TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?
Brief Summary: The purpose of this study is to determine whether anti arrhythmic medication, specifically Amiodarone, is required during the first three months post surgical ablation.

Hypothesis: Amiodarone will not be required during the first three months as verified by no increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to include patients' first follow up with cardiologist at approximately 3 months post surgery.


Options:
A: Time to first recurrence of electrocardiographically documented, symptomatic AF or atrial flutter/tachycardia between 3 and 12 months post ablation in the absence of antiarrhythmic drug therapy. (Between 3 and 12 months post ablation)
B: 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)
C: Recurrence of atrial arrhythmia (1 year)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Aliskiren Effect on Plaque Progression In Established Atherosclerosis Using High Resolution 3D MRI (ALPINE): A Double Blind Placebo Controlled Trial
Brief Summary: This study is being done to assess the effectiveness of short term (\~9 months) Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic and abdominal aorta. This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for hypertension but in this study is used for a new indication. Recent studies with animals have shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study, the investigators would like to evaluate whether the investigational drug Aliskiren, which is not FDA approved for this indication has the same beneficial effects in people with atherosclerotic disease.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: To investigate the combined effect of aliskiren and valsartan on vascular structure, assessed by wall to lumen ratio of retinal arterioles, in hypertensive patients. (After 8 weeks of treatment with aliskiren versus placebo)
C: Change from baseline in diastolic blood pressure after 8 weeks
D: Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment (Baseline and end of treatment ( 17 to 36 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients
Brief Summary: The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for next 6 months on disease activity and progression in patients with Multiple Sclerosis.


Options:
A: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
B: Rate of Change in NAA Levels Adjusted for Water Content. (1 year)
C: Number of Participants Experiencing Serious Adverse Events (six months)
D: Expanded Disability Status Scale (EDSS) (Change from baseline at 12 months); Multiple Sclerosis Functional Composite (MSFC) (Change from baseline at 12 months); fatigue scores (Change from baseline at 12 months); depression score (Change from baseline at 12 months); Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI (Change from baseline at 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study aims to investigate metabolic effects of a standardized green tea extract, containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis patients.


Options:
A: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)
B: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
C: Number of Participants Experiencing Serious Adverse Events (six months)
D: Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo (Three months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
Brief Summary: Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.


Options:
A: Persistent wheeze (0 to 3 years of age)
B: The proportions of women who will reach the IOM defined desirable 25(OH)D level ≥20ng/ml. (At delivery); Infant bone mineral content (BMC) (one to six weeks)
C: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)
D: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
Brief Summary: Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.


Options:
A: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)
B: Proportion of participants experiencing maternal HIV progression (Second Trimester until 12 months post partum); Proportion of small-for-gestational age infants (Birth); Proportion of stunted infants (height-for-age z-score < -2) (12 months postpartum (1 year of age))
C: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
D: Persistent wheeze (0 to 3 years of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo
Brief Summary: The purpose of this study was to compare with a clinical randomized controlled split-mouth design study the changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.


Options:
A: The restoration survival (changes from baseline up to 36 months) (The treatments will be evaluated after 1 week up to 36 months)
B: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. (1year control data for all treatments primo 2008)
C: Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. (6 months)
D: Pair-wise radiographic lesion progression (1, 2, and 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Prospective Cardiovascular Patient Cohort and Biobank and Provision of Genomic Analyses With Focus on Platelet Function and Platelet Mediated Inflammatory Processes
Brief Summary: Molecular targets on platelets are pivotal for the development of new pharmacological substrates for platelet inhibition and to better understand the impact of platelet-mediated inflammatory processes for the progression of heart disease, such as coronary heart disease and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19 encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs. Therefore, a prospective patient cohort with exact phenotypic characterisation according to standardized protocols is necessary to enable the examination of the clinical relevance of potential molecular targets. A supplementary provision of high quality bio-material enables the systematic examination of new promising platelet-biomarkers in cardiovascular disease, which already have produced significant results on experimental animal and/or cell biologic models. Primary objective of the central project is to establish a prospective cardiological cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated Biobank and thus to review the clinical significance of potential targets deriving from individual subprojects within the research group (German Research Council KFO 274/1-1) to safeguard a translational approach.


Options:
A: The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke (From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))
B: Major vascular complication (for Dabigatran) (Average of 1 year follow-up); Major upper gastrointestinal complication (for Omeprazole) (Average of 1 year follow-up)
C: Mortality (4 years)
D: Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease
Brief Summary: The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.


Options:
A: Change of intrahepatic triglyceride contents (12 months)
B: Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) (48 weeks)
C: Improvement in hepatic histology (after 96 weeks of treatment)
D: Change in Liver Fat (24 weeks); Change in Liver Fibrosis (24 weeks); Change in Liver Injury (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease
Brief Summary: The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.


Options:
A: Aerobic Fitness; Resting Blood Pressure; Body Fatness; Blood Lipids; C-reactive Protein
B: Aerobic fitness (before and after the 10 week intervention)
C: Change of intrahepatic triglyceride contents (12 months)
D: Glycemic Control (0 and 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Intensive and Conventional Exercise Intervention of Nonalcoholic Fatty Liver Disease
Brief Summary: The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.


Options:
A: percent liver fat as determined by nMR spectroscopy (6 months)
B: Change of intrahepatic triglyceride contents (12 months)
C: Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS). (8 weeks after baseline)
D: Resolution of NAFLD by proton-magnetic resonance spectroscopy (Month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
Brief Summary: Ulcerative Colitis (UC) is a life-long incurable disease with remissions and exacerbations. Inflammation confined to the rectum occurs in a quarter of patients and can be extremely hard to treat. Many medications have been tried in order to control the inflammation, but they do not always work. One of the newer medications is the immunosuppressing medication, tacrolimus that has been shown to be effective in UC when taken orally. Unfortunately, the oral use of this medication can have numerous serious side effects. In order to overcome these side effects, the use of topical rectal tacrolimus has been examined. Pilot studies in ulcerative proctitis (inflammation confined to the rectum) resistant to conventional therapies have demonstrated a clinical remission in 75% of patients and although the medication was well absorbed through the lining of the bowel, the levels in the blood were very low and no serious side effects were reported. The findings suggest that this preparation is indeed effective for inflammation in the distal bowel and that the method of administration reduces side effects. Further work, however, now needs to be undertaken to validate the original findings.


Options:
A: Percentage of Participants With Remission at Week 8 (Week 8)
B: Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition) (Week 8); Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition) (Week 8); Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition) (Week 44); Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition) (Week 44)
C: Clinical response (8 weeks)
D: Percentage of Participants With Remission at Week 8 (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
Brief Summary: The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.


Options:
A: Change in atrial fibrillation burden (from Baseline and 12 months)
B: To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. (3 years)
C: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
D: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
Brief Summary: The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.


Options:
A: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
B: recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug (1 year)
C: Blood Pressure Reduction (3 months)
D: Change in systolic blood pressure (ABPM mean value) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study
Brief Summary: The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 3b and 4).


Options:
A: annual change of GFR; annual change of Ccr; annual change of 1/Cr; incidence rate of the doubling of sCr; time to the doubling of sCr
B: Primary composite endpoint (15 months after randomization)
C: changes in glomerular filtration rate (1 year)
D: Time to renal death, defined as the first event between start of renal replacement therapy or patient death (Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Adverse Pregnancy Outcome With Vitamin D Supplementation During Pregnancy
Brief Summary: We hypothesized that vitamin D supplementation during pregnancy can prevent adverse pregnancy outcome.


Options:
A: Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor (18 months)
B: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
C: Persistent wheeze (0 to 3 years of age)
D: Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement (12, 16, 28 weeks and at maternal delivery and neonatal birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster-Randomized Clinical Trial Of Two Educational Strategies In Cardiovascular Health (CVH) In Child Population. The Savinghearts Project
Brief Summary: AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º grade in the community of Madrid.

DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an experimental group that the investigators organized a concert teaching focused on messages cardio, a second group or control group to which they will host a healthy breakfast as it has been offering the Community of Madrid .

MEASUREMENTS: The primary end result is the increase of correct answers on a standardized test to be administered before and after the activity.

Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall weight and center from before the intervention at 6 months of it.


Options:
A: Body mass index percentile ranking (5 months)
B: BMI (One year)
C: Change in Knowledge and attitudes in Cardiovascular Health (Before the intervention (baseline) and 7 days after and 6 months after the intervention.)
D: Growth trajectories (using BMI, waist circumference), body composition (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Explore the Impact of Testosterone Solution 2% on Symptoms of Ejaculatory Dysfunction in Men With Testosterone Deficiency
Brief Summary: The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.


Options:
A: Change from baseline on the total score of the AMS rating scale (Month 6)
B: Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks (Baseline, 16 weeks)
C: Lean body mass (approximately three years)
D: waist-to-hip ratio (3 years)

Answer: B