TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation
Brief Summary: The recent Surgeon General's Report calls for effective and readily available treatment approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for connecting adolescent smokers with smoking cessation assistance. This study will adapt the Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps teens stop smoking compared to another teen smoking cessation app that does not include mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen would be relatively easy to disseminate widely and have tremendous public health significance


Options:
A: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
B: 30-day point prevalence abstinence (12 month post randomization)
C: Smoking Abstinence (End of Treatment (8 weeks))
D: Feasibility of study recruitment into the three interventions (Baseline); Feasibility of retention of participants at 3-month follow-up (3-month follow-up); Feasibility of retention of participants at 6-month follow-up (6-month follow-up); Acceptability of the three interventions (3-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Double-blind, Randomized Study to Evaluate a Single Shot Adductor Canal Nerve Block Versus Femoral Nerve Block Combined With LIA (Local Infiltration Analgesia): Early Postoperative Period Functional Outcomes After Total Knee Replacement
Brief Summary: The purpose of this study is to determine if patients undergoing a Total Knee Arthroplasty who receive a single shot Adductor Canal nerve block and local infiltration will have improved functional outcomes compared to individuals who receive a femoral nerve block and local infiltration during the first 24 hours post surgery.


Options:
A: Change i muscle strength of the quadriceps muscle, after the blockade (0 and 120 minutes)
B: Changes in Visual pain scale (Changes from the baseline visual pain scale to 1 week after surgery)
C: Quadriceps muscle strength (MVIC) difference between the ACB and FNB after total knee arthroplasty. (Baseline, 6, 24, 48 hours and at 6 month after nerve block performance)
D: Pain scores (3 days postoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain. Randomised, Single Blinded Clinical Trial
Brief Summary: Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the dimminution of pain of patients


Options:
A: Immediate reduction in pain intensity (at ED discharge (within 3 hours from ED admission))
B: Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks) (pretreatment, postreatment and follow-up(15 days))
C: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)
D: electromyographic activity (1 Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
Brief Summary: The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based cardiac rehabilitation facility. Patients can wait for elective heart surgery for as long as 3-4 months. During this time, individuals are often fearful of making things worse, causing them to stop being active and further deteriorate their physical condition. This wait period presents a potential opportunity for health care providers to engage the patient to take control of their self-managed care prior to surgery with the intent of improving post-surgical outcomes. Patients randomized to the PREHAB intervention group will participate in supervised exercise twice per week in a program designed to improve physical functioning and exercise capacity. The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and improve overall quality of life.


Options:
A: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))
B: Glucometabolic state (12 months); Atherosclerosis (12 months)
C: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)
D: Controlled Blood pressure (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
Brief Summary: The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based cardiac rehabilitation facility. Patients can wait for elective heart surgery for as long as 3-4 months. During this time, individuals are often fearful of making things worse, causing them to stop being active and further deteriorate their physical condition. This wait period presents a potential opportunity for health care providers to engage the patient to take control of their self-managed care prior to surgery with the intent of improving post-surgical outcomes. Patients randomized to the PREHAB intervention group will participate in supervised exercise twice per week in a program designed to improve physical functioning and exercise capacity. The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and improve overall quality of life.


Options:
A: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))
B: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)
C: coronary collateral blod flow (4 weeks)
D: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study
Brief Summary: The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.


Options:
A: Change from baseline of the best corrected visual acuity at 100% contrast (Baseline, 6 months)
B: Brain Atrophy by MRI (% change brain volume from baseline to year 2)
C: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
D: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking
Brief Summary: The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to standard care smoking cessation counseling (control group) in a sample of low-income sedentary male and female smokers. The study will also test the hypothesis that the participants randomized to the LMPA intervention will have greater quit rates at one-week and one-month post quit day follow ups.


Options:
A: smoking cessation (12 months)
B: Depression Score (6 months); Abstinent From Smoking (6 months); Days Walk Per Week (6 months); Minutes Per Week of Moderate Physical Activity (6 months); Minutes Per Week of Vigorous Physical Activity (6 months)
C: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
D: Smoking Cue Reactivity on Quit Day (4-weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking
Brief Summary: The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to standard care smoking cessation counseling (control group) in a sample of low-income sedentary male and female smokers. The study will also test the hypothesis that the participants randomized to the LMPA intervention will have greater quit rates at one-week and one-month post quit day follow ups.


Options:
A: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)
B: Quit line re-enrollment (At 6 months)
C: Smoking Cue Reactivity on Quit Day (4-weeks)
D: Tobacco Abstinence - 6 Month Follow-up (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study in Older Subjects to Assess Safety and the Reversal of Rivaroxaban Anticoagulation With Intravenously Administered Andexanet Alpha
Brief Summary: The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.


Options:
A: Graft patency (28 days)
B: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II) (Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II))
C: Symptomatic recurrent PE/DVT during the 6-month study treatment period.
D: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II) (Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)
Brief Summary: In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel or carboplatin + pemetrexed for 4 to 6 21-day cycles). Participants in the platinum-based chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance therapy after the 4 to 6 cycles of chemotherapy. The primary study hypothesis is that pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy.


Options:
A: Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% (Up to approximately 44 months)
B: Number of subjects reporting adverse events (Screening through 90 days after the last dose of study medication); Objective response (At least 24 weeks as compared to baseline); Number of subjects experiencing dose-limiting toxicities (DLTs) (Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab)
C: Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants Who Experienced Selected Adverse Events (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months))
D: Overall Survival (OS) in the TC3 or IC3-WT Populations (From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)); Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations (From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)
Brief Summary: In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel or carboplatin + pemetrexed for 4 to 6 21-day cycles). Participants in the platinum-based chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance therapy after the 4 to 6 cycles of chemotherapy. The primary study hypothesis is that pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy.


Options:
A: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
B: Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% (Up to approximately 44 months)
C: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Brief Summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.


Options:
A: Percentage of Participants Experiencing Treatment Emergent Adverse Events (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline (Baseline; Days 4, 5, 6, 7, 8, 10, and 17)
B: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)
C: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
D: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Brief Summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.


Options:
A: Sustained virological response (SVR) (24 weeks post treatment end (ie weeks 48 or 72))
B: 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)
C: Percentage of Participants Experiencing Treatment Emergent Adverse Events (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline (Baseline; Days 4, 5, 6, 7, 8, 10, and 17)
D: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)

Answer: D