TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Brief Summary: Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality.

Hypotheses:

1. Weekly supplementation with vitamin A (7000 µg retinol equivalent \[RE\]) to reproductive age women will reduce maternal deaths by 33%.
2. This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
3. There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.

Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.


Options:
A: Pregnancy-related mortality and all cause mortality (Continuous)
B: Mortality; Morbidity
C: Mortality; Hospitalisations
D: 24-week infant mortality rate

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure
Brief Summary: The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery


Options:
A: mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection (4 days)
B: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)
C: IL-6 (1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours)
D: Rise in creatinine above baseline (7 days postoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure
Brief Summary: The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery


Options:
A: Absolute change in serum creatinine from baseline to peak level within the first five postoperative days.
B: Development of acute renal failure (28 days)
C: Proportion of patients developing an increase in serum creatinine greater than 25% from baseline to peak level within first five postoperative days.
D: Rise in creatinine above baseline (7 days postoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
Brief Summary: To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.


Options:
A: Urinary Protein/Creatinine Ratio at Week 52 [LOCF] (Assessed at baseline and Week 52 (LOCF))
B: Median Percent Change in Triglycerides From Baseline to Week 8. (Baseline to 8 weeks)
C: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
D: The primary outcome is the time to occurrence of a major; cardiovascular event, defined as the composite outcome of the; following clinical endpoints; CHD death; Non-fatal/Non-procedure related MI; Resuscitated cardiac arrest or fatal/non-fatal stroke

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
Brief Summary: To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.


Options:
A: Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities (7days after index surgery)
B: Decrease in incidence of deep vein thrombosis
C: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
D: Coagulation factor VIII (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
Brief Summary: To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.


Options:
A: Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) (up to 5 years)
B: attack number (1 year)
C: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
D: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
Brief Summary: The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms.


Options:
A: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))
B: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale (Baseline and 6 weeks)
C: Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
Brief Summary: The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms.


Options:
A: Change in Clinical Global Impressions (CGI) Global Improvement (Change from Baseline at 8 Weeks); Change in Clinical Global Impressions (CGI) Global Improvement (Change from Open-Label Baseline at 8 Weeks); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Baseline at 8 Weeks.); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Open-Label Baseline at 8 Weeks)
B: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))
C: The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores (Baseline, Week 8)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
Brief Summary: The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms.


Options:
A: Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit; Clinical Global Impression Improvement (CGI)- Change from Baseline to Final Visit; Aberrant Behavior Checklist (ABC) (hyperactivity/irritability sections)- Change from Baseline to Final Visit; Vineland Adaptive Behavior Scale- Change from Baseline to Final Visit; MacArthur Communicative Development Inventory (MCDI)- Change from Baseline to Final Visit; Conners' Parent Rating Scale-Revised: Long form (CPRS-R:L)- Change from Baseline to Final Visit
B: Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline)
C: Children's Psychiatric Rating Scale (Weekly)
D: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Post-TBI Depression - A Randomized Clinical Trial
Brief Summary: Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in terms of changes in mood (primarily depression and anxiety), participation in activities and life satisfaction.


Options:
A: Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status (Six months)
B: Beck Depression Inventory - II (Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)
C: Hamilton Rating Scale for Depression (HAM-D) (16 weeks, 24 weeks); Symptom Checklist-20 (SCL-20) (16 weeks, 24 weeks)
D: Remission of depression (DSM-IV diagnosis no longer met) (baseline); Remission of depression (DSM-IV diagnosis no longer met) (one week after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (six months after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (one year after treatment completion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of the NK1 Antagonist GR205171 in Posttraumatic Stress Disorder
Brief Summary: This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD).

People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for this study. Participants undergo the following tests and procedures:

Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All participants receive placebo (sugar pill) at the start of the study. At some point within the first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to continue with placebo for the remainder of the 10-week treatment period.

Clinic visits: Patients come to the clinic once a week during treatment. The following procedures are done at various visits.

* Interviews, self report questionnaires and psychiatric rating scales at every visit.
* Physical examination, blood and urine tests. Blood is drawn up to 10 times during the study.

Follow-up visits continue for up to 3 months after the end of the study, during which patients are offered standard clinical treatment.


Options:
A: Changes in CAPS Scores. (Baseline, 8 weeks)
B: Clinician Administered PTSD Scale (CAPS) (8weeks)
C: Symptoms of post-traumatic stress disorder (Measured at Month 3); Symptoms of depression (Measured at Month 3)
D: Structured Interview of Posttraumatic Stress Disorder (SIP) (Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)
Brief Summary: This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).


Options:
A: ARR - PDEs (Baseline to Month 36)
B: Freedom of relapse (Within 2 years)
C: Number of Days Until First On-study Relapse (12 months)
D: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)
Brief Summary: This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).


Options:
A: Hazard ratio for relapses (During the first and during the second 52 weeks)
B: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)
C: ARR - PDEs (Baseline to Month 36)
D: Time to First Relapse (Baseline up to 96 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)
Brief Summary: This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).


Options:
A: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
B: ARR - PDEs (Baseline to Month 36)
C: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
D: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)
Brief Summary: This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).


Options:
A: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
B: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity (From the first dose of study drug administration up to Week 24); Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Pulse Rate (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Temperature (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Electrocardiogram (ECGs) (Baseline, Week 12 and 36); Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels (Baseline up to Week 36); Number of Subjects With Positive Neutralizing Antibody (NAb) (Baseline, Week 12 and 36)
C: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
D: ARR - PDEs (Baseline to Month 36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CARE-2 (Calcium Acetate (PhosLo®)/Sevelamer(Renagel®) Evaluation Study 2)
Brief Summary: The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.


Options:
A: electron-beam CT coronary artery calcification AGATSTON score (change at 12 mo from baseline)
B: Change in serum phosphorus (4 weeks)
C: Change in Serum Phosphorus Levels From Week 24 to Week 27 (Week 24, Week 27)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EPIC (Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease): A Prospective, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel Arm, Study of PhosLo on Phosphorus Levels in Subjects With Chronic Kidney Disease
Brief Summary: The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.


Options:
A: serum phosphorus (change from baseline to mean during 2 weeks active therapy)
B: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment (6 weeks)
C: Responder rates achieving target serum phosphate levels. (Week 12)
D: serum phosphorus (weeks 5-24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Postpartum Weight Loss in Overweight Women
Brief Summary: The purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention will be significantly greater in the AMP intervention arm than in the minimal care arm.


Options:
A: 1: Differences in Change in Weight between Groups - Body Weight (kg) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Weight between Groups - waist circumference (cm) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
B: Self-Reported physical activity (Baseline, 3 months, and 6 months)
C: weight loss (4 and 12 month)
D: BMI change from baseline to 12 months post-intervention (24 months postpartum) will be assessed via self-report and validated by in-person weight measurement. The proportion of women who lose 10% of baseline BMI

Answer: D