Macon

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 evaluating the addition of contact X-ray brachytherapy CXB to total neoadjuvant therapy TNT in adults with intermediate low or mid rectal adenocarcinoma. The goal is to increase survival while preserving the rectum in patients with tumors sized between 3.1 to 6 cm and specific clinical stages cT2N1 or T3N0-1, M0. This is an open-label, phase III randomized controlled trial comparing two treatment approaches. One group receives standard TNT with six cycles of modified FOLFIRINOX chemotherapy over 12 weeks followed by neoadjuvant chemoradiotherapy nCRT consisting of 50 Gy radiation over 5 weeks with concurrent capecitabine. The experimental group receives the same TNT regimen plus three fractions of CXB given every two weeks between the end of chemotherapy and the start of nCRT. After treatment, patients undergo clinical, endoscopic, and radiological evaluations. Seven weeks post-nCRT, patients with a complete clinical response may have local excision or be monitored, depending on center preference. Those without complete response will have total mesorectal excision TME surgery followed by adjuvant chemotherapy with either mFOLFOX or capecitabine for 12 weeks. The main outcome is survival with organ preservation assessed 15 months after the first patient is included. Participants will have regular monitoring and assessments throughout the study.

This research evaluates 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 by assessing how well it restores forefoot function at 3 to 4 months after surgery using the AOFAS-LMIS score. Participants receive treatment with the Lync4 intramedullary osteosynthesis device, which is implanted in the toes to address arthritis and bone alignment issues. The study monitors patients primarily at 3 to 4 months post-operation, with additional follow-ups if bone healing is incomplete. Secondary evaluations include pain reduction using the Visual Analogue Scale VAS, bone consolidation through radiographic exams, and monitoring for any adverse events or device defects throughout the study. During the study, participants will have clinical and radiographic assessments of their foot at 3 to 4 months after surgery, with an extra visit at 6 months if needed to confirm bone healing. Researchers will track pain levels, functional recovery, and safety outcomes, including any complications or device problems. The entire follow-up averages about 6 months, ensuring thorough monitoring of treatment effects and safety.

In intensive care units, patients often need central venous catheters for care and safe medication delivery, but these devices can lead to infections. Most prevention focuses on how catheters are inserted and handled, but the length of time the catheter stays in place is a main source of infection. This research compares changing infusion sets every 7 days versus every 4 days to see if less frequent changes increase infection risk while considering impacts on nursing workload and costs. The study involves two groups one where infusion sets connected to the catheter are replaced every 7 days, and another where they are replaced every 4 days, the current standard recommendation. Each replacement involves disconnecting old sets and replacing them with new sterile ones. Both procedures are performed by qualified nurses during the patients ICU stay. Participants are adult ICU patients with a central venous catheter placed less than 72 hours ago and expected to remain for at least 7 days. Researchers will monitor infections related to the catheter from insertion until 48 hours after removal, along with bloodstream infections, catheter colonization, ICU length of stay, mortality, nursing time, and replacement costs. The study follows patients up to 90 days to collect these outcomes and assess the effects of the different replacement schedules.

Researchers are evaluating the use of a low-protein diet LPD with specially designed low-protein foods called FLAVIS in patients with chronic kidney disease CKD stages 3A to 5 who are not on dialysis. The study aims to compare this approach to a standard low-protein diet without these low-protein foods to see if it helps patients better manage their protein intake and potentially improve their quality of life. This trial is randomized and controlled, led by Dr. Schr AG SPA, following the 2020 KDOQI nutrition guidelines for CKD. Participants are randomly assigned to one of two groups one will follow a low-protein diet according to current practice, while the other will follow the same diet but with the addition of FLAVIS low-protein products. The intervention group will receive FLAVIS products to include in their diet. The study tracks dietary adherence, protein intake, and other health measures over a 12-month period. During the study, participants will attend scheduled visits at baseline, 1, 3, 6, 9, and 12 months. Researchers will monitor protein intake, diet compliance, body mass index BMI, weight, body composition, blood and urine markers, diabetic glycemic profiles, patient quality of life, and satisfaction with the diet. Safety will be assessed by tracking adverse events throughout the 12 months. Participants will complete diet records and self-administered questionnaires as part of the data collection process.

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.

This research focuses on understanding the role of bacterial biofilm formation on arterial catheters in patients admitted to intensive care units ICU. Since about 29.3% of bloodstream infections in ICUs are linked to vascular devices, including 7.7% from arterial catheters, the study aims to better describe the structure and microbiological makeup of these biofilms. Investigators hope that this knowledge will help prevent infections or lead to more targeted treatments when bacteremias occur. The study observes critically ill patients aged 18 and older who have had an arterial catheter in place for more than two days while in the ICU. Researchers use dynamic full-field optical coherence tomography D-FF-OCT to analyze the arterial catheter sections before conducting microbiological tests on the biofilm. This observational study does not involve experimental treatments but focuses on detailed imaging and bacterial or fungal identification. Participants will have their arterial catheters removed according to usual ICU procedures, and the catheter sections will be analyzed to assess biofilm structure type, thickness, and dynamic signal distribution using D-FF-OCT. These measurements are taken two days after catheter removal. The study also includes microbiological identification of bacteria or fungi present in the biofilm. The involvement includes monitoring and sample analyses without altering patient care, with results intended to improve understanding of infection risks associated with arterial catheter biofilms.