Clinical Research Directory

Implementing PrEP for Women Who Inject Drugs

Women who inject drugs are among the most vulnerable to acquiring HIV, but very few women who inject drugs are prescribed pre-exposure prophylaxis (PrEP) for HIV prevention largely due to barriers within our healthcare system. This research will consider the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP to women who inject drugs, thereby reducing new HIV infections in this population.

Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology

Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.

DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores

DEL-DIP is a prospective observational study employing a Delphi methodology (at least two online rounds) to elicit and consolidate the views of an expert panel within the INNOPREV project. The study aims to develop operational recommendations to support the coordinated implementation of Polygenic Risk Scores (PRS) and wearable devices in cardiovascular prevention. Specifically, it addresses the following research question: which recommendations and requirements-genomic, digital, and clinical/organizational-are necessary to integrate PRS and wearable technologies into routine practice and healthcare services, and for which of these elements do experts achieve consensus (defined as a Content Validity Index, CVI, \> 79%)

Effect of the SCOT-HEART 2 Trial on Lifestyle.

This study will recruit 400 participants who are taking part in the Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (SCOT-HEART 2) trial. The investigator will assess diet, activity and habits at the start of the study and 6 months later. This will help us understand the effects taking part in the study may have on lifestyle. In addition, for participants who have CT scans, the investigator will present the results of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to patients.

GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification

A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification

Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients

The prevalence of dyslipidemia is high among patients with hypertension and diabetes mellitus, which increases the risk of cardiovascular disease. However, many patients lack awareness and adherence to treatment and lifestyle modifications. Therefore, a more structured and intensive approach to management and education is required. This study aims to implement intensive dyslipidemia management and education for patients registered at the Hanam City Hypertension and Diabetes Education Center and evaluate changes in blood lipid levels accordingly. Additionally, the study will analyze the impact of intensive education on patients' quality of life, health behaviors, and treatment adherence, ultimately contributing to the development of effective management strategies.

Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention

\[Purpose of the Clinical Study\]:The purpose of this study is to conduct a clinical comparison of low-dose rosuvastatin plus ezetimibe combination therapy and high-dose rosuvastatin monotherapy in patients with minimal to intermediate coronary artery disease without percutaneous coronary intervention to confirm non-inferiority in the reduction of key cardiovascular events. \[Hypothesis\]:In patients who have not undergone percutaneous coronary intervention for minimal to moderate coronary artery disease, low-dose rosuvastatin and ezetimibe combination therapy are non-inferior in terms of reducing major cardiovascular events compared to high-dose rosuvastatin monotherapy.

Non-pharmacological Prevention of POD in Frailty Elderly Undergoing Elective Surgery Applied by Nursing Teams

The increase in the population over 60 years of age who could receive surgery due to changes in life expectancy and advances in surgical and anesthetic techniques. Likewise, elderly people (EP) may have a higher risk of postoperative morbidity and mortality compared to young people, with frailty being one of the risk factors that increases adverse outcomes in this period and increases the probability of developing syndromes such as postoperative delirium (POD). Assessment of frailty in EP prior to surgery is not routine, so it is unknown how many frail and/or pre-frail EP undergo surgery in health care systems. There is an association between being frail and developing greater delirium and/or postoperative cognitive deficit, which in summary translates into an increase in perioperative morbidity and mortality. For the prevention of POD, there are pharmacological and non-pharmacological measures that seek to promote orientation with respect to their environment and make it as familiar as possible, stimulate early aspects of memory and thinking skills, as well as promote sleep using environmental hygiene measures. In Chile, protocols of non-pharmacological measures have been proposed by occupational therapy teams, which have had positive results in reducing POD in frail elderly patients. These measures are temporal-spatial reorientation, physical mobilization, correction of sensory deficits, environmental management, sleep protocol, and reduction of anticholinergic drugs with statistically significant results in the reduction of POD. In accordance with the above, the objective of this study is to evaluate the impact of non-pharmacological measures applied by the nursing team in reducing the incidence of POD during the post-surgical period in fragile and pre-fragile EP undergoing elective non-cardiac surgeries. It is expected that in the end, frail and pre-frail EP who receive non-pharmacological interventions by the nursing team will present a lower incidence of POD at 24 hours compared to those who receive traditional care.

LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering

Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk. There is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.

Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.

FIT FIRST Teen - School Intervention Study

The goal of this cluster randomised controlled trial is to investigate the effects of the FIT FIRST Teen program on adolescents' physical fitness, motivation, and well-being, as well as the implementation of such a program within schools. The main questions it aims to answer are: Research Question 1: Does the FIT FIRST Teen program improve cardiorespiratory fitness, body composition, and muscle strength among adolescents? Research Question 2: Does the FIT FIRST Teen program improve well-being, motivation towards physical activity, and body image among adolescents? Research Question 3: What are the challenges that teachers and schools will face regarding the implementation of the FIT FIRST Teen program? The research team will compare the FIT FIRST Teen program to a control (usual physical education curricula) to see if such a program improves adolescents' physical fitness, motivation, and well-being. Participating schools will: * Participate in a training course, where the core principles of the FIT FIRST Teen program will be delivered. * Implement the FIT FIRST Teen program for a full school year (three 45-minute lessons a week). * Keep a logbook where the weekly practised activities will be reported.

The Parental Journey. Digital Tool for Security in Parenthood, a Way to Promote Public Health. A Pilot Study.

The goal of this randomized clinical pilot study is to evaluate the feasibility and experience of the internet-based parental support program "Parenting - a journey together". This program is intended to be delivered via the national Support and Treatment Platform and used within primary care to enhance traditional parental support within child health care when needed. The main questions it aims to answer are: 1. Is the digital parental support intervention feasible and helpful within primary care? 2. How do parents perceive the program "Parenting - a journey together"? 3. Does the program increase the sense of parental ability and security in parenting by reflecting on attitudes and approaches in interaction with the child? Participants in this study will be parents of children aged 2-5 years who have expressed interest in participating in the study and in the parental support program. Participants will be randomized into either the intervention group or the control group. Participants will be asked to complete validated questionnaires measuring the parent-child relationship, perceived parental ability, stress, and well-being before and after the parental support program, and again after 3 months. These results will then be compared with those of the control group.The knowledge gained from the pilot study can contribute to the development of digital parental support interventions within primary care. If the pilot study proves that the interactive digital parenting program is feasible for use in child health centers and is perceived as helpful by parents, a larger randomized controlled (RCT) study, (not included in this application) will be conducted to evaluate its effectiveness.