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Izumi Sato, Yohei Kawasaki, Kazuki Ide, Iori Sakakibara, Keiko Konomura, Hiroshi Yamada, Yasuhiro Tanaka
The National Center Biobank Network (NCBN), consisting of six national centers (NCs) for advanced and specialized medical care, was launched in Japan in 2012 to collect biological specimens and health-related data. The common data formats of the six NCs, however, are not widely known outside the NCs. Therefore, we investigated whether the data elements collected by the NCBN could be made to conform to the international standards of the Clinical Data Interchange Standards Consortium (CDISC). We attempted to map the NCBN data elements (202 items) onto the Study Data Tabulation Model (SDTM), a set of CDISC standards on the submission format of electronic clinical data approved by the Food and Drug Administration...
February 2016: Biopreservation and Biobanking
Dong Li, Han-bing Qi, Guo-zhong Wu
A novel inversion method of optical constants of diesel fuel that is one of semitransparent liquid was developed based on spectral transmittance radio inversion calculation of optical cell with glass-liquid fuel-glass configuration, which was validated by measured the optical constants of water. The measurements of transmittance spectrogram of optical cell filled with diesel fuel in the infrared wavelength 2 - 15 μm at normal incidence were investigated by Bruke V70 FTIR spectrometer. The optical constants and thermal radiative physcial parameters of diesel fuel were achieved...
March 2015: Guang Pu Xue Yu Guang Pu Fen Xi, Guang Pu
Takayuki Anzai, Masamichi Kaminishi, Keizo Sato, Laura Kaufman, Hijiri Iwata, Dai Nakae
The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium)...
April 2015: Journal of Toxicologic Pathology
Yan Deng, Anand Rangarajan, Stephan Eisenschenk, Baba C Vemuri
In this paper, we cast the problem of point cloud matching as a shape matching problem by transforming each of the given point clouds into a shape representation called the Schrödinger distance transform (SDT) representation. This is achieved by solving a static Schrödinger equation instead of the corresponding static Hamilton-Jacobi equation in this setting. The SDT representation is an analytic expression and following the theoretical physics literature, can be normalized to have unit L2 norm-making it a square-root density, which is identified with a point on a unit Hilbert sphere, whose intrinsic geometry is fully known...
June 2014: Proceedings
A Shah, R Botchu, R U Ashford, W J Rennie
OBJECTIVE: Soft-tissue lesions are common and often benign. Owing to the rarity of soft-tissue sarcomas (STSs), evidence has shown that patients are increasingly referred urgently onto the 2-week wait pathway, which may have a detrimental impact on the management of patients with a proven STS. Imaging plays a vital role in lesion characterization and can be used to triage referrals to reduce the caseload of a sarcoma multidisciplinary team (MDT). In our institution, we established a sarcoma diagnostic triage meeting (SDTM)...
May 2015: British Journal of Radiology
Anne S Lindblad, Zorayr Manukyan, Tejashri Purohit-Sheth, Gary Gensler, Paul Okwesili, Ann Meeker-O'Connell, Leslie Ball, John R Marler
BACKGROUND: Site monitoring and source document verification account for 15%-30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification. PURPOSE: To determine whether a central review by statisticians using data submitted to the Food and Drug Administration (FDA) by clinical trial sponsors can identify problem sites and trials that failed FDA site inspections...
April 2014: Clinical Trials: Journal of the Society for Clinical Trials
Wolfgang Kuchinke, J Aerts, S C Semler, C Ohmann
OBJECTIVES: Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. METHODS: Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies...
2009: Methods of Information in Medicine
Douglas B Fridsma, Julie Evans, Smita Hastak, Charles N Mead
OBJECTIVES: The Biomedical Research Integrated Domain Group (BRIDG) project is a collaborative initiative between the National Cancer Institute (NCI), the Clinical Data Interchange Standards Consortium (CDISC), the Regulated Clinical Research Information Management Technical Committee (RCRIM TC) of Health Level 7 (HL7), and the Food and Drug Administration (FDA) to develop a model of the shared understanding of the semantics of clinical research. DESIGN: The BRIDG project is based on open-source collaborative principles and an implementation-independent, use-case driven approach to model development...
March 2008: Journal of the American Medical Informatics Association: JAMIA
Sandhya Xirasagar, Scott F Gustafson, Cheng-Cheng Huang, Qinyan Pan, Jennifer Fostel, Paul Boyer, B Alex Merrick, Kenneth B Tomer, Denny D Chan, Kenneth J Yost, Danielle Choi, Nianqing Xiao, Stanley Stasiewicz, Pierre Bushel, Michael D Waters
MOTIVATION: The CEBS data repository is being developed to promote a systems biology approach to understand the biological effects of environmental stressors. CEBS will house data from multiple gene expression platforms (transcriptomics), protein expression and protein-protein interaction (proteomics), and changes in low molecular weight metabolite levels (metabolomics) aligned by their detailed toxicological context. The system will accommodate extensive complex querying in a user-friendly manner...
April 1, 2006: Bioinformatics
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