TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial
Brief Summary: Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel wall that delay or inhibit the process of restenosis. Some reports have found that DES are associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this risk is not known. Current evidence is therefore insufficient to balance the long-term risk and benefit of BMS vs DES.

The purpose of this trial is to compare the long-term effects on MI and total mortality of BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients will be randomized to treatment with BMS or DES. Clinical events will be registered for 5 years after treatment. The study hypothesis is that there is no difference in the risk of death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and run by university researchers and is sponsored by not-for-profit organizations.


Options:
A: In segment Late Lumen Loss (6 months post index procedure)
B: First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) (After five years of follow-up)
C: Major adverse cardiac events (MACEs) in the overall population, defined as the composite of cardiac death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (30 days, 6 months, 1,2 and 5 years)
D: MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Multi-center, Double-blind, Randomized, Placebo-controlled Phase IIb Trial to Determine the Effects of Bardoxolone Methyl (RTA 402) on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease With an eGFR of 20 - 45 mL/Min/1.73m2
Brief Summary: This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2 diabetes and chronic kidney disease.


Options:
A: Change in GFR (ml/Min) (baseline and after diuretics administration); Renal Vascular Resistance (mm Hg/[ml/Min]) (baseline and after diuretics administration)
B: Percentage change of 24-hour proteinuria (6 months)
C: weight loss
D: To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomization (6 months (24 weeks)); To determine the safety and tolerability of bardoxolone methyl when administered for 12 months (52 weeks)following randomization to type 2 diabetic patients with CKD (eGFR 20 - 45 mL/min/1.73m2). (1 year (52 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regimen in the Prevention of Acute Rejection Following Renal Transplantation
Brief Summary: The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.


Options:
A: Plasma Creatinine (6 months)
B: Incidence and severity of acute rejection episodes (1 year)
C: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis (12 months); Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints (12 months)
D: To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR); Non-inferiority of the composite of graft loss and death at 52 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regimen in the Prevention of Acute Rejection Following Renal Transplantation
Brief Summary: The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.


Options:
A: A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.
B: The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.
C: Plasma Creatinine (6 months)
D: GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen (From randomization at BL2 (Month 3) to Month 12 post-transplant)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Continuous Positive Airway Pressure in Patients With Resistant Hypertension and Obstructive Sleep Apnea
Brief Summary: Obstructive sleep apnea (OSA) is an important cause of refractory hypertension but the impact of treatment with continuous positive airway pressure (CPAP) is not completely understood. The aim of this project is to study the effects of CPAP on blood pressure control and its influences on cardiac remodeling and arterial stiffness in patients with refractory hypertension and moderate or severe OSA.


Options:
A: Ambulatory blood pressure monitoring (Change from Baseline in Blood Pressure at 6 months)
B: Structural and functional brain changes (at baseline and after 3 months of treatment)
C: Incidence of hypertension; Incidence of cardiovascular events
D: A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. (Reviewed 6-monthly; average patient follow up, 4.5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-Week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects With Hypercholesterolemia
Brief Summary: The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.


Options:
A: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) (8 weeks)
B: Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. (16 weeks)
C: Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (Baseline to 8 weeks)
D: The changes in transvalvular aortic velocities and the changes in aortic valve area. (Between baseline and close-out measurments.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Brief Summary: The purpose of this study is to assess objective tumor response in the single agent treatment of PEP02, irinotecan, or docetaxel for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma


Options:
A: In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. (Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization)
B: Progression free survival (8 weeks)
C: objective tumor response
D: Overall Survival Time (OS) (Randomization up to 27.5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study
Brief Summary: This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.


Options:
A: hemoglobin A1c levels (at six months)
B: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
C: Change in Systolic Blood Pressure (6 months prior to 6 months after the intervention period)
D: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study
Brief Summary: This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.


Options:
A: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale (Baseline and 1 year); Changes in Minutes of Moderate Physical Activity (Baseline and 1 year); Changes in Minutes of Vigorous Exercise (Baseline and 1 year)
B: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
C: HBA1c Glycosylated hemoglobin (one year for every patient)
D: Hemoglobin A1c

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study
Brief Summary: This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.


Options:
A: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
B: Systolic blood pressure (9 months); Diastolic blood pressure (9 months)
C: Body weight change (baseline and after 4weeks of lifestyle intervention)
D: Quality of life measured through responses to standardized health questionnaires: SF-12; EQ-5D; IWQoL(Impact of Weight on Quality of Life); PSS(Patient satisfaction survey); Mod WLIQ:(Modified Waiting-list impact questionnaire) (Every Six months for 2 years (At time =0, 6, 12, 18, 24 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Bilateral, Cosmetic Sub-muscular Breast Augmentation
Brief Summary: The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.


Options:
A: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores (through 72 hours)
B: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefit (Wound closure to time hospital discharge order written or Day 30, whichever is sooner.)
C: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours (0 to 72 hours)
D: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4 (0 to 96 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Brief Summary: The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.


Options:
A: Overall Survival (From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months))
B: disease control rate (eight weeks)
C: overall survival (9 months)
D: Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind Extension of the Study 27025 (REFLEX) to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION)
Brief Summary: REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum \[FBS\]-free/human serum albumin \[HSA\]-free formulation of interferon \[IFN\]-beta-1a (RNF).


Options:
A: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)
B: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
C: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months (Baseline (Day 1 of Study 27025) up to 36 Months)
D: Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time (up to 60 months after start of treatment); Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time (up to 60 months after start of treatment); Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60 (60 months after start of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for the Treatment of Smokeless Tobacco Use
Brief Summary: Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.


Options:
A: effectiveness (2 years)
B: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
C: 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))
D: Primary efficacy and Safety endpoint: (within 12 month from enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for the Treatment of Smokeless Tobacco Use
Brief Summary: Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.


Options:
A: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
B: Smoking behavior (after 5 hrs abstinence)
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: Quit Rate (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for the Treatment of Smokeless Tobacco Use
Brief Summary: Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.


Options:
A: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
B: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
C: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
D: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for the Treatment of Smokeless Tobacco Use
Brief Summary: Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.


Options:
A: 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)
B: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
C: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
D: Cigarette use (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for the Treatment of Smokeless Tobacco Use
Brief Summary: Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially circumvents the limitations of using nicotine replacement therapy or bupropion pharmacotherapy in ST users. The overall goal of this line of research is to develop effective pharmacologic treatments for ST users to increase long-term (≥ 6 months) abstinence rates. The central hypothesis of this application is that varenicline is efficacious for the treatment of ST users.


Options:
A: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
B: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
C: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
D: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)

Answer: D