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  • Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis

    Phase

    N/A

    Span

    136 weeks

    Sponsor

    IRCCS Sacro Cuore Don Calabria di Negrar

    Antwerp

    Recruiting

  • A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients

    A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 [roginolisib hemi-fumarate]) in combination with dostarlimab with or without docetaxel in Advanced Non small-cell lung cancer (NSCLC) patients. This study will enrol approximately 45 male and female patients aged over 18 years with advanced NSLCL who have process on standard of care immune checkpoint therapy and platinum doublet chemotherapy or standard immunotherapy without chemotherapy. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).

    Phase

    1/2

    Span

    145 weeks

    Sponsor

    iOnctura

    Antwerp

    Recruiting

  • The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome

    Phase

    N/A

    Span

    355 weeks

    Sponsor

    University Hospital, Antwerp

    Antwerp

    Recruiting

    Healthy Volunteers

  • Study of JK06 in Patients with Unresectable Locally Advanced or Metastatic Cancer

    This Phase 1/2, open label, dose escalation and cohort expansion study is designed to evaluate and characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of JK06 administered intravenously (IV) in patients with unresectable, locally advanced, or metastatic cancer. The study consists of a Dose Escalation phase to determine the MTD/recommended phase 2 dose (RP2D) of JK06, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK06 in tumor specific cohorts.

    Phase

    1/2

    Span

    197 weeks

    Sponsor

    Salubris Biotherapeutics Inc

    Antwerp

    Recruiting

  • Testing and Evaluating a Psychoeducation Tool and Guidelines for Victims of Violence in Belgian Hospitals.

    Phase

    N/A

    Span

    32 weeks

    Sponsor

    University Hospital, Ghent

    Antwerp

    Recruiting

    Healthy Volunteers

  • Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.

    Inclusion and exclusion criteria Inclusion criteria Patients treated with CartiONE for knee cartilage lesion more than 6 months prior to inclusion in this study. The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index knee surgery report, and posttreatment observations and re-intervention reports, if applicable. Exclusion criterion Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation. Statistics This is a retrospective, open label, non-randomized, single arm trial. Since different questionnaires for effectiveness and for quality of life (e.g., KOOS, EQ-5D,...) may have been used, the total score of the questionnaires ranging from the minimum total score (i.e. 0 or 1) to the maximum total score will be transformed into the range from 0 respective 1 to 100. Now they can be combined across patients and effectiveness questionnaires or across patients and quality of life questionnaires. Details will be provided in the Statistical Analysis Plan. There are two co-primary endpoints: Primary endpoint safety: Adverse events with particular focus on Treatment failure rate and on other AESIs Primary endpoint effectiveness: MOCART sub-score 1 "Volume fill of cartilage defect" Efficacy/Effectiveness: Key secondary endpoints: Non-inferiority in MOCART/MOCART 2.0 total scores when measured at two different visits, i.e., at the reference visit and later. Non-inferiority in mean "Radiologist's overall knee status assessment" when measured on a scale from 0 (extremely bad) to 100 (extremely good) at two different visits, i.e., at the reference visit and later. Other secondary endpoints: Improvement in other effectiveness questionnaire total scores Improvement in quality-of-life total scores Improvement in other questionnaires when applicable Exploratory endpoint: "Radiologist's overall knee status assessment" on a scale from 0 (extremely bad) to 100 (extremely good) of the two readers.

    Phase

    N/A

    Span

    96 weeks

    Sponsor

    Cartilage Repair Systems BV

    Antwerp

    Recruiting

  • Transfer of Microorganisms Between Green Areas and Humans

    Several hypotheses propose that the modern surge in immune disorders is related to diminished contact with nature. Specifically, the Biodiversity hypothesis emphasizes that contact with natural environments enriches the human microbiome and is necessary for promoting immune balance. This project aims to investigate whether visiting green areas can contribute to changes in human microbiome composition. Additionally, the investigators aim to explore the environmental, health and lifestyle factors that can influence these microbiome changes. Adults and/or children will be asked to visit a green space (such as an urban park) and perform specific activities (such as walking or pushing a stroller) for a defined time period. Before and after this visit, swabs of their skin and nose will be collected to analyze microbiome changes. In addition, questionnaires will be administered to the participants, with the goal to align microbiome changes with environmental, health, lifestyle and demographic factors.

    Phase

    N/A

    Span

    150 weeks

    Sponsor

    Universiteit Antwerpen

    Antwerp

    Recruiting

    Healthy Volunteers

  • Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health

    Phase

    N/A

    Span

    66 weeks

    Sponsor

    University Hospital, Antwerp

    Antwerp

    Recruiting

    Healthy Volunteers

  • Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

    Inflammatory bowel diseases (IBD) are a group of immune mediated disorders primarily targeting the gastro-intestinal tract and consist of two distinct phenotypes: Crohn's disease (CD) and ulcerative colitis (UC) that share similarities in both clinical presentation, pathophysiology and treatment. A small proportion of IBD patients cannot be correctly characterized in one of those categories and is referred to as IBD type unclassified (IBDU), which is often classified under UC for clinical research purposes. TNF inhibitors are one of the most frequently prescribed biological therapies and remain an important part of the therapeutic arsenal with international guidelines recommending their use in moderate-to-severe CD and UC when conventional treatments have failed. Infliximab, a chimer monoclonal antibody against tumor necrosis factor (TNF), was the first anti-TNF agent to be approved for treating IBD as early as 1999. After losing its product patent in 2013, several biosimilars of infliximab have been commercialized including CT-P13. Originally only available in an intravenous (IV) formulation, a subcutaneous (SC) formulation of CT-P13 has been registered for treating moderate-to-severe CD and UC as well. However, many questions on the use of these subcutaneous formulations of infliximab in daily clinical practice remain unanswered, especially in patients who previously required IV dose optimization of infliximab. The primary objective of the AMARETTO trial is to compare clinical and biological outcome between a regimen with SC infliximab every week and SC infliximab every other week among patients who were in clinical and biological remission with an optimized IV schedule when they switched to SC infliximab. The secondary objectives of this study are: - To compare treatment optimization and discontinuation between a regimen with SC inflixmab every week and SC infliximab every other week among patients who were in clinical and biological remission with an optimized IV schedule when they switched to infliximab SC. - To evaluate the willingness and the experience of patients switching to SC infliximab. - To compare clinical and biological outcome, as well as treatment optimization and discontinuation between a regimen with SC infliximab (every week or every other week) and IV infliximab among patients who were in clinical and biological remission with an optimized IV schedule. This study is a national, multicenter, randomized, open-label, prospective, pragmatic trial in Belgium. The trial design is as follows: - All subjects will undergo screening procedures. The screening visit of eligible patients will include the review of inclusion and exclusion criteria, and the informed consent form procedure. After screening, if the patient fulfils all inclusion and none of the exclusion criteria, and is willing to participate, the gastroenterologist will record the characteristics of patients and of the disease, medical and surgical history, current and past IBD treatments physical examination, the PRO-2 score about the last 3 days before the visit, blood analysis, stool analysis and patients will be asked to fill in a questionnaire about health-related quality of life. - Afterwards the patients will visit the gastroenterologist 4 times in one year (week 0, week 8, week 24 and week 52, however the specific weeks can vary depending on the IV dosing schedule). During these visits a physical examination will be done, the PRO-2 score based on the 3 previous days before the visit will be calculated, a blood analysis and stool analysis will be done, the concomittant medication will be collected and patients will be asked to answer the questionnaire about the health related quality of life. NOTE: patients that switch to subcutaneous infliximab will be asked to collect all at home administrations in a diary and to additionnaly answer a questionnaire about the satisfaction of switching to subcutaneous infliximab.

    Phase

    4

    Span

    138 weeks

    Sponsor

    Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

    Antwerp

    Recruiting

  • The Effectiveness of a Functional Capacity Evaluation Among Persons on Sick Leave or Work Disability

    This research project on the use of Functional Capacity Evaluations (FCE) within the context of benefit insurance in Belgium falls under the joint control of the National Institute for Sickness and Disability Insurance (RIZIV), the Haute École de Leonard Vinci and KU Leuven . KU Leuven hereby acts as the study's principal, but together with RIZIV and Haute École determines the objectives of the study as joint controllers. An FCE consists of the evaluation of functional capacities based on medical reporting, observations and/or a series of standardised tests performed by an occupational therapist. This evaluation can give socially insured persons and medical advisors of the mutualities more insight into the participation possibilities of the socially insured person in function of the previous or next job. To date, the advisory doctor does not yet have the opportunity to have these evaluations carried out in Belgium. The aim of this study is therefore to examine the impact of these FCEs with regard to people on incapacity for work who meet the following conditions: 1. Belgian citizens on sick leave or work disability who meet the criteria determined by the article 100§1 and 100 §2 of the coordinated law of 14 July 1994, or by article 19 and/or 20 of the RD 20 July 1971. 2. The person's medical situation is stabilised (no significant evolution due to illness, procedure, treatment) 3. It is not a purely mental/psychiatric disorder 4. From the point of view of the consulting physician, there is a lack of consistent information on the capacity to return to work 5. Inclusion takes place from the 6th month of incapacity 6. The person is of working age: 18-65 years In this RCT, 10 consulting physicians, 30 occupational therapists, and 200 persons on incapacity will be recruited. Then, persons on sick leave/work disability are randomly divided into two groups: 1) Persons in the control group receive the usual counselling by the medical advisor. 2) Persons in the intervention group receive usual care and an FCE. In the latter group, the person on sick leave is matched by the researchers to an occupational therapist in his region, and is invited to a FCE. After the evaluation, the person reviews the results with the occupational therapist, and a report of the FCE is provided to the medical advisor. Finally, the person is contacted by the medical advisor if they wish to take certain actions as a result of the FCE report. To measure the impact of the FCE, the intervention and control groups thereby complete a questionnaire at four points in time: at baseline, after 3 months, after 6 months, and after 9 months. This questionnaire is composed of validated instruments, and in addition to background characteristics, it questions work ability, self-efficacy, expectations of returning to work, any (steps taken to) return to work, pain intensity, illness perception, and beliefs regarding returning to work. As a second objective, the impact on the medical advisors' (and other parties') decision-making process will be investigated through qualitative interviews and focus groups. To this end, a process evaluation will be conducted. This includes an examination of the implementation of the study, the usability, feasibility and quality of FCEs and their reporting, and the underlying causal mechanisms of the intervention. Using interviews and focus groups with medical advisors the impact of the FCE on the decision-making process will be investigated. Using interviews with occupational therapists, return-to-work coordinators and mediators of the regional services the usability, feasibility and quality of the FCE will be investigated.

    Phase

    N/A

    Span

    51 weeks

    Sponsor

    KU Leuven

    Antwerp

    Recruiting

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