Haguenau

Food Protein Induced Enterocolitis Syndrome (FPIES) is a non-IgE mediated food allergy that mainly appears in infancy and can cause severe vomiting, diarrhea, and dehydration. This condition is often unfamiliar to many clinicians, and its diagnosis relies on specific clinical criteria established in 2017. This study aims to collect detailed clinical information and allergy test results for children diagnosed with acute FPIES and to describe its progression and atypical forms over three years in a French population. The study will include children aged 0 to 17 years with confirmed acute FPIES, diagnosed either by the 2017 JACI clinical criteria or by oral food challenge. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used to monitor patients. Participants will be seen by allergologists at the start and annually for three years. If tolerance to the offending food is not acquired, an oral food challenge will be conducted in a hospital setting to evaluate resolution. This multicenter French prospective study will gather data on FPIES evolution, including the development of IgE sensitization and clinical symptoms of IgE-mediated allergy. Throughout the study, children will undergo clinical evaluations and allergy testing at inclusion and yearly follow-up visits. Researchers will assess tolerance acquisition over an average of six years, monitor multiple FPIES cases, and record personal atopic conditions. The study will last three years for inclusion and three years of follow-up per patient, aiming to improve management of FPIES in France by understanding its unique food triggers and long-term outcomes.

Malignant hypertension is a very severe type of high blood pressure that can be fatal if not treated. It mainly affects younger adults aged 35 to 55 and carries a high risk of serious heart and kidney problems. Despite its severity and increasing cases, research on malignant hypertension is limited, with diagnostic criteria and treatment guidelines that have not changed since 1929. This study aims to create the first prospective, multicenter registry to better understand the disease's epidemiology, care practices, and biological aspects, and to modernize its definition and diagnosis. The study plans to enroll 500 patients diagnosed with malignant hypertension based on classic criteria, including severe high blood pressure above 180/110 mmHg and evidence of organ damage. It will collect detailed data on patient characteristics, affected organs, and treatment approaches used in various centers. This registry will help develop new diagnostic and treatment recommendations based on solid scientific evidence and may lead to future therapeutic trials. Participants will be followed to evaluate their health outcomes over five years, focusing on their cardiovascular and renal prognosis. Researchers will analyze how patient profiles and the number and type of organ damage affect their long-term outlook. The study will document epidemiology, care pathways, organ involvement, and management strategies in detail to improve understanding and care of malignant hypertension.

Researchers are studying patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the United States and Europe to understand their characteristics, treatment patterns, and outcomes over time. The study focuses on individuals who are receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or failure of prior therapies. The research includes a United States sub-study to evaluate mavacamten's safety and a European sub-study to assess both its effectiveness and safety in real-world settings. Participants may receive mavacamten according to its product label or other symptomatic therapies such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide based on standard care. The study includes those starting mavacamten, currently on other treatments, or untreated due to intolerance or failure of prior therapy. Treatment is observed during routine clinical care without altering prescribed therapy. Data collection occurs over several years to monitor long-term outcomes. During the study, participants will be regularly assessed for heart function and symptoms, including measuring the left ventricular outflow tract gradient and monitoring the incidence of new or worsening heart failure up to five years. Researchers will gather information on patient health, treatment safety, and heart function changes through echocardiography and symptom evaluations. The study allows for long-term observation to better understand real-world treatment effects and outcomes in obstructive HCM patients.

Researchers are evaluating the effectiveness of different antimicrobial treatments for infections caused by difficult-to-treat Pseudomonas aeruginosa bacteria. This infection is especially challenging for patients who are critically ill or have weakened immune systems. The study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older drugs like aminoglycosides and colistin in real-life clinical settings across multiple hospital centers in France. Participants will receive intravenous antimicrobial therapy tailored to treat their difficult-to-treat P. aeruginosa infection. The study observes the use of new and older antimicrobial drugs to assess their clinical efficacy. Patient data and bacterial samples will be collected and analyzed centrally to better understand drug resistance mechanisms and treatment outcomes. Participants will be monitored for clinical cure shortly after completing therapy and on Day 7 ± 2 days. Researchers will collect clinical information through electronic case-report forms and send bacterial isolates to a national center for detailed testing. Outcomes include cure rates, resistance development, adverse events, and mortality rates, with follow-up during hospitalization and up to 28 days after treatment. The study aims to provide valuable real-world data on treating these challenging infections.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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.

Researchers are evaluating whether an early, personalized rehabilitation program that combines nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for adults who have been critically ill and required mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this extended rehabilitation approach to usual care given during and after ICU stay. The study includes patients starting invasive mechanical ventilation recently and aims to support recovery from critical illness through tailored interventions. Participants are assigned to either the rehabilitation group or the control group. The rehabilitation group receives a customized program beginning early in the ICU and continuing through the post-ICU hospital stay and then at home for a total of 12 weeks. This program uses goal-directed nutrition and physical activity adjusted over time by specialists including dieticians, physiotherapists, and physical-activity instructors. The control group receives the usual care available at each ICU from day 0 to day 180. Throughout the study, participants will be monitored to assess their recovery progress, with the primary outcome measuring the distance walked in 6 minutes at 6 months. Researchers will gather data on physical function and health improvements during and after the rehabilitation period. The study includes follow-up assessments up to 180 days to evaluate the long-term effects of the rehabilitation program compared to usual care.

Chronic kidney disease (CKD) is a widespread health concern linked to high risks of mortality, cardiovascular disease, and progression to end-stage kidney disease, especially when paired with hypertension. Lowering blood pressure (BP) is known to reduce these risks, but optimal drug treatment strategies for patients with moderate to severe CKD and uncontrolled hypertension remain unclear. This trial evaluates whether a diuretic-based blood pressure lowering approach is more effective than usual care in reducing cardiovascular events, death, and kidney failure in this population. Participants will be assigned to either an antihypertensive treatment plan using a specific diuretic-based algorithm or to standard care for intensifying blood pressure control. All participants have moderate to severe CKD and uncontrolled hypertension despite treatment with at least one renin-angiotensin system blocker at the highest tolerated dose. The study compares these two approaches to blood pressure management over time, focusing on their impact on health outcomes. Throughout the study, participants will be monitored for up to 36 months to track the occurrence of end-stage kidney disease, significant declines in kidney function, cardiovascular events, and overall survival. Blood pressure control will be assessed by office, home, or ambulatory monitoring. Safety and treatment effects will be evaluated regularly to understand how these blood pressure strategies affect patients with CKD and uncontrolled hypertension.

Researchers are evaluating the performance and safety of the FHK4-CK knee prosthesis, designed for patients needing complex primary or revision knee arthroplasty due to gonarthrosis. This new medical device complements an existing first-line prosthesis range and aims to offer surgeons a versatile and reliable option for restoring mobility and quality of life. The study is a pilot with a follow-up period of two years to assess outcomes after implantation. The FHK4-CK prosthesis is a class III device that will be implanted using specialized instruments and surgical techniques defined by the manufacturer. It is intended for patients with major axial deviation, peripheral failure, or bone defects requiring either first-time arthroplasty or revision after failure of an earlier implant. The device and associated procedures are designed to simplify surgery, improve compatibility with existing prostheses, and reduce risks. Participants will undergo functional performance assessments before surgery and at 6 weeks, 6 months, 12 months, and 24 months post-surgery. During the study, patients will complete questionnaires and be monitored for safety and prosthetic function. The study requires informed consent, health insurance coverage, and the ability to participate in follow-up visits over two years to evaluate the device's effectiveness and safety.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.