Saint Jean De Vedas

Researchers are evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicenter, non-interventional study focuses on the feasibility and effectiveness of biportal and uniportal endoscopic techniques to reduce operative morbidity and hospitalization time in elderly patients with spinal pathologies. The study addresses the challenges of traditional lumbar decompression surgery, which often involves longer hospital stays and higher risks for this age group due to comorbidities and bone fragility. The treatment involves endoscopic lumbar decompression surgery using either biportal or uniportal methods, performed as outpatient procedures to minimize surgical trauma and preserve lumbar spine function and stability. Patients will receive the surgery on one spinal level as indicated for their condition. The study does not intervene beyond standard care but collects data through questionnaires administered by the surgeon, including assessments of patients' autonomy in daily activities. Participants will be followed for three months after surgery, with evaluations including clinical examinations, quality of life assessments, medical history reviews, and self-administered questionnaires. Follow-up visits will collect information on clinical progress, imaging results, therapeutic interventions, and medication use to monitor recovery and identify any complications. The primary outcome measured is the number of patients requiring conventional hospitalization or readmission after surgery within the three-month period.

This research aims to evaluate the real-life effectiveness, safety, usage, tolerance, and satisfaction of four CE-marked isotonic and hypertonic seawater-based nasal sprays. It focuses on infants, children, adults, and pregnant or breastfeeding women who suffer from acute and chronic sinonasal conditions such as upper respiratory tract infections, COVID-19, bronchiolitis, allergic rhinitis, chronic rhinosinusitis, and post-surgery recovery. The study seeks to answer key questions on how well these nasal sprays work and how safe and satisfactory they are in everyday use. Participants will use one of four nasal sprays designed for different age groups and indications. The sprays are applied by spraying 1 to 3 seconds into each nostril multiple times daily, depending on the product and condition. Treatment for nasal symptoms ranges from 2 to 6 times a day, while hygiene and prevention uses are less frequent. The nasal sprays are used according to their intended purpose and population, including special instructions for babies, children, and adults. During the study, participants or their parents/caregivers will perform nasal washes following healthcare provider advice and complete online questionnaires about their symptoms and experience. Researchers will monitor nasal symptom improvement over 5 days for acute conditions and up to 14 days for chronic conditions. The study includes assessments of nasal symptom intensity, nasal breathing impairment, safety, and user satisfaction. Participants are expected to comply with study requirements for up to 3 months and have daily internet access for questionnaire completion.

Lumbar spinal fusion surgery is known to be particularly painful, more so than other types of lumbar surgeries. Researchers are investigating whether using an erector spinae plane block can reduce the need for morphine pain medication in the 72 hours after surgery. This study is a randomized, double-blind, controlled trial conducted in the setting of an Enhanced Rehabilitation After Surgery (RAAC) program to improve pain management and recovery after lumbar spinal fusion. The study involves two groups of patients undergoing 1 or 2 level lumbar spinal fusion surgery. One group receives an ultrasound-guided erector spinae plane block with levobupivacaine anesthetic, while the other group receives a placebo injection of saline solution under the same conditions. The anesthetist performs the block after the patient is asleep, injecting the study solution bilaterally near the spine with ultrasound guidance. Participants will be monitored closely with data collected at multiple time points: 3, 4, 6, 9, 12, 18, 24, 36, 48, 72 hours, and one month after the block. Researchers will track how much morphine patients use after surgery and assess pain control and recovery progress. The study aims to improve postoperative pain management and rehabilitation following lumbar spinal fusion surgery.

The trial investigates spinal conditions such as spinal stenosis and spondylolisthesis, focusing on reducing the need for lumbar fusion surgery. It evaluates the use of endoscopic techniques for decompressing the lumbar spine, aiming to preserve its natural stability and function. This approach is considered a less invasive alternative to traditional surgical methods, with the hypothesis that it can lower the frequency of more extensive spinal fusion procedures. The study centers on endoscopic decompression procedures as a treatment option for patients with specific lumbar spine pathologies. These minimally invasive surgeries are designed to be optimized and cause less tissue damage. Participants are patients who have spinal conditions requiring surgical intervention, including those with complications such as lumbar scoliosis or degenerative spondylolisthesis. The endoscopic approach is assessed as a potentially effective way to avoid lumbar arthrodesis. Participants will be monitored primarily for the need for any additional surgical interventions within one year after treatment. The study involves evaluations using preoperative imaging, such as radiographs and MRI, to classify spinal abnormalities and determine eligibility. Safety and outcomes are tracked over the course of a year to understand the effectiveness of the endoscopic procedures in reducing the requirement for further surgery.

Researchers are investigating the safety, effectiveness, and cost-efficiency of the LUMINOR4 Drug Eluting Balloon (DEB) for treating new and recurring lesions in the superficial femoral artery and popliteal artery. This study particularly focuses on complex cases such as calcified, long lesions, or occlusions, where the use of additional debulking devices may improve treatment outcomes. The registry includes a wide range of patients with peripheral arterial disease and follows them for up to five years. Participants will be treated with the LUMINOR4 paclitaxel eluting balloon, which is designed to open narrowed or blocked arteries while delivering medication to prevent re-narrowing. The study allows the use of crossing devices, laser treatment, or atherectomy if needed during the initial procedure. If the balloon treatment is insufficient, bailout stenting is permitted. The treatment targets lesions starting from just below the common femoral bifurcation to the popliteal artery, ensuring at least one patent outflow artery to the ankle. During the study, participants will be monitored for up to 36 months to assess both the primary efficacy endpoint—measured by the artery's openness via ultrasound at 12 months—and overall medical safety. Follow-up includes imaging, clinical evaluation, and safety assessments to track the durability of the treatment. The total participation involves long-term monitoring to evaluate outcomes and potential risks associated with the device and procedure.

Recent research has observed a rise in the age at which puberty begins, both in the United States and Europe, with a noted increase in cases of precocious puberty that varies by region. Early puberty can lead to early menstruation, shorter adult height, and psychological effects. Due to limited studies and data, the reasons behind these trends remain unclear, though environmental factors such as endocrine disruptors and nutrition are considered possible contributors. This study aims to create a national observatory to monitor early and advanced puberty in collaboration with pediatric endocrinologists to improve epidemiological understanding. The observatory will focus on identifying cases of precocious and advanced puberty in private healthcare settings. It will include groups with suspected early puberty (girls under 8 years, boys under 9 years) and advanced puberty (girls aged 8 to under 10 years, boys aged 9 to under 11 years) based on the appearance of first pubertal signs. A control group of children without signs of puberty, matched by age and sex, will also be included. The study intends to enroll at least 75% of eligible patients and collect at least 80% of the main data. Participants will have consultations with pediatric endocrinologists who will collect clinical data over a period of up to 48 months. The study will monitor data completeness and recruitment rates, aiming to maintain high-quality data collection throughout the observation period. The observatory seeks to provide a reliable, detailed field approach to supplement existing epidemiological information on pubertal development.

Researchers are investigating how markers related to bone mineral metabolism, specifically osteoprotegerin and fibroblast growth factor 23, are connected to the occurrence of cardiovascular events in people with chronic kidney disease who are not on dialysis. The study focuses on understanding if these biological markers can predict heart-related health problems over a long period. This research aims to improve knowledge about risk factors for cardiovascular disease in this patient group. Participants will have their plasma levels of osteoprotegerin and fibroblast growth factor 23 measured. Additionally, the degree of vascular calcification will be assessed using a specialized imaging technique called multidetection computerized tomography. These assessments take place at the start of the study to establish baseline measurements for each participant. Throughout the 7-year follow-up period, researchers will monitor participants for the occurrence of any cardiovascular events. The main outcome is to determine if the initial levels of osteoprotegerin relate to the risk of experiencing such events. Regular assessments and monitoring will help track participant health and the progression of any cardiovascular complications during this time.

This research aims to evaluate how the Omnipod 5 Automated Insulin Delivery System affects blood sugar control, quality of life, satisfaction, patient experience, and rates of sudden diabetes complications in real-world conditions. The study focuses on individuals with type 1 diabetes, both adults and children aged 2 years and older, who have started using the Omnipod 5 System with a FreeStyle Libre 2 Plus sensor in France. Participants use the Omnipod 5 System, a tubeless insulin pump that delivers insulin automatically when paired with compatible continuous glucose monitors. This non-interventional study follows patients for 12 months after they begin using the device in automated mode to collect data on device use and glycemic control. During the 12 months, researchers will monitor participants' blood glucose levels, quality of life, device safety, and usage patterns. They will measure changes in the time blood sugar stays within a target range (70-180 mg/dL) from baseline to 12 months. Participants will complete questionnaires and stay in contact with study staff throughout the follow-up period to track outcomes and ensure safety.

This clinical trial is a prospective, single-center, randomized study investigating the use of a tourniquet during surgery for hallux valgus, a foot deformity. Patients who need surgery on both feet with similar deformities are enrolled, and each patient serves as their own control to compare outcomes with and without a tourniquet. Participants will undergo surgery on both feet on the same day. One foot will be operated on using a tourniquet during the procedure, while the other foot will be operated on without a tourniquet. This allows direct comparison of the two approaches within the same individual. During the study, researchers will measure the average pain experienced in the first week after surgery. Patients must be adults over 18 years old and will be closely monitored to assess pain and recovery following their surgeries.