TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)
Brief Summary: The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild to moderately demented patients with Alzheimer's disease compared to placebo.


Options:
A: Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale. (Baseline, 6 months, 12 months)
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: Cognition measured according to ADAS-cog, MMSE scales
D: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)
Brief Summary: The purpose of this study is to determine whether alpha-tocopherol, memantine (Namenda), or the combination will significantly delay clinical progression in mild to moderately demented patients with Alzheimer's disease compared to placebo.


Options:
A: Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.
B: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)
C: 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)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy
Brief Summary: The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).


Options:
A: Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level (Baseline and 12 weeks)
B: Change in PD20 histamine
C: Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. (End of 12-week treatment period)
D: Time to first severe asthma exacerbation (At each clinic visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy
Brief Summary: The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).


Options:
A: Rate of Exacerbations Requiring Systemic Corticosteroids (Measured during the 12-month follow-up period)
B: Change in PD20 histamine
C: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
D: Time to first severe asthma exacerbation

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy
Brief Summary: The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).


Options:
A: Time to first severe asthma exacerbation
B: Time to first severe asthma exacerbation
C: Number of Severe Asthma Exacerbations Per Participant. (6 months)
D: Change in PD20 histamine

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Study of the Efficacy and Safety of RISPERDAL Long-acting Microspheres (RISPERDAL CONSTA) Administered Once Monthly in Adults With Schizophrenia or Schizoaffective Disorder
Brief Summary: The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.


Options:
A: Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.
B: relapse rate (1 year)
C: Rehospitalizations and psychotic relapse at two years
D: relapse rate (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Brief Alcohol Intervention for Incarcerated Women
Brief Summary: The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.


Options:
A: Linkage to alcohol assistance; Change in drinks per day
B: Proportion of Risky Drinkers Measured by AUDIT-C (6 weeks); Proportion of Patients Attending to Specialized Treatment (6 weeks)
C: alcohol use (6 months); HIV risk taking (6 months)
D: Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Brief Alcohol Intervention for Incarcerated Women
Brief Summary: The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.


Options:
A: Linkage to alcohol assistance; Change in drinks per day
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: alcohol use (6 months); HIV risk taking (6 months)
D: Discontinuation of consumption of prescription drugs (one year); Reduction of consumption of prescription drugs (one year); Utilization of formal help (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Brief Summary: The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.


Options:
A: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)
B: Change in glucose tolerance (from baseline to 52 wks, 53 wks, 260 wks, and 261 wks)
C: Change in area under the 0-2 hour prandial glucose curve at 12 weeks
D: Mean Percentage Change in Fasting Body Weight From Baseline (Week 0, week 56); Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 (Week 0, week 56); Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0 (Week 0, week 56)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
Brief Summary: In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase functional CFTR protein in the cells of participants with CF due to a nonsense mutation.


Options:
A: Treatment Period: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 196)
B: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)
C: N/A
D: Change From Baseline to End of Treatment in Total Chloride Transport (Baseline of Cycle 1 and Cycle 2, Day 14 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response (Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Normalization Between Baseline and End of Treatment (Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
Brief Summary: In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase functional CFTR protein in the cells of participants with CF due to a nonsense mutation.


Options:
A: Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in One Second (FEV1) at Baseline (Baseline (Week 1)); Percentage Change From Baseline in Percent-Predicted of FEV1 at Week 48 (End of Treatment (EOT) (Week 48))
B: Change From Baseline to End of Treatment in Total Chloride Transport (Baseline of Cycle 1 and Cycle 2, Day 14 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response (Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Normalization Between Baseline and End of Treatment (Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days))
C: CFTR activity as assessed by nasal transepithelial potential difference (TEPD) (84 days)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
Brief Summary: The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

1. In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
2. In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.


Options:
A: To contribute to the ADDITION-Europe study, to assess screening and intensive treatment on 5 year cardiovascular outcomes (At end of study)
B: Change in ambulatory activity (walking) (12 months)
C: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
D: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
Brief Summary: The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

1. In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
2. In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.


Options:
A: change in glycated hemoglobin levels (six months)
B: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)
C: Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 (Baseline, Month 12)
D: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
Brief Summary: The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

1. In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
2. In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.


Options:
A: Composite outcome of multiple cardiovascular risk factors (2 year)
B: Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up (Six months)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
D: All cause mortality (3, 5, and 10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
Brief Summary: The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

1. In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
2. In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.


Options:
A: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
B: N/A
C: Change in HgbA1c (Glycemic control) (baseline, six month, one year, two years and three years)
D: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
Brief Summary: The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

1. In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
2. In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.


Options:
A: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
B: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
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: Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.


Options:
A: hemoglobin A1c
B: Relative risk of major maternal hypoglycaemia (after 24 hours)
C: Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin (90 days)
D: - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral/Pharmacological Telemedicine Interventions for BP Control
Brief Summary: There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (less than 140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.


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: Primary composite outcome (4 years)
C: Blood Pressure and Hemaglobin A1c
D: Changes in mean SBP (From baseline (T1) to 12 months (T3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral/Pharmacological Telemedicine Interventions for BP Control
Brief Summary: There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (less than 140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.


Options:
A: Cholesterol Level (1 year)
B: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
C: 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)
D: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)

Answer: C