TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


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: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
D: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
D: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
B: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
C: N/A
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements
B: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
C: Expired-air Carbon Monoxide Confirmed Smoking Abstinence (52 weeks)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


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: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
C: 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)
D: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
Brief Summary: To evaluate the safety of pregabalin in patients with fibromyalgia.


Options:
A: To evaluate the safety of pregabalin in patients with fibromyalgia
B: Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) (Randomization to Week 19); Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event (Randomization to Week 19)
C: 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
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women. - A Randomised Control Trial
Brief Summary: Urogenital Chlamydia trachomatis infection is the most common bacterial sexually transmitted infection in Norway. Urogential C.trachomatis infection can easily be treated with antibiotics. However, left untreated it is a major cause of pelvic inflammatory disease (PID) that can lead to complications such as infertility, ectopic pregnancy and chronic pelvic pain in women. Most infections are asymptomatic and many do not seek the doctor for testing. Therefore cases remain undetected and untreated.We want to determine the efficacy and feasibility of screening for urogenital C. trachomatis infection with home sampling (intervention) compared to the current strategy of conventional sampling at the doctor's office (control) in identifying men and women aged 18-25 years with urogenital C.trachomatis infection (Part A). We also want to identify factors influencing the acceptability of home sampling for C.trachomatis infections (Part B)and determine factors associated with C.trachomatis infections (Part C).


Options:
A: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group (At the time of Visit 5 (i.e. at 18.5 years of age))
B: Number of tests received
C: Yield ratio tested for uro-genital C.trachomatis infection; Yield ratio diagnosed for uro-genital C.trachomatis infection; Yield ratio treated for uro-genital C.trachomatis infection
D: Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women. - A Randomised Control Trial
Brief Summary: Urogenital Chlamydia trachomatis infection is the most common bacterial sexually transmitted infection in Norway. Urogential C.trachomatis infection can easily be treated with antibiotics. However, left untreated it is a major cause of pelvic inflammatory disease (PID) that can lead to complications such as infertility, ectopic pregnancy and chronic pelvic pain in women. Most infections are asymptomatic and many do not seek the doctor for testing. Therefore cases remain undetected and untreated.We want to determine the efficacy and feasibility of screening for urogenital C. trachomatis infection with home sampling (intervention) compared to the current strategy of conventional sampling at the doctor's office (control) in identifying men and women aged 18-25 years with urogenital C.trachomatis infection (Part A). We also want to identify factors influencing the acceptability of home sampling for C.trachomatis infections (Part B)and determine factors associated with C.trachomatis infections (Part C).


Options:
A: Yield ratio tested for uro-genital C.trachomatis infection; Yield ratio diagnosed for uro-genital C.trachomatis infection; Yield ratio treated for uro-genital C.trachomatis infection
B: chlamydia and gonorrhea tests completed; chlamydia and gonorrhea infections detected
C: Number of tests received
D: Long term infertility complications (2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia or Schizoaffective Disorder With Risperidone as an Active Control
Brief Summary: To evaluate the efficacy, safety and tolerability of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder with risperidone as an active control.


Options:
A: Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline (Screen, baseline, Days 4,7,14,21,28,35,42)
B: Clinical Utility Index (CUI) (Baseline through Week 6)
C: PANSS-total score
D: A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (baseline, up to 7 weeks of treatment); A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients (baseline, up to 7 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Physical Activity in Older Adult MCO Members
Brief Summary: The purpose of this study is to determine whether a new phone and mail based coaching/support program that has been developed is more effective in helping people stay physically active than existing programs that are currently available to all HealthPartners members. We hypothesize that the intervention program will lead to a greater likelihood of physical activity maintenance among moderately active older adults than a usual care condition.


Options:
A: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)
B: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
C: Physical activity measured by accelerometry. (3 months post-randomisation)
D: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Physical Activity in Older Adult MCO Members
Brief Summary: The purpose of this study is to determine whether a new phone and mail based coaching/support program that has been developed is more effective in helping people stay physically active than existing programs that are currently available to all HealthPartners members. We hypothesize that the intervention program will lead to a greater likelihood of physical activity maintenance among moderately active older adults than a usual care condition.


Options:
A: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
B: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)
C: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
D: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maintaining Physical Activity in Older Adult MCO Members
Brief Summary: The purpose of this study is to determine whether a new phone and mail based coaching/support program that has been developed is more effective in helping people stay physically active than existing programs that are currently available to all HealthPartners members. We hypothesize that the intervention program will lead to a greater likelihood of physical activity maintenance among moderately active older adults than a usual care condition.


Options:
A: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
B: Physical activity level
C: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
D: Self-Reported physical activity (Baseline, 3 months, and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc, Mental Health, and School Performance
Brief Summary: This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.


Options:
A: Fetal loss, low birth weight and pre-term birth. (Delivery)
B: Symptoms of depression (Baseline and post supplementation)
C: Change in length and length-for-age Z-score (12 months); Change in weight and weight-for-age (12 months); Incidence of diarrhea and laboratory-confirmed malaria (12 months); Change in plasma zinc concentration (12 months)
D: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HALT Progression of Polycystic Kidney Disease Study A
Brief Summary: The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR \>60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B; NCT01885559). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study A will be followed for at least 5 years, while those enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. The two concurrent randomized clinical trials differ by eligibility criteria, interventions and outcomes to be studied.


Options:
A: Study A: Percent Annual Change in Total Kidney Volume (Baseline and 2-, 4- and 5-year follow-up)
B: renal volume measured by high resolution magnetic resolution imaging (1.5 yrs)
C: Change in renal function (serial eGFR measurements from month 3 until end of treatment visit (month 30))
D: Change in kidney function from baseline to month 24 (Baseline, 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.


Options:
A: Brief Pain Inventory (BPI) Change (Baseline to 6 weeks)
B: Change in Mean Pain Severity Score From Baseline to 13 Weeks (Baseline and 13 weeks)
C: Change in Brain Gray Matter Volume (16 weeks compared to baseline)
D: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.


Options:
A: Primary efficacy variable: Absolute change in the neuropathy impairment score lower limbs enlarged by 7 objective items (NISLL+7) between baseline (mean of Visit 0.3 and 0.4 or last available value before randomisation, respectively) and endpoint (4 years)
B: Number of Participants With All-Cause Mortality (five years)
C: Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). (Baseline and 9 months)
D: Change in Mean Pain Severity Score From Baseline to 13 Weeks (Baseline and 13 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Study to Evaluate the Efficacy of a Remote Digital Observation Camera Protocol in the Evaluation and Thrombolytic Treatment of Acute Stroke Patients in the Remote Hospital Setting
Brief Summary: The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site.


Options:
A: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization (6 months post randomization)
B: HBA1c Glycosylated hemoglobin (one year for every patient)
C: Appropriateness of Decision to Treat or Not Treat With Thrombolytics (potentially within 3 hours of symptom onset)
D: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study
Brief Summary: This study is testing if a medication called domperidone will help women produce more milk so that they can keep breastfeeding and not use formula. The study is also testing what dose of domperidone works best to increase breast milk production.


Options:
A: Percentage of mothers who exclusively breastfeed their child (At 6 weeks postpartum)
B: success of continuing breastfeeding; amount of supplementation used
C: Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks)
D: Early lactation difficulties (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-masked, Multi-center, Phase II Study Assessing the Safety and Efficacy of Two Concentrations of Ranibizumab (Intravitreal Injections) Compared With Non-treatment Control for the Treatment of Diabetic Macular Edema With Center Involvement
Brief Summary: This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.


Options:
A: Central subfield macular thickness (CSFT) change (Monthly from baseline to Week 48)
B: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
C: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year (Baseline, Year 1)
D: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 (Baseline through the end of study (Month 12))

Answer: D