TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Vocational Rehabilitation on Mentally III Veterans
Brief Summary: To study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).


Options:
A: UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) (3 months)
B: Functional Assessment Short Test (FAST) (Baseline); Functional Assessment Short Test (FAST) (6 months); Functional Assessment Short Test (FAST) (12 months)
C: Obtain Competitive Employment (1 calendar year)
D: Clinical, neuropsychological, and functional outcomes (Measured at Years 1 and 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.


Options:
A: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (36 months)
B: Time to first occurrence of uveitis in the study eye. (2 years)
C: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
D: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.


Options:
A: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)
B: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
C: Time to first occurrence of uveitis in the study eye. (2 years)
D: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.


Options:
A: Time to first occurrence of uveitis in the study eye. (2 years)
B: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
C: N/A
D: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy
Brief Summary: The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy


Options:
A: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (One month post-catheterization)
B: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (one month post-catheterization)
C: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) (One month post-catheterization)
D: increase of the ejection fraction of the left ventricle (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm) to Improve Glycemic Control Through Behavioral and Therapeutic Changes
Brief Summary: Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. Effective presentation and data analysis are essential. We examined HbA1c changes using the OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).


Options:
A: Hemoglobin A1c (HbA1c)
B: Blood Pressure and Hemaglobin A1c
C: Hemoglobin A1c
D: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline (Baseline (Day 1)); Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12 (Month 12)
B: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: Percentage of Participants With Less Than 11 Tender Points at Month 6 (Month 6); Percentage of Participants With Less Than 11 Tender Points at Month 12 (Month 12)
C: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
D: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 12, compared to baseline)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
C: Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) (Randomization to Week 19); Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event (Randomization to Week 19)
D: Pain score evaluation by NRS (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
B: Brief pain inventory (6 weeks)
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
B: Composite responder analysis based on pain and patient global status, with or without physical function.
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test (Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS); Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test (Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
C: Area of pin-prick hyperalgesia (Change from baseline visit to day 14 of treatment sessions); Area of touch-evoked allodynia (Change from baseline visit to day 14 of treatment sessions)
D: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
C: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
D: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
B: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
B: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
C: last observation carried forward (LOCF) mean change from baseline to week 8 on the Hamilton Depression Scale (HAM-D) total score. (8 weeks)
D: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Robotic Arm Rehabilitation in Stroke Patients
Brief Summary: The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.


Options:
A: Wolf Motor Function Test (8 Weeks)
B: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
C: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))
D: Fugl Mayer motor score for upper extremity (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Robotic Arm Rehabilitation in Stroke Patients
Brief Summary: The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.


Options:
A: Change from Baseline in Fugl-Meyer Scale at 28 weeks. (at inclusion, week 4 and week 28); Change from Baseline in Box and Block Test at 28 weeks. (at inclusion, week 4 and week 28.)
B: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
C: Wolf Motor Function Test (8 Weeks)
D: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study
Brief Summary: For schizophrenic patients who remained in remission while on maintenance medication, there may come a point in time when the relative risk for relapse become so low that discontinuation of therapy can be considered. This study is to investigate whether that point in time is reached in 12 months following the first episode illness. Moreover, it also aims to identify other predictors of relapse as well as to evaluate the costs and benefits of maintenance therapy.


Options:
A: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline to Week 6)
B: Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
C: For patients in remission while on maintenance medication, the study investigates whether medication discontinuation can be reached in 12 months following a first episode illness.
D: Time From Baseline to the First Symptom Relapse During the Double-blind Phase (Up to 34 Weeks and Bi-Weekly thereafter until Week 92)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Brief Summary: To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.


Options:
A: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
B: Progression-free Survival (Randomization until progression (up to 2 years))
C: Progression Free Survival (PFS) (Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months))
D: Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib (Cycle 1 (21 days)); Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) of Lenvatinib (Cycle 1 (21 days)); Objective Response Rate (ORR) Based on Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) Version 1.1 at Week 24 (Week 24)

Answer: B