• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.261-264
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• 1994

This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients In the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline. they receive the best standard treatment. In the analyses of results. all those in the second group. regardless of treatment. are compared with those in the first group. Any loss of statistical efficiency can be overcome by Increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage' that, before providing consent, a patient will know whether an experimental treatment is to be used.

• Journal of Pharmaceutical Investigation
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• v.30 no.2
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• pp.139-143
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• 2000

Gene therapy is becoming a very promising and feasible medical intervention as the understanding of human diseases extends to their molecular levels. Since the first US Food and Drug Administration (FDA)-approved human gene therapy protocol was approved in 1990, over 300 human clinical trial protocols had been approved worldwide so far. Even though some of the domestic gene therapy clinical trials also proved promising and more are awaiting, it should be emphasized that many safety aspects as well as effectiveness aspects should be considered during the development process. Moreover, there seems to be less restricted guidelines from the National Control Authority (NCA) in initiating human clinical trials. This article is intended to suggest some basis and points to consider in the development and evaluation of gene therapy products including antisense oligonucleotides pharmaceuticals.

• The Korean Journal of Applied Statistics
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• v.11 no.2
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• pp.423-433
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• 1998

In agricultural field experiments, the completely randomized block design is often used for the analysis of variety trials. An important assumption is that every experimental unit in each block has the some fertility. But, in most agricultural field experiments there often exists a systematic heterogeneity in fertility among the experimental units. To account for the heterogeneity, we propose to use the hierarchical generalized linear models. We compare our analysis of the data from Scottish Agricultural colleges list with that using Markov chain Monte Carlo method.

• Proceedings of the Korean Society of Tribologists and Lubrication Engineers Conference
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• 2000.11a
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• pp.100-106
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• 2000

Recently, the population of vehicles using LPG as fuel has been increasing due to relatively low fuel price and low tax. Although gasoline engine oils we usually used to lubricate LPG engines, some troubles such as oil thickening and TBN depletion were found in them under severe operating condition. In order to investigate the deterioration mechanism of lubricants in LPG engine, field trials were performed. The results from the field trials showed that the deterioration of oils in LPG engine is different from that in normal gasoline engine. LPG engine oil was deteriorated mainly through oxidation and nitration at high temperature rather than contamination of fuel combustion products.

• Journal of Oriental Neuropsychiatry
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• v.22 no.4
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• pp.21-30
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• 2011

Objectives : This study was performed to review the research trends in treatment for acute alcohol intoxication in traditional Chinese medicine. Methods : 19 studies were selected by searching CNKI(China National Knowledge Infrastructure) from 2006 to 2011, and we performed a systemic review of them. Results : All studies are controlled clinical trials using pharmacopuncture therapy. Each experimental group was given various kinds of pharmacopuncture therapy, whereas each control group was given another western medicine or treatment. Emergent treatment was used in both groups. The results of 15 studies showed that pharmacopuncture therapy has an effect on the treatment of acute alcohol intoxication. However the quality of these clinical trials wasn't high. Conclusions : It seems that the researches for acute alcohol intoxication have been performed actively in traditional Chinese medicine. We hope that our study can activate clinical research for this disorder in Korean traditional medicine.

• Journal of Hospice and Palliative Care
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• v.24 no.3
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• pp.144-153
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• 2021

Purpose: Advance care planning (ACP) is widely understood to improve end-of-life care. This systematic review and meta-analysis aimed to examine the effects of ACP interventions on decision conflict and psychological distress. Methods: A search of PubMed, CINAHL, CENTRAL, EMBASE, KISS, KoreaMed, and RISS was conducted in November 2020. The study included randomized controlled trials. Data were pooled using fixed- and random-effects models. Results: Fourteen studies were identified that cumulatively included 1,548 participants. ACP interventions were effective in alleviating decision conflict (d=-0.53; 95% CI: -0.83 to -0.23), depression (d=-1.22; 95% CI: -1.71 to -0.74) and anxiety (d=-0.76; 95% CI: -1.12 to -0.39). Conclusion: ACP interventions have significant positive effects on reducing decision conflict and psychological distress. A high level of bias was shown related to allocation concealment and blinding. The results of this study are expected to be useful for end-of-life care providers to improve the effectiveness of ACP interventions.

• Communications for Statistical Applications and Methods
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• v.26 no.2
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• pp.163-173
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• 2019

Simon's two-stage designs are frequently used in phase II single-arm trials for efficacy studies. A concern of safety studies is too many patients who experience an adverse event. We show that Simon's two-stage designs for efficacy studies can be similarly used to design a two-stage safety study by modifying some of the design parameters. Given the type I and II error rates and the proportion of adverse events experienced in the first stage cohort, we prescribe a procedure whether to terminate the trial or proceed with a stage 2 trial by recruiting additional patients. We study the relationship between a two-stage design with a safety endpoint and an efficacy endpoint as well as use simulation studies to ascertain their properties. We provide a real-life application and a free R package gen2stage to facilitate direct use of two-stage designs in a safety study.

• Journal of Gynecologic Oncology
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• v.29 no.6
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• pp.96.1-96.12
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• 2018

The 3-weekly regimen of carboplatin and paclitaxel is the backbone of first line adjuvant chemotherapy for advanced ovarian cancer. The landmark Japanese Gynaecologic Oncology Group (JGOG) 3016 study demonstrated significant improvements in progression-free survival and overall survival with dose dense weekly administration of paclitaxel in combination with 3-weekly carboplatin. However, efforts to replicate these benefits have failed in subsequent phase III trials. Weekly paclitaxel is purported to have enhanced antitumor activity, with stronger anti-angiogenic effects, and yet is better tolerated. In this review, we explore the rationale for dose dense weekly paclitaxel, and compare the relevant trials as well as quality of life considerations. Possible reasons for the difference in outcomes between the JGOG 3016 and other studies are reviewed, with a focus on how the addition of bevacizumab, the variations between histological and molecular subtypes of epithelial ovarian cancers, and ethnic pharmacogenetic differences may potentially affect the efficacy of dose dense paclitaxel.

• Journal of Ocean Engineering and Technology
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• v.34 no.6
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• pp.387-393
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• 2020

Frictional resistance comprises more than 60% of the total resistance for most merchant ships. Active and passive devices have been used to reduce frictional resistance, but the most effective and practical device is an air lubrication system. Such systems have been applied in several ships, and their effects have been verified in sea trials. On the other hand, there are some differences between the results predicted in model tests and those measured in sea trials. In this study, numerical analyses were carried out for a model and a full-scale ship. A new extrapolation method was proposed to improve the estimation of the full-scale resistance of a ship with an air lubrication system. The volume of fluid (VOF) method was considered for the numerical models of the air layer. The numerical method was validated by comparing the experimental data on the air layer pattern and the total resistance.

• BMB Reports
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• v.54 no.1
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• pp.21-30
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• 2021

Clinical trials have demonstrated that an increased number of effector cells, especially tumor-specific T cells, is positively linked with patients' prognosis. Although the discovery of checkpoint inhibitors (CPIs) has led to encouraging progress in cancer immunotherapy, the lack of either T cells or targets for CPIs is a limitation for patients with poor prognosis. Since interleukin (IL)-2 and IL-7 are cytokines that target many aspects of T-cell responses, they have been used to treat cancers. In this review, we focus on the basic biology of how these cytokines regulate T-cell response and on the clinical trials using the cytokines against cancer. Further, we introduce several recent studies that aim to improve cytokines' biological activities and find the strategy for combination with other therapeutics.