TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: 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))
C: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
D: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
C: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
D: Number of Participants With Smoking Abstinence at Month 6 (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Continuous Nicotine Abstinence (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
B: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
C: Quit Rate (Study weeks 6 through 9)
D: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: Quit Rate (4 months)
B: 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))
C: Treatment Satisfaction (End of treatment (seven weeks after baseline))
D: Number of Participants With Smoking Abstinence at Month 6 (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
B: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
C: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
D: effectiveness (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: Tobacco use (Six-month follow-up)
B: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: Number of Participants With Smoking Abstinence at Month 6 (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: Continuous Nicotine Abstinence (8 weeks)
B: 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)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: Number of Participants With Smoking Abstinence at Month 6 (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: End-Stage Renal Disease Intra-dialysis Lifestyle Education Study
Brief Summary: The purpose of this study is to compare the effects of intra-dialysis yoga to an educational program among patients with end-stage renal disease. The investigators hypothesize that yoga as compared to the educational program will significantly improve quality of life.


Options:
A: Proportion of participants screened as eligible who enroll (34 months); Proportion of participants who enrolled who completed the 8 week-trial (34 months); Tolerability of Meditation Intervention on a 10-point Likert scale (8 weeks)
B: The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year. (Baseline, 6 months, 12 months)
C: Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks. (Baseline, 6 weeks, 12 weeks, and 24 weeks)
D: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Proximal Humerus Fractures Randomized Control Trial
Brief Summary: The primary objective is to determine if a difference exists in functional outcomes, as measured by the Constant score, when comparing nonoperative management and locking plate surgical fixation of low-energy displaced proximal humerus fractures in the elderly population over a 2-year follow-up period. Secondary outcomes will include an assessment of the ASES score, the SF-36 quality of life score, complication rates, re-operation rates, radiographic time to union, radiographic malunion, hardware position and evidence of avascular necrosis or posttraumatic osteoarthritis .


Options:
A: Disabilities of the Shoulder, Arm and Hand-Score (DASH) (24 months)
B: Change in Constant Score (From baseline to up until 24-Months Post-Operative)
C: Constant Shoulder Score (5 years)
D: Change in disability of the arm, shoulder and hand (DASH) (DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
Brief Summary: To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from growth restriction to support its use later as prolonged therapy in those pregnancies at higher risk for such complication.


Options:
A: compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups (6 weeks after postpartum)
B: Number of participants who develop intrauterine/fetal growth restriction or perinatal death. (19 weeks of pregnancy - seventh day of life)
C: The principal outcome is birth weight at delivery and neonatal morbidity (Crib Score) (6 weeks)
D: improvement of the Doppler indices following treatment (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group
Brief Summary: This study will assess whether post-surgery therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA \[\> 1 mm metastasis\], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death-ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo as post-surgery therapy in Part 1. In Part 2, participants who experience a disease recurrence are eligible for pembrolizumab treatment (if treated with placebo in Part 1) or pembrolizumab rechallenge (if treated with pembrolizumab in Part 1). Participants deriving benefit from pembrolizumab will be given the opportunity to transfer to a pembrolizumab extension study, if available, upon study closure, and will be monitored following the standard of assessments of the pembrolizumab extension study.


Options:
A: Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants (6 months); Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression (6 months)
B: Arm C: Number of Participants With the Pathologic Response Rate (up to 2 years)
C: Safety as measured by the frequency of grade 3/4 immune-related adverse events, using CTCAE 4.03 (During the first 12 weeks.); Response rate according to RECIST 1.1 (At 6 weeks); Pathological response according to central pathological revision, according to pathological response criteria (At 6 weeks); Pathologic response rate according to central revision of the marked index lymph node (At 6 weeks, prior surgery); RFS at 24 months in patients achieving pCR or pnCR in their marked index lymph node and did not undergo CLND. RFS will be calculated from date of resection of the marked lymph node. (24 months); RFS at 24 months in patients with pNR and being subsequently treated with adjuvant nivolumab+optional radiotherapy (or dabrafenib/trametinib if BRAFV600E pos. and treatment is approved). RFS will be calculated from day of resection of marked lymph node. (24 months)
D: Recurrence Free Survival (RFS) (From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group
Brief Summary: This study will assess whether post-surgery therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA \[\> 1 mm metastasis\], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death-ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo as post-surgery therapy in Part 1. In Part 2, participants who experience a disease recurrence are eligible for pembrolizumab treatment (if treated with placebo in Part 1) or pembrolizumab rechallenge (if treated with pembrolizumab in Part 1). Participants deriving benefit from pembrolizumab will be given the opportunity to transfer to a pembrolizumab extension study, if available, upon study closure, and will be monitored following the standard of assessments of the pembrolizumab extension study.


Options:
A: Recurrence-free Survival (RFS) (up to 36 months)
B: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
C: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
D: Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants (6 months); Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
Brief Summary: The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.


Options:
A: Safety Will be Evaluated by Number of AE (Total AEs and SAEs within 450 days post-infusion)
B: Heart Failure Mortality (5 years); Changes in Left Ventricular Ejection Fraction (5 years)
C: Number of Temporary Weans From LVAD Support Tolerated (up to 6 months); Number of Participants With Adverse Events (up to 6 months)
D: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (One month post-catheterization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Before and After Study to Measure the Effect of an Urban Sanitation Intervention on Child Health, in Low-income Neighborhoods of Maputo, Mozambique
Brief Summary: The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.


Options:
A: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
B: Diarrhoea (<5s) (21 months)
C: Combined prevalence of bacterial and protozoan enteric infections (12 month follow-up)
D: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Before and After Study to Measure the Effect of an Urban Sanitation Intervention on Child Health, in Low-income Neighborhoods of Maputo, Mozambique
Brief Summary: The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.


Options:
A: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
C: Diarrhea in Children Under 5 (one year after the intervention)
D: Combined prevalence of bacterial and protozoan enteric infections (12 month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Text Reminders Improve Uptake of Cervical Screening? A RCT.
Brief Summary: Cervical cancer is the most common cancer in women under 35 years and is a major public health concern. Fortunately, the natural history of this malignancy can be beneficially improved through cytological screening. However, the success of screening programmes depends on their ability to attract the "at risk" population, as well as the analytical sensitivity and specificity of the screening test. In the UK, screening consistently falls short of the 80% national target and recent evidence shows uptake is decreasing, in part due to the introduction of HPV vaccination programmes. In the under 30s London population, average coverage only reached 50% in 2013. Given this information, the cervical screening programme is under increasing pressure to improve uptake, and need an evidence based intervention.

We aim to improve the uptake of cervical screening using SMS messaging through a randomised controlled trial. The trail will evaluate both the prevalent and incident rounds of screening and within the intervention group, analyse how the content of text reminders influences their effectiveness. Specifically we will evaluate a) neutral b) messenger c) social norms d) framed gain/loss reminders. Unlike our previous trial, this SMS reminder will encourage the booking of an appointment which has never been tested, rather than simply reminding women to attend. All women being invited for cervical screening, registered at participating GPs within Hillingdon will be eligible to participate. Women will also be provided with a 2 week window during which they can opt out of the research. Given the sample sizes we predict the trial will take 9 months.


Options:
A: Intention to treat analysis (13 months)
B: Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery)
C: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)
D: Neonatal death (28 days)

Answer: A