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Filter by:The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the cohort expansion phase. This study is the sub study of the Master protocol (NCT04126200).
This will be an open-label, prospective, single-centre, randomised, controlled, parallel-group medical device investigation. The investigational plan will include four visits in total at the investigational site. One visit (Visit 2) will consist in the hospitalisation period and will last 3/4 days. Patients will be admitted to hospital in the day preceding the TURBT (Day -1; in case the TURBT is programmed in the morning) or in the day of the TURBT (Day 0; in case the TURBT is programmed in the afternoon) and will stay in the hospital for 3/4 days after the intervention (performed on Day 0). Patients will then be discharged, if considered as appropriate based on Investigator's judgment, following the removal of the catheter and the first clear urination. Patients will be asked to remain in the same geographic area of the investigational site up to the end of study visit.
Chronic rhinosinusitis with nasal polyps (CRSwNP) or nasal polyposis is a frequent disease leading to a decreased quality of life. The validated course of treatment is firstly a medical one with saline irrigations and topical corticosteroids, followed by surgery (ethmoidectomy) if the medical treatment fails. In many cases, CRSwNP becomes a recurrent disease despite maximal treatment as previously indicated and it becomes refractory, with a chronically reduced quality of life. New treatments known as Biologics or Biotherapies in France such as Dupilumab are now available in situations of severe recurrent CRSwNP despite the appropriate treatment. The goal of this study is to assess the clinical effectiveness of Dupilumab and patient satisfaction, in a cohort of french patients, focusing on the change in quality of life that is expected from said treatment, over a period of one year. Patients will undergo 6 months of treatment with Dupilumab, the treatment will then be stopped for the next 6 months. The primary judgment criteria will be the SNOT 22 score, measured before treatment, after 6 months of treatment, and 6 months after stopping treatment, over a telephonic conversation.
The CLIMATE Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific efforts, somatosensory amplification, self-efficacy, health literacy and commitment to the GP, degree of urbanisation of the patients' administration district and characteristics of the patients' neighborhood are associated with these effects.
This is a single arm, multicentric phase II study of milademetan plus fulvestrant in patients with ER+, HER2- ABC harboring GATA3 mutation(s) in the tumor and/or in ctDNA who have progressed on or after prior treatments including a CDK4/6 inhibitor. Frameshift or truncating GATA3 mutations will be identified by next generation sequencing (NGS) performed on either tissue or circulating DNA. Given the well-known safety profile of fulvestrant and the absence of significant toxicity expected from the association of fulvestrant and milademetan, a safety run-in is planned. During the course of the study, the Steering Committee will specifically review the occurrence of toxicities defined as DLTs in the safety run-in.
The objective is to evaluate the impact of a pharmacist-led therapeutic education intervention on the knowledge of hospitalized heart failure patients. The knowledge score on heart failure disease and medications will be compared between two groups one month after hospitalization. The intervention group will receive a therapeutic education intervention and usual hospital care and the control group will receive only usual hospital care.
This study uses different types of functional magnetic resonance imagining (fMRI) to generate individual transcranial magnetic stimulation (TMS) targets. During the TMS/fMRI imagining sessions, the investigators stimulate a target of either high or low regional controllability during a working memory task to investigate network responses and the impact of TMS on behavior.
Behavior dysregulation is commonly associated with people with autism spectrum disorder (ASD). Irritability is a major safety concern in adults with ASD. This study will assess the efficacy and safety of JZP541 in the treatment of adults with irritability associated with ASD.
Aneurysmal subarachnoid haemorrhage (SAH) carries a high morbidity and mortality, which is in part due to the development of secondary brain injury. The mechanisms behind this remain incompletely understood, but oxidative/nitrosative stress and disturbances in vasoregulatory mechanisms are believed to be involved. The present study aims to characterise the transcerebral exchange of oxidative/nitrosative stress markers and nitric oxide metabolites during the early phase after SAH compared to healthy volunteers, including the influence of induced changes in arteriel oxygen tension.
This clinical trial is evaluating a drug called AC176 in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least one prior systemic therapy. The main goals of this study are to: Evaluate the safety and tolerability of AC176, evaluate pharmacokinetics and preliminary antitumor activity of AC176