Montivilliers

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

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.

Researchers are conducting an observational study called the France PCI Registry to monitor and improve care in interventional cardiology, focusing on procedures like coronary angiography and angioplasty. This national observatory started in 2014 in the Centre Val de Loire region and aims to build a reliable database of interventional cardiology activities. The study is led by the Club Rgional des Angioplasticiens de la rgion Centre and seeks to optimize patient care times, especially for those with STEMI a type of heart attack. The study collects data fully integrated with usual coronary activity reporting software across multiple catheterization labs. It tracks interventional cardiology activities over a year and monitors secondary outcomes such as improving care times for STEMI patients within 24 hours. There are no investigational drugs or treatments administered, as this is an observational study gathering information from routine clinical practice. Participants who have undergone coronary angiograms or angioplasty are involved through data collection during their usual care. The study regularly evaluates data quality to maintain an exhaustive and reliable database. Researchers measure the volume and quality of interventional cardiology procedures and how quickly STEMI patients receive care. Participation lasts as long as the data collection period, with ongoing observation but no additional interventions or treatments.

Researchers are studying the impact of Ziwig Endotest4, a medical device that identifies endometriosis from a saliva sample using advanced sequencing and algorithms. This non-invasive test aims to reduce diagnostic delays and guide treatment strategies for women with suspected endometriosis. The study focuses on how the Endotest results affect patients quality of life, emotional experiences, coping strategies, and care pathways, areas not yet fully documented. Participants are women aged 18 to 43 who have been prescribed the Endotest. The study is observational and involves completing validated self-report questionnaires, such as EHP 56 and RAND-36, at the start, six months, and twelve months. Clinical data will also be collected from medical records to track the impact of the Endotest on patient care, including tests, treatments, and procedures like laparoscopy, as well as on assisted reproductive technology journeys. During the study, participants will complete questionnaires at baseline, six months, and twelve months to assess quality of life, anxiety levels, pelvic sensitivity, and adaptation strategies. The research team will monitor the patients care pathways and compare outcomes based on Endotest results across different countries. The study aims to provide valuable, generalizable data over an average follow-up period of one year to inform both clinicians and patients.

Bronchiectasis is a chronic lung disease involving permanent widening of parts of the airways, leading to mucus buildup, infections, and ongoing inflammation. Researchers are evaluating whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups compared to enhanced standard care in patients with non-cystic fibrosis bronchiectasis. This study focuses on long-term effects over about two years. Participants will be randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device daily at home along with remote physiotherapy and standard care. The SIMEOX device delivers short pulses of negative air pressure through a mouthpiece to help loosen and move mucus from the lungs. Remote physiotherapy sessions occur once a month for the first three months and then every three months thereafter. During the study, participants will be monitored for changes in quality of life using questionnaires at 6, 12, and 24 months, and the number of lung exacerbations over about 24 months will be recorded. Lung function tests spirometry will also be conducted periodically. Researchers will track treatment adherence, hospitalizations, and any adverse events. The total study duration per participant is around two years, with regular assessments to evaluate the impact of the SIMEOX device combined with physiotherapy.

Researchers are collecting biological samples to improve diagnosis and treatment of rare neuroimmune disorders affecting the central and peripheral nervous system. These disorders include Paraneoplastic Neurological Syndromes PNS and Autoimmune Encephalitis AE, which involve immune system activity. The study aims to support faster and more accurate diagnosis, benefiting patients with these conditions by enhancing future treatment approaches. Participants diagnosed with PNS or AE will have biological samples collected once, including blood and possibly cerebrospinal fluid if available. Blood samples will be used to obtain serum, buffy coat, plasma, and peripheral blood mononuclear cells. If cerebrospinal fluid is drawn for diagnosis, any remaining sample will be stored. This collection will occur during a single visit, and samples will be stored for up to 10 years. During the study, participants will provide consent and undergo sample collection only once. Researchers will monitor the blood samples and cerebrospinal fluid biocollection over 10 years. The study emphasizes scientific collaboration and ongoing research to improve understanding and treatment of these neurological disorders. Participation duration focuses on the collection and long-term storage of biological samples.

Researchers are investigating the return to work RTW for patients who have been treated for hematological malignancies such as leukemia, lymphoma, and multiple myeloma. This study evaluates whether an early consultation focused on RTW can improve the rate and quality of patients returning to their jobs after cancer treatment. The study is prospective, randomized, and multicenter, aiming to address the lack of interventional research in this area and build on previous findings about the importance of psychological factors like RTW self-efficacy in oncology. Participants are divided into two groups one receives the return-to-work after cancer consultation, conducted by specialists such as occupational pathologists, psychologists, nurses, or social workers, while the other group receives usual care without this consultation. The consultation lasts about one hour and covers assessment of medical, social, and psychological status, guidance through RTW stages, identification of obstacles, legal information, and possible work adjustments. Patients are treated according to local practice if not in the consultation group. Throughout the study, participants will be monitored for RTW status at 12 months, changes in professional situation, quality of life, anxiety and depression, and RTW self-efficacy using standardized scales. The consultations perceived benefit is also assessed. The study tracks these outcomes at baseline, 3, 6, and 12 months, aiming to provide detailed insight into the impact of early RTW support. The total study duration extends up to one year for each participant.

Researchers are evaluating the safety and effectiveness of Remote Ischemic PreConditioning RIPC in lymphoma patients receiving anthracycline chemotherapy. This multinational, phase II, randomized clinical trial compares RIPC to a sham procedure to understand its impact on preventing heart damage caused by anthracyclines. The study includes patients scheduled for at least five chemotherapy cycles and uses heart imaging and blood tests to monitor heart function. Participants will be randomly assigned to either the RIPC group or the sham control group. The RIPC group will undergo weekly sessions of blood pressure cuff inflation on the arm, with four cycles of 5 minutes inflation at 200 mmHg followed by 5 minutes deflation during the entire chemotherapy period. The sham group will receive similar weekly sessions but with low pressure that does not stop blood flow. The study includes baseline heart MRI and biomarker tests before chemotherapy, repeated after the third chemotherapy cycle, at the last chemotherapy cycle, and nine weeks post-chemotherapy. Throughout the study, participants will have heart function evaluated using cardiac magnetic resonance imaging and blood tests for heart injury markers. Follow-up visits will occur to monitor clinical events for up to 42 months after treatment ends, with a median follow-up of 36 months. The main outcome measured is the rate of heart damage events related to anthracycline use, assessed nine weeks after finishing chemotherapy.

Chronic obstructive pulmonary disease COPD is a serious lung condition that reduces exercise tolerance and quality of life. Pulmonary rehabilitation helps improve breathing, exercise capacity, and overall well-being, but many patients face barriers such as travel difficulties and limited rehab center availability. This research compares a home-based telerehabilitation program to traditional center-based pulmonary rehabilitation to assess their effects on exercise endurance in adults with COPD. The study randomly assigns participants aged 45 to 80 with stable COPD to either a home-based or center-based rehabilitation group. Both groups complete 24 sessions over eight weeks, including endurance training on a cycle ergometer, muscle strengthening, balance exercises, and therapeutic education tailored to individual needs. The home-based group uses equipment like a cycle ergometer, pulse oximeter, activity tracker, and a tablet app for guidance and remote monitoring, while the center-based group attends sessions at rehabilitation centers. Both groups have initial and final in-person assessments. Participants will undergo assessments before and after the program, including exercise endurance tests on a cycle ergometer. Researchers will monitor adherence, physical activity, quality of life, cognitive function, and health events over one year. Regular support and education aim to ensure safety and effectiveness. The total involvement includes rehabilitation sessions, assessments, and follow-up evaluations, with safety measures in place to minimize exercise-related risks.

This research focuses on fathers during the perinatal period, a time of significant psychological changes, identity challenges, anxiety, and risk of depression. The study aims to validate the Edinburgh Postnatal Depression Scale EPDS as a screening tool for postnatal depression specifically in French fathers, addressing a gap since EPDS is widely used for women but not yet validated for men in this context. Fathers participate by completing the PH-Q9, EPDS, and socio-demographic questionnaires online at the start of the study and again 6 to 8 weeks after their childs birth. Those included at the maternity hospital or through their wives also undergo the Mini International Neuropsychiatric Interview MINI at inclusion, which is a standard diagnostic tool for postnatal depression. Fathers recruited via an awareness campaign complete the questionnaires but do not have the MINI interview. Participants will be assessed twice at inclusion and 6 to 8 weeks postpartum, with those at maternity wards also receiving the MINI interview at inclusion. Researchers will measure depression risk using EPDS and confirm diagnosis with MINI. The study includes socio-demographic data collection, with no masking or randomization. Participation involves online questionnaires and an interview for some, with the overall goal to improve screening methods for paternal postnatal depression.