TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome
Brief Summary: The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome


Options:
A: Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants (Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years); Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants (From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years)
B: Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period (Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).); Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period ("Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).)
C: Composite Safety Endpoint (one year); Primary Efficacy Endpoint (one year)
D: Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT (from the end of the first infusion up to 4 hours after the last infusion on Day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Multicenter Trial of Adjunctive Intravenous Therapy With Sodium-selenite(Selenase®, Double-blinded) and a Procalcitonin Guided Causal Therapy (Open) of Severe Sepsis or Septic Shock.
Brief Summary: Severe sepsis and septic shock are diseases of infectious origin with a high risk of death. The purpose of this study is to determine whether the intravenous application of selenium (given as sodium-selenite) can reduce mortality in patients with severe sepsis or septic shock. Additionally, it is investigated, whether the measurement of procalcitonin - a marker of infection - can be used to guide anti-infectious measures in this disease.


Options:
A: Antibiotic use; Length of stay in hospital
B: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
C: To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy. (6 months)
D: All cause mortality (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Multicenter Trial of Adjunctive Intravenous Therapy With Sodium-selenite(Selenase®, Double-blinded) and a Procalcitonin Guided Causal Therapy (Open) of Severe Sepsis or Septic Shock.
Brief Summary: Severe sepsis and septic shock are diseases of infectious origin with a high risk of death. The purpose of this study is to determine whether the intravenous application of selenium (given as sodium-selenite) can reduce mortality in patients with severe sepsis or septic shock. Additionally, it is investigated, whether the measurement of procalcitonin - a marker of infection - can be used to guide anti-infectious measures in this disease.


Options:
A: All cause mortality (28 days)
B: mortality/survival (28 day)
C: Duration of antibiotic treatment for the first episode of infection; Total duration of antibiotic therapy; Antibiotic-free days at 28 days after study enrollment
D: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Restricting the Use of AS-AQ Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial
Brief Summary: Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in \<48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.


Options:
A: N/A
B: N/A
C: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) (Three years)
D: Assessment of the councils delivered by the community-based service provider to the parents or guardians of children and assessment of the observance of the treatment given by the parents or guardians. (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
B: Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment (weeks 9-12); Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment (weeks 13-16); Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment (8 weeks)
C: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
B: Abstinence at 12 months postpartum (through 12 months)
C: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
D: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
B: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
C: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
D: Comparison of Prolonged Abstinence (up to12 weeks post-quit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Cigarette use (8 weeks)
B: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
C: 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)
D: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
B: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
C: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
B: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Validated smoking cessation (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
B: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
C: Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) (Baseline and 12 months)
D: Bone mineral density screening rates

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
B: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Validated smoking cessation (6 months)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Percent Compliance With Chantix (Months 1, 2, 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)
B: Efficacy of extended versus standard quit and win contests (6 Months)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Tobacco use (Six-month follow-up)

Answer: C