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.

In this case report, the authors present three cases of post-tracheostomy site bleeding successfully treated using embolization, supplemented by CT and angiography images. This report highlights that embolization can be a viable alternative when surgical or endoscopic interventions fail or are not applicable in cases of post-tracheostomy bleeding.

Objective: This study aimed to investigate the closure rate and adverse effects of combination therapy with acetaminophen and ibuprofen for hemodynamically significant patent ductus arteriosus (hsPDA) compared with monotherapy with ibuprofen in extremely preterm infants (EPTs). Methods: This was a single-center, retrospective, and historical control study of infants with hsPDA born at <28 weeks of gestation and a birth weight <1,000 g. Based on the first-line therapeutic policy for hsPDA, the cohort was classified into a monotherapy group (period I: January 2019-July 2021) and a combination therapy group (period II: September 2021-August 2023). Baseline characteristics, treatment outcomes, adverse effects, and morbidities were compared between the groups. Results: Of the 43 EPTs with hsPDA, 26 received monotherapy with ibuprofen during period I, and 17 received combination therapy with acetaminophen and ibuprofen during period II. The successful closure rates after the first medical therapy were 42.3% in the monotherapy group vs. 76.5% in the combination therapy group (P=0.027). No significant difference in adverse effects during medication use was observed between the groups. Conclusion Combination therapy with acetaminophen and ibuprofen improved the closure rate for hsPDA without detectable adverse effects. Combination therapy could be considered the first therapeutic option for hsPDA in EPTs. Further well-designed studies are needed to define the safety and effectiveness of combination therapy.

Objective: To evaluate and assesse useful factors in predicting early preterm birth (PTB) and de termined the increased risks of early PTB for the combinations of these factors compared to late PTB. Methods: The 77 singleton pregnancies with PTL were enrolled. They had undergone examinations including cervical length (CL) and fetal fibronectin (fFN), polymerase chain reaction for sexually transmitted disease, and cervical culture. We first evaluated the statistical significance of the primary predictors (known risk factors before pregnancy) and secondary predictors (fFN, CL, high-sensitivity C-reactive protein [hsCRP] and cervical bacterial analysis). Next, we analyzed the various combinations of meaningful factors. Results: CL <2.5 cm (P=0.007; odds ratio [OR], 3.598), hsCRP ≥0.9 mg/dL (P=0.011; OR, 3.79), and fFN ≥50 ng/mL (P=0.035; OR, 2.75) were more predictive of early PTB than late PTB. The highest OR was observed for the combination of all 3 factors (P=0.039; OR, 7.75). The fFN positivity and hsCRP ≥0.9 mg/dL was in OR 6.094 (P=0.013). The CL<2.5 cm and hsCRP ≥0.9 mg/dL was in OR 5.333 (P=0.009). Finally, the CL <2.5 cm and fFN positivity was in OR 3.946 (P=0.013). The interval between diagnosis and delivery in women with all 3 factors was 8 days shorter than that for women without these factors (P=0.04). Conclusion Our study is the first to demonstrate the potential risks of PTB using the combination of commonly used in clinical factors, and revealed quantification by the ORs. We will be useful reference value for patients counselling for prediction of early PTB.

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.

In this case report, the authors present three cases of post-tracheostomy site bleeding successfully treated using embolization, supplemented by CT and angiography images. This report highlights that embolization can be a viable alternative when surgical or endoscopic interventions fail or are not applicable in cases of post-tracheostomy bleeding.

Objective: This study aimed to investigate the closure rate and adverse effects of combination therapy with acetaminophen and ibuprofen for hemodynamically significant patent ductus arteriosus (hsPDA) compared with monotherapy with ibuprofen in extremely preterm infants (EPTs). Methods: This was a single-center, retrospective, and historical control study of infants with hsPDA born at <28 weeks of gestation and a birth weight <1,000 g. Based on the first-line therapeutic policy for hsPDA, the cohort was classified into a monotherapy group (period I: January 2019-July 2021) and a combination therapy group (period II: September 2021-August 2023). Baseline characteristics, treatment outcomes, adverse effects, and morbidities were compared between the groups. Results: Of the 43 EPTs with hsPDA, 26 received monotherapy with ibuprofen during period I, and 17 received combination therapy with acetaminophen and ibuprofen during period II. The successful closure rates after the first medical therapy were 42.3% in the monotherapy group vs. 76.5% in the combination therapy group (P=0.027). No significant difference in adverse effects during medication use was observed between the groups. Conclusion Combination therapy with acetaminophen and ibuprofen improved the closure rate for hsPDA without detectable adverse effects. Combination therapy could be considered the first therapeutic option for hsPDA in EPTs. Further well-designed studies are needed to define the safety and effectiveness of combination therapy.

Objective: To evaluate and assesse useful factors in predicting early preterm birth (PTB) and de termined the increased risks of early PTB for the combinations of these factors compared to late PTB. Methods: The 77 singleton pregnancies with PTL were enrolled. They had undergone examinations including cervical length (CL) and fetal fibronectin (fFN), polymerase chain reaction for sexually transmitted disease, and cervical culture. We first evaluated the statistical significance of the primary predictors (known risk factors before pregnancy) and secondary predictors (fFN, CL, high-sensitivity C-reactive protein [hsCRP] and cervical bacterial analysis). Next, we analyzed the various combinations of meaningful factors. Results: CL <2.5 cm (P=0.007; odds ratio [OR], 3.598), hsCRP ≥0.9 mg/dL (P=0.011; OR, 3.79), and fFN ≥50 ng/mL (P=0.035; OR, 2.75) were more predictive of early PTB than late PTB. The highest OR was observed for the combination of all 3 factors (P=0.039; OR, 7.75). The fFN positivity and hsCRP ≥0.9 mg/dL was in OR 6.094 (P=0.013). The CL<2.5 cm and hsCRP ≥0.9 mg/dL was in OR 5.333 (P=0.009). Finally, the CL <2.5 cm and fFN positivity was in OR 3.946 (P=0.013). The interval between diagnosis and delivery in women with all 3 factors was 8 days shorter than that for women without these factors (P=0.04). Conclusion Our study is the first to demonstrate the potential risks of PTB using the combination of commonly used in clinical factors, and revealed quantification by the ORs. We will be useful reference value for patients counselling for prediction of early PTB.

Objective: This study aimed to investigate the closure rate and adverse effects of combination therapy with acetaminophen and ibuprofen for hemodynamically significant patent ductus arteriosus (hsPDA) compared with monotherapy with ibuprofen in extremely preterm infants (EPTs). Methods: This was a single-center, retrospective, and historical control study of infants with hsPDA born at <28 weeks of gestation and a birth weight <1,000 g. Based on the first-line therapeutic policy for hsPDA, the cohort was classified into a monotherapy group (period I: January 2019-July 2021) and a combination therapy group (period II: September 2021-August 2023). Baseline characteristics, treatment outcomes, adverse effects, and morbidities were compared between the groups. Results: Of the 43 EPTs with hsPDA, 26 received monotherapy with ibuprofen during period I, and 17 received combination therapy with acetaminophen and ibuprofen during period II. The successful closure rates after the first medical therapy were 42.3% in the monotherapy group vs. 76.5% in the combination therapy group (P=0.027). No significant difference in adverse effects during medication use was observed between the groups. Conclusion Combination therapy with acetaminophen and ibuprofen improved the closure rate for hsPDA without detectable adverse effects. Combination therapy could be considered the first therapeutic option for hsPDA in EPTs. Further well-designed studies are needed to define the safety and effectiveness of combination therapy.

Objective: To evaluate and assesse useful factors in predicting early preterm birth (PTB) and de termined the increased risks of early PTB for the combinations of these factors compared to late PTB. Methods: The 77 singleton pregnancies with PTL were enrolled. They had undergone examinations including cervical length (CL) and fetal fibronectin (fFN), polymerase chain reaction for sexually transmitted disease, and cervical culture. We first evaluated the statistical significance of the primary predictors (known risk factors before pregnancy) and secondary predictors (fFN, CL, high-sensitivity C-reactive protein [hsCRP] and cervical bacterial analysis). Next, we analyzed the various combinations of meaningful factors. Results: CL <2.5 cm (P=0.007; odds ratio [OR], 3.598), hsCRP ≥0.9 mg/dL (P=0.011; OR, 3.79), and fFN ≥50 ng/mL (P=0.035; OR, 2.75) were more predictive of early PTB than late PTB. The highest OR was observed for the combination of all 3 factors (P=0.039; OR, 7.75). The fFN positivity and hsCRP ≥0.9 mg/dL was in OR 6.094 (P=0.013). The CL<2.5 cm and hsCRP ≥0.9 mg/dL was in OR 5.333 (P=0.009). Finally, the CL <2.5 cm and fFN positivity was in OR 3.946 (P=0.013). The interval between diagnosis and delivery in women with all 3 factors was 8 days shorter than that for women without these factors (P=0.04). Conclusion Our study is the first to demonstrate the potential risks of PTB using the combination of commonly used in clinical factors, and revealed quantification by the ORs. We will be useful reference value for patients counselling for prediction of early PTB.