Protocol for a randomised, double-masked, sham-controlled phase 4 study on the efficacy, safety and tolerability of intravitreal aflibercept monotherapy compared with aflibercept with adjunctive photodynamic therapy in polypoidal choroidal vasculopathy: the ATLANTIC study

PURPOSE: The purpose of this study is to compare the efficacy and safety of intravitreal aflibercept (IVA) with sham photodynamic therapy (sPDT) versus IVA with verteporfin PDT (vPDT) in a Caucasian population with treatment-naive polypoidal choroidal vasculopathy (PCV), enrolling into a treat and extend (T&E) regimen. METHODS AND ANALYSIS: Randomised, double-masked, sham-controlled, multicentre phase 4 investigator-driven clinical trial. The primary outcomes are (1) change in best-corrected visual acuity (BCVA) from baseline and (2) polyp regression at week 52, assessed by indocyanine green angiography (ICGA). Fifty patients with treatment-naive PCV will be recruited from Portuguese and Spanish clinical sites. Eligible patients will receive monthly IVA for 3 months (week 0, week 4 and week 8). At week 16, all patients will repeat ICGA and undergo central randomisation (1:1 ratio) into one of the following groups: Group 1-IVA T&E + vPDT; Group 2-IVA T&E + sPDT. PDT will be performed at week 16, week 28 and week 40 in the presence of active polyps. After week 16, the presence of macular fluid on optical coherence tomography will determine the schedule of observations. When present, the interval between visits/injections will decrease 2 weeks (minimum 6 weeks). When not, the interval between visits/injections will increase 2 weeks (maximum 12 weeks). Efficacy will be evaluated based on BCVA, central retinal thickness and polyp regression. Safety parameters will include assessment of intraocular pressure, adverse events and serious adverse events. ETHICS AND DISSEMINATION: This study was designed and shall be implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines for Good Clinical Practice, with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki. The study received approval from Comissão de Ética para a Investigação Clínica and Comité Ético de investigación Clínica del Hospital Universitari de Bellvitge. TRIAL REGISTRATION NUMBER: This study is registered under the EudraCT number: 2015-001368-20 and the ClinicalTrials.gov Identifier: NCT02495181.info:eu-repo/semantics/publishedVersio

LINFOPENIA T CD4 NO LUPUS ERITEMATOSO SISTÉMICO

Abstract: Background: Systemic Lupus Erythematosus (SLE) is an inflammatory chronic disease characterized by the presence of autoantibodies, immunocomplex production and organ injury. Several alterations of the immune system have been described, namely of CD4 T cells, with particular focus on regulatory subgroup. Objective: Quantify peripheral CD4 T cells in a population of patients with SLE and correlate it with lupus activity, affected organs, therapeutics and infections. Methods: Retrospective study involving all SLE patients seen in the clinical immunology outpatient clinic of the Hospital Geral Santo António, Porto that has done some peripheral blood flow cytometry study. Results: Twenty-nine patients have been evaluated, 16 were taking glucocorticoids and six immunossupressors. The mean SLEDAI at the study time was nine and the ECLAM was three. Thirty-one percent of the patients had leukopenia, 76% lymphocytopenia and the same number CD4 depletion. Fifty-five percent of the patients had CD4 levels lower than 500/mm3, 31% lower than 200/mm3. All patients with SLEDAI ?20 and ECLAM ?4 had CD4 counts inferior to 500/mm3 and all patients with inactive disease had CD4 superior to 500/mm3. There have been three opportunistic infections: cryptococcal meningitis, pulmonary aspergilosis, Pneumocystis jirovecii pneumonia, all in patients with CD4 counts lower than 500/mm3. Conclusion: Decreased CD4 T cells counts have been very common in this study population. There is an inverse relation between CD4 cells counts and disease activity. Opportunistic infections occurred in patients with severe CD4 depletion. Keywords: Systemic Lupus Erythematosus; CD4 T Lymphocytes; Lymphocytopenia; SLE Activity; Opportunistic infection

LINFOPENIA T CD4 NO LUPUS ERITEMATOSO SISTÉMICO

Abstract: Background: Systemic Lupus Erythematosus (SLE) is an inflammatory chronic disease characterized by the presence of autoantibodies, immunocomplex production and organ injury. Several alterations of the immune system have been described, namely of CD4 T cells, with particular focus on regulatory subgroup. Objective: Quantify peripheral CD4 T cells in a population of patients with SLE and correlate it with lupus activity, affected organs, therapeutics and infections. Methods: Retrospective study involving all SLE patients seen in the clinical immunology outpatient clinic of the Hospital Geral Santo António, Porto that has done some peripheral blood flow cytometry study. Results: Twenty-nine patients have been evaluated, 16 were taking glucocorticoids and six immunossupressors. The mean SLEDAI at the study time was nine and the ECLAM was three. Thirty-one percent of the patients had leukopenia, 76% lymphocytopenia and the same number CD4 depletion. Fifty-five percent of the patients had CD4 levels lower than 500/mm3, 31% lower than 200/mm3. All patients with SLEDAI ?20 and ECLAM ?4 had CD4 counts inferior to 500/mm3 and all patients with inactive disease had CD4 superior to 500/mm3. There have been three opportunistic infections: cryptococcal meningitis, pulmonary aspergilosis, Pneumocystis jirovecii pneumonia, all in patients with CD4 counts lower than 500/mm3. Conclusion: Decreased CD4 T cells counts have been very common in this study population. There is an inverse relation between CD4 cells counts and disease activity. Opportunistic infections occurred in patients with severe CD4 depletion. Keywords: Systemic Lupus Erythematosus; CD4 T Lymphocytes; Lymphocytopenia; SLE Activity; Opportunistic infection

A Comprehensive Review of Prognostic Factors in Patients with Gastric Adenocarcinoma.

Gastric adenocarcinoma remains associated with a poor long-term survival, despite recent therapeutical advances. In most parts of the world where systematic screening programs do not exist, diagnosis is often made at advanced stages, affecting long-term prognosis. In recent years, there is increasing evidence that a large bundle of factors, ranging from the tumor microenvironment to patient ethnicity and variations in therapeutic strategy, play an important role in patient outcome. A more thorough understanding of these multi-faceted parameters is needed in order to provide a better assessment of long-term prognosis in these patients, which probably also require the refinement of current staging systems. This study aims to review existing knowledge on the clinical, biomolecular and treatment-related parameters that have some prognostic value in patients with gastric adenocarcinoma

Octatosylaminophthalocyanine: a reusable chromogenic anion chemosensor

Detailed herein is the use of 2,3,9,10,16,17,23,24-octatosylaminophthalocyanine as a chromogenic chemosensor for anions. The host:guest complexes formed during the sensing event can be regenerated by acid treatment without loss of the sensing ability. This allows the phthalocyanine chemosensor to be reused. This system also responds in a colorimetric manner when exposed to the neutral solvent molecules, dimethyl sulfoxide and methanol. A single-crystal X-ray structure of the Pc 1:2 MeOH complex was obtained. It illustrates the main interactions between the host:guest species in the solid state. Fits of the binding curves are consistent with this stoichiometry predominating in the solution state

Proliferação Melanocítica Uveal Difusa Bilateral (BDUMP) como forma de apresentação de adenocarcinoma do pulmão

Objectivo: Descrever um caso da rara síndroma de proliferação melanocítica uveal difusa bilateral(BDUMP). Descrição do Caso Clínico: Doente, do sexo masculino, 64 anos, fumador, com história de Perda progressiva e grave da acuidade visual bilateral nos últimos 9 meses. A observação apresentava melhor acuidade visual corrigida (MAVC) de 20/50 no OD e de 20/70 no OE, catarata bilateral e tumor pigmentado da íris no OE. Para além destas alterações apresentava ainda bilateralmente vários tumores coroideus pigmentados e múltiplas pequenas lesões vermelho-acastanhadas ao nível do epitélio pigmentado da retina, com correspondente hiperfluorescência precoce na angiografia fluoresceínica e perda de autofluorescência. Com base nos dados clínicos foi feito o diagnóstico de BDUMP e iniciada uma avaliação sistémica que conduziu ao diagnóstico de adenocarcinoma do pulmão, detectado por TC e confirmado por biópsia. Conclusões: BDUMP é uma síndroma paraneoplásica rara que ocorre em doentes com carcinoma sistémico, muitas vezes oculto. A consideração desta entidade clínica pode conduzir a um diagnóstico mais precoce de uma neoplasia potencialmente com melhoria do prognóstico associado

And after the Sensory Processing Disorders? - What answers does the DSM-5 have

Introduction: From the question of whether the diagnosis of Sensory Processing Disorder (SPD) should have classification matching in the DSM-5 or whether it constitutes a pre-morbid condition for other pathologies, a retrospective study was conducted in 2016 titled Regulatory Disturbances: The Return to the Past - Conditioners of Evolution. The study did not show a significant association between the abnormal results obtained in the SDQ scale by children with PRPS and therapeutic intervention, which allowed us to conclude that it is imperative to rethink the intervention of these cases. From these results and the lack of corresponding diagnosis in DSM-5, the present study intends to understand what possible diagnoses these children have in the latency / adolescence and adult age and what are the therapeutic interventions required. Objectives: Characterize the sample of children diagnosed with Sensory Processing Disorder who used the psychiatry consultation at the unity of infant mental health (UPI) between 2006-2013; characterize the results obtained at the follow-up; check current medical status, pharmacological therapy, other therapeutic interventions, and if they present another corresponding diagnosis in the DSM-5. Methods: Retrospective and follow-up study using the Clinical Processes of the first consultations performed between the years 2006 and 2013 at the UPI. Evaluation of the current state was made by telephone through a structured interview to the main caregivers and the application of the SDQ. The information will be submitted to statistical processing (in SPSS®), with descriptive analysis and correlation of variables. The sample is of Convenience. Results: 55 children with SPD (N=55), 47 of their caregivers answered a telephone interview (n=47). No statistically significant association was found between any SPD type and current diagnosis of ADHD nor parental perception of current state. Significant association between SPD diagnosis and abnormal results in subscales of hyperactivity (p = 0.027) and behavior problems (p = 0.017) of the SDQ. Discussion and Conclusion: The wide dispersion of diagnoses found may pose two hypotheses: SPD should be considered as an independent diagnostic category; symptomatology (alterations in the SP) can be common to different pathologies. It is important to carry out prospective studies in children diagnosed with SPD, in order to determine if it may be a future diagnostic category in the DSM.info:eu-repo/semantics/publishedVersio

Children's experiences of food poverty in Portugal: Findings from a mixed‐method case study approach

While observers acknowledge that the 2007–2008 crisis increased food insecurity, few studies considered how being food poor affects children's daily lives. In this paper, I discuss how children from low‐income families in Portugal experience food and deal with food scarcity. I draw on data from a larger European study, which employed a case study approach with a combination of semi‐structured interviews and photo‐elicitation. Children's accounts reveal how food poverty is embedded in their lives, affecting the quality and quantity of food, reducing opportunities to socialize with kin and friends and creating emotional stress. Visual methods added depth to our understanding.info:eu-repo/semantics/publishedVersio