Essey Les Nancy

This observational study evaluates the Polymer Free Sirolimus Eluting Coronary Stent System, known as the Vivo ISAR, in everyday clinical practice for patients with coronary artery stenosis. The purpose is to collect real-world data on clinical outcomes over a 12-month follow-up period, focusing on patients who receive this stent system as part of their routine care. The study is sponsored by Translumina GmbH and involves standard procedures and medications with known safety profiles. Participants will be treated with the Vivo ISAR stent during percutaneous coronary intervention to improve coronary artery diameter in those experiencing symptoms of ischemic heart disease. The study monitors patients who receive the stent in one or multiple vessels, observing their progress without altering standard care practices. The follow-up extends to 12 months after the procedure to assess various success rates and treatment effects. During the study, participants undergo routine clinical evaluations including assessments of device and procedural success shortly after treatment, and measures of target lesion failure and reperfusion at 12 months. Researchers also evaluate antiplatelet therapy adherence and effectiveness. The total participation involves regular check-ups and data collection to understand long-term outcomes and safety of the Vivo ISAR stent system in typical healthcare settings.

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.

This research aims to evaluate the outcomes of treating chronic total occlusion CTO in coronary arteries, a condition linked to worse heart health compared to other coronary artery diseases. The study investigates whether using the latest drug-eluting stents in a procedure called Percutaneous Coronary Intervention PCI is better than optimal medical therapy OMT alone. It focuses on two groups asymptomatic patients with significant myocardial ischemia and symptomatic patients with moderate ischemia, to understand effects on major cardiovascular events and quality of life. All participants will begin with three months of optimal medical therapy. After this, they will be assigned to one of two groups based on symptoms and ischemia level Cohort A includes asymptomatic patients with at least 10% ischemia, randomized to PCI or continued OMT Cohort B includes symptomatic patients with at least 5% ischemia, also randomized to PCI or OMT, with the option for PCI after six months if symptoms persist. An additional Cohort C includes patients who do not meet criteria for randomization but will be followed in a registry. Participants will undergo regular follow-ups for up to five years in Cohort A and six months in Cohort B. Researchers will assess major adverse cardiovascular and cerebrovascular events MACCE and quality of life using the Seattle Angina Questionnaire. Before randomization, patients will be monitored for symptom class and ischemia levels using nuclear imaging. Safety and health status will be tracked through clinical visits, with the study aiming to provide clearer evidence on CTO treatment benefits and risks over time.

The trial investigates the impact of different antibiotic treatments on the digestive tract colonization by extended-spectrum beta-lactamase-producing Enterobacteriaceae E-ESBL in children with febrile urinary tract infections UTIs. E-ESBL bacteria are a significant public health concern due to their resistance to many antibiotics. This research compares the emergence of E-ESBL strains in stools following treatment with either intravenous amikacin or other recommended antibiotics like ceftriaxone or cefixime in young children. Participants receive treatment for febrile UTIs with either amikacin given intravenously or with usual antibiotics such as intravenous or intramuscular ceftriaxone or oral cefixime. Before starting antibiotics, an anorectal swab is taken to check for E-ESBL colonization. A follow-up swab is performed three to four days after starting treatment to assess changes in bacterial presence. Children are monitored for the presence and type of E-ESBL bacteria in their stools four days after treatment begins. Researchers also track antibiotic resistance patterns, fever resolution, side effects related to antibiotic use, and the rate of UTI relapse over one and a half months. Participation involves stool sampling and clinical evaluations during the treatment period, with the study expected to complete by mid-2026.

Researchers are evaluating the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in people with coronary artery disease who have atherosclerotic lesions longer than 36 mm and up to 44 mm in their native coronary arteries. The study focuses on lesions with a reference vessel diameter between 2.25 mm and 4.0 mm. This is a prospective, multicenter, single-arm study sponsored by Teleflex, aiming to treat subjects with these specific lesions using this device. Participants will receive the Orsiro Mission stent, which consists of a cobalt chromium stent platform coated with a bioabsorbable polymer containing the drug sirolimus. This device is designed to be implanted in the coronary arteries during percutaneous coronary intervention PCI. The study involves a single group receiving this stent to assess its performance in treating lesions of the specified length and size. During the study, participants will have follow-up visits to monitor outcomes and safety. Those enrolled in the United States will be followed for 2 years with visits at 1, 6, 12 months, and 2 years after the procedure. Participants outside the United States will be followed for 5 years with additional visits at 3 and 5 years. Researchers will measure target lesion failure at 12 months as the primary outcome and will also track device and procedure success, deaths, heart attacks, major cardiac events, revascularizations, and stent thrombosis throughout the follow-up period.

Rotator cuff injuries affect about 30% of the general population, and when repair fails, patients often suffer persistent pain. During revision surgeries, bacteria can be found in about 30% of cases without clear infection signs, known as low-level infections, which may contribute to poor outcomes. This study investigates the impact of unexpected positive cultures UPC found during rotator cuff re-intervention and aims to determine how these cultures influence clinical outcomes and tendon healing. The research compares two groups of patients undergoing rotator cuff revision those with positive microbiological samples and those with negative samples taken during surgery. The study involves collecting and analyzing bacteriological samples from operative elements like sutures and tendon tissue during the re-intervention. Antibiotics are not given immediately after surgery or during the first month unless a pathogenic microorganism is identified, in which case antibiotic treatment starts and the participant discontinues the study. Participants will be followed at 1 month, 3 months, 6 months, and 1 year after surgery. Assessments include shoulder functional recovery, tendon healing using MRI-based Sugaya scores, occurrence of post-operative complications, and identification of pathogenic bacteria. Questionnaires and clinical evaluations will track outcomes, with safety and healing monitored over the year to understand the influence of positive cultures on recovery.