TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection.
Brief Summary: This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment or deferred treatment (placebo control). The primary efficacy hypothesis was that the proportion of participants receiving combination therapy in the Immediate Treatment Arm who achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is superior to 73%.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
B: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
C: Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients) (Baseline and up to 4 weeks); Occurrence of Adverse Events (AEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time (Baseline and up to 4 weeks)
D: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) (Week 24 (12 weeks after the end of treatment)); Percentage of Participants Experiencing at Least One Adverse Event (Up to Week 14 (14 days after the Blinded Treatment was completed)); Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event (Up to Week 12 (end of Blinded Treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Feasibility, Cluster Randomised Controlled Trial Comparing Restrictive Versus Liberal Blood Transfusion Strategies in Adult Patients Admitted With Acute Upper Gastrointestinal Bleeding
Brief Summary: Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.


Options:
A: Hemoglobin difference (14 days)
B: Hemoglobin Concentration (In-hospital up to 30 days post randomization); Red Blood Cell Transfusion (In-hospital up to 30 days post randomization)
C: Adherence to the study protocol (up to 28 days)
D: Amount of FFP (Fresh Frozen Plasma) transfusion in both groups (42 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Feasibility, Cluster Randomised Controlled Trial Comparing Restrictive Versus Liberal Blood Transfusion Strategies in Adult Patients Admitted With Acute Upper Gastrointestinal Bleeding
Brief Summary: Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.


Options:
A: Adherence to the study protocol (up to 28 days)
B: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
C: Timed Up and Go-test (TUG)in seconds. (30 days)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Feasibility, Cluster Randomised Controlled Trial Comparing Restrictive Versus Liberal Blood Transfusion Strategies in Adult Patients Admitted With Acute Upper Gastrointestinal Bleeding
Brief Summary: Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.


Options:
A: Mortality at the 45th day (45 days)
B: Postoperative Functional mobility; Restricting factors for functional mobility
C: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
D: Adherence to the study protocol (up to 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Volatile Anesthetics to Reduce Mortality in Cardiac Surgery: A Multicentre Randomized Controlled Study
Brief Summary: There is initial evidence that the choice of anesthesia can influence survival in the specific setting of coronary artery bypass grafting surgery (CABG).

A recent international consensus conference included volatile agents among the few drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin release and mortality in patients receiving volatile anesthetics when compared to patients receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can translate into a reduced mortality rate in patients receiving volatile agents. The level of evidence for these four studies is not high (one meta-regression, one underpowered randomized controlled study, one retrospective study and one meta-analysis of small randomized studies) and there is need for a large multicentre randomized controlled study to confirm these findings, as suggested by the international consensus conference on this topic published in 2011 (Landoni et al 2011).

The purpose is to provide a large multicentre controlled randomized trial to demonstrate that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass).

The results of this study can support the use of volatile agents in all CABG procedures worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be reduced from 3% to 2% using volatile agents).


Options:
A: Total Number of Days in Hospital (Within 60 days of randomization)
B: composite of post-operative all-cause mortality and major complications (participants will be followed for the duration of hospital stay after the index cardiac operation, an expected average of 2 weeks)
C: mortality (1 year)
D: 90-day mortality (90 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Brief Summary: The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.


Options:
A: Quality of Life (1-year post treatment)
B: Overall survival (5 years)
C: Overall Survival (OS) (From date of randomization to date of death (Up to approximately 18 months))
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Cognitive Remediation Outcomes in Schizophrenia
Brief Summary: The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.


Options:
A: Change from Baseline Social Cognition at 6 months (Baseline (Intake)/6 months follow-up after trianing completion)
B: Cognitive performance as measured by a neuropsychological battery (Measured at Weeks 8, 14, and 8 and Month 6 follow-up)
C: Cognitive Function Measured by MCCB Composite Score (4-6 month period); Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale (4-6 month period)
D: Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score) (At 6 weeks and At 12 weeks); Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure) (At 6 weeks and At 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study MEA117106: Mepolizumab vs. Placebo as add-on Treatment for Frequently Exacerbating COPD Patients
Brief Summary: This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection.

In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy.

Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.


Options:
A: Rate of Moderate or Severe Exacerbations (From randomization to Week 52)
B: Percentage decrease of sputum eosinophils from baseline (6 months)
C: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)
D: Rate of Moderate or Severe Exacerbations in Participants in the High Stratum (From randomization to Week 52); Rate of Moderate or Severe Exacerbations in the mITT Population (From randomization to Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study MEA117113: Mepolizumab vs. Placebo as Add-on Treatment for Frequently Exacerbating COPD Patients Characterized by Eosinophil Level
Brief Summary: This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.


Options:
A: Rate of Moderate or Severe Exacerbations (From randomization to Week 52)
B: Percentage decrease of sputum eosinophils from baseline (6 months)
C: Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL (Immediately following the first IP dose through week 56)
D: Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) (Day 1 up to 393)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) 100/25 mcg Once Daily Compared With Vilanterol Inhalation Powder (VI) 25 mcg Once Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second \[FEV1\]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.


Options:
A: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal)
D: Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 (Baseline to Day 84)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy
Brief Summary: The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines


Options:
A: Home Record: Severity of Delayed Nausea (average of day 1 afternoon, evening and night, and all of days 2 and 3)
B: Delayed Phase Complete Response (CR) Rate (24 - 120 Hours)
C: Patient vomiting
D: No Emetic Episodes and No Rescue Medication (>24 to 120 hours post chemotherapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
B: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)
D: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
C: Number of Participants With a Quit Attempt (6 months)
D: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
B: Change in Carbon Monoxide Level (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week); Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL (Baseline, 4 week, 8 week, 13 week, 26 week); Change in the use of e-cigarettes (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week)
C: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
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: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Percent Treatment Sessions Attended (52 weeks)
B: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: Primary efficacy and Safety endpoint: (within 12 month from enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
B: Smoking Behavior (Nine weeks)
C: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
D: Primary efficacy and Safety endpoint: (within 12 month from enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
B: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
C: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
D: Tobacco use abstinence (26 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Continuous abstinence Weeks 13 -24.
B: 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).)
C: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
D: Primary efficacy and Safety endpoint: (within 12 month from enrollment)

Answer: D