Libourne

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 the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

Myeloproliferative Neoplasms MPN are blood cancers linked to a higher risk of blood clots. This research focuses on understanding how the presence of a genetic mutation called JAK2V617F in different blood cell types and endothelial cells relates to the risk of developing these clots. Researchers aim to identify specific patterns of this mutation in various cell populations that might help predict which patients are at higher risk for thrombosis. The study involves 120 patients diagnosed with either Polycythemia Vera PV or Essential Thrombocythemia ET. Blood samples will be collected to isolate platelets, red blood cells, granulocytes, and endothelial cells. Using digital PCR technology, the level of the JAK2V617F mutation will be measured in these cells. Patients with or without a history of thrombosis and different types of thrombosis will be compared to identify any associations with the mutation profiles. Participants will be involved at the time of diagnosis or within one year of diagnosis before starting cytoreductive treatment. Researchers will evaluate the mutation level in different blood cells and endothelial cells, assess the type of MPN, and measure the risk score for thrombosis. The main outcome is the history of thrombosis at diagnosis. This observational study does not involve treatment but collects blood samples and clinical data to better understand thrombosis risks in MPN patients.

This research aims to evaluate a newly developed tool designed to assess the condition of the oral cavity in adult patients who are orally intubated in intensive care units. Oro-tracheal intubation often causes lesions in the mouth and throat, which can affect the patients hospital stay and quality of life. Currently, no assessment tools are specifically adapted for these intubated patients, highlighting the need for a specialized evaluation method. The study involves using the new Mouth Assessment Tool MAT by nurses to evaluate the oral condition of adults undergoing oro-tracheal intubation in intensive care. This tool has been created with input from experts in intensive care, oral health, hygiene, wound healing, and patient partners to ensure relevance and usability in daily nursing practice. The study will assess the tools metrological performance, content validity, construct validity, and reliability at the time of patient inclusion. Participants will be adults in intensive care who are orally intubated. Nurses will use the MAT to assess oral health at inclusion Day 0. Researchers will monitor how well the tool measures oral condition, its validity, and consistency. The study will evaluate the tools ability to support better mouth care protocols and improve patient outcomes by providing accurate assessments. The trial is observational and will continue until October 2028.

Researchers are evaluating a combined physical therapy and yoga program with patient education to reduce osteoarticular and musculoskeletal pain caused by hormone therapy in women treated for breast cancer. This study addresses the common side effects of hormone therapy that affect quality of life and treatment adherence. The research also aims to examine changes in inflammatory markers to understand yogas potential impact on inflammation. Participants in the experimental group will attend one 90-minute yoga-therapeutic education session weekly for six weeks, led by a trained physical therapist. They will also practice daily 15-minute yoga sessions at home using guided audio tools for a total of 12 weeks. The control group will receive standard care without yoga sessions during the study but will be offered the program afterward. During the 12-week study, participants will undergo assessments of pain levels, compliance with the yoga program, physical flexibility, respiratory capacity, quality of life, fatigue, anxiety, depression, and self-competence. Researchers will track hormone therapy adherence and measure inflammatory biomarkers. These evaluations aim to determine if the combined intervention improves symptoms and overall well-being compared to standard care.

Researchers are investigating the best way to manage fever in patients with septic shock, a severe condition caused by infection leading to organ failure and requiring mechanical ventilation. This study compares two fever management strategies allowing fever to run its course or controlling fever to maintain normal body temperature using external cooling. The trial aims to determine which approach better improves survival by looking at death rates 60 days after treatment starts. Participants will be randomly assigned to one of two groups one group will receive external cooling to keep their body temperature normal for 48 hours, while the other group will have their fever left untreated without antipyretic therapy. The study uses a special randomization method to ensure groups are comparable and includes a subgroup of patients with lung injury. Safety is closely monitored by an independent committee that can stop the study if needed. During the trial, patients will be monitored for various health outcomes including organ function, need for ventilator support, kidney therapy, and blood pressure support over specific time points. Researchers will also track side effects such as shivering, seizures, low body temperature, heart rhythm problems, infections, and development of lung or kidney complications. The total study duration includes follow-up to assess these outcomes and safety events up to 60 days after randomization.

This trial involves patients with oral cavity cancer who have undergone reconstructive surgery using a flap. It aims to evaluate whether sparing the surgical flap during post-operative radiotherapy can reduce treatment toxicity while still maintaining local disease control. The study is a randomized Phase III trial comparing two radiotherapy approaches. Participants are assigned to one of two groups the experimental group receives post-operative radiotherapy that spares the surgical flap, while the control group receives standard post-operative radiotherapy without flap sparing. Radiotherapy is delivered using intensity-modulated radiation therapy IMRT with photons or proton therapy IMPT. The goal is to assess the feasibility and impact of flap-sparing radiotherapy versus current standard practice. During the study, participants will be monitored for local-regional cancer control up to two years after radiotherapy. Researchers will also evaluate the occurrence of acute and late ear, nose, and throat ENT toxicities within 12 months following treatment. Participants must have performance status 0-2 and be candidates for post-operative radiotherapy. The total study duration extends through treatment and follow-up, with safety and disease control assessments conducted throughout.

Researchers are analyzing the real-world experience of patients treated with Glofitamab for relapsed or refractory large B-cell lymphoma DLBCL. This observational study focuses on patients who participated in the French Expanded Access Programme EAP, with more than 300 treated patients and a median follow-up expected to exceed nine months. The study particularly aims to confirm the response rates of Glofitamab in patients who have previously received CAR-T therapy and to determine the best timing to start the treatment. The study includes patients who received at least one infusion of Glofitamab following pretreatment with Obinutuzumab as part of the Early Phase Access program. The treatment details are collected retrospectively from patients enrolled before November 1, 2024. The primary outcome being assessed is the best complete response rate during treatment, based on investigator evaluation using Lugano 2014 criteria at six months. Participants data will be reviewed to measure treatment effectiveness and safety, including complete metabolic response rates, progression-free survival, event-free survival, overall survival, rates of immune-related side effects like neurotoxicity and cytokine release syndrome, ICU admissions, and hospitalization events over six months. This analysis helps to better understand Glofitamabs performance in a large real-world patient group, with continued monitoring of outcomes and adverse events during the follow-up period.

This research aims to understand how Hizentra, a subcutaneous immunoglobulin treatment, is used in the care of adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP, a rare autoimmune neurological disorder. The study focuses on the process and effects of switching patients from intravenous immunoglobulin IVIg to subcutaneous immunoglobulin SCIg therapy, exploring real-life conditions, tolerability, and treatment effectiveness using patient-reported outcomes. This observational study is sponsored by CSL Behring and is conducted across multiple centers nationally. Participants will be monitored over a 36-month period, including a 24-month enrollment phase and a 12-month follow-up. Treatment involves switching from IVIg to Hizentra, a subcutaneous injection solution, with no active intervention by researchers. The study tracks the timing, dosage, administration frequency, and methods of Hizentra use in everyday practice, including self-administration or assistance by a nurse. During the study, participants will use a patient application to report outcomes related to treatment tolerance and efficacy. Researchers will collect data on disability scales, walking tests, quality of life scores, and medication dosing details at regular intervals throughout the 12-month follow-up. The main outcome measured is the length of time participants continue treatment with Hizentra. Safety and treatment effects will be monitored without altering participants usual care.