Saint Nazaire

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.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

Researchers are evaluating two antibiotic treatments for community-acquired pneumonia CAP in patients aged 65 years or older who are hospitalized in non-intensive care unit ICU wards. The study aims to compare the clinical effectiveness and safety of amoxicillin alone versus amoxicillin combined with clavulanate. This trial addresses an important gap in evidence about the best antibiotic choice for older adults with CAP, as current broad-spectrum antibiotic use is debated due to possible side effects and antibiotic resistance concerns. Participants will be randomly assigned to receive either amoxicillin or amoxicillinclavulanate for 5 days. Both medications are approved for treating respiratory infections and can be given orally or intravenously. Amoxicillin is given as 500 mg capsules or 1 g IV every 8 hours, while amoxicillinclavulanate is given as tablets containing 500 mg amoxicillin with 62.5 mg clavulanate or IV vials with 1 g amoxicillin and 200 mg clavulanate every 8 hours. This open-label, non-inferiority trial will compare outcomes at 30 days after treatment begins. During the study, participants will be monitored for clinical responses, cure rates, antibiotic treatment duration, hospital stay length, mortality, and adverse events related to antibiotics. Researchers will also track pneumonia recurrence, ICU transfers, and compliance with treatment. Follow-up assessments include clinical evaluations and laboratory tests up to 30 days after hospital admission. The study will provide important data to guide antibiotic use in older adults with CAP.

Radiotherapy for breast cancer can cause arm lymphedema, which is swelling that may lead to long-term discomfort and affect quality of life. This clinical trial is designed to assess whether an artificial intelligence AI tool that predicts individual risk of arm lymphedema after radiotherapy can help patients and doctors make better treatment decisions. The trial includes women aged 18 or older with breast cancer needing regional lymph node radiotherapy after surgery, regardless of hormone receptor or tumor status. Participants will be randomly assigned to two groups. In the experimental group, patients and physicians will see the AI-predicted risk through a web app that explains risk factors and suggests measures like compression sleeves. In the control group, this risk information will not be shared. Both groups receive the same radiotherapy treatment they would normally have, with no changes to dose or technique. The AI tool is evaluated only for its impact on decision-making and outcomes. Throughout two years, participants will have regular check-ups to track treatment choices, side effects, shoulder movement, breast appearance, quality of life, and the accuracy of the AI tools predictions. Researchers will also monitor how well patients follow recommendations for using compression sleeves, as well as cancer recurrence and survival. Questionnaires and clinical exams will be conducted at baseline, during treatment, and at multiple follow-up points to gather detailed information.

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

Researchers are evaluating the effectiveness and safety of combining pembrolizumab and capecitabine as a post-operative treatment for patients with triple negative breast cancer TNBC who have residual disease after receiving neoadjuvant chemotherapy with pembrolizumab. This Phase II trial aims to measure invasive disease-free survival over two years in this patient group, comparing the investigational treatment to a standard care cohort treated with pembrolizumab alone. Participants in the experimental arm will receive pembrolizumab at a fixed dose of 200 mg intravenously every three weeks for a total of nine cycles during the adjuvant phase. Capecitabine tablets will be taken orally at 1250 mgm twice daily for 14 days followed by 7 days off, repeated for eight cycles, with dose reduction during radiotherapy if needed. Local radiotherapy will be given as per standard practice when indicated. An external cohort receiving standard care pembrolizumab after surgery will be observed for comparison. During the study, participants will undergo assessments to monitor survival outcomes including invasive disease-free survival, overall survival, and distant disease-free survival for up to 3.5 years. Safety will be evaluated by tracking acute and late toxicities throughout the study period. Participants will have laboratory tests, tumor tissue analysis, and clinical examinations as part of their follow-up. The trial runs until August 2028 and includes regular visits and monitoring to evaluate treatment effects and safety.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Small Bowel Obstruction SBO is a common emergency condition diagnosed mainly by abdominal CT scans, which help guide treatment including medical care or surgery. However, CT scans expose patients to radiation, increase costs, and extend emergency department stays. Researchers are evaluating the use of Point of Care Ultrasound POCUS combined with clinical judgment Gestalt probability to safely exclude SBO in patients with low or moderate risk, potentially reducing the need for CT scans. In this observational study, trained emergency physicians will perform POCUS on patients with suspected SBO who have low or moderate Gestalt clinical probability. The ultrasound will look for signs like dilated, fluid-filled intestinal loops in different abdominal zones. After POCUS, all patients will receive a CT scan to confirm SBO presence or absence, serving as the gold standard. The main goal is to assess how well POCUS can rule out SBO in this specific patient group. Participants will be followed for 28 days, with data collected on the accuracy of POCUS compared to CT, time from ultrasound to CT results, and any false positives or negatives. Physicians will also evaluate the ease and usefulness of POCUS. This study aims to show that POCUS can reduce unnecessary CT scans, lowering radiation exposure, costs, emergency department length of stay, and workload for radiologists.

Researchers are studying ways to reduce the duration of immunotherapy treatment in patients with advanced non-small cell lung cancer NSCLC who have their disease controlled after initial treatment. The study focuses on comparing a shorter immunotherapy maintenance period of 6 months to the usual 2 years to see if less treatment can still be effective. This phase II-III randomized study enrolls patients with stage IV NSCLC who have not received prior treatment for advanced disease. Participants will first receive a combination of chemotherapy and pembrolizumab for about 6 months, using specific chemotherapy drugs based on their cancer type. After this induction, patients showing disease control without severe side effects will be randomly assigned to one of two groups continuing pembrolizumab with or without pemetrexed for certain cancer types for up to 2 years or observation with or without pemetrexed. Researchers will monitor various factors including patient characteristics and tumor markers. During the study, participants will attend scheduled visits for treatment and monitoring, including imaging scans to measure tumor response and laboratory tests to check health status. Quality of life and survival will be tracked up to about 24 months after randomization. The study also collects data on side effects and progression-free survival to better understand the benefits and risks of shorter versus longer immunotherapy maintenance.

This research aims to understand patients views on deprescribing medications in palliative cancer care, focusing on the challenges of polymedication that can reduce quality of life and increase healthcare costs. The study also investigates factors influencing patients beliefs about deprescribing and evaluates a questionnaire, the rPATD, to measure these perceptions in this specific population. The study consists of two main parts over three years. First, about 25 patients will participate in individual semi-structured interviews over eight months to gather detailed qualitative data. Then, a larger group of 300 patients will complete self-administered questionnaires, including the rPATD and the BMQ, over twelve months to quantify attitudes toward deprescribing. An additional questionnaire on health literacy will also be given during this second phase. Participants will be involved through interviews and questionnaires assessing their perceptions, beliefs, and literacy related to medication use and deprescribing. The researchers will analyze these responses to identify different patient profiles and factors affecting attitudes toward medication reduction. Outcomes focus on patients perceptions at study entry, measured using validated tools, without treatment interventions. The study is observational and aims to improve deprescribing approaches in palliative oncology care.