Saint-symphorien, Belgium

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

Continuous Glucose Monitoring for Women with Gestational Diabetes

At diagnosis of GDM, women will receive education on the management of GDM with lifestyle and need to monitor glucose with SMBG. Within one week of GDM diagnosis, all participants will be asked to use a blinded CGM (Freestyle Libre Pro IQ,) during a run-phase. Women randomized to the control arm, will be asked to intermittently wear a blinded CGM sensor (Freestyle Libre Pro IQ) during 14 days at least two time points in pregnancy (at 31.0-33.6 weeks and between 36.0-38.6 weeks). For women diagnosed with early GDM (<20 weeks), blinded CGM will be needed 3 times in pregnancy with a first time at 20.0-23.9 weeks. Women randomized to the intervention arm will be recommended tu use the rt-CGM (Freestyle Libre 3) till the delivery. In line with normal routine, a 75g OGTT will be performed between 6-24 weeks postpartum to screen for glucose intolerance. Participants will be asked to also wear a blinded CGM (Freestyle Libre Pro IQ) at this last study visit.

Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy

WP 1: Gradual introduction of less heated cow's milk proteins in 20'-cooked cow's milk tolerant children. When inclusion criteria are met and informed consent from the parents (and when old enough, assent from the children) is obtained, children will be included in the trial. During the inclusion visit an open 20' cooked milk oral food challenge (OFC) needs to be passed in the hospital. Each visit a validated pedQuality of life (QoL) questionnaire will be taken and blood will be drawn to determine baseline specific IgE (sIgE) and IgG4 to cow's milk. Subjects (n=75) are randomized in a 1/1/1 ratio across three arms for 12 months to study the arm's tolerance inducing capacity (see Arms and Interventions for more information). After 6 months patients are invited for an intermediate visit. After 12 months, a OFC with unheated milk will be performed in all children during their challenge visits. Three months after the OFC, the children will be invited for a termination visit. Children who did not pass the OFC with unheated cow's milk after 12 months, will be invited to an observational 48 months follow-up study, in order to later-on retrieve the potential moment of complete cow's milk tolerance induction by clinical files. WP2: Study of the immunological mechanisms (Treg and Breg induction and switch to IgG4-producing B cells). Venous blood will be taken from all 75 children recruited for WP1 at enrolment and at the challenge and termination visit and from 15 healthy age-matched children, after obtaining children's oral or written assent (where appropriate) and parent's informed consent. Peripheral blood mononuclear cells (PBMCs) will be isolated and stimulated by cow's milk proteins as well as a positive control. Membrane markers associated with regulatory activity on T cells will be studied by flow cytometry (FC), as well as cytokine production in the supernatant by meso scale discovery. Furthermore, B cells will be studied after PBMC stimulation by FC. Cow's milk specific IgG4 and cytokine production will also be studied in this culture supernatant. WP3: In vitro BATs to mimic the outcome of OFC. In vitro Basophil activation tests (BATs) will be fine-tuned by preparing extracts for 20', 15', 10', 5' cooked and fresh cow's milk. Fine-tuning will include the comparison of new protein extract batches with the first batches, the absence of background basophil activation upon contact with the lowest dose of allergen extract and the comparison of basophil activation of healthy and of allergic children in different phases of cow's milk tolerance, who should show differences depending on the grade of tolerance. After fine-tuning, BATs will be performed as described above with 3 (or 5) extracts from cow's milk at baseline, challenge visit and termination visit in all children recruited within the study.

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

Inflammatory bowel diseases (IBD) are a group of immune mediated disorders primarily targeting the gastro-intestinal tract and consist of two distinct phenotypes: Crohn's disease (CD) and ulcerative colitis (UC) that share similarities in both clinical presentation, pathophysiology and treatment. A small proportion of IBD patients cannot be correctly characterized in one of those categories and is referred to as IBD type unclassified (IBDU), which is often classified under UC for clinical research purposes. TNF inhibitors are one of the most frequently prescribed biological therapies and remain an important part of the therapeutic arsenal with international guidelines recommending their use in moderate-to-severe CD and UC when conventional treatments have failed. Infliximab, a chimer monoclonal antibody against tumor necrosis factor (TNF), was the first anti-TNF agent to be approved for treating IBD as early as 1999. After losing its product patent in 2013, several biosimilars of infliximab have been commercialized including CT-P13. Originally only available in an intravenous (IV) formulation, a subcutaneous (SC) formulation of CT-P13 has been registered for treating moderate-to-severe CD and UC as well. However, many questions on the use of these subcutaneous formulations of infliximab in daily clinical practice remain unanswered, especially in patients who previously required IV dose optimization of infliximab. The primary objective of the AMARETTO trial is to compare clinical and biological outcome between a regimen with SC infliximab every week and SC infliximab every other week among patients who were in clinical and biological remission with an optimized IV schedule when they switched to SC infliximab. The secondary objectives of this study are: - To compare treatment optimization and discontinuation between a regimen with SC inflixmab every week and SC infliximab every other week among patients who were in clinical and biological remission with an optimized IV schedule when they switched to infliximab SC. - To evaluate the willingness and the experience of patients switching to SC infliximab. - To compare clinical and biological outcome, as well as treatment optimization and discontinuation between a regimen with SC infliximab (every week or every other week) and IV infliximab among patients who were in clinical and biological remission with an optimized IV schedule. This study is a national, multicenter, randomized, open-label, prospective, pragmatic trial in Belgium. The trial design is as follows: - All subjects will undergo screening procedures. The screening visit of eligible patients will include the review of inclusion and exclusion criteria, and the informed consent form procedure. After screening, if the patient fulfils all inclusion and none of the exclusion criteria, and is willing to participate, the gastroenterologist will record the characteristics of patients and of the disease, medical and surgical history, current and past IBD treatments physical examination, the PRO-2 score about the last 3 days before the visit, blood analysis, stool analysis and patients will be asked to fill in a questionnaire about health-related quality of life. - Afterwards the patients will visit the gastroenterologist 4 times in one year (week 0, week 8, week 24 and week 52, however the specific weeks can vary depending on the IV dosing schedule). During these visits a physical examination will be done, the PRO-2 score based on the 3 previous days before the visit will be calculated, a blood analysis and stool analysis will be done, the concomittant medication will be collected and patients will be asked to answer the questionnaire about the health related quality of life. NOTE: patients that switch to subcutaneous infliximab will be asked to collect all at home administrations in a diary and to additionnaly answer a questionnaire about the satisfaction of switching to subcutaneous infliximab.

Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention

This is a prospective, randomised, double-blind, multicenter, placebo-controlled phase III pragmatic superiority trial comparing colchicine 0.5 mg with placebo administered orally once-daily in up to 2770 participants with CAD treated with PCI. Participants will be randomised in a 1:1 ratio to receive either colchicine 0.5 mg or placebo as an adjunct to standard of care. The trial is event driven with trial closure being performed when the targeted number of 566 primary endpoint events has been reached. Participants will be seen by the site staff 1 month after randomisation and thereafter every 12 months as per standard of care (SOC) and for IMP dispense and compliance, completing questionnaires and outcome event assessment until end of study. After the first month, a telephone visit will be scheduled every 6 months in between two standard of care on-site visits.

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)

This non-interventional study will investigate the effectiveness of T-DXd, the patients demographic and clinical characteristics, treatment patterns including prophylactic medications and interventions for reduction of serious adverse events (SAEs), serious adverse drug reactions (ADRs) and safety event of interest (SEIs), tolerability, and patient survey of T-DXd, in cases with advanced HER2-positive gastric or GEJ adenocarcinoma receiving T-DXd as second line of treatment and beyond treatment option. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No investigational drug will be administered in this study. Data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) will also be collected in a disease registry part of the study.