Ecully

Researchers are evaluating the safety and performance of Teknimed's arthroplasty products, including CEMFIX e and GENTAFIX e bone cements and the CEMSTOP e cement restrictor, which have been used for over 20 years. These products are designed to help fix joint prostheses to bones during joint replacement surgeries, which commonly address conditions like osteoarthritis, osteonecrosis, and trauma. The study focuses on collecting real-life long-term safety and effectiveness data through a retrospective and prospective observational design. The study involves patients undergoing cemented joint arthroplasty procedures using Teknimed's bone cements and cement restrictor. It is a global, multicenter, single-arm, non-controlled study where participants will be followed according to local medical care standards. Both patients who have already had surgery with these products since January 2016 and those scheduled for such procedures are included. Participants will be monitored for up to 15 years, with primary outcomes including survival rate of the device and rates of superficial or deep postoperative infections. Data collection includes clinical follow-up visits and routine medical care assessments. The study aims to confirm the long-term safety and performance of Teknimed arthroplasty products in real-world use.

Researchers are investigating early maladaptive schemas in French health care professionals who experience burnout compared to those without burnout and non-professionals with burnout. The study is non-interventional, comparative, and multicenter, aiming to understand vulnerability markers and potential therapeutic targets related to burnout. Participants include care professionals with burnout, care professionals without burnout, and non-professionals with burnout, matched by age and gender. The study assesses maladaptive early patterns using several questionnaires, including the Young Schema Questionnaire Short form, Maslach Burnout Inventory, Montgomery-Asberg Depression Rating Scale, and White Bear Suppression Inventory. Participants complete these assessments to compare profiles and domains of early maladaptive schemas among the different groups. Participants will be evaluated using the Young Schema Questionnaire Short form over 21 days. The study collects data on burnout symptoms, depression, and thought suppression to better understand psychological patterns related to burnout. Participants must provide informed consent and be members of a social security scheme. Safety and exclusion criteria are monitored throughout the study.

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 evaluating two surgical treatments for patients with symptomatic Grade II or III internal haemorrhoidal disease who have not responded to medical or instrumental treatments. This study aims to compare the failure rates of Doppler-Guided Haemorrhoidal Artery Ligation (DGHAL) with mucopexy versus Radiofrequency Ablation (RFA), a newer technique with promising low recurrence rates. The trial seeks to show that RFA is not inferior to DGHAL in treating haemorrhoids. The study involves two treatment groups. In the first, DGHAL uses a Doppler probe to locate and ligate haemorrhoidal arteries, cutting off blood supply to the haemorrhoidal tissue, followed by mucopexy to lift the prolapsed mucosa. The second group receives RFA, where a metal probe delivers radiofrequency energy under the anal mucosa to sclerose haemorrhoidal veins. Each haemorrhoidal bundle is treated separately with this method. Participants will be monitored to assess treatment failure rates one year after surgery. The study includes adults aged 18 to 80 with Grade II or III haemorrhoids requiring surgery. Researchers will collect data on symptoms, recurrence, and safety. The trial includes informed consent, social security coverage verification, and excludes those with certain medical histories or conditions. The total participation time involves post-operative follow-up lasting at least one year.

Researchers are evaluating the safety and quality of outpatient care compared to conventional hospital care for patients with acute uncomplicated appendicitis who undergo laparoscopic appendectomy. The study focuses on whether same-day discharge is as safe and effective as staying overnight in the hospital. This approach aims to improve patient satisfaction, reduce hospital stays, lower healthcare costs, and limit exposure risks during situations like the COVID-19 pandemic. The trial compares two treatments: ambulatory appendectomy, where the surgery is done in an outpatient unit and patients leave the hospital the same day, and conventional appendectomy, where patients stay overnight under observation after surgery in a digestive surgery department. Patients included are those with confirmed uncomplicated appendicitis and meet specific health and monitoring criteria, such as having a relative available for monitoring after discharge and living close to a hospital. Participants will be followed for 30 days after surgery to monitor overall safety and recovery. Researchers will assess complications, health status, and any morbi-mortality events during this period. The study includes careful screening before surgery, ongoing safety monitoring, and uses imaging and laboratory tests to confirm eligibility and health status. The total participation period covers the surgery day and 30 days of postoperative follow-up.