• Asian Pacific Journal of Cancer Prevention
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• v.14 no.2
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• pp.877-883
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• 2013

Background and Objective: There has been no universally agreed standard chemotherapy regimen for patients with advanced biliary tract carcinomas (BTC). We aimed to fully display and evaluate the clinical evidence for gemcitabine or gemcitabine-cisplatin combination for advanced BTC. Methods: Systematic searches were performed to identify relevant randomized controlled trials (RCTs) and uncontrolled trials. Overall survival (OS), progression-free survival (PFS), overall response rates (ORR), tumor control rates (TCR), and toxicity were evaluated. Evidence levels of the results were evaluated with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Results of the eleven gemcitabine-cisplatin trials and ten gemcitabine trials showed both chemotherapy regimens had benefits with reference to mean OS (8.63 vs. 8.79 months), mean PFS (4.86 vs. 4.72 months), pooled ORR (25.3% vs. 19.6%) and TCR (55.2% vs. 53.1%). Two RCTs showed the gemcitabine-cisplatin combination to prolong the mean PFS (mean difference [MD] 2.57, 95%CI 1.69 3.45), substantially increasing the mean OS (MD 3.59, 95% CI 3.48 3.71), and producing a similar effect in ORR (risk ratio [RR] 1.59, 95%CI 1.04 2.43), increasing TCR (RR 1.15, 95%CI 1.02 1.31) compared with gemcitabine alone, with generally manageable grade 3 or 4 adverse events. The evidence level of OS was moderate, and other outcomes (ORR, PFS, TCR, anaemia, neutropenia) were at low evidence levels. Conclusion: Available evidence was limited with low quality, which showed that both gemcitabine-cisplatin and gemcitabine alone had clinical activity with acceptable safety profiles, and gemcitabine-cisplatin appeared to be more useful for advanced BTC patients than gemcitabine alone.

• The Journal of Korean Obstetrics and Gynecology
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• v.31 no.4
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• pp.89-109
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• 2018

Objectives: The purpose of this systematic review is to assess the effects of herbal medicine with in vitro fertilization-embryo transfer (IVF-ET) based on the current evidence. Methods: Eligible randomized controlled trials (RCT) searched from Pubmed which compared a combination of herbal medicine and IVF with IVF alone were included. Results: Sixteen trials, in which 2025 women involved, were included in this review. The review results showed that the effect of traditional herbal medicine can improve the clinical pregnancy rate (herbal medicine intervention: 30.36~63.64%, Control: 9.38~47.5%) and rate of high quality oocytes and embryos. The mechanism may be through regulating follicular fluid to improve microenvironment for oocytes which would lead to a successful embryo implantation. Conclusions: This analysis showed that combination of IVF and traditional herbal medicine used in the included trials improve clinical pregnancy rate and IVF success. During in vitro fertilization, TCM can regulate the microenvironment in the follicular fluid to mature the oocyte, improve the quality of the embryo, and help the development and implantation of the embryo. Further large randomized placebo controlled trials are needed to confirm the effectiveness of traditional herbal medicine with concurrent IVF.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.4
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• pp.87-96
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• 2011

Objectives: This study aims to systematically evaluate the effectiveness of Eastern-Western integrative medicine for musculoskeletal disorders compared with Eastern or Western Medicine. Methods: Systematic sea-mes of 9 major Korean databases were conducted for articles published up to July 2011. Searching keyword was "Integrative Medicine". Prospective studies dealt with musculoskeletal disorders by Eastern-Western integrative medicine were included. Quality assessment of included studies was evaluated by Cochrane risk of bias tool. Results: 470 studies in total were seamed, Amalg them 7 studies met our inclusion criteria(3 randomized controlled clinical trials, 2 non-randomized controlled trials and 2 uncontrolled clinical trials). Included studies dealt with lumbar pan(3), shoulder pain(2), pain after traffic injury(1), spinal compression fracture(1). Eastern-Western integrative medicine showed better or equal effect for the treatment of various muscloskeletal disorders compared with Eastern or Western medicine alone. Conclusions: There is very weak evidence for the effectiveness of Eastern-Western integrative medicine for musculoskeletal disorders compared with Eastern or Western medicine alone. Well designed randomized controlled trials with rigorous methodology are needed to evaluate the effectiveness of Eastern-Western integrative medicine objectively in the future.

• Journal of Ginseng Research
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• v.46 no.1
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• pp.71-78
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• 2022

Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.16 no.5
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• pp.205-212
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• 2016

Recently, researches for the integration and standardization of clinical data in the Western medicine and Korean medicine is in progress. If an integration of similar clinical data as well as heterogeneous clinical data is possible based on one standardization, we can able to derive implicit medical knowledge from integrated clinical data. In this paper, we implemented Korean clinical database based on internationally known CDISC standardization to efficiently store Korean clinical data and constructed E-CRF system for convenient data input in clinical sites. Furthermore, we showed example of an integration of Korean clinical data from 4 clinical sites. The results of our study will help to establish the foundation for the extraction of implicit medical knowledge from integrated clinical data. Also, our results may support efficient management through data integration, prevention of repetitive or unnecessary clinical trials, facilitation of collaborative study and convenient research through the distribution of refined clinical data.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.270-284
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• 1994

Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately. the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. 'In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view. these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally. we discuss some important practical issues such as estimation following group sequential testing, anal ysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials. and the role of administrative analyses.

• Journal of The Korean Society of Integrative Medicine
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• v.4 no.4
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• pp.33-39
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• 2016

Purpose : The aim of this study was to investigate the effects of plastic ankle foot orthosis on adult post-stroke hemiplegic patients walking ability and balance. Method : The searched for the case controlled clinical trials about the effects of plastic ankle foot orthosis(pAFO) for walking ability and balance using quantitative gait analysis in adult post-stroke patients. Ten trials were selected from Riss4U databases published until June 2016 in Korea. The selected trials contained a control group with pre-test and post-test design, measured walking ability and balance as a dependent variable. Result : The selected ten trials involved a total of 180 patients. The walking speed, cadence, the portion of double limb supporting, stride length on affected side were improved by plastic ankle foot orthosis. Conclusion : The plastic ankle foot orthosis has some evidence to improve the walking ability and balance in post-stroke hemiplegic patients.

• Kyungpook Mathematical Journal
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• v.64 no.2
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• pp.287-301
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• 2024

From the mathematical and statistical point of view, a segment of a DNA strand can be viewed as a sequence of four-state (A, C, G, T) trials. Herein, we consider the distributions of runs and patterns related to the run lengths of multi-state sequences, especially for four states (A, B, C, D). Let X₁, X₂, . . . be a sequence of four state independent and identically distributed trials taking values in the set 𝒢 = {A, B, C, D}. In this study, we obtain exact formulas for the probability distribution function for the discrete distribution of runs of B's of order k. We obtain longest run statistics, shortest run statistics, and determine the distributions of waiting times and run lengths.

• The Journal of Korean Medicine
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• v.31 no.4
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• pp.1-8
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• 2010

Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

• Journal of Oriental Neuropsychiatry
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• v.20 no.4
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• pp.137-148
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• 2009

Objectives : The purpose of this study is to review the recent trends in the clinical trial studies that have been published since 2004. Methods : We reviewed the Medline & Pubmedcentral databases by using searching word of "acupuncture". Then 20 articles were selected within total 803 articles. In oriental medicine journals in Korea, we investigated 6 journals represented Korean Oriental medicine and chose 13 articles. Results & Conclusions : 1. We found 33 articles in journals. 2. The patterns of study were as follows: Randomized Controlled Trials(18), Single case series clinical study(9), Case-Control clinical study(4), Randomized crossover Trial(1) and Prospective Clinical analysis(1). 3. The fields of study were as follows: Combined anxiety, depression & other psychiatic symptoms(18), Stress & heart rate variablity(5), The single study of anxiety(5), The single study of depression(3), Stress & pupil variablity(1), Stress and heart rate & pupil variablity(1). 4. The methods of acupuncture were as follows: Acupuncture on points of 14 meridians(24), Auricular acupuncture(3), Electro acupuncture(2) and Both Auricular & Electro acupuncture(1). 5. Stomach meridian(足陽明胃經) and ST36(足三里) were used mostly.