TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Shoe Cushioning, Body Mass and Running Biomechanics on Injury Risk: a Randomized Controlled Trial
Brief Summary: The main goal is to investigate the influence of shoe cushioning and body mass on the risk of running-related injury. This study will allow to determine if shoe cushioning needs to be adapted to the mass of the runner in order to minimize injury risk. The influence of shoe cushioning on running technique will also be investigated.

This study consists in a 6-month follow-up period during which leisure-time runners are required to perform a running activity at least once a week and to upload all their running as well as other sporting activities onto a secured web-based training calendar named "Training and Injury Prevention Platform for Sports" (TIPPS) on a weekly basis. Any injury sustained during this period should also be uploaded onto the TIPPS system using the injury questionnaire provided on the website. Finally, the day of the visit to the laboratory (study start), their running style will be analysed during a 15-minute run on an instrumented treadmill at the participant's usual running speed. Anthropometric measurements will also taken.

Before the beginning of the study, the participants will receive a pair of running shoes free of charge. These shoes will either have a soft or hard sole. Both shoe versions have cushioning properties that correspond to the range of values from the shoes available on the market. They will be administered through random allocation. Neither the participants nor the research team will know which shoe version was provided to the participant, in order to respect the double-blinded methodology of this study. The participants will be required to use these shoes for all running sessions, and only for running activities.

Hypotheses:

H1: Running shoes with greater stiffness are associated with a higher injury risk in leisure-time runners.

H2: High body mass is associated with a higher injury risk in leisure-time runners.

H3: Runners with a high body mass experience a lower injury risk in shoes with greater stiffness.

H4: A higher step length, a lower step frequency, and higher peak vertical impact forces are associated with a higher injury risk.

H5: Running shoes with greater stiffness will be associated with higher vertical impact peak forces and a shorter contact time.

H6: High body mass will be associated with higher peak vertical impact forces, increased contact time, increased duty factor, and decreased step frequency.


Options:
A: Running-related injury (First-time) (6 months)
B: Change in Strength (Week 0, Week 8); Change in Running Mechanics (Week 0, Week 8); Change in Postural Control (Week 0, Week 8)
C: Knee Extension Strength (Baseline, 8-weeks, 16-weeks and 24-weeks); Participation Rate (Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.)
D: Pain (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of an Innovative Web-based School Nutrition Intervention to Increase Fruits and Vegetables and Dairy Products in Adolescents
Brief Summary: The goal of this study is to evaluate the impact of an innovative web-based school nutrition intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit and dairy products in high school students and to identify facilitators and/or barriers influencing its success.


Options:
A: Bottle use frequency (Beverage container assessment done at 12,15,18,21 and 24 months)
B: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
C: Change in fruits and vegetables and dairy products (Before and after the intervention (0 and 6 wk))
D: Body fat percentage (One year (interim analysis))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Using a Theory-based SMS/VM Intervention to Improve Sexual and Reproductive Health of Female Entertainment Workers in Cambodia: Study Protocol of a Randomized Controlled Trial
Brief Summary: In Cambodia, HIV is prevalent in several high-risk groups including among female entertainment workers (FEWs) who work at entertainment venues such as karaoke bars and massage parlors and may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health services such as testing and treatment for HIV and sexually transmitted infections (STIs) and contraception has been difficult because they are hidden and stigmatized. Mobile phone-based interventions may prove to be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a two-arm randomized controlled trial of a mobile health intervention (the Mobile Link) aiming to improve sexual and reproductive health outcomes among FEWs in Cambodia. A two-armed randomized controlled trial (RCT) will be used to determine the effectiveness of a mobile phone-based text/voice messaging intervention. The intervention will be developed through a participatory process; 50 FEWs will work alongside researchers in focus groups to modify and tailor behavior change theory-based text and voice messages. Then, 600 FEWs will be recruited and randomly assigned into one of two arms: (1) a control group and (2) a mobile phone message group (either text messages or voice messages, delivery method chosen by participant). The primary outcome measures include HIV testing, condom use, STI testing and treatment and contraceptive use. If the Mobile Link trial is successful, an increase in condom use, screening and treatment for HIV and STI and contraception use is expected. These outcomes would lead to a reduction in the prevalence of HIV, STIs and unintended pregnancies. This trial is unique in a number of ways. First, the option of participation mode is offered to allow participants to choose the message medium that best links them to services. Second, this is the first RCT of a mobile phone-based behavior change intervention using SMS/VMs to support linkage to sexual and reproductive health services in Cambodia. Third, we are working with is a hidden, hard-to-reach and dynamic population with which traditional methods of outreach have not been fully successful.


Options:
A: Full on time early vaccination coverage (OPV0 and BCG) (First month of life)
B: Recent HIV Testing (past 6 months); Condom Use with Clients (Past 1 month); Condom Use with boyfriend/husband/romantic partner (Past 1 month); Contraceptive Prevalence Rate (Past 1 month); Abortion Rate (Past 6 months); Workplace Alcohol Consumption (Past 6 months); Gender-Based harassment rate (Past 6 months); Gender-based violence rate (Past 6 months); STI Screening (Past six months)
C: Adherence to cervical cancer screening (step1) (Up to 20 months)
D: Neonatal death (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase II Trial of Olaparib, Chemotherapy or Olaparib and Cediranib in Patients With Platinum-resistant Ovarian Cancer
Brief Summary: The trial will compare the drugs olaparib and cediranib with standard chemotherapy in platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated including the participants quality of life.


Options:
A: Progression free survival (up to 18 months)
B: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
C: Progression-free survival
D: Progression Free Survival (PFS) (from date of randomisation to date of progression or death, which ever occurs earlier. Assessed up to 5 years 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase II Trial of Olaparib, Chemotherapy or Olaparib and Cediranib in Patients With Platinum-resistant Ovarian Cancer
Brief Summary: The trial will compare the drugs olaparib and cediranib with standard chemotherapy in platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated including the participants quality of life.


Options:
A: Progression Free Survival (2 years)
B: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
C: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)
D: Progression free survival (up to 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase II Trial of Olaparib, Chemotherapy or Olaparib and Cediranib in Patients With Platinum-resistant Ovarian Cancer
Brief Summary: The trial will compare the drugs olaparib and cediranib with standard chemotherapy in platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated including the participants quality of life.


Options:
A: Progression-free Survival (3 years)
B: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)
C: Progression free survival (up to 18 months)
D: Percentage of Participants with Complete Resection After IDS (After IDS (approximately 4 months from randomization)); Percentage of Participants with Different CC Scores After IDS (After IDS (approximately 4 months from randomization))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase II Trial of Olaparib, Chemotherapy or Olaparib and Cediranib in Patients With Platinum-resistant Ovarian Cancer
Brief Summary: The trial will compare the drugs olaparib and cediranib with standard chemotherapy in platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated including the participants quality of life.


Options:
A: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
B: To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 (assessed at each visit)
C: Progression free survival (up to 18 months)
D: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cumulative Live Birth Rate With eSET After In-vitro Fertilization With Preim-plantation Genetic Screening by Next Generation Sequencing Versus Conventional In-vitro Fertilization: A Pragmatic Randomized Controlled Clinical Trial
Brief Summary: The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.


Options:
A: Cumulative live birth rate (22 months)
B: Delivery rate (2 years)
C: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
D: Ongoing pregnancy (12 weeks after embryo transfer for the patient)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Brief Summary: Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.


Options:
A: Overall MEMS Adherence to Antiretroviral Medication (6 weeks); MEMS Adherence to Antiretroviral Medication Based on Dose Timing (6 weeks)
B: Recent HIV Testing (past 6 months); Condom Use with Clients (Past 1 month); Condom Use with boyfriend/husband/romantic partner (Past 1 month); Contraceptive Prevalence Rate (Past 1 month); Abortion Rate (Past 6 months); Workplace Alcohol Consumption (Past 6 months); Gender-Based harassment rate (Past 6 months); Gender-based violence rate (Past 6 months); STI Screening (Past six months)
C: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)
D: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Brief Summary: Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.


Options:
A: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
B: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
C: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
D: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Brief Summary: Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.


Options:
A: Reduction in body weight (From baseline to 6 weeks postpartum)
B: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
C: Effect of resveratrol on oocyte quality (40 days)
D: Pregnancy rate (7 weeks after assisted fertilisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Brief Summary: Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.


Options:
A: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
B: MV Coverage at 12 months of age (12 months of age)
C: Rate of Premature birth (before 37 weeks gestation)
D: HPV completion rate (One Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Brief Summary: Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.


Options:
A: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
B: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)
C: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
D: Clinic attendance for pills pick up (six months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Online Tool (COBPeer) Dedicated to Junior Peer Reviewers for Assessing the Reporting of Randomized Controlled Trial Reports
Brief Summary: The peer review process is a cornerstone of biomedical research publication. Despite being essential, the assessment of the completeness of the reporting and the identification of switched outcomes are not appropriately performed. Furthermore, these tasks do not suppose a high level of expertise and could be performed by junior researchers.

To assess the completeness of reporting and identified switched outcome(s), junior peer reviewers could use a simple online tool (COBPeer) based on the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist and Elaboration and Explanation publication for reporting parallel-group RCTs. The tool would feature bullet points eliciting the meaning of each checklist item. The aim of this study that will compare the accuracy of junior peer reviewers using the tool to that of usual peer reviewers when evaluating the completeness of reporting and switched of primary outcome(s) in reports of RCTs


Options:
A: Overall completeness of reporting (Following manuscript revision (usually 2-3 months))
B: Completeness of reporting (Through study completion, an average of 1 year)
C: the mean number of items accurately classified per manuscript (through study completion, an average of 6 month)
D: Completeness of reporting (Through study completion, an average of 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Multiple Doses of GLPG2222 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation
Brief Summary: This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.


Options:
A: Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score (From Baseline Through Week 24)
B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Baseline (Day 1) up to end of study (Week 196)); Number of Participants With Clinically Significant Laboratory Abnormalities (Baseline (Day 1) up to end of study (Week 196))
C: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)
D: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Multiple Doses of GLPG2222 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation
Brief Summary: This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of CF and homozygous for the F508del Cystic Fibrosis Transmembrane conductance Regulator (CFTR) mutation.


Options:
A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 (Baseline, Through Week 12)
C: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
D: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))

Answer: D