There are about 13428 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 is a multicentre, prospective, randomized controlled trial that will investigate the role and performance of the 3rd generation resorbable magnesium scaffolds "DREAMS 3G" labeled under the name "Freesolve" vs contemporary biodegradable polymer scaffolds in non ST-segment elevation acute coronary syndromes. Patients fulfilling the eligibility criteria will be enrolled and undergo PCI with either Freesolve or Orsiro platforms for the culprit lesion only. They will be followed-up for 12 months (1, 6 and 12 months). The primary endopoint will be Target Lesion Failure as defined by ARC definitions.
In this study the diagnostic accuracy of a diagnostic tool for the diagnosis of post-capillary pulmonary hypertension will be investigated. The diagnostic tool was designed based on artificial intelligence, using machine learning on a database of 344 patients with group 1 or group 2 pulmonary hypertension. The tool uses 20 non-invasive parameters which are derived from laboratory results, ECG, echocardiography and spirometry. Based on these parameters, the predictive tool estimates the probability of group 2 pulmonary hypertension. During this clinical study, patients with an intermediate or high suspicion of pulmonary hypertension, with an indication for a diagnostic right heart catheterization, will be included. Patients with risk factors for group 3, 4 or 5 pulmonary hypertension will be excluded. The necessary parameters to run the predictive model will be extracted from the patients medical file. Patients will undergo a standard of care right heart catheterization (gold standard). Afterwards the results of the predictive model will be compared to those of the right heart catheterization, to allow the assessment of the sensitivity, specificity, positive and negative predictive value of the predictive tool.
At discharge after a hospitalization, many older people are not as able as before their hospital stay and have difficulty performing their daily activities at home. For example, washing and dressing themselves, housework or shopping are often more difficult after discharge from hospital. However, most older people do not receive any support in regaining their physical status and self-reliance. As a result, they often need permanent help from informal or professional caregivers. Their quality of life is also impacted and they have an increased risk of new hospital admissions. Rehabilitation centers and hospital rehabilitation wards help the elderly to regain their daily functioning, but the number of places is very limited. This means that support for home rehabilitation is necessary for the vast majority of older people (almost 82,000 people per year). However, most of the time there is no support for home rehabilitation and the effect of such home rehabilitation programs has been little studied. Although studies show that home rehabilitation can improve physical functioning, the effect on impairments in daily activities and the quality of life of older people are not clear. In a future multicenter RCT, the investigators want to study whether training and guidance by a physiotherapist contributes to the recovery of older people after discharge from hospital. Patients will either receive standard care after hospitalization discharge, or intensive guidance from a physiotherapist. The patients guided by the physiotherapist are trained and supervised three times a week, for six weeks, to improve their muscle strength, balance, walking and mobility. The aim of the intensive home rehabilitation program is that the individual benefits from it in the longer term. Therefore, whether individuals who received the program are less limited in their daily functioning than those who did not receive the intensive rehabilitation program is checked after six months. In addition, the quality of life, physical functioning and healthcare costs for these two groups are also compared. To ensure that the study is feasible, a small pilot study will first be performed. Here, the aim is to assess the feasibility of recruitment (screening and retaining participants, reasons for refusal and participant profiles), study procedures and intervention. This includes time registration by the study team and physiotherapists, assessment of study burden and experiences with the execution of the protocol. The findings of this pilot study will help deciding about progressing to a future definitive RCT.
the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.
Hearing loss is one of the most prevalent impairments in the world. The World Health Organization estimates that as of 2020, around 466 million people worldwide are affected by disabling hearing loss, of which 34 million are children. Without appropriate diagnosis and treatment, hearing impairment can cause difficulties with communication, learning, social-emotional functioning, employment and quality of life. Early intervention is especially important for children, for whom unaddressed hearing loss has been proven to affect speech and language development, educational attainments, and social skills. Through early detection and interventions many of these impacts can be mitigated, highlighting the importance of accurate hearing diagnostics. Evaluation of speech intelligibility is a fundamental component of hearing assessment and rehabilitation. The current gold standard in measuring speech intelligibility relies heavily on behavioural tests. While these tests are reliable and fast in healthy adults, it is challenging to assess speech intelligibility for patients who cannot communicate clearly, such as young children. For example, behavioral tests require active participation from the patient, such as raising their hand when a sound is heard, or repeating words and sentences. Objective measures, for instance using electro-encephalography (EEG), could overcome the current challenges in hearing assessment and do not require active participation from the patient. For example, in Flanders, all newborns are screened with an objective test where a few sensors on the head detect brainwaves in response to sounds. However, objective tests only use simple sound stimuli, such as tones or clicks, which cannot be used to measure important high-level hearing outcomes, such as speech understanding. In other words, current objective tests are used to check if a person can hear a word, but they can't indicate if the person can understand the word. An obvious missing link in audiological practice is a diagnostic test that can measure high-level hearing outcomes such as speech understanding in an objective way. For this reason, CORGEE was developed. CORGEE uses a novel method of "neural speech tracking" to objectively measure speech intelligibility using EEG. In the current study, the efficacy and the clinical validity of the CORGEE software will be evaluated in young children with a hearing impairment.
The National Institute on Aging together with the Alzheimer's Association (NIA-AA) recently proposed the ATN classification which is based upon the pathological processes present in Alzheimer's disease (amyloid, tau and neurodegeneration). The amyloid and tau status can be defined using cerebrospinal fluid analysis but also non-invasively using an amyloid or tau PET scan. The N status can be defined using an [18F]-FDG PET scan which is in Belgium part of standard of care. Recently, it has been demonstrated, using different amyloid PET tracers, that early-frame amyloid scans can be a surrogate for [18F]-FDG PET scan.
The Montreal Cognitive Assessment (MoCA) is a screening test for detecting cognitive impairment that assesses several cognitive domains (attention and concentration, arithmetic and orientation, memory, etc.). The instructions as well as some test items of the MoCA are presented auditory (spoken). Consequently, performance on the MoCA may be co-dependent on hearing. Therefore, to rule out the possible negative influence of hearing loss on performance on the MoCA, a MoCA for individuals with hearing loss was recently developed. More specifically, the original MoCA was modified by providing the instructions audiovisually (spoken with visual support) as well as by replacing hearing-dependent items. Since replacing items may affect sensitivity and specificity, the MoCA for persons with hearing loss should be revalidated.
The aim of the study is to collect data in children with developmental coordination disorder (DCD) aged between 7 and 17 years for analyses of the gait pattern while walking at the Gait Real-time Analysis Interactive Lab (GRAIL) at the university hospital of Ghent. Children with DCD will be asked to take a motor test (M-ABC-2) as well as walk on the treadmill during a single session of approximately 3 hours. The following data will be collected on the GRAIL while subjects walk at different gait speeds: 3D kinematics, kinetics, and EMG. Additionally, 3D kinematics, kinetics, and EMG data will be collected when performing either a cognitive (Stroop Color and Word Test) or motor (requiring arm swing) dual-task while walking at comfortable walking speed..
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.