There are about 13392 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.
As we get older, our hearing deteriorates and an age-related hearing loss can develop. Having a hearing loss can make it more difficult for people to understand conversations. Hearing aids can help in these situations, but difficulties often remain in more challenging situations, for example, when a conversation is being held in a group or when background noise is present. These difficulties are often not only related to the hearing loss but also to how these sounds are processed in the brain. Auditory rehabilitation is believed to help persons with a hearing impairment train their listening and communication skills. Auditory rehabilitation includes sensory management to enhance auditory function; knowledge and skills to improve the outcome; perceptual training and counselling. For this reason, the ALICE app was developed. The ALICE app contains monitoring tests, listening training exercises and counselling for persons with a hearing impairment. In the current study, the ALICE app will be evaluated by persons with a hearing impairment. The experimental group will use the ALICE app in addition to the standard of care (hearing aid or cochlear implant) while the control group will receive the standard of care. Listening and communication skills will be evaluated pre and post training by a speech perception test in noise and questionnaires.
Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and research. Prior research shows that an interactive attention control training in which participants learn to unravel scrambled sentences ("life is my a party mess") in a positive manner ("my life is a party") by receiving feedback on their eye movements while attending to the valenced words, can facilitate participants to be more able to re-interpret negative information in a positive manner. In the current study we want to test the effect of psycho-education in combination with a 10 day attention control training to see if this has a positive effect on depressive, anxiety and stress symptoms, emotion regulation and self-esteem in depressed patients. The study takes place in a psychiatric hospital (Alexianen Zorggroep Tienen) while participants are staying there to receive treatment.
Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the potential QT interval prolongation (all Bazett) in former extreme low birth weight (ELBW, <1000 g) infants or preterms. Consequently, if investigators truly want to assess the presence or absence of either a difference or a prolongation of QTc intervals in this specific population, pooling of published data is likely the most effective approach (potential number of cases = 24 + 49 + 93 = 166; potential number of controls in the same studies = 24 + 53 + 87 = 164), preferably based on individual data. Although the sample is to a large extent pragmatic (as available), the investigators hereby aim to target the 5 ms QTc prolongation applied by the authorities (FDA, EMA) in paired healthy adult volunteer studies as 'golden' standard as primary outcome variable [EMA guideline, FDA guidance].
Different studies showed large variation between care processes in multiple diseases, which lead to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes. Since international studies have demonstrated wide variations in care processes for acute stroke, it would be interesting to repeat these investigations in the population of stroke patients. Worldwide, stroke is a leading cause of disability and death. Every two seconds, someone across the world experiences a symptomatic stroke. 50% of stroke survivors has moderate to severe neurologic deficits, 25% of them depend on others. In Belgium, stroke is one of the most important causes of invalidity. Every year approximately 18 000 people in Belgium experiences a stroke, which results in almost one person every two hours, with a mortality rate of 30%. The world health organization has the ambition to significantly reduce the mortality and risk factors for non-communicable diseases by 2025. The mortality and disability in stroke patients can be reduced by organized stroke care, which includes effective strategies in stroke management, treatment and prevention. Also, other health domains, like functional recovery, healthcare costs and patient satisfaction, were positively related to adherence on stroke guidelines. This evidence had been converted in several clinical guidelines for stroke care. However, the adherence to these guidelines is variable. As already mentioned before, international studies have demonstrated wide variations in care processes for acute stroke. However, a positive relationship has been shown between the implementation of evidence-based clinical guidelines and the quality of stroke care. Therefore, it is important to both implement these guidelines and to improve the adherence to them. The aim of this study is to map the variation in stroke care in Flemish hospitals and to get an overview about the variation within and between these hospitals. During this study, electronic patient records will be analyzed to check which interventions are performed in a specific patient and of which no information could be found in de patient record.
The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® & Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels. Participants will use Tresiba® & Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor. NovoPen® 6 is a smart pen, which collects and stores the date and time of injections and number of units of insulin participants have taken. NovoPen® 6 can transfer participants insulin dosing information to the mobile application, which participants use to see their continuous blood sugar level. This will allow participants to see their insulin doses along with continuous blood sugar level in the mobile application. Participants will keep using their own continuous blood sugar monitoring device and the mobile application to see these data during the study. The study will last for about 9-11 months. Participants will be asked to complete 2 questionnaires in this study. One questionnaire is about overall satisfaction of using a digital health solution and other is about quality of life. Participants will complete these questionnaires during their normally scheduled visit with the study doctor, on 2 separate occasions
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients
Since 1988, simulation has been proposed as a teaching tool in Anesthesia. The simulation environment allows to teach learners non-technical skills which are a combination of cognitive, social, and personal resources complementary to procedural skills that contribute to an efficient and safe performance. Non-technical skills traditionally used in Anesthesia are task management, situational awareness, teamwork and decision making. They can be indirectly measured with validated scales (e.g. Anesthesia Non-Technical Skills (ANTS) system). In addition to these basic skills, specific skills such as Anesthesia Crisis Resource Management (ACRM) are required when the patient presents a critical clinical situation. Simulation, as proposed by Gaba, was initially practiced in centers specifically designed for this purpose. More recently, we have proposed the model of in situ simulation, i.e. in the usual workplace with the usual work team, as another option for the practice of simulation. There are many theories about the transfer of learning. Transfer can be defined as what remains of the completed training that the learner actually uses, i.e. the final real effect. Nevertheless, almost 30 years after the introduction of simulation in the training of anesthesiologists, data demonstrating the interest of this teaching in terms of transfer of learning of non-technical skills to clinical practice or benefits for patients are rare. The main objective of this study is to evaluate the transfer of non-technical skills taught in a training program including in situ simulation to clinical practice by anesthesiology residents.
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.