• Title/Summary/Keyword: eCRF

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Status Report on Usage of Electronic Case Report Form for Clinical Study (임상연구 전자증례기록지의 사용 현황 조사)

  • Baek, Young-Hwa;Kim, Ho-Seok;Lee, Si-Woo;Jin, Hee-Jeong
    • The Journal of the Korea Contents Association
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    • v.12 no.12
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    • pp.714-720
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    • 2012
  • With the help of information technology, it is the most important to collect clinical data correctly in clinical trials. For this, recently, in many pharmaceutical companies and Clinical Research Organizations (CRO) have tried to adopt an Electronic Case Report Form (eCRF) system. The eCRF system is a computerized system designed for collecting and managing clinical data in clinical trials. Although the eCRF is recognized as a significant system for clinical trials, until now there are no widely useable, due to the huge effort and expense at the initiatory stage of adopting eCRF system. In this study, we inquired the use of eCRF system developed for clinical trial at Korea Institute of Oriental Medicine. Especially, we focused on the time required for entering clinical data into the eCRF, hours of use, and the number of queries according to the time flow.

Generation of eCRF converted to CDISC/SDTM standard (CDISC/SDTM 표준으로 변환된 eCRF 생성)

  • Hong, Yeong-Pyo;Yu, Yong-Bin;Kim, Suk-Il
    • Proceedings of the KAIS Fall Conference
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    • 2010.11b
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    • pp.673-676
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    • 2010
  • 본 연구에서는 임상시험 데이터를 수집하는 CRF를 웹의 표준인 XML 기반으로 설계하고, 임상시험데이터 표준인 SDTM으로 변환된 eCRF를 생성하는 XML 기반 프로세스을 개발했다. 데이터구조와 폼이 분리되는 XML 기반 개발 프로세스는 XML Schema로 eCRF를 개발하고, SDTM을 적용한 XML 문서를 생성한다. 생성된 XML 문서에서 SDTM 규약에 맞는 도메인별로 변환방법을 제시한다. 이에 eCRF 분석과 데이터베이스 설계 및 구현이 동시에 이루어진다.

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eCRF use case in Korean Medicine Global Health Business - Focused on Smoking Cessation Program in Vietnam (2017) - (해외 한의약 건강증진사업에서 eCRF시스템 활용사례 - 2017년 베트남 금연사업을 중심으로 -)

  • Mok, Kyungyul;Lee, Eunkyung;Kang, Sohyeon;Park, Jaeeun;Shine, Yong-Cheol;Jang, Bo-Hyoung;Ko, Seong-Gyu
    • Journal of Society of Preventive Korean Medicine
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    • v.22 no.1
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    • pp.91-105
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    • 2018
  • Objectives : The purpose of this study was to introduce the case of using eCRF system in the Smoking Cessation Program project in Vietnam (2017). And aimed to derive the usefulness of the eCRF system and it potential for future global health business. Method : Introduce the smoking cessation program in vietnam (2017). Smoking Cessation was conducted in three provices of central vietnam Tamphu, Binhtu, Duytrinh) and eCRF was developed on the web environment by building AMP(Apache, PHP, MySQL). Dedicated application have also been developed for user. Result : Using the eCRF, the results of the program of the smoking cessation participants were recorded on the Database server. The implemented system focused on the role of a case recording platform that was simplified in function rather than an electronic version of the case report. It was useful for monitoring. Conclusions : The eCRF system was useful in global health business, and upgrading the system to reflect the feedback derived from the project could potentially be used in other projects. In addition, there are few cases where ICT is used in overseas health promotion projects using Oriental medicine, so further research is needed.

A Case Report of Chronic Renal Failure(stage4) on Stroke Patient through Integrative Medicine Therapy. (만성 신부전 환자의 중풍치료에 대한 한·양방 협진효과 증례보고)

  • Hwang, Yunkyeong;Lee, Boram;Kim, Wonill
    • Herbal Formula Science
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    • v.24 no.3
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    • pp.233-242
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    • 2016
  • Objective : Chronic renal failure(CRF) is defined as a permanent reduction in glomerular filtration rate(GFR), resulting in Structural and functional abnormalities. The purpose of this thesis is to report the improvement of a CRF stage4 on stroke patient through integrative medicine therapy.Methods : We treated the patient with herbal medication(Sibjeondaebo-tang gagambang), acupuncture and moxibustion as well as Western medication. We measured the Creatinine, BUN, eGFR in the serum and observed clinical symptoms During 4monthsResult : After treatment, the level of BUN and Creatinine was decreased and eGFR was increased. And the symptoms of CRF(edema, anorexia, general weakness) were improved.Conclusion : This study suggests that Integrative Medicine Therapy is effective in the treatment of CRF symptoms. In the future, for the effective management of CRF, It is considered necessary to build a systematic integrative medicine therapy.

Implementation of database and E-CRF for efficient integration of Korean clinical data (한의 임상 정보의 효율적 통합을 위한 한의임상 데이터베이스 및 E-CRF 입력 시스템 구축)

  • So, Ji Ho;Jeon, Young Ju;Lee, Bum Ju
    • The Journal of the Institute of Internet, Broadcasting and Communication
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    • v.16 no.5
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    • pp.205-212
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    • 2016
  • Recently, researches for the integration and standardization of clinical data in the Western medicine and Korean medicine is in progress. If an integration of similar clinical data as well as heterogeneous clinical data is possible based on one standardization, we can able to derive implicit medical knowledge from integrated clinical data. In this paper, we implemented Korean clinical database based on internationally known CDISC standardization to efficiently store Korean clinical data and constructed E-CRF system for convenient data input in clinical sites. Furthermore, we showed example of an integration of Korean clinical data from 4 clinical sites. The results of our study will help to establish the foundation for the extraction of implicit medical knowledge from integrated clinical data. Also, our results may support efficient management through data integration, prevention of repetitive or unnecessary clinical trials, facilitation of collaborative study and convenient research through the distribution of refined clinical data.

Evaluation of Therapeutic Effect of the Extract from Rhubarb (Rheum officinalis) in Dogs with Chronic Renal Failure (개의 만성 신부전에서 대황 추출물의 치료학적 효과의 평가)

  • Kim, Ye-Won;Hyun, Changbaig
    • Journal of Veterinary Clinics
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    • v.29 no.6
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    • pp.435-440
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    • 2012
  • This study was designed to evaluate the clinical efficacy and safety of Rhubarb extracts ($Rubenal^{(R)}$) in dogs with chronic renal failure (CRF). Client-owned 40 dogs with CRF graded International renal interest Society (IRIS) II-III were enrolled in this study. The dogs were equally allocated and blindly administered with $Rubenal^{(R)}$ or placebo. The following items were evaluated at day 0, 30, 90 and 180: body condition score (BCS), clinical score (appetite, polydipsia/polyuria, quality of life score), hemogram (WBC, RBC, PCV), serum biochemistry (ALT/AST, ALP, Creatinine/BUN, total protein, albumin), serum electrolyte (Na, K, Cl, Ca, P), systolic blood pressure, urinalysis (UPC, USG) and IRIS stage. In this study, we found that the $Rubenal^{(R)}$ preparation was well tolerated by dogs and induced no adverse effects. Statistically significant improvements were observed in clinical score (quality of life score by vet and clients), serum BUN and creatinine levels, serum phosphorus concentration, level of proteinuria, and the IRIS score of CRF in dogs after 6 month of treatment of $Rubenal^{(R)}$. Those findings suggested that the Rhubarb extracts can improve the clinical signs of CRF (i.e. azotemia, hypertension, proteinuria, hyperphosphoremia) and the quality of life (i.e. BCS, clinical score) and can retard the progression of CRF in dogs. Therefore the Rhubarb extracts can be a good supplementary drug for treating dogs with subclinical and clinical renal diseases. However, care should be taken for interpreting our result, because this study is not double-blinded controlled study but pilot study.

Construction of eCRF System for Collecting Constitution Clinical Information (체질임상정보 수집을 위한 eCRF 시스템 구축)

  • Jin, Hee-Jeong;Yoo, Jong-Hyang;Jang, Eun-Su;Lee, Si-Woo
    • Korean Journal of Oriental Medicine
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    • v.16 no.2
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    • pp.101-108
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    • 2010
  • Objectives : Recently, in Sasang Constitution Medicine (SCM), many researchers have studied to construct objective diagnose tool for the SCM type. It is most important to collect correct constitutional clinical data in these studies. Methods : In our work, we construct a web-based system for collecting constitutional clinical data effectively. Results & Conclusion : The system offers 4 types of input programs, which helps to collect clinical information from various hospitals, and performs verification service to minimize input errors. Currently, we have collected about four thousands data using the our system and we will provide several analysis tool in the system for researchers.

The Anti-Depressive Effects of BanHaHuBakTang-kami (BHHBT) after Chronic Immobilization Stress in C57BL/6 Mice (우울증 생쥐 모델에서 반하후박탕가미(半夏厚朴湯加味)의 항우울 효과)

  • Kim, Kook-Ki;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.25 no.2
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    • pp.191-202
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    • 2014
  • Objectives: The purpose of this study was to examine the anti-depressive effects of BanHaHuBakTang-kami (BHHBT) on an animal model of depression induced by chronic immobility stress. Methods: Mice were treated daily with immobilization stress for 2 hours over a period of 21 days. To examine the effect of BHHBT, we performed behavioral, biochemical and histological analysis to measure immobility time (FST), brain neurotransmitter concentration (HPLC, ELISA), hippocampal damage (H&E staining) and CRF-R1 expression (immunohistochemistry). Results: BHHBT has reduced the immobility time of immobilization stress exposed mice in the forced swimming test. BHHBT has increased the amount of serotonin in the brain. BHHBT has increased the expression level of serotonin in the brain. BHHBT 540 mg/kg were sufficient to prevent tissue damage in the hippocampus region. BHHBT has reduced the expression level of CRF receptors in the hippocampus region. Conclusions: These results suggest that BHHBT may have anti-depressive effects on mice treated with immobilization stress by reducing immobility, increasing brain serotonin concentration and reducing CRF-R1 expression in the hippocampus region.

CRF-Based Figure/Ground Segmentation with Pixel-Level Sparse Coding and Neighborhood Interactions

  • Zhang, Lihe;Piao, Yongri
    • Journal of information and communication convergence engineering
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    • v.13 no.3
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    • pp.205-214
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    • 2015
  • In this paper, we propose a new approach to learning a discriminative model for figure/ground segmentation by incorporating the bag-of-features and conditional random field (CRF) techniques. We advocate the use of image patches instead of superpixels as the basic processing unit. The latter has a homogeneous appearance and adheres to object boundaries, while an image patch often contains more discriminative information (e.g., local image structure) to distinguish its categories. We use pixel-level sparse coding to represent an image patch. With the proposed feature representation, the unary classifier achieves a considerable binary segmentation performance. Further, we integrate unary and pairwise potentials into the CRF model to refine the segmentation results. The pairwise potentials include color and texture potentials with neighborhood interactions, and an edge potential. High segmentation accuracy is demonstrated on three benchmark datasets: the Weizmann horse dataset, the VOC2006 cow dataset, and the MSRC multiclass dataset. Extensive experiments show that the proposed approach performs favorably against the state-of-the-art approaches.