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Angola
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Romero J.E.,Jaume I University | Chiva J.A.,Jaume I University | Peris-Vicente J.,University of Valencia | Ochoa-Aranda E.,Hospital Provincial
Bioanalysis | Year: 2017

Aim: A micellar liquid chromatographic method to determine several anticancer drugs (pazopanib, dabrafenib and regorafenib) in plasma was developed and validated by the guidelines of the EMA. Experimental: Plasma samples were directly injected, after a 1/5-dilution in a micellar solution. The drugs were resolved in <18 min using a C18 column. The mobile phase was an aqueous solution of 0.12 M SDS - 2% 1-pentanol, buffered at pH 7. The detection was performed by absorbance at 260 nm. Results: The values of the main validation parameters were: LOD (0.1-1 mg/l), calibration range (0.2-2 to 80 mg/l), accuracy (-12.5 to +11.7%) and precision (<11.9%). Conclusion: The procedure was conducted by minimum cost, effort, manipulation, time and quantity of hazardous chemicals. The method was useful to determine the drugs at their respective target concentrations, and was found useful for clinical analysis. © 2017 Future Science Ltd.


Esteve-Romero J.,Jaume I University | Ochoa-Aranda E.,Hospital Provincial | Bose D.,Dr Hari Singh Gour University | Rambla-Alegre M.,Jaume I University | And 2 more authors.
Analytical and Bioanalytical Chemistry | Year: 2010

A simple micellar liquid chromatographic procedure is described to determine tamoxifen in plasma. To perform the analysis, tamoxifen solutions were diluted in water and UV-irradiated for 20 min to form the photocycled derivative with a phenanthrene core which shows intense fluorescence. Samples were then directly injected, thus avoiding long extraction and experimental procedures. The resolution from the matrix was performed with a mobile phase containing 0.15 M SDS-7% n-butanol at pH 3 running at 1.5 mL/min through a C18 column at 40 °C. Detection was carried out by fluorescence, and the excitation and emission wavelengths were 260 and 380 nm, respectively. The chromatographic analysis time was less than 15 min. The analytical methodology was validated following the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines. The response of the drug in plasma was linear and in the 0.5-15 μg/mL range, with r 2 > 0.999. Accuracy and precision were <9% in both cases. The limits of detection and quantification (in nanograms per millilitre) were 50 and 150 in plasma, respectively. The method developed herein shows no interferences by endogenous compounds. Finally, the analytical method was used to determine the amount of tamoxifen in the plasma of several breast cancer patients from a local hospital. © 2010 Springer-Verlag.


Peris-Vicente J.,Jaume I University | Ochoa-Aranda E.,Hospital Provincial | Bose D.,Dr Hari Singh Gour University | Esteve-Romero J.,Jaume I University
Talanta | Year: 2015

A method was developed for the analysis of tamoxifen and its main derivatives (4-hydroxytamoxifen, N-desmethyl-tamoxifen, tamoxifen-N-oxide and endoxifen) in human plasma, using micellar liquid chromatography coupled with fluorescence detection. Analytes were off-line derivatized by sample UV-irradiation for 20 min to form the photocycled fluorescent derivatives. Then samples were diluted, filtered and directly injected, thus avoiding extraction steps. The analytes were resolved using a mobile phase containing 0.08 M SDS-4.5% butanol at pH 3 running at 1.5 mL/min through a C18 column at 40 °C, without interferences from endogenous compounds in plasma. Excitation and emission wavelengths were 260 and 380 nm, respectively. The chromatographic analysis time was less than 40 min. The analytical methodology was validated following the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines in terms of: selectivity, linear range (0.3-15 μg/mL), linearity (r 2>0.999), sensitivity (LOD, 65-80 ng/mL; LOQ, 165-200 ng/mL), intra- and interday accuracy (-12.2-11.5%) and precision (<9.2%) and robustness (<6.3%). The method was used to quantify the tamoxifen and tamoxifen derivatives in several breast cancer patients from a local hospital, in order to study the correlation between the genotype of the patient and the ability to metabolize tamoxifen. © 2014 Elsevier B.V.


PubMed | Hospital Puerta Of Hierro Majadahonda, Hospital General Of Alicante, Cluzeau Hospital, Hospital Provincial and 14 more.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017

LBA8002 Background: Findings from the SLCG phase II customized chemotherapy trial (NCT00883480) showed that RAP80, a component of the BRCA1 complex, influenced outcome both in p with low BRCA1 expression treated with cisplatin (cis)/gemcitabine (gem) and in p with intermediate/high BRCA1 levels treated with cis/docetaxel (doc) or with doc alone. Together with the French Lung Cancer Group, the SLCG has performed a prospective, randomized phase III trial comparing noncustomized cis/doc with customized therapy in metastatic NSCLC p. A parallel phase II study (ChiCTR-TRC-12001860) is being carried out in China under the auspices of the SLCG.Since 6 March 2008, 391 p with wild-type EGFR have been randomized 1:1 to the control or experimental arm. p in the control arm receive cis/doc; p in the experimental arm receive treatment according to their BRCA1 and RAP80 levels: p with low RAP80, regardless of BRCA1 levels, cis/gem; p with intermediate/high RAP80 and low/intermediate BRCA1, cis/doc; p with intermediate/high RAP80 and high BRCA1, doc alone. The primary endpoint is progression-free survival (PFS).At the planned interim analysis (cut-off, 15 October 2012; N=279), PFS was 5.49 months (m) in the control and 4.38 m in the experimental arm (P=0.07). Overall survival (OS) was 12.66 m in the control and 8.52 m in the experimental arm (P=0.006). Response rate (RR) was 37.3% in the control and 27% in the experimental arm (P=0.07). In the multivariate analysis including PS, treatment arm, BRCA1, RAP80, histology, smoking status, and metastatic site, only extrathoracic metastases were associated with an increased risk of progression (HR, 1.78; P=0.02).Based on the negative results for PFS at the interim analysis, accrual has been closed on this study. Negative results may be due to the poor predictive capacity of RAP80 and the inclusion of doc alone as a treatment in the experimental arm. In addition, doc/cis may not be the ideal combination for the control arm.NCT00617656.


PubMed | World Health Organization, Hospital Provincial, Imperial College London, Swiss Tropical and Public Health Institute and 4 more.
Type: | Journal: Parasites & vectors | Year: 2016

By 2020, the global health community aims to control and eliminate human helminthiases, including schistosomiasis in selected African countries, principally by preventive chemotherapy (PCT) through mass drug administration (MDA) of anthelminthics. Quantitative monitoring of anthelminthic responses is crucial for promptly detecting changes in efficacy, potentially indicative of emerging drug resistance. Statistical models offer a powerful means to delineate and compare efficacy among individuals, among groups of individuals and among populations.We illustrate a variety of statistical frameworks that offer different levels of inference by analysing data from nine previous studies on egg counts collected from African children before and after administration of praziquantel.We quantify responses to praziquantel as egg reduction rates (ERRs), using different frameworks to estimate ERRs among population strata, as average responses, and within strata, as individual responses. We compare our model-based average ERRs to corresponding model-free estimates, using as reference the World Health Organization (WHO) 90% threshold of optimal efficacy. We estimate distributions of individual responses and summarize the variation among these responses as the fraction of ERRs falling below the WHO threshold.Generic models for evaluating responses to anthelminthics deepen our understanding of variation among populations, sub-populations and individuals. We discuss the future application of statistical modelling approaches for monitoring and evaluation of PCT programmes targeting human helminthiases in the context of the WHO 2020 control and elimination goals.


Roca B.,Hospital General | Diaz M.D.,Hospital General | Roca M.,Hospital Provincial
International Journal of STD and AIDS | Year: 2015

We report a unique case of acute bacterial prostatitis probably caused by Listeria monocytogenes in an HIV-infected patient. For the best of our knowledge, this is the first case reported of a patient with this association. Our case illustrates the protean clinical presentations that L. monocytogenes infections may adopt, particularly in immunocompromised patients. © 2015, © The Author(s) 2015.


Gonzalez-Darder J.M.,Hospital Clinico Universitario Of Valencia | Vera-Roman J.M.,Hospital General | Pesudo-Martinez J.V.,Hospital General | Cerda-Nicolas M.,Hospital Clinico Universitario Of Valencia | Ochoa E.,Hospital Provincial
Acta Neurochirurgica | Year: 2011

Purpose: Lymphomatoid granulomatosis (LYG) is an angiocentric Epstein-Barr virus (EBV) related B-cell proliferation associated with a reactive T-cell component with an uncertain malignant potential. LYG present at diagnosis as a mass lesion in the central nervous system (CNS) is rare, and only a few cases have been reported. In this article we present four cases of tumoral CNS-LYG and propose some guidelines for its management. Methods: Clinical, pathological, imaging and laboratory information of four immunocompetent patients, all of them treated surgically, with a final diagnosis of LYG and presenting with an isolated intracranial tumoral mass is reviewed. Results: Two parenchymal lesions were located in the cerebellum and temporal lobe, and the other two involved the cavernous sinus. At surgery they were avascular, hard, lard-like, necrotic and plastic well-defined lesions, with invasion of the leptomeninges and thrombosis of the small leptomeningeal arteries and veins. Intraoperative pathology excluded any tumor. Pathological studies showed a polymorphic and polyclonal infiltration around, in the wall and into the lumen of medium-sized cortical and leptomeningeal vessels causing their obstruction and tissular necrosis. EBV-infected cells were present. Conclusions: Making a preoperative diagnosis of CNS-LYG appearing initially as a tumoral mass is difficult because of the lack of pathognomonic clinical symptoms or imaging signs. Surgical management with radical resection of the mass is almost always followed by the long-term local control of the lesion, although the disease may have a disseminated, systemic or malignant evolution. © 2011 Springer-Verlag.


Roca B.,Hospital General | Roca M.,Hospital Provincial | Girones G.,Hospital General
HIV Clinical Trials | Year: 2016

Objective: To find factors associated with increased homocysteine plasma level in HIV-infected patients. Methods: Cross-sectional study, carried out as a supplementary task to the standard care of HIV-infected patients. The possible association of increased homocysteine plasma level with blood analyses results was assessed with a multiple linear regression analysis, using the automatic linear modeling available in SPSS version 22. Results: A total of 145 patients were included. Creatinine was higher than normal in 7 patients (5%), prothrombin time was shortened in 36 patients (25%), and a monoclonal gammopathy was detected in 2 patients (1%). In the regression analysis, an association was found between high homocysteine plasma level and the following variables: low prothrombin time (β coefficient −0.286, confidence interval −1.1854 to −0.754, p < 0.001), high creatinine (coefficient 9.926, confidence interval 6.351–15.246, p < 0.001), low folic acid (coefficient −0.331, confidence interval −0–483 to −0.187, p < 0.001), and low vitamin B12 (coefficient −0.007, confidence interval −0.01 to −0.001, p = 0.005). Conclusion: An association was found between increased homocysteine plasma level and shortened prothrombin time. © 2016 Informa UK Limited, trading as Taylor & Francis Group


PubMed | Hospital Provincial and Hospital General
Type: Journal Article | Journal: HIV clinical trials | Year: 2016

To find factors associated with increased homocysteine plasma level in HIV-infected patients.Cross-sectional study, carried out as a supplementary task to the standard care of HIV-infected patients. The possible association of increased homocysteine plasma level with blood analyses results was assessed with a multiple linear regression analysis, using the automatic linear modeling available in SPSS version 22.A total of 145 patients were included. Creatinine was higher than normal in 7 patients (5%), prothrombin time was shortened in 36 patients (25%), and a monoclonal gammopathy was detected in 2 patients (1%). In the regression analysis, an association was found between high homocysteine plasma level and the following variables: low prothrombin time ( coefficient -0.286, confidence interval -1.1854 to -0.754, p<0.001), high creatinine (coefficient 9.926, confidence interval 6.351-15.246, p<0.001), low folic acid (coefficient -0.331, confidence interval -0-483 to -0.187, p<0.001), and low vitamin B12 (coefficient -0.007, confidence interval -0.01 to -0.001, p=0.005).An association was found between increased homocysteine plasma level and shortened prothrombin time.


Introduction: Clinical research is the form of research nearest to clinical practice. Material and methods: For the years 1992, 1996, 2000, 2004, and 2008, we identified all indexed articles published by Spanish dermatologists and calculated the percentages corresponding to clinical research according to a previously validated definition; we then calculated the proportion of clinical research articles offering higher levels of evidence. For 2008, we compared these percentages to those of French and British dermatologists and Spanish rheumatologists. We also compared these groups' rates of productivity in 2008 in relation to articles providing higher levels of evidence. Results: In 2008, 36% of Spanish dermatologists' publications reported clinical research; 7% were studies offering higher levels of evidence. The proportions did not change significantly over the period studied. Clinical research publications accounted for 35% and 43% of the articles by French and British dermatologists in 2008 and 54% of articles by Spanish rheumatologists in that year. The proportion of publications reporting clinical research was significantly higher for Spanish rheumatologists than for Spanish dermatologists. The proportions of publications offering higher levels of evidence were significantly different in 2008 only for the comparison between Spanish dermatologists and rheumatologists. Other differences were not statistically significant. In the comparison of rates of productivity in clinical research offering higher levels of evidence, British dermatologists were significantly more productive than Spanish dermatologists. Conclusions: Differences were observed in relation to specialty (Spanish dermatologists vs rheumatologists) and nationality (Spanish vs British dermatologists). The reasons for the differences identified need to be studied in order to improve this situation. © 2009 Elsevier España, S.L. y AEDV.

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