TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Brief Summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: stroke; new or recurrent transient ischemic attack; new or recurrent acute myocardial infarction; new occurrence or exacerbation of heart failure; new occurrence or exacerbation angina pectoris; dissecting aneurysm of the aorta; lower limb arterial obstruction; transition to dialysis; doubling of plasma creatinine (Cr) levels
C: Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.8 years); Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.8 years)
D: Change from baseline in diastolic blood pressure after 26 weeks

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Brief Summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Options:
A: Change from baseline in diastolic blood pressure after 26 weeks
B: Change from baseline in diastolic blood pressure after week 8
C: Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment (Baseline, 104 weeks)
D: Change from baseline in diastolic blood pressure after 52 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-week, Randomized, Double-blind, Parallel-group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-hour ABPM, With Lisinopril 10 mg as a Reference
Brief Summary: After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks


Options:
A: Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
B: Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks
C: Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization (up to End of Study (78 months))
D: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) (Baseline to 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-week Multi-center, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren (150 mg and 300 mg) Administered Alone and in Combination With Valsartan (160 mg and 320 mg) in Patients With Hypertension
Brief Summary: To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: Change from baseline in diastolic blood pressure after week 8
C: To investigate the combined effect of aliskiren and valsartan on vascular structure, assessed by wall to lumen ratio of retinal arterioles, in hypertensive patients. (After 8 weeks of treatment with aliskiren versus placebo)
D: Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment (Baseline and end of treatment ( 17 to 36 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction
Brief Summary: This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.


Options:
A: Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
B: Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions (72 hours after initiation of study medication up to Day 20)
C: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. (15 weeks)
D: Serologically confirmed HIV infection (Throughout study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain
Brief Summary: This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).


Options:
A: Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase (9 weeks)
B: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
C: Mean pain score
D: Daily Evening Patient Reported Pain Intensity Scores (Baseline and 6 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION
Brief Summary: This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.


Options:
A: Progression-free survival rate at 6 months
B: Overall Survival (OS) (Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant)
C: TTF2 (approximate 6 months after first line treatment)
D: Progression-Free Survival (From the time of randomization until progression of disease or death (up to 30 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Anorexia and weight loss are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.


Options:
A: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)
B: Change in Lean Body Mass (Change in Lean Body Mass from Baseline Over 12 Weeks); Change in Handgrip Strength (Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks)
C: Body weight; Lean body mass; Functional performance
D: Body Weight; Lean Body Mass; Functional Performance

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Brief Summary: The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment.

The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.


Options:
A: Change in the total weekly number of incontinence episodes (Baseline to Treatment Week 12/Premature Discontinuation)
B: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
C: N/A
D: Total number of urinary incontinence episodes per week

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Effects of Aerobic Exercise for Adults With Impaired Glucose Tolerance: A Controlled Trial
Brief Summary: The specific aims for the study will be to determine if aerobic exercise enhances cognition for older adults who are at risk for developing type II diabetes mellitus (T2DM), and to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects randomized to the aerobic exercise group. Sedentary older adults diagnosed with impaired glucose tolerance using an oral glucose tolerance test will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity, and body fat composition and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline associated with T2DM for older adults.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: Coronary heart disease 10 year risk (12 months)
D: Change in cognitive scores; Change in insulin sensitivity

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Long-Acting Risperidone in the Maintenance Treatment of First-Episode Schizophrenia
Brief Summary: Many patients who have recently received a diagnosis of schizophrenia (e.g., "first-episode schizophrenia") respond very well to their antipsychotic medication when they are acutely ill. Once they are more stable, research has shown that first-episode patients need to remain on their antipsychotic medication. Follow-up studies show that stopping medication prematurely is the most common cause of relapse and readmission. It is important to have new ways to help patients stay stable in the community in order for them to continue on with their rehabilitation and recovery process.

Over the last decade, new antipsychotic medications have been developed that are more effective and have fewer side effects than older antipsychotics. The new medicines are often called "atypical", and were only available by pill or capsule for long-term treatment. Most recently, one of the atypical medications - risperidone - became available as a long-acting injection that can be given once every 2 weeks.

The hypothesis of this study is that patients recovering from an acute episode and who then go on to receive a long-acting version of atypical antipsychotic medication (long-acting risperidone microspheres) will stay on their medications for longer than those who take their atypical medication (any available first-line atypical) in the oral (pill) form.


Options:
A: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia (Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks))
B: Hospitalization-free Survival - Time to Event (From randomization until date of first re-hospitalization, assessed up to 24 months); Hazard Ratio for Hospitalization (24 months)
C: Likelihood of accepting a recommendation of long-acting atypical antipsychotic medication; Compare the time until the first episode of antipsychotic nonadherence as defined by 2 or more weeks of continuous and intentional cessation of all prescribed antipsychotic medication; Compare the total amount of outpatient days spent adherent to antipsychotic medication as a proportion of outpatient days in the study; Compare patient and family attitudes and satisfaction with antipsychotic medication given by long-acting route vs. oral route of drug delivery; 5. Modify and adapt psychoeducational material designed for multiple episode patients to better fit the needs of recently diagnosed patients with schizophrenia.
D: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy
Brief Summary: The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.


Options:
A: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period (6 months)
B: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
C: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)
D: Guillain Barré Syndrome (GBS) disability score (1 year); MRC sum score (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy
Brief Summary: The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.


Options:
A: Responder Rate (25 weeks)
B: proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. (28weeks); proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. (52weeks)
C: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period (6 months)
D: Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period (Up to 25 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Diabetic Cardiovascular Complications With Vitamin E 400 IU Treatment to High Risk Patients by Haptoglobin Phenotype (I CARE - Israel Cardiovascular Atherosclerosis Risk and Vitamin E)
Brief Summary: The purpose of this study is to determine whether Vitamin E treatment to Diabetic patients, who carry the Haptoglobin 2-2 Phenotype, prevents cardiovascular complications such as acute MI and Stroke.


Options:
A: A combination of CVD mortality non fatal MI and Stoke at a 4 year follow up.
B: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
C: Cardiovascular disease; Cancer
D: Outcomes assessed will be based on the ongoing ocular examination and historical data that will be obtained at each visit. The visual acuity data and the photographic documentation of the two diseases will be of particular importance. (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Actos Now for Prevention of Diabetes (ACT NOW)
Brief Summary: The purpose of this study is to examine whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus


Options:
A: Prevention of Type 2 Diabetes (2.4 years)
B: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)
C: Time to occurrence of fatal or non-fatal stroke
D: Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) (Baseline, 6 months, 12 months, 18 months, and 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Actos Now for Prevention of Diabetes (ACT NOW)
Brief Summary: The purpose of this study is to examine whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus


Options:
A: Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA) (Baseline and Month 12.)
B: Prevention of Type 2 Diabetes (2.4 years)
C: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
D: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Actos Now for Prevention of Diabetes (ACT NOW)
Brief Summary: The purpose of this study is to examine whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus


Options:
A: Effect of treatment on the nominal change in FDG uptake of atherosclerotic plaque from baseline after 4 months of treatment as measured by FDG-PET/CT imaging. (Baseline and 4 months after treatment)
B: Prevention of Type 2 Diabetes (2.4 years)
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: Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.8 years); Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.8 years)

Answer: B