Roanne

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 studying prostate cancer patients undergoing radical prostatectomy to compare three surgical methods robot-assisted laparoscopy, conventional laparoscopy, and laparotomy. The study aims to evaluate the impact of these techniques on urinary and erectile functions, as well as their cost-effectiveness and long-term outcomes. This large, multicenter prospective observational study responds to previous concerns about the lack of high-quality evidence for robot-assisted surgery in prostate cancer treatment. Participants will undergo one of the three prostatectomy procedures robot-assisted laparoscopy, conventional laparoscopy, or laparotomy. Urinary and erectile functions will be assessed before and after surgery using standardized scores like the EPIC 50 and the International Index of Erectile Function IIEF-5. Outcomes including urinary incontinence, erectile dysfunction, and prostate-specific antigen PSA levels will be followed for up to five years. Cost-effectiveness will be evaluated at 12 months using the EQ5d-5L score. Throughout the study, participants will be evaluated at multiple time points, including 45 days and up to five years after surgery, to monitor urinary and erectile functions and other prostatectomy-related effects. Assessments involve questionnaires and clinical measurements. This comprehensive follow-up is designed to help determine the benefits and risks of each surgical approach, supporting informed decisions for patients and healthcare authorities. The study excludes patients without French health insurance or those unable to consent, focusing on adult males scheduled for prostatectomy.

Researchers are investigating whether adding local vibration sessions to the dorsiflexor muscles of the affected leg can improve neuromotor recovery in patients who are in the subacute phase after a stroke. This study compares two groups of stroke patients one receiving vibration therapy alongside standard rehabilitation and the other receiving sham vibration with standard rehabilitation. The main goal is to see if this vibration program can help patients walk faster. The treatment involves 40 sessions over 8 weeks during hospitalization, with five sessions per week. One group receives actual vibration therapy at a frequency of 100Hz on the dorsiflexor muscles, while the other group receives sham vibration without effective stimulation. Both groups also continue with the usual rehabilitation program for stroke recovery. Participants will undergo various assessments including walking speed measured by a 10-meter walk test at 2 months, and other walking performance tests over several months. Additional evaluations include motor function, spasticity, autonomy in walking, muscle strength, and neuromuscular fatigue using tools like electromyograms and gait analysis. These tests occur at different timepoints up to 4 months to monitor recovery and treatment effects.

Researchers are evaluating the effectiveness of the Apneal4 app on smartphones for diagnosing sleep apnea syndrome SAS in adults who require polysomnography PSG as part of their routine care. The study aims to determine if Apneal4 can accurately classify SAS severity into four categories, estimate the Apnea-Hypopnea Index AHI, detect sleep stages, differentiate between central and obstructive apneas, and identify patient movements compared to PSG. Participants will wear a smartphone equipped with the Apneal4 app on their chest during a full night of sleep at home while undergoing polysomnographic recording. They will also complete several questionnaires assessing sleep symptoms and their experience with the Apneal4 app. The study will monitor these measures over an average of one year to evaluate device performance and patient acceptability. During the study, participants will be assessed using both the Apneal4 device and standard PSG. Researchers will compare Apneal4 results with screening questionnaires like NoSAS, Berlin, and Epworth. Participants will complete questionnaires about their sleep symptoms and the devices ease of use. The primary outcome is the performance of Apneal4 in diagnosing sleep apnea-hypopnea syndrome. Safety and feasibility will be monitored throughout the study, which is expected to last about one year per participant.

Researchers are evaluating the medical benefit of spa therapy on skin and soft tissue fibrosis that occurs as a late reaction at least 6 months after radiotherapy for breast cancer or Upper Aerodigestive Tract UADT cancer. This randomized, controlled, multicenter trial aims to assess improvements in quality of life related to dermatological sequelae of fibrosis. The study focuses on patients with severe late reactions and compares immediate versus delayed spa treatment. The intervention being studied is a dermatologically oriented thermal cure that includes sedative and muscle-relaxing baths, decongestant sprays, and high-pressure thread-like showers using thermal water. Educational workshops on relaxation, sophrology, and hygiene are also part of the therapy. Participants are randomly assigned to receive spa treatment either immediately within 6 weeks of inclusion or after a 6-month delay, allowing comparison of outcomes between early and late treatment groups. Participants will be involved for at least 6 months, during which they will self-assess their dermatological quality of life using the DLQI score and undergo evaluations of generic and cancer-specific quality of life. Additional assessments include self-reported sequelae, radiological examinations of lesions, thickness, and volume, as well as monitoring of treatment and medical consultations. Adverse events and long-term quality of life benefits up to 12 months will be recorded to understand the therapys impact and safety.

Researchers are evaluating a physical activity program designed to encourage and sustain regular exercise in men with prostate cancer. Despite known benefits, many prostate cancer patients are not sufficiently active, and this study aims to assess a combined approach involving personalized exercise plans, peer motivational support, and health professional guidance. The goal is to improve adherence to physical activity over a longer term than previous interventions, which typically lasted less than six months. The study involves an experimental group receiving the Acti-Pair program, which includes motivational support from peers who meet WHO physical activity recommendations, personalized exercise projects supported by sport health centers, and prescriptions from general practitioners and physical activity professionals. The control group receives usual care, consisting of advice and recommendations to increase activity independently at home. The study is designed as a randomized, stepped-wedge trial. Participants will be monitored over 12 months with objective and subjective measurements of physical activity, inactivity, physical capacity, muscle strength, fatigue levels, and quality of life assessed at multiple time points. The study also evaluates adherence, motivation, satisfaction, and the time health professionals and peers dedicate to the program. Outcomes include the cost-effectiveness of the intervention and factors influencing its implementation and sustainability.

Status epilepticus SE is a serious neurological emergency marked by prolonged or multiple seizures that can cause lasting impairments and has a high risk of death and complications. Despite advances, mortality remains about 20% overall and up to 40% in refractory cases. Many survivors experience cognitive, physical, and mental difficulties, but the long-term impact on quality of life after intensive care treatment is not well understood. This study aims to continue observing these effects over time, focusing on patient-reported outcomes and experiences following SE requiring ICU care. This observational study follows adults who survived ICU management for SE, assessing their health and well-being more than 3 months but less than 5 years after ICU discharge. It builds on previous registry data and collects detailed information on cognitive function, physical disability, mental health, social support, and family burden. The study includes repeated assessments at 3 and 12 months to track changes and experiences over time. Participants will be evaluated through questionnaires and patient-reported measures to capture their quality of life, cognitive and physical impairments, anxiety, depression, and post-traumatic stress disorder. The study also assesses social support and experiences of both patients and their relatives with the healthcare system. Researchers aim to better understand the long-term effects of SE and ICU care, with the study lasting until March 2027.

Researchers are collecting detailed data on adults experiencing convulsive and non-convulsive status epilepticus SE or pseudo status epilepticus. This observational study aims to understand the circumstances, treatment, and outcomes of SE in critically ill patients by gathering extensive clinical and demographic information. The study is sponsored by the Ictal Group and tracks patient progress up to one year after SE onset. Participants with SE are observed without intervention, focusing on data collection such as seizure onset, treatment timing, EEG monitoring results, and seizure characteristics. The study includes both convulsive and non-convulsive SE cases, as well as pseudo SE, using standardized forms to document pre-hospital and hospital care details. Outcome evaluations are scheduled at ICU and hospital discharge, and follow-ups occur at 90 days and one year after SE. During the study, participants vital status and neurological outcomes are assessed using the Glasgow Outcome Scale at multiple timepoints. Researchers also monitor seizure recurrence, total seizure duration, and length of hospital stay. The study tracks mortality rates at ICU and hospital discharge and up to ten years in secondary measures. Data collection includes patient chart reviews and phone interviews to ensure comprehensive follow-up over time.

Researchers are investigating the best approach to treat patients with cutaneous squamous cell carcinoma CSCC who have a high risk of the cancer returning after surgery. This study compares two strategies adding radiation therapy after surgery called adjuvant radiotherapy versus closely monitoring patients without immediate additional treatment. The goal is to see if disease-free survival DFS, which means the time patients remain free from cancer recurrence, differs between these two approaches. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy starting within 8 to 12 weeks after surgery, delivering a total dose of 45 to 50 Gy to the area where the tumor was removed. Radiation may be given externally with high-energy photons or electrons, or through brachytherapy. The other group will undergo regular monitoring without additional treatment after surgery. Both groups will continue follow-up until cancer recurrence or death, with decisions for any further treatment left to the treating physician. Participants will be followed every 4 months for the first 2 years and then every 6 months thereafter. During visits, doctors will perform clinical exams, review any other treatments the patient is receiving, conduct imaging tests, and assess quality of life through questionnaires. The study will track outcomes such as disease-free survival, local and regional recurrence, metastatic recurrence, overall survival, treatment tolerance, and quality of life. Follow-up will continue until death or progression of disease, with assessments up to 36 months for many outcomes.

Post-menopausal osteoporosis is a common cause of disability and loss of independence in women aged 50 to 65. The decrease in hormone replacement therapy use has increased the risk of osteoporotic fractures in women before age 70, highlighting the need for effective prevention methods. This study investigates whether mother-of-pearl supplementation can help limit bone loss in postmenopausal women at risk of osteoporosis. Participants are randomly assigned to one of two groups one receiving mother-of-pearl capsules 800 mg daily, providing 320 mg calcium plus monthly vitamin D, and the other receiving calcium carbonate capsules 800 mg daily, equivalent to 320 mg calcium plus monthly vitamin D as a control. The study is double-blind and compares the effects of these supplementations over 12 months. Women in the study will undergo assessments of bone loss at the lumbar spine and femur, bone remodeling measurements, and monitoring of tolerance to mother-of-pearl supplementation. These evaluations occur from the start of the study through 12 months. The study follows participants for safety and effectiveness over this period, with the goal of understanding the impact on bone health.