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.
Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?
Obstructive sleep apnea (OSA) is a prevalent kind of sleep-disordered breathing affecting one-seventh of the world's population. Almost 45 percent of this population suffers from mild to severe apnea. However, in many cases it remains undiagnosed, leading to increased health risks. Sleep-disordered breathing, as seen in OSA, can have serious long-term consequences, including sympathetic nervous system activation, sleep disturbances, heart remodeling, and cardiovascular disease development. Polysomnography is the standard method for assessing sleep-breathing disorders, which requires the attachment of various sensors by a trained technician or a healthcare professional. However, if the diagnosis of OSA depends on referral to a sleep laboratory, and if the referral is reliant on symptoms of an OSA syndrome, then current screening approaches may exclude a large population of individuals at risk. Besides, the number of sleep centers and caregivers is limited, and the associated costs are high. Therefore, alternative techniques allowing home monitoring are necessary. The goal of this observational study is to evaluate the accuracy of the Kinocardiography technique in detecting apneic episodes during sleep and comparing the results with the gold standard polysomnography in 47 patients suffering from obstructive sleep apnea. We hypothesize that this device is able to detect sleep-disordered breathing events, and thus to compute the apnea-hypopnea index, with an accuracy that is close to that of the polysomnography. Participants who meet the criteria will be invited to participate in this protocol and do both polysomnography and kinocardiography records simultaneously at night during sleep.
The goal of this study is to learn about the real wold behavior of developed machine learning models that predict the plasma concentration of piperacillin-tazobactam and meropenem in critically ill patients admitted to the intensive care unit (ICU). The main aim of the study is to validate the performance of these machine learning models. To this end, daily measured plasma concentrations of the investigated antimicrobials will be compared with the predicted concentration by the machine learning algorithms. Additional goals of the study include: - To describe the total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the ICU. - To quantify the correlation between plasma concentrations of piperacillin-tazobactam and meropenem and the development of side effects. - To evaluate the perceived necessity of therapeutic drug monitoring (TDM) of consultants and physicians in training working in the ICU. - To evaluate the perceived added value of daily TDM. Samples (where possible taken routinely) from participating patients will be analyzed for meropenem and piperacillin-tazobactam plasma concentration. Participating physicians will be asked to fill in a short daily questionnaire during the time a patient under their care is treated with the antimicrobial under investigation.
Conventional continuous mandatory mechanical ventilation relies on the passive recoil of the chest wall for expiration. This results in an exponentially decreasing expiratory flow. Flow controlled ventilation (FCV), a new ventilation mode with constant, continuous, controlled expiratory flow, has recently become clinically available and is increasingly being adopted for complex mechanical ventilation during surgery. In both clinical and pre-clinical settings, an improvement in ventilation (CO2 clearance) has been observed during FCV compared to conventional ventilation. Recently, Schranc et al. compared flow-controlled ventilation with pressure-regulated volume control in both double lung ventilation and one-lung ventilation in pigs. They report differences in dead space ventilation that may explain the improved CO2 clearance, although their study was not designed to compare dead space ventilation within the group of double lung ventilation. Dead space ventilation, or "wasted ventilation", is the ventilation of hypoperfused lung zones, and is clinically relevant, as it is a strong predictor of mortality in patients with the acute respiratory distress syndrome (ARDS) and is correlated with higher airway driving pressures which are thought to be injurious to the lung (lung stress). This trial aims to study the difference in dead space ventilation between conventional mechanical ventilation in volume-controlled mode and flow controlled-ventilation.
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
This is a dual arm (arm 1 and arm 2) multi-centric non-randomized (prospective) study. Two new multicentric cohorts will be set up in 4 Belgian HIV reference centers (UZ Gent, UZ Brussel, University Hospital Liege and St. Pierre Hospital Brussels): cohort 1 will comprise PLWH in whom ART was initiated during acute HIV infection minimum 3 years ago but no more than 10 years ago (short-term ART cohort); cohort 2 will comprise PLWH on ART since >20 years (long-term ART cohort). Participants will be included based on suppressed viremia and uninterrupted ART since initiation. Participants will undergo one blood sampling and one leukapheresis. In and exclusion criteria are described below.
The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: - The primary aim is to perform the psychometric validation of the EUonQoL-Kit. - Secondary aims are to assess its acceptability, to validate the static and dynamic versions against each other, and to provide estimates of QoL across European countries. The EUonQoL-Kit will be administered to a sample of patients from 45 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,500 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: - FACT-G (Functional Assessment of Cancer Therapy - General) and EQ-5D-5L (5-level European Quality of Life Five Dimension), to test concurrent validity. - Live-CAT version, to validate the static and dynamic versions against each other. - EUonQoL-Kit, at least 1 hour after the first completion, to assess test-retest reliability.
The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.
The goal of this clinical trial is to determine the safety (phase II), then efficacy (phase III) of baricitinib plus standard of care (SOC) as compared to SOC alone for the treatment of hospital-acquired pneumonia in patients with a pro-inflammatory profile.