Mont De Marsan

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

This research evaluates the clinical and organisational impact of a home-based post-operative monitoring strategy using the MultiSenseae device in elderly patients aged 65 and over who have undergone major surgery. The study involves 80 patients across multiple centers to understand how this device affects care after surgery. Participants will be monitored at home using the MultiSenseae device, which is placed on the patients back and allows doctors to remotely track six biological parameters. The study includes patients scheduled for specific types of surgeries such as colectomy, hepatic laparoscopy, hysterectomy, adnexectomy, parietal surgery, rectal resection, and stoma closure. All participants will receive this monitoring intervention. During the study, participants recovery and care will be assessed through various measures including the percentage of patients with satisfactory care within 7 days, hospital stay length, unplanned rehospitalizations, emergency visits, complications, and quality of recovery up to 30 days after surgery. Patient and healthcare professional satisfaction and device usability will also be evaluated. The total study duration extends up to 30 days post-operation, with some assessments continuing up to 8 months.

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.

Researchers are studying ICU Acquired Weakness by evaluating whether early sitting out of bed in an arm-chair position improves functional recovery in patients who are ventilated in intensive care. This trial compares this early armchair positioning to a conservative strategy of sitting in bed, aiming to clarify if the armchair is essential for improving muscle and functional outcomes, as current guidelines do not strongly recommend this practice. Participants who have been awake with a certain alertness level RASS score between -1 and 1 for over 12 hours are randomly assigned to either daily chair sessions lasting at least 30 minutes or to no chair positioning. The chair sessions continue until ICU discharge or day 28, with careful monitoring of tolerance and a maximum session duration of 4 hours. The study follows patients through their ICU stay to assess recovery. During the study, researchers assess functional levels at ICU discharge or day 28, along with mobility scales, muscle strength scores, length of ICU and hospital stays, ventilator-free days, and mortality rates up to six months. Patients are monitored closely for safety and recovery progress throughout their ICU stay, with data collected to understand the impact of early armchair positioning on their health and function.

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

This research aims to describe how patients aged 18 years or older with moderate to severe atopic dermatitis AD are managed with systemic therapy. It focuses on patients eligible for or currently receiving systemic treatments, following their care under real-world conditions. The study involves French dermatologists experienced in AD management, whether practicing in hospitals or private offices. Treatment decisions are made independently by the physicians and not influenced by the study enrollment. Participants will receive systemic treatments for AD prescribed by their doctors as part of routine care, with no investigational drugs involved. Information will be collected during regular visits according to usual clinical practice. The study will follow patients for one year, tracking their treatments and management without altering standard care. During the year, patients will be assessed at baseline, 6 months, and 12 months. Researchers will collect data on previous and current treatments, treatment adherence, changes in disease severity, itch, sleep disturbance, skin pain, quality of life, psychological health, work absences, and hospitalizations related to AD. This comprehensive follow-up aims to better understand how systemic therapies are used and their impact on patients in everyday clinical settings.

Researchers are evaluating the timing of antibiotic therapy for patients suspected of having non-severe ventilator-associated pneumonia VAP in intensive care units. This study compares immediate antibiotic treatment started right after respiratory sampling with a conservative approach that waits for microbiological confirmation before beginning treatment. Delaying antibiotics may reduce unnecessary use and antibiotic resistance but might risk worse outcomes if infection is present. The study is a randomized controlled trial led by Nantes University Hospital to better understand these strategies in patients without severe symptoms like septic shock or severe respiratory distress. The trial has two groups the immediate strategy group receives empiric antibiotics within one hour after randomization based on clinical judgment and local protocols. If respiratory samples later test negative, antibiotics are stopped if positive, targeted therapy continues for seven days. The conservative strategy group does not start antibiotics until respiratory sample cultures or PCR results confirm infection. If confirmed, appropriate antibiotics are administered for seven days without waiting for susceptibility testing. Both approaches focus on managing suspected VAP to balance timely treatment and antibiotic stewardship. Participants will be monitored from day 0 to day 28, with assessments including mortality and mechanical ventilation status at day 28 as the main outcome. Additional evaluations cover organ failure scores, lung infection scores, duration of ventilation, use of supportive therapies, hospital and ICU stay lengths, infection incidence, antibiotic use, and cost-utility analysis up to day 90. The study involves informed consent, respiratory sampling within two hours of suspicion, and excludes patients with severe VAP or significant immunosuppression. This comprehensive follow-up aims to clarify the impact of antibiotic timing on patient outcomes and antibiotic resistance in ICU settings.

Researchers are investigating the best noninvasive respiratory support method for patients in intensive care units ICUs who develop respiratory failure after planned removal of their breathing tube extubation. This condition affects about 20% of ICU patients, and many require reintubation, which is linked to high mortality rates. The study aims to compare whether alternating non-invasive ventilation NIV with high-flow nasal oxygen reduces death rates compared to high-flow nasal oxygen alone in these patients. The trial is a multicenter, randomized, controlled study where patients with post-extubation respiratory failure are assigned to one of two groups. One group receives continuous high-flow nasal oxygen treatment for 48 hours, while the other group receives NIV alternating with high-flow nasal oxygen during the same period. NIV involves pressure-support breathing with specific settings to help patients breathe, and the study ensures balance in patient groups based on carbon dioxide levels in the blood. Participants will be closely monitored with assessments including timing of death, reintubation events, days without ventilator use, length of ICU and hospital stay, and mortality at different time points up to 90 days. The main outcome measured is death rate 28 days after respiratory failure onset. The study includes clinical evaluations and blood gas tests to guide treatments and decisions. Participation duration includes the initial 48-hour treatment period and follow-up assessments extending to 90 days.

Kidney cancer accounts for 2 to 3% of solid cancers in adults, with over 431,000 cases diagnosed worldwide each year. In France alone, around 13,500 patients undergo total or partial nephrectomy annually. Advances in minimally invasive surgery and enhanced recovery after surgery RAAC programs have shortened hospital stays, but these changes can disrupt patient care quality and follow-up. This research evaluates the use of the UroConnect remote monitoring device to improve patient support and nursing coordination in the perioperative care pathway for kidney tumor surgery. The study compares two groups one receiving standard care without digital follow-up tools, and another using the UroConnect device. UroConnect offers a patient interface for self-questionnaires and educational materials, plus a caregiver interface to help nurses coordinate perioperative care more efficiently. The purpose is to formalize a nurse coordinator role tailored for oncological surgery and to implement tools supporting this role across several French centers. Participants will be monitored for 30 days after surgery, with assessments including unscheduled care use, patient anxiety, satisfaction, reasons for seeking care, and hospital stay length. Longer-term evaluations at 24 months will review device usage, nursing coordination activities, cost analyses, and qualitative feedback. The study aims to better understand how digital coordination affects patients, caregivers, and the healthcare system, with total participation spanning at least two years.

Researchers are investigating the preventive effect of clopidogrel on the development of systemic sclerosis SSc, a severe autoimmune disease involving immune dysfunction, blood vessel damage, and tissue scarring. The study focuses on people with Raynaud phenomenon and specific SSc-related autoantibodies, who are at risk of developing full systemic sclerosis. This Phase IIIII trial aims to assess whether early platelet activation control can reduce disease progression. Participants will be randomly assigned to receive either clopidogrel 75 mg daily or a placebo for two years in a double-blind manner. The study will include a 24-month treatment period followed by a 36-month follow-up, totaling five years. Clopidogrel targets platelet activation, which lab and animal studies suggest plays a key role in SSc-related fibrosis. Throughout the study, participants will have clinical exams, blood tests, and patient-reported outcome assessments every six months. Researchers will measure the frequency of SSc development after five years according to established criteria, along with skin fibrosis, hand function, and antibody presence. The trial also monitors disease features and safety over the entire 60-month period.