TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
Brief Summary: The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in patient admitted with Community-acquired pneumonia.

The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with CAP.


Options:
A: Clinical efficacy at the end of treatment
B: length of hospital stay (30 days)
C: Time to clinical stability (30 days)
D: Rate of non-response to empiric antimicrobial treatment (5 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
Brief Summary: The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in patient admitted with Community-acquired pneumonia.

The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with CAP.


Options:
A: Clinical efficacy at the end of treatment
B: Duration of mechanical ventilation (0-28 days)
C: Septic shock (14 days)
D: In-hospital mortality (Day 180)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
Brief Summary: The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in patient admitted with Community-acquired pneumonia.

The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with CAP.


Options:
A: In-hospital mortality (Day 180)
B: Clinical efficacy at the end of treatment
C: length of hospital stay (30 days)
D: Length of stay in ICU and length of stay in the hospital. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Compare Effectiveness of 4 Months Rifampin (4 RIF) With 9 Months Isoniazid (9 INH) in the Prevention of Active TB in Children: The P4v9 Trial
Brief Summary: Tuberculosis (TB) is spread by airborne transmission from adults with active contiguous TB to children, especially those living in the same household. Once children are exposed and infected they are at very high risk to develop active TB - which can be lethal if not detected and treated promptly. This makes it very important to detect TB infection as soon as possible, and treat this while it is still latent or dormant. Current therapy for latent TB infection is 9 months of Isoniazid; this is very effective if taken properly but because treatment is so long many children do not finish this. Four months of Rifampin is a recommended alternative. In adults this has been shown to be safer with much higher completion rates. However the effectiveness of this treatment is unclear, and is being studied in an ongoing study. The investigators plan to compare the safety as well as the acceptability and effectiveness of 4 months Rifampin with 9 months Isoniazid (standard treatment) in children in several sites in Canada and other countries.

It is hypothesized that among children at high risk for development of active TB, intolerance/adverse events will not be worse (non-inferiority), among those randomized to 4RIF compared to those randomized to 9INH. In addition completion of latent tuberculosis infection (LTBI) therapy will be significantly greater (superiority), and subsequent rates of active TB will not be significantly higher (non-inferiority) in children taking 4RIF.


Options:
A: Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children (Through to week 96); Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children (Through to week 96)
B: TB incidence (Jan 2003 to July 2011); Mortality (Jan 2003 to July 2011)
C: Adverse events of all grades (Treatment duration)
D: Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication (up to one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients
Brief Summary: The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.

The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.


Options:
A: Number of exacerbations after 48 weeks of intermittent pulse treatment (After 48 weeks of treatment)
B: Additional antibiotic therapy to study medication during treatment period or until the test of cure visit (at day 30) (up to day 30)
C: Number of Patients Who Were Cured (Day 9-11)
D: Clinical efficacy at the end of treatment

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Impact of Computer-Based Decision Support for the Management of Asthma in Primary Care
Brief Summary: Asthma is a health problem that afflicts many Canadians. Better methods are needed to provide primary care physicians with ways of implementing current guidelines into regular practice for optimal disease management. This study will test the benefits of providing computer-based decision-support for asthma to primary care physicians, with links to home monitoring for their patients. To add value and to ensure regular use for the physician for all of his/her patients, these computerized decision-support tools will be linked to an electronic prescribing and drug management system. The investigators will evaluate the effectiveness of the computer-based decision-support system by determining whether asthma patients of physicians who receive computer-assisted management tools have better disease control after 33 months of implementation compared to asthma patients of physicians who have the electronic prescription and drug management system alone. To answer this question, the investigators will conduct a cluster randomized controlled trial in a population of approximately 100 physicians in 40 clinics in Quebec, and a total of approximately 4500 of their patients with asthma.


Options:
A: poor asthma control (2006-2009)
B: Proportion of clinical failure by day 7 compared among the 3 study arms. (10 months)
C: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
D: Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence (12 months post enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Open Label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus (RAD001) With Basiliximab, Corticosteroids and Lower Levels Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Recipients
Brief Summary: This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.


Options:
A: The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.
B: Plasma Creatinine (6 months)
C: Core Study: Number of Patients With Composite Efficacy Endpoint (12 months); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 24); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 48)
D: renal function as measured by serum creatinine at 6 months post-transplant

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Open Label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus (RAD001) With Basiliximab, Corticosteroids and Lower Levels Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Recipients
Brief Summary: This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.


Options:
A: Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. (6 months)
B: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
C: Time to first BPAR episode or treatment failure (6 months)
D: renal function as measured by serum creatinine at 6 months post-transplant

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 7-Day Multicenter Randomized Double-Blind, Double-Dummy Parallel Group Trial to Assess the Safety and Efficacy of 400 mg Lumiracoxib Once Daily Versus 500 mg Naproxen Twice Daily in Patients With Acute Musculoskeletal Pain Due to Uncomplicated Soft Tissue Injury
Brief Summary: This study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.


Options:
A: analgesic efficacy both at rest and with movement (72 hours)
B: Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores (2 hours)
C: Decrease in sum of pain intensity difference scores over first 5 days of treatment
D: Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm (60 minutes post-analgesia)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of the Angiotensin II Antagonist Valsartan on Diastolic Function in Patients With Hypertension and Diastolic Dysfunction
Brief Summary: Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately.

This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.


Options:
A: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
B: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
C: All strokes (fatal and non-fatal) (Duration of trial)
D: Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension
Brief Summary: A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Options:
A: Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)). (baseline to 18 weeks of treatment)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: 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.]))
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension
Brief Summary: A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


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: Change in mean home systolic BP for the group treated initially with monotherapy compared to the group treated initially with combination therapy. (1 year)
C: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. (3 years)
D: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension
Brief Summary: A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Options:
A: Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks (Baseline, 8 weeks, 16 weeks, and 24 weeks); Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 (Baseline to 24 weeks)
B: 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.]))
C: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)
D: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension
Brief Summary: A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Options:
A: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks
B: 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.]))
C: 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)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension
Brief Summary: A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Options:
A: composite cardiovascular events (participants will be followed for the duration of the study, an expected median follow-up 3.07 years)
B: Primary composite outcome (4 years)
C: Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD (8-12 months after stroke onset)
D: 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.]))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension
Brief Summary: A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Options:
A: N/A
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: 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.]))
D: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension
Brief Summary: A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Options:
A: To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.
B: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 (Baseline, Month 12)
C: 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.]))
D: To evaluate the number of patients who reach target blood pressure (BP) and; LDL-C targets as defined by their governing guidelines.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate the Effectiveness of Valsartan 320 mg in Combination With Lisinopril 20 mg Versus Monotherapy With Lisinopril 40 mg or Valsartan 320 mg in Hypertensive Patients With Microalbuminuria on the Reduction of Urinary Albumin Creatinine Ratio
Brief Summary: The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20 mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria (MAU).


Options:
A: To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection
B: change in Six-minutes walk test (After 6 months); Rate of occurrence of worsening renal function (through 2 months); Rates of discontinuation of- or intolerance to the used agent for RAAS inhibition (enalapril/telmisartan) (Through 6 months)
C: Change from baseline in urinary albumin excretion after 30 weeks
D: pulse wave velocity (aortic and brachial) (0, 8, 16 and 24 weeks after start of intervention)

Answer: C