotional eating
Medication on a regular basis, exception: oral contraception
History of cannabis use or any other drug of abuse for at least 12 months prior to the study
Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
Pregnant or breastfeeding women

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 253952546
Number Of Facilities 2
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 60
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 7

Designs

Sequence: 30519662
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Diagnostic
Time Perspective
Masking Single
Intervention Model Description single-blinded, randomised – controlled, crossover
Subject Masked True

Responsible Parties

Sequence: 28885963
Responsible Party Type Principal Investigator
Name Prof Dr Jan Tack
Title Principal Investigator
Affiliation Universitaire Ziekenhuizen KU Leuven

]]>

<![CDATA[ Study to Assess the Safety and Tolerability of PBF-1650 in Healthy Volunteers. ]]>
https://zephyrnet.com/NCT03798236
2018-12-10

https://zephyrnet.com/?p=NCT03798236
NCT03798236https://www.clinicaltrials.gov/study/NCT03798236?tab=tableNANANASingle center, randomized, double-blind, placebo-controlled clinical study to assess the safety and tolerability of PBF-1650 in order to obtain the Maximum Tolerated Dose (MTD).
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2020-06-30
Start Month Year December 10, 2018
Primary Completion Month Year March 30, 2019
Verification Month Year June 2020
Verification Date 2020-06-30
Last Update Posted Date 2020-06-30

Detailed Descriptions

Sequence: 20716280
Description The clinical trial will be a dose escalation study without therapeutic benefit, in which PBF-1650 will be administered as single oral ascending- dose to healthy young male volunteers. Up to four different rising doses will be tested (40 mg, 80 mg, 120 and 240 mg) in groups/cohorts of 8 participants. Thus, four groups/cohorts will participate. For each dose level / group, the participants will be randomized to active or placebo with 2 participants being randomly assigned to placebo and 6 to the active drug. First, one volunteer will receive active drug (subgroup 1); after at least 48h of safety and tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after at least another 48h of safety and tolerability parameters assessment a third subgroup of 4 volunteers will receive 3 active drug and 1 placebo. After evaluation of safety parameters of corresponding dose level, the process will replicate one week afterwards in the following dosages.

The pharmacokinetics profile of PBF-1650 after single oral dose administration of the four dose levels will be also assessed.

Facilities

Sequence: 200053186
Name Clinica Universidad de Navarra
City Pamplona
State Navarra
Zip 31007
Country Spain

Conditions

Sequence: 52156426
Name Psoriasis
Downcase Name psoriasis

Id Information

Sequence: 40148180
Id Source org_study_id
Id Value PBF-1650CT-01

Countries

Sequence: 42557700
Name Spain
Removed False

Design Groups

Sequence: 55577860 Sequence: 55577861 Sequence: 55577862 Sequence: 55577863 Sequence: 55577864
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Placebo Comparator
Title PBF-1650 40mg Title PBF-1650 80mg Title PBF-1650 120mg Title PBF-1650 240mg Title Placebo

Interventions

Sequence: 52471963 Sequence: 52471964
Intervention Type Drug Intervention Type Drug
Name PBF-1650 oral capsules Name Placebo oral capsule
Description Adenosine A3 receptor (AA3R) antagonist Description solid microcrystalline cellulose

Keywords

Sequence: 79848016 Sequence: 79848017 Sequence: 79848018
Name Adenosine A3 receptor antagonist Name autoimmune diseases Name Immune modulator
Downcase Name adenosine a3 receptor antagonist Downcase Name autoimmune diseases Downcase Name immune modulator

Design Outcomes

Sequence: 177327742
Outcome Type primary
Measure Number of Adverse events
Time Frame 7 Days
Description Adverse Events will be qualified according to the definitions and values stated in CTCAE V04 v4)

Browse Conditions

Sequence: 193431915 Sequence: 193431916 Sequence: 193431917
Mesh Term Psoriasis Mesh Term Skin Diseases, Papulosquamous Mesh Term Skin Diseases
Downcase Mesh Term psoriasis Downcase Mesh Term skin diseases, papulosquamous Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48306010 Sequence: 48306011
Agency Class INDUSTRY Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Palobiofarma SL Name Clínica Universidad de Navarra

Design Group Interventions

Sequence: 68130811 Sequence: 68130812 Sequence: 68130813 Sequence: 68130814 Sequence: 68130815
Design Group Id 55577862 Design Group Id 55577863 Design Group Id 55577860 Design Group Id 55577861 Design Group Id 55577864
Intervention Id 52471963 Intervention Id 52471963 Intervention Id 52471963 Intervention Id 52471963 Intervention Id 52471964

Eligibilities

Sequence: 30757328
Gender Male
Minimum Age 18 Years
Maximum Age 45 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Healthy male subjects, 18-45 years (inclusive) of age at the time of enrollment.
Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner use some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.
Clinically acceptable blood pressure and pulse rate in supine and standing position (SBP between 140-100 mm Hg/ DBP between 90-50 mm Hg / HR between 100-50 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
Body weight within normal range (Quetelet's index between 19 and 26) expressed as weight (kg) / height (m2).
Able to understand the nature of the study and comply with all their requirements.
Free acceptance to participate in the study by obtains signed informed consent form approved by the Ethics Committee (CEIm).

Exclusion Criteria:

History of serious adverse reactions or hypersensitivity to any drug.
Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
Background or clinical evidence of chronic diseases.
Acute illness two weeks before drug administration.
Having undergone major surgery during the previous 6 months.
Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication).
History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 g or high consumption of stimulating beverages (> 5 coffees, teas or coca cola drinks/ day).
Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
Need of any prescription medication within 14 days prior to the administration of the investigational drug and non-prescription medication or herbal medicines within 7 days prior to the administration of the drug. Paracetamol (acetaminophen) is allowed, at doses up to 1 g daily, at the investigator discretion.
Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested.
Having donated blood during 3 months' period before inclusion in the study.
Existence of any surgical or medical condition which might interfere with the absortion, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract
12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradychardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
Symptoms of a significant somatic or mental illness in the four-week period preceding drug administration.
History of hepatitis HBV and / or HCV and / or positive serology results, which indicate the presence of hepatitis B surface antigen and / or detectable HCV ribonucleic acid (RNA).
Positive results from the HIV serology.
Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation.
Positive results of the drugs at screening period or the day before starting treatment period. A minimum list of 6 drugs will be screened for inclusion: Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the Principal Investigator).
Known hypersensitivity to the study drug or the composition of the galenical form.
History of psychiatric diseases or epileptic seizures.
Pill swallowing difficulties.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254224849
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 3
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 45
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30503553
Allocation Randomized
Intervention Model Sequential Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Intervention Model Description Single center, randomized, double-blind, placebo-controlled clinical study.
Subject Masked True
Investigator Masked True

Responsible Parties

Sequence: 28869831
Responsible Party Type Sponsor

]]>

<![CDATA[ Optimal Treatment Protocol for Selective Laser Trabeculoplasty ]]>
https://zephyrnet.com/NCT03798223
2019-01-10

https://zephyrnet.com/?p=NCT03798223
NCT03798223https://www.clinicaltrials.gov/study/NCT03798223?tab=tableNANANAA randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-03-07
Start Month Year January 10, 2019
Primary Completion Month Year May 31, 2025
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-03-07

Detailed Descriptions

Sequence: 20662749
Description A randomized controlled trial in which individuals scheduled for SLT are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use.

Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mJ) below the microbubble formation limit ("low" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the patient and is coded in the records.

The results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort.

Facilities

Sequence: 199443235 Sequence: 199443236 Sequence: 199443237 Sequence: 199443238
Name Ogonkliniken, Sodra Alvsborgs Sjukhus Name Ogonkliniken, Sahlgrenska Universitetssjukhuset Name Ogonkliniken, Skaraborgs Sjukhus Name Ogonkliniken NU-sjukvarden
City Boras City Molndal City Skovde City Uddevalla
State Vastra Gotaland State Vastra Gotaland State Vastra Gotaland State Vastra Gotaland
Zip 50182 Zip 43130 Zip 54142 Zip 45153
Country Sweden Country Sweden Country Sweden Country Sweden

Conditions

Sequence: 52017646 Sequence: 52017647 Sequence: 52017648
Name Glaucoma, Open-Angle Name Pseudoexfoliation Glaucoma Name Ocular Hypertension
Downcase Name glaucoma, open-angle Downcase Name pseudoexfoliation glaucoma Downcase Name ocular hypertension

Id Information

Sequence: 40038230 Sequence: 40038231
Id Source org_study_id Id Source secondary_id
Id Value Optimal SLT Id Value 254861
Id Type Other Identifier
Id Type Description FoU i VGR ID nr

Countries

Sequence: 42434532
Name Sweden
Removed False

Design Groups

Sequence: 55424238 Sequence: 55424239 Sequence: 55424240 Sequence: 55424241
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title 180/low Title 180/high Title 360/low Title 360/high
Description SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles. Description SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects. Description SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles. Description SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.

Interventions

Sequence: 52329996
Intervention Type Procedure
Name SLT
Description A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).

Keywords

Sequence: 79621519
Name Selective Laser Trabeculoplasty
Downcase Name selective laser trabeculoplasty

Design Outcomes

Sequence: 176844688 Sequence: 176844689 Sequence: 176844690 Sequence: 176844691 Sequence: 176844692 Sequence: 176844693 Sequence: 176844694 Sequence: 176844695 Sequence: 176844696 Sequence: 176844697 Sequence: 176844698
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in intraocular pressure (IOP) Measure Achievement of 20% reduction in IOP Measure Survival (no additional intervention) Measure Survival (SLT allowed) Measure Pain perioperatively: on a scale Measure Pain postoperatively: on a scale Measure Light sensitivity postoperatively Measure Impairment of vision postoperatively Measure Redness postoperatively Measure Flare (inflammation measurement of the anterior chamber) Measure Adverse events
Time Frame Before SLT and thereafter regularly for 3 years Time Frame For 3 years Time Frame For 3 years Time Frame For 3 years Time Frame Immediately after treatment Time Frame During the first month Time Frame During the first month Time Frame During the first month Time Frame During the first month Time Frame Pre-operatively and then one day, one week and one month post-operatively. Time Frame 3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks).
Description The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures.

Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.

Description See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group. Description Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser). Description See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure. Description The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol. Description The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain. Description The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity. Description The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment. Description The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness. Description 15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter. Description The type and frequency of adverse events will be recorded and analyzed in each of the study arms.

Browse Conditions

Sequence: 192877654 Sequence: 192877655 Sequence: 192877656 Sequence: 192877657 Sequence: 192877658 Sequence: 192877659 Sequence: 192877660
Mesh Term Glaucoma Mesh Term Ocular Hypertension Mesh Term Glaucoma, Open-Angle Mesh Term Exfoliation Syndrome Mesh Term Eye Diseases Mesh Term Iris Diseases Mesh Term Uveal Diseases
Downcase Mesh Term glaucoma Downcase Mesh Term ocular hypertension Downcase Mesh Term glaucoma, open-angle Downcase Mesh Term exfoliation syndrome Downcase Mesh Term eye diseases Downcase Mesh Term iris diseases Downcase Mesh Term uveal diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48176014 Sequence: 48176015
Agency Class OTHER_GOV Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Vastra Gotaland Region Name Göteborg University

Overall Officials

Sequence: 29196897 Sequence: 29196898
Role Study Chair Role Principal Investigator
Name Marcelo Ayala, MD, PhD Name Tobias Dahlgren, MD
Affiliation Vastra Gotaland Region Affiliation Vastra Gotaland Region

Design Group Interventions

Sequence: 67943650 Sequence: 67943651 Sequence: 67943652 Sequence: 67943653
Design Group Id 55424239 Design Group Id 55424238 Design Group Id 55424241 Design Group Id 55424240
Intervention Id 52329996 Intervention Id 52329996 Intervention Id 52329996 Intervention Id 52329996

Eligibilities

Sequence: 30675398
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension.
intra-ocular pressure (IOP) at least 18 mmHg treatment day.
treatment is performed by an experienced laser surgeon.
SLT treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient.

Exclusion Criteria:

change of IOP-lowering medication during the last three months.
planned change of intra-ocular-pressure-lowering medication.
previous glaucoma surgery (other than SLT and ALT)
previous intra-ocular surgery during the last three months.
previous intra-ocular inflammatory disease during the last year.
planned intra-ocular surgery.
hyper-pigmented anterior chamber angle.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253866424
Number Of Facilities 4
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 8

Designs

Sequence: 30422156
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description The treatment protocol is masked for the patient and for the nurses conducting measures of intraocular pressure during follow-up.
Subject Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28788683
Responsible Party Type Sponsor

]]>

<![CDATA[ Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis ]]>
https://zephyrnet.com/NCT03798210
2017-01-01

https://zephyrnet.com/?p=NCT03798210
NCT03798210https://www.clinicaltrials.gov/study/NCT03798210?tab=tablePeter Benno, MD, PhDpeter.benno@endoskopienheten.se+46 70 579554Explorative investigation to study the effect of the endogenous bacterium Lactobacillus reuteri ATCC PTA 4659 as a nutrient additive against relapse in ulcerative colitis. Forty patients will be studied with a randomized parallel design over one year. Patients with established treatment against relapse of ulcerative colitis with mesalazine ≤4 grams will be requested to participate in the study, allocated to 20 patients with placebo and 20 with active treatment L. reuteri as an “add-on”. Inklusion: 18-80 years of age, ≥1 relapse with bleeding during previous 12 months with a disease activity Mayo Clinical Score ≤2, treatment with mesalazine ≤4,0 g daily. Exklusion: >80 years of age, no registered bleeding during recent 12 months, on-going steroid treatment, immunosuppressives, biologics or adhesion inhibitors, antibiotics or other clinical trial. behandling med probiotika. Disease monitoring will be done with:

Time to disease relapse with macroscopic bleeding and Mayo score ≥5, blood chemistry and CRP, lipopolysaccharides and gut permeability, fecal calprotectin, and short health scale at 4 weeks, 26 weeks and 52 weeks.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-14
Start Month Year January 1, 2017
Primary Completion Month Year January 31, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-14

Detailed Descriptions

Sequence: 20721652
Description Research question To study whether dietary supplementation with L. reuteri ATCC PTA 4659 (Lr4659) is safe and can reduce the relapse rate and have a positive effect in patients with ulcerative colitis (UC).

Lr4659 is a naturally occurring strain of human origin. It is a typical member of the L. reuteri species, with typical sugar fermentation patterns, reuterin production and growth characteristics. Identification using 16SrRNA gene analysis shows that it has 99% similarity with the type strain of L. reuteri thus confirming that it belongs to this well-known and well-studied species that is considered safe for human consumption. In vitro studies indicate that this strain has strong tolerance to acid environments, as do many other L. reuteri strains and that it has the unusual ability to interfere with TNFalpha mediated propagation of inflammatory responses in human macrophages.

Treatment with the probiotic bacterium L. reuteri has been shown to prevent dextran sodium sulfate (DSS)-induced colitis in rats. During DSS-induced colitis, the number of bacteria in the inner firmly-adherent mucus layer increased and bacterial composition of the two layers no longer differed. However, L. reuteri decreased the bacterial translocation from the intestine to mesenteric lymph nodes during DSS treatment, which might be an important part of the mechanisms by which L. reuteri ameliorates DSS-induced colitis in rats.

Study design This is a double-blind randomized clinical trial. Randomization will be done to either mesalazine plus Lr4659, or to mesalazine plus placebo for a continuous treatment until new bleeding episode or a maximum of 52 weeks.

Forty patients with UC in remission, medicated with <4 g mesalazine and aged over 18 years will be recruited. After written consent to the study the subjects in whom the eligibility criteria are confirmed the subjects will be randomized to receive either 2 daily doses of Lr4659 (n=15) or the corresponding placebo. The total length of study treatment is 52 weeks.

Concomitant treatment During the period of the study, the subjects will refrain from ingestion of any kind of probiotic or bacterial preparation.

The objective is to determine whether dietary supplementation with Lr4659 is able to: Prolong time in remission and Time from last bleeding episode until re-bleeding, Time from start of study treatment until re-bleeding, Reduce Mayo score reduction by at least 50%, Reduce f-calprotectin, Reduce recovered sucralose in the sucralose gut permeability test, Reduce zonulin expression from gut mucosa, Impact microflora composition

Study Product and Dosage Lr4659, consisting of L. reuteri ATCC PTA 4659 will be delivered at a dose of 5×108 colony forming units (CFU) as a powder in capsules. One dose is to be taken in the morning and one in the evening yielding a total daily dose of 1×109 CFU/day. Placebo capsules are identical to Lr4659 except for the active ingredient. The study products will be taken daily throughout the entire 52-week study-period.

Inclusion criteria for study: UC confirmed by biopsy, Mayo full score < 2, Total or left-sided UC, Stable diagnose of UC >1 year, History of more than 1 yearly recurrence, Current remission period exceeding 2 months, 18-80 years of age, Baseline 5-ASA ≤4g daily, Mentally fit to participate, Informed consent obtained Exclusion criteria: Crohn's disease, Ulcerative proctitis, Infective colitis, Liver disease, Current use of probiotics, Current medication acetylsalicylic acid (ASA), non-steroidal antiinflammatory drugs (NSAID), corticosteroids, anticoagulants, serotonin-selective re-uptake inhibitors (SSRI), serotonin-noradrenaline re-uptake inhibitors (SNRI), azathioprine (AZA), 6-mercaptopurin (6-MP), thioguanin (TG), anti-TNF-alpha biologicals, Participation in other clinical trials

Analyses Evaluation of the clinical Mayo score will be done by ocular inspection and immediate recording in the CRF.

C-reactive protein (CRP) will be locally analysed according to clinical routine by Department of clinical chemistry, Uppsala University Hospital.

Fecal calprotectin will be analysed according to local routines (Bühlmann, Schönenbuch, Switzerland) by Department of clinical chemistry, Uppsala University Hospital).

"Gut" permeability focuses on colonic permeability as studied with recovery of different sugar components in the urine. 24-hour urine will be analysed by an in-house high performance liquid chromatography (HPLC) method by GastroLab, Uppsala University Hospital.

Fecal microbiology, alfa-diversity, beta-diversity

Expected findings: Prolonged interval to next flare of UC with rectal bleeding. Reduced calprotectin and CRP levels.

Facilities

Sequence: 200108214
Status Recruiting
Name Uppsala University
City Uppsala
Zip 75185
Country Sweden

Facility Contacts

Sequence: 28106424 Sequence: 28106425
Facility Id 200108214 Facility Id 200108214
Contact Type primary Contact Type backup
Name Per M Hellström, Prof Name Peter Benno, MD, PhD
Email per.hellstrom@medsci.uu.se Email peter.benno@endoskopienheten.se
Phone +46 70 3727423 Phone +46 70 5795554

Conditions

Sequence: 52171269
Name Ulcerative Colitis Flare
Downcase Name ulcerative colitis flare

Id Information

Sequence: 40158659
Id Source org_study_id
Id Value ATCC PTA 4659

Countries

Sequence: 42568963
Name Sweden
Removed False

Design Groups

Sequence: 55593208 Sequence: 55593209
Group Type Placebo Comparator Group Type Experimental
Title Placebo Title Lactobacillus reuter's
Description Look and taste-alike placebo tablets in white plastic vials. Description Lactobacillus reuteri tablets in white plastic vials.

Interventions

Sequence: 52485512 Sequence: 52485513
Intervention Type Dietary Supplement Intervention Type Dietary Supplement
Name Lactobacillus reuteri Name Placebo
Description Study group split in two arms for experimental treatment with Lactobacillus reuteri or placebo. Description Placebo

Keywords

Sequence: 79868590 Sequence: 79868591 Sequence: 79868592 Sequence: 79868593
Name ulcerative colitis Name prevention Name microbiota Name Lactobacillus
Downcase Name ulcerative colitis Downcase Name prevention Downcase Name microbiota Downcase Name lactobacillus

Design Outcomes

Sequence: 177378982 Sequence: 177378983 Sequence: 177378984 Sequence: 177378985 Sequence: 177378986
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other
Measure Rectal bleeding with Mayo score ≥5 Measure Increased fecal calprotectin Measure Increased CRP Measure Serum Zonulin Measure Gut permeability
Time Frame 12 months Time Frame 12 months Time Frame 12 months Time Frame 12 months Time Frame 12 months
Description Rectal bleeding as sign of increased inflammatory activity as determined by the Mayor Clinic Score for evaluation of disease activity in ulcerative colitis Description Gut inflammatory biomarker Description General inflammatory biomarker Description Gut permeability biomarker Description Recovery of sugar molecules in urine as marker of increased permeability

Browse Conditions

Sequence: 193486859 Sequence: 193486860 Sequence: 193486861 Sequence: 193486862 Sequence: 193486863 Sequence: 193486864 Sequence: 193486865 Sequence: 193486866 Sequence: 193486867 Sequence: 193486868
Mesh Term Colitis Mesh Term Colitis, Ulcerative Mesh Term Ulcer Mesh Term Gastroenteritis Mesh Term Gastrointestinal Diseases Mesh Term Digestive System Diseases Mesh Term Colonic Diseases Mesh Term Intestinal Diseases Mesh Term Pathologic Processes Mesh Term Inflammatory Bowel Diseases
Downcase Mesh Term colitis Downcase Mesh Term colitis, ulcerative Downcase Mesh Term ulcer Downcase Mesh Term gastroenteritis Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term digestive system diseases Downcase Mesh Term colonic diseases Downcase Mesh Term intestinal diseases Downcase Mesh Term pathologic processes Downcase Mesh Term inflammatory bowel diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319321
Agency Class OTHER
Lead Or Collaborator lead
Name Uppsala University

Overall Officials

Sequence: 29285368
Role Principal Investigator
Name Per M Hellström, Prof
Affiliation Uppsala University

Central Contacts

Sequence: 12008884 Sequence: 12008885
Contact Type primary Contact Type backup
Name Per M Hellström, Prof Name Peter Benno, MD, PhD
Phone +46 70 3727423 Phone +46 70 579554
Email per.hellstrom@medsci.uu.se Email peter.benno@endoskopienheten.se
Role Contact Role Contact

Design Group Interventions

Sequence: 68149165 Sequence: 68149166
Design Group Id 55593209 Design Group Id 55593208
Intervention Id 52485512 Intervention Id 52485513

Eligibilities

Sequence: 30765372
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Diagnosis of UC confirmed by biopsy
Mayo full score < 2
Total or left-sided UC
Stable diagnose of UC >1 year
History of more than 1 yearly recurrence
Current remission period exceeding 2 months
18-75 years of age
Baseline 5-ASA ≤2g daily
Mentally fit to participate
Informed consent obtained

Exclusion Criteria:

Crohn's disease
Ulcerative proctitis
Infective colitis
Liver disease
Current use of probiotics
Current medication acetylsalicylic acid (ASA), non-steroidal antiinflammatory drugs (NSAID), corticosteroids, anticoagulants, serotonin-selective re-uptake inhibitors (SSRI), serotonin-noradrenaline re-uptake inhibitors (SNRI), azathioprine (AZA), 6-mercaptopurin (6-MP), thioguanin (TG), anti-TNF-alpha biologicals
Participation in other clinical trials

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253884848
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2
Number Of Other Outcomes To Measure 2

Designs

Sequence: 30511538
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Triple
Masking Description Pre-masked randomized tablet vials with Lactobacillus reuteri, or corresponding placebo
Intervention Model Description Lactobacillus reuteri versus placebo on prevention of flare in ulcerative colitis/proctosgmoiditis
Subject Masked True
Caregiver Masked True
Investigator Masked True

Responsible Parties

Sequence: 28877833
Responsible Party Type Principal Investigator
Name Per Hellström
Title Prof, MD, PhD
Affiliation Uppsala University

]]>

<![CDATA[ Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers ]]>
https://zephyrnet.com/NCT03798197
2019-01-30

https://zephyrnet.com/?p=NCT03798197
NCT03798197https://www.clinicaltrials.gov/study/NCT03798197?tab=tableNANANAAssessment of the effect of a high fat meal on the quantity in blood of a female sex hormone called estetrol (E4).

The study also aims at determining how subject tolerate the study drug and how safe it is for them.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-05-07
Start Month Year January 30, 2019
Primary Completion Month Year April 6, 2019
Verification Month Year May 2019
Verification Date 2019-05-31
Last Update Posted Date 2019-05-07

Facilities

Sequence: 200280653
Name MC Comac Medical Ltd.
City Sofia
Country Bulgaria

Conditions

Sequence: 52221608
Name Food-effect
Downcase Name food-effect

Id Information

Sequence: 40195680 Sequence: 40195681
Id Source org_study_id Id Source secondary_id
Id Value MIT-Do001-C101 Id Value 2018-003761-34
Id Type EudraCT Number

Countries

Sequence: 42609695
Name Bulgaria
Removed False

Design Groups

Sequence: 55649890 Sequence: 55649891
Group Type Active Comparator Group Type Experimental
Title 30 mg estetrol (E4) without food (fasted) Title 30 mg estetrol (E4) with food (fed)
Description Treatment A (reference): One 30 mg E4 tablet administered orally following an overnight fast of at least 10 hours. Description Treatment B (test): One 30 mg E4 tablet administered orally 30 min after the start of an FDA prescribed high-fat breakfast preceded by at least a 10 hours overnight fast.

Interventions

Sequence: 52535421
Intervention Type Drug
Name 30 mg estetrol (E4)
Description All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or at the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (sequence AB), or Treatment B followed by Treatment A (sequence BA).

Keywords

Sequence: 79941864 Sequence: 79941865
Name Estetrol Name Menopausal hormone therapy
Downcase Name estetrol Downcase Name menopausal hormone therapy

Design Outcomes

Sequence: 177561776 Sequence: 177561777 Sequence: 177561778 Sequence: 177561779 Sequence: 177561780 Sequence: 177561781 Sequence: 177561782
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Maximum concentration (Cmax) of Estetrol in plasma Measure Area under the curve (AUC) from time zero to the last determinable concentration of Estetrol Measure AUC0-inf of Estetrol Measure Time of Cmax (Tmax) Measure Terminal phase rate constant (ke) Measure Terminal half-life (t1/2) Measure Number of subjects with adverse events as measure of safety and tolerability
Time Frame Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose Time Frame Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose Time Frame Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose Time Frame Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose Time Frame Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose Time Frame Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose Time Frame From Day 28 prior screening to end of study (Day 4 of Period 2)
Description PK sampling Description PK sampling Description PK sampling Description PK sampling Description PK sampling Description PK sampling

Sponsors

Sequence: 48366492
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Donesta Bioscience

Overall Officials

Sequence: 29312953
Role Principal Investigator
Name Dobrin Svinarov, MD
Affiliation MC Comac Medical Ltd.

Design Group Interventions

Sequence: 68217502 Sequence: 68217503
Design Group Id 55649891 Design Group Id 55649890
Intervention Id 52535421 Intervention Id 52535421

Eligibilities

Sequence: 30794756
Gender Female
Minimum Age 40 Years
Maximum Age 65 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Overtly healthy postmenopausal females as determined by medical history, physical examination including breast examination, gynecological examination, cervical smear (Pap smear) if subject has cervix, vital signs, and laboratory tests performed within 28 days before first study drug intake.
Between the ages of 40 and 65 years inclusive at the time of signing the informed consent (IC).
Between the Body Mass Index (BMI) of 18 and 30 kg/m2 inclusive and body weight ≥ 45 kg.
For non-hysterectomized women: intact uterus with bi-layer endometrial thickness ≤ 5 mm on transvaginal ultrasound (TVUS).
Non-smokers.
Negative test results for selected drugs of abuse and cotinine.
Venous access sufficient to allow blood sampling as per the protocol.
Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
Subject has provided signed and dated written IC before participation in the study.

Exclusion Criteria:

For non-hysterectomized women: uterine disease or medical condition including:

Bi-layer endometrial thickness >5mm as determined by TVUS;
Presence of fibroid(s) that obscure(s) evaluation of endometrium by TVUS;
History or presence of uterine cancer;
Presence of any significant uterine, ovarian or other adnexa related abnormality as determined by TVUS;
Presence of an endometrial polyp.
Undiagnosed vaginal bleeding in the last 12 months.
Any history of malignancy.
History of venous or arterial thromboembolic disease
Abnormal blood pressure.

Use of :

Any prescription drugs within 28 days prior to the first study dose administration.
Any over-the-counter (OTC) medication or dietary supplements (vitamins included) within 14 days prior to the first study dose administration.
Users of progestin implants or oestrogen alone injectable drug therapy are not allowed to participate unless treatment was stopped more than 3 months prior to screening.
Users of oestrogen pellet or progestin injectable drug therapy are not allowed to participate unless treatment was stopped more than 6 months prior to screening.
Subjects who are not in euthyroid condition.
History of hypersensitivity or existing contraindication to E4 or intolerance to any component of the formulations or test meal.
Presence or history of gallbladder disease, unless cholecystectomy has been performed.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
History or presence of immunodeficiency diseases including a positive human immunodeficiency virus (HIV) test result, positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.
History of illicit drug or alcohol abuse within 12 months prior to first study dose or evidence of such abuse as indicated by laboratory values within 28 days prior to first study dose.
Consumption of foods or beverages containing the following products during the specified timeframes prior to study drug administration in Period 1: caffeine or xanthine – 48 hours; alcohol – 48 hours; grapefruit/seville orange/citrus fruit and/or star fruit – 7 days. Others Fruit juices: 72 hours prior to study drug administration.

Donation or loss of

≥ 450 mL blood within 1 month prior to initial study drug administration.
≥ 250 mL blood within 2 weeks prior to initial study drug administration.
Sponsor, Contract Research Organization (CRO) or Investigator's site personnel or their relatives directly affiliated with this study.
History or presence of clinically relevant disease of any major system organ class (SOC) (e.g. cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological, neurological, psychiatric or orthopedic disease) as judged by the Investigator.
Previous completion or withdrawal from this study.
Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to study entry.
Is judged by the Investigator to be unsuitable for any reason.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004400
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 2
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 40
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30540796
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26696967
Intervention Id 52535421
Name 30 mg E4 tablet

Responsible Parties

Sequence: 28907116
Responsible Party Type Sponsor

]]>

<![CDATA[ Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch Mode With or Without Bioglass ]]>
https://zephyrnet.com/NCT03798184
2018-11-19

https://zephyrnet.com/?p=NCT03798184
NCT03798184https://www.clinicaltrials.gov/study/NCT03798184?tab=tableNANANAComposite restoration of non-carious cervical lesions has always been a challenge for the clinician, considering that the most frequent cause of failure is retention loss.

Adhesion of composite restoration may be obtained by following four different etching techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols. With the introduction of universal adhesives such as Prime&Bond Active (Dentsply Sirona) it is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching technique with orthophosphoric acid.

On the other hand, there has been an increase in the awareness of the importance of remaining dental tissue preservation, avoiding preparation of a cavity. This is why it is now preferable to use bioactive glass in order to increase micromechanical retention on the dental surface, instead of the classical approach of preparing the surface with burs.

To date, there are no studies evaluating the clinical performance of the universal adhesive Prime&Bond Active on direct resin composite restoration of non-carious cervical lesions neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate the retention rate of composite restorations using Prime&Bond Active and a previous sandblasted surface with bioglass in a three-year follow-up, as well as the presence of marginal discoloration, marginal integrity and marginal caries.
<![CDATA[

Studies

Study First Submitted Date 2018-11-18
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year November 19, 2018
Primary Completion Month Year November 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-09

Detailed Descriptions

Sequence: 20709987
Description The protocol to be followed in the study is as follows:

Obtention of a written informed consent of all participants.
Complete medical and dental clinical record.
Administration of anesthesia and absolute rubber dam isolation.
Cavity cleaning with a prophylactic brush and rubber cup with pumice.

Randomly assigning each non-carious cervical lesion to one of the four experimental groups:

5.1. Selective enamel etching and surface roughening with bioglass 5.2. Selective enamel etching without surface roughening. 5.3. Self-etch and surface roughening with bioglass. 5.4. Self-etch without surface roughening.

In experimental groups which need surface roughening (group 5.1 and 5.3), sandblasting with bioactive glass will be used in enamel.

In experimental groups with selective enamel etch (5.1 and 5.2), 37 % orthophosphoric acid is applied for 15 seconds in enamel, followed by profuse washing with air/water spray for ten seconds and dried using air for 10 seconds without desiccating dentin.

In groups 5.3 and 5.4 this step is omitted.

Application of universal adhesive Prime&Bond Active on enamel and dentin for 20 seconds. Subsequently, evaporation of the solvent is realized by applying air for 5 seconds and then light curing for 20 seconds.
Application of a "bulk fill" composite resin and light curing, following manufacturer's instructions.
Finishing and polishing of the restoration.
Monitoring and follow up: visits will be performed at six months, one year, two years and three years. In each evaluation, two independent clinicians who do not participate in the clinical procedures will evaluate each direct composite restoration according to USPHS criteria (Modified United States Public Health Service).

The primary objective is to evaluate the retention of the restoration. The secondary objectives are to evaluate marginal discoloration, marginal integrity and marginal caries.

Facilities

Sequence: 199965067
Name University of Valencia
City Valencia
Country Spain

Conditions

Sequence: 52138996 Sequence: 52138997 Sequence: 52138998 Sequence: 52138999 Sequence: 52139000 Sequence: 52139001
Name Self-etch Name Selective-etch Name Bioactive Glass Name Direct Resin Composite Restoration Name Non-carious Cervical Lesion Name Universal Adhesive
Downcase Name self-etch Downcase Name selective-etch Downcase Name bioactive glass Downcase Name direct resin composite restoration Downcase Name non-carious cervical lesion Downcase Name universal adhesive

Id Information

Sequence: 40135060
Id Source org_study_id
Id Value 2/2018

Countries

Sequence: 42542684
Name Spain
Removed False

Design Groups

Sequence: 55559338 Sequence: 55559339 Sequence: 55559340 Sequence: 55559341
Group Type Experimental Group Type Active Comparator Group Type Experimental Group Type Active Comparator
Title Selective-etch with bioglass surface roughening Title Selective-etch without bioglass surface roughening Title Self-etch with bioglass surface roughening Title Self-etch without bioglass surface roughening

Interventions

Sequence: 52454906
Intervention Type Procedure
Name Non-carious cervical lesion restoration
Description Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass

Keywords

Sequence: 79822811 Sequence: 79822812 Sequence: 79822813 Sequence: 79822814
Name Prime&Bond Active Name Bioactive glass Name non-carious cervical lesion Name direct resin composite
Downcase Name prime&bond active Downcase Name bioactive glass Downcase Name non-carious cervical lesion Downcase Name direct resin composite

Design Outcomes

Sequence: 177263626 Sequence: 177263627 Sequence: 177263628 Sequence: 177263629
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Retention rate Measure Marginal discoloration Measure Marginal integrity Measure Marginal caries
Time Frame Three years Time Frame Three years Time Frame Three years Time Frame Three years
Description Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination. Description Presence of marginal staining between the restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service) Description The quality of the interface between restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service) Description The presence of clinical diagnosis of caries will be evaluated following USPHS criteria (Modified United States Public Health Service)

Browse Conditions

Sequence: 193366504 Sequence: 193366505 Sequence: 193366506 Sequence: 193366507 Sequence: 193366508 Sequence: 193366509 Sequence: 193366510
Mesh Term Uterine Cervical Diseases Mesh Term Uterine Diseases Mesh Term Genital Diseases, Female Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Genital Diseases
Downcase Mesh Term uterine cervical diseases Downcase Mesh Term uterine diseases Downcase Mesh Term genital diseases, female Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term genital diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290704
Agency Class OTHER
Lead Or Collaborator lead
Name University of Valencia

Design Group Interventions

Sequence: 68107448 Sequence: 68107449 Sequence: 68107450 Sequence: 68107451
Design Group Id 55559338 Design Group Id 55559339 Design Group Id 55559340 Design Group Id 55559341
Intervention Id 52454906 Intervention Id 52454906 Intervention Id 52454906 Intervention Id 52454906

Eligibilities

Sequence: 30747720
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Patients ≥ 18 years without systemic disease.
Presence of a non-carious cervical lesion with a minimum of 1.5 mm in depth and extent to dentin.
Non-carious cervical lesions in premolars and molars.

Exclusion Criteria:

Presence of rampant caries or advanced periodontal disease.
Consumption of > 2 cigarette pack/ day.
Presence of severe xerostomia or bruxism.
Methacrylate allergy.
Pregnancy.

Teeth with pulpal and/or periapical pathology, and endodontically treated teeth are excluded from the study.

Teeth with previous pulp capping or previous class V restorations will also be excluded.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121848
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30494003
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Subject Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28860283
Responsible Party Type Principal Investigator
Name Cristina Pasarín Linares
Title Teaching Assistant
Affiliation University of Valencia

]]>

<![CDATA[ Reduction of Exit Site Infection in Peritoneal Dialysis Patients ]]>
https://zephyrnet.com/NCT03798171
2018-05-15

https://zephyrnet.com/?p=NCT03798171
NCT03798171https://www.clinicaltrials.gov/study/NCT03798171?tab=tableNANANAIn peritoneal dialysis patients, the presence of the catheter presents a risk of infection – exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit.

This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year May 15, 2018
Primary Completion Month Year May 15, 2021
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-09

Detailed Descriptions

Sequence: 20727156
Description Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange.

The presence of the catheter presents a risk of infection – exit site infection, tunnel infection or peritonitis – a cause of morbidity and treatment failure.

Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen.

This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze.

The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017).

Facilities

Sequence: 200159116
Status Recruiting
Name Tel Aviv Sourasky Medical Canter
City Tel Aviv
Country Israel

Facility Contacts

Sequence: 28113716
Facility Id 200159116
Contact Type primary
Name Orit Kliuk Ben Bassat, MD
Email oritkl@tlvmc.gov.il
Phone 97236973270

Conditions

Sequence: 52185425
Name Peritoneal Dialysis Catheter Infection
Downcase Name peritoneal dialysis catheter infection

Id Information

Sequence: 40169032
Id Source org_study_id
Id Value 0077-18-TLV

Countries

Sequence: 42580626
Name Israel
Removed False

Keywords

Sequence: 79888628 Sequence: 79888629 Sequence: 79888630 Sequence: 79888631
Name peritoneal dialysis Name exit site Name infection Name peritonitis
Downcase Name peritoneal dialysis Downcase Name exit site Downcase Name infection Downcase Name peritonitis

Design Outcomes

Sequence: 177431855 Sequence: 177431856
Outcome Type primary Outcome Type secondary
Measure exit-site infection rate Measure peritonitis rate
Time Frame 36 months Time Frame 36 months
Description number of exit-site infection during 3 years of follow up, compared to historical data Description number of peritonitis episodes during 3 years of follow up, compared to historical data

Browse Conditions

Sequence: 193539859 Sequence: 193539860 Sequence: 193539861 Sequence: 193539862
Mesh Term Infections Mesh Term Communicable Diseases Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term infections Downcase Mesh Term communicable diseases Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48332269
Agency Class OTHER_GOV
Lead Or Collaborator lead
Name Tel-Aviv Sourasky Medical Center

Eligibilities

Sequence: 30773543
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 99 Years
Healthy Volunteers No
Population peritoneal dialysis patients in Tel Aviv Sourasky medical center
Criteria Inclusion Criteria:

peritoneal dialysis patients capable to sign an informed consent or have an official guardian

Exclusion Criteria:

patient's refusal

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253952566
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30519674
Observational Model Case-Only
Time Perspective Prospective

Responsible Parties

Sequence: 28885975
Responsible Party Type Principal Investigator
Name michal roll
Title Department of nephrology
Affiliation Tel-Aviv Sourasky Medical Center

]]>

<![CDATA[ Prevalence and Characterization of Persistent Dyspnea After Hospitalization ]]>
https://zephyrnet.com/NCT03798158
2019-04-11

https://zephyrnet.com/?p=NCT03798158
NCT03798158https://www.clinicaltrials.gov/study/NCT03798158?tab=tableNANANAThe investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire.
<![CDATA[

Studies

Study First Submitted Date 2018-11-21
Study First Posted Date 2019-01-09
Last Update Posted Date 2021-07-23
Start Month Year April 11, 2019
Primary Completion Month Year April 30, 2025
Verification Month Year July 2021
Verification Date 2021-07-31
Last Update Posted Date 2021-07-23

Facilities

Sequence: 200053207
Status Recruiting
Name ADOREPS
City Paris
Zip 75013
Country France

Facility Contacts

Sequence: 28097502
Facility Id 200053207
Contact Type primary
Name Capucine MORELOT, MD,PhD
Email capucine.morelot@aphp.fr
Phone 01 42 16 77 71
Phone Extension 0033

Conditions

Sequence: 52156443 Sequence: 52156444
Name Dyspnea Name Pulmonary Disease
Downcase Name dyspnea Downcase Name pulmonary disease

Id Information

Sequence: 40148189
Id Source org_study_id
Id Value 2018-A02757-48

Countries

Sequence: 42557706
Name France
Removed False

Interventions

Sequence: 52471972
Intervention Type Other
Name Multidisciplinary Dyspnea Profile questionnaire
Description Multidisciplinary Dyspnea Profile questionnaire at the beginning and the end of an hospitalization

Design Outcomes

Sequence: 177327803 Sequence: 177327804 Sequence: 177327805
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease Measure Characterization of persistent dyspnea using MDP Measure Outcome of patients with persistent dyspnea after hospitalization
Time Frame An average of one week, until the end of the hospitalization Time Frame An average of one week, until the end of the hospitalization Time Frame 6 months
Description 6 months mortality, incidence of rehospitalization

Browse Conditions

Sequence: 193431946 Sequence: 193431947 Sequence: 193431948 Sequence: 193431949
Mesh Term Dyspnea Mesh Term Respiratory Tract Diseases Mesh Term Respiration Disorders Mesh Term Signs and Symptoms, Respiratory
Downcase Mesh Term dyspnea Downcase Mesh Term respiratory tract diseases Downcase Mesh Term respiration disorders Downcase Mesh Term signs and symptoms, respiratory
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48306027
Agency Class OTHER
Lead Or Collaborator lead
Name Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Eligibilities

Sequence: 30757334
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population Every consecutive patient admitted to hospitalization for a respiratory cause having a significant dyspnea
Criteria Inclusion Criteria:

Age over 18 years old
Able to respond the questionnaire
Presenting at admission a dyspnea over 3/10 on numerical analogic scale
Admitted for a respiratory cause

Exclusion Criteria:

cognitive impairment
aphasia
no french-speaking person

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254226515
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30503559
Observational Model Other
Time Perspective Prospective

Responsible Parties

Sequence: 28869837
Responsible Party Type Sponsor

]]>

<![CDATA[ Surgical Retinotomy for the Treatment of Glaucoma ]]>
https://zephyrnet.com/NCT03798145
2021-12-31

https://zephyrnet.com/?p=NCT03798145
NCT03798145https://www.clinicaltrials.gov/study/NCT03798145?tab=tableNANANAGlaucoma is a leading cause of blindness worldwide. It is caused by persistently elevated intraocular pressure causing progressive visual field loss. While a number of conventional medical and surgical therapies exist, a significant number of patients fail to respond resulting in persistently elevated intraocular pressure and eventual blindness. While outflow from the eye primarily occurs through the front of the eye, there is an often overlooked pathway to remove fluid that is beneath the retina. Surgical removal of retina to create paths for outflow (surgical retinotomy) in areas damaged by glaucoma can provide access to this alternative outflow pathway thereby reducing intraocular pressure and halting the vision loss.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2020-07-17
Start Month Year December 2021
Primary Completion Month Year December 2024
Verification Month Year July 2020
Verification Date 2020-07-31
Last Update Posted Date 2020-07-17

Detailed Descriptions

Sequence: 20735826
Description The goal of this study is to demonstrate that focal surgical retinotomies (holes in the retina) can result in predictable and lasting reduction in intraocular pressure while eliminating the risks associated with surgical retinectomy (broad areas of retinal removal).

In the late 1990s and early 2000s, Joussen et al pioneered a technique to lower intraocular pressure in patients with advanced untreatable glaucoma. All patients had intraocular pressures on average above 40 that were unresponsive to any available treatments. Forty-four patients underwent broad areas of retinal removal (retinectomy). All patients exhibited dramatic reductions in intraocular pressure which were maintained for 5 years (Joussen 2003). Unfortunately, the technique carried significant risks. 1) a subset of patients had excessively low intraocular pressure reductions. 2) a subset of patients had secondary proliferative vitreoretinopathy (a scarring response) that resulting in retinal deatchment. Despite its incredible effectiveness, these risks made clinicians hesitant to adopt the technique. Additionally, glaucoma specialists are unable to perform the technical procedures required creating a chasm between diagnosing physician (glaucoma specialist) and the treating physician (retina specialist). Finally, surgical microtools tools at the time were still in their infancy.

The current proposal attempts to make critical modifications to the technique used by Joussen et al. (2003). First and foremost, we plan to use surgical retinotomies (holes in the retina) in lieu of a broad surgical retinectomy (broad peripheral retinal removal). This is a critical difference. Removal of the peripheral retina to the ora serrata carries significant risk of postoperative proliferative vitreoretinopathy. This is largely due to residual vitreous which cannot be removed from the far peripheral retina. This residual vitreous contracts in the postoperative period causing elevation of the retinectomy edges allowing for retinal detachment. Surgical retinotomies (holes in the retina), that do not involve the vitreous base are commonly used in retina surgery and do not carry anywhere close to the risk of retinal detachment that surgical retinectomy carries. As an example, the majority of retinal detachments are repaired by draining fluid through an iatrogenic surgical retinotomy (a hole created by the surgeon in the retina). These holes are created in the posterior retina and yet are virtually always undetectable by the patient. (Of note, a peripheral retinotomy is even harder to detect). More recently, there has been an upsurge of free-flap autologous retinal transplantation for macular holes (Grewal 2016) and macular degeneration (Parolini 2018). In these surgical procedures, an area of peripheral retina is removed and transplanted to the macula. The site of removal leaves a hole in the retina. In these studies the rate of redetachment in patients in whom a retinotomy was created is no higher than that of other standard retina surgeries. It is therefore clear that creation of retinal holes (retinotomy) is far different in terms of long-term risks than broad retinal removal to the ora serrata (retinectomy). Additionally, this increase in retina transplantation has been made possible by the microsurgical surgical tools that are now available. However, in the case of both the retinal detachment repair and autologous transplantation, the retinotomy size is not sufficient to induce intraocular pressure lowering effects. We therefore seek to build upon the original work from Joussen et al (2003) which showed that retina removal can have dramatic intraocular pressure lowering effects, but seek to use surgical retinotomies (holes in the retina) to achieve this retinal removal thereby avoiding his surgical complications while capitalizing on the long-term efficacy. By varying the size and number of surgical retinotomy, we will be able to provide a normogram for effective prediction of intraocular pressure lowering effects. By effectively predicting the magnitude of this surgical procedure, ophthalmologists will have a predictable and reliable method for treating glaucoma. Furthermore, because a surgical retinotomy does not close, it is predicted to provide a life-long effect.

Conditions

Sequence: 52208226
Name Glaucoma
Downcase Name glaucoma

Id Information

Sequence: 40186236
Id Source org_study_id
Id Value 49075

Design Groups

Sequence: 55634813
Group Type Experimental
Title Surgical Retinotomy
Description Surgical retinotomy will be constructed in the area of the scotoma.

Interventions

Sequence: 52522205
Intervention Type Procedure
Name Surgical Retinotomy
Description Surgical removal of small areas of retinal to increase outflow through the posterior drainage pathway.

Design Outcomes

Sequence: 177511815 Sequence: 177511816
Outcome Type primary Outcome Type secondary
Measure Intraocular Pressure Measure Visual Field Progression
Time Frame 2 years Time Frame 2 years
Description Percentage Reduction in Intraocular Pressure Description Visual Field Progression on HVF 24-2 or Goldmann Visual Field

Browse Conditions

Sequence: 193627459 Sequence: 193627460 Sequence: 193627461
Mesh Term Glaucoma Mesh Term Ocular Hypertension Mesh Term Eye Diseases
Downcase Mesh Term glaucoma Downcase Mesh Term ocular hypertension Downcase Mesh Term eye diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48353803
Agency Class OTHER
Lead Or Collaborator lead
Name Stanford University

Design Group Interventions

Sequence: 68199367
Design Group Id 55634813
Intervention Id 52522205

Eligibilities

Sequence: 30786942
Gender All
Minimum Age 50 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Glaucoma with reproducible and progressive peripheral field loss Elevated Intraocular pressure despite topical medications and filtering surgery (trabeculectomy, tube shunts) Pseudophakia (prior cataract surgery) Greater than 50 years old

Exclusion Criteria:

Uveitic Glaucoma Foveal threatening visual field loss (field loss within 5 degrees of fixation) (i.e. advanced glaucoma) Active ophthalmic infection Monocular (functional vision in only one eye) Rapidly progressive glaucoma (as assessed by more than -1.00 MD drop over three months of visual field testing) Non-native English Speakers

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253989727
Registered In Calendar Year 2019
Were Results Reported False
Has Single Facility False
Minimum Age Num 50
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30533012
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28899306
Responsible Party Type Principal Investigator
Name Ira Schachar
Title Principal Investigator
Affiliation Stanford University

Study References

Sequence: 52103207 Sequence: 52103208 Sequence: 52103209 Sequence: 52103210 Sequence: 52103211
Pmid 26720054 Pmid 12928275 Pmid 29210941 Pmid 21336153 Pmid 29578892
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Grewal DS, Mahmoud TH. Autologous Neurosensory Retinal Free Flap for Closure of Refractory Myopic Macular Holes. JAMA Ophthalmol. 2016 Feb;134(2):229-30. doi: 10.1001/jamaophthalmol.2015.5237. No abstract available. Citation Joussen AM, Walter P, Jonescu-Cuypers CP, Koizumi K, Poulaki V, Bartz-Schmidt KU, Krieglstein GK, Kirchhof B. Retinectomy for treatment of intractable glaucoma: long term results. Br J Ophthalmol. 2003 Sep;87(9):1094-102. doi: 10.1136/bjo.87.9.1094. Citation Parolini B, Grewal DS, Pinackatt SJ, Baldi A, Di Salvatore A, Besozzi G, Finzi A, Cardillo D, Mahmoud TH. COMBINED AUTOLOGOUS TRANSPLANTATION OF NEUROSENSORY RETINA, RETINAL PIGMENT EPITHELIUM, AND CHOROID FREE GRAFTS. Retina. 2018 Sep;38 Suppl 1(Suppl 1):S12-S22. doi: 10.1097/IAE.0000000000001914. Citation Ramli N, Htoon HM, Ho CL, Aung T, Perera S. Risk factors for hypotony after transscleral diode cyclophotocoagulation. J Glaucoma. 2012 Mar;21(3):169-73. doi: 10.1097/IJG.0b013e318207091a. Citation Jain K, Dubey S, Pegu J. Comparison of Efficacy and Complications of Cyclophotocoagulation and Second Glaucoma Drainage Device After Initial Glaucoma Drainage Device Failure. J Glaucoma. 2018 Aug;27(8):e140. doi: 10.1097/IJG.0000000000000955. No abstract available.

]]>

<![CDATA[ Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic. ]]>
https://zephyrnet.com/NCT03798132
2019-01-01

https://zephyrnet.com/?p=NCT03798132
NCT03798132https://www.clinicaltrials.gov/study/NCT03798132?tab=tableNANANApathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker’s method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year January 1, 2019
Primary Completion Month Year June 11, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-09

Detailed Descriptions

Sequence: 20721656
Description we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.

Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI < 10, moderate if 10-20, and large if >20.

Facilities

Sequence: 200108479
Status Recruiting
Name South Egypt Cancer Institute
City Assiut
Zip 11517
Country Egypt

Facility Contacts

Sequence: 28106429
Facility Id 200108479
Contact Type primary
Name Shimaa Ahmed, Lecturer
Email shimaaabdalla@aun.edu.eg
Phone 01007653325

Conditions

Sequence: 52171278
Name Peritoneal Carcinomatosis
Downcase Name peritoneal carcinomatosis

Id Information

Sequence: 40158666
Id Source org_study_id
Id Value SouthECI

Countries

Sequence: 42568969
Name Egypt
Removed False

Interventions

Sequence: 52485523
Intervention Type Diagnostic Test
Name laparoscopy
Description evaluation of peritoneal carcinomatosis by laparoscopy

Keywords

Sequence: 79868608
Name Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures.
Downcase Name ovarian neoplasms, laparoscopy, cytoreduction surgical procedures.

Design Outcomes

Sequence: 177379007 Sequence: 177379008
Outcome Type primary Outcome Type secondary
Measure peritoneal carcinomatosis Measure surgical decision making.
Time Frame one year Time Frame one year
Description Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement. Description correlation of peritoneal carcinomatosis categorization with surgical decision

Browse Conditions

Sequence: 193486903 Sequence: 193486904 Sequence: 193486905 Sequence: 193486906 Sequence: 193486907 Sequence: 193486908 Sequence: 193486909 Sequence: 193486910 Sequence: 193486911 Sequence: 193486912
Mesh Term Carcinoma Mesh Term Peritoneal Neoplasms Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Abdominal Neoplasms Mesh Term Neoplasms by Site Mesh Term Digestive System Neoplasms Mesh Term Digestive System Diseases Mesh Term Peritoneal Diseases
Downcase Mesh Term carcinoma Downcase Mesh Term peritoneal neoplasms Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term abdominal neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term digestive system neoplasms Downcase Mesh Term digestive system diseases Downcase Mesh Term peritoneal diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319330
Agency Class OTHER
Lead Or Collaborator lead
Name Shimaa Abdalla Ahmed

Eligibilities

Sequence: 30765378
Sampling Method Non-Probability Sample
Gender Female
Minimum Age 18 Years
Maximum Age 100 Years
Healthy Volunteers No
Population pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent preoperative CT and diagnostic laparoscopy
Criteria Inclusion Criteria:pathologically proved ovarian cancer patients underwent contrast enhanced abdominopelvic CT and diagnostic laparoscopy before cytoreductive surgery –

Exclusion Criteria:recurrent ovarian cancer

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253884890
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 100
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30511544
Observational Model Cohort
Time Perspective Retrospective

Responsible Parties

Sequence: 28877839
Responsible Party Type Sponsor-Investigator
Name Shimaa Abdalla Ahmed
Title lecturer of radiodiagnosis
Affiliation South Egypt Cancer Institute

Study References

Sequence: 52063424
Pmid 18801470
Reference Type background
Citation Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.

]]>

<![CDATA[ TAF Switch in F3/4 CHB pt With Partial Response to NUC (ESTAB-AFPVR) ]]>
https://zephyrnet.com/NCT03798119
2019-02-25

https://zephyrnet.com/?p=NCT03798119
NCT03798119https://www.clinicaltrials.gov/study/NCT03798119?tab=tableMing-Lung Yu, Prof.fish6069@gmail.com+88673121101A total of 80 adult chronic hepatitis B patients with advanced liver fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on nucleot(s)ide analogs (except tenofovir alafenamide) therapy with detectable HBV DNA after 52 weeks of therapy will switch prior NUCs to TAF 25 mg/day for 96 weeks
<![CDATA[

Studies

Study First Submitted Date 2018-12-24
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-04-26
Start Month Year February 25, 2019
Primary Completion Month Year August 31, 2020
Verification Month Year December 2018
Verification Date 2018-12-31
Last Update Posted Date 2019-04-26

Detailed Descriptions

Sequence: 20741208
Description Study Overview

Dosage regimen: Patients of CHB with advanced fibrosis and partial virological response to NUCs will be considered eligible for the present study. The enrollment will be up to the physician's discretion. The drug will be administered 1 pill (25 mg) per day orally, per manufacturers' instructions, and can be taken with food.

Compliance: Enrolled patients must be monitored according to the protocol, GCP, and clinical practice guidelines.

Study population: Approximately 80 adult CHB patients with advanced fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on NUCs (except TAF) therapy with detectable HBV DNA after 52 weeks of therapy will switch prior NUCs to TAF 25 mg/day for 96 weeks. For patients of fibrosis stage 3, the numbers of enrolled patients will be no more than 40% of total enrolled patients.

Study Objectives

Primary objective:

• To describe the improvement of rate of viral suppression with TAF in patients of partial virological response with previous anti-HBV NUCs.

Secondary objective

To describe the persistence or improvement of rate of ALT normalization (local and AASLD criteria) with TAF in patients of partial virological response with previous anti-HBV NUCs.
To describe the trends in serum creatinine, calculated creatinine clearance, and renal tubular function with TAF.
To describe the trends in bone mineral density with TAF.
To describe the progression/regression of liver fibrosis with TAF.
To describe the prespecified factors associated with viral suppression and/or ALT normalization after switching to TAF, including viral resistance profiles, HBsAg levels and HBV viral loads at the initiation of prior NUC and at the time of TAF switching, HBV genotype, hepatic fibrosis, age, sex, prior preparations of NUCs, and host immunogenetics.

Study Procedures:

Pre-Screening: Patients who are currently under HBV NUC, except TAF therapy, with liver fibrosis stage 3 or 4 at the initiation of NUC, and with detectable HBV DNA after week 52 of therapy will be considered eligible in this prospective interventional cohort study. If the patient is deemed eligible to participate, the site will evaluate the potential patient using the inclusion/exclusion criteria and fill out the CRF for the screening visit. The local coordinator will transmit the pre-screening data to the central coordinator prior to the actual screening/baseline visit. If the patient is deemed eligible by the Primary Investigator, the patient will be given a study ID and allowed to enter the study.

Screening/Baseline: Written and informed consent will be obtained prior to any study protocol-related procedures or data abstraction. If the patient has been pre-screened approved and all lab data are available, the participant will begin the study TAF treatment on the screening/baseline visit. The screening/baseline visit consists of obtaining written and informed consent, reviewing the inclusion/exclusion criteria, confirming medical history, completing a physical examination with vital signs and body weight, reviewing any concomitant medications and study drug dispensing. HCV, HDV, and HIV antibody test will be performed after written informed consent is obtained. The samples of HDV antibody test will be collected at local site and sent to KMUH, tested by central lab. Baseline resistance testing will also be performed by direct sequencing.

Procedures: laboratory tests including CBC (complete blood count) panel, Serum Bilirubin (total/direct), AST, ALT, GGT, Albumin, BUN, Creatinine, Na, K, Phosphate, Prothrombin time (INR), and Urine routine/creatinine/phosphate will be done every visit. Pregnant test (only for women of child-bearing potential), Child-Pugh score, and FIB-4 score should also be done every visit. AFP (alpha-fetoprotein), and Abdominal ultrasound should also be done every 3 to 6 months for HCC surveillance. HBV serological markers including HBeAg/HBeAb, HBV DNA quantification (by central lab.) will be done every visit and HBsAg quantification (by central lab.) every 6 months. Bone Density Scan (DEXA) will be done at week 24, 48, and 96. Fibroscan/CAP will be performed at week 48, and 96 to determine regression of fibrosis. Blood will be drawn at the site at which the participant was recruited, and processed by a lab technician in the clinical laboratory at that respective site, except HDV antibody test and HBsAg/HBV DNA quantification which will be performed by the central lab. at KMUH.

Treatment Visits: Treatment will consist of TAF 25 mg daily with food for 96 weeks. Treatment visits will occur at week 4, 12, 24, 36, 48, 72, and 96 as per routine clinical care, except for those who developed virological breakthrough, SAE, or others judged by the investigators. At every visit, the patient must bring all study drugs (including empty bottles), so that the study coordinator can count compliance using the number of remaining pills.

This schedule of clinic visits and laboratory tests are routine and standard practice for investigators in their treatment of similar patients with CHB. Patients will be encouraged to adhere to these recommendations. Results of these laboratory tests and clinical evaluations will be recorded as well as any additional evaluations that are done as part of the patient's clinical care that is pertinent to the objective of the study.

Discontinuation criteria: The study can be terminated at any time for any reasons by Primary Investigator. Though there is no formal treatment stopping rules in this study, patients might be asked to stop if there are any adverse events that the investigator feels make it the patient's best interest to stop treatment.

Withdrawal of Subjects

Withdrawal Criteria:

Failure to follow study instructions or protocol violation that in the judgment of the investigator
Serious Adverse Events that in the judgment of the investigator
Development of virological breakthrough (defined as reappearance of HBV DNA or at least one log10 elevation of HBV DNA from nadir in 2 consecutive measurements one month apart. further treatment plans are at the discretion of the treating physician and patient.
Any medical, psychosocial or administrative or other reasons that in the judgment of the investigator, be detrimental to the patient's well-being.
Death
Withdrawal of informed consent

Adverse Events and Toxicity Management

Assessment of safety: Safety assessments will include monitoring of laboratory results, vital signs, treatment-emergent adverse events, serious adverse events, etc. Safety assessments will be performed at every clinic visit as part of clinical care and during follow-up visits.

If, in Primary Investigator's judgment, a clinical significant worsening from baseline is observed in any laboratory or other test parameters, physical exam finding, or vital sign, a corresponding clinical adverse event should be recorded.

If a specific medical diagnosis has been made, that diagnosis or syndrome should be recorded as the adverse event, whenever possible. However, a complete description of the signs, symptoms, and investigations which led to the diagnosis should be provided. For example, if clinically significant elevations of liver function tests are known to be secondary to hepatitis, "hepatitis" and not "elevated liver function tests" should be recorded. If the cause is not known, the abnormal test or finding should be recorded as an adverse event, using appropriate medical terminology (e/g/ thrombocytopenia, peripheral edema).

Maintenance of Safety Information: Safety information will be maintained in a clinical database/repository in a retrievable format. At a minimum, at the end of the treatment phase (="last patient off treatment") as well as the end of the follow-up phase (="last patient out") of the study, Primary Investigator shall provide all adverse events, both serious and non-serious, in report format.

Statistics

Data management and analysis will be performed at Kaohsiung Medical University Hospital.

Sample size to be used in the analysis: We calculated that a sample size of 80 patients with a 10% dropout rate would provide 85% power to show increased to 30% of virologic response (HBV DNA <LLOQ) rate after 52 weeks of TAF therapy, compared to 15% of continuing prior NUC therapy with a type I error rate of 0.05 for the one-tailed analyses of the primary endpoint.

Statistical methods to be employed: Descriptive and comparative statistics will be performed for all demographic and clinical variables that are outcome endpoints for this pilot study.

Level of significance: A 95% confidence interval will be used.

Termination of trial: Termination of the trial will be upon completion of follow-up of all 80 subjects enrolled and/or up to the discretion of the primary investigator.

Procedure for missing, unused, spurious data: Data that is missing, unused or spurious data will all be treated as missing data. This data will be marked as an empty field.

Deviation from the original statistical plan: Any deviation from the original statistical plan will be up to the discretion of the primary investigator.

Selection of subjects to be included in analyses: All eligible subjects that have not been withdrawn from the study will be included in analyses.

Interim analysis An interim analysis will be performed at Week 24 after all the 80 patients enrolled.

Facilities

Sequence: 200280666
Status Recruiting
Name Kaohsiung Medical University Hospital
City Kaohsiung
Zip 807
Country Taiwan

Facility Contacts

Sequence: 28132875
Facility Id 200280666
Contact Type primary
Name Ming-Lung Yu, DR
Email fish6069@gmail.com
Phone +88673121101
Phone Extension 7475

Browse Interventions

Sequence: 96133248 Sequence: 96133249 Sequence: 96133250 Sequence: 96133251 Sequence: 96133252 Sequence: 96133253 Sequence: 96133254 Sequence: 96133255 Sequence: 96133256
Mesh Term Tenofovir Mesh Term Antiviral Agents Mesh Term Anti-Infective Agents Mesh Term Reverse Transcriptase Inhibitors Mesh Term Nucleic Acid Synthesis Inhibitors Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Anti-HIV Agents Mesh Term Anti-Retroviral Agents
Downcase Mesh Term tenofovir Downcase Mesh Term antiviral agents Downcase Mesh Term anti-infective agents Downcase Mesh Term reverse transcriptase inhibitors Downcase Mesh Term nucleic acid synthesis inhibitors Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term anti-hiv agents Downcase Mesh Term anti-retroviral agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52221615 Sequence: 52221616
Name Hepatitis B Name Fibrosis and Cirrhosis of Liver
Downcase Name hepatitis b Downcase Name fibrosis and cirrhosis of liver

Id Information

Sequence: 40195688
Id Source org_study_id
Id Value KMUHIRB-F(II)-20180111

Countries

Sequence: 42609699
Name Taiwan
Removed False

Design Groups

Sequence: 55649898
Group Type Experimental
Title Switch to TAF
Description Subjects who meet the inclusion and exclusion criteria will switch prior NUCs to TAF 25 mg/day for 96 weeks

Interventions

Sequence: 52535430
Intervention Type Drug
Name Tenofovir Alafenamide
Description Subjects in this group will switch prior nucleot(s)ide analogs to Tenofovir Alafenamide 25 mg/day for 96 weeks

Keywords

Sequence: 79941882 Sequence: 79941883 Sequence: 79941884 Sequence: 79941885 Sequence: 79941886
Name Hepatitis B Name advanced fibrosis Name Cirrhosis Name Switch Name Tenofovir alafenamide
Downcase Name hepatitis b Downcase Name advanced fibrosis Downcase Name cirrhosis Downcase Name switch Downcase Name tenofovir alafenamide

Design Outcomes

Sequence: 177561821 Sequence: 177561822 Sequence: 177561823 Sequence: 177561824 Sequence: 177561825 Sequence: 177561826 Sequence: 177561827
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Rate of virological response Measure Rate of virological response Measure Rate of ALT normalization Measure Changes of serum creatinine Measure Changes of calculated creatinine clearance (Cockcroft-Gault) Measure Changes in bone mineral density Measure Changes in liver fibrosis
Time Frame at 48 weeks of TAF therapy. Time Frame at 96 weeks of treatment Time Frame at week 48 and 96 Time Frame at week 48 and 96 Time Frame at week 48 and 96 Time Frame at week 48 and 96 Time Frame at week 48 and 96
Description HBV DNA <LLOQ Description HBV DNA <LLOQ Description by local (<40 U/L), and AASLD (male ≤35, female ≤25 U/L) criteria Description determined by Fibroscan

Browse Conditions

Sequence: 193678811 Sequence: 193678812 Sequence: 193678813 Sequence: 193678814 Sequence: 193678815 Sequence: 193678816 Sequence: 193678817 Sequence: 193678818 Sequence: 193678819 Sequence: 193678820 Sequence: 193678821 Sequence: 193678822 Sequence: 193678823 Sequence: 193678824 Sequence: 193678825 Sequence: 193678826 Sequence: 193678827 Sequence: 193678828
Mesh Term Hepatitis A Mesh Term Hepatitis B Mesh Term Hepatitis Mesh Term Liver Cirrhosis Mesh Term Fibrosis Mesh Term Liver Diseases Mesh Term Digestive System Diseases Mesh Term Hepatitis, Viral, Human Mesh Term Virus Diseases Mesh Term Infections Mesh Term Enterovirus Infections Mesh Term Picornaviridae Infections Mesh Term RNA Virus Infections Mesh Term Pathologic Processes Mesh Term Blood-Borne Infections Mesh Term Communicable Diseases Mesh Term Hepadnaviridae Infections Mesh Term DNA Virus Infections
Downcase Mesh Term hepatitis a Downcase Mesh Term hepatitis b Downcase Mesh Term hepatitis Downcase Mesh Term liver cirrhosis Downcase Mesh Term fibrosis Downcase Mesh Term liver diseases Downcase Mesh Term digestive system diseases Downcase Mesh Term hepatitis, viral, human Downcase Mesh Term virus diseases Downcase Mesh Term infections Downcase Mesh Term enterovirus infections Downcase Mesh Term picornaviridae infections Downcase Mesh Term rna virus infections Downcase Mesh Term pathologic processes Downcase Mesh Term blood-borne infections Downcase Mesh Term communicable diseases Downcase Mesh Term hepadnaviridae infections Downcase Mesh Term dna virus infections
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366508
Agency Class OTHER
Lead Or Collaborator lead
Name Kaohsiung Medical University Chung-Ho Memorial Hospital

Overall Officials

Sequence: 29312957
Role Principal Investigator
Name Ming-Lung Yu, Prof.
Affiliation Kaohsiung Medical University

Central Contacts

Sequence: 12020615
Contact Type primary
Name Ming-Lung Yu, Prof.
Phone +88673121101
Email fish6069@gmail.com
Phone Extension 7475
Role Contact

Design Group Interventions

Sequence: 68217513
Design Group Id 55649898
Intervention Id 52535430

Eligibilities

Sequence: 30794761
Gender All
Minimum Age 20 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Male or female, age ≥20 years
CHB diagnosis confirmed by positive HBsAg or HBV DNA for more than 6 months, or documented history of CHB in medical record before initiation of NUC therapy.
Currently maintained on nucleot(s)ide analogues (except TAF) therapy for more than one year, with detectable HBV DNA after 52 weeks of therapy, detectable HBV DNA within 3-6 months prior to screening, and remains detectable HBV DNA at screening.
Patients with liver fibrosis stage 3 (defined as Metavir fibrosis stage 3 by liver biopsy, or fibrosis-4 score 3.25 ~ 6.49, or ARFI 1.80 ~ 1.99 m/s, or Fibroscan 9.5~12.4 kPa), or cirrhosis (defined as Metavir fibrosis stage 4 by liver biopsy, or APRI >2, or fibrosis-4 score ≥ 6.5, or ARFI ≥ 2.0 m/s, or Fibroscan ≥12.5 kPa, or image diagnosis with splenomegaly or esophageal/gastric varices) at the initiation of prior NUC therapy or during the prior NUC therapy. The liver biopsy should be within 5 years, or during the prior NUC therapy and other non-invasive assessments should be within 6 months at the initiation of NUC therapy or during the prior NUC therapy.
Estimated creatinine clearance > 15 ml/min (using the Cockcroft-Gault method) within 6 months prior to screening. (Note: multiply estimated rate by 0.85 for women).
Willing and able to provide informed consent
Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria:

Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
Previous recipient of a liver transplant
Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis D (HDV)
Severe or uncontrolled comorbidities, determined by the Investigator.
Known history of serum albumin level <3 g/dL, or total bilirubin level >3 mg/dL, or presence of ascites.
Known history of hepatic encephalopathy, and/or variceal bleeding.
Malignancy history including hepatocellular carcinoma, except cancers curable by surgical resection (e.g. basal cell skin cancer and squamous cell cancer within 5 yrs of screening).
On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 11). Subjects on prohibited medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Screening.
Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study.
Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance.
Any other clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable or unable to comply with any of the study procedures

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004405
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 20
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30540801
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28907121
Responsible Party Type Sponsor

]]>

<![CDATA[ A Study of Pazopanib and Durvalumab for Metastatic Soft Tissue Sarcoma ]]>
https://zephyrnet.com/NCT03798106
2019-04-10

https://zephyrnet.com/?p=NCT03798106
NCT03798106https://www.clinicaltrials.gov/study/NCT03798106?tab=tableNANANAPazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-06-12
Start Month Year April 10, 2019
Primary Completion Month Year August 10, 2022
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-12

Detailed Descriptions

Sequence: 20806775
Description Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. Pro-angiogenic factors suppress various immune functions whereas antiangiogenic agents have potential to modulate the tumor microenvironment and improve immunotherapy. An analysis of patients with RCC treated with pazopanib demonstrated that elevated expression of PD-L1 correlates with shorter PFS. Investigator also identified 43% of PD-L1 expression in STS and PD-L1 expression had worse overall survival (5-year survival rate: 48% in PD-L1 positive vs. 68% in PD-L1 negative, p=0.015). In detail, PD-L1 expression was reported 52.6% in synovial sarcoma, 37.6% in rhabdomyosarcoma, and 100% in epithelioid sarcoma. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.

Facilities

Sequence: 200819705
Name Severance Hospital, Yonsei University Health System
City Seoul
Zip 03722
Country Korea, Republic of

Browse Interventions

Sequence: 96390469 Sequence: 96390470 Sequence: 96390471
Mesh Term Durvalumab Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents
Downcase Mesh Term durvalumab Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52388085
Name Sarcoma
Downcase Name sarcoma

Id Information

Sequence: 40312974
Id Source org_study_id
Id Value 4-2018-0743

Countries

Sequence: 42736004
Name Korea, Republic of
Removed False

Design Groups

Sequence: 55834560
Group Type Experimental
Title durvalumab+pazopanib
Description Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks

Interventions

Sequence: 52698065
Intervention Type Drug
Name Durvalumab, pazopanib
Description Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks

Design Outcomes

Sequence: 178180389
Outcome Type primary
Measure Objective Response Rate
Time Frame 12 weeks
Description antitumor efficacy of durvalumab and pazopanib

Browse Conditions

Sequence: 194310797 Sequence: 194310798 Sequence: 194310799 Sequence: 194310800
Mesh Term Sarcoma Mesh Term Neoplasms, Connective and Soft Tissue Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms
Downcase Mesh Term sarcoma Downcase Mesh Term neoplasms, connective and soft tissue Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48521352
Agency Class OTHER
Lead Or Collaborator lead
Name Yonsei University

Design Group Interventions

Sequence: 68444001
Design Group Id 55834560
Intervention Id 52698065

Eligibilities

Sequence: 30890752
Gender All
Minimum Age 19 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Histologically confirmed STS progression to 1 or 2 prior chemotherapy
Age > 18 years at time of study entry.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
Body weight >30kg
Adequate laboratory findings
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Patient is willing and able to comply with the protocol for the duration of the study
Must have a life expectancy of at least 12 weeks
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Patients with evidence of portal hypertension (including splenomegaly detected radiographically) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to enrollment, and the findings do not represent a high bleeding risk.

Exclusion Criteria:

More than 4 prior cytotoxic regimens
Participation in another clinical study with an investigational product during the last 2 weeks
Receipt of the last dose of anticancer therapy 14 days prior to the first dose of study drug
Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or pazopanib
Mean QT interval corrected for heart rate (QTc) >480 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 2 weeks prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
History of allogenic organ transplantation.
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness
History of active infection
History of another primary malignancy
History of leptomeningeal carcinomatosis who are neurologically unstable or have required active treatment
Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product(IP).
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose.
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
No history of any of the following in the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease class III or IV congestive heart failure, as defined by the New York Heart Association), thromboembolic events

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254131700
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 40
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 19
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30636501
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29003104
Responsible Party Type Principal Investigator
Name Hyo Song Kim
Title professor
Affiliation Yonsei University

]]>

<![CDATA[ MINVI Echocardiography Sub-Study ]]>
https://zephyrnet.com/NCT03798093
2019-01-07

https://zephyrnet.com/?p=NCT03798093
NCT03798093https://www.clinicaltrials.gov/study/NCT03798093?tab=tableNANANANon-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-02-27
Start Month Year January 7, 2019
Primary Completion Month Year June 1, 2021
Verification Month Year February 2023
Verification Date 2023-02-28
Last Update Posted Date 2023-02-27

Detailed Descriptions

Sequence: 20788508
Description Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents. The consent will have a check box to indicate if they consent to the additional test.

Echocardiographic measurements will be performed on all infants at 12 hours +/-3 hours of age by our research sonographers who are blinded to infant randomization. Measurements will be taken according to a standard operating procedure to assess systemic blood flow, by superior vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular output (LVO) (ml/kg/min), measures of left and right venitricular tissue Doppler and strain imaging. These measurements will be performed off line at a later time. Data will be entered into REDCap.

If any structural abnormalities are found, the attending pediatrician will be notified of the abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic purposes. Any additional studies including an official complete echocardiogram and or cardiology consultation will be left to the discretion of the attending pediatrician, as he/she deems necessary

Facilities

Sequence: 200667511
Name Sharp Mary Birch Hospital for Women and Newborns
City San Diego
State California
Zip 92123
Country United States

Conditions

Sequence: 52342248
Name Birth Asphyxia
Downcase Name birth asphyxia

Id Information

Sequence: 40281123
Id Source org_study_id
Id Value MINVI Echo Study

Countries

Sequence: 42701844
Name United States
Removed False

Design Groups

Sequence: 55783959 Sequence: 55783960
Group Type Active Comparator Group Type Active Comparator
Title Umbilical Cord Milking Title Early Cord Clamping
Description The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials. Description This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.

Interventions

Sequence: 52653186 Sequence: 52653187
Intervention Type Procedure Intervention Type Procedure
Name Umbilical Cord Milking Name Early Cord Clamping
Description At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds. Description The umbilical cord is clamped within 30 seconds of delivery.

Keywords

Sequence: 80104921 Sequence: 80104922 Sequence: 80104923
Name Umbilical Cord Milking Name Immediate Cord Clamping Name Resuscitation
Downcase Name umbilical cord milking Downcase Name immediate cord clamping Downcase Name resuscitation

Design Outcomes

Sequence: 178011080 Sequence: 178011081 Sequence: 178011082 Sequence: 178011083 Sequence: 178011084
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Cardiac Output Measure Right Ventricular Output Measure SVC Flow Measure Peak Systolic Strain and Strain rate Measure Peak Systolic Tissue Doppler
Time Frame 12 +/- 6 hours of life Time Frame 12 +/- 6 hours of life Time Frame 12 +/- 6 hours of life Time Frame 12 +/- 6 hours of life Time Frame 12 +/- 6 hours of life
Description Cardiac Output measured by Left Ventricular Output Description Obtained from the modified short axis view of Cardiac Ultrasound Description SVC flow (Diameter obtained from the infaclavicular view (hybrid view), Doppler from the subcostal view) Description Measures of Left and Right Ventricular Strain and Strain rate Description Measure of left and right ventricular peak systolic Tissue Doppler velocity

Browse Conditions

Sequence: 194138399 Sequence: 194138400 Sequence: 194138401 Sequence: 194138402 Sequence: 194138403 Sequence: 194138404
Mesh Term Asphyxia Neonatorum Mesh Term Asphyxia Mesh Term Death Mesh Term Pathologic Processes Mesh Term Wounds and Injuries Mesh Term Infant, Newborn, Diseases
Downcase Mesh Term asphyxia neonatorum Downcase Mesh Term asphyxia Downcase Mesh Term death Downcase Mesh Term pathologic processes Downcase Mesh Term wounds and injuries Downcase Mesh Term infant, newborn, diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48479096 Sequence: 48479097
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Sharp HealthCare Name Sharp Mary Birch Hospital for Women & Newborns

Overall Officials

Sequence: 29376217
Role Principal Investigator
Name Anup Katheria, MD
Affiliation Sharp Mary Birch Hospital for Women & Newborns

Design Group Interventions

Sequence: 68381678 Sequence: 68381679
Design Group Id 55783959 Design Group Id 55783960
Intervention Id 52653186 Intervention Id 52653187

Eligibilities

Sequence: 30864432
Gender All
Minimum Age 35 Weeks
Maximum Age 42 Weeks
Healthy Volunteers No
Criteria Inclusion Criteria:

Non-vigorous newborns born between 35-42 weeks gestation

Exclusion Criteria:

Known major congenital or chromosomal anomalies of newborn Known cardiac defects other than small ASD, VSD and PDA Complete placental abruption/cutting through the placenta at time of delivery Monochorionic multiples Cord Avulsion Presence of non-reducible nuchal cord Perinatal providers unaware of the protocol

Adult False
Child True
Older Adult False

Calculated Values

Sequence: 253949548
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 29
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 35
Maximum Age Num 42
Minimum Age Unit Weeks
Maximum Age Unit Weeks
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30610250
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Diagnostic
Time Perspective
Masking None (Open Label)
Intervention Model Description Cluster Randomized Crossover

Responsible Parties

Sequence: 28976783
Responsible Party Type Principal Investigator
Name Anup Katheria, M.D.
Title Director, Neonatal Research Institute
Affiliation Sharp HealthCare

]]>

<![CDATA[ Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin ]]>
https://zephyrnet.com/NCT03798080
2019-02-19

https://zephyrnet.com/?p=NCT03798080
NCT03798080https://www.clinicaltrials.gov/study/NCT03798080?tab=tableNANANAPrimary Objective:

To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.

Secondary Objectives:

To assess the effects of iGlarLixi in comparison with insulin glargine
To assess the safety in each treatment group
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-07-19
Start Month Year February 19, 2019
Primary Completion Month Year December 1, 2020
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2022-07-19

Detailed Descriptions

Sequence: 20770281
Description The maximum study duration per patient will be approximately 33 weeks: an up to 2-week screening period (it can be exceptionally extended up to one additional week), a 30-week, open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin for both treatments), and a 3-day post-treatment safety follow-up period.

Facilities

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Name Investigational Site Number 1560044 Name Investigational Site Number 1560001 Name Investigational Site Number 1560039 Name Investigational Site Number 1560005 Name Investigational Site Number 1560054 Name Investigational Site Number 1560015 Name Investigational Site Number 1560010 Name Investigational Site Number 1560030 Name Investigational Site Number 1560025 Name Investigational Site Number 1560016 Name Investigational Site Number 1560053 Name Investigational Site Number 1560045 Name Investigational Site Number 1560021 Name Investigational Site Number 1560018 Name Investigational Site Number 1560019 Name Investigational Site Number 1560041 Name Investigational Site Number 1560040 Name Investigational Site Number 1560007 Name Investigational Site Number 1560026 Name Investigational Site Number 1560042 Name Investigational Site Number 1560003 Name Investigational Site Number 1560032 Name Investigational Site Number 1560033 Name Investigational Site Number 1560028 Name Investigational Site Number 1560013 Name Investigational Site Number 1560017 Name Investigational Site Number 1560035 Name Investigational Site Number 1560038 Name Investigational Site Number 1560046 Name Investigational Site Number 1560008 Name Investigational Site Number 1560037 Name Investigational Site Number 1560031 Name Investigational Site Number 1560011 Name Investigational Site Number 1560002 Name Investigational Site Number 1560027 Name Investigational Site Number 1560047 Name Investigational Site Number 1560012 Name Investigational Site Number 1560006 Name Investigational Site Number 1560049 Name Investigational Site Number 1560020 Name Investigational Site Number 1560050 Name Investigational Site Number 1560036 Name Investigational Site Number 1560023 Name Investigational Site Number 1560022 Name Investigational Site Number 1560052
City Baotou City Beijing City Beijing City Changchun City Changchun City Changsha City Chenzhou City Chongqing City Fuzhou City Guangzhou City Guangzhou City Guangzhou City Hefei City Hohhot City Huanggang City Jiaxing City Jinan City Jinan City Jinzhou City Kaifeng City Kunming City Lanzhou City Luoyang City Nanjing City Nanjing City Nanjing City Nanjing City Nanjing City Nantong City Pingxiang City Qingdao City Qinhuangdao City Shanghai City Shanghai City Shanghai City Shanghai City Shenyang City Tianjin City Urumqi City Xining City Xining City Xuzhou City Yangzhou City Zhuzhou City Zigong
Zip 014010 Zip 100034 Zip 102218 Zip 130033 Zip 130041 Zip 410013 Zip 400010 Zip 354200 Zip 510080 Zip 510080 Zip 510515 Zip 230022 Zip 010017 Zip 250000 Zip 250013 Zip 121000 Zip 475000 Zip 650032 Zip 730000 Zip 210008 Zip 210011 Zip 210029 Zip 226001 Zip 337055 Zip 266003 Zip 200240 Zip 201700 Zip 110004 Zip 300121 Zip 830000 Zip 810007 Zip 810016 Zip 225001 Zip 412007 Zip 643002
Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China

Browse Interventions

Sequence: 96249052 Sequence: 96249053 Sequence: 96249054 Sequence: 96249055 Sequence: 96249056 Sequence: 96249057 Sequence: 96249058
Mesh Term Insulin Mesh Term Insulin, Globin Zinc Mesh Term Metformin Mesh Term Insulin Glargine Mesh Term Lixisenatide Mesh Term Hypoglycemic Agents Mesh Term Physiological Effects of Drugs
Downcase Mesh Term insulin Downcase Mesh Term insulin, globin zinc Downcase Mesh Term metformin Downcase Mesh Term insulin glargine Downcase Mesh Term lixisenatide Downcase Mesh Term hypoglycemic agents Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52296014
Name Type 2 Diabetes Mellitus
Downcase Name type 2 diabetes mellitus

Id Information

Sequence: 40248542 Sequence: 40248543
Id Source org_study_id Id Source secondary_id
Id Value EFC14944 Id Value U1111-1190-7781
Id Type Other Identifier
Id Type Description UTN

Countries

Sequence: 42666848
Name China
Removed False

Design Groups

Sequence: 55732672 Sequence: 55732673
Group Type Experimental Group Type Active Comparator
Title Soliqua (insulin glargine/lixisenatide) Title Lantus (insulin glargine)
Description iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks Description Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks

Interventions

Sequence: 52607832 Sequence: 52607833 Sequence: 52607834
Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Insulin glargine/Lixisenatide (HOE901/AVE0010) Name Insulin glargine (HOE901) Name Metformin
Description Pharmaceutical form: solution

Route of administration: subcutaneous

Description Pharmaceutical form: solution

Route of administration: subcutaneous

Description Pharmaceutical form: tablet

Route of administration: oral

Design Outcomes

Sequence: 177838273 Sequence: 177838261 Sequence: 177838262 Sequence: 177838263 Sequence: 177838264 Sequence: 177838265 Sequence: 177838266 Sequence: 177838267 Sequence: 177838268 Sequence: 177838269 Sequence: 177838270 Sequence: 177838271 Sequence: 177838272
Outcome Type secondary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Immunogenicity (antibody variables) Measure Change in HbA1c Measure Patients with HbA1c <7.0% Measure Patients with HbA1c ≤ 6.5% Measure Change in postprandial plasma glucose (PPG) Measure Change in self-monitored plasma glucose (SMPG) profile Measure Patients with HbA1c <7.0% with no body weight gain Measure Change in body weight Measure Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia Measure Patients requiring rescue therapy Measure Change in fasting plasma glucose (FPG) Measure Confirmed hypoglycemia Measure Adverse events (AEs)
Time Frame From Baseline to Week 30 Time Frame From Baseline to Week 30 Time Frame At Week 30 Time Frame At Week 30 Time Frame From Baseline to Week 30 Time Frame From Baseline to Week 30 Time Frame At Week 30 Time Frame From Baseline to Week 30 Time Frame At Week 30 Time Frame From Baseline to Week 30 Time Frame From Baseline to Week 30 Time Frame From Baseline to Week 30 Time Frame From Baseline to Week 30
Description Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30 Description Change in glycated hemoglobin (HbA1c) from baseline to Week 30 Description Percentage of patients reaching HbA1c <7% at Week 30 Description Percentage of patients reaching HbA1c ≤ 6.5% at Week 30 Description Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30 Description Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value) Description Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30 Description Absolute change in body weight from baseline to Week 30 Description Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9mmol/L]) symptomatic hypoglycemia during the 30-week randomized treatment period Description Percentage of patients requiring rescue therapy during the 30-week randomized treatment period Description Absolute change in FPG from baseline to Week 30 Description Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms Description Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30

Browse Conditions

Sequence: 193963989 Sequence: 193963990 Sequence: 193963991 Sequence: 193963992 Sequence: 193963993
Mesh Term Diabetes Mellitus Mesh Term Diabetes Mellitus, Type 2 Mesh Term Glucose Metabolism Disorders Mesh Term Metabolic Diseases Mesh Term Endocrine System Diseases
Downcase Mesh Term diabetes mellitus Downcase Mesh Term diabetes mellitus, type 2 Downcase Mesh Term glucose metabolism disorders Downcase Mesh Term metabolic diseases Downcase Mesh Term endocrine system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48436341
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Sanofi

Overall Officials

Sequence: 29352619
Role Study Director
Name Clinical Sciences & Operations
Affiliation Sanofi

Design Group Interventions

Sequence: 68317383 Sequence: 68317384 Sequence: 68317385 Sequence: 68317386
Design Group Id 55732672 Design Group Id 55732673 Design Group Id 55732673 Design Group Id 55732672
Intervention Id 52607832 Intervention Id 52607833 Intervention Id 52607834 Intervention Id 52607834

Eligibilities

Sequence: 30837933
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion criteria :

Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1).
Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1).
Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at least 2 months before screening visit (V1). Total daily dose should be within the range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations of ±20% within 2 months prior to screening are acceptable.
For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1 to 2 out of:
Metformin (≥1500 mg/day or maximal tolerated dose).
Sulfonylurea (SU)/glinide.
Alpha-glucosidase inhibitor (alpha-GI).
Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be repeated once to confirm).
Signed written informed consent.

Exclusion criteria:

Age <18 years at screening visit (V1).
Screening glycated hemoglobin A1c(HbA1c) <7.0% or >10.5%.
History of hypoglycemia unawareness.
History of metabolic acidosis, including diabetic ketoacidosis within one year prior to screening.
Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.
Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin, within one year prior to screening (Note: Short term treatment [≤10 days] due to intercurrent illness is allowed).
History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reason or lack of efficacy.
Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
Use of weight loss drugs within 3 months prior to screening.
Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening.
Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
Planned coronary, carotid, or peripheral revascularization procedures to be performed during the study period.
Known history of drug or alcohol abuse within 6 months prior to screening.
Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
Laboratory findings at screening visit:
Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).
Calcitonin ≥20 pg/mL (5.9 pmol/L).
Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm3 and/or platelets <100 000/mm3.
Positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCAb).
Positive urine pregnancy test in female of childbearing potential.
For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
Mean fasting self-monitored plasma glucose (SMPG) is >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254149857
Number Of Facilities 45
Registered In Calendar Year 2019
Actual Duration 21
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 12

Designs

Sequence: 30583832
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26729453 Sequence: 26729454 Sequence: 26729455
Intervention Id 52607832 Intervention Id 52607832 Intervention Id 52607833
Name Soliqua Name iGlarLixi Name Lantus

Responsible Parties

Sequence: 28950249
Responsible Party Type Sponsor

Study References

Sequence: 52196531
Pmid 35762489
Reference Type background
Citation Yuan X, Guo X, Zhang J, Dong X, Lu Y, Pang W, Gu S, Niemoeller E, Ping L, Nian G, Souhami E; LixiLan-L-CN investigators. Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25.

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<![CDATA[ Correlation Between Monitoring Renal Hemodynamics by Esophageal Ultrasound and Acute Kidney Injury After Heart Surgery ]]>
https://zephyrnet.com/NCT03798067
2019-01-02

https://zephyrnet.com/?p=NCT03798067
NCT03798067https://www.clinicaltrials.gov/study/NCT03798067?tab=tableHui Zhang504099077@qq.com+8615996938739Acute kidney injury (AKI) is a common complication of cardiac surgery, which seriously affects the postoperative complication rate and mortality of patients.Acute kidney injury occurs in 5-30% of patients after cardiac surgery, but severe acute kidney injury requiring dialysis is relatively rare.At present, the diagnosis of AKI is based on serum creatinine (Scr) or urine volume. However, the changes of serum creatinine value have hysteresis, and the increase of serum creatinine level lags behind kidney injury for 48 ~ 72 h.Some drugs can also affect creatinine levels.Urine volume is also affected by many factors.Due to the lack of sensitivity and specificity of SCr, it is very important to find and adopt new early AKI markers.Kidney is an important metabolic organ of human body. Different from cerebrovascular system, kidney lacks automatic regulation ability and is easily affected by perfusion flow.Previous experiments have shown that placing a multi-plane esophageal probe into the human stomach through the esophagus can monitor the changes of left renal blood flow before, during and after cardiovascular surgery extracorporeal circulation, and has good repeatability, which may become an effective means to monitor renal blood flow during cardiovascular surgery.

In conclusion, this study intends to use esophageal ultrasound as a means to monitor renal blood flow, observe the changes of intraoperative renal hemodynamic indexes, and use KDIGO ( Kidney Disease:Improving Global Outcomes)as the standard of renal injury to explore the correlation between intraoperative hemodynamic changes and postoperative AKI, providing a new perspective for the pathophysiological study of AKI after cardiopulmonary bypass.
<![CDATA[

Studies

Study First Submitted Date 2019-01-01
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year January 2, 2019
Primary Completion Month Year August 30, 2019
Verification Month Year December 2018
Verification Date 2018-12-31
Last Update Posted Date 2019-01-09

Detailed Descriptions

Sequence: 20780445
Description The mechanism of acute kidney injury after CPB has not been fully elucidated, and current studies suggest that the main mechanisms are as follows:

(1) endogenous/exogenous nephrotoxic substances;(2) metabolic factors: mainly reflected in the preoperative status of patients, such as obesity, low body weight, etc.;(3) hemodynamic factors: hemodynamic instability is an important mechanism for further renal injury process such as ischemia reperfusion, which is mainly reflected in: a.preoperative and postoperative hypotension: cardiogenic shock caused by cardiac insufficiency and low cardiac displacement;Non-cardiogenic shock (vasoactive drugs/allergies/postoperative bleeding);b. hemodynamic instability of intraoperative intervention: deep anesthesia, intraoperative blood loss, CPB-related intraoperative low perfusion (long CPB time, low circulation flow, low mean arterial pressure in CPB), embolic release (atherosclerotic emboli/air emboli), aorta and distal arteriotomy;(4) neurohumoral system factors: hormones such as epinephrine, norepinephrine, renin and thyroxine change to varying degrees during cardiac surgery and CPB, thus affecting the body state and systemic blood vessels;(5) inflammation and oxidative stress.

Kidney is an important metabolic organ of human body. Different from cerebrovascular system, kidney lacks automatic regulation ability and is easily affected by perfusion flow.For patients at high risk of postoperative acute kidney injury, appropriate intraoperative perfusion may reduce the incidence of postoperative acute kidney injury.

Esophageal ultrasound was used as a means of monitoring renal blood flow to observe the changes in intraoperative renal hemodynamic indexes. Meanwhile, KDIGO was used as the standard for renal injury. AKI was divided into two groups according to whether postoperative AKI occurred, and the correlation between intraoperative hemodynamic changes and postoperative AKI in the two groups was discussed.It provides new ideas for the early diagnosis of postoperative acute kidney injury.

Conditions

Sequence: 52321624
Name Postoperative Acute Kidney Injury
Downcase Name postoperative acute kidney injury

Id Information

Sequence: 40266290
Id Source org_study_id
Id Value XYFY-2018-0008

Design Outcomes

Sequence: 177935236 Sequence: 177935237 Sequence: 177935238 Sequence: 177935239 Sequence: 177935240 Sequence: 177935241 Sequence: 177935242
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure AUC(RI) Measure AUC(PI) Measure Changes in biomarkers Measure Length of ICU stay Measure Length of hospital stay Measure Use of renal replacement therapy Measure Survival rate
Time Frame RI monitored 30 minutes after cardiopulmonary bypass termination Time Frame PI monitored 30 minutes after cardiopulmonary bypass termination Time Frame Before surgery and at 4 hours, 12 hours, and 24 hours after surgery Time Frame an average of 2 days Time Frame an average of 10 days Time Frame Until 3 months after discharge Time Frame At 1, 7 and 30 days after discharge
Description ROC curve(receiver operating characteristic curve)will be drawn according to the incidence of renal resistance index (RI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value(Area Under Curve) will be statistically analyzed. Description ROC curve will be drawn according to the incidence of renal pulsatility index (PI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value will be statistically analyzed. Description Analysis of insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) concentrations (both induction factors for G1 cell cycle arrest are associated with acute kidney injury and are predicted as biomarkers). Description All patients are routinely transferred to ICU after surgery Description All patients are routinely transferred to ICU after surgery Description The use of postoperative renal replacement therapy depends on the diagnosis and treatment of ICU staff. Description Record the survival rate after hospital discharged.

Browse Conditions

Sequence: 194059651 Sequence: 194059652 Sequence: 194059653 Sequence: 194059654 Sequence: 194059655 Sequence: 194059656 Sequence: 194059657 Sequence: 194059658 Sequence: 194059659
Mesh Term Acute Kidney Injury Mesh Term Wounds and Injuries Mesh Term Renal Insufficiency Mesh Term Kidney Diseases Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases
Downcase Mesh Term acute kidney injury Downcase Mesh Term wounds and injuries Downcase Mesh Term renal insufficiency Downcase Mesh Term kidney diseases Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48460219
Agency Class OTHER
Lead Or Collaborator lead
Name Xuzhou Medical University

Overall Officials

Sequence: 29365449
Role Study Director
Name Jin Dong Liu, M.S
Affiliation The Affiliated Hospital of Xuzhou Medical University

Central Contacts

Sequence: 12046243 Sequence: 12046244
Contact Type primary Contact Type backup
Name Jin Dong Liu, M.S Name Hui Zhang
Phone +86-13951355136 Phone +8615996938739
Email liujindong1818@163.com Email 504099077@qq.com
Role Contact Role Contact

Eligibilities

Sequence: 30852468
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Population 60 patients undergoing elective cardiac surgery in the Affiliated Hospital of Xuzhou Medical University.
Criteria Inclusion Criteria:

Aged between 18 and 70;
Elective cardiopulmonary bypass for patients undergoing cardiac surgery

Exclusion Criteria:

Acute myocardial infarction surgery within 7 days
Emergency surgery
Known renal artery stenosis, renal malformation;Renal failure
Congenital esophageal malformation
Patients with previous history of stomach and esophagus should avoid intraoperative esophageal ultrasound examination
Existing acute kidney injury, kidney transplantation, chronic kidney disease and glomerular filtration rate less than 30 ml/min,
Pregnancy

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254272364
Registered In Calendar Year 2019
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30598320
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28964810
Responsible Party Type Principal Investigator
Name Jin Dong Liu
Title Principal Investigator
Affiliation Xuzhou Medical University

Study References

Sequence: 52226154 Sequence: 52226155 Sequence: 52226156 Sequence: 52226157
Pmid 22163121 Pmid 28869251 Pmid 30471559 Pmid 26995003
Reference Type result Reference Type result Reference Type result Reference Type result
Citation Weisse AB. Cardiac surgery: a century of progress. Tex Heart Inst J. 2011;38(5):486-90. Citation Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4. Citation Bellos I, Pergialiotis V, Kontzoglou K. Renal resistive index as predictor of acute kidney injury after major surgery: A systematic review and meta-analysis. J Crit Care. 2019 Apr;50:36-43. doi: 10.1016/j.jcrc.2018.11.001. Epub 2018 Nov 15. Citation Regolisti G, Maggiore U, Cademartiri C, Belli L, Gherli T, Cabassi A, Morabito S, Castellano G, Gesualdo L, Fiaccadori E. Renal resistive index by transesophageal and transparietal echo-doppler imaging for the prediction of acute kidney injury in patients undergoing major heart surgery. J Nephrol. 2017 Apr;30(2):243-253. doi: 10.1007/s40620-016-0289-2. Epub 2016 Mar 19.

]]>

<![CDATA[ Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s) ]]>
https://zephyrnet.com/NCT03798054
2019-02-15

https://zephyrnet.com/?p=NCT03798054
NCT03798054https://www.clinicaltrials.gov/study/NCT03798054?tab=tableNANANAPrimary Objectives:

The co-primary objective of this study is:

To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.
To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.

Secondary Objectives:

To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone.
To assess the safety in each treatment group.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-07-19
Start Month Year February 15, 2019
Primary Completion Month Year March 1, 2021
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2022-07-19

Detailed Descriptions

Sequence: 20832666
Description The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-week randomized treatment period and a 3-day post-treatment safety follow up period.

Facilities

Sequence: 201122093 Sequence: 201122094 Sequence: 201122095 Sequence: 201122096 Sequence: 201122097 Sequence: 201122098 Sequence: 201122099 Sequence: 201122100 Sequence: 201122101 Sequence: 201122102 Sequence: 201122103 Sequence: 201122104 Sequence: 201122105 Sequence: 201122106 Sequence: 201122107 Sequence: 201122108 Sequence: 201122109 Sequence: 201122110 Sequence: 201122111 Sequence: 201122112 Sequence: 201122113 Sequence: 201122114 Sequence: 201122115 Sequence: 201122116 Sequence: 201122117 Sequence: 201122118 Sequence: 201122119 Sequence: 201122120 Sequence: 201122121 Sequence: 201122122 Sequence: 201122123 Sequence: 201122124 Sequence: 201122125 Sequence: 201122126 Sequence: 201122127 Sequence: 201122128 Sequence: 201122129 Sequence: 201122130 Sequence: 201122131 Sequence: 201122132 Sequence: 201122133 Sequence: 201122134 Sequence: 201122135 Sequence: 201122136 Sequence: 201122137 Sequence: 201122138 Sequence: 201122139 Sequence: 201122140 Sequence: 201122141 Sequence: 201122142 Sequence: 201122143 Sequence: 201122144 Sequence: 201122145 Sequence: 201122146 Sequence: 201122147 Sequence: 201122148 Sequence: 201122149 Sequence: 201122150 Sequence: 201122151 Sequence: 201122152 Sequence: 201122153 Sequence: 201122154 Sequence: 201122155 Sequence: 201122156 Sequence: 201122157 Sequence: 201122158 Sequence: 201122159 Sequence: 201122160 Sequence: 201122161 Sequence: 201122162 Sequence: 201122163 Sequence: 201122164 Sequence: 201122165 Sequence: 201122166 Sequence: 201122167 Sequence: 201122168 Sequence: 201122169 Sequence: 201122170 Sequence: 201122171
Name Investigational Site Number 1560001 Name Investigational Site Number 1560006 Name Investigational Site Number 1560049 Name Investigational Site Number 1560039 Name Investigational Site Number 1560009 Name Investigational Site Number 1560027 Name Investigational Site Number 1560016 Name Investigational Site Number 1560053 Name Investigational Site Number 1560056 Name Investigational Site Number 1560010 Name Investigational Site Number 1560037 Name Investigational Site Number 1560050 Name Investigational Site Number 1560044 Name Investigational Site Number 1560033 Name Investigational Site Number 1560028 Name Investigational Site Number 1560012 Name Investigational Site Number 1560023 Name Investigational Site Number 1560035 Name Investigational Site Number 1560036 Name Investigational Site Number 1560011 Name Investigational Site Number 1560024 Name Investigational Site Number 1560047 Name Investigational Site Number 3440001 Name Investigational Site Number 1560025 Name Investigational Site Number 1560026 Name Investigational Site Number 1560048 Name Investigational Site Number 1560034 Name Investigational Site Number 1560005 Name Investigational Site Number 1560052 Name Investigational Site Number 1560031 Name Investigational Site Number 1560022 Name Investigational Site Number 1560014 Name Investigational Site Number 1560043 Name Investigational Site Number 1560041 Name Investigational Site Number 1560032 Name Investigational Site Number 1560038 Name Investigational Site Number 1560013 Name Investigational Site Number 1560007 Name Investigational Site Number 1560004 Name Investigational Site Number 1560029 Name Investigational Site Number 1560003 Name Investigational Site Number 1560054 Name Investigational Site Number 1560019 Name Investigational Site Number 1560059 Name Investigational Site Number 1560021 Name Investigational Site Number 1560017 Name Investigational Site Number 1560058 Name Investigational Site Number 1560018 Name Investigational Site Number 1560008 Name Investigational Site Number 1560055 Name Investigational Site Number 1560051 Name Investigational Site Number 1560030 Name Investigational Site Number 1560040 Name Investigational Site Number 1560060 Name Investigational Site Number 1560046 Name Investigational Site Number 1560045 Name Investigational Site Number 1560002 Name Investigational Site Number 1560015 Name Investigational Site Number 1560057 Name Investigational Site Number 4100009 Name Investigational Site Number 4100012 Name Investigational Site Number 4100010 Name Investigational Site Number 4100004 Name Investigational Site Number 4100003 Name Investigational Site Number 4100016 Name Investigational Site Number 4100011 Name Investigational Site Number 4100013 Name Investigational Site Number 4100001 Name Investigational Site Number 4100002 Name Investigational Site Number 4100005 Name Investigational Site Number 4580001 Name Investigational Site Number 4580005 Name Investigational Site Number 4580003 Name Investigational Site Number 4580006 Name Investigational Site Number 4580002 Name Investigational Site Number 4580004 Name Investigational Site Number 1580003 Name Investigational Site Number 1580005 Name Investigational Site Number 1580004
City Beijing City Beijing City Beijing City Cangzhou City Changchun City Changchun City Changsha City Chengdu City Chengdu City Chenzhou City Chongqing City Chongqing City Dongguan City Guangzhou City Guangzhou City Handan City Hangzhou City Harbin City Harbin City Hengshui City Hohhot City Hohhot City Hong Kong City Huang Shi City Huanggang City Huizhou City Huzhou City Jinan City Jinhua City Jinzhou City Nanjing City Nanjing City Nanjing City Nanning City Qingdao City Qinhuangdao City Shanghai City Shanghai City Shanghai City Shanghai City Shenyang City Shenzhen City Suzhou City Suzhou City Tianjin City Tianjin City Urumqi City Wuhan City Xi'An City Xi'An City Xingtai City Xining City Yanji City Yueyang City Yueyang City Zhengzhou City Zhenjiang City Zhuzhou City Zigong City Ansan-Si City Busan City Guri-Si, Gyeonggi-Do City Gwangju City Seongnam-Si City Seoul City Seoul City Seoul City Seoul City Seoul City Wonju City Kelantan City Kuala Lumpur City Kuala Lumpur City Kuching City Putrajaya City Seremban City Taichung City Tainan Hsien City Taipei
Zip 1000029 Zip 101200 Zip 102218 Zip 061000 Zip 130033 Zip 130041 Zip 410013 Zip 610081 Zip 611130 Zip 400010 Zip 400013 Zip 510120 Zip 056002 Zip 150001 Zip 150001 Zip 053000 Zip 010017 Zip 010050 Zip 516001 Zip 250013 Zip 321000 Zip 121000 Zip 210029 Zip 530021 Zip 266042 Zip 200072 Zip 200240 Zip 201700 Zip 110022 Zip 518000 Zip 215006 Zip 300052 Zip 300121 Zip 830000 Zip 430014 Zip 710061 Zip 054031 Zip 810007 Zip 133000 Zip 414000 Zip 212001 Zip 412007 Zip 643002 Zip 15355 Zip 49241 Zip 11923 Zip 61469 Zip 13620 Zip 01832 Zip 03181 Zip 03722 Zip 05278 Zip 08308 Zip 26426 Zip 16150 Zip 56000 Zip 59100 Zip 93586 Zip 70300 Zip 407 Zip 710 Zip 11031
Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country China Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Malaysia Country Malaysia Country Malaysia Country Malaysia Country Malaysia Country Malaysia Country Taiwan Country Taiwan Country Taiwan

Browse Interventions

Sequence: 96509963 Sequence: 96509964 Sequence: 96509965 Sequence: 96509966 Sequence: 96509967 Sequence: 96509968 Sequence: 96509969 Sequence: 96509970 Sequence: 96509971
Mesh Term Insulin Mesh Term Insulin, Globin Zinc Mesh Term Metformin Mesh Term Insulin Glargine Mesh Term Lixisenatide Mesh Term Sodium-Glucose Transporter 2 Inhibitors Mesh Term Hypoglycemic Agents Mesh Term Physiological Effects of Drugs Mesh Term Molecular Mechanisms of Pharmacological Action
Downcase Mesh Term insulin Downcase Mesh Term insulin, globin zinc Downcase Mesh Term metformin Downcase Mesh Term insulin glargine Downcase Mesh Term lixisenatide Downcase Mesh Term sodium-glucose transporter 2 inhibitors Downcase Mesh Term hypoglycemic agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term molecular mechanisms of pharmacological action
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52455860
Name Type 2 Diabetes Mellitus
Downcase Name type 2 diabetes mellitus

Id Information

Sequence: 40362363 Sequence: 40362364
Id Source org_study_id Id Source secondary_id
Id Value EFC14943 Id Value U1111-1190-7669
Id Type Other Identifier
Id Type Description UTN

Countries

Sequence: 42796426 Sequence: 42796427 Sequence: 42796428 Sequence: 42796429 Sequence: 42796430
Name China Name Korea, Republic of Name Malaysia Name Taiwan Name Hong Kong
Removed False Removed False Removed False Removed False Removed True

Design Groups

Sequence: 55909723 Sequence: 55909724 Sequence: 55909725
Group Type Experimental Group Type Active Comparator Group Type Active Comparator
Title Soliqua (insulin glargine/lixisenatide) Title Lantus (insulin glargine) Title Lyxumia (lixisenatide)
Description iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. Description Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Description Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.

Interventions

Sequence: 52766015 Sequence: 52766016 Sequence: 52766017 Sequence: 52766018 Sequence: 52766019
Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Insulin glargine/Lixisenatide (HOE901/AVE0010) Name Insulin glargine (HOE901) Name Lixisenatide (AVE0010) Name Metformin Name SGLT2 inhibitor
Description Pharmaceutical form: solution

Route of administration: subcutaneous

Description Pharmaceutical form: solution

Route of administration: subcutaneous

Description Pharmaceutical form: solution

Route of administration: subcutaneous

Description Pharmaceutical form: tablet

Route of administration: oral

Description Pharmaceutical form:tablet

Route of administration: oral

Design Outcomes

Sequence: 178449122 Sequence: 178449123 Sequence: 178449124 Sequence: 178449125 Sequence: 178449126 Sequence: 178449127 Sequence: 178449128 Sequence: 178449129 Sequence: 178449130 Sequence: 178449131 Sequence: 178449132 Sequence: 178449133
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in HbA1c Measure Change in postprandial plasma glucose (PPG) Measure Change in fasting plasma glucose (FPG) Measure Change in self-monitored plasma glucose (SMPG) profile Measure Patients with HbA1c <7.0% Measure Patients with HbA1c ≤ 6.5% Measure Change in body weight Measure Patients with HbA1c <7.0% with no body weight gain Measure Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia Measure Confirmed hypoglycemia Measure Adverse events (AEs) Measure Immunogenicity (antibody variables)
Time Frame From Baseline to Week 24 Time Frame From Baseline to Week 24 Time Frame From Baseline to Week 24 Time Frame From Baseline to Week 24 Time Frame At Week 24 Time Frame At Week 24 Time Frame From Baseline to Week 24 Time Frame At Week 24 Time Frame At Week 24 Time Frame From Baseline to Week 24 Time Frame From Baseline to Week 24 Time Frame From Baseline to Week 24
Description Change in glycated hemoglobin (HbA1c) from baseline to Week 24 Description Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 24 (for all patients in iGlarLixi or insulin glargine group and patients who receive morning injection in the lixisenatide group) Description Absolute change in FPG from baseline to Week 24 Description Absolute change in 7-point SMPG profiles from baseline to Week 24 (each time point and average daily value) Description Percentage of patients reaching HbA1c <7% at Week 24 Description Percentage of patients reaching HbA1c ≤ 6.5% at Week 24 Description Absolute change in body weight from baseline to Week 24 Description Percentage of patients reaching HbA1c <7% with no body weight gain at Week 24 Description Percentage of patients reaching HbA1c <7% with no body weight gain at Week 24 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia during the 24 week treatment period Description Including severe hypoglycemia and episodes of hypoglycemia documented with PG ≤70 mg/dL (3.9 mmol/L) regardless of symptoms from baseline to Week 24 Description Number of AEs, serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 24 Description Anti-lixisenatide antibodies and anti-insulin antibodies (depending on the treatment group) from baseline to Week 24

Browse Conditions

Sequence: 194573865 Sequence: 194573866 Sequence: 194573867 Sequence: 194573868 Sequence: 194573869
Mesh Term Diabetes Mellitus Mesh Term Diabetes Mellitus, Type 2 Mesh Term Glucose Metabolism Disorders Mesh Term Metabolic Diseases Mesh Term Endocrine System Diseases
Downcase Mesh Term diabetes mellitus Downcase Mesh Term diabetes mellitus, type 2 Downcase Mesh Term glucose metabolism disorders Downcase Mesh Term metabolic diseases Downcase Mesh Term endocrine system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48583822
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Sanofi

Overall Officials

Sequence: 29434316
Role Study Director
Name Clinical Sciences & Operations
Affiliation Sanofi

Design Group Interventions

Sequence: 68539472 Sequence: 68539473 Sequence: 68539474 Sequence: 68539475 Sequence: 68539476 Sequence: 68539477 Sequence: 68539478 Sequence: 68539479 Sequence: 68539480
Design Group Id 55909723 Design Group Id 55909724 Design Group Id 55909725 Design Group Id 55909724 Design Group Id 55909725 Design Group Id 55909723 Design Group Id 55909724 Design Group Id 55909725 Design Group Id 55909723
Intervention Id 52766015 Intervention Id 52766016 Intervention Id 52766017 Intervention Id 52766018 Intervention Id 52766018 Intervention Id 52766018 Intervention Id 52766019 Intervention Id 52766019 Intervention Id 52766019

Eligibilities

Sequence: 30928773
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion criteria :

Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1), treated for at least 3 months prior to the screening visit (V1) with metformin alone or metformin and a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl peptidase-4 (DPP-4) inhibitor or a sodium-glucose co transporter 2 (SGLT-2) inhibitor and who are not adequately controlled with this treatment.
Signed written informed consent.

Exclusion criteria:

Age < legal age of majority at the screening visit (V1).
Body mass index (BMI) >40 kg/m² at screening.
Glycated hemoglobin A1c (HbA1c) at screening visit:
<7.5% or >11% for patients previously treated with metformin alone;
<7.0% or >10% for patients previously treated with metformin and a second oral antidiabetic treatment.
History of hypoglycemia unawareness.
History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.
Previous treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reasons or lack of efficacy.
Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
Use of weight loss drugs within 3 months prior to screening.
Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.
Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
Planned coronary, carotid, or peripheral artery revascularization procedures to be performed during the study period.
Known history of drug or alcohol abuse within 6 months prior to screening.
Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
Laboratory findings at screening visit (V1):
Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).
Calcitonin ≥20 pg/mL (5.9 pmol/L).
Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm3 and/or platelets <100 000/mm3.
Positive urine pregnancy test in female of childbearing potential.
Patient who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
Use of SU, glinide, alpha-GI, DPP-4 inhibitor, and SGLT-2 inhibitor after start of run-in (from V2 [Week -4]).
HbA1c at V4 (Week -1) : <7.0% or >10%.
Fasting plasma glucose >250 mg/dL (13.9 mmol/L) at V4 (Week-1) (can be repeated once to confirm).
Metformin maximal tolerated dose <1500 mg/day.
Amylase and/or lipase >3 ULN at V4 (Week-1).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254207105
Number Of Facilities 79
Registered In Calendar Year 2019
Actual Duration 24
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 11

Designs

Sequence: 30674428
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26815508 Sequence: 26815509 Sequence: 26815510 Sequence: 26815511
Intervention Id 52766015 Intervention Id 52766015 Intervention Id 52766016 Intervention Id 52766017
Name Soliqua Name iGlarLixi Name Lantus Name Lyxumia

Responsible Parties

Sequence: 29041154
Responsible Party Type Sponsor

Study References

Sequence: 52365475
Pmid 35441412
Reference Type background
Citation Yang W, Dong X, Li Q, Cheng Z, Yuan G, Liu M, Xiao J, Gu S, Niemoeller E, Chen L, Ping L, Souhami E; LixiLan-O-AP trial investigators. Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial. Diabetes Obes Metab. 2022 Aug;24(8):1522-1533. doi: 10.1111/dom.14722. Epub 2022 May 12.

]]>

<![CDATA[ Early Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision ]]>
https://zephyrnet.com/NCT03798041
2019-02-01

https://zephyrnet.com/?p=NCT03798041
NCT03798041https://www.clinicaltrials.gov/study/NCT03798041?tab=tableNANANAWound healing after surgery is a complex procedure. Liquefaction of the fat and necrosis of inactivated tissue, as well as blood clots are always accumulated mostly within 24 hours after surgery. As such, early debridement within 24 hours after surgery might improve the healing of the wounds. This study is designed to compare the impact of early debridement of the wound versus regular dressing (24 hours later) on the wound healing. 100 patients will be included in this study, and divided into 2 groups randomly. Then, the healing of the wound, stitch removal time, incidence of incision complications will be compared between the two groups.
<![CDATA[

Studies

Study First Submitted Date 2019-01-01
Study First Posted Date 2019-01-09
Last Update Posted Date 2021-12-09
Start Month Year February 1, 2019
Primary Completion Month Year March 16, 2021
Verification Month Year March 2021
Verification Date 2021-03-31
Last Update Posted Date 2021-12-09

Facilities

Sequence: 200755284
Name The First Affiliated Hospital of Xi'an Jiaotong University
City Xi'an
State Shaanxi
Zip 710061
Country China

Conditions

Sequence: 52358776
Name Surgical Wound
Downcase Name surgical wound

Id Information

Sequence: 40292936
Id Source org_study_id
Id Value XJTU1AFCRC2017SJ-007-1

Countries

Sequence: 42716029
Name China
Removed False

Design Groups

Sequence: 55801750 Sequence: 55801751
Group Type Experimental Group Type No Intervention
Title Debridement group Title Control group
Description The subjects in this group will be debrided within 24 hours after surgery. Description The subjects in this group will experience wound dressing change regularly 24 hours after surgery.

Interventions

Sequence: 52669676
Intervention Type Behavioral
Name Debridement Within 24 Hours After Surgery
Description Debrided within 24 hours after surgery

Keywords

Sequence: 80126473 Sequence: 80126474
Name Surgical Wound Name Suture, Complication
Downcase Name surgical wound Downcase Name suture, complication

Design Outcomes

Sequence: 178071550 Sequence: 178071551
Outcome Type primary Outcome Type secondary
Measure healing time, d (day) Measure incidence of incision complications
Time Frame From date of surgery to the date of stitches off (up to 1 month) Time Frame From the date of surgery to stitches off (up to 1 month)
Description since the ending of surgery to stitches off. Description The incision complications include infection, dehiscence, fat liquefaction, etc.

Browse Conditions

Sequence: 194200534 Sequence: 194200535
Mesh Term Wounds and Injuries Mesh Term Surgical Wound
Downcase Mesh Term wounds and injuries Downcase Mesh Term surgical wound
Mesh Type mesh-list Mesh Type mesh-list

Sponsors

Sequence: 48493783
Agency Class OTHER
Lead Or Collaborator lead
Name First Affiliated Hospital Xi'an Jiaotong University

Overall Officials

Sequence: 29384517
Role Principal Investigator
Name Xu-Feng Zhang, MD, PhD
Affiliation First Affiliated Hospital Xi'an Jiaotong University

Design Group Interventions

Sequence: 68405039
Design Group Id 55801750
Intervention Id 52669676

Eligibilities

Sequence: 30873493
Gender All
Minimum Age 18 Years
Maximum Age 65 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

the patient with major abdominal incision.

Exclusion Criteria:

Pregnant woman
Patient with diabetes
Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
Severe lung diseases such as COPD and asthma
Patients undergoing emergent surgery or infectious surgery
Patients with surgical site infection or abdominal abscess
No autonomy, inability or unwillingness to participate in follow-up

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254046623
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 25
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30619287
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28985814
Responsible Party Type Sponsor

]]>

<![CDATA[ The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis ]]>
https://zephyrnet.com/NCT03798028
2017-12-26

https://zephyrnet.com/?p=NCT03798028
NCT03798028https://www.clinicaltrials.gov/study/NCT03798028?tab=tablePing Zhu, Doctorzhuping@fmmu.edu.cn86-29-84773951This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-09
Start Month Year December 26, 2017
Primary Completion Month Year December 31, 2019
Verification Month Year December 2018
Verification Date 2018-12-31
Last Update Posted Date 2019-01-09

Facilities

Sequence: 199965068
Status Recruiting
Name Xijing Hospital
City Xi'an
State Shaanxi
Zip 710032
Country China

Facility Contacts

Sequence: 28086648
Facility Id 199965068
Contact Type primary
Name Ping Zhu
Email zhuping@fmmu.edu.cn
Phone 862984773951
Phone Extension 862984773951

Conditions

Sequence: 52139002
Name Rheumatoid Arthritis
Downcase Name rheumatoid arthritis

Id Information

Sequence: 40135061
Id Source org_study_id
Id Value 2014ZX09508002

Countries

Sequence: 42542685
Name China
Removed False

Design Groups

Sequence: 55559342 Sequence: 55559343
Group Type Experimental Group Type No Intervention
Title UC-MSCs treatment Title no UC-MSCs treatment
Description the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment. Description the participants will receive the placebo in combined with the present treatment.

Interventions

Sequence: 52454907
Intervention Type Biological
Name UC-MSCs
Description The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.

Keywords

Sequence: 79822815 Sequence: 79822816
Name anemia Name Interstitial pulmonary disease
Downcase Name anemia Downcase Name interstitial pulmonary disease

Design Outcomes

Sequence: 177263630 Sequence: 177263631 Sequence: 177263632 Sequence: 177263633 Sequence: 177263634 Sequence: 177263635 Sequence: 177263636 Sequence: 177263637
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Improvement rate of blood routine hemoglobin (HGB) compared to baseline. Measure Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline. Measure The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70. Measure White blood cell count and platelet count improved compared to the baseline. Measure Improvement rate of blood routine hemoglobin (HGB) compared to baseline. Measure Improvement rate of forced vital capacity (FVC) and/or carbon monoxide Measure Image improvement of lung on high resolution CT. Measure Improvement of 6-minute walking distance compared to baseline.
Time Frame 24 weeks Time Frame 24 weeks Time Frame 12 weeks and 24 weeks Time Frame 12 weeks and 24 weeks Time Frame 12 weeks Time Frame 12 weeks Time Frame 24 weeks Time Frame 12 weeks and 24 weeks
Description The HGB increases by 10g compared to the baseline is considered improvement. Description FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement. Description The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria. Description White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9. Description The HGB increases by 10 g compared to the baseline is considered improvement. Description FVC increases by 0.5% and DLCO increases by 10% compared to baseline Description The area change of image of lung.

Browse Conditions

Sequence: 193366511 Sequence: 193366512 Sequence: 193366513 Sequence: 193366514 Sequence: 193366515 Sequence: 193366516 Sequence: 193366517 Sequence: 193366518
Mesh Term Arthritis Mesh Term Arthritis, Rheumatoid Mesh Term Joint Diseases Mesh Term Musculoskeletal Diseases Mesh Term Rheumatic Diseases Mesh Term Connective Tissue Diseases Mesh Term Autoimmune Diseases Mesh Term Immune System Diseases
Downcase Mesh Term arthritis Downcase Mesh Term arthritis, rheumatoid Downcase Mesh Term joint diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term rheumatic diseases Downcase Mesh Term connective tissue diseases Downcase Mesh Term autoimmune diseases Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48290705 Sequence: 48290706 Sequence: 48290707
Agency Class OTHER Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Xijing Hospital Name Changhai Hospital Name Southwest Hospital, China

Central Contacts

Sequence: 12000487
Contact Type primary
Name Ping Zhu, Doctor
Phone 86-29-84773951
Email zhuping@fmmu.edu.cn
Role Contact

Design Group Interventions

Sequence: 68107452
Design Group Id 55559342
Intervention Id 52454907

Eligibilities

Sequence: 30747721
Gender All
Minimum Age 18 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria.
Age limits:18 to 70 years old.
Freely given informed consent.
Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)>11.0或 Clinical Disease Activity Index (CDAI) >10.0.
Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT.
Poor response to current treatment. The current treatment refers to receive the medicines (including Leflunomide, Methotrexate, Sulphasalazine, Hydroxychloroquine, Cyclosporine A,and Tacrolimus, alone or in combination ) for 3 months, and maintain the stable-dose of drugs for at least 1 month.
More than 3 months and a stable dose for at least 1 month are required if glucocorticoid is used. The dose of glucocorticoid is less than or equal to10mg/ day of prednisone.

Exclusion Criteria:

Participants who received glucocorticoid therapy by intra-articular injection within 1 week.
Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.
Complication with other connective tissue disease (except for Sjogren syndrome) .
Participants with chronic and acute infection (bacteria, virus and parasite,etc.).
Participants with acute and chronic tuberculosis infection.
Malignant tumors or participants with a family history of malignant tumors.
Participants have a family history of allergic conditions.
Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV).
Participants suffer from central nervous system demyelinating disease or multiple sclerosis (MS) currently or in the past.
Participants received live vaccines with 3 months.
Drug abuse and alcoholism.
Participants with severe mental or neurological disorders that affect informed consent and/or the presentation or observer of adverse events.
Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan within 1 year.
Participants received stem cell therapy in the past.
Participants received any biological agents within 3 months.
Anemia (such as anemia with dysplasia) and interstitial lung disease for other reasons.
Participants with cardiovascular and cerebrovascular damage, such as thrombosis.
Participants taking drugs that affect the test for blood and lung.
Participants taking any traditional Chinese medicine.
Participants taking immune modulators such as Transfer Factor, Thymosin and Intravenous Immunoglobulin (IVIG), and so on.
Other cases that participants are considered by investigator that they did not meet the requirements for enrollment.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254121849
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30494004
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Subject Masked True

Intervention Other Names

Sequence: 26655414
Intervention Id 52454907
Name placebo

Responsible Parties

Sequence: 28860284
Responsible Party Type Sponsor

]]>

<![CDATA[ Neurologic Outcome After Mitral Valve Surgery ]]>
https://zephyrnet.com/NCT03798015
2009-02-28

https://zephyrnet.com/?p=NCT03798015
NCT03798015https://www.clinicaltrials.gov/study/NCT03798015?tab=tableNANANAReconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss.

This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy.

Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-04-20
Start Month Year February 2009
Primary Completion Month Year December 2021
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2022-04-20

Facilities

Sequence: 199426922
Name Herzchirurgie University Hospital Basel
City Basel
Zip 4031
Country Switzerland

Conditions

Sequence: 52012341
Name Mitral Valve Reconstruction
Downcase Name mitral valve reconstruction

Id Information

Sequence: 40034264
Id Source org_study_id
Id Value 2018-02143; ch18Grapow3

Countries

Sequence: 42430370
Name Switzerland
Removed False

Design Groups

Sequence: 55418113
Title mitral valve surgery
Description outcome of mitral valve surgery (stroke yes or no)

Interventions

Sequence: 52324665
Intervention Type Other
Name mitral valve surgery
Description assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery

Keywords

Sequence: 79613814 Sequence: 79613815 Sequence: 79613816 Sequence: 79613817 Sequence: 79613818
Name mitral valve surgery Name mitral valve stenosis Name mitral valve insufficiency Name minimal invasive mitral valve surgery Name neurological outcome
Downcase Name mitral valve surgery Downcase Name mitral valve stenosis Downcase Name mitral valve insufficiency Downcase Name minimal invasive mitral valve surgery Downcase Name neurological outcome

Design Outcomes

Sequence: 176823858
Outcome Type primary
Measure occurence of stroke (yes/ no) subsequent to mitral valve surgery
Time Frame post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)
Description assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery

Sponsors

Sequence: 48170886
Agency Class OTHER
Lead Or Collaborator lead
Name University Hospital, Basel, Switzerland

Overall Officials

Sequence: 29193996
Role Principal Investigator
Name Martin Grapow, Prof. Dr. MD
Affiliation Klinik für Herzchirurgie, Universitätsspital Basel

Design Group Interventions

Sequence: 67936194
Design Group Id 55418113
Intervention Id 52324665

Eligibilities

Sequence: 30672192
Sampling Method Probability Sample
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Population patients undergoing a surgical mitral valve reconstruction or replacement at the University Hospital Basel from 2009 until today
Criteria Inclusion Criteria:

surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale)

Exclusion Criteria:

other surgical interventions then the surgical interventions mentioned in the inclusion criteria
pre- existing neurological deficit; neurologic limitation in daily life
emergency surgery

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254302744
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 156
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30418962
Observational Model Cohort
Time Perspective Retrospective

Responsible Parties

Sequence: 28785479
Responsible Party Type Sponsor

]]>

<![CDATA[ Neuro-muscular Exercise Training Verses Quadriceps Training in Mild to Moderate Knee Osteoarthritis ]]>
https://zephyrnet.com/NCT03798002
2019-01-15

https://zephyrnet.com/?p=NCT03798002
NCT03798002https://www.clinicaltrials.gov/study/NCT03798002?tab=tableNANANAA randomized controlled trial in which Neuro-muscular exercise training and Isolated quadriceps training program would be applied on patients with symptomatic knee Osteoarthritis by using different tools and changes would be examined pre and post intervention .The participants fulfilling inclusion criteria would be randomly allocated to two groups. Both groups received different protocols and will be assessed on data collection tool on their first and last visit by using Numeric Pain Rating Scale (NPRS), The Western Ontario and McMaster Osteoarthritis Index (WOMAC), Timed Up and Go test (TUG test), 30sec chair stand test,6min walk test (6MWT).Participants of both groups will be pre-tested before the application of interventional programs and post-tested after the application of respective intervention.
<![CDATA[

Studies

Study First Submitted Date 2019-01-05
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-08-08
Start Month Year January 15, 2019
Primary Completion Month Year April 30, 2019
Verification Month Year August 2019
Verification Date 2019-08-31
Last Update Posted Date 2019-08-08

Detailed Descriptions

Sequence: 20716289
Description The knee joint is a complex modified hinge joint with the greatest range of movement. Three bones come together to form the joint, which are the femur, tibia, and patella. Osteoarthritis, commonly known as wear-and-tear arthritis, is a condition in which the natural cushioning between joints, cartilage wears away. The bones of the joints rub more closely against one another with less of the shock-absorbing benefits of cartilage. The rubbing results in pain, swelling, stiffness, decreased ability to move and, sometimes, the formation of bone spurs.

Osteoarthritis is widespread among physically active individuals . The quadriceps weakness commonly associated with osteoarthritis of the knee is widely believed to result from disuse atrophy secondary to pain in the involved joint. However, quadriceps weakness may be an etiologic factor in the development of osteoarthritis. Several studies have indicated that Physical modalities for the treatment of knee pain in patients with osteoarthritis include physical therapy, exercise, weight loss, and the use of braces or heel wedges. High- and low-intensity aerobic exercises are equally effective in improving functional status, gait, pain, and aerobic capacity in persons with knee osteoarthritis water-based and land-based exercises reduce knee pain and physical disability and aerobic walking, quadriceps strengthening, resistance exercise reduce pain and disability.Several proptocols are available for management of knee joint osteoarthritis. These protocols include Neuro motor training exercise and isolated quadriceps training program. Neuromotor training is basically combination of three parts warming up, a circuit program, and cooling down. Main principle of Neuro-motor training is to improve sensorimotor control and compensatory functional stability.[3]Patients with symptomatic osteoarthritis pain, stiffness, flexibility and decreases range of motion is a common clinical finding. Flexibility is an important component of fitness needed for most desirable musculoskeletal functioning and maximizing the performance of physical activities. Flexibility is a biomechanical property of the body tissues and it determines the range of motion possible without injury at a joint or group of joints. Decrease range of motion has been shown to predispose a person to several musculoskeletal overuse injuries and considerably affect a person level of function.Changes in joint appearance/ joint deformities be one of the more commonly established causes of osteoarthritis. The target in treating patients with OA should be the safest possible intervention, with the best pain relief and prevention of further functional disability. Neuromotor training is also one of the treatment option related to physical therapy in reducing knee pain with home plane exercises to gain required ROM and resume function. Time up and go test (TUG test).the tug is internationally accepted functional dynamic test of balance with known reliability and validity as well as being low cost and easy to apply. The tug test measures the time in seconds that takes a subject to stand up from chair and sit down. Subject will score less than 10 seconds are consider normal, less than 15 sec are at risk of fall ,less than 20 sec are independent in ambulation and able to climb the stairs, and greater than 30 seconds need help with chair. The 30 Second Chair Stand Test, in conjunction with other measures such as the 4-Stage Balance Test, Timed Up and Go (TUG) Test and an assessment of postural hypotension can help to indicate if a patient is at risk of falling. Purpose is to test leg strength and endurance Equipment: A chair with a straight back, without arm rests, placed against a wall to prevent it moving. Sit in the middle of the chair. Place each hand on the opposite shoulder crossed at the wrists. Place your feet flat on the floor. Keep your back straight and keep your arms against your chest. On "Go", rise to a full standing position and then sit back down again. Repeat this for 30 seconds. On "Go" begin timing. Do not continue if you feel the patient may fall during the test. Count the number of times the patient comes to a full standing position in 30 seconds and record it in the box below. If the patient is over halfway to a standing position when 30 seconds have elapsed, count it as a stand. If the patient must use his or her arms to stand then stop the test and record "0" for the number below.The western Ontario and McMaster universities osteoarthritis (womac) is a widely used by health professionals to evaluate the condition of patient with osteoarthritis of knee . womac measures 5 items for pain score 0-20. 2 for stiffness score 0-8 and 17 for functional limitation score 0-68. Physical functioning question of daily activities such as siting standing walking lying on bed taking of socks getting in or out of bath. Numeric pain rating scale (NPRs) is used for measure of pain intensity. In NPRS 0-10 integers that best reflects the intensity of pain. 0 represent no pain.

Previous studies were more focused on hydrotherapeutic exercises, muscle stretching strengthening, aerobics. There is still a challenge to explore best type of exercise therapy for improving sensorimotor function, alleviating symptoms and showing the disease process in different sub groups of patients with degenerative knee disease

Facilities

Sequence: 200053274 Sequence: 200053275
Name Imran Amjad Name Riphah International University
City Islamabad City Islamabad
State Punjab
Zip 46000 Zip 46000
Country Pakistan Country Pakistan

Conditions

Sequence: 52156483
Name Knee Osteoarthritis
Downcase Name knee osteoarthritis

Id Information

Sequence: 40148199
Id Source org_study_id
Id Value RiphahI Maryam Khan

Countries

Sequence: 42557722
Name Pakistan
Removed False

Design Groups

Sequence: 55577890 Sequence: 55577891
Group Type Experimental Group Type Active Comparator
Title Neuro-muscular exercise training Group Title quadriceps training program
Description Neuro-muscular exercise training will be administer to Knee OA patients. Description quadriceps stretching and strengthening exercises will be administer to Knee OA patients.

Interventions

Sequence: 52471996 Sequence: 52471997
Intervention Type Other Intervention Type Other
Name Neuro-muscular exercise training Group Name quadriceps training program
Description Training takes place 3 days a week for 8 weeks follow up, under the supervision of physical therapist A training session lasts for 40 minutes, and consists of three parts.

PART 1:Warming up:

warm-up period consists of ergometer cycling for 10 minutes

PART 2: Circuit program:

comprises four exercises, core stability/postural function; postural orientation; lower extremity muscle strength; and functional exercises. Each exercise is performed 2-3 sets 10-15 repetitions.

PART 3:Cooling down:

The cooling down part consists of walking exercises forward and backwards, about 10 meters in each direction, in front of mirror (mobility exercises for the lower extremity muscles for a total of about 10 minutes. Changes in patient's symptom assessed by structural questionnaire

Description Apply Tens (10min+ hot pack 7-10min) Before excercise ROM,Quadriceps and hamstring stretching exercise's and strengthening exercises.

4th-6th week (in addition): Straight leg raise, Quads over a roll, Hamstring curls. 7th and 8th week (in addition): Elastic band exercise, Hamstring curls, Quads chair, isometric strengthening All exercises are performed in set of 10 repetitions. 1 set of all exercises was twice a day for first 3 week, and 2 sets twice a day until 6th week and then 3 sets twice a day until 8th week

Keywords

Sequence: 79848067 Sequence: 79848068 Sequence: 79848069
Name isolated quadriceps training Name Neuro-muscular exercise training Name knee Osteoarthritis
Downcase Name isolated quadriceps training Downcase Name neuro-muscular exercise training Downcase Name knee osteoarthritis

Design Outcomes

Sequence: 177327866 Sequence: 177327867
Outcome Type primary Outcome Type secondary
Measure WOMAC Scale Measure Numeric pain rating scale(NPRS)
Time Frame From baseline to 8th week Time Frame From baseline to 8th week
Description WOMAC is western Onterio and McMaster Osteoarthritis Index. Its scores are from 0-100 Description Numeric pain rating scale is used to measure pain. Its score is from 0-10, with 0 means no pain and10 means worst pain.

Browse Conditions

Sequence: 193432017 Sequence: 193432018 Sequence: 193432019 Sequence: 193432020 Sequence: 193432021 Sequence: 193432022
Mesh Term Osteoarthritis Mesh Term Osteoarthritis, Knee Mesh Term Arthritis Mesh Term Joint Diseases Mesh Term Musculoskeletal Diseases Mesh Term Rheumatic Diseases
Downcase Mesh Term osteoarthritis Downcase Mesh Term osteoarthritis, knee Downcase Mesh Term arthritis Downcase Mesh Term joint diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term rheumatic diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48306061
Agency Class OTHER
Lead Or Collaborator lead
Name Riphah International University

Overall Officials

Sequence: 29277922
Role Principal Investigator
Name imran Amjad, Phd*
Affiliation Associate Professor

Design Group Interventions

Sequence: 68130859 Sequence: 68130860
Design Group Id 55577890 Design Group Id 55577891
Intervention Id 52471996 Intervention Id 52471997

Eligibilities

Sequence: 30757344
Gender All
Minimum Age 40 Years
Maximum Age 65 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

UL/BL knee OA,
Age 40-65, both genders,
American college of rheumatology criteria for knee OA,
Grade 2 or 3 on Kellgren/Lawrence classification for Knee OA.

Exclusion Criteria:

Knee surgery
Rheumatoid arthritis
Any neurological condition affecting lower limbs and balance
Use of assistive devices for walking.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254227709
Number Of Facilities 2
Registered In Calendar Year 2019
Actual Duration 3
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 40
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30503569
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Single
Subject Masked True

Responsible Parties

Sequence: 28869847
Responsible Party Type Sponsor

Study References

Sequence: 52049388 Sequence: 52049389 Sequence: 52049390 Sequence: 52049391 Sequence: 52049392 Sequence: 52049393 Sequence: 52049394 Sequence: 52049395
Pmid 19560995 Pmid 9230035 Pmid 23559821 Pmid 23461090 Pmid 27836677 Pmid 24931956 Pmid 23924144 Pmid 22141334
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Weng MC, Lee CL, Chen CH, Hsu JJ, Lee WD, Huang MH, Chen TW. Effects of different stretching techniques on the outcomes of isokinetic exercise in patients with knee osteoarthritis. Kaohsiung J Med Sci. 2009 Jun;25(6):306-15. doi: 10.1016/S1607-551X(09)70521-2. Citation Slemenda C, Brandt KD, Heilman DK, Mazzuca S, Braunstein EM, Katz BP, Wolinsky FD. Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med. 1997 Jul 15;127(2):97-104. doi: 10.7326/0003-4819-127-2-199707150-00001. Citation Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561. Citation Merashly M, Uthman I. Management of knee osteoarthritis: an evidence-based review of treatment options. J Med Liban. 2012 Oct-Dec;60(4):237-42. Citation Holsgaard-Larsen A, Clausen B, Sondergaard J, Christensen R, Andriacchi TP, Roos EM. The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial. Osteoarthritis Cartilage. 2017 Apr;25(4):470-480. doi: 10.1016/j.joca.2016.10.022. Epub 2016 Nov 9. Citation Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15. Citation Ageberg E, Nilsdotter A, Kosek E, Roos EM. Effects of neuromuscular training (NEMEX-TJR) on patient-reported outcomes and physical function in severe primary hip or knee osteoarthritis: a controlled before-and-after study. BMC Musculoskelet Disord. 2013 Aug 8;14:232. doi: 10.1186/1471-2474-14-232. Citation Bennell KL, Egerton T, Wrigley TV, Hodges PW, Hunt M, Roos EM, Kyriakides M, Metcalf B, Forbes A, Ageberg E, Hinman RS. Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2011 Dec 5;12:276. doi: 10.1186/1471-2474-12-276.

]]>

<![CDATA[ VAC069: A Study of Blood-stage Controlled Human P. Vivax Infection ]]>
https://zephyrnet.com/NCT03797989
2019-01-10

https://zephyrnet.com/?p=NCT03797989
NCT03797989https://www.clinicaltrials.gov/study/NCT03797989?tab=tableNANANAThis is a clinical study to assess the safety and feasibility of Plasmodium vivax (P. vivax) controlled blood-stage human malaria infection (CHMI), by inoculation using a newly created source of P. vivax malaria-infected blood.

25 healthy malaria-naïve UK volunteers, aged 18 – 50, will be recruited through the five phases of the study at the CCVTM, Oxford. Volunteers will undergo primary, secondary and tertiary P. vivax blood-stage challenges, which will be induced by injection of P. vivax infected blood. After the first challenge, the optimal dose for blood-stage CHMI will be selected and used for the second and third challenges. Through each challenge period, volunteers will have blood taken at regular intervals to measure the parasite growth, quantify the sexual parasite forms and assess the immune response to P. vivax infection. Transmission of P. vivax from volunteers to the Anopheline mosquito vectors will also be assessed.

In each challenge, following diagnosis, volunteers will be treated with a standard antimalarial course of oral artemether-lumefantrine (Riamet), given over 60 hours. Volunteers who take part in this study will be involved in the trial for approximately 2 years, receiving each of the three challenges at intervals of approximately 5 (and up to 9) months. Volunteers will be followed for 3 months after their last challenge.
<![CDATA[

Studies

Study First Submitted Date 2018-11-29
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-08-17
Start Month Year January 10, 2019
Primary Completion Month Year December 31, 2022
Verification Month Year August 2022
Verification Date 2022-08-31
Last Update Posted Date 2022-08-17

Detailed Descriptions

Sequence: 20838459
Description This study aims primarily to assess the safety and feasibility of controlled blood-stage human P. vivax malaria infection. This will be the first time that this source of P. vivax infected blood will be utilised and the first P. vivax bloodstage CHMI in Europe. If demonstrated to be safe, it is intended that this parasitised blood bank be used in future CHMI studies to evaluate candidate vaccines.

This study will also assess parasite growth, including quantifying the sexual-stage parasites in the blood, as well as the transmission of P. vivax from volunteers to the Anopheline mosquito vectors and the immune responses in primary, secondary and tertiary P. vivax blood-stage challenge, as further secondary aims. Natural immunity to P. vivax is acquired over time, following repeated exposure. Repeated blood-stage challenge would improve understanding of how the human immune response to P. vivax infected is acquired, and how parasite growth changes in a second or third exposure. Repeated challenges can also be used to test if potential vaccine candidates can protect against repeated malaria infection. If proven to be safe and feasible in this study, this will provide a basis for conducting P. vivax blood-stage re-challenge studies for evaluation of new vaccine candidates.

The study is funded through The Wellcome Trust and MultiViVax, a European Commission Horizon 2020 funded project.

Facilities

Sequence: 201180557
Name Centre for Clinical Vaccinology & Tropical Medicine
City Oxford
State Oxfordshire
Zip OX3 7LE
Country United Kingdom

Conditions

Sequence: 52470523
Name Malaria, Vivax
Downcase Name malaria, vivax

Id Information

Sequence: 40373226
Id Source org_study_id
Id Value VAC069

Countries

Sequence: 42808786
Name United Kingdom
Removed False

Design Groups

Sequence: 55925841 Sequence: 55925842 Sequence: 55925843 Sequence: 55925844 Sequence: 55925845 Sequence: 55925846 Sequence: 55925847 Sequence: 55925848 Sequence: 55925849 Sequence: 55925850 Sequence: 55925851 Sequence: 55925852 Sequence: 55925853 Sequence: 55925854 Sequence: 55925855 Sequence: 55925856
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title Phase A: Group 1 Title Phase A: Group 2 Title Phase A: Group 3 Title Phase B: Group 4 Title Phase B: Group 6 Title Phase C: Group 5 Title Phase C: Group 7 Title Phase C: Group 9 Title Phase D: Group 8 Title Phase D: Group 10 Title Phase D: Group 12 Title Phase E: Group 11 Title Phase E: Group 13 Title Phase E: Group 15 Title Phase F: Group 14 Title Phase F: Group 16
Description Each volunteer will receive one vial of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI. Description Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI. Description Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI. Description The six volunteers from Groups 1, 2 and 3 in will undergo secondary challenge using the optimal inoculum, as determined in Phase A of the study. They will constitute 'Group 4' in Phase B. This will occur approximately eight months (and up to nine months) later after their primary challenge. Description Three new malaria naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls to Group 4. Description The six volunteers from Group 4 in Phase B will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 5 in Phase C. This will occur approximately sixteen months (and up to twenty months) later after their secondary challenge. Description The three volunteers from Group 6 who underwent primary challenge in Phase B undergo secondary challenge, again using the optimal inoculum as determined in Phase A, and will now form Group 7 in Phase C. This will occur approximately six months (and up to nine months) later after their primary challenge. Description Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 5 and 7. Description The three volunteers from Group 7 in Phase C will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 8 in Phase D. This will occur approximately five months (and up to ten months) after their secondary challenge. Description The four to eight volunteers from Group 9 in Phase C will undergo secondary challenge, using the optimal inoculum as determined in Phase A, and form Group 10 in Phase D. This will occur approximately six months (and up to nine months) later after their primary challenge. Description Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 8 and 10. Description The four to eight volunteers from Group 10 in Phase D will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 11 in Phase E. This will occur approximately five months (and up to ten months) after their secondary challenge. Description The four to eight volunteers from Group 12 in Phase D will undergo secondary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 13 in Phase E. This will occur approximately five months (and up to ten months) after their secondary challenge. Description Two new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 11 and 13. Description The four to eight volunteers from Group 13 in Phase E will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 14 in Phase F. This will occur approximately five months (and up to ten months) after their secondary challenge. Description Two new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Group 14.

Interventions

Sequence: 52780794
Intervention Type Biological
Name P. vivax infected inoculum (parasitised red blood cells)
Description In the first controlled human malaria infection (CHMI, Phase A), inoculation of parasitised red blood cells will be at three different doses (1 vial, 1:5 dilution, 1:20 dilution). The optimal inoculation dose will then be selected and administered to all participants in each of the second and third CHMI.

Design Outcomes

Sequence: 178502132 Sequence: 178502133 Sequence: 178502134 Sequence: 178502135 Sequence: 178502136 Sequence: 178502137 Sequence: 178502138 Sequence: 178502139
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Safety of primary P. vivax blood-stage CHMI as measured by (S)AE occurrences Measure The optimal inoculation dose to take forward to future P. vivax CHMI studies Measure Feasibility of primary P. vivax blood-stage CHMI as measured by successful infection (development of detectable persistent parasitaemia by thick film and qPCR +/- clinical symptoms) Measure Safety of secondary and tertiary P. vivax controlled blood-stage CHMI as measured by (S)AE occurrences Measure Immune response to primary, secondary and tertiary P. vivax pre-treatment Measure Gametocytaemia Measure Feasibility of secondary and tertiary P. vivax controlled blood-stage CHMI as measured by successful infection (development of detectable persistent parasitaemia by thick film and qPCR +/- clinical symptoms) Measure Transmissibility of gametocytes from the infected volunteer to Anopheline mosquito vector, which will be assesed by Direct Membrane Feeding Assays (DMFA)
Time Frame 36 months Time Frame 3 months Time Frame 36 months Time Frame 36 months Time Frame 36 months Time Frame 36 months Time Frame 36 months Time Frame 36 months
Description Choosing the optimal inoculation dose to take forward to future P. vivax CHMI studies will be decided based on the following algorithm:

Ideal choice = the first group (2/2 volunteers) to reach diagnosis criteria (within 21 days). N.B. If both volunteers in Group 1 develop infection AND both volunteers in Group 2 (or 3) reliably develop infection within 5 days of Group 1 (and within the 21-day window) then the lowest dose group should be chosen.

Description As measured by antibody, B cell and T cell responses through experimental injection of P. vivax infected erythrocytes Description As measured by qPCR in primary, secondary and tertiary P. vivax blood-stage CHMI.

Browse Conditions

Sequence: 194630640 Sequence: 194630641 Sequence: 194630642 Sequence: 194630643 Sequence: 194630644 Sequence: 194630645
Mesh Term Malaria Mesh Term Malaria, Vivax Mesh Term Infections Mesh Term Protozoan Infections Mesh Term Parasitic Diseases Mesh Term Vector Borne Diseases
Downcase Mesh Term malaria Downcase Mesh Term malaria, vivax Downcase Mesh Term infections Downcase Mesh Term protozoan infections Downcase Mesh Term parasitic diseases Downcase Mesh Term vector borne diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48597456
Agency Class OTHER
Lead Or Collaborator lead
Name University of Oxford

Overall Officials

Sequence: 29442268
Role Principal Investigator
Name Angela M Minassian, MBBS MA DPhil MRCP FRCPath
Affiliation University of Oxford

Design Group Interventions

Sequence: 68559836 Sequence: 68559837 Sequence: 68559838 Sequence: 68559839 Sequence: 68559840 Sequence: 68559841 Sequence: 68559842 Sequence: 68559843 Sequence: 68559844 Sequence: 68559845 Sequence: 68559846 Sequence: 68559847 Sequence: 68559848 Sequence: 68559849 Sequence: 68559850 Sequence: 68559851
Design Group Id 55925841 Design Group Id 55925842 Design Group Id 55925843 Design Group Id 55925844 Design Group Id 55925845 Design Group Id 55925846 Design Group Id 55925847 Design Group Id 55925848 Design Group Id 55925850 Design Group Id 55925851 Design Group Id 55925849 Design Group Id 55925852 Design Group Id 55925853 Design Group Id 55925854 Design Group Id 55925855 Design Group Id 55925856
Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794 Intervention Id 52780794

Eligibilities

Sequence: 30937139
Gender All
Minimum Age 18 Years
Maximum Age 50 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Healthy adult aged 18 to 50 years.
Red blood cells positive for the Duffy antigen/chemokine receptor (DARC).
Normal serum levels of Glucose-6-phosphate dehydrogenase (G6PDH).
Negative haemoglobinopathy screen
Able and willing (in the Investigator's opinion) to comply with all study requirements.
Willing to allow the Investigators to discuss the volunteer's medical history with their General Practitioner.
Women only: Must practice continuous effective contraception for the duration of the clinic visits (first 3 months post-CHMI).
Agreement to permanently refrain from blood donation
Written informed consent to participate in the trial.
Reachable (24/7) by mobile phone during the period between CHMI and completion of all antimalarial treatment.
Willing to take a curative anti-malarial regimen following CHMI.
Willing to reside in Oxford for the duration of the study, until antimalarials have been completed.
Answer all questions on the informed consent quiz correctly.

Exclusion Criteria:

History of clinical malaria (any species).
Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g.trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).
Haemoglobin <120 g/L for a female volunteer or <130 g/L for a male volunteer prior to primary CHMI. (However, for enrolment into secondary and tertiary CHMIs slightly lower haemoglobin values (≤0.5 g/L) will be permitted at the discretion of the Investigator, to account for the blood volume donated during the previous CHMI).
Receipt of immunoglobulins within the three months prior to enrolment.
Receipt of blood transfusion at any time in the past.
Peripheral venous access unlikely to allow twice daily blood testing (as determined by the Investigator).
Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.
Planned receipt of a COVID-19 vaccine between 2 weeks before the day of CHMI until completion of antimalarial treatment
Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
History of allergic disease or reactions likely to be exacerbated by malaria infection.
Pregnancy, lactation or intention to become pregnant during the study.
Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone.
Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone.
Any clinical condition known to prolong the QT interval.
History of cardiac arrhythmia, including clinically relevant bradycardia.
Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
Family history of congenital QT prolongation or sudden death.
Contraindications to the use of both of the proposed anti-malarial medications Riamet and Malarone.
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
History of serious psychiatric condition that may affect participation in the study.
Any other serious chronic illness requiring hospital specialist supervision.
Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 25 standard UK units every week.
Suspected or known injecting drug abuse in the 5 years preceding enrolment.
Hepatitis B surface antigen (HBsAg) detected in serum.
Seropositive for hepatitis C virus (antibodies to HCV) at screening or at C-7 (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
Positive family history in both 1st AND 2nd degree relatives < 50 years old for cardiac disease.
Volunteers unable to be closely followed for social, geographic or psychological reasons.
Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested.
Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate.
Additional exclusion criteria for Groups 6-13: Body weight <50Kg, as measured at screening

Exclusion criteria on day of CHMI:

Acute disease, defined as moderate or severe illness with or without fever.
Current COVID-19 infection, defined as ongoing symptoms with positive COVID-19 PCR swab test taken during current illness or positive COVID-19 PCR swab test within preceding 14 days without symptoms.
Pregnancy.
Potential volunteers who are due to have a COVID-19 vaccine in the period between 2 weeks before the day of malaria challenge and expected time of completion of malaria treatment will not be enrolled (estimate up to 3 weeks after day of challenge based on experience in this study to date). If a volunteer receives an appointment for COVID-19 vaccination after they have undergone malaria challenge but before reaching malaria diagnosis criteria, they will be advised to delay their COVID-19 vaccination until after reaching malaria diagnostic criteria and completion of antimalarial treatment. If a participant does not wish to delay their COVID-19 vaccination, they will be treated with antimalarial treatment at that time point and withdrawn from the study but will be encouraged to complete follow-up for safety.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254239523
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 50
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30682761
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29049488
Responsible Party Type Sponsor

Study References

Sequence: 52380760 Sequence: 52380761
Pmid 35664997 Pmid 34609964
Reference Type derived Reference Type derived
Citation Hou MM, Barrett JR, Themistocleous Y, Rawlinson TA, Diouf A, Martinez FJ, Nielsen CM, Lias AM, King LDW, Edwards NJ, Greenwood NM, Kingham L, Poulton ID, Khozoee B, Goh C, Mac Lochlainn DJ, Salkeld J, Guilotte-Blisnick M, Huon C, Mohring F, Reimer JM, Chauhan VS, Mukherjee P, Biswas S, Taylor IJ, Lawrie AM, Cho JS, Nugent FL, Long CA, Moon RW, Miura K, Silk SE, Chitnis CE, Minassian AM, Draper SJ. Impact of a blood-stage vaccine on Plasmodium vivax malaria. medRxiv. 2022 May 30:2022.05.27.22275375. doi: 10.1101/2022.05.27.22275375. Preprint. Citation Minassian AM, Themistocleous Y, Silk SE, Barrett JR, Kemp A, Quinkert D, Nielsen CM, Edwards NJ, Rawlinson TA, Ramos Lopez F, Roobsoong W, Ellis KJ, Cho JS, Aunin E, Otto TD, Reid AJ, Bach FA, Labbe GM, Poulton ID, Marini A, Zaric M, Mulatier M, Lopez Ramon R, Baker M, Mitton CH, Sousa JC, Rachaphaew N, Kumpitak C, Maneechai N, Suansomjit C, Piteekan T, Hou MM, Khozoee B, McHugh K, Roberts DJ, Lawrie AM, Blagborough AM, Nugent FL, Taylor IJ, Johnson KJ, Spence PJ, Sattabongkot J, Biswas S, Rayner JC, Draper SJ. Controlled human malaria infection with a clone of Plasmodium vivax with high-quality genome assembly. JCI Insight. 2021 Dec 8;6(23):e152465. doi: 10.1172/jci.insight.152465.

]]>

<![CDATA[ The Effects Of DBS Of Subthalamıc Nucleus On Functionality In Patıents With Parkinson’s Disease: Short-Term Results ]]>
https://zephyrnet.com/NCT03797976
2018-01-01

https://zephyrnet.com/?p=NCT03797976
NCT03797976https://www.clinicaltrials.gov/study/NCT03797976?tab=tableBircan Yucekaya, MScbircanyucekaya@hotmail.com03262455516Parkinson’s disease is a progressive chronic neurodegenerative disease. In cases where drug treatment is insufficient and drug use is not possible due to drug side effects, highly effective and low-risk surgical treatment options could be used. In Parkinson’s Disease; findings such as chest wall rigidity and weakness of the respiratory muscle strength occur. The aim of this study was to determine the effect of preop and postop DBS surgery on respiratory muscle strength, respiratory function and physical performance in patients with Parkinson’s disease.
<![CDATA[

Studies

Study First Submitted Date 2018-12-18
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-03-15
Start Month Year January 1, 2018
Primary Completion Month Year September 30, 2019
Verification Month Year March 2019
Verification Date 2019-03-31
Last Update Posted Date 2019-03-15

Detailed Descriptions

Sequence: 20721661
Description In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle strength, exercise capacity, functionality, and muscle strength will be evaluated

Facilities

Sequence: 200108508
Status Recruiting
Name Hatay Mustafa Kemal University
City Antakya
State Hatay
Zip 30100
Country Turkey

Facility Contacts

Sequence: 28106439 Sequence: 28106440
Facility Id 200108508 Facility Id 200108508
Contact Type primary Contact Type backup
Name Bircan Yucekaya, MSc Name Deran Oskay, PhD
Email bircanyucekaya@hotmail.com Email deranoskay@yahoo.com
Phone +903262455516 Phone 312 2162600
Phone Extension 15514 Phone Extension 2162627

Conditions

Sequence: 52171329 Sequence: 52171328 Sequence: 52171330 Sequence: 52171331
Name Surgery Name Parkinson Disease Name Respiration; Decreased Name Muscle Weakness
Downcase Name surgery Downcase Name parkinson disease Downcase Name respiration; decreased Downcase Name muscle weakness

Id Information

Sequence: 40158679
Id Source org_study_id
Id Value Hatay Mustafa Kemal U 1

Countries

Sequence: 42568978
Name Turkey
Removed False

Design Groups

Sequence: 55593243
Group Type Experimental
Title Parkinson's Disease Group
Description MIP and MEP Respiratory Function Test Strength Test

Interventions

Sequence: 52485553
Intervention Type Device
Name MIP and MEP
Description Pre-op, Post-op of, 1 month after surgery, 3 months after surgery

Design Outcomes

Sequence: 177379100 Sequence: 177379101 Sequence: 177379102 Sequence: 177379103 Sequence: 177379104
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Functional exercise capacity Measure Pulmonary functions Measure Inspiratory and expiratory muscle strength (MIP, MEP) Measure Muscle strength Measure Grip Test (Peripheral muscle strength)
Time Frame Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months Time Frame Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months Time Frame Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months Time Frame Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months Time Frame Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Description 6 minute walking test Description Spirometry Description Mouth pressure device Description Muscle Testing Device (N) Description Hand Held Dynamometer (kgf)

Browse Conditions

Sequence: 193487024 Sequence: 193487025 Sequence: 193487026 Sequence: 193487027 Sequence: 193487028 Sequence: 193487029 Sequence: 193487030 Sequence: 193487031 Sequence: 193487032 Sequence: 193487033 Sequence: 193487034 Sequence: 193487035 Sequence: 193487036 Sequence: 193487037 Sequence: 193487038
Mesh Term Muscle Weakness Mesh Term Parkinson Disease Mesh Term Parkinsonian Disorders Mesh Term Basal Ganglia Diseases Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Movement Disorders Mesh Term Synucleinopathies Mesh Term Neurodegenerative Diseases Mesh Term Muscular Diseases Mesh Term Musculoskeletal Diseases Mesh Term Neuromuscular Manifestations Mesh Term Neurologic Manifestations Mesh Term Pathologic Processes
Downcase Mesh Term muscle weakness Downcase Mesh Term parkinson disease Downcase Mesh Term parkinsonian disorders Downcase Mesh Term basal ganglia diseases Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term movement disorders Downcase Mesh Term synucleinopathies Downcase Mesh Term neurodegenerative diseases Downcase Mesh Term muscular diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term neuromuscular manifestations Downcase Mesh Term neurologic manifestations Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319344
Agency Class OTHER
Lead Or Collaborator lead
Name Mustafa Kemal University

Overall Officials

Sequence: 29285377 Sequence: 29285378 Sequence: 29285379
Role Study Director Role Study Chair Role Principal Investigator
Name Deran Oskay, PhD Name Bircan Yucekaya, MSc Name Atilla Yılmaz, Med. Dr
Affiliation Gazi University Faculty of Health Science Department of Physical Therapy Affiliation Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation Affiliation Hatay Mustafa Kemal University Department of Neurosurgery

Central Contacts

Sequence: 12008898 Sequence: 12008899
Contact Type primary Contact Type backup
Name Deran Oskay, PhD Name Bircan Yucekaya, MSc
Phone 0312 2162600 Phone 03262455516
Email deranoskay@yahoo.com Email bircanyucekaya@hotmail.com
Phone Extension 2162627 Phone Extension 15514
Role Contact Role Contact

Design Group Interventions

Sequence: 68149218
Design Group Id 55593243
Intervention Id 52485553

Eligibilities

Sequence: 30765390
Gender All
Minimum Age 40 Years
Maximum Age 70 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Lack of any neurological disease other than Parkinson's
DBS surgery to be performed in the STN region

Exclusion Criteria:

Patients with advanced cognitive impairment
Patients with pulmonary, neurological and orthopedic diseases affecting functionalities
Pregnancy
Patients in whom the stimulation was canceled due to infection after surgery.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253886010
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 40
Maximum Age Num 70
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30511556
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26673768 Sequence: 26673769
Intervention Id 52485553 Intervention Id 52485553
Name Respiratory Function Test Name Muscle Test

Responsible Parties

Sequence: 28877851
Responsible Party Type Principal Investigator
Name Bircan Yücekaya
Title Lecturer
Affiliation Mustafa Kemal University

Study References

Sequence: 52063431 Sequence: 52063432 Sequence: 52063433
Pmid 17130410 Pmid 20022689 Pmid 21841525
Reference Type background Reference Type background Reference Type background
Citation Stemper B, Beric A, Welsch G, Haendl T, Sterio D, Hilz MJ. Deep brain stimulation improves orthostatic regulation of patients with Parkinson disease. Neurology. 2006 Nov 28;67(10):1781-5. doi: 10.1212/01.wnl.0000244416.30605.f1. Citation Trachani E, Constantoyannis C, Sirrou V, Kefalopoulou Z, Markaki E, Chroni E. Effects of subthalamic nucleus deep brain stimulation on sweating function in Parkinson's disease. Clin Neurol Neurosurg. 2010 Apr;112(3):213-7. doi: 10.1016/j.clineuro.2009.11.015. Epub 2009 Dec 22. Citation Hyam JA, Brittain JS, Paterson DJ, Davies RJ, Aziz TZ, Green AL. Controlling the lungs via the brain: a novel neurosurgical method to improve lung function in humans. Neurosurgery. 2012 Feb;70(2):469-77; discussion 477-8. doi: 10.1227/NEU.0b013e318231d789.

]]>

<![CDATA[ Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation ]]>
https://zephyrnet.com/NCT03797963
2019-01-08

https://zephyrnet.com/?p=NCT03797963
NCT03797963https://www.clinicaltrials.gov/study/NCT03797963?tab=tableNANANAThe study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using two different xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor elevation.

A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of autogenous cortical bone (collected by a bone scraper from the access window to the maxillary sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core biopsies will be obtained at the site of implant placement 6 months after the floor elevation. Histological sections will be subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
<![CDATA[

Studies

Study First Submitted Date 2019-01-06
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-05-23
Start Month Year January 8, 2019
Primary Completion Month Year February 2, 2021
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-23

Facilities

Sequence: 200584875
Name Universidad de Granada
City Granada
Zip 18071
Country Spain

Conditions

Sequence: 52319484
Name Sinus Floor Augmentation
Downcase Name sinus floor augmentation

Id Information

Sequence: 40264680
Id Source org_study_id
Id Value 480CEIH2018

Countries

Sequence: 42684031
Name Spain
Removed False

Design Groups

Sequence: 55758277 Sequence: 55758278
Group Type Active Comparator Group Type Experimental
Title PBM+ACB Title ABB+ACB
Description Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone Description Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone

Interventions

Sequence: 52630545 Sequence: 52630546
Intervention Type Device Intervention Type Device
Name PBM+ACB Name ABB+ACB
Description Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone Description Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone

Keywords

Sequence: 80073482 Sequence: 80073483 Sequence: 80073484 Sequence: 80073485 Sequence: 80073486 Sequence: 80073487
Name Maxillary sinus augmentation Name Sinus lift Name Biomaterial Name Anorganic bovine bone Name Porcine bone mineral Name Implant dentistry
Downcase Name maxillary sinus augmentation Downcase Name sinus lift Downcase Name biomaterial Downcase Name anorganic bovine bone Downcase Name porcine bone mineral Downcase Name implant dentistry

Design Outcomes

Sequence: 177927064 Sequence: 177927065 Sequence: 177927066 Sequence: 177927067 Sequence: 177927068 Sequence: 177927069
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Sinus floor height change Measure Sinus floor height change after 12 months Measure Sinus floor height change after 18 months Measure Area of new mineralized tissue Measure Area of non-mineralized tissue Measure Area of remaining graft particles
Time Frame From surgery to 6 months Time Frame From surgery to 12 months Time Frame From surgery to 18 months Time Frame 6 months Time Frame 6 months Time Frame 6 months
Description CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change Description CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change Description CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change Description Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure Description Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure Description Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure

Sponsors

Sequence: 48458176
Agency Class OTHER
Lead Or Collaborator lead
Name Universidad de Granada

Overall Officials

Sequence: 29364318
Role Principal Investigator
Name Pablo Galindo-Moreno, DDS, MS, PhD
Affiliation Universidad de Granada

Design Group Interventions

Sequence: 68349130 Sequence: 68349131
Design Group Id 55758277 Design Group Id 55758278
Intervention Id 52630545 Intervention Id 52630546

Eligibilities

Sequence: 30851235
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Partially edentulous patients.
Kennedy class I in the upper jaw.
Less than 5 mm of residual crestal bone to the maxillary sinus.
Need for the replacement of teeth with dental implants.

Exclusion Criteria:

Sinus pathology (sinusitis, mucocele, cysts).
Smokers.
Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254267857
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 25
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30597092
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Subject Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28963575
Responsible Party Type Principal Investigator
Name Pablo Galindo-Moreno
Title Full Professor
Affiliation Universidad de Granada

Study References

Sequence: 52223815 Sequence: 52223816 Sequence: 52223817
Pmid 29071736 Pmid 17355356 Pmid 35224778
Reference Type background Reference Type background Reference Type result
Citation Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26. Citation Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12. Citation Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.

]]>

<![CDATA[ Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas ]]>
https://zephyrnet.com/NCT03797950
2018-11-01

https://zephyrnet.com/?p=NCT03797950
NCT03797950https://www.clinicaltrials.gov/study/NCT03797950?tab=tableNANANADespite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. At the same time, access to mobile phones has increased rapidly, offering new opportunities to track and deliver health services. This research project uses these newly available mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to get essential vaccines. To increase documentation, investigators will train volunteers in each community to report new births via mobile phone to a central coordinator, and send small monetary rewards via mobile phone to volunteers for this reporting. To increase vaccination coverage, investigators will send reminder messages directly to mothers, and will also test small monetary rewards to volunteers and to mothers as an incentive to complete recommended vaccinations. The designs to provide vaccination encouragement will be tested through a small community randomized controlled trial in 15 selected villages in Ghana’s Northern region. The primary outcome for the pilot study will be the percentage of children who received both the polio birth dose (OPV0) vaccination within two weeks of life (14 days) and the BCG vaccination within the first four weeks (28 days) of life.
<![CDATA[

Studies

Study First Submitted Date 2018-11-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2020-03-03
Start Month Year November 1, 2018
Primary Completion Month Year July 9, 2019
Verification Month Year March 2020
Verification Date 2020-03-31
Last Update Posted Date 2020-03-03

Detailed Descriptions

Sequence: 20710006
Description Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. Early vaccination coverage is particularly low in settings where a large share of women deliver at home, as it is the case in Ghana's Northern region, where only a minority of women seek out facilities for delivery. In Ghana, 95% of children receive BCG vaccination within the first two years of life, but only about half of these children receive the vaccine within the first 30 days after delivery. Less than 50% of children in Ghana's Northern region receive Bacillus Calmette-Guérin (BCG) vaccines within the first three months of their life, and less than 40% get polio vaccination, exposing a large number of infants to these diseases.

Recent research conducted in this region shows that the large majority of households have access to mobile phones, even in the most rural areas. this project uses mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to essential vaccines. Evidence from other low resource settings suggests that even small rewards can often result in substantial increases in vaccine uptake – investigators will test this hypothesis using mobile networks in rural areas of Northern Ghana.

The main objective of this study is to assess the extent to which mobile-phone based reminder or reward systems can increase early vaccination coverage. Investigators will assess two specific interventions through the pilot study:

a mobile-phone based call and text system which will be used to contact mothers to highlight the importance of early vaccinations, provide reminders (nudges) to mothers encouraging them to get their newborn vaccinated and providing information on where and when vaccinations are available in their community.
a community volunteer-based system that will provide small mobile credit rewards to both community volunteers and mothers for completing the early vaccinations within the first month of newborn life.

Research Hypotheses (H1-3) H1: Nudging mothers through voice and text messages will increase early vaccination coverage.

H2: Nudging mothers through community volunteers and small rewards will increase early vaccination coverage.

Given that birth documentation remains low in many parts of Ghana, investigators will also test a new community-based reporting model, under which volunteers appointed by the community will receive small rewards for reporting births that occur in their communities. Investigators will test the extent to which such a program results in successful reporting of births:

H3: Providing small mobile-phone based incentives to volunteers selected by communities for reporting births will result in accurate and timely reporting of births in rural areas.

The study is an open label cluster-randomized controlled trial with three arms: a control arm, a voice reminder arm (group A), and a cash incentive arm (group B). During the intervention phase community volunteers will be appointed to document all births in 10 randomly selected treatment communities (group A and group B), and will receive small cash rewards delivered via "mobile money" for all documented births. In each of two active treatment arms, women across five villages will be enrolled in a proactive program over a period of six months. In intervention group A, participating women will receive reminders about vaccinations recommended at birth delivered via mobile phones. In intervention group B, participating women will receive encouragement from a community-appointed volunteer to complete recommended vaccinations and community volunteers and woman will receive small cash rewards delivered via "mobile money" for completing the recommended birth dose vaccinations on time. No volunteer will be appointed to documents births in the 5 control-arm villages and no women in the 5 control-arm villages will be actively enrolled nor receive a pro-active program intervention during the intervention phase.

After the intervention phase is complete, an endline population-based household survey will be conducted in the 15 study villages (5 control, 5 treatment group A, 5 treatment group B) to evaluate the effect of the intervention programs on vaccine coverage.

Facilities

Sequence: 199965114
Name Innovations for Poverty Action
City Tamale
State Karaga
Country Ghana

Conditions

Sequence: 52139050
Name Immunization Coverage
Downcase Name immunization coverage

Id Information

Sequence: 40135100
Id Source org_study_id
Id Value GHS-ERC008/07/18

Countries

Sequence: 42542716
Name Ghana
Removed False

Design Groups

Sequence: 55559405 Sequence: 55559406 Sequence: 55559407
Group Type No Intervention Group Type Experimental Group Type Experimental
Title Control Title Voice Reminder (Group A) Title Cash Incentive (Group B)
Description No active intervention Description Community-appointed volunteers will document births in the community and will receive small monetary rewards via "mobile money" for all documented births. Enrolled women will receive reminders via mobile phone to highlight the importance of early vaccinations for newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Information on where and when these vaccines will be available in the woman's community will be provided. Description Community-appointed volunteers will document births in the community and will receive small monetary rewards via "mobile money" for all documented births. Volunteers will encourage enrolled women to seek early vaccination for their newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Volunteers will provide information on where and when these vaccines will be available in the woman's community. Volunteers and enrolled women will receive small monetary rewards via "mobile money" for receiving OPV0 and BCG vaccinations on time.

Interventions

Sequence: 52454962 Sequence: 52454963
Intervention Type Behavioral Intervention Type Behavioral
Name Voice Reminder (Group A) Name Cash Incentive (Group B)
Description Woman with a recent delivery will be contacted via mobile phone by a central study staff member to encourage them to vaccinate their newborn with OPV0 and BCG, and information on where and when vaccines are available in this community will be provided. Community volunteers will receive small incentives for documenting births in the community. Description Mobile phone based monetary incentives will be provided to community volunteers and to women with a recent delivery who vaccinate newborns with OPV0 and BCG on time. Community volunteers will receive small incentives for documenting births in the community.

Keywords

Sequence: 79822883 Sequence: 79822884 Sequence: 79822885 Sequence: 79822886 Sequence: 79822887
Name OPV Name BCG Name vaccine delivery Name mhealth Name incentives
Downcase Name opv Downcase Name bcg Downcase Name vaccine delivery Downcase Name mhealth Downcase Name incentives

Design Outcomes

Sequence: 177264009 Sequence: 177264010 Sequence: 177264011 Sequence: 177264012
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type other
Measure Full on time early vaccination coverage (OPV0 and BCG) Measure On time BCG coverage Measure On time OPV coverage Measure Birth documentation and reporting coverage
Time Frame First month of life Time Frame First month of life Time Frame First two weeks of life (14 days) Time Frame First month of life
Description Percentage of infants born during study who received both BCG and OPV0 vaccinations on time (OPV0 within first 2 weeks of life and BCG within first month of life) Description Percentage of infants who received BCG vaccination on time (within first month of life) Description Percentage of infants born during study who received OPV0 on time (within first two weeks of life) Description Percentage of live births in the community during the study which are documented and reported by community health volunteers

Sponsors

Sequence: 48290751 Sequence: 48290752
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Swiss Tropical & Public Health Institute Name Innovations for Poverty Action

Overall Officials

Sequence: 29268554
Role Principal Investigator
Name Guenther Fink, PhD
Affiliation Swiss Institute for Tropical and Public Health

Design Group Interventions

Sequence: 68107524 Sequence: 68107525
Design Group Id 55559406 Design Group Id 55559407
Intervention Id 52454962 Intervention Id 52454963

Eligibilities

Sequence: 30747752
Gender Female
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

Women who have given birth to a live-born, surviving infant in the last two weeks (14 days) and reside in the community.

Exclusion Criteria:

Women who do not reside in the community.
Women whose newborn has passed away.

Gender Description Woman who have recently given birth
Gender Based True
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254122018
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 8
Were Results Reported False
Has Us Facility False
Has Single Facility True
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30494035
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Health Services Research
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28860315
Responsible Party Type Sponsor

Study References

Sequence: 52032785 Sequence: 52032786
Pmid 34010312 Pmid 32813276
Reference Type derived Reference Type derived
Citation Levine G, Salifu A, Mohammed I, Fink G. Mobile nudges and financial incentives to improve coverage of timely neonatal vaccination in rural areas (GEVaP trial): A 3-armed cluster randomized controlled trial in Northern Ghana. PLoS One. 2021 May 19;16(5):e0247485. doi: 10.1371/journal.pone.0247485. eCollection 2021. Citation Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

]]>

<![CDATA[ Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II ]]>
https://zephyrnet.com/NCT03797937
2018-11-01

https://zephyrnet.com/?p=NCT03797937
NCT03797937https://www.clinicaltrials.gov/study/NCT03797937?tab=tableNANANAThe goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.
<![CDATA[

Studies

Study First Submitted Date 2018-03-05
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-05-11
Start Month Year November 1, 2018
Primary Completion Month Year November 1, 2021
Verification Month Year May 2022
Verification Date 2022-05-31
Last Update Posted Date 2022-05-11

Detailed Descriptions

Sequence: 20812465
Description Using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls.

More specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years.

Facilities

Sequence: 200869503 Sequence: 200869504
Name Universitair Ziekenhuis Brussel Name Nationaal Multiple Sclerose Centrum Melsbroek
City Jette City Melsbroek
State Brussel State Vlaams-Brabant
Zip 1090 Zip 1820
Country Belgium Country Belgium

Conditions

Sequence: 52402790
Name Multiple Sclerosis
Downcase Name multiple sclerosis

Id Information

Sequence: 40322741
Id Source org_study_id
Id Value 2018BDM2

Countries

Sequence: 42745775
Name Belgium
Removed False

Design Groups

Sequence: 55849953 Sequence: 55849954 Sequence: 55849955 Sequence: 55849956
Group Type Experimental Group Type No Intervention Group Type No Intervention Group Type No Intervention
Title Multiple sclerosis (MS) patients Title Healthy controls Title Multiple sclerosis (MS) patients undergoing a relapse Title Multiple sclerosis (MS) patients from multiplex MS families
Description Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. Description Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. Description Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. Description Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Interventions

Sequence: 52711568
Intervention Type Other
Name Magnetic resonance imaging (MRI)
Description MRI scanner

Design Outcomes

Sequence: 178234742 Sequence: 178234743
Outcome Type primary Outcome Type secondary
Measure Clinical evidence for active disease Measure Radiological evidence for active disease
Time Frame 3 years Time Frame 3 years
Description Time to first relapse (after baseline) will be reported for all patients. Description Occurrence of new contrast-enhancing T1 hyper intense lesions, or changes in white matter lesion volume (i.e. new or enlarging T2 hyper intense lesions)

Browse Conditions

Sequence: 194366338 Sequence: 194366339 Sequence: 194366340 Sequence: 194366341 Sequence: 194366342 Sequence: 194366343 Sequence: 194366344 Sequence: 194366345 Sequence: 194366346
Mesh Term Multiple Sclerosis Mesh Term Sclerosis Mesh Term Pathologic Processes Mesh Term Demyelinating Autoimmune Diseases, CNS Mesh Term Autoimmune Diseases of the Nervous System Mesh Term Nervous System Diseases Mesh Term Demyelinating Diseases Mesh Term Autoimmune Diseases Mesh Term Immune System Diseases
Downcase Mesh Term multiple sclerosis Downcase Mesh Term sclerosis Downcase Mesh Term pathologic processes Downcase Mesh Term demyelinating autoimmune diseases, cns Downcase Mesh Term autoimmune diseases of the nervous system Downcase Mesh Term nervous system diseases Downcase Mesh Term demyelinating diseases Downcase Mesh Term autoimmune diseases Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48534970
Agency Class OTHER
Lead Or Collaborator lead
Name National MS Center Melsbroek

Overall Officials

Sequence: 29406024
Role Principal Investigator
Name Marie D'hooghe, M.D.
Affiliation National MS Center Melsbroek

Design Group Interventions

Sequence: 68462979
Design Group Id 55849953
Intervention Id 52711568

Eligibilities

Sequence: 30898806
Gender All
Minimum Age 18 Years
Maximum Age 55 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria patients:

Diagnosis of MS (as defined by the 2010 McDonald criteria).
Occurrence of symptoms no longer than 5 years before baseline.
Aged 18-65.
Willingness to participate in the study and to sign the informed consent.

Exclusion Criteria patients:

Treatment with high doses of systemic steroids 2 months before baseline.
Use of antibiotics 3 months before baseline.
Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer).
Other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1 and 2, psoriasis).

Additional inclusion criteria for MS patients undergoing a relapse:

• Ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for >=24 hours in the absence of fever.

Additional exclusion criteria for MS patients undergoing a relapse:

Treatment with cortisone before collection of baseline faecal sample.
Evidence of a relapse less than 2 months before baseline.
Switching disease modifying treatment less than 2 months before baseline.

Inclusion criteria healthy controls:

Willingness to participate to the study and to sign the informed consent.
Aged >=18.

Exclusion criteria healthy controls:

Neurodegenerative disorders.
Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer) or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1, psoriasis).
Use of antibiotics 3 months before baseline.
Treatment with high doses of systemic steroids 2 months before baseline.

Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254148383
Number Of Facilities 2
Registered In Calendar Year 2018
Actual Duration 36
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 55
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30644534
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29011158
Responsible Party Type Principal Investigator
Name Marie D'hooghe
Title Prof. Dr.
Affiliation National MS Center Melsbroek

]]>

<![CDATA[ Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary? ]]>
https://zephyrnet.com/NCT03797924
2019-04-25

https://zephyrnet.com/?p=NCT03797924
NCT03797924https://www.clinicaltrials.gov/study/NCT03797924?tab=tableNANANAIn this study the investigators would like to show that when patients undergo upper limb surgery under supraclavicular brachial plexus block, additional blocking of the Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet pain.
<![CDATA[

Studies

Study First Submitted Date 2019-01-01
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-05-24
Start Month Year April 25, 2019
Primary Completion Month Year December 20, 2020
Verification Month Year May 2022
Verification Date 2022-05-31
Last Update Posted Date 2022-05-24

Detailed Descriptions

Sequence: 20770231
Description The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm. Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet pain is complex and the study team hypothesize that blocking the ICBN has no impact on tourniquet pain. Patients will receive a supraclavicular block and be divided into two groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will receive a supraclavicular block as their primary anesthetic and then be divided into two groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics, conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will be the primary measures of this study.

Facilities

Sequence: 200512321
Name University of Florida
City Gainesville
State Florida
Zip 32618
Country United States

Browse Interventions

Sequence: 96248925 Sequence: 96248926 Sequence: 96248927 Sequence: 96248928 Sequence: 96248929 Sequence: 96248930 Sequence: 96248931
Mesh Term Ropivacaine Mesh Term Anesthetics, Local Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents
Downcase Mesh Term ropivacaine Downcase Mesh Term anesthetics, local Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52295908 Sequence: 52295909
Name Nerve Block Name Pain
Downcase Name nerve block Downcase Name pain

Id Information

Sequence: 40248464 Sequence: 40248465
Id Source org_study_id Id Source secondary_id
Id Value IRB201802525 Id Value OCR19802
Id Type Other Identifier
Id Type Description OnCore

Countries

Sequence: 42666781
Name United States
Removed False

Design Groups

Sequence: 55732569 Sequence: 55732570
Group Type Active Comparator Group Type Placebo Comparator
Title ICBN with ropivacaine Title No ICBN block
Description Participants will receive ICBN with ropivacaine. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. Description Participants will have the site prepped, but no ICBN block given. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.

Interventions

Sequence: 52607737 Sequence: 52607738
Intervention Type Drug Intervention Type Behavioral
Name Receive ICBN with ropivacaine Name No ICBN block
Description ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space. Description The site of injection will be prepped with tinted chlorhexidine

Keywords

Sequence: 80044123 Sequence: 80044124 Sequence: 80044125
Name Intercostobrachial Nerve Block Name Tourniquet Pain Name Upper Limb Surgeries
Downcase Name intercostobrachial nerve block Downcase Name tourniquet pain Downcase Name upper limb surgeries

Design Outcomes

Sequence: 177837930 Sequence: 177837931 Sequence: 177837932 Sequence: 177837933 Sequence: 177837934
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI) Measure Change between the 2 groups depth of anesthesia during surgery to alleviate tourniquet pain as assessed by the American Society of Anesthesiologist (ASA) Continuum of Depth of Sedation definition of general anesthesia and levels of sedation/analgesia. Measure Change between the 2 groups assessed by intraoperative opioid consumption Measure Change between the 2 groups assessed by time to onset of tourniquet pain Measure Change between the 2 groups in reported severity of tourniquet pain
Time Frame From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) Time Frame From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) Time Frame From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) Time Frame From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) Time Frame From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Description Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet Description Determine required depth of anesthesia during surgery to alleviate tourniquet pain Description Determine amount of intraoperative opioid consumption due to tourniquet pain Description Determine the time to onset of tourniquet pain Description Determine if ICBN has an affect on the severity of tourniquet pain as assessed by Descriptor Differential Scale of Pain Intensity (DDSI) There are 10 points along which patients can rate their pain intensity to the right and left of each descriptor, so the pain is rated on a 21 point scale for each descriptor. Pain intensity is defined as a mean of the ratings and can range from 0 to 20.

Sponsors

Sequence: 48436237
Agency Class OTHER
Lead Or Collaborator lead
Name University of Florida

Overall Officials

Sequence: 29352550
Role Principal Investigator
Name Linda Le-Wendling, MD
Affiliation University of Florida

Design Group Interventions

Sequence: 68317268 Sequence: 68317269
Design Group Id 55732569 Design Group Id 55732570
Intervention Id 52607737 Intervention Id 52607738

Eligibilities

Sequence: 30837863
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

American Society of Anesthesiologists (ASA) 1-3
Distal upper extremity surgery with anticipated use of tourniquet
Outpatient surgery
Patients who desire regional anesthesia as primary anesthetic

Exclusion Criteria:

ASA 4 or greater
Allergies to local anesthetic
Refusal of regional anesthesia
History of chronic pain syndromes
Patients who do not desire regional anesthesia as primary anesthetic

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254143704
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 20
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30583762
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking Double
Masking Description In order to blind anesthesia providers in the room and nurses in Post-op Anesthesia Care Unit (PACU), the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.
Intervention Model Description Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
Subject Masked True
Caregiver Masked True

Intervention Other Names

Sequence: 26729420
Intervention Id 52607737
Name Naropin

Responsible Parties

Sequence: 28950179
Responsible Party Type Sponsor

Study References

Sequence: 52196400 Sequence: 52196401 Sequence: 52196402 Sequence: 52196403 Sequence: 52196404 Sequence: 52196405
Pmid 23053464 Pmid 3767015 Pmid 3591250 Pmid 8092519 Pmid 1550287 Pmid 9613307
Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result Reference Type result
Citation Satsumae T, Yamaguchi H, Inomata S, Tanaka M. Magnesium sulfate attenuates tourniquet pain in healthy volunteers. J Anesth. 2013 Apr;27(2):231-5. doi: 10.1007/s00540-012-1493-4. Epub 2012 Oct 7. Citation Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80. Citation Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x. Citation Crews JC, Cahall M, Behbehani MM. The neurophysiologic mechanisms of tourniquet pain. The activity of neurons in the rostroventral medulla in the rat. Anesthesiology. 1994 Sep;81(3):730-6. doi: 10.1097/00000542-199409000-00027. Citation MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. doi: 10.1097/00000542-199204000-00020. Citation Tschaikowsky K, Hemmerling T. Comparison of the effect of EMLA and semicircular subcutaneous anaesthesia in the prevention of tourniquet pain during plexus block anaesthesia of the arm. Anaesthesia. 1998 Apr;53(4):390-3. doi: 10.1046/j.1365-2044.1998.00301.x.

]]>

<![CDATA[ Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT ]]>
https://zephyrnet.com/NCT03797911
2019-03-23

https://zephyrnet.com/?p=NCT03797911
NCT03797911https://www.clinicaltrials.gov/study/NCT03797911?tab=tableNANANAThis study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.
<![CDATA[

Studies

Study First Submitted Date 2018-12-12
Study First Posted Date 2019-01-09
Last Update Posted Date 2021-12-28
Start Month Year March 23, 2019
Primary Completion Month Year April 16, 2021
Verification Month Year December 2021
Verification Date 2021-12-31
Last Update Posted Date 2021-12-28

Detailed Descriptions

Sequence: 20796477
Description It is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. But there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects.

Facilities

Sequence: 200765873
Name Andrea Carralero Martinez
City Barcelona
Zip 08004
Country Spain

Conditions

Sequence: 52363108 Sequence: 52363109 Sequence: 52363110 Sequence: 52363111 Sequence: 52363112 Sequence: 52363113
Name Pelvic Pain Name Pelvic Pain Syndrome Name Chronic Pain Name Chronic Pain Syndrome Name Chronic Pelvic Inflammatory Disease Name Physical Therapy
Downcase Name pelvic pain Downcase Name pelvic pain syndrome Downcase Name chronic pain Downcase Name chronic pain syndrome Downcase Name chronic pelvic inflammatory disease Downcase Name physical therapy

Id Information

Sequence: 40295958
Id Source org_study_id
Id Value RAP39426977

Countries

Sequence: 42719126
Name Spain
Removed False

Design Groups

Sequence: 55806575 Sequence: 55806576
Group Type Experimental Group Type Placebo Comparator
Title active resistive capacitive monopolar radiofrequency Title Inactive resistive capacitive monopolar radiofrequency
Description Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): The intervention group will receive the treatment with activated resistive capacitive monopolar radiofrequency system, with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.

The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy.

Description Application of the technique in the control group (inactivated resistive capacitive monopolar radiofrequency therapy): The control group will receive the treatment with inactivated resistive capacitive monopolar radiofrequency system (placebo), with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.

The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy.

Interventions

Sequence: 52673830 Sequence: 52673831
Intervention Type Combination Product Intervention Type Combination Product
Name Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education Name Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
Description Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education. Description Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.

Design Outcomes

Sequence: 178088331 Sequence: 178088332 Sequence: 178088333 Sequence: 178088334 Sequence: 178088335 Sequence: 178088336 Sequence: 178088337
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain Measure Assess quality of life Measure Assess kinesiophobia Measure Assess catastrophism Measure Assess the degree of adherence to treatment Measure Assess number of participants with high adherence to treatment Measure Assess number of participants with adverse effects
Time Frame baseline and 10 weeks Time Frame baseline, 5 and 10 weeks Time Frame baseline, 5 and 10 weeks Time Frame baseline, 5 and 10 weeks Time Frame 10 weeks Time Frame 10 weeks Time Frame 10 weeks
Description The objective is to assess if there is a change in the perception of pain intensity according to VAS (Visual Analog Scale). Compare baseline and at the end of the intervention.

The Visual Analog Scale is a validated questionnaire that scores between 0 and 10 the perception of pain that the patient has. In a line of 10 cm the patient will mark his intensity of the pain taking into account that 0 means "I have no pain" and 10 means "I have an unbearable pain".

The Visual Analog Scale (VAS) suitably collects the pain intensity perceived by the patient and allows to assess the severity of the disease, as well as the improvement obtained with the treatment.

Description Asess the perceived quality of life of patients in the study according to the SF-12 questionnaire.

The Short-Form 12 Health Survey was designed in 1994 with the aim that, through the self-completion of a brief questionnaire, the perception of physical and mental quality of life could be objectified in a simpler way than the original questionnaire SF -36. This simple questionnaire of 12 items representing the 8 dimensions of health was originally developed in English. It is a questionnaire that has proven to be valid and reliable to be used in clinical practice as an instrument to assess the quality of life. The 8 dimensions are the physical function (2 items), physical role (2 items), body pain (1 item), general health (1 item), vitality (1 item), social function (1 item), emotional role (2) items) and mental health (2 items). The result is two variables (physical and mental) that value quality in these two aspects.

Description Asess the kinesiophobia suffered by patients in the study according to the TSK-11 (Tampa Scale of Kinesiophobia) questionnaire.

The Tampa Scale of Kinesiophobia (TSK-11), validated in Spanish, adequately captures the patient's movement capacity taking into account the perceived pain intensity in 11 questions. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment.

Description Asess the catastrophism suffered by patients in the study according to the Catastrophism scale.

The Catastrophism Scale, also validated in Spanish, allows us to assess the catastrophic intensity of the disease, a more psychological aspect, but also very relevant in this chronic and disabling pathology. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment. It is a questionnaire of 20 questions.

Description Assess the degree of adherence to treatment (%) of the patients who are in this study. Description Assess the number of patients (n) with high adherence who are in this study. Description Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.

Browse Conditions

Sequence: 194216755 Sequence: 194216756 Sequence: 194216757 Sequence: 194216758 Sequence: 194216759 Sequence: 194216760 Sequence: 194216761 Sequence: 194216762 Sequence: 194216763 Sequence: 194216764 Sequence: 194216765 Sequence: 194216766 Sequence: 194216767 Sequence: 194216768 Sequence: 194216769 Sequence: 194216770 Sequence: 194216771 Sequence: 194216772
Mesh Term Pelvic Inflammatory Disease Mesh Term Pelvic Infection Mesh Term Syndrome Mesh Term Chronic Pain Mesh Term Pelvic Pain Mesh Term Somatoform Disorders Mesh Term Disease Mesh Term Pathologic Processes Mesh Term Pain Mesh Term Neurologic Manifestations Mesh Term Mental Disorders Mesh Term Infections Mesh Term Adnexal Diseases Mesh Term Genital Diseases, Female Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Genital Diseases
Downcase Mesh Term pelvic inflammatory disease Downcase Mesh Term pelvic infection Downcase Mesh Term syndrome Downcase Mesh Term chronic pain Downcase Mesh Term pelvic pain Downcase Mesh Term somatoform disorders Downcase Mesh Term disease Downcase Mesh Term pathologic processes Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations Downcase Mesh Term mental disorders Downcase Mesh Term infections Downcase Mesh Term adnexal diseases Downcase Mesh Term genital diseases, female Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term genital diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48497976
Agency Class OTHER
Lead Or Collaborator lead
Name RAPbarcelona

Design Group Interventions

Sequence: 68410887 Sequence: 68410888
Design Group Id 55806575 Design Group Id 55806576
Intervention Id 52673830 Intervention Id 52673831

Eligibilities

Sequence: 30876064
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Have an age equal to or greater than 18 years
Having chronic pelvic pain of six or more months of evolution.

Exclusion Criteria:

Failure to grant informed consent.
Have fibromyalgia.
Present a pacemaker or other type of electronic implant.
Suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
Previous treatment with chemotherapy and / or radiotherapy in the pelvic area.
Suffering from neuromuscular diseases (amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis or spinal muscular atrophy).
Have myelopathy and osteomyelitis.
Have neurological and / or metabolic pathology that alters the response capacity: diabetes, parkinson's disease, senile dementia …
Have an alteration of the central nervous system (traumatic or spinal vascular injury)
Suffer oncological processes with sacral involvement.
Have a severe mental disorder.
Have vulvodynia
Be pregnant.
Have undergone surgery in the last 3 months in the pelvic area.
Have hypersensitivity of the skin, hyposensitivity and / or rejection of manual contact.
Inability to correctly complete the questionnaires or understand the study protocol.
Having initiated other pelvic physiotherapy treatments during the study intervention.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254071410
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 25
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30621855
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Triple
Masking Description Triple blind
Subject Masked True
Caregiver Masked True
Investigator Masked True

Responsible Parties

Sequence: 28988391
Responsible Party Type Principal Investigator
Name Andrea Carralero Martínez
Title Physical therapist
Affiliation RAPbarcelona

Study References

Sequence: 52267526
Pmid 34016168
Reference Type derived
Citation Carralero-Martinez A, Munoz Perez MA, Pane-Alemany R, Blanco-Ratto L, Kauffmann S, Ramirez-Garcia I. Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2021 May 20;22(1):356. doi: 10.1186/s13063-021-05321-6.

]]>

<![CDATA[ Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care ]]>
https://zephyrnet.com/NCT03797898
2019-03-05

https://zephyrnet.com/?p=NCT03797898
NCT03797898https://www.clinicaltrials.gov/study/NCT03797898?tab=tableNANANAParent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator (“Parent Coach”) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician’s attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.

The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.
<![CDATA[

Studies

Study First Submitted Date 2018-12-20
Study First Posted Date 2019-01-09
Last Update Posted Date 2023-06-26
Start Month Year March 5, 2019
Primary Completion Month Year July 14, 2022
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-26
Results First Posted Date 2023-06-26

Detailed Descriptions

Sequence: 20699473
Description Well-Child Care (WCC) visits for child preventive care during the first three years of life are critical because they may be the only opportunity before a child reaches preschool to identify and address important social, developmental, behavioral, and health issues that could have significant impact and long-lasting effects on children's lives as adults. Despite its potential, multiple studies have demonstrated that pediatric providers fail to provide all recommended preventive and developmental services at these visits and that most parents leave the visit with unaddressed psychosocial, developmental, and behavioral concerns. Further, these missed opportunities are more pronounced for children in low-income families.

A critical problem is that the structure of WCC in the U.S. cannot support the vast array of WCC needs of families. Key structural problems include (a) reliance on clinicians (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services, (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of education and guidance services in WCC, and (c) lack of a systematic, patient-driven method for visit customization to meet families' needs. These structural problems contribute to the wide variations in processes of care and preventive care outcomes, resulting in poorer quality of WCC and perhaps worse health outcomes, particularly for children in low-income communities.

To address the gaps in current WCC this study introduces a new model of care to meet the needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.

To assess the efficacy of PARENT, the investigators will conduct a cluster randomized controlled trial (RCT). The study will be conducted in partnership with 10 clinics.

In preparation for the trial, investigators will use a Community Engagement & Intervention Implementation process that has been successful in previous studies to guide the intervention adaptation process, Parent Coach training, practice workflow, and intervention implementation in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset. The project's community partners include two federally-qualified health centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics participating in the study. The total number of clinics participating in the study is 10 clinics randomized at the clinic level to intervention or control condition. The intervention clinics will implement PARENT for all well-visits through age 2 years at their clinical site, and the control clinics will continue usual care (clinician directed well-visit). 1,000 families will be enrolled at infant age ≤12 months and remain in the study for a period of 12 months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.

Facilities

Sequence: 199814740 Sequence: 199814741
Name University of California, Los Angeles Name Seattle Children's Research Institute
City Los Angeles City Seattle
State California State Washington
Zip 90095 Zip 98121
Country United States Country United States

Conditions

Sequence: 52110905 Sequence: 52110906
Name Preventive Health Services Name Health Promotion
Downcase Name preventive health services Downcase Name health promotion

Id Information

Sequence: 40111874 Sequence: 40111875
Id Source org_study_id Id Source secondary_id
Id Value STUDY00000413 Id Value 5R01HD088586
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/5R01HD088586

Countries

Sequence: 42514950
Name United States
Removed False

Design Groups

Sequence: 55527987 Sequence: 55527988
Group Type Experimental Group Type No Intervention
Title Intervention Title Control
Description Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Description usual care well child care

Interventions

Sequence: 52425311
Intervention Type Other
Name Parent Coach
Description The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.

Design Outcomes

Sequence: 177168195 Sequence: 177168196 Sequence: 177168197 Sequence: 177168198 Sequence: 177168199 Sequence: 177168200 Sequence: 177168201 Sequence: 177168202 Sequence: 177168203
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits Measure Healthcare Utilization: Emergency Department Utilization Measure Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit Measure Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits Measure Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Measure Healthcare Utilization: Hospitalizations Measure Healthcare Utilization: Well Child Care Visits Up to Date Measure Experiences of Care: Helpfulness of Care Assessment by Parent Report Measure Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report
Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame Data not collected due to COVID Pandemic restrictions on in clinic observations. Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment
Description Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.

scale, 0-100, higher is better

Description any emergency department care visit for the index child in past 12 months (parent report) Description time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations. Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. Description any hospitalizations for index child in past 12 months by parent report Description up to date on well child care by clinic electronic medical record review at 12 months post enrollment Description parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better Description receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better

Sponsors

Sequence: 48264432 Sequence: 48264433
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Seattle Children's Hospital Name Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Overall Officials

Sequence: 29251161
Role Principal Investigator
Name Tumaini R Coker, MD/MBA
Affiliation Seattle Children's

Design Group Interventions

Sequence: 68069128
Design Group Id 55527987
Intervention Id 52425311

Eligibilities

Sequence: 30731156
Gender All
Minimum Age 18 Years
Maximum Age 65 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to 12- month WCC visit.
Parent is English or Spanish proficient
For multiple gestations, one infant will be randomly selected as the index child. Infants with special health care needs will not be excluded from the study, since these children generally need the same recommended preventive care services.

Exclusion Criteria:

More than one child attending Well-Child Care
Legal guardian of child is under 18 years of age
Parents who are employed by one of the federally-qualified health centers (FQHCs)
Parents/legal guardian not planning to continue receiving well child care services at this clinic for their child in the next 12 months

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253996239
Number Of Facilities 2
Number Of Sae Subjects 1
Registered In Calendar Year 2018
Actual Duration 40
Were Results Reported True
Months To Report Results 6
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 7

Designs

Sequence: 30477548
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Health Services Research
Time Perspective
Masking None (Open Label)

Drop Withdrawals

Sequence: 28924406 Sequence: 28924407 Sequence: 28924408 Sequence: 28924409 Sequence: 28924410 Sequence: 28924411
Result Group Id 56032938 Result Group Id 56032939 Result Group Id 56032938 Result Group Id 56032939 Result Group Id 56032938 Result Group Id 56032939
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Reason Lost to Follow-up Reason Lost to Follow-up Reason Withdrawal by Subject Reason Withdrawal by Subject Reason Became ineligible Reason Became ineligible
Count 60 Count 69 Count 9 Count 7 Count 5 Count 2

Milestones

Sequence: 40948211 Sequence: 40948212 Sequence: 40948213 Sequence: 40948214 Sequence: 40948215 Sequence: 40948216
Result Group Id 56032938 Result Group Id 56032939 Result Group Id 56032938 Result Group Id 56032939 Result Group Id 56032938 Result Group Id 56032939
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Description 452 parent participants with a child ≤12 months arriving for a well child visit Description 485 parent participants with a child ≤12 months arriving for a well child visit
Count 452 Count 485 Count 378 Count 407 Count 74 Count 78
Count Units 5 Count Units 5 Count Units 5 Count Units 5 Count Units 0 Count Units 0

Participant Flows

Sequence: 3916057
Recruitment Details Participants were recruited from two multi-site federally qualified health centers (FQHCs) in California and Washington State, with 6 and 4 participating practices each. The first participant was enrolled March 5, 2019 and the last participant was enrolled July 1, 2021. **PLEASE NOTE that there were not multiple phases to the trial. this study was a cluster RCT that did not have multiple phases to the trial.
Pre Assignment Details Of 937 enrolled participants, 914 remained enrolled and were eligible to complete 12-month follow-up.

Participants are unique parent/child dyads. The parents were enrolled and each parent had an index child that they provided data on. This was the child for who they were coming to the clinic for a well child visit, and the child had to be 12 months of age or younger.

Units Analyzed clinics

Outcome Counts

Sequence: 73882865 Sequence: 73882866 Sequence: 73882867 Sequence: 73882868 Sequence: 73882869 Sequence: 73882870 Sequence: 73882871 Sequence: 73882872 Sequence: 73882873 Sequence: 73882874 Sequence: 73882875 Sequence: 73882876 Sequence: 73882877 Sequence: 73882878 Sequence: 73882879 Sequence: 73882880 Sequence: 73882881 Sequence: 73882882
Outcome Id 30755253 Outcome Id 30755253 Outcome Id 30755254 Outcome Id 30755254 Outcome Id 30755255 Outcome Id 30755255 Outcome Id 30755256 Outcome Id 30755256 Outcome Id 30755257 Outcome Id 30755257 Outcome Id 30755258 Outcome Id 30755258 Outcome Id 30755259 Outcome Id 30755259 Outcome Id 30755260 Outcome Id 30755260 Outcome Id 30755261 Outcome Id 30755261
Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032942 Result Group Id 56032943 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 375 Count 407 Count 376 Count 407 Count 0 Count 0 Count 378 Count 407 Count 378 Count 407 Count 376 Count 406 Count 419 Count 465 Count 378 Count 407 Count 378 Count 407

Provided Documents

Sequence: 2576077
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2021-01-14
Url https://ClinicalTrials.gov/ProvidedDocs/98/NCT03797898/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27904510 Sequence: 27904511 Sequence: 27904512 Sequence: 27904513 Sequence: 27904514 Sequence: 27904515
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 1 Subjects Affected 0 Subjects Affected 1
Subjects At Risk 452 Subjects At Risk 452 Subjects At Risk 452 Subjects At Risk 485 Subjects At Risk 485 Subjects At Risk 485
Created At 2023-08-08 16:04:57.635433 Created At 2023-08-08 16:04:57.635433 Created At 2023-08-08 16:04:57.635433 Created At 2023-08-08 16:04:57.635433 Created At 2023-08-08 16:04:57.635433 Created At 2023-08-08 16:04:57.635433
Updated At 2023-08-08 16:04:57.635433 Updated At 2023-08-08 16:04:57.635433 Updated At 2023-08-08 16:04:57.635433 Updated At 2023-08-08 16:04:57.635433 Updated At 2023-08-08 16:04:57.635433 Updated At 2023-08-08 16:04:57.635433

Reported Events

Sequence: 527140373 Sequence: 527140374
Result Group Id 56032944 Result Group Id 56032945
Ctgov Group Code EG000 Ctgov Group Code EG001
Time Frame 12 months Time Frame 12 months
Event Type serious Event Type serious
Subjects Affected 0 Subjects Affected 1
Subjects At Risk 452 Subjects At Risk 485
Description As there were no risk of harm to participant dyads, we did not conduct a systematic approach to collecting data on harms. However, if in the course of the 12-month data collection, we gained information on participant harm to either the parent or child of the dyad, we report those as "adverse events". The only such information we received was on one parent of the parent/child dyads enrolled, and this event (parent death) is reported both in the serious adverse event and in all cause mortality. Description As there were no risk of harm to participant dyads, we did not conduct a systematic approach to collecting data on harms. However, if in the course of the 12-month data collection, we gained information on participant harm to either the parent or child of the dyad, we report those as "adverse events". The only such information we received was on one parent of the parent/child dyads enrolled, and this event (parent death) is reported both in the serious adverse event and in all cause mortality.
Event Count 0 Event Count 1
Organ System General disorders Organ System General disorders
Adverse Event Term death Adverse Event Term death
Frequency Threshold 0 Frequency Threshold 0
Assessment Non-systematic Assessment Assessment Non-systematic Assessment

Responsible Parties

Sequence: 28843938
Responsible Party Type Principal Investigator
Name Tumaini Coker
Title Associate Professor
Affiliation Seattle Children's Hospital

Result Agreements

Sequence: 3846801
Pi Employee No

Result Contacts

Sequence: 3846766
Organization Seattle Children's
Name Tumaini R. Coker, MD, MBA
Phone 206-884-0559
Email Tumaini.Coker@seattlechildrens.org

Outcomes

Sequence: 30755253 Sequence: 30755254 Sequence: 30755255 Sequence: 30755256 Sequence: 30755257 Sequence: 30755258 Sequence: 30755259 Sequence: 30755260 Sequence: 30755261
Outcome Type Primary Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits Title Healthcare Utilization: Emergency Department Utilization Title Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit Title Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits Title Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Title Healthcare Utilization: Hospitalizations Title Healthcare Utilization: Well Child Care Visits Up to Date Title Experiences of Care: Helpfulness of Care Assessment by Parent Report Title Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report
Description Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.

scale, 0-100, higher is better

Description any emergency department care visit for the index child in past 12 months (parent report) Description time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations. Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. Description any hospitalizations for index child in past 12 months by parent report Description up to date on well child care by clinic electronic medical record review at 12 months post enrollment Description parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better Description receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better
Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame Data not collected due to COVID Pandemic restrictions on in clinic observations. Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment Time Frame 12 months post enrollment
Population all participants completing 12 month survey Population Data were not collected due to COVID 19 pandemic restrictions on in clinic observations Population all participants completing 12 month survey Population Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population all participants completing 12 month survey Population all enrolled participants who remained eligible, and consented to chart review by the 12-month post intervention assessment Population all participants completing 12 month survey Population all participants completing 12 month survey
Units score on a scale Units Participants Units Participants Units Participants Units Participants Units Participants Units score on a scale Units score on a scale
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean

Outcome Measurements

Sequence: 235255591 Sequence: 235255592 Sequence: 235255593 Sequence: 235255594 Sequence: 235255584 Sequence: 235255585 Sequence: 235255586 Sequence: 235255587 Sequence: 235255588 Sequence: 235255589 Sequence: 235255577 Sequence: 235255578 Sequence: 235255579 Sequence: 235255580 Sequence: 235255581 Sequence: 235255582 Sequence: 235255583 Sequence: 235255590
Outcome Id 30755260 Outcome Id 30755260 Outcome Id 30755261 Outcome Id 30755261 Outcome Id 30755257 Outcome Id 30755257 Outcome Id 30755257 Outcome Id 30755258 Outcome Id 30755258 Outcome Id 30755259 Outcome Id 30755253 Outcome Id 30755253 Outcome Id 30755254 Outcome Id 30755254 Outcome Id 30755256 Outcome Id 30755256 Outcome Id 30755257 Outcome Id 30755259
Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941 Result Group Id 56032940 Result Group Id 56032941
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Classification Behavioral Concerns Elicited & Addressed Classification Developmental Screening Classification Developmental Screening Classification Behavioral Concerns Elicited & Addressed
Title Experiences of Care: Helpfulness of Care Assessment by Parent Report Title Experiences of Care: Helpfulness of Care Assessment by Parent Report Title Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report Title Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report Title Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Title Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Title Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Title Healthcare Utilization: Hospitalizations Title Healthcare Utilization: Hospitalizations Title Healthcare Utilization: Well Child Care Visits Up to Date Title Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits Title Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits Title Healthcare Utilization: Emergency Department Utilization Title Healthcare Utilization: Emergency Department Utilization Title Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits Title Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits Title Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Title Healthcare Utilization: Well Child Care Visits Up to Date
Description parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better Description parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better Description receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better Description receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. Description any hospitalizations for index child in past 12 months by parent report Description any hospitalizations for index child in past 12 months by parent report Description up to date on well child care by clinic electronic medical record review at 12 months post enrollment Description Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.

scale, 0-100, higher is better

Description Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.

scale, 0-100, higher is better

Description any emergency department care visit for the index child in past 12 months (parent report) Description any emergency department care visit for the index child in past 12 months (parent report) Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items Description Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. Description up to date on well child care by clinic electronic medical record review at 12 months post enrollment
Units score on a scale Units score on a scale Units score on a scale Units score on a scale Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units score on a scale Units score on a scale Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants
Param Value 77.8 Param Value 69.8 Param Value 89.0 Param Value 85.5 Param Value 292 Param Value 310 Param Value 332 Param Value 12 Param Value 9 Param Value 309 Param Value 73.9 Param Value 63.3 Param Value 140 Param Value 147 Param Value 253 Param Value 203 Param Value 305 Param Value 295
Param Value Num 77.8 Param Value Num 69.8 Param Value Num 89.0 Param Value Num 85.5 Param Value Num 292.0 Param Value Num 310.0 Param Value Num 332.0 Param Value Num 12.0 Param Value Num 9.0 Param Value Num 309.0 Param Value Num 73.9 Param Value Num 63.3 Param Value Num 140.0 Param Value Num 147.0 Param Value Num 253.0 Param Value Num 203.0 Param Value Num 305.0 Param Value Num 295.0
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 25.2 Dispersion Value 30.7 Dispersion Value 22.5 Dispersion Value 27.1 Dispersion Value 23.4 Dispersion Value 27.8
Dispersion Value Num 25.2 Dispersion Value Num 30.7 Dispersion Value Num 22.5 Dispersion Value Num 27.1 Dispersion Value Num 23.4 Dispersion Value Num 27.8

Study References

Sequence: 52005445 Sequence: 52005446 Sequence: 52005447 Sequence: 52005448 Sequence: 52005449
Pmid 28232142 Pmid 26908675 Pmid 23457149 Pmid 24936004 Pmid 34842563
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type derived
Citation Mimila NA, Chung PJ, Elliott MN, Bethell CD, Chacon S, Biely C, Contreras S, Chavis T, Bruno Y, Moss T, Coker TR. Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Acad Pediatr. 2017 Sep-Oct;17(7):747-754. doi: 10.1016/j.acap.2017.02.004. Epub 2017 Feb 14. Citation Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10. Citation Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c. Citation Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16. Citation Hurst R, Liljenquist K, Lowry SJ, Szilagyi PG, Fiscella KA, Weaver MR, Porras-Javier L, Ortiz J, Sotelo Guerra LJ, Coker TR. A Parent Coach-Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 25;10(11):e27054. doi: 10.2196/27054.

Baseline Counts

Sequence: 11367863 Sequence: 11367864 Sequence: 11367865
Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 438 Count 476 Count 914

Result Groups

Sequence: 56032935 Sequence: 56032936 Sequence: 56032937 Sequence: 56032938 Sequence: 56032939 Sequence: 56032940 Sequence: 56032941 Sequence: 56032942 Sequence: 56032943 Sequence: 56032944 Sequence: 56032945
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title Intervention Title Control Title Total Title Intervention Title Control Title Intervention Title Control Title Intervention Title Control Title Intervention Title Control
Description Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).

Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.

Description usual care well child care Description Total of all reporting groups Description Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).

Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.

Description Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit. Description Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).

Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.

Description usual care well child care Description Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).

Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.

Description Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit. Description Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).

Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.

Description usual care well child care

Baseline Measurements

Sequence: 125413943 Sequence: 125413944 Sequence: 125413945 Sequence: 125413946 Sequence: 125413947 Sequence: 125413948 Sequence: 125413949 Sequence: 125413950 Sequence: 125413951 Sequence: 125413952 Sequence: 125413953 Sequence: 125413954 Sequence: 125413955 Sequence: 125413956 Sequence: 125413957 Sequence: 125413958 Sequence: 125413959 Sequence: 125413960 Sequence: 125413961 Sequence: 125413962 Sequence: 125413963 Sequence: 125413964 Sequence: 125413965 Sequence: 125413966 Sequence: 125413967 Sequence: 125413968 Sequence: 125413971 Sequence: 125413969 Sequence: 125413970 Sequence: 125413972 Sequence: 125413973 Sequence: 125413974 Sequence: 125413975 Sequence: 125413976 Sequence: 125413977 Sequence: 125413978 Sequence: 125413979 Sequence: 125413980 Sequence: 125413981 Sequence: 125413982 Sequence: 125413983 Sequence: 125413984 Sequence: 125413985 Sequence: 125413986 Sequence: 125413987 Sequence: 125413988 Sequence: 125413989 Sequence: 125413990 Sequence: 125413991 Sequence: 125413992 Sequence: 125413993 Sequence: 125413994 Sequence: 125413995 Sequence: 125413996 Sequence: 125413997 Sequence: 125413998 Sequence: 125413999 Sequence: 125414000 Sequence: 125414001 Sequence: 125414002 Sequence: 125414003 Sequence: 125414004 Sequence: 125414005 Sequence: 125414006 Sequence: 125414007 Sequence: 125414008 Sequence: 125414009 Sequence: 125414010 Sequence: 125414011 Sequence: 125414012 Sequence: 125414013 Sequence: 125414014 Sequence: 125414015 Sequence: 125414016 Sequence: 125414017 Sequence: 125414018 Sequence: 125414019 Sequence: 125414020 Sequence: 125414021 Sequence: 125414022 Sequence: 125414023 Sequence: 125414024 Sequence: 125414025 Sequence: 125414026 Sequence: 125414027 Sequence: 125414028 Sequence: 125414029 Sequence: 125414030 Sequence: 125414031 Sequence: 125414032 Sequence: 125414033 Sequence: 125414034 Sequence: 125414035 Sequence: 125414036 Sequence: 125414037 Sequence: 125414038 Sequence: 125414039 Sequence: 125414040 Sequence: 125414041 Sequence: 125414042 Sequence: 125414043 Sequence: 125414044 Sequence: 125414045 Sequence: 125414046 Sequence: 125414047 Sequence: 125414048 Sequence: 125414049 Sequence: 125414050 Sequence: 125414051 Sequence: 125414052 Sequence: 125414053 Sequence: 125414054 Sequence: 125414055 Sequence: 125414056 Sequence: 125414057 Sequence: 125414058 Sequence: 125414059 Sequence: 125414060 Sequence: 125414061 Sequence: 125414062 Sequence: 125414063 Sequence: 125414064 Sequence: 125414065 Sequence: 125414066 Sequence: 125414067 Sequence: 125414068 Sequence: 125414069 Sequence: 125414070 Sequence: 125414071 Sequence: 125414072 Sequence: 125414073 Sequence: 125414074 Sequence: 125414075 Sequence: 125414076 Sequence: 125414077 Sequence: 125414078 Sequence: 125414079 Sequence: 125414080 Sequence: 125414081 Sequence: 125414082 Sequence: 125414083 Sequence: 125414084 Sequence: 125414085 Sequence: 125414086 Sequence: 125414087 Sequence: 125414088 Sequence: 125414089 Sequence: 125414090 Sequence: 125414091 Sequence: 125414092 Sequence: 125414093 Sequence: 125414094 Sequence: 125414095 Sequence: 125414096 Sequence: 125414097 Sequence: 125414098 Sequence: 125414099 Sequence: 125414100 Sequence: 125414101
Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937 Result Group Id 56032935 Result Group Id 56032936 Result Group Id 56032937
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Classification Mother Classification Mother Classification Mother Classification Father Classification Father Classification Father Classification Grandmother Classification Grandmother Classification Grandmother Classification Latino Classification Latino Classification Latino Classification Non-Latino Black Classification Non-Latino Black Classification Non-Latino Black Classification Non-Latino Asian Classification Non-Latino Asian Classification Non-Latino Asian Classification Non-Latino White Classification Non-Latino White Classification Non-Latino White Classification Non-Latino Multi-Racial Classification Non-Latino Multi-Racial Classification Non-Latino Other Classification Non-Latino Multi-Racial Classification Non-Latino Other Classification Non-Latino Other
Category English Category English Category English Category Spanish Category Spanish Category Spanish Category Other Category Other Category Other Category United States Category United States Category United States Category Country other than U.S. Category Country other than U.S. Category Country other than U.S. Category Married Category Married Category Married Category Divorced Category Divorced Category Divorced Category Living with a partner Category Living with a partner Category Living with a partner Category Separated Category Separated Category Separated Category Single (never married & currently not living with a partner) Category Single (never married & currently not living with a partner) Category Single (never married & currently not living with a partner) Category 1 adult Category 1 adult Category 1 adult Category 2 adults Category 2 adults Category 2 adults Category 3 adults Category 3 adults Category 3 adults Category 4 or more adults Category 4 or more adults Category 4 or more adults Category 1 child Category 1 child Category 1 child Category 2 children Category 2 children Category 2 children Category 3 children Category 3 children Category 3 children Category 4 or more children Category 4 or more children Category 4 or more children Category Medicaid (Medi-Cal/Apple Health) Category Medicaid (Medi-Cal/Apple Health) Category Medicaid (Medi-Cal/Apple Health) Category Private Insurance Plan Category Private Insurance Plan Category Private Insurance Plan Category Military Category Military Category Military Category Uninsured Category Uninsured Category Uninsured Category More than one Category More than one Category More than one Category Unknown Category Unknown Category Unknown Category Chronic medical problems Category Chronic medical problems Category Chronic medical problems Category No chronic medical problems Category No chronic medical problems Category No chronic medical problems Category Trouble paying for any household expenses in past 12 months Category Trouble paying for any household expenses in past 12 months Category Trouble paying for any household expenses in past 12 months Category No trouble paying for any household expenses in past 12 months Category No trouble paying for any household expenses in past 12 months Category No trouble paying for any household expenses in past 12 months Category Less than high school Category Less than high school Category Less than high school Category High school graduate or GED Category High school graduate or GED Category High school graduate or GED Category 2-Year college or some college Category 2-Year college or some college Category 2-Year college or some college Category 4-Year college degree or greater Category 4-Year college degree or greater Category 4-Year college degree or greater Category < $29,999 per year Category < $29,999 per year Category < $29,999 per year Category $30,000 to $49,999 per year Category $30,000 to $49,999 per year Category $30,000 to $49,999 per year Category $50,000 to $69,999 per year Category $50,000 to $69,999 per year Category $50,000 to $69,999 per year Category $70,000 or more Category $70,000 or more Category $70,000 or more Category Excellent Category Excellent Category Excellent Category Very good Category Very good Category Very good Category Good Category Good Category Good Category Fair/poor Category Fair/poor Category Fair/poor
Title Age, Continuous Title Age, Continuous Title Age, Continuous Title Sex/Gender, Customized Title Sex/Gender, Customized Title Sex/Gender, Customized Title Sex/Gender, Customized Title Sex/Gender, Customized Title Sex/Gender, Customized Title Sex/Gender, Customized Title Sex/Gender, Customized Title Sex/Gender, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Race/Ethnicity, Customized Title Primary language spoken at home Title Primary language spoken at home Title Primary language spoken at home Title Primary language spoken at home Title Primary language spoken at home Title Primary language spoken at home Title Primary language spoken at home Title Primary language spoken at home Title Primary language spoken at home Title Respondent country of birth Title Respondent country of birth Title Respondent country of birth Title Respondent country of birth Title Respondent country of birth Title Respondent country of birth Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Respondent marital status Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of adults in the home Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Number of children that parent has Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child health insurance Title Child chronic medical problems Title Child chronic medical problems Title Child chronic medical problems Title Child chronic medical problems Title Child chronic medical problems Title Child chronic medical problems Title Trouble paying for any household expenses Title Trouble paying for any household expenses Title Trouble paying for any household expenses Title Trouble paying for any household expenses Title Trouble paying for any household expenses Title Trouble paying for any household expenses Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Highest level of education completed Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Household Annual Income Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title Child's current overall health Title PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health Title PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health Title PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health Title PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health Title PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health Title PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health Title PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score Title PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score Title PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score
Description Child Age (months). Parents reported on age of child. We did not collect data on parent age Description Child Age (months). Parents reported on age of child. We did not collect data on parent age Description Child Age (months). Parents reported on age of child. We did not collect data on parent age Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent race/ethnicity (child race/ethnicity not collected) Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent primary language spoken at home Description Parent reported parent country of birth Description Parent reported parent country of birth Description Parent reported parent country of birth Description Parent reported parent country of birth Description Parent reported parent country of birth Description Parent reported parent country of birth Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported parent marital status Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent reported insurance type for enrolled child Description Parent report of enrolled child chronic medical problems Description Parent report of enrolled child chronic medical problems Description Parent report of enrolled child chronic medical problems Description Parent report of enrolled child chronic medical problems Description Parent report of enrolled child chronic medical problems Description Parent report of enrolled child chronic medical problems Description Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months Description Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months Description Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months Description Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months Description Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months Description Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent highest level of education Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported household annual income Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description Parent reported child's current overall health Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Mental Health was calculated by summing two 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 25.8-64.6. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Mental Health was calculated by summing two 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 25.8-64.6. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Mental Health was calculated by summing two 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 25.8-64.6. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Physical Health was calculated by summing 2 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 23.4-63.3. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Physical Health was calculated by summing 2 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 23.4-63.3. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Physical Health was calculated by summing 2 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 23.4-63.3. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Emotional Support was calculated by summing 4 5-point Likert scale questions for a total possible of 4-20 (17 values), then converting those sums to corresponding PROMIS T-scores, for T-score values ranging from 25.7-62.0. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Emotional Support was calculated by summing 4 5-point Likert scale questions for a total possible of 4-20 (17 values), then converting those sums to corresponding PROMIS T-scores, for T-score values ranging from 25.7-62.0. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals Description PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Emotional Support was calculated by summing 4 5-point Likert scale questions for a total possible of 4-20 (17 values), then converting those sums to corresponding PROMIS T-scores, for T-score values ranging from 25.7-62.0. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals
Units months Units months Units months Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units T-Score Units T-Score Units T-Score Units T-Score Units T-Score Units T-Score Units T-Score Units T-Score Units T-Score
Param Type Mean Param Type Mean Param Type Mean Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Number Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean Param Type Mean
Param Value 4.0 Param Value 4.7 Param Value 4.4 Param Value 414 Param Value 454 Param Value 868 Param Value 20 Param Value 22 Param Value 42 Param Value 1 Param Value 0 Param Value 1 Param Value 321 Param Value 343 Param Value 664 Param Value 24 Param Value 22 Param Value 46 Param Value 14 Param Value 13 Param Value 27 Param Value 52 Param Value 56 Param Value 108 Param Value 16 Param Value 15 Param Value 25 Param Value 31 Param Value 10 Param Value 35 Param Value 212 Param Value 243 Param Value 455 Param Value 197 Param Value 199 Param Value 396 Param Value 28 Param Value 34 Param Value 62 Param Value 218 Param Value 249 Param Value 467 Param Value 218 Param Value 227 Param Value 445 Param Value 164 Param Value 181 Param Value 345 Param Value 6 Param Value 8 Param Value 14 Param Value 165 Param Value 189 Param Value 354 Param Value 13 Param Value 12 Param Value 25 Param Value 89 Param Value 86 Param Value 175 Param Value 21 Param Value 23 Param Value 44 Param Value 232 Param Value 257 Param Value 489 Param Value 67 Param Value 82 Param Value 149 Param Value 117 Param Value 114 Param Value 231 Param Value 144 Param Value 169 Param Value 313 Param Value 130 Param Value 126 Param Value 256 Param Value 82 Param Value 105 Param Value 187 Param Value 81 Param Value 76 Param Value 157 Param Value 405 Param Value 450 Param Value 855 Param Value 7 Param Value 7 Param Value 14 Param Value 1 Param Value 0 Param Value 1 Param Value 17 Param Value 15 Param Value 32 Param Value 4 Param Value 3 Param Value 7 Param Value 2 Param Value 1 Param Value 3 Param Value 10 Param Value 6 Param Value 16 Param Value 426 Param Value 470 Param Value 896 Param Value 238 Param Value 289 Param Value 527 Param Value 194 Param Value 186 Param Value 380 Param Value 111 Param Value 120 Param Value 231 Param Value 159 Param Value 166 Param Value 325 Param Value 127 Param Value 152 Param Value 279 Param Value 39 Param Value 38 Param Value 77 Param Value 246 Param Value 236 Param Value 482 Param Value 83 Param Value 111 Param Value 194 Param Value 25 Param Value 29 Param Value 54 Param Value 16 Param Value 22 Param Value 38 Param Value 293 Param Value 325 Param Value 618 Param Value 89 Param Value 105 Param Value 194 Param Value 43 Param Value 44 Param Value 87 Param Value 8 Param Value 1 Param Value 9 Param Value 54.7 Param Value 53.9 Param Value 54.3 Param Value 51.1 Param Value 50.6 Param Value 50.9 Param Value 57.6 Param Value 57.2 Param Value 57.4
Param Value Num 4.0 Param Value Num 4.7 Param Value Num 4.4 Param Value Num 414.0 Param Value Num 454.0 Param Value Num 868.0 Param Value Num 20.0 Param Value Num 22.0 Param Value Num 42.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 321.0 Param Value Num 343.0 Param Value Num 664.0 Param Value Num 24.0 Param Value Num 22.0 Param Value Num 46.0 Param Value Num 14.0 Param Value Num 13.0 Param Value Num 27.0 Param Value Num 52.0 Param Value Num 56.0 Param Value Num 108.0 Param Value Num 16.0 Param Value Num 15.0 Param Value Num 25.0 Param Value Num 31.0 Param Value Num 10.0 Param Value Num 35.0 Param Value Num 212.0 Param Value Num 243.0 Param Value Num 455.0 Param Value Num 197.0 Param Value Num 199.0 Param Value Num 396.0 Param Value Num 28.0 Param Value Num 34.0 Param Value Num 62.0 Param Value Num 218.0 Param Value Num 249.0 Param Value Num 467.0 Param Value Num 218.0 Param Value Num 227.0 Param Value Num 445.0 Param Value Num 164.0 Param Value Num 181.0 Param Value Num 345.0 Param Value Num 6.0 Param Value Num 8.0 Param Value Num 14.0 Param Value Num 165.0 Param Value Num 189.0 Param Value Num 354.0 Param Value Num 13.0 Param Value Num 12.0 Param Value Num 25.0 Param Value Num 89.0 Param Value Num 86.0 Param Value Num 175.0 Param Value Num 21.0 Param Value Num 23.0 Param Value Num 44.0 Param Value Num 232.0 Param Value Num 257.0 Param Value Num 489.0 Param Value Num 67.0 Param Value Num 82.0 Param Value Num 149.0 Param Value Num 117.0 Param Value Num 114.0 Param Value Num 231.0 Param Value Num 144.0 Param Value Num 169.0 Param Value Num 313.0 Param Value Num 130.0 Param Value Num 126.0 Param Value Num 256.0 Param Value Num 82.0 Param Value Num 105.0 Param Value Num 187.0 Param Value Num 81.0 Param Value Num 76.0 Param Value Num 157.0 Param Value Num 405.0 Param Value Num 450.0 Param Value Num 855.0 Param Value Num 7.0 Param Value Num 7.0 Param Value Num 14.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 17.0 Param Value Num 15.0 Param Value Num 32.0 Param Value Num 4.0 Param Value Num 3.0 Param Value Num 7.0 Param Value Num 2.0 Param Value Num 1.0 Param Value Num 3.0 Param Value Num 10.0 Param Value Num 6.0 Param Value Num 16.0 Param Value Num 426.0 Param Value Num 470.0 Param Value Num 896.0 Param Value Num 238.0 Param Value Num 289.0 Param Value Num 527.0 Param Value Num 194.0 Param Value Num 186.0 Param Value Num 380.0 Param Value Num 111.0 Param Value Num 120.0 Param Value Num 231.0 Param Value Num 159.0 Param Value Num 166.0 Param Value Num 325.0 Param Value Num 127.0 Param Value Num 152.0 Param Value Num 279.0 Param Value Num 39.0 Param Value Num 38.0 Param Value Num 77.0 Param Value Num 246.0 Param Value Num 236.0 Param Value Num 482.0 Param Value Num 83.0 Param Value Num 111.0 Param Value Num 194.0 Param Value Num 25.0 Param Value Num 29.0 Param Value Num 54.0 Param Value Num 16.0 Param Value Num 22.0 Param Value Num 38.0 Param Value Num 293.0 Param Value Num 325.0 Param Value Num 618.0 Param Value Num 89.0 Param Value Num 105.0 Param Value Num 194.0 Param Value Num 43.0 Param Value Num 44.0 Param Value Num 87.0 Param Value Num 8.0 Param Value Num 1.0 Param Value Num 9.0 Param Value Num 54.7 Param Value Num 53.9 Param Value Num 54.3 Param Value Num 51.1 Param Value Num 50.6 Param Value Num 50.9 Param Value Num 57.6 Param Value Num 57.2 Param Value Num 57.4
Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation Dispersion Type Standard Deviation
Dispersion Value 4.0 Dispersion Value 4.0 Dispersion Value 4.0 Dispersion Value 8.5 Dispersion Value 8.2 Dispersion Value 8.3 Dispersion Value 8.4 Dispersion Value 7.9 Dispersion Value 8.2 Dispersion Value 7.0 Dispersion Value 7.6 Dispersion Value 7.3
Dispersion Value Num 4.0 Dispersion Value Num 4.0 Dispersion Value Num 4.0 Dispersion Value Num 8.5 Dispersion Value Num 8.2 Dispersion Value Num 8.3 Dispersion Value Num 8.4 Dispersion Value Num 7.9 Dispersion Value Num 8.2 Dispersion Value Num 7.0 Dispersion Value Num 7.6 Dispersion Value Num 7.3
Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914 Number Analyzed 438 Number Analyzed 476 Number Analyzed 914
Population Description 911 participants responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 participants responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 participants responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 906 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 906 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 906 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 907 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 905 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 905 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) Population Description 905 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)

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<![CDATA[ A Study of People With Type 2 Diabetes Who Have Diseases That Affect the Heart and Blood Vessels. The Study Will Also Look at the Treatment of a Group of These People in Hospitals in Portugal ]]>
https://zephyrnet.com/NCT03797885
2019-01-15

https://zephyrnet.com/?p=NCT03797885
NCT03797885https://www.clinicaltrials.gov/study/NCT03797885?tab=tableNANANAThis study aims to estimate the number of patients with cardiovascular disease and risk factors in patients who had been diagnosed with type 2 diabetes mellitus. Simultaneously, this study also intends to obtain more information about the management of type 2 diabetes mellitus patients with established cardiovascular disease. This study is non-interventional, which means that will not require participant’s further related visits or procedures. The study will collect the participant’s clinical data from the current visit and, when applicable, within the last 3 years.
<![CDATA[

Studies

Study First Submitted Date 2019-01-02
Study First Posted Date 2019-01-09
Last Update Posted Date 2020-11-20
Start Month Year January 15, 2019
Primary Completion Month Year October 15, 2019
Verification Month Year November 2020
Verification Date 2020-11-30
Last Update Posted Date 2020-11-20

Facilities

Sequence: 200280835 Sequence: 200280836 Sequence: 200280837 Sequence: 200280838 Sequence: 200280839 Sequence: 200280840 Sequence: 200280841 Sequence: 200280842 Sequence: 200280843 Sequence: 200280844 Sequence: 200280845 Sequence: 200280846 Sequence: 200280847 Sequence: 200280848
Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site Name Novo Nordisk Investigational Site
City Almada City Caldas da Rainha City Leiria City Lisboa City Lisboa City Lisboa City Matosinhos City Portimão City Porto City Porto City Viana do Castelo City Vila Nova de Gaia City Vila Real City Viseu
Zip 2805-267 Zip 2500-176 Zip 2410-197 Zip 1349-019 Zip 1500-650 Zip 1600-777 Zip 4464-513 Zip 8500-338 Zip 4099-001 Zip 4200-319 Zip 4901-858 Zip 4434-502 Zip 5000-508 Zip 3504-509
Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal Country Portugal

Conditions

Sequence: 52221752
Name Diabetes Mellitus, Type 2
Downcase Name diabetes mellitus, type 2

Id Information

Sequence: 40195787 Sequence: 40195788
Id Source org_study_id Id Source secondary_id
Id Value NN2211-4435 Id Value U1111-1207-2878
Id Type Other Identifier
Id Type Description World Health Organization (WHO)

Countries

Sequence: 42609770
Name Portugal
Removed False

Design Groups

Sequence: 55650041 Sequence: 55650042
Title Patients with type 2 diabetes mellitus (T2DM) Title Patients with T2DM and established cardiovascular disease
Description Patients with type 2 diabetes, at the hospital setting. Description Subgroup of patients with type 2 diabetes and established cardiovascular disease

Interventions

Sequence: 52535556
Intervention Type Other
Name No treatment given
Description No treatment is administered to the participants for this study

Design Outcomes

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Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in waist circumference Measure Change in body mass index Measure Hospital appointments Measure Hospitalisation episodes Measure Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis Measure Hypoglycaemic episodes Measure Hyperglycaemic episodes Measure Presence of T2DM complications (yes/no) Measure Types of T2DM complications Measure Emergency visits Measure Change in blood pressure Measure Change in urine albumin Measure Change in urine albumin Measure Change in glycosylated hemoglobin (HbA1c) Measure Change in HbA1c Measure Change in Estimated Glomerular Filtration Rate (eGFR) Measure Change in total cholesterol Measure Change in low-density lipoprotein cholesterol Measure Change in high-density lipoprotein cholesterol Measure Change in triglyceride Measure Type of pharmacological treatment
Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame Baseline (month 0) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months) Time Frame During 3 years before baseline (0 to -36 months)
Description Measured in cm Description Measured in kg/m^2 Description Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments Description Number of episodes Description Proportion of subjects.

CVRFs are defined as a history of one or more of the following criteria:

Overweight or obese
Family history of CVD (1st degree)
Hypertension
Hypercholesterolemia
Low high-density lipoproteins
Hypertriglyceridemia
Smoking habits
Sedentary lifestyle -as per Investigator discretion according to his/her normal practice.

CVD is defined as a history of one or more of the following events:

Stroke
Transient ischaemic attack
Ischaemic heart disease including myocardial infarction
Congestive heart failure
Atrial fibrillation
Aortic aneurism
Peripheral or carotid artery disease

Description Number of episodes Description Number of episodes Description Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively Description Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation. Description Number of visits Description Measured in mmHg Description Measured in mg/24 hours Description Measured in microgram/minute Description Measured in mmol/mol Description Measured in % Description Measured in mL/min/1.73 m^2 Description measured in mg/dl Description measured in mg/dl Description measured in mg/dl Description measured in mg/dl Description Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy

Browse Conditions

Sequence: 193679338 Sequence: 193679339 Sequence: 193679335 Sequence: 193679336 Sequence: 193679337
Mesh Term Metabolic Diseases Mesh Term Endocrine System Diseases Mesh Term Diabetes Mellitus, Type 2 Mesh Term Diabetes Mellitus Mesh Term Glucose Metabolism Disorders
Downcase Mesh Term metabolic diseases Downcase Mesh Term endocrine system diseases Downcase Mesh Term diabetes mellitus, type 2 Downcase Mesh Term diabetes mellitus Downcase Mesh Term glucose metabolism disorders
Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48366626
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Novo Nordisk A/S

Overall Officials

Sequence: 29313015
Role Study Director
Name Clinical Reporting Anchor and Disclosure (1452)
Affiliation Novo Nordisk A/S

Design Group Interventions

Sequence: 68217673 Sequence: 68217674
Design Group Id 55650042 Design Group Id 55650041
Intervention Id 52535556 Intervention Id 52535556

Eligibilities

Sequence: 30794839
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population Patients with type 2 diabetes mellitus
Criteria Inclusion Criteria:

Main study population (Data collection – Prevalence):

Signed Informed Consent Form (ICF) obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
Male or female patient, age greater or equal to 18 years at the time of signing ICF
Patients diagnosed with type 2 diabetes

Subgroup (Data collection – Patient management):

Patients followed at the hospital setting by the endocrinologist or internal medicine specialist (ambulatory diabetes management) and with available medical records, retrospectively within the last three years
Patients with type 2 diabetes mellitus and established cardiovascular disease diagnosed at least three years ago

Exclusion Criteria:

Previous participation in this study. Participation is defined as signed ICF
Female patient who is pregnant or breast-feeding
Patients with type 1 diabetes
Participation in a clinical trial within the last 3 years

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254004522
Number Of Facilities 14
Registered In Calendar Year 2019
Actual Duration 9
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 20

Designs

Sequence: 30540879
Observational Model Cohort
Time Perspective Cross-Sectional

Responsible Parties

Sequence: 28907199
Responsible Party Type Sponsor

]]>

<![CDATA[ Psoriatic Oligoarthritis Intervention With Symptomatic thErapy ]]>
https://zephyrnet.com/NCT03797872
2019-04-17

https://zephyrnet.com/?p=NCT03797872
NCT03797872https://www.clinicaltrials.gov/study/NCT03797872?tab=tableNANANAPOISE is a two arm interventional trial nested within a cohort (Trials Within Cohorts or TWiCs design). This tests less aggressive early therapy in patients newly diagnosed with low impact oligoarticular PsA. Arm 1 will receive standard step up therapy in the cohort and act as the control group. Arm 2 will receive local steroid injections to active joints and will be able to use non-steroidal anti-inflammatory drugs (NSAIDs) only
<![CDATA[

Studies

Study First Submitted Date 2018-12-18
Study First Posted Date 2019-01-09
Last Update Posted Date 2021-05-10
Start Month Year April 17, 2019
Primary Completion Month Year July 16, 2020
Verification Month Year March 2020
Verification Date 2020-03-31
Last Update Posted Date 2021-05-10
Results First Posted Date 2021-05-10

Detailed Descriptions

Sequence: 20543846
Description Arm 1: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard practice in these PsA clinics following current international recommendations and National requirements for the prescription of biologic therapy. Whilst physician discretion is used, most commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to at the discretion of the rheumatologist. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations usually with a TNF inhibitor as first line. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Further details are available in the PsA clinic treatment protocol which is Appendix D in the MONITOR-PsA protocol.

Arm 2: Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local glucocorticoid injections to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication as indicated for individuals. Local glucocorticoid injections will include injections with methylprednisolone or triamcinolone. All active joints will be treated with glucocorticoid injections. Glucocorticoid injections can be either be given as an intra-articular injection to an inflamed joint or as an intra-muscular injection if multiple joints are involved. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). If Participants require DMARD therapy, they will be offered rescue therapy as per usual clinical care but will be asked to continue with data collection for the trial. This is to ensure that sufficient data is collected for the trial but risks in delaying treatment to the individual are mitigated.

Facilities

Sequence: 198363087
Name Oxford University Hospitals NHS Trust
City Oxford
State Oxfordshire
Zip OX3 7LD
Country United Kingdom

Browse Interventions

Sequence: 95148125 Sequence: 95148126 Sequence: 95148127 Sequence: 95148128 Sequence: 95148129 Sequence: 95148130 Sequence: 95148131 Sequence: 95148132 Sequence: 95148133 Sequence: 95148134 Sequence: 95148135 Sequence: 95148136 Sequence: 95148137 Sequence: 95148138 Sequence: 95148139 Sequence: 95148140 Sequence: 95148141 Sequence: 95148142 Sequence: 95148143 Sequence: 95148144 Sequence: 95148145 Sequence: 95148146 Sequence: 95148147 Sequence: 95148148 Sequence: 95148149 Sequence: 95148150 Sequence: 95148151 Sequence: 95148152 Sequence: 95148153 Sequence: 95148154 Sequence: 95148155 Sequence: 95148156 Sequence: 95148157 Sequence: 95148158 Sequence: 95148159 Sequence: 95148160 Sequence: 95148161 Sequence: 95148162 Sequence: 95148163 Sequence: 95148164 Sequence: 95148165 Sequence: 95148166 Sequence: 95148167 Sequence: 95148168 Sequence: 95148169
Mesh Term Sulfasalazine Mesh Term Methylprednisolone Mesh Term Methylprednisolone Acetate Mesh Term Methylprednisolone Hemisuccinate Mesh Term Prednisolone Mesh Term Prednisolone acetate Mesh Term Triamcinolone Mesh Term Triamcinolone Acetonide Mesh Term Triamcinolone hexacetonide Mesh Term Methotrexate Mesh Term Triamcinolone diacetate Mesh Term Leflunomide Mesh Term Prednisolone hemisuccinate Mesh Term Prednisolone phosphate Mesh Term Abortifacient Agents, Nonsteroidal Mesh Term Abortifacient Agents Mesh Term Reproductive Control Agents Mesh Term Physiological Effects of Drugs Mesh Term Antimetabolites, Antineoplastic Mesh Term Antimetabolites Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antineoplastic Agents Mesh Term Dermatologic Agents Mesh Term Enzyme Inhibitors Mesh Term Folic Acid Antagonists Mesh Term Immunosuppressive Agents Mesh Term Immunologic Factors Mesh Term Antirheumatic Agents Mesh Term Nucleic Acid Synthesis Inhibitors Mesh Term Anti-Inflammatory Agents Mesh Term Antiemetics Mesh Term Autonomic Agents Mesh Term Peripheral Nervous System Agents Mesh Term Gastrointestinal Agents Mesh Term Glucocorticoids Mesh Term Hormones Mesh Term Hormones, Hormone Substitutes, and Hormone Antagonists Mesh Term Neuroprotective Agents Mesh Term Protective Agents Mesh Term Antineoplastic Agents, Hormonal Mesh Term Anti-Infective Agents Mesh Term Anti-Inflammatory Agents, Non-Steroidal Mesh Term Analgesics, Non-Narcotic Mesh Term Analgesics Mesh Term Sensory System Agents
Downcase Mesh Term sulfasalazine Downcase Mesh Term methylprednisolone Downcase Mesh Term methylprednisolone acetate Downcase Mesh Term methylprednisolone hemisuccinate Downcase Mesh Term prednisolone Downcase Mesh Term prednisolone acetate Downcase Mesh Term triamcinolone Downcase Mesh Term triamcinolone acetonide Downcase Mesh Term triamcinolone hexacetonide Downcase Mesh Term methotrexate Downcase Mesh Term triamcinolone diacetate Downcase Mesh Term leflunomide Downcase Mesh Term prednisolone hemisuccinate Downcase Mesh Term prednisolone phosphate Downcase Mesh Term abortifacient agents, nonsteroidal Downcase Mesh Term abortifacient agents Downcase Mesh Term reproductive control agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term antimetabolites, antineoplastic Downcase Mesh Term antimetabolites Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antineoplastic agents Downcase Mesh Term dermatologic agents Downcase Mesh Term enzyme inhibitors Downcase Mesh Term folic acid antagonists Downcase Mesh Term immunosuppressive agents Downcase Mesh Term immunologic factors Downcase Mesh Term antirheumatic agents Downcase Mesh Term nucleic acid synthesis inhibitors Downcase Mesh Term anti-inflammatory agents Downcase Mesh Term antiemetics Downcase Mesh Term autonomic agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term gastrointestinal agents Downcase Mesh Term glucocorticoids Downcase Mesh Term hormones Downcase Mesh Term hormones, hormone substitutes, and hormone antagonists Downcase Mesh Term neuroprotective agents Downcase Mesh Term protective agents Downcase Mesh Term antineoplastic agents, hormonal Downcase Mesh Term anti-infective agents Downcase Mesh Term anti-inflammatory agents, non-steroidal Downcase Mesh Term analgesics, non-narcotic Downcase Mesh Term analgesics Downcase Mesh Term sensory system agents
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51714173
Name Psoriatic Arthritis
Downcase Name psoriatic arthritis

Id Information

Sequence: 39795366
Id Source org_study_id
Id Value 18/SC/0261

Countries

Sequence: 42195324
Name United Kingdom
Removed False

Design Groups

Sequence: 55135056 Sequence: 55135057
Group Type Active Comparator Group Type Experimental
Title Standard care Title Local/IM steroid injections
Description Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Description Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).

Interventions

Sequence: 52036214 Sequence: 52036215 Sequence: 52036216 Sequence: 52036217 Sequence: 52036218
Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug Intervention Type Drug
Name Methotrexate Name Sulfasalazine Name Leflunomide Name Methylprednisolone Name Triamcinolone
Description Methotrexate up to 25mg/week as tolerated po or sc Description Sulfasalazine up to 3g daily po Description Leflunomide 10-20mg daily po Description For IA or IM injection 20-120mg Description For IA or IM injection 20-120mg

Design Outcomes

Sequence: 175894300 Sequence: 175894301 Sequence: 175894302 Sequence: 175894303
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study Measure Psoriatic Arthritis Disease Activity Score (PASDAS) Measure Ultrasound Score of Synovitis Measure Ultrasound Score of Enthesitis
Time Frame 48 weeks Time Frame 48 weeks Time Frame 0 weeks Time Frame 0 weeks
Description To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). Description A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2. Description A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276 Description A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30

Browse Conditions

Sequence: 191649731 Sequence: 191649732 Sequence: 191649733 Sequence: 191649734 Sequence: 191649735 Sequence: 191649736 Sequence: 191649737 Sequence: 191649738 Sequence: 191649739 Sequence: 191649740 Sequence: 191649741 Sequence: 191649742
Mesh Term Arthritis Mesh Term Arthritis, Psoriatic Mesh Term Joint Diseases Mesh Term Musculoskeletal Diseases Mesh Term Spondylarthropathies Mesh Term Spondylarthritis Mesh Term Spondylitis Mesh Term Spinal Diseases Mesh Term Bone Diseases Mesh Term Psoriasis Mesh Term Skin Diseases, Papulosquamous Mesh Term Skin Diseases
Downcase Mesh Term arthritis Downcase Mesh Term arthritis, psoriatic Downcase Mesh Term joint diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term spondylarthropathies Downcase Mesh Term spondylarthritis Downcase Mesh Term spondylitis Downcase Mesh Term spinal diseases Downcase Mesh Term bone diseases Downcase Mesh Term psoriasis Downcase Mesh Term skin diseases, papulosquamous Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47895883 Sequence: 47895884
Agency Class OTHER Agency Class OTHER_GOV
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Oxford Name National Institute for Health Research, United Kingdom

Design Group Interventions

Sequence: 67592148 Sequence: 67592149 Sequence: 67592150 Sequence: 67592151 Sequence: 67592152
Design Group Id 55135056 Design Group Id 55135056 Design Group Id 55135056 Design Group Id 55135057 Design Group Id 55135057
Intervention Id 52036214 Intervention Id 52036215 Intervention Id 52036216 Intervention Id 52036217 Intervention Id 52036218

Eligibilities

Sequence: 30499693
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Participants consented to the PsA inception cohort (MONITOR-PsA) and to be approached for alternate interventional therapies.

Participants with mild disease as defined by:

Oligoarticular disease with <5 active joints at baseline assessment.
Low disease activity as defined by a PsA disease activity score (PASDAS) ≤3.2.
Low impact of disease as defined a PsA impact of disease (PSAID) ≤4.
Participant is willing and able to give informed consent for participation in the trial.
Male or female.
Aged 18 years or above.
Female Participants of child bearing potential and male Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception (defined as true abstinence, oral contraceptives, implants, intrauterine device, barrier method with spermicide, or surgical sterilization) during the trial and for 3 months thereafter if receiving DMARD therapy (excluding sulfasalazine).

Participant has clinically acceptable laboratory results within 6 weeks of enrolment:

Haemoglobin count > 8.5 g/dL
White blood count (WBC) > 3.5 x 109/L
Absolute neutrophil count (ANC) > 1.5 x 109/L
Platelet count > 100 x 109/L
ALT and alkaline phosphatase levels <3 x upper limit of normal
In the Investigator's opinion, is able and willing to comply with all trial requirements.
Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria:

≥1 poor prognostic factors for psoriatic arthritis, from

raised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP
radiographic damage defined as the presence of ≥ 1 erosion on plain radiographs of the hands and feet
health assessment questionnaire (HAQ) score > 1
Contraindications to non-steroidal anti-inflammatory drugs
Previous treatment for articular disease with synthetic DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologic DMARDs (including TNF, IL12/23 or IL17 inhibitor therapies) or targeted synthetic DMARDs (PDE4 of JAK inhibitor therapies).
Female patient who is pregnant, breast feeding or planning pregnancy during the course of the trial.
Significant renal or hepatic impairment.
Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Patients who have participated in another research trial involving an investigational product in the past 12 weeks.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254040581
Number Of Facilities 1
Registered In Calendar Year 2018
Actual Duration 15
Were Results Reported True
Months To Report Results 7
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30248907
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Masking Description Blinded assessor will perform clinical evaluations
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26449144 Sequence: 26449145 Sequence: 26449146 Sequence: 26449147 Sequence: 26449148
Intervention Id 52036214 Intervention Id 52036215 Intervention Id 52036216 Intervention Id 52036217 Intervention Id 52036218
Name methotrexate sodium Name sulfasalazine pill Name leflunomide pill Name methylprednisolone acetate Name triamcinolone acetonide

Milestones

Sequence: 40675576 Sequence: 40675577 Sequence: 40675578 Sequence: 40675579 Sequence: 40675580 Sequence: 40675581
Result Group Id 55732955 Result Group Id 55732956 Result Group Id 55732955 Result Group Id 55732956 Result Group Id 55732955 Result Group Id 55732956
Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code FG000 Ctgov Group Code FG001
Title STARTED Title STARTED Title COMPLETED Title COMPLETED Title NOT COMPLETED Title NOT COMPLETED
Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study Period Overall Study
Count 1 Count 0 Count 0 Count 0 Count 1 Count 0

Participant Flows

Sequence: 3888691
Recruitment Details The POISE trial opened on 17 April 2019 in Oxford and 19 September 2019 in Bath.

The study remained open until 16 July 2020 as planned.

Outcome Counts

Sequence: 73393043 Sequence: 73393044 Sequence: 73393045 Sequence: 73393046 Sequence: 73393047 Sequence: 73393048 Sequence: 73393049 Sequence: 73393050
Outcome Id 30547991 Outcome Id 30547991 Outcome Id 30547992 Outcome Id 30547992 Outcome Id 30547993 Outcome Id 30547993 Outcome Id 30547994 Outcome Id 30547994
Result Group Id 55732957 Result Group Id 55732958 Result Group Id 55732957 Result Group Id 55732958 Result Group Id 55732957 Result Group Id 55732958 Result Group Id 55732957 Result Group Id 55732958
Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code OG000 Ctgov Group Code OG001
Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure Scope Measure
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants
Count 1 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0 Count 0

Provided Documents

Sequence: 2560043
Document Type Study Protocol and Statistical Analysis Plan
Has Protocol True
Has Icf False
Has Sap True
Document Date 2019-08-27
Url https://ClinicalTrials.gov/ProvidedDocs/72/NCT03797872/Prot_SAP_000.pdf

Reported Event Totals

Sequence: 27710638 Sequence: 27710639 Sequence: 27710640 Sequence: 27710641 Sequence: 27710642 Sequence: 27710643
Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG000 Ctgov Group Code EG001 Ctgov Group Code EG001 Ctgov Group Code EG001
Event Type serious Event Type other Event Type deaths Event Type serious Event Type other Event Type deaths
Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality Classification Total, serious adverse events Classification Total, other adverse events Classification Total, all-cause mortality
Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0 Subjects Affected 0
Subjects At Risk 1 Subjects At Risk 1 Subjects At Risk 1 Subjects At Risk 0 Subjects At Risk 0 Subjects At Risk 0
Created At 2023-08-06 07:44:58.127991 Created At 2023-08-06 07:44:58.127991 Created At 2023-08-06 07:44:58.127991 Created At 2023-08-06 07:44:58.127991 Created At 2023-08-06 07:44:58.127991 Created At 2023-08-06 07:44:58.127991
Updated At 2023-08-06 07:44:58.127991 Updated At 2023-08-06 07:44:58.127991 Updated At 2023-08-06 07:44:58.127991 Updated At 2023-08-06 07:44:58.127991 Updated At 2023-08-06 07:44:58.127991 Updated At 2023-08-06 07:44:58.127991

Responsible Parties

Sequence: 28629715
Responsible Party Type Sponsor

Result Agreements

Sequence: 3819435
Pi Employee No

Result Contacts

Sequence: 3819400
Organization University of Oxford
Name Professor Laura Coates
Phone +447870257823
Email laura.coates@ndorms.ox.ac.uk

Outcomes

Sequence: 30547991 Sequence: 30547992 Sequence: 30547993 Sequence: 30547994
Outcome Type Primary Outcome Type Secondary Outcome Type Secondary Outcome Type Secondary
Title Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study Title Psoriatic Arthritis Disease Activity Score (PASDAS) Title Ultrasound Score of Synovitis Title Ultrasound Score of Enthesitis
Description To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). Description A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2. Description A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276 Description A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30
Time Frame 48 weeks Time Frame 48 weeks Time Frame 0 weeks Time Frame 0 weeks
Population All participants included Population Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis Population Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis Population Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis. The US was not performed as this was only for participants in the intervention group.
Units Participants
Param Type Count of Participants

Outcome Measurements

Sequence: 233726597
Outcome Id 30547991
Result Group Id 55732957
Ctgov Group Code OG000
Title Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
Description To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).
Units Participants
Param Type Count of Participants
Param Value 0
Param Value Num 0.0

Study References

Sequence: 51604931
Pmid 35035537
Reference Type derived
Citation Rombach I, Tucker L, Tillett W, Jadon D, Watson M, Francis A, Sinomati Y, Dutton SJ, Coates LC. Clinical effectiveness of symptomatic therapy compared with standard step-up care for the treatment of low-impact psoriatic oligoarthritis: the two-arm parallel group randomised POISE feasibility study. Ther Adv Musculoskelet Dis. 2022 Jan 10;13:1759720X211057668. doi: 10.1177/1759720X211057668. eCollection 2021. Erratum In: Ther Adv Musculoskelet Dis. 2022 Feb 9;14:1759720X221077827.

Baseline Counts

Sequence: 11289985 Sequence: 11289986 Sequence: 11289987
Result Group Id 55732952 Result Group Id 55732953 Result Group Id 55732954
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002
Units Participants Units Participants Units Participants
Scope overall Scope overall Scope overall
Count 1 Count 0 Count 1

Result Groups

Sequence: 55732952 Sequence: 55732953 Sequence: 55732954 Sequence: 55732955 Sequence: 55732956 Sequence: 55732957 Sequence: 55732958 Sequence: 55732959 Sequence: 55732960
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code FG000 Ctgov Group Code FG001 Ctgov Group Code OG000 Ctgov Group Code OG001 Ctgov Group Code EG000 Ctgov Group Code EG001
Result Type Baseline Result Type Baseline Result Type Baseline Result Type Participant Flow Result Type Participant Flow Result Type Outcome Result Type Outcome Result Type Reported Event Result Type Reported Event
Title Standard Care Title Local/IM Steroid Injections Title Total Title Standard Care Title Local/IM Steroid Injections Title Standard Care Title Local/IM Steroid Injections Title Standard Care Title Local/IM Steroid Injections
Description Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.

Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc

Sulfasalazine: Sulfasalazine up to 3g daily po

Leflunomide: Leflunomide 10-20mg daily po

Description Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).

Methylprednisolone: For IA or IM injection 20-120mg

Triamcinolone: For IA or IM injection 20-120mg

Description Total of all reporting groups Description Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.

Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc

Sulfasalazine: Sulfasalazine up to 3g daily po

Leflunomide: Leflunomide 10-20mg daily po

Description Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).

Methylprednisolone: For IA or IM injection 20-120mg

Triamcinolone: For IA or IM injection 20-120mg

Description Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.

Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc

Sulfasalazine: Sulfasalazine up to 3g daily po

Leflunomide: Leflunomide 10-20mg daily po

Description Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).

Methylprednisolone: For IA or IM injection 20-120mg

Triamcinolone: For IA or IM injection 20-120mg

Description Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.

Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc

Sulfasalazine: Sulfasalazine up to 3g daily po

Leflunomide: Leflunomide 10-20mg daily po

Description Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).

Methylprednisolone: For IA or IM injection 20-120mg

Triamcinolone: For IA or IM injection 20-120mg

Baseline Measurements

Sequence: 124593395 Sequence: 124593396 Sequence: 124593397 Sequence: 124593398 Sequence: 124593399 Sequence: 124593400 Sequence: 124593401 Sequence: 124593402 Sequence: 124593403 Sequence: 124593404 Sequence: 124593405 Sequence: 124593406 Sequence: 124593407 Sequence: 124593408 Sequence: 124593409 Sequence: 124593410 Sequence: 124593411 Sequence: 124593412
Result Group Id 55732952 Result Group Id 55732953 Result Group Id 55732954 Result Group Id 55732952 Result Group Id 55732953 Result Group Id 55732954 Result Group Id 55732952 Result Group Id 55732953 Result Group Id 55732954 Result Group Id 55732952 Result Group Id 55732953 Result Group Id 55732954 Result Group Id 55732952 Result Group Id 55732953 Result Group Id 55732954 Result Group Id 55732954 Result Group Id 55732952 Result Group Id 55732954
Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG001 Ctgov Group Code BG002 Ctgov Group Code BG002 Ctgov Group Code BG000 Ctgov Group Code BG002
Classification United Kingdom Classification United Kingdom
Category <=18 years Category <=18 years Category <=18 years Category Between 18 and 65 years Category Between 18 and 65 years Category Between 18 and 65 years Category >=65 years Category >=65 years Category >=65 years Category Female Category Female Category Female Category Male Category Male Category Male
Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Age, Categorical Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Sex: Female, Male Title Race and Ethnicity Not Collected Title Region of Enrollment Title Region of Enrollment
Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units Participants Units participants Units participants
Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Count of Participants Param Type Number Param Type Number
Param Value 0 Param Value 0 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 0 Param Value 1 Param Value 1
Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 0.0 Param Value Num 1.0 Param Value Num 1.0
Number Analyzed 1 Number Analyzed 0 Number Analyzed 1 Number Analyzed 1 Number Analyzed 0 Number Analyzed 1 Number Analyzed 1 Number Analyzed 0 Number Analyzed 1 Number Analyzed 1 Number Analyzed 0 Number Analyzed 1 Number Analyzed 1 Number Analyzed 0 Number Analyzed 1 Number Analyzed 1 Number Analyzed 1 Number Analyzed 1
Population Description Race and Ethnicity were not collected from any participant.

]]>

<![CDATA[ THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia. ]]>
https://zephyrnet.com/NCT03797859
2019-01-08

https://zephyrnet.com/?p=NCT03797859
NCT03797859https://www.clinicaltrials.gov/study/NCT03797859?tab=tableNANANATransnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion.

We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2019-01-23
Start Month Year January 8, 2019
Primary Completion Month Year May 1, 2019
Verification Month Year January 2019
Verification Date 2019-01-31
Last Update Posted Date 2019-01-23

Detailed Descriptions

Sequence: 20762931
Description THRIVE is previously shown feasible as sole mode of ventilation in selected patients during general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation and a degree of ventilation was observed. However, a slowly developed respiratory acidosis was also observed over time.

Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth breathing enhance the effects of the high flows of oxygen levels applied by increasing the airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear whether the efficiency of THRIVE depends on the particular circumstances of airway management. Physiologic characterization of THRIVE performance under standardized conditions of airway management and under close monitoring by systematic analysis of blood gas dynamics over time during general anesthesia is needed.

We plan to study the blood gas dynamics during THRIVE apnea ventilation during general anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under 7.15 and/or PaCO2-rise > 12 kPa will lead to cessation of THRIVE.

Facilities

Sequence: 200458204 Sequence: 200458205
Name Rigshospitalet Name Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
City Copenhagen City Copenhagen
State Hoevdstaden
Zip 2100 Zip 2100
Country Denmark Country Denmark

Conditions

Sequence: 52277464 Sequence: 52277465 Sequence: 52277466
Name Apnea Name Ventilation Therapy; Complications Name Respiratory Acidosis
Downcase Name apnea Downcase Name ventilation therapy; complications Downcase Name respiratory acidosis

Id Information

Sequence: 40235469
Id Source org_study_id
Id Value H-18017844

Countries

Sequence: 42653066
Name Denmark
Removed False

Interventions

Sequence: 52589530
Intervention Type Procedure
Name Apneic ventilation
Description Ventilation by THRIVE

Design Outcomes

Sequence: 177770698
Outcome Type primary
Measure Respiratory acidosis
Time Frame Max. 60 minutes
Description Development of respiratory acidosis (pH < 7.15 or paCO2 > 12) over time on study

Browse Conditions

Sequence: 193892782 Sequence: 193892783 Sequence: 193892784 Sequence: 193892785 Sequence: 193892786 Sequence: 193892787 Sequence: 193892788
Mesh Term Acidosis, Respiratory Mesh Term Acidosis Mesh Term Acid-Base Imbalance Mesh Term Metabolic Diseases Mesh Term Respiratory Insufficiency Mesh Term Respiration Disorders Mesh Term Respiratory Tract Diseases
Downcase Mesh Term acidosis, respiratory Downcase Mesh Term acidosis Downcase Mesh Term acid-base imbalance Downcase Mesh Term metabolic diseases Downcase Mesh Term respiratory insufficiency Downcase Mesh Term respiration disorders Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48418649
Agency Class OTHER
Lead Or Collaborator lead
Name Rigshospitalet, Denmark

Overall Officials

Sequence: 29342619
Role Principal Investigator
Name Michael S Kristensen, MD
Affiliation Senior consultant, Rigshospitalet

Eligibilities

Sequence: 30827037
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Population Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is not mandatory.
Criteria Inclusion Criteria:

Adult (age over 18 years)
Elective surgery where intubation is not mandatory
The patient can understand the information about the study and give their informed written consent of participation

Exclusion Criteria:

ASA (American Society of Anaesthesiologists class) > 3
NYHA (New York Heart Association class) > 2
BMI > 30 kg/m2
Symptomatic respiratory disease
Symptomatic cardiac disease
Evidence of arteriosclerotic disease
Neuromuscular disease
Pregnancy
Presumed or predicted difficult airway (SARI – Simplified Airway Risk Index score > 4)
Known or suspected nasal congestion/stenosis or catharalia

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254123732
Number Of Facilities 2
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30572967
Observational Model Case-Only
Time Perspective Prospective

Responsible Parties

Sequence: 28939389
Responsible Party Type Principal Investigator
Name Michael Seltz Kristensen
Title SENIOR CONSULTANT
Affiliation Rigshospitalet, Denmark

]]>

<![CDATA[ Comparison of Fixation Suture Type in Glaucoma Surgery ]]>
https://zephyrnet.com/NCT03797846
2018-01-01

https://zephyrnet.com/?p=NCT03797846
NCT03797846https://www.clinicaltrials.gov/study/NCT03797846?tab=tableNANANAThe aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea.

This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.
<![CDATA[

Studies

Study First Submitted Date 2019-01-03
Study First Posted Date 2019-01-09
Last Update Posted Date 2020-07-14
Start Month Year January 1, 2018
Primary Completion Month Year January 1, 2019
Verification Month Year July 2020
Verification Date 2020-07-31
Last Update Posted Date 2020-07-14

Detailed Descriptions

Sequence: 20716296
Description The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.

Facilities

Sequence: 200053300
Name Medical University
City Białystok
Zip 15-089
Country Poland

Conditions

Sequence: 52156500 Sequence: 52156501
Name Glaucoma Eye Name Glaucoma
Downcase Name glaucoma eye Downcase Name glaucoma

Id Information

Sequence: 40148214
Id Source org_study_id
Id Value 1771

Countries

Sequence: 42557735
Name Poland
Removed False

Design Groups

Sequence: 55577910 Sequence: 55577911
Group Type Active Comparator Group Type Active Comparator
Title Corneal Suture Title Muscle Suture
Description intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery Description intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery

Interventions

Sequence: 52472012
Intervention Type Procedure
Name combined glaucoma surgery
Description combined procedure with trabeculectomy and cataract removal

Keywords

Sequence: 79848096 Sequence: 79848097 Sequence: 79848098 Sequence: 79848099
Name ptosis Name combined procedures Name glaucoma Name post-surgery complication
Downcase Name ptosis Downcase Name combined procedures Downcase Name glaucoma Downcase Name post-surgery complication

Design Outcomes

Sequence: 177328009 Sequence: 177328010 Sequence: 177328011
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure IOP Measure BCVA Measure MRD
Time Frame baseline and twelve months after surgery Time Frame baseline and twelve months after surgery Time Frame baseline and twelve months after surgery
Description the change in the level of intraocular pressure Description the change in the best corrected visual acuity Description the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm

Browse Conditions

Sequence: 193432080 Sequence: 193432078 Sequence: 193432079
Mesh Term Eye Diseases Mesh Term Glaucoma Mesh Term Ocular Hypertension
Downcase Mesh Term eye diseases Downcase Mesh Term glaucoma Downcase Mesh Term ocular hypertension
Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48306087
Agency Class OTHER
Lead Or Collaborator lead
Name Medical University of Bialystok

Overall Officials

Sequence: 29277931
Role Study Chair
Name Zofia Mariak, Prof
Affiliation Medical University of Bialystok

Design Group Interventions

Sequence: 68130877 Sequence: 68130878
Design Group Id 55577910 Design Group Id 55577911
Intervention Id 52472012 Intervention Id 52472012

Eligibilities

Sequence: 30757357
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria:

co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacities Classification System III)
primary open-angle glaucoma and secondary pseudoexfoliative glaucoma, in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic
documented progression of loss of field of vision
significant daily IOP fluctuations
no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medications

Exclusion Criteria:

no consent to participation in the study
prior surgical and laser procedures in the area of the eye
narrow- or closed-angle glaucoma
post-inflammatory or post-traumatic secondary glaucoma
chronic illness of the cornea or optic nerve
advanced macular degeneration
active inflammatory process
pregnancy
systemic steroid therapy

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254227935
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 12
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30503582
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description A prospective randomized trial with a 6 month follow-up period

Responsible Parties

Sequence: 28869860
Responsible Party Type Principal Investigator
Name Joanna Konopińska
Title MD, PhD
Affiliation Medical University of Bialystok

Study References

Sequence: 52049407
Pmid 25803293
Reference Type background
Citation Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15.

Ipd Information Types

Sequence: 3332718
Name Study Protocol

]]>

<![CDATA[ Spinal Anesthesia for External Cephalic Version ]]>
https://zephyrnet.com/NCT03797833
2019-01-07

https://zephyrnet.com/?p=NCT03797833
NCT03797833https://www.clinicaltrials.gov/study/NCT03797833?tab=tableNANANAThis study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.
<![CDATA[

Studies

Study First Submitted Date 2019-01-07
Study First Posted Date 2019-01-09
Last Update Posted Date 2022-10-27
Start Month Year January 7, 2019
Primary Completion Month Year January 31, 2029
Verification Month Year October 2022
Verification Date 2022-10-31
Last Update Posted Date 2022-10-27

Detailed Descriptions

Sequence: 20587369
Description Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.

The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.

The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.

Facilities

Sequence: 198728093 Sequence: 198728094
Name Skåne University Hospital Name Skåne University Hospital
City Lund City Malmö
Country Sweden Country Sweden

Browse Interventions

Sequence: 95372136 Sequence: 95372137 Sequence: 95372138
Mesh Term Anesthetics Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs
Downcase Mesh Term anesthetics Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 51825421
Name Breech Presentation; Before Labor
Downcase Name breech presentation; before labor

Id Information

Sequence: 39882881
Id Source org_study_id
Id Value 2018/634

Countries

Sequence: 42281325
Name Sweden
Removed False

Design Groups

Sequence: 55248203 Sequence: 55248204
Group Type No Intervention Group Type Active Comparator
Title Standard treatment Title Spinal anaesthesia
Description ECV according to standard practice. Description ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg)

Interventions

Sequence: 52146766
Intervention Type Procedure
Name Spinal Anaesthesia
Description Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg

Keywords

Sequence: 79304278
Name breech presentation, external version, spinal anaesthesia
Downcase Name breech presentation, external version, spinal anaesthesia

Design Outcomes

Sequence: 176258167 Sequence: 176258165 Sequence: 176258166 Sequence: 176258168
Outcome Type secondary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Overall maternal satisfaction post partum Measure External version success rate Measure Overall maternal satisfaction post external version attempt Measure Caesarian section rate
Time Frame 3 months Time Frame 1 hour Time Frame 1 hour Time Frame 1 months
Description Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum) Description Rate of successful version as assessed by gynaecologist after maximum three attempts. Description Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts. Description The mode of delivery, assessed from the medical charts after delivery.

Browse Conditions

Sequence: 192092730 Sequence: 192092731 Sequence: 192092732 Sequence: 192092733 Sequence: 192092734
Mesh Term Breech Presentation Mesh Term Obstetric Labor Complications Mesh Term Pregnancy Complications Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases
Downcase Mesh Term breech presentation Downcase Mesh Term obstetric labor complications Downcase Mesh Term pregnancy complications Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47997671
Agency Class OTHER
Lead Or Collaborator lead
Name Region Skane

Overall Officials

Sequence: 29082516
Role Principal Investigator
Name Andreas Herbst, MD PhD
Affiliation Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden

Design Group Interventions

Sequence: 67731683
Design Group Id 55248204
Intervention Id 52146766

Eligibilities

Sequence: 30562564
Gender Female
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria:

Pregnant nulliparous women.
Breech presentation of fetus, eligible for external version.

Exclusion Criteria:

Unwilling to participate.
Unable to understand written and oral Swedish in the absence of interpreter.
Contraindications to spinal anaesthesia.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254249532
Number Of Facilities 2
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30310848
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28689480
Responsible Party Type Sponsor

Study References

Sequence: 51719082 Sequence: 51719083 Sequence: 51719084 Sequence: 51719085
Pmid 25962611 Pmid 27131581 Pmid 25674710 Pmid 28723831
Reference Type background Reference Type background Reference Type background Reference Type background
Citation Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10. Citation Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27. Erratum In: Am J Obstet Gynecol. 2017 Mar;216(3):315. Citation Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;(2):CD000184. doi: 10.1002/14651858.CD000184.pub4. Citation Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796.

]]>

<![CDATA[ Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly(Mrs AVS) ]]>
https://zephyrnet.com/NCT03797820
2018-10-01

https://zephyrnet.com/?p=NCT03797820
NCT03797820https://www.clinicaltrials.gov/study/NCT03797820?tab=tableNANANAAortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification,cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.
<![CDATA[

Studies

Study First Submitted Date 2018-12-24
Study First Posted Date 2019-01-09
Last Update Posted Date 2021-07-15
Start Month Year October 1, 2018
Primary Completion Month Year September 30, 2023
Verification Month Year July 2021
Verification Date 2021-07-31
Last Update Posted Date 2021-07-15

Facilities

Sequence: 200108545
Status Recruiting
Name Second Affiliated Hospital Zhejiang University School of Medicine
City Hangzhou
State Zhejiang
Zip 310000
Country China

Facility Contacts

Sequence: 28106461
Facility Id 200108545
Contact Type primary
Name Xianbao Liu, MD
Email liuxb2009@hotmail.com
Phone +86-13857173887

Conditions

Sequence: 52171335
Name Valvular Heart Disease
Downcase Name valvular heart disease

Id Information

Sequence: 40158684
Id Source org_study_id
Id Value SAHZJU CT012

Countries

Sequence: 42568997
Name China
Removed False

Interventions

Sequence: 52485557
Intervention Type Other
Name Our study type is observational
Description Our study type is observational

Design Outcomes

Sequence: 177379132 Sequence: 177379133 Sequence: 177379134 Sequence: 177379135
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement Measure Hospitalization for heart failure Measure Surgical or transcatheter aortic valve replacement Measure Cardiovascular death
Time Frame one year Time Frame one year Time Frame one year Time Frame one year
Description time from enrolled to first occurrence of any of the components of the composite outcome Description time from enrolled to first occurrence of the outcome Description time from enrolled to first occurrence of the outcome Description time from enrolled to first occurrence of the outcome

Browse Conditions

Sequence: 193487064 Sequence: 193487065 Sequence: 193487066 Sequence: 193487067 Sequence: 193487068 Sequence: 193487069
Mesh Term Heart Diseases Mesh Term Aortic Valve Stenosis Mesh Term Heart Valve Diseases Mesh Term Cardiovascular Diseases Mesh Term Aortic Valve Disease Mesh Term Ventricular Outflow Obstruction
Downcase Mesh Term heart diseases Downcase Mesh Term aortic valve stenosis Downcase Mesh Term heart valve diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term aortic valve disease Downcase Mesh Term ventricular outflow obstruction
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48319349 Sequence: 48319350 Sequence: 48319351 Sequence: 48319352 Sequence: 48319353 Sequence: 48319354 Sequence: 48319355 Sequence: 48319356 Sequence: 48319357 Sequence: 48319358
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER_GOV Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Second Affiliated Hospital, School of Medicine, Zhejiang University Name First Affiliated Hospital of Wenzhou Medical University Name Second Affiliated Hospital of Wenzhou Medical University Name Jinhua Central Hospital Name The Second Affiliated Hospital of Jiaxing University Name The Fourth Affiliated Hospital of Zhejiang University School of Medicine Name The Central Hospital of Lishui City Name Sir Run Run Shaw Hospital Name Ningbo Medical Center Lihuili Hospital Name Ningbo No. 1 Hospital

Eligibilities

Sequence: 30765394
Sampling Method Non-Probability Sample
Gender All
Minimum Age 60 Years
Maximum Age 90 Years
Healthy Volunteers No
Population Patients over 60 years old and moderate or above aortic stenosis
Criteria Inclusion Criteria:

1. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg

Exclusion Criteria:

Patients cannot be followed up for any reasons.
Patients in critical condition may be die in one year.
Patients have been enrolled in this study.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253886099
Number Of Facilities 1
Registered In Calendar Year 2018
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 60
Maximum Age Num 90
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30511560
Observational Model Cohort
Time Perspective Prospective

Links

Sequence: 4388089
Url http://www.ncbi.nlm.nih.gov/pubmed/27908608
Description A hospital-based survey of patients with severe valvular heart disease in China

Responsible Parties

Sequence: 28877855
Responsible Party Type Principal Investigator
Name Jian'an Wang,MD,PhD
Title President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
Affiliation Second Affiliated Hospital, School of Medicine, Zhejiang University

Study References

Sequence: 52063435
Pmid 27908608
Reference Type background
Citation Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.

]]>