Haguenau

Food Protein Induced Enterocolitis Syndrome FPIES is a type of non-IgE mediated food allergy that usually occurs in infancy and is often not well known by clinicians. The study aims to collect clinical information and allergy test results from children diagnosed with the acute form of FPIES and to observe their condition over three years. It seeks to better understand the evolution of FPIES, including atypical forms, with no prior prospective data available from France. Children diagnosed with acute FPIES will be followed in this national prospective study conducted at sixteen French centers. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used for diagnosis and monitoring. Patients will be seen at an initial visit and then annually for up to three years. If tolerance to the offending food is not acquired, an oral food challenge will be performed in the hospital for confirmation. Participants will undergo yearly allergist visits for evaluation of symptoms and allergy testing. Researchers will measure the rate of tolerance acquisition to foods over one, two, and three years post-inclusion, as well as the progression to IgE sensitization and clinical IgE-mediated allergy. Additional outcomes include the presence of multiple FPIES episodes and related atopic conditions. The study will provide insights into the natural history and management of FPIES in children.

Malignant hypertension is a very serious form of high blood pressure that can be fatal if untreated. This research aims to create the first large, multicenter database to better understand this disease, including its modern epidemiology, how patients are currently managed, and the diseases diagnostic criteria. The study will help improve knowledge and may lead to new treatment trials and evidence-based recommendations. The study is an observational registry enrolling patients diagnosed with malignant hypertension based on classic definitions, including severe blood pressure elevation and organ damage. It plans to recruit 500 patients and follow them for five years to study their prognosis and the impact of different patient characteristics and organ involvement. By collecting detailed data on disease features and care pathways, the study hopes to update definitions and management approaches. Participants will be observed over five years, with researchers collecting information on their health status, organ damage, and treatment. The main outcome measured is the five-year prognosis of patients. This long-term follow-up will provide detailed knowledge about the disease course and help identify factors influencing outcomes, without any study treatments or interventions being assigned.

Researchers are evaluating real-world patient characteristics, treatment methods, and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM in the United States and Europe. The study includes patients receiving mavacamten, other treatments, or no treatment due to intolerance or treatment failure. The US sub-study focuses on safety of mavacamten, while the European sub-study assesses both safety and effectiveness of mavacamten in everyday care. Participants may receive mavacamten or standard treatments like beta blockers, non-dihydropyridine calcium channel blockers, or disopyramide as prescribed by their doctors. The study observes these groups over time in routine clinical settings without altering their care. The study includes two main groups based on treatment type and monitors outcomes up to five years. Participants undergo evaluations including echocardiograms, heart function assessments using New York Heart Association NYHA class, left ventricular outflow tract gradient measurements, and patient-reported health questionnaires. Researchers also track heart failure events, arrhythmias, major cardiovascular events, hospitalizations, mortality, and biomarkers like NT-proBNP and cardiac troponin. Follow-up varies by region, lasting up to 18 months in Europe and up to 5 years in the United States.

Researchers are evaluating different antimicrobial therapies for infections caused by difficult-to-treat Pseudomonas aeruginosa, a type of bacteria resistant to many common antibiotics. This study focuses on comparing new beta-lactambeta-lactamase inhibitor combinations, cefiderocol, and older treatments like aminoglycosides and colistin to understand their effectiveness in real-life settings for patients facing these challenging infections. The study is a prospective, multicenter cohort involving patients who require intravenous antibiotic treatment for their P. aeruginosa infections. Participating patients will receive one of the available antimicrobial options, and their bacterial samples will be analyzed centrally to assess susceptibility and resistance mechanisms. The study collects clinical data throughout treatment and monitors outcomes such as cure rates, resistance development, adverse events, and mortality. Participants will be followed until hospital discharge and up to 28 days after treatment completion. Researchers will track clinical cures, microbiological eradication, adverse events, emergence of resistance, and acquisition of other multidrug-resistant bacteria. Data collection includes electronic case reports and laboratory testing on bacterial isolates. The total participation duration varies according to hospital stay and follow-up schedules, with rigorous monitoring of safety and treatment outcomes.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

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 evaluating how an early and extended rehabilitation program that combines personalized nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for patients who have undergone invasive mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this tailored rehabilitation program to usual care, aiming to support recovery from critical illness. The study is a multicenter randomized controlled trial led by Nantes University Hospital. Participants will be assigned randomly to either the rehabilitation group or the usual care group. Those in the rehabilitation group receive a customized program starting early in the ICU and continuing through the post-ICU ward and at home for 12 weeks. This program involves goal-directed nutrition and physical activities adjusted to each patients progress, with support from dieticians, physiotherapists, and physical activity instructors. The usual care group receives standard nutritional support and physiotherapy based on local practices from day 0 to day 180. Throughout the study, participants will undergo various assessments including walking distance measured by a 6-minute walk test at 6 months, muscle strength, muscle mass, physical activity levels, calorie and protein intake, body weight, mortality rates, blood glucose monitoring, and quality of life surveys. These evaluations occur at multiple time points during and after hospitalization, up to one year. The study includes careful monitoring of mechanical ventilation duration, infections, hospital stay lengths, and other safety outcomes. Participant involvement spans from ICU admission through long-term follow-up.

Chronic kidney disease CKD is a serious global health issue often complicated by hypertension, which increases risks for death, heart problems, and kidney failure. Lowering blood pressure is known to reduce these risks, but the best drug strategies for controlling blood pressure in CKD patients remain unclear. Researchers believe that patients with CKD and uncontrolled hypertension may have excess fluid, and that using diuretics as a second treatment after standard drugs may help improve outcomes. This trial compares two approaches for managing uncontrolled hypertension in patients with moderate to severe CKD. One group will follow a specific treatment plan using diuretics to adjust blood pressure medication, while the other group will receive usual care based on their clinicians standard methods. The study is an open-label, cluster randomized controlled Phase 3 trial evaluating these strategies over time. Participants will be monitored for up to 36 months to assess key health outcomes including progression to end-stage kidney disease, decline in kidney function, cardiovascular events, and overall mortality. The trial will also track blood pressure changes, medication use, protein levels in urine, and quality of life. Regular assessments will help researchers understand the impact of diuretic-based treatment compared to usual care in this patient population.

Researchers are evaluating the FHK-CK knee prosthesis designed for complex first-time and revision knee replacement surgeries, addressing the growing need due to increasing life expectancy and the widespread use of total knee arthroplasty. This device aims to complement the existing FHK standard prosthesis range, providing surgeons with a versatile and reliable option to improve patient mobility and quality of life. The study is a pilot evaluation focusing on performance and safety with a follow-up period of two years. The study involves implanting the FHK-CK prosthesis, which is a class III medical device not yet CE-marked, along with specialized instruments developed by expert surgeons. The prosthesis is intended for patients with primary or secondary gonarthrosis requiring complex knee arthroplasty or revision surgery after a failed first implant. Surgery will be conducted following established guidelines and specific instructions for the device, with assessments at multiple time points up to 24 months after implantation. Participants will be assessed for functional performance before surgery and at 6 weeks, 6 months, 12 months, and 24 months post-surgery. Additional evaluations include monitoring adverse events, revision rates, device deficiencies, patient and surgeon satisfaction, and quality of life at scheduled intervals. The study also ensures participants can understand and respond to questionnaires, with outcomes tracked over approximately two years to determine the prosthesiss tolerance and overall impact.

This research aims to observe patients with HER2-negative early breast cancer in France who are treated with the drug Olaparib as part of their regular care. The study focuses on understanding how many patients complete the full course of adjuvant Olaparib treatment. It is a national, multicenter, prospective cohort study designed to gather real-world data on this patient group. The study follows patients who begin Olaparib treatment as decided by their doctors. There are no experimental treatments or placebo groups since this is an observational study. Researchers will monitor patients for up to 18 months after they start the Olaparib therapy to gather detailed information about treatment duration and patient characteristics. Participants will be observed throughout their treatment period, with data collected on how long they stay on Olaparib and any relevant medical history or genetic details such as BRCA mutation types. The main outcome measured is the proportion of patients completing the full 18-month treatment. Secondary outcomes include time to treatment discontinuation and variant types. No additional interventions are required, and the study monitors patients progress through their usual clinical visits.