TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study to Explore the Efficacy and Feasibility of Upfront Bi-monthly Rotations Between Everolimus and Pazopanib in Patients With Advanced or Metastatic Clear Cell Renal Cancer
Brief Summary: In this study will be examined whether alternating treatment between two classes of drugs (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal cancer.


Options:
A: Progression free survival (Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year)
B: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)); Overall Survival (OS) (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months))
C: Progression-free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years))
D: Progression Free Survival (PFS) (From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study to Explore the Efficacy and Feasibility of Upfront Bi-monthly Rotations Between Everolimus and Pazopanib in Patients With Advanced or Metastatic Clear Cell Renal Cancer
Brief Summary: In this study will be examined whether alternating treatment between two classes of drugs (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal cancer.


Options:
A: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
B: Progression free survival (Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year)
C: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation
Brief Summary: The aim of this study is to determine whether using a smaller wire results in a higher success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence of adverse events


Options:
A: Post-ERCP Pancreatitis (5 days)
B: The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal (30 days after ERCP); The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis (30 days after ERCP)
C: Percentage of successful selective biliary cannulation
D: Post-ERCP pancreatitis (30 days after ERCP)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Embryo Transfer of a Euploid Embryo Versus Double Embryo Transfer: A Randomized Controlled Trial
Brief Summary: This study seeks to compare the pregnancy and delivery rates of patients who undergo a single embryo transfer, when the embryo has been tested and determined to be chromosomally normal, with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer of untested embryos.


Options:
A: Ongoing Pregnancy (Gestational Age of 20 Weeks)
B: Live birth rate per randomized patient (single embryo transfer vs. 2 embryo transfer) (2 years)
C: Sustained Implantation Rate Per Embryo Transferred (Within 1 year)
D: live born delivery rate (at birth of the child)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis
Brief Summary: The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.


Options:
A: Remission rates at 6 months (6 months)
B: Number of major relapse (BVAS>10) in each group at the end of the maintenance treatment (18 months treatment + 10 months follow-up) (28 months)
C: Disease free period, time from remission to relapse or study end.
D: Renal recovery (Three months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: PROgenitor Cell Release Plus Exercise to Improve functionaL Performance in PAD: The PROPEL Study
Brief Summary: The PROPEL study will test the hypothesis that GM-CSF combined with supervised treadmill exercise will significantly improve functional performance in patients with PAD more than GM-CSF alone or supervised treadmill exercise alone. In addition to identifying novel therapeutic options for patients with PAD, the current proposal is expected to identify mechanisms by which functional impairment is improved in patients with PAD.


Options:
A: Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 (13 weeks)
B: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
C: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)
D: Peak Walking Time (at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PROgenitor Cell Release Plus Exercise to Improve functionaL Performance in PAD: The PROPEL Study
Brief Summary: The PROPEL study will test the hypothesis that GM-CSF combined with supervised treadmill exercise will significantly improve functional performance in patients with PAD more than GM-CSF alone or supervised treadmill exercise alone. In addition to identifying novel therapeutic options for patients with PAD, the current proposal is expected to identify mechanisms by which functional impairment is improved in patients with PAD.


Options:
A: Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment); Ankle brachial pressure indices(ABPI) measured at rest and post exercise (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment)
B: maximum walking distance (one year)
C: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)
D: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
Brief Summary: Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.


Options:
A: Eclampsia (24 hours postpartum)
B: Magnesium concentration (00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00)
C: Need to continue therapy for another 12 hours. (24 hours)
D: Time of magnesium sulfate therapy (minutes); Blood pressure; Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Weight Loss on Portal Pressure in Patients With Compensated Cirrhosis and Overweight/Obesity
Brief Summary: Overweight/obesity is increasing both in the general population and in patients with cirrhosis. In compensated patients with cirrhosis increased BMI is a risk factor for clinical decompensation independent of liver function and portal pressure. Nonetheless, patients with cirrhosis and obesity show a progressive increase in portal pressure, which might explain their increased risk of complications. Since obesity is a potentially modifiable risk factor, we designed this proof-of-concept study to assess the effects of weight loss (obtained by 4 months of diet and exercise) on portal pressure in patients with compensated cirrhosis and overweight/obesity.


Options:
A: Change in peak exercise pulmonary oxygen uptake (VO2peak). (Baseline (day 1) and Study End (8 weeks))
B: Improvement in QOL questionnaires (3 months); Lack of deterioration in portal hypertension (3 months)
C: HVPG change (4 months)
D: Chronic Respiratory Questionnaire (At least 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
Brief Summary: Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.


Options:
A: Recurrence of pleural effusion (2 months following intervention)
B: Survival at 1 year after treatment (1 year)
C: Feasibility of recruiting 30 patients within 12 months and randomising them to either EDIT Management or Standard Care (12 months)
D: To measure the standard deviation of Visual Analogue Scale scores for breathlessness (Daily from randomisation to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy
Brief Summary: Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures.

Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.


Options:
A: HRQOL urinary irritative score (12 month)
B: change in physical activity (6 months)
C: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)
D: Gain in range of movement measured in degrees (Three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy
Brief Summary: Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures.

Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.


Options:
A: Accelerometer, average counts of dynamic acceleration (physical activity) (1 week at baseline and at 12 months)
B: Hematological and Immunological Recovery (This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT))
C: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)
D: Fatigue (immediately before and after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Care Intervention Research-Quality of Prenatal and Maternal Care: Bridging the Know-do Gap (QUALMAT)
Brief Summary: Besides a dramatic lack of financial and human resources in developing countries, health care is additionally endangered by quality deficiencies caused by low staff motivation. This lack of motivation leads to an insufficient translation of knowledge into optimal utilization of resources. The "know-do" gap represents a challenge that must be addressed to strengthen health services performance towards achieving the Millennium Development Goals (MDGs). This is in particular true for some sensitive sectors like pre-natal and maternal health care. General objective of this research is to improve maternal health through better pre-natal and maternal care services offered by better motivated health workers. A computer-assisted clinical decision support system (CDSS) will be developed, implemented and tested aiming at (I) quality improvement of maternal and newborn care and (II) assessment of provider's performance. Based on this tool a commonly agreed incentive scheme to increase motivation will be shaped and tested in three SSA - countries, namely Burkina, Ghana, and Tanzania.

The incentive scheme might contain both non-monetary and monetary incentives and will be designed according to the human resource policy in the three countries. The planned approach is an implementation study with control arms containing one hospital and 6 first line health facilities in each of the study districts and an equal number of facilities in the control arm. A set of indicators for measurement of changes in quality of delivered services will be identified in order to follow up the sustainability and effectiveness of the strategies after their implementation. The study findings will allow understanding the important factors of staff motivation and facilitate adequate management for improvement of maternal and neonatal health care. "Knowing is not enough, we must apply; Wanting to do, is not enough, we must do it1"

- J.W. v. Goethe


Options:
A: Referral Rates to Local Hospitals (Month 7, Month 12); Number of Neonatal Deaths (Month 12)
B: Use of IV fluid (Intervention is 3 months per hospital)
C: motivation (2 years)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Detection and Progression of Subclinical Atherosclerosis and Its Relationship to Coronary Risk Factors
Brief Summary: The overall objective of this study is to characterize the prevalence and progression rate of subclinical atherosclerotic lesions and to study their association to the imaging characteristics of atheroma plaques and to the presence of genetic, epigenetic, metabolomic, and environmental factors, including dietary habits, physical activity, biorhythms, psychosocial characteristics, and exposure to environmental pollutants


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: Changes in adipose tissue (Baseline and 3 months and 6 months)
C: Triglyceride level, glycated hemoglobin level, fasting plasma glucose (baseline and every 3 months during year 1, every 6 months therafter)
D: To assess the prevalence and 6-year progression rate of subclinical atherosclerotic disease in a population aged 40-54 years using basic and advanced cardiovascular imaging techniques. (20 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial
Brief Summary: The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered implementation intention intervention and a standard recommendation group on physical activity behaviour and (b) document the effects of these interventions on quality of life (QoL), fatigue, symptom management, and physical functioning.

Hypotheses: Evidence exists that an implementation intention intervention can lead to significant improvements in PA levels and that regular PA has been shown to improve QoL, fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the researcher-assisted implementation intention intervention will have higher PA levels at the 1- and 3-month follow-ups compared to the self-completed implementation intention intervention and the standard recommendation group; (2) prostate cancer survivors in the researcher-assisted implementation intention intervention will show significant improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the self-completed implementation intention intervention and the standard recommendation group at the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed implementation intention intervention will have higher PA levels, and better improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the standard recommendation group at the 1- and 3-month follow-ups.


Options:
A: Change in Physical activity Levels From Baseline to Month 1 and Month 3 (baseline, 1 month, 3 months)
B: Six Minute Walk Distance 6MWD (Change from baseline in 6MWD at 12 weeks)
C: FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires (6 months)
D: Medical Outcomes Survey-Short Form (SF-36, acute) (pre-chemotherapy baseline, 6 weeks post-1st infusion, & 12-weeks post-initial infusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Brief Summary: A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to \<18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).


Options:
A: Spleen Volume (60 months)
B: PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo (PAP Baseline (Day 1), Week 39)
C: Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period (Baseline up to Week 52); Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP (Week 52 up to week 208)
D: Hemoglobin (Baseline, months 9, 12 and 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Catheter Ablation Versus Medical Treatment of AF in Heart Failure
Brief Summary: Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.


Options:
A: Difference in ejection fraction between groups (6 months)
B: Peak oxygen consumption at cardiopulmonary exercise test (12 months)
C: Number or patients with a recurrence of any atrial arrhythmia (2 years)
D: Atrial fibrillation burden (Two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Diet on Body Composition
Brief Summary: The purpose of this study is to compare a diet containing whole grains versus an energy matched diet using refined grains on body composition and metabolism.


Options:
A: Change in Hemoglobin A1c (6 months); Change in Fasting Glucose (6 months)
B: Variation of serum polyphenol concentration (1 year); Variation of plasma lipids (1 year)
C: Microbiota diversity (one year); Inflammation, CRP (2 months)
D: Change in body composition (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Diabetes
Brief Summary: Diabetes is a common and serious chronic disease. However, there is a large gap between the level of care that people should receive (based on research and guidelines) and the level of care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the Canadian Diabetes Association has a strategy to improve heart disease screening and treatment for people with diabetes. This study will evaluate whether the strategy works. The focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them delivery better care for their diabetic patients. In Ontario, only half of doctors received this Toolkit. We will compare the quality of care received by diabetic patients whose doctors received this Toolkit versus those who doctors did not.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: A1c (January 2005-present); Blood Pressure (January 2005-present); Lipids (January 2005-present)
C: HbA1c; Muscular strength
D: Death or non-fatal myocardial infarction (Up to 10 months)

Answer: D