TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation
Brief Summary: The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018


Options:
A: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation
Brief Summary: The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018


Options:
A: 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)
B: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
C: Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment (within a week of the index dental encounter)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation
Brief Summary: The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018


Options:
A: Percent Compliance With Chantix (Months 1, 2, 3)
B: effectiveness (2 years)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Brief Summary: The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.


Options:
A: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (Baseline, and the Endpoint (average of weeks 5, 6, 7).)
B: Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks (Baseline and 7 weeks)
C: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Baseline (following ADHD medication washout of 7-28 days)); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 1); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 2); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 3); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 4); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 5); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 6)
D: SKAMP-Combined Scores (2 hours post-dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Brief Summary: The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.


Options:
A: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (Baseline, and the Endpoint (average of weeks 5, 6, 7).)
B: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use (weekly for 14 weeks of trial or for length of participation); ADHD Symptoms Based on ADHD Rating Scale (measured once per week for 14 weeks or length of study participation)
C: Participants Experiencing Collisions During "Surprise Events" in Driving Simulator (6 weeks)
D: Medication Event Monitoring System (MEMS®) Dosage Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Regimen Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Time Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
Brief Summary: The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.


Options:
A: Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index. (Final visit)
B: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses (18 months study duration per subject (4 3-month intermittent treatment courses))
C: Efficacy endpoints (From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.); Number and proportion of subjects experiencing open label treatment-emergent adverse events (From baseline to end of PGL4001 treatment (3months treatment))
D: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (3 months); Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist (Week 13 visit); Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist (Up to week 17)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
Brief Summary: This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.


Options:
A: response (WHO criteria) (staging every 8 weeks)
B: Recurrence of the original cancer (From the beginning to end of the study); Development of a new gastric cancer (From beginning to end of study); Death due to any cause (From the beginning to the end of study); Adverse events (From beginning to end of study); Clinical laboratory tests (From beginning to end of study)
C: Overall survival (every course for first three courses, then every other course)
D: Objective response rate; Safety

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Benefit of STent Placement and Blood Pressure and Lipid-Lowering for the Prevention of Progression of Renal Dysfunction Caused by Atherosclerotic Ostial Stenosis of the Renal Artery (STAR)
Brief Summary: Background:

Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement. However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure. Medical treatment focuses on the latter. Lipidlowering drugs (statins) could reduce renal failure progression and could reduce the overall high cardiovascular risk. The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown. Therefore, the STAR-study aims to compare the effects of renal artery stent placement together with medication vs. medication alone on renal function in ARAS patients.

Method:

Patients with an ARAS of ≥50% and renal failure (creatinine (Cr) clearance \<80 mL/min/1.73 m2) are randomly assigned to stent placement with medication or to medication alone. Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is a reduction in Cr clearance \>20% compared to baseline. This trial will include 140 patients.


Options:
A: Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy (Measured at every 3 months for the first year and annually thereafter); Cardiovascular or Renal Death (Measured at every 3 months for the first year and annually thereafter); Myocardial Infarction (Measured at every 3 months for the first year and annually thereafter); Hospitalization for Congestive Heart Failure (Measured at every 3 months for the first year and annually thereafter); Stroke (Measured at every 3 months for the first year and annually thereafter); 30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days (Measured at every 3 months for the first year and annually thereafter); Need for Renal Replacement Therapy (Measured at every 3 months for the first year and annually thereafter)
B: Dialysis; Death; Doubling of creatinine
C: Progressive renal function loss (= reduction in estimated Cr clearance by >20%) after 2 yrs follow-up, with an extended follow-up of 5 yrs
D: Difference between treatments in change of estimated glomerular filtration rate (eGFR) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Automated Step-count Feedback to Promote Physical Activity in Diabetes
Brief Summary: The primary purpose of this study is to test an Internet based program along with an enhanced pedometer to promote walking in people with diabetes. The major research question to be answered is if counseling and feedback that emphasizes a 10-minute minimum duration for physical activity bouts result in a different pattern of walking behavior compared to counseling and feedback focusing only on total daily accumulated steps.


Options:
A: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))
B: change in number of care goals met (one year)
C: Step-count bout ratio = 7 day average of steps taken during 10 minute bouts in one day divided by total steps taken during the same day
D: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Diabetes Education Program Evaluation
Brief Summary: The study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. We expect an improvement in overall glycemic control in the experimental group of at least 20%. We also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ADA standards of care4 in the experimental group.


Options:
A: HbA1c (12 months)
B: HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,
C: Mortality (From diabetes diagnosis until median14 year after study start); Diabetic retinopathy (at 6 year and 14 year after study start); Urinary albumin concentration (at 6 year and 14 year after study start); Myocardial infarction (From diabetes diagnosis until median14 year after study start); Stroke (From diabetes diagnosis until median14 year after study start)
D: changes in HbA1c (from baseline to 12 and 24 weeks); changes in systolic and diastolic blood pressure (from baseline to 8, 16, and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Diabetes Education Program Evaluation
Brief Summary: The study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. We expect an improvement in overall glycemic control in the experimental group of at least 20%. We also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ADA standards of care4 in the experimental group.


Options:
A: Patient is receiving a statin (July 2009 to April 2010)
B: HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,
C: change in number of care goals met (one year)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Valsartan in Elderly Isolated Systolic Hypertension
Brief Summary: The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.


Options:
A: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
B: composite cardiovascular events (participants will be followed for the duration of the study, an expected median follow-up 3.07 years)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Valsartan in Elderly Isolated Systolic Hypertension
Brief Summary: The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.


Options:
A: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))
B: Primary composite outcome (4 years)
C: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
D: composite cardiovascular events (participants will be followed for the duration of the study, an expected median follow-up 3.07 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
Brief Summary: This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).


Options:
A: Overall Survival (Induction Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.); Disease-free Survival (Consolidation Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.)
B: overall survival; relapse-free survival
C: Complete remission (CR)-rate after induction therapy (after the second induction cycle); Relapse-free survival, one year after consolidation therapy with high-dose cytarabine considering different temporal sequences (1-3-5 versus 1-2-3) of the consolidation therapy (One year after consolidation therapy); Event-free survival (two years)
D: Objective best response rate (complete remission (CR) and partial remission (PR)) (12 months after randomization of the last patient)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Brief Summary: The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.


Options:
A: Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen (4 months)
B: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
C: The main outcome was change in body weight. (Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.)
D: Clinical pregnancy (within 6 calendar months of randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Brief Summary: The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.


Options:
A: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
B: Serum testosterone
C: To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women (twelve months)
D: Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study (six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Brief Summary: The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.


Options:
A: Changes in fasting insulin and area under the curve for insulin (2 hours) (12 months)
B: Serum androgen levels; Lipid profiles; Blood pressure; Cardiovascular performance; Non-classic cardiovascular risk markers; Indexes of insulin secretion and sensitivity
C: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
D: Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) (baseline and 3 months); Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) (baseline and 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia
Brief Summary: The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.


Options:
A: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score (Week 4); Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score (Week 12 (end of treatment))
B: Wake After Sleep Onset (WASO) at Weeks 5 and 11 (Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET))
C: Pain score evaluation by NRS (8 weeks)
D: To evaluate the efficacy of pregabalin (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale

Answer: D