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发布于:2019-2-12 20:17:26  访问:2 次 回复:0 篇
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Towards the finest of our understanding, the only systematic recording of information takes location in the USA within the context of individual projects, namely by the Fragile X Clinical Analysis Consortium (FXCRC), with its FORWARD Registry and Database, and by our Fragile X World Surveys (twice per year, also supported by the U.S. Centers for Illness Manage) [14,33-35]. Equivalent information are required for Europe, like Germany. The manner and setting of care and specific strategies of management of FXS individuals all through the population are certainly not clear. This registry will consequently apply a nonprobability approach to gather information on a sizable sample of individuals (comfort sample). While things and variables from the FORWARD Registry and Database will likely be employed to permit comparisons among the registries, a number ofThe study has been registered in ClinicalTrials.gov under NCT01711606, and within the VFA database. The rationale, aims, and design and style from the study have been previously presented as posters, e.g., in the 2012 meeting in the Deutsche Gesellschaft f Psychiatrie, Psychotherapie und Nervenheilkunde (DGPPN; German Association for Psychiatry, Psychotherapy, and Neurology).Tabase. Study information is going to be archived for a minimum of ten years by the sponsor, CRO, and in the person centres.Adverse eventsitems that are particular towards the German setting have been added (e.g., setting of care). For the characterisation of sufferers and their management, readily available information in the charts might be employed. Further, individuals and their caregivers will be requested to fill out established and validated questionnaires to assess the good quality of life of patients and caregivers too as caregiver burden. Hence, the registry will present the basis to get a comprehensive description on the characteristics and status of FXS sufferers in Germany in PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/27741243 good detail, will enable for gap analyses (comparisons with suggestions), and can most likely contribute for the optimisation of management of this vulnerable patient group in the future.Trial statusInformation on adverse events (AE) and critical adverse events (SAE) connected towards the administration of any drug will probably be collected on standardized types, regardless of causality, and will include things like sort of occasion, occurrence, duration, and intensity. The investigator is requested to assess causality and to report actions taken and outcomes. Details on AE and SAE will likely be processed by the study sponsor, Novartis Pharma, in accordance with established pharmacovigilance guidelines.The set-up and testing with the entry kind as well as the database have been finalised in the end of 2012. The study is at present open for inclusion, and also the initial patient was included in March 2013. By the time of this report (14 November 2013), 33 individuals happen to be incorporated. Recruitment is planned until December 2013, and also the field (documentation) phase in the study will continue PubMed ID:http://www.ncbi.nlm.nih.gov/pubmed/27797473 till December 2015. Most study supplies are obtainable in English, with the exception of some assessment types (e.g., IQ testing applying validated German instruments).Dissemination of information and publicationsDiscussion Information are incomplete regarding various elements of FXS, like epidemiology, clinical and psychosocial traits of individuals, therapy pathways, and patientoriented parameters, like SparsentanProtocol high-quality of life.
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