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.
This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe hepatic (liver) impairment will be compared with participants with advanced malignancies and normal hepatic function. An advanced malignancy is a cancer that has recurred (come back) after prior treatment or hasn't controlled with treatment. The trial will also study the safety of the study drug in participants (how well it is tolerated).
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test. Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep. The Withings Sleep is a non-contact device, along with an airbag placed under the mattress, which allows screening of SAS from four signals: movement, breathing, heart rate and snoring. The objective of the present study is to validate the diagnostic performance of the Withings Sleep for the detection of SAS compared to PSG.
Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina. The KCE Report 238Cs (2015) recommends " HR-HPV-positive women should not be offered colposcopy immediately. Triage should be done using cytology for this purpose. If cytological abnormalities (ASCUS+) are found, immediate referral should follow for diagnosis and, where appropriate, treatment. If no abnormalities are observed in triage, the subject should be offered follow-up testing (cytology) at six months. ". There is no treatment that is recommended during this lap time. The 2LPAPI® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of HR-HPV infections. Since 2LPAPI® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV. The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI® on the clearance of genital HR-HPV infections.
According to World Health Organization (WHO), non-communicable diseases account for 70% of global mortality. Chronic Respiratory Disease (CRD) affects more than one billion people and is the third leading cause of annual death of five million people after cardiovascular disease and cancer. Asthma and chronic obstructive pulmonary disease (COPD) are the two most common diseases of CRD and are part of obstructive airway disease (OAD). Asthma and COPD are distinguished by the clinical manifestations and therapeutic strategy according to Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD). However, in Vietnam, most patients with OAD are treated with an inhaled corticosteroid (ICS) combined with a long-lasting bronchodilator because the specific diagnosis is not always possible. In addition, a significant proportion of patients have clinical features of both asthma and COPD that is defined as the asthma COPD overlap (ACO). The definition of ACO remains controversial because it is not a distinct disease in which their specific treatment is still under debate that ICS is being generally proposed. It is understood that most OAD in Vietnam is treated with ICS. However, it is now accepted that in COPD (or COPD-like ACO) patients receiving this treatment may promote respiratory infections and even tuberculosis in endemic countries including Vietnam. Few data on the relative prevalence of asthma, COPD, and ACO are available in Vietnam. A recent study in Vietnam proposed defining asthma, COPD and ACO based on symptoms, ventilatory obstruction and bronchodilator (BD) reversibility, cumulative smoking, and age. Mites sensitization and exposure to biomass fume were then evaluated in patients having ACO. By doing so, COPD patients are smoking (≥ 10 pack-years) and have irreversible bronchial obstruction. Asthmatics are those with completely reversible bronchial obstruction OR non-smoking patients (<10 pack-years) and partially reversible obstructive. The other OAD patients were classified as having "ACO". Based on these definitions, the prevalence of COPD, asthma and ACO was 40%, 18% and 42%, respectively. Then ACO was defined as "from COPD, or ACO-COPD" in case of biomass exposure and negative mite skin tests, the others being ACO "from asthma or ACO-asthma". Currently, several biomarkers have been evaluated in the differential diagnosis and prognosis of OAD. The concentration of immunoglobulin E (IgE), the number of eosinophils in blood and sputum, nitric oxide (NO) in exhaled air, and recently periostin have been associated with asthma. On the other hand, biomarkers of systemic inflammation (C-reactive protein (CRP), fibrinogen, TNFα, IL-6 and IL-8) have also been investigated in COPD. Few data are available on the ACO biomarkers. In this study, the investigators will define the different phenotypes of chronic OAD (asthma, ACO-asthma, ACO-COPD and COPD) taking into account the reversibility of bronchial obstruction, cumulative smoking, biomass fume exposure and immediate sensitization to mites. Blood biomarkers and exhaled NO will be measured and analyzed in each phenotype. The treatment of COPD, asthma, ACO-COPD, and ACO-asthma based on the GINA and GOLD recommendations will be compared to the current practice in Vietnam: use of ICS with or without long-acting beta-agonists (LABA). Specific biomarkers will also be evaluated as predictors of treatment response.
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.
The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.
Medical or ritual circumcisions are frequent interventions in children. To provide the best comfort to the patients, the anesthetists use regional anesthesia. Complementary to general anesthesia, this method allows to lower the need of opioids during and after the surgery, as well as a faster recovery. The foreskin is innervated by the dorsal nerve of the penis which is the branch of the pudendal nerve. This nerve arises from the sacral plexus and more precisely the branches S2-3-4. There are two methods to block pudendal nerve. First, the pudendal nerve block is an old anesthetic technique developed in 1908, first for obstetrical analgesia and urological analgesia. It consists in injecting in the ischiorectal fossa, right at the end of Alcock's canal, a solution of local anesthetic. Second, the penile nerve block, described in the middle of the seventies, consists in injecting a solution of local anesthetic that blocks only the terminal part of the pudendal nerve. Those two nerve blocks have been subject to many publications, especially concerning the method to apply to optimize their efficiency. The literature review led to this conclusion: The penile nerve block should be ultrasound guided and the pudendal nerve block should be done with a neurostimulator. The aim of this study is to compare the analgesic efficiency of the ultra-sound guided penile nerve block to the pudendal nerve block with neurostimulation, for the pediatric circumcision.
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD). However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described. An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease. Therefore, this study aims: 1. To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models; 2. To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions; 3. To investigate the associations of the eGFR trajectories with the progression to ESRD and death. Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.