TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project
Brief Summary: The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.


Options:
A: Bone mineral density (BMD) testing rates
B: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
C: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
D: Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository. (3 years (Phase 1 analysis at 1 year))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding the Effects of Therapeutic Intervention on Cardiovascular Risk Markers, Insulin Resistance, and Intra-Hepatic Fat Contents in Obese Children at High Risk for the Metabolic Syndrome.
Brief Summary: In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise) or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will cross over the treatment arms, i.e., those that were doing diet/exercise intervention only will add metformin, those that were doing the diet/exercise plus metformin will discontinue the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be measured as well.

The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome.

The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.


Options:
A: Body weight (24 weeks)
B: Treatment Failure (Loss of Glycemic Control) (Study duration - 2 years to 6.5 years of follow up from randomization)
C: 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)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: 4-week continuous quit rate (CQR) for Weeks 9-12
C: N/A
D: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: 4-week continuous quit rate (CQR) for Weeks 9-12
C: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)
D: Number of cigarettes smoked per day (End of 6 week intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: Quit Rate (4 months)
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
B: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Rating of urges to smoke 1-week after the target quit (1 week)
B: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (12 weeks following start of medication)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: 4-week continuous quit rate (CQR) for Weeks 9-12

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
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: 4-week continuous quit rate (CQR) for Weeks 9-12
D: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: 4-week continuous quit rate (CQR) for Weeks 9-12
C: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Participants Abstinent From Cigarettes (Two years)
B: Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by Exhaled carbon monoxide (CO) (After 8 weeks); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (Baseline, Week 8, Week 12); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use (Daily from Week 2 to Week 12)
C: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
D: 4-week continuous quit rate (CQR) for Weeks 9-12

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
B: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
C: Number of smokers referred to tobacco cessation website (12 months)
D: 4-week continuous quit rate (CQR) for Weeks 9-12

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
Brief Summary: The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)
C: Treatment Satisfaction (End of treatment (seven weeks after baseline))
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes
Brief Summary: Study Objectives

PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.

SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.

* To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
* To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
* To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180

Study Drug: Patients will be randomized to receive either:

* Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
* Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection

Duration of Therapy:

* Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
* Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.
* Patients should receive an ASA and all other standard medical therapies.

Substudy:

* A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (\>48 hrs) coronary angiography and intervention.

Primary Outcome: The first occurence of any component of the following composite up to Day 9:

* Death
* Myocardial Infarction
* Refractory Ischemia


Options:
A: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
B: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
C: Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death (during approximately three years of follow-up)
D: The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks. (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes
Brief Summary: Study Objectives

PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.

SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.

* To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
* To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
* To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180

Study Drug: Patients will be randomized to receive either:

* Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
* Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection

Duration of Therapy:

* Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
* Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.
* Patients should receive an ASA and all other standard medical therapies.

Substudy:

* A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (\>48 hrs) coronary angiography and intervention.

Primary Outcome: The first occurence of any component of the following composite up to Day 9:

* Death
* Myocardial Infarction
* Refractory Ischemia


Options:
A: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
B: proportion of participants who reported using any tobacco dependence treatment during the 3-month study period (3 months)
C: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
D: Safety: All-cause mortality (6 weeks); Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion (6 weeks); Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes
Brief Summary: Study Objectives

PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.

SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.

* To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
* To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
* To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180

Study Drug: Patients will be randomized to receive either:

* Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
* Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection

Duration of Therapy:

* Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
* Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.
* Patients should receive an ASA and all other standard medical therapies.

Substudy:

* A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (\>48 hrs) coronary angiography and intervention.

Primary Outcome: The first occurence of any component of the following composite up to Day 9:

* Death
* Myocardial Infarction
* Refractory Ischemia


Options:
A: Cardiac index (within 1 hour after device implantation)
B: Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. (30 days +/- 10 days)
C: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
D: Major Adverse Cardiac and Cerebrovascular Events (Hospital discharge or 28 days following PCI, whichever occurs sooner)

Answer: C