Issy Les Moulineaux

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 evaluating two psycho-physical interventions for people with moderate to severe alcohol use disorder AUD to reduce heavy drinking days and prevent relapse. The study compares Mindfulness Based Relapse Prevention MBRP, a structured program involving mindfulness practice, with an unguided meditative relaxation program. This research addresses the need for effective therapies in AUD, as only a small percentage of patients receive approved drugs, and some patients are resistant to cognitive behavioral therapies. Participants will be randomly assigned to either the MBRP group or a relaxationmeditation control group. MBRP involves seven sessions lasting 60 to 120 minutes each, covering topics such as triggers, relapse prevention, and mindfulness in daily life, including meditation exercises and discussions on at-home practice. The relaxation group attends seven sessions of unguided relaxation with nature sounds, accommodating up to 12 participants per group. Throughout the study, participants will be monitored for changes in heavy drinking days, alcohol consumption, craving frequency and strength, anxiety, depression, quality of life, emotion regulation, impulsivity, coping mechanisms, and cognitive impairment over 3, 6, and 12 months. Researchers will track the number of meditation sessions and assess mental health and behavioral changes. The primary outcome is the reduction in heavy drinking days six months after inclusion, with continued evaluations up to one year.

Depression is a common mental disorder affecting a significant portion of the population and is linked to increased risks, including suicidal behavior. Major Depressive Episodes MDEs can occur in Major Depressive Disorder MDD or bipolar disorder BD, which affects about 2% of the global population. Bipolar disorder involves episodes of mania or hypomania alternating with depression, and its diagnosis is often delayed by around 7 years, increasing health risks. This research evaluates the clinical and economic impact of the EDIT-Bae blood test, which helps differentiate between bipolar disorder and major depression to improve patient management. The study compares two groups of patients experiencing moderate to severe MDEs one group where doctors use the EDIT-Bae test results to guide treatment, and a control group where the test is done but results are not shared until the study ends. EDIT-Bae involves a blood sample analyzed with advanced RNA sequencing and AI algorithms to support diagnosis. The study plans to recruit 450 patients over 24 months, with each participant involved for 6 months and attending 4 study visits. Participants will be assessed for improvement in depressive symptoms, measured between the start and approximately 15-16 weeks into the study. The research includes clinical evaluations and monitoring over the 6-month period. The study aims to track how the test impacts treatment decisions and patient outcomes, along with health economic effects, to better understand its role in managing bipolar and major depressive disorders.

Sarcopenia is a progressive muscle disorder common in older adults, characterized by loss of muscle mass, strength, and physical performance. This condition increases risks of falls, frailty, and mortality. Researchers are exploring the use of high-definition surface electromyography HD-sEMG to develop a new, non-invasive diagnostic method for sarcopenia. The study targets people aged 75 and older who are hospitalized and suspected of having sarcopenia based on a screening questionnaire score. Participants will undergo HD-sEMG to record muscle activation signals from the rectus femoris muscle during knee movements or chair rises. Additional assessments include body composition via bioimpedancemetry and possibly DEXA scans, muscle strength tests using handgrip measurements, and physical performance evaluations. The study is descriptive and cross-sectional, conducted across multiple centers, with a planned inclusion period of 18 months and a 3-month follow-up after inclusion. Throughout the study, participants will provide data through muscle ultrasound and physical activity questionnaires. Researchers will analyze HD-sEMG signals to differentiate between sarcopenic and non-sarcopenic individuals and to monitor functional recovery and muscle parameters over time. Outcomes include correlations with muscle mass, strength, physical performance, and quality of life. The total study duration is 21 months, with assessments conducted from day 1 through day 90 after inclusion.

Researchers are studying ways to improve how well adult patients with chronic diseases follow their treatment plans. The study aims to increase adherence to therapy by 15% over six months by using a simple, standardized, and repeated message delivered by trained healthcare professionals. This approach is designed to help patients better manage their treatments without changing their prescribed medications. In this trial, healthcare professionals provide patients with a clear 3-point message focused on boosting therapeutic adherence. This message is delivered during patient consultations after the professionals have been trained. The study uses a stepped-wedge design where some patients receive usual care before the message delivery begins, followed by an intervention period where the message is given repeatedly by various healthcare providers involved in the patients hospital care. The delivery of the message is tracked using a checklist. Participants are involved by completing a self-questionnaire about their treatment adherence, helping them engage actively in managing their care. The study measures improvements in adherence at six and twelve months, along with factors predicting better adherence, costs of care, intervention costs, and healthcare professionals satisfaction. The research will help guide better patient care practices and optimize treatment benefits while reducing healthcare resource waste.

Researchers are evaluating the feasibility of a structured bronchopulmonary cancer screening program using thoracic CT scans within a French cohort in the Ile de France region. This screening is organized through a clear and functional process involving trained health center physicians and a coordinated network to identify eligible participants based on specific smoking history and age criteria. The study aims to optimize early detection and management of bronchopulmonary cancer in this population. The screening process includes an initial assessment for eligibility, followed by consultation and referral for a chest CT scan according to the NELSON trial schedule at inclusion, 1 year, 3 years, and 5.5 years. CT scan images are read centrally and interpreted in a structured way. If cancer is suspected, participants are referred to a multidisciplinary team for further evaluation. Smokers are also referred to tobacco cessation programs, and follow-up care is organized as part of the program. Participants will undergo multiple CT scans over several years and attend inclusion visits with health center physicians. Data collected include rates of CT scan completion, eligibility, smoking cessation, and early-stage cancer detection. The study will monitor complications from additional investigations and track demographic factors influencing nodule detection. The total study duration includes follow-up extending beyond 8 years, with safety and outcome evaluations conducted throughout this period to assess screening effectiveness and participant adherence.

Depression affects about 17% of people during their lifetime, with many cases becoming resistant to treatment. Treatment-resistant depression TRD often leads to relapse, recurrence, and reduced quality of life, impacting daily functioning and healthcare needs. This trial explores the use of Vagus Nerve Stimulation VNS as a new treatment option for patients with TRD, including those with bipolar disorder, aiming to address the limitations of current therapies like electroconvulsive therapy ECT. The study is a national, multicenter, randomized, controlled trial comparing VNS plus optimal medical treatment to optimal medical treatment alone. Participants will be randomly assigned to either receive VNS along with the best medical treatment BMT or BMT alone. The VNS device is surgically implanted under general anesthesia, involving electrode placement on the vagus nerve and a stimulator under the skin. Following implantation, stimulation settings are adjusted over several months to reach therapeutic levels. Both groups will be followed for 24 months with regular visits, including medical and psychiatric evaluations, while the experimental group undergoes additional neurosurgical and stimulation adjustment visits. Throughout the study, participants will attend multiple scheduled visits for clinical assessments, including evaluations of depression severity, treatment effects, and safety monitoring. Data on cost-utility and efficacy of VNS will be collected at various intervals up to 24 months. The study aims to provide insight into the long-term benefits and economic impact of VNS compared to standard care for treatment-resistant depression.