TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Improving Care of Acute Lung Injury Patients (ICAP) Study
Brief Summary: Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Individuals with ALI/ARDS often require the use of a respirator or artificial breathing machine, known as a mechanical ventilator, while in an intensive care unit (ICU). Past research has shown that improved short-term clinical outcomes result from the use of a protective mechanical ventilation technique for the lungs. This study will evaluate the effects of lower tidal volume ventilation, and other aspects of critical illness and ICU care, on the long-term clinical outcomes of individuals with ALI/ARDS.


Options:
A: Mortality rate (at day 90)
B: adherence to our explicit mechanical ventilation protocols; (duration of mechanical ventilation); to measure and understand the reasons for crossovers between groups (duration of mechanical ventilation); to estimate the rate of patient recruitment, and understand barriers to recruitment; to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
C: Mortality (Measured at Months 3, 6, 12, 24, 36, 48 and 60)
D: Reduction of the mortality rate of ARDS patients at d90 (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing its severeness, after exposure to a traumatic event.


Options:
A: Cumulative opioid morphine equivalent dose (The first 24 hours)
B: 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)
C: CAPS (1-year follow-up)
D: Primary sedative dose change (24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.


Options:
A: HAM-D17 (Before and after 3 months intervention)
B: Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score. (Week 8 to Week 14)
C: The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation
D: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia
Brief Summary: The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.


Options:
A: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study (Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy)
B: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit))
C: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment (Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
D: The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia
Brief Summary: The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.


Options:
A: Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (Baseline to 12 Weeks)
B: LDL-C lowering efficacy after 6 weeks.
C: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit))
D: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
Brief Summary: The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.


Options:
A: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit))
B: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks)
C: LDL-C lowering efficacy after 6 weeks.
D: Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (Baseline to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
Brief Summary: The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.


Options:
A: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase (12 weeks)
B: Median Percent Change in Triglycerides From Baseline to Week 8. (Baseline to 8 weeks)
C: Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (Baseline to 12 Weeks)
D: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis
Brief Summary: This study is designed to determine whether memantine is an effective treatment for memory and cognitive problems associated with multiple sclerosis when compared to placebo.


Options:
A: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
B: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
C: Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.
D: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)
Brief Summary: To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.


Options:
A: Maximum Observed Plasma Concentration (Cmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Time to Reach Maximum Observed Plasma Concentration (Tmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Decay Half-Life (t1/2) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Apparent Oral Clearance (CL/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Terminal-Phase Volume of Distribution (Vz/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Concentrations After Multiple Doses (Hours 2 and 4 on Day 7)
B: Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) (Baseline and 8 weeks)
C: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
D: Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. (Week 4); Safety Assessments (Baseline through week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)
Brief Summary: To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.


Options:
A: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring (Baseline and end of treatment (10-14 days))
B: Therapeutic efficacy (24 hour)
C: Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) (Baseline and 8 weeks)
D: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter (After 7 days of dosing.); Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter. (After 7 days of dosing.); Oral Clearance (CL/F) Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter. (After 7 days of dosing.); Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter. (After 7 days of dosing.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.
Brief Summary: The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.


Options:
A: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
B: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
C: PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. (48 hours)
D: Change from baseline in total PANSS score to the end of the double-blind phase.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.
Brief Summary: The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.


Options:
A: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
B: The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.
C: Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
D: The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.
Brief Summary: The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.


Options:
A: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
B: body weight change (24 weeks)
C: Change from baseline in weight at week eight (Baseline and week eight)
D: body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: (Intervention Study) A Randomized Controlled Study of the Intensive Therapy and the Conventional Therapy for the Suppression of the Vascular Complications in the Type 2 Diabetic Patients (Follow-up Study) A Randomized Controlled Study Comparing Intensive Therapy and Conventional Therapy in the Reduction of Vascular Complications in Type 2 Diabetic Patients: A Follow-up Study After Intervention
Brief Summary: (Intervention study) The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized controlled study in patients with type 2 DM.

(Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center, open-label, randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients.


Options:
A: The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death (Every 12 months, at the end of the study.)
B: N/A
C: N/A
D: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: (Intervention Study) A Randomized Controlled Study of the Intensive Therapy and the Conventional Therapy for the Suppression of the Vascular Complications in the Type 2 Diabetic Patients (Follow-up Study) A Randomized Controlled Study Comparing Intensive Therapy and Conventional Therapy in the Reduction of Vascular Complications in Type 2 Diabetic Patients: A Follow-up Study After Intervention
Brief Summary: (Intervention study) The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized controlled study in patients with type 2 DM.

(Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center, open-label, randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients.


Options:
A: The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death (Every 12 months, at the end of the study.)
B: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
C: 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)
D: 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.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers
Brief Summary: The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs.

The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.


Options:
A: Appropriateness of treatment (36 months)
B: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)
C: Proportion of cases correctly treated (Outcomes measured during consultation - approximately 30-40 minutes)
D: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)

Answer: B