• Tuberculosis and Respiratory Diseases
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• v.77 no.3
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• pp.105-110
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• 2014

Venous thromboembolism (VTE), which includes pulmonary embolism and deep vein thrombosis, is an important cause of morbidity and mortality. The aim of this review is to summarize the findings from clinically important publications over the last year in the area of VTE. In this review, we discuss 11 randomized controlled trials published from March 2013 to April 2014. The COAG and the EU-PACT trials indicate that pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or marginal usefulness in the Caucasian population. Recent clinical trials with novel oral anticoagulants (NOACs) have demonstrated that the efficacy and safety of rivaroxaban, apixaban, edoxaban, and dabigatran are not inferior to those of conventional anticoagulants for the treatment of VTE. The PEITHO and ULTIMA trials suggested that rescue thrombolysis or catheter-directed thrombolysis may maximize the clinical benefits and minimize the bleeding risk. Lastly, riociguat has a proven efficacy in treating chronic thromboembolic pulmonary hypertension. In the future, NOACs, riociguat, and catheter-directed thrombolysis have the potential to revolutionize the management of patients with VTE.

• Communications for Statistical Applications and Methods
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• v.22 no.5
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• pp.401-413
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• 2015

In this article, we review the statistical methods and theory for dose finding in early phase clinical trials, where the primary objective is to identify an acceptable dose for further clinical investigation. The dose finding literature is initially motivated by applications in phase I clinical trials, in which dose finding is often formulated as a percentile estimation problem. We will present some important phase I methods and give an update on new theoretical developments since a recent review by Cheung (2010), with an aim to cover a broader class of dose finding problems and to illustrate how the general dose finding theory may be applied to evaluate and improve a method. Specifically, we will illustrate theoretical techniques with some numerical results in the context of a phase I/II study that uses trinary toxicity/efficacy outcomes as basis of dose finding.

• 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.

• Journal of the Korean Statistical Society
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• v.6 no.2
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• pp.97-102
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• 1977

For a sequence of Markov dependent Bernoulli trails, asymptotic normality of the number of success runs with length $r \geq 1$ is established, when the number of trials tends to infinity.

• Journal of Society of Preventive Korean Medicine
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• v.19 no.1
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• pp.47-59
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• 2015

Objective : The purpose of this study was to analyze the trend of clinical research on 'mild and sub-clinical depressions' in China. Method : The journal search was performed using China National Knowledge Infrastructure(CNKI). Our inclusion criteria were as follows: TCM clinical trials for mild, sub-clinical, early stage of depression. Exclusion criteria were the following: non-TCM clinical trials, disease-associated depression related clinical trials. Results : We included 16 papers in this study. 1. In this study, we realized there have been several mild and sub-clinical depressions related clinical trials conducted in the field of TCM. 2. The result of 10 Journals used the Hamilton Depression Rating Scale for diagnosis and assessment criteria of mild and sub-clinical depressions. 3. The selected journals categorized by various interventions, such as, herbal medicine(7), acupuncture(4), miscellaneous(5). 4. Also, 7 Journals showed the significant improvements in patients with mild and sub-clinical depressions by TCM interventions, and 5 studies of TCM patent prescription reported that herbal medicine therapy has less side effect than the western medicine. Conclusion : Through this study, we found out that several researchers in China performed clinical trials on mild and sub-clinical depressions constantly. From the result of this study, we need to concern about the necessity of research on the mild and sub-clinical depression in Korea. Therefore, this result could be used as a meaningful reference for the design of future clinical trials.

• Journal of Physiology & Pathology in Korean Medicine
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• v.26 no.2
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• pp.248-252
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• 2012

This study aimed to evaluate the perception of informed consent for subjects who are participated in oriental medicine clinical trials and over 60 years old. In this research, 215 subjects who were participated in clinical trials were surveyed between Apr. 13, 2011 and Jul. 20, 2011. And the collected data was analyzed with computer software of SPSS 17.0. In the case of objective perception, almost all of subjects answered that they have ever heard of the consent form. However, 50.7 points were collected for the question of "As I already signed the consent form, I have to participate in the clinical trials", which showed the subjects had misperception about quitting the clinical trials. In the case of subjective perception, subjects well knew that the purpose of clinical trial is research, not medical treatment. However, the perception about the purpose of clinical trials that they are participated in was low. In the both cases of objective and subjective perception with general characteristics, they showed differences (p<0.045) with the marital status of subjects, however other categories did not show any difference. In conclusion, researchers should provide sufficient explanation as well as adequate Information in order to protect the personality of subjects, so that the subjects can make a right decision.

• The Journal of Korean Obstetrics and Gynecology
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• v.26 no.2
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• pp.66-87
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• 2013

Objectives: The aim of this study was to review systemically clinical trials on the trends of studies for Complementary and Alternative Medicine in the treatment of female sexual dysfunction and provide basic resource for future treatment and suggestions for improving research methods. Methods: Through medical website 'Pubmed', foreign clinical literatures about female sexual dysfunction were searched and domestic clinical literatures about female sexual dysfunction were searched using internet websites 'National assembly library', 'KISS', 'RISS', 'Korean traditional knowledge portal'. Results: Total 19 literatures were selected from January 2000 to June 2012. 15 foreign literatures were selected through medical website and 4 domestic literatures were chosen using internet websites or hand-searching. 5 literatures were published in 2008 and 13 literatures mentioned about age group of patients. FSFI is most common tool for female sexual dysfunction. 9 of 19 literatures were using Herbal medicine for treatment. 5 literatures were about CBT, 6 literatures were about Biofeedback and other one literatures are about Perineal massage. There were 14 Randomized controlled trials and 5 Non-randomized controlled trials. And randomized controlled trials were relatively low in risk of bias than non-randomized controlled trials. Conclusions: Upon these results, in similar future more clinical trials should be done and accumulate Evidence-based literatures.

• Journal of Korean Medicine for Obesity Research
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• v.11 no.1
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• pp.47-60
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• 2011

Objectives The objective of this study was to contribute to the development of pharmacupuncture for obesity treatment by reviewing the studies of pharmacupuncture experimentations and clinical trials. Methods We searched the papers with keywords of 'obesity' and 'pharmacupuncture' in the search site, RISS, Oriental medicine advanced searching integrated system(OASIS), Korean traditional knowledge portal, the society of Korean medicine for obesity research, Korean pharmacupuncture institute, the Korean academy of oriental rehabitation medicine and Korean acupuncture & moxibustion society. Results 1. We reviewed 37 articles searched. 27 articles(73.0%) were animal experimentations, 5 articles(13.5%) were cell experimentations, 4 articles(10.8%) were clinical trials and 1 article(2.7%) was study analysis. 2. The herbs, using for animal experimentations, were atratylodes japonica, coix lachrymajobi, ephedra sinica, crataegus pinnatifida, wild ginseng and etc. Acupucture points were joksamni(ST36), zhongwan(CV12), gansoo(BL18), pungnyung(ST40), umnungchon(SP9), bisu(BL20), gokji (LI11), cheun-chu(ST25) and etc. 3. For cell experimentations, preadipocytes and adipocytes performed on cell cultures with using rats, 3T3-L1 preadipocytes and porcine skin including fat tissue were treated with fel ursi, bovis calculus, ephedrae herba, spirodelae herba, wild ginseng. 4. For clinical trials, Sangsik no.1, Bigiheo, ephedra, green tea and sweet bee venom were injected at the region where a lot of fat like zhongwan(CV12), xiawan(CV10), kwanwon(CV4), cheun-chu(ST25) and thigh. Conclusion Through animal and cell experimentations and clinical trials, the treatment of obesity using local acupuncture therapy was effective. For clinical use, however, it is considered that animal and cell experimentation and clinical trial's connection using one kind of herb and studies about more clinical trials and associated side effects are needed.

• Journal of Korean Biological Nursing Science
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• v.16 no.3
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• pp.192-200
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• 2014

Purpose: The aim of this study was to develop a new course entitled 'Clinical Research Management' to enhance nursing students' clinical competency in handling clinical trials. Methods: The goals and content of the existing current education program for clinical research professionals such as clinical research coordinators and clinical research associates provided by the Korea National Enterprise for Clinical Trials were analyzed to identify the core educational concepts. A focus group interview was performed to investigate essential competency levels for the professionals who were to begin their career in the area of clinical trials after graduating from the college of nursing. Through these initial processes, we identified the core competency required for clinical research professionals and the related course content. Goals and objectives based on the specified four competencies were set and confirmed by expertise review. Results: We developed a new course entitled Clinical Research Management, a 16-week elective subject consisting of various teaching and learning strategies based on four core competencies: basic knowledge on clinical trials, communication, risk management, and ethics. Conclusion: The results of this study will contribute to enhancing nursing students' clinical competency, including knowledge, skills, and attitudes relevant to clinical trials.

• Journal of Korean Neurosurgical Society
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• v.56 no.6
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• pp.455-462
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• 2014

Objective : To propose a new measure for effective monitoring of intraoperative somatosensory evoked potentials (SEP) and to validate the feasibility of this measure for evoked potentials (EP) and single trials with a retrospective data analysis study. Methods : The proposed new measure (hereafter, a slope-measure) was defined as the relative slope of the amplitude and latency at each EP peak compared to the baseline value, which is sensitive to the change in the amplitude and latency simultaneously. We used the slope-measure for EP and single trials and compared the significant change detection time with that of the conventional peak-to-peak method. When applied to single trials, each single trial signal was processed with optimal filters before using the slope-measure. In this retrospective data analysis, 7 patients who underwent cerebral aneurysm clipping surgery for unruptured aneurysm middle cerebral artery (MCA) bifurcation were included. Results : We found that this simple slope-measure has a detection time that is as early or earlier than that of the conventional method; furthermore, using the slope-measure in optimally filtered single trials provides warning signs earlier than that of the conventional method during MCA clipping surgery. Conclusion : Our results have confirmed the feasibility of the slope-measure for intraoperative SEP monitoring. This is a novel study that provides a useful measure for either EP or single trials in intraoperative SEP monitoring.