Melun

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.

This research aims to find out how common cardiac amyloidosis is among older adults aged 80 years and above who have been hospitalized for heart failure and show thickening of the hearts left ventricle. The study is observational and conducted across multiple geriatric and cardiology centers. It focuses on patients who have experienced heart failure with specific heart muscle changes seen on echocardiography. Participants will be recruited over 24 months and followed for 12 months. At the start, researchers will collect medical history, demographic information, clinical data, frailty status, biological and genetic tests, and echocardiogram results. Bone scans using specific tracers will be performed during or after hospital stays to check for heart muscle involvement. Follow-up will include phone calls every three months to track hospitalizations, care facility admissions, and survival. During the study, participants will have regular assessments including frailty scales, cognitive tests, and questionnaires related to neuropathic pain and independence in daily activities. Researchers will evaluate bone scan results to detect amyloidosis and measure other health and functional outcomes. The study aims to provide a clearer picture of cardiac amyloidosis prevalence and patient condition over one year.

Researchers are studying anticoagulation methods for the extracorporeal circuit ECC used during Renal Replacement Therapy RRT in patients with acute kidney injury. The study compares two approaches regional citrate anticoagulation RCA, which uses citrate infusion to reduce ionized calcium and prevent clotting, and a citrate-free method that lowers ionized calcium through a calcium-free dialysate and hemofilter performance. This comparison aims to assess the efficiency and safety of avoiding citrate infusion, which can cause metabolic side effects. Participants will undergo intermittent RRT using Sustained Low-Efficiency Dialysis SLED with two treatment periods in a crossover design. One period involves regional anticoagulation using citrate-free decalcification, and the other uses regional citrate anticoagulation with 4% citrate infusion. The order of treatments is randomized, allowing each participant to receive both interventions sequentially. During each RRT session, researchers will measure plasma urea levels over 8 hours and monitor concentrations of ionized calcium and magnesium at specified intervals. Heart rate and blood pressure will be recorded frequently throughout the sessions. Additionally, occurrences of circuit losses and catheter thrombosis will be tracked. These evaluations help compare the anticoagulation methods effectiveness and safety over the study period, which concludes in November 2025.

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 evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in hospitalized adults with severe community-acquired pneumonia sCAP who require invasive mechanical ventilation IMV. This phase III, randomized, placebo-controlled, double-blind study aims to compare trimodulin plus standard care against placebo plus standard care. The study also investigates detailed pharmacokinetic and pharmacodynamic properties of trimodulin. Participants will be randomly assigned to receive either trimodulin a human immunoglobulin solution containing IgM, IgA, and IgG or a placebo human albumin 1% via intravenous infusion once daily for five consecutive days alongside standard care. After treatment, participants will enter a follow-up phase lasting up to 23 days, including an end-of-follow-up visit or phone call on day 29. If still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a closing visit or call around day 91. During the study, participants undergo various assessments including monitoring of mortality rates up to 28 and 90 days, changes in organ failure scores, clinical cure of pneumonia, ventilator and oxygen use, ICU and hospital stay durations, readmission rates, adverse events, lab tests, electrocardiograms, and vital signs. Safety evaluations and outcome measurements occur throughout treatment and follow-up, with total participation lasting up to approximately 90 days.

Researchers are evaluating the effectiveness of cotrimoxazole compared to standard antibiotic therapy for treating ventilator-associated pneumonia VAP caused by Enterobacteriaceae in adult patients in intensive care units ICU. This multicenter randomized trial aims to determine if cotrimoxazole is not inferior to the best standard care in terms of survival 28 days after treatment begins. Patients with confirmed VAP and susceptibility to cotrimoxazole are included, with specific attention to those with or without septic shock and COVID-19 pneumonia. Participants are randomly assigned to receive either cotrimoxazole or standard antibiotic treatment, such as beta-lactams or fluoroquinolones, for a total of 7 days including initial empiric treatment. The antibiotic dosing and administration are adjusted based on current ICU recommendations. The treatment period can last up to 28 days or until death or ICU discharge if earlier. The study is not blinded due to variable therapies in the control group. During the study, patients are monitored daily until death, ICU discharge, or day 28 for vital signs, antibiotic use, new infections, and Clostridium difficile infection. Clinical and radiological evaluations occur at day 7, and weekly screening for multidrug-resistant bacteria is performed. Survival status is followed up to 90 days through phone or hospital interview. An independent committee reviews clinical and radiological outcomes without knowledge of treatment assignment to ensure unbiased assessment.

Researchers are investigating the use of high-dose intravenous vitamin C combined with thiamine vitamin B1 to manage post-cardiac arrest shock in patients admitted to intensive care units after out-of-hospital cardiac arrest. This condition often leads to cardiac and circulatory failure, causing multi-organ failure and early death in a significant portion of patients. The study is a phase II, multicenter, randomized controlled trial comparing standard care with the addition of high-dose vitamin C and thiamine to assess potential benefits on shock recovery and neurological outcomes. Participants are randomly assigned to one of two groups the control group receiving standard post-cardiac arrest care according to international guidelines, and the experimental group receiving standard care plus high-dose intravenous vitamin C at 50 mgkg every 6 hours for 3 days, starting within an hour after randomization, along with intravenous thiamine 200 mg twice daily for 3 days. From day 4 onwards, standard vitamin C supplementation up to 1000 mg daily and thiamine are allowed in both groups. During the 28-day participation period, patients will be closely monitored for recovery from shock, neurological function, and organ failure. Assessments include measuring the time to stop vasopressors by day 3, survival rates related to shock by day 7, neurological status at day 28, maximum vasopressor doses within 3 days, changes in organ failure scores, and arterial lactate levels. Safety and effectiveness data will be collected throughout to evaluate the impact of the vitamin C and thiamine treatment alongside standard care.

Researchers are evaluating the impact of a temporary accommodation program called HTSH on elderly patients length of stay in hospital services. This observational, multicenter study involves elderly patients discharged from hospitals in the Ile-de-France region who require short-term accommodation in nursing homes or long-term care units. The study aims to assess how this program supports medical and social care and influences decisions about returning home after hospitalization. The study includes a prospective group of 258 subjects and a retrospective group using data from 2021 and 2022. Temporary accommodation beds are provided in dedicated units with specialized staff, physically grouped within establishments supported by the Regional Health Agency. The study compares hospital stay lengths before and after the programs implementation to evaluate its efficiency. Participants will be observed over 24 months with data collected on hospital stay length, patient pathways, profiles, discharge outcomes, quality of life, and caregiver benefits. Medical records and social evaluations are reviewed, and caregivers and professionals involved in the HTSH circuit may also participate. This non-interventional study monitors outcomes without changing usual care, with no specified maximum age and no healthy volunteers included.

This research aims to learn about how well patients hospitalized at Melun Hospital know their own vaccination status and their attitudes towards vaccination. It focuses on understanding the rate of vaccination knowledge among these patients, their willingness to update vaccinations, and how factors like gender, job, having a regular doctor, or chronic illness may influence vaccination status. This is an observational study conducted during the national European Vaccination Week in France. Participants are randomly selected from ten different hospital departments, including internal medicine, infectious diseases, surgery, cardiology, and geriatrics, among others. During hospitalization, patients complete a questionnaire designed by the hospitals Public Health Unit and Hygiene Operational Team. The study does not involve any treatments but gathers information about patients vaccination knowledge and attitudes. Participants will complete the questionnaire during their hospital stay. Researchers will measure how many patients know their vaccination status and how many want to update it. They will also assess the impact of gender, occupation, having a treating physician, and chronic illness on vaccination knowledge. The studys main evaluation happens on the first day of questionnaire completion. The total participation involves only this one-time questionnaire during hospitalization.

Older adults face a high risk of acute respiratory infections, which lead to hospitalization, death, and loss of independence globally. Reduced immune function with age and environmental exposures increase vulnerability and lower vaccine effectiveness. This international study evaluates the impact of hospitalizations caused by respiratory viruses such as influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus on loss of autonomy in people aged 60 and older to guide better prevention and vaccination approaches. The study observes individuals hospitalized with confirmed infections from these respiratory viruses. There are no experimental treatments instead, researchers monitor the patients over time to assess changes in their ability to perform daily activities. Functional dependency is measured at hospital admission, discharge, and at 3 and 6 months after discharge. The study also tracks health outcomes like medical complications, length of hospital stay, ICU admission, readmissions, new medications, and living situation changes. Participants will undergo evaluations of their daily living skills using standardized scores at multiple time points during and after hospitalization. Data on demographics, vaccination status, and comorbidities are collected at baseline. Follow-up phone assessments at 3 and 6 months help capture recovery and long-term effects. The study aims to deepen understanding of how respiratory infections affect older adults independence and support strategies for healthier aging.