TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Diabetes
Brief Summary: Diabetes is a common and serious chronic disease. However, there is a large gap between the level of care that people should receive (based on research and guidelines) and the level of care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the Canadian Diabetes Association has a strategy to improve heart disease screening and treatment for people with diabetes. This study will evaluate whether the strategy works. The focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them delivery better care for their diabetic patients. In Ontario, only half of doctors received this Toolkit. We will compare the quality of care received by diabetic patients whose doctors received this Toolkit versus those who doctors did not.


Options:
A: Death or non-fatal myocardial infarction (Up to 10 months)
B: HbA1c, LDL-cholesterol, Systolic Blood Pressure (Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1))
C: Patient is receiving a statin (July 2009 to April 2010)
D: % 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
Brief Summary: The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.


Options:
A: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)
B: Time to Relapse or an Impending Relapse (time of first relapse up to Day 182 (double blind phase))
C: Time From Baseline to the First Symptom Relapse During the Double-blind Phase (Up to 34 Weeks and Bi-Weekly thereafter until Week 92)
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Brief Summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).


Options:
A: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
B: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)
C: Annualized Relapse Rate (2 years)
D: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Brief Summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).


Options:
A: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)
B: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)
C: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)
D: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Brief Summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).


Options:
A: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
B: Montgomery-Asberg Depression Rating Scale (MADRS) (baseline to 3 months)
C: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)
D: Rate of Change in NAA Levels Adjusted for Water Content. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Brief Summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).


Options:
A: 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)
B: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. (Baseline up to approximately 5 years); Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) (Baseline Extension up to day 10); Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) (Baseline Extension up to day 10); Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) (Baseline Extension up to approximately 5 years); Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) (Baseline Extension up to approximately 5 years); Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) (Baseline Extension up to approximately 5 years)
C: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)
D: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
Brief Summary: The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.


Options:
A: 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)
B: Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA) (12 months or at Target Lesion Revascularization (TLR) time); Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients (12 months); Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) (6 months)
C: Primary Patency (12 Month); Primary Safety Composite (12 month)
D: Event-free Survival (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Scratching in Couples With Unexplained Subfertility
Brief Summary: Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.


Options:
A: Clinical pregnancy rate (10 month)
B: Live Birth (1 year)
C: Clinical pregnancy rate. (one year); Miscarriage rate. (one year); Multiple pregnancy rates (one year)
D: Clinical pregnancy rate (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Scratching in Couples With Unexplained Subfertility
Brief Summary: Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.


Options:
A: Clinical pregnancy rate (6 months)
B: Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS). (2 minutes after biopsy procedure)
C: Clinical pregnancy rate. (one year); Miscarriage rate. (one year); Multiple pregnancy rates (one year)
D: Clinical pregnancy rate (10 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fruit and Vegetable Intake Among Rural Youth Following a School-based Randomized Controlled Trial
Brief Summary: The investigators implemented a theory-based randomized controlled trial in ten rural Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including fruit/vegetable intake as a primary outcome. Schools were randomized to intervention or control groups. Goal setting, peer leaders, and in-class workshops were intervention features. Seventh graders filled out surveys on health behaviors, psycho-social variables, and demographic characteristics. The investigators expected schools receiving the intervention to report a higher fruit-vegetable intake compared to control schools where students received standard health information. Sample (n=1,119) was 48.5% female, 50% White, with a mean age of 12.6 years. Fruit/vegetable intake was significantly higher in intervention schools at immediate post and at 1-year follow-up compared to controls.


Options:
A: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
B: Fruit and vegetable intake (Up to one year)
C: Food Intake (9 month posttest, 21 month follow-up, 33 month follow-up); Physical Activity (baseline, 9 month posttest, 21 month posttest, 33 month posttest); Body Mass Index (baseline, 9 month posttest, 21 month posttest, 33 month posttest)
D: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fruit and Vegetable Intake Among Rural Youth Following a School-based Randomized Controlled Trial
Brief Summary: The investigators implemented a theory-based randomized controlled trial in ten rural Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including fruit/vegetable intake as a primary outcome. Schools were randomized to intervention or control groups. Goal setting, peer leaders, and in-class workshops were intervention features. Seventh graders filled out surveys on health behaviors, psycho-social variables, and demographic characteristics. The investigators expected schools receiving the intervention to report a higher fruit-vegetable intake compared to control schools where students received standard health information. Sample (n=1,119) was 48.5% female, 50% White, with a mean age of 12.6 years. Fruit/vegetable intake was significantly higher in intervention schools at immediate post and at 1-year follow-up compared to controls.


Options:
A: Time to onset and severity of drug use (2 years); Frequency and Quantity of Drinking (2 years); Problem drinking symptoms (2 years)
B: Number of Patients With High Levels of Adolescent PTSD Symptoms (Baseline (injury), then 2, 5, and 12 months post-injury)
C: Fruit and vegetable intake (Up to one year)
D: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: Change in Carbon Monoxide Level (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week); Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL (Baseline, 4 week, 8 week, 13 week, 26 week); Change in the use of e-cigarettes (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week)
B: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
C: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
C: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
D: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: Tobacco use (Six-month follow-up)
B: Continuous Nicotine Abstinence (8 weeks)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: verified abstinence 6 months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)
B: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)
B: Smoking Abstinence (12 months)
C: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

Answer: D