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.
This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
In January 2021, the vaccination campaign against coronavirus disease 2019 (COVID-19) started in Belgium. The vaccination campaign was conducted in several phases, with the first phase targeting priority groups starting in January 2021. The second phase began in June 2021 with the invitation of everyone aged 18 years and older before extending access to 12 years and older from summer 2021. Children aged 5-11 were also invited for vaccination from December 2021 onwards. The presence of a social gradient in COVID-19 infections and subsequent outcomes has been clearly demonstrated. Individuals from lower socioeconomic groups, for example with lower income, lower education level or unemployed are more likely to be infected by the SARS-CoV-2 and to develop severe complications after the infection such as hospitalization, ICU admission or death. Certain sociodemographic characteristics such as male gender, older age, living in crowded households, or belonging to ethnic/racial minorities are also associated with a higher risk of COVID-19 infection and severe outcomes. In addition to disparities in infection, hospitalization and mortality, some studies have also documented a lower COVID-19 vaccination coverage among people from disadvantaged socioeconomic groups during COVID-19 pandemic. Despite widespread vaccine promotion efforts and the fact that Belgium has the 7th highest full vaccine coverage in the European Union (89% of people over 18 years old had completed their primary course of vaccination on 08 April 2022), concerns regarding vaccine equity remain. Vaccine uptake depends on a range of factors, including the socio-cultural environment, pre-existing health needs and individual choice. Identifying differences in vaccination between population groups is crucial to assess the effectiveness of the vaccination strategy in Belgium and its relationship to the further spread of COVID-19. The objective is to identify whether vaccination coverage has been equitable across Belgium and, if not, which groups of individuals are less likely to be covered by the COVID-19 vaccine, with respect to their sociodemographic (SD) and socioeconomic (SE) characteristics. This study therefore aims to highlight SD and SE disparities in the uptake of the first dose of COVID-19 vaccine in Belgium among people of 18 years and over.
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function. Tolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.
This study is open for adults with advanced cancer (solid tumours). This is a study for people for whom previous treatment was not successful. This study tests a medicine called BI 907828. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. The purpose of this study is to find out whether the amount of BI 907828 in the blood is influenced by taking an OATP inhibitor or a CYP3 inhibitor. This study uses an OATP inhibitor called rifampicin and a CYP3 inhibitor called itraconazole. In clinical practice, rifampicin is used as an antibiotic. Itraconazole is used to treat fungal infections. Participants are divided into 2 groups: a rifampicin group and an itraconazole group. Every participant takes BI 907828 as a tablet every 3 weeks. This is called a cycle. - Rifampicin group: In addition to BI 907828, participants take 1 tablet of rifampicin in the second cycle. - Itraconazole group: In addition to BI 907828, participants take itraconazole tablets for 20 days starting 1 week after the second cycle begins Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors take blood samples from the participants to compare the amount of BI 907828 in the blood when it is taken alone and when participants also take rifampicin. Doctors also regularly check participants' health and take note of any unwanted effects.
Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment. The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment. This study aims to find reliable and valid assessment methods for the prognostic factors and upper limb function itself in a small group of BCS and healthy volunteers.
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.
There are in total 3 cohorts. Cohort A: 16 patients will receive a daily dose of 80mg regorafenib up until progressive disease, unacceptable toxicity or withdrawal of consent. Dose can be escalated intra-patient up to 120 mg if no AE with a grad >1 at 28 days. Patients get a baseline evaluation and have a consultation every 2 weeks for evaluation during treatment. This evaluation consists out of lab tests, PET/CT (not bi-weekly), MRI (not bi-weekly) and physical evaluation. Primary endpoint is the anti-tumor activity, secondary endpoints are the Overall Survival Rate, Progression Free Survival and the incidence and severity of AE and Health-Related Quality of Life. Cohort-B: 16 patients who are being treated with BRAF-/MEK- inhibitors will receive additional daily regorafenib in combination with BRAF-/MEK inhibitors. Approved BRAF-/MEK- inhibitor combinations include dabrafenib/trametinib and encorafenib/binimetinib. An interruption of BRAF-/MEK-inhibitors dosing of maximum 4 weeks is allowed between the documentation of progression of disease on this therapy and the initiation of regorafenib study treatment. Dose of regorafenib is 40mg. Cohort-C: 16 patients in Cohort-C will have interrupted treatment with any BRAF- /MEK - inhibitor combination for at least 12 weeks prior to initiating study therapy with regorafenib. At the time of initiating regorafenib study treatment at 40mg, patients will also resume treatment with encorafenib/binimetinib at its standard dosing regimen. The first 6 patients enrolled in each Cohort (B, and -C) will be considered as a safety lead-in study population. If two or more serious treatment-related adverse events are observed among the first 6 patients, enrollment will be suspended (if applicable). The risk/benefit for continuing enrollment will be evaluated and an interim safety report will be provided to the Medical Ethics Committee of the UZ Brussel. If less than two serious treatment-related adverse events are observed, enrollment will be continued without interruption to complete the phase II objective.
Standard IVM currently contains urinary purified hormones which might contain contaminants possibly affecting maturation of embryo development. The investigators will test if the efficiency in terms of oocyte maturation after IVM of recombinant (without contaminants) is equivalent to urinary gonadotropins. Urinary and recombinant FSH and hCG will be used in equivalent bioactivity as measured in IU/ml and specified by the manufacturer. Sibling oocytes of the patient will be subjected to IVM medium containing urinary or recombinant gonadotropins. Oocyte maturation is the primary outcome, however, fertilization rate and preimplantation embryo development will be investigated.
The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.