TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: VRC 307: A D/B Randomized Ph. I Study of Safety/Immunogenicity of a Prime-Boost Schedule of an Investigational DNA Influenza Vaccine, Followed by the Seasonal Influenza Trivalent Inactivated Vaccine (TIV), Compared to TIV Alone in Healthy Adults
Brief Summary: Objectives:

* To evaluate the safety and tolerability of a prime-boost study regimen that includes the recombinant DNA vaccine followed by licensed 2008/2009 FluLaval(Registered Trademark) in adults ages 18-50 years and adults ages 51-70 years as compared with control groups that receive the licensed vaccine only.
* To evaluate whether the study participants in each age group receiving a prime-boost schedule have a greater frequency of H1 or H3 neutralizing antibodies compared with those of the same age group who received only the 2008/2009 trivalent influenza vaccine.
* To evaluate differences in antibody or T cell responses (quantity, quality, or durability) between the two groups.

Eligibility:

* Participants ages 18 to 70 years of age who are available for clinic follow-up through Week 24 and who have no previously undiagnosed clinically significant chronic diseases. Participants will provide blood samples for further testing to determine eligibility. Females must not be or become pregnant during the study.
* Volunteers who have been immunized with the current season FDA-approved influenza vaccine (2008-2009), or who are being treated for tuberculosis may not participate.

Design:

* The study lasts for 24 weeks.
* Week 0: The first day of Week 0 (i.e., Day 0) is defined as the day of enrollment and first injection. Specific eligibility is reviewed. Participants will receive an injection of either the DNA vaccine VRC-FLUDNA047-00-VP (at 4 mg dosage) or a placebo.
* Week 4: All study participants will receive an injection of the trivalent seasonal influenza vaccine, according to the manufacturer's package insert directions.
* Participants will be given 7-day diary cards on which to record temperature and symptoms (e.g., muscle aches, headache, chills, nausea) and injection site reactions (e.g., pain, tenderness). Participants may also enter this information via the Internet. Presence of symptoms may require additional visits to the clinic.
* Participants will return to the clinic 2 weeks after each injection for the following procedures:
* Blood draws for further tests to determine the immune system's response to the vaccine(s) Clinical evaluations: vital signs and weight, examinations of the lymph nodes, and targeted physical exam on any visit if indicated by interim complaints or laboratory findings.


Options:
A: safety (local and systemic reactogenicity, lab tests, AEs)
B: Patients' knowledge about clinical trials measured by the questionnaire Quality of Informed Consent (The questionnaire is sent to patients within a week after consenting to the trial.)
C: N/A
D: total communication score (2 weeks after information was given)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)
Brief Summary: This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.


Options:
A: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)
B: Percentage of Participants in Remission at Week 28 (Week 28); Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2) (Week 28)
C: Percentage of Participant Who Were Non-Failures (Week 48)
D: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring (Week 104 in RA0055 Period 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Impact of Oral Sirolimus on Restenosis Prevention in Patients With In-Stent Restenosis.
Brief Summary: Despite recent advances in interventional cardiology including the success of drug-eluting stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a challenging clinical issue. Given the efficacy of the systemic sirolimus administration to prevent neointimal hyperplasia in animal models and to halt and even reverse the progression of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was to evaluate the efficacy of a 10-day oral sirolimus treatment with two different loading regimens for the prevention of recurrent restenosis in patients with in-stent restenosis.


Options:
A: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first
B: Reduction of LV dilation (six months versus baseline LV end-diastolic volume index by 2D-echocardiogram [echo]) more than 50% in the treated group in comparison to the placebo group (6 months)
C: biochemical markers of brain ischemia and intraoperative cerebral oxymetry data (September 2010)
D: Angiographic restenosis (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients Treated With Radiotherapy.
Brief Summary: The purpose of this study is to evaluate the effectiveness and feasibility of the Screening Inventory of Psychosocial Problems (SIPP) in consultation settings with respect to early recognition and treatment of psychosocial distress, communication between patients and physicians, and psychological distress and quality of life in cancer patients treated with radiotherapy (RT).


Options:
A: The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). (16 weeks)
B: Mental condition (from baseline until 6 months)
C: The primary effect outcome measurement is the number and type of referred patients with psychosocial problems to psychosocial caregivers and type of referrals with respect to psychosocial problems. (Is measured at three (T3) and twelve (T4) months after first measurement)
D: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Smoking Cessation in Heavy Drinking Smokers
Brief Summary: The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.


Options:
A: Continuous Nicotine Abstinence (8 weeks)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Smoking Cessation in Heavy Drinking Smokers
Brief Summary: The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.


Options:
A: 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))
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 Smoking Abstinence at Month 6 (Month 6)
D: Long term abstinence (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Smoking Cessation in Heavy Drinking Smokers
Brief Summary: The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.


Options:
A: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements
B: 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))
C: 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)
D: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Smoking Cessation in Heavy Drinking Smokers
Brief Summary: The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.


Options:
A: 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))
B: 7-day point prevalence abstinence measured at 6 months (6 months)
C: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Smoking Cessation in Heavy Drinking Smokers
Brief Summary: The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.


Options:
A: 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)
B: 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))
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: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Smoking Cessation in Heavy Drinking Smokers
Brief Summary: The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.


Options:
A: 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))
B: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
C: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
D: The primary outcome is prolonged abstinence at 7.5 months following intervention. (7.5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Smoking Cessation in Heavy Drinking Smokers
Brief Summary: The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.


Options:
A: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: 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))
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age
Brief Summary: The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.


Options:
A: The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. (Day 28-35)
B: The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms. (nine months)
C: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
D: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). (Days 1- 8); Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Brief Summary: The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.


Options:
A: Weight, length and Rohrer index at birth, and gestational duration in single pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
B: Birth Size (At birth); Gestational Age (At birth); Child growth (From birth through 24 months); Child development (Up to 7 years post enrollment); Weight-for-age Z score (WAZ) (Up to 7 years post enrollment); Height-for-age Z score (HAZ) (Up to 7 years post enrollment); Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ) (Up to 7 years post enrollment); Body composition (Lean mass/fat free mass index) (Up to 7 years post enrollment)
C: Infant Mortality Through 6 mo of Age (6-months post-birth)
D: Recurrence of cleft lip and palate (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Brief Summary: The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.


Options:
A: Infant Mortality Through 6 mo of Age (6-months post-birth)
B: blood arsenic concentrations (24 weeks)
C: Change of urine arsenic metabolites between baseline and week 8 (baseline, week 8)
D: Change in arsenic methylation (Up to 12 Weeks); Change in in blood arsenic (Up to 12 Weeks); Change in blood monomethyl arsenic (Up to 12 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Case Volume and Adenoma Detection Rates During Screening Colonoscopy
Brief Summary: Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate.


Options:
A: adenoma detection rate (number of polyps/number of patients examined) (6 months)
B: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
C: polyp detection rate (1 year)
D: Correlation of adenoma detection rate with case volume of endoscopists (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
Brief Summary: The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.


Options:
A: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (2 years)
B: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery (2 years)
C: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)
D: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit (1 year post operatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Veritas Collagen Matrix Cystocele Repair Study - Postmarketing Protocol #CP1004
Brief Summary: The purpose of this study is to evaluate the Veritas Collagen Matrix in treating female patients with documented occurence of Pelvic Organ Prolapse as evidenced by a cystocele.


Options:
A: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery (2 years)
B: Recurrence of anterior vaginal wall prolapse
C: Anatomic cure defined by standardized POPQ measures (12 months)
D: Recurrent Stage II or Greater Anterior Vaginal Prolapse (three years)

Answer: A