Nangy, France

Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients with Homozygous Familial Hypercholesterolemia

This is a multicenter, international, long-term observational study investigating the real-world impact of lomitapide on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia (HoFH). Study Design: Observational, open-label, retrospective and prospective study Data will be collected from >26 lipid centers across Europe Patients will serve as their own control, with comparisons between pre-treatment (3 years before lomitapide) and post-treatment (first 3 years of lomitapide therapy) periods Study Population: Approximately 72 adult patients (≥18 years) diagnosed with HoFH Patients must have received lomitapide for at least 12 months Availability of 3 years of pre-treatment clinical records Objectives: Primary Objective: Evaluate the incidence of MACE before and after lomitapide treatment Secondary Objectives: Assess changes in LDL-C, total cholesterol, liver function tests (ALT, AST, GGT), and lipid-lowering therapy usage (e.g., discontinuation of LDL apheresis, addition of PCSK9 inhibitors) Endpoints: Primary Endpoint: Change in MACE incidence over the 3-year treatment period Secondary Endpoints: Changes in lipid levels, liver safety markers, and adherence to treatment protocols Safety Considerations: The study follows real-world clinical practice, with monitoring of adverse events, including liver-related safety concerns associated with lomitapide Data will be collected in an electronic Case Report Form (eCRF) and analyzed following Good Clinical Practice (GCP) guidelines This study aims to generate real-world evidence on the cardiovascular impact of lomitapide in HoFH patients, addressing an unmet clinical need for data on long-term outcomes.

Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital

Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?

A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy

Impact of Perioperative Nutritional Status and Management in the Context of Resectable Pancreatic Adenocarcinoma

Characteristics and Results of Patients Treated by Therapeutic Intensification

Smart Intraoperative Reminder to Implement Safety Principles in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is the gold standard approach for the surgical removal of the gallbladder. However, between 0.3 and 1.5% of patients undergoing laparoscopic cholecystectomy experience a bile duct injury (BDI). This major complication translates into a threefold increase in mortality at 1 year, frequent medico-legal litigations, and an annual cost of about 1 billion dollars in the USA alone. The visual perceptual illusion causing major BDIs can be prevented by implementing the Critical View of Safety (CVS). CVS consists of the clearance of the hepatocystic triangle from fat and connective tissue, the division of the lower part of the gallbladder from its liver bed, and ensuring that only two tubular structures-the cystic duct and the cystic artery-connected to the gallbladder are visible. Unfortunately, CVS implementation in surgical practices is as low as 9% and, in turn, BDIs do not decrease. To improve the implementation of the CVS, multi-society consensus guidelines recommend to time-out to confirm CVS achievement before dividing cystic structures. A large quality improvement study demonstrated that a short time-out to recall CVS principles significantly increases CVS implementation rates. However, the implementation of the time-out and CVS decreases over time. The CVS-Notifier SaMD reminds surgeons to time-out to verify the CVS before the division of the cystic duct. Such a systematic intraoperative reminder to implement best practices could help consistently perform safe laparoscopic cholecystectomies. This first-in-human, exploratory study aims at evaluating the safety, usability, and potential impact of the CVS-Notifier SaMD in laparoscopic cholecystectomy. The study is a single center, non-comparative, case series. Patients undergoing elective laparoscopic cholecystectomy who meet the eligibility criteria and express their consent to participate in the study will be enrolled. The CVS-Notifier SaMD will be installed on a medical grade computer connected to a secondary output of the laparoscopic video system (input) and to an auxiliary screen in the operating room (OR) (output). Surgeons will start the procedure as usual while the CVS-Notifier SaMD unobtrusively analyses the surgical video. When the beginning of the hepatocystic triangle dissection is detected, a visual reminder to verify CVS in an intraoperative time-out notification will appear on the auxiliary OR screen. Surgeons and patients will be asked to fill in a survey to report their experience, after the procedure and before discharge, respectively. Clinical, surgical, and device-related data will be collected and analyzed.

The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.

Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.

Evaluation of the Duration of Obtaining Curative Anticoagulation in Patients With Clinically Significant Pulmonary Embolism in an Intensive Care Unit

Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF). VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm. No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study. The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively. The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.