• 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.

• Journal of Science and Technology Studies
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• v.18 no.3
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• pp.1-45
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• 2018

South Korea has recently emerged as one of the leading countries conducting clinical trials. Seoul, for instance, is now ranked at the top of the list among the cities in the world. This paper examines the rapid growth of research involving human subjects in Korea, not just from the economic perspective (e.g., the growth of global pharmaceutical markets and the subsequent increase in the demand for clinical trials), but from the policy perspective (e.g., the government?s drive to support and promote this field as a new industry). The industrialization of clinical trials in Korea has manifested itself in the rise of international Contract Research Organizations (CRO) doing their business in Korea. They are, figuratively speaking, invited to Korea by the government. This paper intends to uncover and discuss the bioethical issues concerning research on human subjects, the issues that tend to be set aside merely as procedural ones like ??workable documents??. To this end, it investigates the practice of clinical trials by collecting hitherto unherad voices from patient-volunteers, physician-researchers, CRO employees, and government officials. This paper also explores the themes of ??ethical variability?? and ??biocapital?? in order to compare and constrast the case in Korea with those in other countries.

• Journal of Oriental Neuropsychiatry
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• v.25 no.3
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• pp.287-296
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• 2014

Objectives: Alzheimer's Dementia is somewhat common in clinical stages, and there are many reports and papers regarding this subject. We explain the present state of Alzheimer's Dementia in JON (The Journal of Oriental Neuropsychiatry) for the benefits of clinical practice. Methods: We searched for articles in JON from 1990 to 2014 and selected ones that were related to Alzheimer's Dementia; then, we analyzed the data and placed it in four categories, like experimental study, case study, Clinical Data-Analysis study, and clinical trial. Results: 1) We found 47 articles relating to Alzheimer's Dementia in JON from 1997 to 2014: 41 experimental studies, 1 case study, 1 Clinical Data-Analysis study, and 4 Clinical trials. 2) There were Chung-kyung Acupuncture Method, Auricular acupuncture, and Cha-rak Acupuncture Method to treat Alzheimer's Dementia. 3) There were many additional treatments, like aroma therapy. 4) In the experimental study, they reported on several herbs, including herbal prescriptions that affected the suppression of related mRNAs and genes. 5) There were 4 clinical trials regarding herbal prescription that was effective for treating Alzheimer's Dementia. Conclusions: In JON, regarding Alzheimer's Dementia, the majority dealt with experimental studies. Therefore, we also have to expand our sight into other fields of study. We need more clinical trials and case studies for the treatment of Alzheimer's Dementia in Oriental Neuropsychiatry.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.20 no.3
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• pp.138-146
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• 2007

Objective : To observe the trend in clinical study on atopic dermatitis(AD) over the last 3 years in order to develop a study methodology of AD in Oriental Medicine. Methods : Using the Pub med on line site; search terms: atopic dermatitis, field as title/abstract, limitation as published in the last 3 years, only items with links to full text, Humans, Clinical Trial, English. I observed the study contents of all this research and focused on the classification of treatments. I also observed of AD clinical trials registered on a clinical trial site(www.clinicaltrial.gov) on 23rd of June, 2007: study contents, localization and study designs. Results : Through the Pub Med site, I found 169 articles. Classified according to study subject, the studies related to treatment were 114(67.5%); physiology, pathology and prevention 12(7.1%); Diagnosis and Evaluation(7.1%); psychological aspects including quality of life 10(5.9%); diet and management 10(5.9%); epidemiology 7(4.1%); and others 7(4.1%). However, the treatment study of herb-medicine as intervention showed only 1 article. Futhermore, it wasn't based on Oriental Medicine philosophy. In the clinical trial site, there were 31 studies in which patients were recruited or planned for the future. The study on efficacy and safety of the medicine produced 14 trials, 5 comparative trials, 2 phototherapy, 2 diagnosis, 6 physiology and pathology, and 2 epidemiology. The trial institutions were concentrated in U.S.A. Conclusion : I suggest we'd better try to make a good clinical guideline and standardization of diagnosis and herb-medicine in order to develop a clinical study methodology of AD as soon as possible in the future. Even though it 's very hard to find the study methodology, we should aim to achieve positive results and show the evidence of the efficacy and safety of herb-medicine treatment for AD using Oriental Medicine.

• Journal of Oriental Neuropsychiatry
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• v.23 no.4
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• pp.11-36
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• 2012

Objectives : Sleep Disorders are very common in clinical stages and there are many reports and papers regarding this subject. I try to understand the present state of sleep research in JON (The Journal of Oriental Neuropsychiatry) for the benefits of clinical practice. Methods : We searched and read every article on JON from 1990 to 2012 and selected ones that are related to Sleep Disorder; then analyzed the data to 5 categories, like literature study, case study, Clinical Data-Analysis study, experimental study, and clinical trial. Results : 1. We Found 41 articles relating to sleep disorder in JON form 1999 to 2012, and there were 9 literature studies, 13 case studies, 13 Clinical Data-Analysis studies, 4 experimental studies, and 2 clinical trials. 2. There were Sa-Am Acupuncture Method, Pharmacopuncture, electroacupuncture, and Auricular acupuncture to treat Sleep Disorder. 3. There were many additional treatments like Purgative Therapy, etc. 4. They reported the ordinary sleep pattern of Soeumin and Soyangin, too. 5. In the experimental study, they reported several herbs, herbal prescription on the expression of melatonin receptors, and Punsimgeimgamibang on insomnia, anxiety, emotionality in rats. 6. There were 2 clinical trials, one for Hwabyung-patient with insomnia by acupuncture treatment and another for insomnia in the elderly by ETF-I program. 7. There were 2 case of other sleep disorder (enuresis, sleepwalking) and 2 literature study of dream. Conclusions : In JON regarding sleep disorder, the majority was due to insomnia. Therefore, we also have to expand our sight into other sleep diseases. We need more clinical trials and experimental researches for the construction of EBM Sleep Disorder in Oriental Neuropsychiatry.

• Journal of KIISE:Computing Practices and Letters
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• v.15 no.8
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• pp.566-575
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• 2009

Clinical Data Interchange Standards Consortium (CDISC) developed global and platform-independent data standards to improve ineffective processes of clinical trial studies. Regardless of its objective toward global cooperation, the current version of the CDISC standard cannot describe clinical trial data in various languages for multi-national investigators or reviewers. This problem applies not only to tabulated datasets in Study Data Tabulation Model (SDTM) but also to extensible markup language representation of the datasets in Operational Data Model (ODM) instances. In order to address this issue, we propose to extend the current version of SDTM and ODM to collect clinical data for multi-national clinical trials. SDTM needs to have new special-purpose domain for multi-language representation purpose. Additionally, ODM is recommended to extend its XML schema using subtyping or type inheritance mechanism respectively. Our extension of SDTM and ODM enable to represent any granule of study data tabulation model or XML data entities to describe in efficient languages. This result will contribute to collect multi-language data easily for multi-national clinical trials.

• The Journal of Korean Obstetrics and Gynecology
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• v.35 no.4
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• pp.37-56
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• 2022

Objectives: The purpose of this study is to assess the effect of electroacupuncture for treating postpartum hypogalactia. Methods: We searched 9 databases on May, 2022, which contained four English, two Chinese, one Japanese, and two Korean databases. Randomized controlled trials (RCTs) were eligible. Measurement of outcome included total effective rate, lactation amount, serum prolactin level, and degree of breast fullness. The risk of bias was assessed by two independent authors using the Cochrane risk of bias tool. Results: 101 trials were screened, 5 RCTs were finally selected. Number of participants per study ranged from 56 to 273. The treatment group was effective of improving total effective rate, lactation amount, serum prolactin level compared with control group, and the result was stastically significant. The quality of the evidence for specific comparisons ranged from low to high. Conclusions: Included studies showed that electroacupuncture on acupoints related to lactation would be effective way to increase milk supply among mothers who are suffering from postpartum hypogalactia. In the future, further high-quality RCTs are needed to prove effectiveness of electroacupuncture for relieving hypogalactia with low risk of bias.

• Korean Journal of Acupuncture
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• v.29 no.4
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• pp.519-536
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• 2012

Objectives : The purpose of this study is to figure out which acupoints are selected to treat low back pain and attempt to analyze the effectiveness of those acupoints in current clinical trials. Methods : We searched the three electronic databases(PUBMED, RISS, KISS) and manually checked related Korean journals and reference lists up to April 2012. We included randomized controlled trials, clinical controlled trials, and case reports/series using needle type acupuncture( manual acupuncture, electronic acupuncture) to treat low back pain in English and Korean. We investigated the frequency of selected acupoints, change of visual analogue scale of low back pain and statistical significance in each study among trials. Results : We included 37 articles(Domestic 17, International 20) 53 studies(Domestic 28, International 25) in this study. The most frequently adopted acupoints were BL23, BL24, BL25, GB30, BL26, BL60, BL32, BL40, KI3, GV3, ST36 in domestic studies and BL23, BL25, BL40, BL60, GB30, GB34, BL32, BL26 in international studies. There were differential effectiveness of acupoints between domestic and the international studies using statistical significance of visual analog scale for low back pain. Conclusions : These results suggest that both proximal and distal acupoints based on meridian theory were used in clinical trials to treat low back pain. It would be helpful to provide clinical guideline, evaluate the results of clinical trials appropriately, and reveal the effectiveness of acupoints.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.27 no.1
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• pp.31-38
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• 2016

Pharmacotherapy is considered the first line therapy in attention-deficit hyperactivity disorder (ADHD). Many patients also choose complementary medicine such as dietary supplements. Omega-3 has shown some efficacy for improving ADHD symptoms in several studies. The goal of this review is to integrate the previous research findings on omega-3 and understand the issues worth considering in the treatment of ADHD. The terms "attention deficit disorder with hyperactivity", "omega-3", and "dietary supplements" were searched on PubMed, Cochrane, and Google scholar. The search was further limited to clinical trials, reviews, and meta-analyses. Trials that examined treatments for ADHD, used randomized design, and placebo-controlled trials were included. Eighteen clinical trials with a total of 1,141 participants were included in this review. Fifteen trials had parallel designs, comparing an omega-3/6 polyunsaturated fatty acid (PUFAs) or a combination of both to a placebo and three compared omega-3/6 PUFAs to a placebo and psycho-stimulants. Seven of the included trials showed significant improvements in groups receiving omega-3/6 PUFAs compared to placebo groups, however, 11 trials showed no significant differences. Evidence that PUFAs supplementation provides benefits for ADHD was yet limited. Mixed results were due to selection variability criteria, variability of supplementation, and short follow-up intervals.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.342-351
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• 1994