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1

Cole, Cynthia H. "ERRATUM." Pediatrics 77, no. 4 (April 1, 1986): 529. http://dx.doi.org/10.1542/peds.77.4.529.

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There is a new typographical error in the "corrected" theophylline dosage printed on page 813 in the November 1985 (vol 76, No. 5) issue of Pediatrics concerning theophylline dosage in The Harriet Lane Handbook. The correct dosage for infants 6-52 weeks old should be 0.2 x age in weeks + 5.0 (not 1.2 x age in weeks + 5.0).
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Raheel, Shafay, Cynthia S. Crowson, Kerry Wright, and Eric L. Matteson. "Risk of Malignant Neoplasm in Patients with Incident Rheumatoid Arthritis 1980–2007 in relation to a Comparator Cohort: A Population-Based Study." International Journal of Rheumatology 2016 (2016): 1–6. http://dx.doi.org/10.1155/2016/4609486.

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Objective.To determine whether the incidence of malignancy is increased in patients with rheumatoid arthritis (RA) compared to a matched comparison cohort and to identify risk for any individual malignancy in RA.Methods.A cohort of 813 Olmsted County, Minnesota, residents who first fulfilled 1987 ACR criteria for RA in 1980–2007 was previously identified by medical record review. Medical records of 813 RA cases and a comparison cohort of age and sex matched Olmsted County residents without RA were evaluated retrospectively for cancer occurrence. Patients in both cohorts were followed until death, migration from Olmsted County, or 12/31/2014.Results.The RA and non-RA cohorts (mean age at incidence/index date: 55.9 [SD: 15.7] years; 68.4% females in both cohorts) were followed on average of 14.1 (SD: 7.7) and 14.9 (SD: 8.1) years, respectively. Prior to RA incidence/index date, 52 RA patients and 66 non-RA subjects had malignancies excluding NMSC (p=0.21). During follow-up, significantly more malignancies occurred in patients with RA (n=143) than in comparator subjects (n=118; hazard ratio: 1.32;p=0.027). Inclusion of NMSC obviated this difference.Conclusion.After excluding NMSC, there was a small to moderately increased risk of malignancies in patients with RA. Cancer surveillance is imperative in all patients with RA.
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YAO, L., N. YANG, Q. LIU, M. WANG, W. ZHANG, W. F. QIAN, Y. F. HU, and J. DING. "Detection ofNeospora caninumin aborted bovine fetuses and dam blood samples by nested PCR and ELISA and seroprevalence in Beijing and Tianjin, China." Parasitology 136, no. 11 (August 7, 2009): 1251–56. http://dx.doi.org/10.1017/s0031182009990813.

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SUMMARYNeospora caninuminfection is a significant cause of abortion in cattle. We investigated the tissue distribution ofN. caninumin aborted bovine fetuses and dam blood samples by a nested PCR assay, and compared the nested PCR with ELISA in the diagnosis ofN. caninuminfection. In total, 26 aborted fetuses and 813 blood samples were collected from 8 dairy herds in Beijing (n=212) and Tianjin (n=601), China. Fifteen fetuses (57·7%) were testedN. caninum-positive by the nested PCR.N. caninumDNA was detected from the brain of 52%, kidneys of 22%, skeletal muscle of 18%, and heart of 4% of the aborted fetuses. The PCR-positive cases (55%, 11/20) were higher than seropositive cows (40%, 8/20) in a subset of 20 fetuses, but the PCR results of blood samples of the 20 cows were all negative. The seroprevalence of the 813 samples was 15·5% (43·4% of samples from Beijing, 5·7% of samples from Tianjin), compared to the PCR-positive blood samples of 0·9%. Our study showed that the nested PCR is a valuable diagnostic tool for the primary diagnosis ofN. caninumin aborted fetuses, while ELISA is the preferred assay for testing blood samples collected from cows. The two assays are complementary in determining whether abortions are associated withN. caninuminfection in cattle.
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Karnath, B. M., M. D. Carlo, and M. D. Holden. "260 USE OF SIMULATED HEART AND LUNG SOUNDS IN STANDARDIZED PATIENT EXAMINATIONS FOR TESTING CLINICAL REASONING SKILLS." Journal of Investigative Medicine 52, Suppl 1 (January 1, 2004): S303.4—S303. http://dx.doi.org/10.1136/jim-52-suppl1-813.

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Lisdiyanti, Puspita, Hiroko Kawasaki, Yantyati Widyastuti, Susono Saono, Tatsuji Seki, Yuzo Yamada, Tai Uchimura, and Kazuo Komagata. "Kozakia baliensis gen. nov., sp. nov., a novel acetic acid bacterium in the alpha-proteobacteria." International Journal of Systematic and Evolutionary Microbiology 52, no. 3 (May 1, 2002): 813–18. http://dx.doi.org/10.1099/00207713-52-3-813.

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Magadum, Basavaraj, Rn Kanpure, Op Singh, Bk Kachouli, and J. Bhandari. "Effects of pruning intensity and plant growth regulators on growth, yield and quality of guava (Psidium Guajava L.) CV. Sardar." Bangladesh Journal of Botany 52, no. 3 (October 12, 2023): 813–20. http://dx.doi.org/10.3329/bjb.v52i3.68923.

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Effects of pruning intensity and spray of plant growth regulators (PGR) on dfferent parameters of Guava (Psidium Guajava L.) Sardar were investigated. Growth, quality and yield attributing characters were improved at 30 cm pruning intensity. With respect to effect of plant growth regulators, application of 600 ppm NAA improved all the characters except minimum number of days taken to flower initiation (39.47), acidity (0.33 %), TSS (12.11 oBrix) and total sugars (6.79 %) which were recorded in 600 ppm ethephon. The interaction studied showed that P3G2 (30 cm pruning + 600 ppm NAA) had recorded the highest value with growth, yield and quality, while the combination of P3G3 (30 cm pruning + 600 ppm ethephon) was good for qualitative parameters. Bangladesh J. Bot. 52(3): 813-820, 2023 (September)
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Barnett, Allain J., Kerri Finlay, and Beatrix E. Beisner. "Functional diversity of crustacean zooplankton communities: towards a trait-based classification.Freshwater Biology, 52, 796-813. DOI: 10.1111/j.1365-2427.2007.01733.x." Freshwater Biology 58, no. 8 (July 1, 2013): 1755–65. http://dx.doi.org/10.1111/fwb.12177.

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8

Donaldson-Davis, Kayon. "RETIREMENT FINANCIAL LITERACY LEVELS AMONG JAMAICANS." Innovation in Aging 3, Supplement_1 (November 2019): S580. http://dx.doi.org/10.1093/geroni/igz038.2151.

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Abstract Although the general literacy rate (ability to read and write at a 6th-grade level or higher) of Jamaicans is 89%, the number of people who are adequately prepared financially is not comparable. Dissertation research findings revealed that 52% (n=203) of respondents had not received any financial education. Approximately 71% of respondents who reported high levels of financial distress and low financial well-being, had not received financial information about retirement planning. Results from the 2012 Social Status on the Elderly in Jamaica showed that 60.5% (n=1,716) of respondents had no pension and of those receiving money from abroad, most (75.0%, n=813) indicated that they received it only occasionally. Those who were self-employed, women and rural residents were most likely not to have a pension. This paper describes financial literacy levels among Jamaicans using two separate data sets – the 2012 Social Status on the Elderly and the 2018 Financial Preparation Study.
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Squire, J., and A. Bhattacharjee. "COHERENT NONHELICAL SHEAR DYNAMOS DRIVEN BY MAGNETIC FLUCTUATIONS AT LOW REYNOLDS NUMBERS." Astrophysical Journal 813, no. 1 (October 28, 2015): 52. http://dx.doi.org/10.1088/0004-637x/813/1/52.

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Stanley, Andrew C., Frank Vittemberger, Lena M. Napolitano, Kathleen P. O'Hara, Karen Mcginnis, Diane Lockhart, and Wayne E. Silva. "The Use of Delayed Computerized Tomography in the Evaluation of Blunt Abdominal Trauma: A Preliminary Report." American Surgeon 65, no. 4 (April 1999): 369–74. http://dx.doi.org/10.1177/000313489906500418.

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This purpose of this study was to analyze the use of abdominal computed tomography (CT) imaging in patients with possible blunt abdominal trauma. A retrospective analysis of all trauma patients over a 1-year period (1993–1994) was conducted, with prospective study protocol in 52 patients using serial abdominal exam and hematocrits (Hcts) instead of abdominal CT for evaluation of blunt abdominal trauma. Urgent abdominal CT was used as the initial diagnostic test for evaluation of blunt abdominal trauma in 813 patients over this 1-year period. CT was obtained in 379 (46.6%) of these patients who arrived hemodynamically stable (admission systolic blood pressure ≥ 90), had a Glasgow Coma Scale > 13, and had admission Hct ≥ 35 because of distracting injuries, possible traumatic brain injury, or alcohol/drug use, which might render the abdominal physical exam unreliable. Only 47 CT scans (12.4%) were positive, and three patients (0.8%) required laparotomy. In an effort to more efficiently use abdominal CT, we performed a prospective study in 52 patients with possible blunt abdominal trauma, admission systolic blood pressure ≥ 90, Hct ≥ 35, Glasgow Coma Scale > 13, and a normal abdominal exam on admission. These patients were followed with serial abdominal examinations and Hcts every 6 hours for 24 hours, and delayed CT, when applicable. CT was obtained in seven patients (13.5%) for evaluation of fall in Hct or abnormal abdominal examination; all were negative for abdominal injury. A protocol using serial abdominal exams, Hcts, and delayed abdominal CT imaging may be useful in select patients to decrease the high number of negative routine abdominal CTs that are obtained in the evaluation of blunt abdominal trauma.
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Nguyen, Binh T., and Lisa M. Powell. "The impact of restaurant consumption among US adults: effects on energy and nutrient intakes." Public Health Nutrition 17, no. 11 (July 30, 2014): 2445–52. http://dx.doi.org/10.1017/s1368980014001153.

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AbstractObjectiveTo examine the effect of fast-food and full-service restaurant consumption on adults’ energy intake and dietary indicators.DesignIndividual-level fixed-effects regression model estimation based on two different days of dietary intake data was used.SettingParallel to the rising obesity epidemic in the USA, there has been a marked upward trend in total energy intake derived from food away from home.SubjectsThe full sample included 12 528 respondents aged 20–64 years who completed 24 h dietary recall interviews for both day 1 and day 2 in the National Health and Nutrition Examination Survey (NHANES) 2003–2004, 2005–2006, 2007–2008 and 2009–2010.ResultsFast-food and full-service restaurant consumption, respectively, was associated with an increase in daily total energy intake of 813·75 kJ (194·49 kcal) and 858·04 kJ (205·21 kcal) and with higher intakes of saturated fat (3·48 g and 2·52 g) and Na (296·38 mg and 451·06 mg). Individual characteristics moderated the impacts of restaurant food consumption with adverse impacts on net energy intake being larger for black adults compared with their white and Hispanic counterparts and greater for middle-income v. high-income adults.ConclusionsAdults’ fast-food and full-service restaurant consumption was associated with higher daily total energy intake and poorer dietary indicators.
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KURNOSOV, V. V., and V. R. TIHONOVA. "Hood Furnace - Universal Unit for Burning Ceramics." Stroitel'nye Materialy, no. 5 (2023): 48–52. http://dx.doi.org/10.31659/0585-430x-2023-813-5-48-52.

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Mundt, Marlon P., James H. Stein, Michael C. Fiore, and Timothy B. Baker. "Economic Evaluation of Enhanced vs Standard Varenicline Treatment for Tobacco Cessation." JAMA Network Open 7, no. 4 (April 29, 2024): e248727. http://dx.doi.org/10.1001/jamanetworkopen.2024.8727.

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ImportanceSmoking is the leading preventable cause of death and illness in the US. Identifying cost-effective smoking cessation treatment may increase the likelihood that health systems deliver such treatment to their patients who smoke.ObjectiveTo evaluate the cost-effectiveness of standard vs enhanced varenicline use (extended varenicline treatment or varenicline in combination with nicotine replacement therapy) among individuals trying to quit smoking.Design, Setting, and ParticipantsThis economic evaluation assesses the Quitting Using Intensive Treatments Study (QUITS), which randomized 1251 study participants who smoked into 4 conditions: (1) 12-week varenicline monotherapy (n = 315); (2) 24-week varenicline monotherapy (n = 311); (3) 12-week varenicline combination treatment with nicotine replacement therapy patch (n = 314); or (4) 24-week varenicline combination treatment with nicotine replacement therapy patch (n = 311). Study enrollment occurred in Madison and Milwaukee, Wisconsin, between November 11, 2017, and July 2, 2020. Statistical analysis took place from May to October 2023.Main Outcomes and MeasuresThe primary outcome was 7-day point prevalence abstinence (biochemically confirmed with exhaled carbon monoxide level ≤5 ppm) at 52 weeks. The incremental cost-effectiveness ratio (ICER), or cost per additional person who quit smoking, was calculated using decision tree analysis based on abstinence and cost for each arm of the trial.ResultsOf the 1251 participants, mean (SD) age was 49.1 (11.9) years, 675 (54.0%) were women, and 881 (70.4%) completed the 52-week follow-up. Tobacco cessation at 52 weeks was 25.1% (79 of 315) for 12-week monotherapy, 24.4% (76 of 311) for 24-week monotherapy, 23.6% (74 of 314) for 12-week combination therapy, and 25.1% (78 of 311) for 24-week combination therapy, respectively. The total mean (SD) cost was $1175 ($365) for 12-week monotherapy, $1374 ($412) for 12-week combination therapy, $2022 ($813) for 24-week monotherapy, and $2118 ($1058) for 24-week combination therapy. The ICER for 12-week varenicline monotherapy was $4681 per individual who quit smoking and $4579 per quality-adjusted life-year (QALY) added. The ICER for 24-week varenicline combination therapy relative to 12-week monotherapy was $92 000 000 per additional individual who quit smoking and $90 000 000 (95% CI, $15 703 to dominated or more costly and less efficacious) per additional QALY.Conclusions and RelevanceThis economic evaluation of standard vs enhanced varenicline treatment for smoking cessation suggests that 12-week varenicline monotherapy was the most cost-effective treatment option at the commonly cited threshold of $100 000/QALY. This study provides patients, health care professionals, and other stakeholders with increased understanding of the health and economic impact of more intensive varenicline treatment options.
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Lagat, Fredrick Kiprop. "EFFECT OF RISK EVALUATION ON PERFORMANCE OF FINANCIAL INSTITUTIONS." Journal of Accounting 2, no. 1 (August 14, 2017): 54–68. http://dx.doi.org/10.47941/jacc.183.

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Purpose: The purpose of the study was to determine the effect of risk evaluation on performance of financial institutions.Methodology: The study used explanatory research design. The study used stratified random sampling to select respondents from target population comprising of managers of 46 commercial banks, 52 Micro Finance institutions (MFIs) and 200 SACCOs and a sample size of 239 respondents obtained. Data was collected using questionnaires. Descriptive statistics was presented, while inferential statistics was done using Pearson product moment correlation.Results: There was a positive influence of risk evaluation [r = .813, p<.05] on the performance of financial institutions was obtained. The risk evaluation positively influenced the performance of financial institutions. The risk evaluation had positive relationship with performance of financial institutions (P<0.05). The null hypothesis HO3 stating that there is no significant effect of risk evaluation on performance of financial institutions was rejected. This indicates that for each increase in the risk evaluation, there is 0.821 increase in performance of financial institutions.Unique contribution to theory, practice and policy: The study has established the importance of ownership structure as a system of corporate governance that significantly moderates the relationship between risk management practices and performance of financial institutions can exploit various risk management practices identification, analysis, evaluation and monitoring should be enhanced so as to bring efficiency in the performance of financial institutions. These may be achieved through establishment and implementation of risk identification, analysis, evaluation and monitoring policy framework which will significantly influence performance of financial institutions and enhance shareholder capabilities to evaluate all risks that can hinder the financial institutions from achieving their set objectives
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Guajardo Salinas, Gustavo E., Roger Nutt, and Gerardo Rodriguez-Araujo. "Del Nido cardioplegia in low risk adults undergoing first time coronary artery bypass surgery." Perfusion 32, no. 1 (July 28, 2016): 68–73. http://dx.doi.org/10.1177/0267659116661051.

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Objectives: Single-dose del Nido cardioplegia has been used in the pediatric population for many years. Only a small amount of data exists about its use in adult cardiac surgery. We sought to compare the outcomes of all patients undergoing coronary artery bypass, using our 4:1 blood cardioplegia versus single-dose 1:4 del Nido cardioplegia, at our institution. Methods: Data were retrospectively reviewed from all patients during 2 consecutive years (2013-2014). We switched our cardioplegia protocol from 4:1 blood cardioplegia to exclusively 1:4 single-dose del Nido cardioplegia in early 2014. A total of 408 patients were evaluated. Two hundred and forty-nine consecutive patients underwent coronary artery bypass using blood cardioplegia and 159 using del Nido Cardioplegia. Results: Cardiopulmonary bypass time, cross-clamp time, in-hospital mortality and length of stay were similar (p>0.05): 63 ± 23 vs. 65 ± 21 min, 50 ± 20 vs. 52 ± 20 min, 0.8% vs. 0.6% and 6.4 ± 3 vs. 5.8 ± 3 days, respectively. For secondary outcomes: patients requiring defibrillation was 105/249 (42%) vs. 13/159 (8%) (p<0.0001), blood transfusion was required in 96/249 (38%) vs. 48/159 (30%) (p<0.085), total volume administered was 1139mL vs. 813 mL per case (p<0.0001), hematocrit change was 11.6% vs. 10.9% (p<0.04) and the mean cost per dose was $157.54 vs $5.74. Conclusions: Single-dose del Nido cardioplegia is an effective and economic cardioplegia and can be used with good outcomes in coronary surgery. Most patients have spontaneous return of sinus rhythm and there is a trend towards decreased transfusion rate.
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Ramirez, Cody, Felix Frenkel, Olga Plotnikova, Vladislav Belousov, Alexander Bagaev, Elena Ocheredko, Susanna Kiwala, et al. "Identification of predicted neoantigen vaccine candidates in follicular lymphoma patients." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): 8054. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.8054.

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8054 Background: Follicular lymphoma (FL) is incurable with conventional therapies and poorly responsive to immune checkpoint blockade. There is a need for new therapies without long-term complications of chemotherapy and with curative potential. We hypothesize that FL contains tumor-specific mutant antigens (TSMAs) that can be targeted by the immune system by vaccination. Recent reports have highlighted the potential for unique immunoglobulin peptides to elicit immune response in lymphomas. We utilized whole exome sequencing (WES) and RNA sequencing (RNA-Seq) of FL patient samples to infer HLA genotype, and predict TSMAs with the goal of designing a personalized cancer vaccine, supported by recent reports of this approach in solid cancers. Methods: DNA and RNA from 58 patients’ FL biopsies underwent WES and RNA-Seq. pVACtools and MiXCR predicted potential somatic and B-cell clonotype neoantigens, which were filtered to identify high quality TSMAs. B-cell oligoclonality was determined by comparison to B-cell receptor (BCR) repertoire profiling of healthy individual lymph nodes. RNA-seq data allowed us to identify expressed TSMAs. Complementary in silico analysis based on mRNA-based peptide reconstruction and custom HLA affinity binding predictions were performed. Results: An average of 52 somatic mutations per patient (range: 2-172) were identified. At least one high quality TSMA was predicted for 57 of 58 patients. Five or more TSMA candidates were identified for 52 (90%) patients with a mean of 17 predicted peptides per patient (range: 0-45). 81% (813/1,004) of the total predicted TSMA peptides arose from missense mutations, 9% (94/1,004) from indels, and 10% (97/1,004) from BCR. 78% (45/58) of patients have both somatic and BCR vaccine candidates, while 21% (12/58) of patients had only somatic vaccine candidates. Predicted TSMAs were identified in multiple genes recurrently mutated in lymphoma (e.g., BCL2). There was a high prediction concordance with the orthogonal BostonGene Vaccine Module V1 pipeline. These pre-clinical results led to a first-in-human pilot trial of personalized TSMA vaccine combined with anti-PD-1 mAb for rel/ref FL patients (NCT03121677), with one response observed within 4 patients evaluable for response to date. Conclusions: TSMA peptides suitable for cancer vaccines were identified for most FL patients via next-generation sequencing, MiXCR and pVACtools. This pre-clinical study suggests that FL patients will be candidates for TSMA vaccine clinical trials and pilot clinical results provide proof of concept for this approach.
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Burden, Eleanor G., Timothy J. Batten, Christopher D. Smith, and Jonathan P. Evans. "Reverse total shoulder arthroplasty." Bone & Joint Journal 103-B, no. 5 (May 1, 2021): 813–21. http://dx.doi.org/10.1302/0301-620x.103b.bjj-2020-2101.

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Aims This systematic review asked which patterns of complications are associated with the three reverse total shoulder arthroplasty (RTSA) prosthetic designs, as classified by Routman et al, in patients undergoing RTSA for the management of cuff tear arthropathy, massive cuff tear, osteoarthritis, and rheumatoid arthritis. The three implant design philosophies investigated were medial glenoid/medial humerus (MGMH), medial glenoid/lateral humerus (MGLH), and lateral glenoid/medial humerus (LGMH). Methods A systematic review of the literature was performed via a search of MEDLINE and Embase. Two reviewers extracted data on complication occurrence and patient-reported outcome measures (PROMs). Meta-analysis was conducted on the reported proportion of complications, weighted by sample size, and PROMs were pooled using the reported standardized mean difference (SMD). Quality of methodology was assessed using Wylde’s non-summative four-point system. The study was registered with PROSPERO (CRD42020193041). Results A total of 42 studies met the inclusion and exclusion criteria. Rates of scapular notching were found to be significantly higher in MGMH implants (52% (95% confidence interval (CI) 40 to 63)) compared with MGLH ((18% (95% CI 6 to 34)) and LGMH (12% (95% CI 3 to 26)). Higher rates of glenoid loosening were seen in MGMH implants (6% (95% CI 3 to 10)) than in MGLH implants (0% (95% CI 0 to 2)). However, strength of evidence for this finding was low. No significant differences were identified in any other complication, and there were no significant differences observed in PROMs between implant philosophies. Conclusion This systematic review has found significant improvement in PROMS and low complication rates across the implant philosophies studied. Scapular notching was the only complication found definitely to have significantly higher prevalence with the MGMH implant design. Cite this article: Bone Joint J 2021;103-B(5):813–821.
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Salvagno, Gian, Brandon Henry, Laura Pighi, Nitto de, and Giuseppe Lippi. "Total anti-SARS-CoV-2 antibodies measured 6 months after Pfizer-BioNTech COVID-19 vaccination in healthcare workers." Journal of Medical Biochemistry 41, no. 2 (2022): 199–203. http://dx.doi.org/10.5937/jomb0-33999.

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Background: This study aimed at monitoring the kinetics of serum total anti-SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies in a cohort of healthcare workers after voluntary vaccination with Pfizer-BioNTech coronavirus disease 2019 (COVID-19) mRNA-based vaccine. Methods: The study population consisted of 787 healthcare workers (mean age 44±12 years; 66% females), who received two 30 mg doses of Pfizer-BioNTech COVID-19 vaccine, 3 weeks apart. Venous blood was drawn before the first vaccine dose, immediately before the second vaccine dose, and then at 1, 3 and 6 months after the second vaccine dose. Serological testing employed the total antiSARS-CoV-2 antibodies measurement with Roche Elecsys Anti-SARS-CoV-2 S chemiluminescent immunoassay. Results: The median serum levels of total anti-SARS-CoV-2 antibodies reached the peak (1762 kU/L) 1 month after the second vaccine dose, but tended to progressively decline at the 3-month (1086 kU/L) and 6-month (802 kU/L) follow-up points. Overall, the values after 3and 6months were 37% and 57% lower than the corresponding concentrations measured at the peak. No healthcare worker had total anti-SARS-CoV-2 antibodies below the method-dependent cut-off after 6 months. The decline compared to the peak was more accentuated in baseline seropositive persons than in those who were baseline seronegative (74% vs. 52%) cohort. The 6-month post-vaccination anti-SARS-CoV-2 antibodies in subjects aged <65 years remained over 2-fold higher than in those aged ≥65 years (813 vs. 343 kU/L) and also remained consistently higher in women than in men. Conclusions: Gradual decline of total anti-SARS-CoV-2 antibodies occurred 6 months after Pfizer-BioNTech COVID-19 vaccination, though values remained higher than the method-dependent cut-off, with no case of sero-negativization.
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Kodagali, Rohit, Sudeep Gupta, Senthill J. Rajappa, Suresh Hariram Advani, Amit Agarwal, Shyam Aggarwal, Chanchal Goswami, Palanki Satya Dattatreya, Devavrat Arya, and Shekhar Patil. "A non-interventional, multicenter study to assess prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal, and fallopian tube cancer patients in India." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): e13073-e13073. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e13073.

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e13073 Background: BRCA1 and BRCA2 are tumour suppressor genes.1,2 Functional BRCA proteins regulate cell growth and prevent abnormal cell division that might lead to tumour development. Approximately 17% (Range 3 – 27 %) of ovarian cancer patients worldwide have a BRCA mutation.3 This study aimed to estimate the prevalence of germline BRCA mutations among previously and newly diagnosed ovarian, primary peritoneal or fallopian tube cancer patients in India. Methods: This is a non-interventional, cross-sectional, multicenter, prospective, observational study conducted at 15 sites from different geographical regions across India. The study targets to enroll 240 patients over 6 months. The calculated sample size for this study is 228, assuming 5 % precision and a dropout rate of 10 %. The study enrolled females with new or previous diagnosis of ovarian, primary peritoneal, or fallopian tube cancer. No study medication was administered as a part of study procedure. Results: In the interim analysis performed on the first 100 enrolled patients, 22% of Ovarian, primary peritoneal or fallopian tube cancer patients were found to be BRCA1/BRCA2 mutation positive (CI 0.1433-0.3139). 52% of these enrolled patients were found to have serous histopathology, 23.1% of which were found to be BRCA1/2 positive. The percentage of BRCA1/2 mutation status in patients who had a family history of ovarian or breast cancer was found to be 66.7% and 62.5% respectively. Conclusions: In this study, the prevalence of BRCA1 and BRCA2 mutations among patients with ovarian, primary peritoneal and fallopian tube cancer patients in the first 100 patients enrolled was found to be 22%. References: 1. Vos S, et al. Crit Rev Oncol Hematol. 2018 Jul;127:29-41; 2. Solodskikh SA et al. Mutat Res. 2019 Jan;813:51-57; 3. Alsop K, et al. J Clin Oncol. 2012;30(21):2655-2663.
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McGinn, Thomas A. J. "The XII Tables, the Decemvirate, and modern scholarship - DONATELLA MONTEVERDI, LA QUESTIONE DECEMVIRALE: ITINERARI E RISULTATI DI UNA COMPLESSA VICENDA STORIOGRAFICA (Wolters Kluwer CEDAM; Milano2019). Pp. xxviii + 526. ISBN 978-8-813-36883-8. EUR. 52." Journal of Roman Archaeology 33 (2020): 505–7. http://dx.doi.org/10.1017/s1047759420000033.

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McCaffrey, Kathryn, Matthew Fisher, Lucie Kutikova, Lee Bowman, Andrew Evens, Leo Gordon, Heather Auto, and Charles Bennett. "Comparison of Out-of-Pocket Costs for Patients (pts) with Hodgkin’s Disease (HD), Indolent Non-Hodgkin’s Lymphoma (INHL) and Aggressive Non-Hodgkin’s Lymphoma (ANHL)." Blood 106, no. 11 (November 16, 2005): 2241. http://dx.doi.org/10.1182/blood.v106.11.2241.2241.

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Abstract Background We report preliminary results from an ongoing study on the out-of-pocket costs (costs incurred by a pt as a result of treatment and illness of cancer that are not covered by healthcare insurance) for a cohort of lymphoma pts. How out-of-pocket costs vary according to demographics such as household income and education were reported previously. Herein, we explore two clinical factors that may influence out-of-pocket costs. We compare costs for HD, INHL and ANHL by time since diagnosis (Dx) and treatment type (with or without rituximab) for NHL. Methods Lymphoma pts provided information on out-of-pocket costs for 3-month periods before and after lymphoma Dx. Difference between these costs was calculated. From current sample of 56 pts, 4 outliers with high costs preceding lymphoma Dx were excluded. Direct medical costs are costs related to medical care such as medications, procedures and doctor visits. Direct non-medical costs are peripheral costs related to cancer such as costs for meals, transportation, childcare, and phone calls. Dx date and treatment data were abstracted from pt medical charts. Results The majority of lymphoma pts were < 65 years old (76%), married (65%), and employed (58%). All pts were undergoing active treatment and had healthcare insurance coverage, with the majority insured with private plans (81%). 21% of pts were relapse pts; 25% of pts had stage I–II lymphoma, 44% had stage III–IV, and 31% had unknown stage. Median monthly total out-of-pocket costs for all lymphoma types were $374. Direct medical costs for HD pts were 1.9 and 1.1-fold higher than for INHL and ANHL pts, respectively. Direct non-medical costs were highest for ANHL. Total costs for NHL pts ≤ 3 months since Dx were 3.3-fold higher than for pts > 3 months since Dx, which was consistent by NHL subtype. Total costs for NHL pts undergoing treatment without rituximab were 3.5-fold higher than costs for pts with rituximab. Conclusion The median monthly out-of-pocket costs were greatest for HD ($457), followed by ANHL ($434) and INHL ($247), and were primarily driven by costs related to medical care. For NHL pts, factors associated with high costs included ≤ 3 months since Dx ($681) and treatment without rituximab ($813). It is important to consider the costs to individual pts to ensure more comprehensive economic analyses of cancer. Median Monthly Out-of-Pocket Costs N Direct Medical Cost $ (range) Direct Non-Medical Cost $ (range) Total Cost $ (range) *Dx date not confirmed for 1 NHL pt All Pts 52 271 (−67–3545) 50 (−56–850) 374 (0–3775) HD 15 311 (−67–3203) 27 (−56–410) 457 (0–3365) ≤ 3 months since Dx 5 308 (−67–2033) 20 (−56–175) 328 (67–2048) > 3 months since Dx 10 372 (0–3203) 94 (0–410) 561 (0–3365) NHL 37 225 (−33–3545) 50 (0–850) 286 (10–3775) INHL 17 145 (−33–1928) 40 (0–850) 247 (10–2043) ANHL 20 283 (−32–3545) 111 (0–600) 434 (30–3775) + Rituximab 29 145 (−33–3545) 45 (0–600) 232 (10–3775) − Rituximab 8 549 (100–850) 138 (28–850) 813 (137–1700) ≤ 3 months since Dx 12 458 (42–3545) 108 (0–383) 681 (42–3775) > 3 months since Dx 24* 141 (−33–2650) 42 (0–850)208 (10–3250)
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Fernández-García, Silvia, Laura del Campo-Albendea, Dharshini Sambamoorthi, Jameela Sheikh, Karen Lau, Nana Osei-Lah, Anoushka Ramkumar, et al. "Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis." BMJ Global Health 9, no. 4 (April 2024): e014247. http://dx.doi.org/10.1136/bmjgh-2023-014247.

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ObjectiveTo assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes.DesignSystematic review and meta-analysis.Data sourcesMajor databases between December 2019 and January 2023.Study selectionNine pairs of reviewers contributed to study selection. We included test-negative designs, comparative cohorts and randomised trials on effects of COVID-19 vaccines on infection-related and pregnancy outcomes. Non-comparative cohort studies reporting reactogenicity outcomes were also included.Quality assessment, data extraction and analysisTwo reviewers independently assessed study quality and extracted data. We undertook random-effects meta-analysis and reported findings as HRs, risk ratios (RRs), ORs or rates with 95% CIs.ResultsSixty-seven studies (1 813 947 women) were included. Overall, in test-negative design studies, pregnant women fully vaccinated with any COVID-19 vaccine had 61% reduced odds of SARS-CoV-2 infection during pregnancy (OR 0.39, 95% CI 0.21 to 0.75; 4 studies, 23 927 women; I2=87.2%) and 94% reduced odds of hospital admission (OR 0.06, 95% CI 0.01 to 0.71; 2 studies, 868 women; I2=92%). In adjusted cohort studies, the risk of hypertensive disorders in pregnancy was reduced by 12% (RR 0.88, 95% CI 0.82 to 0.92; 2 studies; 115 085 women), while caesarean section was reduced by 9% (OR 0.91, 95% CI 0.85 to 0.98; 6 studies; 30 192 women). We observed an 8% reduction in the risk of neonatal intensive care unit admission (RR 0.92, 95% CI 0.87 to 0.97; 2 studies; 54 569 women) in babies born to vaccinated versus not vaccinated women. In general, vaccination during pregnancy was not associated with increased risk of adverse pregnancy or perinatal outcomes. Pain at the injection site was the most common side effect reported (77%, 95% CI 52% to 94%; 11 studies; 27 195 women).ConclusionCOVID-19 vaccines are effective in preventing SARS-CoV-2 infection and related complications in pregnant women.PROSPERO registration numberCRD42020178076.
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Matei, Daniela, Virginia L. Filiaci, Marcus Randall, Margaret Steinhoff, Paul DiSilvestro, Katherine M. Moxley, Byoung Kim, et al. "A randomized phase III trial of cisplatin and tumor volume directed irradiation followed by carboplatin and paclitaxel vs. carboplatin and paclitaxel for optimally debulked, advanced endometrial carcinoma." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 5505. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.5505.

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5505 Background: Patients with stage III/IVA uterine cancer (UC) carry high risk of systemic and local recurrence. Chemotherapy was shown to reduce systemic recurrence, however the risk of local failure remains high. Methods: The primary endpoint of this open label, randomized phase III trial was to determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (C-RT, experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival, RFS) when compared to carboplatin and paclitaxel for 6 cycles (CT, control arm) in patients with stages III-IVA (<2 cm residual disease) or FIGO 2009 stage I/II serous or clear cell UC and positive cytology. Secondary objectives were assessment of overall survival (OS), acute and late toxicities, and quality of life. A 28.5% reduction in the rate of recurrence or death was considered significant. Treatment randomization and analysis were stratified by gross residual tumor and age. Results: Between 6/2009 and 7/2014, 813 patients were enrolled and randomized (407 C-RT and 406-CT). Of those, 733 were eligible (344 C-RT and 360 CT), and 680 received the trial intervention (333 C-RT and 347 CT). Median follow up is 47 months. Patients characteristics were balanced between arms. There were 201 (58%) > grd 3 toxicity events in the C-RT arm and 227 (63%) in the CT arm. The most common > grd 3 events were myelosupression (40% vs. 52%), gastrointestinal (13% vs. 4%), metabolic (15% vs. 19%), neurological (7% vs. 6%), infectious (4% vs. 5%). Treatment hazard ratio for RFS was 0.9 (C-RT vs. CT; CI 0.74 to 1.10). C-RT reduced the incidence of vaginal (3% vs. 7%, HR = 0.36, CI 0.16 to 0.82), pelvic and paraaortic recurrences (10% vs. 21%, HR=0.43, CI 02.8 to 0.66) compared to CT, but distant recurrences were more common with C-RT vs. CT (28% vs. 21%, HR 1.36, CI 1 to 1.86). The analysis is premature for OS comparison. Conclusions: Although C-RT reduced the rate of local recurrence compared to CT; the combined modality regimen did not increase RFS in optimally debulked, stage III/IVA UC. Clinical trial information: NCT00942357.
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Souza, Gregory Lauar, Rhayssa Fernanda de Andrade Rocha, Andressa Do nascimento Silveira, Handerson Dias Duarte de Carvalho, Cristóvão D. M. Oliveira, Edna M. M. Leite, Estevão Urbano Silva, Lucca G. Giarola, Bráulio R. G. M. Couto, and Carlos E. F. Starling. "2475. Incidence of Multidrug-Resistant, Extensively Drug-Resistant and Pandrug-Resistant Gram-Negative Bacteria in Brazilian Intensive Care Units." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S857. http://dx.doi.org/10.1093/ofid/ofz360.2153.

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Abstract Background The Centers for Disease Control and Prevention (CDC) proposed standard definitions for acquired resistance in bacterias. Resistant bacteria were categorized as multidrug-resistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR). This study describes the incidence of Gram-negative MDR, XDR and PDR in 12 private and adult intensive care units (ICU’s) from Belo Horizonte, Minas Gerais, the sixth most populated city in Brazil, with approximately 3 million inhabitants. Methods Data were collected between January/2013 to December/2017 from 12 ICU’s. The hospitals used prospective healthcare-associated infections (HAI) surveillance protocols, in accordance to the CDC. Antimicrobial resistance from six Gram-negatives, causing nosocomial infections, were evaluated: Acinetobacter sp., Klebsiella sp., Proteus sp., Enterobacter sp., Escherichia coli, and Pseudomonas sp.. We computed the three categories of drug-resistance (MDR+XDR+PDR) to define benchmarks for the resistance rate of each Gram-negative evaluated. Benchmarks were defined as the superior limits of 95% confidence interval for the resistance rate. Results After a 5 year surveillance, 6,242 HAI strains were tested: no pandrug-resistant bacteria (PDR) was found. Acinetobacter sp. was the most resistant Gram-negative: 206 strains from 1,858 were XDR (11%), and 1,638 were MDR (88%). Pseudomonas sp.: 41/1,159 = 3.53% XDR; 180/1,159 = 15.53% MDR. Klebsiella sp.: 2/1,566 = 0,1% XDR; 813/1,566 = 52% MDR. Proteus sp.: 0/507 = 0% XDR; 163/507 = 32% MDR. Enterobacter sp.: 0/471 = 0% XDR; 148/471 = 31% MDR. Escherichia coli: 0/681 = 0% XDR; 157/681 = 23% MDR. Benchmarks for the global resistance rate of each Gram-negative (MDR+XDR+PDR): Acinetobacter sp. = 92%; Klebsiella sp. = 62%; Proteus sp. = 40%; Enterobacter sp. = 48%; Escherichia coli = 33%; Pseudomonas sp. = 30%. Conclusion This study has calculated the incidence of Gram-negative MDR, XDR and PDR, and found a higher incidence of MDR Acinetobacter sp., with an 88% multiresistance rate. Henceforth, developing countries healthcare institutions must be aware of an increased risk of infection by Acinetobacter sp.. Benchmarks have been defined, and can be used as indicators for healthcare assessment. Disclosures All authors: No reported disclosures.
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Asenova, Svetlana, Ulrike Bacher, Andreas Gerritzen, Axel R. Zander, and Nicolaus Kröger. "Role of Free Light Chain Assay Ratio to Distinguish Between CR According EBMT Criteria or Stringent Complete Remission (sCR) According IMWG in Multiple Myeloma Patients." Blood 114, no. 22 (November 20, 2009): 1787. http://dx.doi.org/10.1182/blood.v114.22.1787.1787.

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Abstract Abstract 1787 Poster Board I-813 Introduction The qualitative assay for free light chain has been reported to be sensitive and specific for detecting and monitoring diseases caused by monoclonal gammopathies such as multiple myeloma. More recently the International Myeloma Working Group proposed uniform response criteria including a new definition of stringent complete remission (sCR). The definition of stringent complete remission requires beside absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence also normalization of free light chain ratio in serum. Patients and Methods We evaluate the value of free light chain assay to determine stringent CR by monitoring 87 patients with multiple myeloma who achieved complete remission (n=52) or very good partial remission (n=35) between January 2003 and December 2008. Free light chain measurements were performed with the commercially available Free liteTM Kit (Binding Site, Heidelberg, Germany). Because of the shorter half-life of free light chain assay ratio, only patients were included, if the complete or very good partial remission remains stable for at least 3 months. The comparison between immunofixation and free light chain ratio was performed at least 6 weeks after immunofixation becomes negative for the first time. 87 patients (50 mal and 37 female) were included, 67 had intact immunoglobulin and 11 had light chain immunoglobulin at time of diagnosis. The remission status was determined either after allogeneic (n = 73) or autologous (n = 7) stem cell transplantation or after conventional bortezomib or lenalidomide containing chemotherapy (n = 7). Results 35 out of 87 patients achieved a very good partial or near complete remission with still positive immunofixation. In 22 out of those 35 patients the free light chain kappa ratio was within the normal range of 0.26 – 1.65 mg/l (63 %). Only in 13 patients with persistent immunofixation positivity the free light chain ratio was outside the normal range (37%). 52 patients achieved complete remission according to the EBMT criteria with negative immunofixation for at least 3 months. In those patients all (100 %) had a normal free light chain kappa/lambda ratio. In a subgroup of patients (n = 10) who relapsed during follow-up from complete remission sequential monitoring of immunofixation and free light assay was performed as recently described [4]. In 9 out of 10 patients a free light chain ratio became abnormal at a median 90 days before immunofixation became positive. Conclusions The free light chain assay ratio is a useful marker for a faster detection of remission or progression in myeloma patients. However, these results do not support additional value of free light chain ratio to determine the depth of remission in immunofixation negative patients. More sensitive methods such as imunophenotyping analysis by FACS or molecular primer should be used to determine depth of complete remission since these methods have shown relevant clinical impact. Disclosures No relevant conflicts of interest to declare.
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Giri, Upama, Eric Vick, Sophia SeoHyeon Lee, Alaa Altahan, Noam Avraham VanderWalde, Paxton Vandiver Dickson, Jeremiah Lee Deneve, and Michael Gary Martin. "Survival outcomes for various treatment modalities in early-stage grade 3 follicular lymphoma (FL3): a National Cancer Database (NCDB) study." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 7551. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.7551.

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7551 Background: The prognosis, response to therapy and curability of FL3 is controversial. 5-year Overall Survival (OS) in the literature ranges from 35-72% (Ganti 2006). The aim of this study was to compare the OS for patients with early-stage FL3 managed with single- and multi-agent chemotherapy (CT) with and without radiotherapy (RT). Methods: We identified patients (pts) diagnosed with stage I & II FL3 between 2004 – 2012 from the NCDB and categorized into 3 groups based on therapy – pts given single agent CT with or without RT were combined due to small sample sizes (SA±RT), multi-agent CT without RT (MA-RT), and multi-agent CT with RT (MA+RT). We calculated OS for each group using Kaplan-Meier method and compared the results using Log Rank test. Cox regression model was used to identify factors which had significant impact on OS. Results: 1,563 pts were identified – 827 (53%) with stage I and 736 (47%) with stage II FL3. Median age was 61 yrs (range 18-90yrs); 750 (48%) males, 813 (52%) females; 1423 (91%) whites, 76 (5%) blacks. 112 (7%) received SA±RT, 886 (57%) MA-RT and 565 (37%) MA+RT. 5-year OS for MA+RT (95%) was significantly more than MA-RT (87%; HR 0.33, P<0.001) or SA±RT (88%; HR 0.38, P=0.007). Cox regression indicated that age (HR 1.05, P<0.001), sex (HR 0.66 for females, P=0.02), comorbidities (HR 1.60 for Charlson Deyo Score 1, P=0.04; HR 3.07 for Score 2, P=0.001), stage (HR 1.79, P=0.001), insurance status (HR 0.22 for insured, P<0.001) and increasing year of diagnosis (HR 0.92, P=0.03) also had significant impact on OS. Median radiation dose for the MA+RT was 36Gy (interquartile range 30.6 – 36Gy), and the proportion of patients who received greater than 36Gy decreased from 55% in 2004 to 38% in 2012 and at the same time, the proportion of patients who received intensity modulated RT increased from 5% in 2004 to 15% in 2012. Use of MA CT declined (2004 95% v 2012 89%, P=0.02) but there was no significant trend in use of RT (2004 39% v 2012 34%) during the periods studied. Conclusions: For pts with early-stage FL3, there was an association of improved survival with the use of MA+RT over other treatment strategies and appear to have outcomes superior to what has been previously reported.
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Song, H., H. Wei, M. Zhang, L. Wu, Z. Wu, C. Aichun, B. Wang, et al. "FRI0593 CORRELATION BETWEEN DISEASE ACTIVITY AND MENTAL HEALTH OF AS PATIENTS: A CROSS-SECTION STUDY WITH SELF-ASSESSMENTS BASED ON SMART SYSTEM OF DISEASE MANAGEMENT (SSDM) MOBILE TOOLS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 902.1–902. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1774.

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Background:WHO survey showed that the prevalence of anxiety and depression in Chinese population and Chinese patients with chronic diseases were between 3.1% - 4.2% and 3.1% - 7.3%, respectively. Ankylosing Spondylitis Disease Activity Score (ASDAS) and Hospital Anxiety and Depression Scale (HADS) are commonly used to evaluate AS patients’ disease activity and mental health. All those assessments were mainly performed by health professionals (HCPs) with paper questionnaire previously. SSDM is a novel smart disease management tool that allows patients to do self-assessments on ASDAS and HADS by mobile terminals.Objectives:To estimate the prevalence of anxiety and depression in Chinese patients with AS and to analyze the potential association between disease activity and mental health.Methods:Under the guidance and training by HCPs, AS patients downloaded SSDM and performed self-assessments bundle of ASDAS and HADS with SSDM. ASDAS<=1.3, 1.3-2.1, 2.1-3.5 and >3.5 are defined as inactive (IDA), moderate (MDA), high (HDA) and very high (VHDA) disease activity, respectively. ASDAS score <=1.3 represents inactive disease status and achievement of T2T. HADS score >=8 can be diagnosed with anxiety or depression.Results:From June 2016 to Jan 2020, 1,931 AS patients (1,118 male, 813 female) with a mean age of 34.09 ± 11.86 (12-82) years and the median disease duration of 2.61 years from 207 hospitals performed bundle self-assessments for 2,477 times in total. According to the HADS and ASDAS assessment results, the prevalence of anxiety and depression in all patients was 36.7% and 39.3% respectively, which was significantly higher than that in the WHO survey in Chinese population and chronic disease patients. The proportion of patients achieved and failed on T2T was 29% and 71%, respectively. The prevalence of anxiety (A) and depression (D) was 25% and 23% among T2T achievers; and 37% and 32% among T2T failures, respectively (pA<0.05, pD<0.05).According to ASDAS, in IDA, MDA, HDA and VHDA subgroups, the prevalence of anxiety and depression was 27%, 36%, 41%, 52% and 29%, 38%, 45%, 56%, respectively. The correlation coefficients of anxiety (A) and depression (D) with ASDAS were rA=0.9908 and rD=0.9964. It suggested that with the increase of disease activity, the proportion of AS patients with anxiety and depression increased significantly. (Figure 1)Figure 1.The prevalence of anxiety and depression according to ASDAS.Conclusion:The prevalence of anxiety and depression in AS patients was significantly higher than that in the WHO survey in Chinese population and chronic disease patients. Higher prevalence of anxiety and depression were associated with higher levels of disease activity. SSDM is an effective mobile interface to monitor and study entanglement of disease activity and mental health in AS patients, which build a foundation for proactive interventions in future.Acknowledgments:Smart system of disease management (SSDM) was developed by Shanghai Gothic Internet Technology Co., Ltd.Disclosure of Interests:None declared
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Abisror, N., Y. Nguyen, L. Marozio, E. Esteve-Valverde, S. Udry, D. E. Pleguezuelo, P. Billoir, et al. "AB0457 OBSTETRICAL OUTCOME AND TREATMENTS DURING PREGNANCY IN SERONEGATIVE PRIMARY APS: DATA FROM EUROPEAN RETROSPECTIVE STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1527.1–1527. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3537.

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Background:Objectives:To compare clinical characteristics, pregnancies, and treatments during pregnancies of seronegative and seropositive APS, and analyse factors associated with adverse obstetrical outcomes.Methods:Inclusion criteria were: (1) thrombotic arterial and/or venous; and /or obstetrical primary clinical APS (Sydney criteria); (2) absence of conventional antiphospholipid antibodies; (3) presence of at least one non-conventional APL among IgA ACL, IgA antiB2GPI, anti-vimentin G/M, anti-annexin V G/M, anti-PE G/M, anti-PS/PT G/M antibodies. The exclusion criteria were: (1) seropositive APS with conventional APS; (2) associated SLE or SLE like (SLE features and / or positive antinuclear autoantibodies); (3) other systemic connective tissue disease (Sjogren’s syndrome, systemic sclerosis, myositis).Results:187 women (mean 33±5 years) with seronegative APS were included from 12 centers in the world and compared to 285 patients with seropositive APS. Seronegative APS have mostly obstetrical phenotypes rather than venous thrombosis in comparison to seropositive APS. The maternal and fetal outcomes and the rates of live births were not significantly different in seronegative and seropositive APS, except for higher rates of intrauterine deaths (15% vs 5%; p=0.03) and lower live birth term (36±3 vs 38±3 weeks of gestation; p=0.04) in the seropositive APS group. The cumulative incidence of adverse obstetrical events was significantly improved in treated seronegative APS vs untreated ones (log rank<0.05), whereas there was no difference between patients who received aspirin or aspirin-LMWH combinationConclusion:Patients with clinical manifestations of APS without conventional APL should undergo testing for non-criteria APL. The diagnosis of seronegative APS could be important for a better care of these patients.Table 1.Characteristics of seronegative and seropositive APS women.Seronegative APSN=187Seropositive APSN=285APS featuresThrombotic APS Arterial APS (n;%)0105 (37)* Venous APS (n;%)9 (6)154 (54)*Obstetrical APS (n;%)168 (89)89 (31)*Mix APS (n;%)8 (4)16 (6)Non criteria features (n;%)16 (9)141 (49)*Obstetrical history Miscarriages (n;%)66 (35)18 (6)* Intrauterine deaths (n;%)60 (32)46 (16)* Prematurity <34 wg (n;%)43 (23)31 (11)*Table 2.Pregnancy outcome and treatment in seronegative and seropositive APS.Seronegative APS pregnanciesN=108Seropositive APS pregnanciesN=75Thrombotic APS Arterial APS (n;%)020 (27)* Venous APS (n;%)8 (7)42 (56)*Obstetrical APS (n;%)93 (86)36 (48)*Mix APS (n;%)6 (6)18 (24)Aspirin (n;%) / Aspirin alone95 (88) / 32 (30)57 (76)* / 2 (3)*LMWH isocoagulant amounts (n;%)63 (58)39 (52)Aspirin-LMWH (n;%)65 (60)55 (73)Preeclampsia/HELLP syndrome (n;%)7 (7)12 (16)*IUGR (n;%)5 (5)7 (10)Fetal loss (n;%)33 (31)22 (29)Miscarriage / Intrauterine deaths23 (21) / 5 (5)11 (15) / 11 (15)*Prematurity<34 weeks of gestation (n;%)6 (6)9 (12)Term of fetal loss (weeks gestation)10±813±7Live births (n;%)75 (69)53 (70)Term of live birth (weeks gestation)38±336±3*Disclosure of Interests: :None declared
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Cho, Seongkoo, Steven F. Buchsbaum, Monika M. Biener, Justin T. Jones, and Roger Qiu. "The Importance of Electrochemically Active Surface Area in the Corrosion Behavior of Additively Manufactured 316L Stainless Steel." ECS Meeting Abstracts MA2022-01, no. 16 (July 7, 2022): 1015. http://dx.doi.org/10.1149/ma2022-01161015mtgabs.

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Surfaces of additively manufactured (AM) stainless steel (SS) by fusing metallic powders are known to be much rougher than those produced by conventionally fabrication methods. The measured surface roughness (Sa or Sq) can range from a few to tens of microns depending on the build angle. Recent studies have shown that the large surface roughness associated with printing conditions makes the AM SS surfaces susceptible to localized corrosion and open-circuit corrosion [1, 2]. Sa or Sq have also long been used to characterize the corrosion behavior of traditionally manufactured metals [3]. However, the open-circuit corrosion rate of the traditional metals has been mainly studied in the submicron-scale surface roughness, and some results have showed that changes in the roughness of hundreds of nanometers or more have little effect on the change in the corrosion rate [4]. In addition, when applied to AM materials, no consistent correlation between the pitting breakdown potential (Eb) and surface roughness has been observed. In this study, the dependence of the corrosion behavior on the electrochemically active surface area of AM 316L SS, defined as the total area of the curvilinear surface that is exposed to the electrolyte, has been explored. The localized corrosion susceptibility was evaluated under full immersion in 3.5 wt% NaCl solution through potentiodynamic polarization for testing articles with different surface roughness. While no correlation to Sa or Sq was displayed, the Eb values showed a clear statistical trend with respect to the electrochemically active surface area: the lager the active surface area, the smaller the Eb. The observed correlation fits well with a previously reported stochastic pitting model on metal surfaces [5]. In addition, by normalizing linear polarization resistance and electrochemical impedance spectra with the electrochemically active surface area, it can be confirmed that the as-printed surface roughness of AM 316L SS did not have a significant effect on the change of the open-circuit corrosion phenomenon under static immersion conditions. Our results suggest that electrochemically active surface area is an appropriate parameter to characterize the corrosion behavior of AM metal surfaces. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. References 1. Melia, M.A., et al., How build angle and post-processing impact roughness and corrosion of additively manufactured 316L stainless steel. Npj Materials Degradation, 2020. 4(1). 2. Ni, C., Y. Shi, and J. Liu, Effects of inclination angle on surface roughness and corrosion properties of selective laser melted 316L stainless steel. Materials Research Express, 2019. 6(3). 3. Walter, R. and M.B. Kannan, Influence of surface roughness on the corrosion behaviour of magnesium alloy. Materials & Design, 2011. 32(4): p. 2350-2354. 4. Li, W. and D.Y. Li, Influence of surface morphology on corrosion and electronic behavior. Acta Materialia, 2006. 54(2): p. 445-452. 5. Shibata, T., 1996 W R Whitney Award lecture: Statistical and stochastic approaches to localized corrosion. Corrosion, 1996. 52(11): p. 813-830.
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Kohl, D. M., R. L. Monson, L. E. Enwall, and J. J. Rutledge. "187 INCREASED NUMBER OF EXPANDED BOVINE BLASTOCYSTS IN SOF AND CR1 RELATIVE TO KSOM." Reproduction, Fertility and Development 19, no. 1 (2007): 210. http://dx.doi.org/10.1071/rdv19n1ab187.

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Assessment of morphological stage grade is a subjective procedure. Stage grade is of vital importance to, among other things, recipient synchrony for the purpose of establishing successful pregnancies. Asynchronous embryo transfer has led to decreases in pregnancy rates (Farin et al. 1995 Biol. Reprod. 52, 676–682) and has been implicated in contributing to large offspring syndrome (Young et al. 1996 Theriogenology 45, 231). Differences in embryo kinetics based on culture conditions have been well documented (Mello et al. 2005 Reprod. Fert. Dev. 17, 221 abst). Whether such differences are the result of species, breed, metabolic stress, sire effects, or separation from an in vivo environment has yet to be determined. The correlation between oxygen respiration rates and embryo morphology as well as embryo diameter in bovine embryos produced in vitro has shown promise in the development of a more objective predictor of embryo quality and perhaps pregnancy initiation (Lopes et al. 2005 Reprod. Fert. Dev. 17, 151 abst). As well, recent examination of gene expression patterns of in vitro-derived bovine embryos seems to indicate that longer periods of in vitro culture are associated with lower rates of embryo survival (Lonergan et al. 2006 Theriogenology 65, 137–152). We hypothesize that differences do exist in the number, rate, and morphological appearance of blastocysts and that these parameters are in large part based on culture conditions in vitro. The objective of this experiment was to determine the timing and distribution of blastocyst formation of in vitro-produced bovine embryos cultured in SOF8, CR18AA, and KSOM8, under a standard incubation environment. Bovine ovaries from a local abattoir were aspirated and matured for 18-22. Oocytes were fertilized with frozen-thawed Percoll-separated semen from a Holstein bull. Presumptive zygotes were vortexed to remove cumulus cells and placed into 3 different culture media in a highly humidified atmosphere containing 20% oxygen, 5% carbon dioxide, and compressed air at 38.5�C. Embryos were evaluated specifically at 168 h post-insemination (Day 7) and assigned a morphological stage grade (IETS) to determine fixed time point differences. A total of 6 complete replicates were performed. Only embryos exhibiting the presence of a blastocoel at this time were documented (early blast, mid-blast, expanded blast). At 168 h post-insemination, there were no significant differences in the total number of embryos reaching early or mid-blast stage in any of the media. However, chi-square analysis revealed an increase in the number of expanded blastocysts in SOF (n = 813) and CR1 (n = 838) treatments compared to KSOM (n = 824; P &lt; 0.0001). Expanded blastocysts in SOF were also greater in number than in CR1 (P &lt; 0.05). Embryo selection based on development to the expanded blastocyst stage on Day 7 may prove useful in increasing pregnancy rates, and may validate qualitative correlations based on oxygen consumption and gene expression profiles for embryos produced in vitro.
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Connell, Nathan T., and Joseph D. Sweeney. "Correlation Of ADAMTS13 Activity With Baseline Characteristics and Management Patterns In Patients With Suspected Thrombotic Thrombocytopenic Purpura In The State Of Rhode Island." Blood 122, no. 21 (November 15, 2013): 3556. http://dx.doi.org/10.1182/blood.v122.21.3556.3556.

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Abstract Introduction While the activity level of ADAMTS13 can be helpful in diagnosing patients with thrombotic thrombocytopenic purpura (TTP), the current long turnaround time of this test for most institutions limits its role in early clinical decision-making about the initiation of plasma exchange. Levels of ADAMTS13<10% are pathognomonic of TTP and levels in excess of 10% indicate an alternate cause of thrombotic microangiopathy. The aim of the study was to look at recent practice in the State of Rhode Island regarding the criteria for initiation of plasma exchange with a subsequent categorization of those patients based on ADAMTS13 activity levels. Methods Patients with a diagnosis of TTP were identified from hospital records of the major hospitals in Rhode Island which perform therapeutic apheresis in calendar years 2011 and 2012. From a chart review and blood bank records, baseline clinical parameters were collected, the number of therapeutic plasma exchanges (TPE) performed and the volume of plasma utilized. Pre-treatment ADAMTS13 activity was recorded if available in addition to the number of days from the initiation of TPE to test result availability. An analysis was performed to examine if patients who had a pre-treatment ADAMTS13 activity level ≤10% differed in baseline characteristics or response to TPE from those with activity levels >10%. Based on the normality of the distribution of the data, independent t-tests or Wilcoxon rank-sum tests were performed using SAS version 9.3. Results During this two year period, 24 patients received plasma exchange in Rhode Island for a presumptive diagnosis of TTP. The mean age was 47 years (range 20-89 years) and 38% were male. ADAMTS13 activity was available for 20 patients and 7 (30% of those exchanged) had documented pre-treatment activity levels ≤10% consistent with TTP. The median turnaround time for the ADAMTS13 assay was 10 days (range 2-52). Mean baseline parameters at the time of presentation are shown in the table. As expected, creatinine levels were lower in those patients with true TTP (p=0.0410). ADAMTS13 activity level was predictive of the number of days to a platelet count ≥150 x 109/L (Pearson correlation 0.56; p-value 0.0458). Overall, 4238 units of plasma were utilized for exchange. Of these 4238 units, 1886 were transfused to patients who were subsequently shown to have an ADAMTS13 activity >10%, and 813 of the 1886 units (20% of all plasma exchanged) were transfused after the results of enzyme activity were available in this population. Conclusions Based on an ADAMTS13 >10%, a significant volume of plasma was unnecessarily transfused. Reducing the turnaround time for the ADAMTS13 assay in tertiary care centers could help clinicians better determine which patients will benefit from plasma exchange, avoiding the morbidity and expense associated with large volume plasma exchange. Disclosures: No relevant conflicts of interest to declare.
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32

Sangal, Rohit B., Huifeng Su, Hazar Khidir, Vivek Parwani, Beth Liebhardt, Edieal J. Pinker, Lesley Meng, Arjun K. Venkatesh, and Andrew Ulrich. "Sociodemographic Disparities in Queue Jumping for Emergency Department Care." JAMA Network Open 6, no. 7 (July 28, 2023): e2326338. http://dx.doi.org/10.1001/jamanetworkopen.2023.26338.

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ImportanceEmergency department (ED) triage models are intended to queue patients for treatment. In the absence of higher acuity, patients of the same acuity should room in order of arrival.ObjectiveTo characterize disparities in ED care access as unexplained queue jumps (UQJ), or instances in which acuity and first come, first served principles are violated.Design, Setting, and ParticipantsRetrospective, cross-sectional study between July 2017 and February 2020. Participants were all ED patient arrivals at 2 EDs within a large Northeast health system. Data were analyzed from July to September 2022.ExposureUQJ was defined as a patient being placed in a treatment space ahead of a patient of higher acuity or of a same acuity patient who arrived earlier.Main Outcomes and MeasuresPrimary outcomes were odds of a UQJ and association with ED outcomes of hallway placement, leaving before treatment complete, escalation to higher level of care while awaiting inpatient bed placement, and 72-hour ED revisitation. Secondary analysis examined UQJs among high acuity ED arrivals. Regression models (zero-inflated Poisson and logistic regression) adjusted for patient demographics and ED operational variables at time of triage.ResultsOf 314 763 included study visits, 170 391 (54.1%) were female, the mean (SD) age was 50.46 (20.5) years, 132 813 (42.2%) patients were non-Hispanic White, 106 401 (33.8%) were non-Hispanic Black, and 66 465 (21.1%) were Hispanic or Latino. Overall, 90 698 (28.8%) patients experienced a queue jump, and 78 127 (24.8%) and 44 551 (14.2%) patients were passed over by a patient of the same acuity or lower acuity, respectively. A total of 52 959 (16.8%) and 23 897 (7.6%) patients received care ahead of a patient of the same acuity or higher acuity, respectively. Patient demographics including Medicaid insurance (incident rate ratio [IRR], 1.11; 95% CI, 1.07-1.14), Black non-Hispanic race (IRR, 1.05; 95% CI, 1.03-1.07), Hispanic or Latino ethnicity (IRR, 1.05; 95% CI, 1.02-1.08), and Spanish as primary language (IRR, 1.06; 95% CI, 1.02-1.10) were independent social factors associated with being passed over. The odds of a patient receiving care ahead of others were lower for ED visits by Medicare insured (odds ratio [OR], 0.92; 95% CI, 0.88-0.96), Medicaid insured (OR, 0.81; 95% CI, 0.77-0.85), Black non-Hispanic (OR, 0.94; 95% CI, 0.91-0.97), and Hispanic or Latino ethnicity (OR, 0.87; 95% CI, 0.83-0.91). Patients who were passed over by someone of the same triage severity level had higher odds of hallway bed placement (OR, 1.01; 95% CI, 1.00-1.02) and leaving before disposition (OR, 1.02; 95% CI, 1.01-1.04).Conclusions and RelevanceIn this cross-sectional study of ED patients in triage, there were consistent disparities among marginalized populations being more likely to experience a UQJ, hallway placement, and leaving without receiving treatment despite being assigned the same triage acuity as others. EDs should seek to standardize triage processes to mitigate conscious and unconscious biases that may be associated with timely access to emergency care.
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Magnus, Dan, Santosh Bhatta, and Julie Mytton. "432 Establishing injury surveillance in emergency departments in Nepal: epidemiology and burden of paediatric injuries." Emergency Medicine Journal 37, no. 12 (November 23, 2020): 825.2–827. http://dx.doi.org/10.1136/emj-2020-rcemabstracts.7.

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Aims/Objectives/BackgroundGlobally, injuries cause more than 5 million deaths annually. Children and young people are a particularly vulnerable group and injuries are the leading cause of death in people aged 5–24 years globally and a leading cause of disability.In most low and middle-income countries where the majority of global child injury burden occurs, systems for routinely collecting injury data are limited. There is a continuing need for better data on childhood injuries and for injury surveillance.The aim of our study was to introduce a hospital-based injury surveillance tool – the first of its kind in Nepal and explore its feasibility. We undertook prospective collection of data on all injuries/trauma presenting to 2 hospital emergency departments to describe the epidemiology of paediatric hospital injury presentations and associated risk factors.Methods/DesignA new injury surveillance system for use in emergency departments in Nepal was designed and used to collect data on patients presenting with injuries. Data were collected prospectively in two hospitals 24 h a day over 12 months (April 2019 - March 2020) by trained data collectors using tablet computers.Abstract 432 Table 1Socio-demographic profile and characteristics of injury among children attending emergency of hospitals in Makwanpur district, Nepal, April 2019 – March 2020 (N=2696)CharacteristicsFrequencyGender Male 1778 Female 918 Age groups 0–4 years 653 5–9 years 866 10–14 years 680 15–17 years 497 Median year (IRQ) 8 (5 – 13) Ethnicity/caste Janajati 1384 Brahmin/Chhetri 892 Dalit 148 Madhesi 146 Muslim 74 Others 50 Unknown 2 Place where injury occurred Home/Compound 1576 Highway/road/street 636 School 233 Recreational area 138 Workplace 76 Other 37 Activities at the time injury occurred Leisure/Play 1889 Travelling (other than to/from school/work) 296 Work 202 Travelling (to/from school/work) 184 Education 42 Organised sports 11 Other 52 Unknown 20 Intent of injury Unintentional 2560 Intentional (self-harm) 61 Intentional (assault) 75 Unintentional (n=2560) Fall 912 Animal or insect related 728 Road traffic injury 356 Injured by a blunt force 201 Stabbed, cut or pierced 176 Fire, burn or scald 65 Poisoning 52 Suffocation/choking 36 Electrocution 12 Drowning and submersion 7 Other 13 Unknown 2 Self-harm (n=61) Poisoning 38 Hanging, strangulation, suffocation 12 Stabbed, cut or pierced 6 Injured by blunt object 4 Other 1 Assault (n=75) Bodily force (physical violence) 43 Injured by blunt object 18 Stabbed, cut or pierced 8 Pushing from a high place 2 Poisoning 2 Sexual assault 1 Other 1 Nature of injury (one most severe) Cuts, bites or open wound 1378 Bruise or superficial injury 383 Fracture 299 Sprain, strain or dislocation 243 Internal injury 124 Head Injury/Concussion 83 Burns 67 Other 115 Unknown 2 Not recorded 2 Severity of injury No apparent injury 125 Minor 1645 Moderate 813 Severe 111 Not recorded 2 Disposition Discharged 2317 Admitted to hospital 164 Transferred to another hospital 179 Died 21 Leave Against Medical Advice (LAMA) 11 Unknown 2 Not recorded 2 Note:Not recorded = missing cases95% CI calculated using one proportion test and normal approximation method in Minitab.Abstract 432 Table 2Distribution of injuries by age-group, sex and mechanism of injury among children attending emergency of hospitals in Makwanpur district, Nepal, April 2019 – March 2020Age groups & Sex0 - 4 years5 - 9 years10–14 years15–17 yearsMaleFemaleTotalIntent & mechanismsn (%)n (%)n (%)n (%)n (%)n (%)n (%)Unintentional Fall 239 (26.2) 328 (36.0) 249 (27.3) 96 (10.5) 636 (69.7) 276 (30.3) 912 (100) Animal or insect related 175 (24.0) 260 (35.7) 190 (26.1) 103 (14.1) 470 (64.6) 258 (35.4) 728 (100) Road traffic injury 49 (13.8) 108 (30.3) 86 (24.2) 113 (31.7) 223 (62.6) 133 (37.4) 356 (100) Injured by a blunt force 54 (26.9) 74 (36.8) 49 (24.4) 24 (11.9) 150 (74.6) 51 (25.4) 201 (100) Stabbed, cut or pierced 20 (11.4) 56 (31.8) 49 (27.8) 51 (29.0) 127 (72.2) 49 (27.8) 176 (100) Fire, burn or scald 42 (64.6) 10 (15.4) 9 (13.8) 4 (6.2) 27 (41.5) 38 (58.5) 65 (100) Poisoning 33 (63.5) 6 (11.5) 5 (9.6) 8 (15.4) 26 (50.0) 26 (50.0) 52 (100) Suffocation/choking 24 (66.7) 5 (13.9) 2 (5.6) 5 (13.9) 20 (55.6) 16 (44.4) 36 (100) Electrocution 2 (15.7) 0 (0.0) 3 (25.0) 7 (58.3) 10 (83.3) 2 (16.7) 12 (100) Drowning and submersion 1 (14.3) 1 (14.3) 3 (42.9) 2 (28.6) 3 (42.9) 4 (57.1) 7 (100) Other 6 (46.2) 4 (30.8) 3 (23.1) 0 (0.0) 10 (76.9) 3 (23.1) 13 (100) Unknown 2 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (100) 2 (100) Total 647 (25.3) 852 (33.3) 648 (25.3) 413 (16.1) 1702 (66.5) 858 (33.5) 2560 (100) Self-harm Poisoning 0 (0.0) 0 (0.0) 6 (15.8) 32 (84.2) 7 (18.4) 31 (81.6) 38 (100) Hanging 0 (0.0) 0 (0.0) 3 (25.0) 9 (75.0) 4 (33.3) 8 (66.7) 12 (100) Stabbed, cut or pierced 0 (0.0) 0 (0.0) 2 (33.3) 4 (66.7) 1 (16.7) 5 (83.3) 6 (100) Injured by blunt object 0 (0.0) 2 (50.0) 2 (50.0) 0 (0.0) 4 (100) 0 (0.0) 4 (100) Other 0 (0.0) 0 (0.0) 0 (0.0) 1 (100) 1 (100) 0 (0.0) 1 (100) Total 0 (0.0) 2 (3.3) 13 (21.3) 46 (75.4) 17 (27.9) 44 (72.1) 61 (100) Assault Bodily force (physical violence) 3 (7.0) 1 (2.3) 11 (25.6) 28 (65.1) 37 (86.0) 6 (14.0) 43 (100) Injured by blunt object 2 (11.1) 8 (44.4) 4 (22.2) 4 (22.2) 13 (72.2) 5 (27.8) 18 (100) Stabbed, cut or pierced 1 (12.5) 0 (0.0) 2 (25.0) 5 (62.5) 7 (87.5) 1 (12.5) 8 (100) Pushing from a high place 0 (0.0) 1 (50.0) 1 (50.0) 0 (0.0) 1 (50.0) 1 (50.0) 2 (100) Poisoning 0 (0.0) 1 (50.0) 0 (0.0) 1 (50.0) 1 (50.0) 1 (50.0) 2 (100) Sexual assault 0 (0.0) 0 (0.0) 1 (100) 0 (0.0) 0 (0.0) 1 (100) 1 (100) Other 0 (0.0) 1 (100) 0 (0.0) 0 (0.0) 0 (0.0) 1 (100) 1 (100) Total 6 (8.0) 12 (16.0) 19 (25.3) 38 (50.7) 59 (78.7) 16 (21.3) 75 (100) Abstract 432 Table 3Association of injury location, nature and severity with age among children attending emergency of hospitals in Makwanpur district, Nepal, April 2019 – March 2020Age groups0 – 4 years5 – 9 years10–14 years15–17 yearsTotalChi-SquareInjury characteristicsn (%)n (%)n (%)n (%)n (%)P valueLocation of injury sustained Home/Compound 537 (34.1) 504 (32.0) 319 (20.2) 216 (13.7) 1576 (100) <0.001 Highway/road/street 85 (13.4) 196 (30.8) 190 (29.9) 165 (25.9) 636 (100) School 15 (6.4) 107 (45.9) 85 (36.5) 26 (11.2) 233 (100) Recreational area 9 (6.5) 44 (31.9) 55 (39.9) 30 (21.7) 138 (100) Workplace 1 (1.3) 4 (5.3) 19 (25.0) 52 (68.4) 76 (100) Other 6 (16.2) 11 (29.7) 12 (32.4) 8 (21.6) 37 (100) Total 653 (24.2) 866 (32.1) 680 (25.2) 497 (18.4) 2696 (100) Nature of injury Cuts, bites or open wound 328 (23.8) 506 (36.7) 314 (22.8) 230 (16.7) 1378 (100) <0.001 Bruise or superficial injury 81 (21.1) 99 (25.8) 118 (30.8) 85 (22.2) 383 (100) Fracture 48 (16.1) 101 (33.8) 112 (37.5) 38 (12.7) 299 (100) Sprain, strain or dislocation 48 (19.8) 78 (32.1) 72 (29.6) 45 (18.5) 243 (100) Internal injury 44 (35.5) 8 (6.5) 18 (14.5) 54 (43.5) 124 (100) Head Injury/Concussion 18 (21.7) 26 (31.3) 18 (21.7) 21 (25.3) 83 (100) Burns 42 (62.7) 9 (13.4) 10 (14.9) 6 (9.0) 67 (100) Other 41 (35.7) 38 (33.0) 18 (15.7) 18 (15.7) 115 (100) Unknown 2 (100) 0 (0.0) 0 (0.0) 0 (0.0) 2 (100) Total 652 (24.2) 865 (32.1) 680 (25.2) 497 (18.4) 2694 (100) Severity of injury No apparent injury 39 (31.2) 45 (36.0) 26 (20.8) 15 (12.0) 125 (100) <0.001 Minor 419 (25.5) 535 (32.5) 406 (24.7) 285 (17.3) 1645 (100) Moderate 171 (21.0) 262 (32.2) 225 (27.7) 155 (19.1) 813 (100) Severe 23 (20.7) 23 (20.7) 23 (20.7) 42 (37.8) 111 (100) Total 652 (24.2) 865 (32.1) 680 (25.2) 497 (18.4) 2694 (100) Abstract 432 Table 4Association of injury location, nature and severity with sex among children attending emergency of hospitals in Makwanpur district, Nepal, April 2019 – March 2020SexMaleFemaleTotalChi-SquareInjury characteristicsn (%)n (%)n (%)P valueLocation of injury sustained Home/Compound 979 (62.1) 597 (37.9) 1576 (100) <0.001 Highway/road/street 421 (66.2) 215 (33.8) 636 (100) School 176 (75.5) 57 (24.5) 233 (100) Recreational area 111 (80.4) 27 (19.6) 138 (100) Workplace 62 (81.6) 14 (18.4) 76 (100) Other 29 (78.4) 8 (21.6) 37 (100) Total 1778 (65.9) 918 (34.1) 2696 (100) Nature of injury Cuts, bites or open wound 959 (69.6) 419 (30.4) 1378 (100) <0.001 Bruise or superficial injury 246 (64.2) 137 (35.8) 383 (100) Fracture 200 (66.9) 99 (33.1) 299 (100) Sprain, strain or dislocation 154 (63.4) 89 (36.6) 243 (100) Internal injury 50 (40.3) 74 (59.7) 124 (100) Head Injury/Concussion 59 (71.1) 24 (28.9) 83 (100) Burns 27 (40.3) 40 (59.7) 67 (100) Other 79 (68.7) 36 (31.3) 115 (100) Unknown 2 (100) 0 (0.0) 2 (100) Total 1776 (65.9) 918 (34.1) 2694 (100) Severity of injury No apparent injury 81 (64.8) 44 (35.2) 125 (100) 0.048 Minor 1102 (67.0) 543 (33.0) 1645 (100) Moderate 533 (65.6) 280 (34.4) 813 (100) Severe 60 (54.1) 51 (45.9) 111 (100) Total 1776 (65.9) 918 (34.1) 2694 (100) Abstract 432 Table 5Distribution of injuries by outcome and mechanism of injury among children attending emergency of hospitals in Makwanpur district, Nepal, April 2019 – March 2020Outcome of injuryDischargedAdmittedTransferredDiedLAMAUnknownTotalIntent & mechanismsn (%)n (%)n (%)n (%)n (%)n (%)n (%)Unintentional Fall 787 (86.5) 65 (7.1) 53 (5.8) 0 (0.0) 4 (0.4) 1 (0.1) 910 (100) Animal/insect bite/sting 704 (96.7) 3 (0.4) 19 (2.6) 0 (0.0) 1 (0.1) 1 (0.1) 728 (100) Road traffic injury 260 (73.0) 47 (13.2) 44 (12.4) 5 (1.4) 0 (0.0) 0 (0.0) 356 (100) Injured by a blunt force 190 (94.5) 4 (2.0) 6 (3.0) 0 (0.0) 1 (0.5) 0 (0.0) 201 (100) Stabbed, cut or pierced 165 (93.8) 8 (4.5) 3 (1.7) 0 (0.0) 0 (0.0) 0 (0.0) 176 (100) Fire, burn or scald 52 (80.0) 12 (18.5) 1 (1.5) 0 (0.0) 0 (0.0) 0 (0.0) 65 (100) Poisoning 30 (57.7) 4 (7.7) 16 (30.8) 1 (1.9) 1 (1.9) 0 (0.0) 52 (100) Suffocation/choking/asphyxia 24 (66.7) 4 (11.1) 6 (16.7) 1 (2.8) 1 (2.8) 0 (0.0) 36 (100) Electrocution 7 (58.3) 2 (16.7) 2 (16.7) 1 (8.3) 0 (0.0) 0 (0.0) 12 (100) Drowning and submersion 4 (57.1) 0 (0.0) 0 (0.0) 3 (42.9) 0 (0.0) 0 (0.0) 7 (100) Other 12 (92.3) 1 (7.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 13 (100) Unknown 2 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (100) Total 2237 (87.5) 150 (5.9) 150 (5.9) 11 (0.4) 8 (0.3) 2 (0.1) 2558 (100) Self-harm Poisoning 5 (13.2) 8 (21.1) 23 (60.5) 0 (0.0) 2 (5.3) 0 (0.0) 38 (100) Hanging 1 (8.3) 0 (0.0) 1 (8.3) 10 (83.3) 0 (0.0) 0 (0.0) 12 (100) Stabbed, cut or pierced 6 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 6 (100) Injured by blunt object 4 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 4 (100) Other 1 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (100) Total 17 (27.9) 8 (13.1) 24 (39.3) 10 (16.4) 2 (3.3) 0 (0.0) 61 (100) Assault Bodily force (physical violence) 34 (79.1) 5 (11.6) 3 (7.0) 0 (0.0) 1 (2.3) 0 (0.0) 43 (100) Injured by blunt object 18 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 18 (100) Stabbed, cut or pierced 6 (75.0) 1 (12.5) 1 (12.5) 0 (0.0) 0 (0.0) 0 (0.0) 8 (100) Pushing from a high place 2 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (100) Poisoning 1 (50) 0 (0.0) 1 (50.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (100) Sexual assault 1 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (100) Other 1 (100) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (100) Total 63 (84.0) 6 (8.0) 5 (6.7) 0 (0.0) 1 (1.3) 0 (0.0) 75 (100) Abstract 432 Figure 1Seasonal variation of injuries identified by the injury surveillance system over a year among children attending emergency of hospitals in Makwanpur district, Nepal, April 2019 – March 2020Results/ConclusionsThe total number of ED patients with injury in the study was 10,154.2,696 were patients aged <18 years. Most injuries in children were unintentional and over half of children presenting with injuries were <10 years of age. Falls, animal bites/stings and road traffic injuries accounted for nearly 75% of all injuries with some (drowning, poisonings and burns) under-represented. Over half of injuries were cuts, bites and open wounds. The next most common injury types were superficial injuries (14.2%); fractures (11.1%); sprains/dislocations (9.0%). Child mortality was 1%.This is the biggest prospective injury surveillance study in a low or middle country in recent years and supports the use of injury surveillance in Nepal for reducing child morbidity and mortality through improved data.CHILD PAPER: RESULTS SECTIONTotal number of ED patients: 33046Total number of ED patient with injury: 10154 (adult=7458 & children=2696)8.2% (n=2696) patients with injury were children aged <18 yearsHetauda hospital: 2274 (84.3%)Chure hill hospital: 422 (15.7%)
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34

Halkes, Constantijn J. M., Inge Jedema, Judith Olde Wolbers, Esther M. van Egmond, Peter A. Von Dem Borne, Erik W. A. F. Marijt, and J. H. Frederik Falkenburg. "Low Incidence of Post-Transplant EBV-Related Disease After Alemtuzumab-Mediated T Cell Depletion Is Explained by the Differential Susceptibility to Alemtuzumab of B Cells and Protective CD8 and CD4 T Cells." Blood 116, no. 21 (November 19, 2010): 2330. http://dx.doi.org/10.1182/blood.v116.21.2330.2330.

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Abstract Abstract 2330 In vivo T cell depletion with anti-thymocyte globulin (ATG) or alemtuzumab (anti-CD52) before reduced intensity allogeneic stem cell transplantation (alloSCT) in combination with in vitro T cell depletion with alemtuzumab reduces the risk of GVHD. Detectable levels of circulating antibodies are present up to several months after the alloSCT, leading to a delayed immune reconstitution which is associated with an increased incidence of opportunistic infections and early relapses. Prior to 2007, combined in vitro (Alemtuzumab 20 mg added “to the bag”) and in vivo T cell depletion with horse-derived ATG (h-ATG) resulted in good engraftment without GVHD in the absence of GVHD prophylaxis after reduced intensity alloSCT using conditioning with fludarabine and busulphan. Due to the unavailability of h-ATG, rabbit-derived ATG (r-ATG) 10–14 mg/kg was introduced in the conditioning regimen in 2007. Strikingly, in this cohort of patients, early EBV reactivation and EBV-associated post-transplantation lymphoproliferative disease (PTLD) was observed in 10 out of 18 patients at a median time of 6 weeks after alloSCT (range 5 to 11 weeks) in the absence of GVHD or immunosuppressive treatment. Analysis of T and B cell recovery early after transplantation revealed preferential depletion of T cells as compared to B cells, thereby allowing unrestricted proliferation of EBV infected B cells. Due to this unacceptable high incidence of EBV-related complications, in the conditioning regimen r-ATG was replaced by low dose alemtuzumab (15 mg i.v. day -4 and -3) in 2008. In this cohort of 60 patients, only 2 patients experienced transient EBV reactivation during the first 3 months after alloSCT and one patient developed an EBV-associated lymphoma 4 weeks after alloSCT. To investigate the mechanisms underlying the low incidence of EBV reactivation using alemtuzumab for T cell depletion, we studied the in vivo and in vitro effects of alemtuzumab on different lymphocyte subsets. First, lineage-specific reconstitution was studied in 20 patients from the alemtuzumab cohort with known CD52 negative diseases (11 AML and 9 multiple myeloma) to exclude the confounding effect of antibody absorption by malignant cells. Whereas at 3 weeks after alloSCT detectable numbers of circulating NK cells and T cells were observed (medians 71 (range 6–378), and 12 (range 1–1164)E6/L, respectively), no circulating B cells could be detected (median 0, range 0–1 E6/L). At 6 weeks after alloSCT, NK and T cell numbers further increased (medians 212 (52-813), and 130 (range 25–1509)E6/L, respectively), whereas B cell numbers still remained low in the majority of patients (median 15, range 0–813E6/L). In all patients, T cells were detectable before the appearance of circulating B cells. Furthermore, the expression of CD52 and the sensitivity to alemtuzumab-mediated complement-dependent cell lysis (CDC) of B cells, T cells and NK cells was measured in vitro. The highest CD52 expression was observed on B cells (mean fluorescence intensity (MFI) 120), resulting in 95% lysis after incubation with 10ug/mL alemtuzumab and rabbit complement. NK cells showed a significantly lower CD52 expression (MFI 41), which was also reflected by a lower susceptibility to alemtuzumab-mediated CDC (62% lysis). Interestingly, differential expression of CD52 was observed on CD4 and CD8 T cells (MFI 120 and 101, respectively). Cytotoxicity analysis revealed relative protection of CD8 compared to CD4 T cells against alemtuzumab-mediated CDC, resulting in 52% and 90% lysis, respectively. Based on these results, we investigated in detail the presence and phenotype of the CD4 and CD8 subsets and EBV-specific CD8 T cells using tetramer staining at 6 weeks after alloSCT. In accordance with the in-vitro expression and susceptibility data, circulating CD52+ CD8 T cells including EBV-specific T cells were detectable. Interestingly, the majority of circulating CD4 T cells (64-93%, n=4) lacked CD52 expression, explaining their capacity to persist in the presence of alemtuzumab. We conclude that in vivo and in vitro T cell depletion with alemtuzumab is associated with a relatively low risk of EBV-associated PTLD because of efficient B cell depletion and persistent EBV immunity allowed by the relative insusceptibility for alemtuzumab of CD8 T cells and the development of CD52 negative escape variants of CD4 T cells. Disclosures: No relevant conflicts of interest to declare.
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35

Simak, Jan, Monique P. Gelderman, Hua Yu, Violet Wright, Noah Alberts-Grill, John T. Stranix, and Alison E. Baird. "Elevated Circulating Endothelial Microparticles in Acute Stroke Patients: A Correlation with Brain Lesion Volume and Outcome." Blood 104, no. 11 (November 16, 2004): 3504. http://dx.doi.org/10.1182/blood.v104.11.3504.3504.

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Abstract Elevated endothelial cell membrane microparticles (EC MP) in blood have been demonstrated in various diseases with a vascular injury component. The aim of this study was to investigate if circulating EC MP show a relationship with outcome after acute stroke and with the ischemic brain lesion volume measured by magnetic resonance diffusion-weighted imaging (DWI). We analyzed EC MP in the blood of 42 acute stroke patients (AS): 20 patients with National Institutes of Health Stroke Scale (NIHSS) scores < 5 were classified as mild stroke (MS) (median NIHSS= 2; 25th–75th%: 0–2), while the other 22 patients with NIHSS ≥5 (NIHSS=12; 6–21) were classified as moderate to severe stroke (SS). Peripheral venous blood samples were collected at a median time of 36 hours (18–52) after the onset of clinical symptoms. The patients outcome was based on the Rankin disability score at the time of hospital discharge. Blood samples of 23 age matched control volunteers (CTRL) were used for comparison. EC MP analysis used a three-color flow cytometry assay (Simak et al, British J Haematol125, 804–813, 2004). EC MP were identified by antibodies to EC antigen CD105 (endoglin) and the highly specific CD144 (VE-cadherin). Platelet, white, and red blood cell MP were identified using cell specific antibodies to CD41, CD45, and CD235a, respectively. Plasma counts of CD105+CD41−CD45- EC MP were elevated in SS (median: 840/μL; 25th–75th%: 565–1079/μL) as compared to CTRL (415/μL; 201–624/μL; p=0.014). Moreover, CD105+CD144+ EC MP were elevated in SS (261/μL; 137–433/μL) when compared to MS (154/μL; 99–182/μL; p=0.031) or CTRL group (140/μL; 79–247/μL; p=0.031). Interestingly, CD105+CD41−CD45- EC MP, but not CD105+CD144+ EC MP, exhibited a significant correlation (p=0.005; r=0.45) with DWI brain lesion volume in AS group. However, CD105+CD144+ EC MP in the admission samples highly correlated (p=0.0007; r=0.54) with the Rankin disability score in the AS group at hospital discharge, while correlation of CD105+CD41−CD45- EC MP with the Rankin score was not as significant (p=0.007; r=0.44). We further analyzed 12 MS and 12 SS follow-up samples collected at a median period of 10 days (7–14) after the first sampling. Surprisingly, in SS follow-up samples, CD105+ EC MP populations decreased, while CD144+CD105−CD41- EC MP significantly increased, as compared to the samples at admission. In conclusion, the SS patient group had elevated different phenotypes of EC MP in the plasma samples at admission when compared to MS or CTRL groups. This is likely a reflection of the severity of ischemic-reperfusion injury of the brain vasculature. Elevated endoglin-positive EC MP were associated with brain ischemic lesion volume, whereas EC MP positive for both endoglin and VE-cadherin in the admission samples showed highly significant correlation with the patients disability outcome. The increased VE-cadherin-positive EC MP in follow-up samples may reflect a continuing endothelial injury in SS patients. Analysis of different phenotypes of EC MP in peripheral blood of stroke patients may be indicative of volume, character and severity of brain vascular injury and could be of diagnostic and prognostic use.
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Aggarwal, A., R. Gupta, R. Chatterjee, V. Negi, B. K. Das, P. Ghosh, D. Danda, and V. Shobha. "POS0773 AUTOANTIBODIES IN A MULTI-INSTITUTIONAL INDIAN COHORT (INSPIRE) OF SLE PATIENTS: PREVALENCE, CLUSTER ANALYSIS AND PHENOTYPE ASSOCIATION." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 673. http://dx.doi.org/10.1136/annrheumdis-2022-eular.4173.

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BackgroundSystemic Lupus Erythematosus (SLE) is characterized by an array of autoantibodies. Different autoantibodies have been associated with different clinical features like anti-dsDNA antibodies with nephritis and anti-phospholipid antibodies with pregnancy loss. However, the prevalence of autoantibodies has been variable across different ethnic groups. Data on the Indian population is limited.ObjectivesTo assess the prevalence of different autoantibodies in a multi-institutional cohort (INSPIRE) of Indian SLE patients and to test their association with various clinical features using cluster analysisMethodsThe patients (n=1053) enrolled in a multi-institutional cohort of Indian patients (Indian SLE inception cohort for Research [INSPIRE]) were included.1 Antibodies were assayed using Immunoline (Euroimmune, Germany) 17 antigen kit. Anti-phospholipid antibodies (IgG and IgM anti-cardiolipin antibodies (ACLs), IgG anti-Beta 2 GpI antibodies) were measured using ELISA (Euroimmune). Lupus anticoagulant was available in a subset of patients.The prevalence data for autoantibodies were analyzed using an intensity of only ++ and above on Immunoline assay as significant. Univariate analysis by Chi-square test was done to identify associations between individual autoantibodies and their clusters with clinical manifestations.ResultsThe clinical features were fever in 702, alopecia in 813, oral ulcers in 628, acute cutaneous lupus (ACLE) in 520, proteinuria in 400, pleural effusion in 181, thrombocytopenia in 250 and autoimmune hemolytic anemia in 137 patients.The prevalence of various autoantibodies by ELISA was anti-dsDNA antibodies in 70.2% (551/784), IgG Anti- beta-2 GpI in 4.47% (42/938), IgG ACL in 6.14% (61/992) and IgM ACL in 7.1% (54/760). Lupus anticoagulant was present in 13.9% (112/ 805). By Immunoline assay, the prevalence for anti-Ro 52, anti-Ro 60, anti-La and anti-Ribosomal P was 28.49%, 33.14%, 10.07% and 24.03% respectively (Table 1).Table 1.Prevalence of different autoantibodies in the INSPIRE lupus cohortS. No.AutoantibodyPrevalence (%) (n=1053)1.dsDNA28.112.Nucleosomes27.833.Histones24.884.Ro_52_SSA28.495.Ro_60_SSA33.146.SSB-La10.077.Ribosomal P24.038.nRNP36.759.Sm33.1410.Scl-703.2311.PM-Scl0.3812.Jo-10.0913.CENP-B0.3814.PCNA1.3315.AMA-M22.28Cluster analysis (Figure 1) revealed association (Odds ratio with 95% confidence interval) of Cluster 1 (antibodies against dsDNA, histones and nucleosomes) with arthritis (1.51 [1.18-1.94]), proliferative nephritis (3.05[2.08-4.48]) and pleural effusion (1.49[1.08-2.05]), cluster 2 (antibodies against Sm, nRNP, Ro52, Ro60 and Ribosomal P) with ACLE (1.3[1.02-1.65]) and non-proliferative nephritis (1.64[1.09-2.46]) and cluster 3 (antiphospholipid antibodies) with thrombocytopenia (3.34[1.57-7.11]).Figure 1.Cluster analysis of autoantibodies (Cluster 1: dsDNA, histone and nucleosome; cluster 2: Sm, nRNP, Ro52, Ro60 and Ribosomal P; cluster 3: cardiolipin, β2GP1 and La and lupus anticoagulant; cluster 4: Scl-70, Jo-1, PCNA, AMA-M2, PM-SCL and CENP-B)ConclusionThe prevalence of anti-Sm antibody and Anti-Ribosomal P antibody is higher whereas that of anti-La antibody is lesser in the Indian SLE patients as compared to other cohorts of SLE patients with different ethnicities.2 Cluster analysis reveals co-occurrence of different autoantibodies in our patients and their significant association with various clinical manifestations which suggests a possible pathogenic role of autoantibodies or a common genetic basis for it.References[1]Shobha V, Aggarwal A, Rajasekhar L, Jain A, Gupta R, Das B, et al. Indian SLE Inception cohort for Research (INSPIRE): the design of a multi-institutional cohort. Rheumatol Int. 2021 May;41(5):887-894.[2]Yang J, Xu Z, Sui M, Han J, Sun L, Jia X, et al. Co-Positivity for Anti-dsDNA, -Nucleosome and -Histone Antibodies in Lupus Nephritis Is Indicative of High Serum Levels and Severe Nephropathy. PLoS One. 2015 Oct 14;10(10):e0140441.Disclosure of InterestsAmita Aggarwal: None declared, Ranjan Gupta Grant/research support from: Dr. Ranjan Gupta has received 2 grants for educating patients and primary care physicians about rheumatoid arthritis managment., Rudrarpan Chatterjee: None declared, Vir Negi: None declared, Bidyut Kumar Das: None declared, Parasar Ghosh: None declared, Debashish Danda: None declared, Vineeta Shobha: None declared
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Lenshin, Alexander S., Konstantin A. Barkov, Natalya G. Skopintseva, Boris L. Agapov, and Evelina P. Domashevskaya. "Влияние режимов электрохимического травления при одностадийном и двухстадийном формировании пористого кремния на степень окисления его поверхностных слоев в естественных условиях." Kondensirovannye sredy i mezhfaznye granitsy = Condensed Matter and Interphases 21, no. 4 (December 19, 2019): 534–43. http://dx.doi.org/10.17308/kcmf.2019.21/2364.

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В работе методами растровой электронной микроскопии и ультрамягкойрентгеновской эмиссионной спектроскопии были проведены исследования особенностейформирования многослойных структур пористого кремния и установлено влияние изменения плотности тока при электрохимическом травлении монокристаллических пластин кремния на фазовый состав поверхностных слоев сформированной пористой структуры. ЛИТЕРАТУРА1. Moshnikov V., Gracheva I., Lenshin A., Spivak Yu. Porous silicon with embedded metal oxides for gassensing applications // Journal of Non-Crystalline Solids, 2012 v. 358(3), pp. 590–595. DOI: https://doi.org/10.1016/j.jnoncrysol.2011.10.0172. Pacholski C. Photonic crystal sensors based on porous silicon // Sensors, 2013, v. 13(4), pp. 4694–4713.DOI: https://doi.org/10.3390/s1304046943. Harraz F. Porous silicon chemical sensors and biosensors: A review // Sensors and Actuators B, 2014,v. 202, pp. 897–912. DOI: https://doi.org/10.1016/j.snb.2014.06.0484. Jane A., Dronov R., Hodges A., Voelcker N. Porous silicon biosensors on the Advance // Trends in Biotechnology, 2009, v. 27(4), pp. 230–239. DOI: https://doi.org/10.1016/j.tibtech.2008.12.0045. RoyChaudhuri C. A review on porous silicon based electrochemical biosensors: beyond surface areaenhancement factor // Sensors and Actuators B: Chemical, 2015, v. 10, pp. 310–323. DOI: http://dx.doi.org/10.1016/j.snb.2014.12.0896. Canham L. Properties of porous silicon. Ed. by Canham L., Malvern: DERA, 1997, 400 p.7. Lenshin A., Kashkarov V., Spivak Yu., Moshnikov V. Investigations of nanoreactors on the basisof p-type porous silicon: Electron structure and phase composition // Materials Chemistry and Physics, 2012,v. 135(2–3), pp. 293–297. DOI: https://doi.org/10.1016/j.matchemphys.2012.03.0958. Lenshin A., Kashkarov V., Turishchev S., Smirnov M., Domashevskaya E. Effect of natural aging onphotoluminescence of porous silicon // Technical Physics Letters, 2011, v. 37(9), pp. 789-792. DOI: https://doi.org/10.1134/s10637850110901249. Seredin P., Lenshin A., Goloshchapov D., Lukin A., Arsentyev I., Bondarev A., Tarasov I. Investigationsof nanodimensional Al2O3 fi lms deposited by ion-plasma sputtering onto porous silicon // Semiconductors,2015, v. 49(7), pp. 915–920. DOI: https://doi.org/10.1134/s106378261507021010. Qian M., Bao X.Q., Wang L.W., Lu X., Shao J., Chen X.S. Structural tailoring of multilayer poroussilicon for photonic crystal application. // Journal of Crystal Growth, 2006, v. 292(9), pp. 347–350. DOI:https://doi.org/10.1016/j.jcrysgro.2006.04.03311. Verma D., Khan F., Singh S. Correlation between refl ectivity and photoluminescent properties ofporous silicon fi lms // Solar Energy Materials & Solar Cells, 2011, v. 95(1), pp. 30–33. DOI: https://doi.org/10.1016/j.solmat.2010.05.03012. Theiß W. The dielectric function of porous silicon – how to obtain it and how to use it // ThinSolid fi lms, 1996, v. 276 (1–2), pp. 7–12. DOI: https://doi.org/10.1016/0040-6090(95)08036-813. Caballero-Hernandez J., Godinho V., Lacroix B., Haro M., Jamon D., Fernandez A. Fabrication of opticalmultilayer devices from porous silicon coatings with closed porosity by magnetron sputtering // ACS Appl.Mater. Interfaces, 2015, v. 7(25), pp. 13889–13897. DOI: https://doi.org/10.1021/acsami.5b0235614. Terekhov V, Kashkarov V, Manukovskii E., Schukarev A., Domashevskaya E. Determination of thephase composition of surface layers of porous silicon by ultrasoft X-ray spectroscopy and X-ray photoelectronspectroscopy techniques // J. Electron. Spectrosc., 2001, v. 114–116, pp. 895–900. DOI: https://doi.org/10.1016/s0368-2048(00)00393-515. Shulakov A. X-ray emission depth-resolved spectroscopy for investigation of nanolayers. // Journalof Structural Chemistry, Supplement, 2011, v. 52(S1), pp. 1–12. DOI: https://doi.org/10.1134/s002247661107001816. Mashin A., Khokhlov A., Mashin N., Domashevskaya E., Terekhov V. X-ray spectroscopic studyof electronic structure of amorphous silicon and silicyne // Semiconductors, 2001, v. 35(8), pp. 956–961.DOI: https://doi.org/10.1134/1.139303517. Domashevskaya E., Kashkarov V., Manukovskii E., Shchukarev A., Terekhov V. XPS, USXS and PLSinvestigations of porous silicon // J. Electron. Spectrosc., 1998, v. 88–91, pp. 969–972. DOI: https://doi.org/10.1016/s0368-2048(97)00274-018. Lenshin A., Kashkarov V., Domashevskaya E., Bel’tyukov A., Gil’mutdinov F. Investigations of thecomposition of macro-, micro- and nanoporous silicon surface by ultrasoft X-ray spectroscopy and X-rayphotoelectron spectroscopy // Applied Surface Science, 2015, 359, pp. 550–559. DOI: https://doi.org/10.1016/j.apsusc.2015.10.14019. Suriani Yaakob, Mohamad Abu Bakar, Jamil Ismail, Noor Hana Hanif Abu Bakar, KamarulaziziIbrahim. The formation and morphology of highly doped N-type porous silicon: effect of short etchingtime at high current density and evidence of simultaneous chemical and electrochemical dissolutions //Journal of Physical Science, 2012, v. 23(2), pp. 17–31. Available at: http://jps.usm.my/wp-content/uploads/2014/10/23.2.2.pdf (accessed 11.11.2019)
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Parasuraman, Shreekant V., Ahmad B. Naim, Dilan C. Paranagama, Maureen Thyne, Sara Goldberger, John O. Mascarenhas, James Mangan, Salman Fazal, Carole B. Miller, and Ruben A. Mesa. "Financial Burden of Myeloproliferative Neoplasms on Patients: Results from the MPN Landmark Survey in the United States." Blood 126, no. 23 (December 3, 2015): 5561. http://dx.doi.org/10.1182/blood.v126.23.5561.5561.

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Abstract Background: Myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET) are chronic myeloproliferative neoplasms (MPNs). Patients across all 3 MPNs experience marked disease burden in terms of symptoms and negative effects on quality of life (QoL), productivity, and activities of daily living (ADL). To improve the lives and health of patients with MPNs, it is also important to have a current understanding of these burdens from a financial standpoint. This analysis of MPN Landmark survey data examined the financial burden of patients who reported that their MPN affected their employment (ie, reduced work hours, discontinued employment, or went on medical disability) or experienced no such effects on their employment. Methods: Patients diagnosed with MF, PV, or ET were recruited to participate in a real-world retrospective study (MPN Landmark survey) in the US (fielded May - July 2014). Only respondents who were diagnosed before 2013 and were 16 to 65 years of age at the time of diagnosis were eligible for this analysis. Participants were asked if their MPN had an impact in terms of reduced work hours, discontinued employment, medical disability, or no impact; the first 3 categories were not mutually exclusive. Participants provided information on their annual household income in 2013 before taxes by selecting from the following categories: ≤$15,000, $15,001-$25,000, $25,001-$35,000, $35,001-$50,000, $50,001-$75,000, $75,001-$100,000, and >$100,000. The mid value of each range was used to calculate mean income levels within each subgroup evaluated. Results: A total of 813 patients completed the web-based Landmark survey and 369 eligible patients were included in this analysis (MF, 85; PV, 172; ET, 112). Median age among patients with ET was slightly lower than among patients with MF and PV at time of MPN diagnosis (ET, 48 years; MF, 56 years; PV, 53 years). The majority of respondents were women (MF, 62%; PV, 52%; ET, 75%). Almost all patients (99%) had health insurance, primarily group commercial insurance through an employer (MF, 46%; PV, 53%; ET, 57%) and Medicare (MF, 40%; PV, 34%; ET, 24%). Most patients had at least some college education (ie, some college, 4-year degree, or postgraduate degree): MF, 86%; PV, 90%; ET, 88%. The mean 2013 household income of patients with MF, PV, and ET were similar to each other ($79,800, $80,200, and $80,400, respectively) and slightly higher than the total 2013 US mean household income of $75,839. A notable proportion of patients in each MPN group reported that their disease led to reduced work hours, discontinued employment, and medical disability: MF, 38%, 35%, and 33%, respectively; PV, 33%, 28%, and 15%; ET, 28%, 21%, and 4%. Patient demographics, such as age and health insurance status, were similar among patients who reported MPN-associated effects on employment and patients who did not within each MPN. In each MPN group, the mean percentage household income loss in patients with reduced work hours, discontinued employment, and medical disability were: MF, 16%, 18%, and 28%, respectively; PV, 15%, 24%, and 17%; and ET, 0%, 24%, and 37%, compared with patients who did not experience any effects of their MPN on employment (Figure 1). Discontinued employment and medical disability tended to have a greater impact compared with reduced work hours across MPNs. Conclusion: Patients withMPNs may experience a considerable negative impact on their employment status, which in turn may be associated with reduced annual household income. Therefore, across all MPNs, forestalling or reversing discrete aspects of the diseases that negatively impact individual productivity is an important factor in the management of these chronic neoplasms. Disclosures Parasuraman: Incyte Corporation: Employment, Equity Ownership. Naim:Incyte Corporation: Employment, Equity Ownership. Paranagama:Incyte Corporation: Employment, Equity Ownership. Thyne:Incyte Corporation: Speakers Bureau. Mascarenhas:Incyte Corporation: Research Funding; Novartis Pharmaceuticals Corporation: Research Funding; Promedior: Research Funding; Roche: Research Funding; CTI Biopharma: Research Funding; Kalobios: Research Funding. Mangan:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Fazal:Bristol Myers Squibb: Consultancy, Honoraria, Speakers Bureau; Ariad: Consultancy, Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau. Miller:Incyte Corporation: Honoraria, Research Funding. Mesa:Promedior: Research Funding; Gilead: Research Funding; Incyte Corporation: Research Funding; NS Pharma: Research Funding; CTI Biopharma: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; Genentech: Research Funding; Pfizer: Research Funding.
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Castillo, Jorge J., Flora Mulkey, Susan Geyer, Jonathan E. Kolitz, William Blum, Bayard L. Powell, Richard A. Larson, and Richard M. Stone. "Obesity Is An Adverse Prognostic Factor For Overall and Disease-Free Survival In Adult Acute Promyelocytic Leukemia But Not In Acute Myeloid Leukemia: A Pooled Analysis From Four Alliance Prospective Studies." Blood 122, no. 21 (November 15, 2013): 832. http://dx.doi.org/10.1182/blood.v122.21.832.832.

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Abstract Introduction There are mounting data associating obesity with an increased risk of developing acute myeloid leukemia (AML) and acute promyelocytic leukemia (APML). However, the role of obesity in the outcome of patients with AML and APML has not been extensively evaluated. In this study, we assess the effect of obesity in relapse and survival rates of clinical trial patients with AML and APML. Methods Data on patients ≥18 years from 4 prospective clinical trials from the Cancer and Leukemia Group B (Alliance) were pooled for this analysis (n=2,093). This reflects exclusion of 72 patients deemed ineligible or non-evaluable, and 8 patients without height or weight data. Three studies were in de novo AML: 9621 (n=393), 10503 (n=541) and 19808 (n=714), and one study was in de novo APML: 9710 (n=445). BMI was calculated following the formula (BMI=weight/height2) and categorized according to WHO criteria as underweight/normal (BMI <25 kg/m2), overweight (BMI 25-29.9 kg/m2) and obese (BMI 30+ kg/m2). AML and APML cohorts were analyzed separately. Baseline BMI was evaluated in relation to clinical characteristics, including age, gender, ECOG performance status (PS), and race/ethnicity. Univariate and multivariable logistic regression models were used to assess relationships of these factors with obesity. Analysis of clinical outcomes included overall survival (OS) in all patients, and disease-free survival (DFS) in those patients who achieved a complete response. The impact of obesity was evaluated using Kaplan-Meier methods and log-rank tests. Multivariate Cox regression analyses were used to assess prognostic impact of obesity while adjusting for other factors such as age, gender, PS, race and ethnicity on OS and DFS. P-values <0.05 were considered statistically significant. Results In the AML cohort (n=1,648), median age was 46 years (range: 18-66 years), 53% were men, 87% had PS 0-1, 17% were non-white and 7% Hispanic. For the APML cohort (n=445), median age was 43 years (range: 18-80 years), 52% were male, 82% had PS 0-1, 18% were non-white and 11% Hispanic. The proportion of obesity at study entry for AML and APML was 38% and 50%, respectively. APML patients experienced a superior OS than AML patients (5-year OS: 81% vs. 37%). In AML, age, gender and race were all significantly related to whether or not patients were obese in univariate and multivariate settings. In APML, only age and race were significantly associated with obesity. Median follow-up time was 6.8 years for AML and 8.5 years for APML patients. In the AML cohort, 1058 of 1648 patients have died, and 813 of 1246 patients evaluable for DFS had an event. For APML, 102 of 445 patients died and 106 of 401 patients evaluable for DFS had an event. DFS and OS distributions were not significantly different in obese vs. non-obese AML patients (p=0.8 and p=0.6, respectively). However, obese APML patients had a significantly shorter OS than non-obese patients (HR=1.61, p=0.02; 5-year OS rates: 76% vs. 85%, respectively). Similarly, obese APML patients tended to have shorter DFS than non-obese patients (HR=1.49, p=0.05; 5-year DFS rates: 74% vs. 82%, respectively). Only focusing on those APML patients between 18-60 years of age, differential OS and DFS in obese patients was more pronounced with corresponding worse survival (OS: HR=2.13, p=0.003; DFS: HR=1.75, p=0.015). Conclusion Obesity did not influence OS and DFS in AML. However, in a multivariate analysis, obese APML patients had significantly inferior OS and DFS than non-obese patients. Multivariate analysis suggests that the adverse impact of obesity in APML is independent of age, sex, performance and race/ethnicity. Previous studies have suggested that obesity is a risk factor for developing APML; we now show that obesity at diagnosis also confers a worse prognosis. Reasons for our findings could include potential pharmacological issues, such as relative dose intensity, which needs further research. Moreover, it will be necessary to determine if our findings will be replicated in patients with APML treated without chemotherapy as is now becoming the standard of care for those who present with white blood cell counts <10,000/uL. Disclosures: No relevant conflicts of interest to declare.
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Blanco Cáceres, B. A., Á. Andreu-Suárez, M. Valero, D. Benavent, M. Sanz, J. Campos Esteban, O. Rusinovich, et al. "POS1574 SAPHO SYNDROME, CLINIC CHARACTERISTICS FROM THE SAPHO-SORCOM COHORT." Annals of the Rheumatic Diseases 82, Suppl 1 (May 30, 2023): 1163–64. http://dx.doi.org/10.1136/annrheumdis-2023-eular.6386.

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BackgroundThe SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, and osteitis) is a rare disease (<1/10,000) with multiple cutaneous and musculoskeletal manifestations [1]. The most common dermatological manifestations are palmoplantar pustulosis (PPP) and severe acne (SA). Musculoskeletal manifestations are diverse, including the thoracic wall, spine, temporomandibular joint, and peripheral joints [2]. It is considered as part of spondyloarthropathies, however, no significant relationship with HLA-B27 has been found [3]. For treatment, non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying drugs (DMARDs) and bisphosphonates have been traditionally used. More recently, new therapies such as apremilast and biological DMARDs (4) are being used more frequently.ObjectivesTo examine the characteristics of individuals diagnosed with SAPHO syndrome during follow-up at multiple Rheumatology Services in Spain.MethodsThis is a descriptive, cross-sectional, multi-center study, carried out in the Rheumatology Services of several hospitals in Spain. A convenience sampling was carried out, including all patients with SAPHO under active follow-up.Results50 patients were included (76% women), with a mean age of 48.56 (±12,28) years. The mean BMI was 24.84 (±4.31). Regarding cardiovascular risk factors, 36.2% and 23.4% were smokers and ex-smokers, respectively. 18% had hypertension, 28% had dyslipidaemia and 8% were diabetic.Regarding of the musculoskeletal involvement, the most affected region was the anterior chest wall (74%), followed by peripheral arthritis (56%) and the spine (34%). 24% presented enthesitis and only 6% dactylitis. The most frecuent skin involvement was palmpplantar pustulosis in 54% (27), the distribution of dermatological manifestations is shown in Figure 1.Figure 1.Skin manifestations in SAPHO syndrome.In laboratory tests at diagnosis, acute phase reactants were slightly elevated, with a mean of CRP of 11.13 (±17.34) and ESR of 21.21 (±24.56). HLA-B27 and CW6 were positive in 12% (6) and 6% (3) of patients, respectively. The most commonly used imaging tests in the diagnosis and follow-up were plain x-rays (90%), MRI (76%), bone scintigraphy (72%), and CT scan (52%). The least used test was ultrasound, used in 17 patients (34%).The treatment was mostly based in NSAIDs, 94% of patients received it at some point. 60% used DMARDsc (mostly methotrexate). 50% of patients received bDMARDs, and 9 patients received more than two bDMARDs throughout the follow-up. The distribution of the first bDMARD used is shown in Table 1.Table 1.First bDMARD used in the treatment of SAPHO syndrome in our cohort.bDMARDN% patients (25/50)% FAMEb/other molec’s (25/25)Adalimumab122448Infliximab4816Etanercept3612Ustekinumab248Secukinumab124Anakinra124Apremilast124Cartolizumab-pegol124Total2550100The course of the disease was mostly recurrent (54%) with asymptomatic periods between flare-ups. About half of the patients (44%) in follow-up currently have active disease.ConclusionOur cohort presented axial involvement like other series and significant peripheral involvement. The most frequent skin condition was PPP. Half of the patients in our cohort required bDMARD, with ADL being the most widely used.References[1]Heldmann F, Kiltz U, Baraliakos X, Braun J. [SAPHO syndrome]. Z Rheumatol. Octubre de 2014;73(8):729-41.[2]Hayem G, Bouchaud-Chabot A, Benali K, Roux S, Palazzo E, Silbermann-Hoffman O, et al. SAPHO syndrome: a long-term follow-up study of 120 cases. Semin Arthritis Rheum. diciembre de 1999;29(3):159-71.[3]Colina M, Govoni M, Orzincolo C, Trotta F. Clinical and radiologic evolution of synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome: A single center study of a cohort of 71 subjects. Arthritis Care Res. 2009;61(6):813-21.[4]Daoussis D, Konstantopoulou G, Kraniotis P, Sakkas L, Liossis S-N. Biologics in SAPHO syndrome: A systematic review. Semin Arthritis Rheum. febrero de 2019;48(4):618-25.AcknowledgementsTo the Sociedad de Reumatología de la Comunidad de Madrid (SORCOM).Disclosure of InterestsBoris Anthony Blanco Cáceres Speakers bureau: MSD, Janssen, Novartis, UCB, Grant/research support from: Gebro, Pfizer, Novartis, Janssen, MSD, África Andreu-Suárez: None declared, Marta Valero: None declared, Diego Benavent: None declared, María Sanz: None declared, José Campos Esteban: None declared, Olga Rusinovich: None declared, Juan Molina Collada: None declared, patricia Castro: None declared, Vega Jovani: None declared, María Jesús Montesa: None declared, Eva Tomero Muriel: None declared, Álvaro García Martos: None declared, RAQUEL ALMODOVAR: None declared, Fernando Lozano Morillo: None declared.
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Asai, S., N. Takahashi, Y. Kuwatsuka, M. Ando, N. Ishiguro, and T. Kojima. "THU0088 PREDICTORS OF DISEASE FLARE AFTER DISCONTINUATION OF CONCOMITANT METHOTREXATE IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH TOCILIZUMAB." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 256.1–257. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1095.

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Background:All biologics should primarily be combined with a conventional synthetic DMARD, such as methotrexate (MTX), in rheumatoid arthritis (RA) patients. However, the use of MTX may lead to the development of adverse events (AEs), and de-escalation of MTX while maintaining a favorable disease activity state may be beneficial from the perspective of reducing AEs during long-term RA treatment. Several studies have evaluated the impact of MTX discontinuation in RA patients who achieved good clinical response with tocilizumab (TCZ) plus MTX combination therapy, finding that discontinuing MTX is noninferior to continuing MTX in terms of maintaining clinical response (1-3). However, information on risk factors for disease flare after MTX discontinuation is lacking.Objectives:To investigate predictors of disease flare after MTX discontinuation in Japanese RA patients with sustained low disease activity undergoing TCZ plus MTX combination therapy.Methods:Participants of this multicenter, open-label, uncontrolled, prospective study were RA patients maintaining low disease activity (Clinical Disease Activity Index [CDAI] ≤10) for ≥12 weeks with TCZ plus MTX. Patients had to be receiving MTX orally at a stable dose of ≥6 mg/week, and TCZ at a stable dosage regimen irrespective of the route of administration, for ≥12 weeks prior to obtaining informed consent. MTX was discontinued after 12 weeks of biweekly administration while continuing TCZ therapy (Fig. 1). Disease flare was defined as a CDAI score >10 or intervention with rescue treatments for any reason. The impact of baseline characteristics on disease flare at week 64 (52 weeks after MTX discontinuation) was assessed with logistic regression models.Results:Efficacy analyses were performed in 49 patients, of whom 15 had a disease flare by week 64. The proportion [95% confidence interval (CI)] of patients who maintained low disease activity without a flare at week 64 was 69.4% (54.6 – 81.8%) (Fig. 2A). According to Kaplan-Meier estimates, the cumulative flare-free rate was 70.0% at week 64 (Fig. 2B). The dosing interval of TCZ was longer than that described on the drug label (i.e., intravenously every 4 weeks, or subcutaneously every 2 weeks) in 27% and 6% of patients with and without a flare, respectively (Table 1). Multivariate analysis revealed that male sex [odds ratio (OR): 18.00, 95% CI: 2.80-115.56] and extended dosing interval of TCZ (OR: 12.00, 95% CI: 1.72-83.80) were independent predictors of disease flare.Table 1.Impact of baseline variables on disease flareNon-flareFlareOdds ratio (95% confidence interval)(n=34)(n=15)UnivariateMultivariateAge, years62 ± 1163 ± 91.01 (0.95-1.08)aMale, %64010.67 (1.83-62.18)*18.00 (2.80-115.56)*Weight, kg54 ± 858 ± 151.03 (0.98-1.09)aDisease duration, years11 ± 813 ± 91.03 (0.95-1.11)aRF positive, %76861.85 (0.34-10.04)ACPA positive, %85100-bRoute of TCZ, intravenous, %59802.80 (0.66-11.79)Extended TCZ dosing interval, %6275.82 (0.93-36.28)†12.00 (1.72-83.80)*MTX dose, mg/week8.2±2.28.0±2.60.95 (0.73-1.25)aUse of glucocorticoids, %26331.39 (0.37-5.18)Use of csDMARDs other than MTX, %9335.17 (1.04-25.57)*-Previous biologic use, %56803.16 (0.75-13.26)CDAI remission, %65731.50 (0.39-5.75)CRP, mg/dl0.04 ± 0.060.04 ± 0.060.42 (0.00-15115.38)aMMP-3, ng/ml58.5 ± 22.476.6 ± 37.61.02 (1.00-1.05)a†-Data are shown as mean ± SD or percentage.aOdds ratio for 1-unit increase in each item.bOdds ratio was not evaluated. *P<0.05. †P<0.10.Conclusion:Male patients and those receiving TCZ at an extended dosing interval are at high risk of disease flare after discontinuation of concomitant MTX.This work was supported by Chugai Pharmaceutical Co., Ltd.References:[1]Kremer JM. Arthritis Rheumatol 2018.[2]Edwards CJ. Rheumatology (Oxford) 2018.[3]Pablos JL. Clin Exp Rheumatol 2019.Disclosure of Interests:Shuji Asai Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Janssen, Takeda, and UCB Japan, Nobunori Takahashi Speakers bureau: AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen, Mitsubishi Tanabe, Ono, Pfizer, Takeda, and UCB Japan, Yachiyo Kuwatsuka: None declared, Masahiko Ando: None declared, Naoki Ishiguro Grant/research support from: AbbVie, Asahi Kasei, Astellas, Chugai, Daiichi-Sankyo, Eisai, Kaken, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, and Zimmer Biomet, Consultant of: Ono, Speakers bureau: Astellas, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Pfizer, and Taisho Toyama, Toshihisa Kojima Grant/research support from: Chugai, Eli Lilly, Astellas, Abbvie, and Novartis, Consultant of: AbbVie, Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eli Lilly, Janssen, Mitsubishi Tanabe, Pfizer, and Takeda
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Mesa, Ruben, Carole B. Miller, Maureen Thyne, James Mangan, Sara Goldberger, Salman Fazal, Xiaomei Ma, et al. "Impact of Myeloproliferative Neoplasms (MPNs) on Patients’ Overall Health and Productivity: Results from the MPN LANDMARK SURVEY in the United States." Blood 124, no. 21 (December 6, 2014): 3183. http://dx.doi.org/10.1182/blood.v124.21.3183.3183.

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Abstract Background: Myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET), are chronic MPNs associated with a broad array of symptoms that may negatively impact patients’ quality of life (QoL). To enhance patient care, it is important to have a current and clear understanding of how MPNs affect the overall health and daily lives of patients. The MPN LANDMARK SURVEY was developed to examine patients’ perceptions of these MPNs related to disease burden, QoL, productivity, and activities of daily living (ADLs). Methods: Eligible patients diagnosed with an MPN were recruited to participate in an online survey conducted from May–July 2014in the US. Patients were asked about the overall burden of disease and impact of symptoms on their QoL, productivity, and ADLs. Descriptive analyses were conducted to assess these outcomes and examined by calculated (not reported) prognostic risk score (MF - DIPSS: Passamonti, Blood 2010; PV: Tefferi, Leuk 2013; ET - IPSET: Passamonti, Blood 2012) and symptom severity quartiles, which were determined using the MPN Symptom Assessment Form (MPN-SAF) total symptom scores. Results: 813 patients (MF=207; PV=380; ET=226) responded to the survey. A majority of patients were female (MF, 54%; PV, 62%; ET, 72%), approximately half were aged 60–74 years (MF, 55%; PV, 51%; ET, 46%), and most were covered by health insurance (>98%). Nearly half (48%) were diagnosed within the last 5 years and average time to diagnosis from first symptoms was >2 years. A high proportion of patients had intermediate to high prognostic risk scores (MF, 94%; PV, 87%; ET, 44%). The majority of patients reported feeling anxious or worried about their MPN (MF, 91%; PV, 78%; ET, 74%). Among all groups, fatigue was the most severe symptom reported (mean MPN-SAF score=6.0–6.4 on a scale of 0–10). A subset of patients in each group described their symptoms as very severe (severity score ≥7 on a scale of 0–10; MF: fatigue [59%], problems with sexual desire [49%], inactivity [46%]; PV: inactivity [48%], fatigue [49%], problems with sexual desire [49%]; and ET: problems with sexual desire [49%], fatigue [50%], headaches [40%]). The majority of patients reported that MPN-related symptoms reduced their QoL (MF, 81%; PV, 66%; ET, 57%); this was reported in all risk groups but more frequently by patients with a high risk score vs a low risk score in MF and ET (MF, 89% vs 69%; PV, 63% vs 65%; ET, 71% vs 59%). A more substantial QoL impact was reported by patients in high vs low symptom quartiles (MF, 95% vs 51%; PV, 94% vs 33%; ET, 93% vs 15%). Similarly, MPNs also had a marked negative impact on reduced work hours, sick days, voluntary job termination, receipt of medical disability, early retirement, and ADLs (Table 1). For example, among patients employed, approximately one fourth reported missing ≥1 day of work (MF, 29%; PV, 19%; ET, 23%) in the last 30 days before the survey. Even patients with low prognostic risk scores often reported missing ≥1 day of work (MF, 33%; PV, 23%; ET, 22%) or cancelling ≥1 day of planned activities (MF, 46%; PV, 35%; ET, 34%). Patients in the high vs low symptom quartiles were more likely to call in sick to work (MF, 48% vs 0%; PV, 52% vs 4%; ET, 38% vs 0%) or cancel ≥1 day of planned activities (MF, 77% vs 5%; PV, 56% vs 7%; ET, 67% vs 3%). Conclusion: The findings from this large, first-of-its-kind survey demonstrate a marked burden of disease across all 3 MPNs that is not limited to symptoms but extends to QoL, productivity, and ADLs. Although high prognostic risk scores have long been associated with a significant burden of disease, in this study, patients with a low risk score also reported significant burden. The symptom burden reported is consistent with previous studies, thus validating the present dataset. MPN treatment considerations should include reducing the symptom burden and improving QoL and productivity to enhance the overall health and lives of MPN patients. Disclosures Mesa: Incyte Corporation: Research Funding; CTI: Research Funding; Gilead: Research Funding; Genentech: Research Funding; Eli Lilly: Research Funding; Promedior: Research Funding; NS Pharma: Research Funding; Sanofi: Research Funding; Celgene: Research Funding. Miller:Incyte Corporation: Honoraria, Research Funding. Thyne:Incyte Corporation: Speakers Bureau. Mangan:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees; Alexion Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Goldberger:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Fazal:Incyte Corporation: Consultancy, Research Funding, Speakers Bureau; Gilead: Research Funding, Speakers Bureau. Ma:Incyte Corporation: Consultancy. Wilson:Incyte Corporation: Honoraria. Dubinski:Incyte Corporation: Employment, Equity Ownership. Boyle:ICF International: Employment, Equity Ownership. Mascarenhas:Incyte Corporation: Consultancy, Research Funding; Novartis Pharmaceuticals Corporation: Research Funding.
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PAI, Chih-Hung, Kuo-Min KO, and Troy SANTOS. "A Study of the Effect of Service Recovery on Customer Loyalty Based On Marketing Word Of Mouth in Tourism Industry." Revista de Cercetare si Interventie Sociala 64 (March 6, 2019): 74–84. http://dx.doi.org/10.33788/rcis.64.6.

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Akamavi, R K., Mohamed, E., Pellmann, K., & Xu, Y. (2015). Key determinants of passenger loyalty in the low-cost airline business. Tourism Management, 46, 528-545. Baldus, B.J., Voorhees, C., & Calantone, R. (2015). Online brand community engagement: Scale development and validation. Journal of Business Research, 68(5), 978-985. Boo, H.V. (2017). Service Environment of Restaurants: Findings from the youth customers. Journal of Asian Behavioural Studies, 2(2), 67-77. Bowen, T.J., & Chen, S.L. (2015). Transitioning Loyalty Programs: A Commentary on the Relationship Between Customer Loyalty & Customer Satisfaction. International Journal of Contemporary Hospitality Management, 27(3), 415-430. Casidy, R., & Shin, H. (2015). The effects of harm directions and service recovery strategies on customer forgiveness and negative word-of-mouth intentions. Journal of Retailing and Consumer Services, 27, 103-112. Chang, J.H. (2017). The role of relationship on time and monetary compensation. The Service Industries Journal, 37, 915-935. Fan, A., Mattila, A.S., & Zhao, X. (2015). How does social distance impact customers’ complaint intentions? A cross-cultural examination. International Journal of Health Policy and Management, 47, 35-42. Gohary, A., Hamzelu, B., & Alizadeh, H. (2016). Please explain why it happened! How perceived justice and customer involvement affect post co-recovery evaluations: a study of Iranian online shoppers. Journal of Retailing and Consumer Services, 31, 127-142. Guo, L., Lotz, S.L., Tang, C., & Gruen, T.W. (2015). The role of perceived control in customer value cocreation and service recovery evaluation. Journal of Service Research, 19(1), 39-56. Heidenreich, S., Wittkowski, K., Handrich, M., & Falk, T. (2015). The dark side of customer co-creation: exploring the consequences of failed co-created services. The Journal of the Academy of Marketing Science, 43(3), 279-296. Hsu, C.L., & Lin, J.C.C. (2016). Effect of perceived value and social influences onmobile app stickiness and in-app purchase intention.Technological Forecasting and Social Change, 108, 42-53. Kashif, M., Zarkada, A., & Ramayah, T. (2016).The impact of attitude, subjective norms, and perceived behavioural control on managers’ intentions to behave ethically. Total Quality Management & Business Excellence, 29(5-6), 1-21. Li, M., Qiu, S.C., & Liu, Z., (2016). The Chinese way of response to hospitality service failure: The effects of face and guanxi. International Journal Hospital Management, 57, 18-29. Liu, S.Q., & Mattila, A.S. (2015). “I Want to Help” versus “I Am Just Mad” how affective commitment influences customer feedback decisions. Cornell Hospitality Quarterly, 56(2), 213-222. Oman, B., Pepur, M., & Arneric, J. (2016). The impact of service quality and sport-team identification on the repurchase intention. Journal of Contemporary Management Issues, 21(1), 19-46. Ozuem, W., Patel, A., Howell, K.E. & Lancaster, G. (2016). An Exploration of Consumers' Response to Online Service Recovery Initiatives. International Journal of Market Research, 59(1), 97-115. Park, J., & Ha, S. (2016). Co-creation of service recovery: Utilitarian and hedonic value and post-recovery responses. Journal of Retailing and Consumer Services, 28, 310-316. Rezaei, S., Shahijan, M.K., Amin, M., & Ismail, W.K.W. (2016). Determinants ofapp stores continuance behavior: A pls path modellingapproach. Journal of Internet Commerce, 15(4), 408-440. Sengupta, S.A., Balaji, M., & Krishnan, B.C. (2015). How customers cope with service failure? A study of brand reputation and customer satisfaction. Journal of Business Research, 68(3), 665-674. Sloan, S., Bodey, K., & Gyrd-Jones, R. (2015). Knowledge sharing in online brand communities. Qualitative Market Research: An International Journal, 18(3), 320-345. Tan, C., Benbasat, I. & Cenfetelli, R.T. (2016). An Exploratory Study of the Formation and Impact of Electronic Service Failures. MIS Quarterly, 40(1), 1-31. Van Vaerenbergh, Y., & Orsingher, C. (2016). Service Recovery: An Integrative Framework and Research Agenda. The Academy of Management Perspectives, 30(3), 328-346. Varela, J.C.S., Svensson, G., Brambilla, F.R., & Oliveros, M.E.G. (2015) Perceived Justice & Emotions in a Negative Service Encounter: A Latin American Perspective. In: Kubacki K. (eds). Ideas in Marketing: Finding the New and Polishing the Old. Developments in Marketing Science: Proceedings of the Academy of Marketing Science. Cham: Springer. Vyas, V. & Raitani, S. (2015). A Study of the Impact of Relationship Marketing on Cross-Buying. Journal of Relationship Marketing, 14(2), 79-108. Weber, K., Sparks, B., & Hsu, C.H. (2016). The effects of acculturation, social distinctiveness, and social presence in a service failure situation. International Journal Hospital Management, 56, 44-55. Wu, J., Huang, L., Zhao, J.L., & Hua, Z. (2015).The deeper, the better? Effect of online brand community activity on customer purchase frequency. Information & Management, 52(7), 813-823. Yang, A., Chen, Y., & Huang, Y. (2017). Enhancing customer loyalty in tourism services: the role of customer-company identification and customer participation. Asia Pacific Journal of Tourism Research, 22(7), 735-746. Zhang, H., Zhang, K.Z., Lee, M.K., & Feng, F. (2015). Brand loyalty in enterprise microblogs: Influence of community commitment, IT habit, and participation. Information Technology & People, 28(2), 304-326.
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Kulmanova, Nurgul, and Muhtar Saduov. "Triage scales, used in inpatient emergency departments (review article)." Journal "Medicine" 7-8, no. 217-218 (January 13, 2021): 45–52. http://dx.doi.org/10.31082/1728-452x-2020-217-218-7-8-44-52.

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The article describes different types of sorting scales used in inpatient emergency departments in different countries. Triage scales are designed to optimize patient waiting times according to the severity of their medical condition in order to treat the most intense symptom as quickly as possible and reduce the negative impact on the prognosis of a long delay before starting treatment. The aim of the study is to analyze the literature data describing the scales for triage in the emergency department, their comparative characteristics, and assessment of their reliability and reliability. Material and methods. An online literature research was conducted in databases such as Pubmed, Web of Science and Scopus, as well as on-line publications in Russian and English languages. The following terms were used to search for relevant literature sources: emergency department, triage, emergency severity index. A total of 813 literary sources were found, 37 of which were selected for further analysis. Inclusion criteria: studies performed in people, published in English, Russian, as well as full versions of articles. Exclusion criteria: summary of reports, newspaper publications, personal messages. Results and discussion. Analysis of the literature data allows us to judge a variety of approaches and systems of medical sorting of patients requiring emergency medical care, especially in cases of mass disasters and injuries. Analysis of existing sorting scales has shown that these scales are fivestep and adapted to the region and the health system, but there is no single universal scale. Conclusion. The introduction of structured triage by specially trained medical personnel in the emergency Department helps to accurately identify patients whose lives are at risk, especially during periods of insufficient treatment effectiveness. Therefore, five-level triage systems are recommended by national and international societies of emergency medicine. Keywords: triage, system triage, emergency severity index, emergency department.
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Heinicke, Thomas, Rainer Krahl, Christoph Kahl, Sebastian Scholl, Hans-Heinrich Wolf, Detlev Hähling, Ute Hegenbart, et al. "Prognostic Factors for Overall Survival in Relapsed Acute Myeloid Leukemia." Blood 124, no. 21 (December 6, 2014): 3666. http://dx.doi.org/10.1182/blood.v124.21.3666.3666.

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Abstract Purpose: To define prognostic factors for overall survival in adult patients (pts) with relapsed acute myeloid leukemia (AML). Introduction: Prognostic factors for overall survival after AML relapse are poorly defined. Here, we investigate patient and disease related factors in terms of their impact on prognosis after AML relapse in a cohort of 495 adult AML relapse patients treated in two prospective AML trials of the East German Society of Hematology and Oncology (OSHO). Patients and methods: We retrospectively evaluated all consecutive relapsed AML pts treated in two OSHO trials (OSHO #61 (pts < 60 years) and OSHO #69 (pts > 60 years)). Age, cytogenetic risk at initial diagnosis, FLT3/NPM1 mutational status, type of AML (de novo versus secondary to myelodysplastic syndrome or myeloproliferative neoplasia (MDS/MPN) versus therapy related), time interval from first complete remission (CR1) to relapse and allogeneic stem cell transplantation (alloSCT) as consolidation in CR1 were evaluated in univariate and multivariate analysis. Results: Between March 2002 and July 2014, a total of 862 and 968 patients (pts) were enrolled in the OSHO #61 and #69 trial, respectively. Five hundred and thirty two of 690 (77%) documented pts achieved first complete remission in the #61 and 501 of 813 (62%) pts in the #69 trial. Of these, 495 pts (252 male, 243 female) experienced AML relapse, 207(39%) pts in #61 and 288(57%) pts in #69. Median age at relapse was 63 years (range 18 to 86 years). Initial diagnoses were de novo AML, secondary AML to MDS/MPN and therapy related AML in 332(67%) pts, 129 (25.9%) pts and 30 (6%) pts, respectively. Time from CR1 to relapse was < = 6 months in 198 (40%) pts, 7 to 18 months in 226 (45.7%) pts and > 18 months in 71 (14.3%) pts. Initial karyotpe was available for 449 pts (90.7 %). It was favorable, intermediate and poor in 20 (4.5%) pts, 301(67%) pts and 128(28.5%) pts, respectively. Sixty two (13.9%) relapsed pts had a monosomal karyotype at initial diagnosis. NPM1/FLT3 mutational status at initial diagnosis was available in 354 (78.8%) pts, 378 (71%) pts in #61 and 370 (74%) pts in #69. One hundred and three (20.8%) had allogeneic stem cell transplantation as consolidation in CR1 (56 pts) in #61 and (47 pts) in #69. Relapse therapy was documented in 450 (91%) pts. Six pts that had immunosuppression withdrawn as the only therapy and nine pts that had received a tyrosine kinase inhibitor as monotherapy were excluded from further analysis due to small numbers. All other treatments were as follows: intensive chemotherapy (INT) n=225, alloSCT with or without prior INT n=50, donor lymphocyte infusions (DLi) with or without prior chemotherapy n=22, palliative mild cytoreductive chemotherapy (mCT) n=66, azacitidine (Aza) n=52, best supportive care (BSC) n=20. With these, CR was achieved in 78 (36%), 34 (68%), 8 (36%), 6 (9%), 1 (2%), 0 (0%), respectively. Median overall survival probability (OS) for all 495 relapsed patients was 6 months. It was 11.3 months, 5.7 months, 4.5 months and 4.6 months for patients aged 18 to 50 years, 51 to 60 years, 61 to 70 years and 71 to 86 years, respectively (p<0.0005). Initial cytogenetics also influenced OS, it was 10.4 months, 7.5 months and 3.8 months for patients with a favorable, intermediate and poor karyotype, respectively (p<0.0005). Having a monosomal karyotype at initial diagnosis was associated with a median OS of only 2.3 months (p<0.001). Initial FLT3/NPM1 mutational status had no impact on OS after relapse. OS was 4 months, 7.1 months and 16.9 months for pts with a time interval from CR1 to relapse of <= 6 months, 7 to 18 months and > 18 months, respectively (p<0.0005). In univariate analysis age (p<0.0005), initial cytogenetic risk (p<0.0005), type of AML (p=0.01), interval from CR1 to relapse (p<0.0005), alloSCT in CR1 (p=0.03) and type of relapse therapy (p<0.0005) had a significant impact on OS. In multivariate analysis favorable prognostic factors for OS were lower age (p<0.0005), favorable initial cytogenetics (p=0.01), longer interval from CR1 to relapse (p<0.0005) and not having undergone alloSCT in CR1. Conclusions: Our study shows that outcome of relapsed AML pts is poor. Younger age, favorable cytogenetics at initial diagnosis, a longer interval from CR1 to relapse and not having undergone alloSCT as consolidation in CR1 are positive prognostic factors, whereas type of AML and FLT3/NPM1 mutational status have no significant impact on survival after relapse. Disclosures Off Label Use: Azacitidine is licensed in Germany for the treatment of adult patients with the following conditions, who are not eligible for haematopoietic stem cell transplantation: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, • acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia,according to World Health Organisation (WHO) classification.. Wolf:Bayer: Honoraria; Geo Pharma: Honoraria. Sayer:Takeda: Other; Medac: Other. Al-Ali:Novartis: Consultancy, Honoraria, Research Funding; Celgene: Honoraria, Research Funding.
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Casemir, Kirstin. "Rezension zu Leopold Schütte, Wörter und Sachen aus Westfalen 800 bis 1800." Namenkundliche Informationen, July 6, 2015. http://dx.doi.org/10.58938/ni680.

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Leopold Schütte: Wörter und Sachen aus Westfalen 800 bis 1800. Zweite, überarbeitete und erweiterte Auflage (Veröffentlichungen des Landesarchivs Nordrhein-Westfalen 52), Duisburg: Landesarchiv Nordrhein-Westfalen 2014, 813 S. – ISBN 978-3-932892-32-5, Preis: EUR 19,80 (DE).
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Abd Ghani, Faizah. "Profil Personaliti dalam Kalangan Pensyarah UTM yang Cemerlang dalam Pengajaran dan Pembelajaran Berdasarkan Penilaian Pengajaran Pensyarah." Jurnal Teknologi 60, no. 1 (December 15, 2012). http://dx.doi.org/10.11113/jt.v60.1447.

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This study aims to identify the personality profile among UTM lecturers who were excellent in teaching and learning based on the lecturers‟ teaching evaluation system (PPP) for semester 2 session 2007/2008 and semester 1 2008/2009. This study is corellational study and used the Big Five Personality Traits as framework research. A total of 52 lecturers had been selected using purposive sampling method. NEO-PIR inventory set by McCrae and Costa (1992) and translated by Khairul Anwar (2000) had been used in this study. It shows a high level of reliability which demonstrated the alpha Cronbach value of .870 for Neuroticism, .804 for Extraversion, .790 for Openness to Experience, .682 for Agreeableness and .904 for Conscientiousness. Overall, the value of alpha Cronbach is .813. The data collected were analyzed using 'Statistical Packages for Social Sciences(SPSS v12 for windows). The result of the descriptive analysis showed that the majority of excellent lecturers have conscientiousness profile of personality (mean=182.57), followed by agreeableness (mean=175.75) and extraversion (mean=160.019). The finding also showed that there was no significant between the profile of personality and achievement among the excellent lecturers. Keywords:Personality profile; lecturer; excellent; teaching and learning; teaching evaluation Kajian ini bertujuan untuk mengkaji profil personaliti pensyarah UTM yang cemerlang dalam pengajaran dan pembelajaran berdasarkan Penilaian Pengajaran Pensyarah (PPP) bagi semester 2 sesi 2007/2008 dan semester 1 sesi 2008/2009. Kajian ini merupakan kajian korelasi dan menggunakan Teori Tret Personaliti Big Five sebagai kerangka kajian. Seramai 52 orang pensyarah cemerlang dalam PPP dilibatkan sebagai responden. Persampelan bertujuan digunakan dalam kajian ini dan Soal selidik NEO-PI-R oleh McCrae and Costa (1992) yang diterjemahkan oleh Khairul Anwar (2000) digunakan sebagai instrumen kajian. Soal Selidik ini mempunyai nilai kebolehpercayaan yang baik berdasarkan nilai alpha Cronbach .870 bagi domain Neuroticism (N), .804 bagi domain Extraversion (E), .790 bagi domain Openness to Experience (O), .682 bagi domain Agreeableness (A), dan .904 bagi domain Conscientiousness (C). Nilai alpha Cronbach bagi keseluruhan item adalah .813. Data yang telah dikumpul dianalisis menggunakan „Statistical Packages for Social Sciences’ (SPSS) versi 12.0 for windows. Analisis deskriptif menunjukkan bahawa majoriti pensyarah yang cemerlang memiliki profil personaliti conscientiousness (min=182.57) diikuti dengan agreeableness (min=175.75) dan extraversion (min=160.019). Dapatan kajian menunjukkan tidak terdapat hubungan profil personaliti dengan pencapaian pensyarah yang cemerlang. Kata kunci: Profil personaliti; pensyarah; cemerlang; pengajaran dan pembelajaran; penilaian pengajaran
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Martinez Santos, P., A. Aurtenetxe Perez, M. J. Lopez Gude, J. A. Barbera, M. Lopez Meseguer, R. Lopez Reyes, A. Martinez Menaca, et al. "P4672Current outcome of chronic thromboembolic pulmonary hypertension in Spain." European Heart Journal 40, Supplement_1 (October 1, 2019). http://dx.doi.org/10.1093/eurheartj/ehz745.1054.

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Abstract Background Chronic thromboembolic pulmonary hypertension (CTEPH) treatment has evolved over the last decade. Increasing evidence regarding new therapeutic developments has shown clinical benefit among these patients in different scenarios. However, there is scarce information about the long-term impact of these achievements in a real-life population on a national scale. We aimed to analyze the impact of current CTEPH therapies on survival in Spain. Methods We prospectively collected epidemiological, clinical and prognostic data from CTEPH patients consecutively included in the Spanish REHAP registry from January 1, 2007, to December 31, 2017. All-cause mortality data were gathered during this period. Results Eight hundred thirteen patients were included. The mean age was 61 (15) years and 58.1% were women. Out of the 813 patients, 537 (66%) were referred to an expert PH-center. Overall, 245 (30.1%) patients were selected for surgery and 52 (6.4%) for percutaneous treatment and 452 (60.5%) received medical treatment exclusively with specific PH drugs. Survival rates of patients who underwent an invasive procedure (pulmonary thrombendarterectomy or balloon pulmonary angioplasty) were remarkably high. Figure 1. Cumulative survival from date Conclusions Patients who underwent pulmonary thrombendarterectomy or balloon pulmonary angioplasty associated a better outcome. Acknowledgement/Funding We gratefully acknowledge all investigators of the REHAP Registry. We express our gratitude to Actelion, Ferrer, GlaxoSmithKline (GSK) and Merck Sharp
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Sabater-Pastor, Frederic, Katja Tomazin, Grégoire P. Millet, Julien Verney, Léonard Féasson, and Guillaume Y. Millet. "VO2max and Velocity at VO2max Play a Role in Ultradistance Trail-Running Performance." International Journal of Sports Physiology and Performance, 2023, 1–6. http://dx.doi.org/10.1123/ijspp.2022-0275.

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Purpose: Previous research has shown that maximal oxygen uptake (VO2max) significantly influences performance in trail-running races up to 120 km but not beyond. Similarly, the influence of running economy on performance in ultratrail remains unclear. The aim of our study was, therefore, to determine the physiological predictors of performance in a 166-km trail-running race. Methods: Thirty-three experienced trail runners visited the laboratory 4 to 8 weeks before the race to undergo physiological testing including an incremental treadmill test and strength assessments. Correlations and regression analyses were used to determine the physiological variables related to performance. Results: Average finishing time was 37:33 (5:52) hours. Performance correlated significantly with VO2max (r = −.724, P < .001), velocity at VO2max (r = −.813, P < .001), lactate turn point expressed as percentage of VO2max (r = −.510, P = .018), cost of running (r = −.560, P = .008), and body fat percentage (r = .527, P = .012) but was not related to isometric strength. Regression analysis showed that velocity at VO2max predicted 65% of the variability in performance (P < .001), while a model combining VO2max and cost of running combined predicted 62% of the variability (P = .008). Conclusion: This is the first study to show that VO2max and velocity at VO2max are significant predictors of performance in a 166-km trail-running race. This suggests that ultratrail runners should focus on the development of these 2 qualities to optimize their race performance.
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50

Giovannoni, Gavin, Patricia K. Coyle, Patrick Vermersch, Bryan Walker, Julie Aldridge, Axel Nolting, Andrew Galazka, Caroline Lemieux, and Thomas P. Leist. "Integrated Lymphopenia Analysis in Younger and Older Patients With Multiple Sclerosis Treated With Cladribine Tablets." Frontiers in Immunology 12 (December 24, 2021). http://dx.doi.org/10.3389/fimmu.2021.763433.

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Cladribine tablets (CladT) preferentially reduce B and T lymphocyte levels. As aging is associated with a decline in immune function, the effect of CladT on lymphocyte levels may differ by age. This post hoc analysis combined data from the Phase 3 CLARITY, CLARITY Extension, and ORACLE-MS studies to examine the effect of age (≤50 or &gt;50 years) on lymphopenia following CladT 3.5 mg/kg (CladT3.5; cumulative dose over 2 years) treatment over 96 weeks. Both CladT3.5 and placebo were given over Weeks 1 and 5 (Year 1 treatment) and Weeks 48 and 52 (Year 2 treatment) from the start of the studies. Absolute lymphocyte count (ALC) and levels of lymphocyte subsets were examined in 1564 patients (Age ≤50 [placebo: N=566; CladT3.5: N=813]; Age &gt;50 [placebo: N=75; CladT3.5: N=110]). In both age groups, following CladT3.5 treatment, nadir for ALC occurred at Week 9 (8 weeks following start of Year 1 treatment) and Week 55 (7 weeks following start of Year 2 treatment) of the 96-week period; for CD19+ B lymphocytes, nadir occurred at Week 9 (Year 1) and Week 52 (Year 2). For CD4+ T lymphocytes, nadir occurred at Week 16 (Year 1) in both age groups, and at Weeks 60 and 72 (Year 2) in the Age ≤50 and &gt;50 groups, respectively. Nadir for CD8+ T lymphocytes occurred at Week 16 (Year 1) and Week 72 (Year 2) in the Age ≤50 group and levels remained in the normal range; nadir occurred at Week 9 (Year 1) and Week 96 (Year 2) in the Age &gt;50 group. Lymphocyte recovery began soon after nadir following CladT3.5 treatment and median levels reached normal range by end of the treatment year in both age groups. By Week 96, ~25% of patients treated with CladT3.5 reported ≥1 episode of Grade ≥3 lymphopenia (Gr≥3L). The rate of certain infections was numerically higher in older versus younger patients who experienced Gr≥3L. In conclusion, CladT3.5 had a similar effect on ALC and lymphocyte subsets in both younger and older patient groups.
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