There are about 13446 clinical studies being (or have been) conducted in Belgium. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting.
The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia 1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL, 2. Leads to a clinically relevant reduction of blood pressure on the short term, 3. Leads to a change in oxidative stress biomarkers. Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks: - Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day - Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.
Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved. The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital.
The validation of the French version of the Exercise in Mental Illness Questionnaire - Health Practitioner Version (EMIQ-HP) is a prospective observational case-only study involving: (a) translation to French, (b) an expert consensus meeting with French speaking experts from Canada to reach a first version, (c) back translation to English, (d) evaluation of the back-translation by the original authors of the EMIQ-HP, (e) an expert consensus meeting with French speaking experts from Canada to reach a final version based on comments of the original authors, and (f) test-retest reliability study. Test-retest reliability will be analysed through two points of measurement with an interval of 7 days.
The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants. The study is seeking the following participants: - Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests. - Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds). - Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.
The goal of this quasi-experimental study is to evaluate the effectiveness of a physical literacy-based intervention for chronic disease management in adults with chronic diseases participating in adapted physical activity group sessions in Belgium. The main questions it aims to answer are: - How does incorporating physical literacy elements in adapted physical activity sessions affect participants overall physical literacy levels? - Can a physical literacy-oriented adapted physical activity program enhance long-term engagement in physical activities and improve health outcomes for chronic disease patients? Participants will: - Undergo assessments for physical literacy levels and health outcomes at the beginning, after three months, and at the end of the six-month period. - Engage, in intervention groups, in adapted physical activity sessions, which may include physical fitness exercises and educational components on physical literacy. Researchers will compare 3 groups: a control group, a traditional Adapted Physical Activity (APA) group, and a Physical Literacy Oriented APA (APA+PL) group to see if integrating physical literacy components results in improved physical literacy levels, better sustained engagement in physical activities, and enhanced health outcomes.
Breast cancer related lymphedema (BCRL) is due to its chronicity and impact an extremely dreaded complication after breast cancer treatment. The prevalence rate of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, the prevalence rate of subjective arm and trunk/ breast BCRL is much higher than that of objective BCRL. Subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without any objectively measurable swelling. At this moment, it is not clear how many breast cancer patients experience subjective arm or trunk/breast BCRL and what the underlying mechanisms may be. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and the severity of subjective arm or trunk/breast BCRL, including sensory processing problems (1. nociceptive and/or 2. neuropathic and/or 3. central) and the presence of disturbed lymphatic transport without clinical manifestation (4. subclinical BCRL). The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6. and 12 month(s) post-surgery and the transitions between the different types of BCRL and to compare the amount of swelling at arm or trunk/ breast, the presence or severity of subclinical BCRL and peripheral and central sensory processing problems between patients with different types of BCRL. In addition, the present study will be undertaken to determine the contributing factors to the severity of subjective arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6. and 12 month(s) post-surgery).
NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Two skin diseases are characterized by the presence of gene variants that cause an impairment in NOTCH signaling: hidradenitis suppurativa(HS) and Dowling-Degos disease(DDD). To date, both HS and DDD are orphan diseases still lacking of specific treatments. This project aims at improving the current knowledge on the pathogenesis of HS and DDD, by deepening the understandings on the role played by keratinocytes in these pathologies and also by determining why mutations found in the same pathway cause different diseases. This study aimed to obtain in vitro models, derived directly from patients (from hair follicles) and from keratinocytes (HaCaT) cell cultures, for the study of these skin pathologies and also for the testing of novel innovative therapies such as photobiomodulation therapy.
The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is: - Are signs of central sensitization present in tension-type headache? Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing). Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group.