Saint Denis

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 studying whether adaptive stereotactic body radiotherapy (SBRT) offers dosimetric benefits compared to non-adaptive SBRT for men with localized prostate cancer. The study focuses on patients aged 60 and older with low or intermediate risk prostate cancer, evaluating how anatomical changes like bladder filling and rectal volume affect radiation dosing. This research also looks at the total dose received by organs at risk, patient quality of life over two years, and overall and recurrence-free survival. Participants undergo five low-dose CT scans before each SBRT session, performed within about 10 minutes prior to treatment. These scans check for anatomical variations that might require recalculating the radiation dose during the treatment course. The study carefully monitors the radiation dose delivered and adjusts as needed to optimize treatment while minimizing risk to surrounding tissues. During the study, patients will have repeated imaging and assessments to track anatomical changes and radiation effects. Researchers collect data on treatment accuracy, patient-reported quality of life, and survival outcomes over 24 months. Safety and treatment effectiveness are monitored closely throughout the study period to understand the potential advantages of adaptive SBRT for prostate cancer.

Researchers are evaluating the effectiveness of different antimicrobial treatments for infections caused by difficult-to-treat Pseudomonas aeruginosa bacteria. This infection is especially challenging for patients who are critically ill or have weakened immune systems. The study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older drugs like aminoglycosides and colistin in real-life clinical settings across multiple hospital centers in France. Participants will receive intravenous antimicrobial therapy tailored to treat their difficult-to-treat P. aeruginosa infection. The study observes the use of new and older antimicrobial drugs to assess their clinical efficacy. Patient data and bacterial samples will be collected and analyzed centrally to better understand drug resistance mechanisms and treatment outcomes. Participants will be monitored for clinical cure shortly after completing therapy and on Day 7 ± 2 days. Researchers will collect clinical information through electronic case-report forms and send bacterial isolates to a national center for detailed testing. Outcomes include cure rates, resistance development, adverse events, and mortality rates, with follow-up during hospitalization and up to 28 days after treatment. The study aims to provide valuable real-world data on treating these challenging infections.

Dunnigan's syndrome is a partial familial lipodystrophy due to a mutation in the Lamine A LMNA gene. This very rare syndrome is 20 times more common in Réunion compared to the rest of Europe with several families suffering from a unique variant of LMNA, the p.(Thr655Asnfs\*49) variant known as the "Reunion variant", the appearance of which in Reunion dates back to the 17th century. This variant is expressed in homozygous and heterozygous form and has only been identified in subjects from Reunion. Clinically, patients with Dunnigan's have an absence of subcutaneous fatty tissue which mainly affects the lower part of the body and leads to severe insulin resistance responsible for early diabetes. To detect these metabolic complications as early as possible, an annual follow-up of the subjects is recommended with the performance of an OGTT test annually in non-diabetic subjects. This problem is identical for patients with cystic fibrosis leading to the same recommendation. However, whether in our experience of monitoring patients with Dunningan's lipodystrophy, in subjects at risk of diabetes or in subjects with cystic fibrosis, the OGTT test and even more so its repetition is poorly accepted, which can lead to lack of patient follow-up. An alternative solution to the OGTT is therefore justified. In the literature, different avenues have been explored. First, given oral glucose intolerance, replacement with a standardized breakfast has been explored in several studies. Another alternative tested in the population of subjects with cystic fibrosis is the use of an interstitial glucose sensor for screening for carbohydrate abnormalities. In view of the literature, we formulate several hypotheses that will be tested in our study: 1. The intake of a standardized breakfast containing 75g of carbohydrates is comparable to the ingestion of 75g of glucose on the result of the OGTT test at 120 min for the diagnosis of carbohydrate abnormalities (diabetes and prediabetes) in patients with Dunnigan's lipodystrophy. 2. The continuous recording of interstitial glycaemia over several days allows the diagnosis of glucidic abnormalities equivalent to the classic OGTT in this population; possibly by identifying glycemic variations not seen by a single OGTT test. Thus the installation of an interstitial sensor over several days could be an alternative to the realization of the OGTT in the identification of carbohydrate disorders in patients with Dunnigan's lipodystrophy. 3. There will be a similar profile but a time lag between venous glycemic curves and interstitial blood glucose measurements after OGTT. 4. Replacing the oral glucose load of the classic OGTT (gold standard) with a standardized carbohydrate breakfast leads to similar interstitial glycaemia curves but with a time lag.

Leptospirosis is a bacterial infection caused by contact with water or soil contaminated by animal urine. It is a significant health problem worldwide, with nearly one million cases annually and a mortality rate ranging from 5 to 10%, increasing up to 50% in severe cases. In Reunion Island, leptospirosis is common due to the climate, with many cases requiring hospitalization and intensive care. This research focuses on studying the long-term effects of leptospirosis beyond one year after infection, as some patients experience chronic symptoms such as fatigue, kidney issues, muscle weakness, and neurological or cardiac problems. The study involves biological sampling, including blood and urine collection, to analyze immune responses and detect ongoing infection. Samples are processed and stored for further testing. Patients who were hospitalized for confirmed leptospirosis within the last 12 to 18 months and are part of a prior cohort are invited to participate. The study includes clinical and biological data collection through questionnaires and medical follow-up. Participants will have medical visits and telephone interviews to assess their health status, quality of life, and use of alternative medicines. The main outcome measured is the proportion of patients experiencing chronic symptoms two years after infection. The study also collects information on health literacy and complementary health approaches. Participants are expected to be residents of Reunion and able to respond to phone questionnaires, with follow-up planned for up to one year after enrollment.

Anal canal cancers are becoming more common in France, with about 2,000 new cases each year. People living with HIV have a 30 times higher risk of developing anal cancer compared to the general population. This risk is especially high in people over 30, including heterosexual men and women living with HIV. However, routine proctological exams and HPV screening are not systematically offered to these groups. This study focuses on screening for anal HPV, particularly the HPV-16 type linked to anal cancer, in people over 30 living with HIV, including those not currently offered screening. The study compares two methods of HPV screening: self-sampling and sampling performed by healthcare professionals using anal swabs. Participants will perform anal swabbing themselves and also have it done by a healthcare provider. This approach aims to assess how well the results from self-sampling match those from professional sampling and how acceptable self-sampling is to participants. The study is conducted at the University Hospital of Reunion Island. Participants will be involved in anal swabbing and will complete a questionnaire. Researchers will evaluate the agreement between HPV-16 test results from self-collected and professionally collected samples within 7 days. The study also monitors participants' ability to perform self-sampling and their response to the screening process. The total participation duration and follow-up details are based on the short-term evaluation of HPV genotype concordance.

Researchers are investigating the effect of listening to standardized music sequences before surgery on reducing postoperative pain in patients undergoing proctologic surgery for conditions like hemorrhoids, fistulas, or anal fissures. This interventional, randomized study involves 550 participants at Clinique Saint Vincent in France and aims to assess how music influences pain management, analgesic use after surgery, and quality of life during the month following surgery. Participants will be randomly assigned to either a music intervention group or a control group. Those in the music group will listen to standardized music sequences tailored to their preferences using the Music Careae application. This includes one 20-minute session in a dedicated room before surgery and daily 20-minute sessions at home for 28 days after surgery using their own devices such as a smartphone, tablet, or computer. During the study, participants will be monitored for pain intensity immediately after surgery in the recovery room and will be followed for 28 days post-surgery. Researchers will evaluate postoperative pain levels, use of pain medication, and quality of life. The overall study will last 28 months, with participants providing informed consent and having access to the necessary technology to use the music application.

Researchers are evaluating the effects of passive music therapy on anxiety and pain in patients undergoing ear, nose, and throat (ENT) surgery. This study focuses on whether a single preoperative session of music therapy can reduce anxiety during the perioperative period and postoperative pain. The research involves a larger patient group than previous studies to provide more conclusive evidence. Participants randomly assigned to the music therapy group will receive a 20-minute session using the Music Care® app upon admission to the operating room. During the session, patients lie on a stretcher in a designated room and listen to music that follows a specific U-shaped sequence of changing tempo and sound qualities. Patients can select music styles based on their personal tastes and cultural backgrounds. The study will include 500 patients undergoing various types of ENT surgeries at a single center in France. Participation lasts for two days, during which anxiety levels are measured from hospital admission to discharge using a visual scale. Researchers will monitor anxiety variation to assess the impact of the music therapy. The overall study is planned to run for 27 months.

Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe deficiency of ADAMTS13 due to autoantibodies, leading to harmful blood clots in small vessels. The current standard treatment combines daily plasma exchange (PEX), immunosuppressive drugs, and caplacizumab, which has helped reduce death and complications. However, PEX is invasive, time-consuming, and linked to complications, so researchers want to explore a treatment without PEX to reduce patient burden. This study evaluates a PEX-free regimen that uses daily plasma infusions (15 mL/kg/day) instead of plasma exchange, combined with corticosteroids or rituximab and caplacizumab. The plasma infusions involve quarantined or viral-inactivated plasma products. This approach aims to provide effective treatment with fewer risks and less complexity. The study is a multicenter, single-arm, non-inferiority trial assessing this combined therapy's safety and effectiveness. Participants will be closely monitored for 30 days after plasma therapy, tracking outcomes like death, treatment failure, disease worsening, or low ADAMTS13 activity. Researchers will assess how well the PEX-free regimen works compared to historical data. The study includes thorough clinical and laboratory evaluations to ensure patient safety and gather important treatment response information.

This research aims to explore the health literacy profiles of patients with type 1, type 2, or gestational diabetes in Reunion Island and France. The purpose is to gather important information that may help improve patients' access to health information, therapeutic education, and health services. The study focuses on understanding how well diabetic patients understand and use health information to manage their condition. All participants will complete the Health Literacy Questionnaire (HLQ) one time during the study. There are no experimental treatments or medications; this is an observational study focused solely on collecting questionnaire data related to health literacy. Participants will be involved by completing the HLQ once at the time of inclusion. Researchers will use this data to assess participants' health literacy profiles. The study mainly measures health literacy status at inclusion without additional follow-up or interventions. Participation will involve only answering the questionnaire once, with no additional medical procedures or tests required.