TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
C: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)
D: Annualized Relapse Rate (ARR) at 1 Year (1 Year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.


Options:
A: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
B: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)
C: Total Number of Gadolinium-Enhancing T1 Lesions (Week 12 to Week 24)
D: Annualized Relapse Rate (ARR) at 1 Year (1 Year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Mono-therapy in Patients With Visual Impairment Due to Diabetic Macular Edema
Brief Summary: CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema.

CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.


Options:
A: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 (Baseline through the end of study (Month 12))
B: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 (Baseline to 1-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Mono-therapy in Patients With Visual Impairment Due to Diabetic Macular Edema
Brief Summary: CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema.

CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.


Options:
A: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
B: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
C: Visual acuity; Central macular thickness
D: Change from Baseline in Visual Acuity (VA) to Month 12 (Baseline, Month 12); Change from Baseline in Visual Acuity (VA) to Month 24 (Baseline, Month 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Saving and Empowering Young Lives in Europe in Israel, Evaluation, Intervention and Prevention
Brief Summary: SEYLE is a health promoting program for adolescents in European schools. Its main objectives are to lead adolescents to better health through decreased risk-taking and suicidal behaviors, to evaluate outcomes of different preventive programs and to recommend effective culturally adjusted models for promoting health of adolescents in different European countries. Because of the significance of the SEYLE program and the importance of suicide research, Israel is honored to take part in this program and be a collaborator in it's implementation and research.


Options:
A: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
B: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
C: N/A
D: evaluate the efficacy of different preventive programs. (2012)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Study to Assess the Clinical Tolerability, Feasibility and Effectiveness Under Field Conditions of the Combination of Nifurtimox and Eflornithine (NECT) for the Treatment of T.b.Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Stage
Brief Summary: Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase.

Overall objectives:

Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the National HAT Control Programme, NGO treatment centers).

Primary objective:

* Assess the clinical response of the NECT co-administration under field conditions.

Secondary objectives:

* Assess the incidence and type of adverse events (AE), and the capacity of the treatment centers to deal with these.
* Assess the feasibility of the implementation of the NECT coadministration by the health center.
* Assess the effectiveness of the NECT co-administration at 24\* months after treatment.


Options:
A: Proportion of patients discharged alive from the hospital or the treatment center
B: success or failure at 18 months FU visit (18 months after treatment)
C: N/A
D: Outcome (success or failure) at the test of cure (ToC) visit 12 months after the end of treatment (EOT). (12 months after end of treatment (day 11))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
Brief Summary: Aims:

1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.
2. To determine the compliance and complications associated with both strategies.

Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).

Study groups:

* Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.
* Group II: colonoscopy.

Sample-size calculation: 27,749 subjects in each study group (total: 55,498).


Options:
A: Colorectal cancer-related mortality (10 years)
B: Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation (3 months)
C: Transfer of Skills to Clinical Colonoscopy (less than 2 weeks)
D: Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS) (4-6 weeks post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dental and Medical Office Internet/Intranet Motivational Enhancement Therapy to Reduce Teen Tobacco, Alcohol, and Drug Use
Brief Summary: The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.


Options:
A: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
B: efficacy of varied smoking cessation interventions (1 year)
C: Frequency of tobacco, alcohol, marijuana, and other drug use (3 months, 6 months)
D: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Prevalence of Low Back Symptoms in a Finnish Forestry Company - Effectiveness of Primary Care Interventions for Non-acute Low Back Symptoms in Occupational Health. Two Separate Randomised Controlled Trials (RCT) of Various Levels.
Brief Summary: The purpose of this study is:

* Epidemiological part: characteristics of low back pain patients from a forestry company in Finland. Data is collected from occupational health databases and self administered questionnaires.
* Intervention: To determine the effectiveness and cost-effectiveness of several different interventions in subacute low back pain (LBP) patients in occupational health (OH).


Options:
A: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)
B: N/A
C: Change in pain Intensity (Baseline and 6 weeks after beginning treatment.); Change in functional disability (Baseline and 6 weeks after beginning treatment.)
D: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Prevalence of Low Back Symptoms in a Finnish Forestry Company - Effectiveness of Primary Care Interventions for Non-acute Low Back Symptoms in Occupational Health. Two Separate Randomised Controlled Trials (RCT) of Various Levels.
Brief Summary: The purpose of this study is:

* Epidemiological part: characteristics of low back pain patients from a forestry company in Finland. Data is collected from occupational health databases and self administered questionnaires.
* Intervention: To determine the effectiveness and cost-effectiveness of several different interventions in subacute low back pain (LBP) patients in occupational health (OH).


Options:
A: 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)
B: N/A
C: Intensity of pain, measured at baseline, 90, and 180 days later (6 months); Disability, measured at baseline, 90, and 180 days later (6 months); Sick leave, measured at baseline, 90, and 180 days later (6 months)
D: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Corticoids in Severe Community-acquired Pneumonia
Brief Summary: The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.


Options:
A: Clinical efficacy at the end of treatment
B: Rate of non-response to empiric antimicrobial treatment (5 days)
C: length of hospital stay (30 days)
D: Time to clinical stability (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Corticoids in Severe Community-acquired Pneumonia
Brief Summary: The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.


Options:
A: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)
B: Rate of non-response to empiric antimicrobial treatment (5 days)
C: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
D: Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) (7 days postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Corticoids in Severe Community-acquired Pneumonia
Brief Summary: The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.


Options:
A: rate of hospital acquired pneumonia (day-28)
B: Septic shock (14 days)
C: mortality
D: Rate of non-response to empiric antimicrobial treatment (5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Corticoids in Severe Community-acquired Pneumonia
Brief Summary: The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.


Options:
A: Rate of non-response to empiric antimicrobial treatment (5 days)
B: In-hospital mortality (Day 180)
C: Time to clinical stability (30 days)
D: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Telehealth Care Management and Tobacco Cessation for Veterans With PTSD
Brief Summary: The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.


Options:
A: 7-day Point Prevalence Abstinence From Cigarettes (24 months)
B: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)
C: 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)
D: 7-day Point Prevalence Abstinence From Smoking (6 month)

Answer: C