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.
The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique. This study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer
The aim of this study was to characterize the host-related response of peri-implant soft tissue induced by 3 different materials: titanium, resin and PEEK (polyetheretherketone) on man. The primary endpoint is to asses the histological data available: Histological analyses are carried out with immunohistology (CD68, CD3, CD20, macrophages), non decalcified histology to appreciate the structure of the peri implant soft tissues (Sulcus depth, junctional epithelium, connective tissue adhesion). Moreover: scanning electronic microscope (SEM) of the experimental abutment is performed to juge the cell adhesion on the abutment surface. The secondary endpoint is to assess clinical data, radiological bone remodeling regarding the different material. The hypothesis is that resin abutment lead to more inflammation than PEEK or titanium.
Health CASCADE (Marie Skłodowska-Curie grant agreement n° 956501) aims to address complex public health problems by making co-creation a scientifically sound methodology, aided by evidence-based methods, practices, and technologies. The current study, which focuses on co-creation in the school context is part of this overarching European project. Healthy sleep is important for adolescents' mental and physical health and cognitive functioning. However, sleep difficulties are among the top three health complaints in European adolescents. This indicates a need for successful interventions. Co-creation is a promising approach to design tailored interventions. By actively involving all relevant stakeholders, co-creation has been shown to increase self-efficacy, self-consciousness, empowerment, and feelings of ownership. However, co-created interventions are localized and therefore less generalizable to a broader population. Moreover, the process is very time- and cost- consuming. To make co-creation more feasible, research should focus on the upscaling of existing interventions. The investigators propose that the co-creation process is still absolutely vital for intervention success but that it can be shortened. The investigators aim to scale up an existing intervention to promote healthy sleep. This existing intervention was developed using co-creation together with the target group (adolescents aged 13 to 15) and parents, and implemented with support of teachers and fellow students. To investigate whether the shorter co-creation process is needed in order to scale up the intervention to another setting and context, the investigators will use a three-arm cluster controlled trial. This will include one co-creation intervention school, one standard implementation school (this school receives the existing intervention without a shortened co-creation process), and one control school. The co-creation process will be structured by using the Intervention Mapping Protocol to ensure an evidence-based framework. The effect of the intervention will be evaluated using actigraphy and questionnaires, while the process will be evaluated using questionnaires, interviews, and focus groups.
The investigators will conduct retrospective observational cohort study at the Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek (Belgium), which is a large center specifically focusing on neurological management, multidisciplinary care and/or rehabilitation in patients with MS. Primary endpoint For each DMT category, as defined above, the proportion of patients with a worse COVID-19 outcome (i.e., hospitalization and/or death) will be compared between those 'protected' versus 'unprotected' by vaccination at the time of SARS-CoV-2 infection. Corrections will be applied for any eventual imbalance in demographics, potentially relevant to COVID-19 outcome, between subgroups that are compared to each other, if indicated/feasible.
To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an automated skin prick test. This study will provide a comparison between manual and automated skin prick test in allergic and non-allergic individuals with a panel of common inhalant allergens. The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common aeroallergens compared to a manual skin prick test (SPT). It is a prospective monocentric study that will include 120 study participants.
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
Only very few studies have prospectively looked at the effect of repeated intensive plasma donation. In collaboration with the Rode Kruis Vlaanderen, we have recently found that repeated whole blood donation with a 3-month interval in between induced a drop in markers for iron status, which worsened with the number of donations. The repetition effect of the donations, whether whole blood or plasma, can be different from the effects measured after one single donation. It is therefore critical to test and document this repetitive effect to build trustable and valid guidelines concerning repetitive plasma donation.
The goal of this clinical trial is to compare in patients who need an implantation of a veinous access device the sedation with anesthesiologic drugs and with hypnosis using virtual reality material. The main question it aims to answer is: • is hypnosis using virtual reality as safe and powerfull than usual anesthesiologic drugs. Participants will complete a preoperative and postoperative questionnaire. They will be contacted by phone pre and postoperatively. If there is a comparison group: Researchers will compare drug induced sedation and hypnosis induced by virtual reality to see if they are similar in efficacy and sides effects.
Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. In general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (OR). Potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal. Recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. Compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. A few trials also registered a higher success rate in completeness of resection. No significant differences in odds of surgical complications have been reported. Most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed. Recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 Fr. intrauterine BIGATTI Shaver (IBS®). This means less need for cervical dilation, and potential use without anesthesia. At this moment, there are no prospective studies available on feasibility of the 19 Fr. intrauterine BIGATTI Shaver (IBS®). Before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation. Trial objectives: Assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. The primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation. Secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.
For more than 50 years it has been shown that preoperative evaluations by anesthesiologists include too many unnecessary tests. Many of the tests ordered do not change the management of the patients. One example are preoperative coagulation tests which rarely give relevant information and can be omitted if the patients have a negative structured bleeding questionnaire. This situation has lead to the publication of many guidelines on preoperative evaluation, one of the most comprehensive being the 2022 guidelines by the European Society of Cardiology for the preoperative evaluation of cardiac patients undergoing non-cardiac surgery. In Belgium, an independent center of experts, the Kenniscentrum - Centre d'Expertise (KCE) was created to give expert and independent opinions on healthcare related subjects. These recommendations are often used by Belgian authorities to guide public health law and determine which medical procedures or tests are covered by the social security. The KCE has published an extensive guide on preoperative evaluation of patients undergoing non-cardiac surgery (KCE Reports 280Bs. D/2016/10.273/102.) These guidelines are freely available, either in print version, on the dedicated Website or as an App, and have been extensively spread in the anesthesiology community. Laboratory tests not recommended in these guidelines are not covered by the social security if no solid reason is given in the medical chart. In this retrospective study, adherence to the KCE guidelines on preoperative evaluations will be evaluated in a tertiary University hospital. All patients, scheduled for elective surgery, will be included for a period of 3 month. For every patient the recommended tests will be determined and compared to the actual tests prescribed by the anesthesiologist during the preadmission visit.