Villefranche Sur Saone

Researchers are conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome INS, a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the diseases characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.

Researchers are observing the outcomes of Eurosilicone Luna breast implants in women aged 18 to 65 undergoing breast augmentation or reconstruction. This study aims to determine the frequency and rate of implant rupture and capsular contracture Baker III-IV over a 10-year period after surgery. It includes women undergoing primary or revision surgeries for cosmetic or medical reasons, including reconstruction after mastectomy, with or without associated therapies. Participants receive breast implant surgeries performed according to the surgeons preference, including choices about incision location and implant placement. The study covers primary or revision breast augmentation with or without mastopexy and breast reconstruction that may be immediate or delayed, with possible chemotherapy or radiotherapy. The implants studied are the Eurosilicone Luna mammary implants. No treatments are assigned by the study, as it is observational. During the 10-year follow-up, participants will have regular assessments to track implant rupture, capsular contracture, local complications, and any secondary surgeries needed. Researchers will also evaluate patient satisfaction. Monitoring includes clinical evaluations and adherence to follow-up appointments as per the study protocol. The total participation duration spans 10 years to observe long-term outcomes and safety.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating the efficacy and safety of a combination of KarXT and KarX-EC to treat cognitive impairment in individuals with mild to moderate Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to understand how these treatments affect thinking and memory problems associated with Alzheimers. The study is sponsored by Bristol-Myers Squibb and focuses on participants aged 60 to 85 years diagnosed according to specific clinical criteria and biomarkers. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. The medications are given at specified doses on designated days, though exact dosing schedules are not detailed in the summary. The study follows a parallel-group design, comparing the effects of the active drugs against placebo over a treatment period lasting 24 weeks. During the study, participants and their caregivers will attend visits where cognitive function and daily living abilities are assessed using tools such as the Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog11 and Clinicians Interview-Based Impression Plus Caregiver Input CIBIC. Safety is closely monitored through reports of adverse events, vital signs, laboratory tests, ECGs, and other clinical evaluations. The study lasts through the treatment period up to 24 weeks, with continuous monitoring of participant health and cognitive changes.

Researchers are studying advanced non-small cell lung cancer NSCLC with ALK gene rearrangement treated with next-generation tyrosine kinase inhibitors TKIs as first-line therapy. This prospective study, part of the national EXPLORE ALK cohort, aims to understand the biological characteristics and resistance mechanisms of this cancer type. It involves patients with stage IIIB or IV NSCLC who are not eligible for curative locoregional treatment and have confirmed ALK rearrangement. The study collects tumor tissue samples at diagnosis and at disease progression, if available, to analyze ALK fusion partners, variants, and co-mutations using RNA sequencing. Blood samples are taken at diagnosis, first tumor evaluation, and disease progression to analyze circulating tumor DNA ctDNA with next-generation sequencing. Treatments studied include alectinib, brigatinib, lorlatinib, and entrectinib, either marketed or under early access programs. Participants provide blood samples and allow use of tumor tissue for centralized biological analyses. Researchers measure progression-free survival up to 72 months as the primary outcome, along with overall survival, response rates, duration of response, ctDNA clearance, and resistance mechanisms associated with treatment and ALK fusion partners. The study involves regular evaluations over several years to monitor treatment outcomes and biological changes.

Researchers are evaluating different antimicrobial therapies for infections caused by difficult-to-treat Pseudomonas aeruginosa, a type of bacteria resistant to many common antibiotics. This study focuses on comparing new beta-lactambeta-lactamase inhibitor combinations, cefiderocol, and older treatments like aminoglycosides and colistin to understand their effectiveness in real-life settings for patients facing these challenging infections. The study is a prospective, multicenter cohort involving patients who require intravenous antibiotic treatment for their P. aeruginosa infections. Participating patients will receive one of the available antimicrobial options, and their bacterial samples will be analyzed centrally to assess susceptibility and resistance mechanisms. The study collects clinical data throughout treatment and monitors outcomes such as cure rates, resistance development, adverse events, and mortality. Participants will be followed until hospital discharge and up to 28 days after treatment completion. Researchers will track clinical cures, microbiological eradication, adverse events, emergence of resistance, and acquisition of other multidrug-resistant bacteria. Data collection includes electronic case reports and laboratory testing on bacterial isolates. The total participation duration varies according to hospital stay and follow-up schedules, with rigorous monitoring of safety and treatment outcomes.

Rare diseases affect about one in 2,000 people, including approximately three million in France, and many are genetic, often beginning severely in childhood. This research focuses on rare pediatric autoimmune and autoinflammatory diseases such as systemic lupus, juvenile dermatomyositis, and juvenile idiopathic arthritis. These diseases involve either the bodys adaptive immune system attacking itself or an excessive innate immune response, and the exact causes remain not fully understood. Recent advances have improved diagnosis, especially in early, familial, and syndromic cases, but studying these conditions is challenging due to their rarity and limited biological samples. The study aims to build a biological collection of samples including primary cells, DNA, RNA, lymphoblastic lines, and serum. This collection will support various research projects to identify genetic and immunological abnormalities linked to these rare diseases. Participants include minors or adults with rare dysimmune diseases starting in childhood or with familial or syndromic forms, as well as healthy volunteers, with no upper age limit but weighing over 5 kg. Participants provide blood samples for genetic analysis and immunological assessments to identify mutations and biomarkers related to disease diagnosis, prognosis, and activity. Researchers will measure mutations responsible for these diseases and assess disease activity using tools like the Systemic Lupus Erythematosus Disease Activity Index and biomarkers including anti-double stranded DNA and interferon levels. The study includes consented patients and healthy volunteers affiliated with social security, with ongoing monitoring for safety and comprehensive data collection throughout the study period.

Researchers are studying adults with bronchiectasis who have a recent infection of Pseudomonas aeruginosa PA in their airways. This infection is linked to more frequent worsening of symptoms, lower quality of life, and a higher risk of death. The study compares two antibiotic treatment plans to find out if a simpler oral and inhaled antibiotic combination works as well as a more intensive treatment involving intravenous antibiotics. This research aims to provide clearer evidence to guide how these infections should be treated for better health and economic outcomes. The study tests two treatment approaches over a 3-month period. One group receives an oral fluoroquinolone antibiotic combined with inhaled colistimethate sodium, starting with 14 days of both followed by 2.5 months of inhaled antibiotic alone. The other group gets intravenous beta-lactam antibiotic plus the same oral and inhaled antibiotics in the initial 14 days, then continues inhaled treatment alone for 2.5 months. After treatment, participants are followed for 9 more months to monitor their health and infection status, totaling 12 months from the start of therapy. Participants will have regular check-ups during and after treatment to measure how well PA is eradicated and to track any return of infection or worsening symptoms. Questionnaires will assess quality of life and treatment burden at the start, 3 months, and 12 months. Researchers will also monitor antibiotic resistance, adverse events, and healthcare costs over one year. This comprehensive follow-up helps evaluate both the medical and economic impact of the two antibiotic regimens in managing early PA airway infection in bronchiectasis.

Researchers are investigating advanced small cell lung cancer SCLC in adults to determine if adding a medicine called obrixtamig to the standard treatment of atezolizumab, carboplatin, and etoposide improves survival compared to the standard treatment alone. Obrixtamig is a molecule designed to help the immune system fight cancer. The study also tests a new medical device that measures levels of the tumour marker DLL3. This is a phase III clinical trial sponsored by Boehringer Ingelheim, using a randomized design to compare treatments. Participants are randomly assigned to one of two groups. One group receives obrixtamig together with the standard treatment, while the other group receives only the standard treatment. All treatments are given through infusions into a vein. Participants receiving obrixtamig will stay overnight at the study site after their first two treatments. The study lasts up to three years, during which tumour size and health status are regularly checked. Throughout the study, participants visit the study site regularly for assessments. Doctors monitor tumour response and check for any side effects or unwanted reactions. The main outcome is overall survival measured up to 36 months. Additional outcomes include progression-free survival, symptom changes, response rates, and monitoring of treatment-related side effects. The study team closely tracks participant health and evaluates quality of life using questionnaires during the first year.

Researchers are studying the impact of a special training program for nurses and nursing assistants on elderly patients aged 75 and over who are hospitalized in specialized wards. The goal is to see if this training, adapted from a successful American nursing program called NICHE, can improve the care of elderly patients by reducing hospital-related complications and shortening the length of hospital stays. This training involves teaching healthcare staff about better geriatric care practices, especially to prevent confusion and other hospital-related issues common in older patients. The study compares two groups of patients one group admitted after the introduction of specially trained geriatric nurses and nursing assistants, and a control group admitted before this training was introduced. The training program is coordinated by Geriatric Mobile Teams GMT, who support and guide the nursing staff, helping to spread good geriatric care practices similar to hygiene correspondents in hospitals. The program is designed to improve overall hospital care for older patients by focusing on evidence-based practices. Participants length of hospital stay is measured as the number of days from admission to discharge, with data collected up to one month after admission. The study observes patients during their hospital stay to evaluate the effects of the training program on preventing complications related to hospitalization. The study spans from May 2023 to July 2027. Researchers assess patient outcomes based on medical records, including complications and duration of hospitalization, to determine if this nursing training improves care for elderly hospital patients.