• The Journal of Korean Obstetrics and Gynecology
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• v.30 no.1
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• pp.42-55
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• 2017

Objectives: This study were investigated clinical studies published in international and Korea's journals to assess the effect of Korean Medicine for infertility. Methods: PubMed and Oriental Medicine Advanced Searching Integrated System (OASIS) were searched for this review up to Nov 2016.: using terms of 'infertility' and 'subfertile'. Results: Fifty clinical studies were finally selected. All studies were assessed as the noncomparative studies, and mainly case reports. The year of publication of literatures was the highest at from 2011 to 2015, accounted for 44%. Among 50 studies, there were 5 studies on males, 43 studies on females and 2 studies on both male and female. The number of subjects varies from 1 to 1277. The number of studies with subjects less than 10 was the greatest. Of all the studies, only three were institutional review board (IRB) approved. There were 9 studies that indicated whether the grant was supported. The duration of treatment was between 30 and 360 days, and most cases were within 180 days. Intervention methods were 100% for herb medicine, 40% added on acupuncture, and 29% added on moxibustion. Conclusions: Further clinical trials of well designed is needed to accumulate enough information to establish the evidence for Korean Medicine for infertility.

• Child Health Nursing Research
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• v.21 no.4
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• pp.347-354
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• 2015

Purpose: This descriptive study was performed to explore trends in child health nursing research by analyzing the themes, contents and structure of articles published in 2014 in Child Health Nursing Research, the official journal of the Korean Academy of Child Health Nursing. Methods: Thirty-eight articles were reviewed using keywords, author (s), subjects, ethical considerations, designs, statistics involved, funding resources, and others. Results: Ten domains from 160 keywords were identified as follows, child related, psycho-social variable related, parents and family related, nursing and health related, and others. A mean of 2.9 authors per article was identified and 71% of the authors were academic- affiliated. Twenty-eight articles were human-participant related while 21 articles addressed both Institutional Review Board and written consent. Non-experimental design was the most commonly used method followed by experimental design, and qualitative design. The duration for acceptance was a mean of 89.1 days from submission with most articles requiring a second round of article review. Half of the articles were supported by grant organizations such as Korean National Research Foundation. Conclusion: The findings of the analysis show an improvement in the scientific quality with a diversity of articles in Child Health Nursing Research.

• Journal of Korean society of Dental Hygiene
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• v.14 no.2
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.

• Korean Medical Education Review
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• v.25 no.2
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• pp.109-113
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• 2023

An educational outcome cohort has been established at Keimyung University School of Medicine to help make educational policy decisions and improve educational programs based on data. The purpose of the educational outcome cohort is to support educational policy decisions for achieving graduation outcomes smoothly and to accomplish the intended human resources development of the university through objective analyses and regular monitoring, providing continuous feedback. The data collected for the educational outcome cohort include the student identifications of freshmen, entrance exam scores, premedical and medical school grades, titles and forms of student academic research, the results of psychological testing, scholarship recipient lists, volunteer clubs, and so forth. The data are collected using an information utilization agreement approved by the Institutional Review Board, and the collected data are encrypted and stored on a dedicated computer for enhanced personal information security. Proposals to access and utilize the educational outcome cohort data must be discussed and approved by the Educational Outcome Cohort Committee, which decides on the scope and method of utilization. The collected and managed educational outcome cohort data have been used to develop comparative programs to improve students' competency and to support admission policy decisions through an analysis of the characteristics and performance of medical school students. The establishment and utilization of the educational outcome cohort will play an important role in determining the School of Medicine's educational policies and suggesting new directions for educational policies in the future.

• The Journal of KAIRB
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• v.1 no.1
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• pp.5-21
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• 2019

Purpose: Institutional review board (IRB) classifies risks of clinical trials into less than minimal risk, minor increase over minimal risk, and more than minimal risk. Based on classification and evaluation for risk, IRB decides whether permitting consent exemption or asking additional protection for clinical research subject or not. The purpose of this study is to analyze how IRB members evaluate minimal risk by sending questionnaire survey with 12 predetermined scenarios. Methods: IRB members and researchers (pediatrician, gastroenterologist, neurologist, and neurosurgeon) in 11 different hospitals were asked to answer survey questions via email or online. We analyzed the differences of answers among several subgroups in each predetermined scenarios. Result: Responders were 212 personnel(110 researchers and 102 IRB members) from 11 centers. There were significant differences between IRB members and researchers in response such as blood sampling, skin prick test, one time catheterization in a girl, spinal tapping in child, non-enhance MRI in child, non-enhance MRI with chrolal hydrate in a child, spinal tapping without anesthesia in adult, bioequivalence test, gastric endoscopy, and non-enhance CT. significant differences between medical IRB members and non-medical members were also revealed in one time catheterization in a girl, spinal tapping in a child, non-enhance MRI in a child, bioequivalence test. Depending on researchers' department, they responded differently in several questionnaires as well. Conclusions: We have found that IRB members and researchers evaluate the risks differently. Researchers compared to IRB members, medical IRB members compared to non-medical members answered less than minimal risk in many cases. In assessing and evaluating the risks associated with the study, medical IRB members answered predetermined scenarios as less dangerous compared to non-medical IRB members. Difference among researchers where also revealed significantly. Researchers answered predetermined scenarios as less dangerous compare to other department researchers, especially in predetermined scenarios containing procedures they are familiar with.

• Journal of Korean Medicine Rehabilitation
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• v.27 no.4
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• pp.11-19
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• 2017

Objectives We attempted to investigate the trends of Korean Medical treatments for neck pain caused by whiplash injury by analyzing domestic clinical studies. Methods We searched for studies listed on Korean electronic databases (KTKP, OASIS, RISS, KMbase, NDSL, KCI, and National Assembly Library). Clinical studies were chosen according to the inclusion criteria. Subsequently, we compared and analyzed the data. Results The search yielded 35 studies, of which there were 12 randomized controlled trials (RCTs), 15 non-randomized controlled trials (NRCTs), 6 case reports, and 2 before-after studies. Among these, 54.7% of participants were in the acute stage of the damage period. Pharmacopuncture was used the most in main treatment methods. Only 14.3% of studies mentioned approval by an institutional review board (IRB) and only 8.6% of studies considered side effects. Conclusions There is some evidence that Korean Medical treatment is effective for neck pain caused by whiplash injury. Since all studies, however, were exposed to the risk of bias. Therefore, future studies of a higher quality are required.

• Journal of Korean Medicine Rehabilitation
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• v.25 no.2
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• pp.89-96
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• 2015

Objectives This study is to investigate domestic trends of chuna manual therapy on traffic accident for recent 10 years. Methods We searched the studies on chuna manual therapy for traffic accident in 6 Korean web databases. Consequently, 17 research papers were founded. We analyzed these papers according to their published year, the titles of journal, the type of study, the number of cases, the sites of injury, assessment scales of study, and ethics of research. Results 17 papers were published since 2005. The studies on chuna manual therapy about traffic accident were mainly published in the journal of korean society of chuna manual medicine for spine & nerves and the journal of korean medicine rehabilitation. All papers were clinical research include 2 case series, 2 non randomized controlled trials (NRCTs), 13 randomized controlled trials (RCTs). The most frequently occured symptom was neck pain. In assessment scales, visual analog scale (VAS) was mainly used. All clinical studies were not mentioned about approval of institutional review board (IRB). Conclusions In this study, we analyzed the trends of chuna manual therapy on traffic accident in Korea from 2005 to 2014. In reviewing published papers, we found several weak points in methods of research and quality of study protocol. It is needed to adjust these problems for development of future researches.

• Herbal Formula Science
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• v.27 no.3
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• pp.213-221
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• 2019

Objectives : The purpose of this study is to confirm the efficacy and safety of the treatment of gastritis with 'Hwangryunhaedok-tang'. Methods : Total 20 people, between 19 and 65 years old, will be recruited to participate in a comparative clinical trial. All subjects will take 2 capsules of Hwangryunhaedok-tang (Redoxin Cap.), 3 times a day, 30 minutes after meals, for 8 weeks. Outcomes will be measured at the baseline, 4th week, and 8th week. Primary outcomes is the improvement rates of gastritis symptoms, such as heartburn, nausea/vomiting, abdominal bloating, anorexia, heartburn, and trim. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2018011), and registered in Clinical Research information Service, one of WHO. Recruitment opened in April 2019 and is supposed to be completed by December 2019. Conclusions : This trial will provide clinical information to determine the efficacy and safety of treatment of gastritis with 'Hwangryunhaedok-tang'.

• Journal of Korean Medicine Rehabilitation
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• v.26 no.3
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• pp.119-128
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• 2016

Objectives The purpose of this study is to investigate the efficacy of E10 on the relief of cervical myalgia. Methods This study is a one group pre-post, pilot trial test. After the approval of institutional review board (IRB), we have recruited 25 patients suffering from cervical myalgia. 23 patients (2 patients dropped out) was treated by using E10 on the cervical muscle and acupuncture points, three times a week for a total of two weeks from February 2016 to April 2016. Evaluations of VAS for bothersomeness of neck pain (VASB), VAS for pain intensity (VASP), NDI, SF-36, X-ray, thermography, etc. before and 1 week after treatment were carried out. The primary outcome measure was the VASB, measured 1 week after the end of the therapy. Results VASB scores was significantly decreased from $72.5{\pm}9.9$ to $50.4{\pm}9.9$. VASP scores was significantly decreased from $71.5{\pm}10.5$ to $48.5{\pm}18.3$. Results showed significant improvements in VASB, VASP, NDI, SF-36 from the baseline. However, in X-ray, thermography, there was no singnificant difference. Conclusions This study demonstrates the effectiveness of E10 treatment for relieving cervical myalgia.

• The Journal of Pediatrics of Korean Medicine
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• v.33 no.4
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• pp.37-46
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• 2019

Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.