Xinzo De Limia, Spain
Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk
Phase
4Span
170 weeksSponsor
University Hospital, BrestBrest
Recruiting
Epidemiology of Gonococcal Arthritis (EpGAr)
Phase
N/ASpan
22 weeksSponsor
University Hospital, BrestBrest
Recruiting
Hepatic Doppler to Assess Venous Congestion During Invasive Mechanical Ventilation (DOHECOV)
Phase
N/ASpan
189 weeksSponsor
University Hospital, BrestBrest
Recruiting
Role of High-Throughput Whole Genome Sequencing for the Diagnosis and Care of Atypical Diabetes
The prevalence of diabetes is 7.4% in France among people aged 20 to 79 years in 2015. We must also consider "pre-diabetes" (subjects with glucose intolerance), whose prevalence is equivalent to that of diabetes (2012 estimate). The incidence of diabetes is exploding both for type 2 diabetes, which represents 85% of diabetes, and for type 1 diabetes, which represents 10% of cases and starts one out of two times before the age of 20. Diabetes typing is essential to guide therapeutic choices, particularly the use of insulin. This typing is based on the pathophysiology of the disease, distinguishing insulinopenia from autoimmune causes in type 1 diabetes, monogenic diabetes, secondary or atypical diabetes and type 2 diabetes, where insulinopenia and insulin resistance coexist. Thus, while a formal biological diagnosis is possible for some forms of atypical diabetes and for type 1 diabetes, no biological parameter is currently available for type 2 diabetes, which remains a diagnosis of exclusion. As a result, diabetes represents a source of diagnostic and therapeutic erraticism, amplified by the clinical heterogeneity of type 2 diabetes, which is obvious and underestimated, and by a clinical phenotyping of patients that is often defective. The economic consequences are important because the health costs are very different depending on whether or not patients are treated with insulin. Type 1 and type 2 diabetes are examples of chronic, non-transmissible, multigenic, multifactorial diseases. However, less than 10% of the heritability of type 2 diabetes is currently explained by the associated genetic variants. And although genetic tests exist to diagnose certain monogenic diabetes, this diagnosis is made in less than 20% of cases, mainly in the presence of an atypical clinical presentation of diabetes. Moreover, there is no reason to rule out the hypothesis of paucigenic forms, at the interface of monogenic diabetes and multigenic forms as usually envisaged, as has been observed in chronic pancreatitis, which is also accompanied by diabetes. The study will be conducted according to a randomized trial design comparing two diagnostic strategies defined as follows: - Control strategy: in silico analysis of a panel of validated genes (ISApanel - Diabetome 1). Patients recruited along the control procedure will stay in their group using current genetic diagnosis practices and standard of care that may differ from one center to another. - Intervention strategy: whole genome sequencing coupled with multidisciplinary conciliation meeting. We plan to randomize one patient in the control group for two in the intervention group. The main objective of the study is to assess the contribution of whole genome sequencing (WGS) coupled with a multidisciplinary conciliation meeting (MCM) on diagnosis of atypical forms of diabetes compared to an in-silico analysis of a panel of validated genes (ISApanel), corresponding to current practice. The target population is 1020 adults with atypical diabetes for whom it is possible to obtain a blood sample.
Phase
N/ASpan
527 weeksSponsor
Institut National de la Santé Et de la Recherche Médicale, FranceBrest
Recruiting
Stakeholder Perspectives on the Need for a Digital Solution in Pediatric Rehabilitation
In France, around 3 million children are carriers of a chronic disease. These children require individualized, highly specialized rehabilitation care supported by interdisciplinary teams, often over many years. Rehabilitation is defined as "a set of interventions designed to optimize the functioning and reduce the disability of people with health problems as they interact with their environment". The main objective of rehabilitation is thus to promote the child's social participation in his or her daily life, whether at home, school or leisure. To achieve this goal, the partnership between all the professionals involved with the child, the child and his or her family is essential. The exchange of information between these stakeholders must be optimal throughout the child's care. However, there are many gaps in access to and sharing of information around the child, due to the multiplicity of stakeholders involved, the constant changes (care structures, school, etc.) and the wide variety of contexts (school, home, private practice, leisure, hospital). E-health or digital health presents multiple opportunities to promote access to information, improve monitoring of children, involve the family in care and reduce the mental burden associated with information exchanges, which are mainly handled by the family. The Deneo KID project, led by W.Inn, Brest University Hospital's innovation center, and carried out in partnership with the Deneo company, aims to meet these challenges. It aims to develop a digital solution for exchanging information between the various players involved in the child's care. This study is therefore directly in line with the Deneo KID project. Indeed, it is recognized in the literature that taking into account the needs and expectations of users (families, professionals, children) from the earliest design phases of a digital solution is essential to foster its usability, acceptability and future appropriation by its users. But this is not enough, and the literature shows a high percentage of failure in digital health innovation projects. For a solution to be adopted by its users, it is also essential to take into account the obstacles and brakes to the implementation of this type of solution at different levels (professionals, decision-makers). Indeed, authors have highlighted organizational factors likely to hinder or support the adoption of this type of solution, such as organizational support, or the persuasive strategies and techniques implemented by the organization to encourage the adoption of a solution by the professionals on a team. Considering these elements, the investigators have chosen to include not only people concerned by the use of the solution, but also people empowered to lead change, i.e. decision-makers in settings welcoming children with chronic health conditions. Decision-makers is defined as those involved in decision-making concerning the implementation of digital solutions in the various structures working for the health of children with chronic health conditions. They may be health managers or senior health managers in hospitals and rehabilitation centers, directors or heads of department in medico-social establishments, or association leaders. This will enable us to work with decision-makers to define appropriate implementation strategies to encourage adoption of the solution in care environments, and thus guarantee the success of the Deneo KID project. A qualitative focus group study of families of children with chronic illnesses was already carried out in 2022, supported by the Ildys Foundation (PITChREHAB study). Its aim was to explore the needs and expectations of families of children with chronic illnesses with regard to digital solutions to promote the exchange of information related to their child's rehabilitation. This study highlighted multiple opportunities for families, as well as essential functionalities to be included in the future Deneo KID solution from the families' point of view. The ProChildRehab study is the second stage in the development of the Deneo KID solution. It focuses on the needs of child-facing professionals and decision-makers for a digital solution designed to facilitate the exchange of information about children with disabilities. The ProChildRehab study is the second stage in the development of the Deneo KID solution. It focuses on the needs of professionals working with children and decision-makers for a digital solution designed to facilitate the exchange of information about children with disabilities. The ProChildRehab study was approved by the CHU de Brest territory ethics committee on 14/03/2024. Since then, interviews have been carried out with 18 health, education and leisure professionals working with children with disabilities (psychologist, PRM doctor, specialist teacher, AESH, Handisport leader, etc.) and 6 decision-makers (health executive, SESSAD director, Handisport manager, etc.). Further interviews are planned, as data saturation has not yet been reached (there is some redundancy in the answers, but new ideas are still being contributed). Analysis of these interviews is underway (an iterative process in qualitative research, with analysis concurrent with data collection). Initial results suggest that the views of patients concerned by this future digital solution should be taken into account. Indeed, there is no consensus on several points, such as the psychological information that could be shared by the child and his parents with professionals via the platform (e.g. the child's morale), the fact of sharing photos of daily life and therefore quite intimate (e.g. photos of the house), the usefulness of proposing self-rehabilitation exercises to patients via the platform (rehabilitation overload for children vs. ensuring continuity of services), or the perception of what the child's "reality" is (e.g. professionals who ask for more information on the child's reality to better support him/her vs. other professionals who say that this information is confidential). The investigators would therefore like to explore with young people the acceptability of certain features, particularly in terms of the information that is acceptable for them to exchange about their health via this platform. The aim is to question people who could be concerned by the sharing of information through this future solution, i.e. young people with disabilities who are living or have lived through the care of a child with a disability. These initial data obtained and the need to go out and interview patients corroborate with the literature on the subject, which highlights the gaps between patients' and clinicians' perceptions of their needs and interests with regard to e-health and advocates an "alignment of concerns" on both sides.
Phase
N/ASpan
106 weeksSponsor
University Hospital, BrestBrest
Recruiting
Healthy Volunteers
Thoracic Fluid Content During Stabilization and Therapeutic De-escalation in Septic Shock
During the resuscitation phase of shock, fluid administration represents one of the cornerstones of care in order to increase cardiac output and improve microvascular blood flow. However, inappropriate fluid administration can increase tissue edema which compromises recovery after the resolution of shock state. Recently, Sakr et al. demonstrated that a higher fluid balance at 72 hours was associated with hospital mortality after septic shock. Furthermore, an administration of more than 5 liters of fluid during the first ICU stay was independently associated with an increase in mortality and hospital costs. Therefore, treating fluid removal appears to be a key component of the de-escalation phase of shock. Thus, all valuable parameters which potentially reflect tissue edema may help clinicians to individualized the necessity of fluid removal during the stabilization and de-escalation phase of shock. Among them, extra-vascular lung water (EVLW) measured with trans-pulmonary thermodilution is able to detect changes in thoracic fluid content but needs to be monitored invasively and only sequential values are recorded (each thermodilution measure). On the other hand, lung ultrasonography may help clinicians to assess fluid overload but its ability to quantify thoracic fluid content is difficult and subjective. Bio reactance is a non-invasive, rapid and continuous method to measure body fluid compartment. All measures can be performed at bedside. Bio reactance monitoring devices allow measurement of hemodynamic parameters such as cardiac index or stroke volume but also Thoracic Fluid Content (TFC). TFC is measured through the changes in impedance of thoracic tissue to the electrical current. This parameter represents the whole fluid content in the thorax (intravascular, extravascular and intra-pleural). TFC has already been evaluated in several context. During hemodialysis, TFC is correlated to the amount of fluid removal and might help clinician to improve hemodialysis session management in ICU. In cardiac surgery, electrical impedance is correlated with changes in fluid balance. In ICU, TFC is able to predict a mechanical ventilation weaning failure with a moderate accuracy (AUC 0.69 [0.57 - 0.8], bet cut-off value > 50 k.Ω-1) in patients with moderate to severe alteration of left ventricular ejection fraction. The main objective of the current study will evaluated correlation between thoracic fluid content (TFC) measurement and other valuable indices of fluid overload used at bedside. Secondary objectives will be to evaluate association between TFC and other clinical outcomes (organ dysfunction, mortality and quality of life after hospital living).
Phase
N/ASpan
105 weeksSponsor
University Hospital, BrestBrest
Recruiting
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
Phase
N/ASpan
87 weeksSponsor
Clinique Pasteur LanrozeBrest
Recruiting
Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence (PREDICT-CE)
Phase
N/ASpan
237 weeksSponsor
University Hospital, BrestBrest
Recruiting
Observatory of Immunological Thrombopenic Purpura in the Brest Region
Creation of a global clinical and biological database for all patients diagnosed, treated and followed for ITP in the University Hospital of Brest. UHB is the regional reference center (competence center) on hemorrhagic diseases. Dr Pan-Petesch, who is responsible of the local competence center, is affiliated to the national sector of auto-immune cytopenias CERECAI-MARIH).
Phase
N/ASpan
1067 weeksSponsor
University Hospital, BrestBrest, Bretagne
Recruiting
Follow-up of the Systemic Lupus Erythematosus Cohort as Part of the Multidisciplinary Consultation at Brest CHRU
Phase
N/ASpan
522 weeksSponsor
University Hospital, BrestBrest
Recruiting