Clinical trials

This study aims to evaluate the practical and research utility of a new test assessing language and memory in people with MS. To this end, we are administering the test to a group of 100 individuals with MS who are receiving treatment at the National MS Center Melsbroek. These data will allow us to determine whether scores on the new test correlate with those of established cognitive tests. Subsequently, we will administer the new test to 100 individuals without an MS diagnosis who are matched for age, gender, and education level. This will enable us to assess whether there are significant differences in scores between individuals with MS and those without the diagnosis. One year later, we will re-administer the tests to the participants with MS to determine the extent to which changes in scores on the new test correspond to changes in scores on established tests.

Intrathecal drug delivery is an effective treatment option for patients with chronic (non-) cancer pain or spasticity who do not achieve sufficient benefit from conventional therapies. After intrathecal pump implantation, intrathecal pump refilling is an essential postoperative maintenance procedure that requires procedural competence to be performed safely and consistently. Despite the absence of a standardized intrathecal pump refill protocol, the REFFIL-IT study aims to train 40 participants in intrathecal pump refilling. Based on the learning curve during simulation-based training and the number of complete simulated refill procedures required to achieve stable procedural competence, a step-by-step standardized intrathecal pump refill protocol will be developed. The REFILL-IT study aims to contribute to the safe and correct intrathecal pump refilling in patients with chronic (non-) cancer pain and spasticity.

In this trial the investigators assess the effectiveness of applying a hemadsorber (cytosorb®) in removing benzodiazepines or tricyclic antidepressants in intoxicated patients admitted to ICU with prolonged impaired consciousness. This is a one arm interventional investigation where a hemadsorption filter is applied in patients fulfilling inclusion criteria 8 hours after admission. Plasma titer of the neurodepressing drug will be collected sequentially both before and after start of hemadsorption to evaluate the speed of drug elimination before and after application of a hemadsorption filter. Pre- and post filter titers will be obtained to evaluate adsorbability and to evaluate time to saturation of the filter.

Study Overview This study aims to evaluate the visual outcomes, quality of vision, and patient satisfaction after receiving an extended range PRoF intraocular lens (IOL) during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This surgery is typically performed to treat patients with both corneal endothelial dysfunction and cataracts. By testing a newer IOL, the PureSee™ extended PRoF IOL, this study hopes to improve the way ophthalmologists plan surgeries and select IOLs for these patients, ultimately helping surgeons optimize the results and expand the options available for people undergoing this procedure. Purpose of the Study The goal of this study is to evaluate how well the PureSee™ IOL works in terms of intermediate visual acuity (how well participants can see things at an arm's length). The investigators will also measure the quality of vision, satisfaction, and whether participants need glasses after surgery. The investigators have set the following goals for this study: Primary Goal: To measure how well patients can see intermediate distances (uncorrected intermediate visual acuity, or UIVA) after receiving the PureSee™ IOL during triple DMEK surgery. Secondary Goals: To understand how independent patients are from glasses after surgery. To measure patients' uncorrected and best-corrected visual acuity (sharpness of vision) at distance, intermediate, and near vision after surgery. To evaluate the uncorrected defocus curve (how the vision of participants changes when focusing at different distances). To measure contrast sensitivity (how well participants can see in low-light conditions or with subtle contrasts). Who Can Join This Study? To participate in this study, participants need to: Be undergoing triple DMEK surgery for endothelial dysfunction and cataract at the time of enrollment. Be eligible to receive an extended range of vision IOL as part of the procedure. This study is looking for patients who are interested in understanding how new IOL technology might improve their postoperative vision quality and reduce their dependence on glasses. What Will Happen During the Study? Participants will have their visual outcomes and satisfaction measured at specific times following surgery. This includes: Testing uncorrected and best-corrected visual acuity at several distances (distance, intermediate, and near). Completing a survey about how satisfied they are with their vision and how often they need glasses or contact lenses. Undergoing testing to measure contrast sensitivity (how well participants can see in low-light conditions). Why Is This Study Important? The results of this study will help doctors make better decisions about which IOLs to use during triple DMEK surgery. By evaluating the PureSee™ extended PRoF IOL, the investigators hope to expand options for patients and potentially improve visual outcomes and postoperative satisfaction. Ultimately, this study could help improve the quality of life for patients who have both cataracts and endothelial dysfunction. Study Duration Participants can expect to undergo their last assessment 6 months post-surgery to track their progress.

Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.

This study examines in hospitalized patients, treated with sulfamethoxazole, high dose ciprofloxacin or high dose iv amoxicillin, the incidence of drug-induced urinary crystal formation and its association with acute kidney injury development.

The goal of this longitudinal clinical trial is to measure variability of interstitial glucose levels with a user-friendly real-time continuous glucose monitoring (CGM) technology at regular intervals in normo- and dysglycemic multiple autoantibody-positive individuals (age 5-39 years), in comparison with single autoantibody-positive individuals in the same age range. Participants will asked to undergo repeated oral glucose tolerance tests (OGTTs) (age 5-39 years) and hyperglycemic clamp tests (age 12-39 years) in parallel for a period of at least 2-3 years. In case of confirmed dysglycemia, we propose to perform CGM and OGTT every 3 months. The main questions the study aims to answer are: 1. Do the amplitude and time trends of CGM-derived glycemic variability indices and OGTT- and clamp-derived variables differ between the intermediate, high and very high risk groups? 2. Can (changes in) CGM-derived glycemic variability indices predict/detect dysglycemia in initially normoglycemic (single or multiple autoantibody-positive) individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables? 3. Can (changes in) CGM-derived glycemic variability indices predict clinical onset in (stage 1 or 2) multiple autoantibody-positive individuals with the same diagnostic efficiency as OGTT- or clamp-derived variables? 4. Can correlating (changes in) CGM-derived indices with (changes in) OGTT- and clamp-derived variables help to better understand the sequence of events leading to dysglycemia and clinical onset, as well as the relative contribution of beta cell function and insulin action to glycemic variability according to disease stage and biological and phenotypical characteristics of the individuals?

The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.

Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Conventional pharmacologic management, ranging from simple analgesics to strong opioids, is frequently limited by insufficient efficacy and systemic side effects. Intrathecal drug delivery (IDD) offers targeted, continuous medication infusion directly into the intrathecal space, allowing lower systemic doses and potentially reducing side effects while maintaining effective analgesia. The CAREGIVER study is a randomized, controlled trial designed to evaluate whether patients with severe refractory cancer pain receiving IDD experience a difference in HRQoL compared to those receiving conventional medical management (CMM) with oral pain medications.

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.

Knee replacement surgeries are one of the most frequently performed elective surgeries, with approximately 29,000 such procedures carried out annually in Belgium. Although these surgeries have been increasingly refined over the years, leading to better surgical outcomes, there is still room for improvement in terms of pre-surgical biopsychosocial patient preparation. Such preparation aims to optimally inform patients before their surgery and to start preparing them for rehabilitation and resumption of activities after surgery. Therefore, we aim to assess the added value and feasibility of prehabilitation within the knee replacement care pathway. The primary objective is to investigate the feasibility, acceptability and safety of multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) for people undergoing total knee arthroplasty (TKA). The secondary objective is to explore the effect of BPS-teleprehab versus best-evidence preoperative advice for people undergoing TKA on activity outcomes, functioning, pain, symptoms of central sensitization, quality of life, cognitive-emotional factors, joint awareness, satisfaction with the surgery, healthcare and medication use and productivity loss. The tertiary objective is to explore baseline associations between the collected outcome measures, demographics and medical data in people scheduled for TKA. Furthermore, this pilot trial will inform potential protocol modifications in prepara- tion of an eventual fully powered randomized controlled trial to investigate the ef- fectiveness of BPS-teleprehab in people undergoing TKA.

In infertility treatment, embryos are created in vitro after eggs have been fertilised by sperm using in vitro fertilisation or intracytoplasmic sperm injection techniques. These embryos, resulting from hormonal ovarian stimulation, can be transferred shortly after egg retrieval (fresh transfer) or frozen for later use. Both natural menstrual cycles and artificial cycles (using hormones to mimic a normal cycle) can prepare the uterus for embryo transfer. Patients with regular menstrual cycles often prefer the non-medicated approach. However, these cycles offer less flexibility in timing because they rely on ovulation. As the number of FET cycles increases worldwide, scientists are exploring the possibility of inducing ovulation in smaller follicles to increase the flexibility of natural cycles. However, the safety for future pregnancies is unknown. This study aims to better understand the function of the corpus luteum, the follicle remnant in the ovary after ovulation, by measuring several factors that change throughout the cycle due to substances produced by the corpus luteum. The results of the study will have a direct impact on clinical practice by increasing the flexibility of frozen transfer cycles.

Frozen shoulder remains a challenging disease to treat as pain and loss of range of motion can persist for many months or even years. This loss of function can have a severe impact on the patient's activities, participation and overall quality of life. The use of ultrasound-guided (USG) suprascapular nerve blocks (SSNB) and/or intra-articular corticoid injections (IACI) has been supported by many studies. However, double blinded randomized clinical trials using a combination of SSNB and IACI are rare. The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB, compared to a glenohumeral IACI combined with a sham SSNB. Outcome measures of interest are shoulder-related disability reported by the patients, shoulder pain and shoulder stiffness. These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis. As key secondary objectives, the investigators aim to identify which physical examination tests, or combinations of those, are correlated with MRI diagnostic criteria and favor a more positive evolution. Finally, through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB + IACI.

Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with non-small cell lung cancer (NSCLC) planned for surgical resection.

Chronic endometritis is an inflammatory condition of the endometrium. This inflammation can negatively affect fertility and pregnancy. The pathology is frequently (+-10%) observed in women with fertility problems. Today, diagnosis of chronic endometritis is not evident, since no well-validated classification scales are available. In the UZ Brussel the pathology department applies its own in-house scoring system, based on the presence and position of plasma cells within the histological images. Despite limited research so far, it recently became clear that the endometrium is colonized by micro-organisms (the microbiome). However, it is still unclear what role these microorganisms play in chronic endometritis and fertility problems. Chronic endometritis is often diagnosed in the context of fertility problems, and the patient is treated 'blindly' with broad-spectrum antibiotics such as doxycycline. Broad-spectrum antibiotics unnecessarily eradicate many microorganisms in our body, including the ones that positively influence implantation. The exact cause of chronic endometritis is unknown, so treatment remains empirical. The research and knowledge in the endometrial microbiome is constantly expanding, mainly due to the rise of research into the links between pathologies and human microbiota. It is becoming increasingly clear that the composition of the microbiome can play a vital role in health and disease. Regarding the influence of the endometrial microbiome on different pathologies, such as chronic endometritis and implantation failure or miscarriage, there is still no consensus. Despite multiple studies on the endometrial microbiome, we are not yet able to define a normal or healthy endometrial microbiome. In this project, we want to gain insight into the microorganisms that are present in the female reproductive tract based on various techniques. The analyses will performed on a transvaginal ultrasound, endometrial biopsies which will be harvested during (guided biopsy) and after (blind pipelle biopsy) the hysteroscopy and a vaginal swab. The biopsy is routinely taken at Brussels IVF for the detection of plasma cells in the anatomopathology lab for the diagnosis of chronic endometritis. In the microbiology lab we will investigate which microorganisms are present in the female reproductive tract with and without the histological diagnosis of chronic endometritis. This will be done based on the state-of-the-art analytical techniques metagenomics (sequencing) and culturomics (culture).

The primary goal of this project is providing evidence that a home-based combined cognitive-motor training program improves cognition in persons with multiple sclerosis (MS), compared to single cognitive and motor rehabilitation. Secondary goals are to assess the effects on walking performance and to identify the mechanisms of improvement and predictors of treatment response. The main backbone of this project will be a randomized controlled two-centre clinical trial, in which an at-home computerised cognitive-motor rehabilitation program using telemedicine aimed at improving working memory in persons with MS will be evaluated. Based on the information gathered during this trial, possible mechanisms of improvement will be identified by analysing anatomical and neurophysiological changes on structural MRI and resting-state and task-related EEG before and after rehabilitation. Furthermore, factors that can predict treatment response to the rehabilitation program will be identified.

Morbidity and mortality of CLD is driven by the extent of liver fibrosis, characterized by scar formation and disruption of the normal liver architecture. HSCs play a central role in liver fibrosis development. When hepatocytes are damaged, HSCs undergo myofibroblast differentiation, transitioning into an activated state. So far, no efficient biomarkers can estimate the degree of HSC activation or reversal across all aetiologies of CLD, although this could be a more sensitive marker than fibrosis measurement which is secondary to HSC activation. This study aims to correlate biomarkers to the fibrosis stage in a larger cohort of patients with CLD across all aetiologies.

Recent evidence suggests that combining liver stiffness measurement (LSM) with spleen stiffness measurement (SSM) significantly improves risk stratification in patients with PBC. In a study the addition of spleen stiffness to liver stiffness enhanced the prediction of liver decompensation, providing a more precise evaluation of portal hypertension. Furthermore, when combined with platelet count, this approach effectively identified patients with a low probability of harboring HRVs. This could allow clinicians to safely avoid unnecessary endoscopic procedures in selected patients, improving patient comfort and reducing healthcare costs. Therefore, our patients participating in this trial will undergo follow up (every 6 months) as per Standard of care. This includes a blood draw, FibroScan and Ultrasound. Together with this, 2 questionnaires will be completed (not as per SOC) and during the FibroScan, a spleen stiffness measurement will be performed.

This study aims to learn more about anal cancer risk in men who have sex with men (MSM) who are using Pre-Exposure Prophylaxis (PrEP) to prevent HIV. Specifically, we want to check how common High-Grade Squamous Intraepithelial Lesions (HSIL) are in this group, how well anal swabs can screen for these lesions, and how having HSIL affects their quality of life. We'll also test if DNA methylation testing can give us extra information about the lesions. The main questions the study aims to answer are: * How common are HSIL in MSM using PrEP? * How accurate are anal swabs for detecting HSIL in this group? * How does having HSIL affect the quality of life of MSM using PrEP? * Can DNA methylation testing help improve our understanding of HSIL in these individuals? Participants will: * Answer questions about their health and quality of life. * Have an anal smear collected for testing. * Undergo High-Resolution Anoscopy (HRA) to check for HSIL and get a biopsy if deemed necessary.

This study focuses on understanding how well patients who have recovered from an ICU stay absorb nutrients when receiving enteral (tube) feeding. Proper nutrition is crucial for recovery, but we don't fully understand how efficiently enteral feeding works in ICU survivors. The study will use advanced techniques like bomb calorimetry to measure the energy content of stool, and indirect calorimetry to measure patients' resting energy expenditure (REE). This will help assess the effectiveness of enteral feeding in these patients, providing valuable information about their metabolic needs and nutritional status. The study will also look into the environmental impact of enteral feeding, particularly food waste. By understanding how much of the nutrition is absorbed versus excreted, the study hopes to suggest more sustainable feeding practices and reduce unnecessary waste in hospitals. Key Goals: * Primary Goal: Measure how much energy from enteral feeding is absorbed by patients post-ICU by analyzing their stool and energy expenditure. * Secondary Goal: Assess how enteral feeding can be made more sustainable, with less waste generated from unused nutritional products. This research will help improve nutritional care for ICU patients, enhance recovery, and potentially lead to more environmentally friendly healthcare practices.

This exploratory study's primary objective is the changes of irritable bowel syndrome (IBS) symptom severity by cardiovascular endurance training (CET) in relation to the baseline sedentary or non-active lifestyle. Secondary endpoints focus on the mechanisms associated with these changes. These mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. Virtually all IBS guidelines mention lifestyle modifications as a management option. Research on the role of physical activity remains underassessed as compared to the other interventions. Therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of IBS patients. This study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness.

Neuromuscular Blocking Agents (NMBAs) are routinely administered to patients in a multiplicity o anaesthetic settings in order to paralyze and impede (re)active muscular contraction. The availability of monitoring devices allowing an accurate measurement fo the degree of neuromuscular block during anesthesia has raised the standards for a proper evidence-based use of NMBAs. For this purpose, one of the most widely used methods is the Train of Four (TOF): transcutaneous application of a series of 4 square-wave supra-maximal electrical stimuli over the course of a nerve of choice (most commonly the ulnar nerve). These are applied at a frequency of 2Hz, and each with a duration of 0.2ms. These stimuli elicit a motor response on the adductor pollicis muscle, which on its turn dictates the adduction of the thumb. The acceleration of this movement can be followed by means of an uni/multi-directional accelerometer attached to the thumb. The ratio of the acceleration of the 4th and 1st elicited contractions is called the TOF-Ratio - a clinically and scientifically established method of assessing neuromuscular block recovery. A value of 1 translates a full recovery of the muscular function of a patient. In modern Anesthesia, the bar for deeming a recovery as adequate has been set at a minimum of a TOF-ratio of \>0.9, with some authors advocating a ratio of 1 as the only acceptable and complications avoiding result.

The clinical study is titled the CRYONIC PROTOCOL, which stands for Cryotherapy for Neurolysis In Chronic Pain. It is structured as a prospective, multi-cohort observational study. Purpose of the Study: The overarching purpose of the CRYONIC PROTOCOL study is to assess the Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders. The study focuses on evaluating the effectiveness of ultrasound-guided peripheral nerve cryoneurolysis, a minimally invasive technique that uses extreme cold to induce temporary nerve blocks, for patients with treatment-resistant chronic musculoskeletal pain. The study also seeks to determine if cryoneurolysis itself leads to meaningful improvements in both pain intensity and functional ability in the included patient cohorts.

Mitochondria are structures inside cells that are responsible for producing energy from nutrients through a series of steps, using oxygen. To have an idea of how well the mitochondria can produce energy, we can measure how much oxygen they use. The goal of this study is to: 1. To compare the oxygen use between people with long COVID and people who completely recovered after COVID-19, using three techniques that measure the oxygen use in blood cells, on the skin and in the muscle 2. To test how similar these three techniques are in measuring the oxygen used in the three different tissues Participants will: * Complete surveys, * Wear an activity tracker (7 days), * Undergo several non-invasive tests, and * Donate a blood sample The study will take place in UZ Brussel hospital and will take 2 study visits, approximately 7 days apart.

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells in case of imminent gonadotoxic treatment during childhood. In case of total azoospermia or absence of spermatozoa that can be used for intra-cytoplasmic injection (ICSI) in adulthood, the investigators intend to perform the first in men autologous testicular tissue transplantation to restore fertility.