La Celle Sous Gouzon

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease CKD and proteinuria, a condition where the kidneys leak protein into the urine. This study aims to evaluate the long-term safety of finerenone when added to standard treatments called ACE inhibitors or angiotensin receptor blockers ARBs, which are commonly used to control blood pressure and protect kidney function. The research also seeks to understand how well finerenone can reduce protein levels in urine and support kidney health over time. Participants will receive finerenone in doses adjusted by age and body weight, taken orally for up to 18 months alongside their usual ACEI or ARB treatment. The study includes patients who previously took part in a related trial and will follow them for about 19 months, including a one-month follow-up after treatment ends. The research involves one group receiving finerenone openly without placebo or comparison groups. During the study, participants will attend at least 8 to 12 visits depending on their treatment start status. At these visits, doctors will measure vital signs like blood pressure, heart rate, weight, and height perform physical exams collect blood and urine samples to monitor kidney function and protein levels and conduct heart tests using electrocardiograms and echocardiography. Participants and their caregivers will also answer questions about medication use, side effects, and overall well-being. Safety will be closely monitored by tracking any medical problems that arise during the trial.

Researchers are investigating the mental workload impact of new lower limb prosthetic systems in people with above-knee amputations. This observational study aims to understand how different prosthetic technologies affect users, both in laboratory settings and daily life, by measuring mental workload and related functional outcomes. Participants use above-knee prostheses with prosthetic knees and feet and are assessed using various scales and tests over an 8-week period. The study collects data on goal achievement, walking tests, balance confidence, prosthesis satisfaction, and incidents of stumbles or falls to evaluate prosthetic system impact. Throughout the study, participants will undergo evaluations at the start, 4 weeks, and 8 weeks, including functional walking tests and questionnaires. A smartphone is required for participation to help design therapeutic goals and track progress. The study follows participants for 8 weeks, monitoring outcomes like the Goal Attainment Scale as the primary measure of success.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Venous leg ulcers are the final stage of chronic venous disease caused by advanced chronic venous insufficiency. These ulcers affect the quality of life of patients and are more common in older adults, with prevalence increasing with age. Managing chronic ulcers involves several care procedures, including debridement, which can be painful and only slightly relieved by pre-treatment analgesics. Music therapy, especially the standardized U-shaped method, has shown effectiveness in reducing pain and anxiety in various medical areas but has not yet been studied during debridement care for leg ulcers. This trial evaluates the use of musicotherapy alongside classic debridement care and usual analgesic treatment to reduce pain during leg ulcer care. Participants in the experimental group will receive a musicotherapy session using the Music Care application with headphones, starting 10 minutes before debridement, continuing during the procedure up to 40 minutes, and ending 10 minutes after. The control group will receive standard debridement and analgesic care without musicotherapy. Participants will be assessed for pain management effectiveness using the U-shaped musicotherapy method over an 18-month period. Researchers will measure pain levels, analgesic consumption, anxiety variations, blood pressure, and heart rate before and after debridement. The study is randomized, controlled, and open-label, aiming to provide data on musicotherapys role in pain and anxiety relief during chronic wound care.

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 studying moderate to severe traumatic brain injury TBI complicated by subarachnoid hemorrhage SAH, focusing on the occurrence and evolution of cerebral vasospasm CV with clinical impact. CV is well described in aneurysmal SAH but less understood in traumatic cases, despite its potential impact on patient outcomes. This study aims to better define the incidence and characteristics of CV in this population at Martinique University Hospital using advanced imaging techniques. The study involves hospitalized patients with moderate or severe TBI Glasgow Score 13 and traumatic SAH seen on initial brain CT scan. Patients will receive routine clinical monitoring including daily transcranial Doppler TCD and biological assessments. If neurological deterioration or increased intracranial pressure occurs between days 3 and 12, a cerebral CT scan with an additional brain perfusion sequence will be performed to diagnose CV. Treatment to improve cerebral perfusion and manage intracranial pressure will continue as per standard care. Participants will be closely monitored during hospitalization with clinical exams, imaging, and neurological assessments. The study will estimate the incidence of CV with clinical impact over 42 months and describe its characteristics and risk factors. Neurological outcomes will be compared at 30 days and 6 months, with quality of life also assessed. Informed consent will be obtained from patients or their representatives, and data collection will include multiple follow-up points to understand CVs effect on recovery and prognosis.

Researchers are conducting an observational study to assess the performance and safety of OROSEDAL, an oral spray medical device, in children and adults with sore throat or minor oral lesions such as minor aphthous ulcers and oral lichen planus. This study takes place in real-life general practice settings and includes patients aged 8 years and older who have had symptoms for less than 15 days and significant pain levels. The goal is to gather real-world information on how OROSEDAL is used and its effects on pain and discomfort. Participants are those who have been prescribed OROSEDAL independently of the study. They will use the product as directed, and data will be collected at the start, daily through self-assessment diaries, and at Day 6 7 days or upon early study exit. The study focuses on pain relief, swallowing discomfort, treatment use, safety, device performance, and patient compliance in typical care settings. During the study, participants will record their pain, swallowing discomfort, symptoms, and any adverse events daily. Researchers will evaluate pain reduction at Day 1 evening as the primary outcome and assess additional measures such as pain at Day 6, immediate pain relief after use, and overall patient-rated effectiveness. Safety and any device issues will be monitored from inclusion through Day 6. The study duration per participant is approximately 6 days.

Researchers are evaluating the clinical performance and safety of RIVADOUCE VEGETABLE SKINCARE OIL in preventing pressure ulcers in adults at risk. This observational post-market clinical follow-up study is conducted in real-life settings across multiple centers, focusing on patients with a Braden Scale score under 18 and no existing pressure ulcers. The study follows international standards and aims to gather updated evidence for device certification under EU regulations. The skincare oil is applied gently by effleurage to pressure-prone areas such as the sacrum, heels, ischial, and trochanteric regions as part of routine prevention protocols. A total of 252 adult patients will be enrolled and followed for 35 days, with a small allowance of 5 days variation. The study does not involve randomization or control groups, focusing on real-life product use and monitoring. Participants will be monitored for the development of pressure ulcers, timing of their onset, progression, and any adverse events potentially related to the device. Compliance with product use will also be tracked. The primary outcome is the proportion of patients developing at least one pressure ulcer of stage 1 or higher during the study period. Safety and performance data collected will help support ongoing product approval and clinical use.

Researchers are conducting a French non-interventional longitudinal multicenter cohort study to evaluate the added value of olaparib for treating patients with metastatic castration-resistant prostate cancer mCRPC in real-world settings. The study aims to assess treatment sequencing, effectiveness, safety, and BRCA testing patterns, helping to inform future clinical practice. This observational study is sponsored by AstraZeneca. The study observes adult male patients who have started olaparib treatment within at least the last two months or who participated in a funded early access program. There are no assigned treatment groups or interventions beyond olaparib use as decided by their physician. Data collection continues up to 32 months to capture treatment patterns and patient characteristics. Participants data on treatment duration, disease progression, therapy sequences, symptomatic skeletal events, and BRCA testing timing will be collected and analyzed up to 24 months from olaparib initiation. Socio-demographic and clinical characteristics of patients and physicians will be gathered at the end of enrollment. The study monitors reasons for dose changes, interruptions, and treatment cessation, ensuring comprehensive real-world evidence about olaparib in mCRPC patients.

Researchers are evaluating treatments for adults with locally advanced or metastatic urothelial carcinoma bladder cancer who have progressed after prior therapy with enfortumab vedotin EV plus pembrolizumab. This global, multicenter, randomized, open-label Phase 23 trial compares a new drug, Datopotamab Deruxtecan Dato-DXd combined with either carboplatin or cisplatin, against the standard gemcitabine combined with carboplatin or cisplatin. The study aims to identify the recommended dose for Phase 3 and assess preliminary safety and efficacy during Part A, followed by a larger Phase 3 evaluation. Participants in Part A receive Dato-DXd at doses of 4 mgkg or 6 mgkg with platinum chemotherapy every three weeks. In Part B, participants receive the selected recommended dose of Dato-DXd or gemcitabine, each combined with either carboplatin or cisplatin, administered intravenously every three weeks. The specific platinum drug and dosing schedule are based on eligibility and investigator judgment, including options for split-dose cisplatin in certain cases. During the trial, participants undergo regular assessments including imaging scans to monitor tumor response, safety evaluations, and laboratory tests. The primary outcomes include overall response rate in Phase 2 and progression-free survival and overall survival in Phase 3, tracked up to approximately 34 to 38 months. Participants are followed throughout treatment and for a period afterward to evaluate treatment effects and safety under medical supervision.