Quebéc City, Canada

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).

Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer

The survival of patients with metastatic lung cancer has significantly improved with platinum-based treatments and, more recently, with targeted therapies and immunotherapies. However, despite therapeutic advances, lung cancer remains the world's leading cause of cancer-related death (approximately 2 million per year), due to innate or acquired tumour resistance to treatments. The combination of chemotherapy (platinum-doublets) and immunotherapy (immune checkpoint inhibitors) shows promising results in terms of overall survival (OS) and progression-free survival (PFS) for the treatment of first-line stage IV non-small cell lung cancer (NSCLC) patients, leading to such combinations becoming a real backbone of the Standard of Care (SoC) for NSCLC patients. These results may be attributable to the immunogenic effects of chemotherapy-induced tumour cell death, which, when used with immune checkpoint inhibitors, is an approach that may improve the clinical outcomes of cancer patients. However, conventional chemotherapy's severe systemic toxicities represent a limiting factor in terms of administered dose and frequency, requiring long rest phases (i.e., interruption of treatment) leading to a relatively limited frequency of chemotherapy treatment in current clinical practice (4 to 6 cycles of intravenous (iv) administration, all separated by a 3-week interruption period). This limitation, associated with high mortality, especially in the advanced stages of lung cancer, demonstrates that the treatments/combinations currently used are far from optimal. Administration of cisplatin by inhalation (pulmonary route) is a promising additional approach that may overcome the limitations of conventional chemotherapy and increase the efficacy of the current SoC via sustained local attack on the lung tumours of patients treated using immune checkpoint inhibitors with or without iv chemotherapy. Use of a dry powder inhaler (DPI) enables a high therapeutic response by delivering high local concentrations of a well-established active substance without the usual undesired reactions that limit the use of high doses when administered through the conventional systemic route. Thanks to limited systemic exposure to the cytotoxic active ingredient with the use of a dry powder inhaler, such add-on treatment enables considering 5 times weekly administration of inhaled chemotherapy at the patient's home. Increasing the frequency of local chemotherapy treatment in this way may enhance activation of the systemic anti-tumour immune response via local activation and stimulation of tumour-specific antigen release as a result of a safe, sustained and prolonged local effect, compared to the peak/short effect of iv chemotherapy. This study may provide insights into whether this add-on treatment might be a safe option for NSCLC patients.

The TRICURE EU Pivotal Study

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma

The occurrence of pancreatic cancer is increasing in Belgium. Although this type of cancer is severe, there are only a limited number of treatment options. The preferred treatment is usually surgery. However, this is only possible in certain circumstances. If surgery is not possible, chemotherapy is administered to improve survival. A combination of chemotherapy and SBRT followed by surgery if possible has already been used in some studies and will be investigated in a larger number of subjects with the TORPEDO study. A patient needs to sign an informed consent form before participating in the TORPEDO study. Participation in the TORPEDO study consists of the following phases: screening, induction chemotherapy, restaging and randomization, treatment, resectability assessment whether or not followed by surgery and a follow-up phase. During the screening phase, eligibility of the patient to participate in the study will be assessed. Demographics data, information regarding medical history, prior medications and adverse events will be recorded. Moreover, a clinical assessment, blood tests to assess general blood parameters, a CT chest/abdomen and MRI pancreas will be performed. Eligible patients (according to the inclusion criteria and exclusion criteria) will receive induction chemotherapy (standard of care) during 12 weeks. Either 6 cycles of mFOLFIRINOX or 3 cycles of gemcitabine / nab-paclitaxel will be administered. If, within one week after the end of chemotherapy (restaging), CT chest/abdomen and MRI pancreas do not show extrapancreatic disease and in absence of massive gastric or intestinal invasion, subjects will be randomized 1:1 to either treatment with chemotherapy (arm A) or treatment with a combination of chemotherapy and SBRT (5 x 8 Gy) (arm B). During the treatment phase, all subjects will receive 4 weeks of chemotherapy (either 2 cycles of mFOLFIRINOX or 1 cycle of gemcitabine/nab-paclitaxel). 7 to 28 days after the end of this chemotherapy treatment, subjects randomized in arm B will undergo SBRT (5 fractions of 8 Gy), preceded by the implantation of fiducial markers and simulation. 28 days after the end of the chemotherapy (arm A) or after the last SBRT fraction (arm B), various data will be collected (e.g. clinical assessment, blood tests such as determination of tumor marker CA19-9 level, CT chest/abdomen and MRI pancreas, questionnaires regarding quality of life and the occurence of adverse events) and resectability will be multidisciplinary determined. At 6 weeks (+/- 2 weeks) after chemotherapy (arm A) or SBRT (arm B), subjects considered suitable will have surgery. All subjects will receive another 8 weeks of chemotherapy (4 cycles of mFOLFIRINOX or 2 cycles of gemcitabine/nab-paclitaxel). The follow-up phase consists of ten-weekly follow-up visits during 2 years. These follow-up visits consist of a clinical assessment, CT chest/abdomen imaging, blood sampling, elicitation of AE's and assessment of the subject's quality of life through questionnaires. After these 2 years, patients will be followed by standard of care, six monthly during the following 3 years. After five years, patients will be followed on a yearly basis (standard of care). Follow-up data (survival status) will be collected.

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

Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients' sensation.

SCAD : a Registry of Spontaneous Coronary Artery Dissection

Observational, multicentre, international retrospective and prospective cohort study. Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled. Patient data will be collected at the following time-points: - First SCAD event visit (retrospectively on chart review) - First follow-up: at time of enrolment - Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion Approximately 30 countries and 120 sites will participate in this registry.

Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults with Refractory or Unexplained Chronic Cough

Approximately 325 participants will take part in the study. It is anticipated that up to 600 participants will be screened. Participation will be approximately 13 weeks.

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

The RECLAIM Study.