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NCT ID: NCT06174662 Recruiting - Pain Clinical Trials

The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial

MUSICU
Start date: February 2, 2024
Phase: N/A
Study type: Interventional

This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).

NCT ID: NCT06173687 Recruiting - Hearing Loss Clinical Trials

Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant

DICE
Start date: January 29, 2024
Phase: N/A
Study type: Interventional

This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the subjects encounter during their daily life outside of the clinic. Improving the monitoring of both aspects may lead to improvements in monitoring and personalising the fitting to optimise hearing outcomes for persons with a cochlear implant.

NCT ID: NCT06173674 Recruiting - Clinical trials for Preoperative Anxiety

The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety in Older Patients

fa-MIPA
Start date: December 4, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical feasibility study is to learn about the acceptability and feasibility of a music intervention in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure. The primary question it aims to answer is: • What is the feasibility and acceptability of a music intervention to reduce PA in older patients undergoing cardiac surgery and TAVI? The secondary question is: • What is the effect of a music intervention on PA levels and the incidence of POD in older patients undergoing cardiac surgery and TAVI? Participants will - listen to music before the surgery/TAVI procedure - be evaluated for preoperative anxiety levels and postoperative delirium - be interviewed to learn about their perspectives regarding the music intervention

NCT ID: NCT06172348 Completed - Healthy Volunteers Clinical Trials

A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults

Start date: February 1, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare if three forms of study medicine (called ritlecitinib) get processed differently in healthy adults. This study is seeking healthy participants who have: - Aged 18 years or older; - male or female who are healthy as determined by medical assessment; - BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb). All participants in this study will receive a ritlecitinib oral dose in three different forms (solution, capsule 1 and capsule 2). The study will take up to 2.5 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 13 days. There will be 4 periods in total for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first three periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period.

NCT ID: NCT06171620 Recruiting - Pain Clinical Trials

Virtual Sedation During Elective Procedures in the Cathlab

Start date: June 26, 2023
Phase: N/A
Study type: Interventional

This study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab). To assess the effectiveness of VR in the clinical setting of daily practice within the cathlab, a comparative effectiveness trial will be conducted. A sample of patients scheduled for a planned procedure in the cathlab of UZ Brussel will be selected using convenience sampling. Participants eligible for this study will be assigned to either the control group or the intervention group after signing the informed consent form. The control group in this study will receive standard care according to current practice for the planned procedure, while the intervention group will receive standard care along with the virtual reality headset intervention. The primary outcome of anxiety will be measured using the Visual Analog Scale (VAS) for anxiety and the State-Trait Anxiety Inventory (STAI) questionnaire. The secondary outcome of pain will be measured using the VAS scale for pain. Other outcomes such as satisfaction and potential nausea during the procedure will be assessed through a questionnaire that participants will fill out after the procedure. The physician who performed the procedure in the intervention group, as well as the involved nurses during the procedure, will complete a similar questionnaire to evaluate the use of the VR headset from the operators' perspective. The outcomes of the two groups will be statistically compared using the SPSS software package.

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).