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Analysing vaccine efficacy evaluated in phase 3 clinical trials carried out during outbreaks

Infectious Disease Modelling 2024年第4期9卷 1027-1044页

作者： Francisco Antonio Bezerra Coutinho Marcos Amaku fernanda castro boulos Jose Alfredo de Sousa Moreira Joao Italo DiasFranca Julio Antonio do Amaral Eliana Nogueira castro de Barros Claudio Jose Struchiner Esper Jorge Kallas Eduardo Massad School of Medicine University of Sao PauloBrazil Instituto Butantan Sao PauloBrazil School of Applied Mathematics Fundacao Getulio VargasRio de JaneiroBrazil

In this paper we examine several definitions of vaccine efficacy(VE)that we found in the literature,for diseases that express themselves in outbreaks,that is,when the force of infection grows in time,reaches a maximum and then *** fact that the disease occurs in outbreaks results in several problems that we *** propose a mathematical model that allows the calculation of VE for several *** trials usually needs a large number of volunteers that must be ***,all volunteers should be enrolled in approximately the same time,but this is generally impossible for logistic reasons and they are enrolled in a fashion that can be replaced by a continuous density function(for example,a Gaussian function).The outbreak can also be replaced by a continuous density function,and the use of these density functions simplifies the ***,for example Gaussian functions,one of the problems one can immediately notice is that the peak of the two curves do not occur at the same *** model allows us to conclude:First,the calculated vaccine efficacy decreases when the force of infection increases;Second,the calculated vaccine efficacy decreases when the gap between the peak in the force of infection and the peak in the enrollment rate increases;Third,different trial protocols can be simulated with this model;different vaccine efficacy definitions can be calculated and in our simulations,all result are approximately the *** final,and perhaps most important conclusion of our model,is that vaccine efficacy calculated during outbreaks must be carefully examined and the best way we can suggest to overcome this problem is to stratify the enrolled volunteer's in a cohort-by-cohort basis and do the survival analysis for each cohort,or apply the Cox proportional hazards model for each cohort.

关键词： Vaccine efficacy Clinical trials Mathematical models Simulations Covid-19

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Delay Times and Clinical Outcomes in Acute Myocardial Infarction: Comparison of Periods before and during the COVID-19 Pandemic—Myocardial Infarction and the Pandemic

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World Journal of Cardiovascular Diseases 2024年第6期14卷 392-400页

作者： Clarice Teixeira Silva Araújo Arnon Salviato Mameri Thúlio Carrera Guarçoni Venturini Marcus Tadeu Aguilar Constantino Matos Igor Morais Araujo Lopes Luiz Gustavo Ribeiro de Carvalho Murad Cleberson Duartes Ovani Guilherme Vassalo Morais fernanda Venturini de castro Danielle Lopes Rocha Lucas Crespo de Barros Rodolfo Costa Sylvestre Luiz Fernando Machado Barbosa Roberto Ramos Barbosa Internal Medicine Universidade Federal do Esprito Santo (UFES) Vitria Brazil Hospital Santa Casa de Misericrdia de Vitria Vitria Brazil Hospital Santa Rita de Cssia Vitria Brazil Hospital Estadual Dr. Jayme Santos Neves Serra Brazil Grupo Kora Sade Vitria Brazil Hospital Estadual Infantil e Maternidade Alzir Bernardino Alves (HIMABA) Vila Velha Brazil

Introduction: At the beginning of the COVID-19 pandemic, a drop in the number of patients treated for cardiac emergencies raised concern about cardiovascular mortality in that period. An increase in care delay for patients with ST-segment elevation myocardial infarction (STEMI) may have affected clinical outcomes. Objectives: To analyze delay times and clinical outcomes of patients with STEMI undergoing primary percutaneous coronary intervention (PPCI), before and during the COVID-19 pandemic. Methods: Retrospective observational study that included patients with STEMI undergoing PPCI from December 2018 to July 2021. The COVID-19 pandemic cases were divided into two groups: pandemic I—from March to August 2020;and pandemic II—from September 2020 to July 2021. Patients were compared according to the period of hospitalization. Primary outcomes were delay times in assistance and clinical outcomes (acute kidney injury [AKI], post-procedural vascular complications and in-hospital mortality). Results: 108 patients were included, 39 (36.1%) in the pre-pandemic period, 13 (12.1%) in pandemic I and 56 (51.8%) in pandemic II. Time from onset of symptoms to arrival at the service and door-to-balloon time did not differ significantly among groups. Vascular complications were more frequent during the pandemic (I and II) than in the pre-pandemic period (2.5% pre-pandemic vs 15.4% pandemic vs 12.5% pandemic II;p = 0.03). AKI incidence was similar in all three periods. There was a non-significant increase in in-hospital mortality during the COVID-19 pandemic. Conclusion: In patients with STEMI, there was an increase in vascular complications and a trend toward increased mortality during the COVID-19 pandemic. Delay times to admission and reperfusion did not differ significantly between before and during the pandemic.

关键词： Myocardial Infarction Primary Percutaneous Coronary Intervention Coronary Reperfusion Pandemic COVID-19

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Insights into the swelling process and drug release mechanisms from cross-linked pectin/high amylose starch matrices

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Asian Journal of Pharmaceutical Sciences 2014年第1期9卷 27-34页

作者： fernanda M.Carbinatto Ana Do´ris de castro Raul C.Evangelista Beatriz S.F.Cury Graduate Program in Pharmaceutical Sciences and Department of Drugs and Pharmaceuticals School of Pharmaceutical SciencesSa˜o Paulo State UniversityBrazil

Cross-linked pectin/high amylose mixtures were evaluated as a new excipient for matrix tablets formulations,since the mixing of polymers and cross-linking reaction represent rational tools to reach materials with modulated and specific properties that meet specific therapeutic ***:In this work the influence of polymer ratio and cross-linking process on the swelling and the mechanism driving the drug release from swellable matrix tablets prepared with this excipient was ***:Cross-linked samples were characterized by their micromeritic properties(size and shape,density,angle of repose and flow rate)and liquid uptake *** tablets were evaluated according their physical properties and the drug release rates and mechanisms were also ***:Cross-linked samples demonstrated size homogeneity and irregular shape,with liquid uptake ability insensible to ***-linking process of samples allowed the control of drug release rates and the drug release mechanism was influenced by both polymer ratio and cross-linking *** drug release of samples with minor proportion of pectin was driven by an anomalous transport and the increase of the pectin proportion contributed to the erosion of the ***:The cross-linked mixtures of high amylose and pectin showed a suitable excipient for slowing the drug release rates.

关键词： High amylose starch Pectin Cross-linking Swelling Drug delivery mechanism

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Documentary research on social innovation in health in Latin America

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Infectious Diseases of Poverty 2020年第2期9卷 92-92页

作者： Diana Maria castro-Arroyave Luisa fernanda Duque-Paz Centro Internacional de Entrenamiento e Investigaciones Medicas(CIDEIM) CaliColombia Icesi University CaliColombia

Background:Identifying social innovation in health initiatives,promoting quality of life through them,and transforming current health conditions demand the knowledge,comprehension and appropriation of the theoretical and methodological developments of this concept Academic developments in social innovation have mainly occurred in and been documented for English-speaking countries,although relevant experiences have been implemented in Latin *** this article,we describe and analyze how social innovation in health is being approached and understood in this *** text:To identify the theoretical and methodological developments of social innovation in health between 2013 and 2018,a scoping review with a mixed approach was carried *** texts in English,Spanish and Portuguese were selected for a process of reflexive analysis of intra and intertextual *** approaches identified in the studied initiatives were *** most applied approaches were innovation in health,technological innovation in health and social innovation,each with twelve publications,and social innovation in health and ecohealth with ten and seven publications *** approaches showed a general interest in reaching the goals of the Sustainable Development Goals(SDGs),the Alma Ata Declaration and the Ottawa ***:The social innovation in health approach in Latin America adopts educational strategies,identifies risk factors,optimizes resources,promotes interculturality,participation,community empowerment,and enhances intersectorality and *** an approach,process,program or solution,social innovation in health is a conceptual category under *** research provides a baseline for other systematic reviews on the subject.

关键词： Community-based health Documental research Public health Social innovation in health Social change

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Photodegradation and Removal of Diclofenac by the Green Alga Nannochloropsis oculata

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Phyton-International Journal of Experimental Botany 2021年第5期90卷 1519-1533页

作者： Danaé Samara Sánchez-Sandoval Omar González-Ortega Mara fernanda Navarro-Martínez Juan Marcos castro-Tapia Ramón Fernando García de la Cruz Ruth Elena Soria-Guerra Facultad de Ciencias Químicas Universidad Autónoma de San Luis PotosíSan Luis Potosí78210México

The emerging contaminants(ECs)are organic compounds including *** products are consumed in large quantities,favoring their continuous entrance to the environment and affecting the health of living *** is a non-steroidal anti-inflammatory drug with analgesic properties of prolonged *** is the commonest postoperative analgesic,and it is highly consumed without *** recent years,the capability of microalgae to remove pharmaceuticals in water has been tested as a promising *** this work,the removal efficiency of diclofenac(16µg/mL)by the microalga Nannochloropsis oculata CCAP 186/7 was *** major nutrient concentrations in Bold’s Basal Medium were modified(nitrogen and carbon:50 and 100%of their original concentration)to know their effect in the removal of *** degradation by light was also *** maximum removal capacity of diclofenac in the medium was 68.8%.The percentage of diclofenac adsorbed on the cell wall was between 6 and 12.7%.Around 23.6%of diclofenac was degraded by light after 18 *** did not show growth inhibition due to the presence of *** results obtained point to the promissory application of *** as a bioremediation system for diclofenac removal.

关键词： Adsorption emerging contaminants microalgae pharmaceuticals phycoremediation photodegradation

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Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar(CT-P13)in patients with inflammatory bowel disease

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World Journal of Gastroenterology 2018年第46期24卷 5288-5296页

作者： María fernanda Guerra Veloz Federico Argüelles-Arias Luisa castro Laria Belén Maldonado Pérez Antonio Benítez Roldan Raúl Perea Amarillo Vicente Merino Bohórquez Miguel Angel Calleja Angel Caunedo Alvarez Angel Vilches Arenas Department of Gastroenterology University Hospital Virgen MacarenaSeville 41007Spain Pharmacy Unit University Hospital Virgen MacarenaSeville 41007Spain Preventive Medicine and Public Health University Hospital Virgen MacarenaSeville 41007Spain

BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with *** An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar(CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the ***98 patients(CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar(P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar(P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar(CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

关键词： Crohn’s disease Ulcerative colitis CT-P13 Inflammatory bowel disease Biosimilar agent Infliximab original Efficacy

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Galectin-3 expression favors metastasis in murine melanoma

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Advances in Bioscience and Biotechnology 2013年第10期4卷 55-62页

作者： Andreia Neves Comodo Andre Luis Lacerda Bachi Maria fernanda Soares Marcello Franco Vicente de Paulo castro Teixeira Departamento de Patologia Universidade Federal de Sao PauloSao PauloBrasil Departamento de Microbiologia Imunologia e ParasitologiaUniversidade Federal de Sao PauloSao PauloBrasil

Galectin-3 is a member of the lectin family that binds β-galactosides and plays an important role in several types of tumors. Melanoma is an invasive cancer responsible for 80% of deaths associated to skin cancers. There are some evidences that galectin-3 interacts with β-catenin, a molecule involved with Wnt signaling pathway. Here, we evaluate the role of galectin-3 intumor growth and metastasis, as well as its interaction with β-catenin. Murine melanoma cells (B16F10) were injected subcutaneously and intravenously in male C57BL/6 wild-type (WT) and galectin-3 knock-out (KO) mice. Tumor growth and lung melanoma colonies were assessed. The expression of galectin-3 and β-catenin was evaluated by immuno-histochemistry. We observed that tumor growth did not differ between the groups. However, to metastasis, the number of lung colonies in WT mice was significantly increased in comparison to that observed in KO mice. The cytoplasm expression of galectin-3 was observed in subcutaneous and metastatic tumors,w in both groups. We observed its nuclear expression in some of subcutaneous tumors of KO mice. The expression of β-catenin was detected in cell membrane of all subcutaneous tumors analyzed, whereas in the metastatic tumors we observed both cytoplasm and cell membrane staining. Altogether, our data suggest that galectin-3 favors the metastasis of melanoma cells and this process is not associated with β-catenin.

关键词： Melanoma Galectin-3 Wnt Signaling β-Catenin Metastasis

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Multicentric Cervical Paraganglioma. Rare Case of Five Locations in One Patient. Case Report and Literature Review

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International Journal of Otolaryngology and Head & Neck Surgery 2014年第2期3卷 82-88页

作者： José Francisco de Sales Chagas Maria Beatriz Nogueira Pascoal José Luis Braga de Aquino Luis Antonio Brandi Filho fernanda Fruet Douglas Alexandre Rizzanti Pereira Amilcar de castro Matos Thalita Ruba fernanda Callegari Department of Pathology School of Medicine Catholic Uni-versity of Campinas Campinas Brazil Head and Neck Service School of Medicine Catholic University of Campinas Campinas Brazil School of Medicine Catholic University of Campinas Cam-pinas Brazil

Objective: To report a case of a multiple paraganglioma with 5 concurrent locations and also describe a complication not found in the literature, spontaneous tumor bleeding. Introduction: The paragangliomas are mostly benign and more frequent in women. Can be multiple, and these are considered as the most likely source of familial origin (30%-35%). The multicentric lesions can occur at different life stages not being necessarily simultaneous, a fact that prevents image exam research to be conclusive for tumor presence or absence. In this way the examination of the family members of patients, specially young ones, diagnosed with multicentric tumors may lead to negative results which doesn’t meant that the disease can be developed at a later time period. Therefore routine examination is not justifiable when symptoms relative to tumor presence are not present. Case report: A female patient of 32 years old complaining of tinnitus and diagnosed with five paragangliomas (jugulo-timpanic, bilateral carotid body and bilateral brachiocephalic trunk) through imaging studies. She reported suffering relatives of paragangliomas. Conclusion: The paper reports a rare case and perhaps unique in the literature, multiple paraganglioma with five locations and discusses difficult choice of treatment and complications.

关键词： Glomus Tumor Paraganglioma Glomus Jugulare Carotid Body Tumor Postoperative Complications

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Overweight and abdominal fat are associated with normal bone mineral density in patients with ulcerative colitis

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World Journal of Gastrointestinal Pharmacology and Therapeutics 2022年第4期13卷 57-66页

作者： Mirella Brasil Lopes Andre castro Lyra Raquel Rocha fernanda Gomes Coqueiro Carla Andrade Lima Carolina Cunha de Oliveira Genoile Oliveira Santana Programa de Pós-graduação em Medicina e Saúde Universidade Federal da BahiaSalvador 40110-060Brazil Departamento Ciências da Nutrição Universidade Federal da BahiaSalvador 40110-060Brazil Departamento de Nutrição Universidade Federal de SergipeLagarto 49060-110Brazil Departamento Ciências da Vida Universidade do Estado da BahiaSalvador 41.150-000Brazil

BACKGROUND Low bone mineral density(BMD)is common in patients with inflammatory bowel ***,nutritional risk factors for low BMD in the ulcerative colitis(UC)population are still poorly *** To investigate the association of anthropometric indicators and body composition with BMD in patients with *** This is a cross-sectional study on adult UC patients of both genders who were followed on an outpatient basis.A control group consisting of healthy volunteers,family members,and close people was also *** nutritional indicators evaluated were body mass index(BMI),total body mass(TBM),waist circumference(WC),body fat in kg(BFkg),body fat in percentage(BF%),trunk BF(TBF),and also lean *** composition and BMD assessments were performed by dual-energy X-ray *** The sociodemographic characteristics of patients with UC(n=68)were similar to those of healthy volunteers(n=66)(P>0.05).Most patients(97.0%)were in remission of the disease,58.8%were eutrophic,33.8%were overweight,39.0%had high WC,and 67.6%had excess BF%.However,mean BMI,WC,BFkg,and TBF of UC patients were lower when compared to those of the control group(P<0.05).Reduced BMD was present in 41.2%of patients with UC(38.2%with osteopenia and 2.9%with osteoporosis)and 3.0%in the control group(P<0.001).UC patients with low BMD had lower BMI,TBM,and BFkg values than those with normal BMD(P<0.05).Male patients were more likely to have low BMD(prevalence ratio[PR]=1.86;95%confidence interval[CI]:1.07-3.26).Those with excess weight(PR=0.43;95%CI:0.19-0.97)and high WC(PR=0.44;95%CI:0.21-0.94)were less likely to have low *** Patients with UC in remission have a high prevalence of metabolic bone *** fat appears to protect against the development of low BMD in these patients.

关键词： Ulcerative colitis Bone mineral density Body composition Fat body Abdominal fat

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In vitro induced pluripotency from urine-derived cells in porcine

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World Journal of Stem Cells 2022年第3期14卷 231-244页

作者： Kaiana Recchia Lucas Simões Machado Ramon Cesar Botigelli Naira Caroline Godoy Pieri Gabriela Barbosa Raquel Vasconcelos Guimarães de castro Mariana Groke Marques Laís Vicari de Figueiredo Pessôa Paulo Fantinato Neto Flávio Vieira Meirelles Aline fernanda de Souza Simone Maria Massami Kitamura Martins Fabiana Fernandes Bressan Department of Surgery Faculty of Veterinary Medicine and Animal SciencesUniversity of São PauloPirassununga 13635-000São PauloBrazil Department of Pharmacology and Biotechnology Institute of BioscienceSão Paulo State UniversityBotucatu 18618-689São PauloBrazil Department of Veterinary Medicine Faculty of Animal Sciences and Food EngineeringUniversity of São PauloPirassununga 13635-000São PauloBrazil Embrapa Suínos e Aves Empresa Brasileira de Pesquisa AgropecuáriaConcordia 89715-899Santa CatarinaBrazil Department of Animal Sciences Faculty of Animal Sciences and Food EngineeringUniversity of São PauloPirassununga 13635-000São PauloBrazil

BACKGROUND The generation of induced pluripotent stem cells(iPSC)has been a game-changer in translational and regenerative medicine;however,their large-scale applicability is still hampered by the scarcity of accessible,safe,and reproducible *** porcine model is a large biomedical model that enables translational applications,including gene editing,long term in vivo and offspring analysis;therefore,suitable for both medicine and animal *** To reprogramme in vitro into pluripotency,and herein urine-derived cells(UDCs)were isolated from porcine *** The UDCs were reprogrammed in vitro using human or murine octamer-binding transcription factor 4(OCT4),SRY-box2(SOX2),Kruppel-like factor 4(KLF4),and C-MYC,and cultured with basic fibroblast growth factor(bFGF)*** characterize the putative porcine iPSCs three clonal lineages were submitted to immunocytochemistry for alkaline phosphatase(AP),OCT4,SOX2,NANOG,TRA181 and SSEA 1 *** transcripts related to the pluripotency(OCT4,SOX2 and NANOG)were analyzed via reverse transcription quantitative realtime polymerase chain reaction in different time points during the culture,and all three lineages formed embryoid bodies(EBs)when cultured in suspension without bFGF *** The UDCs were isolated from swine urine samples and when at passage 2 submitted to in vitro *** of putative iPSCs were obtained only from UDCs transduced with the murine factors(mOSKM),but not from human factors(hOSKM).Three clonal lineages were isolated and further cultured for at least 28 passages,all the lineages were positive for AP detection,the OCT4,SOX2,NANOG markers,albeit the immunocytochemical analysis also revealed heterogeneous phenotypic profiles among lineages and passages for NANOG and SSEA1,similar results were observed in the abundance of the endogenous transcripts related to pluripotent *** the clonal lineages when cultured in suspension without

关键词： Induced pluripotent stem cells Noninvasive Pluripotency Reprogramming Urine Porcine

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