TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...
Brief Summary: This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
B: Change in disease activity. (6 months)
C: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy
Brief Summary: The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.


Options:
A: increase of the ejection fraction of the left ventricle (6 months)
B: Change in left ventricular ejection fraction (6 months)
C: Safety will be assessed by: post-procedure assessments, physical exam, vital signs, laboratory tests, and adverse events including MACE (Major Adverse Cardiac Event) occurrences. (Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12)
D: Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmias, pulmonary edema, acute heart failure, unstable angina and major bleeding) (Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy
Brief Summary: The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.


Options:
A: Change in left ventricular ejection fraction (6 months)
B: Change in Maximal Oxygen Consumption (VO2max) (Measured at Baseline and Month 6); Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo (Measured at Baseline and Month 6); Change in Reversible Defect Size (Measured at Baseline and Month 6)
C: Changes in left ventricular ejection fraction from baseline to 6 months' follow-up (3 year)
D: Improvement in global ejection fraction on LV angiography (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lawrence Latino Diabetes Prevention Project
Brief Summary: The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a \>30% probability of developing diabetes in the next 7.5 years per a predictive equation. The project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban Latino community. Individuals were identified primarily from a community health center's patient panel, screened for study eligibility, randomized to either a usual care or a lifestyle intervention condition, and followed for one year.


Options:
A: Weight loss. (1 year); HgbA1c (1 year)
B: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
C: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
D: Reach (RE-AIM Framework) (up to 12 months); Effectiveness (RE-AIM Framework) (up to 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Women With Infants
Brief Summary: This is a study testing ways to motivate new mothers to become more physically active over a one year period.


Options:
A: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
B: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline (Baseline); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 (1 Year); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 (2 Years); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 (3 Years)
C: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Women With Infants
Brief Summary: This is a study testing ways to motivate new mothers to become more physically active over a one year period.


Options:
A: Postpartum weight retention (no more than 1.5 years)
B: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
C: Number of at risk participants developing GDM during pregnancy
D: body weight (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Women With Infants
Brief Summary: This is a study testing ways to motivate new mothers to become more physically active over a one year period.


Options:
A: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)
B: Physical activity measured by accelerometry. (3 months post-randomisation)
C: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
D: 7-Day Physical Activity Recall (7-Day PAR) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Women With Infants
Brief Summary: This is a study testing ways to motivate new mothers to become more physically active over a one year period.


Options:
A: Affect Balance Scale (4 weeks)
B: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
C: Infant weight for height (One year after study entry)
D: Postpartum weight retention (no more than 1.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Women With Infants
Brief Summary: This is a study testing ways to motivate new mothers to become more physically active over a one year period.


Options:
A: Adherence to the pedometer-based physical activity regimen (24 weeks post baseline)
B: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
C: Feasibility of Using Facebook and Text Messaging to Deliver a Physical Activity Program to African American Women (Post Intervention (up to 8 weeks))
D: smoking status (six month followup)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Women With Infants
Brief Summary: This is a study testing ways to motivate new mothers to become more physically active over a one year period.


Options:
A: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
B: Physical activity measured by accelerometry. (3 months post-randomisation)
C: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
D: Physical activity level

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Women With Infants
Brief Summary: This is a study testing ways to motivate new mothers to become more physically active over a one year period.


Options:
A: Physical activity measured by accelerometry. (3 months post-randomisation)
B: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
C: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
D: 7-Day Physical Activity Recall (7-Day PAR) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
Brief Summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).


Options:
A: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years); Number of Participants With Death (From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit))
B: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 (Baseline and week 12)
C: Pulmonary artery mean pressure at rest (Peak change from baseline within 6 hours after a single dose of study drug)
D: Safety and tolerability (12 weeks treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Spot Sign for Predicting and Treating Intracerebral Hemorrhage Growth Study
Brief Summary: The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug recombinant activated factor VII (rFVIIa) to placebo to determine the effect of rFVIIa on intracerebral hemorrhage growth.


Options:
A: Number of Study Subjects With Life-threatening Thromboembolic Complications (through day 4 after completion of study drug administration); Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. (From baseline to 24 hours); The Sensitivity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.); The Specificity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.)
B: ICH size (24 hours)
C: ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. (24+/-3 hours)
D: Number of eligible patients who received allocated treatment (90 days); Rate of eligible patients randomised (18 months); Proportion of eligible patients and randomised (18 months); Proportion of participants followed up at 90 days (90 days); Proportion of patients with full outcome data available, and reasons for non-availability (90 days); Proportion of eligible patients approached (18 months); Adherence to intervention (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tocolysis for Preterm Labor
Brief Summary: Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of all practitioners, but recent data suggest magnesium given this way may be harmful for the baby's future development. Other drugs such as antiprostaglandin agents are very effective in stopping uterine activity, but particularly when used for \>48 hours have been associated with both maternal and fetal sides effects. Lastly, calcium channel antagonists are effective in stopping contractions and have very little in the way of maternal and fetal side effects, but less data is available in the United States on their use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping preterm labor. The primary outcomes will be to see which agent stops the uterine contractions most effectively, for the longest period of time with fewest relapses and results in significant prolongation of pregnancy. If one of these agents is clearly superior to the other two it would help women avoid early delivery or have significant extension of their pregnancy to avoid some of the complications of preterm birth in the baby.


Options:
A: latency period interval between time of tocolysis and delivery (24 hours up to 7 days)
B: Number of Participants With Delay of Preterm Delivery by 48 Hours. (Participants will be followed for the duration of the hospital stay, an expected average of 1 week)
C: The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor. (3-5 days after delivery)
D: Prolongation of pregnancy (From allocation to the delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: HEMOTOL: Effects of New Dialysis On-line Monitoring Devices on Hemodynamic Stability During Intermittent Hemodialysis in Critically Ill Patients With Acute Kidney Injury : a Prospective Randomized Study.
Brief Summary: The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.


Options:
A: Interdialytic weight gain (Each dialysis treatment (3x per week) - 2 years of treatment data); Pre-dialysis Blood Pressure (Each dialysis treatment (3x per week)- 2 years of treatment data)
B: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
C: composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, (12 months); a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite (12 months)
D: Intra-Dialytic Hypotension (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients
Brief Summary: To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.


Options:
A: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)
B: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment (Baseline and Week 8)
C: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)
D: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment (Baseline and Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients
Brief Summary: To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.


Options:
A: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment (Baseline and Week 8)
B: Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
C: To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily.
D: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses
Brief Summary: The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses.

Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters.

This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.


Options:
A: Overview of Adverse Events [AE] (from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)); Overview of AE With Potential Risk of Occurence (from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)); Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] (from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max))
B: ITP: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS (ITP: Baseline up to Week 96)
C: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
D: Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions (Up to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy
Brief Summary: The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.


Options:
A: Proportion of preterm births (once, after delivery); Number of serious adverse events (Cumulative during pregnancy and neonatal period)
B: Maternal parasitaemia at delivery (Delivery)
C: Number of Participants With Placental Malaria (at delivery estimated to be within 10 to 30 weeks of study entry); Incidence of Malaria, Pregnant Women (Time at risk will begin following administration of first dose of study drug to delivery)
D: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy
Brief Summary: The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.


Options:
A: Treatment Failure (PCR adjusted) (Day 63); Safety profiles including significant changes in relevant laboratory values (Until delivery)
B: proportion of infants with low birthweight (<2,500 grams)
C: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)
D: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy
Brief Summary: The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.


Options:
A: proportion of infants with low birthweight (<2,500 grams)
B: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight
C: Treatment Failure (PCR adjusted) (Day 63); Safety profiles including significant changes in relevant laboratory values (Until delivery)
D: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)

Answer: D