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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

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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