TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal
Brief Summary: The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.


Options:
A: Cocaine Abstinence During Weeks 9 to 16 Inclusive (Over 8 weeks ( Study Weeks 9 to 16 inclusive))
B: Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline (14 days after each dose of vaccine or placebo)
C: culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility. (1095 days)
D: adverse events (immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).


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: 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
C: 100 mm visual analog scale (VAS)
D: Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period (4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility
Brief Summary: The purpose of this study is to compare two different strategies to implement the existing Guideline programme on Subfertility, as issued by the Dutch Society of Obstetrics and Gynaecology (NVOG). Therefore, an innovative patient-directed strategy will be compared to a control strategy and effectiveness, costs and feasibility of both strategies will be assessed.


Options:
A: Percentage of time spent in any activity during a week by patients (Four months)
B: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (half year after intervention); Costs of both Implementation strategies (half year after intervention)
C: Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14); Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14)
D: Practice-level colon cancer screening rate (12-months post baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility
Brief Summary: The purpose of this study is to compare two different strategies to implement the existing Guideline programme on Subfertility, as issued by the Dutch Society of Obstetrics and Gynaecology (NVOG). Therefore, an innovative patient-directed strategy will be compared to a control strategy and effectiveness, costs and feasibility of both strategies will be assessed.


Options:
A: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)
B: Episiotomies; Oxytocin use in third stage of labor
C: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (half year after intervention); Costs of both Implementation strategies (half year after intervention)
D: Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Scandinavian Candesartan Acute Stroke Trial
Brief Summary: The purpose of this trial is to assess whether the blood pressure lowering agent candesartan (an angiotensin receptor type 1 blocker) is effective when given to patients with acute stroke and elevated blood pressure.

Hypothesis:

AT1 receptor blockade with candesartan in acute stroke will:

1. reduce the risk of death or major disability at 6 months by a 6% absolute risk reduction, relative to placebo.
2. reduce the risk of the combined event of "vascular" death, myocardial infarction, or stroke during the first 6 months by a 25% relative risk reduction, relative to placebo


Options:
A: Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. (3 months)
B: Death or major disability (defined by the modified Rankin scale) at 6 months (6 months); The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months (6 months)
C: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)
D: Number of participants enrolled per month (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Scandinavian Candesartan Acute Stroke Trial
Brief Summary: The purpose of this trial is to assess whether the blood pressure lowering agent candesartan (an angiotensin receptor type 1 blocker) is effective when given to patients with acute stroke and elevated blood pressure.

Hypothesis:

AT1 receptor blockade with candesartan in acute stroke will:

1. reduce the risk of death or major disability at 6 months by a 6% absolute risk reduction, relative to placebo.
2. reduce the risk of the combined event of "vascular" death, myocardial infarction, or stroke during the first 6 months by a 25% relative risk reduction, relative to placebo


Options:
A: Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization (90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization)
B: Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol (Within 6 weeks post-aSAH)
C: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)
D: Death or major disability (defined by the modified Rankin scale) at 6 months (6 months); The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Placebo Controlled, Double Blind Trial of Metformin in Obese Adolescents.
Brief Summary: This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight.


Options:
A: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)
B: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months (Baseline and 6 months); Change From Baseline in Fibrinogen at 6 Months (Baseline and 6 months); Change From Baseline in Interleukin 6 (IL-6) at 6 Months (Baseline and 6 months); Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months (Baseline and 6 months)
C: The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.
D: Change in BMI Standard Deviation Score (baseline to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Brief Summary: The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.


Options:
A: Clinician Administered Posttraumatic Stress Disorder Scale (12 week)
B: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)
C: Impact of Event Scale - Revised (IES-R) (7 days after first infusion)
D: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (2 weeks after the first infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Brief Summary: The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.


Options:
A: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)
B: mean subjective wake time after sleep onset (WASO) (Week 1)
C: Incidence of Adverse Events (Up to 25 weeks (24 weeks treatment period & 1 week follow-up))
D: Latency To Persistent Sleep (LPS) (10 days (5 intervals of two consecutive nights)); Sleep Latency (SL) (10 days (5 intervals of two consecutive nights))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AIM HIGH: Niacin Plus Statin to Prevent Vascular Events
Brief Summary: The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.


Options:
A: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
B: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization (Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.)
C: Coagulation factor VIII (28 days)
D: Thrombin generation (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: AIM HIGH: Niacin Plus Statin to Prevent Vascular Events
Brief Summary: The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart disease than the statin alone.


Options:
A: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)
B: N/A
C: Antioxidative Properties of Endothelial Progenitor Cells (3 months); FDD (3 months)
D: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization (Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Proton Pump Inhibitor Treatment Stop: Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting
Brief Summary: The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease.

This is evaluated in a discontinuation trial.


Options:
A: The Number of Patients With Complete Resolution of Heartburn by Week 4 (week 4 of treatment); The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4 (4 weeks); The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4 (4 weeks); The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4 (4 weeks)
B: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomisation to day 14); Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomization to day 14)
C: Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR. (Week 3 through Week 6)
D: Failure of patient perceived symptom control despite treatment with project medication (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Brief Summary: The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).


Options:
A: Patency at 12-months (12 months); Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month (30-Days and 12-Months)
B: Event-free Survival Rate (12 months); Primary Patency (12 months)
C: Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. (30 Day, 6 Month, and 12 Month)
D: In-stent late lumen loss (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Brief Summary: The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).


Options:
A: Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days. (30 days); Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA). (6 months)
B: Event-free Survival (6 months)
C: Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure (12 months post index procedure); Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure (12 months post index procedure)
D: Event-free Survival Rate (12 months); Primary Patency (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial to Determine the Efficacy of Early Versus Standard Antiretroviral Therapy in HIV Infected Adults With CD4+ T Cell Counts Between 200 and 350 Cells/mm3
Brief Summary: Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.


Options:
A: Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) (30 months); prevalence of HIV resistance (ANRS12253 associated study) (30 month after ARV initiation)
B: Change in proportion of participants who both link to care at assigned study unit within 1 month and are retained in care at the designated study unit 12 months after HIV (Human Immunodeficiency Virus) diagnosis (one month after enrollment, 12 months after enrollment)
C: Survival (At 36 months)
D: Change in the CSF CFUs between the immediate and standard ART initiation groups (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
Brief Summary: The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).


Options:
A: Change in whole-body insulin sensitivity (Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly)
B: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (Baseline to Week 8)
C: Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) (Baseline (Day 1)); Atopic Dermatitis Severity Index (ADSI) Score at Day 14 (Day 14); Atopic Dermatitis Severity Index (ADSI) Score at Day 28 (Day 28); Atopic Dermatitis Severity Index (ADSI) Score at Day 42 (Day 42); Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 (Baseline (Day 1), Day 28)
D: Safety Assessed by Adverse Events (throughout the 5-year study); Growth Velocity (Height) (throughout the 5-year study); Growth Velocity (Weight) (throughout the 5-year study); Potential Effect on the Developing Immune System (throughout the 5-year study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Novel cardiovascular risk factors modification (2 years)
C: Changes in Insulin secretion rate (Baseline and 96 weeks)
D: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Change from baseline in HbA1c at 24 weeks
C: Change from baseline in HbA1c at 24 weeks
D: Change From Baseline in A1C at Week 24 (Weeks 0-24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria
Brief Summary: This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.


Options:
A: Time to HIV seroconversion during trial participation (evaluated quarterly)
B: Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
C: Combined incidence of HIV-1 and HIV-2
D: Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. (minimum of 12 months and a maximum of 14 months per participant); The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). (minimum of 12 months and a maximum of 14 months per participant)

Answer: B