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An innovation in flow cytometry data collection and analysis producing a correlated multiple sample analysis in a single file.

The problems associated with rapid analysis and interpretation of data from multicolor immunofluorescence panels have been a formidable barrier to their routine use. Using present flow cytometry concepts, a panel of 11 tubes each containing multiple phenotypic markers or controls requires postdata acquisition manipulation of many multiparameter histogram and listmode files. We have developed a method that compresses all of the information from such a panel into a single listmode data file during run time. A single data file is used to record the entire phenotypic analysis for a particular patient or series within an experiment. This is accomplished by the incorporation of a tube identifier parameter (TIP) as well as the fluorescence and light scatter parameters normally collected. The TIP can then be used for gating discrimination of any tube or set of tubes within a panel. When the TIP is correlated with the PRISM parameter the entire patient phenotypic image can be represented within a single two-parameter histogram we have called a phenogram. This phenogram can be generated in real time, providing on-line preprocessing of a complex multicolor experiment. By examining the image created by the phenogram it is possible to rapidly flag abnormalities such as incorrect gating. This procedure was carried out on an EPICS Elite flow cytometer in its standard configuration with the addition of hardware to provide an input for the TIP.

Data Collection↗

A program designed to facilitate the repetitive acquisition, display, and disk storage of sensory evoked responses.

We present an algorithm that permits automated acquisition, display, and disk storage of single or dual channel sensory evoked potential waveforms using a Pathfinder II evoked response monitor. Once initiated, data acquisition and storage continue at user-specified intervals without additional user input. A cascade screen display provides trend monitoring. The file for data storage is established and searched using standard Pathfinder commands. The algorithm is written in MECOL, the Pathfinder specific programming language. This programming code imposed a number of limitations that had to be overcome to create a versatile and user friendly algorithm. During clinical use in our operating rooms, the program has been found effective and easy to use by both veteran and novice Pathfinder operators. The "hands-off" trend monitoring permitted by this algorithm has reduced the labor-intensive aspect of sensory evoked potential monitoring.

Evoked Potentials, Somatosensory↗

Experience with the use of generalized data base management systems in cooperative group clinical trials (a project of the Gynecologic Oncology Group).

Roswell Park Management Information System (RPMIS) is a formatted video-based system of programs for file creation, data entry, editing, updating, retrieval, and report generation. It has been utilized in more than 800 intrainstitutional research studies at Roswell Park. The Gynecologic Oncology Group (GOG) is a multiinstitutional, multidisciplinary cooperative group. Its clinical trials encompass the planning, initiation, execution, analysis, and presentation of results of management and treatment of patients with gynecologic cancer. The GOG Statistical Office, located at Roswell Park Memorial Institute, is responsible for data management and analysis of all patients entered into GOG protocols. Present annual accrual is approximately 2000 patients per year; 38 protocols are actively accruing patients while follow-up continues on 14 studies that are closed to patient entry. A previous paper (J Med Syst 7:235-242, 1983) described a time study comparing use of RPMIS and a paper batch processing system in GOG data management. The time study results and potential advantages of RPMIS warranted a gradual total conversion to this system. Presently GOG maintains 43 separate, self-contained applications of RPMIS and routinely develops a new system in conjunction with each new study initiated. This paper documents GOG experience with RPMIS during the past 4 years.

Clinical Trials as Topic↗

Fondaparinux for prevention of venous thromboembolism in major orthopedic surgery.

OBJECTIVE: To review clinical information related to fondaparinux, a synthetic pentasaccharide recently approved for the prevention of deep-vein thrombosis (DVT) in patients undergoing major orthopedic surgeries and for extended DVT prophylaxis after hip fracture surgery. DATA SOURCES: Primary and review articles were identified by MEDLINE (1983-June 2003) using the key words pentasaccharide, Org31540, SR90107A, DVT prophylaxis, and fondaparinux. Additional sources were found listed in articles, abstracts, and unpublished data on file from the manufacturer. Articles selected were based on their coverage of the pharmacology, pharmacokinetics, safety, and efficacy of fondaparinux. STUDY SELECTION AND DATA EXTRACTION: All of the articles identified were evaluated and all information deemed relevant was included. DATA SYNTHESIS: Fondaparinux is a selective antithrombin-dependent, indirect inhibitor of activated factor Xa. It has a favorable and predictable pharmacokinetic profile when administered subcutaneously, and has a long half-life, allowing once-daily dosing. Fondaparinux lacks in vitro cross-reactivity with heparin-induced antibodies. Major Phase III studies have demonstrated that subcutaneous fondaparinux sodium 2.5 mg given at least 6 hours postoperatively resulted in a 55% reduction in the risk of venous thromboembolism (VTE) in patients undergoing hip fracture surgery, total hip replacement surgery, or knee replacement surgery compared with standard enoxaparin therapy. It has a safety profile similar to that of enoxaparin with respect to clinically relevant major bleeding, including fatal bleeding, nonfatal bleeding, and bleeding requiring repeat surgery. The use of fondaparinux for prolonged prophylaxis after hip fracture has demonstrated further reduction in VTE events without increasing the risk of bleeding. CONCLUSIONS: Fondaparinux is the first of a new class of synthetic factor Xa inhibitors that demonstrated greater efficacy compared with enoxaparin for the prevention of VTE in major orthopedic surgery without an increase in clinically relevant bleeding. Given the favorable cost-effectiveness analysis and improved efficacy profile, fondaparinux should be considered for formulary addition for DVT prophylaxis in patients undergoing hip and knee replacement surgery. In patients undergoing hip fracture surgery, fondaparinux should be considered the DVT prophylaxis of choice. Extended thromboprophylaxis up to 28 days resulted in additional reduction in VTE (both symptomatic and venography-proven DVT) in patients with hip fracture surgery.

Adult↗

Safety, permanency, and in-home services: applying administrative data.

This article describes the construction and use of safety and permanency indicators, two aspects of a full set of indicators that also includes child well-being and family functioning. The indicators were constructed from Philadelphia's Family and Child Tracking System and were used to examine the city's Services to Children in their Own Home (SCOH) program. Cohort datasets were constructed through the use of extract files, and two independent data file construction algorithms were employed to calibrate the accuracy of the data construction process. The primary unit of analysis was the "family" spell in SCOH services. Contextual variables included family structure, race, and service intensity. The indicators associated with SCOH spells included reports of maltreatment after service, founded maltreatment after service, and out-of-home placement after service. Event history techniques were used to conduct the data analysis. Baseline indicator data for Philadelphia are presented, and future uses for such data are discussed.

Child↗

A study design to measure the outcomes of education in data security issues among health care professionals.

The purpose of this paper is to describe a study design compiled to measure the outcomes of education in health care data security issues. Based on previous studies the knowledge in data security is not very comprehensive and health care professionals feel that they need more education and training in information technology, specially in the filed of data security issues.

Computer Security↗

Prevention of nonvertebral fractures by alendronate. A meta-analysis. Alendronate Osteoporosis Treatment Study Groups.

OBJECTIVE: To evaluate the effect of treatment with alendronate sodium, a potent aminobisphosphonate, on the incidence of nonvertebral fractures in postmenopausal women with osteoporosis. DATA SOURCES: Published data and data on file at Merck Research Laboratories. STUDY SELECTION: All completed prospective, randomized, placebo-controlled alendronate trials of at least 2 years' duration (5 studies). DATA EXTRACTION: All subjects were women with osteoporosis between the ages of 42 and 85 years, postmenopausal at least 4 years, with lumbar spine bone mineral density (measured using dual-energy x-ray absorptiometry) at least 2.0 SD below the mean for young adult women. All women randomized to treatment with placebo or alendronate at a dose higher than 1 mg per day for at least 2 years were included. DATA SYNTHESIS: In the placebo group (n=590), 60 women reported nonvertebral fractures during 1347 patient-years at risk (overall rate, 4.45 women with fractures per 100 patient-years at risk). In the alendronate group (n = 1012), 73 women reported nonvertebral fractures during 2240 patient-years-at risk (overall rate, 3.26 women with fractures per 100 patient-years at risk). The estimated cumulative incidence of nonvertebral fractures after 3 years was 12.6% in the placebo group and 9.0% in alendronate group. The relative risk for nonvertebral fracture estimated using the Cox proportional hazards model was 0.71 (95% confidence interval,0.502-0.997) (P=.048). A reduction in risk was consistent across each of the studies and at each major site of osteoporotic fracture, including the hip and wrist. CONCLUSION: In postmenopausal women with osteoporosis, treatment with alendronate reduces the risk of nonvertebral fractures over at least 3 years.

Adult↗

Long-term changes in medication during pregnancy.

The Finnish Register of Congenital Malformations, established in 1963, rendered possible the study of changes in medication during pregnancy. The study consisted of 659 control mothers who had delivered a healthy child during the years 1964-1984. The data of this long-term follow-up study were collected by interviews at Maternal Health Care Centers after delivery and were completed by filed antenatal data. The results show a continuous decreasing trend in the usage of analgesics and tranquilizers but not in the usage of antiemetics, antibiotics, and vitamins. We believe that in Finland the publicity aimed at unnecessary medication during pregnancy has affected both the mothers and the health personnel.

Analgesics↗

[Analysis of factors affecting the results of assisted reproduction using a system for information mining of the SHLUK database].

OBJECTIVE: To retrospective explorating computer analysis of data about therapeutic cycles in assisted reproduction technology (ART) to confirm applicability of system for data mining SHLUK in partial analysis of fertilisation phase of therapeutic cycle. Relations between parameters of sperm count analysis and outcome of in vitro fertilisation were analyzed. DESIGN: Retrospective analysis. SETTING: 1st Depart of Obstet. and Gynaecol., Masaryk University, Brno; FEI, VSB, Ostrava. METHODS AND MATERIAL: Conditions of successful therapy in single phases of ART therapeutic cycles, were analysed using system SHLUK, which included a lot of methods for data mining. Analysis of relation between reasons and results in ART therapeutic cycles was done through method IMPL and method of group implication GRIMPL. Analysed file included data about 8516 therapeutic cycles ART in 4470 patients and data about 666 clinical pregnancies stored in electronical form in clinical data register. The model analysis of fertilisation tested relations between parameters of sperm analysis and outcome of in vitro fertilisation. Fertilisation rate (FR)--ratio of fertilized oocytes/obtained oocytes was evaluated as fertilisation stage outcome. RESULTS: Significantly higher FR--60.9% was in the group with sperm concentration before preparation 41-60 mil/ml. When sperm concentration before preparation was under 10 mil/ml--FR was significantly lower--42.2%. Motility of sperm before preparation under 10%--FR was significantly lower--45.3%. Motility of sperm before preparation 41-50%--FR was significantly higher--56.9%. Significantly higher FR--minimal 56.0% was in group of examinations with sperm after preparation was 41-90%, then FR was significantly higher--53.5%. In sperm survival test, where more than 30% of sperm survive 24 hours of cocultivation with oocytes FR was significantly higher--minimal 55.9%. CONCLUSION: Applicability of system for data mining SHLUK in the analysis of factors with influence on assisted reproduction outcome was proved. System for data mining SHLUK makes possible to define statistically significant relations between attributes of fertilisation stage of ART cycles and it is able to postulate basic hypothesis about existing reasons and results in therapeutic cycles of ART.

Data Interpretation, Statistical↗

[Fabrication of 3-dimensional skull model with rapid prototyping technique and its primary application in repairing one case of cranio-maxillo-facial trauma].

OBJECTIVE: To investigate the methods of establishing 3-dimensional skull model using electron beam CT (EBCT) data rapid prototyping technique, and to discuss its application in repairing cranio-maxillo-facial trauma. METHODS: The data were obtained by EBCT continuous volumetric scanning with 1.0 mm slice at thickness. The data were transferred to work-station for 3-dimensional surface reconstruction by computer-aided design software and the images were saved as STL file. The data can be used to control a laser rapid-prototyping device (AFS-320QZ) to construct geometric model. The material for the model construction is a kind of laser-sensitive resin power, which will become a mass when scanned by laser beam. The design and simulation of operation can be done on the model. The image data were transferred to the device slice by slice. Thus a geometric model is constructed according to the image data by repeating this process. Preoperative analysis, surgery simulation and implant of bone defect could be done on this computer-aided manufactured 3D model. One case of cranio-maxillo-facial bone defect resulting from trauma was reconstructed with this method. The EBCT scanning showed that the defect area was 4 cm x 6 cm. The nose was flat and deviated to left. RESULTS: The 3-dimensional skull was reconstructed with EBCT data and rapid prototyping technique. The model can display the structure of 3-dimensional anatomy and their relationship. The prefabricated implant by 3-dimensional model was well-matched with defect. The deformities of flat and deviated nose were corrected. The clinical result was satisfactory after a follow-up of 17 months. CONCLUSION: The 3-dimensional model of skull can replicate the prototype of disease and play an important role in the diagnosis and simulation of operation for repairing cranio-maxillo-facial trauma.

Adult↗

The Chemnitz LogAnalyzer: a tool for analyzing data from hypertext navigation research.

Computer-based studies usually produce log files as raw data. These data cannot be analyzed adequately with conventional statistical software. The Chemnitz LogAnalyzer provides tools for quick and comfortable visualization and analyses of hypertext navigation behavior by individual users and for aggregated data. In addition, it supports analogous analyses of questionnaire data and reanalysis with respect to several predefined orders of nodes of the same hypertext. As an illustration of how to use the Chemnitz LogAnalyzer, we give an account of one study on learning with hypertext. Participants either searched for specific details or read a hypertext document to familiarize themselves with its content. The tool helped identify navigation strategies affected by these two processing goals and provided comparisons, for example, of processing times and visited sites. Altogether, the Chemnitz LogAnalyzer fills the gap between log files as raw data of Web-based studies and conventional statistical software.

Adult↗

Connecticut's new comprehensive and universal early childhood health assessment form.

Health assessments are required for entrance into child care, Head Start, and preschool programs. However, state and federal screening and documentation mandates vary, and programs create their own forms for keeping required data on file. Inconsistent recording formats present challenges for primary care providers who must document each child's health status and for program administrators who wish to collect data across groups of children. This article describes how the passage of new legislation in Connecticut establishing a statewide prekindergarten program presented the opportunity to develop a comprehensive early childhood health form for all early childhood programs, which promotes children's access to health services and coordination of care among health care professionals, early childhood providers, and families.

Child Day Care Centers↗

Review of in vitro activity, pharmacokinetic characteristics, safety, and clinical efficacy of cefprozil, a new oral cephalosporin.

OBJECTIVE: To review the pharmacokinetics, microbiology, clinical efficacy, safety, and tolerance of cefprozil, a new, broad-spectrum oral cephalosporin. DATA SOURCES: Published clinical trials and microbiologic, pharmacokinetic, and safety data were identified by MEDLINE; additional references were derived from bibliographies of these articles; microbiologic data on file were provided by Bristol-Myers Squibb. STUDY SELECTION: Only published comparative clinical trial reports are included in the review of clinical efficacy. Noncomparative clinical data pertaining to uses of cefprozil not approved by the Food and Drug Administration are not included. DATA SYNTHESIS: Data are presented on the in vitro microbiologic activity of cefprozil against 10,152 bacterial isolates, including most of the clinically important streptococci (e.g., Streptococcus pyogenes, Streptococcus pneumoniae), beta-lactamase-positive and -negative Staphylococcus aureus and Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Clostridium difficile, and numerous other gram-negative aerobes and anaerobes. In clinical trials, cefprozil appears to be at least as effective as commonly used comparison agents such as cefaclor, cefixime, and amoxicillin/clavulanic acid. Additionally, cefprozil is better tolerated than the latter two agents, especially with regard to gastrointestinal adverse effects. CONCLUSIONS: Cefprozil is a broad-spectrum cephalosporin that provides coverage against both gram-negative and -positive bacteria that may cause otitis media, pharyngitis/tonsillitis, skin and skin-structure infections, secondary bacterial infection of acute bronchitis, and acute bacterial exacerbations of chronic bronchitis. The beta-lactamase stability of cefprozil appears to exceed that of other oral cephalosporins for some important pathogens. Cefprozil is used primarily for second-line treatment as less-expensive, first-line generic alternatives generally are available. Cefprozil demonstrates clinical advantages over many other orally administered beta-lactam antibiotics in terms of antimicrobial spectrum, a once- or twice-daily dosing regimen, and/or reduced incidence of adverse effects.

Administration, Oral↗

Risk factors for prostate cancer.

PURPOSE: To review the current state of knowledge regarding risk factors for prostate cancer. DATA SOURCES: Analysis of the literature through the use of MEDLINE as well as identification of papers through review of article bibliographies and the authors' personal files. Current data were also extracted from the Surveillance, Epidemiology, and End Results Program (SEER) database. DATA SELECTION: A review of risk factors for the development of prostate cancer. Emphasis was placed on identifying larger, controlled studies. DATA SYNTHESIS: The clinical incidence of prostate cancer is increasing. Risk factors for prostate cancer appear to include age, race, positive family history, vasectomy, and dietary fat intake. CONCLUSIONS: It appears that prostate cancer results from an interplay between endogenous hormones and environmental influences that include, most prominently, dietary fat.

Aged↗

[Establishment of minimum medical geographic information systems database in China].

OBJECTIVE: To establish a minimum medical geographic information systems (GIS) database as a spatial decision supporting system (SDSS), and to use the database into public health practice in China. METHODS: Spatial data collected from different sources were standardized as decimal degree format, including: (1) satellite images covering areas of China; (2) digital maps of China in vector files; (3) diseases database and relevant models. RESULTS: Necessary satellite images for the database have been collected from NOAA AVHRR, Landsat TM, etc., including the normalized difference vegetation index (NDVI) images from AVHRR, earth surface temperature images from AVHRR, GTOPO30 DEM images from USGS and landuse images from USGS. The digital vector files for GIS analysis were collected including political (county, provinces, country) boundaries file, environmental (drainage, land cover, soil type) vector file, population data and climate data; Data on diseases mainly generated from survey or case reporting. Relevant models on transmission of Schistosoma japonicum and Plasmodium vivax, and models of Oncomelania hupensis and Anophores sinansis were developed, and the relevant environmental factors related to incidence of cancers were mapped, to test and verify those database. CONCLUSION: The database unified the data from different sources for users. Minimum medical data included in the database could be used in the practice of public health. It is expected that this database be used in a wider range.

Animals↗

Racial and community factors influencing coronary artery bypass graft surgery rates for all 1986 Medicare patients.

OBJECTIVE: This study examines the differences in the rates of coronary artery bypass grafting (CABG) between white and black Medicare patients. DESIGN: This is a cross-sectional study with data from the 1986 Health Care Financing Administration hospital claims records on all Medicare patients, the 1988 update of the Bureau of Health Professions area resource file, and the 1985 Census Bureau's county population estimates file. SETTING: Data are from all Medicare patients in the United States in 1986. MAIN OUTCOME MEASURES: Sex- and age-adjusted CABG rates for whites and blacks over the age of 65 years were computed for each of 50 states and 305 Standard Metropolitan Statistical Areas (SMSAs). RESULTS: Nationally the CABG rate was 27.1 per 10,000 for whites (40.4 for white men and 16.2 for white women), but only 7.6 for blacks (9.3 for black men and 6.4 for black women). Racial differences were greater in the Southeast, particularly in nonmetropolitan areas, than in other regions. Neither white nor black SMSA rates were associated with the rate of admission for acute myocardial infarction (an indication of the amount of coronary artery disease). White rates, but not black rates, were associated with the number of thoracic surgeons per 100,000 people. CONCLUSIONS: For patients insured by Medicare, race is strongly associated with CABG rates, and this association is greater for men than for women and greater in the Southeast than in other parts of the country. Physician supply may relate to the CABG rates for whites.

Black or African American↗

Computer database for melanoma: a clinical management and research tool to ensure continuous quality assessment.

The need for an efficient method to handle data and for chart documentation is more apparent today than at any time in the past. High volume clinics for screening, diagnosis, and treatment are the rule rather than the exception in modern practice. A papermill medical record department or tumor registry fails on a day-to-day basis because of inefficiency of data collection, filing, storage, and abstraction. Requirements of the Joint Commission for the Accreditation of Health Care Organizations (JCAHO) include the setting of standards and the ability to query data to ensure the standards are met. A PC-based software program has been developed with the following features: (1) ongoing timed queries of the data are possible on any variable collected in the database to monitor trends in the standards established for care in the clinic; (2) a daily update of the database is performed so that it may be used as a clinical management tool, acting as an electronic medical record or as a clinical research tool; (3) the software will summarize the chart by abstracting a predetermined list of key data elements to improve clinical efficiency; (4) chart documentation is improved for Medicare coding requirements to maximize physician reimbursement; and (5) clinic notes and referral letters are generated the same day as the clinic visit to allow patients to have a copy of their clinic notes or for same day FAXing to the referring doctors. To date, > 1,200 patients with melanoma have been registered and entered into the system.(ABSTRACT TRUNCATED AT 250 WORDS)

Databases, Factual↗

Micronized fenofibrate: a new fibric acid hypolipidemic agent.

OBJECTIVE: To review the efficacy and safety of fenofibrate in the management of hyperlipidemias. DATA SOURCES: A MEDLINE search (1974-October 1998), Current Contents search, additional references from article bibliographies, and the package insert from the manufacturer were used to identify data for evaluation. Studies evaluating fenofibrate (peer-reviewed publications, package insert data) were considered for inclusion. Abstracts and data on file with the manufacturer were not considered for inclusion. STUDY SELECTION: English-language literature was reviewed to evaluate the pharmacology, pharmacokinetics, clinical use, and tolerability of fenofibrate. Data from animals and in vitro systems were included only when necessary to explain the drug's pharmacology. DATA SYNTHESIS: Micronized fenofibrate is a fibric acid derivative approved by the Food and Drug Administration (FDA) in February 1998 for the treatment of types IV and V hyperlipidemia. Data from the peer-reviewed literature also support the use of fenofibrate in types IIa, IIb, and III hyperlipidemias. Micronized fenofibrate 67-201 mg/d is useful as monotherapy or as an adjunct to other hypolipidemics and dietary therapy. In placebo-controlled clinical trials, regular formulation fenofibrate 300-400 mg/d lowered serum triglyceride (TG) concentrations by 24-55%, total cholesterol by 9-25%, low-density lipoprotein cholesterol (LDL-C) concentrations by 6-35%, and raised high-density lipoprotein cholesterol (HDL-C) concentrations by 8-38%. Few comparative data exist regarding fenofibrate versus clofibrate and gemfibrozil. In noncomparative and comparative clinical trials, fenofibrate appeared to be well tolerated. The most common causally related adverse events were digestive, musculoskeletal, and dermatologic in nature. Concurrent use of fenofibrate and a hydroxymethylglutaryl-coenzyme A inhibitor may increase the risk of myopathy and/or rhabdomyolysis, although recent data suggest that concurrent use of fenofibrate with low-dose simvastatin or pravastatin is safe. Fenofibrate may enhance the effect of oral anticoagulants. CONCLUSIONS: Fenofibrate reduces serum TG, total cholesterol, and LDL-C, and raises HDL-C to clinically relevant degrees. Its spectrum of activity appears to exceed that recommended for types IV and V hyperlipidemia to encompass types IIa, IIb, and III hyperlipidemias as well. To this extent, it may be considered a broader-spectrum fibrate than is indicated by its FDA approval. Adverse effects of fenofibrate appear to be similar to those of other fibrates and require routine monitoring (clinical, liver function). Long-term safety data are readily available from drug registries in many countries where the product has been available for nearly two decades. Cost-effectiveness studies comparing fenofibrate with other hypolipidemics demonstrate benefits of fenofibrate over simvastatin in types IIa and IIb hyperlipidemia. The need for dosage titration of the micronized preparation from 67 mg/d upward to a final dose of 200 mg/d is also not supported by peer-reviewed literature (except in the case of renal impairment). Although preliminary data on plaque regression are encouraging, published clinical studies evaluating the impact of fenofibrate on cardiovascular morbidity and mortality are awaited. Micronized fenofibrate is worthy of formulary inclusion.

Clinical Trials as Topic↗