TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
B: Number of Participants With Smoking Cessation (12 WEEK)
C: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
D: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
C: Number of Participants With a Quit Attempt (6 months)
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
C: Smoking Status (at week 48)
D: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: Continuous abstinence Weeks 13 -24.
D: Smoking Abstinence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) (12 weeks); Sustained Abstinence at the 12-week Follow up (12 weeks); Number of Days of Varenicline Use (12 weeks); Number of Active Smoking Cessation Activities Used (12 weeks)
D: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Percent Treatment Sessions Attended (52 weeks)
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
C: Biochemically verified 7 day point prevalence abstinence from smoking.
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief Summary: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.


Options:
A: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
B: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
C: Days to Relapse (4 weeks)
D: Participants Abstinent From Cigarettes (Two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder
Brief Summary: Major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. N-methyl-D-aspartate (NMDA), one subtype of glutamate receptors, plays an important role in learning and memory. N-methyl-D-aspartic acid (NMDA) enhancing agents, such as sarcosine (N-methylglycine), have been used as adjunctive therapy of schizophrenia. Sarcosine improved not only psychotic but also depressive symptoms in patients with schizophrenia. To confirm its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine in efficacy for major depressive patients.


Options:
A: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores (6 weeks)
B: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14 (Day 1 and Day 14)
C: 17-item Hamilton Depression Rating Scale (week 0, 2, 4, 6); Remission rate (week 0, 2,4, 6); GAF(Global Assessment of Function) (Week 0, 2, 4, 6)
D: Montgomery-Asberg Depression Rating Scale (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N-methylglycine (Sarcosine) for Treatment of Major Depressive Disorder
Brief Summary: Major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. N-methyl-D-aspartate (NMDA), one subtype of glutamate receptors, plays an important role in learning and memory. N-methyl-D-aspartic acid (NMDA) enhancing agents, such as sarcosine (N-methylglycine), have been used as adjunctive therapy of schizophrenia. Sarcosine improved not only psychotic but also depressive symptoms in patients with schizophrenia. To confirm its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine in efficacy for major depressive patients.


Options:
A: 17-item Hamilton Depression Rating Scale (week 0, 2, 4, 6); Remission rate (week 0, 2,4, 6); GAF(Global Assessment of Function) (Week 0, 2, 4, 6)
B: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis (Baseline up to Endpoint (Double-blind Induction Phase [Day 28]))
C: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. (60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
D: Change in depressive symptoms (After 4th treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) NATHAN1 A Randomized, Placebo-controlled, Double-blind Multi-centre Trial With 2 Parallel Groups
Brief Summary: To assess clinical efficacy and safety of long-term orally administered thioctic acid in the treatment of diabetic polyneuropathy.


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: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Number of Participants With All-Cause Mortality (five years)
D: Change in Mean Pain Severity Score From Baseline to 13 Weeks (Baseline and 13 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Crossover, Open-label Phase 1 Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)
Brief Summary: To determine the safety and tolerability of single oral doses of HPN-100 as a formulation (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy male subjects.


Options:
A: Part A: The Rate of AEs and Tolerability of HPN-100 (Part A: 28 days); Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0 (Part B: 112 Days)
B: The rate of adverse events (33 Days)
C: Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours (Baseline to 24 hours); Change in HE Grade at 24 Hours (Baseline to 24 hours)
D: The rate of adverse event

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.


Options:
A: Mean Annual Rate of Respiratory Events (Up to 2 years)
B: Time to first upper respiratory tract infection (One year); Time to first moderate / severe COPD exacerbation (One year)
C: Reduction of allergic bronchial inflammation (Up to 3 months); Reduction of allergic bronchial inflammation (Up to 3 months)
D: Change From Baseline in Serum 25OHD (During the 7-month follow-up period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.


Options:
A: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
B: Time to first upper respiratory tract infection (One year); Time to first moderate / severe COPD exacerbation (One year)
C: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
D: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
B: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
C: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)
D: NEC onset (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
B: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
C: NEC onset (6 weeks)
D: Sepsis (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: Probiotics Prevent Hirschsprung's Disease Associated Entercolitis (two years)
B: NEC onset (6 weeks)
C: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)
D: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: NEC onset (6 weeks)
B: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Necrotizing enterocolitis (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of NEC in Preterm Infants With B. Lactis
Brief Summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Options:
A: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
B: NEC onset (6 weeks)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions
Brief Summary: The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.


Options:
A: The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period (Approximately 6 months); The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period (Approximately 6 months)
B: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
C: MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT (18 months (12-30 months post-index procedure)); Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT (18 months (12-30 months post-index procedure)); GUSTO Severe or Moderate Bleeding - Randomized DES ITT (18 months (12-30 months post-index procedure))
D: Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (From start of study treatment until follow-up (up to 390 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerance of Healthy Term Infants Fed Infant Formulas
Brief Summary: The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.


Options:
A: The primary variable is Gastrointestinal tolerance. (1-28 days of age)
B: Composite measure of Growth (1 year)
C: Weight Gain Velocity (0 - 16 weeks)
D: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
Brief Summary: The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.


Options:
A: Days to a Severe Asthma Exacerbation (48 weeks)
B: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
Brief Summary: The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.


Options:
A: median time to next exacerbation. (1 year)
B: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)

Answer: D