TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
Brief Summary: Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.

The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).

This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.


Options:
A: N/A
B: Survival (Up to 5 years); Grade 4 or 5 toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Up to 5 years)
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: Assessment of Ocular Adverse Events (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
Brief Summary: Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.

The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).

This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.


Options:
A: N/A
B: The primary efficacy outcome measure is the mean change from baseline in BCVA score (6 months)
C: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)
D: The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit (Change from baseline to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia
Brief Summary: This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine; evaluate the safety and tolerability of IM olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine depot; and determine the blood levels of IM olanzapine depot in patients at different points in time after an injection.


Options:
A: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). (12 weeks)
B: Relapse (Every 2 weeks up to 26 weeks)
C: The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period (After 68 relapse events)
D: Determine comparative efficacy in patients with schizophrenia of non-inferiority of IM olanzapine depot high and low doses versus oral olanzapine based on exacerbation rates after 6 months of maintenance treatment; Determine comparative efficacy in patients with schizophrenia of superiority of IM olanzapine depot low, med and high doses versus very low dose based on time to exacerbation of symptoms of schizophrenia

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients
Brief Summary: 5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.


Options:
A: Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments (12 months)
B: Circulating GH- and IGF-1 concentrations measured every 2 weeks (6 months)
C: Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. (At 24 weeks)
D: Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of the Rapid (Next Day) Antidepressant Effects of an NMDA Antagonist
Brief Summary: Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants.

This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder.

This study was designed to address the questions:

Does the NMDA antagonist ketamine produce rapid antidepressant effects in patients with treatment-resistant major depression? What are the neurobiological correlates of antidepressant response (examining multi-modal MRI, MEG, polysomnography and serum markers) Patients, ages 18 to 65 years with treatment-resistant major (unipolar) depression will in a double-blind crossover study receive either intravenous ketamine or saline solution.


Options:
A: Change in MADRS Total Score From Baseline to Week 6 (6 weeks)
B: Episodes of Depression or Elation (15 months (duration of trial and 3 month follow-up))
C: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (Up to 7 days following the last dose of study drug (Up to 23 days)); Part 1: Number of Participants With Serious Adverse Events (SAEs) (Up to 30 days following the last dose of study drug (Up to 46 days)); Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 16 days)); Part 2: Number of Participants With AEs (Up to 7 days following the last dose of study drug (Up to 35 days)); Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 28 days))
D: MADRS Score - Baseline (Baseline); MADRS Score - Day 1 Following Intervention (Day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of the Rapid (Next Day) Antidepressant Effects of an NMDA Antagonist
Brief Summary: Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants.

This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder.

This study was designed to address the questions:

Does the NMDA antagonist ketamine produce rapid antidepressant effects in patients with treatment-resistant major depression? What are the neurobiological correlates of antidepressant response (examining multi-modal MRI, MEG, polysomnography and serum markers) Patients, ages 18 to 65 years with treatment-resistant major (unipolar) depression will in a double-blind crossover study receive either intravenous ketamine or saline solution.


Options:
A: MADRS Score - Baseline (Baseline); MADRS Score - Day 1 Following Intervention (Day 1)
B: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. (60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
C: Change in Depression Patient Health Questionnaire 9 (PHQ9) Scoring (Change from Baseline Score 24 hours prior to starting ECT to PHQ9 score 72 hours following last ECT session)
D: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study to Evaluate The Efficacy of Mycophenolate Mofetil Added to The Systemic Immunosuppressive Regimen First Used For Treatment of Chronic Graft-Versus-Host Disease
Brief Summary: RATIONALE: Mycophenolate mofetil added to immunosuppressive treatment regimens may be effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell transplantation. It is not yet known whether immunosuppressive treatment regimens are more effective with or without mycophenolate mofetil in treating chronic graft-versus-host disease.

PURPOSE: This randomized phase III trial is studying whether the addition of mycophenolate mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly diagnosed chronic graft-versus-host disease.


Options:
A: To estimate the response rate (CR and PR) of pentostatin when used to treat refractory-chronic GVHD in children. (To end of study)
B: N/A
C: Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy (2 years)
D: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study to Evaluate The Efficacy of Mycophenolate Mofetil Added to The Systemic Immunosuppressive Regimen First Used For Treatment of Chronic Graft-Versus-Host Disease
Brief Summary: RATIONALE: Mycophenolate mofetil added to immunosuppressive treatment regimens may be effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell transplantation. It is not yet known whether immunosuppressive treatment regimens are more effective with or without mycophenolate mofetil in treating chronic graft-versus-host disease.

PURPOSE: This randomized phase III trial is studying whether the addition of mycophenolate mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly diagnosed chronic graft-versus-host disease.


Options:
A: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (2 years)
B: Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy (2 years)
C: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)
D: To estimate the response rate (CR and PR) of pentostatin when used to treat refractory-chronic GVHD in children. (To end of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
Brief Summary: The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.


Options:
A: Renal function at the beginning and at the end of therapy (two weeks)
B: Treatment Success (Day 14)
C: Survival
D: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
Brief Summary: The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.


Options:
A: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)
B: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
C: Renal function at the beginning and at the end of therapy (two weeks)
D: Treatment Success (Day 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
Brief Summary: The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.


Options:
A: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)
B: Renal function at the beginning and at the end of therapy (two weeks)
C: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
D: Treatment Success (Day 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
Brief Summary: This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.


Options:
A: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)
B: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 (24 months)
C: Time to First Skeletal Related Event (Up to 10 years)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
Brief Summary: The purpose of this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea (OSA) following continuous positive airway pressure (CPAP) treatment.


Options:
A: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (8 weeks)
B: all-cause mortality (one year)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Acute hypercapnic respiratory failure episode (up to 102 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
Brief Summary: This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.


Options:
A: Number of Participants With New Vertebral Fractures (36 months)
B: Incidence of hip fxs; Incidence of new vertebral fxs
C: Number of Participants With Adverse Events (AEs) (84 months); Number of Participants With Laboratory Toxicities of Grade ≥ 3 (84 months); Number of Participants With Antibodies to Denosumab (Every 12 months through Month 84)
D: To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
Brief Summary: This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.


Options:
A: The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment. (baseline and 6 months)
B: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
C: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 (Baseline and month 12)
D: Number of Participants With New Vertebral Fractures (36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
Brief Summary: This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.


Options:
A: The percent change in the lumbar spine BMD (12 months)
B: Bone density by means of bone densitometry with dual energy x-ray absorptiometry (DEXA) at three body sites (lumbar region, femoral head, wrist) prior to treatment initiation the start and at the end of treatment; N-telopeptide of type I collagen (NTx) levels, TRACP-5b, with ELISA, prior to the start of treatment initiation and every 3 or 6 months; Serum Bone alkaline phosphatase, Osteocalcin, OPG and S-RANKL with ELISA, prior to the start of treatment initiation, and every 3 or 6 months
C: N/A
D: Number of Participants With New Vertebral Fractures (36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
Brief Summary: This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.


Options:
A: extent of aortic and coronary artery calcification with and without the use of alendronate; bone mineral density with and without the use of alendronate
B: Percentage of Participants With New Vertebral Fracture Through Month 12 (12 Months); Percentage of Participants With New Vertebral Fracture Through Month 24 (24 months)
C: 1.Changes of calcification score of coronary arteries and aorta; 2.Changes of bone density
D: Number of Participants With New Vertebral Fractures (36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
Brief Summary: This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.


Options:
A: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
B: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
C: Incidence of hip fxs; Incidence of new vertebral fxs
D: Number of Participants With New Vertebral Fractures (36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients With Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)
Brief Summary: The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).


Options:
A: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period (Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke (Randomization through end of study (30-month visit))
D: Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. (96 hours after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients With Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)
Brief Summary: The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).


Options:
A: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
B: Release of troponin evaluated by the peak of troponin during the hospital phase (during the hospital phase)
C: Net Adverse Clinical Event (30-day)
D: Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. (96 hours after randomization)

Answer: D