Essey Les Nancy

Researchers are evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System called Vivo ISAR in patients with coronary artery stenosis. The study aims to collect clinical outcome data in real-world patients with coronary artery disease, following standard care procedures. The goal is to assess results and safety with a 12-month follow-up after treatment. Participants receive treatment using the Vivo ISAR stent device, which is designed to improve blood flow by widening narrowed coronary arteries in patients with symptomatic ischemic heart disease. The study involves patients undergoing percutaneous coronary intervention, with the Vivo ISAR stent used exclusively when stenting one or more vessels. During the study, participants will be monitored for clinical outcomes including the rate of target lesion failure within 12 months after the procedure. Researchers will collect relevant data on health status and treatment effects as part of routine clinical practice. The study is observational and follows patients over a year to evaluate the device's performance and safety in everyday medical care.

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.

This research investigates the effect of treating chronic total occlusions (CTO) in coronary arteries on heart disease patients with significant myocardial ischemia. It aims to compare two approaches: Percutaneous Coronary Intervention (PCI) using the latest drug-eluting stents versus optimal medical therapy (OMT). The study focuses on two groups: asymptomatic patients with at least 10% myocardial ischemia and symptomatic patients with at least 5% ischemia, assessing whether PCI improves major cardiovascular outcomes or quality of life compared to medical treatment alone. All participants first receive 3 months of OMT. Then, based on symptoms and ischemia levels, they are divided into Cohort A (asymptomatic with ≥10% ischemia) or Cohort B (symptomatic with ≥5% ischemia). Each cohort is randomized to either PCI or continued OMT. Cohort C includes patients enrolled but not qualifying for A or B. Cohort A is followed for 5 years to assess major adverse cardiovascular and cerebral events, while Cohort B is followed for 6 months, focusing on quality of life improvements measured by the Seattle Angina Questionnaire. PCI involves procedures to open the blocked artery using specialized stents. Participants undergo regular assessments including nuclear imaging to measure ischemia, angina classification, and quality of life questionnaires. Researchers monitor outcomes like mortality, heart attacks, strokes, hospitalizations, and arrhythmias over the follow-up periods. Safety and efficacy of PCI versus OMT are evaluated by tracking adverse events and quality of life changes. The study plans to enroll 1,560 patients, with detailed follow-up visits to collect clinical data and patient-reported outcomes.

The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is an important public health concern, especially in children with urinary tract infections (UTIs). These bacteria can lead to increased use of penem antibiotics, which may cause resistant strains. This study evaluates the effects of different antibiotic treatments on the presence of E-ESBL in the digestive tract of children aged 3 months to under 3 years who have febrile UTIs. The goal is to compare the impact of intravenous amikacin versus intravenous or intramuscular ceftriaxone or oral cefixime on the emergence of these bacteria in stools. Participants receive one of the antibiotic treatments as monotherapy: amikacin given intravenously, ceftriaxone administered either intravenously or intramuscularly, or cefixime taken orally. Before starting treatment, an anorectal swab is collected to check for E-ESBL bacteria, and a second swab is taken three to four days after beginning the antibiotic therapy to monitor any changes. During the study, children are monitored for the presence of E-ESBL in their stools on day 4 through these swabs. Parents provide consent and confirm their understanding of the study information. The study measures the bacterial carriage in the digestive tract after treatment and ensures safety by excluding children currently hospitalized or on multiple antibiotics. The participation duration aligns with the timing of these assessments.

This research aims to evaluate the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in treating patients with coronary artery disease who have atherosclerotic lesions between 36 mm and 44 mm in length in native coronary arteries with a vessel diameter of 2.25 mm to 4.0 mm. The study includes patients from the United States and other countries, with different follow-up durations based on location. Patients in the United States are followed for 2 years after the initial procedure, while those outside the United States are followed for 5 years. Participants will receive the Orsiro Mission stent, which is a device combining a cobalt chromium stent platform with a sirolimus drug contained in a bioabsorbable polymer coating. This stent is designed to be placed in the coronary artery to treat the lesion with a single device. The treatment targets one lesion per patient, with certain allowances for additional non-target lesion treatments using other approved methods if needed. Throughout the study, participants will have scheduled follow-up visits to monitor their health and the performance of the stent. In the United States, visits occur at 1, 6, 12, and 24 months after the procedure, while outside the United States, additional visits at 3 and 5 years are included. Researchers will assess the rate of target lesion failure at 12 months and monitor safety and device effectiveness through clinical evaluations and imaging as appropriate.

Rotator cuff injuries are common, affecting about 30% of the general population. When initial rotator cuff repair does not heal properly, patients may continue to experience pain. During revision surgery, bacteria can be found in about 30% of cases without clear infection symptoms, called unexpected positive cultures (UPC). The impact of UPC on healing and outcomes after rotator cuff revision surgery is not well understood, and there is no consensus on how to manage these cases, especially regarding antibiotic use. This study will prospectively compare patients undergoing rotator cuff revision surgery who have either positive or negative bacteria cultures from samples taken during their surgery. The research involves collecting normally discarded samples such as sutures, tendon debridement tissue, and cleaning products for bacteriological analysis. Antibiotic treatment will not be started immediately after surgery or during the first month unless a pathogenic microorganism is identified, in which case antibiotics will be given and the patient will stop the study. Participants will be followed and assessed at 1 month, 3 months, 6 months, and 1 year after surgery. Researchers will evaluate shoulder function, tendon healing, post-operative complications, and other functional scores over this time. They will also describe the types of bacteria found in positive cultures. The study aims to better understand the effect of unexpected positive cultures on recovery and healing after rotator cuff revision.