Libourne

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 evaluating the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

Researchers are studying Philadelphia-negative myeloproliferative neoplasms (MPN), which include Polycythemia Vera (PV), essential thrombocythemia (ET), and prefibrotic myelofibrosis (PreMF). These chronic blood cancers involve specific mutations like JAK2V617F and carry a high risk of blood clots that can cause serious health problems. Current treatments include low-dose aspirin to reduce arterial clots, but patients still face risks of thrombosis and bleeding. This trial explores whether direct oral anticoagulants (DOACs), such as Apixaban or Rivaroxaban, might better prevent these clotting events in patients with the JAK2V617F mutation. Participants will be randomly assigned to receive either a DOAC (Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once daily) or low-dose aspirin (100 mg once daily). The study focuses on high-risk MPN patients with JAK2V617F mutation and will compare the effectiveness and safety of DOACs versus aspirin for preventing blood clots. Treatment will continue with close monitoring throughout the study. During the study, researchers will track the time until any arterial or venous blood clots occur over a 24-month follow-up period. Participants will undergo regular assessments to monitor clotting events, bleeding risks, and overall health. The trial aims to gather detailed information on how well these treatments prevent thrombosis and their safety profiles, helping to guide future care for patients with these blood disorders.

Myeloproliferative Neoplasms (MPN) are blood cancers linked with a higher risk of blood clots, involving platelets, red blood cells, white blood cells, and blood vessel cells. Some studies have looked at the JAK2V617F gene mutation in white blood cells to predict clot risk, but results have been mixed. This research aims to study the amount of this mutation in different blood cell types and blood vessel cells to find patterns that may relate to clot risk in MPN patients. The study will include 120 patients with polycythemia vera (PV) or essential thrombocythemia (ET) who have the JAK2V617F mutation. Blood samples will be taken to isolate platelets, red blood cells, granulocytes, and endothelial cells. The mutation level will be measured in these cells using digital PCR technology. Researchers will explore how these patterns connect to clot history at diagnosis, MPN type, clot risk scores, and clot types. Participants will undergo a special blood draw alongside routine tests. The study will analyze the mutation levels in different cells and their association with clot risk and disease characteristics. The main measurement is the history of thrombosis when the disease is diagnosed. Safety and consent procedures are followed, and patients will be included at diagnosis or within one year without prior cytoreductive treatment, with consent and registry inclusion.

This research aims to develop and evaluate a new 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 patient's hospital stay and quality of life. Currently, there are no specific oral assessment tools tailored for these patients, making this new tool necessary to improve care and monitoring. The study involves using the newly developed Mouth Assessment Tool (MAT), which will be applied by nurses to assess the oral condition of patients undergoing oro-tracheal intubation in intensive care. This tool has been designed with input from experts in intensive care, oral health, hygiene, wound healing, and patient partners to ensure relevance and accuracy for daily clinical use. The evaluation focuses on the tool's metrological performance, meaning its accuracy and reliability in assessing oral health in this specific patient group. Participants will be assessed at inclusion (Day 0) using the MAT by a nurse. Researchers will monitor and evaluate the tool's effectiveness in measuring oral health status accurately. The study includes patients aged 18 or older who are intubated and admitted to adult intensive care units. Consent is obtained from patients or their legal representatives. The study aims to ensure that this new tool can support better oral care and potentially improve patient outcomes in intensive care settings.

Researchers are evaluating the effectiveness of 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 significant impact of such pain on quality of life and treatment adherence, exploring whether adding a therapeutic education program in postural yoga can help patients manage their pain and improve self-efficacy. The study also aims to analyze changes in inflammation-related cytokines before and after treatment to understand yoga's potential biological effects. Participants in the study are divided into two groups: one group receives a physical therapy-yoga educational program involving daily 15-minute yoga sessions at home using a guide and audio instructions for 12 weeks, plus one 90-minute weekly yoga-therapeutic education session led by a trained physical therapist during the first 6 weeks. The other group serves as a control and does not receive any yoga sessions or therapeutic education. This randomized, open-label, controlled trial builds on a promising pilot study and is conducted across multiple centers. Throughout the 12-week study period, participants' pain levels and quality of life are monitored, along with assessments of fatigue and self-efficacy. Researchers will evaluate the primary outcome of pain reduction and examine biological markers by measuring cytokine levels at the start and end of the program. Patients' adherence to the home yoga practice is supported by educational materials, and safety and treatment effects are carefully observed to understand the benefits and feasibility of this approach in breast cancer patients experiencing hormone therapy-related pain.

Researchers are investigating the best way to manage fever in patients with septic shock, a severe condition characterized by infection leading to organ failure and requiring mechanical ventilation. The study compares two fever management strategies: allowing fever to run its course versus controlling fever to maintain normal body temperature using external cooling. This trial follows a prior pilot study that suggested fever control might improve shock resolution and organ function, but its effect on mortality is still unclear. Participants will be randomly assigned to either respect fever or receive external cooling to maintain normothermia for 48 hours. The study uses an adaptive randomization method to balance groups and includes a subgroup of patients with acute respiratory distress syndrome (ARDS). Safety will be monitored closely by an independent committee, which may stop the trial if one strategy shows harm. An interim analysis will assess if fever control benefits patients with ARDS and guide continuation of the trial. Patients involved will be adults with septic shock, fever above 38.3°C, requiring invasive mechanical ventilation and sedation. Researchers will monitor mortality up to 60 days after randomization as the primary outcome. The study includes ongoing infection treatment and close safety monitoring. Participation involves observing the effects of fever management on survival and organ function over the study period.

This research focuses on patients with oral cavity cancer who have undergone reconstructive surgery involving a flap. The study aims to compare two types of post-operative radiotherapy to assess the possibility of sparing the surgical flap from radiation. The goal is to reduce treatment-related toxicity while maintaining effective local control of the cancer. This is a randomized Phase III trial evaluating feasibility and outcomes. Participants will be assigned to one of two groups: the experimental group receiving post-operative radiotherapy that spares the surgical flap, and the control group receiving standard post-operative radiotherapy without flap sparing, which is the current practice. Radiotherapy is delivered using intensity-modulated radiation therapy (IMRT) with photons or proton therapy (IMPT). Concomitant chemotherapy is allowed and considered as a stratification factor. Throughout the study, participants will be monitored for loco-regional control of the cancer two years after completing radiotherapy. Researchers will assess how well the cancer is controlled locally while evaluating the safety and side effects of sparing the flap during radiotherapy. The study involves informed consent and includes assessments related to treatment adherence, toxicity, and cancer control outcomes.

This research aims to analyze the use of Glofitamab in patients with relapsed or refractory Large B-cell Lymphoma (DLBCL) treated under the Expanded Access Programme (EAP) in France. The study focuses on evaluating the effectiveness and safety of Glofitamab in a real-world setting, including a subgroup of patients previously treated with chimeric antigen receptor T-cell therapy (CAR-T). The goal is to confirm reported response rates and to determine the best timing for starting Glofitamab treatment. Participants in this study received Glofitamab as a treatment for DLBCL, with prior pretreatment using Obinutuzumab. The study involves retrospective analysis of patients who enrolled in the French Glofitamab EAP before November 1, 2024, and who have received at least one infusion of Glofitamab. No additional interventions or treatment arms are described, as the study reviews data from real-world use. During the study, researchers will assess the best complete response rate (CRR) to Glofitamab treatment over a six-month period using the Lugano 2014 criteria. The analysis includes a median follow-up of more than nine months to monitor treatment outcomes and safety. Participants' data will be collected only if they have consented or did not oppose their data use for this study.

Researchers are studying the use of Hizentra®, a subcutaneous immunoglobulin treatment, in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a rare autoimmune neurological disorder. The study aims to understand how patients switch from intravenous immunoglobulin (IVIg) treatments to subcutaneous immunoglobulin (SCIg) like Hizentra® in real-life settings. The study also evaluates the tolerability and effectiveness of Hizentra® using patient-reported outcomes collected through a mobile application. This is a national, prospective, non-interventional study conducted over an estimated 36 months, including a 24-month enrollment period and a 12-month follow-up. Participants will receive Hizentra®, which is administered as a subcutaneous injection solution. The study focuses on patients who are planned to switch from IVIg to Hizentra® and have been stable on their treatment for at least three months. The approach allows for treatment to be administered outside of specialist centers. Researchers will observe and document how patients use Hizentra® in everyday practice without changing the usual care. No additional experimental treatments are given as this is a non-interventional study. During the study, participants will use a patient application to report on their treatment experience, including tolerability and efficacy. The main outcome measured is the length of time the treatment continues, up to 12 months. The study monitors patient health and treatment adherence during this period to provide real-world data on Hizentra® use. Participants must have access to a smartphone, tablet, or computer to use the application. Overall, the study aims to gather comprehensive information about switching treatments and managing CIDP with Hizentra® in daily life.