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NCT ID: NCT06357026 Not yet recruiting - Clinical trials for Coronary Artery Disease

Phitys I™ Percutaneous Left Ventricular Assist System Study

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.

NCT ID: NCT06357065 Not yet recruiting - Clinical trials for Physical Inactivity in Children

Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health: MOV-ES Project

MOV-ES
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The epidemic of physical inactivity affects the entire world and is responsible for more than 5 million deaths per year. The call of the United Nations, through the 2030 Agenda and the Sustainable Development Goals, encourages the creation of favorable environments for physical activity based on the ecological model of physical activity. Given this context, active transportation can be an accessible, economical, and sustainable method to increase daily physical activity. The rate of school children who use active transport has decreased, being replaced by motorized transport, causing congestion and high levels of pollution in cities. In the Chilean context, there are studies of active transportation in the Chilean population; however, they are scarce in the school population and none of them is an intervention study, demonstrating the incipient development of this area in the country. The benefits of promoting active transportation not only favor the lifestyles of school children but also include additional co-benefits such as the improvement of mental health and better academic performance, in addition to the reduction of exhaust and greenhouse gas emissions. Objectives. This proposal consists of three phases with the following objectives: Phase I: i) to synthesize the evidence about interventions aimed at estimating the effect on health of active transport in the secondary students; and ii), using qualitative techniques, to explore, from the basis of grounded theory, barriers and facilitators perceived by professors, students and parents about the development and implementation of the MOV-ES intervention. Phase II. Pilot and feasibility trial: a) to test the effect of MOV-ES intervention on improving body composition (body fat percentage and muscle mass), physical fitness (aerobic capacity and muscular strength), executive function and mental fitness (mood disorders, cognitive functioning) in the secondary students; and b), to examine the acceptability by professors, parents and students of the intervention by using ad hoc questionnaires. Phase III: to test the effectiveness of the MOV-ES intervention on physical activity, physical fitness, cognition and mental health through a cluster randomized controlled trial. Expected results: This project will give rise to the following master's and doctoral theses, with their corresponding articles of high scientific impact: 1) Barriers and facilitators of teachers, parents and students for active transport from a qualitative approach; 2) Association between the built environment, urban features, and active transportation in high school students, 3) Effectiveness of an active transportation educational intervention on physical fitness and body composition, 4) Effectiveness of an active transportation educational intervention on the cognition of schoolchildren. It is expected that the results of the MOV-ES Project will transcend the physical health of schoolchildren and will have an impact on the school community, especially by decongesting the school environment. Through these results, the Ministry of Education, regional DAEM, municipalities, and educational establishments will be able to propose public policies that favor the practice of physical activity and the acquisition of healthy habits at school age. All of the above is based on quality indicators proposed by the Education Quality Agency.

NCT ID: NCT06357728 Not yet recruiting - Clinical trials for Gestational Diabetes

Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy

I-CHAP
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test: Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure. The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT. Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes. The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT. Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis.

NCT ID: NCT06358092 Not yet recruiting - Portal Hypertension Clinical Trials

Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension

Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research.

NCT ID: NCT06358547 Not yet recruiting - Infertility Clinical Trials

Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women.

NCT ID: NCT06358989 Not yet recruiting - Insulin Resistance Clinical Trials

Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults

Start date: April 1, 2024
Phase:
Study type: Observational

The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults

NCT ID: NCT06359431 Not yet recruiting - Cervical Cancer Clinical Trials

A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Objective: The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum. In addition, establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care. Study sites: The study will be carried out in six health facilities in the centre region of Cameroon. Study Period: The study is expected to take 11 months; 4 months for protocol development and approval, 4 months for the training and implementation phase with data collection, 3 months for data analysis, reporting writing and dissemination. Study design: The study will be a multicentre, randomised control single blind trial. Patient participation will be a single study visit. Eligible subjects, consenting to participate will act as their own controls, and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum. The order of usage of the specula will be randomised, and the women will be blinded on knowing which speculum is being used at a particular time. Level of patient comfort will be evaluated using a visual analogue scale, percentage visualisation of the cervix will be determined following insertion of each of the specula, and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine. Patient population: All women between the ages of 21 years and 49 years who come in for consultation. Enrolment size: 81 women will be enrolled in the study. Study procedure: A speculum examination will be done on the day of consultation. Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires. Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum, while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine. The remote clinicians will be blinded on the diagnosis proposed by the clinician on site. Primary endpoints: The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort with the novel smart speculum compared to the Standard of care speculum (traditional speculum), reliability of the speculum in carrying out cervical cancer screening using telemedicine. Ethical considerations: The protocol will be submitted for the approval of the National Human Health Research Committee. Written informed consent will be sought for all participants before enrolment into the study.

NCT ID: NCT06359964 Not yet recruiting - Prostate Cancer Clinical Trials

Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis.

NCT ID: NCT06362980 Not yet recruiting - NSCLC Clinical Trials

A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations

EGFR
Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.

NCT ID: NCT06363682 Not yet recruiting - Clinical trials for Each Endoscopic Intervention Using X-rays

Interventional Reference Levels (IRL) in Digestive Endoscopy

EndoscopX
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure. Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure. Secondary objective(s) : - Application of regulatory texts - Assessment of patient radiation protection - Radiation protection assessment for workers