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.
This study evaluated the long-term safety of treatment with trastuzumab in participants with metastatic or locally advanced cancer with human epidermal growth factor 2 (HER2) overexpression who had completed a prior study with trastuzumab.
This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP.
The purpose of this study is to investigate the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs). The investigators also aim at identifying the underlying causes of these preventable ADRs. The endpoint measurements will be compared with a group of patients taking vitamin-K antagonists (VKAs). For this purpose, a protocol for a prospective observational study was developed. The study was approved by the Ethics Committee of the CHU UCL Namur (site Godinne) and the Cliniques Universitaires Saint-Luc. Patients admitted to the emergency department of these two teaching hospitals with a thrombotic or a bleeding event while under DOAC or VKA are included. After a comprehensive medication history, the appropriateness of prescribing is evaluated, using an adapted version of the Medication Appropriateness Index. Causality, severity and preventability of adverse events are assessed by two pharmacists and two hematologists using predefined scales. Second, for cases of serious and preventable ADRs, semi-structured interviews are performed with general practitioners to understand the underlying causes of medication errors. Based on the results, risk-minimization strategies that specifically target the problems encountered in clinical practice will be proposed.
The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125 COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125 COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ genotype). Soluble and imaging biomarkers will be investigated addressing different aspects of disease pathways postulated to be relevant for COPD progression.
The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in participants with advanced solid tumors.
The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
The PATHway system is designed to help patients remain physically active and maintain a good cardiovascular health. It proposes a novel approach that aims to empower patients to self-manage their CVD, set within a collaborative care context with health professionals. This will be achieved via a patient-centric holistic approach that specifically addresses the above barriers. It involves an internet-enabled and sensor-based home exercise platform. It is represented by several modules with an exercise module as the core component which will provide individualized rehabilitation programs that use regular, socially inclusive exercise sessions as the basis upon which to provide a personalized, comprehensive lifestyle intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable patients to both better understand and deal with their own condition and to lead a healthier lifestyle in general. The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle and health related physical fitness and cost-effectiveness of the PATHway intervention in patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).
BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.
Hospitals face the challenge to continually improve their quality of care. In order to achieve this goal, they have to focus on both improving clinical practice and increasing the involvement of patients in the healthcare process. Both factors are equally important to quality of care. The World Health Organization highlights the role that patients and their family could play in the improvement of healthcare. Active patient participation reduces communication errors, increases patient empowerment and is associated with positive health and psychosocial outcomes. A possible strategy to improve patient participation through communication can be bedside shift report (BSR). Bedside shift report is a process where shift-to-shift report between nurses is, if approved by the patient, executed at the patient's bedside in order to improve the patient's involvement. Bedside shift report has the potential to result in more patient satisfaction, better clinical outcomes, improvement of health education and enhanced team coherence. Preliminary research indicates that BSR decreases safety incidents and adverse events and readmissions, positively influences staff satisfaction, offers beneficial financial effects by reducing nurses' overtime, and allows direct patient care to start earlier. Despite of these effects, rigorous and large-scale scientific research on this topic is lacking. Currently, the available evidence is scarce and mostly consists of single case or small-scale studies. Longitudinal results on effectiveness and sustainability of BSR are also unknown or inconclusive. There is a need for an increased number of controlled studies to evaluate the impact of BSR on patient, staff and economic outcomes and its longitudinal results. The aim of this study is four-folded: 1. The development and fine-tuning of a BSR-intervention and implementation protocol by using diagnostic interviews, co-design, and pilot studies. 2. A quantitative evaluation of BSR in comparison with care as usual on patient-related, clinical, and nurse-related outcomes. 3. A qualitative evaluation of the feasibility, appropriateness and meaningfulness of BSR as a method to improve communication and patient participation with a particular interest in the experience of benefits and disadvantages by healthcare professionals and patients. 4. A process evaluation of BSR to determine the intervention fidelity and to assess the evolution of BSR over the period of the study (e.g. adaptations, consistent practice). The study design was based on the Medical Research Council-framework for developing and evaluating complex interventions. Power calculation indicates a minimum of 5 experimental wards with 35 patients should be included in the study. The hospital, the specialization of the ward and the nurse-patient ratio will be used for the matched controlled assignment.