• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.26 no.2
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• pp.78-87
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• 2013

Objectives : This work aimed to review clinical trial trend of Korean medicine's face rejuvenation and suggest future trial using embedded needle(Maesun) based on Evidence-based medicine's PICO Model. Methods : 46 papers were searched from Oasis and DBPia, then 8 papers were engaged in review of clinical trial trend. Based on PICO model, clinical trial's patient, intervention, and outcome measurement were suggested. Results : Evidence level of clinical trials is relatively low, because their study designs are almost case report or case series. No study have comparison groups. Outcome measurement is varied, however, 3D face scanner were used to measure before-after changes of face. Based on review, we suggested that necessity of intervention standardization, measuring of normal control group and 2D/3D combined outcome measurement of face. Conclusions : There are many demands for revealing efficacy and safety of Korean medicine's intervention, also for face rejuvenation using embedded needle. For meeting the level of demands, more rigorous works are needed.

• Journal of Acupuncture Research
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• v.28 no.5
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• pp.87-96
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• 2011

Objectives : The aim of this study is to review clinical trials using moxibustion on hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of moxibustion were performed in nine electronic databases (four international databases and five Korean databases) and handsearch. English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of twelve studies met the inclusion criteria. Seven randomized controlled trial, three non-randomized trials and two before-after studies were included. Seven studies used direct moxibustion(two are scarring one) and five used indirect one. Five of twelve studies used moxibustion treatment just one time, except for that most frequency was once daily or 2-3 times per week for 1-2 months. Of ten randomized or non-randomized studies, three used antihypertension drug control and another three used waiting list control. Compare to baseline, change of blood pressure after moxibustion treatment was significant in all studies. However, the results of effect in blood pressure between moxibustion and controlled were not consistent. Methodological quality of clinical trials included in this review was low and has risk of bias, especially in blinding of parcitipant. Conclusions : There are little high-quality clinical trials of moxibustion for hypertension. To evaluate the effect of moxibustion, more rigorous trials are warranted. Also, methodology of clinical trials have to be descripted in detail.

• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.196-203
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• 2006

Objectives : The aim of this study is to investigate how does the methods of treatment and diagnosis of Traditional Korean Medicine(TKM) get the evidence of efficacy and safety and what type of efficient body and appropriate facility of the coordination center for clinical trial in TKM. Methods : We have got the information of clinical trial center or clinical collaboration center by site invitation, search of paper and reports and internet exploration for the domestic or foreign site. Results : Coordination center for clinical trial usually involves every steps of clinical trials, such as development of Case Report From (CRF), design of study, calculation of sample size, randomization, maintenance of blinding, monitoring and audit of the resource document, data and CRF, data entry, quality control of data, analysis and report. Conclusions : The body needs several aresa of experts, which are epidemiologists, biostatisticians, research nurses for coordination, data manager and programmer, and administrator. This body would be enhance and help he clinical researches including clinical trials in TKM.

• 대한예방의학회:학술대회논문집
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• 2002.10a
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• pp.192-193
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• 2002

• Journal of Gastric Cancer
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• v.16 no.2
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• pp.93-97
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• 2016

Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.

• Herbal Formula Science
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• v.27 no.3
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• pp.213-221
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• 2019

Objectives : The purpose of this study is to confirm the efficacy and safety of the treatment of gastritis with 'Hwangryunhaedok-tang'. Methods : Total 20 people, between 19 and 65 years old, will be recruited to participate in a comparative clinical trial. All subjects will take 2 capsules of Hwangryunhaedok-tang (Redoxin Cap.), 3 times a day, 30 minutes after meals, for 8 weeks. Outcomes will be measured at the baseline, 4th week, and 8th week. Primary outcomes is the improvement rates of gastritis symptoms, such as heartburn, nausea/vomiting, abdominal bloating, anorexia, heartburn, and trim. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2018011), and registered in Clinical Research information Service, one of WHO. Recruitment opened in April 2019 and is supposed to be completed by December 2019. Conclusions : This trial will provide clinical information to determine the efficacy and safety of treatment of gastritis with 'Hwangryunhaedok-tang'.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.2
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• pp.49-55
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• 2023

Objectives The purpose of this study is to analyze randomized controlled trials about neuromuscular electrical stimulation for muscle wasting with cancer patient and evaluate it's motor functionality effect. Methods Studies will be searched from 7 online databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure [CNKI], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]). Participants will be cancer patients with muscle loss, regardless of cause, gender, race or age, interventions will be neuromuscular electrical stimulation. Other treatments than interventions will be the control group and the main outcome will be reviewed by motor functionality effect. Results Randomized controlled trials about neuromuscular electrical stimulation for muscle wasting should be included in the study. Primary outcomes include motor functionality effect. Secondary outcomes evaluate adverse event. The data uses Review Manager Software 5.4. Conclusions The conclusion of this study will provide a basis for determining whether neuromuscular electrical stimulation treatment for muscle wasting with cancer patient treatment is an effective and safe treatment method in clinical practice.

• KSII Transactions on Internet and Information Systems (TIIS)
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• v.5 no.10
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• pp.1830-1840
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• 2011

CDISC (Clinical Data Interchanging Standards Consortium) standards are to support the acquisition, exchange, submission and archival of clinical trial and research data. SDTM (Study Data Tabulation Model) for Case Report Forms (CRFs) was recommended for U.S. Food and Drug Administration (FDA) regulatory submissions since 2004. Although the SDTM Implementation Guide gives a standardized and predefined collection of submission metadata 'domains' containing extensive variable collections, transforming CRFs to SDTM files for FDA submission is still a very hard and time-consuming task. For addressing this issue, we developed metadata based SDTM mapping rules. Using these mapping rules, we also developed a semi-automatic tool, named CDISC Transformer, for transforming clinical trial data to CDISC standard compliant data. The performance of CDISC Transformer with or without MDR support was evaluated using CDISC blank CRF as the 'gold standard'. Both MDR and user inquiry-supported transformation substantially improved the accuracy of our transformation rules. CDISC Transformer will greatly reduce the workloads and enhance standardized data entry and integration for clinical trial and research in various healthcare domains.

• Korean Journal of Acupuncture
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• v.26 no.4
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• pp.53-66
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• 2009

Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.

• 대한임상약리학회:학술대회논문집
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• 2005.12a
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• pp.3-3
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• 2005