Background: As the number of large-scale studies involving multiple organizations producing data has steadily increased, an integrated system for a common interoperable format is needed. In response to the coronavirus disease 2019 (COVID-19) pandemic, a number of global efforts are underway to develop vaccines and therapeutics. We are therefore observing an explosion in the proliferation of COVID-19 data, and interoperability is highly requested in multiple institutions participating simultaneously in COVID-19 pandemic research. Results: In this study, a laboratory information management system (LIMS) approach has been adopted to systemically manage various COVID-19 non-clinical trial data, including mortality, clinical signs, body weight, body temperature, organ weights, viral titer (viral replication and viral RNA), and multiorgan histopathology, from multiple institutions based on a web interface. The main aim of the implemented system is to integrate, standardize, and organize data collected from laboratories in multiple institutes for COVID-19 non-clinical efficacy testings. Six animal biosafety level 3 institutions proved the feasibility of our system. Substantial benefits were shown by maximizing collaborative high-quality non-clinical research. Conclusions This LIMS platform can be used for future outbreaks, leading to accelerated medical product development through the systematic management of extensive data from non-clinical animal studies.

Purpose: Treatment with 4 cycles of docetaxel and cyclophosphamide (TC) in the adjuvant setting is associated with better outcomes than treatment with doxorubicin and cyclophosphamide (AC). However, Western guidelines have indicated that TC confers a high risk (>20%) of febrile neutropenia (FN), while AC confers an intermediate risk (10%–20%) of FN. Threrefore, we evaluated the incidence of FN and the clinical utilization of pegfilgrastim prophylaxis after adjuvant TC chemotherapy. Methods: We categorized 201 patients who received adjuvant TC chemotherapy into 3 groups according to the method of prophylaxis and compared neutropenic events, other adverse events, and hospital care costs in the 3 groups. Results: The incidence of grade 4 neutropenia decreased from 93.0% in patients without prophylaxis to 82.4% in those who received secondary prophylaxis and 16.7% in those who received primary prophylaxis. Although the incidence of FN was not different between patients without prophylaxis and patients who received secondary prophylaxis (15.7% and 14.9%), none of the patients who received primary prophylaxis developed FN. Moreover, a decrease in neutropenic events resulted in a significant decrease in the mean duration of neutropenia (2.50 days to 0.08 days, P < 0.001), the risk of hospitalization (29.8% to 2.2%, P < 0.001), and the mean total hospital care cost for all chemotherapy cycles (790.80 to 486.00 US dollars, P < 0.001). Conclusion The use of pegfilgrastim prophylaxis during adjuvant TC chemotherapy is associated with significant decreases in the incidence of neutropenic events, hospitalization, and hospital care cost compared to those seen in patients without prophylaxis.

Background/Aims: We examined the concordance rate among fasting plasma glucose (FPG), 2-hour post-challenge glucose (2hr PG), and hemoglobin A1c (HbA1c) in the diagnosis of diabetes in a population with a high-risk for type 2 diabetes mellitus (T2DM) in Korea. Methods: Among the participants from the Korean Diabetes Prevention Study, individuals with FPG ≥ 100 mg/dL, body mass index (BMI) ≥ 23.0 kg/m2, and no previous history of T2DM were consecutively enrolled after a 75 g glucose tolerance test. We analyzed the differences in the clinical characteristics in subjects with stage 1 (FPG, 100 to 109 mg/dL) and stage 2 (FPG, 110 to 125 mg/dL) impaired fasting glucose (IFG). Results: Of 1,637 participants, 27.2% had T2DM and 59.3% had IFG and/or impaired glucose tolerance (IGT). The mean age was 55.0 ± 8.1 years and the mean BMI was 26.3 ± 2.7 kg/m2. Based on FPG criteria, 515 (31.4%) and 352 (21.5%) subjects were classified as having stage 1 and stage 2 IFG, respectively. The 19.0% of stage 1 and 43.5% of stage 2 subjects showed 2hr PG levels in the diabetic range. Even for those in the normal FPG range, 63 (9.5%) participants showed a 2hr PG level of ≥ 200 mg/dL. Of 446 subjects with newly-diagnosed diabetes, 340 (76.2%) showed FPG levels < 126 mg/dL. Conclusions The oral glucose tolerance test should be actively considered for Korean adults who are overweight or obese with the IFG range (FPG, 100 to 125 mg/ dL) to allow for early detection of diabetes and prompt intervention.

Purpose: The regimen including concurrent docetaxel, doxorubicin, and cyclophosphamide (TAC) has been categorized as an important risk factor for febrile neutropenia (FN).This comparative study examined the clinical impact of long-acting granulocyte colonystimulating factor (G-CSF) (pegfilgrastim) during adjuvant TAC chemotherapy in Korean patients with advanced breast cancer. Methods: We analyzed data from 239 patients who received 6 cycles of adjuvant TAC chemotherapy. We categorized patients into 2 groups according to the use of primary prophylactic pegfilgrastim and compared the incidence and risk of FN, hospital care costs, and survival in the 2 groups. Results: The incidence of FN decreased from 54.2% to 21.2% in all patients, after the use of pegfilgrastim. The analysis of a total of 1,432 chemotherapy cycles showed that the incidence of FN decreased from 36.1% to 9.1% after the use of pegfilgrastim. Moreover, the decrease in the incidence of FN with the use of pegfilgrastim resulted in a significant decrease in the mean duration of neutropenia (4.15 to 1.29 days), the risk of hospitalization (99.5% to 29.7%) and the mean total hospital care cost (USD 3,038 to USD 2,347). High relative dose intensity (RDI) in patients treated with pegfilgrastim than in those not treated with pegfilgrastim (99.18% vs. 93.85%) was associated with a better overall survival (p = 0.033). Conclusions The use of pegfilgrastim during adjuvant TAC chemotherapy was significantly associated with a decrease in the incidence and risk of FN, hospital care costs, and risk of death compared to the use of adjuvant TAC without primary prophylaxis.

Since Wands et al. reported for the first time in 1975 the reactivation of the hepatitis B virus in hematologic disease patients who had been receiving chemotherapy, the efficacy of chemotherapy and immunosuppressants has improved. As a result, the frequency of the reactivation of hepatitis B is increasing. Reported herein is a case of a non-Hodgkin lymphoma patient in her 70s who was suspected to have had HBsAg negative/anti-HBs negative occult HBV infection. The patient experienced fulminant hepatitis caused by the reactivation of hepatitis B, and died three months after the R-CHOP regimen was completed. In the HBsAg negative plus HBV DNA-negative case, there were few instances of viral activation of HBV. In this case, antiviral therapy was needed when the patient was confirmed to have become HBV DNA positive through regular monitoring, but its necessity is often overlooked, unlike the preemptive antiviral treatment in the HBsAg positive cases.
DNA ; Drug Therapy* ; Hematologic Diseases ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Hepatitis B* ; Hepatitis* ; Humans ; Immunosuppression ; Immunosuppressive Agents ; Lymphoma* ; Lymphoma, Non-Hodgkin ; Virus Activation ; Rituximab

A subaortic membrane is an uncommon cause for left ventricular outflow tract obstruction. Hypertrophic cardiomyopathy with dynamic left ventricular outflow tract obstruction would mask the presence of the subaortic membrane on transthoracic echocardiography and cause a false diagnosis. We report a patient with subaortic stenosis due to flail subaortic membrane misdiagnosed as obstructive hypertrophic cardiomyopathy on transthoracic echocardiography, identified on transesophageal echocardiography and cardiac catheterization.
Cardiac Catheterization ; Cardiac Catheters ; Cardiomyopathy, Hypertrophic ; Constriction, Pathologic ; Echocardiography ; Echocardiography, Transesophageal ; Humans ; Masks ; Membranes

Cytomegalovirus (CMV) infection is an important cause of morbidity and mortality among transplant recipients. The first line standard therapy for CMV pneumonia is treatment with a combination of ganciclovir and immunoglobulin. Nevertheless, the mortality of CMV pneumonia is 30~70%. Leflunomide has been recently reported to have novel anti-CMV activity by inhibiting viron assembly. It is also cheaper and is more easily given orally as compared to ganciclovir. We report here on an allogenic stem cell transplant recipient who developed CMV pneumonia that was refractory to ganciclovir and immunoglobulin. The patient was successfully treated with a combination of leflunomide and ganciclovir.
Biological Agents ; Cytomegalovirus ; Ganciclovir ; Humans ; Immunoglobulins ; Isoxazoles ; Pneumonia ; Stem Cell Transplantation ; Stem Cells

PURPOSE: To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. MATERIALS AND METHODS: Our study was open labelled prospective phase IV multi-center study. the study population included patients with more 4 numeric rating scale(NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups; patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief; second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. RESULTS: Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, p=0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. CONCLUSION: Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There was no major side effect.
Academies and Institutes ; Acute Pain ; Analgesics ; Female ; Fentanyl* ; Humans ; Male ; Nausea ; Prospective Studies ; Quality of Life ; Radiotherapy* ; Sleep Initiation and Maintenance Disorders ; Transdermal Patch*

PURPOSE: To evaluate the clinical and radiological results of an opening wedge osteotomy for an osteoarthritic knee, and compared these results with those of a closing wedge osteotomy. MATERIALS AND METHODS: The study included 27 patients (29 cases) with an opening wedge osteotomy (Group A) and 30 patients (30 cases) with a closing wedge osteotomy (Group B). The radiological results obtained regarding the degree of osteoarthritis, femur-tibia angle, tibial alignment, posterior tibial slope and patellar height using the Insall-Salvati's method were analyzed. HSS score was used for evaluation of the clinical results. RESULTS: Preoperatively, there were no significant differences between the two groups regarding the degree of osteoarthritis, the femur-tibia angle, tibial alignment, posterior tibial slope, and patellar height. Two years after surgery, the femur-tibia angle and tibial alignment were significantly improved to 7.7degrees valgus and 1.3degrees valgus, respectively, and the patellar height was not changed significantly in group A. Similar degrees RESULTs were obtained in group B. The tibial posterior slope increased from 3degrees to 10.7degrees in group A and decreased from 4degrees to 3.7degrees in group B. Clinically, the HSS score was improved from 74 points preoperatively to 93 points 2 years postoperatively in the opening group, and was similar to the improvement observed in the closing group. The complications included 1 delayed union in the opening group, and 3 cases of superficial peroneal nerve palsy and 1 delayed union in the closing group. CONCLUSION: An opening wedge osteotomy is a relatively simple and safe procedure that gives similar radiological and clinical outcomes to a closing wedge osteotomy, without peroneal nerve palsy. However, surgeons should take care in preventing an increase in the tibial posterior slope.
Humans ; Knee ; Osteoarthritis ; Osteotomy* ; Paralysis ; Peroneal Nerve

PURPOSE: The incidence of retinopathy of prematurity(ROP) which is one of the most common cause of childhood blindness has not decreased despite the restricted use of oxygen. There may be other factors responsible for ROP which could not be explained solely by improved survival of very low birth weight infants. We tried to clarify perinatal risk factors that are nrelated to the occurrence of ROP. METHODS: We enrolled 239 infants with gestational ages less than 33 wks or with birth weight less than 1,800 gm who had received ophthalrnologic examination between Jan. 1995 and Dec. 1997. The patients were categorized into two groups,' "No ROP" group as control(n=185) and ROP group as study population(n=54), and we compared the perinatal risk factors between the two. RESULTS: 54(22.6%) out of 239 infants were diagnosed as having ROP. The annual incidence of ROP decreased but the incidence of treated ROP increased. The incidence of ROP decreased with longer gestation and higher birth weight. Mean gestational age was 30.3 weeks in the study group vs 31.0 weeks in the control group, and mean birth weight was 1,390 gm and 1,586 gm, respectively. Significant factors contributing to increased incidence of ROP included: duration of oxygen therapy, ventilator therapy, total parenteral nutrition and hospitalization, frequency of hyperoxia, hypercarbia, and transfusion and respiratory distress syndrome, umbilical artery catheterization, intraventricular hemorrhage, sepsis, bronchopulmonary dysplasia, use of dexamethasone and aminophylline, pneumonia, air leak syndrome, and hyperglycemia. The incidence of ROP and treated ROP was not influenced by the mode of surfactant treatment(prophylactic vs rescue) in RDS patients and the mode of dexamethasone treatment(short vs long) in BPD patients. CONCLUSION: The risk factors for retinopathy of prematurity included gestational age, birth weight and duration of oxygen, as well as other aforementioned perinatal factors. The occurrence of ROP can be decreased by preventing preterm birth, minimizing the use of oxygen, and further morbidity can be prevented by performing proper ophthalmologic examination and doing an appropriate follow-up.
Aminophylline ; Birth Weight ; Blindness ; Bronchopulmonary Dysplasia ; Catheterization ; Catheters ; Dexamethasone ; Gestational Age ; Hemorrhage ; Hospitalization ; Humans ; Hyperglycemia ; Hyperoxia ; Incidence ; Infant ; Infant, Newborn ; Infant, Very Low Birth Weight ; Oxygen ; Parenteral Nutrition, Total ; Pneumonia ; Pregnancy ; Premature Birth ; Retinopathy of Prematurity* ; Risk Factors* ; Sepsis ; Umbilical Arteries ; Ventilators, Mechanical