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Real-World Evidence in Localized Pancreatic: Coping with Uncertainty in Unselected Populations

Journal of Cancer Therapy 2024年第4期15卷 164-178页

作者： María I. Pamies Ramón Diana Ibarra Anguita Paula Rodríguez Payá Alvaro Muñoz Abad David Sánchez García María Valero Revert Beatriz Grau Mirete Mariano Martínez Marín Alicia Calero Amaro Lorena Rodríguez Cazalla javier gallego plazas Medical Oncology Department Elche University Hospital Elche (Alicante) Spain General Surgery Department Elche University Hospital Elche (Alicante) Spain General Surgery Department Vega Baja Hospital Orihuela (Alicante) Spain

Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based on clinical trials in selected populations. Hence, exploring with real world evidence (RWE) clinicians’ preferences for treatment options and their results seems pertinent. Methods: In a set of consecutive patients with localized pancreatic cancer assisted in a third level hospital from January 2013 to December 2022, medical records, symptoms, diagnostic process, distribution between subtypes, and treatment plans, with safety and efficacy results, were assessed. Results: A total of 152 patients with localized disease were included (43.4% R, 21.0% BR, 33.6% LAU). The population characteristics exemplified differences between daily practice and clinical trials. Tumor location and symptoms were as expected. Treatment plan was conditioned by PS or comorbidities in 23.0% of patients. In patients with R disease, surgery followed by different adjuvant chemotherapy (CT) regimes was the antineoplastic treatment of choice (64.8%) with efficacy results (OS 37.5 months;95% CI 18.4 - 56.7), in the range of contemporary standards. The common use of neoadjuvant CT for BR disease (94.4%), with surgery in 50% of them, and its results (OS 30.8 months;95% CI 10.5 - 51.2) reflected current controversies of treatment recommendations and evolution in this scenario. Paliative CT with or without radiotherapy was the standard specific treatment in LAU disease (95.1%) with survival results (PFS: 10.8 months;95% CI 8.8 - 12.7. OS: 20.3 months;95% CI 13.5 - 27.2) that justify the distinct character and the specific study of this entity. Conclusion: RWE for localized pancreatic cancer aroused from the analysis of this population confirms the distinct nature of patients assisted in daily practice, as well as mirrors the complexity of decision making in clinical assumptions in which a

关键词： Real-World Evidence Localized Pancreatic Cancer

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Systemic Inflammation Response Index and weight loss as prognostic factors in metastatic pancreatic cancer: A concept study from the PANTHEIA-SEOM trial

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World Journal of Gastrointestinal Oncology 2024年第2期16卷 386-397页

作者： Vilma Pacheco-Barcia Sara Custodio-Cabello Fatima Carrasco-Valero Magda Palka-Kotlowska Axel Mariño-Mendez Alberto Carmona-Bayonas javier gallego A J Muñoz Martín Paula Jimenez-Fonseca Luis Cabezon-Gutierrez Department of Medical Oncology Hospital Universitario de TorrejonMadrid 28850Spain Department of Internal Medicine Hospital Universitario de TorrejonMadrid 28850Spain Department of Medical Oncology Hospital Universitario Central de AsturiasOviedo 33011Spain Department of Medical Oncology Hospital Universitario Morales MeseguerUniversity of MurciaMurcia 30001Spain Department of Medical Oncology Hospital General Universitario de ElcheElche 03202Spain Department of Medical Oncology Hospital General Universitario Gregorio MarañónUniversidad Complutense MadridMadrid 28007Spain Universidad Francisco de Vitoria Madrid 28223Spain

BACKGROUND The prognostic value of the Systemic Inflammation Response Index(SIRI)in advanced pancreatic cancer is recognized,but its correlation with patients´nutritional status and outcomes remains *** To study the prognostic significance of SIRI and weight loss in metastatic pancreatic *** The PANTHEIA-Spanish Society of Medical Oncology(SEOM)study is a multicentric(16 Spanish hospitals),observational,longitudinal,non-interventional initiative,promoted by the SEOM Real World-Evidence work *** pilot study sought to analyze the association between weight loss and inflammatory status as defined by *** cohort stems from a proof-of-concept pilot study conducted at one of the coordinating *** with pathologically confirmed metastatic pancreatic adenocarcinoma,treated from January 2020 to January 2023,were *** index was calculated using the product of neutrophil and monocyte counts,divided by lymphocyte counts,obtained within 15 days before initiation *** study evaluated associations between overall survival(OS),SIRI and weight *** A total of 50 patients were included.66%of these patients were male and the median age was 66 *** sites:36%liver,12%peritoneal carcinomatosis,10%lung,and 42%multiple *** the first line palliative chemotherapy treatments:50%received gemcitabine plus nab-paclitaxel;28%,modified fluorouracil,leucovorin,irinotecan and oxaliplatin,and 16%were administered gemcitabine.42%had a weight loss>5%in the three months(mo)preceding diagnosis.21 patients with a SIRI≥2.3×10^(3)/L exhibited a trend towards a lower median OS compared to those with a SIRI5%weight loss before diagnosis,the median OS was 6 mo,in contrast to 19 mo for those who did not experience such weight loss(P=0.003).Patients with a weight loss>5%showed higher SIRI *** difference was statistically significant(P<0.000).For pat

关键词： Pancreatic cancer Nutrition Prognostic factor Inflammation Advanced cancer Systemic inflammatory response index Weight loss

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Colorectal Cancer Surgery in Extreme Elderly Population

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Journal of Cancer Therapy 2015年第1期6卷 12-20页

作者： javier gallego plazas Elena Asensio Juan C. Navalon Inmaculada Lozano Jose M. Navarro Guillermo Ricote Montse Olcina Almudena Cotes Henry M. Ore Alejandra Magdaleno Maria C. Ors Maria J. Escudero Miguel A. Morcillo Servicio de Oncología Médica Hospital General Universitario de Elche-Hospital Vega Baja Alicante Espana Servicio de Cirugía General Hospital Vega Baja Alicante Espana

Background: Colorectal cancer surgery in extreme elderly population (380 years) is a growing problem and a subject in question. Experiences and results in this scenario are limited. Methods: Medical records of patients?380 years old hospitalized in General Surgery Department in Vega Baja Hospital between January 1st 2008 and December 31st 2012 were retrospectively reviewed. Patients diagnosed with colorectal cancer (CRC) were selected. Data regarding comorbidities, treatment performed, complications and survival were collected. Results: 95 patients (74 colon, 21 rectum) were identified: median age 83.0 years (80 - 93), 64.2% males. 93.7% of patients were operated on: median hospital and post-operative stay of 11 and 9 days, respectively;curative intention surgery 82.1%. 4.2% of patients were treated with interventionist procedures, and 2.1% of patients in a conservative way. 17.9% and 4.2% of patients came up with early and late complications, respectively. Early and late mortality occurred in 9.5% and 3.2% of patients, respectively. By March 2014, with a median follow up of 43.8 months, median overall survival for colorectal cancer patients was 2.7 years (95%IC, 2.0 - 3.2). Univariaye Cox Regresion analysis revealed the presence of cardiomyopathy (p = 0.024), the presence of chornic kidney disease (p = 0.025), the presence of comorbidities (vs absence) (0.026), the number of comorbidities (0.034), type of admission (p = 0.001), treatment with surgery (p = 0.001) and the incidence of early (p = 0.004) or late complications (p = 0.023) associated to overall survival with statically significance. Multivariate Cox Regression analysis showed number of comorbidities (HR = 1.104;95%CI: 0.851 - 1.431;p = 0.456), treatment with surgery (HR = 4.928;95%CI: 1.815 - 13.385;p = 0.002), programmed admission into hospital (HR = 2.316;95%CI: 1.298 - 4.133;p = 0.004), and the incidence of late complications (HR = 4.629;95%CI: 1.279 - 16.750;p = 0.020) independently associated with o

关键词： Colorectal Cancer Surgery Elderly

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Numerical modeling of nutrient transport to assess the agricultural impact on the trophic state of reservoirs

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International Soil and Water Conservation Research 2023年第1期11卷 197-212页

作者： Franklin Torres-Bejarano Jesús García-gallego javier Salcedo-Salgado Department of Environmental Engineering University of CordobaCarrera 6 No.77-305230002MonteriaColombia Environmental Engineering Program University of CordobaCarrera 6 No.77-305230002MonteriaColombia

A trophic state increase relates to surface water bodies nutrient enrichment,due to the chemical products used such as fertilizers in agriculture and residues from cattle raising *** research consists of nutrient transport numerical modeling to analyze the Betancíreservoir trophic state in Colombia;Water samples were collected to analyze total nitrogen,total phosphorus,ammonia,nitrates,nitrites,phosphates,chlorophyll-a,dissolved oxygen,BOD,COD,suspended solids,and water *** water quality model MOHID Studio was implemented and after its calibration,scenarios of increase and decrease of nutrients and inflows to the reservoir through its main tributaries were simulated to reproduce the agricultural activity changes in the basin and the effects that would have on the reservoir's trophic state dynamics;Therefore,the Carlson Trophic Status Index was calculated for each *** results show that variations in total nitrogen concentration and increased inflows present short-term consequences on the reservoir's trophic *** the incoming total nitrogen con-centrations by 100%causes the reservoir to change from a light eutrophic to a hypereutrophic *** results of this research provide a starting tool to water resources integrated management in reservoirs.

关键词： Environmental modeling Trophic state index Nutrient transport Eutrophication Water pollution

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1D alignment of proteins and other nanoparticles by using reversible covalent bonds on cyclic peptide nanotubes

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Organic Chemistry Frontiers 2022年第5期9卷 1226-1233页

作者： Juan M.Priegue Iria Louzao Ivan gallego javier Montenegro Juan R.Granja Singular Research Centre in Chemical Biology and Molecular Materials (CIQUS)Organic Chemistry DepartmentUniversity of Santiago de Compostela(USC)15782 Santiago de CompostelaSpain

Self-assembling cyclic peptide nanotubes are supramolecular structures whose diameter and external surface properties are precisely *** this communication we describe a general strategy to align different molecules on... 详细信息

关键词： nanoparticles alignment surface

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Validation of GIS layers in the EU:getting adapted to available reference data

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International Journal of Digital Earth 2011年第S01期4卷 42-57页

作者： Francisco javier gallego IPSC Joint Research Centre of the ECIspraItaly

An optimal validation of a thematic map would ideally require in-situ observations of a large sample of units specifically conceived for the map under *** is often not possible due to budget *** alternative can be using photo-interpretation of high or very high resolution images instead of in-situ observations or using available data sets that do not fully comply with the ideal characteristics:unit size,reference date or sampling *** paper illustrates some examples of use of available data in the European *** land cover maps,the best existing data set is probably Land Use/Cover Areaframe Survey(LUCAS)that has been conducted by Eurostat on four occasions since *** LUCAS is based on systematic sampling,advantages and limitations of systematic sampling are discussed.A fine-scale population density map is presented as an example of a situation in which reference data on a statistical sample cannot be collected.

关键词： accuracy assessment area frame sampling systematic sampling LUCAS land cover maps population density

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From Network Functions to NetApps: The 5GASP Methodology

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Computers, Materials & Continua 2022年第5期71卷 4115-4134页

作者： Jorge gallego-Madrid Ramon Sanchez-Iborra Antonio Skarmeta University of Murcia Murcia30100Spain University Center of Defense General Air Force AcademySan Javier30720Spain

As the 5G ecosystem continues its consolidation,the testing and validation of the innovations achieved by integrators and verticals service providers is of preponderant *** this line,5GASP is a European H2020-funded project that aims at easing the idea-to-market process through the creation of an European testbed that is fully automated and self-service,in order to foster rapid development and testing of new and innovative 5G Network Applications(NetApps).The main objective of this paper is to present the 5GASP’s unified methodology to design,develop and onboard NetApps within the scope of different vertical services,letting them use specific 5G ***,we examine the whole 5GASP process in a tutorial fashion by adopting a specific use case focusing on the integration of a virtual On-Board Unit(vOBU)service that permits offloading processing from the attached vehicle and serving data-access *** demonstrated,the presented workflow permits the agile,rigorous,and safe development,testing and certification of NetApps,which will enable valuable in-network services for 5G and beyond infrastructures.

关键词： 5G NetApp 5GASP vOBU

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Machine learning-based zero-touch network and service management:a survey

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Digital Communications and Networks 2022年第2期8卷 105-123页

作者： Jorge gallego-Madrid Ramon Sanchez-Iborra Pedro M.Ruiz Antonio F.Skarmeta Department of Information and Communication Engineering University of Murcia30100MurciaSpain Department of Engineering and Applied Techniques University Center of Defense30729San Javier Air Force BaseSpain

The exponential growth of mobile applications and services during the last years has challenged the existing network ***,the arrival of multiple management solutions to cope with this explosion along the end-to-end network chain has increased the complexity in the coordinated orchestration of different segments composing the whole *** Zero-touch Network and Service Management(ZSM)concept has recently emerged to automatically orchestrate and manage network resources while assuring the Quality of Experience(QoE)demanded by *** Learning(ML)is one of the key enabling technologies that many ZSM frameworks are adopting to bring intelligent decision making to the network management *** paper presents a comprehensive survey of the state-of-the-art application of ML-based techniques to improve ZSM *** this end,the main related standardization activities and the aligned international projects and research efforts are deeply *** this dissection,the skyrocketing growth of the ZSM paradigm can be ***,different standardization bodies have already designed reference architectures to set the foundations of novel automatic network management functions and resource *** with these advances,diverse ML techniques are being currently exploited to build further ZSM developments in different aspects,including multi-tenancy management,traffic monitoring,and architecture coordination,among ***,different challenges,such as the complexity,scalability,and security of ML mechanisms,are also identified,and future research guidelines are provided to accomplish a firm development of the ZSM ecosystem.

关键词： Zero-touch network and service management(ZSM) Next generation networks(NGN) Artificial intelligence(AI) Machine learning(ML)

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The Study of Carbamoyl Phosphate Synthetase 1 Deficiency Sheds Light on the Mechanism for Switching On/Off the Urea Cycle

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Journal of Genetics and Genomics 2015年第5期42卷 249-260页

作者： Carmen Díez-Fernández José gallego Johannes H?berle javier Cervera Vicente Rubio Institute for Biomedicine of Valencia of the Spanish Research Council Medical School of the Catholic University of Valencia University Children's Hospital Zurich and Children's Research Center Centre for Biomedical Networking Research on Rare Diseases of the Carlos Ⅲ Health Institute

Carbamoyl phosphate synthetase i （CPS1） deficiency （CPS1D） is an inborn error of the urea cycle having autosomal （2q34） recessive inheritance that can cause hyperammonemia and neonatal death or mental retardation. We analyzed the effects on CPS1 activity, kinetic parameters and enzyme stability of missense mutations reported in patients with CPS1 deficiency that map in the 20-kDa C-terminal domain of the enzyme. This domain turns on or off the enzyme depending on whether the essential allosteric activator of CPS 1, N-acetyl- L-glutamate （NAG）, is bound or is not bound to it. To carry out the present studies, we exploited a novel system that allows the expression in vitro and the purification of human CPS1, thus permitting site-directed mutagenesis. These studies have clarified disease causation by individual mutations, identifying functionally important residues, and revealing that a number of mutations decrease the affinity of the enzyme for NAG. Patients with NAG affinity-decreasing mutations might benefit from NAG site saturation therapy with N-carbamyl-L- glutamate （a registered drug, the analog of NAG）. Our results, together with additional present and prior site-directed mutagenesis data for other residues mapping in this domain, suggest an NAG-triggered conformational change in the 134-~4 loop of the C-terminal domain of this enzyme. This change might be an early event in the NAG activation process. Molecular dynamics simulations that were restrained according to the observed effects of the mutations are consistent with this hypothesis, providing further backing for this structurally plausible signaling mechanism by which NAG could trigger urea cycle activation via CPS1.

关键词： Urea cycle diseases Inborn errors Hyperammonemia Site-directed mutagenesis Restrained molecular dynamics Allosteric regulation Carbamoyl phosphate synthetase 1 Enzyme

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An overview of animal models for investigating the pathogenesis and therapeutic strategies in acute hepatic failure

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World Journal of Gastroenterology 2009年第25期15卷 3086-3098页

作者： María Jesús Tuón Marcelino Alvarez Jesús M Culebras javier González-gallego Centro de Investigación Biomédica en Red de Enfermedades Hepáticas (CIBERehd) and Institute of Biomedicine University of León Department of Animal Health University of León Surgery Unit Hospital of León

Acute hepatic failure (AHF) is a severe liver injury accompanied by hepatic encephalopathy which causes multiorgan failure with an extremely high mortality rate, even if intensive care is provided. Management of severe AHF continues to be one of the most challenging problems in clinical medicine. Liver transplantation has been shown to be the most effective therapy, but the procedure is limited by shortage of donor organs. Although a number of clinical trials testing different liver assist devices are under way, these systems alone have no significant effect on patient survival and are only regarded as a useful approach to bridge patients with AHF to liver transplantation. As a result, reproducible experimental animal models resembling the clinical conditions are still needed. The three main approaches used to create an animal model for AHF are: surgical procedures, toxic liver injury and infective procedures. Most common models are based on surgical techniques (total/partial hepatectomy, complete/transient devascularization) or the use of hepatotoxic drugs (acetaminophen, galactosamine, thioacetamide, and others), and very few satisfactory viral models are available. We have recently developed a viral model of AHF by means of the inoculation of rabbits with the virus of rabbit hemorrhagic disease. This model displays biochemical and histological characteristics, and clinical features that resemble those in human AHF. In the present article an overview is given of the most widely used animal models of AHF, and their main advantages and disadvantages are reviewed.

关键词：肝功能衰竭动物模型治疗急性发病

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