TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine
Brief Summary: The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).


Options:
A: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
B: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
C: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
D: The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. (Throughout the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine
Brief Summary: The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).


Options:
A: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
B: The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. (Throughout the study)
C: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
D: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine
Brief Summary: The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).


Options:
A: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
B: Patients With Any Treatment-emergent Adverse Event (Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit)
C: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
D: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Brief Summary: The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).


Options:
A: Clinical Global Impression-Scale(CGI-S) (12 weeks)
B: Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)); Expressive Vocabulary Test (EVT) (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))
C: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
D: Patients With Any Treatment-emergent Adverse Event (Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Brief Summary: This grant involved the development, implementation, and assessment of the feasibility and acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was from their primary male partner (Raj et al. 2001).

Specific aims of this study are as follows:

1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use with at-risk Indian wives.
2. To determine the feasibility and acceptability of RHANI Wives with at risk wives\* in India. A two-group cluster randomized trial will involve random assignment of 12 neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a control condition (n=150). Intervention effects on the more proximal and likely safer sex mediating outcome of marital communication for this feasibility trial will be assessed via surveys at baseline and 3 month follow-up.

NOTE: Only 220 participants were able to be recruited into the study.

\*At risk wives are defined as having a husband at higher risk for transactional sex based on wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7 days) or partner violence perpetration


Options:
A: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
B: condom use (4.5 months)
C: Intimate partner violence (One year)
D: The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components. (6 weeks post randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Brief Summary: This grant involved the development, implementation, and assessment of the feasibility and acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was from their primary male partner (Raj et al. 2001).

Specific aims of this study are as follows:

1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use with at-risk Indian wives.
2. To determine the feasibility and acceptability of RHANI Wives with at risk wives\* in India. A two-group cluster randomized trial will involve random assignment of 12 neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a control condition (n=150). Intervention effects on the more proximal and likely safer sex mediating outcome of marital communication for this feasibility trial will be assessed via surveys at baseline and 3 month follow-up.

NOTE: Only 220 participants were able to be recruited into the study.

\*At risk wives are defined as having a husband at higher risk for transactional sex based on wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7 days) or partner violence perpetration


Options:
A: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
B: Change in IPV assessments (Screening and at 2 months post-birth.)
C: Change in partner violence victimization (summary score) (baseline to 12 months); Change in reproductive coercion (summary score) (baseline to12 months)
D: condom use (4.5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Brief Summary: This grant involved the development, implementation, and assessment of the feasibility and acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was from their primary male partner (Raj et al. 2001).

Specific aims of this study are as follows:

1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use with at-risk Indian wives.
2. To determine the feasibility and acceptability of RHANI Wives with at risk wives\* in India. A two-group cluster randomized trial will involve random assignment of 12 neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a control condition (n=150). Intervention effects on the more proximal and likely safer sex mediating outcome of marital communication for this feasibility trial will be assessed via surveys at baseline and 3 month follow-up.

NOTE: Only 220 participants were able to be recruited into the study.

\*At risk wives are defined as having a husband at higher risk for transactional sex based on wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7 days) or partner violence perpetration


Options:
A: Incident Gender-Based Violence (GBV) (3 months postpartum); Incident GBV (6 months postpartum)
B: depression (On completion of intervention and six months post-intervention)
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: condom use (4.5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
Brief Summary: This grant involved the development, implementation, and assessment of the feasibility and acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was from their primary male partner (Raj et al. 2001).

Specific aims of this study are as follows:

1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use with at-risk Indian wives.
2. To determine the feasibility and acceptability of RHANI Wives with at risk wives\* in India. A two-group cluster randomized trial will involve random assignment of 12 neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a control condition (n=150). Intervention effects on the more proximal and likely safer sex mediating outcome of marital communication for this feasibility trial will be assessed via surveys at baseline and 3 month follow-up.

NOTE: Only 220 participants were able to be recruited into the study.

\*At risk wives are defined as having a husband at higher risk for transactional sex based on wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7 days) or partner violence perpetration


Options:
A: Depression, PTSD (Change from 0-12 weeks, 12-24 weeks and 24-36 weeks)
B: Change in Number of Health Risks (Two months); Change in Number of Health Risks (Four months)
C: condom use (4.5 months)
D: Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) (Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The main hypothesis of the study is that anaesthesia of the hip using infiltration with a local anesthetic solution is preferable over traditional analgesia with oral opioid medications in the acute stage of the management of patients with a fracture of the hip.

To study the hypothesis the investigators designed a prospective randomised study where patients are assigned in two groups, the first receiving local hip anesthesia and the other placebo treatment. Both groups are eligible to use of standard oral pain treatment.

Effect of analgesia as well as medical complications will be recorded.


Options:
A: Pain scores at rest (45 minutes after the injection)
B: The incidence of post-operative delirium after hip fracture surgery (immeidately to 5 days post operatively)
C: Pain (3 hours)
D: Opiate Requirements (72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integration of Small-scale Aquaculture With Homestead Food Production for Improved Household Food Security and Nutrition in Rural Cambodia
Brief Summary: The project is a three arm randomized control trial in rural Cambodia designed to evaluate the impact of homestead food production (home gardens) with and without fish ponds versus control on household food security, dietary intake of women and youngest child, biochemical nutritional status of women, and household livelihoods over a 22 month period. Baseline and end line surveys will be conducted that involve questionnaires and a blood sample.


Options:
A: Child nutritional status
B: Incidence of Diarrhea (2 weeks)
C: Change from Baseline in nutritionally related biochemical measures at 22 months (At baseline and 22 months)
D: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integration of Small-scale Aquaculture With Homestead Food Production for Improved Household Food Security and Nutrition in Rural Cambodia
Brief Summary: The project is a three arm randomized control trial in rural Cambodia designed to evaluate the impact of homestead food production (home gardens) with and without fish ponds versus control on household food security, dietary intake of women and youngest child, biochemical nutritional status of women, and household livelihoods over a 22 month period. Baseline and end line surveys will be conducted that involve questionnaires and a blood sample.


Options:
A: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
B: Change from Baseline in nutritionally related biochemical measures at 22 months (At baseline and 22 months)
C: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
D: Targeted fruit and vegetable (TFV) intake (Intake in prior 24 hours; assessed in two follow-up rounds (4-6 mo and 9-11 mo post-implementation) with 10% replicate subsample in each round; data pooled across two follow-up rounds and replicate samples for primary analysis)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.
Brief Summary: The purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.


Options:
A: body weight change (24 weeks)
B: Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo (Measured at the last study visit)
C: Change from baseline in weight at week eight (Baseline and week eight)
D: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants (Baseline, 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.
Brief Summary: The purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.


Options:
A: Change from baseline in weight at week eight (Baseline and week eight)
B: Weight loss (3 months)
C: Change in Weight (Measured at each visit from baseline to end of study over a 12 week period)
D: Glucose tolerance (Baseline - 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
Brief Summary: The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.


Options:
A: All-cause mortality over the first 24 weeks after starting ART (Week 24)
B: Total long chain PUFA in erythrocyte membranes at 3 months (3 months)
C: Recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema of both feet) (Weekly till recovery or 16 weeks after enrollment, whichever is earlier)
D: Weight gain during the 12-week follow-up (in grams)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Weekly Low-dose Methotrexate (LDM) in the Prevention of Cardiovascular Events Among Stable Coronary Artery Disease Patients With Type 2 Diabetes or Metabolic Syndrome
Brief Summary: The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).


Options:
A: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
B: Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components (From randomization, to end of treatment plus 30 days, up to approximately 6 years); Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery (24 months); Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits (From randomization up to approximately 6 years)
C: Number of Subjects With Major Adverse Cardiovascular Events (From randomization to trial end (April 2, 2018) up to a maximum of 5 years); Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization (From randomization to trial end (April 2, 2018) - up to a maximum of 5 years)
D: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy
Brief Summary: This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).


Options:
A: efficacy (24 to 160 hours); tolerability (24 to 160 hours); cost-effectiveness (24 to 160 hours)
B: Plasma levels of study drugs will be taken on Day 1 & 8. (taken on Day 1 & 8.)
C: The Percentage of Participants With No Vomiting - Overall Stage (Hour 0 on Day 1 to Day 5 (approximately 120 hours))
D: Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) (25 to 120 hours after initiation of MEC); Percentage of Participants With Infusion-site Thrombophlebitis (Day 1 through Day 17, inclusive); Percentage of Participants With Severe Infusion-site Reactions (Day 1 through Day 17, inclusive)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Persistent MRSA Eradication Protocol (PMEP)
Brief Summary: The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA infection are needed.

The purpose of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250 mg twice a day) or taste matched placebo and will be followed for 3 additional months. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled in this trial.


Options:
A: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
B: MRSA Culture Status (Day 28)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture (Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol)

Answer: D