TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
B: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)
C: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)
D: Acceptability of Lethal Means Decision Aid (Baseline); Decision Making Quality in Emergency Department (ED) (Baseline); Home Firearm Storage (Baseline and 1 week follow up); Decision Making Quality - Follow up (1 week follow up); Suicidal Ideation and Behavior at One Month (1 month post baseline); Suicidal Ideation and Behavior at Three Months (3 months post baseline); Vital Statistics (Suicide death) (3 months post baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
B: Changes in Beck Scale for Suicide Ideation (Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
C: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
D: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))
B: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
C: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
D: Functioning Assessment Scale Test (FAST) (up to three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). (weeks: 0, 2, 4, 6, 8, 10, 12); Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. (0, 6, 12)
B: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
C: Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score (Baseline (Day 0) to Week 10)
D: Parasuicidal behaviour (intermittent)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: Functioning (social and occupational) (baseline, 12-month)
B: 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))
C: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
D: USCD Performance-Based Skills Assessment (2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: AMOUNT OF EMPLOYMENT (24 months)
B: 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)
C: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
D: Number of relapses during intervention (During the entire 6 months study period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Trial of Post-Suicide Attempt Case Management for the Prevention of Further Attempts in Japan (ACTION-J)
Brief Summary: This study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts


Options:
A: Number of suicide reattempts in every group (6 months)
B: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
C: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
D: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
Brief Summary: To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease


Options:
A: Reduction in biochemical blood parameters (pro-inflammatory cytokines) (21 days)
B: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)
C: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)
D: Percentage of Participants With Mucosal Healing and No Deep Ulcerations (48 weeks after Randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
Brief Summary: To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease


Options:
A: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)
B: Percentage of Subjects Achieving Clinical Remission (Week 156)
C: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)
D: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
Brief Summary: To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease


Options:
A: Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time (Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408); Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time (Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408)
B: Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26 (Week 26)
C: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)
D: Induction of clinical remission (CDAI score < 150 at Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomised Phase II Trial on the Therapy of Advanced Gastric Cancer or Adenocarcinoma of the Esophagogastric Junction in Patients Older Than 65 Years With Specific Regard of Quality of Life and Pharmacogenetic Risk Profile
Brief Summary: In this trial, FLOT will be evaluated as therapy option for elderly patients (\>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.


Options:
A: median overall survival (2 years follow-up)
B: median survival
C: Overall Survival (OS) (Randomization up to 28 months post-randomization)
D: response (WHO criteria) (staging every 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomised Phase II Trial on the Therapy of Advanced Gastric Cancer or Adenocarcinoma of the Esophagogastric Junction in Patients Older Than 65 Years With Specific Regard of Quality of Life and Pharmacogenetic Risk Profile
Brief Summary: In this trial, FLOT will be evaluated as therapy option for elderly patients (\>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.


Options:
A: Progression-Free Survival (PFS) (Randomization to measured PD or date of death from any cause (up to Month 25.0))
B: Progression Free Survival (PFS) (5 years)
C: Overall Survival (OS) (From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months))
D: response (WHO criteria) (staging every 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomised Phase II Trial on the Therapy of Advanced Gastric Cancer or Adenocarcinoma of the Esophagogastric Junction in Patients Older Than 65 Years With Specific Regard of Quality of Life and Pharmacogenetic Risk Profile
Brief Summary: In this trial, FLOT will be evaluated as therapy option for elderly patients (\>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.


Options:
A: objective tumor response
B: overall survival
C: response (WHO criteria) (staging every 8 weeks)
D: Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma (Up to 2 years post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
Brief Summary: The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.


Options:
A: Target Lesion Primary Patency at 6 Months (6 months); Target Lesion Primary Patency at 12 Months (12 Months); Target Lesion Primary Patency at 24 Months (24 Months); Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure (30 days)
B: Incidence of PTE after thrombectomy of native and prosthetic AVFs. (The presence of PTE will be evaluated within 24 hours after treatment.); PTE resolution rate 1 month after thrombectomy of native and prosthetic AVFs. (The resolution of PTE will be evaluated 1-month after the treatment)
C: Primary patency of arterial-venous graft (time from initial thrombectomy to next graft intervention either: angioplasty, thrombectomy or surgical revision) (time from initial thrombectomy to next graft intervention)
D: Technical success (1 minute after the final balloon angioplasty); Primary patency (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.
Brief Summary: The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.

Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.


Options:
A: Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1 (12 weeks)
B: Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal (7, 14, 21, 28, 56 days)
C: Number of Participants Who Achieved Clinical Remission at Day 56 (Baseline up to Day 56)
D: Rate of clinical remission

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.
Brief Summary: The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.

Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.


Options:
A: Clinical and Endoscopic Remission. (8 weeks)
B: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))
C: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
D: Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1 (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sleep Apnea cardioVascular Endpoints Study - Investigating the Effectiveness of Treatment With CPAP vs Standard Care in Reducing CV Morbidity and Mortality in Patients With Co-existing CV Disease and Moderate-severe Obstructive Sleep Apnea.
Brief Summary: Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times during sleep. It is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA.


Options:
A: A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. (Reviewed 6-monthly; average patient follow up, 4.5 years)
B: Effect of intensive intervention on CPAP adherence (24 months)
C: Differences in compliance among the three different strategies, measured by CPAP hours of use (six months follow-up)
D: Average hours of CPAP use per night: experimental pathway vs. traditional pathway (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sleep Apnea cardioVascular Endpoints Study - Investigating the Effectiveness of Treatment With CPAP vs Standard Care in Reducing CV Morbidity and Mortality in Patients With Co-existing CV Disease and Moderate-severe Obstructive Sleep Apnea.
Brief Summary: Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times during sleep. It is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA.


Options:
A: Sympathetic tone (MSNA) (Change from baseline after one month of intervention)
B: subjective sleepiness and other OSAS symptoms (3 months, 1 year, 2 years); quality of life (3 months, 1 year, 2 years); percentage of withdrawal and cross-over to other CPAP mode (3 months, 1 year, 2 years); objective vigilance (3 months, 1 year, 2 years); blood pressure (3 months, 1 year, 2 years); cost/utility ratios (3 months, 1 year, 2 years)
C: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)
D: A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. (Reviewed 6-monthly; average patient follow up, 4.5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 2 Year Prospective, Multicentre, Open-label, Randomised, Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen.
Brief Summary: The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.


Options:
A: N/A
B: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 (Baseline and month 12)
C: Correction of metabolic acidosis (12 months)
D: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks

Answer: A