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Relationship of BRCA1 and BRCA2 mutations with cancer burden in the family and tumor incidence.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The aim of the present study is to analyze the relationship of the incidence of mutations in the two major genes BRCA1 and BRCA2 conferring risk of breast cancer (BC) and ovarian cancer (OC) with the cancer burden in families and with the presence and age of onset of BC/OC. We included 704 index patients (IP) and 668 family members of the IP who tested positive for BRCA1/BRCA2 who were studied in the Program of Genetic Counselling in Cancer of the Valencia Community (Spain). We found 129 IPs…



Mutaciones de BRCA1 y BRCA2 en familias estudiadas en el Programa de Consejo Genético en el Cáncer de la Comunidad Valenciana.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The objective of the present study was to investigate the mutational spectrum of BRCA1 and BRCA2 in the Valencian Community, comparing this spectrum with that reported in Spain. We also analyze the association of the mutations with the family history of the selected families.



Enantiomeric quality control of antihistamines in pharmaceuticals by affinity electrokinetic chromatography with human serum albumin as chiral selector.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The present paper deals with the enantiomeric separation of six antihistaminic enantiomers by affinity electrokinetic chromatography (AEKC)-partial filling technique using human serum albumin (HSA) as chiral selector. A multivariate optimization approach of the most critical experimental variables in enantioresolution, running pH, HSA concentration and HSA plug length (SPL) was carried out since there are interactions between variables that could not be considered in an univariate optimization…



Enantioseparation of phenotiazines by affinity electrokinetic chromatography using human serum albumin as chiral selector: application to enantiomeric quality control in pharmaceutical formulations.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Nowadays, there is a special interest within the pharmaceutical laboratories to develop single enantiomer formulations and consequently a need for analytical methods to determine the enantiomeric purity of drugs. The present paper deals with the enantiomeric separation of promethazine and trimeprazine enantiomers by affinity electrokinetic chromatography (AEKC)-partial filling technique using human serum albumin (HSA) as chiral selector. A multivariate optimization of the most critical…



Evaluation of enantioselective binding of propanocaine to human serum albumin by ultrafiltration and electrokinetic chromatography under intermediate precision conditions.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Stereoselectivity in protein binding can have a significant effect on the pharmacokinetic and pharmacodynamic properties of chiral drugs. In this paper, the enantioselective binding of propanocaine (PRO) enantiomers to human serum albumin (HSA), the most relevant plasmatic protein in view of stereoselectivity, has been evaluated by incubation and ultrafiltration of racemic PRO-HSA mixtures and chiral analysis of the bound and unbound fractions by electrokinetic chromatography using HSA as…



Exposición a fármacos citotóxicos en el personal sanitario.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

To quantify levels of exposure to cytotoxic drugs among health professionals in order to establish an exposure threshold and implement measures to increase protection and safety.



Intimate partner violence and perinatal health: a systematic review.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Physical, psychological and sexual intimate partner violence (IPV) has been described in the literature as different types of IPV experienced by women during pregnancy all over the world.



Comparing variation across European countries: building geographical areas to provide sounder estimates.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

In geographical studies, population distribution is a key issue. An unequal distribution across units of analysis might entail extra-variation and produce misleading conclusions on healthcare performance variations. This article aims at assessing the impact of building more homogeneous units of analysis in the estimation of systematic variation in three countries.



Lack of mitochondrial toxicity of darunavir, raltegravir and rilpivirine in neurons and hepatocytes: a comparison with efavirenz.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Growing evidence associates the non-nucleoside reverse transcriptase inhibitor efavirenz with several adverse events. Newer antiretrovirals, such as the integrase inhibitor raltegravir, the non-nucleoside reverse transcriptase inhibitor rilpivirine and the protease inhibitor darunavir, claim to have a better toxicological profile than efavirenz while producing similar levels of efficacy and virological suppression. The objective of this study was to determine the in vitro toxicological profile…



Bifidobacterium pseudocatenulatum CECT7765 promotes a TLR2-dependent anti-inflammatory response in intestinal lymphocytes from mice with cirrhosis.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Intestinal homeostasis plays an important role in bacteria-derived complications in cirrhosis. Intestinal lymphocytes are responsible for immune effector functions and can be modulated by certain probiotics. We evaluate the interaction between Bifidobacterium pseudocatenulatum CECT7765 and intestinal lymphocytes in mice with cirrhosis.



Central nervous system (CNS) cancer in children and young people in the European Union and its involvements with socio-economic and environmental factors.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Malignant central nervous system (CNS) tumors are the leading cause of death by cancer in children and the second commonest pediatric cancer type. Despite several decades of epidemiologic research, the etiology of childhood CNS tumors is still largely unknown. A few genetic syndromes and therapeutic ionizing radiation are thought to account for 5-10% of childhood cancer, but the etiology of other cases remains unknown. Nongenetic causes, like environmental agents, are thought to explain them.…



Generation of a disease-specific iPS cell line derived from a patient with Charcot-Marie-Tooth type 2K lacking functional GDAP1 gene.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Human CMT2-FiPS4F1 cell line was generated from fibroblasts of a patient with Charcot-Marie-Tooth disease harbouring the following mutations in the GDAP1 gene in heterozygosis: p.Q163X/p.T288NfsX3. This patient did not present mutations in the PM22, MPZ or GJB genes. Human reprogramming factors OCT3/4, KLF4, SOX2 and C-MYC were delivered using a non-integrative methodology that involves the use of Sendai virus.



Role of intestinal microbiota in transplantation outcomes.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

While allogeneic hematopoietic stem cell transplantations have a curative potential, infections and graft-versus-host disease remain significant problems. The intestinal microbiota can influence responses to cancer chemotherapy and the role of the microbiota in affecting allogeneic hematopoietic stem cell transplantation outcomes is increasingly appreciated. The following paper discusses the most recent developments in this area.



Zinc and smoking habits in the setting of hypertension in a Spanish populations.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The objective of this study was to evaluate the relationship between trace and toxic amounts of zinc (Zn) in biological samples (blood and urine) and the smoking habits of hypertensive patients and healthy control subjects in Valladolid (Spain). In order to compare biological samples, the concentrations of these samples were measured using inductively coupled plasma mass spectrometry. The limits of detection for Zn in blood plasma ranged between 4.22 and 17.34 µmol l(-1) and were <0.08 µmol…



Progastrin represses the alternative activation of human macrophages and modulates their influence on colon cancer epithelial cells.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Macrophage infiltration is a negative prognostic factor for most cancers but gastrointestinal tumors seem to be an exception. The effect of macrophages on cancer progression depends on their phenotype, which may vary between M1 (pro-inflammatory, defensive) to M2 (tolerogenic, pro-tumoral). Gastrointestinal cancers often become an ectopic source of gastrins and macrophages present receptors for these peptides. The aim of the present study is to analyze whether gastrins can affect the pattern of…



Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative…



Trends in socioeconomic inequalities in preventable mortality in urban areas of 33 Spanish cities, 1996-2007 (MEDEA project)

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Preventable mortality is a good indicator of possible problems to be investigated in the primary prevention chain, making it also a useful tool with which to evaluate health policies particularly public health policies. This study describes inequalities in preventable avoidable mortality in relation to socioeconomic status in small urban areas of thirty three Spanish cities, and analyses their evolution over the course of the periods 1996-2001 and 2002-2007. Methods: We analysed…



Diet quality and nutrient density in subjects with metabolic syndrome: Influence of socioeconomic status and lifestyle factors. A cross-sectional assessment in the PREDIMED-Plus study.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

BACKGROUND: Socioeconomic disparities and lifestyle factors are likely to determine the overall quality of the diet. In addition, overeating is compatible with inadequate micronutrient intake and it can lead to adverse health outcomes. OBJECTIVE: To assess adequacy of dietary nutrient intake and to investigate the influence of socioeconomic and lifestyle factors on nutrient density in a large primary cardiovascular prevention trial conducted in healthy participants with metabolic…



A novel common variant in DCST2 is associated with length in early life and height in adulthood.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Common genetic variants have been identified for adult height, but not much is known about the genetics of skeletal growth in early life. To identify common genetic variants that influence fetal skeletal growth, we meta-analyzed 22 genome-wide association studies (Stage 1; N = 28 459). We identified seven independent top single nucleotide polymorphisms (SNPs) (P < 1 × 10(-6)) for birth length, of which three were novel and four were in or near loci known to be associated with adult height (…



Epidemiology of congenital diaphragmatic hernia in Europe: a register-based study.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Published prevalence rates of congenital diaphragmatic hernia (CDH) vary. This study aims to describe the epidemiology of CDH using data from high-quality, population-based registers belonging to the European Surveillance of Congenital Anomalies (EUROCAT).



Southern East Asian origin and coexpansion of Mycobacterium tuberculosis Beijing family with Han Chinese.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The Beijing family is the most successful genotype of Mycobacterium tuberculosis and responsible for more than a quarter of the global tuberculosis epidemic. As the predominant genotype in East Asia, the Beijing family has been emerging in various areas of the world and is often associated with disease outbreaks and antibiotic resistance. Revealing the origin and historical dissemination of this strain family is important for understanding its current global success. Here we characterized the…



Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

We compared the ability of biennial fecal immunochemical testing (FIT) and one-time sigmoidoscopy to detect colon side-specific advanced neoplasms in a population-based, multicenter, nationwide, randomized controlled trial.



Pre-Columbian mycobacterial genomes reveal seals as a source of New World human tuberculosis

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Modern strains of Mycobacterium tuberculosis from the Americas are closely related to those from Europe, supporting the assumption that human tuberculosis was introduced post-contact(1). This notion, however, is incompatible with archaeological evidence of pre-contact tuberculosis in the New World(2). Comparative genomics of modern isolates suggests that M. tuberculosis attained its worldwide distribution following human dispersals out of Africa during the Pleistocene epoch(3), although this…



Efavirenz and the CNS: what we already know and questions that need to be answered.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The NNRTI efavirenz has long been one of the most frequently employed antiretroviral drugs in the multidrug regimens used to treat HIV infection, in accordance with its well-demonstrated antiretroviral efficacy and favourable pharmacokinetics. However, growing concern about its adverse effects has sometimes led to efavirenz being replaced by other drugs in the initial treatment selection or to switching of therapy to efavirenz-free regimens in experienced patients. Neurological and…



Fast and low-cost decentralized surveillance of transmission of tuberculosis based on strain-specific PCRs tailored from whole genome sequencing data: a pilot study.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Molecular epidemiology has transformed our knowledge of how tuberculosis (TB) is transmitted. Whole genome sequencing (WGS) has reached unprecedented levels of accuracy. However, it has increased technical requirements and costs, and analysis of data delays results. Our objective was to find a way to reconcile speed and ease of implementation with the high resolution of WGS. The targeted regional allele-specific oligonucleotide PCR (TRAP) assay presented here is based on allele-specific PCR…



Vitamin D insufficiency and subclinical atherosclerosis in non-diabetic males living with HIV.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Vitamin D insufficiency (VDI) has been associated with increased cardiovascular risk in the non-HIV population. This study evaluates the relationship among serum 25-hydroxyvitamin D [25(OH)D] levels, cardiovascular risk factors, adipokines, antiviral therapy (ART) and subclinical atherosclerosis in HIV-infected males.



Draft Genome Sequence of Mycobacterium brumae ATCC 51384.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Here, we report the draft genome sequence of Mycobacterium brumae type strain ATCC 51384. This is the first draft genome sequence of M. brumae, a nonpathogenic, rapidly growing, nonchromogenic mycobacterium, with immunotherapeutic capacities.



Ultrafast Assessment of the Presence of a High-Risk Mycobacterium tuberculosis Strain in a Population.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

A persistent 8-year infection by a Beijing Mycobacterium tuberculosis strain from a previous outbreak after importation from West Africa obliged us to investigate secondary cases. We developed a multiplex PCR method based on whole-genome sequencing to target strain-specific single nucleotide polymorphisms (SNPs). In 1 week, we analyzed 868 isolates stored over 6 years. Only 2 cases (immigrants from Guinea Conakry) harbored the strain, which ruled out transmission-despite opportunities-and…



Pre- and postnatal exposures to pesticides and neurodevelopmental effects in children living in agricultural communities from South-Eastern Spain.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Childrens exposure to neurotoxic compounds poses a major problem to public health because oftheir actively developing brain that makes them highly vulnerable. However, limited information is available on neuropsychological effects in children associated with pre- and postnatal exposures to pesticides.



Polymorphisms of pesticide-metabolizing genes in children living in intensive farming communities.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Polymorphisms in genes encoding xenobiotic-metabolizing enzymes (XME) are important parameters accounting for the wide inter-individual variability to environmental exposures. Paraoxonase-1 (PON1), butyrylcholinesterase (BChE) and Cytochrome-P450 constitute major classes of XME involved in the detoxification of pesticide chemicals, in particular organophosphates. This study explored the allelic frequency, linkage disequilibrium and haplotype analysis of ten common polymorphic variants of seven…



Bone metabolic changes during pregnancy: a period of vulnerability to osteoporosis and fracture.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Changes in bone density and bone markers suggest that pregnancy is associated with deterioration of bone mass in the mother. The metabolism of calcium resets to allow for the needs imposed by the building of the fetal skeleton. The fetus contributes to the process through the output of regulators from the placenta. Understanding of the whole process is limited, but some changes are unambiguous. There is an increase in the circulating levels of vitamin D, but its functional impact is unclear.…



Cadmium exposure and neuropsychological development in school children in southwestern Spain.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

This study assessed the association between cadmium exposure and neuropsychological development in children from a region with high industrial and mining activities in southwestern Spain. We conducted a cross-sectional study with 261 children aged 6-9 years between January and March 2012. Cadmium exposure was measured in urine and hair of children, and neuropsychological development was assessed with the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV) and with three…



Halorhabdus rudnickae sp. nov., a halophilic archaeon isolated from a salt mine borehole in Poland.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Two halophilic archaea, designated strains WSM-64(T) and WSM-66, were isolated from a sample taken from a borehole in the currently unexploited Barycz mining area belonging to the "Wieliczka" Salt Mine Company, in Poland. Strains are red pigmented and form non-motile cocci that stain Gram-negative. Strains WSM-64(T) and WSM-66 showed optimum growth at 40 °C, in 20% NaCl and at pH 6.5-7.5. The strains were facultative anaerobes. The major polar lipids of the two strains were…



Night shift work, chronotype and prostate cancer risk in the MCC-Spain case-control study.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Night shift work has been classified as a probable human carcinogen based on experimental studies and limited human evidence on breast cancer. Evidence on other common cancers, such as prostate cancer, is scarce. Chronotype is an individual characteristic that may relate to night work adaptation. We evaluated night shift work with relation to prostate cancer, taking into account chronotype and disease severity in a population based case-control study in Spain. We included 1,095 prostate cancer…



Genome-wide mapping of transcriptional start sites defines an extensive leaderless transcriptome in Mycobacterium tuberculosis.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Deciphering physiological changes that mediate transition of Mycobacterium tuberculosis between replicating and nonreplicating states is essential to understanding how the pathogen can persist in an individual host for decades. We have combined RNA sequencing (RNA-seq) of 5' triphosphate-enriched libraries with regular RNA-seq to characterize the architecture and expression of M. tuberculosis promoters. We identified over 4,000 transcriptional start sites (TSSs). Strikingly, for 26% of the…



Differential effects of anti-TNF-a and anti-IL-12/23 agents on human leukocyte-endothelial cell interactions.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Enhanced leukocyte recruitment is an inflammatory process that occurs during early phases of the vascular dysfunction that characterises atherosclerosis. We evaluated the impact of anti-TNF-a (adalimumab, infliximab and etanercept) and anti-IL-12/23 (ustekinumab) on interactions between human leukocytes and endothelial cells in a flow chamber that reproduced in vivo conditions. Clinical concentrations of anti-TNF-a were evaluated on the leukocyte recruitment induced by a variety of endothelial…



Characteristics and Outcomes of Granulomatosis With Polyangiitis (Wegener) and Microscopic Polyangiitis Requiring Renal Replacement Therapy: Results From the European Renal Association-European Dialysis and Transplant Association Registry

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: This study describes the incidence and outcomes of European patients requiring renal replacement therapy (RRT) for kidney failure due to antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Study Design: Cohort study. Setting & Participants: 12 renal registries providing individual RRT patient data to the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry in 1993-2012 participated. Predictor: Cause of primary kidney…



Population Genomics of Mycobacterium tuberculosis in Ethiopia Contradicts the Virgin Soil Hypothesis for Human Tuberculosis in Sub-Saharan Africa.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Colonial medical reports claimed that tuberculosis (TB) was largely unknown in Africa prior to European contact, providing a "virgin soil" for spread of TB in highly susceptible populations previously unexposed to the disease [1, 2]. This is in direct contrast to recent phylogenetic models which support an African origin for TB [3-6]. To address this apparent contradiction, we performed a broad genomic sampling of Mycobacterium tuberculosis in Ethiopia. All members of the M.…



Mammographic and clinical characteristics of different phenotypes of screen-detected and interval breast cancers in a nationwide screening program.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

In the context of a population-based screening program, we aimed to evaluate the major mammographic features and clinicopathological characteristics of breast tumors at diagnosis and the associations between them, focusing on tumors with the worst prognosis. We analyzed cancers diagnosed in a cohort of 645,764 women aged 45-69 years participating in seven population-based screening programs in Spain, between January 1, 2000 and December 31, 2006 and followed up until June 2009. We included all…



Impact of risk factors on different interval cancer subtypes in a population-based breast cancer screening programme.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Interval cancers are primary breast cancers diagnosed in women after a negative screening test and before the next screening invitation. Our aim was to evaluate risk factors for interval cancer and their subtypes and to compare the risk factors identified with those associated with incident screen-detected cancers.



Role of circulating miRNAs as biomarkers in idiopathic pulmonary arterial hypertension: possible relevance of miR-23a.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Idiopathic pulmonary hypertension (IPAH) is a rare disease characterized by a progressive increase in pulmonary vascular resistance leading to heart failure. MicroRNAs (miRNAs) are small noncoding RNAs that control the expression of genes, including some involved in the progression of IPAH, as studied in animals and lung tissue. These molecules circulate freely in the blood and their expression is associated with the progression of different vascular pathologies. Here, we studied the expression…



Walking, biking or sport: how Spanish women attending breast cancer screening meet physical activity recommendations?

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The aim is to analyse physical activity (PA), the fulfillment recommendation of at least 150 min of moderate PA, through walking/biking (W&B), sport, both types of PA and the factors associated with inactivity by Spanish women who attended breast cancer screening programmes.



Hormonal contraception and postmenopausal hormone therapy in Spain: time trends and patterns of use.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

This study aims to describe time trends in and patterns of use of hormonal contraception and postmenopausal hormone therapy and to identify factors associated with their use among Spanish women.



Correlation of zinc with oxidative stress biomarkers.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Hypertension and smoking are related with oxidative stress (OS), which in turn reports on cellular aging. Zinc is an essential element involved in an individual's physiology. The aim of this study was to evaluate the relation of zinc levels in serum and urine with OS and cellular aging and its effect on the development of hypertension. In a Spanish sample with 1500 individuals, subjects aged 20-59 years were selected, whose zinc intake levels fell within the recommended limits. These…



Hypertension and the fat-soluble vitamins A, D and E.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Hypertension affects populations globally and is thus a public health and socio-economic problem. Macronutrient and micronutrient deficiencies are common in the general population, and may be even more prevalent in hypertensive patients. This study aimed to determine a possible association between hypertension and intake of fat-soluble vitamins A, D and E. Participants were from the cross-sectional Hortega nutrition study conducted with a random sample of 1514 people (50.3% women, 49.7% men)…



Anthropometric Status and Nutritional Intake in Children (6-9 Years) in Valencia (Spain): The ANIVA Study.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The aim of our study was to assess nutritional intake and anthropometric statuses in schoolchildren to subsequently determine nutritional adequacy with Spanish Dietary Reference Intake (DRIs). The ANIVA study, a descriptive cross-sectional study, was conducted in 710 schoolchildren (6-9 years) in 2013-2014 in Valencia (Spain). Children's dietary intake was measured using 3-day food records, completed by parents. Anthropometric measures (weight and height) were measured according to…



Participation and detection rates by age and sex for colonoscopy versus fecal immunochemical testing in colorectal cancer screening

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

To compare two strategies for colorectal cancer screening: one-time colonoscopy versus fecal immunochemical testing (FIT) (and colonoscopy for positive) every 2 years, in order to determine which strategy provides the highest participation and detection rates in groups of sex and age. This analysis was performed with data from the first screening round within the COLONPREV study, a population-based, multicenter, nationwide trial carried out in Spain. Several logistic regression models were…



Tumor phenotype and breast density in distinct categories of interval cancer: results of population-based mammography screening in Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Introduction: Interval cancers are tumors arising after a negative screening episode and before the next screening invitation. They can be classified into true interval cancers, false negatives, minimal sign cancers, and occult tumors based on mammographic findings in screening and diagnostic mammograms. This study aimed to describe tumor-related characteristics and the association of breast density and tumor phenotype within four interval cancer categories. Methods: We included 2,245 invasive…



Clinical and radiological features of breast tumors according to history of false-positive results in mammography screening

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Women with a false-positive result after a screening mammogram have an increased risk of cancer detection in subsequent participations, especially after assessments involving cytology or biopsy. We aimed to compare women's personal characteristics, tumoral features and the radiological appearance of cancers with and without a previous false-positive result generated by additional imaging or invasive procedures. Methods: From 1996 to 2007, 111,098 women aged 45-69 years…



Differences in radiological patterns, tumour characteristics and diagnostic precision between digital mammography and screen-film mammography in four breast cancer screening programmes in Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Objectives To compare tumour characteristics between cancers detected with screen-film mammography (SFM) and digital mammography (DM) and to evaluate changes in positive predictive values (PPVs) for further assessments, for invasive procedures and for distinct radiological patterns in recalled women. Methods 242,838 screening mammograms (171,191 SFM and 71,647 DM) from 103,613 women aged 45-69 years, performed in four population-based breast cancer screening programmes in Spain, were included…



Effect of start age of breast cancer screening mammography on the risk of false-positive results

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Objective. To estimate the false-positive (FP) risk according to the start age of mammography screening (45-46 or 50-51 years). Method. Data from eight regions of the Spanish breast cancer screening programme from 1990 to 2006 were included (1,565,364 women). Discrete time-hazard models were used to ascertain the effect of age and time-related, programme-related and personal variables on FP leading to any further procedure and to invasive procedures (FPI). In a subset we estimated the…



The Incidence of AIDS-Defining Illnesses at a Current CD4 Count >= 200 Cells/mu L in the Post-Combination Antiretroviral Therapy Era

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background. Few studies consider the incidence of individual AIDS-defining illnesses (ADIs) at higher CD4 counts, relevant on a population level for monitoring and resource allocation. Methods. Individuals from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) aged >= 14 years with >= 1 CD4 count of >= 200 mu L between 1998 and 2010 were included. Incidence rates (per 1000 person-years of follow-up [PYFU]) were calculated for each ADI within different CD4…



Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ). Adults aged >= 50 or >= 70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment. At enrollment…



Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was >= 90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged >= 50 (ZOE-50) and >= 70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of…



i-CONSENT: Presentation of the Project and the Importance of Participants' Perspectives in the Informed Consent Process

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Informed consent is essential in ensuring the autonomy of participants in clinical research. However, informed consent documents are often complex and difficult to understand, and do not incorporate the patients' perspective. The informed consent process has become more focused on acquiring the participant's signature on the informed consent form, rather than being a contract that ensures the patient's autonomy through clear and complete information about all relevant aspects of…



Contents of the Minor's Assent in Medical Research: Differences between the Scientific Literature and the Legal Requirements

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

From an ethical and legal point of view, the assent of the minor to participate in a medical study is a subject of great importance. There is still a debate about the requirements to consider this assent valid and binding. This review analyses and compares the contents of the assent from the points of view of the legislation and the scientific literature.



Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial The MMR-161 Study Group

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: The potency of live viral vaccines decreases over time. We compared the immunogenicity and safety of GSK measles-mumps-rubella vaccine (MMR-RIT) formulations at two different potencies with that of the commercially-available MMR II formulation. Methods: In this phase III observer-blind clinical study (NCT01681992), 4516 healthy children aged 12-15 months were randomized (1:1:1 ratio) to receive one dose of MMR-RIT at the minimum potency used for this study (MMR-RIT-Min) or MMR-RIT…



Feasibility of Point-of-Care Testing for Influenza Within a National Primary Care Sentinel Surveillance Network in England: Protocol for a Mixed Methods Study

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Point-of-care testing (POCT) for influenza promises to provide real-time information to influence clinical decision making and improve patient outcomes. Public Health England has published a toolkit to assist implementation of these tests in the UK National Health Service. Objective: A feasibility study will be undertaken to assess the implementation of influenza POCT in primary care as part of a sentinel surveillance network. Methods: We will conduct a mixed methods study to…



Studying the Herd Immunity Effect of the Varicella Vaccine in the Community of Valencia, Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

In 2013, the Spanish Agency of Medicines blocked the varicella vaccine distribution based on a partial coverage of the vaccine that hypothetically could induce an increase of cases in adults: as non vaccinated children reach adulthood without having had contact with the virus in case the herd immunity stopped the virus circulation, or a hypothetical loss of vaccine protection in the long run. Also, this measure wanted to avoid increasing the number of cases of herpes zoster in adults. In this…



Optimizing strategies for meningococcal C disease vaccination in Valencia (Spain)

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Meningococcal C (MenC) conjugate vaccines have controlled invasive diseases associated with this serogroup in countries where they are included in National Immunization Programs and also in an extensive catch-up program involving subjects up to 20 years of age. Catch-up was important, not only because it prevented disease in adolescents and young adults at risk, but also because it decreased transmission of the bacteria, since it was in this age group where the organism was…



Evaluation of 13-valent pneumococcal conjugate vaccine and concomitant meningococcal group C conjugate vaccine in healthy infants and toddlers in Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Given the concurrent administration of multiple vaccines during routine pediatric immunizations, efforts to elucidate the potential interference of any vaccine on the immune response to the concomitantly administered antigens are fundamental to prelicensure clinical research. Methods: This phase 3 randomized controlled trial of 13-valent pneumococcal conjugate vaccine (PCV13) versus 7-valent PCV (PCV7) assessed immune responses of concomitantly administered meningococcal group C…



Pharmacoeconomic assessment of implementing a universal PCV-13 vaccination programme in the Valencian public health system (Spain)

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Heptavalent pneumococcal conjugate vaccine (PCV-7) was licensed to provide immunity against pneumococcal disease caused by seven serotypes of S. pneumoniae. Thirteen-valent pneumococcal conjugate vaccine (PCV-13) includes 6 additional serotypes for preventing invasive pneumococcal disease. Objective: The objective of this study was to estimate the potential health benefits, costs, and cost-effectiveness of vaccination with PCV-13 in the Community of Valencia and to generate…



Epidemiology and cost of herpes zoster and postherpetic neuralgia among patients treated in primary care centres in the valencian community of Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Data on the epidemiology and costs related to herpes zoster (HZ) and postherpetic neuralgia (PHN) in Spain are scarce; therefore, studies are needed to evaluate the epidemiological and economic impact of HZ and its most common complication, PHN. The present study aimed to estimate the clinical and economic burden of HZ and PHN in Valencia (Spain). Methods: We prospectively analyzed the burden of HZ and PHN and their attributable costs in patients from 25 general practices in the…



MF59 (TM)-adjuvanted seasonal influenza vaccine in young children

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Influenza is a viral disease of the upper respiratory tract, which is manifested in seasonal epidemic waves associated with excess morbidity and mortality. Although efforts at prevention have traditionally been focused on the elderly, interest is growing on the specific features of influenza disease in children and the opportunities for prevention in this age group. Owing to recent improvements in surveillance schemes and diagnostic tools it has been realized that young children experience a…



Using random networks to study the dynamics of respiratory syncytial virus (RSV) in the Spanish region of Valencia

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Seasonal fluctuations in the incidence of several respiratory infections are a feature of epidemiological surveys all around the world. This phenomenon is characteristic of influenza and respiratory syncytial virus pandemics. However, the explanation of the seasonal outbreaks of these diseases remains poorly understood. Many statistical studies have been carried out in order to provide a correlation of the outbreaks with climatic or social factors without achieving a definitive conclusion. Here…



Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Two randomized trials of 13-valent pneumococcal conjugate vaccine (PCV13) relative to PCV7 evaluated the immune responses of coadministered antigens comprising Infanrix (R) hexa/Infanrixe (R)-IPV + Hib (diphtheria, tetanus, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b). After the 3-dose infant series, immunogenic noninferiority was demonstrated for all concomitantly administered antigens between the PCV13 and PCV7 groups. All antigens…



Cost analysis of a vaccination strategy for respiratory syncytial virus (RSV) in a network model

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

In this paper an age-structured mathematical model for respiratory syncytial virus (RSV) is proposed where children younger than one year old, who are the most affected by this illness, are specially considered. Real data of hospitalized children in the Spanish region of Valencia are used in order to determine some seasonal parameters of the model. Once the parameters are determined, we propose a complete stochastic network model to study the seasonal evolution of the respiratory syncytial…



Pertussis in adults with persistent cough: a prospective follow up study in primary care.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Despite high coverage of pertussis vaccine, B. pertussis has remained endemic and adults are recognized as reservoir for infection among incompletely immunized infants. Between November 15th 2004 and November 14th 2006, 37 general practitioners, attending 56,658 adults, recruited all patients with persistent cough. A diagnosis of pertussis was considered in those with an unexplained cough, lasting 14 or more days and a positive polymerase chain reaction (PCR) or enzyme-linked immunosorbent…



Effectiveness of MF59 (TM)-adjuvanted subunit influenza vaccine in preventing hospitalisations for cardiovascular disease, cerebrovascular disease and pneumonia in the elderly

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Annual circulation of influenza virus coincides with a peak in cardiovascular and pneumonia mortality/morbidity. This study aimed to determine the effectiveness of MF59 (TM) -adjuvanted subunit influenza vaccine in preventing hospitalisation due to acute coronary syndrome (ACS), cerebrovascular accident (CVA) and pneumonia in the elderly. Three case-control studies were performed during the 2004-2005 influenza season in three health districts in Valencia, Spain (total elderly [> 64 years of…



Rotavirus gastroenteritis among children under five years of age in Valencia, Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The population-based incidence of rotavirus gastroenteritis in children < 5 years of age in Valencia, Spain, over a 1-year period (December 1, 2003, to November 30, 2004) was determined. A total of 553 episodes of gastroenteritis in children < 5 years of age (mean age, 22.8 +/- 14.5 months) were recorded (annual incidence of 138 per 1,000). A positive enzyme-linked immunoadsorbant assay result for rotavirus antigen was obtained in 15% of the samples. The incidence of rotavirus…



Reactogenicity and immunogenicity profile of a two-dose combined hepatitis A and B vaccine in 1-11-year-old children

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

This study was conducted to compare the reactogenicity, immunogenicity and safety of a combined two-dose (0, 6 months) hepatitis A and B vaccine (720 EL U HAV, 20 mcg HBsAg) with the established three-dose (0, 1 and 6 months) hepatitis A and B vaccine (360 EL U HAV, 10 mcg HBsAg). A total of 511 children aged 1-11 years who had not previously received a hepatitis A or B vaccine were enrolled in the study. Both vaccines were well tolerated, and were shown to be safe and immunogenic. The analysis…



Seroprevalence of Varicella Among Children and Adolescents in Valencia, Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

This study assessed the seroprevalence of varicella antibodies in children and adolescents in Spain and evaluated the reliability of two methods for detecting susceptible individuals: (1) parental-reported history of varicella and (2) medically-documented histories maintained by the pediatrician. A total of 186 children (6 to 15 years of age) were recruited in 13 pediatric offices of Valencia, Spain. A brief case report form was completed including previous history of varicella referred by the…



Immunogenicity and reactogenicity of a combined adsorbed tetanus toxoid, low dose diphtheria toxoid, five component acellular pertussis and inactivated polio vaccine in six-year-old children

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: The objective of this study was to assess the immunogenicity and reactogenicity of the combined adsorbed tetanus toxoid, low dose diphtheria toxoid, 5-cornponent acellular pertussis and inactivated polio vaccine (TdcP-IPV) as compared with a pediatric dose diphtheria formulation, combined with adsorbed tetanus toxoid and 3-component acellular pertussis (DTacP), in 6-yearold children who were immunized with 4 doses of diphtheria-tetanus-whole cell cellular pertussis (DTwcP) plus oral…



Effectiveness of the MF59-adjuvanted influenza vaccine in preventing emergency admissions for pneumonia in the elderly over 64 years of age

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Case-control study designed to determine the effectiveness of an MF59-adjuvanted influenza vaccine in the population aged 65 years and older living in the community. Detailed health histories were obtained on both cases and controls that included a functional measure of co-morbidity (Barthel Index). Subjects were all eligible persons admitted to various hospitals with a diagnosis of pneumonia during the winter months and were matched by sex, hospital and admission week to controls admitted for…



Incidence of pertussis in persons <= 15 years of age in Valencia, Spain: seroprevalence of antibodies to pertussis toxin (PT) in children, adolescents and adults

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Purpose. To determine the incidence of pertussis in persons less than or equal to15 years in age in Valencia, Spain. To assess the prevalence of IgG antibodies to pertussis toxin (PT) in children, adolescents and adults. Methods. Prospective study conducted at paediatric primary care centres. All persons less than or equal to15 years in age presented with persistent cough were enrolled. Parents completed a brief questionnaire and immunization history was obtained from paediatrician records. A…



Risk factors for invasive disease among children in Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Objective. To identify the risk factors related to invasive disease caused by Haemophilus influenzae type b (Hib), Neisseria meningitidis, and Streptococcus pneumoniae. Methods. Case-control. study. All hospitals of the region of Valencia in Spain (covering 95% of the population of Valencia). The patients are children aged less than 15 years in whom Hib, N. meningitidis or S. pneumoniae are isolated from normally sterile sites. Results. From 1995 to 1998, 275 cases of invasive disease were…



Epidemiology and economic impact of varicella in immunocompetent children in Spain. A nation-wide study

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The epidemiology and burden of varicella was assessed through the prospective study of 683 children under 15 years, by 58 primary care paediatricians working on seven autonomous communities of Spain. The mean age was 4.5 +/- 2.7 years, and 566 (83%) were secondary cases. There were 111 complications in 101 children (14.8%), skin superinfection being the most frequent (8.9%), followed by respiratory tract (4.5%) and eye (2.2%) infections. The mean number of visits to the paediatric clinic was 1…



Epidemiology of invasive Streptococcus pneumoniae infections in children in Spain, 1996-1998

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Streptococcus pneumoniae is a significant cause of meningitis and septicemia in early infancy, being associated to a high case-fatality rates and serious sequelae. Objective: To investigate the burden of invasive disease caused by S. pneumoniae in Valencia, Spain, during a threeyear period (1996-1998). Methods: Hospital-based prospective active surveillance program for invasive bacterial diseases in children < 15 years of age in Valencia, from December 1, 1995 to January 1999…



Impact of non-routine vaccination on the incidence of invasive Haemophilus influenzae type b (Hib) disease: Experience in the Autonomous Region of Valencia, Spain

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Objective: This study assessed the impact of non-routine vaccination against invasive Haemophilus influenzae (Hib) disease before the introduction of universal childhood Hib vaccination. Methods: Data were obtained from a prospective surveillance program for invasive bacterial diseases in children < 15 years of age that was begun in the Autonomous Re.-ion of Valencia on 1 December 1995. Results: An incidence of 15.5 cases of invasive Hib disease per 100 000 children < 5 years of age was…



Epidemiological pattern of meningococcal disease in Valencia, Spain. Impact of a mass immunization campaign with meningococcal C polysaccharide vaccine

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The objective of this study was to define the epidemiological pattern of meningococcal disease in the autonomous region of Valencia, Spain, and the impact of a mass immunization campaign against serogroup C meningococcus. Data were obtained from a prospective surveillance program for invasive bacterial diseases in children < 15 y of age that began in the Valencia region on I December, 1995. During the period 1996-98, 213 cases of meningococcal disease were detected, representing an annual…



Ibuprofen prophylaxis for adverse reactions to diphtheria-tetanus-pertussis vaccination: A randomized trial

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The aim of this study was to determine the effectiveness of ibuprofen prophylaxis in reducing the adverse effects of diphtheria-tetanus-pertussis (DTP) and oral polio vaccination in children 3, 5, and 7 months of age and to compare its effects with those of the present policy of treating adverse reactions when they occur. This 12-month, multicenter, randomized, open-label trial was conducted in six ambulatory, primary care centers. A total of 256 healthy children aged 3 months (+/-15 days)…



Depression in women suffering perinatal loss

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Objective: To analyze depression in women who have suffered perinatal loss in the present study. Methods: The level of depression was studied, by means of the Beck Depression Inventory (BDI), in two groups of women, mothers who suffered perinatal loss and received psychological intervention for 1 year and mothers with live-birth babies. The BDI was recorded immediately after delivery and at 6 and 12 months postpartum. A third group of women with perinatal loss who received no intervention were…



Adverse events after polysaccharide meningococcal A & C vaccine

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

The incidence of adverse events due to meningococcal polysaccharide A&C vaccine mas studied in 312 subjects 18 months to 20 y of age who were part of a mass vaccination program. Fever > 38 degrees C occurred in 5.1% (95% CI: 3.1-8.4%). Injection site pain nas reported in 78.8% (95% CI: 74.3-83.4%), was severe in 7.4% (95% CI: 4.7-10.9%) and was most frequent in the oldest age group.



Validation of self-reported perception of proximity to industrial facilities: MCC-Spain study

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

Background: Self-reported data about environmental exposures can lead to measurement error. Objectives: To validate the self-reported perception of proximity to industrial facilities. Methods: MCC-Spain is a population-based multicase-control study of cancer in Spain that recruited incident cases of breast, colorectal, prostate, and stomach cancer. The participant's current residence and the location of the industries were geocoded, and the linear distance between them was calculated (…



PROGRESSION OF ABCA4-RELATED RETINOPATHY-PROGNOSTIC VALUE OF DEMOGRAPHIC, FUNCTIONAL, GENETIC, AND IMAGING PARAMETERS.

Repositorio: r-FISABIO: Repositorio Institucional de Producción Científica

To investigate the prognostic value of demographic, functional, genetic, and imaging parameters on retinal pigment epithelium atrophy progression secondary to ABCA4-related retinopathy.