Clinical Research Directory

A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis

Atopic dermatitis is a common chronic inflammatory skin condition characterized by impaired skin barrier function, leading to increased transepidermal water loss (TEWL), dry skin, and itching. Restoration of the skin barrier is an important component of treatment. Cholesterol is a key lipid in the stratum corneum that plays a role in maintaining skin barrier integrity. This study aims to evaluate the efficacy and safety of 2% cholesterol cream in improving skin barrier function and clinical symptoms in patients with mild to moderate atopic dermatitis aged 7-17 years. Participants will be randomly assigned to receive either 2% cholesterol cream or a placebo (cream base), applied twice daily for 12 weeks. Outcomes will include measurements of transepidermal water loss (TEWL), skin hydration, skin pH, Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and pruritus numeric rating scale (NRS). The results of this study may support the use of cholesterol-containing topical formulations as a safe and effective treatment option for atopic dermatitis.

Enhancing Mental and Physical Health of Women Veterans

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

Enhancing Mental and Physical Health of Women Veterans 3.0

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)

This study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.

Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.

Identification of Asymptomatic Patients at Very High Cardiovascular Risk: Contribution of a Strategy Based on Carotid and Coronary Explorations, Compared to Simple Risk Calculation Using the European "SCORE 2" Algorithm. (IDEA-CVR)

To prevent myocardial infarction ( MI), coronary atheroma development by LDL-cholesterol deposition in the arterial wall is the basis. Since atheromatous plaques develop slowly before becoming symptomatic, their early detection in asymptomatic patients and the implementation of an effective strategy to prevent their progression constitute the most promising primary prevention strategy. In younger subjects, the main modifiable pro-atheromatous factors are smoking and an excessively high LDL-C level, partly genetically predetermined, but also favored by a diet too rich in saturated fats and a lack of physical activity. In the French national MI registry, the average age of patients is 62 years (Arch Cardiovasc Dis 2021 Oct;114(10):647-655). Half of MIs therefore occur at working age due to rupture of atheromatous plaques, which had developed during the months/years preceding the acute event. According to the latest recommendations of the European Society of Cardiology (ESC) on CV prevention published in August 2021, the visualization of coronary or carotid atheromatous plaques justifies considering the patient as having atherosclerotic cardiovascular disease (ASCVD), and automatically places them in the "very high CV risk" category, with an LDL-cholesterol target of \<0.55 g/L. However, these recommendations do not clearly define the criteria justifying the use of imaging in asymptomatic patients. In current practice, CV risk stratification for asymptomatic patients with no prior CV disease is currently based on risk calculation using the European "SCORE 2" algorithm, available online. It allows the calculation of the absolute risk in % of occurrence of a fatal or non-fatal CV event (myocardial infarction, stroke) over 10 years. The main objective of this study is to describe patients reclassified as "very high CV risk" following the detection of atheroma plaques formed in relation to their risk level estimated by SCORE2.

The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.

Despite the availability of medications, many people around the world continue to live with long-term health problems like heart disease, stroke and diabetes. In Canada, heart disease is a leading cause of death. Managing these health issues can be done by changing diet and lifestyle. Specific ways of eating have been proven to improve risk for heart disease and stroke. However, because doctors often have limited time, nutrition education, and lack of tools for counseling patients on nutrition, they can often only provide minimal support to help patients make necessary lifestyle changes. Digital tools and mobile applications offer an opportunity to involve doctors and patients in delivering nutrition interventions. This approach has the potential to save time, provide education, and reduce healthcare costs. This study is being done to understand the effect of a digital heart health program added to standard of care, compared with standard of care alone on heart health. All eligible participants in this study will be randomized (determined by chance) to one of two possible interventions: 1) a digital heart health program + standard of care; 2) standard of care. Standard is care is defined as the best practice based on guidelines for the treatment of a condition. All participants will be followed for seven years and will be asked to complete online questionnaires and complete blood work at their nearest LifeLabs clinic, as well as wear a continuous glucose monitor and wrist actigraph (at 3 time points in the first year). In addition, participants randomized to the digital heart health program + standard of care will be expected to use the heart health app and join 16 online synchronous sessions over the first year. After seven years, the intervention phase of the study will end and the study will become a cohort study. All participants at the 7-year time point will be invited to use the heart health app. As part of the cohort study, participants will be asked to continue completing the same questionnaires online and completing bloodwork at their nearest LifeLabs every four years for the duration of their participation in the cohort study. The main questions this study aims to answer are: 1. Will a digital heart health program added to standard of care result in a clinically meaningful reduction in blood cholesterol and other risk factors after 1-year compared to standard of care alone? 2. Will a digital heart health program added to standard of care result in a reduction in major cardiovascular events after 7-years compared to standard of care alone? 3. Are the observed effects sustained beyond the 7-years of the intervention? We hypothesize that the digital heart health program added to standard of care will result in a clinically meaningful reduction in blood cholesterol and other risk factors for heart disease after 1-year and reduce major cardiovascular events after 7-years compared to standard of care alone.

Interprofessional Pharmacogenomics (IPGx) Registry and Repository

This program collects genetic and health information to help doctors choose the right medications for patients.

Whey Protein Comparisons for Blood Lipid Effects

The goal of this clinical trial is to learn if hydrolyzed whey protein can help serum cholesterol stay in normal range in adults. As a side inquiry, a few blood measures will be taken that are relevant to low level inflammation. The main questions the study aims to answer are: * Will hydrolyzed whey lower serum cholesterol readings in adults with starting values in the upper end of normal to the lower end of elevated? * Will the hydrolyzed whey affect a general measure of inflammation and two measures of indirect relevance to inflammation? Researchers will compare hydrolyzed whey to a conventional whey (a control protein not expected to affect serum cholesterol readings) to see if the hydrolyzed whey lowers serum cholesterol. Participants will: * Drink one protein beverage every day for 6 weeks; * Go to a LabCorp facility for a blood draw before and after the 6 weeks.

Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

The purpose of this study is to assess whether introducing table olives into the diet results in health-related benefits for young adults. Several studies have shown that addition of olives as part of somebody's diet has a positive impact on cardiovascular, metabolic, and inflammatory factors. However, there have not been many studies among young, healthy adults. This study will compare levels of specific biomarkers, collected through blood draw, at the beginning of the study and after 5 weeks, to evaluate the effects of investigational daily olive consumption.

Natural Heart Health Supplement Trial

We are running a 3-month trial of an experimental natural heart health supplement. Participants will take a daily dose of an experimental natural heart health supplement in powdered format, chocolate flavor. The trial will assess changes in heart biomarkers such as Total Cholesterol, HDL-C, LDL-C, Triglycerides, and High-Sensitivity C-reactive protein (hs-CRP).