TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: NCI-AARP Diet and Health Study
Brief Summary: This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument.

In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.


Options:
A: Incident Cancer (12/31/2030); All cause and disease specific mortality (12/31/2030); Chronic diseases (12/31/2030)
B: Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid) (Baseline and 10 weeks); Changes in fat content of skeletal muscle and liver (Baseline and 10 weeks)
C: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)
D: Physical Activity Energy Expenditure (kJ/Day or kcal/Day) (7 days (across 12 weeks) - Primary outcome at week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity
Brief Summary: Study to evaluate the utility of prospective HLA-B\*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B\*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B\*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B\*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.


Options:
A: Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
B: The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. (48 Weeks)
C: Number of Participants With Virologic Suppression (Throughout study, including breastfeeding, assessed up to 24 months); Number of HIV+ Infants (Throughout study, including breastfeeding, assessed up to 24 months)
D: HIV PCR (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity
Brief Summary: Study to evaluate the utility of prospective HLA-B\*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B\*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B\*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B\*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.


Options:
A: The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism
B: Progression-Free Survival (PFS) Time (Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
C: Progression-free survival (from randomization till first evidence of progression)
D: Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Treating Paroxysmal Atrial Fibrillation. The Ablation for Paroxysmal Atrial Fibrillation (APAF2) Trial
Brief Summary: Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been formally assessed in a randomized controlled trial.

The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a randomized controlled trial.


Options:
A: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) (The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.); The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events (Within 7 Days of Ablation Procedure)
B: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
C: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
D: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Treating Paroxysmal Atrial Fibrillation. The Ablation for Paroxysmal Atrial Fibrillation (APAF2) Trial
Brief Summary: Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been formally assessed in a randomized controlled trial.

The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a randomized controlled trial.


Options:
A: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
B: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
C: Atrial fibrillation burden (Two years)
D: Acute Procedural Success (APS) (371.4 Minutes (Average)); Freedom From Chronic Treatment Failure (CTF) (12 month follow up period); Treatment Success (12 months); Freedom From Major Atrial Fibrillation Events (MAFEs) (12 Months); Cryoablation Procedure Events (CPEs) (To end of ablation procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Treating Paroxysmal Atrial Fibrillation. The Ablation for Paroxysmal Atrial Fibrillation (APAF2) Trial
Brief Summary: Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been formally assessed in a randomized controlled trial.

The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a randomized controlled trial.


Options:
A: The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
B: All-cause mortality or worsening heart failure requiring unplanned hospitalization (7 years)
C: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
D: Time to Recurrence of AF lasting longer than 15 seconds (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.


Options:
A: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
B: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
C: Time to First Relapse (Baseline up to 96 weeks)
D: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
C: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
D: Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 (10 days); Safety of FTY720 (10 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.


Options:
A: Time to First Relapse (Baseline up to 96 weeks)
B: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Brief Summary: This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.


Options:
A: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
B: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
C: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period (12 months)
D: Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period (Day 1 to Month 4); Injection-Related Adverse Event Rate Per Year in the Extension Period (Month 5 up to Month 10); Injection-Related Adverse Events in the Extension Period (Month 5 up to Month 10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement Therapy Methods for Pregnant Women
Brief Summary: This study will compare the effectiveness of counseling plus use of a nicotine patch with counseling alone for helping pregnant women quit smoking. Smoking during pregnancy is the most preventable cause of fetal and newborn health problems such as low birth weight, fetal growth retardation, sudden infant death syndrome, spontaneous abortion, decreased lung function and premature delivery.

African-American and Hispanic women 18 years of age or older, smoke cigarettes, and live in the District of Columbia metropolitan area may be eligible for this study. Candidates are recruited from the George Washington University and Providence Hospital prenatal health clinics. They are screened with a review of their medical records and a survey that includes questions about their age, residency, race and ethnicity, educational level and employment status, number of weeks pregnant, and exposure to cigarette smoke and other types of tobacco.

Participants answer questions about their smoking behavior, then receive a 10-minute counseling session and watch a videotape about quitting smoking. Women who are not able to quit smoking in 1 week are then randomly assigned to one of two treatment groups. One group continues to receive counseling sessions during the remainder of their pregnancy; the second group receives nicotine patches as well as the counseling sessions. In addition, all participants watch a video about smoking and receive a guide to help them quit. Women who receive the patches must stop smoking completely. If they cannot stop immediately, their participation in the study ends. The behavioral counseling sessions for all the women are a series of conversations between the women and a trained counselor to help the woman through the process of quitting.

Participants are followed during the study with six clinic visits and three telephone calls. During the first visit, the women answer a series of questions about their smoking habits and health concerns. A portion of the urine sample they provide during their routine prenatal visit is used by this study to assess their cotinine (a breakdown product of nicotine) levels. Saliva and breath samples to test for cotinine and carbon monoxide levels are collected at each visit. Saliva is collected by brushing the inside of the cheek with a cotton swab, and breath samples are collected by having the woman blow into a tube connected to a machine. Participants are evaluated four times during the study with questions about their smoking behavior.

With the women's permission, their medical records, health, and treatments during pregnancy are reviewed. At the end of the pregnancy, the infant's weight and health are also reviewed.


Options:
A: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
B: Cotinine validated quit rates.
C: Biochemically-validated smoking cessation (middle and late pregnancy)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement Therapy Methods for Pregnant Women
Brief Summary: This study will compare the effectiveness of counseling plus use of a nicotine patch with counseling alone for helping pregnant women quit smoking. Smoking during pregnancy is the most preventable cause of fetal and newborn health problems such as low birth weight, fetal growth retardation, sudden infant death syndrome, spontaneous abortion, decreased lung function and premature delivery.

African-American and Hispanic women 18 years of age or older, smoke cigarettes, and live in the District of Columbia metropolitan area may be eligible for this study. Candidates are recruited from the George Washington University and Providence Hospital prenatal health clinics. They are screened with a review of their medical records and a survey that includes questions about their age, residency, race and ethnicity, educational level and employment status, number of weeks pregnant, and exposure to cigarette smoke and other types of tobacco.

Participants answer questions about their smoking behavior, then receive a 10-minute counseling session and watch a videotape about quitting smoking. Women who are not able to quit smoking in 1 week are then randomly assigned to one of two treatment groups. One group continues to receive counseling sessions during the remainder of their pregnancy; the second group receives nicotine patches as well as the counseling sessions. In addition, all participants watch a video about smoking and receive a guide to help them quit. Women who receive the patches must stop smoking completely. If they cannot stop immediately, their participation in the study ends. The behavioral counseling sessions for all the women are a series of conversations between the women and a trained counselor to help the woman through the process of quitting.

Participants are followed during the study with six clinic visits and three telephone calls. During the first visit, the women answer a series of questions about their smoking habits and health concerns. A portion of the urine sample they provide during their routine prenatal visit is used by this study to assess their cotinine (a breakdown product of nicotine) levels. Saliva and breath samples to test for cotinine and carbon monoxide levels are collected at each visit. Saliva is collected by brushing the inside of the cheek with a cotton swab, and breath samples are collected by having the woman blow into a tube connected to a machine. Participants are evaluated four times during the study with questions about their smoking behavior.

With the women's permission, their medical records, health, and treatments during pregnancy are reviewed. At the end of the pregnancy, the infant's weight and health are also reviewed.


Options:
A: Cotinine validated quit rates.
B: Biochemically-validated smoking cessation (middle and late pregnancy)
C: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
D: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))

Answer: A