Saint Nazaire

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 studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are evaluating the clinical effectiveness and safety of two antibiotic treatments, amoxicillin alone versus amoxicillin/clavulanate, for community-acquired pneumonia (CAP) in patients aged 65 years or older who are hospitalized in non-intensive care unit (ICU) wards. The study addresses an important public health concern about reducing inappropriate antibiotic use, especially since broad-spectrum antibiotics may cause side effects and contribute to antibiotic resistance. This Phase 3 trial aims to fill the evidence gap on the best antibiotic choice for older adults with CAP by directly comparing these two treatments. Participants will be randomly assigned to receive either intravenous or oral amoxicillin or amoxicillin/clavulanate for five days. The amoxicillin group will take 500 mg capsules three times daily or 1 g intravenously every eight hours. The amoxicillin/clavulanate group will receive two tablets of 500 mg/62.5 mg orally every eight hours or 1 g/200 mg intravenously every eight hours. Both regimens are approved for respiratory infections, and the study will assess clinical outcomes at 30 days after starting treatment to determine if amoxicillin alone is not worse than the combination therapy. During the study, participants will be monitored for clinical signs and safety outcomes up to 30 days after inclusion. Researchers will evaluate the patients' clinical response to treatment and any side effects. The trial involves multiple centers and includes follow-up calls or contacts to ensure adherence and collect necessary data. This study will provide important information to guide future treatment guidelines for older adults hospitalized with CAP.

Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.

Researchers are evaluating the effectiveness and safety of combining pembrolizumab with capecitabine to improve invasive disease-free survival in patients who have triple negative breast cancer (TNBC) and still have residual disease after receiving neoadjuvant chemotherapy that included pembrolizumab. This Phase II study focuses on patients with localized TNBC who did not achieve a complete pathological response after initial treatment. An additional group of patients treated with pembrolizumab alone as standard care will be observed for comparison. Participants in the experimental group will receive pembrolizumab as an intravenous infusion on Day 1 of each cycle for a total of 9 cycles. Capecitabine tablets will be taken orally at a dose of 1250 mg/m² twice daily on days 1 to 14 of each 21-day cycle, for 8 cycles. Dose adjustments of capecitabine may occur during radiotherapy if needed. Local radiotherapy will be given according to standard practice when indicated. The study will also register data from an external cohort treated with pembrolizumab alone after surgery to compare outcomes. During the study, participants will undergo assessments to monitor their health and response to treatment, including laboratory tests and evaluations of organ and bone marrow function. Researchers will track invasive disease-free survival over 2 years as the primary outcome. Safety will be carefully monitored throughout the treatment period. Participants must comply with study visits and procedures, and the total follow-up will include monitoring for at least 2 years to assess long-term treatment effects and disease status.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Small Bowel Obstruction (SBO) often leads to emergency department visits and is usually diagnosed using an abdominal CT scan. Although CT scans help guide treatment decisions such as surgery or medical management, they have drawbacks including radiation exposure, higher costs, and longer emergency department stays. Researchers are evaluating the use of Point of Care Ultrasound (POCUS) combined with a clinical assessment called Gestalt probability to safely rule out SBO in patients with low or moderate risk, potentially reducing the need for CT scans. In this diagnostic multicenter study, trained emergency physicians perform POCUS on patients presenting with suspected SBO who have been assessed as having low or moderate Gestalt clinical probability. The ultrasound looks for signs of SBO in nine abdominal zones using a curvilinear probe. After POCUS, all patients undergo a CT scan, which serves as the gold standard for confirming SBO. The study aims to assess the ability of POCUS to exclude SBO in this patient group, with participation lasting 28 days including follow-up. Participants are involved during their emergency department visit with POCUS and CT imaging, followed by a phone call at 28 days. Researchers collect information on POCUS findings, duration, difficulty, and investigator details, while CT results are interpreted independently. The main outcome measures include the accuracy of POCUS to rule out SBO in patients with low or moderate Gestalt probability, aiming to improve patient care by reducing unnecessary CT scans, radiation exposure, costs, and radiologist workload.

Researchers are investigating a new approach to immunotherapy duration for patients with metastatic non-small cell lung cancer (NSCLC). This phase II-III randomized trial focuses on patients with stage IV NSCLC who have not received prior treatment for advanced disease. The study aims to compare the standard two-year immunotherapy maintenance with a shorter six-month (27-week) treatment period in patients who achieve disease control after initial chemo-immunotherapy induction, addressing the need to optimize treatment duration while maintaining disease control. Participants will first receive a combination of chemotherapy and pembrolizumab as initial treatment: either paclitaxel-carboplatin for squamous cell carcinoma (SCC) patients or pemetrexed-platinum for non-SCC patients, along with pembrolizumab every three weeks. After six months, patients who show disease control without severe toxicity will be randomly assigned to either continue pembrolizumab (with or without pemetrexed for non-SCC) until disease progression or unacceptable toxicity or complete two years of treatment, or to observation (with or without pemetrexed for non-SCC). Throughout the study, participants will undergo regular assessments including imaging to measure tumor response according to RECIST 1.1 criteria. Researchers will monitor overall survival at 18 months in phase II and about 24 months after randomization in phase III. Additional evaluations include performance status, PD-L1 expression, and safety monitoring. The total participation duration includes the initial six-month induction followed by the randomized maintenance or observation phase, allowing comprehensive evaluation of long-term outcomes and treatment impact.

Polymedication in palliative oncology care is a significant public health issue that can increase risks of harmful drug effects, reduce quality of life, and raise healthcare costs. While deprescribing tools have been developed in geriatrics to reduce medication burden, this study focuses on understanding how patients with advanced cancer perceive deprescribing in palliative care. The research aims to explore patients' attitudes and beliefs about deprescribing and to evaluate the reliability of the rPATD questionnaire in this population, alongside an ancillary study investigating the relationship between health literacy and perceptions of deprescribing. The study is a 3-year national, prospective, observational, multicenter project using a mixed-methods design. It begins with a qualitative phase involving semi-directed individual interviews with about 25 patients over 8 months. This is followed by a quantitative phase where 300 patients complete self-administered questionnaires including the rPATD, BMQ (Beliefs about Medicines Questionnaire), and a health literacy questionnaire (FCCHL/HLS14) over 12 months. The questionnaires assess perceptions of treatments, deprescribing, medication beliefs, and health literacy. Participants will be involved through interviews and questionnaire completion. Researchers will analyze patients' perceptions of deprescribing, medication beliefs, and health literacy. The primary outcome is to study patients' perceptions of deprescribing at study inclusion. The study seeks to improve understanding of deprescribing in palliative oncology care to develop tailored approaches that reduce medication burden, improve quality of life, and lower risks of medication-related harm.

Cerebral lesions cause two-thirds of deaths in patients admitted to intensive care after cardiac arrest. Neuroprotective treatments are key in caring for patients with these brain injuries, but they must be based on accurately assessing the severity of brain damage. Early assessment of neurological prognosis at intensive care admission is challenging and not well studied. This research aims to evaluate early biomarker tests to predict brain injury severity in patients resuscitated after cardiac arrest, helping to identify those needing focused neuroprotection and those who might avoid unnecessary treatments. The study is a prospective observational trial involving patients admitted to intensive care after out-of-hospital cardiac arrest who are comatose on arrival. Researchers will measure specific biomarkers, including UCHL-1 and GFAP, at the time of admission to intensive care. These biomarkers will be studied for their ability to predict neurological outcomes. The study does not include any intervention or treatment changes but focuses on collecting and assessing biomarker data early after cardiac arrest. Participants will be closely followed for 90 days after enrollment. Researchers will assess neurological outcomes using the modified Rankin scale at day 90. The study involves collecting clinical data and biomarker levels upon admission, and outcomes will be measured to determine the predictive value of these early tests. Consent will be obtained from a relative or by emergency procedure if no relative is present. The total involvement includes initial biomarker testing and follow-up assessments to evaluate recovery and neurological status.