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Davalos A.,Hospital Universitari Germans Trias i Pujol | Alvarez-Sabin J.,Hospital Universitari Of La Vall Dhebron | Castillo J.,Hospital Clinico Universitario Of Santiago | Diez-Tejedor E.,Hospital Universitario La Paz | And 8 more authors.
The Lancet | Year: 2012

Background Citicoline is approved in some countries for the treatment of acute ischaemic stroke. The drug has shown some evidence of efficacy in a pooled analysis. We sought to confirm the efficacy of citicoline in a larger trial. Methods We undertook a randomised, placebo-controlled, sequential trial in patients with moderate-to-severe acute ischaemic stroke admitted at university hospitals in Germany, Portugal, and Spain. Using a centralised minimisation process, patients were randomly assigned in a 1:1 ratio to receive citicoline or placebo within 24 h after the onset of symptoms (1000 mg every 12 h intravenously during the first 3 days and orally thereafter for a total of 6 weeks [2×500 mg oral tablets given every 12 h]). All study participants were masked. The primary outcome was recovery at 90 days measured by a global test combining three measures of success: National Institutes of Health Stroke Scale ≤1, modified Rankin score ≤1, and Barthel Index ≥95. Safety endpoints included symptomatic intracranial haemorrhage in patients treated with recombinant tissue plasminogen activator, neurological deterioration, and mortality. This trial is registered, NCT00331890. Results 2298 patients were enrolled into the study from Nov 26, 2006, to Oct 27, 2011. 37 centres in Spain, 11 in Portugal, and 11 in Germany recruited patients. Of the 2298 patients who gave informed consent and underwent randomisation, 1148 were assigned to citicoline and 1150 to placebo. The trial was stopped for futility at the third interim analysis on the basis of complete data from 2078 patients. The final randomised analysis was based on data for 2298 patients: 1148 in citicoline group and 1150 in placebo group. Global recovery was similar in both groups (odds ratio 1.03, 95% CI 0.86-1.25; p=0.364). No significant differences were reported in the safety variables nor in the rate of adverse events. Interpretation Under the circumstances of the ICTUS trial, citicoline is not efficacious in the treatment of moderateto-severe acute ischaemic stroke.

Alio J.L.,Vissum Corporation | Alio J.L.,University Miguel Hernández | Toffaha B.T.,Vissum Corporation | Pena-Garcia P.,University Miguel Hernández | Sadaba L.M.,Clinica Universitaria de Navarra
Journal of Refractive Surgery | Year: 2015

PURPOSE: To describe the main causes of explantation of phakic intraocular lenses (PIOLs) according to the anatomical site of implantation (angle supported, iris fixated, or posterior chamber). METHODS: This multicentric, retrospective, and consecutive study sponsored by the Spanish Ministry of Health comprised a total of 240 eyes (226 patients) explanted due to PIOL complications. Clinical data of 144 angle-supported lenses, 24 iris-fixated lenses, and 72 posterior chamber lenses explanted were recorded preoperatively and postoperatively. RESULTS: Mean age of the patients at explantation was 46.30 ± 11.84 years (range: 25 to 80 years). The mean time between implantation and explantation was 381.14 ± 293.55 weeks (range: 0.00 to 1,551.17 weeks). It was 422.33 ± 287.81 weeks for the angle-supported group, 488.03 ± 351.95 weeks for the iris-fixated group, and 234.11 ± 4,221.60 weeks for the posterior chamber group. It was 8.10 ± 5.52 years for the angle-supported group, 9.36 ± 6.75 years for the iris-fixated group, and 4.49 ± 4.25 years for the posterior chamber group. This period of time was significantly shorter in the posterior chamber group (P <.001). Overall, the main causes of explantation were cataract formation (132 eyes, 55%), endothelial cell loss (26 eyes, 10.83%), corneal decompensation (22 eyes, 9.17%), PIOL dislocation/decentration (16 eyes, 6.67%), inadequate PIOL size or power (12 eyes, 5%), and pupil ovalization (10 cases, 4.17%). Cataract development was the cause of explantation in 51.39% of angle-supported cases, 45.83% of iris-fixated cases, and 65.28% of posterior chamber cases. Endothelial cell loss was the cause of explanation in 15.97% of angle-supported PIOLs, 8.33% of iris-fixated PIOLs, and 1.39% of posterior chamber PIOLs. CONCLUSIONS: Cataract is the main cause of PIOL explanation, especially in posterior chamber PIOLs. In the angle-supported group, endothelial cell loss was the second cause of explanation.

Peters B.R.,Dallas Hearing Foundation | Wyss J.,Cochlear AG European Headquarters | Manrique M.,Clinica Universitaria de Navarra
Laryngoscope | Year: 2010

Objectives/Hypothesis: The goal of this study is to ascertain worldwide experience with bilateral cochlear implantation (BCI) with regard to patient demographics, trends in provision of BCI to adult and child patient populations, differences and similarities in BCI candidacy criteria, diagnostic requirements, and treatment approaches among clinicians in high-volume cochlear implant centers. Study Design: Retrospective/prospective. Methods: An electronic survey consisting of 59 mainly multiple-choice questions was developed for online completion. It examined the implant experience and clinical opinion of expert cochlear implant (CI) centers worldwide on the indications, motivations, and contraindications for adult and pediatric, simultaneous and sequential BCI candidacy. Centers were chosen to complete the survey based on their known reputation as a center of excellence. Patient demographics were queried for two time periods to elucidate trends: 2006 and prior, and for the year 2007. Results: Seventy-one percent (25/35) of the CI clinics approached completed the survey. Collectively, these 25 clinics represent experience with approximately 23,200 CI users globally, representing 15% of the total estimated CI population worldwide. The total number of BCI surgeries reflected in their experience (2,880) represents 36% of the estimated number worldwide as of December 2007. Cumulatively to the end of 2007, 70% of all BCI surgeries have occurred in children, with the 3- to 10-year-old age group having the highest representation (33% of all BCIs), followed in order by adults (30%), children under 3 years of age (26%), and children between 11 and 18 years of age (11%). Seventy-two percent of all BCI surgeries were performed sequentially (70% of children, 76% of adults). Children <3 years of age represent the only age group of all patients in which simultaneous surgeries predominate (58% simultaneous). For all other age groups, sequential surgeries far outnumber simultaneous (3-10 years, 84% sequential; 11-18 years, 94% sequential; adults, 76% sequential). Prior to January 2007, 68% of BCIs were performed in children. This increased to 79% for the year 2007 (P <.001). With regard to children only, a change is apparent over time in terms of the age group making up the majority of pediatric BCI surgeries performed. Prior to 2007, children 3 to 10 years of age made up 50% of the children undergoing BCI, whereas those <3 years made up only 33%. In 2007 this shifted more toward the younger age group (47% for those <3 years and 40% for 3-10-year-olds; P <.001). United States clinics had a higher proportion of adult BCI patients (59% children, 41% adults) than the non-United States clinics (78% children, 22% adults; P <.001). The majority of responders do not hold to a minimum or maximum age by which they limit BCI. Conclusions: Worldwide experience with BCI is now quite extensive and provides a useful base for evaluating clinical outcomes across patient categories and for providing further support during the patient/parent counseling process. Laryngoscope, 120:S17-S44, 2010 Copyright © 2010 The American Laryngological, Rhinological, and Otological Society, Inc.

Plasticity makes possible adaptative modelling of the nervous system to experiences i.e. learning and development. To review current literature on clinical long term evolution and functional magnetic resonance imaging (fMRI) features of brain remodelling after focal stroke in left perisylvian regions involved in basic language processing during infancy and childhood. Each of the main neurocognitive subsystems develops with different timing, so altered plasticity and vulnerability are diverse, according with age at insult and its topography. Genetic programming makes human brain capable for installing basic formal linguistic abilities on an associative perisylvian subsystem, highly specialised. A focal lesion of this region leads to remodelling phenomena by disinhibition of contralateral frontal and perisylvian structures and by a more or less efficacious activation of neighboring homolateral cortex, as it has been shown by fMRI studies and DTI tractography. As a result, very early local stroke to language areas is generally well compensated in terms of linguistic behaviour. Meanwhile acquired aphasias into middle and late childhood, even if they have a better prognosis than in adults, they fail to resume without lexical access defaults and/or difficulties in written language. Brain plasticity can promote restoration and further development of language following a stroke in left peri-sylvian areas, specially when lesion occurs at perinatal to middle childhood.

Bejarano Herruzo B.,Clinica Universitaria de Navarra | Manrique M.,Clinica Universitaria de Navarra
Neurocirugia | Year: 2010

Introduction. Since its first description by Kux in 1954, the thoracic endoscopic (thoracoscopic) sympathectomy has rendered the open techniques obsolete in the treatment of the hyperhidrosis and other sympathetic-related diseases. Aim. The goal of this article is to present a critical review of the current indications, results and complications of the endoscopic thoracic sympathectomy. Material and methods. An extensive search and review of published papers on the thoracoscopic sympathectomy was undertaken. Results. The thoracoscopic sympathectomy has evolved as a therapeutic choice in patients with focal hyperhidrosis, pain syndromes and peripheral vascular disorders, particularly. The results, recurrences and complications are similar to the previously established open procedures; nevertheless, the morbidity, the hospital stay and the time to return to activities of daily living are substantially reduced. The highest success and satisfaction rates (over 95%) were observed among patients treated for focal hyperhidrosis. Conclusions. The success and complication rates of thoracoscopic sympathectomy are comparable to those of open techniques, with an easier postoperative period and an earlier return to labor and daily living.

Casanova C.,Hospital Universitario la Candelaria | De Torres J.P.,Clinica Universitaria de Navarra | Aguirre-Jaime A.,Hospital Universitario la Candelaria | Pinto-Plata V.,Brigham and Women's Hospital | And 5 more authors.
American Journal of Respiratory and Critical Care Medicine | Year: 2011

Rationale: Chronic obstructive pulmonary disease (COPD) is thought to result in rapid and progressive loss of lung function usually expressed as mean values for whole cohorts. Objectives: Longitudinal studies evaluating individual lung function loss and other domains of COPD progression are needed. Methods: We evaluated 1,198 stable, well-characterized patients with COPD (1,100 males) recruited in two centers (Florida and Tenerife, Spain) and annually monitored their multidomain progression from1997 to 2009. Patients werefollowed for a medianof 64 months and up to 10 years. Their individual FEV 1 (L) and BODE index slopes, expressed as annual change, were evaluated using regression models for repeated measures. A total of 751 patients with at least three measurements were used for the analyses. Measurements and Main Results: Eighteen percent of patients had a statistically significant FEV 1 slope decline (-86 ml/yr; 95% confidence interval [CI], -32 to -278 ml/yr). Higher baseline FEV 1 (relative risk, 1.857; 95% CI, 1.322-2.610; P < 0.001) and low body mass index (relative risk, 1.071; 95% CI, 1.035-1.106; P < 0.001) were independently associated with FEV 1 decline. The BODE index had a statistically significant increase (0.55, 0.20-1.37 point/yr) in only 14% of patients and these had more severe baseline obstruction. Concordance between FEV 1 and BODE change was low (κ Cohen, 16%). Interestingly,73%of patients had no significant slope change in FEV 1 or BODE. Only the BODE change was associated with mortality in patients without FEV 1 progression. Conclusions: The progression of COPD is very heterogeneous. Most patients show no statistically significant decline of FEV 1 or increase in BODE. The multidimensional evaluation of COPD should offer insight into response to COPD management.

Samaniego E.,Complejo Asistencial Universitario Of Leon | Redondo P.,Clinica Universitaria de Navarra
Actas Dermo-Sifiliograficas | Year: 2013

Lentigo maligna is a type of in situ melanoma. It develops mainly in middle-aged and elderly individuals on areas of the skin chronically exposed to sunlight. It progresses to its invasive form, lentigo maligna melanoma, in 5% to 50% of cases. Management of lentigo maligna is open to debate, with a notable lack of randomized trials and specific guidelines and protocols. Early diagnosis and treatment is necessary to achieve cure if possible and prevent progression to invasive melanoma with the corresponding risk of metastasis. The treatment of choice for lentigo maligna is surgery. When surgery is not possible, other alternatives are available although outcomes and rates of recurrence are variable. The objective of this study was to review the diagnostic methods and criteria for lentigo maligna, as well as the different surgical options and alternatives to surgery, in order to provide information on the best approach in each case. © 2012 Elsevier España, S.L. y AEDV. Todos los derechos reservados.

Alcazar J.L.,Clinica Universitaria de Navarra | LEOn M.,Clinica Instituto Diagnostico SA | Galvan R.,Clinica Universitaria de Navarra | Guerriero S.,University of Cagliari
Ultrasound in Obstetrics and Gynecology | Year: 2010

Objective To assess whether the analysis of cyst content using mean gray value (MGV) can discriminate ovarian endometriomas from other unilocular ovarian cysts in premenopausal women. Methods: Stored three-dimensional (3D) volumes from 54 unilocular ovarian cysts diagnosed in 50 premenopausal women (mean age, 37 (range, 22-50) years) were analyzed to calculate the MGV from cyst content. Cysts with solid components or septations were excluded. MGV was calculated in all cases with the Virtual Organ Computer-aided AnaLysis™ technique. The Bmode presumptive diagnosis based on the examiner's subjective impression was also recorded. Results: Sixteen of the cysts resolved spontaneously and were given a final clinical diagnosis of hemorrhagic functional cyst, while 38 cysts were removed surgically (diagnosed histologically as seven simple cysts, three hemorrhagic cysts, 20 endometriomas, five mucinous cysts and three paraovarian cysts). B-mode diagnoses were as follows: seven simple cysts, 18 hemorrhagic cysts, 24 endometriomas, three mucinous cysts and two paraovarian cysts. MGV was significantly higher in ovarian endometrioma when compared with all other kinds of cyst. The receiver-operating characteristics curve showed that using an MGV cut-off ≥15.560 had a sensitivity of 85% and a specificity of 76.5% for diagnosing ovarian endometrioma (area under the curve, 0.831; 95% CI, 0.718-0.944). These figures were similar to those for B-mode diagnosis (sensitivity, 90%; specificity, 82%) (McNemar test, P = 1.000). Combining B-mode and MGV gave a sensitivity of 80% and a specificity of 91%. Conclusion Cyst content MGV is higher in ovarian endometrioma than it is in other unilocular ovarian cysts. The diagnostic performance of MGV is similar to that of the examiner's subjective impression. The combination of both criteria achieves the highest specificity. Copyright © 2009 ISUOG. Published by John Wiley & Sons, Ltd.

To analyse our experience in the treatment of refractory chronic migraine, episodic frequent refractory migraine (≥10 days/month), with onabotulinumtoxin A (OnabotA). Retrospective analysis of patients with refractory migraine who underwent, at least two sessions of OnabotA pericranial injections following the PREEMPT protocol between 2008 and 2012. The efficacy of OnabotA was evaluated comparing the basal situation with 12-16 weeks after the second session. We analysed the subjective improvement of the patients, number of days with headache, preventive and abortive drugs consumption, and adverse effects. Forty-one patients (37 women, 4 male) were identified. 65.8% patients experienced subjective improvement after OnabotA treatment. 36.58% responded (reduction of > 50% in headache days). Differences between days with headache before the first session (24.5 ± 7.3), and 12-16 weeks after the second session (17.4 ± 11.6), as well as the differences between the number of abortive drugs taken before the first session (26.8 ± 23.1) and 12-16 weeks after the second session (16.7 ± 19.3), were statistically significant (p < 0.001). Subgroups analysis showed that all differences were significant, except for the reduction of the number of days with headache in patients with episodic frequent refractory migraine. Our work shows that treatment with OnabotA is safe and useful in patients with episodic and chronic refractory migraine, including those patients with medication overuse headache.

Procedural learning disorder, or non-verbal learning disorder, affects the automation of perceptual motor and cognitive skills and routines. To further our knowledge of the neurocognitive dysfunction in this disorder and, more specifically, to analyse the difficulties experienced when going from recognition of the constituting elements of something to an understanding of the whole. Contrasting simultaneous visual information and the swift recognition of contradictions are especially difficult abilities for children with procedural learning disorder. These difficulties may reflect a central coherence dysfunction and can partly account for the deficient ability to adapt their social behaviour displayed by these children.

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