TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cell Therapy for Coronary Heart Disease: Infusion of Autologous Ex Vivo Cultivated Endothelial Progenitor Cells (EPCs)" and Autologous Bone Marrow Progenitor Cells in Crossover Design for Improvement of Vascularization and Cardiac Function
Brief Summary: Impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy.

The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (\>= 3 months) myocardial infarction.


Options:
A: N/A
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: Change in global left ventricular function (measured by quantitative left ventricular angiography)
D: Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol (Baseline and 12 month visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cell Therapy for Coronary Heart Disease: Infusion of Autologous Ex Vivo Cultivated Endothelial Progenitor Cells (EPCs)" and Autologous Bone Marrow Progenitor Cells in Crossover Design for Improvement of Vascularization and Cardiac Function
Brief Summary: Impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy.

The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (\>= 3 months) myocardial infarction.


Options:
A: Global Left Ventricular Ejection Fraction change (6 months)
B: Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. (6 months)
C: Change in global left ventricular function (measured by quantitative left ventricular angiography)
D: Global Left Ventricular Function (Measured at Baseline and Month 6); Regional Left Ventricular Function (Infarct Zone Wall Motion) (Measured at Baseline and Month 6); Regional Left Ventricular Function (Border Zone Wall Motion) (Measured at Baseline and Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity
Brief Summary: This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.


Options:
A: Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 (Baseline and week 3)
B: Asthma Control (8 weeks (from Week 0 to Week 8))
C: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
D: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)


Options:
A: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
B: Hazard ratio for relapses (During the first and during the second 52 weeks)
C: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
D: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
C: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
D: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (Baseline, Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)


Options:
A: Annualized Relapse Rate (2 years)
B: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
C: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
D: Annualized Relapse Rate (ARR) at 1 Year (1 Year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)


Options:
A: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
B: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
C: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial
Brief Summary: This is a trial comparing the efficacy of oral ritodrine in the form of sustained release capsules for the maintenance of uterine quiescence after successfully treated episode of threatened preterm labor.


Options:
A: Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation (48 hours after administration of tocolytic agent)
B: the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
C: The time of delivery (6 months)
D: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures (At delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata
Brief Summary: This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.


Options:
A: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
B: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month (Baseline, Final Month (last 28 days of treatment))
C: Percent change from baseline in uterine volume and volume of the largest fibroid. (Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.); Duration of amenorrhea (Day 1 to 1st post treatment menses)
D: Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) (Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata
Brief Summary: This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.


Options:
A: Myoma size (2004 to 2007)
B: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))
C: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
D: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (3 months); Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist (Week 13 visit); Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist (Up to week 17)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata
Brief Summary: This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.


Options:
A: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
B: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))
C: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (3 months); Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist (Week 13 visit); Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist (Up to week 17)
D: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses (18 months study duration per subject (4 3-month intermittent treatment courses))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbohaler 160/4.5 μg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open-label, Parallel-group, Multi-centre Study (SALTO)
Brief Summary: The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.


Options:
A: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
B: N/A
C: Rate of Exacerbations Requiring Systemic Corticosteroids (Measured during the 12-month follow-up period)
D: Time to first severe asthma exacerbation

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection
Brief Summary: Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.


Options:
A: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)
B: Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence (Over a median follow-up time of 28 months post-Dose 1)
C: Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population (From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)); Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population (From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))
D: Overall Survival (From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection
Brief Summary: Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.


Options:
A: Overall Survival (Up to 66 months)
B: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)
C: Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence (Over a median follow-up time of 28 months post-Dose 1)
D: Progression-Free Survival (50Events)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns
Brief Summary: Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.


Options:
A: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (at D14 and D21.)
B: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
C: Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns
Brief Summary: Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.


Options:
A: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)
B: Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants (up to 6 months)
C: The primary outcome measurement was death or NEC (≧stage 2) (From April 1, 2005 to May 30, 2007)
D: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (at D14 and D21.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of the Canadian C-Spine Rule: Phase III
Brief Summary: Many thousands of trauma patients are seen in Canadian emergency departments each year. On rare occasions, such patients have a broken neck (cervical spine fracture) but in 98 percent of cases the xrays ordered by the doctors are normal. The total cost of inexpensive but high volume tests such as neck x-rays adds considerably to rising health care costs. In addition, these patients are often immobilized with uncomfortable backboards and collars for many hours, tying up valuable space and time in our crowded emergency departments.

This research group recently developed and tested a highly accurate and reliable guideline called the Canadian C-Spine Rule to help physicians be much more selective in their use of neck x-rays and to minimize the period of immobilization. This research project will evaluate the true effectiveness of the Rule when implemented with simple and inexpensive measures. This study will involve 14,000 patients in 12 busy emergency departments across Canada.

This Canadian C-Spine Rule is designed to allow physicians to be much more selective in their use of neck xrays without the risk of missing a fracture or dislocation of the neck and to reduce the length of time of immobilization. Widespread use of the guideline could lead to large savings for our health care systems without jeopardizing patients and could greatly expedite care of trauma patients in our crowded emergency departments.


Options:
A: Successful completion of follow-up colonoscopy; Number of patients completing colonoscopy during the study period
B: The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition (3 months)
C: colorectal cancer screening (15 months)
D: Cervical spine radiography ordering proportions (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycine vs Placebo for the Schizophrenia Prodrome
Brief Summary: Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.


Options:
A: Scale of Prodromal Symptoms Total Score (Baseline); Change in Scale of Prodromal Symptoms Total Score (Change from Baseline at 8 Weeks)
B: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)
C: Brief Assessment of Cognition in Schizophrenia (BACS) (6 and 12 months)
D: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up

Answer: A