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Calzada de Don Diego, Spain

Langley J.M.,Dalhousie University | Carmona Martinez A.,Instituto Hispalense Of Pediatria | Chatterjee A.,Creighton University | Halperin S.A.,Dalhousie University | And 16 more authors.
Journal of Infectious Diseases | Year: 2013

Background. Mismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently. Methods. In a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3-17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6-35 months of age. Results. A total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination- inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam). Conclusion. QIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs. Clinical Trials Registration. NCT01198756. © The Author 2013. Source

Walker C.,European University at Madrid | Rodriguez T.,European University at Madrid | Herranz A.,Hospital Universitario La Paz | Espinosa J.A.,Quiron University Hospital | And 2 more authors.
International Urogynecology Journal and Pelvic Floor Dysfunction | Year: 2012

Introduction and hypothesis: This study was conducted to evaluate the effects of an alternative model of birth (AMB) on the incidence of assisted vaginal delivery (AVD) and perineal trauma (PT). Methods: One hundred ninety-nine women with epidural anesthesia were randomized to a traditional model of birth (TMB) (n096) or AMB (n0103). Women in TMB pushed immediately after complete dilatation and delivered in lithotomy position. In AMB, women followed a postural changes protocol while they delayed pushing and used a specific lateral position for delivery. Results: AMB was associated with a significant reduction in AVD compared with TMB (19.8% vs 42.1%, p<0.001). TMB was strongly associated with AVD (OR04.49; p< 0.05), which, in turn, was significantly associated with nulliparity (OR05.52; p<0.005) and fetal head unengaged at full dilatation (OR05.35; p<0.05). AMB significantly increased the intact perineum rate compared with TMB (40.3% vs 12.2%, p<0.001). Episiotomy rate was significantly reduced in AMB (21.0% vs 51.4%, p<0.001). Conclusion: A combination of postural changes during the passive expulsive phase of labor and lateral position during active pushing time is associated with reductions in AVD and PT. © The International Urogynecological Association 2012. Source

Acero J.,Complutense University of Madrid | Acero J.,Quiron University Hospital | Garcia E.,Clinic i Provincial Hospital | Garcia E.,University of Barcelona
Oral and Maxillofacial Surgery Clinics of North America | Year: 2011

Reoperative reconstruction of the midface is a challenging issue because of the complexity of this region and the severity of the aesthetic and functional sequela related to the absence or failure of a primary reconstruction. The different situations that can lead to the indication of a reoperative reconstructive procedure after previous oncologic ablative procedures in the midface are reviewed. Surgical techniques, anatomic problems, and limitations affecting the reoperative reconstruction in this region of the head and neck are discussed. © 2011 Elsevier Inc. Source

Perez-Valderrama B.,University of Seville | Arranz Arija J.A.,Gregorio Maranon General University Hospital | Rodriguez Sanchez A.,University of Leon | Pinto Marin A.,Hospital Universitario La Paz | And 30 more authors.
Annals of Oncology | Year: 2016

Background: Patients with metastatic renal carcinoma (mRCC) treated with first-line pazopanib were not included in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic model. SPAZO (NCT02282579) was a nation-wide retrospective observational study designed to assess the effectiveness and validate the IMDC prognostic model in patients treated with first-line pazopanib in clinical practice. Patients and methods: Data of 278 patients, treated with first-line pazopanib for mRCC in 34 centres in Spain, were locally recorded and externally validated. Mean age was 66 years, there were 68.3% male, 93.5% clear-cell type, 74.8% nephrectomized, and 81.3% had ECOG 0-1. Metastatic sites were: lung 70.9%, lymph node 43.9%, bone 26.3%, soft tissue/skin 20.1%, liver 15.1%, CNS 7.2%, adrenal gland 6.5%, pleura/peritoneum 5.8%, pancreas 5%, and kidney 2.2%. After median follow-up of 23 months, 76.4% had discontinued pazopanib (57.2% due to progression), 47.9% had received second-line targeted therapy, and 48.9% had died. Results: According to IMDC prognostic model, 19.4% had favourable risk (FR), 57.2% intermediate risk (IR), and 23.4% poor risk (PR). No unexpected toxicities were recorded. Response rate was 30.3% (FR: 44%, IR: 30% PR: 17.3%). Median progression-free survival (whole population) was 11 months (32 in FR, 11 in IR, 4 in PR). Median and 2-year overall survival (whole population) were 22 months and 48.1%, respectively (FR: not reached and 81.6%, IR: 22 and 48.7%, PR: 7 and 18.8%). These estimations and their 95% confidence intervals are fully consistent with the outcomes predicted by the IMDC prognostic model. Conclusion: Our results validate the IMDC model for first-line pazopanib in mRCC and confirm the effectiveness and safety of this treatment. © The Author 2015. Source

Fernandez-Jaen A.,Quiron University Hospital | Fernandez-Mayoralas D.M.,Quiron University Hospital | Calleja Perez B.,Quiron University Hospital | Munoz Jareno N.,Neuropediatrics Section | Del Rosario Campos Diaz M.,Psicoaula Center
Pediatric Neurology | Year: 2010

The study objective was to assess the efficacy and tolerability of atomoxetine in the treatment of attention deficit hyperactivity disorder symptoms in patients with mental retardation. In a 16-week, open-label, prospective study, 48 children with mental retardation and attention deficit hyperactivity disorder were recruited; the patients received atomoxetine, with a single final dose of 1.2 mg/kg per day reached at 3 weeks. The measure of efficacy was scores on Clinical Global Impression Severity scale (CGI-S), Conners, and Attention Deficit Hyperactivity Disorder Rating Scale ADHDRS-IV. A statistically significant difference was documented between the mean CGI-S scores before and after treatment: baseline CGI-S = 5.31 (S.D. = 0.85); post-treatment CGI-S = 4.13 (S.D. = 0.97), with a difference of 1.18 points (S.D. = 0.84) and a 95% confidence interval for the difference of 0.92-1.43 (P < 0.001). A statistically significant reduction (P < 0.01) was observed with respect to all the variables of the ADHDRS-IV and Conners scales. Slightly less than one third of the patients (31%) presented adverse events, the majority of which were mild, with irritability being the most frequent event. Atomoxetine appears to be to useful in improving attention deficit hyperactivity disorder symptoms in mentally retarded patients. Larger, randomized, controlled, double-blind studies are required to confirm the efficacy observed in this first study. © 2010 by Elsevier Inc. All rights reserved. Source

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