TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
Brief Summary: Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.


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: Changes in estimated glomerular filtration rate (Changes in eGFR at month 6)
C: A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack) (36 Months); Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) (36 Months); Heart failure (36 Months); Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) (36 Months); Diabetic complications (nephropathy, retinopathy and neuropathy) (36 Months); Renal dysfunction (doubling of serum creatinine, end stage renal diseases) (36 Months); All cause mortality (36 Months)
D: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
Brief Summary: Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.


Options:
A: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
B: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
C: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
D: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
Brief Summary: Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.


Options:
A: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
B: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril. (5 year); To obtain two percutaneous renal biopsies from each patient, five years apart. (5 year)
C: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
Brief Summary: Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.


Options:
A: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks
B: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
C: A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack) (36 Months); Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) (36 Months); Heart failure (36 Months); Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) (36 Months); Diabetic complications (nephropathy, retinopathy and neuropathy) (36 Months); Renal dysfunction (doubling of serum creatinine, end stage renal diseases) (36 Months); All cause mortality (36 Months)
D: Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death (At least 3 years of mean follow up period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of a Clinical Pathway for Nursing Home Pneumonia.
Brief Summary: Nursing home residents are frequently transferred to hospital for management of pneumonia. This often leads to hospital related complications and is a burden on the acute care health system. The purpose of this study is to assess whether managing residents with pneumonia and lower respiratory tract infection on site in the nursing home can reduce hospital admissions and can reduce complications and improve quality of life for residents. We have randomized residents with nursing home acquired pneumonia to on-site management, using a clinical pathway, versus usual care.


Options:
A: Hospital admission, length of stay
B: Reductions in hospitalization (1 year)
C: Change in knowledge of and self-efficacy concerning ACP (One questionnaire at baseline (T0), one questionnaire at follow-up (T1, 8 months after T0))
D: Participation in social, leisure and communicative activities. (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
Brief Summary: This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).


Options:
A: N/A
B: Adequate Clinical and parasitological response (Day 63)
C: adequate clinical and Parasitological response (ACPR)by day 28.
D: Overall Cure Rate at Day 42

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
Brief Summary: This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).


Options:
A: Overall Cure Rate at Day 42
B: Incidence of clinical episodes of malaria (over entire course of follow-up); Risk of treatment failure at Day 28 defined as any early treatment failure or late clinical/parasitological failure adjusted and unadjusted by genotyping to distinguish recrudescence (treatment failure due to drug resistance) and new infections (28 days following each malaria treatment)
C: PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping. (Day 28); PCR adjusted treatment failure up to day 28 (TF28A): all early failures before day 14 plus the recurrent parasitaemias detected at day 14 or later and classified by genotyping as recrudescence. (Day 28)
D: Adequate Clinical and parasitological response (Day 63)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
Brief Summary: This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).


Options:
A: Cure rate (63 days)
B: Crude Cure Rate on Day 14 (Day 14)
C: PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR) (Day 56)
D: Overall Cure Rate at Day 42

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Consortium for Translation of Psychosocial Depression Theories to Interventions and Dissemination - Project 2: Phase I Randomized Controlled Trial of Patient Preference, Stepped-Care Treatment For Distress in Heart Disease Patients
Brief Summary: The specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or depressed mood" is defined by a score on the Beck Depression Inventory (BDI) \>10. The specific treatment approach utilized follows the, "Improving Mood-Promoting Access to Collaborative Treatment" (IMPACT) Clinical Trial, and involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol, patients choose between brief, problem focused psychotherapy and anti-depressant medication. Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up' treatment if patients are not demonstrating sufficient symptom reduction.


Options:
A: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)
B: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)
C: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)
D: Acceptability (From the completion of the manual till 4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Consortium for Translation of Psychosocial Depression Theories to Interventions and Dissemination - Project 2: Phase I Randomized Controlled Trial of Patient Preference, Stepped-Care Treatment For Distress in Heart Disease Patients
Brief Summary: The specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or depressed mood" is defined by a score on the Beck Depression Inventory (BDI) \>10. The specific treatment approach utilized follows the, "Improving Mood-Promoting Access to Collaborative Treatment" (IMPACT) Clinical Trial, and involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol, patients choose between brief, problem focused psychotherapy and anti-depressant medication. Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up' treatment if patients are not demonstrating sufficient symptom reduction.


Options:
A: Perceived control measure by Control Attitude Scale (3 months)
B: Rates of Adequate Depression Treatment at Discharge (5 days after enrollment)
C: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
D: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Consortium for Translation of Psychosocial Depression Theories to Interventions and Dissemination - Project 2: Phase I Randomized Controlled Trial of Patient Preference, Stepped-Care Treatment For Distress in Heart Disease Patients
Brief Summary: The specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or depressed mood" is defined by a score on the Beck Depression Inventory (BDI) \>10. The specific treatment approach utilized follows the, "Improving Mood-Promoting Access to Collaborative Treatment" (IMPACT) Clinical Trial, and involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol, patients choose between brief, problem focused psychotherapy and anti-depressant medication. Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up' treatment if patients are not demonstrating sufficient symptom reduction.


Options:
A: Stage of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Process of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Decisional balance for coronary heart disease patients with depression (2 - days (T0) before discharge.); Self-efficacy for coronary heart disease patients with depression: scale (2 - days (T0) before discharge.); Hamilton Rating Scale for Depression (2 - days (T0) before discharge.)
B: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
C: Hamilton Rating Scale of Depression (HAM-D) (Baseline, Week 4, Week 8, Week 12)
D: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pimozide Augmentation of Clozapine in Schizophrenia
Brief Summary: This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.


Options:
A: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. (Baseline to Week 6)
B: Positive Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12); Negative Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12)
C: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)
D: Positive Symptom Item Scores by Week and Treatment Group (Baseline and every two weeks for 16 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylaxis of Posttraumatic Stress Disorder With Post-Trauma Propranolol
Brief Summary: This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals.


Options:
A: Primary sedative dose change (24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment))
B: Oxygenation (PO2/FIO2 ratio) (2 years)
C: Safety and Tolerability (6-9 months); Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for PTSD (2-3 years); Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for early Acute Stress Disorder (ASD) (2-3 years); Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for prolonged Acute Stress Disorder (ASD) (2-3 years)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuation Phase CBT for Youth With MDD
Brief Summary: This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.


Options:
A: Mood Severity Index (Measured at Months 6 and 12)
B: recurrence of depression (52 weeks)
C: Relapse of depressive symptoms (Measured at Months 3 and 9)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuation Phase CBT for Youth With MDD
Brief Summary: This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.


Options:
A: recurrence of depression (52 weeks)
B: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
C: N/A
D: Relapse of depressive symptoms (Measured at Months 3 and 9)

Answer: D