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NCT ID: NCT06171360 Recruiting - Breast Cancer Clinical Trials

A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors

CICLIBIOME
Start date: November 15, 2022
Phase:
Study type: Observational

Ciclibiome is a prospective study including BC patients starting treatment with a CDK4/6 inhibitor (in the metastatic and in the adjuvant setting). This study will focus on the interplay between the gut microbiome (its composition and evolution during treatment), circulating immune, metabolic and cytokine biomarkers (before and during treatment), and response outcomes to the CDK4/6 inhibitor. The main aim of the study is to highlight the existence of a microbial, immune and/or metabolic biomarker of response to CDK4/6 inhibition in BC, assessable by a stool or blood sample examination. Ultimately, this will allow to study new potential combination partners for CDK4/6 inhibitors in escalation trials for poor prognosis patients.

NCT ID: NCT06171204 Recruiting - Knee Arthrosis Clinical Trials

The Use of Stromal Vascular Fraction for Knee Arthrosis

Start date: September 19, 2022
Phase: N/A
Study type: Interventional

A trial to investigate the safety and efficacy of SVF for the treatment of knee arthrosis. Patients will undergo a single liposuction to obtain the SVF. The SVF will then be isolated and frozen in our laboratory. The SVF will then be injected up to 2 times into the fat pad of the patient's knee.

NCT ID: NCT06171191 Recruiting - Sleep Clinical Trials

Move ARound And Get Active: an Intervention to Optimize 24-hour Movement Behaviours in Preschoolers

MARGA
Start date: July 27, 2023
Phase: N/A
Study type: Interventional

In 2019, the World Health Organization established new guidelines for physical activity, sedentary screen time, and sleep for children under 5 years old. Unfortunately, only a few (6%) of preschoolers in Flanders, Belgium, adhere to these guidelines. The aim of this study is to test a health program developed to optimize 24-hour behaviors in preschoolers and encourage more children to follow the guidelines. The program was created using the Intervention Mapping Protocol in collaboration with parents. It consists of seven sessions for parents and preschoolers, providing strategies to encourage compliance with the guidelines. The program's effectiveness will be evaluated through a randomized controlled trial, with the intervention group attending the sessions and the control group receiving the intervention materials at the end of the study.

NCT ID: NCT06169761 Recruiting - Healthy Clinical Trials

Tongue Protrusion Assessment in Healthy Adult (FLEPI)

Start date: December 11, 2023
Phase:
Study type: Observational

This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).

NCT ID: NCT06168409 Recruiting - Clinical trials for Resistant Hypertension

A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Bax24
Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

NCT ID: NCT06166680 Recruiting - Healthy Clinical Trials

Tongue Muscular Assessment in Healthy Children

TMAC
Start date: December 1, 2023
Phase:
Study type: Observational

This study aims to obtain normative values for tongue motor functions in healthy children.

NCT ID: NCT06163391 Recruiting - Clinical trials for Advanced Solid Tumor

A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer

Start date: May 9, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined

NCT ID: NCT06162858 Recruiting - Healthy Clinical Trials

Reaching Motion During Functional Activities

REACHRSA
Start date: October 15, 2023
Phase: N/A
Study type: Interventional

Taking and moving objects is essential. When this becomes difficult, it affects daily functioning. This study aims to determine movement patterns, at the level of the shoulder, during different functional movements in elderly people aged 60 years and older. Movement patterns of people without shoulder problems and patients with a reverse shoulder prosthesis will be compared. These insights can contribute to improving functional rehabilitation in patients with a reverse shoulder prosthesis (RSA).

NCT ID: NCT06159231 Recruiting - Clinical trials for Coronary Artery Disease

FAME II-10-year Follow-Up

FAME2-10yFU
Start date: April 25, 2023
Phase:
Study type: Observational

The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.

NCT ID: NCT06158464 Recruiting - Return to Work Clinical Trials

The Effectiveness of a Functional Capacity Evaluation Among Persons on Sick Leave or Work Disability

FCE
Start date: September 14, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate Functional Capacity Evaluations in persons on sick leave or work disability. The main questions it aims to answer are: - What is the impact of FCE on the person on sick leave/work disability (quantitative) - What is the impact of FCE on the decision-making process by the medical advisor? (qualitative) - What is the usability, feasibility and quality of FCE for the medical advisor, occupational therapist, mediators of the regional services, and return-to-work coordinators? (qualitative) This is a randomized controlled trial (RCT). Participants in the control group will receive care-as-usual by the medical advisor. Participants in the intervention group will receive an FCE on top of care-as-usual. This is performed by an occupational therapist in their region, and a report of the FCE is delivered to the medical advisor. Both groups are asked to complete questionnaires at baseline, and after 3,6, and 9 months. Researchers will compare questionnaire results from participants in the control and intervention group, to see if their workability (primary outcome), steps to return to work, expectations to return to work, return to work beliefs, time until (partial) reintegration, self-efficacy in return to work, pain scale, and illness perception (secondary outcomes) are affected differently.