1.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
2.Role of Mindfulness in the Effects of Organizational Culture on Depression in Korean Physical Therapists
Jong-Hyun LEE ; Jinwon LEE ; Jaejin HWANG ; Du-Jin PARK ; Won-Jin KIM ; Kyung-Sun LEE
Safety and Health at Work 2024;15(4):441-451
Objective:
The study aimed to investigate whether mindfulness could mitigate the impact of job and interpersonal demands arising from stressful organizational cultures in predicting depression during the COVID-19 pandemic.
Methods:
A total of 280 Korean physical therapists participated in this study. To verify the mediated moderation model, this study implemented an SPSS 26.0 PROCESS Macro (v.3.5) that was based on the verification of Hayes' conditional indirect effect.
Results:
The study confirmed the moderated mediation effect of mindfulness on the mediating relationship between stressful organizational culture, job demands/interpersonal demands, and depression. Moreover, the conditional indirect effect of mindfulness was found to be statistically significant. However, the impact on interpersonal stress differed from anticipated outcomes.
Conclusions
Mindfulness, applicable within the framework of the Job Demands-Resources model theory, served as a resource variable and moderated the impact of organizational culture on members' depression. Amidst ongoing debates on mindfulness effectiveness, this study partially confirmed its potential within the Job Demands-Resources model, suggesting a role in mitigating the influence of organizational culture on members' depression as a resource variable.
3.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
4.Role of Mindfulness in the Effects of Organizational Culture on Depression in Korean Physical Therapists
Jong-Hyun LEE ; Jinwon LEE ; Jaejin HWANG ; Du-Jin PARK ; Won-Jin KIM ; Kyung-Sun LEE
Safety and Health at Work 2024;15(4):441-451
Objective:
The study aimed to investigate whether mindfulness could mitigate the impact of job and interpersonal demands arising from stressful organizational cultures in predicting depression during the COVID-19 pandemic.
Methods:
A total of 280 Korean physical therapists participated in this study. To verify the mediated moderation model, this study implemented an SPSS 26.0 PROCESS Macro (v.3.5) that was based on the verification of Hayes' conditional indirect effect.
Results:
The study confirmed the moderated mediation effect of mindfulness on the mediating relationship between stressful organizational culture, job demands/interpersonal demands, and depression. Moreover, the conditional indirect effect of mindfulness was found to be statistically significant. However, the impact on interpersonal stress differed from anticipated outcomes.
Conclusions
Mindfulness, applicable within the framework of the Job Demands-Resources model theory, served as a resource variable and moderated the impact of organizational culture on members' depression. Amidst ongoing debates on mindfulness effectiveness, this study partially confirmed its potential within the Job Demands-Resources model, suggesting a role in mitigating the influence of organizational culture on members' depression as a resource variable.
5.Role of Mindfulness in the Effects of Organizational Culture on Depression in Korean Physical Therapists
Jong-Hyun LEE ; Jinwon LEE ; Jaejin HWANG ; Du-Jin PARK ; Won-Jin KIM ; Kyung-Sun LEE
Safety and Health at Work 2024;15(4):441-451
Objective:
The study aimed to investigate whether mindfulness could mitigate the impact of job and interpersonal demands arising from stressful organizational cultures in predicting depression during the COVID-19 pandemic.
Methods:
A total of 280 Korean physical therapists participated in this study. To verify the mediated moderation model, this study implemented an SPSS 26.0 PROCESS Macro (v.3.5) that was based on the verification of Hayes' conditional indirect effect.
Results:
The study confirmed the moderated mediation effect of mindfulness on the mediating relationship between stressful organizational culture, job demands/interpersonal demands, and depression. Moreover, the conditional indirect effect of mindfulness was found to be statistically significant. However, the impact on interpersonal stress differed from anticipated outcomes.
Conclusions
Mindfulness, applicable within the framework of the Job Demands-Resources model theory, served as a resource variable and moderated the impact of organizational culture on members' depression. Amidst ongoing debates on mindfulness effectiveness, this study partially confirmed its potential within the Job Demands-Resources model, suggesting a role in mitigating the influence of organizational culture on members' depression as a resource variable.
6.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
7.Role of Mindfulness in the Effects of Organizational Culture on Depression in Korean Physical Therapists
Jong-Hyun LEE ; Jinwon LEE ; Jaejin HWANG ; Du-Jin PARK ; Won-Jin KIM ; Kyung-Sun LEE
Safety and Health at Work 2024;15(4):441-451
Objective:
The study aimed to investigate whether mindfulness could mitigate the impact of job and interpersonal demands arising from stressful organizational cultures in predicting depression during the COVID-19 pandemic.
Methods:
A total of 280 Korean physical therapists participated in this study. To verify the mediated moderation model, this study implemented an SPSS 26.0 PROCESS Macro (v.3.5) that was based on the verification of Hayes' conditional indirect effect.
Results:
The study confirmed the moderated mediation effect of mindfulness on the mediating relationship between stressful organizational culture, job demands/interpersonal demands, and depression. Moreover, the conditional indirect effect of mindfulness was found to be statistically significant. However, the impact on interpersonal stress differed from anticipated outcomes.
Conclusions
Mindfulness, applicable within the framework of the Job Demands-Resources model theory, served as a resource variable and moderated the impact of organizational culture on members' depression. Amidst ongoing debates on mindfulness effectiveness, this study partially confirmed its potential within the Job Demands-Resources model, suggesting a role in mitigating the influence of organizational culture on members' depression as a resource variable.
8.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
9.Role of Mindfulness in the Effects of Organizational Culture on Depression in Korean Physical Therapists
Jong-Hyun LEE ; Jinwon LEE ; Jaejin HWANG ; Du-Jin PARK ; Won-Jin KIM ; Kyung-Sun LEE
Safety and Health at Work 2024;15(4):441-451
Objective:
The study aimed to investigate whether mindfulness could mitigate the impact of job and interpersonal demands arising from stressful organizational cultures in predicting depression during the COVID-19 pandemic.
Methods:
A total of 280 Korean physical therapists participated in this study. To verify the mediated moderation model, this study implemented an SPSS 26.0 PROCESS Macro (v.3.5) that was based on the verification of Hayes' conditional indirect effect.
Results:
The study confirmed the moderated mediation effect of mindfulness on the mediating relationship between stressful organizational culture, job demands/interpersonal demands, and depression. Moreover, the conditional indirect effect of mindfulness was found to be statistically significant. However, the impact on interpersonal stress differed from anticipated outcomes.
Conclusions
Mindfulness, applicable within the framework of the Job Demands-Resources model theory, served as a resource variable and moderated the impact of organizational culture on members' depression. Amidst ongoing debates on mindfulness effectiveness, this study partially confirmed its potential within the Job Demands-Resources model, suggesting a role in mitigating the influence of organizational culture on members' depression as a resource variable.
10.Analysis of Characteristics and Risk Factors of Patients with Single Gastric Cancer and Synchronous Multiple Gastric Cancer among 14,603 Patients
Du Hyun SONG ; Nayoung KIM ; Hyeong Ho JO ; Sangbin KIM ; Yonghoon CHOI ; Hyeon Jeong OH ; Hye Seung LEE ; Hyuk YOON ; Cheol Min SHIN ; Young Soo PARK ; Dong Ho LEE ; So Hyun KANG ; Young Suk PARK ; Sang-Hoon AHN ; Yun-Suhk SUH ; Do Joong PARK ; Hyung Ho KIM ; Ji-Won KIM ; Jin Won KIM ; Keun-Wook LEE ; Won CHANG ; Ji Hoon PARK ; Yoon Jin LEE ; Kyoung Ho LEE ; Young Hoon KIM ; Soyeon AHN ; Young-Joon SURH
Gut and Liver 2024;18(2):231-244
Background/Aims:
Synchronous multiple gastric cancer (SMGC) accounts for approximately 6% to 14% of gastric cancer (GC) cases. This study aimed to identify risk factors for SMGC.
Methods:
A total of 14,603 patients diagnosed with GC were prospectively enrolled. Data including age, sex, body mass index, smoking, alcohol consumption, family history, p53 expression, microsatellite instability, cancer classification, lymph node metastasis, and treatment were collected. Risk factors were analyzed using logistic regression analysis between a single GC and SMGC.
Results:
The incidence of SMGC was 4.04%, and that of early GC (EGC) and advanced GC (AGC) was 5.43% and 3.11%, respectively. Patients with SMGC were older (65.33 years vs 61.75 years, p<0.001) and more likely to be male. Lymph node metastasis was found in 27% of patients with SMGC and 32% of patients with single GC. Multivariate analysis showed that SMGC was associated with sex (male odds ratio [OR], 1.669; 95% confidence interval [CI], 1.223 to 2.278; p=0.001), age (≥65 years OR, 1.532; 95% CI, 1.169 to 2.008; p=0.002), and EGC (OR, 1.929; 95% CI, 1.432 to 2.600; p<0.001). Survival rates were affected by Lauren classification, sex, tumor size, cancer type, distant metastasis, and venous invasion but were not related to the number of GCs. However, the survival rate of AGC with SMGC was very high.
Conclusions
SMGC had unique characteristics such as male sex, older age, and EGC, and the survival rate of AGC, in which the intestinal type was much more frequent, was very good (Trial registration number: NCT04973631).

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