Paris Cedex 20, France

A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis

DBTP- Double blind treatment period (24 weeks) ETP - Extension treatment period (28 weeks) OLTP- Open label treatment period (68 weeks) Off-treatment follow up period (52 weeks)

PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

The CLOSE trial (NCT00562289, NEJM 2017) has unambiguously demonstrated the superiority of patent foramen ovale (PFO) closure over antiplatelet therapy alone in patients aged up to 60 years with a PFO associated with an atrial septal aneurysm (ASA) or a large right-to-left shunt (so-called "high-risk PFO"), and an otherwise unexplained ischemic stroke. Oral anticoagulant therapy is also a logical approach assuming that PFO-related strokes are due to paradoxical embolism which implies a venous source of embolism, or to direct embolization of a thrombus formed at the atrial level. The CLOSE trial also suggested that oral anticoagulants might reduce stroke recurrence compared to aspirin. There is accumulating evidence that presence of a PFO is significantly associated with cryptogenic stroke in patients over 60 years. Cryptogenic ischemic strokes represent about one third of all ischemic strokes in patients older than 60 years. However, the optimal therapeutic strategy in patients older than 60 years with a PFO and an otherwise unexplained ischemic stroke is unknown, because these patients were excluded from randomized trials. The hypothesis tested in this trial is that transcatheter PFO closure plus long-term antiplatelet therapy is superior to antiplatelet therapy alone and that oral anticoagulant therapy is superior to antiplatelet therapy to prevent recurrent stroke in patients aged 60 to 80 years who have a high-risk PFO and a recent otherwise unexplained ischemic stroke.

Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa

Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant

The AG10-501 ACT-EARLY study is a randomized, multicenter, double-blind, placebo- controlled study of acoramidis for prevention of ATTR (with specific reference to either its cardiomyopathic or polyneuropathic manifestations). Participants will be stratified at randomization. The study population will be asymptomatic carriers of a known pathogenic TTR gene variant. A participant must be 18 to 75 inclusive years of age, and the age of the participant must be no more than 10 years younger than the predicted age of disease onset (PADO) based either on family history (pedigree analysis) or, if family history is insufficient, based on a TTR Variant Actuarial table from published literature. For example, if PADO for a given individual is found to be 50 years, the age of the participant must be between 40 and 75 years inclusive.

Dimensional and Developmental Profiles of Psychosis in Children and Adolescents

This study relates to the organization of a collection of clinical, biological / genetic and radiological (MRI) data from people with a psychotic episode and from their families. These data will be analyzed to clarify whether there is a different response to antipsychotic treatment based on developmental and clinical expression.To answer the question asked in the research, it is planned to include people with at least one psychotic episode,The target population will be a prospective cohort of patients admitted to a hospital or psychiatric clinic for the treatment of psychotic symptoms.Comprehensive medical evaluation will be carried out according to the clinical features and medical history of each patient, to identify medical causes of psychosis. Comprehensive neuropsychological and speech / language evaluation will be completed. A child psychiatrist-diagnostician will complete the Lifetime Dimensions of Psychosis Scale - Child and Adolescent version at baseline. When the patient and parents agree, structural and functional MRI examinations will also be completed, and blood will be drawn for DNA extraction and analysis. Selected assessments (including evaluation of treatment response to specific antipsychotic drugs) will be performed at follow-up visits after 1, 3 and 5 years.

Periodontitis and Inflammation: Study on Biological Samples

It's a cross-sectional, monocenter prospective, open-label, non randomized case control study to collect tissue, crevicular, salivary, and serum samples as part of the patient's routine care in oral medicine departments to form a biological collection. The samples and the clinical data of the patients. Patients will be recruited in the oral medicine departments of AP-HP Charles Foix hospital (Ivry/seine) by periodontists in three groups (Cases : Group 1 : Gingivitis, Group 2 : Periodontitis, and Controls = healthy periodontium. All patients will require surgical care). The time-line of the research is consistent with the usual patient management in oral medicine departments. Inclusion period is 36 months. There is no specific follow-up due to the research. Gingival tissue sampling during surgery of patients will be performed after their inclusion. Assessment Criteria : 1. Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by imaging on sections. 2. Identification by immunohistofluorescence (on tissues) of the expression of matrix proteins described as regulating neutrophil function, and search of co-location between these proteins and certain neutrophil subtypes. 3. Identification by immunohistofluorescence (on tissue) of key bacteria of oral dysbiosis in periodontitis, and search for co-localization between these bacteria and certain neutrophil subtypes. 4. Assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within tissue neutrophils during periodontal health, gingivitis and periodontitis. 5. Differentiation and activity of osteoclasts in co-culture with isolated oral /blood neutrophils in patients.

Validation of a Digital Multidimensional Assessment Tool for the Elderly in Geriatric Consultations

The use of digital tools on tablets to gather information from patients is on the increase. Numerous computerised tools exist for identifying health problems and have been validated in the medical world. However, there are currently no digital tools adapted to the elderly in a consultation context. In this project, the investigators want to carry out a cross-sectional observational study to assess the validity of a multidimensional assessment tool on a tablet, self-administered by patients or carers, and also the appropriateness of using it with these groups. Objectives Multidimensional assessment tools have the advantage of enabling several issues to be addressed systematically. In this research, the investigators want to assess the validity of a multidimensional assessment tool in digital format in a population of elderly people and carers. To do this, the investigators intend to use scales that already exist and are usually used in paper format: the ADL and IADL for dependency, the Mini MNA for nutrition, the Cornell and GDS-15 for depression, the mini Zarit for estimating the burden on carers and the Cetaf score and short FES-I for the risk of falling. These assessment tools have been adapted to digital format and brought together to form a comprehensive multidimensional assessment tool. The investigators' first objective was to assess the validity of this set of scales in digital format compared with their original paper versions, but the investigators also want to measure the acceptability of this assessment tool in a geriatric population and among family carers. In addition, the investigators plan to assess the adaptability of this tool and its compatibility in a geriatric consultation setting. Finally, the investigators want to measure doctors' satisfaction with the collection of this information, as a time-saving tool for these professionals. Methods Eighty patients and eighty carers will be included in this study, recruited from the geriatric consultation service (outpatient geriatrics department) at Charles Foix Hospital. These will be people aged over 65, and family carers if it is not possible to carry out the test on a self-administered basis. To do this, the investigators are planning a quantitative study to compare the scores obtained by the digital version of the test with the data described by the doctors in the reports, and in particular the same scales systematically filled in by the medical profession. In addition, the investigators want to analyse what users say and assess their experience of practical issues (grip, legibility, impression of confidentiality when filling in the form in the waiting room, etc.). Outlook A multi-theme self-questionnaire assessment of elderly people and their carers waiting for a consultation would save professionals time (in terms of completion time and calculation of results), make data more secure, save paper and provide a complete and systematic scan of a number of potentially serious risks.

Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples

It's a cross-sectional, monocenter, prospective, open-label, non-randomized case control study to collect saliva and serum samples as part of the patient's routine care in oral medicine department to form a biological collection. Patients will be recruited in the oral medicine department of AP-HP Charles Foix hospital (Ivry/Seine) by periodontists in 2 groups (CASES: Group 1 for children with DS/T21 divided into 2 subgroups according the periodontal health, and CONTROLS: Group 2 divided into 4 subgroups according to the systemic and periodontal health) Inclusion period is 12 months. There is no specific follow-up due to the research. Assessment criteria: - Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by flow cytometry. - Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within blood neutrophils, during periodontal health, gingivitis and periodontitis.

Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

Patients hospitalized in orthogeriatric unit after HFS will be monitored for nocturnal SpO2 with a pulse oximeter continuously during 3 nights. In-hospital complications will be recorded prospectively in all patients, especially the occurrence of delirium with the CAM scale. The hypoxia vs non-hypoxia (more than 20% of the time spent with SpO2<90%) groups will be analyzed for clinical characteristics, comorbidities and medication use. The statistical association between severe post-operative nocturnal hypoxemia and occurrence of delirium will be assessed. The dependance between this association and daytime SpO2 will also be assessed. The potential confirmation of an association between post-operative nocturnal hypoxemia in patients with HFS and the occurrence of delirium will lead the reflection on a clinical trial testing the benefit of oxygen therapy in the prevention of post-operative delirium, to improve the medical care of orthogeriatric patients.

Access HBV Assays - European Union (EU) Clinical Trial Protocol -

Sensitivity to final status on presumed HBV serological marker positive subjects will be calculated. Specificity will be calculated from hospitalized patients and blood donors specimens. False Initial Reactive Rate will be calculated on fresh hospitalized patient samples for Access HBsAg assay only (Qualitative).