• Title/Summary/Keyword: Clinical Protocols

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TMA-OM(Tissue Microarray Object Model)과 주요 유전체 정보 통합

  • Kim Ju-Han
    • Proceedings of the Korean Society for Bioinformatics Conference
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    • 2006.02a
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    • pp.30-36
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    • 2006
  • Tissue microarray (TMA) is an array-based technology allowing the examination of hundreds of tissue samples on a single slide. To handle, exchange, and disseminate TMA data, we need standard representations of the methods used, of the data generated, and of the clinical and histopathological information related to TMA data analysis. This study aims to create a comprehensive data model with flexibility that supports diverse experimental designs and with expressivity and extensibility that enables an adequate and comprehensive description of new clinical and histopathological data elements. We designed a Tissue Microarray Object Model (TMA-OM). Both the Array Information and the Experimental Procedure models are created by referring to Microarray Gene Expression Object Model, Minimum Information Specification For In Situ Hybridization and Immunohistochemistry Experiments (MISFISHIE), and the TMA Data Exchange Specifications (TMA DES). The Clinical and Histopathological Information model is created by using CAP Cancer Protocols and National Cancer Institute Common Data Elements (NCI CDEs). MGED Ontology, UMLS and the terms extracted from CAP Cancer Protocols and NCI CDEs are used to create a controlled vocabulary for unambiguous annotation. We implemented a web-based application for TMA-OM, supporting data export in XML format conforming to the TMA DES or the DTD derived from TMA-OM. TMA-OM provides a comprehensive data model for storage, analysis and exchange of TMA data and facilitates model-level integration of other biological models.

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Korean Brain Tumor Society Consensus Review for the Practical Recommendations on Glioma Management in Korea

  • Chul-Kee Park;Jong Hee Chang
    • Journal of Korean Neurosurgical Society
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    • v.66 no.3
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    • pp.308-315
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    • 2023
  • Recent updates in genomic-integrated glioma classification have caused confusion in current clinical practice, as management protocols and health insurance systems are based on evidence from previous diagnostic classifications. The Korean Brain Tumor Society conducted an electronic questionnaire for society members, asking for their ideas on risk group categorization and preferred treatment for each individual diagnosis listed in the new World Health Organization (WHO) classification of gliomas. Additionally, the current off-label drug use (OLDU) protocols for glioma management approved by the Health Insurance Review and Assessment Service (HIRA) in Korea were investigated. A total of 24 responses were collected from 20 major institutes in Korea. A consensus was reached on the dichotomic definition of risk groups for glioma prognosis, using age, performance status, and extent of resection. In selecting management protocols, there was general consistency in decisions according to the WHO grade and the risk group, regardless of the individual diagnosis. As of December 2022, there were 22 OLDU protocols available for the management of gliomas in Korea. The consensus and available options described in this report will be temporarily helpful until there is an accumulation of evidence for effective management under the new classification system for gliomas.

Detection of furcation involvement using periapical radiography and 2 cone-beam computed tomography imaging protocols with and without a metallic post: An animal study

  • Salineiro, Fernanda Cristina Sales;Gialain, Ivan Onone;Kobayashi-Velasco, Solange;Pannuti, Claudio Mendes;Cavalcanti, Marcelo Gusmao Paraiso
    • Imaging Science in Dentistry
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    • v.47 no.1
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    • pp.17-24
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    • 2017
  • Purpose: The purpose of this study was to assess the accuracy, sensitivity, and specificity of the diagnosis of incipient furcation involvement with periapical radiography (PR) and 2 cone-beam computed tomography (CBCT) imaging protocols, and to test metal artifact interference. Materials and Methods: Mandibular second molars in 10 macerated pig mandibles were divided into those that showed no furcation involvement and those with lesions in the furcation area. Exams using PR and 2 different CBCT imaging protocols were performed with and without a metallic post. Each image was analyzed twice by 2 observers who rated the absence or presence of furcation involvement according to a 5-point scale. Receiver operating characteristic (ROC) curves were used to evaluate the accuracy, sensitivity, and specificity of the observations. Results: The accuracy of the CBCT imaging protocols ranged from 67.5% to 82.5% in the images obtained with a metallic post and from 72.5% to 80% in those without a metallic post. The accuracy of PR ranged from 37.5% to 55% in the images with a metallic post and from 42.5% to 62.5% in those without a metallic post. The area under the ROC curve values for the CBCT imaging protocols ranged from 0.813 to 0.802, and for PR ranged from 0.503 to 0.448. Conclusion: Both CBCT imaging protocols showed higher accuracy, sensitivity, and specificity than PR in the detection of incipient furcation involvement. Based on these results, CBCT may be considered a reliable tool for detecting incipient furcation involvement following a clinical periodontal exam, even in the presence of a metallic post.

Predictors of massive transfusion protocols activation in patients with trauma in Korea: a systematic review

  • Dongmin Seo;Inhae Heo;Juhong Park;Junsik Kwon;Hye-min Sohn;Kyoungwon Jung
    • Journal of Trauma and Injury
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    • v.37 no.2
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    • pp.97-105
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    • 2024
  • Purpose: Massive transfusion protocols (MTPs) implementation improves clinical outcomes of the patient's resuscitation with hemorrhagic trauma. Various predictive scoring system have been used and studied worldwide to improve clinical decision. However, such research has not yet been studied in Korea. This systematic review aimed to assess the predictors of MTPs activation in patients with trauma in Korea. Methods: The PubMed, Embase, Cochrane Library, Research Information Sharing Service databases, KoreaMed, and KMbase were searched from November 2022. All studies conducted in Korea that utilized predictors of MTPs activation in adult patients with trauma were included. Results: Ten articles were eligible for analysis, and the predictors were assessed. Clinical assessments such as systolic and diastolic blood pressure, shock index (SI), prehospital modified SI, modified early warning system (MEWS) and reverse SI multiplied by the Glasgow Coma Scale (rSIG) were used. Laboratory values such as lactate level, fibrinogen degradation product/fibrinogen ratio, and rotational thromboelastometry (ROTEM) were used. Imaging examinations such as pelvic bleeding score were used as predictors of MTPs activation. Conclusions: Our systematic review identified predictors of MTPs activation in patients with trauma in Korea; predictions were performed using tools that requires clinical assessments, laboratory values or imaging examinations only. Among them, ROTEM, rSIG, MEWS, SI, and lactate level showed good effects for predictions of MTPs activation. The application of predictors for MTP's activation should be individualized based on hospital resource and skill set, also should be performed as a clinical decision supporting tools.

A Clinical Analysis of Patients Who Visited Emergency Department due to Chemical Incident Occurred at Industrial Place: A Retrospective Study (산업장 화학 사고로 응급실에 내원한 환자의 임상적 고찰: 일개병원의 후향적 연구)

  • Shin, Hee Jun;Oh, Se Kwang;Yoo, Byeong Dai;Jun, Duck Ho;Lee, Dong Ha;Woo, Kuck Hyeun;Yoon, Seong Yong;Choi, Sung Yong
    • Journal of The Korean Society of Clinical Toxicology
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    • v.13 no.2
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    • pp.78-86
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    • 2015
  • Purpose: The purpose of this study is to understand what kinds of chemical substances have been used annually and to investigate incidents that occurred due to chemical hazard release and to analyze statistically clinically chemical injury patients who visited one regional emergency medical center in Gumi city with documented references review. Methods: Annual chemical waste emission quantity (Kg/Year) (Cwep) was reproduced using national web site data governed by the Ministry of Environment and 5 years (from 1 .Jan. 2010 to 31. Dec. 2014) of medical records of chemical injury patients who visited our emergency department were reviewed retrospectively. By applying exclusion criteria, 446 patients of 460 patients were selected. Results: Dichloromethane, Toluene, Trichloroethylene, and Xylene were always included within Top 5 of Cweq. Six cases of chemical incidents were reported and in 3 of 6 cases involving Hydrogen fluoride were included during the study period. Male gender and twenties were the most prevalent group. Injury evoking chemicals were Hydrogen fluoride, unknown, complex chemicals (over 2 substances) in sequence. The most frequent site of wounds and injuries was the respiratory tract. Gas among status, intoxication among diagnosis, and discharge among disposition was most numerous in each group. Conclusion: There have been no uniform clinical protocols for chemical wounds and injuries due to various kinds of chemicophysical properties and ignorance of antidotes. Therefore conduct of a multicenter cohort study and experiments for ruling out chemicals according to chemicophysical priority as well as development of antidotes and clinical protocols for chemical injury patients is needed.

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Photobiomodulation and implants: implications for dentistry

  • Tang, Elieza;Arany, Praveen
    • Journal of Periodontal and Implant Science
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    • v.43 no.6
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    • pp.262-268
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    • 2013
  • The use of dental implants has become a mainstay of rehabilitative and restorative dentistry. With an impressive clinical success rate, there remain a few minor clinical issues with the use of implants such as peri-implant mucositis and peri-implantitis. The use of laser technology with implants has a fascinating breadth of applications, beginning from their precision manufacturing to clinical uses for surgical site preparation, reducing pain and inflammation, and promoting osseointegration and tissue regeneration. This latter aspect is the focus of this review, which outlines various studies of implants and laser therapy in animal models. The use of low level light therapy or photobiomodulation has demonstrated its efficacy in these studies. Besides more research studies to understand its molecular mechanisms, significant efforts are needed to standardize the clinical dosing and delivery protocols for laser therapy to ensure the maximal efficacy and safety of this potent clinical tool for photobiomodulation.

An Analysis of Clinical Trials for Understanding and Application of Pragmatic Clinical Trial (실용적 임상연구에 대한 이해와 적용을 위한 연구 사례 분석)

  • Yun, Young-Ju;Kang, Kyung-Won;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.26 no.5
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    • pp.105-116
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    • 2009
  • The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

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Analysis of Indicated Points and Main Factors Affecting the Quality of Clinical Research for the Development of Internal Audit Tools (자체점검 도구 개발을 위한 지적사항 및 임상연구의 품질에 작용하는 요인 분석)

  • Hye Yun Jang;Jung-Hee Jang;Yoon Jin Lee
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.14-20
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    • 2023
  • Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

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Nursing Protocols of Cold Application in Different Medical Institutions in Korea (전국 의료기관의 냉 요법 실무지침 및 임상간호사의 냉 요법 실무 현황)

  • Shin, Yong Soon
    • Journal of Korean Clinical Nursing Research
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    • v.21 no.3
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    • pp.355-365
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    • 2015
  • Purpose: The purpose of this study was to evaluate nursing protocols for superficial cryotherapy in different medical institutions. Methods: The study was conducted with a cross-sectional descriptive design. The medical institutions including general hospitals, hospitals, and geriatric hospitals were randomly selected. A total of 435 nurses from 126 institutions completed a questionnaire. Data were collected from December 2014 to June 2015. Results: Forty-two institutions (39.5%) had nursing protocol for cryotherapy. The nurses reported that durations of cold application were 2 minutes to 5 hours. Frequently used cold therapy devices in order of frequency were frozen gel packs, ice packs, and frozen IV fluid bags. There were variances in the duration of cold application according to the types of institution ($x^2=7.78$, p=.020) and nursing units ($x^2=26.42$, p<.001). In addition, intervals of cold application were different according to the nursing units (x=12.23, p=.032). There were differences in cold application instruments by regional groups (x=70.38, p<.001). Most of the nurses (95.6%) responded that national nursing protocol for superficial cryotherapy were needed. Conclusion: There were difficulties in providing consistent nursing interventions because of the practical differences and absence of evidence-based guidelines for cryotherapy. The researchers recommend that basic studies with various instruments be conducted and proper nursing protocols be developed for cryotherapy.

Controlled Inquiry Rates of Clinical Interviews in Telehomecare

  • Moskowitz, Samuel E.
    • 제어로봇시스템학회:학술대회논문집
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    • 2003.10a
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    • pp.1945-1950
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    • 2003
  • Conceived to acquire personal information for an electronic medical record, the clinical interview contains probing questions. The number and type of inquiries are assumed to fulfill medical protocols, and therefore are deemed essential for treatment - but the rate can and should be controlled. High rates of inquiry merely intimidate the patient and affect replies. The purpose of this paper is to mathematically formulate permissible rates of clinical interviews held during telehomecare virtual visits and designed to avoid patient anxiety. Mental stress is derived as a function of the weight of importance assigned by the patient, virtual visit duration, and the rate of questioning in the direction of greater sensitivity. Two operations are of interest: Collecting and recording information by the provider, and maintaining synchrony of questions and answers by the patient. The Lorentz transformation yields the patient’s view of the operational rates. Conservation of information momentum is postulated and applied before and after replies are recorded. It is shown that the weight of importance designated by the patient to collecting and recording personal information is driven by a singularity that depends on the rate of questioning. The findings should serve as a guideline in interviewer training programs.

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