TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Brief Personalized Feedback Intervention in University Students
Brief Summary: Excessive alcohol consumption in university students continues for be a serious public health concern with a variety of negative consequences. There have been a number of different brief interventions developed to address this issue among university students. The current project will add to this literature by evaluating the use of a personalized feedback intervention (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine whether providing access to the CYDU will result in short-term reductions in drinking. This issue is important as use of these interventions is not a mandatory requirement for university students so the issue is whether making materials of this type available leads to any reductions in risky drinking. It is hypothesized that students provided access to the CYDU will display greater reductions in drinking at a six-week follow-up as compared to students who were not provided access to the CYDU.


Options:
A: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)
B: Montgomery Asberg Depression Rating Scale (3 month)
C: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)
D: Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period. (Measured on all participants included one time a month for six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Wireless Technology in Clinical Practice: Does Feedback of Daily Walking Activity Improve Walking Outcomes of Individuals Receiving Rehabilitation Post-stroke?
Brief Summary: Regaining independent walking is the top priority for individuals recovering from stroke. Thus, physical rehabilitation post-stroke should focus on improving walking function and endurance. However, the amount of walking completed by individuals with stroke attending rehabilitation is far below that required for independent community ambulation. There has been increased interest in accelerometer-based monitoring of walking post-stroke. Walking monitoring could be integrated within the goal-setting process for those with ambulation goals in rehabilitation. The purpose of this study is to determine the effect of accelerometer-based feedback of daily walking activity during rehabilitation on the frequency and duration of walking post-stroke.


Options:
A: N/A
B: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)
C: N/A
D: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Wireless Technology in Clinical Practice: Does Feedback of Daily Walking Activity Improve Walking Outcomes of Individuals Receiving Rehabilitation Post-stroke?
Brief Summary: Regaining independent walking is the top priority for individuals recovering from stroke. Thus, physical rehabilitation post-stroke should focus on improving walking function and endurance. However, the amount of walking completed by individuals with stroke attending rehabilitation is far below that required for independent community ambulation. There has been increased interest in accelerometer-based monitoring of walking post-stroke. Walking monitoring could be integrated within the goal-setting process for those with ambulation goals in rehabilitation. The purpose of this study is to determine the effect of accelerometer-based feedback of daily walking activity during rehabilitation on the frequency and duration of walking post-stroke.


Options:
A: Jette Late Life Functional and Disability Instrument (LLFDI) (3 months)
B: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))
C: Rate of recruitment to the studies (12 weeks (pilot study))
D: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Treatment With Aldosterone Antagonism Attenuates Cardiomyopathy in Duchenne Muscular Dystrophy
Brief Summary: Duchenne muscular dystrophy (DMD), the most common muscular dystrophy, leads to skeletal and cardiac muscle damage. Treatment of pulmonary complications has improved survival; however, heart muscle disease or cardiomyopathy has emerged as a leading cause of death, typically by the third decade. Although myocardial changes begin early, clinically significant heart disease is rarely detected in the first decade of life. Consequently, DMD cardiomyopathy frequently goes unrecognized (and untreated) until advanced (and irreversible).

Current DMD cardiovascular care guidelines recommend beta-blockers and angiotensin converting enzyme inhibitors (ACEIs) when decreased ejection fraction (EF) is noted by echocardiography (echo); however, this strategy has not significantly improved outcomes. Our team has recently made a breakthrough in a mouse study, showing in a model that causes the same heart muscle disease in humans with DMD adding an old medicine traditionally used for high blood pressure and late-stage heart failure can actually prevent heart muscle damage. Because of this drug's proven safety in both children and adults, it is ready to be studied immediately in an RCT in patients with DMD to hopefully show, as we did in mice, that we can prevent the devastating consequences of heart muscle damage.


Options:
A: 12-month Change in Myocardial Strain (baseline and 12 months)
B: Cardiac Ejection Fraction as Measured by Echocardiogram (12 month visit)
C: To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD (48 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis
Brief Summary: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.


Options:
A: Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52. (Baseline and Week 52)
B: RA inflammatory activity over 18 months based on repeated DAS28 measures (over 18 months)
C: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring (Week 104 in RA0055 Period 2)
D: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan
Brief Summary: To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.


Options:
A: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
B: Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) (Baseline and Week 12)
C: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)
D: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Care Rehabilitation After Acute Coronary Syndrome
Brief Summary: Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people suffering from Heart Disease. It involves;

* Dietary counseling,
* Exercise training,
* Psychosocial support,
* Physician
* smoking cessation
* Patient education

The purpose is quick and complete recovery and to reduce the chance of recurrence.

In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital based cardiac rehabilitation at discharge.

The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the Regions, who runs the hospitals, to the municipalities.

Shared care is in this setting that elements of treatment are completed different places in Health Care.

The aim of this study is:

* to establish a shared care model for Cardiac rehabilitation following admission with Acute Coronary Syndrome and
* to compare this model to the existing hospital based cardiac rehabilitation after admission with Acute Coronary Syndrome.

Primary outcome is participation in cardiac rehabilitation.


Options:
A: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
B: Participation in cardiac rehabilitation (4 months)
C: Mortality rate (10-year)
D: Cardiopulmonary function (Measured at Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study
Brief Summary: There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.


Options:
A: Proportion of Patients With Complete TMA Response (Through 26 weeks)
B: The effect of OMS721 as measured by platelet count change from baseline (26 weeks)
C: TMA complication-free survival (5 Years)
D: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)
Brief Summary: Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery?


Options:
A: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
B: Pain While Active - 18 hr (18 hours); Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery (24 hours)
C: Urinary Tract Infections (three weeks post-operative)
D: To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures. (Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects With Paroxysmal Atrial Fibrillation
Brief Summary: The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment. AFB is defined as the total time a participant is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.


Options:
A: Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug (6 weeks)
B: Atrial Fibrillation Burden (AFB) at Baseline (Baseline); Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12 (Baseline; Week 12); Absolute Change From Baseline in AFB by Week 12 (Baseline; Week 12)
C: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
D: Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation (3, 6, 12 weeks and 6 months post-procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.
Brief Summary: Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to the liver. This is major surgery that offers a chance of cure, but can be associated with complications. Fitter patients are less likely to have serious complications. We are interested in finding out whether a short exercise program can improve patient fitness before surgery and whether this can reduce surgical complications.

We plan to measure the fitness of patients who are going to have liver surgery. We will then give them an exercise programme for 4 weeks, after which we will assess their fitness again.

We are also interested in whether fitter people have better Liver function. To assess this we will take a small sample of liver tissue during the operation for laboratory analysis of its function.

Hypothesis

1. A short period of exercise can significantly improve fitness prior to liver surgery
2. Greater Fitness is associated with better liver function.


Options:
A: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
B: Anaerobic threshold prior to liver resection (4 weeks)
C: Oxygen consumption (VO2) (4 weeks (before surgery))
D: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.
Brief Summary: Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to the liver. This is major surgery that offers a chance of cure, but can be associated with complications. Fitter patients are less likely to have serious complications. We are interested in finding out whether a short exercise program can improve patient fitness before surgery and whether this can reduce surgical complications.

We plan to measure the fitness of patients who are going to have liver surgery. We will then give them an exercise programme for 4 weeks, after which we will assess their fitness again.

We are also interested in whether fitter people have better Liver function. To assess this we will take a small sample of liver tissue during the operation for laboratory analysis of its function.

Hypothesis

1. A short period of exercise can significantly improve fitness prior to liver surgery
2. Greater Fitness is associated with better liver function.


Options:
A: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
B: Anaerobic threshold prior to liver resection (4 weeks)
C: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
D: Six Minute Walk Test (6MWT) (up to 8 weeks after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters
Brief Summary: The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.


Options:
A: UTIs (Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).)
B: Quality of Life (0-100 Point) (6 weeks)
C: Mean Residual Urine Volume (3 catheterisations on 1 day)
D: Percentage of Participants (1 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Use of Rapid Molecular Testing for Staphylococcus Aureus for Patients With Cutaneous Abscesses in the Emergency Department With Standard of Care.
Brief Summary: This study expands upon pilot data for feasibility since May 2011. The study aims to evaluate the effect of rapid test availability on use of targeted spectrum antibiotics for non-MRSA abscesses in ambulatory patients in the Emergency Department (ED). The multi-institutional study will assess the feasibility of providing the GeneXpert® MRSA/SA SSTI assay to the ED and evaluate the impact of delivering the test result to clinicians in real-time on patient management decisions regarding the use of antimicrobial agents. Patients are randomized to standard culture (control arm) or to the GeneXpert® assay plus standard culture.


Options:
A: Number of bacteraemia and of fungemia - overall - each condition (max Day 30)
B: Duration of Antimicrobial Therapy (Hours) (Approximately 4 days after enrollment)
C: Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis. (After fourteen days of antimicrobial treatment)
D: Number of Participants With Antibiotic Usage at the Time of the ED Visit (Baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The RITA-study -- An Open Study to Evaluate the Blood Lipid Lowering Effect of Rosuvastatin Versus Fluvastatin and the Bilateral Interaction Between Everolimus and Rosuvastatin in Renal Transplant Recipients
Brief Summary: Renal transplant recipients need life long immunosuppression and one of the new drugs is everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects are increased blood cholesterol levels. Many renal transplant recipients are treated with a cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering drug on the market with a potential higher cholesterol lowering potency. In the present study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels more than fluvastatin in renal transplant patients.


Options:
A: Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
B: 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)
C: Change from baseline in low density lipoprotein cholesterol after 12 weeks
D: Reduction in Low density lipoprotein cholesterol (LDL-C) (week 6 and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin
Brief Summary: The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrine tumor (NET) of gastrointestinal (GI) or lung origin without a history of, or current symptoms of carcinoid syndrome.


Options:
A: Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment (From date of randomization to progression or death, whichever comes first, assessed up to 27 months)
B: Progression Free Survival (PFS) (From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months)
C: Percentage of Days With Subcutaneous Octreotide as Rescue Medication (16-week DB phase)
D: Proportion of Patients Alive and Progression-free at 6 Months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects
Brief Summary: The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to determine the accuracy, efficiency, costs, and cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including the novel Xpert MTB/Rif test.


Options:
A: To compare the characteristics of subjects with relapsed tuberculosis verses the characteristics of subjects that do not experience relapse disease (Over course of the study)
B: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
C: All-cause mortality (8 weeks)
D: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)

Answer: D