Proactively Establishing a Biologic Specimens Repository for Large Clinical Trials: An Idea Whose Time has Come

Large randomized clinical trials are becoming more costly, and resources to support them increasingly scarce. Biologic materials, such as blood, DNA, body fluids, or tissue samples collected and stored as a component of these studies represent an invaluable resource, to answer immediate secondary hypotheses, but also as archived material, linked to the study data, for the use of investigators long into the future. The regulatory climate surrounding the storage and future unconstrained utilization of biologic materials is evolving quickly. It is no longer acceptable simply to store samples and use them in an unbridled and unregulated fashion. Thus, to fully utilize the tremendous potential of biologic samples generated from large clinical trials and their related databases, investigators should consider proactively creating a biologic specimen repository, or biorepository. A repository likely assures appropriate subject consent, sample provenance, secure storage, and codified procedures for sample and data retrieval and sharing that protect the subject's confidentiality, the investigator's need for accurate data, and the limited resource. Importantly, the biorepository specimens/samples are typically collected in addition to local and core specimens obtained for the parent study that provide baseline assessments for safety and efficacy outcomes.     

基于机构知识库构架的眼科知识服务平台建设

目的：构建基于机构知识库构架的眼科知识服务平台,实现机构知识储存管理、学者成果展示分享、眼科文献聚类分析。方法：通过了解国内外机构知识库和专科文献数据库的现实功能和服务模式,分析眼科知识服务平台功能需求,在此基础上搭建机构知识库框架,建立眼科标准术语库,自动采集、清洗文献数据。结果：实验结果显示,平台运行稳定,具备严格的身份认证与权限控制机制;成功构建了医院、科室、学者三级学术成果库,可满足成果分享和科研管理需求;按照中图分类法、眼科专病和眼科主题词3个维度组织眼科文献数据,实现共词、聚类等文献计量分析功能。结论：结合机构知识库和专科数据库理念构建的眼科特色服务平台,可减少科研人员信息获取能力和水平的限制,节省他们的时间和精力。     

军队疾病预防控制网站的设计与实现

目的：建立军队疾病预防控制网站,在全军范围内实现疾控信息发布、资源共享、业务交流,为广大官兵宣传疾病防控、健康维护的相关知识。方法以内容管理系统和元数据仓储平台为基础,采用B／S系统结构,利用JSP、MySQL等编程技术与工具完成系统开发。结果设计实现的军队疾病预防控制网已上线运行,构建了疾控资料库,实现了内容发布、全文检索、知识分类与聚合、在线咨询等一整套功能。结论网站对于展示军队疾控建设工作、宣传相关法规知识、解决广大官兵健康需求、提高基层部队防病能力,都起到了积极的作用。     

高强度聚焦超声肿瘤治疗剂量分析和控制系统

高强度聚焦超声(HIFU)消融治疗肿瘤是一种新兴的热门肿瘤治疗手段,但由于人体组织的复杂性,HIFU治疗的剂量研究是目前的一个难点。对高强度聚焦超声(HIFU)肿瘤治疗剂量控制进行了探讨,从肿瘤的深度、大小、特性和肿瘤生长部位的组织特性等方面进行了分析,利用现有的治疗病例建立知识库,并在此基础上进行推理和自学习,在得到一个新病例的时候可由系统为临床医生提供参考的治疗剂量。     

Heritable disorders of connective tissue: Description of a data repository and initial cohort characterization

We describe a data repository on heritable disorders of connective tissue (HDCT) assembled by the National Institutes of Health's National Institute on Aging (NIA) Intramural Research Program between 2001 and 2013. Participants included affected persons with a wide range of heritable connective tissue phenotypes, and unaffected family members. Elements include comprehensive history and physical examination, standardized laboratory data, physiologic measures and imaging, standardized patient‐reported outcome measures, and an extensive linked biorepository. The NIA made a commitment to make the repository available to extramural investigators and deposited samples at Coriell Tissue Repository (N = 126) and GenTAC registry (N = 132). The clinical dataset was transferred to Penn State University College of Medicine Clinical and Translational Science Institute in 2016, and data elements inventoried. The consented cohort of 1,009 participants averaged 39 ± 18 years (mean ± SD, range 2–95) at consent; gender distribution is 71% F and 83% self‐report Caucasian ethnicity. Diagnostic categories include Ehlers–Danlos syndrome (classical N = 50, hypermobile N = 99, vascular N = 101, rare types and unclassified N = 178), Marfan syndrome (N = 33), Stickler syndrome (N = 60), fibromuscular dysplasia (N = 135), Other HDCT (N = 72). Unaffected family members (N = 218) contributed DNA for the molecular archive only. We aim to develop further discrete data from unstructured elements, analyze multisymptom HDCT manifestations, encourage data use by other researchers and thereby better understand the complexity of these high‐morbidity conditions and their multifaceted effects on affected persons.     

Selected Topics from the 10th Conference on Retroviruses and Opportunistic Infections

Abstract

Purpose: Saliva is a good source of DNA for genomic research, and leukocytes are a predominant source of DNA in human saliva. Advanced human immunodeficiency virus (HIV)-type 1 infection disrupts tonsillar architecture and depletes tonsillar lymphocytes. We tested whether HIV-1 infection reduces extracted human DNA yield from saliva. Methods: Approximately 2 mL of expectorated saliva was collected from HIV-infected adults during routine primary care clinic visits and from healthy, HIV-negative controls. Human DNA was manually extracted and was specifically quantified by assaying for the RNAse P gene. Results: Seventy-five individuals were studied, including 25 HIV-infected adults with <200 CD4+ T cells/mm³ (i.e., acquired immunodeficiency syndrome), 25 with >200 CD4+ T cells/mm³, and 25 HIV-negative controls. Overall DNA yield was 64.7 μg [29.0–139.7 μg] (median [interquartile range]). Yields were comparable among HIV-infected individuals with lower CD4+ T cell counts (74.3 μg [39.4–151.4 μg]), higher CD4+ T cell counts (63.9 μg [29.2–172.1 μg]), and HIV-negative controls (61.4 μg [28.4–123.4 μg]) (p > .05). Conclusion: Infection with HIV-1 does not reduce human DNA yield from saliva. Expectorated saliva should provide sufficient extracted native DNA for genomic studies in HIV-infected individuals.     

Representativeness of enrollment into a perinatal research repository

Objective: To describe enrollment and compare demographic and clinical characteristics of neonates enrolled in the perinatal research repository (PRR) with eligible, but non-enrolled neonates.

Methods: Characteristics from enrolled infants were compared with eligible, but non-enrolled infants using t-tests, Wilcoxon rank tests and χ² tests.

Results: Between 1 January 2010 and 31 December 2011, 622 infants admitted to the neonatal intensive care unit (NICU), born <37 weeks were screened for the PRR were eligible for enrollment. Of these, 233 enrolled in the study. There were no significant differences between enrolled and non-enrolled infants with regard to race, birth weight, gestational age and Apgar scores. Enrolled patients had a significantly longer length of stay [mean (standard deviation)?=?55.0 (58.9) versus 38.0 (45.8)?days; p?p?p?p?Conclusions: These results suggest that a specimen collecting repository can enroll a sufficiently representative sample of eligible patients.     

环境卫生专业规划编制创新点探讨

介绍了环境卫生专业规划常规编制的主要内容,从垃圾源头分类减量减少垃圾渗沥液产生,中水回用于道路水洒保洁,贮粪池存粪调节污水厂BOD浓度,设置储存库回收利用废旧电池等方面对环境卫生专业规划编制创新点进行了探讨.     

高校图书馆机构知识库著作权的合理使用策略

合理使用机构知识库的数字资源,可以提升学术成果引用率和传播范围。在对合理使用制度的研究基础上,以西安交通大学机构知识库合理使用策略的研究与实践为例,从签署共享协议、成立专项服务团队、建立数据流量监控3方面介绍了合理使用策略,提出了完善机构知识库合理使用制度的建议,从而提升学术成果使用率,实现机构知识库的合理使用。     

Opening of the National Biobank of Korea as the Infrastructure of Future Biomedical Science in Korea

On April 26, 2012, the Korea National Institute of Health officially held the opening ceremony of newly dedicated biobank building, ‘National Biobank of Korea’. The stocked biospecimens and related information have been distributed for medical and public health researches. The Korea Biobank Project, which was initiated in 2008, constructed the Korea Biobank Network consisting of the National Biobank of Korea (NBK) with 17 regional biobanks in Korea. As of December 2011, a total of 525,416 biospecimens with related information have been secured: 325,952 biospecimens from the general population obtained through cohort studies and 199,464 biospecimens of patients from regional biobanks. A large scale genomic study, Korea Association Resource (KARE) and many researches utilized the biospecimens secured through Korea Genome Epidemiology Study (KoGES) and Korea Biobank Project (KBP). Construction of ‘National Biobank of Korea’, a dedicated biobank building at Osong means that NBK can manage and check quality of the biospecimens with promising distribution of 26 million vials of biospecimen, which provide the infrastructure for the development of health technology in Korea. The NBK and the National Library of Medicine (to be constructed in 2014) will play a central role in future biomedical research in Korea.