• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.313-319
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• 1994

Phase I of the Trials of Hypertension Prevention was a multicenter, randomized, controlled trial designed to determine the efficacy of seven nonpharmacologic interventions in reducing blood pressure among persons with high-normal diastolic blood pressure. the initial goal for recruitment was to enroll 2,100 participants over a nine-month period. The yield from the first screening visit to randomization was 13% overall, with clinic-specific yields ranging from 4.5% to 31.7%. After five months of recruitment, approximately 60% of the goal for that point in the recruitment timetable had been randomized. Clinical centers falling short of their goals at that time altered their recruitment strategies and intensified their efforts, and centers that had exceeded their goals recruited additional participants. As a result, 2,182 participants, or 104\% of the goal for recruitment, were randomized over a 13-month period. Those clinics using a cohort, or wave, type of enrollment were most successful in achieving their recruitment goals within the prescribed timetable.

• 대한핵의학회:학술대회논문집
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• 1999.05a
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• pp.228-241
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• 1999

Percutaneous coronary angioplasty is well established therapeutic modality in the management of coronary artery disease. However, the high restenosis rate of 30 to 50% limits its usefulness. The principal mechanism of restenosis, intimal hyperplasia, is the proliferative response of vessel wall to injury, which consists largely of smooth muscle cells. A large body of animal investigations and a limited number of clinical studies have established the ability of ionizing radiation to reduce neointimal proliferation and restenosis rate significantly. Human studies have been reported that intravascular radiation after first restenosis inhibits a second restenosis. Encouraged by these reports, we are also conducting a double blind, placebo-controlled, randomized trial to evaluate this new therapeutic modality in patients with coronary artery stenosis. The objective of our trial is to determine the safety and efficacy of catheter-based solutional beta emitting radioisotope system in preventing restenosis after angioplasty. This review describes the vascular brachytherapy systems and isotopes that have been utilized in the initial clinical trials performed in this area of post PTCA coronary restenosis. The results of many worldwide ongoing clinical trials will determine whether this new technology will change the future practice of vascular intervention.

• Journal of Korean Medicine for Obesity Research
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• v.12 no.1
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• pp.48-58
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• 2012

Objectives These prescribing recommendations have been written to guide clinicians on the appropriate use of Bangpungtongseong-san(BT) and Bangkihwangki-tang(BH) in the treatment of obesity. These recommendation are aimed at providing evidence based information concerning diagnosis and management of obesity. Methods We collected all relevant references about treatment effect of BT and BH on obesity in the forms of meta-analysis, systematic review, randomized controlled trial, case-control study, observational study and practice guideline from international and domestic databases and paper journals. We examined treatment effect, side effects, recommendations for dose, indication and contraindication of BT and BH. Results The treatment effect of BT and BH on obesity has been proved through clinical trial. BT is indicated for obese patients (Body mass index, $BMI{\geq}25$) with strong abdomen and a tendency to constipation, BH is indicated for obese patients ($BMI{\geq}25$) with a fair skinned, soft muscled, edematous and sweat easily. Conclusion We wish the information contained in theses recommendations will help clinicians reach a reasonable and beneficial decision with evidence-based results. Further studies are strongly needed to develop better treatment strategies for herbal medicines on obesity.

• The Korean Journal of Applied Statistics
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• v.11 no.2
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• pp.269-285
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• 1998

One of the most important issues in the area of clinical trial research is the determination of the sample size required to insure a specified power in detecting a real or clinically relevant difference of a stated magnitude. Increasingly, medical journals are requiring authors to provide information on the sample size needed to detect a given difference. We restrict our attention to the designs far comparirng two survival distributions. These are concerned with the survival time which is defined as the interval from a baseline(e.g. randomization) to failure (e.g. death, recurrence of disease). Survival times axe right censored when patients have not foiled by the time of analysis or have been loss to follow-up during the trial. For different types of clinical trials for comparing survival distributions, there have been marry research in sample size determination. We review the existing literature concerning commonly used sample size formulae in the design of randomized clinical trials, and compare the assumption, the power and the sample size calculation of these methods. We also compare by simulation the expected power and observed power of each method under various circumstances. As a result, guidelines in terms of practical usage are provided.

• 대한임상약리학회:학술대회논문집
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• 2003.12a
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• pp.20-21
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• 2003

• Journal of Dental Anesthesia and Pain Medicine
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• v.23 no.1
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• pp.55-55
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• 2023

• Journal of Korean Neurosurgical Society
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• v.65 no.6
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• pp.765-771
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• 2022

Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

• Journal of Haehwa Medicine
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• v.22 no.2
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• pp.37-45
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• 2014

Recently, interest in detoxification therapies is increasing. Coffee enema has been most frequently used as one of detoxification therapies. However, there is lack of scientific basis for coffee enema, regarding its clinical efficacy and safety respectively. This study aimed to produce the general features of coffee enema such as definition, protocols, clinical applications and efficacies, and side effects. Total 37 articles coffee enema were collected from 7 databases including PubMed, and reviewed thoroughly. The majority of papers were review studies or case reports for effects/side-effects of coffee enema. The quality of papers was generally poor, and no randomized controlled clinical trial (RCT) was exist. This study shows the current status of coffee enema-related study, and suggests the demand for RCT study to develop the evidence-based detoxification therapy using coffee enema.

• Journal of Korean Dental Science
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• v.3 no.2
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• pp.34-39
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• 2010

In our daily practice, we think about the diagnosis of our patient and get into a situation wherein we have to make a clinical decision. Diagnosis and treatment come from the knowledge and experiences that each dentist should have, but sometimes, we can have doubts on our decisions. "On what evidence did I make such decision? Was that really right?" Drawing our attention these days as a possible answer to this question, evidence-based dentistry seeks to apply the best available evidence gained from the scientific method to medical decision making. To make a good decision, the strength of evidence is assessed. Specifically, randomized controlled trial, systematic review, and meta-analysis are considered the highest level of evidence; cohort study, case control study, case series, animal study, bench test, and biological plausibility follow. With the approach of evidence-based dentistry, we can make objective, scientifically sound clinical decisions. It is also patient-oriented, incorporating clinical experiences and stressing good judgments; thorough and comprehensive, it uses transparent methodology. That is the reason evidence-based dentistry can be better than other assessment methods when we make a clinical decision in modern dentistry.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.4
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• pp.45-57
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• 2014

Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.