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31st European Safety and Reliability Conference, ESREL 2021 ; : 2862-2869, 2021.
Article in English | Scopus | ID: covidwho-1994250

ABSTRACT

Questions and answers are a fast way to assess complex day-to-day situations. They can be adopted to the framing conditions and are path-dependent, allowing in-depth analysis of critical issues. Questionnaires try to take up the natural setting using pre-defined sets of questions that cover an area. Often, for comparison of results, they use fixed sets of questions. The paper shows how to use questionnaires to determine semi-quantitative scores of socio technical systems to assess the status of their risk and resilience analysis and management. It maps qualitative as well as quantitative questions on semi-quantitative scales at different system and analysis levels up to overall assessment level. Main focus is on a formalism that allows a dimensional analysis of ordered sets of questions. To this end the questions are related to resilience and risk dimensions understood as concepts allowing a semi-quantitative multiple binning of results, e.g., an answer can be attributed to one or more risk management phases, to resilience cycle or catastrophe management cycle phases, to system layers, and/or to technical resilience capabilities. This allows the simultaneous use of several risk control and resilience generation frameworks, analysis and management concepts. It is shown how extensive quantities are defined that do not depend on the number of questions using normalization conditions. Thus, the user can remove predefined and add new questions as appropriate. The approach is applied to the critical infrastructure domain and to companies affected by the Covid-19 pandemic. © ESREL 2021. Published by Research Publishing, Singapore.

2.
Journal of Hepatology ; 77:S142, 2022.
Article in English | EMBASE | ID: covidwho-1967495

ABSTRACT

Background and aims: In trials conducted in India, recombinant granulocyte colony stimulating factor (GCSF) improved survival in alcohol-associated hepatitis (AH). The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States. Method: This prospective, open label trial randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8. SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient’s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30, 000/mm3 on Day 8. Primary outcomewas survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections. Results: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC>30, 000/ mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval {CI}: 0.57–0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44–0.89];p > 0.05). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and therewere no serious adverse events attributed to pegfilgrastim. Conclusion: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.

3.
Gastroenterology ; 162(7):S-1284, 2022.
Article in English | EMBASE | ID: covidwho-1967448

ABSTRACT

BACKGROUND: Turmeric (curcumin) is a commonly used over-the-counter herbal product whose uses include diarrhea, arthritis, cancer and even COVID-19. Recently turmeric has been implicated in cases of clinically apparent liver injury with jaundice. The aim of this case series is to describe the clinical, histologic and human leukocyte antigen (HLA) associations of turmeric-associated hepatotoxicity as seen in the U.S. Drug Induced Liver Injury Network (DILIN) Prospective Study. METHODS: All adjudicated cases enrolled in DILIN between 2003-2020 with turmeric as an implicated product were reviewed. Causality was assessed using a 5-point expert opinion score. Available products were collected and analyzed for the presence of turmeric using ultra-high-performance liquid chromatography. Genetic analyses included HLA sequencing. RESULTS: Of 1697 cases of drug-induced liver injury judged to be definite, highly likely or probable (high confidence), nine (0.5%) were attributed to turmeric, all of which were enrolled since 2012, and 6 since 2017 (Figure). The 9 cases included 7 women, 8 whites, with a mean age of 51 years (range, 35-62 years) and BMI 25 kg/m2 (range, 15-40). Seven patients used alcohol, but none to excess, and none had underlying liver disease. Turmeric was used for an average of 102 days before onset of injury (range, 30-425 days). Initial mean ALT was 1179 U/L (range, 328-2245), ALP 211 U/L (41-441), total bilirubin 5.9 mg/dL (1.2-10.8), and INR 1.0 (0.9-1.2). Six patients developed jaundice, and serum bilirubin peaked at 9.6 mg/dL (0.8-26), and INR 2.3 (1.0- 9.7). Liver injury was hepatocellular in 8 patients (mean R = 22). Five patients had elevated antinuclear antibody (ANA) titer and two anti-smooth muscle (ASM) antibody, but none were treated with corticosteroids. Liver biopsy in 5 patients showed portal and lobular mixed inflammatory infiltrates with lymphocytes and eosinophils typical of drug-induced liver injury. Five patients were hospitalized, and one patient died of acute liver failure. Chemical analysis confirmed the presence of turmeric in all 7 products analyzed;3 also contained piperine (black pepper), and none contained green tea. Of 7 patients with HLA typing available, 4 carried HLA-B*35:01, a class I HLA allele previously implicated in both green tea and Polygonum multiflorum hepatotoxicity. CONCLUSION: Liver injury due to turmeric appears to be increasing, perhaps, reflecting usage patterns or increased combination with black pepper, which increases its absorption. Turmeric liver injury, similar to that caused by other polyphenolic herbal products, is typically hepatocellular, with a latency of 1 to 6 months, and is linked to HLA-B*35:01. While most cases are self-limited, the injury can be severe and result in death or liver transplantation.

4.
Bratisl Lek Listy ; 123(1): 61-65, 2022.
Article in English | MEDLINE | ID: covidwho-1598390

ABSTRACT

BACKGROUND: We report our experience in starting RATS (robotic-assisted thoracic surgery) lobectomy program during COVID-19 pandemic. METHODS: Data from 20 consecutive cases undergoing RATS lobectomy between August 2020 and April 2021 were prospectively accumulated into our database. RESULTS: The mean operational time was 235±69 minutes (median 210, range 175 to 370). Conversion-to-open rate was 5 %. One patient was converted to an open procedure during surgery due to surgical bleeding. One patient (5 %), with sever chronic obstructive pulmonary disease (COPD), had prolonged air leak with chest drainage 11 days and conservative treatment. Morbidity rate was 10 % (2 patients). Estimated costs of RATS lobectomy in our department were $9,590 (range $8,250-$12,730). 30-days mortality was 0%. CONCLUSIONS: Safe robotic surgery is based not only on improved robotic equipment, but also on good technical skills and medical knowledge. It requires training of the entire operating room team. The learning curve is steep, involving port placement, use of the correct robotic arms, availability of the proper instrumentation, and proper patient positioning (Tab. 2, Ref. 28).


Subject(s)
COVID-19 , Lung Neoplasms , Robotic Surgical Procedures , Humans , Lung Neoplasms/surgery , Pandemics , Pneumonectomy , Retrospective Studies , SARS-CoV-2 , Thoracic Surgery, Video-Assisted
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