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Katharine Batt,1 Wei Gao,2 Rajeev Ayyagari,2 Céline Deschaseaux,3 Parth B Vashi,4 Zhiwen Yao,2 Yao Wang,2 Sophia Kessabi,3 Robert Klamroth51Department of Internal Medicine, Section on Hematology/Medical Oncology, Wake Forest University Baptist Medical Center, Winston-Salem, NC, USA; 2Analysis Group, Inc., Boston, MA, USA; 3Global Market Access Hematology, Bayer Consumer Care AG, Basel, Switzerland; 4US Data Generation and Observational Studies, Bayer Corporation, Whippany, NJ, USA; 5Department for Internal Medicine - Vascular Medicine and Coagulation Disorders, Vivantes Klinikum im Friedrichshain, Berlin, GermanyBackground: BAY 94-9027 is an extended half-life recombinant factor VIII (rFVIII) that prevents bleeding in persons with hemophilia A at twice-weekly, 5-day, and 7-day dosing intervals. In rare diseases such as hemophilia, where small populations preclude head-to-head comparisons in randomized controlled trials, outcomes from different studies can be compared by matching-adjusted indirect treatment comparisons (MAICs) via matched summary statistics of individual patient data. This study compared MAIC-adjusted outcomes of BAY 94-9027 with other FVIII agents for prophylaxis of hemophilia.Methods: Weighted patient data from the BAY 94-9027 PROTECT VIII trial were used to compare annualized bleeding rates (ABRs), percentage of patients with zero bleeds, and factor utilization against published data on rFVIII–Fc fusion protein (rFVIIIFc), BAX 855, and recombinant antihemophilic factor/plasma/albumin-free method (rAHF-PFM).Results: After matching BAY 94-9027 and comparators, the mean BAY 94-9027 utilization was significantly lower than rFVIIIFc pre- and post-matching (66.2 vs 82.2 IU/kg/week; 66.5 vs 82.2 IU/kg/week; both P

Jennifer Pocoski,1 Nanxin Li,2 Rajeev Ayyagari,2 Nikki Church,1 Monika Maas Enriquez,1 Quer Xiang,2 Sneha Kelkar,3 Ella X Du,2 Eric Q Wu,2 Jipan Xie3 1Bayer HealthCare Pharmaceuticals, Whippany, NJ, 2Analysis Group, Inc., Boston, MA, 3Analysis Group, Inc., New York, NY, USA Background: No head-to-head trials comparing recombinant factor VIII (rFVIII) products currently exist. This was a matching-adjusted indirect comparison (MAIC) study of efficacy of BAY 81-8973 with antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM) and turoctocog alfa for the prophylaxis of severe hemophilia A. Methods: A systematic literature review was conducted to identify trials of rAHF-PFM and turoctocog alfa. Comparisons were conducted using BAY 81-8973 individual patient data (IPD) from LEOPOLD trials and published data from rAHF-PFM and turoctocog alfa trials. Differences in outcome reporting were reconciled using transformation of BAY 81-8973 IPD. Patients in pooled LEOPOLD trials were weighted to match baseline characteristics for rAHF-PFM or turoctocog alfa trials using MAICs. After matching, annualized bleed rates (ABRs) were compared using weighted t-tests. Results: Two rAHF-PFM trials and one turoctocog alfa trial were identified. In these trials, rFVIIIs were dosed thrice weekly or every other day; in LEOPOLD trials, BAY 81-8973 was dosed twice- or thrice weekly. Three MAICs were conducted because the two rAHF-PFM trials calculated ABRs differently, matching for age, race, and weight (turoctocog alfa only). BAY 81-8973 had similar ABR of all bleeds vs rAHF-PFM (two trials: 4.8 vs 6.3, 1.9 vs 1.8 [square root transform]) and lower ABR of spontaneous bleeds and trauma bleeds (2.6 vs 4.1, 2.1 vs 4.7; both P

A novel formulation of the flight dynamic equations is presented that permits a rapid solution for the design of trajectory following autopilots for nonlinear aircraft dynamic models. A robust autopilot control structure is developed based on the combination of the good features of the nonlinear dynamic inversion (NDI) method, integrator backstepping method, time scale separation and control allocation methods. The aircraft equations of motion are formulated in suitable variables so that the matrices involved in the block backstepping control design method are diagonally dominant. This allows us to use a linear controller structure for a trajectory following autopilot for the nonlinear aircraft model using the well known loop by loop controller design approach. The resulting autopilot for the fixed-wing rigid-body aircraft with a cascaded structure is referred to as the diagonally dominant backstepping (DDBS) controller. The method is illustrated here for an aircraft auto-landing problem under unknown actuator failures and severe winds. The requirement of state and control surface limiting is also addressed in the context of the design of the DDBS controller. [ABSTRACT FROM AUTHOR]

3:54 PM Abstract No. 342 Prostatic artery embolization with 100- to 300- m microspheres to treat urinary retention caused by benign prostatic hyperplasia: medium-term outcomes with stratified obstructive and irritative symptom analysis To present medium-term results, including stratified International Prostate Symptom Scores (IPSS), for prostatic artery embolization (PAE) with 100- to 300- m microspheres to treat obstructive urinary retention. 4 patients began self-catheterization and 3 patients remained with catheters. [Extracted from the article]

Food lectins are known to affect the absorption of nutrients in experimental animals and altered morphology of the intestinal mucosa due to prolonged feeding of lectins is suggested to be the cause. However, toxic symptoms appear in humans immediately after consumption of lectin rich foods and the mechanism of this immediate action is not known. This study reports the immediate effect of Concanavalin A (Con A) and Phaseolus vulgaris lectin (PHA-P) on the absorption of Ca2+ and sucrose in rat intestine and the possible role of lectin-membrane interactions in the process. Calcium absorption was lowered by Con A, and this was observed to be due to Con A interacting with the intestinal mucosal membrane. Similarly, sucrose absorption was also altered, probably due to Con A binding the intestinal mucosal membrane. On the other hand PHA-P did not have any effect on either sucrose or calcium absorption. Results indicate that the effect on intestinal nutrient absorption depends on the type of lectin used (and its concentration) as well as the type of nutrient, besides the duration of exposure of intestinal mucosa to the lectin. [ABSTRACT FROM AUTHOR]

We have demonstrated the presence of epidermal growth factor (EGF) and its receptors in human non-gestational corpora lutea. To determine further the characteristics of EGF receptor binding, we examined 30 human corpora lutea throughout the luteal phase and during pregnancy. Scatchard plots of EGF binding in 29 of the 30 corpora lutea were curvilinear, suggesting negative co-operativity. The mean +/- SE of the association constant Ka was (0.9 +/- 0.2) x 10(9) l/mol, the dissociation constant Kd was (2.2 +/- 0.3) x 10(-9) mol/l and the number of binding sites (Rt) was (15.8 +/- 2.1) x 10(-19) mol/micrograms protein for non-gestational corpora lutea. The Kd increased significantly in late pregnancies compared to early pregnancies (P = < 0.005), while Rt was significantly higher in term pregnancies than in either early pregnancy (P < 0.01) or the menstrual cycle (P < 0.001). Corpora lutea atretica (n = 2) and ovarian stroma (n = 6) did not show any EGF binding activity. Our findings demonstrate the presence of specific EGF receptors in human corpora lutea of both the menstrual cycle and pregnancy. The changes in EGF binding parameters in early pregnancy suggest that there may be a relationship between the role of EGF and ovarian steroidogenesis. [ABSTRACT FROM AUTHOR]

Abstract No. 61 Prostatic artery embolization with 100- to 300- m microspheres to treat lower urinary tract symptoms attributable to benign prostatic hyperplasia: a single-center analysis of 4-year outcomes. [Extracted from the article]

Abstract No. 60 Prostatic artery embolization with 100- to 300- m microspheres to treat urinary retention attributable to benign prostatic hyperplasia: a single-center analysis of 4-year outcomes. [Extracted from the article]

An interview with Anne Scrivener Agee, vice provost for information technology (IT) and chief information officer (CIO) at the University of Massachusetts at Boston, on security and privacy issues is presented. She describes her responsibilities and role as a CIO. She discusses the things being done by the university to promote awareness of information security and privacy issues. When asked about the future challenges for the university, she cites the regulations that the university has to follow.

Prostate artery embolization (PAE) has emerged as an effective and favorable procedure for treatment lower urinary tract symptoms (LUTS) in patients with BPH. This study evaluates the efficacy of prostate artery embolization (PAE) for the treatment of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS). 256 patients who underwent PAE for either BPH with LUTS, hematuria, urinary retention or a combination of these from January 2014 to May 2019 were evaluated as part of an IRB-approved retrospective analysis at a single institution. [Extracted from the article]

To re-evaluate the safety and efficacy of prostate artery embolization (PAE) for the treatment of benign prostatic hyperplasia (BPH) for prostates > 80 g. At 3 months mean IPSS was 7.3 (V67%, n = 136, P <0.001), mean QOL was 1.2 (V73%, n = 138, P <0.001), mean PVR was 104.5 mL (V52%, n = 42, P <0.001), mean prostate size was 100.5 g (V35%, n = 130, P <0.001). PAE achieved a clinically and statistically significant improvement in lower urinary tract symptoms and secondary outcome measures in patients with prostates > 80g. [Extracted from the article]

Aircraft noise in the vicinity of airports is a well-recognized problem. Rules and regulations are in effect that set limits on the noise levels of aircraft. Although the airplanes in the commercial fleet meet the appropriate regulations, there is always a constant effort within The Boeing Company to lower the noise levels. This requires a thorough understanding of the source mechanisms and propagation effects. The total noise of an airplane is composed of engine noise and airframe noise. The engine noise itself includes various components such as jet, core, fan, and turbine noise. There has been a lack of good quality flight noise data base, especially for wide body aircraft with high bypass ratio engines. To alleviate this, several test programs have been completed within The Boeing Company. The results of one of these programs, the test of a Boeing 747 airplane fitted with Pratt and Whitney JT9D engines, are presented in this paper. From the noise results, regions of jet noise dominance, fan noise dominance, and core noise dominance are identified. Methodology that will be used for more accurate breakdown of the noise components in regions where they are not dominant is outlined. [ABSTRACT FROM AUTHOR]

Abstract: Exome and whole-genome analyses powered by next-generation sequencing (NGS) have become invaluable tools in identifying causal mutations responsible for Mendelian disorders. Given that individual exomes contain several thousand single nucleotide variants and insertions/deletions, it remains a challenge to analyze large numbers of variants from multiple exomes to identify causal alleles associated with inherited conditions. To this end, we have developed user-friendly software that analyzes variant calls from multiple individuals to facilitate identification of causal mutations. The software, termed exomeSuite, filters for putative causative variants of monogenic diseases inherited in one of three forms: dominant, recessive caused by a homozygous variant, or recessive caused by two compound heterozygous variants. In addition, exomeSuite can perform homozygosity mapping and analyze the variant data of multiple unrelated individuals. Here we demonstrate that filtering of variants with exomeSuite reduces datasets to a fraction of a percent of their original size. To the best of our knowledge this is the first freely available software developed to analyze variant data from multiple individuals that rapidly assimilates and filters large data sets based on pattern of inheritance. [Copyright &y& Elsevier]

We have identified a novel human gene, chromosome 6 open reading frame 37 (C6orf37), that is expressed in the retina and maps to human chromosome 6q14, a genomic region that harbors multiple retinal disease loci. The cDNA sequence contains an open reading frame of 1314 bp that encodes a 437-amino acid protein with a predicted molecular mass of 49.2 kDa. Northern blot analysis indicates that this gene is widely expressed, with preferential expression observed in the retina compared to other ocular tissues. The C6orf37 protein shares homology with putative proteins in R. norvegicus, M. musculus, D. melanogaster, and C. elegans, suggesting evolutionary conservation of function. Additional sequence analysis predicts that the C6orf37 gene product is a soluble, globular cytoplasmic protein containing several conserved phosphorylation sites. Furthermore, we have defined the genomic structure of this gene, which will enable its analysis as a candidate gene for chromosome 6q-associated inherited retinal disorders. [Copyright &y& Elsevier]