Macon

Researchers are creating a national, prospective cohort to study children with idiopathic nephrotic syndrome (INS), a rare kidney disease. The goal is to collect detailed data on patients treated in pediatric nephrology centers across France, Reunion Island, Mayotte, and eventually other French overseas territories. This structured follow-up aims to better understand the disease's characteristics and provide a foundation for future clinical trials. The study involves enrolling pediatric patients diagnosed with INS and systematically collecting clinical, biological, psychological, and social data. Biological samples such as blood, urine, hair, and nails will be gathered at disease onset before immunosuppressive treatment begins. Data will be recorded through medical records from hospital visits and consultations, supplemented by annual telephone interviews for patients without active disease. Quality of life, treatment adherence, and aesthetic impact questionnaires will also be collected and integrated into a secure database. Participants will be followed over at least two years, with data collected regularly by clinical research staff. This includes medical validation of clinical information, annual telephone follow-ups, and questionnaire assessments. The study's primary outcome is the number and characteristics of included cases over two years. This ongoing monitoring will support future nested studies and improve understanding of pediatric INS outcomes and management.

Researchers are evaluating the use of contact X-ray brachytherapy (CXB) combined with total neoadjuvant therapy (TNT) to improve outcomes for adults with intermediate low or mid rectal adenocarcinoma. This phase III randomized clinical trial focuses on patients with tumors sized between 3.1 and 6 cm, categorized as cT2N1 or T3N0-1, with no distant metastasis (M0). The main goal is to see if adding CXB to TNT can increase survival while preserving the rectum. The study has two groups: the control arm receiving TNT alone, which includes six cycles of modified FOLFIRINOX chemotherapy over 12 weeks followed by neoadjuvant chemoradiotherapy (nCRT) with 50 Gy radiation and capecitabine over five weeks; and the experimental arm that adds three fractions of CXB every two weeks between the chemotherapy and nCRT. After completing nCRT, both groups undergo clinical, endoscopic, and radiological evaluation seven weeks later. Patients with a complete clinical response may have local excision or be closely monitored, while others will have total mesorectal excision (TME) surgery followed by adjuvant chemotherapy with either mFOLFOX or capecitabine. Participants will be involved throughout this process with regular assessments including clinical exams, imaging, and endoscopy to monitor tumor response and organ preservation. The study will measure survival with organ preservation at 15 months after enrollment. Safety and treatment effects will be closely monitored, and participants will be followed according to the study protocol to assess long-term outcomes and treatment tolerability.

Researchers are evaluating the Lync4 device implanted in the toes to treat arthritis and correct bone misalignments such as mallet toes, claw toes, and hammer toes. The study aims to confirm the clinical benefits, performance, and safety of this device, focusing mainly on restoring forefoot function and bone alignment. The primary goal is to assess improvements in functional capacity using the AOFAS-LMIS score at 3 to 4 months after surgery. The treatment involves using the Lync4 intramedullary osteosynthesis implantable device during surgery for arthritis and bone alignment correction. Some additional surgical procedures like flexor release/tenotomy, MTP arthrolysis/extensor lengthening, tendon transfers, or phalangeal osteotomy may be performed alongside. The study includes 76 feet undergoing this intervention, with follow-up visits scheduled at 3 to 4 months post-operation and an optional 6-month visit if bone union has not occurred. Participants will be monitored through clinical and radiographic examinations to evaluate pain reduction, bone consolidation, functional recovery, and any adverse events or device defects. The main outcome measured is the EFAS score at 3 to 4 months post-surgery, alongside secondary assessments of pain changes, bone healing, and safety throughout the follow-up period. Participants are expected to comply with surgeon recommendations and sign informed consent, with adult patients involved in the study.

Researchers are investigating a new imaging technique called dynamic full-field optical coherence tomography (FF-OCT) to help diagnose Primary Sjögren syndrome (pSS), an autoimmune disease that causes severe dryness in the mouth and eyes, along with fatigue and musculoskeletal pain. The diagnosis typically combines clinical symptoms, specific antibodies, and analysis of minor salivary gland biopsies, but current biopsy methods can take time to yield results. This study aims to compare traditional histopathological analysis of minor salivary gland biopsies with FF-OCT to see if the new method can provide faster, on-site diagnosis. The study uses biopsy samples collected as part of routine care without requiring extra procedures. Participants undergo a minor salivary gland biopsy, and their samples are examined using both conventional histopathology and dynamic FF-OCT. The FF-OCT technique allows visualization of structural changes related to inflammation, which may help identify lymphocytic infiltration characteristic of pSS. Participants' biopsy samples are analyzed, and outcomes are measured by comparing histopathological results with FF-OCT findings 15 days after the biopsy. The study does not require additional examinations beyond usual care. Researchers will assess whether FF-OCT can expedite and improve the diagnostic process for suspected Sjögren syndrome by providing rapid visualization of glandular tissue changes.

Patients in intensive care units often require a central venous catheter to deliver medications safely. These catheters, however, can sometimes cause infections, especially the longer they remain in place. Most prevention efforts focus on how the catheter is inserted and handled, but less attention is given to how long the catheter and its connected infusion sets stay in place, which is a key factor in infection risk. This research compares two schedules for changing the infusion sets connected to central venous catheters. One group will have their infusion sets replaced every 7 days, while the other group will follow the usual practice of replacing them every 4 days. During each replacement, all tubing and connectors will be disconnected and swapped with new sterile equipment to reduce contamination risk. Participants will be monitored from catheter insertion until 48 hours after removal, or up to 90 days in the ICU, to track infection rates related to the catheters. Researchers will collect data on infection complications and assess whether the less frequent 7-day replacement increases infection risk compared to the standard 4-day schedule. This study also considers the impacts on nursing workload and medical resource use.

Researchers are evaluating the effectiveness of a low-protein diet (LPD) using specially developed low-protein foods (FLAVIS products) compared to a standard low-protein diet without these foods in patients with chronic kidney disease (CKD) stages 3A to 5 who are not on dialysis. The study follows recommendations from the KDOQI 2020 clinical practice guideline, which suggests restricting protein intake to reduce the risk of end-stage renal disease and improve quality of life. The FLAVIS products are designed to help patients achieve nutritional goals more easily while following a low-protein diet. Participants are divided into groups where one group receives FLAVIS products alongside their diet follow-up, while the other group follows the low-protein diet without these products. The study aims to monitor protein intake over a 12-month period to assess how effective the FLAVIS products are in facilitating adherence to the diet and meeting protein intake targets. During the study, participants will attend scheduled visits and complete diet records and self-administered questionnaires to track their adherence and nutritional status. Researchers will measure protein intake as the primary outcome after 12 months. Participants must be motivated to follow a low-protein diet and have good nutritional status at the start. Safety monitoring includes assessing any adverse effects and ensuring participants can provide blood samples and perform 24-hour urine collections as required.

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.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

About 29.3% of bloodstream infections in intensive care units (ICU) are linked to vascular devices, including 7.7% related to arterial catheters, affecting patient health outcomes. Researchers are exploring the role of biofilms, which form on the inner surfaces of these devices, in bacterial growth and infections. Currently, there is limited clinical data showing a direct connection between biofilm formation and bloodstream infections, so this study aims to better understand this relationship in ICU patients with arterial catheters. The study evaluates arterial catheter biofilms in ICU patients using dynamic full-field optical coherence tomography (D-FF-OCT) to analyze the structure of biofilms on removed catheter sections before conducting microbiological testing. This process helps characterize biofilm types and their microbial content, aiming to inform improved infection prevention and treatment strategies related to arterial catheters. Participants are ICU patients over 18 years old who have arterial catheters and provide consent or have a relative consent on their behalf. Researchers will assess the biofilm structure type, such as ribbon-shaped or mushroom-shaped, two days after catheter removal using D-FF-OCT. The study includes careful handling and storage of catheter samples and excludes patients unable to provide consent or those whose catheter removal or storage does not follow standard ICU procedures.