Personalized Responses to Dietary Composition Trial 3
DiabetesHeart Diseases6 moreThe PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.
Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease
Cognitive TherapyAnxiety Disorders1 moreThe hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. The aim of Heart & Mind Trial is (I) to determine the type of anxiety in cardiac patients and (ii) to investigate the effect of individual cognitive behavioural therapeutic intervention to reduce anxiety in patients with cardiac disease and anxiety compared to usual care.
Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass...
Congenital Heart DiseaseCongenital Heart Defect1 moreThe goals of this study are: To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery. GFAP will be analyzed via an enzyme-linked immunosorbent assay (ELISA) kit. Patients will also be monitored post-operatively for delirium in the intensive care unit (ICU). To evaluate the renal protective effect of nitric oxide by measuring neutrophil gelatinase-associated lipocalin (NGAL) before and after surgery. NGAL will also be analyzed via an ELISA kit. Patient creatinine will be monitored post-operatively. To evaluate effect of nitric oxide on other ICU outcomes (invasive mechanical ventilation, days to extubation, ICU and hospital length of stay, and blood product administration).
The Soy Treatment Evaluation for Metabolic Health (STEM) Trial
Metabolic SyndromeOverweight and Obesity11 moreStrategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.
Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary...
Contrast-induced NephropathyChronic Kidney Diseases1 moreContrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI. Many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ACE-Is prior to coronary angiography, and whether it decreases or increases the risk of CIN. The importance of this study is to help find an acceptable and reliable answer for the use of ACE-I/ARBs prior to cardiac catheterization. This research aims to study the effect of withholding ACE-Is or ARBs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (GFR<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ACE-I/ARBs pre contrast administration.
Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease...
Rheumatic Heart DiseaseRheumatic Heart Disease in ChildrenThe overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.
Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease
Prediabetic StateCoronary Heart Disease2 moreTo evaluate the feasibility of a 6-month multidisciplinary program to reverse prediabetes in adults with coronary heart disease using the Mediterranean diet, intermittent fasting and exercise.
Effect of Muscle Strengthening Training in Adults With Fontan Circulation
Congenital Heart DiseaseUniventricular HeartAim: to evaluate the effect of muscle strengthening exercise training in adults with Fontan circulation compared to healthy controls. Hypothesis: adults with Fontan circulation have a relatively lower effect of muscle strengthening exercise training compared to healthy controls.
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart...
Congenital Heart DiseaseChild Development2 moreThe proposed study aims to determine the feasibility of the procedures for a future full randomized controlled trial (RCT), which will test the efficacy of a parent-child yoga intervention in reducing attention deficits in children with congenital heart disease (CHD). Specific aims of this single-blind, two-arm, two-center feasibility trial are to evaluate recruitment rates and capacity, withdrawal and dropout rates, adherence to the intervention, acceptability of the randomization process by families, variation in delivery of the intervention between yoga instructors, and standard deviation of main outcomes of the future RCT in order to determine its appropriate sample size. This feasibility study will lead to the first ever RCT to test the efficacy of an intervention strategy for reducing attention deficits in children with CHD. Ultimately, the implementation of this parent-child yoga program will lead to better long-term academic and psychosocial functioning and quality of life for these children and their family.
Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda
Rheumatic Heart DiseaseThe goal of this prospective study is to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease (RHD) in Uganda.