Cannes

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Psoriatic arthritis (PsA) is a type of arthritis that causes joint swelling and stiffness and is often seen in people with the skin condition psoriasis. It results from an overactive immune system attacking healthy tissue. This research aims to describe the long-term use and effectiveness of risankizumab (RZB) compared to other advanced treatments for managing PsA in everyday clinical care. The study is not conducted in the United States but will take place in about 15 countries and include between 900 and 1200 adult participants. Participants will be assigned in a 2 to 1 ratio to receive either risankizumab or other advanced therapeutic agents. The treatments will be given following usual medical guidelines, including approved dosing and indications, as determined by local regulations and professional standards. All study visits will occur during routine clinical care with no extra burden on participants. Participants will be followed and monitored for 24 months to observe treatment persistence. During the study, participants will continue their regular clinical visits without additional procedures or tests required by the study. Researchers will measure how many participants continue their prescribed treatment over the 24-month period. The study focuses on real-world treatment patterns and outcomes in patients with active PsA who have previously shown an inadequate response or intolerance to certain medications. Safety monitoring will align with routine clinical practice throughout the study duration.

Researchers are investigating a new approach to immunotherapy duration for patients with metastatic non-small cell lung cancer (NSCLC). This phase II-III randomized trial focuses on patients with stage IV NSCLC who have not received prior treatment for advanced disease. The study aims to compare the standard two-year immunotherapy maintenance with a shorter six-month (27-week) treatment period in patients who achieve disease control after initial chemo-immunotherapy induction, addressing the need to optimize treatment duration while maintaining disease control. Participants will first receive a combination of chemotherapy and pembrolizumab as initial treatment: either paclitaxel-carboplatin for squamous cell carcinoma (SCC) patients or pemetrexed-platinum for non-SCC patients, along with pembrolizumab every three weeks. After six months, patients who show disease control without severe toxicity will be randomly assigned to either continue pembrolizumab (with or without pemetrexed for non-SCC) until disease progression or unacceptable toxicity or complete two years of treatment, or to observation (with or without pemetrexed for non-SCC). Throughout the study, participants will undergo regular assessments including imaging to measure tumor response according to RECIST 1.1 criteria. Researchers will monitor overall survival at 18 months in phase II and about 24 months after randomization in phase III. Additional evaluations include performance status, PD-L1 expression, and safety monitoring. The total participation duration includes the initial six-month induction followed by the randomized maintenance or observation phase, allowing comprehensive evaluation of long-term outcomes and treatment impact.

Ventilator-associated pneumonia (VAP) is a common and serious infection in intensive care units, often leading to prolonged mechanical ventilation and excessive antibiotic use. This trial evaluates two strategies for starting antibiotic therapy in patients with suspected non-severe VAP: immediate antibiotic treatment after sampling versus waiting for microbiological confirmation before starting treatment. The study aims to balance the risks of unnecessary antibiotic exposure against the dangers of delaying therapy in infected patients, considering concerns about antibiotic resistance and patient outcomes. Participants are randomly assigned to one of two groups. The control group receives immediate empiric antibiotic therapy within one hour of randomization, based on clinical judgment and local protocols; treatment is stopped if respiratory samples are negative or continued for seven days if VAP is confirmed. The conservative strategy group waits for respiratory sample culture and/or PCR results before starting antibiotics; if results are negative, no antibiotics are given, and if positive, treatment is started promptly and continued for seven days without waiting for susceptibility testing. Throughout the study, participants are monitored for death or continued use of invasive mechanical ventilation up to 28 days. Researchers record the proportion of patients who die or remain on ventilation at 28 days as the primary outcome. The study involves patients who have been mechanically ventilated for more than 48 hours and meet specific clinical criteria for suspected VAP without signs of severe illness, with informed consent obtained from patients or their representatives.

Researchers are studying neurocognitive impairment in young adults aged 18 to 45 who have had an ischemic stroke, a serious condition affecting the brain's blood supply. This research aims to understand how cognitive abilities change over time after a stroke, focusing on global cognitive efficiency and specific areas such as memory, attention, and executive functions. The study also explores how pre-existing and stroke-related white matter brain lesions may influence cognitive recovery in this patient group. Participants will undergo cerebral MRI scans at 72 hours, 3 months, and 12 months after their stroke to assess brain lesions. Alongside imaging, they will complete detailed neuropsychological evaluations and functional assessments to trace their cognitive recovery trajectories over a one-year period. These repeated assessments will help identify the prevalence and patterns of cognitive impairment and recovery in young stroke survivors. Throughout the study, participants will be monitored with various tests and questionnaires conducted in French. Researchers will measure changes in global cognitive function and specific neurocognitive domains between 3 and 12 months after the stroke. Safety and adherence will be maintained by excluding those with conditions interfering with test participation and ensuring informed consent. The study provides a comprehensive view of cognitive outcomes and their brain imaging correlates in young adults after ischemic stroke.

Researchers are evaluating the long-term safety and effectiveness of commercially available Corin hip arthroplasty products. This observational study focuses on patients requiring hip replacement surgery due to conditions such as primary, secondary, or post-traumatic osteoarthrosis, femur head necrosis, congenital dislocations, and both primary and revision surgeries. The goal is to gather outcome data to support post-market surveillance and clinical evaluations over extended periods. Participants undergoing hip arthroplasty with Corin hip devices will be observed as part of this post-market clinical follow-up study. The study involves collecting data related to the performance and safety of these implantable devices during and after surgery. There is no experimental intervention, as the devices are commercially approved and already in use. Throughout the study, researchers will monitor participants' outcomes up to 10 years after surgery to evaluate the long-term success of the hip implants. Assessments include safety monitoring, performance reviews, and data collection to support peer-reviewed publications. Participants are expected to attend follow-up visits as part of the evaluation process to help document the implants' long-term effects.

Numerous neurological disorders affecting the central and peripheral nervous system are linked to immune system activity. This research focuses on rare neuroimmune conditions such as Autoimmune Encephalitis (AE) and Paraneoplastic Neurological Syndromes (PNS). Improving diagnosis speed and accuracy for these disorders may help guide better treatment approaches in the future. Participants provide biological samples including blood and cerebrospinal fluid (CSF) for the study. Blood samples are collected once to obtain serum, buffy coat, plasma, and peripheral blood mononuclear cells (PBMC). If CSF is drawn for diagnosis, any leftover sample is also stored. Samples are collected and stored to support better diagnosis and research. During the study, participants contribute blood and possibly CSF samples which will be stored and analyzed over a long term, up to 10 years. Researchers will monitor these biological materials to better understand the disorders and develop improved diagnostic tools and treatments. The study involves consented patients with neurological disorders related to PNS or AE and may include antibody testing results.

Researchers are evaluating capillary lactatemia as a potential tool to predict outcomes in patients with severe polytrauma during the pre-hospital phase. Current methods to assess trauma severity, such as vital signs and existing scoring systems, have limitations and can be subjective. Capillary lactatemia is a quick, safe test that can be performed at the accident scene and may improve the ability to triage patients effectively before hospital arrival. The study involves collecting capillary blood samples during hospital transfer to measure lactatemia values at inclusion and six hours later. This biological intervention aims to determine if capillary lactatemia can serve as an objective marker for poor outcomes in polytrauma patients. The study focuses on patients requiring emergency medical services and transfer to an emergency facility with medical assistance. Participants will be assessed through capillary blood sampling during transport, and their lactatemia levels will be recorded immediately and six hours after inclusion. Researchers will monitor these measurements alongside clinical data to evaluate the predictive value of capillary lactatemia. The study will help improve patient referral and management strategies in pre-hospital trauma care.

Researchers are collecting detailed information about adults who experience convulsive or non-convulsive status epilepticus, a serious condition involving prolonged or repeated seizures. This registry study records data on the circumstances of seizure onset, clinical features, treatments given before and during hospital care, diagnostic test results, and causes of the seizures. The study aims to track outcomes for these patients over time to better understand this condition and its management. Participants in this study are adults aged 18 years or older diagnosed with status epilepticus lasting 5 minutes or more, either as continuous seizures or repeated seizures without full recovery between them. Data collection involves standardized forms capturing demographic details, timing of seizures and treatments, EEG monitoring results, and other clinical information. The study includes follow-up assessments at ICU and hospital discharge, as well as at 90 days and one year after the seizure event. Throughout the study, researchers gather clinical findings, laboratory and EEG results, and treatment information from hospital and pre-hospital sources. They evaluate patient outcomes using measures like vital status and the Glasgow Outcome Scale at multiple time points, including up to one year after the seizure. This comprehensive data helps monitor recovery and long-term effects of status epilepticus in critically ill patients.