TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.


Options:
A: N/A
B: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye (Baseline, Month 39/Final Visit)
C: Increase of ≥5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. (3 year extension, total 5 years study from baseline); Incidence of moderate or severe adverse events over the 3 years of the open-label extension (3 year extension study, total 5 year study from baseline)
D: diffuse macular oedema (1, 3 and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a 60 week study including a double-blind phase followed by an open-label phase.


Options:
A: Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug (Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)); Participants With Treatment-Emergent Adverse Events (TEAEs) (Day 1 to Week 12)
B: Change in Frequency of Headache Days (Baseline, Week 24)
C: Mean change from baseline of Area undercurve of headache diary ( total headache score).; Mean change from baseline of total duration of migraine attack( hours) in 4 weeks.; Mean change from baseline of migraine frequency
D: Change in Frequency of Headache Episodes (Baseline, Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?
Brief Summary: Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.


Options:
A: Mortality; Hospitalisations
B: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
C: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
D: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?
Brief Summary: Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.


Options:
A: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
B: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)
C: Mortality; Hospitalisations
D: Percentage of Participants Developing New Grade >=3 Adverse Events (From study entry until at least 42 days after third vaccination); Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1. (Prior to first vaccination and at least 14 days after third vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?
Brief Summary: Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.


Options:
A: Pregnancy-related mortality and all cause mortality (Continuous)
B: Mortality; Hospitalisations
C: Frequency of circulating Tregs expressing gut homing receptors in infant participants. (17 week post-supplementation)
D: Thymus size measured by ultrasound (through 15 wk of age); peripheral blood naive T-helper lymphocyte concentration (through 15 wk of age); T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC) (through 15 wk of age); T-cell response to BCG (Bacillus Calmette-Guérin; to protect against tuberculosis) and oral polio virus (OPV) immunization (through 15 wk of age); Antibody response to oral polio virus (OPV) immunization (through 15 wk of age); T-cell and antibody response to tetanus toxoid (TT) and hepatitis B virus (HBV) vaccinations given at 6, 10 and 14 wk of age (through 15 wk of age); bacterial translocation to blood (through 15 wk of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries?
Brief Summary: Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.


Options:
A: Mortality; Morbidity
B: Skin prick test (Single observation at time of consent - DAY 1)
C: Frequency of circulating Tregs expressing gut homing receptors in infant participants. (17 week post-supplementation)
D: Mortality; Hospitalisations

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries? Randomized Prospective Studies in Guinea-Bissau
Brief Summary: In the present study the investigators wish to address the effects of different doses of vitamin A supplementation in low and normal birth weight infants.

Hypotheses:

* Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in both normal and low birth weight infants.
* A lower dose of vitamin A may be even more beneficial than a high dose.


Options:
A: Risk of death (Period between receiving the intervention/placebo and six months of age)
B: Mortality; Morbidity
C: Frequency of circulating Tregs expressing gut homing receptors in infant participants. (17 week post-supplementation)
D: Pregnancy-related mortality and all cause mortality (Continuous)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Should Infants Receive High-dose Vitamin A Supplementation With BCG Vaccine at Birth in Developing Countries? Randomized Prospective Studies in Guinea-Bissau
Brief Summary: In the present study the investigators wish to address the effects of different doses of vitamin A supplementation in low and normal birth weight infants.

Hypotheses:

* Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in both normal and low birth weight infants.
* A lower dose of vitamin A may be even more beneficial than a high dose.


Options:
A: Mortality; Morbidity
B: Skin prick test (Single observation at time of consent - DAY 1)
C: Frequency of circulating Tregs expressing gut homing receptors in infant participants. (17 week post-supplementation)
D: Pregnancy-related mortality and all cause mortality (Continuous)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality
Brief Summary: We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.


Options:
A: N/A
B: intestinal parasitic infections (6 months)
C: childhood mortality rate at age 1-6
D: Mortality; Morbidity; All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality
Brief Summary: We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.


Options:
A: childhood mortality rate at age 1-6
B: L:M ratio at 1.5 months (1.5 months)
C: Mortality; Morbidity; All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received
D: Vitamin A status changes (After the intervention, which is approximately 3 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: Determine the efficacy, safety, and tolerability of BG00012 in MS patients.


Options:
A: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)
B: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)
C: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
D: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: Determine the efficacy, safety, and tolerability of BG00012 in MS patients.


Options:
A: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
B: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)
C: To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS (4 years)
D: ARR - PDEs (Baseline to Month 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: Determine the efficacy, safety, and tolerability of BG00012 in MS patients.


Options:
A: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)
B: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
C: Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL) (3 months of treatment)
D: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.


Options:
A: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
B: ARR - PDEs (Baseline to Month 36)
C: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
D: To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.


Options:
A: Hazard ratio for relapses (During the first and during the second 52 weeks)
B: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
C: To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS (4 years)
D: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
Brief Summary: The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.


Options:
A: Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death (during approximately three years of follow-up)
B: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis (From 22 to 165 minutes)
C: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 (Week 1); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 (Week 2); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 (Week 4); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 (Week 12)
D: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (First administration until 31-38 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
Brief Summary: The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.


Options:
A: Thromboembolism occuring between day 7-35 ;; Major bleeding occuring between day 7-35 ;; LMWH induced thrombopenia; All cause mortality
B: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period: up to day 35+/-6)
C: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (First administration until 31-38 days)
D: Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period (Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.


Options:
A: Trough FEV1 after 12 weeks of treatment (12 weeks)
B: Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) (10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication); Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) (Week 48); TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) (Week 48); COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) (48 weeks)
C: N/A
D: Change From Baseline in Trough FEV1 After 48 Weeks (10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication); Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) (Week 48); TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) (Week 48); COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) (48 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)
C: Change From Baseline in Trough FEV1 After 48 Weeks (10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication); Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) (Week 48); TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) (Week 48); COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) (48 weeks)
D: AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) (after 12 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.


Options:
A: Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. (Day 15)
B: morning peak expiratory flow rate (PEFR) (50 weeks)
C: Trough FEV1 after 12 weeks of treatment (12 weeks)
D: Change From Baseline in Trough FEV1 After 48 Weeks (10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication); Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) (Week 48); TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) (Week 48); COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) (48 weeks)

Answer: D