• Title/Summary/Keyword: Clinical research

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Hepatic Lipase C514T Polymorphism and its Relationship with Plasma HDL-C Levels and Coronary Artery Disease in Koreans

  • Park, Kyung-Woo;Choi, Jin-Ho;Chae, In-Ho;Cho, Hyun-Jai;Oh, Se-Il;Kim, Hyo-Soo;Lee, Myoung-Mook;Park, Young-Bae;Choi, Yun-Shik
    • BMB Reports
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    • v.36 no.2
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    • pp.237-242
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    • 2003
  • Hepatic lipase is a key enzyme that is involved in HDL-C metabolism. The goal of this study was to find out the frequency of the hepatic lipase C514T polymorphism, and evaluate its relationship with plasma HDL-C levels and coronary artery disease (CAD) in Koreans. Two hundred and twenty four subjects with no previous history of lipid-lowering therapy, 118 patients with significant CAD, and 106 controls were examined with respect to their genotypes, lipid profiles, and other risk factors for CAD. The frequency of the -514T allele was 0.37 in men and 0.35 in women, which were higher than the frequency that was reported in Caucasians, but lower than the frequency that was reported in African-Americans. The -514T allele was associated with significantly higher HDL-C levels in women. After controlling for age, gender, BMI, DM, and smoking, the non-CC genotype was significantly associated with HDL-C levels, and explained 6% of the HDL-C variation in this study. When the genotypes-distribution was compared between the CAD and non-CAD patients, the hepatic lipase C-514T polymorphism was not associated with the presence of CAD. Koreans have a higher frequency of the hepatic lipase gene 514T allele than Caucasians, and the -514T allele is associated with higher plasma HDL-C levels in Korean women, and perhaps non-smoking men. However, our data does not suggest an association between the polymorphism and an increased risk of CAD.

Bioinformatics and Genomic Medicine (생명정보학과 유전체의학)

  • Kim, Ju-Han
    • Journal of Preventive Medicine and Public Health
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    • v.35 no.2
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    • pp.83-91
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    • 2002
  • Bioinformatics is a rapidly emerging field of biomedical research. A flood of large-scale genomic and postgenomic data means that many of the challenges in biomedical research are now challenges in computational sciences. Clinical informatics has long developed methodologies to improve biomedical research and clinical care by integrating experimental and clinical information systems. The informatics revolutions both in bioinformatics and clinical informatics will eventually change the current practice of medicine, including diagnostics, therapeutics, and prognostics. Postgenome informatics, powered by high throughput technologies and genomic-scale databases, is likely to transform our biomedical understanding forever much the same way that biochemistry did a generation ago. The paper describes how these technologies will impact biomedical research and clinical care, emphasizing recent advances in biochip-based functional genomics and proteomics. Basic data preprocessing with normalization, primary pattern analysis, and machine learning algorithms will be presented. Use of integrated biochip informatics technologies, text mining of factual and literature databases, and integrated management of biomolecular databases will be discussed. Each step will be given with real examples in the context of clinical relevance. Issues of linking molecular genotype and clinical phenotype information will be discussed.

The Analysis of Clinical Trial Research Trend on Mild and Sub-clinical Depression in Traditional Chinese Medicine - using China National Knowledge Infrastructure Database - (경증 및 아임상 우울증의 중의학 임상연구 동향 분석 - China National Knowledge Infrastructure를 중심으로 -)

  • Ko, Youme;Lee, Siwoo;Kim, Sang-Hyuk
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.1
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    • pp.47-59
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    • 2015
  • Objective : The purpose of this study was to analyze the trend of clinical research on 'mild and sub-clinical depressions' in China. Method : The journal search was performed using China National Knowledge Infrastructure(CNKI). Our inclusion criteria were as follows: TCM clinical trials for mild, sub-clinical, early stage of depression. Exclusion criteria were the following: non-TCM clinical trials, disease-associated depression related clinical trials. Results : We included 16 papers in this study. 1. In this study, we realized there have been several mild and sub-clinical depressions related clinical trials conducted in the field of TCM. 2. The result of 10 Journals used the Hamilton Depression Rating Scale for diagnosis and assessment criteria of mild and sub-clinical depressions. 3. The selected journals categorized by various interventions, such as, herbal medicine(7), acupuncture(4), miscellaneous(5). 4. Also, 7 Journals showed the significant improvements in patients with mild and sub-clinical depressions by TCM interventions, and 5 studies of TCM patent prescription reported that herbal medicine therapy has less side effect than the western medicine. Conclusion : Through this study, we found out that several researchers in China performed clinical trials on mild and sub-clinical depressions constantly. From the result of this study, we need to concern about the necessity of research on the mild and sub-clinical depression in Korea. Therefore, this result could be used as a meaningful reference for the design of future clinical trials.

A Study on the Protection of Trial Subjects in Clinical Trials of Investigational New Drug (의약품 임상시험에서 피험자 보호)

  • We, Kye Chan
    • The Korean Society of Law and Medicine
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    • v.13 no.2
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    • pp.79-113
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    • 2012
  • This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

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Combined Regional Variant of Guillain-Barre Syndrome with Paralysis of Pupils and Optic neuritis (동공마비와 시신경염이 동반된 길랑-바레 증후군 이형)

  • Lee, Byeung-Yong;Oh, Sun-Young;Seo, Man-Wook;Kim, Young-Hyun;Shin, Byoung-Soo
    • Annals of Clinical Neurophysiology
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    • v.4 no.1
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    • pp.60-62
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    • 2002
  • Two separate cranial nerve variants of Guillain-Barre syndrome(GBS) have been reported. One is Miller-Fisher syndrome, the other is polyneuritis cranialis. Involvement of the extraocular muscles in variants of GBS is well recognized, but complete external and internal opthalmoplegia is rare. Optic neuritis remains the only consistent, albeit very uncommon, evidence of inflammation of central nervous system myelin in GBS. This propose that GBS is part of a spectrum of central and peripheral inflammation. This case is an unusual clinical variant who had ptosis, opthalmoplegia, areflexia, ataxia, optic neurritis, marked oropharyngeal, and neck and shoulder weakness. This combined regional from is able to misdiagnose initially as botulism or diphtheria and less so, myasthenia. So if we were consider variant from of GBS, it is possible for make a correct diagnosis more easily and treatment without delay.

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Effects of Free Anthraquinones Extract from the Rhubarb on Cell Proliferation and Accumulation of Extracellular Matrix in High Glucose Cultured-Mesangial Cells

  • Wang, Jianyun;Fang, Hui;Dong, Bingzheng;Wang, Dongdong;Li, Yan;Chen, Xiao;Chen, Lijuan;Wei, Tong;Wei, Qunli
    • The Korean Journal of Physiology and Pharmacology
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    • v.19 no.6
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    • pp.485-489
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    • 2015
  • Diabetic nephropathy (DN) is the leading cause of end-stage failure of the kidney, but the efficacy of currently available strategies for the prevention of DN remains unsatisfactory. In this study, we investigated the effects of free anthraquinones (FARs) extract, which was extracted from the rhubarb and purified by macroporous resin DM130 with gradient mixtures of ethanol/water as the lelution solvents, in high glucose-cultured glomerular mesangial cells (MCs). The cell proliferation was determined by CCK-8 assay, the levels of TGF-${\beta}1$, CTGF, ColIV and FN proteins in the supernatant of MCs were measured by ELISA assays, and the mRNA levels of these four genes were detected by RT-PCR. The results showed that the increased proliferation of MCs, the mRNA levels and protein expression of TGF-${\beta}1$, CTGF, ColIV and FN induced by high glucose were inhibited after the treatment with the FARs extract. This indicated that FARs extract could inhibit cell proliferation and the expression of main extracellular matrix induced by high glucose in MCs. The FARs extract exhibited potential values for prophylaxis and therapy of DN.

A Review of Clinical Studies for Journal of Oriental Neuropsychiatry - since 2001 to 2010 - (동의신경정신과학회지에 게재된 임상연구논문 동향분석 - 2001년부터 2010년까지 -)

  • Heo, Eun-Jung;Jeon, Won-Kyung;Kim, Wu-Young;Han, Chang-Hyun
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.3
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    • pp.115-125
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    • 2011
  • Objectives : This study was aimed to review the trend of clinical studies in Journal of Oriental Neuropsychiatry since 2001 to 2010. Methods : We collected 260 clinical studies and analyzed them for publish year, sorts of disease or symptoms, pattern identification diagnosis, and classification of clinical studies. Among them, we selected 46 clinical experimental studies and these studies were further analyzed for publish year, research institution, sort of disease or symptoms, sorts of treatments, number of subject, and pattern identification diagnosis. Results : The number of clinical studies in Journal of Oriental Neuropsychiatry have increased since the year of 2001. There were 62 kinds of diseases and symptoms and Hwa-Byung had the highest number of studies followed by depression, headache, insomnia and so on. The clinical experimental studies, which took up 17% of the clinical studies, have increased since 2001 and was varied with year. There were 13 reserch institutions for clinical experimental studies and they studied about stress, dementia, Hwa-Byung, and so on. Most of studies researched treatment about acupuncture, herb medicine, and meditation treatment for persons under 144. There are only 22% of studies using pattern identification diagnosis. Conclusions : For the development of oriental medicine for psychiatric disease, we need more qualifying clinical studies like RCT. We hope more researchers for psychiatry disease of oriental medicine will be interested in the publication of clinical studies and this will serve to produce advance of oriental medicine as evidence based medecine.

Pros and Cons of Various Research Designs in Clinical Psychiatry (정신과 연구에서 다양한 임상연구방법의 장단점)

  • Ha, Ra Yeon;Cho, Hyun-Sang
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.159-163
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    • 2012
  • An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.