TrialPanorama/Dataset huggingface dataset:
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: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
B: Wet sputum production (45 minutes)
C: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
D: Change in Lung Clearance Index (Immediately pre-intervention and immediately post-intervention); Change in Forced Expiratory Volume in One Second (Immediately pre-intervention and immediately post-intervention); Electronic Impedance Tomography (During intervention); Change in Impulse Oscillation System (Immediately pre-intervention and immediately post-intervention); Sputum Wet Weight (During intervention and for 30 minutes post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Cluster Randomised Controlled Trial of Flooring to Reduce Injuries From Falls in Elderly Care Units
Brief Summary: In hospitals, older people can fall and hurt themselves. The investigators want to see if a new type of flooring can help stop people hurting themselves as badly, if they accidentally fall.


Options:
A: fall-related injury (Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).)
B: Gait Velocity (Discharge (Average Duration of Hospital Stay is 3 weeks))
C: N/A
D: Patient falls over 15 months

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care
Brief Summary: The purpose of this randomized controlled trial is to test the efficacy of a novel intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care agency, self-care behaviors, and transplant-related health.


Options:
A: Self-care agency and self-care behaviors (performing of self-monitoring, adhering to the medical regimen, communicating with the transplant team) (1 year post-discharge)
B: Rx Pill Count (1 year - 1.5 years)
C: Adherence to medication (During 6 months)
D: Number of Medication Errors (1 year); Incidence and Severity of Adverse Drug Events (1 year); Severity of Medication Errors (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pragmatic, Randomized, Controlled Study Evaluating The Impact Of Access To Smoking Cessation Treatment Reimbursement On The Proportion Of Successful Quitters In A Canadian Population Of Smokers Motivated To Quit
Brief Summary: This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment.


Options:
A: Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence (Week 26)
B: 6 Month Self-reported Abstinence From Smoking (6 months)
C: smoking status (six month followup)
D: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Protective Effects of Delayed Cord Clamping in VLBW Infants
Brief Summary: The purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.


Options:
A: Hemoglobin (8 months plus/minus one month)
B: Hematologic status at 6 months of age; Iron status at 6 months of age
C: Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group (December, 2012); Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group (December 2012)
D: Motor function (18-22 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Injuries From Medication-Related Falls by Generating Targeted Computerized Alerts for High Risk Patients Within an Electronic Prescribing System
Brief Summary: Drug-related illness accounts for 5% to 23% of hospital admissions, and is now claimed to be the sixth leading cause of mortality. Older adults are at higher risk of adverse drug-related events, and medication-related fall injuries are the most common adverse event that could be potentially prevented. There are 1.2 million falls per year among Canadian elderly, at a cost of $2.4 billion in health care services, and substantial risk of loss of independence.

The overall purpose of this research program is to reduce medication-related fall injuries by using computerized electronic prescribing and drug management systems to identify high risk patients and provide physicians with patient-specific recommendations for modifying psychotropic medication use to reduce this risk.


Options:
A: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
B: rate of potentially inappropriate psychotropic medication (September 2008-July 2010)
C: rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature
D: Reduce concomitant orders for warfarin and tmp/smx (7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Injuries From Medication-Related Falls by Generating Targeted Computerized Alerts for High Risk Patients Within an Electronic Prescribing System
Brief Summary: Drug-related illness accounts for 5% to 23% of hospital admissions, and is now claimed to be the sixth leading cause of mortality. Older adults are at higher risk of adverse drug-related events, and medication-related fall injuries are the most common adverse event that could be potentially prevented. There are 1.2 million falls per year among Canadian elderly, at a cost of $2.4 billion in health care services, and substantial risk of loss of independence.

The overall purpose of this research program is to reduce medication-related fall injuries by using computerized electronic prescribing and drug management systems to identify high risk patients and provide physicians with patient-specific recommendations for modifying psychotropic medication use to reduce this risk.


Options:
A: The 2 different doses used are non-inferior to each other
B: rate of potentially inappropriate psychotropic medication (September 2008-July 2010)
C: rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (after 30 days)
D: The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder (November 2008-November 2009)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in Combination With Riluzole in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary: The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis.


Options:
A: Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) (9 months: Baseline to study termination (January 2009 - October 2009))
B: to evaluate the long-term safety and tolerability of thalidomide; to compare the total number of adverse events (AE), abnormal laboratory tests, and number of patients who completed the study between groups
C: Rate of decline of ALSFRS-R score (one year)
D: Change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study
Brief Summary: We performed a national cross-sectional and prospective large epidemiological cohort study in patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long documented by compression ultrasonography. Follow-up was three months. All events were adjudicated by a central committee.


Options:
A: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)
B: Incidence of confirmed venous thromboembolism at three months. (3 months)
C: To assess the efficacy and safety of low-molecular-weight heparin - dalteparin in patients with ST (3 months); Combined end-point: occurrence of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism or ultrasonographic blood clot progression or relapse of ST (3 months); Clinically relevant bleeding occurring (during treatment)
D: Rate of Objectively Confirmed VTE Complications (45 +/- 5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization
Brief Summary: To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).


Options:
A: Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. (9 months)
B: Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (From start of study treatment until follow-up (up to 390 days))
C: Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen (Day 1 to 12 months postdose)
D: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis (From 22 to 165 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization
Brief Summary: To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).


Options:
A: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis (From 22 to 165 minutes)
B: Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death (during approximately three years of follow-up)
C: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
D: Composite of all strokes and non-CNS systemic embolism.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
Brief Summary: The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients


Options:
A: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
B: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
C: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
D: Computed tomography ordering proportions (January 2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities
Brief Summary: The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients


Options:
A: Tobacco Abstinence - 6 Month Follow-up (6 months)
B: Failure to persist with medication regimen (6 months)
C: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
D: Modified Medication Possession Ratio (Measured over 19 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study of the TAK 491 Plus Chlorthalidone Fixed-Dose Combination Compared With TAK-491 and Hydrochlorothiazide Coadministration Therapy in Subjects With Moderate to Severe Essential Hypertension
Brief Summary: The purpose of this study is to compare the antihypertensive effect of chlorthalidone vs hydrochlorothiazide when each is used with azilsartan medoxomil, once daily (QD), in participants with moderate to severe essential hypertension.


Options:
A: Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 (Baseline and Week 7)
B: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
C: Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure (Baseline, Week 6 and Week 10.)
D: Reduction of the Estimated 10-year Total Cardiovascular Risk Score (Six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
Brief Summary: This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.


Options:
A: Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies (197 days)
B: Assessment of Primary Renal Response (12 months)
C: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN (18 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.
Brief Summary: Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.


Options:
A: Change From Baseline in HbA1c at Week 52 (Baseline and Week 52)
B: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 (Baseline, week 18)
C: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
D: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.
Brief Summary: Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.


Options:
A: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin) (Week 0, Week 26)
B: Change from baseline in postprandial glucose (baseline to 7 days)
C: N/A
D: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 (Baseline, week 18)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion
Brief Summary: The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival


Options:
A: Number of Participants With Asparaginase-Related Toxicity (30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.); Induction and Post-Induction Nadir Serum Asparaginase Activity Level (Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25.)
B: Two Year Event-free Survival (EFS) (Up to Two Year After Enrollment)
C: Efficacy of dexamethasone vs prednisone during the induction phase (5 years); Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients (5 years); Safety and efficacy of treatment reduction during reintensification in standard-risk patients (5 years); EFS after second delayed reintensification in intermediate-risk patients (5 years); Outcome after extended reintensification therapy in high-risk patients (5 years)
D: Event Free Survival (6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion
Brief Summary: The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival


Options:
A: Event free survival for all patients (January 2014); GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) (January 2014)
B: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
C: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
D: Event Free Survival (6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: 2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB
Brief Summary: Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.


Options:
A: Length of ICU stay (two weeks)
B: To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass (End of CPB)
C: Number of Dual Efficacy Endpoint Events (30 days); Number of Quad Efficacy Endpoint Events (30 days)
D: blood pressure (up to 5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Information Technology in the Primary Prevention of Type 2 Diabetes
Brief Summary: Type 2 diabetes is a major and increasing problem in India and the UK. In clinical trials it can be prevented in people at high risk by lifestyle intervention. While these trials established the proof of principle, they involved a degree of input from healthcare professionals not feasible outside the trial situation. We hypothesize that diabetes prevention can be achieved at lower cost using personalised feedback via mobile phone, based on information on healthy diet and physical activity habits. We shall develop research protocols and computerized algorithms to test this hypothesis in India for application subsequently in the UK and elsewhere.


Options:
A: 2-hour glucose levels; insulin resistance
B: Progression to diabetes (6 monthly intervals for 2 years)
C: Diabetes incidence (During the intervention period + after the intervention has been stopped)
D: Change in weight from baseline (12- and 24-months)

Answer: B