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.
Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer. Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment. They will be followed for occurrence of lower limb lymphedema up till 2 years after their last treatment. Data on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment. Patients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution towards advanced stage LLL will be evaluated.
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.
Atrioventricular node ablation (AVNA) with biventricular (BiV) pacemaker implantation is a feasible treatment option in patients with symptomatic refractory atrial fibrillation and heart failure. However, conduction system pacing (CSP) modalities, including His bundle pacing and left bundle branch pacing, could offer advantages over BiV pacing by providing more physiological activation. The randomized, interventional, multicentric study will explore whether CSP is non-inferior to BiV pacing in echocardiographic and clinical outcomes in heart failure (EF <50%) patients with symptomatic AF and narrow QRS scheduled for AVNA.
The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer
Cardiac arrhythmia, specifically paroxysmal supraventricular tachycardia (SVT), accounts for a substantial proportion of emergency medical services resources utilization. Restoring a normal sinus rhythm (reconversion) should be done quickly and effectively. Reconversion requires increasing the atrioventricular node's refractoriness, which can be achieved by vagal maneuvers, pharmacological agents, or electrical cardioversion. The Valsalva Maneuver (VM) is a commonly used non-invasive reconversion method. It increases myocardial refractoriness by increasing intrathoracic pressure for a brief period, thus stimulating baroreceptor activity in the aortic arch and carotid bodies, resulting in increased parasympathetic (vagus nerve) tone. The effectiveness of conventional vagal maneuvers in terminating SVT, when correctly performed, shows a considerable variation ranging from 19.4% to 54.3%. To improve the effectiveness of the Valsalva Maneuver, the Modified Valsalva Maneuver (MVM) was introduced. While the standard VM is performed when the patient is in a sitting position (45°-90°), the modified VM involves having the patient sit up straight and perform a forced expiration for about 15 seconds, after which the patient is brought into a supine position with the legs raised (45°) for another 15 seconds. This modification should increase relaxation, phase venous return, and vagal stimulation. A recent meta-analysis demonstrated a significantly higher success rate for reconversion to sinus rhythm when using the MVM compared to the standard VM in patients with an SVT (Odds Ratio = 4.36; 95 percent c.i. 3.30 to 5.76; P < .001). More adverse events were reported in the MVM group, although this difference is not significant (Risk Ratio = 1.48; 95 percent c.i. 0.91 to 2.42; P = .11). The available evidence suggests that medication use was lower in the MVM group than in the standard VM group. However, medication use could not be generalized across the different studies. None of the included studies in this review showed a significant difference in length of stay in the emergency department (ED). Hence, the gain of implementing MVM is a higher rate of success with non-invasive reconversion methods. While the available evidence is highly suggestive of supporting the use of the MVM compared to the standard VM in the treatment of adult patients with SVT, implementation seems difficult. Current evaluations, such as the 'gold-standard' randomised controlled trial (RCT) design, rarely adequately or even explicitly address the context-specific drivers behind implementation outcomes and their relationship to the underlying programme theory, making it difficult to interpret their findings in light of other programmes in different settings. As a result, few evaluation strategies are widely accepted as appropriate. The net benefit of interventions and understanding how variable outcomes are achieved remains empirically uncertain. Therefore, it is essential to develop comprehensive, rigorous, and practical methods to evaluate people-centred quality improvement programmes, inform the selection of effective and efficient interventions, and facilitate improvement and scaling-up. In evaluating such complex interventions, the Medical Research Council (MRC) argues for the importance of process evaluation in conjunction with outcome evaluation to account for variability in implementation. The MRC's process evaluation framework guides evaluators to understand the implementation processes (what is implemented and how), mechanisms of intervention (how the delivery of the intervention produces change) and contextual factors that affect implementation and outcomes. Research question This study aimed to evaluate a quality improvement program to improve the non-invasive care for patients with paroxysmal supraventricular tachycardia in the emergency department.
Prospective observational cohort study on the learning curve for the sonographic assessment of labor progress (fetal head position and station) amongst obstetric caregivers. Study participants: convenience sample of 20 obstetric caregivers working in the department of obstetrics and gynecology at the University Hospital of Leuven - recruited over a 12-month period. Format of the training program: 1. Observational phase: the goal is to measure the accuracy of the clinical assessment of fetal head position and station throughout the different stages of labor by caregivers working within the department. 2. Self-study: reading of the 2018 practice guidelines on intra-partum ultrasound by ISUOG and watching the corresponding teaching video. 3. Supervised implementation phase: one-to-one teaching by experienced sonographers, who initially demonstrate, later interactively supervise the quality of the scans acquired by the obstetric caregiver. 4. Proficiency testing: from this point onwards, the trainee independently performs ultrasound scans in labor to asses fetal head position and station. The scans will be repeated by the expert sonographer, the results will be compared (qualitatively and quantitatively) and immediate feedback provided if indicated. Every observation will have a binary outcome (success or failure of trainee acquisition) according to predefined quality assessment criteria. Observations will be continued until proficiency is reached (saturation of the learning curve).
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.
The current study aims to investigate the effect of walking with the SAIRE smart walker on spatiotemporal parameters and gait kinematics in a population who suffer from difficulties during gait, and compare this to walking with a standard walker or no walking aid.
This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.