TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Well-being Among Veterans Enhancement Study (WAVES)
Brief Summary: In spite of the impact on veteran�s health status and treatment cost, depression is under-diagnosed and under-treated. The goal of this study is to learn how to implement a previously tested, effective collaborative care model for improving the quality of depression care across multiple Veterans Integrated Service Networks (VISNs). To achieve this goal, we are conducting a randomized controlled trial of evidence-based quality improvement (EBQI), a dissemination method that relies on expert design and local implementation of evidence-based practice interventions. We hypothesize that EBQI will result in increased rates of assessment and appropriate management of depression. Results will be useful in designing realistic chronic care programs and performance measures for continuing care improvement.


Options:
A: N/A
B: Hamilton Rating Scale for Depression (Screen, Week 9, 17, 24)
C: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
D: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Well-being Among Veterans Enhancement Study (WAVES)
Brief Summary: In spite of the impact on veteran�s health status and treatment cost, depression is under-diagnosed and under-treated. The goal of this study is to learn how to implement a previously tested, effective collaborative care model for improving the quality of depression care across multiple Veterans Integrated Service Networks (VISNs). To achieve this goal, we are conducting a randomized controlled trial of evidence-based quality improvement (EBQI), a dissemination method that relies on expert design and local implementation of evidence-based practice interventions. We hypothesize that EBQI will result in increased rates of assessment and appropriate management of depression. Results will be useful in designing realistic chronic care programs and performance measures for continuing care improvement.


Options:
A: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)
B: Processes of clinical care for diabetes; Cardiovascular risk as determined by UKPDS Risk; Metabolic outcomes (HgbA1c); Metabolic outcomes (LDL Cholesterol); Metabolic Outcomes (Systolic Blood Pressure)
C: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Diabetes Education and Case Management
Brief Summary: This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.


Options:
A: Change in HbA1c at 12 months (12 months)
B: Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
C: HbA1c (6 months)
D: Outcome and process measures from the danish diabetes guideline (1/3 2007-1/6 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Diabetes Education and Case Management
Brief Summary: This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.


Options:
A: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
B: Treatment Completion (13 weeks); PTSD Checklist-Military (PCL-M) (26 weeks); Beck Depression Inventory-II (BDI-II) (26 weeks)
C: The incidence and frequency of COPD exacerbations in each of the intervention groups (December 2008 to March 2009 inclusive); Electronic diary symptoms using the EXACT instrument (Daily recording)
D: Change in HbA1c at 12 months (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Diabetes Education and Case Management
Brief Summary: This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.


Options:
A: Change in HbA1c at 12 months (12 months)
B: Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 (Baseline, Month 12)
C: Program satisfaction, behavioral and emotional outcomes. (3, 6, 9, 12 months after implementation of intervention)
D: HbA1c (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Brief Summary: The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.


Options:
A: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)
B: Percentage of Participants With Depressive Recurrence After Time (t) in Days (Every Visit from Week 34 up to Week 86 (Maintenance Phase))
C: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)
D: Hamilton Rating Scale for Anxiety (Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Quality of End-of-Life Communication for Patients With COPD
Brief Summary: The purpose of this study is to evaluate a multifaceted intervention to improve the quality of end-of-life communication between patients with COPD and their primary care providers using information about patients preferences for end of life care and how to communicate and use this information to activate patients, family members, and healthcare providers.


Options:
A: Quality of Communication (QOC) scale (At 6 months)
B: Hospital Anxiety and Depression Scale (At 6 months)
C: The number of questions asked or the concerns expressed that elicit a medical comment by the patient or the family during the palliative care consultation. (one month)
D: Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale (Measured at enrollment and 2 weeks after targeted clinic visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
Brief Summary: This study will determine the impact of early intervention on the communication and social development of toddlers with autism.


Options:
A: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
B: Social network involvement of autistic children (Measured before and after treatment and at 3-month follow-up)
C: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
D: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
Brief Summary: This study will determine the impact of early intervention on the communication and social development of toddlers with autism.


Options:
A: Reduction in autism severity as measured by the Autism Diagnostic Observation Scale (ADOS) (1 year)
B: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
C: Number of words used spontaneously during language sample (3 months)
D: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
Brief Summary: This study will determine the impact of early intervention on the communication and social development of toddlers with autism.


Options:
A: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
B: N/A
C: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
D: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Functioning in Peripheral Arterial Disease
Brief Summary: The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.


Options:
A: maximal walking distance
B: Six-minute walk distance (Measured at baseline and follow-up study visits); Summary performance score (Measured at baseline and follow-up study visits)
C: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
D: Total Walking Distance (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Functioning in Peripheral Arterial Disease
Brief Summary: The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.


Options:
A: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
B: Quality of Life (1 year)
C: maximum walking distance (one year)
D: Six-minute walk distance (Measured at baseline and follow-up study visits); Summary performance score (Measured at baseline and follow-up study visits)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea
Brief Summary: Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks.


Options:
A: POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13. (Day 12/13); POC: Safety and tolerability of LFF571 (Day 12/13); POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2). (Day 12/13); Cohort 2: Clinical response rate (clinical cure) of LFF571 in patients with mild and moderate C. difficile infections to different LFF571 dose regimens and total daily doses administered orally for 10 days (Day 12/13); Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571 (Day 12/13); Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients. (Day 12/13)
B: Cure Rate at End of Therapy (Study day 10 (+/- 2 days))
C: Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) (Day 0 to Day 84)
D: Resolution of diarrhea

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
B: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
C: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
D: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
B: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
C: Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.
D: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
B: ASAS 40 at week 12
C: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
B: Percentage of patients with ACR 20 response (Week 24)
C: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
D: Percentage of patients with ACR 20 response (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
B: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
C: Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) (Day 1 of Period 1, Day 43 of Period 1)
D: Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. (30-week follow-up visit.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
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 Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)

Answer: B