TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Processes in PTSD: Treatment
Brief Summary: This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder (PTSD) and depression brought on by sexual assault.


Options:
A: Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery (36 weeks)
B: 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
C: Sleep Latency (SL) (After 8 weeks of study participation); Minutes of Wake After Sleep Onset (WASO) (After 8 weeks of study participation); Sleep Efficiency (SE) (After 8 weeks of study participation)
D: Drug Abuse Screening Test (DAST-10) (6 months); Alcohol Use Disorders Identification Test (AUDIT) (6 months); Cigarettes (Estimated Number) (14 days preceding 6 week, 3 month and 6 month follow-up); Amount of Alcohol Use (14 days prior to 6 week, 3 month, 6 month follow-up); Marijuana Use Frequency (14 days prior to 6 week, 3 month, 6 month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis
Brief Summary: The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.


Options:
A: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
B: Intraoperative blood loss (2.5 hours)
C: Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes (10 minutes)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis
Brief Summary: The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.


Options:
A: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
B: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
C: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection (Within 5 minutes); Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection (Within 5 minutes)
D: Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes (10 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Diabetes Telemonitoring (DiaTel) Study
Brief Summary: The purpose of this research study is to compare two different methods of helping veterans with diabetes better manage their disease. This study will compare an "Active Care Management" method using home-based technology and self-monitoring techniques with a lower-intensity "Care Coordination" method based on monthly telephone contact with a nurse.


Options:
A: HbA1c (3 months)
B: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
C: changes in HbA1c (from baseline to 12 and 24 weeks); changes in systolic and diastolic blood pressure (from baseline to 8, 16, and 24 weeks)
D: Participants with a history of established cardiovascular disease (CVD) (Day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Diabetes Telemonitoring (DiaTel) Study
Brief Summary: The purpose of this research study is to compare two different methods of helping veterans with diabetes better manage their disease. This study will compare an "Active Care Management" method using home-based technology and self-monitoring techniques with a lower-intensity "Care Coordination" method based on monthly telephone contact with a nurse.


Options:
A: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
B: Home Monitoring Effectiveness (12 months); Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. (12 months)
C: HbA1c (3 months)
D: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
Brief Summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.


Options:
A: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)
B: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
C: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
D: PASI 75 Response After 12 Weeks of Treatment (12 weeks); IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
Brief Summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.


Options:
A: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
B: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
C: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
D: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
Brief Summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.


Options:
A: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
B: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)
C: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16); Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 (Week 16)
D: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
Brief Summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.


Options:
A: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
B: Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (Week 16)
C: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
D: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
Brief Summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.


Options:
A: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
B: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
C: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
D: • The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment (week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With Attention Deficit/Hyperactivity Disorder
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of three doses of prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult patients with attention deficit/hyperactivity disorder (ADHD).


Options:
A: N/A
B: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (Baseline, and the Endpoint (average of weeks 5, 6, 7).)
C: Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing)
D: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With Attention Deficit/Hyperactivity Disorder
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of three doses of prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult patients with attention deficit/hyperactivity disorder (ADHD).


Options:
A: The change from Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score as assessed by the Investigator at the Final Visit/2 Week Efficacy Assessment Visit
B: Change from baseline in the ADHD rating scale total score (Through Day 42)
C: Percent days abstinent; Time to relapse to heavy drinking
D: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy
Brief Summary: This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.


Options:
A: N/A
B: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)
C: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 Weeks); Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 weeks)
D: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy
Brief Summary: This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.


Options:
A: Change in Endothelial Function (Baseline and 12 weeks)
B: Development of a new or recurrent disease progression event, including all-cause death. (within 24 months after randomization)
C: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)
D: Safety (12 weeks); Efficacy of the Two Doses (4000 and 7000 IU/d) (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivational Interviewing (MI) for ETOH+ Teens in the ER
Brief Summary: The purpose of this study is to determine whether motivational interviewing is effective in reducing alcohol consumption and alcohol problems among young adults who present to an Emergency Room.


Options:
A: alcohol use, alcohol related consequences (3 -12 month period)
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: Alcohol Consumption (6, 9, and 12 months)
D: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR)
Brief Summary: There are many medications available for the treatment of high blood pressure (hypertension), but finding the right one for a specific patient can be challenging. In fact, it is estimated that only 34% of people with hypertension have their blood pressure under control. The hypothesis is that genetic differences between individuals influence their response to antihypertensive medications. This study is aimed at determining the genetic factors that may influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their blood pressure medicine, leading to better control of blood pressure, and less need for the current trial and error process.


Options:
A: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))
B: Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)). (baseline to 18 weeks of treatment)
C: Cognitive Assessment: Trail Making Test Part B (Baseline-12 months); Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall (Baseline-12 months); Cognitive Assessment: Forward Digit Span Test (Baseline-12 months)
D: Change from baseline in diastolic blood pressure after 26 weeks

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Program of Collaborative Care for Alzheimer Disease
Brief Summary: This is a clinical trial to test the effectiveness of current guideline for the care of older adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse care manager to facilitate guideline-level care. We are hypothesizing that patients who receive guideline-level care will have fewer behavioral problems than those who receive the usual care provided in primary care settings


Options:
A: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
B: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)
C: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living
D: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Program of Collaborative Care for Alzheimer Disease
Brief Summary: This is a clinical trial to test the effectiveness of current guideline for the care of older adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse care manager to facilitate guideline-level care. We are hypothesizing that patients who receive guideline-level care will have fewer behavioral problems than those who receive the usual care provided in primary care settings


Options:
A: To determine if a culturally focused psychiatric (CFP) consultation service can improve depressive symptoms and increase diagnosis and treatment of depression in Asian American and Latino American primary care patients at MGH. (6 months after baseline assessment)
B: 20-Item Symptom Checklist Depression Scale (Measured at baseline and after 6 months of treatment)
C: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life
D: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Program of Collaborative Care for Alzheimer Disease
Brief Summary: This is a clinical trial to test the effectiveness of current guideline for the care of older adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse care manager to facilitate guideline-level care. We are hypothesizing that patients who receive guideline-level care will have fewer behavioral problems than those who receive the usual care provided in primary care settings


Options:
A: Depressive symptoms reduction (Measured at months 6 and 12)
B: BSI-12 (Anxiety and Somatization Subscales) (Measured at Month 18)
C: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living
D: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)

Answer: C