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.
Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist that have been correlated with poor patient outcomes. Recently, an "Assisted Fluid Management" (AFM) system has been developed to help ease some of the work associated with GDFT protocol implementation. The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements. To date, there are no large outcome study using this AFM system. The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery.
Seismocardiography (SCG) measures the thoracic vibrations caused by the cardiac contraction and ejection of blood into the great vessels. Current smartphones with gyroscopes and accelerometers can measure these vibrations. Based on these components we measure and quantify the cardiac kinetic energy (kinocardiography) in order to differentiate dyspnea of cardiac origin from dyspnea of other origin. The study is conducted in an emergency service where a smartphone performs the measurement during 3 minutes. The results of the kinocardiography-based classification are then compared to the final diagnosis made by a physician. Currently, 235 patients have been included in the clinical study since May 2022. This rapid and non-invasive measurement allows the aid-to-diagnosis of heart failure without being influenced by other factors like the renal function for example that can be NT-pro BNP blood marker.
The objective of this phase III, placebo-controlled platform study is to investigate the efficacy of drugs for patients with ALS (Amyotrophic lateral sclerosis).
The purpose of the study is to evaluate the safety, efficacy and clinical usefulness of a mechanical support strategy with the impella device.
The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment. The eCAN JA explores the role of telemedicine tools (i.e. TC & TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head & neck (H&N, pilot 1b) and advanced (pilot 2) cancers. The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care. Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care. PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.
A randomized, controlled, and evaluator-blinded trial will be carried out to investigate the effects of 8 weeks of upper limb somatosensory discrimination therapy compared to an equal dose of motor therapy on sensorimotor outcomes in children and adolescents with spastic unilateral cerebral palsy aged 7 to 15 years old. Additionally, the potential role of clinical and neurological baseline characteristics on treatment response will be explored, including the extent of the brain lesion, age and baseline somatosensory function. The researchers primarily expect that the bimanual performance will improve equally in children and adolescents from both intervention groups, as measured immediately after the intervention has ended. The researchers hypothesize, however, that there will be a better retention effect in children and adolescents that received somatosensory discrimination therapy, resulting in differences between both groups in bimanual performance as measured at 6-months follow-up. The researchers further expect larger improvements in somatosensory function for children and adolescents in the somatosensory discrimination group and this both immediately after the intervention and at 6-month follow-up.
The purpose of this study is to understand if carbamazepine reacts with vepdegestrant and affects how it is processed in the bodies of healthy participants. This study is seeking participants who: - are male, or female who cannot have children. - are 18 years or older. - are extremely healthy as decided by medical tests. - have a body mass index (BMI) of 16 to 32 kilogram per meter squared. - have a total body weight of more than 45 kilograms (99 pounds). - can understand the study needs and provide a signed document to take part in the study. All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, all participants will receive carbamazepine by mouth once a day for 19 days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to decide if carbamazepine affects how vepdegestrant is processed differently in healthy adults. The study duration is 27 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. The participants may be allowed to leave on Day 4 or at the end of Period 1 but must return at the study doctor's call to complete the study. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time.
The aim of this study is to investigate whether using a coarse wheat fraction in wire-cut cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.
This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RO7589831 monotherapy in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. RO7589831 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, RO7589831 may be able to block the growth of these types of cancer.
The purpose of this study is to learn about the tastes of different suspensions with the study medicine called PF-07923568 in healthy adult participants. In a suspension, the medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore remains intact in the form of small particles. This study is seeking for healthy participants who: - are aged 18 years of age or older. - can produce a baby must agree to use a highly effective method of birth control. - are confirmed to be healthy by some medical tests. This study can include both men and women. - have body mass index (BMI) of 16 to 32 kg/m2 and a total body weight of more than 45 kilograms. Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two days to see if they are good to taste. Participants will answer a questionnaire after tasting each suspension. The questionnaire will be completed for each suspension. The questionnaire asks participants to test each suspension at 4 different times after tasting and spitting out the suspension. At least 60 minutes will pass between tasting each suspension. The total planned time period of participation is around 5 to 8 weeks. This includes the screening period of up to 28 days. Followed by first administration of study medicine. Then a 3 day in-patient stay at the study clinic. It also includes a follow-up phone call that happens 28-35 days after the final taste test.