Niort

This research aims to evaluate the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis. The study is conducted in France and focuses on understanding how this treatment performs outside of controlled clinical trial settings. Participants in this observational study will be newly starting deucravacitinib as prescribed by their treating clinician. There are no additional study treatments or placebo groups, as the study observes the outcomes of the treatment during routine clinical care. During the study, researchers will assess clinical outcomes including the Physician's Global Assessment (PGA) and the Dermatology Life Quality Index (DLQI) at baseline and at months 4, 12, 18 (optional), and 24. They will also monitor how long participants remain on deucravacitinib treatment, up to 24 months. These evaluations help to measure both the effectiveness and impact on quality of life for participants with plaque psoriasis.

Researchers are evaluating a personalized maintenance therapy for pemphigus, a life-threatening chronic autoimmune blistering disease affecting the skin and mucous membranes. This study focuses on comparing this personalized approach, which uses anti-desmoglein antibody levels as biomarkers, with the standard treatment involving rituximab combined with corticosteroids. The trial builds upon previous successful studies that supported rituximab's approval for pemphigus treatment by the FDA and EMA. Patients in the personalized maintenance group receive additional rituximab infusions based on their antibody levels and disease activity, aiming to prevent relapses and reduce the need for corticosteroids. The standard treatment consists of two doses of rituximab combined with oral corticosteroids, given after a clinical relapse. The study monitors antibody levels and disease activity over time to guide treatment decisions. Participants will undergo regular assessments, including clinical evaluations and antibody measurements, over a 7.5-year period to track the number of disease relapses per patient-year. The study also involves monitoring safety, treatment adherence, and the effectiveness of the personalized treatment strategy compared to the standard approach. Participation includes vaccination requirements and compliance with study protocols to ensure safety and reliable results.

Researchers are studying gene variants of uncertain significance (VUS) found in genes linked to hereditary breast, ovarian, and other cancers. The goal is to better classify these VUS using data from a large French genetic database to improve genetic counseling and help guide clinical decisions, including preventive surgeries. The study originally focused on BRCA1 and BRCA2 genes but now includes multiple cancer-related genes identified through ongoing genetic testing in French families. Participants include index cases who carry specific VUS classified as uncertain or likely causal, along with their selected family members. Saliva samples are collected from these relatives to test for the presence of the variants. The study uses co-segregation analysis, which examines how the variant tracks with disease within families, applying a Bayesian model alongside other genetic and clinical data to estimate the likelihood that a variant causes cancer. Participants provide informed consent and saliva samples for genetic testing. Researchers compile data from multiple families to strengthen the classification of variants. The primary outcome is to perform co-segregation analysis over a period of up to 15 years. This long-term study aims to refine the clinical relevance of genetic variants to support personalized cancer risk assessment and counseling for affected families.

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.

This research aims to evaluate the impact of "relaxing touch" on the use of chemical restraint in patients who are sedated and intubated in intensive care. The study focuses on patients from the time sedation is lifted until extubation, particularly those with reaction anxiety or difficult or failed intubation. It is a randomized prospective study conducted at Niort Hospital. Participants in the study are divided into groups, with one group receiving a relaxing touch intervention. This involves massage of the head, feet, and hands for a total of 30 minutes twice a day: 10 minutes on the head, 10 minutes on the feet, and 10 minutes on the hands. The study monitors patients until extubation occurs, which must be within 48 hours. During the study, patients are closely monitored for the use of chemical restraint over one year. The study includes assessments related to sedation and extubation, and data is collected on the patient's response to the relaxing touch intervention. Researchers also track safety and adherence, with participation limited to patients in intensive care at Niort Hospital who meet the inclusion criteria. The total duration includes the period until extubation and follow-up of chemical restraint use for up to one year.

Researchers are evaluating a new Clinical Decision Support tool designed to help diagnose venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT). This study compares the diagnostic accuracy of the tool using fresh plasma samples versus frozen plasma samples in patients suspected of having VTE, regardless of their initial risk level. The study also examines how well the tool performs across different patient groups, including those with cancer, COVID-19, and various clinical risk profiles. Participants undergo routine coagulation tests and D-Dimer and fibrin formation assays using a device called the STA-R Max analyzer. The Clinical Decision Support tool calculates an exclusion score from these tests using either a manual or machine learning-based algorithm. These tests are performed on both fresh and frozen plasma samples to compare results. Participants are diagnosed and treated according to standard medical care during the study. Throughout the study, researchers measure diagnostic outcomes such as sensitivity, specificity, likelihood ratios, and negative predictive value over periods ranging from 37 to 48 months. They carefully monitor the reproducibility and threshold settings of the decision support tool. Patients' plasma samples are tested and compared to current diagnostic methods including imaging. The study aims to determine if fresh plasma testing provides equivalent performance to frozen plasma testing or if a new diagnostic algorithm is needed.

Researchers are conducting a French prospective observational study to understand how patients aged 18 years and older with moderate to severe atopic dermatitis (AD) are managed when eligible for or currently receiving systemic therapy. The study aims to describe treatment patterns, including previous and current therapies, and monitor drug survival and compliance over time. Experienced dermatologists in hospital and office settings will participate, ensuring treatment decisions reflect real-world clinical practice. Patients will be followed for one year under routine care, with systemic treatment decisions made solely by their physicians independent of study enrollment. The study does not involve specific interventions or changes in treatment but observes the use and management of systemic therapies for AD, including topical corticosteroid use and other systemic options. Participants will complete questionnaires and undergo assessments at baseline, six months, and twelve months. Researchers will collect data on previous and current treatments, therapeutic management of atopic comorbidities, drug survival changes, and treatment adherence. The study focuses on gathering real-life information on systemic therapy use and patient outcomes over the 12-month follow-up period.

Researchers are evaluating the safety and clinical performance of eight different iVascular devices used for endovascular interventions in patients with artery disease affecting the renal, iliac, or femoral arteries. The study includes 209 patients who have undergone these procedures as part of standard care. The goal is to confirm how well these devices work and how safe they are in a real-world setting. The treatments studied involve endovascular interventions using various investigational products from iVascular, such as the Oceanus 18 and 35 Balloon Dilatation Catheters, Luminor 18 and 35 Drug Coated Balloons, Restorer Peripheral Stent System, iVolution Pro Peripheral Self-Expanding Stent System, iCover Covered Peripheral Stent System, and Sergeant Peripheral Support Catheter. These devices are used according to their instructions for use to treat lesions in the renal, iliac, or femoral arteries. Participants are monitored during the procedure and followed for up to two years afterward. Researchers assess the primary safety outcome by tracking serious adverse events and device-related serious adverse events during and after the procedure. They also measure technical success during the procedure. The study involves obtaining informed consent, ensuring appropriate patient eligibility, and monitoring outcomes related to safety and device performance over time.

Researchers are conducting a long-term observational study to understand patients with Chronic Obstructive Pulmonary Disease (COPD) who are treated with dupilumab as part of routine care. The study aims to gather information on patient characteristics, safety, and patient-reported outcomes over time. This study includes adults with uncontrolled COPD despite standard treatments and elevated blood eosinophil levels, reflecting real-world use of dupilumab. Participants will be followed for approximately 36 months at up to 50 sites in France. This study is non-interventional, meaning it observes patients receiving dupilumab as prescribed by their doctors without altering treatment. It collects data retrospectively and prospectively from patients newly starting dupilumab under approved guidelines for COPD. During the study, researchers will analyze various baseline and historical clinical data, including demographics, medical history, lung function, symptom patterns, exacerbations, inflammatory markers, comorbidities, and treatment history. Safety and patient-reported measures will also be assessed over the follow-up period. The study will provide detailed descriptive statistics to better characterize this patient population and the long-term outcomes of dupilumab treatment in COPD.

Lysosomal Acid Lipase (LAL) Deficiency is a rare inherited disorder that causes a severe decrease in the enzyme responsible for breaking down certain fats in the body. This condition can present in infants as a rapidly progressing and often fatal disease called Wolman Disease, or in older children and adults as Cholesteryl Ester Storage Disease (CESD). It leads to serious liver and spleen problems, abnormal fat levels, and increased risk of heart disease. The overall prevalence and natural progression of LAL Deficiency are not well understood. This research is a global, observational registry designed to collect detailed, long-term data from patients with LAL Deficiency. The registry gathers information to improve understanding of the disease and support better care. It also helps monitor the effects of treatments such as sebelipase alfa. Both doctors and patients participate voluntarily in this study, which aims to build a comprehensive knowledge base across many countries and healthcare settings. Participants provide ongoing health information that helps researchers track disease progression, treatment outcomes, and clinical effects over time. The study collects data on symptoms, liver and spleen changes, blood tests, and other health measures. This continuous monitoring supports safety assessments and advances knowledge of LAL Deficiency, guiding future care and treatment strategies for patients.