Saint Denis

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 whether adaptive stereotactic body radiotherapy SBRT offers advantages over non-adaptive SBRT for treating localized prostate cancer in men aged 60 years and older. The study focuses on how anatomical changes, such as bladder filling and rectal volume, might affect radiation dosing. It also examines the overall dose delivered to nearby organs, patient quality of life over two years, and survival without cancer recurrence. Participants receive five low-dose, non-contrast CT scans taken immediately before each SBRT session to check for anatomical changes that could impact treatment. These scans help determine if recalculating the radiation dose is necessary to better target the prostate and protect surrounding organs. The study tracks these measurements across all five treatment sessions within approximately ten days. Throughout the study, patients report on their quality of life and urinary symptoms before treatment and at several points up to 24 months after radiotherapy. Researchers monitor survival and cancer recurrence at multiple intervals within the two-year follow-up. Participants are carefully informed and provide consent, with ongoing evaluations to assess treatment impact and safety over time.

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.

Anal canal cancers are becoming more common in France, especially among people living with HIV, who face a risk 30 times higher than the general population. This study focuses on people living with HIV aged 30 or older, including heterosexual men and women without vaginal cervical lesions, to evaluate anal HPV screening methods. The goal is to assess the agreement and acceptance of self-screening compared to screening performed by healthcare professionals as part of a strategy to detect anal cancer risk. Participants will be randomly assigned to one of two groups one group will perform anal self-swabbing first followed by a healthcare professional swabbing, and the other group will have the professional swabbing first followed by self-swabbing. Both methods involve collecting anal swabs to test for HPV, particularly the HPV-16 genotype known for its cancer risk. The study compares the results from the two sampling methods and gathers information on participant preference, satisfaction, and any side effects like discomfort or bleeding. During the study, participants will provide samples and answer questionnaires about their experience. Researchers will evaluate how well the self-sampling matches professional sampling and measure the prevalence of anal HPV infections. The study will also monitor any adverse events and assess overall acceptability of both methods. Participation includes follow-up within 7 days after sampling to gather results and feedback, with the entire process designed to improve anal cancer screening in this high-risk group.

Researchers are evaluating how listening to standardized music sequences before and after proctologic surgery affects postoperative pain. This study focuses on patients undergoing surgery for hemorrhoids, fistulas, or anal fissures. The trial aims to understand whether preoperative and postoperative music can help manage pain, reduce the need for pain medications, and improve quality of life after surgery. Participants are randomly assigned to one of two groups. One group listens to relaxing, standardized music sessions via the Music Careae app, with a 20-minute session before surgery in the hospital and daily 20-minute sessions at home for 28 days after surgery. The control group receives standard care without music therapy. All music sessions allow participants to choose their preferred style, tempo, and tracks. During the study, participants will be closely monitored for pain and anxiety levels from hospitalization through 28 days post-surgery. Researchers will assess pain intensity immediately after surgery in the recovery room and track analgesic use, healing time, quality of life, patient satisfaction, and hospital stay duration. The study lasts 28 months overall, with each participant followed for 28 days.

Music therapy uses the effects of music on the body and mind to help treat illness or trauma. This research focuses on passive music therapy, where patients listen to calming music, to see if it can reduce anxiety and pain around the time of ENT ear, nose, throat surgery. Previous smaller studies suggested benefits but were limited by their size, so this study includes a larger patient group to better understand the effects. The study compares two groups one that receives a 20-minute session of passive music therapy using an app before surgery, and a control group that receives standard care without music therapy. The music therapy involves listening to selected calming music through headphones while resting before entering the operating room. This randomized study will be conducted at a single center with about 500 participants. Participants will be involved for about two days, covering admission, surgery, and discharge. Researchers will measure anxiety levels using visual scales and questionnaires, monitor pain levels, blood pressure, medication use, surgery timing, and satisfaction of patients and staff. The study will also look at the economic impact of the therapy during the hospital stay, with all assessments done within 6 to 24 hours depending on the surgery type.

Immune thrombotic thrombocytopenic purpura iTTP is a serious condition caused by a severe deficiency of ADAMTS13, leading to the buildup of large von Willebrand factor multimers and formation of blood vessel clots. The current standard treatment combines daily plasma exchange PEX, immunosuppressive drugs, and caplacizumab, which has shown to reduce death, complications, and the number of PEX sessions. However, PEX is invasive, time-consuming, and linked to complications, so researchers are exploring treatments without PEX to ease patient care. This study aims to evaluate the safety and effectiveness of a regimen without PEX using plasma infusion, corticosteroidsrituximab, and caplacizumab. The study replaces daily PEX with daily plasma infusions at a dose of 15 mL per kilogram of body weight, using different types of plasma such as quarantine fresh frozen plasma or inactivated plasma. This PEX-free regimen is combined with immunosuppression using corticosteroids and rituximab alongside the anti-adhesive drug caplacizumab. This approach is being tested as a single experimental treatment group for adults diagnosed with iTTP. Participants will be monitored for 30 days after starting plasma therapy to evaluate treatment outcomes. Researchers will assess the proportion of participants who experience death, treatment failure, disease worsening, or low ADAMTS13 activity below 20%. The study includes clinical and laboratory evaluations to track safety and effectiveness. The overall goal is to determine if this PEX-free regimen can provide a feasible alternative treatment for iTTP with fewer complications.

This observational study aims to explore the health literacy profiles of patients with type 1, type 2, or gestational diabetes in Reunion Island and metropolitan France. The goal is to gather information that can help improve access to health information, therapeutic education, and health services for diabetic patients. The study is sponsored by the Centre Hospitalier Universitaire de la Runion. Participants in this study will complete the Health Literacy Questionnaire HLQ one time. This questionnaire is designed to assess various aspects of health literacy related to managing diabetes. The study does not involve any treatment or intervention beyond this questionnaire. During the study, participants will complete the HLQ once at the time of inclusion. Researchers will analyze the health literacy profiles based on the questionnaire results. The primary outcome measure is the health literacy profile in Reunion Island at inclusion, with secondary measures including profiles from both Reunion Island and France. Participants will not undergo any additional procedures, and the total participation time is limited to the completion of the questionnaire.

Atopic dermatitis AD is a common, long-lasting inflammatory skin condition in children that causes itching and skin lesions, affecting quality of life. This research evaluates a hypnosis program as a possible new therapy to help manage AD symptoms. The study is a pilot randomized controlled trial designed to test the feasibility of hypnosis in children and teenagers with AD, addressing the need for alternative treatments due to challenges like chronicity and treatment costs. Participants will be divided into two groups one receiving a therapeutic education program alone, and the other receiving the same program combined with two standardized hypnosis sessions using a superhero costume technique. The hypnosis group will also practice self-hypnosis at home using an audio recording to reinforce the sessions. The study aims to assess how well this hypnosis program can be integrated into care for AD. During the study, researchers will monitor patient recruitment over 24 months and evaluate compliance with self-hypnosis at 1, 3, and 6 months after joining the study. They will also track patient satisfaction, dropout rates, parents impressions, improvements to the hypnosis program, and overall effectiveness at these intervals. The trial involves children aged 8 to 17 with mild to severe AD, and participation will include follow-up assessments at scheduled times.

Researchers are studying adolescents aged 13 to 14 who were born with esophageal atresia, a birth defect where the esophagus is interrupted and ends in a dead end. Surgery is required soon after birth to restore esophagus continuity, but many children continue to experience health issues such as acid reflux, eating difficulties, breathing problems, and growth challenges throughout life. This study aims to assess the long-term outcomes and develop detailed molecular profiles of esophageal tissue and blood samples from this rare condition. The study includes two groups adolescents with esophageal atresia and a control group without the condition. Participants undergo upper gastrointestinal endoscopy with biopsy sampling as part of their usual care. Quality of life questionnaires designed specifically for this research, including the Pediatric Quality of Life Inventory and EA-QoL, are used. Clinical and molecular data from tissue and blood samples will be analyzed together to understand disease impact and molecular changes. Data will be stored and shared through the France Cohortes platform. Participants will have their gastroesophageal reflux disease GERD status assessed along with measures of quality of life, nutrition, and respiratory health. Researchers will analyze molecular profiles from plasma and esophageal biopsies, and look at factors associated with GERD from birth through adolescence. Participation involves clinical data collection, questionnaires, and biological sampling during routine care. Data from this study will contribute to understanding the long-term effects of esophageal atresia and aid future research.