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NTHi killing activity is reduced in COPd patients and is associated with a differential microbiome

rESPIrATOrY rESEArCH 2025年第1期26卷 1-14页

作者： Gopalakrishnan, Vancheswaran Sparklin, Ben Kim, Jung Hwan Bouquet, Jerome Kehl, Margaret Kenny, Tara Morehouse, Christopher Caceres, Carolina Warrener, Paul Hristova, Ventzislava A. Wilson, Susan Shandilya, Harini Barnes, Arnita ruzin, Alexey Wang, Junmin Oberg, Lisa Angermann, Bastian Mccrae, Christopher Platt, Adam Muthas, daniel Hess, Sonja Tkaczyk, Christine Sellman, Bret r. Ostridge, Kristoffer Belvisi, Maria G. Wilkinson, Tom M. A. Staples, Karl J. digiandomenico, Antonio MICA II Study Grp, Vancheswaran AstraZeneca BioPharmaceut R&D Bioinformat Res & Early Dev Vaccines & Immune Ther Gaithersburg MD USA AstraZeneca BioPharmaceut R&D Bacterial Vaccines Res & Early Dev Vaccines & Immu Gaithersburg MD USA AstraZeneca BioPharmaceut R&D Virol & Vaccine Discovery Res & Early DevVaccines & Immune Therapies Gaithersburg MD USA AstraZeneca BioPharmaceut R&D Res & Early Dev Translat Sci ManagementVaccines & Immune Therapie Gaithersburg MD USA AstraZeneca Ctr Genom Res CGR BioPharmaceut R&D Dynam OmicsDiscovery Sci Gaithersburg MD USA AstraZeneca Oncol R&D Biol Engn Gaithersburg MD USA AstraZeneca BioPharmaceut R&D Quantitat Biol Data Sci & Quantitat BiolDiscovery Sci AstraZeneca Gaithersburg MD USA AstraZeneca Translat Sci & Expt Med Res & Early Dev BioPharmaceut R&DResp & Immunol Gothenburg Sweden AstraZeneca Translat Sci & Expt Med BioPharmaceut R&D Res & Early DevResp & Immunol Gaithersburg MD USA AstraZeneca BioPharmaceut R&D Res & Early Dev Translat Sci & Expt MedResp & Immunol Cambridge England AstraZeneca Res & Early Dev Vaccines & Immune Therapies BioPharmaceut R&DMicrobial Antibodies & Technol Gaithersburg MD 20878 USA Univ Southampton Fac Med Clin & Expt Sci Southampton England AstraZeneca Res & Early Dev Resp & Immunol BioPharmaceut R&D Gothenburg Sweden Univ Hosp Southampton NIHR Southampton Biomed Res Ctr Southampton England

Chronic obstructive pulmonary disease (COPd) is a chronic lung disease characterized by airway obstruction and inflammation. Non-typeable Haemophilus influenzae (NTHi) lung infections are common in COPd, promoting frequent exacerbations and accelerated lung function decline. The relationship with immune responses and NTHi are poorly understood. Herein, we comprehensively characterized the respiratory microbiome and mycobiome of patients while investigating microbial dynamics and host immune changes attributable to NTHi killing activity. Mild-to-moderate COPd patients encompassing frequent and infrequent exacerbators and healthy volunteers (HV) were enrolled. Microbial composition, proteomics and NTHi killing activity was analyzed using bronchoalveolar lavage fluid (BALF). In addition, antigen-antibody titers in sera to COPd pathogens were determined using a multiplex assay. differential abundance analysis revealed an enrichment of Actinobacteria and Bacteroidetes in the BALF of COPd and HV subjects respectively. Significant differences in the IgA titer response were observed against NTHi antigens in COPd vs. HV. Notably, there was also significantly greater killing activity against NTHi in BALF from COPd vs. HV subjects (Or = 5.64;95% CI = 1.75-20.20;p = 0.001). Stratification of COPd patients by NTHi killing activity identified unique microbial and protein signatures wherein Firmicutes, Actinobacteria and haptoglobin were enriched in patients with killing activity. We report that differences in host immune responses and NTHi-killing activity are associated with microbiome changes in mild-to-moderate COPd. This is suggestive of a potential link between the respiratory microbiome and immune activity against NTHi in the context of COPd pathogenesis even at this disease stage.

关键词： COPd Non-typeable Haemophilus influenzae Microbiome Exacerbations

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Gauging the ungauged: estimating rainfall in a West African urbanized river basin using ground-based and spaceborne sensors

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HYdrOLOGICAL SCIENCES JOUrNAL 2024年第2期69卷 259-273页

作者： Bogerd, Linda Pinto, rose B. Leijnse, Hidde Meirink, Jan Fokke van Emmerik, Tim H. M. Uijlenhoet, remko Wageningen Univ Hydrol & Environm Hydraul Grp POB 47 NL-6700 AA Wageningen Netherlands Royal Netherlands Meteorol Inst KNMI R&D Observat & Data Technol De Bilt Netherlands Royal Netherlands Meteorol Inst KNMI R&D Satellite Observat De Bilt Netherlands Delft Univ Technol Dept Water Management Delft Netherlands

Accurate precipitation observations are crucial for hydrological forecasts, notably over rapidly responding urban areas. This study evaluated the accuracy of three gridded spaceborne rainfall products (Integrated Multi-satellitE retrievals for GPM (IMErG), Meteosat Second Generation Visible (MSG-VIS), and MSG-Infrared (MSG-Ir)) and the non-governmental Trans-African Hydro-Meteorological Observatory (TAHMO) gauges across the Odaw catchment (Accra, Ghana) from January 2020-July 2022. IMErG is hardly able to capture the strong spatial variability of rainfall required for flood forecasting, but agrees in annual sums with TAHMO and MSG-Ir. MSG-Ir has difficulties during the wet season. MSG-VIS, only available during daylight, shows limited accuracy and gives high estimates while other products do not detect rain. TAHMO gauges effectively record high-intensity events and their strong spatial variability, although some (daily) accumulations are doubtful and data gaps exist due to technical issues. These findings assist hydrological modelers in selecting appropriate datasets at suitable spatiotemporal resolutions for their research.

关键词： precipitation floods Accra raingauges satellite measurements

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development of a Knowledge-Based Multimodal deep Learning System for Automatic Breast Lesion Segmentation and diagnosis in MG/dMr Images 8

Development of a Knowledge-Based Multimodal Deep Learning Sy...

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8th International Conference on Computer Science and Engineering, UBMK 2023

作者： Araz, Nusret Orhan, Gozde Cavusoglu, Mustafa Surmeli, Hulusi Emre Bayram, Bulent Cakar, Tuna Head of Data Science and Ai Mlpcare R&d Department Istanbul Turkey Data Scientist Mlpcare R&d Department Istanbul Turkey Head of Project Management Mlpcare R&d Department Istanbul Turkey Yildiz Technical University Geomatic Engineering Istanbul Turkey Mef University Computer Engineering Istanbul Turkey

ISBN: (纸本)9798350340815

deep learning networks (dLNs) rely on labeled training datasets as their fundamental building blocks. While various databases exist worldwide, there is currently no domestic solution available in our country. This project aims to create a domestic database by automatically segmenting breast lesions in MG/dMr images based on their types and developing a knowledge-based multimodal dL-based integrated computer-aided diagnosis system to analyze the images, thereby providing the system with continuous learning capability. different brands of devices exist for MG/dMr, necessitating the multimodal operation of image processing/artificial intelligence algorithms. To achieve this goal, the network was trained first, and then prelearned data were transferred to enable the training of data from different networks once accurate results are obtained. The developed system has the potential to enable the automatic detection of breast lesions, ensuring fast and high diagnostic accuracy. Additionally, it might also facilitate the retrospective analysis of patients' periodic check-up results. © 2023 IEEE.

关键词： Computer aided diagnosis

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Quality Tolerance Limits' Place in the Quality management System and Link to the Statistical Trial design: Case Studies and recommendations from Early Adopters

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THErAPEUTIC INNOVATION & rEGULATOrY SCIENCE 2023年第4期57卷 839-848页

作者： Wolfs, Marion Bojarski, Lukasz Young, Steve Cesario, Lynne Makowski, Marcin Sullivan, Linda B. Janssen Res & Dev Integrated Data Analyt & Reporting Graaf Engelbertlaan 75 NL-4837 DS Breda Netherlands AstraZeneca R&D BioPharmaceut Dev Operat Ul Postepu 14 PL-02675 Warsaw Poland CluePoints Inc King Of Prussia PA USA Pfizer R&D New York NY USA GlaxoSmithKline GmbH & Co KG Data Strategy & Management Prinzregentenpl 9 D-81675 Munich Germany WCG Metr & Performance Management Indianapolis IN USA

Since the release of ICH E6(r2), multiple efforts have been made to interpret the requirements and suggest ways of implementing quality tolerance limits (QTLs) alongside existing risk-based quality management methodologies. While these efforts have contributed positively to developing a common understanding of QTLs, some uncertainty remains regarding implementable approaches. In this article, we review the approaches taken by some leading biopharmaceutical companies, offering recommendations for how to make QTLs most effective, what makes them ineffective, and several case studies to illustrate these concepts. This includes how best to choose QTL parameters and thresholds for a given study, how to differentiate QTLs from key risk indicators, and how QTLs relate to critical-to-quality factors and the statistical design of the trials.

关键词： Quality tolerance limits Key risk indicators risk based quality management Statistical design Case studies Threshold

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Co-treatment with Gabapentinoid and Japanese Herbal Medicine Goshajinkigan for CIPN is Associated with Longer duration and Higher dose of Chemotherapy

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AdVANCES IN THErAPY 2025年第6期42卷 2833-2852页

作者： Miyano, Kanako Uezono, Yasuhito Yamaguchi, Takuhiro Hashimoto, Wataru Komoriya, Satoshi Jikei Univ Dept Pain Control Res Sch Med Minato Ku Tokyo Japan Juntendo Univ Fac Pharm Lab Pharmacotherapeut Urayasu Chiba Japan Tohoku Univ Grad Sch Med Div Biostat Sendai Miyagi Japan Daiichi Sankyo Co Ltd Data Intelligence Dept Tokyo Japan Daiichi Sankyo Co Ltd R&D Div R&D Management Dept Tokyo Japan

IntroductionIn Japan, both gabapentinoids and the Japanese traditional herbal medicine goshajinkigan (GJG) are used to manage chemotherapy-induced peripheral neuropathy (CIPN);however, evidence for their effectiveness is inconclusive. Patients with CIPN experience reduced quality of life and often undergo reductions in dose or discontinuation of chemotherapy. Therefore, this retrospective cohort study used a real-world database to examine the efficacy of gabapentinoids and GJG therapy for patients with CIPN by evaluating chemotherapy duration and *** from 145,384 patients diagnosed with CIPN while receiving platinum- or taxane-based chemotherapy between April 1, 2008 and March 31, 2022 were stratified by CIPN treatment: simultaneous gabapentinoid (mirogabalin or pregabalin) plus GJG (prescription dates overlap);non-simultaneous gabapentinoid plus GJG (prescription dates do not overlap);gabapentinoid alone;GJG alone;and neither gabapentinoids nor GJG. duration and dose of chemotherapy were the primary *** with either a gabapentinoid or GJG alone was associated with longer duration and higher doses of chemotherapy versus neither gabapentinoids nor GJG in patients treated with carboplatin, cisplatin, or paclitaxel. Combined gabapentinoid plus GJG treatment elicited further longer duration and higher doses of chemotherapy versus gabapentinoid alone or GJG alone in patients treated with carboplatin, oxaliplatin, cisplatin, paclitaxel, or docetaxel. When stratified by cancer type, similar trends were observed regarding combination gabapentinoid plus GJG treatment among patients with colorectal cancer treated with oxaliplatin and patients with gastric, lung, or breast cancer treated with *** treatment with gabapentinoid plus GJG might prevent reductions in dose or discontinuation of chemotherapy, and might be effective for the treatment of CIPN.

关键词： Chemotherapy-induced peripheral neuropathy Gabapentinoid Goshajinkigan Japanese herbal Kampo medicine Platinum-based chemotherapy Taxane-based chemotherapy

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SHAMan: A Versatile Auto-tuning Framework for Costly and Noisy HPC Systems 5th

SHAMan: A Versatile Auto-tuning Framework for Costly and Noi...

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4th International Conference on Optimization and Learning (OLA)

作者： robert, S. Zertal, S. Couvee, P. Atos BDS R&D Data Management Echirolles France Univ UPSacaly UVSQ Guyancourt France

Most of the software of modern computer systems come with many configurable parameters that control the system’s behavior and its interaction with the underlying hardware. © 2022, The Author(s), under exclusive ... 详细信息

ISBN: (纸本)9783031220388;9783031220395

关键词： Computer hardware

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Characterizing the use of dVFS for HPC I/O optimization: a Microbenchmarking Approach 5

Characterizing the use of DVFS for HPC I/O optimization: a M...

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5th Workshop on Challenges and Opportunities of Efficient and Performant Storage Systems-CHEOPS

作者： Nicolas, Louis-Marie Mimouni, Salim Couvee, Philippe Boukhobza, Jalil Inst Polytech Paris Lab STICC CNRS UMR 6285ENSTA F-29806 Brest France Atos BDS R&D Data Management F-38100 Grenoble France

ISBN: (纸本)9798400715297

The scale of HPC clusters has increased over the past decade, eventually achieving exascale in 2022. While the shift to exascale computing meets the rising demand for processing power, it introduces challenges in energy consumption and power efficiency. dynamic Voltage and Frequency Scaling (dVFS), is a common tool that can be used to reduce the processor's power usage. However, while the effect of dVFS during classical compute tasks has already been well-documented, its impact on I/Os has not been covered by the literature. In this paper, we offer a comprehensive investigation of the impact of dVFS on a compute node comprising two AMd EPYC rome 7282 CPU in an HPC cluster. Our contributions include (1) a methodology to microbenchmark the performance and energy consumption impact of dVFS in an HPC system through the use of carefully selected synthetic application, (2) a set of results and analysis related to the behavior of dVFS on the tested HPC nodes, and (3) some guidelines for using dVFS on HPC applications.

关键词： dynamic Voltage and Frequency Scaling Energy-Aware Computing Energy-Aware I/Os High-Performance Computing

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discovery of Clinical Candidate AZd5462, a Selective Oral Allosteric rXFP1 Agonist for Treatment of Heart Failure

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JOUrNAL OF MEdICINAL CHEMISTrY 2024年第6期67卷 4419-4441页

作者： Granberg, Kenneth L. Sakamaki, Shigeki Larsson, Niklas Bergstrom, Fredrik Fuchigami, ryuichi Niwa, Yasuki ryberg, Erik Backmark, Anna Kato, Harutoshi Miyazaki, Shiki Iguchi, Kaori Sakamoto, Toshiaki Persson, Mikael Idei, Akiko Garcia, Luna Prieto Villar, Inmaculada C. Graden, Henrik Bergonzini, Giulia Arvidsson, Torbjorn Fujita, Takuya Althage, Magnus Ulander, Johan Kimura, Junpei Yoneda, Hikaru Fjellstrom, Ola Mochida, Hideki Lal, Mark AstraZeneca Res & Early Dev Med ChemRes & Early Dev BioPharmaceut R&D S-43183 Gothenburg Molndal Sweden Mitsubishi Tanabe Pharma Corp Sohyaku Innovat Res Div Yokohama Kanagawa 2270033 Japan Discovery Biol Discovery Sci R&D AstraZeneca S-43183 Gothenburg Molndal Sweden Drug Metab & Pharmacokinet DMPK Cardiovasc Res & Early Dev Cardiovasc Renal & Metab CVRM BioPharmaceut R&D S-43183 Gothenburg Sweden AstraZeneca Biosci CardiovascRes & Early Dev Cardiovasc Renal & Metab CVRM BioPharmaceut R&D S-43183 Gothenburg Molndal Sweden Cardiovasc Renal & Metab Safety Clin Pharmacol & Safety Sci R&D AstraZeneca S-43183 Gothenburg Molndal Sweden Integrat Res Labs Sweden AB S-41346 Gothenburg Sweden Cpd Synth & Management Discovery Sci R&D Compound Synth & Management S-43183 Gothenburg Molndal Sweden Adv Drug Delivery Pharmaceut Sci R&D AstraZeneca S-43183 Gothenburg Molndal Sweden AstraZeneca Res & Early DevTranslat Sci & Expt Med Cardiovasc Renal & Metab CVRM Biopharmaceut R&D S-43183 Gothenburg Molndal Sweden Data Sci & Modelling Pharmaceut Sci R&D AstraZeneca S-43183 Gothenburg Molndal Sweden AstraZeneca Cardiovasc Renal & Metab CVRM Biopharmaceut Gothenburg Molndal Sweden AstraZeneca Biosci RenalRes & Early Dev Cardiovasc Renal & Metab CVRM Biopharmaceut R&D S-43183 Gothenburg Molndal Sweden

Optimization of the highly potent and selective, yet metabolically unstable and poorly soluble hrXFP1 agonist AZ7976 led to the identification of the clinical candidate, AZd5462. Assessment of rXFP1-dependent cell signaling demonstrated that AZd5462 activates a highly similar panel of downstream pathways as relaxin H2 but does not modulate relaxin H2-mediated cAMP second messenger responsiveness. The therapeutic potential of AZd5462 was assessed in a translatable cynomolgus monkey heart failure model. Following 8 weeks of treatment with AZd5462, robust improvements in functional cardiac parameters including LVEF were observed at weeks 9, 13, and 17 without changes in heart rate or mean arterial blood pressure. AZd5462 was well tolerated in both rat and cynomolgus monkey and has successfully completed phase I studies in healthy volunteers. In summary, AZd5462 is a small molecule pharmacological mimetic of relaxin H2 signaling at rXFP1 and holds promise as a potential therapeutic approach to treat heart failure patients.

关键词： Agonists Anatomy Organic acids rodent models Solubility

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Application of artificial neural networks for existence and controllability in impulsive fractional Volterra-Fredholm integro-differential equations

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APPLIEd MATHEMATICS IN SCIENCE ANd ENGINEErING 2024年第1期32卷

作者： raghavendran, Prabakaran Gunasekar, Tharmalingam Gochhait, Saikat Constituent Symbiosis Int Deemed Univ Symbiosis Inst Digital & Telecom Management Pune India Vel Tech Rangarajan Dr Sagunthala R&D Inst Sci & T Dept Math Chennai India Indian Inst Technol IIT Sch Artifiial Intelligence & Data Sci Jodhpur India Constituent Symbiosis Int Deemed Univ Symbiosis Inst Digital & Telecom Management Pune India

This study focuses on impulsive Volterra-Fredholm integro-differential equations (VFIdEs) under specific order conditions, conducting a rigorous analysis involving fractional Caputo derivatives. By applying the Schauder fixed-point theorem, we prove the existence of solutions and examine the interaction between fractional Caputo derivatives and the equation's integro-differential structure. Furthermore, we explore the application of artificial neural networks (ANNs) to predict system states based on input features, demonstrating how these techniques enhance the understanding of control inputs and system responses. These findings improve the theoretical understanding of impulsive VFIdEs and demonstrate their applications in science and engineering, particularly regarding existence conditions and controllability.

关键词： VFIdEs Caputo fractional derivative controllability ANN

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does the risk of hypersensitivity reactions to iopromide differ by sex, race, or across regions/countries? An analysis of 152 233 patients from 4 observational studies and the company's pharmacovigilance database

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BrITISH JOUrNAL OF rAdIOLOGY 2024年第1164期97卷 2004-2014页

作者： Endrikat, Jan Ullmann, Alexander Gerlinger, Christoph Bhatti, Aasia Lengsfeld, Philipp Michel, Alexander Bayer AG Radiol R&D Mullerstr 178 D-13353 Berlin Germany Univ Med Sch Saarland Dept Gynecol Obstet & Reprod Med D-66421 Homburg Germany Bayer AG Stat & Data Insights D-42113 Wuppertal Germany Bayer US LLC Benefit Risk Management Pharmacovigilance Whippany NJ 07981 USA Bayer Consumer Care AG Div Pharmaceut Integrated Evidence Generat CH-4052 Basel Switzerland

Objective: To analyse the potential impact of patients' sex, race, and region/country on the risk of hypersensitivity reactions after intra-venous or intra-arterial administration of iopromide. Methods: Two analyses were performed. (1) The "Phase-IV-Analysis" evaluated an integrated pooled database of 4 non-interventional studies. (2) The "GPV-Analysis" evaluated case reports from the company's pharmacovigilance database. The Phase-IV-Analysis was a nested case-control analysis of patients who received an injection of iopromide 300/370 mg iodine/mL. Cases had typical/unequivocal HSrs as defined by the ACr Committee on drugs and Contrast Media 2018. The global pharmacovigilance (GPV)-Analysis was based on HSr case reports in the company database. Exposure estimates were derived from sales/market research data. results: The Phase-IV-Analysis comprised 152 233 patients from 37 countries. In the full-analysis set 145 033, 59 412, and 146 649 patients were included in the sex, race, and region/country cohort, respectively. The GPV-Analysis was based on 78.72 million administrations for sex and 118.56 million administrations for region/country. No GPV exposure data by race were available. Sex: Phase-IV-Analysis: The HSr incidence was significantly higher for women (0.72%) vs men (0.55%) (P <= .0001). The unadjusted odds ratio (Or) was 1.3 (95% CI, 1.154-1.499), the adjusted Or was 1.156 (95% CI, 1.006-1.328) (P = .04). GPV-Analysis: reporting rates were 0.0102% for women and 0.0075% for men (P < .0001). Or: 1.36 (95% CI, 1.3-1.43). race: Phase-IV-Analysis: No significantly different HSr incidences for white (0.70%) and Asian (0.61%) patients (P = .3094) were detected. region/country: Phase-IV-Analysis: The overall world HSr-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, United States: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%. GPV-Analysis: The overall world HSr-reporting rate was 0.015%, varying across regions/countries. Conclusion: Women showed a slightl

关键词： Safety hypersensitivity reactions iopromide sex race region/country

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