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.

This study was conducted to observe effects of two methods of setting positive endexpiratory pressure (PEEP) based on the pressure-volume (PV) curve. After lung injury was induced by oleic acid in six mongrel adult dogs, the inflation PV curve was traced and the lower inflection point (LIP) was measured. The 'PEEP(INF)' was defined as LIP+2 cmH2O. After recruitment maneuver to move the lung physiology to the deflation limb of PV curve, decremental PEEP was applied. The lowest level of PEEP that did not result in a significant drop in PaO2 was defined as the 'PEEP(DEF)'. Arterial blood gases, lung mechanics, hemodynamics, and lung volumes (measured on computed tomography during end-expiratory pause) were measured at PEEP of 0 cmH2O, PEEP(INF) and PEEP(DEF) sequentially. The median PEEP(INF) was 13.4 cm H2O (interquartile range, 12.5-14.3) and median PEEP(DEF) was 12.0 cm H2O (10.0-16.5) (p=0.813). PEEP(DEF) was associated with significantly higher PaO2 and lung volumes, and significantly lower shunt fraction and cardiac index when compared to PEEP(INF) (p<0.05). Setting the PEEP based on the deflation limb of the PV curve was useful in improving oxygenation and lung volumes in a canine lung injury model.
Animals ; Dogs ; Lung/pathology ; *Lung Injury ; Lung Volume Measurements/*methods ; Male ; Oxygen/metabolism ; Positive-Pressure Respiration/*methods ; Pressure ; Pulmonary Gas Exchange ; Radiography, Thoracic/methods ; Tomography, X-Ray Computed/*methods

OBJECTIVE: This study assessed the outcomes of using vascular closure devices following percutaneous transfemoral endovascular procedures in the patients who were treated with heparin, abciximab or thrombolytics (urokinase or t-PA) during the procedures. MATERIALS AND METHODS: From March 28, 2003 to August 31, 2004, we conducted a prospective and randomized study in which 1,676 cases of 1,180 patients were treated with one of the two different closure devices (the collagen plug device was Angio-SealTM; the suture-mediated closure device was The Closer STM) at the femoral access site after instituting percutaneous endovascular procedures. Among the 1,676 cases, 108 cases (the drug group) were treated with heparin only (n = 94), thrombolytics only (n = 10), heparin and thrombolytics (n = 3), or abciximab and thrombolytics (n = 1) during the procedures; 1,568 cases (the no-drug group) were treated without any medication. We compared the efficacy and complications between the two groups. Of the drug group, 42 cases underwent arterial closures with the collagen plug devices and 66 cases underwent arterial closures with the suture-mediated closure devices. We also compared the efficacy and complications between these two groups. RESULTS: The immediate hemostasis rates were 92.9% (1,456/1,568) in the no-drug group and 91.7% (99/108) in the drug group. Early complications occurred in four cases of the drug group. These included two episodes of rebleeding with using the Closer S, which required manual compression for at least 10 minutes, and two episodes of minor oozing with using one Angio-Seal and one Closer S, which required two hours of additional bed rest. There was no late complication. So, the total success rates were 90.8% (1,423/1,568) in the no-drug group and 88.0% (95/108) in the drug group. These results were not significantly different between the two groups (p = 0.34). In the drug group, the difference of the successful hemostasis rate between the collagen plug devices and the suture-mediated devices was also not statistically significant (92.9% vs. 84.8%, respectively; p = 0.21). CONCLUSION: Arterial closure of the femoral access site with using vascular closure devices is both safe and effective, even in the patients who received heparin, abciximab or thrombolytics.
Sutures ; Prospective Studies ; Postoperative Complications ; Middle Aged ; Male ; Immunoglobulin Fab Fragments/pharmacology/*therapeutic use ; Humans ; Hemostatic Techniques/*instrumentation ; Hemostasis/*drug effects ; Fibrinolytic Agents/pharmacology/*therapeutic use ; Femoral Artery/*surgery ; Female ; Collagen ; Anticoagulants/pharmacology/*therapeutic use ; Antibodies, Monoclonal/pharmacology/*therapeutic use

BACKGROUND: Thoracic actinomycosis is a relatively uncommon anaerobic infection caused by Actinomyces israelii. There have been only a few case reports of endobronchial actinomycosis. The aim of this study was to evaluate the clinical manifestation and treatment of endobronchial actinomycosis. MATERIAL AND METHODS: Seven patients with endobronchial actinomycosis, who were diagnosed in the past 10 years, were retrospectively reviewed. RESULTS: Cough and sputum were the most common symptoms. The chest radiograph and computed tomography showed necrotic consolidation (n=3), atelectasis (n=2), mass (n=1) and an endobronchial nodule (n=1). Proximal broncholithiasis was observed in five patients. All cases were initially suspected to have either lung cancer or tuberculosis. In these patients, the median duration of intravenous antibiotics was 3 days (range 0-12 days) and the median duration of oral antibiotics was 147 days (range 20-412 days). Two patients received oral antibiotic therapy only. There was no clinical evidence of a recurrence. CONCLUSION: Endobronchial actinomycosis frequently manifests as a proximal obstructive calcified endobronchial nodule that is associated with distal post-obstructive pneumonia. The possibility of endobronchial actinomycosis is suggested when findings of broncholithiasis are present at chest CT. The traditional recommendation of 2-6 weeks of intravenous antibiotics and 6-12 months of oral antibiotic therapy are not necessarily essential in all cases of endobronchial actinomycosis.
Actinomyces ; Actinomycosis* ; Anti-Bacterial Agents ; Bronchoscopy ; Cough ; Diagnosis* ; Humans ; Lung Neoplasms ; Pneumonia ; Pulmonary Atelectasis ; Radiography, Thoracic ; Recurrence ; Retrospective Studies ; Sputum ; Tomography, X-Ray Computed ; Tuberculosis

BACKGROUND: Corticosteroids in combination with cytotoxic drugs are the mainstays of therapy for idiopathic pulmonary fibrosis (IPF). However, there has been no regimen showing any survival benefit. The aim of this study was to describe a short-term clinical experience on interferon gamma-1b (IFN-gamma1b) therapy for IPF, as an antifibrotic agent. METHODS: Medical records of 27 patients who were treated with IFN-gamma1b (2 million IU, 3 times a week, subcutaneous injection) were retrospectively reviewed. Treatment response was assessed using ATS/ERS criteria in 17 patients who received IFN-gamma1b for more than 6 months. In addition, we compared the efficacy of IFN-gamma1b therapy with that of cyclophosphamide+/-prednisolone therapy (n=26). RESULTS: The median age of IFN-gamma treated group (M:F=19:8) was 59 years (44-74 years). Compared to the patients who showed a stable response at 6 months (n=12), the deteriorated group (n=5) had worse baseline lung function (FVC, 55.4+/-11.3% vs. 70.7+/-10.9%, p=0.019; DLco, 50.3+/-7.3% vs. 76.9+/-19.6%, p=0.014). Lower baseline PaO2 on room air breathing was observed in the deteriorated group (68.6+/-7.8mmHg vs. 91.4+/-6.6mmHg p=0.001). Subcutaneous IFN-gamma1b did not show better efficacy than prednisolone. Five patients discontinued IFN-gamma because of severe side effects. ARDS developed in one patient, who eventually died. CONCLUSION: The administration of IFN-gamma1b is not desirable for patients diagnosed with IPF with poor lung function. Long-term and large-scaled clinical studies are needed for its efficacy in IPF.
Adrenal Cortex Hormones ; Humans ; Idiopathic Pulmonary Fibrosis* ; Interferon-gamma ; Interferons* ; Lung ; Medical Records ; Prednisolone ; Pulmonary Fibrosis ; Respiration ; Retrospective Studies

BACKGROUND: Because of the low sensitivity of sputum smear and culture, diagnosis of nontuberculous mycobac?terium (NTM) pulmonary disease, especially in patients with bronchiectasis, is often difficult. We investigated the usefulness of bronchoscopy for the diagnosis of NTM pulmonary disease including M. avium complex (MAC) and M. abscessus in patients with bronchiectasis and multiple pulmonary nodules on chest computed tomography (CT). METHODS: We reviewed 48 cases of patients who were performed bronchoscopic bronchoalveolar lavage (BAL) and transbronchial lung biopsy (TBLB) under suspect of NTM pulmonary disease based on CT findings of bronchiectasis and multiple nodules from April 2002 to June 2003. RESULTS: Twenty five of the 48 patients (54%; 12 MAC, 14 M. abscessus) were diagnosed as NTM pulmonary disease on the basis of the American Thoracic Society diagnostic criteria for NTM pulmonary disease. Sixteen of the 21 patients (76%; 5 MAC, 11 M. abscessus) with 3 or more positive sputum cultures of NTM were confirmed tissue invasion by TBLB. Five of the 24 patients (21%; 4 MAC, 1 M. abscessus) who could not be diagnosed with sputum cultures were diagnosed by bronchoscopic BAL and TBLB. CONCLUSION: Bronchoscopy is helpful for the diagnosis of NTM pulmonary disease and confirmation of tissue invasion by NTM, not only MAC but also M. abscessus, in patients with bronchiectasis and multiple nodules on chest CT scan.
Biopsy ; Bronchiectasis ; Bronchoalveolar Lavage ; Bronchoscopy* ; Diagnosis* ; Humans ; Lung ; Lung Diseases* ; Multiple Pulmonary Nodules ; Mycobacterium avium Complex ; Nontuberculous Mycobacteria ; Sputum ; Thorax ; Tomography, X-Ray Computed

BACKGROUND: There has been a gradual increase in the number of newly diagnosed cases of Mycobacterium avium complex (MAC) pulmonary disease. However, the optimal therapeutic regimen for the disease has not yet established and there is no report about the treatment outcome of MAC pulmonary disease in Korea. This study examined the effect of clarithromycin-based regimen in patients with pulmonary MAC disease without a HIV infection. MATERIALS AND METHODS: Fifty-six patients with pulmonary MAC disease were diagnosed according to the American Thoracic Society criteria from January 2000 to December 2003 at this hospital. Of these patients, 15 were treated with clarithromycin, rifampin, and ethambutol for more than 6 months, together with streptomycin initially (first 6 months) in 8 patients. RESULTS: Six months after the treatment, the sputum cultures converted from positive to negative in 8 patients (53%) and the radiological findings improved in 10 (67%). At 12 months 4 patients (44%) achieved sputum negative conversion and 6 patients out of 9 patients (67%) who were treated for more than 12 months showed radiological improvement. Overall, the sputum findings converted to negative in nine patients (60%) who underwent medical treatment. A pulmonary resection was successfully performed in one patient. Only one patient discontinued the treatment due to side effects such as gastrointestinal intolerance and optic neuritis. CONCLUSION: A combined regimen containing clarithromycin is relatively safe and tolerable even in the elderly outpatients. However, the results of this combined chemotherapy were unsatisfactory and new companion drugs for MAC pulmonary disease are needed. A resection may be considered for localized disease.
Aged ; Clarithromycin ; Drug Therapy ; Ethambutol ; Friends ; HIV Infections ; Humans ; Korea ; Lung Diseases* ; Mycobacterium avium Complex* ; Mycobacterium avium* ; Mycobacterium* ; Nontuberculous Mycobacteria ; Optic Neuritis ; Outpatients ; Rifampin ; Sputum ; Streptomycin ; Treatment Outcome

BACKGROUND: We studied the clinical significance of nontuberculous mycobacteria (NTM) recovered from respiratory specimens for six months in a tertiary referral center. METHODS: We identified all NTM isolates from sputum or bronchial washing from October, 2001 to March, 2002, using polymerase chain reaction-restriction fragment length polymorphism analysis method amplifying the rpoB gene. Patients were classified as having definite, probable, or unlikely NTM disease as defined by the American Thoracic Society and the British Thoracic Society guidelines. RESULTS: 261 isolates of NTM recovered from 162 patients. In 162 patients, M. avium complex (MAC) was the most common species comprising 29.6% (n=48), which was followed by M. fortuitum complex (n=46, 28.4%), M. abscessus (n=26, 16.0%). 29 (17.9%) patients had definite NTM disease, and 13 (8.0%) had probable NTM disease. The common organisms involved in NTM diseases were MAC (n=23, 54.8%), M. abscessus (n=12, 28.6%). In a univariate analysis, predictive factors that were related to NTM disease were BMI <18.5 kg/m2, presence of symptoms, previous history of antituberculous treatment, positive sputum smear, presence of infiltrative, nodular or cavitary lesions at chest radiography, and isolation of MAC or M. abscessus. In a multivariate analysis, isolation of MAC or M. abscessus (OR 16.3, 95% CI 4.2~62.7, p<0.001), cavity at chest radiography (OR 4.8, 95% CI 1.4~16.6, p=0.012), and positive sputum smear (OR 4.3, 95% CI 1.4~13.3, p=0.012) were found to be variables independently associated with pulmonary disease. CONCLSUION: Epidemiology of NTM pulmonary disease in Korea is different from that in other countries. A high index of clinical suspicion as well as an accurate identification of the isolates would be required for the diagnosis of NTM pulmonary disease.
Diagnosis ; Epidemiology ; Humans ; Korea ; Lung Diseases ; Multivariate Analysis ; Mycobacterium avium Complex ; Mycobacterium chelonae ; Nontuberculous Mycobacteria* ; Radiography ; Sputum ; Tertiary Care Centers ; Thorax

The Mycobacterium avium complex (MAC) is the most common pathogen causing nontuberculous mycobacterial pulmonary disease. Despite the introduction of newer, more effective agents for the treatment of MAC, such as clarithromycin, the response to drug therapy in MAC pulmonary disease remains poor, and often frustrating. When MAC pulmonary disease has not been successfully eradicated using drug treatment alone, surgical management is still recognized to play a significant role. A case of MAC pulmonary disease, in a patient whose MAC disease was successfully treated by pulmonary resection, following the failure of drug therapy containing clarithromycin, is reported. To our knowledge, this is the first case report in Korea that the patient underwent a pulmonary resection for the treatment of MAC pulmonary disease.
Clarithromycin ; Drug Therapy* ; Humans ; Korea ; Lung Diseases* ; Mycobacterium avium Complex ; Mycobacterium avium* ; Mycobacterium* ; Nontuberculous Mycobacteria ; Thoracic Surgery

BACKGROUND/AIMS: Despite of increasing numbers of reports on intraductal papillary mucinous tumor (IPMT), there is still difficulty in its' diagnosis, treatment and prediction of prognosis. The purpose of this multicenter study was to evaluate the clinico-pathological features of IPMT in Korea and suggest the prediction criteria of malignancy in IPMT. METHODS: We retrospectively reviewed the clinico-pathological data of 208 patients who underwent operations with IPMT between 1993 and 2002 at 28 institutes in Korea. RESULTS: Of the 208 patients with a mean age of 60.5+/-9.7 years, 147 were men and 61 were women. 124 patients underwent pancreatoduodenectomy, 42 distal pancreatectomy, 17 total pancreatectomy, 25 limited pancreas resection. Benign cases were 128 (adenoma (n=62), borderline (n=66)) and malignant cases were 80 (non-invasive (n=29), invasive (n=51)). A significant difference in 5-year survival was observed between benign and malignant group (92.6% vs. 65.3%; p=0.006). Of the 6 factors (age, location, duct dilatation, tumor appearance, main duct type, and tumor size) that showed the statistical difference in univariate analysis between benign and malignant group, we found three significant factors (tumor appearance (p=0.009), tumor size (p=0.023), and dilated duct size (p=0.010)) by multivariate analysis. CONCLUSION: Although overall prognosis of IPMT is superior to ordinary pancreatic cancer, more curative surgery is recommended in malignant IPMT. Tumor appearance (papillary), tumor size (> or =30 mm) and dilated duct size (> or = 12 mm) can be used as preoperative indicators of malig-nancy in IPMT.
Academies and Institutes ; Diagnosis ; Dilatation ; Female ; Humans ; Korea* ; Male ; Mucins* ; Multivariate Analysis ; Pancreas* ; Pancreatectomy ; Pancreatic Neoplasms ; Pancreaticoduodenectomy ; Prognosis ; Retrospective Studies