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 purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).
Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. A user-friendly and widely applicable algorithm - based on kinetics - to tailor the treatment of acute neonatal hyperammonemia. A single compartmental model was calibrated assuming a distribution volume equal to the patient's total body water (V), as calculated using Wells' formula, and dialyzer clearance as derived from the measured ammonia time-concentration curves during 11 dialysis sessions in four patients (3.2 +/- 0.4 kg). Based on these kinetic simulations, dialysis protocols could be derived for clinical use with different body weights, start concentrations, dialysis machines/dialyzers and dialysis settings (e.g., blood flow QB). By a single measurement of ammonia concentration at the dialyzer inlet and outlet, dialyzer clearance (K) can be calculated as K = QB[(Cinlet - Coutlet)/Cinlet]. The time (T) needed to decrease the ammonia concentration from a predialysis start concentration Cstart to a desired target concentration Ctarget is then equal to T = (-V/K)LN(Ctarget/Cstart). By implementing these formulae in a simple spreadsheet, medical staff can draw an institution-specific flowchart for patient-tailored treatment of hyperammonemia. The aim of this study is to validate these formula with a prospective study.
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.
This study evaluates the association between sedentary behaviour, physical activity, and the cardiometabolic health of Multiple Sclerosis via several cardiovascular, metabolic and anthropometric parameters.
This study is a first-in-human, open-label, 2-part, Phase 1 dose escalation study of DO-2, administered orally to patients with advanced or refractory solid tumours, with MET aberrations, and no available, approved therapeutic alternative.
This is a phase 1/2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas.
Spinal anesthesia remains a mainstay in lower limbs- as in day-case surgeries as well. It consists in injecting a local anesthetic drug into the intrathecal space of a patient's spinal canal. To achieve a suitable sensory and motor block for elective or emergent surgery, the anesthetist must adapt his choice of local anesthetic to the surgery's requirements and the patient's comorbidities, too. Spinal anesthesia is often associated with adverse cardiovascular events, notably hypotension which is a major concern in current anesthetic practice, especially in specific patient populations. Spinal induced hypotension is reported to be commonly related to the sympathetic block level and may be linked to perioperative cardiac and renal complications. Several mechanisms might play a role in the incidence of perioperative hypotension after spinal puncture. A decrease in peripheric systemic vascular resistance from arterial vasodilatation, a reduction of cardiac output due to a decrease in preload from a redistribution of venous blood into lower limbs or even an occurrence or increment of cardiac dysfunction, might compound proper blood flow towards noble organs such as brain, heart and kidneys. Spinal induced hypotension may also be related to a direct reduction of cardiac contractibility by the local anesthetic injection. Compensating mechanisms might be inhibited depending on the level of sympathetic blockade, usually related to the dose of the local anesthetic. Former studies found that intrinsic left ventricular depression might occur during spinal anesthesia as left ventricular volumes per se remain stable. One noticed that diastolic and systolic function (i.e., ventricular outflow tract velocity) decreased significantly after intrathecal levobupivacaine plus fentanyl injection based on transthoracic ultrasound assessment. Other authors use Pro-Brain Natriuretic Peptide to assess myocardial stress induced by surgery and anesthetic management. Other serum markers such as Cortisol, Adreno Cortico-Trope Hormone, Angiotensin are identified to screen and monitor myocardial stress as for instance acute myocardial dysfunction. Hyperbaric prilocaine is an intermediate-acting local anesthetic, whereas bupivacaine may be intermediate- or long-acting depending on the employed dose. Both drugs provide comparable sensory and motor block that meet the anesthesia level requirements in various surgical procedures. In regard to the hemodynamic effects, hypotension has been largely reported following hyperbaric bupivacaine in a dose-dependent way. However, discrepancy exists between the rare studies having investigated prilocaine's effects, probably related to the methodology and the employed doses. Moreover, the hemodynamics effects of these local anesthetics have been barely specifically investigated in a non-cesarean section context. The aim of this study is to compare the cardiovascular effects inflicted by hyperbaric prilocaine and bupivacaine under spinal anesthesia. Cardiovascular response will be assessed by non-invasive hemodynamic monitoring whereas metabolic stress will be evaluated using serum stress markers.
Raltegravir is the preferred INSTI for for treatment of antiretroviral-naïve pregnant women in the US Perinatal Guidelines, alongside Dolutegravir, and for late pregnancy. There are relatively limited information available on its use during early pregnancy, particularly the peri-conception period. The aim of the study is to assess "real-world" maternal, fetal and newborn outcomes following RAL use during pregnancy through pooled analysis of individual patient data from observational studies participating in the European Pregnancy and Paediatric Infections Cohort Collaboration.
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.