TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cognitive Group Treatment for Borderline Outpatients
Brief Summary: This study will expose patients to either a Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy for treating borderline personality disorder.


Options:
A: N/A
B: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
C: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6 (Baseline, Week 1, Week 2, Week 3, Week 4, Week 5)
D: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cognitive Group Treatment for Borderline Outpatients
Brief Summary: This study will expose patients to either a Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy for treating borderline personality disorder.


Options:
A: N/A
B: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
C: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
D: Rate of suicide attempts (Annual)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cognitive Group Treatment for Borderline Outpatients
Brief Summary: This study will expose patients to either a Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy for treating borderline personality disorder.


Options:
A: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
B: N/A
C: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
D: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cognitive Group Treatment for Borderline Outpatients
Brief Summary: This study will expose patients to either a Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy for treating borderline personality disorder.


Options:
A: N/A
B: Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 (The change from baseline at Week 10 in the total ZAN-BPD score was calculated using the MMRM model which is a longitudinal analyses and it incorporates ZAN-BPD measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.)
C: Suicide Attempts (Assessed bimonthly)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides
Brief Summary: RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.


Options:
A: Overall response rate (complete clinical response [CCR) and partial response [PR]) (35 months after first patient in)
B: Progression-free survival
C: Ratio of Response Rates Based on CAILS (Assessment made at Day 1 and every subsequent visit during treatment)
D: Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) (Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Yoga for Chronic Low Back Pain
Brief Summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.


Options:
A: Change in Oswestry Disability Index (ODI) (Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
B: N/A
C: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Yoga for Chronic Low Back Pain
Brief Summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.


Options:
A: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)
B: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
C: N/A
D: Back-related function (6 months); Pain (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Yoga for Chronic Low Back Pain
Brief Summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.


Options:
A: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
B: N/A
C: Back-related function (6 months); Pain (6 months)
D: Change from baseline in low back pain (Baseline, 6 weeks, 12 weeks, 24 weeks); Change from baseline in back-related function (Baseline, 6 weeks, 12 weeks, 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression
Brief Summary: A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder


Options:
A: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) (8 Weeks)
B: Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).; Modified Social Adjustment Scale (SAS II-B; Bauer, 2001); ***Note: all primary outcomes obtained prospectively every 3 months for 18 months
C: Time to Withdrawal From Study (Randomization to Study Withdrawal (up to Week 26))
D: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) (Eight weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Depression in Dementia Caregivers
Brief Summary: The purpose of this study was to develop and examine the initial impact of a distance-based intervention for female family dementia caregivers. As stated in the original proposal, the primary hypothesis of the study was that family caregivers who participated in the Video Intervention would show greater reduction in psychological distress (i.e., on measures of depression and emotional distress following problematic patient behaviors) compared to those in the Basic Education condition, and that this effect would be maintained over time (3 and 6 months post-tx).


Options:
A: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention); Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Post-intervention, assessed 4-14 days after final intervention session.)
B: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)
C: Parental Self-Efficacy (baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge)
D: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Brief Summary: This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.


Options:
A: NIH-CPSI total score and change from baseline (baseline, week 1-8)
B: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
C: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
D: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Brief Summary: This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.


Options:
A: NIH-CPSI score (12 weeks)
B: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score (6 weeks)
C: Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks (Baseline and 12 weeks)
D: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Brief Summary: This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.


Options:
A: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
B: NIH-CPSI total score and change from baseline (baseline, week 1-8)
C: Six point drop in NIH-CPSI total Score
D: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression
Brief Summary: This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.


Options:
A: Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial (Weeks 1 to 12)
B: The change in a measure of psychosis (screen, Days 0, 7, 14, 28, 42, 56)
C: Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56 (56 days)
D: The change in a measure of psychosis (screening and on Days 0, 7, 14, 28, 42, and 56)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clozapine Treatment of Schizophrenic Patients
Brief Summary: This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.


Options:
A: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. (Baseline to Week 6)
B: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
C: Positive Symptom Item Scores by Week and Treatment Group (Baseline and every two weeks for 16 weeks.)
D: Withdrawal from allocated treatment within 3 months.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #468 Phase I - A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson's Disease
Brief Summary: The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical therapy is more effective in improving Parkinson's disease symptoms


Options:
A: relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
B: Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group) (3 months)
C: Improvement in neck postures/movements; Improvement in quality of life
D: The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. (at six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Relaxation Response, Somatic Style and Rheumatoid Arthritis
Brief Summary: This study will evaluate the relative effectiveness of Relaxation Response (RR) training for the treatment of rheumatoid arthritis (RA). The study will compare RR training to RR training with cognitive behavioral therapy and to a standard RA education program.


Options:
A: Brief Pain Inventory-Intensity (BPI-Intensity) (Post-treatment (10-weeks) and follow-up (6 months))
B: Quality of life is measured with the FIQ and the EuroQol-5D. (1, 2, 6 and 12 months later)
C: Somatic symptoms as assessed by the Rheumatoid Arthritis Symptom Questionnaire (12 months)
D: Change in time spent awake during the night. (Change from baseline to the two study follow-ups (immediately and 3-months following treatment)); Change in mood. (Change from baseline to the two follow-up periods (immediately and 3-months following treatment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Single-Masked, Multicenter Study of the Safety, Tolerability, and Efficacy of Multiple-Dose Intravitreal Injections of rhuFab V2 in Combination With Verteporfin (Visudyne(R)) Photodynamic Therapy in Subjects With Neovascular Age Related Macular Degeneration
Brief Summary: The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.


Options:
A: N/A
B: N/A
C: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Single-Masked, Multicenter Study of the Safety, Tolerability, and Efficacy of Multiple-Dose Intravitreal Injections of rhuFab V2 in Combination With Verteporfin (Visudyne(R)) Photodynamic Therapy in Subjects With Neovascular Age Related Macular Degeneration
Brief Summary: The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.


Options:
A: Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses (Up to 4 months)
B: Change of visual acuity over time (12 months)
C: N/A
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Single-Masked, Multicenter Study of the Safety, Tolerability, and Efficacy of Multiple-Dose Intravitreal Injections of rhuFab V2 in Combination With Verteporfin (Visudyne(R)) Photodynamic Therapy in Subjects With Neovascular Age Related Macular Degeneration
Brief Summary: The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.


Options:
A: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
B: Change of visual acuity over time (12 months)
C: EDTRS visual acuity score (0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
B: Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (Baseline and at week 52)
C: N/A
D: Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (At week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: Change from baseline in the total area of the GA lesion(s) (24 months)
B: N/A
C: N/A
D: Change of geographic atrophy size to baseline (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: N/A
B: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: N/A
B: N/A
C: N/A
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) in Subjects With Minimally Classic or Occult Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.


Options:
A: Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) (Baseline, 6 Months)
B: N/A
C: The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit (Change from baseline to 12 months)
D: change in central retinal thickness (six months compared to baseline)

Answer: B