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.
High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as: - Hypoxia: SpO2 < 90% for 1 min - Severe hypoxia: SpO2 < 85% for 1 min - Hemodynamic instability, defined as Arterial pressure < 90/60 - Cardiac arrhythmia - Laryngospasm or bronchospasm - Barotrauma or volutrauma - Need for ICU admission A model predicting the risk for developing any complication will be developped using 2 mathematical methods: - a multivariate analysis - a data mining approach For both approaches, the following variables will be included in the model: - Age - Gender - Weight - Height - BMI - Smoking - Alcohol consumption - Consumption of Other drugs - ASA class - Obstructive pulmonary disease - Restrictive lung disease - COPD status (1, 2, 3, 4) - Interstitial lung disease - Lung tumor - Trachea location - Carina location - Bronchial location - Pulmonary or tracheal stenosis - Presence of stridor - Severe stenosis (< 6 mm) - Baseline SpO2 (pre-intervention) - Pre-intervention oxygen requirement Procedure - Duration (min) - Stent placement - Dilation - Laser treatment - Length of hospital stay Lung function tests - FEV1 (forced expiratory volume) - VC (Vital Capacity) - FEV1/VC (Tiffeneau ratio) - CPT (total lung capacity) - DLCO (carbon monoxide diffusion)
This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups. This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.
This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity. The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome. The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject.
The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders.
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand. Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition.
Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. A baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution). Infants will be followed up to 2 years of corrected age (end of study).
This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.