Brest

Context Chronic diseases are increasing, and healthcare is becoming more complex. Integrated care-that is, care that is coordinated, person-centered, and continuous-is essential to improve efficiency. In pediatric rehabilitation, coordination between the child, their family, and professionals working in hospitals, rehabilitation centers, integrated healthcare and social settings, outpatient settings, private practice is particularly critical. Effective coordination helps promote the child's participation in all areas of life and supports them through major life transitions, such as starting school or moving from adolescence to adulthood. In this context, the digital application "Deneo Kid" was developed at the University Hospital of Brest through a partnership between the company Deneo, which already developed a shared portal for adult sports rehabilitation, and the BEaCHILD research team, specialized in child disability. It was designed based on qualitative studies exploring the needs of parents of children with disabilities (PitchRehab, supported by the Ildys Foundation), young people with disabilities (KidChildRehab, supported by the University Hospital of Brest), and professionals in rehabilitation, education, and leisure (ProChildRehab, supported by the University Hospital of Brest). "Deneo Kid" aims to connect children, their families, and rehabilitation professionals around a coordinated care and life plan centered on their needs, in order to promote integrated pediatric rehabilitation using a digital tool. Funding from the Fondation de l'Avenir has been obtained to conduct a usability and impact study of the application. Additional funding has been requested from IReSP to explore the social determinants of adoption and the economic impact of the application with the support of a sociologist and a health economist from IMT Atlantique, as part of the same usability study. To achieve this, the "Deneo Kid" application will be tested for 3 months with a cohort of users composed of 20 "teams," each including one child living with a neuromotor disability (cerebral palsy, neuromuscular disease, neurodevelopmental disease with motor impairments, etc.), their parents/legal guardians, and at least two rehabilitation professionals involved in their rehabilitation. Participants will be recruited from four pediatric rehabilitation centers in France. A mixed-methods approach will be used, including quantitative data collection and analysis (pre- and post-intervention questionnaires for users, anonymized application usage data collected via Deneo, and costs associated with coordination with and without the application) and qualitative data collection and analysis (interviews and focus groups before and after the study, digital journals, and direct observations). This first small-scale experimental study will provide a better understanding of the usability, acceptability and impact of "Deneo Kid" across different pediatric rehabilitation settings and the factors contributing to its success. It will also provide a solid foundation for future larger-scale studies, contributing to improvements in the quality and efficiency of pediatric rehabilitation care. Target Population The end users of the "Deneo Kid" digital solution include children and young people with disabilities aged 0-25 years, parents or legal guardians of these children, and rehabilitation professionals such as physicians, physiotherapists, occupational therapists, psychomotor therapists, psychologists, speech therapists, specialized educators, and adapted physical activity educators. The term "parents or family" is used throughout the text for simplicity but includes legal guardians. Primary Objective The primary objective of this study is to evaluate the usability of the "Deneo Kid" application among the described user cohort. Secondary Objectives The secondary objectives of the study are: 1. To evaluate the use of the "Deneo Kid" application by all participants. 2. To assess the quality of the application from the perspective of all users. 3. To evaluate the impact of the application on the provision of integrated care from the perspective of families. 4. To assess the effect of the application on the implementation of family-centered care from the perspectives of both families and professionals. 5. To evaluate the acceptability of the application from the viewpoint of all participants. 6. To analyze the influence of the application on communication and relational dynamics among stakeholders. 7. To identify social determinants that affect the adoption of the application in different contexts. 8. To compare the time and costs of care coordination before and after using the application from the perspectives of families and professionals. Primary Outcome Measure The primary outcome is usability, assessed using the System Usability Scale (SUS), completed by adolescents over 16, their parents, and the rehabilitation professionals who follow them. Secondary Outcome Measures 1. Application use: Usage will be monitored through anonymized back-office data, including login times, average connection durations, and feature usage over the three months. 2. Application quality: Quality will be assessed using the validated Mobile Application Rating Scale (MARS) for young adults, families, and professionals after three months of use. 3. Integrated care: Families will complete the Pediatric Integrated Care Survey (PICS) before and after three months to evaluate the impact on integrated care. 4. Family-centered care: Families will complete the Measure of Processes of Care (MPOC) questionnaires, and professionals will complete the MPOC-Service Providers (MPOC-SP) questionnaire before and after three months to assess family-centered care practices. 5. Acceptability: Acceptability will be evaluated through the questionnaire Theoretical Framework Acceptability and through interviews or focus groups with adolescents, parents, and professionals conducted in person or via videoconference. 6. Relational dynamics and communication: interviews and observations on site will assess communication and relationships among participants. 7. Social determinants of adoption: Socio-demographic data collected before the study will be analyzed to identify factors affecting adoption. 8. Time and coordination costs: Direct costs (Deneo subscription) and indirect costs (time spent using the application) will be collected via application usage statistics and coordination practice questionnaires before and after the study. Methodology This is a multicenter, prospective observational study evaluating professional practices using a mixed-methods design with quantitative and qualitative data across 20 child-family-professional teams. Statistics Each participant will be assigned a pseudonym, and only the principal investigators will have access to the key linking names to pseudonyms. Quantitative data will be stored on a secure server in Excel files and analyzed descriptively, reporting frequencies, means with standard deviations, or medians with interquartile ranges depending on the data type. The primary criterion of usability considers a mean SUS score above 51 as acceptable. Qualitative data from interviews and focus groups will be recorded using Zebrix, a local secure platform of the university hospital of Brest, and transcribed verbatim using AI. Analysis will follow the six-phase thematic analysis method of Braun \& Clarke (2016) using NVivo14 software. Inclusion Criteria Children and young people aged 0-25 with a physical disability (such as acquired brain injury, musculoskeletal disorders, rare diseases, congenital heart conditions) causing participation limitations according to the International Classification of Functioning, Disability and Health (WHO, 2007), who are followed in rehabilitation at least once per week by at least two professionals in different sectors with the goal of promoting autonomy and participation. Parents or legal guardians must have access to a computer, smartphone, or tablet. Rehabilitation professionals must work with children with disabilities and have access to digital devices. Exclusion Criteria Refusal to participate. Number of Participants The study aims to include 20 children/young people, their parents, and at least two rehabilitation professionals per child. The total number of participants using the application for three months is expected to be between 80 and 100. Timeline Enrollment will take place over 12 months. Each participant will use the application for three months, between November 2025 and June 2026. The total study duration, including enrollment and follow-up, is 12 months, with data collection and processing expected to take 18 months.

\[68Ga\] Ga-FAPI is an innovative radiotracer in positron emission tomography (PET) coupled to scanner (CT: computed tomography). It targets the membrane glycoprotein FAP (Fibroblast Activation Protein), a specific surface marker of activated fibroblasts, these constituting one of the main populations of the tumor microenvironment. This radiotracer is the subject of a major development program in the field of oncology and hematologic malignancies. In many cancers, preliminary data suggest, in terms of diagnostic performance, the superiority of \[68Ga\] Ga-FAPI over the reference evaluation modality carried out with \[18F\] F-FDG. These results make it possible to consider, in the medium term, the integration of this imaging modality into routine care, for the initial evaluation and monitoring of certain tumor pathologies. If oncology and hematology constitute the most obvious areas of application of \[68Ga\] Ga-FAPI, other areas of potential use were quickly mentioned, due to the involvement of activated fibroblasts in the processes. remodeling of the extracellular matrix and tissue repair in general, beyond tumor pathologies. Non-exhaustively, the potential interest of the radiotracer is thus suggested in the characterization of benign tumor pathologies, in the evaluation of ischemic tissues, in chronic inflammatory diseases and in fibrosing diseases. Numerous preliminary data show that it is relevant to develop knowledge concerning the contribution of \[68Ga\] Ga-FAPI to the evaluation of numerous benign pathologies. It is in this general context that this single-center pilot study project falls, the general objective of which is to determine the preliminary interest of this imaging modality in different chronic inflammatory and/or fibrosing diseases. The pathologies included in this project were selected by taking into account the concomitant presence of unmet medical needs in terms of disease assessment and recognized local clinical research expertise in the area concerned. On these bases, 15 distinct clinical situations were selected, intended to enable the production of pilot data. This approach will be able to determine the interest in continuing clinical development in each area and will help to specify the modalities. The 13 clinical situations selected for this pilot study are: * Rheumatoid arthritis * Spondyloarthritis * Inflammatory enterocolopathies * Liver fibrosis * Fibrosing interstitial lung disease * Systemic sarcoidosis * Polymyalgia rheumatica and giant cell arteritis * Primary Sjögren's syndrome * Systemic scleroderma * Systemic lupus * Inflammatory myopathies * Primary or secondary myelofibrosis * Other orphan systemic diseases * Endometriosis * Chronic thrombo embolic disease

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

In this study, data from patients with INS will be recorded prospectively, regularly and systematically. The cohort will be composed of patients followed by pediatric nephrologists affiliated with the SNP. Metropolitan France, Reunion Island and Mayotte are the geographical areas concerned. It is planned to integrate other French overseas departments and territories, in particular the West Indies. This is therefore a prospective, multicenter, cohort follow-up study. The data will be centralized via a secure website dedicated to the study. Data will be obtained from: * Medical record data (hospitalization/consultations) as part of routine clinical follow-up for patients with active disease. This information will be medically validated and integrated into the database with the help of clinical research staff. * A telephone interview for annual follow-ups for patients whose absence of active disease no longer requires a systematic medical visit. This structured interview will be administered by telephone by the study's clinical research staff. * Self-administered or hetero-administered quality of life questionnaires (PEDS-QL), self-administered or hetero-administered treatment compliance questionnaires (Morisky's Score), and questionnaires on the aesthetic impact of treatments (Ferriman's Score). These questionnaires will be centralized and reported to the database by the study's clinical research staff.

The aim of the study is to assess a new drug called STP938 for the treatment of essential thrombocythaemia (ET). The study with assess how effective STP938 in treating ET, and also assess any side effects of taking the drug. The study will enrol individuals with high risk ET who require treatment to lower their platelet count. Individuals enrolling on the study will have already tried treatment with hydroxycarbamide (also known as hydroxyurea) but are in need of a different treatment as hydroxycarbamide either did not control the platelet count or produced unwanted side effects. STP938 is a new class of drug that inhibits the enzyme cytidine triphosphate synthase 1 (CTPS1). Inhibition of CTPS1 is a novel way of lowering the platelet count. This study is a phase 1b, open-label, multicentre trial. Participants will receive STP938 capsules every day, in cycles of 28 days, for approximately 12 months. Participants may continue to receive study drug for a longer period, so long as it is controlling the platelet count and not causing side effects. During the study, participants will visit the study site about 26 times (2 times per cycle) over an estimated 12 months. Once the treatment is complete, safety follow-up visit(s) will occur to make sure the participant is not experiencing any adverse effects. The following study procedures will be performed: (a) physical examinations (b) ECGs (c) blood tests, (d) urine tests (e) CT/MRI scans (f) bone marrow biopsies (g) drug administration (h) study drug blood level tests and (i) gene testing.

The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks). Participants who prematurely discontinue study treatment (either during Treatment Period 1 or Treatment Period 2) are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.