• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.11
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• pp.420-426
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• 2020

The purpose and main points of the ROK-US Navy were analyzed from various angles using the big data technology Word Cloud for efficient sea trials. First, a comparison of words extracted through keyword cleansing in the ROK-US Navy sea trial showed that the ROK Navy conducted a single equipment test, and the US Navy conducted an integrated test run focusing on the system. Second, an analysis of the ROK-US Navy sea trials showed that approximately 66.6% were analyzed as similar items, of which more than two items were 112 items Approximately 44% of the 252 items of the ROK Navy sea trials overlapped, and that 89 items (35% of the total) could be reduced when integrated into the US Navy sea trials. A ship is a complex system in which multiple equipment operates simultaneously. The focus on checking the functions and performance of individual equipment, such as the ROK Navy's sea trials, will increase the sea trial period because of the excessive number of sea trial targets. In addition, the budget required will inevitably increase due to an increase in schedule and evaluation costs. In the future, further research will be needed to achieve more efficient and accurate sea trials through integrated system evaluations, such as the U.S. Navy sea trials.

• Nutritional Sciences
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• v.9 no.2
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• pp.124-130
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• 2006

To examine the effects of alcohol consumption on body fluid restoration and fat mobilization following exercise induced dehydration, nine healthy collegiate men ($24{\pm}2yrs,\;177{\pm}5cm,\;72{\pm}8kg,\;10.5{\pm}2.3%$ body fat) underwent three experiments. In each experiment, subjects ran on a treadmill to reduce individual body mass to $2.2{\pm}0.1%$ and consumed one of three beverages containing 0, 4, or 8% alcohol over 60 min followed by 4 hr of resting recovery. They consumed approximately 150% of weight loss $(2053{\pm}204,\;2091{\pm}149,\;and\;1943{\pm}295mL)$ and content of alcohol was $9.9{\pm}1.0(0%),\;71.9{\pm}5.1(4%)$, and $132.2{\pm}20.1g$ (8% trial). Body weight, urine volume and samples, blood samples, and thirst sensation were measured five times; at baseline, immediately after exercise, and 0, 1st, and 4th hr of recovery. Blood alcohol concentration after ingestion was $0.0{\pm}0.0(0%),\;0.1{\pm}0.02(4%)$, and $0.2{\pm}0.03%$ (8% trial). No differences in blood sodium and potassium concentrations, and urine specific gravity were noticed over time periods and trials. Thirst sensation tended to be elevated in all trials immediately after exercises and urine output was elevated during the recovery. The magnitude of changes in these variables was proportional to the alcohol concentrations, but not statistically significant. While serum osmolality was not different among trials and time periods in 0 and 4% trials, it was higher during recovery than the baseline in the 8% trial (P<0.01). Triglycerides did not change throughout the time period and among trials. Free fatty acids were elevated after exercise in all trials and 4th hr of recovery in 0% (P<0.05). Subjects' net body fluid balance at 4th hr of recovery was negatively maintained and proportional to alcohol concentrations. Only 8% trials showed a significant reduction at 1st and 4th hr of recovery compared to 0 hr. The results suggested that diuretic effect of alcohol after moderate level of dehydration appeared dose dependent, but beverage containing alcohol up to 4% did not induce impaired rehydration than alcohol free drinks. Alcohol effects on fat mobilization during recovery appeared to be minimal and the mechanism is unclear.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.164-171
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• 2012

The placebo effect, a response observed during the placebo arm of a clinical trial, is produced by the psychobiological action of the placebo as well as by other potential contributors to symptom amelioration such as spontaneous improvement, regression to the mean, biases, concurrent treatments, and study design. From a psychological viewpoint, there are many mechanisms that contribute to placebo effects, including expectations, conditioning, learning, and anxiety reduction. Placebo responses are also mediated by opioid and non-opioid mechanisms including dopamine, serotonin, cholecystokinin, and immune mediators. During recent years, a trend towards increased placebo effects in clinical trials of neuropsychiatric drugs has been noted. Indeed, the placebo effects observed in clinical trials constitute an increasing problem and interfere with signal-detection analyses of potential treatments. Several potential factors including protocol/study design and conduct related factors may account for the placebo effect observed in clinical trials. This paper reviews key issues related to this problem and aims to identify potential solutions.

• Korean Parent-Child Health Journal
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• v.21 no.1
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• pp.50-60
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• 2018

Purpose: This study is a systematic literature review and meta-analysis study conducted to identify the effects of breastfeeding intervention program on premature infants by integrating and analyzing the results of randomized controlled trials and non-randomized trials. Methods: The literature review process was based on the PRISMA (Preference Reporting Items for Systematic Reviews and Meta-Analyzes) guideline. Data retrieval and collection were conducted from May 25 to May 30, 2018, and the articles analyzed were all domestic papers retrieved from the database. Two reviewers independently select the studies and assessed methodological risk of bias of studies using the Cochrane criteria. The topics of breastfeeding interventions were analyzed using descriptive analysis and the effects of intervention were meta-analyzed using the R program. Results: Finally, eight papers were included in the systematic review and meta-analysis. The breastfeeding intervention program for premature infants showed a significant increase in the self-efficacy and the amount of pumping and baby's hight. Conclusion: This study has some limitations due to the few randomized controlled trials and non-randomized trials comparing breastfeeding for premature babies in Korea. Therefore, it needs to be integrated with the research conducted in other countries.

• Journal of Oriental Neuropsychiatry
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• v.28 no.3
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• pp.165-182
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• 2017

Objectives: The purpose of this systematic review was to understand clinical usefulness of Emotional Freedom Techniques (EFT) on students' mental health. Methods: Ten databases were included to extract clinical studies on effects of EFT intervention with students. Characteristics of selected studies were described, and biases were assessed with Risk of Bias (RoB) or Risk of Bias Assessment for Non-Randomized Studies (RoBANS). Results: A total of 14 clinical trials were extracted for analysis. There were 8 randomized-controlled trials (RCTs), 2 non-randomized-controlled trials (nRCTs), and 4 before-after studies. EFT have significant clinical usefulness in public speaking anxiety, test anxiety, stress, depression, learning related emotions, adolescent anxiety, and eating issues. The risk of selection bias in most studies was high or uncertain. Conclusions: EFT is an effective clinical technique for managing students' mental health issues. However, the included studies have been conducted with relatively poor quality and small sample size. Clinical trials with high quality study design and well-designed EFT education programs are needed to generalize clinical usefulness.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.33 no.2
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• pp.12-22
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• 2020

Objectives : The aim of this study is to review the trend of clinical trials conducted with the intradermal acupuncture treatment on dry eye syndrome. Methods : Through 4 foreign online databases(PubMed, Cochrane Library, EMBASE, and CNKI) and 3 domestic online databases(NDSL, RISS, and OASIS), we searched for clinical studies performed acupuncture treatment for dry eye syndrome from 2000 to 2020. Only randomized controlled trials(RCT) were selected and analyzed with the research method. Results : A total of 4 studies were reviewed. Cuanzu(攢竹, BL2), Taiyang(太陽, EX-HN5), and Sibai(四白, ST2) were the most frequently used acupoints in the studies. Among the evaluation indexes, Schirmer I test(SIT), tear film break-up time(BUT) were the most frequently used outcomes. In the most of the 4 studies, intradermal acupuncture treatment showed significant therapeutic effects for dry eye syndrome. Conclusions : These results suggest that it is necessary to develop more detailed standards for intradermal acupuncture treatment method as the method of intradermal acupuncture is getting more diverse, and objective tools are needed to evaluating dry eye syndrome.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.21 no.2
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• pp.94-101
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• 2008

Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

• Journal of Acupuncture Research
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• v.28 no.1
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• pp.109-115
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• 2011

Objectives : This review is to summarize and assess the effects of acupuncture on parasympathetic nervous system(PNS). Methods and Materials : We searched two electronic databases (CNKI, PubMed) for the articles published until Oct. 2010. The randomized clinical trials (RCTs) and uncontrolled clinical trials (UCTs) were considered to be reviewed. We selected four RCTs, seven UCTs and one article which conducted both RCT and UCT, and reviewed them. The quality of RCTs was also assessed with Cochrane criteria. Results : There were four RCTs which reported acupuncture enhanced PNS, and one RCT reported acupuncture reduced PNS. Four UCTs reported acupuncture enhanced PNS, three UCTs reported acupuncture reduced PNS and one UCT reported there was no remarkable change of PNS after acupuncture. Conclusions : Although the majority of reviewed articles showed acupuncture enhance PNS, it is hard to conclude clearly how acupuncture affects PNS due to insufficient quality of trials. Therefore, more trials with strict condition need to be conducted to obviously identify the effects of acupuncture on PNS.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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• pp.35-39
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• 1997

Recent development of human genetics and techniques of gene transfer and expression have opened the way for investigating novel approaches based on the genetic modification of cells to treat both inherited and acquired diseases. This approach is referred to as gene therapy. Over the past few years, gene therapy has moved from the laboratory to phase I clinical trials. Although the clinical performance of gene transfer experiments is still in an early phase of development, the NIH of Health Recombinant DNA Advisory Comittee (RAC) has approved more than 150 protocols that involve gene transfer or putative gene therapy procedures in clinical settings. Many sectors of society in United States have participated in the design and formulation of these clinical trials through local Institutional Review Boards, the National Institutes of Health (NIH) RAC, the Chemotherapy Evaluation Program of the National Cancer institute, and the FDA. Currently, clinical trials involving gene modification are under way at many medical centers throughout the United Slates. The goals of these trials are as follows. (1) The design should be directed to short-term achievable goals. (2) Each clinical trial is best considered as an intermediate step in a multistep process. (3) The design should identify evaluable proximate endpoints for toxicity and for efficacy, (4) The potential benefits and possible risks for patients participating in these trial should be defined.