TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia
Brief Summary: The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting.


Options:
A: Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) (Day 1 to Day 210); The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy) (Day 1 to Day 210)
B: short- and long-term medication and treatment prescribed by physicians in real-life setting (up to 3 years)
C: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
D: Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Illness Management and Recovery (IMR) in Danish Community Mental Health Centres: Protocol of a Randomized, Assessor-blinded Multi-centre Clinical Trial of a Recovery-oriented Program for People with Schizophrenia or Bipolar Disorder
Brief Summary: The aim of this trial is to evaluate the effectiveness of the Illness Management and Recovery program for people diagnosed with schizophrenia or bipolar disorder in according to their level of functioning.


Options:
A: Substance use and function questionnaire (2 years)
B: longest continuous period of cocaine abstinence (Week 8)
C: Global Assessment of Function (9 months and 21 months)
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Primary-school-based Study to Reduce Prevalence of Childhood Obesity in Terres de l'Ebre (Catalunya (Spain) - EDAL-Educació en Estils Saludables de Vida alimentació-2: Study Protocol for a Randomized Controlled Trial
Brief Summary: Our hypothesis is that a regular systematic educational intervention in primary school improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate the effects of a 3-year school-based program of lifestyle improvement, including diet and physical activity, implemented by university students acting as "health promoting agents" (HPA) on the prevalence of obesity.


Options:
A: Reduction in prevalence of obesity (Changes from baseline in prevalence of obesity at 3 academic years)
B: Blood pressure (6 months)
C: changes in body mass index throughout the intervention
D: Body Mass Index (BMI)-for-age percentile (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanisms of Specific Trunk Exercises in Low Back Pain
Brief Summary: The research objective is to determine which physical therapy (PT) treatment is the most efficacious for patients with lower back pain (LBP), who have been subgrouped based on certain clinical features. There is only limited evidence that supports any one PT treatment for patients with LBP since PT treatment outcomes for exercise protocols are equivocal, given the heterogeneous clinical features of patients with LBP. Thus, classification of patients with LBP into subgroups with shared clinical features has been identified as a research priority by several groups in order to prescribe the most efficacious PT treatment for each homogeneous subgroup. The investigators hypothesize that particular PT treatments are most efficacious when applied to patients with LBP, who present with particular clinical and neuromuscular features.


Options:
A: Change From Baseline in Oswestry Disability Scale (0-100%) (Baseline and 7 weeks); Change From Baseline in Oswestry Disability Scale (0-100%) (Baseline and 12 Months); Change From Baseline in Numeric Pain Rating Scale (0-10 Points) (Baseline and 7 weeks); Change From Baseline in Numeric Pain Rating Scale (0-10 Points) (Baseline and 12 months)
B: Five Times Sit-to-stand (5XSTS) (Change from Baseline sit-to-stand at 3 and 6 months)
C: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
D: Change in pain Intensity (Baseline and 6 weeks after beginning treatment.); Change in functional disability (Baseline and 6 weeks after beginning treatment.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis
Brief Summary: This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.


Options:
A: N/A
B: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
C: The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis
Brief Summary: This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.


Options:
A: Modified Total Sharp Score (mTSS) at Month 6 (Month 6); Change From Baseline at Month 6 in mTSS (Month 6); Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 (Month 6); Absolute Blood Pressure (BP) Values (mmHg) (Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24); Change From Baseline in BP Values (mmHg) (Months 1, 2, 3, 6, 9, 12, 15, 18, and 24)
B: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 (Day 169); Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population (Days 85, and 169 and postvisits on Days 28, 56, and 85)
C: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis
Brief Summary: This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.


Options:
A: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
B: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
C: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)
D: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis
Brief Summary: This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.


Options:
A: Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline to Week 12); Part B: Percentage of Participants Achieving ACR20 Response at Week 24 (Baseline to Week 24); Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 (Baseline, Week 16); Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 (Baseline, Week 52)
B: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
C: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium Supplementation for a Healthy Weight (CaSHeW)
Brief Summary: The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D) supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese adults.


Options:
A: Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT)) (Baseline and 12 months)
B: Change in body weight (Baseline and 16 weeks)
C: Chang in Disposition Index, a Measure of Beta Cell Function (baseline and 4 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
Brief Summary: The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.


Options:
A: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)
B: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
C: Number of Participants With Cotinine-Validated Abstinence From Smoking (12 months)
D: Quit line re-enrollment (At 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
Brief Summary: The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.


Options:
A: smoking cessation (6-months)
B: 24-hour Point-prevalence tobacco abstinence (3 months)
C: Three month point-prevalence abstinence from cigarettes (3 months post-intervention)
D: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
Brief Summary: The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.


Options:
A: A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up); A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up)
B: Quit Attempt(s) (Any time within 26 weeks)
C: Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks (Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period)
D: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.
Brief Summary: The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.


Options:
A: smoking cessation (6-months)
B: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)
C: smoking abstinence: self reported abstinence (12 or more months) (12 months)
D: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS.

This study consists of 2 steps. First step is a safety study of the intrathecal(IT) injection of "HYNR-CS inj" in 8 patients with ALS. In this phase 1 study, AE, laboratory test, physical examination, vital signs, Electrocardiogram, and Chest X-Ray examination were evaluated in terms of safety.

Second step is to compare the efficacy and safety between test group and control group of total 64 patients with ALS.


Options:
A: The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Between Treatment Groups and Control Groups. (baseline(Visit 5) and week 16(Visit 9))
B: Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months); Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months)
C: Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis (One year for the first phase; 4 years for the extension phase)
D: Fever (48hours); Unconscious (48hours); Vomiting (48hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Roll Out of the Xpert MTB/Rif for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil: a Stepped Wedge Trial
Brief Summary: Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat TB. The test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. The aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.


Options:
A: Rates of TB treatment initiation (48 hours)
B: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))
C: Time to TB treatment initiation (8 weeks follow up)
D: Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. (week 0); Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. (week 0); Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. (week 0)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Roll Out of the Xpert MTB/Rif for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil: a Stepped Wedge Trial
Brief Summary: Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat TB. The test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. The aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.


Options:
A: Time-to-treatment initiation (Up to 48 days after enrollment)
B: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))
C: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)
D: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Roll Out of the Xpert MTB/Rif for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil: a Stepped Wedge Trial
Brief Summary: Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat TB. The test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. The aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.


Options:
A: All-cause Mortality (6 months post-HAART initiation)
B: All-cause mortality 12 weeks after inclusion (12 weeks)
C: All-cause mortality and incidence of invasive bacterial infections (24 weeks)
D: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))

Answer: D