• Journal of Korean Biological Nursing Science
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• 제16권3호
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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.

• International Journal of Stem Cells
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• 제16권1호
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• pp.16-26
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• 2023

Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.

• 한국임상약학회지
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• 제26권1호
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• pp.13-23
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• 2016

Background: South Korea is rapidly being an aging-society and the demand of long-term care insurance services for elderly patients is rising. In addition, because the elderly taking multiple medicines, the adherence is lowered and the adverse events are easily occurred. Therefore, many are interested in introducing the geriatric pharmacy specialist to manage this situation. Purpose: By applying a similar program such as the geriatric pharmacy specialist working in nursing home, we conducted this study to evaluate the potential contribution to both the health insurance services and financial savings for the elderly patients. Methods: We conducted a trial in an elderly nursing home to collaborate between doctor and pharmacist making a checklist for improving medication adherence and establish a consultation system. Also we applied a smart phone application in the pharmaceutical care processes. Results: Thereby completing the drug therapy related checklist apply to nursing facilities in South Korea. And we got a performance that improves medication adherence when used in the clinical practice settings. Conclusion: By introducing a training program of pharmacy care managers and geriatric professionals such as the United States and Japan, we revealed the elderly nursing home residents and vulnerable elderly people living alone were improved the medication adherence and it will contributed to the health and quality of life of the patients.

• Restorative Dentistry and Endodontics
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• 제49권3호
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• pp.24.1-24.13
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• 2024

Objectives: This study aimed to evaluate the clinical performance of an alkasite restorative material in molars that had undergone root canal treatment. Materials and Methods: The research was registered in Brazilian Registry of Clinical Trials. The randomized clinical trial involved 33 patients, each with at least 1 mandibular molar requiring restoration after receiving endodontic treatment. Patients were randomly assigned to receive either bulk-fill resin composite (Tetric N Ceram Bulk Fill, Ivoclar Vivadent) or the alkasite restorative material (Cention N, Ivoclar Vivadent). Upon completion of the restorations, 3 calibrated professionals utilized the United States Public Health Service criteria to assess various factors, including retention, secondary caries, marginal adaptation, restoration color, marginal pigmentation, and anatomical form. Evaluations were conducted at intervals of 7 days, 6 months, and 17 months. Additionally, the assessment encompassed the presence of radiolucent lines adjacent to the restoration, material deficiencies or excess, contact points, and caries recurrence. The data underwent analysis using the Friedman and Mann-Whitney tests (α = 0.05). Results: After 17 months, the results revealed that the alkasite restorative material exhibited greater wear of anatomical shape compared to the bulk-fill resin composite (p = 0.0189). Furthermore, the alkasite restorative material significantly differed from the natural tooth color in most cases (p = 0.0000). However, no other criteria displayed significant differences between the materials or over time (p > 0.05). Conclusions: The alkasite restorative material (Cention N) emerges as a viable option for restoring endodontically treated teeth, displaying clinically acceptable alterations after a 17-month evaluation period.

• Archives of Plastic Surgery
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• 제39권5호
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• pp.534-539
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• 2012

Background Autologous fat grafting evolved over the twentieth century to become a quick, safe, and reliable method for restoring volume. However, autologous fat grafts have some problems including uncertain viability of the grafted fat and a low rate of graft survival. To overcome the problems associated with autologous fat grafts, we used uncultured adipose tissue-derived stromal cell (stromal vascular fraction, SVF) assisted autologous fat grafting. Thus, the purpose of this study was to evaluate the effect of SVF in a clinical trial. Methods SVF cells were freshly isolated from half of the aspirated fat and were used in combination with the other half of the aspirated fat during the procedure. Between March 2007 and February 2008, a total of 9 SVF-assisted fat grafts were performed in 9 patients. The patients were followed for 12 weeks after treatment. Data collected at each follow-up visit included clinical examination of the graft site(s), photographs for historical comparison, and information from a patient questionnaire that measured the outcomes from the patient perspective. The photographs were evaluated by medical professionals. Results Scores of the left facial area grafted with adipose tissue mixed with SVF cells were significantly higher compared with those of the right facial area grafted with adipose tissue without SVF cells. There was no significant adverse effect. Conclusions The subjective patient satisfaction survey and surgeon survey showed that SVF-assisted fat grafting was a surgical procedure with superior results.

• 여성건강간호학회지
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• 제8권2호
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• pp.222-231
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• 2002

This study was done to develop a digital textbook for students to use over the internet for maternity nursing practice. The textbook is not only for student nurses, but also for nurse midwives and nurses working in the maternity. The process used was as follows; 1. Existing educational media on maternity nursing were reviewed and examined. 2. Workshops and meetings were held to decide the most appropriate type of presentation. 3. The digital content including text, pictures, audios, and videos were developed using Macromedia Dreamweaver, Adobe Photoshop and Adobe Premier. 4.Revisions were made recursively as the content was previewed and implemented over the internet by professionals and the end-users. 5. A database of members and a web survey module were developed and posted. The clinical implication of a digital textbook over the internet is the possibility of using it to educate many student nurses throughout the country and to disseminate the content for whoever needs it in practice settings and facilities. Another implication is that this site stressed interactivity by developing member database and web survey. In conclusion, the study found this first trial of digital textbook to be a unique educational media for nursing skills practice. Further refinement of this media is strongly recommended.