TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema
Brief Summary: The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.


Options:
A: 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)
B: N/A
C: Visual acuity gain (2 years)
D: Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity (from baseline to 1 Year); Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year (from baseline to 1 Year); Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline (from baseline to 1 Year); Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema (from baseline to 1 Year); Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score (from baseline to 1 Year); Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness (from baseline to 1 Year); Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity (from baseline to 1 Year); Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator (from baseline to 1 Year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Thromboprophylaxis During Bariatric Surgery
Brief Summary: This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.

- gastric banding and gastric bypass on anti-Xa activity levels

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.


Options:
A: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)
B: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 (Up to Day 35); Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 (Up to Day 35); Number of Participants With Serious Adverse Events Through Day 35 (Up to Day 35); Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 (Up to Day 28)
C: Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality (30 days)
D: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Thromboprophylaxis During Bariatric Surgery
Brief Summary: This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.

- gastric banding and gastric bypass on anti-Xa activity levels

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.


Options:
A: Anti-factor Xa plasma levels (within 3 days after surgery)
B: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)
C: Restenosis of the treated infrapopliteal artery (12 months); Major amputation (12 months); Clinical driven-target lesion revascularization (12 months); Major cardiovascular events (12 months)
D: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Thromboprophylaxis During Bariatric Surgery
Brief Summary: This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.

- gastric banding and gastric bypass on anti-Xa activity levels

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.


Options:
A: Survival without ventilation (VNI or mechanical ventilation) (day 14); ventilator free survival (day 28)
B: Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28 (Day 1 to Day 28 (28 days))
C: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)
D: Venous thromboembolism (hospitalization stay (up to 28 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Thromboprophylaxis During Bariatric Surgery
Brief Summary: This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.

- gastric banding and gastric bypass on anti-Xa activity levels

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.


Options:
A: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)
B: Incidence of venous thromboembolism detected by imaging (30 days)
C: N/A
D: Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Brief Summary: The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.


Options:
A: Thiobarbituric acid reactive substance; high sensitive C-reactive protein (12 weeks)
B: Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 (Baseline and 12 weeks)
C: Percent Change From Baseline in LDL-C (12 weeks)
D: The change of LDL-C (Baseline to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Brief Summary: The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.


Options:
A: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)
B: Number of Subjects That Experienced Rupture or Aneurysm Related Death (3 years)
C: all cause mortality at 3 years (3 years)
D: Death and major adverse events (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Brief Summary: The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.


Options:
A: Number of Subjects That Experienced Rupture or Aneurysm Related Death (3 years)
B: combined operative mortality and morbidity (5-8 years)
C: all cause mortality at 3 years (3 years)
D: Death and major adverse events (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)
Brief Summary: To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder


Options:
A: Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition (Baseline and Week 12)
B: Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 (Baseline and Week 12)
C: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment). (Baseline, Week 12)
D: Change in mean number of micturitions per 24 hrs (Within a 12-week treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Brief Summary: The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is possible that one or both of the types of injections will prevent vision loss after PRP treatment. However, it is not known whether the benefits of the injections will outweigh the risks. It is possible that because of side effects, the injections may not be as good as laser alone in treating the diabetic retinopathy.


Options:
A: Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks (baseline to 14 weeks)
B: Visual Acuity (36 months)
C: 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)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prednisolone vs. Ciclosporine in Severe Atopic Eczema
Brief Summary: To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.


Options:
A: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Baseline to Week 16)
B: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 (Baseline to Week 16)
C: stable remission in both treatment groups
D: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 (Baseline (Day 1) and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial
Brief Summary: This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.


Options:
A: Total ventilation time during intensive care unit stay.
B: " not acceptable " zone of ventilation (During the four hours of the study protocol); " not acceptable " zone of ventilation (During the 4 hours of the protocol)
C: Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. (first extubation or 28 days)
D: Duration of mechanical ventilation (up to 4 weeks); duration of ICU stay (up to 4 weeks); duration of hospital stay (up to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial Comparing the Effect of 1g of Daily Cinnamon Plus Usual Care to Usual Cre on the Hemoglobin A1c of Uncontrolled Type 2 Diabetics
Brief Summary: This study will randomize diabetics with hemoglobin A1c greater than 7.0 to receive either cinnamon plus usual care or usual care alone. Hemoglobin A1c will be measured at intake and after 90 days.


Options:
A: - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. (3 months)
B: Relative risk of major maternal hypoglycaemia (after 24 hours)
C: hemoglobin A1c
D: Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
Brief Summary: To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.


Options:
A: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
B: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)
C: Endoscopic recurrence of disease (18 months)
D: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 (4 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
Brief Summary: To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.


Options:
A: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)
B: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 (4 Weeks)
C: Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26 (Week 26)
D: Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time (Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408); Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time (Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.


Options:
A: Endoscopic recurrence of disease (18 months)
B: Clinical remission (CDAI<150). (56 weeks)
C: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 (4 Weeks)
D: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.


Options:
A: Induction of clinical remission (CDAI score < 150 at Week 4)
B: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 (4 Weeks)
C: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)
D: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR
Brief Summary: A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.


Options:
A: Progression-free Survival (Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168)
B: Progression Free-survival (From the date of randomization to the date of last follow up, assessed up to 24 months)
C: Investigator-assessed Duration of Progression-free Survival (Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months))
D: Progression Free Survival (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depressed Adolescents With Physical Illness
Brief Summary: The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI) for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time of randomization into the study.

Hypotheses

1. This preliminary randomized trial will demonstrate the feasibility of a large-scale research initiative.
2. Subjects will experience no adverse events, and the CBI group will demonstrate improved negative cognitions, depressive symptomatology, and functioning at the post-intervention and 6- through 12-month follow-ups.


Options:
A: depression (pre, post and 6 months post treatment)
B: Reduction in symptoms of depression (change from baseline) (12 weeks and 52 weeks)
C: Change from Baseline in CDI at 14 weeks (Week 0, Week 14)
D: HbA1c (Change from Baseline to 3 months and from 3 months to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness and Cost-effectiveness of a Collaborative Stepped Care Intervention for the Treatment of Common Mental Disorders in Primary Care Settings in Goa, India
Brief Summary: Depressive and anxiety disorders (termed as 'Common Mental Disorders') affect as many as one in four persons attending primary care; most patients do not receive effective treatments. Although the integration of mental health in primary care is accepted as the only feasible way of managing Common Mental Disorders in developing countries, there is no evidence demonstrating how this can be done in a manner which is effective and affordable. The hypothesis of this trial is that a Collaborative Stepped Care package will be both clinically and cost-effective for the treatment of Common Mental Disorders in primary care.


Options:
A: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
B: Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery (> 3 month or when relevant weight loss has been achieved)
C: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
D: Eyberg Child Behavior Inventory (Baseline, post- intervention and 12-month post-intervention follow-up); Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale) (Baseline, post- intervention and 12-month post-intervention follow-up); Sinovuyo Observational Coding System (Baseline, post- intervention and 12-month post-intervention follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness and Cost-effectiveness of a Collaborative Stepped Care Intervention for the Treatment of Common Mental Disorders in Primary Care Settings in Goa, India
Brief Summary: Depressive and anxiety disorders (termed as 'Common Mental Disorders') affect as many as one in four persons attending primary care; most patients do not receive effective treatments. Although the integration of mental health in primary care is accepted as the only feasible way of managing Common Mental Disorders in developing countries, there is no evidence demonstrating how this can be done in a manner which is effective and affordable. The hypothesis of this trial is that a Collaborative Stepped Care package will be both clinically and cost-effective for the treatment of Common Mental Disorders in primary care.


Options:
A: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)
B: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
C: Change in body pain index using Body Pain Inventory (At recruitment, right before and after the intervention and 12 weeks afterwards); Change in Impact of Events Scale (At recruitment, right before and after the intervention and 12 weeks afterwards)
D: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)

Answer: B