TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #481 - The Home INR Study (THINRS)
Brief Summary: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.


Options:
A: Adherence to OAC therapy (One year)
B: Framingham Risk Score (15 months)
C: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire (Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up))
D: Time to First Event (Death, Stroke, Major Bleed) (Time to event)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #481 - The Home INR Study (THINRS)
Brief Summary: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.


Options:
A: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
B: Time to First Event (Death, Stroke, Major Bleed) (Time to event)
C: Self-Reported Medication Adherence (2 & 4 weeks post discharge)
D: Anticoagulation-related quality of life (Four months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #481 - The Home INR Study (THINRS)
Brief Summary: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.


Options:
A: Proportion of INR values which are in therapeutic range
B: Percentage of Patients With Any Adverse Event (AE) (From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))
C: Mean Percentage of Time in Therapeutic Range (baseline to 3 months)
D: Time to First Event (Death, Stroke, Major Bleed) (Time to event)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)
Brief Summary: The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison therapy that focuses on current problems, Present Centered Therapy.

The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even self-referrals, will enter the study through referrals by mental health clinicians at the participating sites. Following informed consent, subjects will be screened for inclusion and exclusion diagnoses. If they meet these criteria and agree to participate, they will be randomly assigned to one of the two treatments, which will occur weekly for 10 weeks. Subjects will be assessed before treatment, immediately following treatment, and 3 and 6 months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as dissociation and substance abuse; psychosocial functioning, quality of life, physical health, satisfaction with treatment, and service utilization. Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly.


Options:
A: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (12 months)
B: Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); baseline to 2 months post-treatment.); PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version] (Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.)
C: PTSD Checklist (PCL) (Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment)
D: summing totals of 17 DSM-IV symptoms (10 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)
Brief Summary: The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison therapy that focuses on current problems, Present Centered Therapy.

The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even self-referrals, will enter the study through referrals by mental health clinicians at the participating sites. Following informed consent, subjects will be screened for inclusion and exclusion diagnoses. If they meet these criteria and agree to participate, they will be randomly assigned to one of the two treatments, which will occur weekly for 10 weeks. Subjects will be assessed before treatment, immediately following treatment, and 3 and 6 months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as dissociation and substance abuse; psychosocial functioning, quality of life, physical health, satisfaction with treatment, and service utilization. Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: summing totals of 17 DSM-IV symptoms (10 weeks)
C: Depression symptoms; measured immediately post-treatment and 6 months post-treatment; Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment
D: PTSD Symptoms (90 Days, 180 days); HIV Medication Adherence (% Adherent) (180 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)
Brief Summary: The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison therapy that focuses on current problems, Present Centered Therapy.

The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even self-referrals, will enter the study through referrals by mental health clinicians at the participating sites. Following informed consent, subjects will be screened for inclusion and exclusion diagnoses. If they meet these criteria and agree to participate, they will be randomly assigned to one of the two treatments, which will occur weekly for 10 weeks. Subjects will be assessed before treatment, immediately following treatment, and 3 and 6 months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as dissociation and substance abuse; psychosocial functioning, quality of life, physical health, satisfaction with treatment, and service utilization. Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly.


Options:
A: outcome (within study timeframe)
B: Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up (Baseline to 2 months post second experimental session)
C: summing totals of 17 DSM-IV symptoms (10 weeks)
D: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Options:
A: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
B: N/A
C: Number of Participants With Adverse Events (AEs) (From Day 1 to Day 637); Number of Participants With Clinically Significant Laboratory Findings (through Day 637); Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML) (through Day 637); Number of Participants With Human Anti-human Antibodies (HAHA) (Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Options:
A: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
B: N/A
C: N/A
D: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderately to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Options:
A: N/A
B: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
C: N/A
D: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderately to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Options:
A: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
B: Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks (12 weeks)
C: N/A
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
Brief Summary: This study will determine whether glucosamine, chondroitin sulfate and/or the combination of glucosamine and chondroitin sulfate are more effective than placebo and whether the combination is more effective than glucosamine or chondroitin sulfate alone in the treatment of knee pain associated with osteoarthritis (OA) of the knee after six months of follow-up. These substances, marketed in the United States as dietary supplements, have been widely touted by the lay press and by anecdotal personal experience as effective in treating OA. To date, however, only a few small studies have been published in the worldwide literature. The study proposed herein has been carefully constructed to definitively determine the efficacy of these agents.


Options:
A: N/A
B: Average Daily Pain Scores - BS11 Pain Scores. (every day over a 12 week study duration.)
C: Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12 (Baseline, Week 12); Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12 (Baseline, Week 12); Change From Baseline in Knee Adduction Moment at Week 12 (Baseline, Week 12); Change From Baseline in Quadriceps Inhibition at Week 12 (Baseline, Week 12); Change From Baseline in Peak Ground Reaction Force at Week 12 (Baseline, Week 12); Change From Baseline in Total Ground Reaction Force at Week 12 (Baseline, Week 12); Change From Baseline in Stride Length at Week 12 (Baseline, Week 12); Change From Baseline in Walking Speed at Week 12 (Baseline, Week 12); Change From Baseline in Cadence at Week 12 (Baseline, Week 12); Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12 (Baseline, Week 12)
D: 5-Day Sum of Pain Intensity Difference (SPID5) (Day 1 to Day 5); Spontaneous Bowel Movements Per Week (SBMs/Week) (Week 1 to Week 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
Brief Summary: This study will determine whether glucosamine, chondroitin sulfate and/or the combination of glucosamine and chondroitin sulfate are more effective than placebo and whether the combination is more effective than glucosamine or chondroitin sulfate alone in the treatment of knee pain associated with osteoarthritis (OA) of the knee after six months of follow-up. These substances, marketed in the United States as dietary supplements, have been widely touted by the lay press and by anecdotal personal experience as effective in treating OA. To date, however, only a few small studies have been published in the worldwide literature. The study proposed herein has been carefully constructed to definitively determine the efficacy of these agents.


Options:
A: N/A
B: Functional Capacity (14 weeks)
C: Lequesne Index
D: Huskisson Visual Analogue Scale (Monthly); Psoriasis Area and Severity Index (Monthly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Brief Summary: RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.

PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.


Options:
A: Prevention in relapse (Up to 6 months)
B: 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)
C: 7-day point prevalence abstinence measured at 6 months (6 months)
D: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Brief Summary: RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.

PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.


Options:
A: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
B: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: 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
D: Prevention in relapse (Up to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Brief Summary: RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.

PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.


Options:
A: Prevention in relapse (Up to 6 months)
B: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
C: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
D: N/A

Answer: A