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.

OBJECTIVE: To investigate the effect of family caregiving on depression in the first 3 months after spinal cord injury (SCI). METHODS: A retrospective study was carried out on 76 patients diagnosed with an SCI from January 2013 to December 2016 at the Department of Physical Medicine and Rehabilitation of Kyungpook National University Hospital, Korea. Clinical characteristics including age, gender, level of injury, completeness of the injury, time since injury, caregiver information, etiology, and functional data were collected through a retrospective review of medical records. Depression was assessed using the Beck Depression Inventory (BDI). Patients with 14 or more points were classified as depressed and those with scores of 13 or less as non-depressed group. RESULTS: Of the 76 patients, 33 were in the depressed group with an average BDI of 21.27±6.17 and 43 patients included in the non-depressed group with an average BDI of 4.56±4.20. The BDI score of patients cared by unlicensed assistive personnel (UAP) was significantly higher than that of patients cared by their families (p=0.020). Univariate regression analysis showed that motor complete injury (p=0.027), UAP caregiving (p=0.022), and Ambulatory Motor Index (p=0.019) were associated with depression after SCI. Multivariate binary logistic regression analysis showed that motor completeness (p=0.002) and UAP caregiving (p=0.002) were independent risk factors. CONCLUSION: Compared with UAP, family caregivers lowered the prevalence of depression in the first 3 months after SCI.
Caregivers ; Depression ; Gyeongsangbuk-do ; Humans ; Korea ; Logistic Models ; Medical Records ; Physical and Rehabilitation Medicine ; Prevalence ; Retrospective Studies ; Risk Factors ; Spinal Cord Injuries ; Spinal Cord

OBJECTIVE: To evaluate the safety of nasogastric tube (NGT) removal and change to oral feeding with a food thickener for acute stroke patients in whom a videofluoroscopic swallow study (VFSS) confirmed thin liquid aspiration. METHODS: We retrospectively examined data of 199 patients with first stroke who were diagnosed with dysphagia from 2011 to 2015. Swallowing function was evaluated using VFSS. Patients included in this study were monitored for 4 weeks to identify the occurrence of aspiration pneumonia. The penetration-aspiration scale (PAS) was used to assess VFSS findings. The patients were divided into thin-liquid aspiration group (group 1, n=104) and no thin-liquid aspiration group (group 2, n=95). RESULTS: The feeding method was changed from NGT feeding to oral feeding with food thickener (group 1) and without food thickener (group 2). The PAS scores of thin and thick liquids were 6.46±0.65 and 1.92±0.73, respectively, in group 1 and 2.65±0.74 and 1.53±0.58, respectively, in group 2. Aspiration pneumonia developed in 1.9% of group 1 and 3.2% of group 2 (p=0.578), with no significant difference between the groups. CONCLUSION: We concluded that removing the NGT and changing to oral feeding with a food thickener is a safe food modification for acute stroke patients with thin liquid aspiration. Therefore, we recommend that VFSS should be conducted promptly in acute stroke patients to avoid unnecessary prolonged NGT feeding.
Deglutition ; Deglutition Disorders ; Feeding Methods ; Humans ; Pneumonia, Aspiration ; Retrospective Studies ; Stroke*

PURPOSE: This study was conducted to investigate the relationship between serum total testosterone levels and scores on the Aging Male's Symptom (AMS) scale and the International Index of Erectile Function (IIEF) in men with erectile dysfunction with testosterone deficiency syndrome (TDS). MATERIALS AND METHODS: From January 2005 to July 2008, 134 patients who complained of sexual dysfunction such as erectile dysfunction or decreased libido as the main symptoms of TDS with serum total testosterone levels less than 3.5 ng/ml were evaluated by independent t-test and linear regression analysis, respectively. Patients with treated hypogonadism within 6 months, with a history of taking a PDE5 inhibitor or an antidepressant for a depressive disorder, or who had metabolic syndrome were excluded from this study. RESULTS: The AMS scale and its 3 subdomain scores were not significantly correlated with the total testosterone level. By contrast, the total IIEF score and the score of each IIEF domain except sexual desire showed a weakly significantly positive correlation with serum total testosterone. CONCLUSIONS: In TDS patients with erectile dysfunction, there was a low relationship between serum total testosterone levels and the AMS scale and a weakly positive correlation between total testosterone levels and all IIEF domains except sexual desire. There was a low relationship between the AMS scale, the sexual desire domain score of the IIEF, and total testosterone. We should understand these limitations when evaluating patients with erectile dysfunction with TDS. New scales should be developed for the evaluation of erectile dysfunction in these patients.
Aging ; Depressive Disorder ; Erectile Dysfunction ; Humans ; Hypogonadism ; Libido ; Linear Models ; Male ; Sorbitol ; Testosterone ; Tyramine ; Weights and Measures

PURPOSE: Oral testosterone undecanoate and transdermal testosterone gel are the testosterone formulas widely prescribed as hormonal replacement for tesosterone deficiency syndrome (TDS) in male patients. We evaluated the changes in serum testosterone level and the effects of these medicines. MATERIALS AND METHODS: The medical records of 162 patients who were diagnosed with TDS based on serum testosterone (<2.55 ng/ml) and prescribed testosterone formula were analyzed retrospectively. In the 111 patients of group I, tablets of oral testosterone undecanoate were initially given. If the follow up serum testosterone level had not increased enough, the dosages were increased up to 6 tablets. In the 51 patients of group II, one pack of transdermal testosterone gel (5 gm) daily without dosage adjustment was prescribed. Statistical analysis was done to identify any correlations among age, initial and final aging male's symptoms scale (AMS) score, initial, peak and final testosterone level, and duration of therapy. RESULTS: The mean ages of group I and II were 53.4+/-14.5 and 55.2+/-11.9, respectively (p>0.05). The initial and final testosterone levels of the two groups were not significantly different. However, the peak level during treatment was significantly higher in group II (p<0.05). The maximal increment of testosterone level was also significantly higher in group II. Initially, group II reached its peak testosterone level earlier than group I. The final serum levels were not significantly different after adjustment of dosages in group I. Testosterone replacement significantly decreased the AMS scales in both groups. CONCLUSIONS: Both oral testosterone undecanoate and transdermal testosterone gel improved the serum testosterone level and symptom score for those with TDS. Transdermal testosterone gel may reach the peak serum testosterone level faster than oral testosterone undecanoate. Large prospective studies are required to assess the precise role of testosterone replacement therapy.
Aging ; Follow-Up Studies ; Humans ; Hypogonadism ; Male ; Medical Records ; Retrospective Studies ; Sorbitol ; Tablets ; Testosterone ; Tyramine ; Weights and Measures

PURPOSE: To evaluate the efficacy and safety of laparoscopic renal cryoablation (LRC) of small endophytic renal cell carcinoma, for which surgical treatment is technically difficult. MATERIALS AND METHODS: We enrolled patients with endophytic tumors from a prospectively collected database of 45 renal tumors in 39 patients who had undergone LRC from June 2005 to May 2009. An endophytic tumor was defined as less than 40% of the lesion extending off the surface of the kidney. We evaluated surgical and oncological outcomes. RESULTS: Among the treated tumors, 17 tumors (37.8%) were defined as endophytic tumors and 15 tumors from 14 patients were confirmed as renal cell carcinoma (RCC) in the pathologic examination of the tissue biopsy that was conducted at the time of LRC. The mean American Society of Anesthesiologists (ASA) score of the whole patient group was 2.9 (range, 1-4), and 85.7% (12/14) of the patients had an ASA physical status score over 3. The mean tumor size was 2.8 cm (range, 1.7-3.7 cm). The layout of the cryoprobe was carefully planned preoperatively on the basis of radiologic evaluation in all tumors. Multiple cryoprobes (mean, 3.2; range, 2-5) were used. No major complications, including open surgical conversion and nephrectomy due to bleeding, occurred. No patient experienced clinical symptoms of collecting system injuries. During the mean follow-up of 32.6 months (range, 12-51 months), radiologic evidence of tumor recurrence was found in one patient (6.7% for RCC). With the exception of this patient, all other patients have remained free of recurrence or metastasis, as determined by periodic radiologic workups. CONCLUSIONS: In this series of patients with intermediate-term follow-up, LRC for endophytic renal cell carcinoma showed acceptable oncological and surgical outcomes without sequelae in the collecting system.
Biopsy ; Carcinoma, Renal Cell ; Cryosurgery ; Follow-Up Studies ; Hemorrhage ; Humans ; Kidney ; Neoplasm Metastasis ; Nephrectomy ; Prospective Studies ; Recurrence

We report a case of tuberous sclerosis associated with two histologically different renal cell carcinomas (RCCs) and multiple angiomyolipomas (AMLs) in the same kidney. A 43-year-old female was admitted to our hospital with left flank pain and a huge palpable mass in the left flank area. Abdominal computed tomography revealed two concurrent RCCs and multiple AMLs in the left kidney. Because of the clinical suspicion of RCC, the patient underwent left radical nephrectomy. On gross examination, the total size of the resected left kidney was 30.5x17x8 cm. Microscopically, the upper pole tumor features were consistent with chromophobe RCC and the midpole tumor was a clear-cell RCC. The multifocal masses in the remaining remnant parenchyma were AMLs. Six months after surgery, the patient is healthy without signs of tumor recurrence.
Adult ; Angiomyolipoma ; Carcinoma, Renal Cell ; Female ; Flank Pain ; Humans ; Kidney ; Nephrectomy ; Recurrence ; Tuberous Sclerosis