Saint Jean De Vedas

This research aims to evaluate the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. The study focuses on elderly individuals with spinal pathologies, investigating less invasive endoscopic techniques to reduce operative risks and shorten hospital stays, addressing challenges linked to traditional surgeries in this age group. It is a prospective, multicenter, non-interventional study assessing the biportal and uniportal endoscopic approaches feasibility and effectiveness in this population. The treatment involves endoscopic lumbar decompression surgery using either biportal or uniportal methods, specifically performed as outpatient procedures to minimize surgical trauma and preserve lumbar spine function and stability. Patients will undergo surgery on one lumbar level, with the study observing the outpatient care process without additional interventions. The study is non-interventional and collects data through questionnaires and clinical evaluations. Participants will be followed for three months after surgery to monitor clinical progress, including any complications or hospital readmissions. Data collection includes clinical exams, quality of life assessments, medical histories, ongoing treatments, and self-administered questionnaires. The primary outcome measures the success of outpatient care by tracking hospitalizations or readmissions, while secondary outcomes assess treatment safety and efficacy during inclusion and follow-up visits.

Researchers are evaluating four different isotonic and hypertonic seawater-based nasal sprays in real-life settings for their effectiveness, safety, usage, tolerance, and user satisfaction. The study focuses on infants, children, adults, and pregnant or breastfeeding women who have acute or chronic sinonasal conditions such as upper respiratory tract infections, allergic rhinitis, chronic rhinosinusitis, bronchiolitis, COVID-19, and post-surgery nasal issues. The investigation aims to understand how these devices perform when used as intended across various patient groups. Participants will use one of four CE-marked nasal spray devices according to their specific indications and target populations. The sprays include Respimer Hygiene-Prevention for babies, kids, and adults, Respimer Decongestion for babies from two months old and older, and Phytosun arms Hypertonic nasal wash for children six years and older and adults. Usage instructions vary by product, ranging from 1 to 6 sprays per nostril daily, with different frequencies for treatment and prevention purposes. The study period covers up to three months to assess both short-term and longer-term effects. During the study, participants or their parents will complete online questionnaires and follow healthcare providers advice on nasal wash techniques. Researchers will monitor nasal symptom changes, including intensity and frequency, improvement in nasal breathing, quality of life, and satisfaction with the sprays. Effectiveness will be evaluated from day 0 to day 5 for acute conditions and up to day 14 for chronic issues, extending to three months for seasonal symptom management. Safety, tolerance, and usage patterns will also be recorded throughout the study.

Researchers are studying whether an erector spinae plane block can reduce morphine use within 72 hours after lumbar spinal fusion surgery. This surgery is known to be quite painful due to its extensive exposure, and managing postoperative pain is a key goal to help patients recover faster. The study is a randomized, controlled, double-blind trial comparing the block with a placebo injection during surgery. The study involves 130 patients undergoing lumbar spinal fusion on one or two levels. They will be randomly assigned to receive either an injection of levobupivacaine as part of the erector spinae plane block or a placebo saline injection, both guided by ultrasound. The procedure is done under anesthesia during surgery, with the anesthetist injecting the solution near the spine muscles. Both groups will follow the same process so neither patients nor care teams know which treatment is given. Participants will be monitored closely with data collected at multiple times up to one month after surgery, including morphine consumption, pain levels, nausea, complications, and walking ability. The main focus is on morphine use during the first 72 hours post-operation. The study also includes safety checks and functional assessments to evaluate recovery and side effects. Total participation spans from the day of surgery through a 30-day follow-up period.

Researchers are investigating the use of endoscopic surgery as a less invasive alternative to traditional lumbar spine fusion for patients with spinal stenosis and spondylolisthesis. This approach aims to decompress the lumbar spine while preserving its natural function and stability, potentially reducing the need for spinal fusion. The study explores whether endoscopic techniques can lower the rate of more invasive surgical interventions in this population. The study focuses on patients who require spinal decompression surgery and are considered for endoscopic procedures. It observes outcomes related to these minimally destructive surgical methods without introducing experimental drugs or devices. The main goal is to evaluate the rate of surgical reintervention within one year after the initial endoscopic surgery. Participants will be monitored over time to assess if further surgical procedures are needed. Researchers will review medical imaging and clinical data to understand the effectiveness of endoscopic decompression in avoiding fusion surgery. The study involves adults 18 years and older and tracks outcomes related to surgical reintervention during the follow-up period, with participation potentially lasting up to several years.

Researchers are studying the early and advanced onset of puberty in children, focusing on the increasing age of puberty signs observed in the United States and Europe. This observational study aims to understand the causes behind these changes, including environmental endocrine disruptors and nutritional factors, by establishing a national observatory in collaboration with pediatric endocrinologists. The study targets children experiencing early signs of puberty to supplement existing epidemiological data that is currently limited. The study includes three groups based on puberty development children with suspected precocious puberty girls under 8 years, boys under 9 years, children with suspected advanced puberty girls 8 to under 10 years, boys 9 to under 11 years, and a control group of children without signs of puberty development Tanner stage 1. Participants are seen by pediatric endocrinologists during consultations, and their data is collected over a period of up to 48 months. Participants will be involved through consultations where data on their pubertal development is gathered. Researchers will monitor the number of patients recruited, the completeness of collected data, and the inclusion rate of eligible patients. The study plans to reach at least 75% patient inclusion and collect at least 80% of the main data during the observation period. The total study duration extends up to 48 months, allowing thorough follow-up and data analysis to better understand puberty timing changes.

Researchers are studying the links between certain markers of bone mineral metabolism, specifically osteoprotegerin and fibroblast growth factor 23, and the occurrence of cardiovascular events in patients with chronic kidney disease who are not on dialysis. The study aims to understand how these markers relate to heart and blood vessel problems over a long period. Participants will have their blood tested to measure plasma levels of osteoprotegerin and fibroblast growth factor 23, and their vascular calcification will be assessed through imaging scans. These measurements are taken at the start of the study, followed by monitoring for cardiovascular events and kidney function over a 7-year period. During the study, participants will be monitored for the occurrence of cardiovascular events, changes in kidney function, and mortality. The main focus is to see if initial levels of these bone metabolism markers predict cardiovascular problems during the 7 years of follow-up. The study does not involve treatment but evaluates risk factors and outcomes over time.

Researchers are evaluating the Omnipod 5 Automated Insulin Delivery System in people with type 1 diabetes aged 2 years and older. This study aims to observe real-world use of the device over 12 months, focusing on blood sugar control, quality of life, patient satisfaction, and rates of acute diabetes complications. The study is non-interventional and prospective, involving multiple centers in France. Participants use the Omnipod 5 System, a tubeless automated insulin pump designed to deliver insulin under the skin and used with compatible continuous glucose monitors such as the FreeStyle Libre 2 Plus sensor. The study follows patients for 12 months after they start using the system in automated mode. During this time, researchers collect data on how well blood sugar levels are controlled and how participants use the device. Throughout the study, participants complete quality-of-life questionnaires and treatment satisfaction surveys at the start, 6 months, and 12 months. Data on glucose levels, insulin delivery, and diabetes complications are collected continuously during the 12-month period. Safety, device usage patterns, and reasons for stopping the system are also monitored. Participants remain under their usual medical care while contributing data to this observational study.

This clinical trial investigates the use of a tourniquet during hallux valgus surgery, a condition affecting the big toe. It is a prospective, randomized study where each patient will act as their own control, allowing direct comparison of outcomes with and without tourniquet use during surgery. Participants will undergo surgery on both feet on the same day. In one surgical procedure, the surgeon will use a tourniquet as usual, while in the other, the surgery will be performed without a tourniquet. The study compares these two approaches to assess differences in pain and other outcomes. During the first week after surgery, researchers will measure average pain levels. Additional assessments include checking for swelling edema on day 10 after surgery and monitoring any complications during the first week. Participants will be closely followed to evaluate these outcomes and contribute to understanding the impact of tourniquet use in this type of surgery.