TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Brief Summary: Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.


Options:
A: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)
B: Adverse Events (Baseline (Visit 1) to Week 53 (Visit 9))
C: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
D: Change in Ventricular Lactate Levels in the Brain (Baseline and 2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Aerobic Training During Hemodialysis on Exercise Tolerance in End Stage Renal Disease Patients
Brief Summary: The investigators raised the hypothesis that exercise training would be associated with improvement in exercise tolerance and VO2 kinetics in hemodialysis patients.


Options:
A: Change in Body Heat Storage (Changes from baseline at 7 months); Change in Insulin Resistance (Changes from baseline at 7 months); Change in Muscle Size (Changes from baseline at 7 months)
B: Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients (3 months)
C: Change in non-invasive measures of arterial stiffness using applanation tonometry. (4 months and 8 months after study initiation)
D: IRLS severity scale (24 and 48 wks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Approach to MRSA Screening of Colonized Patients and Impact on Hospital Resource Allocation and Patient Care
Brief Summary: Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in hospital settings. Colonization with MRSA puts patients at increased risk for invasive infections, and MRSA infections have been associated with high costs and adverse clinic outcomes. Patients can clear MRSA spontaneously. Improved approaches for identifying patients who are no longer colonized are needed; we hypothesize that more sensitive nucleic acid amplification can be used to improve identification of patients who are no longer colonized.


Options:
A: N/A
B: Bacterial colony counts and the frequency with which methicillin-resistant Staphylococcus aureus was found over time (8 hours)
C: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
D: Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays (1 year); Completion of Screening Protocol in Both Trial Arms (1 year); Discontinuation of Contact Precautions in Both Trial Arms (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Comparative Efficacy and Safety Trial of Intravenous Solutions for the Treatment of Moderate to Severe Dehydration in Children With Acute Gastroenteritis
Brief Summary: The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.


Options:
A: Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV) (Day 1 (4 Hours after start of IV))
B: Mean base excess during hospital stay (Six month control period (before) and 6 month intervention period (after))
C: The primary end point of each phase of this study will be a 6 mmol difference in serum chloride concentration after infusion of the balanced and unbalanced crystalloids and colloids. (Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min)
D: Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. (J1 and J2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Long-chain N-3 Polyunsaturated Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation
Brief Summary: The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids, 2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal or persistent AF in whom a rhythm-control strategy is planned.


Options:
A: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
B: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
C: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (1997-2010)
D: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Long-chain N-3 Polyunsaturated Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation
Brief Summary: The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids, 2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal or persistent AF in whom a rhythm-control strategy is planned.


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
C: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
D: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Long-chain N-3 Polyunsaturated Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation
Brief Summary: The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids, 2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal or persistent AF in whom a rhythm-control strategy is planned.


Options:
A: Sudden cardiac death (12 months)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
C: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
D: Time to first relapse of atrial fibrillation (After a three weeks loading phase)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Long-chain N-3 Polyunsaturated Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation
Brief Summary: The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids, 2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal or persistent AF in whom a rhythm-control strategy is planned.


Options:
A: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
B: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
C: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
D: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Long-chain N-3 Polyunsaturated Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation
Brief Summary: The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids, 2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal or persistent AF in whom a rhythm-control strategy is planned.


Options:
A: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
B: time to clinical relapse (52 weeks)
C: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
D: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Electronic Medical Records to Improve Patient & Public Health in Rural Kenya
Brief Summary: Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.


Options:
A: Cardiac Medication Use (3 and 12 months)
B: Short-term adherence to CRC screening (From randomization to the end of 2 years); Long-term adherence to CRC screening (From randomization to the end of 9 years)
C: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
D: Compliance rates with care guidelines (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cesarean Section Optimal Antibiotic Prophylaxis Trial
Brief Summary: The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.

Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.


Options:
A: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)
B: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first
C: Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) (Up to 6 weeks after delivery)
D: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Brief Summary: Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.


Options:
A: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)
B: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
C: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
D: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Brief Summary: Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.


Options:
A: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
B: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
C: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)
D: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)
Brief Summary: Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.


Options:
A: Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12 (Week 12)
B: Number of Subjects Experiencing Any Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Serious Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Any Infection (throughout entire study (61 +/- 28.9 weeks on average))
C: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
D: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Brief Summary: 0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Options:
A: fat tissue (6 months)
B: Exclusive breastfeeding rate at 6 months postpartum (6 months postpartum); Full breastfeeding rate at 6 months postpartum (6 months postpartum)
C: Exclusive breastfeeding (Six months post-birth); Maternal BMI (Six months post-birth)
D: Any breastfeeding (yes/no) at 3 months (Three months); Exclusive breastfeeding (yes/no) at 3 months (Three months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Brief Summary: 0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Options:
A: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
B: Exhaled Carbon Monoxide Levels (1 month)
C: Adherence to PrEP (Baseline to Week 48)
D: fat tissue (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Brief Summary: 0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Options:
A: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
B: 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
C: Weight for Length Body Mass Index (BMI will be assessed at three years of age for the study participants)
D: fat tissue (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Brief Summary: 0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Options:
A: fat tissue (6 months)
B: Exclusive breastfeeding (6 months postpartum)
C: Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers
D: Breastfeeding duration and intensity (Assessed at 1,3, and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Brief Summary: 0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Options:
A: fat tissue (6 months)
B: Exclusive breastfeeding duration (Six months)
C: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
D: Measles vaccination coverage (10 months)

Answer: A