Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study.

BACKGROUND: In May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines. Within this project, this study aimed to generate background incidence rates of 41 adverse events of special interest (AESI) to contextualize potential safety signals detected following administration of COVID-19 vaccines. METHODS: A dynamic cohort study was conducted using a distributed data network of 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United Kingdom) over the period 2017 to 2020. A common protocol (EUPAS37273), common data model, and common analytics programs were applied for syntactic, semantic and analytical harmonization. Incidence rates (IR) for each AESI and each database were calculated by age and sex by dividing the number of incident cases by the total person-time at risk. Age-standardized rates were pooled using random effect models according to the provenance of the events. FINDINGS: A total number of 63,456,074 individuals were included in the study, contributing to 211.7 million person-years. A clear age pattern was observed for most AESIs, rates also varied by provenance of disease diagnosis (primary care, specialist care). Thrombosis with thrombocytopenia rates were extremely low ranging from 0.06 to 4.53/100,000 person-years for cerebral venous sinus thrombosis (CVST) with thrombocytopenia (TP) and mixed venous and arterial thrombosis with TP, respectively. INTERPRETATION: Given the nature of the AESIs and the setting (general practitioners or hospital-based databases or both), background rates from databases that show the highest level of completeness (primary care and specialist care) should be preferred, others can be used for sensitivity. The study was designed to ensure representativeness to the European population and generalizability of the background incidence rates. FUNDING: The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE.

Occurrence, prevalence, and explanatory environmental variables of Spirocerca vulpis infestation in the foxes of western Spain.

The main aim of this study was to not only establish the prevalence of the recently described Spirocerca vulpis parasite in the wild-life cycle of carnivores in western Spain but to also elaborate a model to explain the risk of infestation based on 16 topo-climatic and habitat variables. During the period from June 2016 to November 2017, 1644 carcasses of red foxes (Vulpes vulpes) and another 105 wild mammals, legally hunted or killed in car accidents, were analyzed. Parasitic nodules of Spirocerca were found in 6% of the foxes, and the molecular analyses established a homology of our samples with the species S. vulpis. There were no differences in the occurrence of the infestation between sexes, but there were differences in terms of age, such that infestation was proportionally more frequent among young individuals. In terms of temporality, a higher percentage of positive cases was observed during the late-autumn and winter months, especially between December and February. This study provides new data on the factors that predispose S. vulpis infection in the red fox. Model results indicate that a spatial pattern exists in the occurrence and prevalence of this species in the studied area (higher probabilities to the west), and that this pattern seems to mainly be associated with topo-climatic variables.

Schwannoma of the biliary tract resembling cholangiocarcinoma: A case report and review.

Schwannomas are benign tumours derived from Schwann cells and are extremely rare in the biliary tract. We present the case of a 62-year-old patient with a common bile duct schwannoma that resembled a cholangiocarcinoma. We also review all 17 previously published cases of schwannoma of the biliary tract and discuss the challenges of preoperative diagnosis.

Predictors of medication use in the Roma population in Spain: a population-based national study.

OBJECTIVES: To describe the prevalence of prescribed and self-medicated use of medication in the Spanish Roma population, and identify the associated factors. STUDY DESIGN: Descriptive cross-sectional study. METHODS: Data from the first National Health Survey conducted on the Roma population in Spain were used. The sample comprised 1000 Spanish Roma adults of both sexes aged ≥16 years. Answers (yes/no) to the question, 'In the last two weeks have you taken the following medicines [in reference to a list of medicines that might be used by the population] and were they prescribed for you by a doctor?' were used to ascertain 'medication use'. 'Self-medication' referred to use of these medicines without medical prescription. Using multivariate logistic regression models, odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to identify associated factors. RESULTS: The overall prevalence of medication use in the Roma population for both sexes was 69.1%, and 38.7% was self-medicated. Females reported higher use of medication than males (75.1% vs 62.3%); however, self-medication was higher among males. Analgesics and antipyretics were used most often (35.8%). Among males, the variables that were independently and significantly associated with a higher probability of medication use were: age; negative perception of health; presence of chronic disease (OR 2.81; 95% CI 1.67-4.73); and medical visits (OR 4.51; 95% CI 2.54-8.01). The variables were the same among females, except for age. CONCLUSION: A high percentage of the Spanish Roma population use medication, and a significant proportion of them self-medicate. The presence of chronic diseases, a negative perception of health and medical consultations were associated with increased use of medication in the study population.

Beneficial effects of sustained activity on the use of dietary protein and carbohydrate traced with stable isotopes 15N and 13C in gilthead sea bream (Sparus aurata).

To determine the effects of sustained swimming on the use and fate of dietary nutrients in gilthead sea bream, a group of fish were forced to undertake moderate and sustained swimming (1.5 BL s(-1)) for 3 weeks and compared with a control group undertaking voluntary activity. The exercise group showed a significant increase in specific growth rate (C: 1.13 ± 0.05; E: 1.32 ± 0.06 % day(-1), P < 0.05) with no significant change in food intake (C: 3.56 ± 0.20; E: 3.84 ± 0.03 % of body weight). The addition of (13)C-starch and (15)N-protein to a single meal of 1 % ration allowed analysis of the fate of both nutrients in several tissues and in their components, 6 and 24 h after force-feeding. In exercised fish improved redistribution of dietary components increased the use of carbohydrates and lipid as fuels. Gilthead sea bream have a considerable capacity for carbohydrate absorption irrespective of swimming conditions, but in trained fish (13)C rose in all liver fractions with no changes in store contents. This implies higher nutrient turnover with exercise. Higher retention of dietary protein (higher (15)N uptake into white muscle during the entire post-prandial period) was found under sustained exercise, highlighting the protein-sparing effect. The combined effects of a carbohydrate-rich, low-protein diet plus sustained swimming enhanced amino acid retention and also prevented excessive lipid deposition in gilthead sea bream.

[Cherubism: diagnosis and treatment in the pediatric age]. / Querubismo: diagnóstico y tratamiento en la edad pediátrica.

Cherubism is a benign bone dysplasia of childhood, exclusively involving maxillary bones and spontaneous resolving after puberty in different grades. Approximately, 280 cases have been reviewed in the literature. It is an autosomal dominant disorder in which the normal bone is replaced by cellular fibrous and immature bone, resulting in painless symmetrical enlargement of the jaws. Diagnosis is based in clinical and radiological findings, confirmed by histology. Treatment is a controversial issue, and it is recommended surgical management as conservative as possible during the rapid growth phases. An aggressive case of cherubism is reported, diagnosed and followed since early childhood until puberty, with progressive involvement of facial bones developing in a disruption of facial contours and occlusion. The patient is treated by several surgical interventions oriented to minimize the aesthetic impact of the disease being as conservative as possible. The highlights of this case are the great proportion of the lesions, the functional and emotional disturbances brought out by these lesions and the difficulty to choose the most appropriate age and form of treatment.

Analysis of 27,248 hospital discharges for heart failure: a study of an administrative database 1998-2002.

AIMS: To describe the epidemiology of hospital admissions for heart failure in 32 hospitals. To define the profile of those attended by Internal Medicine (IM). METHODS AND RESULTS: Analysis of the Minimum-Basic-Data-Set registry of 32 public Spanish hospitals, during 1998-2002, identifying those cases whose main or secondary diagnosis was heart failure, with attention to age, sex, length of stay, season, outcome, number of diagnoses, Diagnostic Related Groups (DRG), and coded procedures. There were 2,787,008 discharges, 27,248 with heart failure (15,737 IM, 7,735 Cardiology and 3,776 other services). Discharges for heart failure increase from 1998 to 2002 (r(2) = 0.7232). Of the total, 44% were men (average age 70.98 years; 95% CI 70.08-70.47) and 56% were women (74.77 years; 95% CI 74.61-74.93; p < 0.0001). The global in-hospital mortality rate was 11.1% and we found differences between Cardiology and MI. MI patients were older (74 years compared to 69, p < 0.0001), had greater comorbidity, a similar length of stay (11.1 days), and a lower number of coded diagnostic procedures. Associated pathologies were different. Seasonal variation is clear. CONCLUSION: The incidence of discharges for heart failure is high and steadily increasing, although this is more evident in IM. The populations attended by the two services are different, which makes it difficult to ascertain differences in handling. The results are slightly different from those reported in other countries.

[Epidemiological characteristics and mortality risk factors in patients admitted in hospitals with soft tissue infections. A multicentric STIMG (Soft Tissue Infections Malacitan Group) study results]. / Características clínicas, epidemiológicas y factores asociados a mortalidad en los pacientes hospitalizados por infecciones de piel y partes blandas. Resultados del estudio multicéntrico STIMG.

OBJECTIVES: To describe the characteristics of patients admitted in hospitals with soft tissue infections, and analyse the variables whose died, in order to define risk groups. METHOD: retrospective analysis of medical reports of all patient admitted during 2002 year for soft tissue infections in public malacitans hospitals. We excluded the patient with soft tissue infections associated with burns, surgery, pressure ulcers, and orbit cellulitis. We analysed clinical, biochemical variables and indications for yields and imaging tests, so the empiric antibiotic treatment established and its correlations with practice guidelines. RESULTS: We analysed 391 admissions of 374 patients. Cellulitis was the most frequent diagnosis (69.3%). We did imaging tests in 51.6%. In 94.3% of cases were treated with empirics antibiotics. The most prescribed drug was amoxiciline plus clavulanate (39%). 27 patients died, 40.7% of them for septic cause. All deceased patients had chronic diseases. The only biochemical parameters associated with mortality were serum proteins and albumina (55 +/- 9 g/L vs. 63 +/- 8 g/L; p = 0.0231) and (22 +/- 7 g/L vs. 29 +/- 7 g/L; p = 0.0125) respectively. CONCLUSIONS: Cellullitis are the most frequent soft tissue infections that requires admissions in hospitals. We overuse imaging test and don t follow the practice guidelines recommendations in antibiotic therapy. Primary soft issue infection s mortality is low and it s restricted to people with chronic illness, deep infections and bad nutritional status.

[Unilateral facial and cerebral hyperplasia associated with neurofibromatosis type 1. Report of four patients]. / Hiperplasia facial y cerebral unilateral asociada a neurofibromatosis tipo 1. Presentacion de cuatro pacientes.

INTRODUCTION: Plexiform neurofibroma in any location is one of the commonest complications associated with neurofibromatosis type 1 (NF1). Plexiform neurofibroma of the upper eyelid and orbit is usually associated with ipsilateral hemifacial hyperplasia. We present four patients with NF1 and plexiform neurofibroma of the eyelid and orbit associated with hemifacial hyperplasia, who also showed hyperplasia of the unilateral cerebral hemisphere. CASE REPORTS: There are four patients, three females and one male, who consulted because of NF1 with plexiform neurofibroma of upper eyelid and hemifacial hyperplasia. Upper eyelid involvement was observed since birth and progressed during the first years of life. The patients showed normal neurological and mental development without motor or cerebellar disorders. Magnetic resonance studies demonstrated the asymmetric hyperplasia of the ipsilateral hemisphere in all four cases and of the cerebellar hemisphere in one case. The degree of hemispheric hyperplasia was related to the size and extension of the plexiform neurofibroma, as well as to the severity of the hemifacial hyperplasia. In our case which had the plexiform neurofibroma extended to the neck and the upper thorax, the hyperplasia not only affected the cerebral hemisphere but also the ipsilateral cerebellar hemisphere. All parts of the hemisphere showed increased size. The cortex of the entire hemisphere showed normal differentiation of the subcortical white matter. CONCLUSION: NF1 appears to be related with facial and cerebral ipsilateral hemihyperplasia. The relation between the size and extension of the orbital, eyelid and facial plexiform neurofibroma and the degree of asymmetry of the hemispheric hyperplasia suggest that different influences of a still unknown agent, possibly a gene, obviously related to NF1, causes both the intracranial and extracranial abnormalities.

[Carotidynia as a form of presentation of paraxysmal hemicrania]. / Carotidinia como forma de presentación de la hemicránea paroxística.

INTRODUCTION: Paroxysmal hemicrania is a well-defined clinical condition about which many articles have been published. Attempts have been made to explain the response of this illness to indomethacin, suggesting its possible cervical origin. In some patients it is set off by stimulation of certain trigger zones situated in this region. The exceptional radiation of the pain seen in our patient clearly supports this theory. CLINICAL CASE: A 34 year old man with a past history of a similar but briefer episode 5 years previously presented to us. He complained of repeated episodes of stabbing pain with no obvious cause. The pain started at the base of the neck and radiated along the right carotid vessels to the cheek, base of the nose and ipsilateral eye. This was accompanied by injection of the conjunctivae, tears, nasal congestion and nasal discharge. Each episode lasted 15 to 30 minutes and was repeated 20 to 25 times a day without any particular relation to the time of day. The neurological examination, MR and angio-MR were normal. Before being seen by us he had been treated with prednisone and verpamil without effect. Indomethacin at a dose of 100 mg/day controlled the problem completely. CONCLUSIONS: We report a case of paroxysmal hemicrania with a spontaneous description of pain starting at the base of the neck and radiating along the carotid vessels. We consider this clinical description to be of interest since it supports the theories of a cervicogenic origin of this type of headache.

Salivary duct carcinoma: a report of nine cases.

Nine cases of salivary duct carcinoma are presented. Eight lesions were located in the parotid gland and one in the submandibular gland. Tumor size was greater than 3 cm in four cases (44%), and facial paralysis was observed in five tumors (62.5%). Lymph node metastases were observed macroscopically or microscopically in seven patients. Perineural and lymphatic invasion were detected in eight and seven cases, respectively. Free surgical margins were obtained in eight of the nine patients (88%). Adjuvant postoperative irradiation was delivered in eight patients. Five patients died of disease in spite of the different clinicopathologic characteristics and aggressiveness of the surgery and irradiation. None of the parameters studied correlated with the final outcome.

[Metastatic parotid tumors. Review of 28 cases]. / Tumores metastásicos parotídeos. Revisión de 28 casos.

A series of 28 patients with tumors metastatic to the parotid gland are reported. The most frequent histologic types were squamous cell carcinoma and melanoma. Most primary tumors occurred in the head and neck. A review of similar cases published in the literature reveals the lack of uniform criteria for the appropriate therapeutic approach for metastatic parotid gland tumors.