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.
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
EMBODY (Effects of a Mindfulness Based interventiOn on ibD disabilitY) aims to evaluate the effects of a mindfulness based intervention on a broad number of disease related disability dimensions in patients with Crohn's disease (abdominal pain, regulation defecation, joint pain, energy, emotions, body image, interpersonal interactions, education and work, sexual function, sleep). Besides, the investigators will measure the effect of the intervention on depression, anxiety, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity. It will be a prospective, randomized-controlled, monocentric, superiority trial using a waiting list with treatment as usual as control arm. Half of the patients will immediately start the mindfulness based intervention (early intervention group). In the other half, there will be a waiting time of 6 months before starting the mindfulness based intervention (late intervention or control group). Clinical disease activity (two-item patient reported outcome (PRO2)), faecal calprotectin and C-reactive protein (CRP) will be collected throughout the trial (pre-, during and post-intervention). The investigators will measure IBD-related disability through the IBD-Disk, a tool for assessing the impact of the disease on ten different dimensions of everyday life dimensions. Depression, anxiety and Stress will be investigated via the Depression Anxiety Stress Scale Short Form (DASS21). Disease acceptance and perceived control will be measured using the Subjective Health Experience (SHE) model. Evolution of the different variables will be compared between both groups (ANOVA).
Even though extensive research on the multisensory integration of auditory and visual stimuli has been carried out, the mechanisms of integration of tactile stimuli with other senses remain less known and understood. Furthermore, the brain mechanisms associated with active and dynamic tactile exploration of a surface have not been extensively studied. In the context of the development of human-computer interaction (HCI) technologies, understanding these mechanisms remains of vital importance for the realization of multisensory devices and to improve the user experience of the general population, but also to benefit the use by clinical populations, e.g., people with visual impairments. The planned experiment aims to study multisensory integration during the active and dynamic tactile exploration of a surface (a natural texture or the screen of a multisensory tactile device). The primary hypotheses are that simultaneous auditory and/or visual stimulation during active tactile exploration of a surface will help participants form a mental representation of the shape or texture they are exploring, and that the recorded brain activity will be compatible with multisensory integration mechanisms at the level of the cerebral cortex. The planned project will include (1) behavioral (psychophysical) experiments, to assess participants' performance in discriminating the spatio-temporal location of tactile, auditory, visual, audio-tactile, audio-visual, and audio-visual-tactile on the screen of a multisensory tactile device and (2) surface electroencephalography (EEG) recording experiments, which will be employed to study the cortical mechanisms of multisensory integration during active and dynamic tactile exploration .
This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.
Multiple sclerosis (MS) is a chronic inflammatory and degenerative disease of the central nervous system (CNS), characterized by a complex interplay of inflammatory demyelination and neuronal damage. The core MS phenotypes defined by clinical course are the relapsing and the progressive forms.Relapsing MS (RMS) is characterized by attacks - also called relapses - defined as new or increasing neurologic dysfunction, followed by periods of partial or complete recovery, without apparent progression of the disease during the periods of remission. In contrast, progressive MS (PMS) is characterized by progressive worsening of neurologic function leading to accumulation of disability over time independent of relapses. Additional descriptors ("active/not-active") serve to better characterize the presence of clinical and/or radiological activity both in relapsing and progressive forms. In recent years, the concept of a silent progression, also known as smouldering MS, is making its way into the common lexicon of MS experts, challenging the current definitions of MS phenotypes. A growing body of literature suggests that the line between RMS and PMS is not as marked as men thought, and that inflammation and neurodegeneration can represent a single disease continuum coexisting early on in the disease course. Whilst it is established that relapse-associated worsening (RAW) can be accounted for by an acute inflammatory focal damage leading to axonal transection and conduction block, the physiopathology underlying the progression independent of relapse activity (PIRA) remains unclear. It is becoming apparent that there is an increasing need for a personalized therapeutic approach by considering the individual MS phenotype of each patient, thereby enabling the choice of the molecule best suited to counteract the predominant disease pattern of that individual patient. There is a limited number of studies combining clinical scores, neurophysiological evaluation and neuroimaging in patients with MS experiencing PIRA. Integrating a multimodal exploration of these patients might allow a step forward in the early recognition, management, and treatment of disability accumulation independent from relapses in patients with MS.
The aim of the study is to assess the recurrence rate and potential long-term complications, at least 48 months, after a robotic assisted transabdominal retromuscular approach (rTARUP technique) for the repair of an umbilical hernia.
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.
Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%. A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS. This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years. After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.