OBJECTIVE: Clinical trials are the most time-consuming and expensive part of the drug development process. Clinical Trial Management Systems (CTMSs) help sponsors of clinical trials manage all aspects of planning, performance, and reporting. Most conventional systems provide data processing functions using database management system (DBMS) procedures, which cause DBMS dependency problems. Thus, it is hard to handle the system by researchers who are unfamiliar with database. It is also difficult to share Electronic Case Report Forms (eCRFs) between institutions because conventional systems rely on specific software. METHODS: PhactaManager was developed for solving these problems by introducing an XML Layer in the application tier using an Entity-Attribute-Value model in the database tier. RESULTS: PhactaManager is a three-tier clinical trial management system that has an XML layer. The XML Layer provides a common DBMS independent eCRF document processing platform. Also we developed XML based eCRF Grammar to describe eCRF documents. The XML data elements described by eCRF grammar was constitute to eCRF by PhactaDesigner which an eCRF document design program. CONCLUSION: We achieved DBMS independency by implementing the XML Layer in PhactaManager. The Development of the eCRF Grammar enables the standardization of eCRF design, data correction and data sharing in multicenter clinical trial.
Database Management Systems ; Information Dissemination

This paper reflects on the standardization activities of nursing documentation. Even though nurses are the most important manpower in terms of collecting patients' data, nursing documentation have been overlooked in the process of developing electronic patients records. It is impossible to complete a computerized patient record system without including nursing documentation. Standardization of nursing documentation is the first step toward a computerized documentation system. In this study nursing documentation forms were gathered from 11 tertiary hospital with more than 500 beds in Seoul. Out of various nursing documentation, 9 essential forms were chosen to standardize. They are admission assessment, form, nursing treatment record, nursing care plan, discharge planning record, patient transfer record, clinical observation record, nursing treatment record, nursing progress notes, critical care flow sheet, and preoperative checklist Forms and data elements were reviewed and analyzed. It was learned that there is no one perfect from that could be used in any agency. Data elements were analyzed and standardized. Data elements to be included in each form were selected. Standardized forms were developed with the selected data element. Guideline outlining how to use each nursing form were developed. Now it is in the process of validating the forms and the guidelines at 240 nursing units at 8 tertiary hospitals. The results of the validation study will be incorporated in the final version of nursing forms and they will be introduced to general nursing population at an open forum to be held by Korean Nurses Association at the end of this year. This standardization activities will have a great impact on nursing practice, education, administration and research.
Checklist ; Critical Care ; Education ; Health Records, Personal ; Humans ; Nursing Informatics* ; Nursing Records* ; Nursing* ; Patient Discharge ; Patient Transfer ; Seoul ; Tertiary Care Centers

Infection by microorganisms may cause fatally erroneous interpretations in the biologic researches based on cell culture. The contamination by microorganism in the cell culture is quite frequent (5% to 35%). However, current approaches to identify the presence of contamination have many limitations such as high cost of time and labor, and difficulty in interpreting the result. In this paper, we propose a model to predict cell infection, using a microarray technique which gives an overview of the whole genome profile. By analysis of 62 microarray expression profiles under various experimental conditions altering cell type, source of infection and collection time, we discovered 5 marker genes, NM_005298, NM_016408, NM_014588, S76389, and NM_001853. In addition, we discovered two of these genes, S76389, and NM_001853, are involved in a Mycolplasma-specific infection process. We also suggest models to predict the source of infection, cell type or time after infection. We implemented a web based prediction tool in microarray data, named Prediction of Microbial Infection (http://www.snubi.org/software/PMI).
Algorithms ; Cell Line ; Chondrocytes/cytology/metabolism/microbiology ; Databases, Genetic ; Gene Expression Profiling ; Host-Pathogen Interactions ; Humans ; Keratinocytes/cytology/metabolism/microbiology ; *Models, Genetic ; Mycoplasma/genetics/metabolism ; Oligonucleotide Array Sequence Analysis

BACKGROUNDS: Living-donor liver transplantation (LDLT) has been established as an efficacious option to resolve the shortage of cadaveric donor organs for pediatric recipients. This surgical innovation has significantly reduced the pretransplantation mortality for children, but the crisis of increasing scarcity of donor organs in our hospital has led us to extend LDLT to adult recipients. However, the extension of LDLT from pediatric recipients to adult recipients has been made only with limited success largely because of the inability of a relatively small-size left-lobe graft to meet the metabolic demands of an adult recipient. It has been postulated that a left-lobe graft smaller than 40% of the recipient's standard liver volume will not result in a successful adult-to-adult LDLT in chronic parenchymal liver disease. METHODS: From February 1997 to October 1997, 10 LDLTs, using 9 extended left-lobe grafts and 1 right-lobe graft, were performed on patients with end-stage parenchymal liver diseases (9 cases of B-hepatitis-induced cirrhosis with or without an associated hepatocellular carcinoma and 1 case of alcoholic cirrhosis) at the Department of Surgery, Asan Medical Center. The ratios of the graft to the standard liver volume of the recipients were in the range of 30% to 55%. RESULTS: All grafts showed immediate function, but delayed normalization of the serum total bilirubin was demonstrated in all recipients receiving left-lobe grafts. There were no mortalities and serious complications in donors. Two recipients died of sepsis 21 days and 40 days after transplantation, and 8 recipients (80%) are alive with good liver function at a median follow-up of 5.1 months (range 2~10 months). CONCLUSIONS: The aim of this article is to report our experience with adult-to-adult LDLT shows that a graft size greater than 30% of the recipient's standard liver volume is able to meet the metabolic demands of adult recipients with chronic parenchymal liver disease and that LDLT might open a new donor pool for adult recipients when the supply of cadaveric organs is severely restricted.
Adult ; Alcoholics ; Bilirubin ; Cadaver ; Carcinoma, Hepatocellular ; Child ; Chungcheongnam-do ; Fibrosis ; Follow-Up Studies ; Humans ; Liver Diseases ; Liver Transplantation* ; Liver* ; Living Donors* ; Mortality ; Sepsis ; Tissue Donors ; Transplants