TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study
Brief Summary: The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.


Options:
A: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)
B: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) (Post treatment 12 week)
C: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (Baseline and 4 weeks)
D: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study
Brief Summary: The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.


Options:
A: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)
B: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (Baseline and 4 weeks)
C: Percentage of Participants With Sustained Viral Response (SVR) at Week 72 (Week 72)
D: Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. (Follow-up Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EXPAND Study - Self Expanding Nitinol Stent Versus PTA With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication. A Prospective, Multi-center, Randomized Clinical Trail With Follow-up Investigations at 1, 3, 6, and 12 Months.
Brief Summary: The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow up investigations at 1, 3, 6 and 12 months. Patients will be randomized either to treatment with stenting with the Astron Pulsar SE (4 or 5 mm diameter) stent or to PTA with optional bailout stenting in case of PTA failure.

The primary objective of this study is to show clinical improvement in the outcome of patients with symptomatic critical limb ischemia or severe intermittent claudication (Rutherford 3, 4, 5) treated with the Astron Pulsar SE (4 or 5 mm diameter) in comparison with PTA or optional bailout stenting in case of PTA failure.


Options:
A: Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). (one year)
B: Angiographic Binary Restenosis (6 months)
C: Rate of sustained clinical improvement at 12 months follow up. Sustained clinical improvement is defined as: Upward shift of at least +1 (for Rutherford category 3) or +2 (for Rutherford categories 4 and 5) on the Rutherford scale. (12 months)
D: Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Trial to Assess Safety of Single Dose vs. Traditional Administration of Thymoglobulin Induction for Renal Transplantation
Brief Summary: In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.


Options:
A: Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria). (Two years); Average of Renal Function (Two years)
B: Incidence and severity of acute rejection episodes (1 year)
C: Incidence and severity of biopsy-confirmed acute rejection (First six months after transplantation)
D: Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function (During first 7 days after kidney transplantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Brief Summary: The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Options:
A: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
B: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
C: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
D: Timed Up and Go-test (TUG)in seconds. (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Brief Summary: The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Options:
A: Adherence to the study protocol (up to 28 days)
B: Glasgow Outcome Scale (at 6 months after injury)
C: Mortality at the 45th day (45 days)
D: Timed Up and Go-test (TUG)in seconds. (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Brief Summary: The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Options:
A: Timed Up and Go-test (TUG)in seconds. (30 days)
B: Hemoglobin difference (14 days)
C: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
D: Mortality at the 45th day (45 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Brief Summary: The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Options:
A: Number of severe complications (grade 3 or more) (up to 1 month after the last day of hospitalization)
B: Timed Up and Go-test (TUG)in seconds. (30 days)
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: Mortality at the 45th day (45 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Brief Summary: The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Options:
A: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
B: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
C: Timed Up and Go-test (TUG)in seconds. (30 days)
D: Methodology of the pilot study (up to 30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Brief Summary: The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Options:
A: Timed Up and Go-test (TUG)in seconds. (30 days)
B: Reduction of elevated levels of blood lactate during 24 following RBC transfusion (24 hours)
C: Adherence to the study protocol (up to 28 days)
D: Glasgow Outcome Scale (at 6 months after injury)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation
Brief Summary: This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.


Options:
A: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)
B: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
C: Uterine Tachysystole (Up to four hours after administration of study drug)
D: success rate of cervical ripening in labor induction (12 hours after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


Options:
A: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
B: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
C: Maximum Nicotine Concentration in Blood (180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)); Concentration of Carboxyhemoglobin in Blood (Baseline and 8 days); Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours (Baseline and 8 days); Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours (Baseline and 8 days); Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours (Baseline and 8 days)
D: 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))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
C: Number of Participants With a Quit Attempt (6 months)
D: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


Options:
A: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: Maximum Nicotine Concentration in Blood (180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)); Concentration of Carboxyhemoglobin in Blood (Baseline and 8 days); Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours (Baseline and 8 days); Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours (Baseline and 8 days); Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours (Baseline and 8 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


Options:
A: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
B: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
C: Smoking Abstinence (12 months)
D: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


Options:
A: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
B: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
C: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
D: tobacco abstinence (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


Options:
A: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
B: Biochemically verified 7 day point prevalence abstinence from smoking.
C: 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))
D: Percent Compliance With Chantix (Months 1, 2, 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


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: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Examination of the Efficacy, Safety, and Gender Differences in Using Varenicline as an Aid to Smoking Cessation in a Population of Methadone Maintained Opioid Dependent Patients (Pilot Trial)
Brief Summary: The main hypotheses guiding the study are:

1. Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo
2. There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo
3. There will be no changes in methadone dosage between abstinent and non-abstinent smokers
4. There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants


Options:
A: Percent Compliance With Chantix (Months 1, 2, 3)
B: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
C: Days to Relapse (4 weeks)
D: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)

Answer: D