TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Incidence of severe stunting (Length-for-age Z score < -3) (1 year after enrolment); Incidence of serious and non-serious adverse events (1 year)
B: Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age (After 24 months of program implementation); Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months) (monthly from study inclusion at 6 months to 23 months of age and at study endline); Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm (Monthly from study inclusion at 6 months to 23 months of age); Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted) (monthly from study inclusion at 6 months to 23 months of age and at study endline)
C: Number of Participants With Nutritional Recovery (12 weeks or upon completion of recovery); Number of Patients With Absence of Bilateral Pedal Pitting Edema (12 weeks or recovery)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Use of LifeStraw Family for children under 2 and all household members (One year)
B: 1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age. (6 weeks, 9 months, 18 months)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
D: To assess the prevalence of diarrhea among under five children (four months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Kenya: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development
Brief Summary: The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.


Options:
A: Duration of diarrhea (within the first 72 hours during hospitalization)
B: COVID-19 incidence (21 days of follow-up, RT-PCR test at day 21)
C: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)
Brief Summary: This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after prior therapy.

Initial Treatment Period:

Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab, higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an open-label fashion.

The starting pembrolizumab dose was initially blinded to Investigators and participants until Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of pembrolizumab.

Switch-to-Pembrolizumab Treatment Period:

Participants who were initially randomized to receive ICC and experienced progressive disease (PD) may have been eligible to switch to receiving pembrolizumab provided they met protocol-specified requirements for switching. Qualified participants were re-randomized to receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03, all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.


Options:
A: Progression-free Survival (PFS) - Initial Treatment Period (Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)); Interim Overall Survival (OS) - Initial Treatment Period (Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)); Final Overall Survival (OS) - Initial Treatment Period (Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019))
B: Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD) (Evaluated after a total of 8 weeks of therapy before definitive surgery.); Response to Neoadjuvant Therapy: Overall Clinical Responses (Evaluated after a total of 8 weeks of therapy before definitive surgery.)
C: Major Pathologic Response (MPR) (54 weeks)
D: Overall Survival (OS) (From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.); Overall Survival (OS) Rate (From randomization to 6 months and or to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Observer-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum, in Healthy Women of Child-Bearing Age
Brief Summary: The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.


Options:
A: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups (Day 0 to Day 56); Assessment of Safety (Day 0 to Day 182)
B: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
C: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups (Day 0 to Day 112); Assessment of the safety (Day 0 to Day 182)
D: Safety and tolerability assessed through diaries for local and systemic tolerability and with follow up for occurrence of any adverse event (7 days post each dose / 57 days post prime)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)
B: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 (Baseline and Day 15)
C: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) (12 weeks after end of therapy (up to 30 weeks)); Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)); Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks))
D: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) (Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
B: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Brief Summary: The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States today. To address the increasing incidence and adverse health outcomes associated with both obesity and mental health problems, a theory-based 15 session intervention program entitled COPE (Creating Opportunities for Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions \& Exercise), will be delivered within high school health classes in order to improve the physical and mental health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).


Options:
A: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
B: Body fat percentage (One year (interim analysis))
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at six months (Baseline, end of intervention (6 months), 1 year after baseline); Change from baseline in weekly time in sedentary activity at six months (Baseline, end of intervention (6 months), 1 year after baseline)
D: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Brief Summary: The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States today. To address the increasing incidence and adverse health outcomes associated with both obesity and mental health problems, a theory-based 15 session intervention program entitled COPE (Creating Opportunities for Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions \& Exercise), will be delivered within high school health classes in order to improve the physical and mental health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).


Options:
A: Changes in Brain function and structure using magnetic resonance imaging (MRI) (20 days during baselines and Post-evaluations (after intervention).); Brain and cognitive functioning assessment by electroencephalogram (EEG) (20 days during baselines and Post-evaluations (after intervention).); Cognitive performance (DKEFS test battery) (20 days during baselines and Post-evaluations (after intervention).); Academic achievement (20 days during baselines and Post-evaluations (after intervention).)
B: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
C: body mass index trajectory (change) (baseline, 1, 2 and 3 years)
D: Metabolic syndrome score (Change during 3 month of intervention compared with change during 3 month control period); Concentration Performance (Change during 3 month of intervention compared with change during 3 month control period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Brief Summary: The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States today. To address the increasing incidence and adverse health outcomes associated with both obesity and mental health problems, a theory-based 15 session intervention program entitled COPE (Creating Opportunities for Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions \& Exercise), will be delivered within high school health classes in order to improve the physical and mental health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).


Options:
A: Our outcome measure was reduction of screen time (4 waves of data)
B: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
C: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
D: Insulin area under the curve (oral glucose tolerance test) (10-15 weeks); Body composition (% body fat, visceral fat) (10-15 weeks); Aerobic fitness (10-15 weeks); Cognition (Executive function) (10-15 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Brief Summary: The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States today. To address the increasing incidence and adverse health outcomes associated with both obesity and mental health problems, a theory-based 15 session intervention program entitled COPE (Creating Opportunities for Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions \& Exercise), will be delivered within high school health classes in order to improve the physical and mental health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).


Options:
A: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
B: Number of unprotected sex acts, unclean drug injections, and sexually transmitted infections (by urinalysis) (12 months)
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: Increase in parental competence at nine intervals over 39 month study period (birth-3 year postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Brief Summary: The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States today. To address the increasing incidence and adverse health outcomes associated with both obesity and mental health problems, a theory-based 15 session intervention program entitled COPE (Creating Opportunities for Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions \& Exercise), will be delivered within high school health classes in order to improve the physical and mental health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).


Options:
A: Change in Body Mass Index Z-score (9 months)
B: Change in body mass index (BMI) z-score (Up to 2 years)
C: increased physical activity (4 months)
D: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Brief Summary: The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States today. To address the increasing incidence and adverse health outcomes associated with both obesity and mental health problems, a theory-based 15 session intervention program entitled COPE (Creating Opportunities for Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions \& Exercise), will be delivered within high school health classes in order to improve the physical and mental health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).


Options:
A: Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention (Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention))
B: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
C: Adult BMI change (Change from baseline at 2 years)
D: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)

Answer: B