TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Brief Summary: This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.


Options:
A: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)
B: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))
C: Development of diabetes (Up to 5 years)
D: Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) (Up to 5 years); Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) (Up to 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Brief Summary: The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.


Options:
A: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
B: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)
C: Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days (Day 7); Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst (Day 7)
D: The improvement of the right hart function on echocardiograms (within the 1st 14 days); Perfusion defect score of lung V/Q scans (within the 1st 14 days); Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment. (within the 1st 14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Brief Summary: The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.


Options:
A: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
B: Patency after 6 months (6 months); Post-thrombotic syndrome after 2 years (yrs) (2 years)
C: Incidence of Post-thrombotic Syndrome (PTS) (During 2-year follow up)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Brief Summary: The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.


Options:
A: Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks (6 weeks); Rate of post-thrombotic syndrome (PTS) (1 year)
B: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
C: Post thrombotic syndrome (percentage of patients with PTS) one year following the acute thrombotic event. (one year)
D: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Brief Summary: The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.


Options:
A: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
B: The improvement of the right hart function on echocardiograms (within the 1st 14 days); Perfusion defect score of lung V/Q scans (within the 1st 14 days); Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment. (within the 1st 14 days)
C: Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage (1,2,3,4, and 5 days); Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36) (90 days); Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome (90 days)
D: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Brief Summary: The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.


Options:
A: Exercise Limitation (1 month); Exercise Limitation (12 months)
B: Time left unprotected to venous thromboembolism (two weeks post trauma)
C: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
D: at 3 months, combined criteria including recurrent PE confirmed by objective tests and fatal PE confirmed by autopsy and death which can not be attribuated to a documented cause and for which PE/DVT can't be ruled out (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
Brief Summary: This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.


Options:
A: Angiomyolipoma Response Rate as Per Central Radiology Review (From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years)
B: Cognitive ability measured by IQ (12 months)
C: Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response (End of core period (Week 48), and end of extension period (up to 4 years))
D: longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (assessments at baseline and 2,6,12 and 24 months); toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events (throughout study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
Brief Summary: This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.


Options:
A: Angiomyolipoma Response Rate as Per Central Radiology Review (From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years)
B: Number With Observed Adverse Side Effects (During the entire study)
C: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
D: Rapamycin level (6 months); Complete blood count (6 months); Total cholesterol (6 months); Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Weight and Diabetes Risk in an Underserved Population
Brief Summary: The purpose of this study is to examine the effectiveness of a lifestyle intervention designed to reduce weight and diabetes risk in a population of individuals with mental illness who are also taking antipsychotic medications. We will examine the effectiveness of the intervention in

1. reducing weight and Body Mass Index;
2. reducing fasting insulin levels and increasing insulin sensitivity; and
3. reducing total cholesterol and LDL cholesterol.


Options:
A: Percentage of Participants That Responded to Treatment (this outcome was assessed throughout the study.)
B: Evaluate the main and interactional effects of risperidone and olanzapine on body mass index (BMI), other measures of obesity, and other health-related factors, including total cholesterol, lipid panels, blood glucose, glycohemoglobin, and prolactin (twelve months)
C: Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made every 6th month till 1 year after 8th week end point. (one year); Schedule for Assessment of Negative Symptoms (SANS): Measure of efficacy will be changes in SANS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made at 6 month and 12 month after 8th week end point. (one year); Serum Prolactin Level (one year); Body Mass Index & Abdominal Circumference (one year); Lipid Panel with LDL Cholesterol (one year); FBS-PP & HbA1c (one year)
D: Body Mass Index (6, 12, 24 months); Weight (6, 12, 24 months); Insulin sensitivity (6, 12, 24 months); Fasting insulin levels (6, 12, 24 months); Cholesterol levels (6, 12, 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Weight and Diabetes Risk in an Underserved Population
Brief Summary: The purpose of this study is to examine the effectiveness of a lifestyle intervention designed to reduce weight and diabetes risk in a population of individuals with mental illness who are also taking antipsychotic medications. We will examine the effectiveness of the intervention in

1. reducing weight and Body Mass Index;
2. reducing fasting insulin levels and increasing insulin sensitivity; and
3. reducing total cholesterol and LDL cholesterol.


Options:
A: Glucose Monitoring Adherence at Acute Outcome (Measured at Month 4); Percent Medication Adherence Via MEMS (month 4); Clinician Rated Depression (MADRS) at the Acute Timepoint (month 4); Depression on the CGI at Acute Outcome (Month 4)
B: Body Mass Index (6, 12, 24 months); Weight (6, 12, 24 months); Insulin sensitivity (6, 12, 24 months); Fasting insulin levels (6, 12, 24 months); Cholesterol levels (6, 12, 24 months)
C: Change from baseline HbA1c at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline blood pressure at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline cholesterol at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline BMI at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline weight at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months); Change from baseline fasting glucose at 3, 9, 15, and 27 months (0, 3, 9, 15, and 27 months)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Automated Telephone Outreach With Speech Recognition to Improve Diabetes Care: A Randomized Controlled Study
Brief Summary: The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care.


Options:
A: % of patients reaching goal HbA1C (<7) (2 years after enrollment); % of patients with BP goal (<130/80) (Two years after enrollment); % of patients with LDL at goal (<100) (2 years after enrollment); % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100) (2 years after enrollment)
B: HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,
C: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (30 months)
D: Completion of dilated eye examination (12-months following intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Automated Telephone Outreach With Speech Recognition to Improve Diabetes Care: A Randomized Controlled Study
Brief Summary: The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care.


Options:
A: Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status). (Baseline, 4 months and 12 months)
B: Modified Medication Possession Ratio (Measured over 19 months)
C: Completion of dilated eye examination (12-months following intervention)
D: Completion of a Fecal Occult Blood Test (FOBT) (within 6 months of randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
B: Continuous abstinence (Russell Standard) (Six months post quit date)
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
B: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
C: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
D: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Cigarette use (8 weeks)
B: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: Quit Rate (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
B: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
C: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
D: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
B: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
C: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
D: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Brief Summary: RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.


Options:
A: Smoking Abstinence (12 months)
B: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)

Answer: C