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.
Objectives: To evaluate the efficacy of gastric per oral endoscopic pyloromyotomy (G-POEM) in the treatment of gastroparesis. Endpoints Primary endpoint: Clinical Efficacy Will be assessed by measurements of Gastroparesis Cardinal Symptoms Index (GCSI) score, Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the 36-Item Short Form Health Survey (SF-36). Outcome criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months. These criteria will be the mean total GCSI score, and SF-36 score based on the values recorded with a Likert scale. GES parameters will be the half gastric emptying time and the RPH2. Secondary endpoint: Safety Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants. In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1 month, 5 months, 7 months and 12 months following the intervention. Other secondary endpoints will be technical success, nutritional status assessed by the measurement of the BMI, pre-albumin and albumin levels and for diabetics the HbA1c. These criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months. Overall design This will be a prospective, sham-randomized, monocentric, interventional, efficacy study. Once baseline eligibility criteria have been met, a first endoscopy under general anesthesia is proposed to the patients. Patients will be randomized blindly in a 1/1 fashion design between the sham arm and the GPOEM arm. At the time of the general anesthesia, a sealed envelope will be opened. Subjects will have a second endoscopy under general anesthesia 6 months later and the sham arm will then beneficiate from a GPOEM procedure and the GPOEM arm a sham procedure. Then, all the patients will be followed for another 6 months. GCSI score, PAGI-SYM, SF36 will be collected at screening, 1,5,7 and 12 months. GES RPH2, RPH4 and half emptying time will be collected at screening, 5 months and 12 months. Study procedures Description procedure in the GPOEM arm: The intervention will be performed under general anesthesia with tracheal intubation in supine position. GPOEM is performed with the following steps: -i: submucosal injection; -ii: mucosal incision upstream the pylorus followed by submucosal tunneling; -iii: antropyloromyotomy; -iv: closure of the tunnel access. Description procedure in the SHAM arm: A diagnostic upper digestive tract endoscopy will be performed under general anesthesia with tracheal intubation in supine position, injection of 1 cc of saline at four quadrants of the pylorus. Post-operative management Once the patients recovered from anesthesia after the procedure, they were administrated analgesics and anti-emetics as needed and esomeprazole 80 mg daily systematically to protect the mucosal access and tunnel from ulceration. Patients will be kept fasted for the first postoperative day (POD 1). In the absence of adverse events, patients will be allowed to resume liquid oral intake for 1 day, a soft-ground diet for 2 additional days, and finally a normal diet. They will be discharged after POD 1 in the absence of adverse events, with a prescription of esomeprazole 40 mg daily by mouth for 1 month and dietary instructions. After 6 months, another endoscopy under general anesthesia will be performed with the SHAM and GPOEM arms are interchanged. After the G-POEM / SHAM procedure, all patients will be rigorously evaluated in the same fashion. They will be assessed clinically before being discharged (POD 1) and then at 1 month and 5 months after the intervention with a clinical examination that included determination of the severity of the symptoms and total GCSI score, PAGI-SYM, SF-36. A GES will be performed at 5 months and 12 months.
For bulbar urethral strictures, it remains unclear whether ventral onlay graft urethroplasty is non-inferior to dorsal onlay graft urethroplasty in terms of patency rates.
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice. Data will be collected both retrospectively and prospectively.
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.
This prospective multicentric academic NAPT study aims to compile a database of all patients who initiate immunotherapy. The NAPT will take place before, during and after AIT to evaluate the cost and effectiveness of the treatment. The study consists of 4 visits and 2 telephone contacts that are repeated annually for 3 years. This study will be conducted in 2 hospitals: UZ Leuven and AZ ST. Jan Brugge on the consultation Ear, Nose and Throat Diseases (ENT) and the department of Internal Medicine / Allergology
In this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made. Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.
The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.
The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.
An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.