TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
Brief Summary: Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.


Options:
A: Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
B: Reduction in Low density lipoprotein cholesterol (LDL-C) (week 6 and 12)
C: Change from baseline in low density lipoprotein cholesterol after 12 weeks
D: compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin (4 weeks); Area Under Curve (AUC) of rosuvastatin in renal transplant recipients treated with everolimus. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post dose. (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: a Multicentered Randomised Controlled Trial to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered
Brief Summary: To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.


Options:
A: Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos. (12 Months)
B: To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
C: Non inferiority of the improvement of the urinary distress inventory one year after treatment. (one year)
D: Non inferiority among the two groups as far as the improvement in the UDI at two years after treatment is concerned.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment
Brief Summary: I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with hypertension. I-START will be evaluated using objective outcome indices: systolic and diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and baroreflex sensitivity. The Heart and Stroke Foundation of Canada "Blood Pressure Action Plan(TM)" (BPAP) will be adminisered over a 4-month period, and evaluated in a 2 (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design, blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada), and stratified for sex and age group (45-59, 60-74 years).


Options:
A: Framingham heart risk score (1 year)
B: Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure (4 months)
C: Change in individual anaerobic threshold according to lactate kinetics during spiroergometry (6 months)
D: change in physical activity (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Cardiovascular Outcomes in African Americans With Diabetes
Brief Summary: The goal of this study is to improve cardiovascular disease (CVD) and cholesterol in African Americans adults with diabetes by addressing the modifiable risk factors of systolic blood pressure (SBP), glycosylated hemoglobin (Hb A1c), and low-density lipoprotein cholesterol (LDL-C). We will evaluate the impact of a tailored CVD risk management intervention administered by nurses via the telephone. The intervention incorporates medication management and behavioral modification and will be tailored to the needs of vulnerable high risk subjects (e.g. African Americans, low socioeconomic status, low literate). It will be integrated into community clinics, thereby enhancing the potential for benefit and generalizability to other settings.

The primary hypothesis is that among African American subjects with diabetes, a nurse administered, tailored cardiovascular risk management intervention targeting both medication management and behavioral patient self-management will decrease SBP by 5 mmHg, Hb A1c by 0.5%, and LDL-C by 20 mg/dl over 12 months relative to the cardiovascular education-only control group.


Options:
A: Patient is receiving a statin (July 2009 to April 2010)
B: hemoglobin A1c levels (at six months)
C: HbA1c (3 months)
D: Change in the outcome (SBP, Hb A1c, or LDL) from baseline to the 12 month evaluation. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Brief Summary: Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.


Options:
A: Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant (30 days)
B: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)
C: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
D: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Brief Summary: Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.


Options:
A: Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant (30 days)
B: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
C: Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks (Baseline and 24 weeks)
D: Time to All Cause Death or First Hospitalization for Worsening Heart Failure (From randomization to the end of study; maximum time on study was 73 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: C-Pulse Implantable Counterpulsation Pump (ICP) Feasibility Study - A Heart Assist System
Brief Summary: The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.


Options:
A: Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging. (6 months compared to baseline)
B: 12-month Change in Myocardial Strain (baseline and 12 months)
C: Number of Surviving Participants That Completed the Study (5 Years); Six Minute Walk Test (6 Months); Cardiopulmonary Exercise Testing (6 Months); Kansas City Cardiomyopathy Questionnaire (KCCQ) (6 Months)
D: Cardiac Ejection Fraction as Measured by Echocardiogram (12 month visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
Brief Summary: The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.

A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.


Options:
A: Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months (One Year)
B: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
C: the target vessel stroke event (within 30 days after stenting)
D: Proportion of patients with events of stroke or death (at 30 days after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
Brief Summary: The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.

A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.


Options:
A: Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months (One Year)
B: the target vessel stroke event (within 30 days after stenting)
C: Proportion of patients with events of stroke or death (at 30 days after randomization)
D: Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment. (Mean length of follow-up was 2.4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Brief Summary: Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.


Options:
A: Health related quality of life (St George's Respiratory Questionnaire) (3 months)
B: Weight of sputum expectorated during each airway clearance therapy session (40 minutes); Weight of sputum expectorated 24 hours post each bronchial session (24 hours)
C: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
D: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Brief Summary: Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.


Options:
A: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
B: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
C: 6 minute walk distance (8 weeks post exacerbation)
D: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Brief Summary: Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.


Options:
A: Sputum Wet and Dry Weight (Produced during each airway clearance therapy session on days 1 and 4)
B: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
C: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)
D: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?
Brief Summary: Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.


Options:
A: Rate of Graded Pulmonary Exacerbations (52 weeks)
B: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
C: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
D: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome
Brief Summary: Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.


Options:
A: sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness (during treatment while at altitude)
B: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
C: Obstructive Apneas (at one month of treatment); Desaturations (at one month of treatment); Sleep Time With Oxygen Saturation Below 90% (at one month of treatment); Apneas (at one month of treatment); Hypopneas (at one month of treatment); Index Apnea/Hypopnea (at one month of treatment); Mixed Apneas (at one month of treatment); Central Apneas (at one month of treatment); Index of Apneas (at one month of treatment); Index of Hypopneas (at one month of treatment)
D: Change in the number of apnea/hypopnea episodes during a sleep study (Start of study, 6 weeks after drug treatment started and 6 weeks after placebo treatment started.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (METS) - Pilot Study
Brief Summary: This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications.


Options:
A: Change in Weight From Baseline (Baseline and 52 weeks); Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline (52 weeks)
B: Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo (Measured at the last study visit)
C: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants (Baseline, 52 weeks)
D: Time from randomization to recurrence of a mood event

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (METS) - Pilot Study
Brief Summary: This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications.


Options:
A: Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo (Measured at the last study visit)
B: Glucose tolerance (Baseline - 16 weeks)
C: Change in Weight (Measured at each visit from baseline to end of study over a 12 week period)
D: Change From Baseline in Weight at 24 Weeks (baseline and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-centre, Long-term Comparative Trial of High Frequency Chest Wall Oscillation Versus Positive Expiratory Pressure Mask in the Treatment of Cystic Fibrosis
Brief Summary: This study is a preliminary study designed to determine the safety and effectiveness of HFCWO using the InCourage vest system as an airway clearance technique for the treatment of CF. The study will compare HFCWO to the most commonly used airway clearance technique in Canada, namely the Positive Expiratory Pressure technique in patients with CF over a period of one year. As this is a preliminary study, it will not be able to determine if the vest is equivelant to PEP, but will provide the information needed to plan a larger study to answer that question.


Options:
A: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
B: Average sputum production, as assessed by sputum wet and dry weights, during each treatment session.
C: Lung Clearance Index (90 minutes post treatment)
D: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-centre, Long-term Comparative Trial of High Frequency Chest Wall Oscillation Versus Positive Expiratory Pressure Mask in the Treatment of Cystic Fibrosis
Brief Summary: This study is a preliminary study designed to determine the safety and effectiveness of HFCWO using the InCourage vest system as an airway clearance technique for the treatment of CF. The study will compare HFCWO to the most commonly used airway clearance technique in Canada, namely the Positive Expiratory Pressure technique in patients with CF over a period of one year. As this is a preliminary study, it will not be able to determine if the vest is equivelant to PEP, but will provide the information needed to plan a larger study to answer that question.


Options:
A: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Hospital Length of Stay (Admission to Discharge)
D: Lung Clearance Index (90 minutes post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-centre, Long-term Comparative Trial of High Frequency Chest Wall Oscillation Versus Positive Expiratory Pressure Mask in the Treatment of Cystic Fibrosis
Brief Summary: This study is a preliminary study designed to determine the safety and effectiveness of HFCWO using the InCourage vest system as an airway clearance technique for the treatment of CF. The study will compare HFCWO to the most commonly used airway clearance technique in Canada, namely the Positive Expiratory Pressure technique in patients with CF over a period of one year. As this is a preliminary study, it will not be able to determine if the vest is equivelant to PEP, but will provide the information needed to plan a larger study to answer that question.


Options:
A: Lung Clearance Index (90 minutes post treatment)
B: Average sputum production, as assessed by sputum wet and dry weights, during each treatment session.
C: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
D: Sputum Wet and Dry Weight (Produced during each airway clearance therapy session on days 1 and 4)

Answer: C