TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive
Brief Summary: The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.


Options:
A: Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) (Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))
B: The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.; The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
C: Therapeutic efficacy (24 hour)
D: Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) (Baseline and 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: Patient is receiving a statin (July 2009 to April 2010)
C: Rate of use of the three home-based technologies (3-months)
D: Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Rates of Adequate Depression Treatment at Discharge (5 days after enrollment)
B: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Recruitment Feasibility: Percent of Participants Screened Eligible (6 months); Recruitment Feasibility: Percent of Participants Enrolled (6 months); MBCT Feasibility: Percent of Participants Retained (6 months); Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment (6 months); Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice (6 months); Control Group Feasibility: Percent of Participants Retained (6 months); Control Group Feasibility: Percent of Participants Adherent to Treatment (6 months); Control Group Feasibility: Percent of Participants Adherent to Home Practice (6 months); Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems (6 months); Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline (At Baseline (Month 0)); Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention (At Post Intervention (Month 3)); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction (At post intervention (Month 3)); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills (6 months); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program (6 months); Control Group Acceptability: Ratings of Intervention Satisfaction (6 months); Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills (6 months); Control Group Acceptability: Percent of Participants Who Would Recommend the Program (6 months); Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction (6 months); Blood Spot Acceptability: Blood Spot Collection Ease (6 months); Blood Spot Acceptability: Blood Spot Collection Comfort (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
C: Hamilton Rating Scale for Depression (Screen, Week 9, 17, 24)
D: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
B: All-cause mortality (within 5 years of enrollment)
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Change in standardized score (Six months after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Weight change
B: Change in Hemoglobin A1C (Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.); Change in Patient Health Questionnaires-9 During Intervention (PHQ-9 will be assessed at baseline, 6-, and 12- months.)
C: Prevalence of latent heart failure and COPD. (6 months)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Overall functioning (18 months); Incremental cost-effectiveness ratio (ICER) (18 months)
B: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
C: All-cause mortality (within 5 years of enrollment)
D: Change in Patient Health Questionnaire-9 items (PHQ-9) score (Baseline, 3-month, 6-month, 9-month, 12-month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
B: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
C: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)
D: Change in PTSD Symptom Severity (PDS) (Baseline, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)
B: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
C: HbA1c level (6 months)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: Blood pressure (One year)
B: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
C: Illicit Opioid Use (6 months); Change in Mental Health Functioning (6 Months)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Liaison Psychiatry in Primary Care
Brief Summary: This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.


Options:
A: This research study may lead to a potentially useful treatment for diabetes management when depression is present. (6 weeks); HbA1c (3-,6-, and 9-months); Depression (3-, 6- and 9-months)
B: Body Mass Index (6, 12, 24 months); Weight (6, 12, 24 months); Insulin sensitivity (6, 12, 24 months); Fasting insulin levels (6, 12, 24 months); Cholesterol levels (6, 12, 24 months)
C: Participant HbA1c levels (one year); Participant cardiovascular risk index (one year)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
Brief Summary: This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).


Options:
A: Duration of diarrhea (4 weeks)
B: Clinical cure rate at test-of-cure (Day 13 or 24-72 hours after end of treatment)
C: POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13. (Day 12/13); POC: Safety and tolerability of LFF571 (Day 12/13); POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2). (Day 12/13); Cohort 2: Clinical response rate (clinical cure) of LFF571 in patients with mild and moderate C. difficile infections to different LFF571 dose regimens and total daily doses administered orally for 10 days (Day 12/13); Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571 (Day 12/13); Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients. (Day 12/13)
D: Cure Rate at End of Therapy (Study day 10 (+/- 2 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.


Options:
A: N/A
B: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
C: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)
D: Time to first occurrence of uveitis in the study eye. (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.


Options:
A: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)
B: Time to first occurrence of uveitis in the study eye. (2 years)
C: N/A
D: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Brief Summary: This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.


Options:
A: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
B: Time to first occurrence of uveitis in the study eye. (2 years)
C: N/A
D: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Outcomes Prevention Evaluation-3
Brief Summary: Heart disease and stroke are major causes of death and disability worldwide and are largely preventable. Cholesterol and blood pressure are major cardiovascular risk factors. Previous studies have shown that certain drugs can effectively and safely lower cholesterol and blood pressure and prevent heart attacks and strokes. Such studies have been conducted primarily in people who had already sustained a heart attack or a stroke, or in people with high cholesterol and blood pressure levels. However, most heart attacks and strokes occur in people with average ("normal") cholesterol and blood pressure. Therefore, in the HOPE-3 trial the investigators will evaluate whether a cholesterol lowering drug, rosuvastatin, and a combination blood pressure lowering pill, candesartan/hydrochlorothiazide, used alone or together can reduce the risk of heart attacks, stroke and their sequelae in people without known heart disease and at average risk.


Options:
A: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)
B: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
C: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: A