Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background and Objectives: De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-STsegment elevation ACS (NSTE-ACS). Methods: This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year. Results: Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48– 0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48–2.26; p=0.915; p for interaction=0.271). Conclusions Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

OBJECTIVE: Under the overcrowding conditions of large emergency departments, the proportion of elderly patients is increasing in Korea. This paper describes the necessity of the preparedness of Korean emergency departments and society for the rapidly aging population. METHODS: This was a retrospective observational study. Patients who presented to a tertiary hospital emergency department (ED) in one year were included. The use of medical resources between young adult (≥20 and <65 years of age) and elderly patients (≥65 years of age) was compared. RESULTS: This study included 26,712 patients. The young adult group and the elderly group was 15,021 (56.2%) and 11,691 (43.8%), respectively. The ratio of firehouse ambulance visit mode (28.6%) and inter-facility transfer visit mode (18.9%) of the elderly group was higher compared to those of the young adult group (26.4% and 10.6%, P<0.001). The elderly group visited more at daytime (P<0.001). With aging, the admission ratios of the elderly group to the general ward (38.9%) and intensive care unit (13.0%) were higher than the young adult group (9.8% and 4.3%, P<0.001). The mean ED length of stay and mean length of hospitalization of the elderly group was longer than that of the young adult group (P<0.001). The medical cost of the elderly group was approximately three times higher than that of the young adult group. CONCLUSION Elderly patients required more emergency medical resources in both the prehospital and hospital stages. Korean emergency departments and society require efforts for not only expansion but also the appropriate use of medical resources in a rapidly aging population.

Sorafenib is the only approved targeted agent as the first line systemic therapy for treatment of advanced hepatocellular carcinoma (HCC). However, the improvement of survival duration under 3 months is far from clinical satisfactory and most patients experience disease progression within 6 months after sorafenib therapy. Unfortunately, second line systemic therapy after treatment failure of sorafenib was not established and there were no clear guidelines for salvage treatment modalities. Recently, studies suggests that combination of sorafenib and single cytotoxic agent can be relatively effective and safe strategy that achieves promising rates of local and systemic control in advanced HCC patients. Based on above suggestions, we herein offer our experience of a case achieved complete remission by combination therapy of sorafenib and tegafur in the patient with progressed disease after sorafenib therapy.
Carcinoma, Hepatocellular* ; Disease Progression ; Humans ; Salvage Therapy ; Tegafur* ; Treatment Failure

PURPOSE: This study aimed to identify research trends in the Journal of Korean Academy of Nursing Administration from 2013 to 2015. METHODS: For this study, 171 articles were analyzed. Research designs, participants, research settings, sampling, and data analyses methods were reviewed using established analysis criteria. Keyword centrality and clusters were generated by keyword network analysis. RESULTS: Most of studies used quantitative methods (82.5%), and sampling mainly focused on nurses (68.8%). The most commonly used data analyses methods were t-test, ANOVA, correlation, and regression. The most central keywords were turnover and empowerment. Network analysis generated four network groups: 1) burnout; 2) turnover; 3) happiness; and 4) nursing professionalism. CONCLUSION: The results of this study identify current trends and interests in Korean nursing administration research. The findings from this study suggest that future studies include a variety of research methods and maintain appropriate research ethics.
Ethics, Research ; Happiness ; Nursing Administration Research ; Nursing Research ; Nursing* ; Power (Psychology) ; Professionalism ; Research Design ; Statistics as Topic

PURPOSE: In Korea, emergency department overcrowding in large hospitals have caused social concern. Moreover, patients with low socioeconomic status visit the emergency department more frequently. This kind of visitation also causes a burden on the national budget, but emergent patient should be treated in emergency department regardless of economic state. So, on establishment of policy about the patient with low socioeconomic status, the frequency of emergency visitation alone is difficult to obtain a sufficient basis for policy-making. METHODS: We retrospectively analyzed adult patients with a disease who visited the Pusan Wide-regional Emergency Center in 2015. Korean Triage and Acuity Scale level I, II or III were defined as emergency, and level IV or V was defined as non-emergency. The ratio of emergency and non-emergency was compared in the National Health Insurance and Medicaid database. RESULTS: The number of patients with National Health Insurance was 16,208 (90.3%) and with Medicaid was 1,737 (9.7%). Among those with National Health Insurance, there were 12,720 (78.5%) emergency cases and 3,488 (21.5%) non-emergency cases. Among those with Medicaid, 1,379 (79.4%) emergency cases and 358 (20.6%) non-emergency cases. Between National Health Insurance and Medicaid, there was no statistically significant difference in the ratio of emergency and non-emergency (p=0.380) CONCLUSION: Accessibility of emergency and non-emergency patients with National Health Insurance and Medicaid to Pusan Wide-regional Emergency Center was not different.
Adult ; Budgets ; Busan ; Emergencies* ; Emergency Service, Hospital ; Humans ; Insurance Coverage* ; Insurance* ; Korea ; Medicaid ; National Health Programs ; Retrospective Studies ; Social Class ; Triage