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 studying real-world patient characteristics, treatment patterns, and both short- and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM across the United States and Europe. The study focuses on patients receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or prior treatment failure. The U.S. portion evaluates the safety of mavacamten in this setting, while the European part assesses both its effectiveness and safety. Participants receive treatments as part of standard care, either mavacamten or other medications such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide. Treatments are prescribed by physicians according to routine clinical management. The study observes outcomes over time without altering prescribed care. During the study, participants are monitored for changes in heart function, symptoms, and adverse events through clinical assessments including echocardiography and patient-reported questionnaires. Researchers evaluate heart failure events, heart function measures like left ventricular outflow tract gradient and ejection fraction, arrhythmias, hospitalizations, mortality, and quality of life scores. Data is collected at baseline and followed for up to five years to understand real-world treatment effects and safety.

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 evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

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 significant global health concern, with hypertension being the leading risk factor for death, cardiovascular problems, and progression to end-stage kidney disease in these patients. Lowering blood pressure is known to reduce these risks, but the best second-line treatment after initial therapy with ACE inhibitors or angiotensin receptor blockers ARBs is unclear. This study aims to compare a diuretic-based blood pressure lowering approach to usual care in patients with moderate to severe CKD and uncontrolled hypertension. Participants are assigned to one of two groups one group receives blood pressure management guided by a diuretic-based algorithm, while the other group follows the usual care provided by their clinicians, which may include pharmacological or non-pharmacological therapies. The study is a randomized, open-label, phase 3 trial using a parallel design. Treatment adjustments are made according to the assigned strategy, and the study will continue for up to 36 months to observe outcomes. During the study, participants will be monitored for kidney function decline, cardiovascular events, all-cause mortality, and blood pressure control. Researchers will assess changes in kidney filtration rate, proteinuria, diuretic use, and quality of life over time. Regular evaluations will include blood pressure measurements and other clinical assessments to track the effectiveness of the treatment strategies. The total participation time can last up to three years, with ongoing monitoring of health outcomes throughout this period.

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 in France with HER2-negative early breast cancer who are treated with olaparib, a medication chosen by their doctors. The study focuses on understanding how often patients complete the full course of olaparib treatment and gathers information on related genetic factors and medical history. It is a national, multicenter, prospective observational study without experimental treatment assignment. Participants in this study receive adjuvant olaparib treatment as part of their usual care under their physicians discretion. The study does not assign treatments but follows patients who start olaparib, tracking their treatment progress for up to 18 months after inclusion. There are no additional interventions or placebo groups. Throughout the study, researchers collect data on treatment completion rates, types of BRCA mutations, variant types, medical history, and the time until olaparib treatment stops. Participation involves observational follow-up, with no extra treatment visits beyond routine care. The overall participation lasts 18 months after a patients enrollment, focusing on real-world treatment experiences and outcomes.