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At least 1,207 records · Page 67Linked to original sources

The evaluation of radioactive microsphere data: remarks on the use of the BMDP and SAS statistical software packages.

We investigated the suitability of BMDP and SAS as an integrated tool for the evaluation of regional blood flow data obtained from the radioactive microsphere technique. Both packages were applied to a recent study on muscle blood flow with a 3-factorial design. The organization of data and files, the strategy of data reduction, and the evaluation by means of statistical and graphical techniques are shown. The method may be applied to any microsphere study design. A considerable amount of time can be saved and data integrity may be improved. The statistical quality of the results may benefit from the broad spectrum of statistical tests available.

Algorithms↗

Pharmacodynamics and pharmacokinetics of cefdinir, an oral extended spectrum cephalosporin.

BACKGROUND: Oral second and third generation cephalosporins are undergoing continuing research and development in the arena of pediatric infectious disease in an attempt to fill voids created by existing agents in the quest for the "ideal" antimicrobial. This paper reviews the in vitro antimicrobial activity (pharmacodynamics) and pharmacokinetics of cefdinir, an extended spectrum oral cephalosporin, with an emphasis on those aspects relevant to the pediatric patient population. METHODS: A MEDLINE literature search was conducted for the years 1985 through 2000, identifying all English language papers examining the in vitro antimicrobial activity and human pharmacokinetics of cefdinir. Bibliographies of these papers were reviewed, as were relevant data on file with the manufacturer. DATA SYNTHESIS: Cefdinir exhibits broad range in vitro activity against Gram-positive and Gram-negative aerobes. It exhibits superior activity against Gram-positive aerobes, compared with drugs like cefixime, ceftibuten, cefuroxime and cefpodoxime. In addition it is stable to hydrolysis by many of the common betalactamases. The pharmacokinetic parameters of cefdinir in children are similar to those obtained in adults using similar milligram per m2 doses (300, 600 mg in adults = 7, 14 mg/kg in children, respectively). CONCLUSIONS: The pharmacodynamic and pharmacokinetic characteristics of cefdinir as described in this paper, as well as the results of the clinical trials program, support the use of this agent in the treatment of a wide variety of pediatric infectious diseases.

Adult↗

Parecoxib for parenteral analgesia in postsurgical patients.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy and safety studies, adverse effects, drug interactions, and dosage and administration of parecoxib sodium, a selective cyclooxygenase-2 (COX-2) inhibitor. DATA SOURCES: Information was obtained from MEDLINE searches of the English-language literature (1996-May 2003). Search terms included parecoxib, parecoxib sodium, SC-69124A, and selective cyclooxygenase-2 inhibitor. STUDY SELECTION AND DATA EXTRACTION: We reviewed available literature, which included abstracts, clinical trials, and data on file with the manufacturer. DATA SYNTHESIS: Parecoxib sodium is a novel selective COX-2 inhibitor under development for parenteral administration. It has produced efficacious analgesia following dental, gynecologic, and orthopedic surgery. The adverse effect profile has been compared with that of ketorolac; no statistically significant differences were identified. There are no documented drug interactions when parecoxib is coadministered with midazolam, propofol, or unfractionated heparin. CONCLUSIONS: Parecoxib sodium is in the final stages of Phase III trials and has a favorable safety and efficacy profile. Its place in moderate to severe postsurgical pain management will be further defined when more pharmacoeconomic and postmarketing safety data are available. Theoretical benefits are its lower potential for gastrointestinal adverse effects compared with ketorolac and lower opioid requirements after surgery.

Cyclooxygenase Inhibitors↗

[Exclusivity of data in drug registration files and Israel's international status with regard to intellectual property rights protection].

Protecting intellectual property rights encourages creativity and innovation, which are key measures for research and development of new drugs and also promotes the introduction of drugs to new markets. Over the past years, many countries have enacted laws implementing the protection of data in drug registration files. Until recently, Israel has not provided any form of data protection. Current moves focus on new legislation granting exclusivity in the marketing of innovative drugs. Although controversial, this legislation aims to secure balance in Israel between the innovative pharmaceutical companies and the public's interest in competitive generic drugs.

Copyright↗

Efficient analysis and extraction of MS/MS result data from Mascot result files.

BACKGROUND: Mascot is a commonly used protein identification program for MS as well as for tandem MS data. When analyzing huge shotgun proteomics datasets with Mascot's native tools, limits of computing resources are easily reached. Up to now no application has been available as open source that is capable of converting the full content of Mascot result files from the original MIME format into a database-compatible tabular format, allowing direct import into database management systems and efficient handling of huge datasets analyzed by Mascot. RESULTS: A program called mres2x is presented, which reads Mascot result files, analyzes them and extracts either selected or all information in order to store it in a single file or multiple files in formats which are easier to handle downstream of Mascot. It generates different output formats. The output of mres2x in tab format is especially designed for direct high-performance import into relational database management systems using native tools of these systems. Having the data available in database management systems allows complex queries and extensive analysis. In addition, the original peak lists can be extracted in DTA format suitable for protein identification using the Sequest program, and the Mascot files can be split, preserving the original data format. During conversion, several consistency checks are performed. mres2x is designed to provide high throughput processing combined with the possibility to be driven by other computer programs. The source code including supplement material and precompiled binaries is available via http://www.protein-ms.de and http://sourceforge.net/projects/protms/. CONCLUSION: The database upload allows regrouping of the MS/MS results using a database management system and complex analyzing queries using SQL without the need to run new Mascot searches when changing grouping parameters.

Databases, Factual↗

On-line analysis of neuromuscular bioelectric potentials.

A computer system is presented which provides for on-line data capture and analysis of evoked end-plate potentials and action potentials, and on-line data capture with off-line analysis of spontaneously occurring miniature end-plate potentials at the end-plate region of the neuromuscular junction. Sampling of evoked waveforms begins after an adjustable delay following the stimulus. Spontaneously occurring waveforms are captured by 'freezing' the contents of a circular buffer. The software provides MENU selectable support functions including storage and retrieval of data and calculated parameters, analog and digital display of waveforms, data calibration and gain modification, data editing, file management, and hardcopy output. Calculated parameters of the waveform are optionally placed in a data base file by the analysis programs. The data base may be used for editing, arithmetic operations, and subsetting of variables as well as statistical analysis and plotting of any selected variables.

Action Potentials↗

The availability of references and the sponsorship of original research cited in pharmaceutical advertisements.

BACKGROUND: The primary goal of pharmaceutical advertisements is to convince physicians to prescribe the manufacturer's product. We sought to determine what materials are cited in support of claims in pharmaceutical ads and medical research articles, and whether health care professionals seeking to verify the claims could obtain these references. METHODS: We reviewed 438 unique ads from the 1999 issues of 10 American medical journals, and a random sample of 400 references in medical research articles selected from the same journals. We classified references as journal article, data on file, meeting abstract or presentation, book or monograph, marketing report, prescribing information, government document or Internet site. We attempted to confirm or obtain each reference through library and Internet searches or by direct request from the manufacturer. The main outcome we sought to determine was the availability of the reference to a clinician. We also ascertained the source of funding for original research cited in the ads and the research articles. RESULTS: In the 438 ads with medical claims, 126 contained no references and 312 contained 721 unique references. Of these ad references, 55% (396/721) cited journal articles and 19% (135/721) cited data on file. In contrast, in the sample of research article references, 88% (351/400) cited journal articles and 8% (33/400) cited books. Overall, 84% of the citations from the ads were available: 98% of journal articles, 86% of books, 71% of meeting abstracts or presentations and 20% of data-on-file references. In all, 99% of the sample of research article references were available. We determined that 58% of the original research cited in the pharmaceutical ads was sponsored by or had an author affiliated with the product's manufacturer, as compared with 8% of the articles cited in the research articles. INTERPRETATION: Many pharmaceutical ads contain no references for medical claims. Although references to journal articles were usually obtainable, other published sources were not as easily acquired. The majority of unpublished data-on-file references were not available, and the majority of original research cited to substantiate claims in the pharmaceutical ads was funded by or had authors affiliated with the product's manufacturer.

Advertising↗

Distributed structure-searchable toxicity (DSSTox) public database network: a proposal.

The ability to assess the potential genotoxicity, carcinogenicity, or other toxicity of pharmaceutical or industrial chemicals based on chemical structure information is a highly coveted and shared goal of varied academic, commercial, and government regulatory groups. These diverse interests often employ different approaches and have different criteria and use for toxicity assessments, but they share a need for unrestricted access to existing public toxicity data linked with chemical structure information. Currently, there exists no central repository of toxicity information, commercial or public, that adequately meets the data requirements for flexible analogue searching, Structure-Activity Relationship (SAR) model development, or building of chemical relational databases (CRD). The distributed structure-searchable toxicity (DSSTox) public database network is being proposed as a community-supported, web-based effort to address these shared needs of the SAR and toxicology communities. The DSSTox project has the following major elements: (1) to adopt and encourage the use of a common standard file format (structure data file (SDF)) for public toxicity databases that includes chemical structure, text and property information, and that can easily be imported into available CRD applications; (2) to implement a distributed source approach, managed by a DSSTox Central Website, that will enable decentralized, free public access to structure-toxicity data files, and that will effectively link knowledgeable toxicity data sources with potential users of these data from other disciplines (such as chemistry, modeling, and computer science); and (3) to engage public/commercial/academic/industry groups in contributing to and expanding this community-wide, public data sharing and distribution effort. The DSSTox project's overall aims are to effect the closer association of chemical structure information with existing toxicity data, and to promote and facilitate structure-based exploration of these data within a common chemistry-based framework that spans toxicological disciplines.

Carcinogens↗

["ARCHIDIA": a system for patients' data collection and computerized filing. Part I. Methodology].

This report describes a computer based program of patient clinical data collection: the ARCHIDIA system. The project relies on descriptive analysis of clinical events according to well defined methodological criteria. This allows the formulation of a concise diagnosis which is, at the same time, exhaustive of all essential information. Two are the basis principles of this methodology: To define, as accurately as possible, the logical steps necessary to elaborate the diagnosis, that is construed by a sequence of codes. To define all the conditions that must be followed so to use any code in a controlled and independent way. These criteria were derived from literature. The major claim of the system is likely to be the introduction of a "common language" between different ICUs. Uniformed diagnostic and clinical criteria are the main source of large data collection for descriptive, analytic and prospective studies. After a one year pilot study performed by 4 ICUs, ARCHIDIA was used, in 1991, by 20 centers from the area of Milan, Pavia, Como, Varese (70% of total) and 4148 patient data were collected. A descriptive analysis will be reported in the following paper.

Electronic Data Processing↗

Development of a predictive model for biodegradability based on BIODEG, the evaluated biodegradation data base.

A file of evaluated biodegradation data was used to develop a model for predicting aerobic biodegradability from chemical structure alone. Chemicals were initially divided into three groups: (i) chemicals that degrade rapidly under most environmental conditions without requiring acclimation; (ii) chemicals that degrade slowly or not at all; and (iii) chemicals that are biodegradable, but only after an acclimation period. Chemicals in the first two groups were then used to develop a model for classifying chemicals as rapidly or not rapidly biodegradable. The model is based on linear regression against 34 preselected substructures, and correctly classifies 92% (211 or 229) of the chemicals in the final training set.

Aerobiosis↗

Development of the toxicological files in environmental chemicals data and information network (ECDIN).

A computer-based data network containing information on potentially toxic chemicals released into the environment is being developed by the Joint Research Centre of the Commission of the European Communities and by research institutions in the member states as part of a program for environmental research. The information requested daily by toxicologists involved in administration, scientific research, and clinical or forensic toxicology covers different fields or disciplines. The data base, which is still in a pilot phase, collects data on environmental chemicals (about 30,000) spread over more than 100 data fields. These include identification; physical and chemical properties; analytical methods; economic data; hazard classifications for transport, handling and storage; waste disposal; environmental dispersion and transformation; toxicology: acute and chronic effects, carcinogenicity, mutagenicity, behavioral effects; occupational air standards, first-aid treatments in case of poisoning or environmental disaster. Data stored in the data bank are original literature data which have been evaluated by specialists.

Data Collection↗

[Digital filing system for medical image data].

To establish practical, effective medical digital image filing systems, various problems remain to be solved. The authors focused on 2 such problems of great importance: image data compression and standard specifications for digital data storage. From a variety of image compression algorithms now available, 2D-Color Doppler image compression was clinically investigated using the Joint Photographic Expert Group (JPEG) method. In low grade compression, the images decompressed showed no significant alterations in image quality, however, in higher grades of compression attained through irreversible coding in the JPEG method, the images showed subtle but significant alterations: emergence of 2 kinds of artifact, i.e., borderline-artifact produced in the DCT procedures and pseudo color spots. The reproducibility of colors was found to be altered by changing the quantization table in the JPEG procedure. It was thought necessary to choose a proper quantization table and examine the DC coefficients (number of pixels) in the DCT procedure to attain practical 2D-Color Doppler image compression by the JPEG method. Although attempts in Japan are being made to establish common standards for electronic data storage, based on MEDIS, in an effort to promote standardization there are many problems to be solved before practical use is possible. To ensure common availability as required by the technical standards, it is necessary to organize minimum-required specifications into common standards and make them open to the public.

Algorithms↗

Prediction of the fish acute toxicity from heterogeneous data coming from notification files.

Four descriptors (Molecular weight, log(Pow), hardness and free energy of solvation) were selected to predict, on a training set of heterogeneous chemical compounds, the fish acute toxicity. The data were extracted from 523 notification files of new chemicals stored at the French Department of the Environment. The selection of the descriptors was carried out by using a statistical technique coupling OLS regression and genetic algorithm. The limits of validity for the final equation are discussed by comparing the actual and predicted activities on several compounds.

Algorithms↗

ADL: an integrated database for filing and study of malignant lymphoma patients.

The filing of clinical data must comply with purposes of logical organization for comparisons and evaluations. ADL (Archives of Data on Lymphomas) is an application program of dBASE III plus (Ashton-Tate) for personal computers, especially suitable for filing and studying patients afflicted with malignant lymphoma. It is subdivided into four data files: general data (private data, stage, therapy); disease data (sites of disease by tests and body area); immunological data (lymphocyte subpopulations, globulin and immunoglobulin dosage, delayed hypersensitivity skin tests); lost patients (register of patients not seen for at least 1 year). It has many utilities (descriptive statistics, clinical report, export service). Congruence checks and verification of names and dates input are included. This program stands as a valuable alternative to more traditional filing systems.

Archives↗