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.

Recent clinical outcomes of multi-regimen chemotherapy in patients with cholangiocarcinoma (CCC) have shown benefits in terms of overall survival. However, repeated endoscopic biliary drainage (EBD) and serious adverse events negatively affect prolongation of the survival period.The aim of this study was to investigate the prevalence of massive hemobilia and the outcomes of its management with fully covered self-expandable metal stents (FC-SEMSs) in patients with hilum-involving CCC receiving multi-regimen chemotherapy. The methods and effects of FCSEMS placement were retrospectively investigated following the occurrence of massive hemobilia during EBD. A total of 356 patients with CCC received multi-regimen chemotherapy. Among them, 181 patients had hilar invasion, and seven patients (3.9%) developed massive hemobilia during repeated EBD using removable stents. In all cases, the tumor encased the right hepatic artery. In six patients (85.7%), hemostasis was immediately and completely achieved by inserting one or two FC-SEMSs proximal to the hilar invasion area. Therefore, if the tumor encases the right hepatic artery, massive hemobilia is likely to occur during multi-regimen chemotherapy.Thus, prompt placement of a FC-SEMS would be an effective treatment option for massive hemobilia in patients with hilum-involving CCC.

Objective: Effective triage of febrile patients in the emergency department is crucial during times of overcrowding to prioritize care and allocate resources, especially during pandemics. However, available triage tools often require laboratory data and lack accuracy. We aimed to develop a simple and accurate triage tool for febrile patients by modifying the quick Sequential Organ Failure Assessment (qSOFA) score. Methods: We retrospectively analyzed data from 7,303 febrile patients and created modified versions of qSOFA using factors identified through multivariable analysis. The performance of these modified qSOFAs in predicting in-hospital mortality and intensive care unit (ICU) admission was compared using the area under the receiver operating characteristic curve (AUROC). Results: Through multivariable analysis, the identified factors were age (“A” factor), male sex (“M” factor), oxygen saturation measured by pulse oximetry (SpO2; “S” factor), and lactate level (“L” factor). The AUROCs of ASqSOFA (in-hospital mortality: 0.812 [95% confidence interval, 0.789–0.835]; ICU admission: 0.794 [95% confidence interval, 0.771–0.817]) were simple and not inferior to those of other more complex models (e.g., ASMqSOFA, ASLqSOFA, and ASMLqSOFA). ASqSOFA also displayed significantly higher AUROC than other triage scales, such as the Modified Early Warning Score and Korean Triage and Acuity Scale. The optimal cutoff score of ASqSOFA for the outcome was 2, and the score for redistribution to a lower level emergency department was 0. Conclusion We demonstrated that ASqSOFA can be employed as a simple and efficient triage tool for emergency febrile patients to aid in resource distribution during overcrowding. It also may be applicable in prehospital settings for febrile patient triage.

Objective: This study aimed to examine the psychiatric impact of the Seoul Halloween crowd crush on individuals related to the victims compared to the general population. It also explores the moderating effect of resilience on the relationship between trauma exposure and psychiatric symptoms. Methods: In total, 2,220 participants completed various post-incident questionnaires (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Hwa-byung symptom scale, post-traumatic stress disorder checklist for DSM-5, and Brief Resilience Scale) 30 days after the incident. Moderation analyses were conducted using the PROCESS macro in the statistical package for the social sciences. Results: Individuals related to the victims exhibited higher symptom severity and a greater risk for clinically significant levels of depression, anxiety, anger, and post-traumatic stress disorder (PTSD) (odds ratio=3.28, 3.33, 1.51, and 4.39 respectively). The impact of relevance to victims on anxiety and PTSD symptoms was moderated by resilience, with a stronger effect observed for individuals with low resilience (β=3.51, 95% confidence interval [CI] 2.78–4.24 for anxiety and β=14.53, 95% CI 12.43–16.63 for PTSD) than for those with high resilience (β=1.69, 95% CI 0.72–2.65 for anxiety and β=8.33, 95% CI 5.56–11.09 for PTSD). Conclusion When related to the victims, it was found that not only PTSD, but also depression, anxiety, and anger could intensify. Resilience emerged as a potential buffer against these adverse effects, emphasizing its significance in mitigating the psychiatric impact of community trauma.

Objective: This study aimed to examine the psychiatric impact of the Seoul Halloween crowd crush on individuals related to the victims compared to the general population. It also explores the moderating effect of resilience on the relationship between trauma exposure and psychiatric symptoms. Methods: In total, 2,220 participants completed various post-incident questionnaires (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Hwa-byung symptom scale, post-traumatic stress disorder checklist for DSM-5, and Brief Resilience Scale) 30 days after the incident. Moderation analyses were conducted using the PROCESS macro in the statistical package for the social sciences. Results: Individuals related to the victims exhibited higher symptom severity and a greater risk for clinically significant levels of depression, anxiety, anger, and post-traumatic stress disorder (PTSD) (odds ratio=3.28, 3.33, 1.51, and 4.39 respectively). The impact of relevance to victims on anxiety and PTSD symptoms was moderated by resilience, with a stronger effect observed for individuals with low resilience (β=3.51, 95% confidence interval [CI] 2.78–4.24 for anxiety and β=14.53, 95% CI 12.43–16.63 for PTSD) than for those with high resilience (β=1.69, 95% CI 0.72–2.65 for anxiety and β=8.33, 95% CI 5.56–11.09 for PTSD). Conclusion When related to the victims, it was found that not only PTSD, but also depression, anxiety, and anger could intensify. Resilience emerged as a potential buffer against these adverse effects, emphasizing its significance in mitigating the psychiatric impact of community trauma.

Objective: This study aimed to examine the psychiatric impact of the Seoul Halloween crowd crush on individuals related to the victims compared to the general population. It also explores the moderating effect of resilience on the relationship between trauma exposure and psychiatric symptoms. Methods: In total, 2,220 participants completed various post-incident questionnaires (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Hwa-byung symptom scale, post-traumatic stress disorder checklist for DSM-5, and Brief Resilience Scale) 30 days after the incident. Moderation analyses were conducted using the PROCESS macro in the statistical package for the social sciences. Results: Individuals related to the victims exhibited higher symptom severity and a greater risk for clinically significant levels of depression, anxiety, anger, and post-traumatic stress disorder (PTSD) (odds ratio=3.28, 3.33, 1.51, and 4.39 respectively). The impact of relevance to victims on anxiety and PTSD symptoms was moderated by resilience, with a stronger effect observed for individuals with low resilience (β=3.51, 95% confidence interval [CI] 2.78–4.24 for anxiety and β=14.53, 95% CI 12.43–16.63 for PTSD) than for those with high resilience (β=1.69, 95% CI 0.72–2.65 for anxiety and β=8.33, 95% CI 5.56–11.09 for PTSD). Conclusion When related to the victims, it was found that not only PTSD, but also depression, anxiety, and anger could intensify. Resilience emerged as a potential buffer against these adverse effects, emphasizing its significance in mitigating the psychiatric impact of community trauma.

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.

Recent clinical outcomes of multi-regimen chemotherapy in patients with cholangiocarcinoma (CCC) have shown benefits in terms of overall survival. However, repeated endoscopic biliary drainage (EBD) and serious adverse events negatively affect prolongation of the survival period.The aim of this study was to investigate the prevalence of massive hemobilia and the outcomes of its management with fully covered self-expandable metal stents (FC-SEMSs) in patients with hilum-involving CCC receiving multi-regimen chemotherapy. The methods and effects of FCSEMS placement were retrospectively investigated following the occurrence of massive hemobilia during EBD. A total of 356 patients with CCC received multi-regimen chemotherapy. Among them, 181 patients had hilar invasion, and seven patients (3.9%) developed massive hemobilia during repeated EBD using removable stents. In all cases, the tumor encased the right hepatic artery. In six patients (85.7%), hemostasis was immediately and completely achieved by inserting one or two FC-SEMSs proximal to the hilar invasion area. Therefore, if the tumor encases the right hepatic artery, massive hemobilia is likely to occur during multi-regimen chemotherapy.Thus, prompt placement of a FC-SEMS would be an effective treatment option for massive hemobilia in patients with hilum-involving CCC.

Objective: Effective triage of febrile patients in the emergency department is crucial during times of overcrowding to prioritize care and allocate resources, especially during pandemics. However, available triage tools often require laboratory data and lack accuracy. We aimed to develop a simple and accurate triage tool for febrile patients by modifying the quick Sequential Organ Failure Assessment (qSOFA) score. Methods: We retrospectively analyzed data from 7,303 febrile patients and created modified versions of qSOFA using factors identified through multivariable analysis. The performance of these modified qSOFAs in predicting in-hospital mortality and intensive care unit (ICU) admission was compared using the area under the receiver operating characteristic curve (AUROC). Results: Through multivariable analysis, the identified factors were age (“A” factor), male sex (“M” factor), oxygen saturation measured by pulse oximetry (SpO2; “S” factor), and lactate level (“L” factor). The AUROCs of ASqSOFA (in-hospital mortality: 0.812 [95% confidence interval, 0.789–0.835]; ICU admission: 0.794 [95% confidence interval, 0.771–0.817]) were simple and not inferior to those of other more complex models (e.g., ASMqSOFA, ASLqSOFA, and ASMLqSOFA). ASqSOFA also displayed significantly higher AUROC than other triage scales, such as the Modified Early Warning Score and Korean Triage and Acuity Scale. The optimal cutoff score of ASqSOFA for the outcome was 2, and the score for redistribution to a lower level emergency department was 0. Conclusion We demonstrated that ASqSOFA can be employed as a simple and efficient triage tool for emergency febrile patients to aid in resource distribution during overcrowding. It also may be applicable in prehospital settings for febrile patient triage.

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.