• 한국컴퓨터정보학회:학술대회논문집
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• 한국컴퓨터정보학회 2014년도 제49차 동계학술대회논문집 22권1호
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• pp.429-432
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• 2014

국내 제약산업의 경쟁력을 제고시키기 위해서는 신약의 심사/허가 기간을 단축시켜 급변하게 변하는 글로벌 제약시장에서 경쟁 우위적 위치를 선점할 수 있도록 기회를 제공할 수 있도록 체계 개선이 시급하다. 신약허가를 위해서는 임상시험 결과에 대한 안전성과 유효성 등에 대한 심사가 수행되게 된다. 하지만 현재 신약허가를 위해서 제약사와 임상시험수탁기관(Contract Research Organization, CRO)에서 데이터 정보체계인 Domain, Variable 및 Parameter 등의 표준을 따르지 않고 다양한 유형의 임상정보데이터를 심사기관에 제출하고 있어 이로 인한 심사기간 증가와 심사업무 비효율성을 야기시키고 있다. 따라서 본 연구에서는 국제민간기구인 CDISC (Clinical Data Interchange Standards Consortium)에서 제정한 글로벌 임상데이터 표준인 CDISC 표준을 준용한 국내 임상시험정보관리 체계 (eCTD 시스템)및 의약품 전주기적 관리체계를 제시하고자 하며, 본 연구를 통한 기대효과로는 국제표준의 임상정보관리 인프라 구축으로 인한 국내 신약개발 및 해외 진출 환경을 마련하여 글로벌 시장선점의 기회를 제공할 수 있고, 규제기관 차원에서는 의약품 허가, 심사업무의 효율성 증가는 물론 전주기적 의약품 안전관리체계를 마련할 수 있을 것으로 사료된다.

• 한국임상약학회지
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• 제16권1호
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• pp.40-45
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• 2006

In clinical trials, it is important to have well designed case report forms (CRF) in order to obtain good quality of data. If CRF design at the first stage of your study goes wrong, after all efforts have been made, you may find practical difficulties in data analysis at the final stage of your study because of incomplete or wrong information. In this paper, the following rules fundamental to CRF design are introduced: rules in general, rules of format or style, categorized responses, forms with multiple records per subject, and international studies. Investigators are well aware of research goals, however sometimes they do not know how to express it on CRF. If they understand the rules fundamental to CRF design, time for CRF development will be saved and CRF completeness will be enhanced.

• Journal of Periodontal and Implant Science
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• 제50권2호
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• pp.83-96
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• 2020

Purpose: The present study aimed to evaluate the clinical benefit of additional toothbrushing accompanying non-surgical periodontal treatment on oral and general health in patients with type 2 diabetes mellitus (T2DM). Methods: We conducted a doubled-blind randomized controlled trial in 60 T2DM patients between June 2013 and June 2014. The patients were randomly assigned to the scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT) group, in which additional toothbrushing was performed by toothpick methods; or the control group. Microbiological and oral examinations were performed for up to 12 weeks following treatment. Non-surgical treatment was conducted in the experimental groups. The SRP group received scaling and root planing and the SRPAT group received additional toothbrushing with the Watanabe method once a week from the first visit through the fifth visit. The primary outcomes were changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels. Periodontal health status was measured by periodontal pocket depth, the calculus index, and bleeding on probing (BOP). Results: Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group. Furthermore, only the SRPAT group showed a statistically significant decrease in serum endotoxin levels. Conclusions: Non-surgical periodontal treatment was effective in improving HbA1c and serum endotoxin levels in T2DM patients. Furthermore, non-surgical treatment with additional tooth brushing had a more favourable effect on gingival bleeding management. Trial RegistrationClinical Research Information Service Identifier: KCT000416.

• 한국산학기술학회논문지
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• 제11권11호
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• pp.4395-4403
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• 2010

본 연구는 2000년 1월부터 2010년 3월까지 Pubmed에 게재된 논문 중, alternative medicine 으로 검색하여 근거중심 대체의학에 대한 연구 현황을 알아보고자 문헌고찰을 하였다. 682편의 연구 중 대체의학에 관한 임상연구는 19개였으며 연구전체 대상자는 2,573명이었다. 논문분석 결과 RCT(Randomized Controlled Trial) 실험 설계연구가 44%였으며 CCT(Controlled Clinical Trials)가 16%, OD(efficacy studies with either a controlled or an Other than controlled Design) 40%였다. 가장 많은 임상실험이 시행된 중재 방법은 Acupuncture과 Massage 였다. 대상 질병군 분포는 근골격계 및 결합조직의 질환과 관련된 '통증 완화'에 대한 임상연구가 20%, 다음으로 특정 감염성 및 기생충성 질환, 신생물이 각각 15% 순이었다. 근거중심 대체의학 현황을 파악하고자 문헌 고찰한 결과 대체의학을 통한 중재가 질병치료에 효과가 있는지에 대한 과학적 근거를 제시한 임상연구가 부족하다. 대체의학의 품질, 안정성, 유효성 확보를 위해 대체의학에 대한 질 높은 연구필요하며 근거중심 대체의학의 활성화가 필요할 것으로 생각된다.

• 가정∙방문간호학회지
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• 제10권2호
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• pp.141-147
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• 2003

The purpose of this study was to develop and apply a Web-based Nursing Education & Instruction Program to help the clinical nurses improving their knowledge and skills of ostomy care. This program was developed in three different steps: analysis. design. and development. The results of the study were as follows: The analysis step was designed to select the study contents for effective and easy educationthrough the analyses of specialized books. This surveyed and analyzed study contents were categorized into five different sections. Introduction. ostomy classification. ostomy management. elimination management. and life style. After that each section describes necessary information of each category. In the design step. the image files used in this program were created using Adobe Photoshop 6.0. and HTML files were designed and developed using Namo Editor 5.0. In the development step. the developed program was published into Web using FTP (File Transfer Protocol) and then finalized after trial operation for testing of real users. In addition. this Web-based Nursing Education & Instruction Program will be used as excellentand effective tool for continuous and lifelong education in nursingfield. In this study. computer-aided education program was developed for ostomy management and managed at the Web-Server (http://hshong.knu.ac.kr/ostomy) in order to help nurses real-time education in clinical field by this program.

• Korean Journal of Acupuncture
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• 제31권1호
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• pp.33-39
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• 2014

목적 : 본 연구는 복강신경총 차단술을 시행한 상복부 암성통증 환자들을 대상으로 침치료가 암관련 통증을 감소시키는 효과적이고 안전한 치료법임을 증명하기에 적합한지를 알아보기 위한 예비연구이다. 방법 : 본 연구는 3주간 진행되는 무작위배정 대조군 예비임상연구이며, 총14명의 피험자들은 시험군 (복강신경총차단술+침치료)과 대조군 (복강신경총차단술)으로 무작위배정된다. 모든 피험자들은 복강신경총 차단술을 1회 시술 받으며, 오직 시험군의 경우에만 주 3회, 2주간 총 6회의 추가적인 침치료를 시술받을 예정이다. 1차 유효성 평가변수는 통증에 대한 VAS를, 2차 유효성 평가변수는 Painvison과 추가 진통제 소비량을 측정한다. 평가는 시험시작 전, 시험 1주, 2주 및 3주후에 이루어지게 된다. 결론 : 본 연구는 추후 본격적인 무작위배정 대조군 임상시험을 위한 예비연구로서, 본 연구를 통해 상복부 암성 통증치료에 있어서 침치료가 복강신경총차단술과 같이 병행치료 했을 때 임상적으로 유효함을 증명할 수 있는 근거를 마련해 줄 것이라 사료된다.

• 한국콘텐츠학회논문지
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• 제12권12호
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• pp.714-720
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• 2012

임상 연구에서 가장 중요한 것은 임상 자료를 정확하게 수집하는 것이다. 이를 위해, 최근 많은 제약회사들과 임상 연구기관에서는 전자 증례기록지(electronic Case Report Form, eCRF)를 도입하려고 노력하고 있다. eCRF는 임상연구에서 임상 자료를 수집하고 관리하기 위해 디자인된 컴퓨터 시스템이다. 하지만, 임상연구에서 eCRF의 중요성을 인식하고 있지만, eCRF 도입 초기에 많은 노력과 비용이 소요되기 때문에 널리 사용되고 있지는 못한다. 본 연구에서는 한의학연구원에서 임상연구를 위해 개발된 eCRF의 사용현황을 실증적 자료를 바탕으로 조사했다. 특히, eCRF에 자료를 입력하는데 걸리는 시간, 사용 시간, 쿼리 수 등을 시간적 흐름에 따른 변화에 중점을 두었다.

• Korean Journal of Acupuncture
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• 제40권2호
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• pp.44-53
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• 2023

Objectives : This study was conducted to reveal the relationship between multiple factors of traditional Korean Medicine diagnosis and consider the further probabilities of treating people with physical and mental problems not defined as diseases, which is called 'Mibyeong' in traditional Korean Medicine. Methods : 40 healthy participants were included in the observational clinical trial. The participants were asked to complete health questionnaires (e.g. State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, Stress Response Inventory) and they went through a traditional diagnosis process, including four stages of diagnosis (looking, listening/smelling, inquiring, and pulse taking), by a Korean Medicine doctor. Both the Korean Medicine doctor and an artery tonometry device performed the pulse diagnosis. Results : Although all participants were healthy people with no history of disease, more than half of participants had a problem related with severe level of fatigue (n=19), sleep disturbance (n=26) and stress (n=27) status according to the related questionnaires. Participants diagnosed with phlegm syndrome by the Korean Medicine doctor showed significantly greater score in phlegm pattern questionnaires than participants who were not. However, there was little agreement between the doctor's pulse diagnosis and radial artery tonometry results. Conclusions : We conducted a pulse diagnosis and measured health-related information along with the traditional Korean Medicine diagnose procedure, including four stages of diagnosis, and we found a linkage between diagnosis of phlegm and the phlegm pattern questionnaire score. The results suggest that a number of healthy participants, with no disease diagnosed, have Mibyoung symptoms which need further clinical management. Thus, we suggest that Mibyoung management programs based on qualified diagnosis tools and traditional Korean medicine diagnosis procedures be developed, and that future research using various diagnostic tools be carried out on a large population.

• 한국간호교육학회지
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• 제5권2호
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• pp.267-284
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• 1999

The purpose of this study are 1. Evaluate the degree of knowledge of Vaginal Birth After Cesarean(VBAC) of Korean nurses. 2. To gather and develop educational material for VBAC. The sample was surveyed Korean Nurses knowledge about VBAC, from November 1998 through March 1999. For the data analysis, the SPSS computer program percentage and frequency were used for descriptive statistics. The x2 and the t-test were used to compare the results of the two sample groups. Open questions asked in the survey were sorted out by content, then displayed in chart form. For the education material, the Internet was the main source of information. Information on the Internet was provided by professional doctors and prenatal educational nurses. The results of the survey are as follows: 1. Out of 97 Nurses 15.3% answered that cesarean deliveries do not need to be performed after previous cesarean sections : however. 46.4% answered that cesarean sections must be performed after previous cesarean sections. 2. Of the nurses surveyed 14% had no knowledge or had never heard of VBAC. 3 Nurses did not have questions from patients concerning VBAC was 34.7%. This led to the conclusion that patients either do not have knowledge about VBAC or patients have no interest in the trial of labor. 4, Nurses indicated that their information about VBAC originated from other people's experiences (31%), Nursing School (25%), Media information (9%), and through literature review (6%). This data led to the conclusion that the knowledge about VBAC may not be extensive enough to counsel and guide patients who are willing to endure the trial of labor. 5. Nurses preferred hospital education programs to develop their knowledge concerning VBAC. Based upon survey, the conclusion was made that General Nurses and Maternity Nurses did not have knowledge about VBAC success rates and the possibility of a trial of labor. In order for nurses to help patients make decisions concerning VBAC, nurses have to gam more knowledge through hospital educational programs. Further more, the study suggests that through hospital educational programs, the possibility and importance of VBAC must be emphasized to nurses who work in maternity areas. Second, through prenatal educational programs, the possibility and importance of VBAC must be explained and emphasized to patients who had previous cesarean sections. Third, the clinical pathways of VBAC need to be developed. Fourth, each hospital needs to develop multi-disciplinary teams, consis-ting of obstetricians, risk management/quality management, staff registered nurses, and the director for perinatal services. This team can review cesarean section rates and help to increase the practice of VBAC.

• 대한한의진단학회지
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• 제11권1호
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• pp.61-71
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• 2007

Background: Bojungikgitang is one of the most common herbs in oriental medicine. Principally, this medicine heals illness from overwork and stress. Therefore, it is frequently used in the ancient community. Because of insufficiency in data, objective judgements are difficult in remedial effects by Bojungikgitang. In order to make objectivity diagnose data, this research is developed. Purpose: The aim of the research is to make questionnaire for the medicine and the objective is to sell to the public from the local clinic. Methods: The questionnaire which includes symptoms and signs for diagnose of Bojungikgitang is studied by the Delphi method and average value. Results: By the Delphi method and average value, 25 Items of questionnaires are choosen for the research. Conclusions: Further research is necessary for modification of questionnaire by statistics and certification by clinical trial. The statistics and verification by clinical trial is necessary with modification for further research.