Montivilliers

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Rigorous assessment of clinical practice plays an important role in improving patient care and outcomes in interventional cardiology. This multicenter observational study called CRAC began in 2014 in the Centre Val de Loire region of France. It uses usual coronary activity report software to collect high-quality, reliable data from five interventional cardiology catheterization labs in the region. This approach aims to create an extensive and trustworthy database that could be expanded to other regions in France. The study collects data continuously from patients who have undergone coronary angiograms or angioplasty procedures. There are no specific interventions or treatments assigned as this is an observational registry monitoring routine clinical activity in interventional cardiology. The data collection and quality assessment are integrated into the regular reporting systems used by participating centers. Participants provide their data while receiving standard care. Researchers regularly evaluate the quality of the collected data to ensure accuracy and completeness. The main outcome being measured is the census of interventional cardiology activity over one year. The study focuses on building a comprehensive national registry to support improved care through careful monitoring and analysis of interventional cardiology procedures.

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.

Numerous neurological disorders affecting the central and peripheral nervous system are linked to immune system activity. This research focuses on rare neuroimmune conditions such as Autoimmune Encephalitis (AE) and Paraneoplastic Neurological Syndromes (PNS). Improving diagnosis speed and accuracy for these disorders may help guide better treatment approaches in the future. Participants provide biological samples including blood and cerebrospinal fluid (CSF) for the study. Blood samples are collected once to obtain serum, buffy coat, plasma, and peripheral blood mononuclear cells (PBMC). If CSF is drawn for diagnosis, any leftover sample is also stored. Samples are collected and stored to support better diagnosis and research. During the study, participants contribute blood and possibly CSF samples which will be stored and analyzed over a long term, up to 10 years. Researchers will monitor these biological materials to better understand the disorders and develop improved diagnostic tools and treatments. The study involves consented patients with neurological disorders related to PNS or AE and may include antibody testing results.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

This clinical trial is a multinational, prospective, phase II study designed to evaluate the safety and effectiveness of Remote Ischemic PreConditioning (RIPC) in patients with lymphoma receiving anthracycline chemotherapy. The study is double-blinded, sham-controlled, and randomized. It aims to reduce anthracycline-induced cardiac toxicity, a common side effect in lymphoma patients undergoing chemotherapy involving anthracyclines. Participants scheduled to receive at least five chemotherapy cycles with anthracyclines are randomly assigned to receive either the RIPC procedure or a sham (simulated) procedure. The RIPC involves using an electric auto-control device on the arm, inflating a blood pressure cuff to 200 mmHg to stop blood flow temporarily. The sham procedure inflates the cuff to a low pressure without stopping blood flow. Baseline cardiac magnetic resonance (CMR) imaging and blood tests for cardiac markers (hsTn and NT-proBNP) are done before treatment. Additional CMR scans and blood tests are performed after the third chemotherapy cycle, during the last cycle, and nine weeks after completing chemotherapy. Throughout the study, participants are closely monitored with CMR scans and blood tests to measure heart function and detect early signs of cardiotoxicity. Follow-up for clinical events continues for up to 42 months, with scheduled visits at 6, 12, 18, 30, and 42 months after the last chemotherapy cycle. The main outcome measured is the rate of anthracycline-induced cardiotoxicity occurring about nine weeks after the final chemotherapy session. The study includes thorough safety and efficacy assessments to understand RIPC's role in protecting the heart during lymphoma treatment.

Chronic obstructive pulmonary disease (COPD) is a serious respiratory condition that reduces exercise tolerance and quality of life. Pulmonary rehabilitation helps improve symptoms like breathlessness and physical capacity, but many patients face barriers, such as transportation and limited access to centers. This research compares the effectiveness of a home-based telerehabilitation program to a traditional center-based pulmonary rehabilitation program for adults with COPD. The primary goal is to measure changes in exercise endurance time after completing the rehabilitation. The study involves two groups over eight weeks, each completing 24 rehabilitation sessions three times per week. The center-based group attends sessions at a facility including warm-up, endurance training on a cycle ergometer, muscle strengthening, balance exercises, and patient education. The home-based group performs similar sessions at home with equipment like a cycle ergometer, pulse oximeter, activity tracker, and a tablet app for guidance and monitoring. Both groups have initial and final assessment visits at the center and receive support from healthcare professionals throughout. Participants will be assessed before and after the program using endurance tests on a cycle ergometer. Evaluations include physical capacity, muscle strength, dyspnea, quality of life, and other health measures. Researchers will monitor adherence, safety, and any adverse effects such as muscle soreness or fatigue. The study also plans a one-year follow-up to track hospitalizations, exacerbations, and mortality. Total participation time is around eight weeks for the rehabilitation programs plus follow-up assessments.

Fatherhood has evolved to include more active involvement during the perinatal period, which can bring psychological challenges such as identity crisis, anxiety, and depression. This study aims to validate the Edinburgh Postnatal Depression Scale (EPDS) as a tool to screen for postnatal depression in French fathers, as it is widely used for women but not yet validated for men during this period. Participants complete the PH-Q9, EPDS, and socio-demographic questionnaires online at the start of the study and again 6 to 8 weeks after their child's birth. Fathers who are included while at the maternity ward also undergo the Mini International Neuropsychiatric Interview (MINI), which is a standard diagnostic test for postnatal depression. During the study, fathers will be assessed using the questionnaires and the MINI interview to detect depression symptoms. The main outcome measure is the MINI conducted at inclusion. This process helps researchers evaluate the EPDS's accuracy as a screening tool for paternal postnatal depression, with follow-up occurring up to 8 weeks postpartum.