Cannes

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.

Researchers are studying ways to reduce the duration of immunotherapy treatment in patients with advanced non-small cell lung cancer NSCLC who have their disease controlled after initial treatment. The study focuses on comparing a shorter immunotherapy maintenance period of 6 months to the usual 2 years to see if less treatment can still be effective. This phase II-III randomized study enrolls patients with stage IV NSCLC who have not received prior treatment for advanced disease. Participants will first receive a combination of chemotherapy and pembrolizumab for about 6 months, using specific chemotherapy drugs based on their cancer type. After this induction, patients showing disease control without severe side effects will be randomly assigned to one of two groups continuing pembrolizumab with or without pemetrexed for certain cancer types for up to 2 years or observation with or without pemetrexed. Researchers will monitor various factors including patient characteristics and tumor markers. During the study, participants will attend scheduled visits for treatment and monitoring, including imaging scans to measure tumor response and laboratory tests to check health status. Quality of life and survival will be tracked up to about 24 months after randomization. The study also collects data on side effects and progression-free survival to better understand the benefits and risks of shorter versus longer immunotherapy maintenance.

Researchers are evaluating the timing of antibiotic therapy for patients suspected of having non-severe ventilator-associated pneumonia VAP in intensive care units. This study compares immediate antibiotic treatment started right after respiratory sampling with a conservative approach that waits for microbiological confirmation before beginning treatment. Delaying antibiotics may reduce unnecessary use and antibiotic resistance but might risk worse outcomes if infection is present. The study is a randomized controlled trial led by Nantes University Hospital to better understand these strategies in patients without severe symptoms like septic shock or severe respiratory distress. The trial has two groups the immediate strategy group receives empiric antibiotics within one hour after randomization based on clinical judgment and local protocols. If respiratory samples later test negative, antibiotics are stopped if positive, targeted therapy continues for seven days. The conservative strategy group does not start antibiotics until respiratory sample cultures or PCR results confirm infection. If confirmed, appropriate antibiotics are administered for seven days without waiting for susceptibility testing. Both approaches focus on managing suspected VAP to balance timely treatment and antibiotic stewardship. Participants will be monitored from day 0 to day 28, with assessments including mortality and mechanical ventilation status at day 28 as the main outcome. Additional evaluations cover organ failure scores, lung infection scores, duration of ventilation, use of supportive therapies, hospital and ICU stay lengths, infection incidence, antibiotic use, and cost-utility analysis up to day 90. The study involves informed consent, respiratory sampling within two hours of suspicion, and excludes patients with severe VAP or significant immunosuppression. This comprehensive follow-up aims to clarify the impact of antibiotic timing on patient outcomes and antibiotic resistance in ICU settings.

Researchers are investigating the urinary microbiotas role in bladder cancer, a common cancer especially affecting men over 60, with smoking as a known risk factor. The study aims to explore whether certain bacteria or viruses in bladder tissue microbiota contribute to bladder cancer development by comparing microbiota from cancerous and healthy bladder tissues in the same patient. This research builds on earlier findings that showed differences in microbiota biodiversity between cancerous and healthy tissues. Participants will undergo biopsies during a procedure called RTUV, performed under anesthesia via cystoscopy in an operating room. The study uses advanced global metagenomics to analyze the bacterial and viral microbiota biodiversity in bladder tissues. This multicenter study will enroll men over 18 undergoing their first RTUV for suspected bladder cancer with specific clinical signs. During the 36-month study, researchers will assess the diversity of bacterial and viral microbiota in bladder tissues. Participants will provide informed consent, and safety will be ensured by screening for infections and contraindications before biopsy. The main measurement is the bacterial microbiota biodiversity, with viral microbiota diversity as a secondary outcome, helping to better understand bladder cancers microbial environment.

Stroke is a major health issue affecting over 150,000 patients in France, with ischemic stroke making up 80-85% of cases in western countries. This research focuses on young adults aged 18 to 45 who have been diagnosed with ischemic stroke. The study aims to understand how cognitive functions change over time after stroke, looking at overall brain function and specific areas like memory, attention, and social cognition. It also investigates how brain lesions, especially in white matter, affect recovery. Participants will undergo cerebral MRI scans at 72 hours, 3 months, and 12 months after their stroke to examine brain lesions. The study involves repeated neuropsychological assessments and functional evaluations to track cognitive recovery and impairment over a year. This approach helps detail the extent and progression of cognitive issues following ischemic stroke in young adults. During the study, participants will complete various tests and questionnaires in French to assess cognitive abilities. Researchers will monitor changes in global cognitive efficiency and specific neurocognitive domains between 3 and 12 months after stroke. The study measures how white matter lesions relate to cognitive recovery, with continuous follow-up over one year to evaluate neurocognitive outcomes and related brain imaging findings.

This research aims to collect long-term safety and effectiveness information on commercially available Corin hip arthroplasty devices. It focuses on patients who have had hip replacement surgery using Corin implants, including those with primary, secondary, or post-traumatic osteoarthrosis, femur head necrosis, congenital dislocations, and revision surgeries. The study supports post-market surveillance and clinical evaluations of these devices. Participants are patients with hip implants from Corin. The study observes their outcomes over many years, starting during surgery and continuing up to 20 years after. Key evaluations include clinical performance, safety, radiological positioning and bone integration of the implants, as well as patient quality of life and satisfaction at various intervals. During the study, participants will undergo assessments at multiple time points including 3 months, 2.5 years, and up to 20 years after surgery. Researchers will collect data on implant outcomes, patient well-being, and implant safety. The main measure is the long-term outcome at 10 years, with additional follow-ups at 15 and 20 years to monitor ongoing performance and safety. The total duration of participation can extend up to 30 years from the start date.

Researchers are collecting biological samples to improve diagnosis and treatment of rare neuroimmune disorders affecting the central and peripheral nervous system. These disorders include Paraneoplastic Neurological Syndromes PNS and Autoimmune Encephalitis AE, which involve immune system activity. The study aims to support faster and more accurate diagnosis, benefiting patients with these conditions by enhancing future treatment approaches. Participants diagnosed with PNS or AE will have biological samples collected once, including blood and possibly cerebrospinal fluid if available. Blood samples will be used to obtain serum, buffy coat, plasma, and peripheral blood mononuclear cells. If cerebrospinal fluid is drawn for diagnosis, any remaining sample will be stored. This collection will occur during a single visit, and samples will be stored for up to 10 years. During the study, participants will provide consent and undergo sample collection only once. Researchers will monitor the blood samples and cerebrospinal fluid biocollection over 10 years. The study emphasizes scientific collaboration and ongoing research to improve understanding and treatment of these neurological disorders. Participation duration focuses on the collection and long-term storage of biological samples.

Status epilepticus SE is a serious neurological emergency marked by prolonged or multiple seizures that can cause lasting impairments and has a high risk of death and complications. Despite advances, mortality remains about 20% overall and up to 40% in refractory cases. Many survivors experience cognitive, physical, and mental difficulties, but the long-term impact on quality of life after intensive care treatment is not well understood. This study aims to continue observing these effects over time, focusing on patient-reported outcomes and experiences following SE requiring ICU care. This observational study follows adults who survived ICU management for SE, assessing their health and well-being more than 3 months but less than 5 years after ICU discharge. It builds on previous registry data and collects detailed information on cognitive function, physical disability, mental health, social support, and family burden. The study includes repeated assessments at 3 and 12 months to track changes and experiences over time. Participants will be evaluated through questionnaires and patient-reported measures to capture their quality of life, cognitive and physical impairments, anxiety, depression, and post-traumatic stress disorder. The study also assesses social support and experiences of both patients and their relatives with the healthcare system. Researchers aim to better understand the long-term effects of SE and ICU care, with the study lasting until March 2027.

Researchers are studying the use of capillary lactatemia to assess the severity of potentially severe polytrauma patients before they reach the hospital. Current tools like vital signs and shock scores have limitations and can be subjective. Capillary lactatemia is a simple and quick test that could help predict poor outcomes in trauma patients, similar to venous lactatemia, but has not yet been studied in this context. The study involves collecting capillary blood samples during the transfer of trauma patients to emergency facilities. These samples are analyzed to measure lactate levels at inclusion and again six hours later. The goal is to see if capillary lactate levels can improve the prediction of severe outcomes and help guide better patient management in the pre-hospital setting. Participants will be trauma patients aged 18 or older, who have suffered serious injuries like road accidents or falls over two meters and require emergency medical assistance. The study measures lactate values at two time points and monitors patient outcomes. Consent is obtained from the patient or a relative, and pregnant women can participate safely. The study runs until December 2027 and includes continuous assessment during hospital transfer and emergency care.