Roanne

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.

Minimally invasive surgery has greatly changed surgical practices since the 1980s, especially in urology where laparoscopy and robot-assisted surgery have advanced treatment of conditions like prostate cancer. In France and other countries, robotic surgery became widespread without strong studies confirming its benefits or guidelines on quality and access. This trial aims to carefully evaluate robot-assisted prostate removal compared to traditional laparoscopic and open surgery techniques to provide clear evidence for patients and healthcare decision-makers. Participants will undergo radical prostatectomy using one of three approaches: robot-assisted laparoscopy, conventional laparoscopy, or open surgery (laparotomy). Urinary and erectile functions will be assessed before and after surgery to compare outcomes across the three groups. This large prospective study is conducted at multiple centers to gather reliable data on the benefits and impacts of each surgical method. During the study, patients will be evaluated for urinary function using the EPIC 50 score 45 days after surgery. Researchers will also assess erectile and urinary functions before and after the prostatectomy. The study focuses on understanding how each surgical technique affects recovery and function, helping to inform patients and health authorities about the real advantages of robot-assisted surgery. Participants must be hospitalized for planned radical prostatectomy and will be monitored throughout their treatment and recovery.

Researchers are evaluating the effects of a local vibration program applied to the dorsiflexor muscles on neuromotor recovery in patients undergoing subacute rehabilitation after a stroke. The study aims to determine if adding vibration therapy to a standard rehabilitation program improves walking speed compared to rehabilitation alone. The trial focuses on patients who have experienced ischemic or hemorrhagic strokes and are in the early recovery phase between 14 days and 3 months post-stroke. Participants will be randomly assigned to one of two groups: an experimental group receiving effective local vibrations at 100Hz on the paretic limb's dorsiflexor muscles, and a control group receiving sham vibration without actual vibration. Both groups will undergo 40 sessions over 8 weeks, with 5 sessions per week during hospitalization. The study includes various assessments such as the 10 meters Walk Test and 2 Minute Walk Test to measure walking speed, as well as evaluations of motor skills, muscle tone, autonomy, neuromuscular fatigue, and gait analysis. Throughout the study, participants will complete multiple tests and questionnaires including the Fugl-Meyer assessment, Modified Ashworth scale, ABILOCO questionnaire, Barthel index, electromyograms, and gait kinematics analysis. Researchers will monitor gait speed primarily at 2 months and collect data on muscle strength, fatigue, and functional autonomy. The total participation lasts for the 8-week intervention period with ongoing evaluations to assess recovery progress and safety.

Researchers are evaluating the effectiveness of the Apneal4 app, used on a smartphone, for diagnosing sleep apnea syndrome (SAS) in adults who need polysomnography (PSG) as part of their routine care. The study aims to see if Apneal4 can accurately classify SAS severity into four categories based on the Apnea-Hypopnea Index (AHI), as well as assess its ability to detect sleep stages, distinguish between central and obstructive apneas, and identify patient movements. Participants will wear a smartphone equipped with the Apneal4 application on their chest while undergoing a full night of PSG at home. They will also complete several questionnaires about their sleep symptoms and experience using the Apneal4 app. The study involves monitoring and comparing the results of Apneal4 with the standard PSG method. During the study, researchers will evaluate the performance of the Apneal4 device in diagnosing sleep apnea-hypopnea syndrome over approximately one year. Participant involvement includes wearing the device overnight, completing questionnaires, and undergoing PSG to provide comprehensive data for comparison. Safety and diagnostic accuracy will be monitored throughout the study period.

Researchers are evaluating the benefits of a specialized spa therapy for patients experiencing severe late skin and soft tissue reactions, called fibrosis, which occur at least six months after radiotherapy for breast cancer or upper aerodigestive tract cancer. This research focuses on improving quality of life related to the skin symptoms caused by this fibrosis, a condition that has received limited attention despite its impact. The study is designed as a controlled, randomized, multicenter trial with simple blinding for investigators. The treatment being studied is a dermatologically oriented thermal cure that combines baths with muscle-relaxing and sedative effects, sprays that reduce swelling, and high-pressure thermal water jets applied for several minutes. Participants also attend educational workshops covering relaxation, sophrology, and hygiene. The study compares immediate treatment with delayed treatment after six months to assess the therapy's effects. Participants will undergo self-assessment of their dermatological quality of life six months after treatment using a specific questionnaire (DLQI). Researchers will monitor skin and soft tissue symptoms, collect patient-reported outcomes, and evaluate safety. The total study duration includes treatment and follow-up to capture changes in quality of life and the skin condition over time.

Researchers are studying prostate cancer patients who are often not active enough despite the benefits of physical activity in reducing cancer mortality and recurrence. This research focuses on a program called ACTI-PAIR that combines personalized physical activity plans, peer motivational support, and guidance from health professionals to help patients increase and maintain regular exercise. The goal is to see if these combined interventions can improve long-term physical activity in prostate cancer patients. The ACTI-PAIR program includes three key approaches: creating a personalized and realistic physical activity plan through sport health centers, coaching by peers who have successfully met World Health Organization (WHO) exercise recommendations, and support from health professionals including general practitioners and adapted physical activity experts. These efforts aim to help patients reach the recommended 150 minutes of brisk walking or similar exercise per week. Participants will be monitored over 12 months to measure their physical activity levels objectively using Metabolic Equivalent of Task (MET) hours per week. The study will track how well patients follow the program and maintain activity, with assessments by healthcare providers and peer coaches to support motivation and adherence. This helps researchers understand if the ACTI-PAIR program effectively increases physical activity and contributes to better health outcomes for prostate cancer patients.

Status epilepticus (SE) is a serious neurological emergency involving prolonged or repeated seizures that can cause long-term impairments. Despite advances in care, SE still leads to significant death and disability, with about 20% of patients dying in the hospital and nearly half experiencing lasting functional problems. These impairments include cognitive, physical, and mental health issues, but their impact on quality of life after intensive care for SE has not been well studied. This study aims to further understand these outcomes by continuing previous patient-reported outcome research in a longitudinal way, also including patient experiences and family burden. The study does not involve specific treatments or interventions but focuses on adults who survived SE requiring intensive care and were previously enrolled in a related registry. Participants are assessed more than 3 months and less than 5 years after their ICU discharge. The study collects detailed information about their long-term health and quality of life, as well as their experiences and the challenges faced by their families. Participants will be involved through follow-up evaluations that include patient-reported outcomes and experiences, aiming to assess the overall impact of SE on their lives. The main measurement is the percentage of global impairment in health-related quality of life at 3 and 12 months. This approach helps capture the cognitive, physical, and mental effects of SE from the patient’s perspective and monitors how these change over time.

Researchers are collecting detailed information about adults who experience convulsive or non-convulsive status epilepticus, a serious condition involving prolonged or repeated seizures. This registry study records data on the circumstances of seizure onset, clinical features, treatments given before and during hospital care, diagnostic test results, and causes of the seizures. The study aims to track outcomes for these patients over time to better understand this condition and its management. Participants in this study are adults aged 18 years or older diagnosed with status epilepticus lasting 5 minutes or more, either as continuous seizures or repeated seizures without full recovery between them. Data collection involves standardized forms capturing demographic details, timing of seizures and treatments, EEG monitoring results, and other clinical information. The study includes follow-up assessments at ICU and hospital discharge, as well as at 90 days and one year after the seizure event. Throughout the study, researchers gather clinical findings, laboratory and EEG results, and treatment information from hospital and pre-hospital sources. They evaluate patient outcomes using measures like vital status and the Glasgow Outcome Scale at multiple time points, including up to one year after the seizure. This comprehensive data helps monitor recovery and long-term effects of status epilepticus in critically ill patients.

Post-menopausal osteoporosis is a significant cause of disability and loss of independence, increasing risks of morbidity and mortality among affected women. Due to side effects, hormone replacement therapy is no longer advised for menopausal women at risk of osteoporosis, which may have led to a rise in osteoporotic fractures, especially in women under 70. There is a clear need for effective prevention of osteoporosis in this population. Mother-of-pearl, derived from marine mollusc shells, is being studied for its potential to prevent bone loss due to its combination of calcium supplementation, anti-resorptive, and bone-building activities. This study evaluates the effects of powdered mother-of-pearl supplementation compared to calcium carbonate in post-menopausal women at risk of becoming osteoporotic. Mother-of-pearl contains calcium carbonate and active organic compounds that can slow bone remodeling by inhibiting bone resorption and promoting mineralization. The study is designed as a multicenter, double-blind, randomized trial comparing mother-of-pearl nutritional supplementation to a positive comparator (calcium carbonate). Participants will be assessed for changes in bone loss at the lumbar spine over 12 months from baseline. Women enrolled will be monitored through bone density measurements and clinical evaluations to track bone health. The study focuses on women aged 50 to 65 years without previous fragility fractures but with a T-score indicating risk of osteoporosis. Safety and effectiveness of mother-of-pearl supplementation in limiting bone loss will be observed throughout the study duration.

Researchers are evaluating the effects of acetylsalicylic acid and atorvastatin on overall survival in male patients with castrate-resistant prostate cancer (CRPC) who are starting their first-line treatment for CRPC. This international, multicenter, open-label phase III clinical trial uses a 2x2 factorial randomized design to study whether these drugs improve survival outcomes in this patient population. Participants receive acetylsalicylic acid at a dose of 100 mg and atorvastatin at 80 mg as part of the trial interventions. The trial compares these treatments in different combinations to assess their impact on overall survival. The study does not specify additional treatment schedules or extension phases but focuses on the effects of these drugs during the initial treatment period for CRPC. During the study, participants are monitored for overall survival, calculated from the date of randomization until death, with follow-up extending up to 15 years. Eligibility assessments include confirming CRPC status with specific testosterone and PSA criteria, imaging for metastases, performance status evaluation, and kidney and liver function tests. Safety is monitored by excluding patients with certain liver conditions, drug contraindications, or serious medical issues, and patient adherence is supported through informed consent and clinical follow-up procedures.