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.

Purpose: Isolated distal deep vein thrombosis (IDDVT) is a localized lesion; nonetheless, the risk of proximal vein propagation makes it difficult to decide on the treatment protocol—that is, whether immediate anticoagulation after diagnosis or surveillance via serial imaging should be employed. This study aimed to investigate the appropriate treatment protocol for IDDVT in kidney transplant recipient (KTR). Methods: Surveillance for venous thromboembolism (VTE) was performed using duplex ultrasonography (DUS) before transplant surgery and at 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after transplant surgery. Dual mechanical prophylaxis was administered to prevent VTE. Results: In total, 60 out of 829 patients (7.2%) developed VTE, with 49 cases (81.6%) of IDDVT. Among IDDVT patients, 15 patients were treated using anticoagulation-first strategy, whereas the remaining 34 patients were treated using surveillance-first strategy. No patient in either group exhibited thrombus extension into the proximal vein or recurrence within 1 year from transplant surgery. Conclusion In Korean KTR, extension of IDDVT into the proximal vein could be prevented safely and effectively by serial DUS surveillance along with the maintenance of mechanical prophylaxis. However, the patients who have high thrombus burden or are difficult to get repeated DUS require the use of anticoagulation in early stages.

This article provides an overview of the developmental history and rationale of medical ethics to establish the code of ethics and professional conduct of the Korean Academy of Child and Adolescent Psychiatry (KACAP). Most medical professional organizations have their own codes of ethics and conduct because they have continuous responsibility to regulate professional activities and conducts for their members. The Ethics and Award Committee of the KACAP appointed a Task-Force to establish the code of ethics and conduct in 2012. Because bioethics has become global, the Ethics Task Force examined global standards. Global standards in medical ethics and professional conduct adopted by the World Medical Association and the World Psychiatric Association have provided the basic framework for our KACAP's code of ethics and professional conduct. The Code of Ethics of the Americal Academy of Child and Adolescent Psychiatry has provided us additional specific clarifications required for child and adolescent patients. The code of ethics and professional conduct of the KACAP will be helpful to us in ethical clinical practice and will ensure our competence in recognizing ethical violations.
Adolescent ; Adolescent Psychiatry* ; Adolescent* ; Advisory Committees ; Awards and Prizes ; Bioethics ; Child* ; Codes of Ethics ; Ethics ; Ethics, Medical* ; Humans ; Mental Competency ; Societies

BACKGROUND/AIMS: The management of job-related stress among health-care workers is critical for the improvement of healthcare services; however, there is no existing research on endoscopy unit workers as a team. Korea has a unique health-care system for endoscopy unit workers. In this study, we aimed to estimate job stress and job satisfaction among health-care providers in endoscopy units in Korea. METHODS: We performed a cross-sectional survey of health-care providers in the endoscopy units of three university-affiliated hospitals in Korea. We analyzed the job stress levels by using the Korean occupational stress scale, contributing factors, and job satisfaction. RESULTS: Fifty-nine workers completed the self-administered questionnaires. The job stress scores for the endoscopy unit workers (46.39±7.81) were relatively lower compared to those of the national sample of Korean workers (51.23±8.83). Job stress differed across job positions, with nurses showing significantly higher levels of stress (48.92±7.97) compared to doctors (42.59±6.37). Job stress and job satisfaction were negatively correlated with each other (R2=0.340, p<0.001). CONCLUSIONS: An endoscopy unit is composed of a heterogeneous group of health-care professionals (i.e., nurses, fellows, and professors), and job stress and job satisfaction significantly differ according to job positions. Job demand, insufficient job control, and job insecurity are the most important stressors in the endoscopy unit.
Cross-Sectional Studies ; Delivery of Health Care ; Endoscopy* ; Job Satisfaction* ; Korea*

Although 3D-complex fractionated atrial electrogram (CFAE) mapping is useful in radiofrequency catheter ablation for persistent atrial fibrillation (AF), the directions and configuration of the bipolar electrodes may affect the electrogram. This study aimed to compare the spatial reproducibility of CFAE by changing the catheter orientations and electrode distance in an in-silico left atrium (LA). We conducted this study by importing the heart CT image of a patient with AF into a 3D-homogeneous human LA model. Electrogram morphology, CFAE-cycle lengths (CLs) were compared for 16 different orientations of a virtual bipolar conventional catheter (conv-cath: size 3.5 mm, inter-electrode distance 4.75 mm). Additionally, the spatial correlations of CFAE-CLs and the percentage of consistent sites with CFAE-CL<120 ms were analyzed. The results from the conv-cath were compared with that obtained using a mini catheter (mini-cath: size 1 mm, inter-electrode distance 2.5 mm). Depending on the catheter orientation, the electrogram morphology and CFAE-CLs varied (conv-cath: 11.5±0.7% variation, mini-cath: 7.1±1.2% variation), however the mini-cath produced less variation of CFAE-CL than conv-cath (p<0.001). There were moderate spatial correlations among CFAE-CL measured at 16 orientations (conv-cath: r=0.3055±0.2194 vs. mini-cath: 0.6074±0.0733, p<0.001). Additionally, the ratio of consistent CFAE sites was higher for mini catheter than conventional one (38.3±4.6% vs. 22.3±1.4%, p<0.05). Electrograms and CFAE distribution are affected by catheter orientation and electrode configuration in the in-silico LA model. However, there was moderate spatial consistency of CFAE areas, and narrowly spaced bipolar catheters were less influenced by catheter direction than conventional catheters.
Atrial Fibrillation ; Catheter Ablation ; Catheters ; Electrodes* ; Electrophysiologic Techniques, Cardiac* ; Heart ; Heart Atria ; Humans

Methicillin-resistant Staphylococcus aureus (MRSA) is a major cause of ear infections. We attempted to evaluate the clinical usefulness of arbekacin in treating chronic suppurative otitis media (CSOM) by comparing its clinical efficacy and toxicity with those of vancomycin. Efficacy was classified according to bacterial elimination or bacteriologic failure and improved or failed clinical efficacy response. Ninety-five subjects were diagnosed with CSOM caused by MRSA. Twenty of these subjects were treated with arbekacin, and 36 with vancomycin. The bacteriological efficacy (bacterial elimination, arbekacin vs. vancomycin: 85.0% vs. 97.2%) and improved clinical efficacy (arbekacin vs. vancomycin; 90.0% vs. 97.2%) were not different between the two groups. However, the rate of complications was higher in the vancomycin group (33.3%) than in the arbekacin group (5.0%) (P=0.020). In addition, a total of 12 adverse reactions were observed in the vancomycin group; two for hepatotoxicity, one for nephrotoxicity, eight for leukopenia, two for skin rash, and one for drug fever. It is suggested that arbekacin be a good alternative drug to vancomycin in treatment of CSOM caused by MRSA.
Adult ; Aged ; Anti-Bacterial Agents/administration & dosage ; Chronic Disease ; Dibekacin/administration & dosage/*analogs & derivatives ; Female ; Humans ; Male ; Methicillin-Resistant Staphylococcus aureus/*drug effects ; Middle Aged ; Otitis Media, Suppurative/diagnosis/*drug therapy/microbiology ; Staphylococcal Infections/diagnosis/*drug therapy/microbiology ; Treatment Outcome ; Vancomycin/*administration & dosage ; Young Adult

BACKGROUND: Azacitidine (AZA) is standard care for patients with myelodysplastic syndrome (MDS) who have not had allogeneic stem cell transplantation. Chromosomal abnormalities (CA) including complex karyotype (CK) or monosomal karyotype (MK) are associated with clinical outcome in patients with MDS. METHODS: We investigated which prognostic factors including CAs would predict clinical outcomes in patients with International Prognostic Scoring System (IPSS) higher risk MDS treated with AZA, retrospectively. CK was defined as the presence of three or more numerical or structural CAs. MK was defined as the presence of two or more distinct autosomal monosomies or single autosomal monosomy with at least one additional structural CA. RESULTS: A total of 243 patients who treated with AZA, were enrolled. CK was present in 124 patients and MK was present in 90 patients. Bone marrow blasts > or =15% and CK were associated with poorer response (P=0.038, P=0.007) and overall survival (OS) (P<0.001, P<0.001) independently. Although MK in CK group was not associated with prognosis, non-MK status in non-CK group reflected favorable OS (P=0.005). The group including >3 CAs was associated with poorer OS (group including <3 CAs vs. only three CAs, P=0.001; group with >3 CAs vs. only three CAs, P=0.001). CONCLUSION: CK was an important prognostic parameter associated with worse outcome. MK may predict poor survival in only non-CK status. The higher number of CAs was associated with poorer survival.
Azacitidine* ; Bone Marrow ; Chromosome Aberrations ; Humans ; Karyotype* ; Monosomy ; Myelodysplastic Syndromes* ; Prognosis ; Retrospective Studies ; Stem Cell Transplantation