• Korean Journal of Clinical Pharmacy
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• v.5 no.2
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

• Women's Health Nursing
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• v.23 no.3
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• pp.166-180
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• 2017

Purpose: The purpose of the study was to have an in-depth understanding of delivery room nurses' experiences of caring for stillborn babies and their parents. Methods: After obtaining approval from the Institutional Review Board, data were collected from March 1 to August 30, 2016. A total of six nurses participated in the study. Semi-structured in-depth interviews were conducted and the data subsequently analyzed. Results: Using thematic analysis, six themes were defined and refined: Emotional distress as a result of encountering stillborn babies; Caring for the deceased baby; Concerns for the mother's pain; Consideration for the father; Conflicts between accepting and dismissing parents' requests; and Strong mindset for the stillborn babies and their parents. Conclusion: The results showed that the nurses' experiences of caring for stillborn babies and their parents might be a difficult and lonely process. However, it could also be a process of attaining maturity by finding meaning and value in one's work. It would be helpful for the delivery room nurses to share examples of effective communication, train through simulation, and learn useful strategies that each nurse can use.

• Journal of Korean society of Dental Hygiene
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• v.16 no.5
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• pp.717-723
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• 2016

Objectives: The purpose of the study is to investigate the relationship between safety and health activities of clinical dental hygienists. Methods: A self-reported questionnaire was completed by 208 dental hygienists in Seoul, Gyeonggido, and Incheon from May 9 to June 30, 2016. The study was approved by institutional review board (IRB). The questionnaire consisted of general characteristics of the subjects (9 items) and safety activities (15 items), and health activities (17 items) by Likert 5 point scale. Except two incomplete answers, data were analyzed using SPSS 22.0 program. Results: The mean of safety activities and health activities was 3.04 and 3.55, respectively. A significant difference was shown in staff safety, facility safety, environmental safety, infection control, and dental technique control (p<0.001). Conclusions: A significant association was shown in safety and health activities of clinical dental hygienists. It is necessary to promote the safety and health activities for the clinical dental hygienists.

• Journal of Korean society of Dental Hygiene
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• v.16 no.5
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• pp.677-685
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• 2016

Objectives: The purpose of the study was to investigate the basic materials required for law revision regarding dental hygienists through perceptions and opinions of legislation amendments. Methods: The study was conducted from April 23, 2016. A self-reported questionnaire was completed by 797 dental hygienists in Seoul and Gyeonggido after receiving informed consent from institutional review board (IRB No. PO1-201602-23-001). Results: Necessity for dental hygienist-related medical law revision accounted for 92.4% and 85.4% of dental hygienists replied that specialized dental hygienist system must be established. The reasons for medical law revision were as follows; roles and education of medical technicians (60.6%), settlement of medical legal problems (48.0%), cooperation with other organizations (29.0%), political negotiations (17.4%), and national consensus (9.5%). The score for 'possible to get legal protection by the system establishment of roles and work scope of dental hygienists' was 4.11 of 5 points. Conclusions: It is important to establish the job scope of dental hygienist. The revision of dental hygienist-related law will help to enhance the status of dental hygienists as professional medical technicians in the future.

• Journal of Korean Foot and Ankle Society
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• v.21 no.2
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• pp.70-74
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• 2017

Fractures and fracture-dislocations of the ankle are caused by a variety of mechanisms. In addition to fractures, injuries of soft tissue, such as ligaments, tendons, nerves, and muscles may also occur. Among these, a tibialis posterior tendon injury is difficult to be identified due to swelling and pain at the fracture site. It is difficult to observe tibialis posterior tendon injury on a simple radiograph; it is usually found during surgery by accident. There are some studies regarding irreducible ankle fracture-dislocations due to interposition of the tibialis posterior tendon; however, to the best of our knowledge, there has not been any report about interposition of injured tibialis posterior tendon. Herein, we report a case of an irreducible fracture-dislocation of the ankle due to injured tibialis posterior tendon interposition that was observed intraoperatively, interrupting the reduction of ankle fracture-dislocation. We obtained satisfactory clinical result after reduction of the trapped tendon, fracture reduction, and internal fixation; therefore, we are willing to report this case with the consent of the patient. This study was conducted with an approval from the local Institutional Ethics Review Board.

• Journal of Biomedical Engineering Research
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• v.35 no.2
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• pp.26-34
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• 2014

Little information is available about the characteristics in revolution gait of hemiplegic elderly, which is frequently represented in daily life. It is also hard to elucidate purely the characteristics due to hemiplegia because of no consideration of aging factors. The aim of study is to identify the alteration characteristics of lower extremity joint angles in both straight and revolution gaits together due to hemiplegia through comparing healthy with hemiplegic elderly. Following Institutional Review Board approval, twelve healthy and hemiplegic elderly were participated and the center of body mass (COM) and lower extremity joint angles were measured during straight and revolution gaits using a computer-aided video motion capture system. The results showed that the gait characteristics were generally altered in both straight and revolution gaits due to hemiplegia (p < 0.05). The gait characteristics were then different between the straight and revolution gaits each other. This study may be valuable by identifying for the first time the alterations of the lower extremity joint angles in both straight and revolution gaits due to pure hemiplegia through comparing healthy elderly with hemiplegic elderly.

• Korean Journal of Acupuncture
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• v.24 no.3
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.42
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• pp.40.1-40.5
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• 2020

Background: Hyaluronic acid (HA) is well known to exert an anti-inflammatory effect during oral wound healing and is commonly applied after tooth extraction. However, no double-blind randomized controlled study comparing two hyaluronate mouthwash products has been conducted so far. The aim of this study was to comparatively analyze the efficacy of Mucobarrier^® and Aloclair^® in terms of clinical symptoms. Results: A total of 112 patients were randomly assigned to assess the degree of discomfort, pain reduction, redness, burning sensation, and swelling between two groups on the day of surgery and 7 days later in a double blind test, with a total 56 Aloclair patients and 56 Mucobarrier patients. There was no statistically significant difference in the overall discomfort, degree of pain reduction, redness, burning sensation, and swelling between the Mucobarrier and Aloclair groups. Conclusion: The local application of hyaluronic acid mouth wash after wisdom tooth extraction is beneficial in reducing overall discomfort and pain reduction, and the clinical utility of Mucobarrier^® is no different from Aloclair^®. Trial registration: Institutional Review Board of Yonsei University College of Dentistry, 2-2018-0036. Registered 10 September 2018-prospectively registered, https://eirb.yuhs.ac/

• The Korean Journal of Emergency Medical Services
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• v.28 no.1
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• pp.77-95
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• 2024

Purpose: This study aimed to analyze the counseling status of overseas Koreans using emergency medical counseling services, identify frequently occurring types of diseases, explore approaches to emergency treatment guidance, and protect overseas Koreans from medical blind spots, thereby enhancing the quality of emergency medical counseling services. Methods: This study was approved by the Institutional Review Board of Kongju National University (KNU_IRB_2023-31), and data were collected and analyzed from 10,951 cases of emergency medical counseling services utilized by overseas Koreans from the National Fire Agency from 2018 to 2022. Results: Emergency medical consultation services for overseas Koreans included a majority of non-trauma patients, with medical consultations being predominant. Terrestrial patients commonly seek advice for internal medical symptoms, whereas maritime patients frequently present with trauma-related symptoms, with a higher incidence of cardiac arrest and altered consciousness cases at sea. The development of self-diagnostic tests based on internal medicine symptoms is necessary for terrestrial patients, whereas stakeholder education is required for maritime patients. Conclusion: Due to the different types of diseases occurring in terrestrial and maritime patients, emergency medical consultation services for overseas Koreans should be implemented according to the specific characteristics of each patient. Therefore, it is necessary to develop and disseminate response manuals that are tailored to medical and trauma-related symptoms.

• The Journal of Churna Manual Medicine for Spine and Nerves
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• v.9 no.1
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• pp.55-65
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• 2014

Objectives : The purpose of this review is to investigate the trends of traditional korean medicine treatments on frozen shoulder. Methods : We investigated the studies on traditional korean medicine treatments for frozen shoulder via searching 6 Korean web databases. As a result, 32 research papers were found to be analyzed according to their published year, the titles of journals, published institution, the types of study, the number of cases, the types of treatments, the instruments for assessment and ethical approvals. Results : 32 papers were published since 1989. The studies on traditional korean medicine treatments about frozen shoulder were mainly published in The journal of korean acupuncture & moxibustion medicine. 10 case series, 7 reviews, 6 non-randomized controlled trials, 5 randomized controlled trials and 4 case reports had been under research. In most of the research, the number of the cases were not enough. In 15 cases of the studies, various traditional korean medicine treatments were used to treat the symptoms. In 8 cases of the studies, one method was used to treat the symptoms. Range of motion(ROM) and visual analogue scale(VAS) were used as primary assessments. Among the 25 clinical studies, 5 of them were accepted by institutional review board(IRB). Conclusion : In this study, we analyzed the trends of traditional korean medicine treatments on frozen shoulder. Reviewing the domestic trends of studies on traditional korean medicine treatments for frozen shoulder and examining the strong and weak points of those treatments are essential for the future studies.