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Found 5 Actively Recruiting clinical trials
RECRUITING
Leptospirosis is a zoonosis caused by spirochetes, pathogenic bacteria of the genus Leptospira. It is transmitted to humans through mucocutaneous lesions by contact with water or soil contaminated by the urine of animal reservoirs (rats, dogs, pigs, cattle, etc.). Exposure to fresh water, contact with water or soil contaminated with animal waste are the main risk factors. This disease is an important public health problem in humans and animals. The annual global incidence is estimated at nearly one million cases with a mortality of 5 to 10% for all cases combined and up to 50% in the event of multi-organ failure. The number of cases is growing and the disease is probably more widespread because it is underdiagnosed. The incidence could increase further in the coming decades due to climate change and rapid urbanization. In the Overseas Departments and Regions (DROM), it is an endemic condition and its incidence is 10 to 100 times higher than that of mainland France, mainly for climatic reasons. In Réunion, the disease is notifiable with a number of notified cases ranging from 70 to more than 100 cases per year in recent years. Nearly 90% of confirmed cases were hospitalized and more than a third of patients stayed in intensive care. Recently, a multicenter cohort of patients hospitalized with leptospirosis in La Réunion (COLEPT) was funded by Inserm to identify the severity factors of the disease in patients hospitalized in one of the 4 hospitals on the island. A community of hospital practitioners active on this theme has been identified and constitutes the core of this project. The main objective of the study, the inclusions of which began in January 2020, is to identify the severity factors of leptospirosis in Reunion. Patient follow-up is planned for up to 1 year with 2 medical visits at 1 month and 1 year and 2 telephone interviews on quality of life. The disease is generally perceived as a purely acute condition with a rapid ad integrum recovery. Nevertheless, the evolution at a distance has been little evaluated. A few publications report complications and elements of chronicity in the medium/long term (\>1 year) which would require monitoring these patients over a longer period. Regarding these potential chronic manifestations, they may be chronic fatigue, uveitis, renal failure, chronic renal carriage with urinary excretion of leptospires, myalgia and muscle weakness, headaches, malaise but also cardiac or neurological manifestations. A Dutch study conducted on subjects with confirmed diagnosis reported 30% of patients with chronic post-leptospirosis symptoms which persisted in 21% of subjects more than 24 months after infection, but very few data are available on the chronic forms. The objective will be to study the future of patients beyond 1 year of infection in clinical and serological terms, but also in terms of quality of life, use of alternative medicines and complementary and health literacy profiles.
RECRUITING
Comunity health actions are set up in populations of women aged 30 to 65 in vulnerable situations living in the outlying areas of Reunion Island. The idea is to evaluate those action on health
RECRUITING
This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study. Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.
RECRUITING
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. Aging of the population and improvement of perioperative management may suggest that the number of these interventions will increase in the next few years. However, recurrence is common and has been described in up to 30% of patients who have undergone laparoscopic repair after a median follow up of 24 months. The use of mesh reinforcement has been suggested to help preventing recurrence after LHH repair with non-absorbable and absorbable mesh. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH. The secondary objectives are : * To compare the improvement of specific symptoms between two arms; * To compare the Quality of life; * To compare the complication rate and thecomplication severity according to the Clavien-Dindo classification; * To assess the cost-effectiveness of standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair as compared to standardized herniorrhaphy with no mesh, in symptomatic LHH, at 2 years, from the French Healthcare system point of view. The expected benefits are : * for the patient the diminution of LHH recurrence rate, quality of life improvement * for Public health: * Reducing the rate of reoperation for LHH; * Reduction of healthcare costs due to a decrease in proton pump consumption and surgical re-interventions; * The use of a synthetic bioprosthesis in laparoscopic surgery could be largely recommended and reimbursed either through the tariff related to the hospital stay (DRG tariff) or in additionto this tariff; * Long term follow-up up to 5 years, could be obtained thanks to the use of French health insurance databases.
RECRUITING
There is a great heterogeneity in the practice of rapid sequence induction in the operating room in the world. There are no recent data assessing the rate of implementation of the latest French formalized expert recommendations in clinical practice. In addition, the modalities for the management of haemodynamic disorders, particularly hypotensive disorders, during rapid sequence induction are not described in these recommendations, although these are frequent events with a non-zero morbidity mortality potential. The goal of this prospective, observational, multicenter, anesthetic study is to describe the clinical practice of French anesthesiologists regarding the prevention of severe hemodynamic disorders during rapid sequence anesthetic induction in adult patients. The primary outcome measure is the occurrence of a major haemodynamic disorder defined by a MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or the occurrence of sustained arrhythmia not present at induction and/or cardiac arrest within the first 10 minutes after induction of anesthesia. The clinical practices of pre-oxygenation, induction and intubation of French anesthesiologists and compliance with the formalized expert recommendations of 2017 and 2018 will also be studied secondarily. The elements for the prevention of gastric fluid inhalation, the organization and equipment used, the anesthetic and non-anesthetic drugs used, the clinical and paraclinical neurological and cardio-respiratory parameters and the nature of the complications following anaesthetic induction will be collected up to the 10th post-induction minute.