• Journal of Life Science
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• v.31 no.11
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• pp.1028-1036
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• 2021

Firefly luciferase (FLuc) can function as an efficient marker in the gene and viral therapies. Nonetheless, its clinical translation has been unaccomplished with the concerns on its exogenous nature and the similarity with human fatty acyl-CoA synthetase. In this study, we aimed to show safety of FLuc by conducting a set of preclinical experiments and a human use. Initially, FLuc permeability across the plasma membrane was investigated by delivering the FLuc-carrying viral vector, OTS-412, or the FLuc recombinant protein. After in vitro infection of OTS-412 into different cancer cell lines, FLuc activity was detected only in the cell lysates, but not in culture media. In addition, recombinant FLuc protein further showed the impermeability against the plasma membrane. Similar result was also observed in the in vivo experiment. After being injected into the VX2 tumor-bearing rabbit, the FLuc exclusively resided within the tumor tissue without being detected in the blood plasma or other organs. Human cancer cell lines originated from various organs were lysed and treated to the FLuc, and none of the human substrates was reactive against the FLuc. As a final step, FLuc recombinant protein was intravenously injected into a human. The luciferase was degraded with the half-life of 20 to 30 minutes in blood, and was untraceable from 1.5 hr after the injection. In addition, the blood plasma was nonresponsive against the fatty acids. Hematological analysis was also comparable between the pre- and post-injection. Altogether, our study collectively demonstrates the safety of the firefly luciferase.

• Pediatric Infection and Vaccine
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• v.31 no.1
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• pp.12-24
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• 2024

The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I² =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01-0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97-5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

• Journal of Chest Surgery
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• v.36 no.9
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• pp.651-658
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• 2003

Since the first implanted in September 1997, the use of On-X prosthetic heart valve has been increasing around in the world. This study was designed to assess the feasibility, safety, and the postoperative hemodynamics with this new valve in clinical setting. Material and Method: The current study was carried out on 52 patients undergoing aortic valve replacement with this prosthesis between April 1999 to August 2002 at Chonnam National University Hospital to evaluate the surgical results. 52％ of the patients were male and the average age at implant was 50$\pm$13 years. The study followed the guidelines of the AATS/STS. Preoperatively, 32(61.5％) patients were in NYHA functional class III or IV and 2 patients had previous aortic valve surgery. Concomitant cardiac surgery was performed in 71.1％. The implanted valve sizes were 19 mm in 13 patients, 21 mm in 26, 23 mm in 10 and 25 mm in 3, respectively. Mean follow-up was 16.6$\pm$10.5 months (1∼39 months). Echocardiographic assessment was performed pre- and immediate postoperatively, as well as 3, 6, 12 months after surgery, evaluating pressure loss and regression of left ventricular hypertrophy. Result: Mean cardiopulmonary bypass time was 191$\pm$94.7 minutes with an aortic cross-clamp time of 142$\pm$51.7 minutes. There was no early and late mortality, Freedom from adverse events at 1 year in the study were as follows: thromboembolism, 95.6$\pm$6％; bleeding events, 90.2$\pm$4％; paravalvular leakage 92.3$\pm$4％; and overall valve-related morbidity at 1 year was 76.6$\pm$3％. There were no cases of valve thrombosis, prosthetic valve endocarditis and structural or non-structural failure. Left ventricular function at 12 months after surgery (EF=62.7$\pm$9.8％) revealed a statistically significant improvement compared to preoperative investigation (EF=55.8$\pm$15.9％, p=0.006). Left ventricular mass index was 247.3$\pm$122.3 g/$m^2$ on preoperative echocardiographic study, but regressed to 155.5$\pm$58.2 g/$m^2$ at postoperative 1 year (p=0.002). Over the follow-up period a further decrease of peak transvalvular gradients was observed in all patients: 62.5$\pm$38.0 mmHg on preoperative assessment, 18.2$\pm$6.8 mmHg at immediate postoperative period (p < 0.0001), 7.6$\pm$5.09 mmHg (p<0.0001) at 6 month, 18.0$\pm$10.8 mmHg (p<0.0001) at 1 year. Conclusion: The On-X prosthetic heart valve performs satisfactorily in the first 1 year period. Clinical outcome by examining NYHA functional classification revealed especially good results. Effective regression of left ventricular hypertrophy and statistically significant decrease of transvalvular gradient were observed over the first year, but longer-term follow-up of this patient group is needed to establish the expected rates for late valve-related events as well as the long-term clinical efficacy of this valve.

• Journal of Korean Academy of Nursing Administration
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• v.6 no.2
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• pp.259-279
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• 2000

This study is a descriptive analytic research measuring nursing service quality, using SERVQUAL model, to make fundamental data and strategies for nursing service improvement. Data were collected by self-reported questionnaire from 202 patients and 142 nurses, from June 7 to 14, 1999. The reliability of instrument were adequate(Cronbach ${\alpha}=.94$). SAS program was utilized for statistical analysis of collected data. The results were as follows; 1. There was a gab between patient's expectation and perception on nursing service(Gap B). Gap D was indicated an affecting factor to decide nursing service quality. Gap C was indicated an indirect affecting factor of nursing service quality. Because it was not statistically significant in total item analysis, but in individual item analysis, 7 items were appeared statistically significant. Gap A was not a gap occurrence factor of nursing service quality. 2. Focuses of nursing service quality improvement strategies were; (1) to direct qualitative improvement of nursing service in order to correspondence patient's nursing service expectation. (2) to make nurse's service activity modified because nurse's practice were not reached patient's expectation level. (3) to need internal, external factor analysis affecting nurse's service activity. 3. Nursing service quality was decided by rather environmental inappropriateness provided nursing service than itself. Therefore, to make nursing service quality improvement, it is required to improve nursing service environment. For this, followings are required; (1) to strengthen nurse's education on lower part of nursing service satisfaction and QI activities. (2) to balance demand and supply of nursing personnel. 3) to fix computerized system for reducing other duties weight except nursing care through analysis of nursing activity. (4) to construct rational cooperating system among related departments. 4. The important parts for nursing service quality improvement were indicated as follows: (1) Gap B: 'prompt reaction', 'examination symptom before patient's complaint', 'hearted nursing service reducing patient's dissatisfaction', 'explanation goals of nursing activities', 'having special Knowledge enough', 'maintenance position comfortably', 'management of patient's physical hygiene'. (2) Gap C: 'maintenance physical safety', 'explanation about hospital rules and facilities'. (3) Gap D: 'tender, safe injection and wound care'. Because above items are mostly improved through nurse's attitude change and quality improvement, it is required to establish nursing standardization and to strengthen nurse's clinical education. As the based on above results, followings are suggested; 1. SERVQUAL model is very useful to make strategies for nursing service quality improvement because it indicates multiple factors affecting hap occurrence. 2. At individual items analysis of Gap C, statistically significant 7 items appeared higher nurse's perception level than patient's perception level on nursing service were trouble perception level on nursing service quality improvement. So. it need further research to analysis about these difference occurring factors. 3. At analysis of Gap D, it is indicated that in nursing service performance process, multiple factors lowing nursing service quality were intruded. So it needs further research to analysis what these factors are and how each factors affect on nursing performance process. 4. nursing service quality measurement is changeable according to sample select time or sampled subject's characteristics. So to develope strategy for nursing service quality improvement is based on the results of periodical analysis.

• The Korean Journal of Applied Statistics
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• v.23 no.1
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• pp.139-150
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• 2010

In recent years, more generic drug products became available. The current regulation for assessing the bioequivalence of two drug formulations is based on the concept of average bioequivalence. This approach has been indicated to be insufficient for assessing switchability between two drug formulations and US FDA has adopted individual bioequivalence as one of the bioequivalence criterion since 2001. The US FDA recommends that individual bioequivalence be assessed based on $2\;{\times}\;4$ crossover design, while a $2\;{\times}\;3$ crossover design may be used as an alternative design to reduce the length and cost of the study. In this paper, a statistical procedure for assessment of individual bioequivalence under $3\;{\times}\;2$ crossover designs is proposed and some statistical points are discussed with $2\;{\times}\;3$ crossover design and $2\;{\times}\;3$ extra-reference design through simulation studies.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.4
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• pp.2159-2165
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• 2013

Cancer registries help to establish and maintain cancer incidence reporting system, serve as a resource for investigation of cancer and its causes, and provide information for planning and evaluation of preventive and control programs. However, their wider role in directly enhancing oncology drug access has not been fully explored. We examined the value of cancer registries in oncology drug access in the Asia-Pacific region on three levels: (1) specific registry variable types; (2) macroscopic strategies on the national level; and (3) a regional cancer registry network. Using literature search and proceedings from an expert forum, this paper covers recent cancer registry developments in eight economies in the Asia-Pacific region - Australia, China, Hong Kong, Malaysia, Singapore, South Korea, Taiwan, and Thailand - and the ways they can contribute to oncology drug access. Specific registry variables relating to demographics, tumor characteristics, initial treatment plans, prognostic markers, risk factors, and mortality help to anticipate drug needs, identify high-priority research area and design access programs. On a national level, linking registry data with clinical, drug safety, financial, or drug utilization databases allows analyses of associations between utilization and outcomes. Concurrent efforts should also be channeled into developing and implementing data integrity and stewardship policies, and providing clear avenues to make data available. Less mature registry systems can employ modeling techniques and ad-hoc surveys while increasing coverage. Beyond local settings, a cancer registry network for the Asia-Pacific region would offer cross-learning and research opportunities that can exert leverage through the experiences and capabilities of a highly diverse region.

• Perspectives in Nursing Science
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• v.7 no.1
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• pp.50-54
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• 2010

The studies of M. Colombo (1989) and W. Lange (1992) showed that 30~40% of people became chronic after suffering from hepatitis B virus (HBV) and C virus (HCV) infection, and about 50% of the chronic cases transformed into primary liver cancer. There have been few studies done in Mongolia on hepatitis infection among health professionals, particularly in nurses. In a study done by Chimedsuren (8), the study showed that 19.4% of people with identified surface hepatitis B antigen (HBsAg) and antibodies to hepatitis C virus and 8% of people with the identified nucleotide of RNA for the hepatitis C virus (polymerase chain reaction) had an acute form of hepatitis C. Studies on the hepatitis virus genome damaging effect on liver cells showed that genotype 8 (A, B, C, D, E, F, G, TTV) had the most damaging effect on liver cells (Hahn and Faeka, 2007). Several studies have shown a relationship between hepatitis B virus infection and a lack of compliance regarding safety regulations and rules by medical personnel. Results of a study from the Maternal and Child Health Research Center showed that tests done to detect hepatitis B virus antigen and antibodies to C virus did not reveal anything. Both antigen and antibodies in 69% cases did not show, and separately, B virus and antibodies to hepatitis C virus were identified in 13% and 9%, respectively. Results of the tests taken from health personnel in Shastin Central Hospital showed that in 76% of the cases, the B virus antigen with C virus antibodies was not identified. In 8% of the cases, the B virus antigen was present on its own. The combination of B the virus antigen and C virus antibodies were present in 8% of nurses and doctors, respectively. 82% of the cases had negative results for the detection of a combination of B virus antigen and C virus antibodies taken from health personnel from the State Central Clinical Hospital whereas the B virus antigen and C virus antibodies by themselves were present in 7% and 14% of the cases, respectively. Combined cases of the B virus antigen and C virus antibodies were identified in 4% of the personnel. Results of the tests taken from the health personnel in the Hospital of the Ministry of Justice and Internal Affairs showed that in 79% of the cases, the B virus antigen with C virus antibodies were not identified. Separately, the B virus and antibodies to hepatitis C virus were identified in 8% and 13% of the cases, respectively.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.37 no.4
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• pp.289-295
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• 2011

Recently, the number of customers who want natural cosmetics without petroleum originated cosmetic ingredients is increasing over the world, however, there are few natural cosmetics that claim functionality in the products. Because there are few functional cosmetic ingredients from nature and though so, it is very difficult to stabilize the final products manufactured by using those functional cosmetic ingredients in the long period. This study is on stabilization of oleanolic acid, insoluble anti-wrinkle cosmetic ingredients from nature, with hydrogenated lecithin in the solubilization product, aiming for developing a formulation of solubilization products which can be certified as organic cosmetics. In case of other synthetic solubilizers, they showed unstability at $45^{\circ}C$ within 2 ~ 3 days, however, for natural origin hydrogenated lecithin a stable product was made without particle size change during 4 weeks. The stability of oleanolic acid in the solubilization product was measured for 24 weeks at $25^{\circ}C$ and $40^{\circ}C$, both samples showed over 90 wt% value of the initial one, which can prove that oleanolic acid was stabilized in the product without any degradation. Also through clinical tests, the effect of moisturizing, anti-wrinkle, safety were confirmed.

• The Journal of Korean Academy of Sensory Integration
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• v.9 no.1
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• pp.11-20
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• 2011

Purpose : In this study, we tried to know that how the occupational therapists applied the core principles of Ayres's sensory integration(ASI) intervention for clients by using the method of self-assessment. Methods : The study period was from May 2010 to June 2010. The subjects were therapists who use a sensory integration intervention. We letted them to do self-assessment about degree of performing the treatment according to the core principles of ASI by using a questionnaire. Total 66 questionnaires were collected. SPSS for Windows version 15.0 was statistically analyzed. Results : There wasn't anybody without considering the 10 core principles of ASI interventions for children. Therapist's answer(more than 90%) was sometimes, often, always except for the guide self-organization in the 10 core principles of ASI intervention. On the basis of total average score of raw score of 10 core principles of ASI intervention, provide sensory opportunities, provide just-right challenges, collaborate on activity choice, maximize child's success, ensure physical safety, and foster therapeutic alliance showed more than 50 points(T value). The guide self-organization, support optimal arousal, create play context, and arrange room to engage child showed less than 50 points T value. Conclusion : The most effective interventions for sensory integration is the treatment based on the core principles of ASI intervention. According to core principle of ASI intervention, checking the quality of care and increasing the quality of care is needed through performing self-assessment.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.2
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• pp.421-425
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• 2012

Cancer can be a major cause of poverty. This may be due either to the costs of treating and managing the illness as well as its impact upon people's ability to work. This is a concern that particularly affects countries that lack comprehensive social health insurance systems and other types of social safety nets. The ACTION study is a longitudinal cohort study of 10,000 hospital patients with a first time diagnosis of cancer. It aims to assess the impact of cancer on the economic circumstances of patients and their households, patients' quality of life, costs of treatment and survival. Patients will be followed throughout the first year after their cancer diagnosis, with interviews conducted at baseline (after diagnosis), three and 12 months. A cross-section of public and private hospitals as well as cancer centers across eight member countries of the Association of Southeast Asian Nations (ASEAN) will invite patients to participate. The primary outcome is incidence of financial catastrophe following treatment for cancer, defined as out-of-pocket health care expenditure at 12 months exceeding 30% of household income. Secondary outcomes include illness induced poverty, quality of life, psychological distress, economic hardship, survival and disease status. The findings can raise awareness of the extent of the cancer problem in South East Asia and its breadth in terms of its implications for households and the communities in which cancer patients live, identify priorities for further research and catalyze political action to put in place effective cancer control policies.