TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
Brief Summary: This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.


Options:
A: To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
B: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) (Baseline (Week 8) and Week 14)
C: Montgomery-Asberg Depression Rating Scale (MADRS) (Baseline (Week 8) to Week 16)
D: Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline (the end of the SSRI/SNRI treatment period), at completion of administration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT of Mechanical Simulator Practice and Usual Training vs. Usual Training on Novice Trainee Clinical ERCP Performance
Brief Summary: In a RCT, mechanical simulator practice enhances clinical ERCP performance of novice trainees during the first 3 months of usual ERCP training.


Options:
A: Technical skills (6 months)
B: Transfer of Skills to Clinical Colonoscopy (less than 2 weeks)
C: Evaluation of trainee skills included success of diagnostic CBD and deep CBD cannulation (3 months)
D: Colorectal cancer-related mortality (10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Telepsychiatry-based Culturally Sensitive Collaborative Treatment of Depressed Chinese Americans
Brief Summary: Hypothesis 1. Telepsychiatry consultations will be acceptable and well-received by depressed Chinese Americans and by their primary care clinicians.

Hypothesis 2. Depressed Chinese Americans in remote primary care clinics receiving T-CSCT will have improved outcomes compared to patients who receive Usual Care by primary care physicians.


Options:
A: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
B: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
C: Hamilton Rating Scale for Depression (Screen, Week 9, 17, 24)
D: Depression (Baseline, t2, t3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Brief Summary: This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.


Options:
A: Determination of the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age. (6 months)
B: First episode of late-onset sepsis or sepsis-associated death (72hrs to 8 weeks of age)
C: Number of confirmed episodes of late-onset sepsis. (1 month)
D: Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) (1-3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Procalcitonin-guided Decision Making on Duration of Antibiotic Therapy in Suspected Neonatal Early-onset Sepsis: Multicenter Prospective Randomized Intervention Study
Brief Summary: In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. This study is designed as a multi-center, prospective, randomized intervention trial. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.


Options:
A: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
B: All cause mortality (28 days)
C: mortality/survival (28 day)
D: The absolute reduction of the duration of antibiotic therapy with unchanged outcome (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
Brief Summary: This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.


Options:
A: Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) (From randomization of the first participant until 28 months later (cut-off date))
B: Time to Progression (TTP). (Patients will be followed over a 2 years period.)
C: overall survival (5 years)
D: Overall Survival (OS) (from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment); Time to Symptomatic Progression (TTSP) (from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of a Single Dose IV Hydrocortisone Given Within 6 Hours of Exposure to a Traumatic Event in PTSD Prevention
Brief Summary: This study is designed to test the hypothesis that a single Hydrocortisone intra venous injection within 6 hours post-trauma facilitates physiological recovery thereby preventing the development of Post Traumatic Stress Disorder (PTSD) in the months following the event. In the absence of such treatment (i.e., under placebo conditions), we hypothesize that a greater proportion of persons would develop PTSD (i.e., fail to recover from acute effects).


Options:
A: The primary outcome is symptom severity at the end of the trial .This will be determined using the Clinician Administered PTSD Scale (CAPS), a scale with established reliability and good psychometric properties. (13 months)
B: Cumulative opioid morphine equivalent dose (The first 24 hours)
C: Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1 (Month 1); Physiological Posterior Probability of PTSD as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 3 (Month 3)
D: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Brief Summary: The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.


Options:
A: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (At baseline and up to 6 month following treatment administration)
B: Forced vital capacity (Every 3 months)
C: Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months); Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months)
D: Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis (One year for the first phase; 4 years for the extension phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Brief Summary: The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.


Options:
A: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (At baseline and up to 6 month following treatment administration)
B: Forced vital capacity (Every 3 months)
C: Fever (48hours); Unconsciousness (48hours); vomiting (48hours)
D: Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis (One year for the first phase; 4 years for the extension phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-center,Proof of Concept,Randomized,Controlled Parallel Group Clinical Trial of the Effects of Exenatide vs. a Long Acting Insulin Analog to Evaluate the Efficacy of Exenatide in Patients With Diabetic Neuropathy and Type 2 Diabetes
Brief Summary: This study will look at whether or not the medication exenatide improves signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy.


Options:
A: Confirmed Clinical Neuropathy (CCN) (18 Months)
B: Change in Left ventricular function from visit 1 to week 24, measured by Ecco (24 weeks)
C: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
D: Change in low-density lipoprotein cholesterol (52-weeks); Change in glycated hemoglobin (52-weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Brief Summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).


Options:
A: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 (Baseline and week 16)
B: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 (Baseline and week 12)
C: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)
D: To investigate the safety, tolerability and feasibility of individual titration of BAY63-2521 according to peripheral systolic blood pressure (3 months); To investigate the long term safety and tolerability of BAY63-2521 (max. 84 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Brief Summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).


Options:
A: Pulmonary Artery Systolic Pressure (PASP)
B: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 (Baseline and week 16)
C: 6 minutes walking distance
D: Number of Participants With Adverse Events (AEs) (Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Brief Summary: The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.


Options:
A: Ten meters walking test (about 4 weeks)
B: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
C: Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) (Baseline, 16 weeks); Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration (Baseline and 16 weeks); Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) (Baseline, 16 weeks); Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) (Baseline, 16 weeks); Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) (Baseline, 16 weeks)
D: Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score (Baseline to 36 months of treatment); Adjusted Mean Change in Adjusted UPDRS Score (Baseline to 36 months of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Brief Summary: The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.


Options:
A: Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. (Baseline to Week 24); Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. (Baseline to Week 24)
B: stride length by gait analysis with an optoelectronic system (VICON®) (3 months of treatment)
C: Cohen-Mansfield (2 weeks)
D: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare
Brief Summary: This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.


Options:
A: Number of patients with less than a mean of one FMF attack per month (4 months)
B: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. (attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)); To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. (12 months of entire study length)
C: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) (16 weeks)
D: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours (Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare
Brief Summary: This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.


Options:
A: Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS) (Baseline (Days -21 to -1) and Week 6 (Days 21-42)); Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B) (Week 15 through Week 24 (randomized withdrawal))
B: Number of patients with less than a mean of one FMF attack per month (4 months)
C: To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period. (12 weeks)
D: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours (Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Brief Summary: The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.

Hypothesis:


Options:
A: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
B: Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention
C: Cognitive-psychosocial functions (3 and 6 months)
D: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Brief Summary: The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.

Hypothesis:


Options:
A: Fatigue as measured by the Brief Fatigue Inventory (prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.)
B: N/A
C: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
D: Cognitive-psychosocial functions (3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Brief Summary: The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.


Options:
A: A composite endpoint including: all-causes mortality, non fatal myocardial infarction (MI) - including silent MI- , non fatal stroke, unplanned coronary revascularization (48 months)
B: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52); Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104 (Baseline and Week 104)
C: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 (Baseline, week 18)
D: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
Brief Summary: This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 (Month 6)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)
C: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
D: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)

Answer: A