Toxicol In Vitro
March 2024
Gallic acid (GA) has antioxidant, anti-inflammatory and antimicrobial properties, while ellagic acid (EA) demonstrates anticancer, antiviral and photoprotective activity. In this study, the combination of these substances incorporated into a poloxamer gel was tested to verify the individual effect of the substances, in addition to taking advantage of a probable complementary effect, aiming to provide additional therapeutic benefits. As a result of the incorporation, formulations containing GA, EA and GA + EA were obtained, which were evaluated for the effects of the Freeze-thaw cycle on pH, which revealed a significant decrease (p < 0.
View Article and Find Full Text PDFInt J Retina Vitreous
April 2021
Background: The main purpose of this study is to compare the vitreous hemorrhage (VH) score reduction and visual acuity outcomes in patients with VH secondary to proliferative diabetic retinopathy (PDR) treated with intravitreal injections of bevacizumab (IVB) versus IVB and pars plana vitrectomy (IVB and PPV).
Methods: Patients with VH secondary to PDR were randomized into 2 groups: in Group A, patients were treated with a total of 3 IVB (1.5 mg/0.
The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.
View Article and Find Full Text PDFThe first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries.
View Article and Find Full Text PDFSao Paulo Med J
February 2015
Context And Objective: Glomerular disease registries are increasing all around the world. The aim of this study was to evaluate the clinical characteristics and treatment response among patients with glomerular diseases followed up in a tertiary hospital in Brazil.
Design And Setting: Analytical cross-sectional study; tertiary-level public hospital.
Context And Objective: The lack of a clear definition for human "race" and the importance of this topic in medical practice continue to create doubt among scholars. Here, we evaluate the use of the variable "race" by medical students in Salvador, Brazil.
Design And Setting: Cross-sectional study at a Brazilian federal public university.
Saint Louis encephalitis virus (SLEV), a member of the genus Flavivirus (family Flaviviridae), is an encephalitogenic arbovirus broadly distributed in the Americas. Phylogenetic analysis based on the full-length E gene sequences obtained for 30 Brazilian SLEV strains was performed using different methods including Bayesian and relaxed molecular clock approaches. A new genetic lineage was suggested, hereafter named genotype VIII, which co-circulates with the previously described genotype V in the Brazilian Amazon region.
View Article and Find Full Text PDFObjective: To evaluate the Brazilian journals cited by the four CAPES medical areas, qualified as 'A' national or 'I' international, regarding the relevance given to ethics in the instructions for authors.
Methods: The instructions for authors of twenty Brazilian journals were studied and 36 types of ethical concerns were identified allowing the following categorization: I - Ethics in human research; II - Scientific integrity; III - Editorial policy.
Results: The results on Category I show that the most frequent instructions (50%) requires previous approval of the research by a institutional Ethics Committee (CEP), followed by indication on how to cite this approval in the body of the article (35%), plus presentation of a copy of the CEP approval (30%).
A sentinel study on viral hepatitis is currently being carried out in the village of Cavunge in a semiarid rural region of the state of Bahia, northeastern Brazil. This study has identified individuals in whom anti-HBc IgG was the only serological marker for hepatitis B virus (HBV). This serological pattern may constitute evidence of occult HBV infection.
View Article and Find Full Text PDFTo determine the seroprevalence of HTLV-1 in Brazil, and to review the virus molecular epidemiology in this Amazon population (Rio Branco-Acre), 219 blood donors were screened for HTLV-1. Only one case of infection (0.46% seroprevalence) was detected during July 2004 screening at the Acre Hospital Foundation (FUNDACRE).
View Article and Find Full Text PDFActa Gastroenterol Latinoam
September 2007
Unlabelled: Visceral Leisshimaniosis or Kalazar is a parasitic infection caused by Leishimania Donovani subspecies. It is transmitted by phlebotomineos and may lead to liver and spleen enlargements as well as immunological impairment. Sometimes it is described liver injury simulating acute or chronic viral hepatitis and even portal hypertension.
View Article and Find Full Text PDFIn the village of Cavunge, located in a dry tropical, semiarid rural region of the state of Bahia, Brazil, a sentinel study on viral hepatitis is underway. We report on the first part of the study. The objective of this study was to determine the prevalence of serological markers for hepatitis A, B and C in the village.
View Article and Find Full Text PDFRev Soc Bras Med Trop
May 2007
In the Subúrbio Ferroviário region of Salvador (Bahia, Brasil) occurrences of schistosomiasis were found. This fact motivated the investigation of the prevalence of the eggs in a group of 268 resident students in one of its neighborhoods (São Bartolomeu). The parasitological test analyzed by the Kato-Katz methodology, showed positive results in 30.
View Article and Find Full Text PDFThis work presents the dynamic simulation of the thermal decomposition of nitrogen trichloride (NCl(3)) during electrolytic chlorine (Cl(2)) production, using an industrial plant as a case study. NCl(3) is an extremely unstable and explosive compound and the decomposition process has the following main problems: changeability of the reactor temperature and loss of solvent. The results of this work will be used to establish a more efficient and safe control strategy and to analyze the loss of solvent during the dynamic period.
View Article and Find Full Text PDFAm J Trop Med Hyg
September 2006
In Brazil, hepatitis delta virus (HDV) is only reported in Western Amazonia, where severe cases of acute and chronic HDV hepatitis have been described. The study area was chosen in the States of Acre and Rondonia where most cases of hepatitis B virus (HBV)/HDV are reported. From December 2003 to October 2004, 40 HBsAg carriers with anti-HDV IgM were selected.
View Article and Find Full Text PDFBackground: Hepatitis B is endemic in the Amazon region.
Methods: Serological markers for hepatitis B virus (HBV) were determined in 266 household members for hepatitis B surface antigen (HBsAg)-positive women (G1) and 395 household members for HBsAg-negative women (G2), randomly selected in Acre State Women's Medical Care Program, in order to evaluate the prevalence of HBV in this population. Before blood sample collection an epidemiological questionnaire was applied.
In Cavunge community, a rural village of the dry tropic in Bahia State, Brazil, a sentinel study on viral hepatitis was developed to characterize the seroprevalence of hepatitis A. The presence of IgG anti-HAV was analyzed in 891 citizens and 85.9% were positive.
View Article and Find Full Text PDFInfectious meningeal syndromes represent a serious medical emergency whose clinical-epidemiologic diagnosis must be immediately established for early initiation of appropriate treatment. However, in many cases data from the clinical exam are insufficient to confirm or rule out the diagnosis. Therefore, the aim of this work was to assess the value of the ocular globe compression sign in 57 patients with suspicion of infectious meningeal syndrome, both male and female and aged four years or older.
View Article and Find Full Text PDFWith the objective of isolating and identifying enteroviral serotypes, which are the most frequent etiologic agents of aseptic meningitis syndrome, cerebrospinal fluid samples were studied from patients referred to the health unit in the City of Belém (State of Pará, Brazil), from March 2002 to March 2003. The samples were inoculated in RD and HEp-2 cells line, and the positive were identified by neutralization test or indirect immunofluorescence. Out of 249 samples, 33 (13.
View Article and Find Full Text PDFThe levels of amines in soybeans as affected by cultivar in two consecutive years and by germination were investigated. Spermidine, spermine, putrescine, agmatine, and cadaverine were detected, whereas tyramine, histamine, tryptamine, serotonine, and phenylethylamine were not. Spermidine was the predominant amine followed by spermine.
View Article and Find Full Text PDFObjective: To describe the occurrence of vaccine-associated paralytic poliomyelitis (VAPP) in Brazil between 1995 and 2001 and to determine the level of risk for this adverse event.
Methods: This retrospective study utilized data from acute flaccid paralysis investigation and notification records from the Ministry of Health in Brazil. Cases were defined as individuals with a diagnosis of acute flaccid paralysis and a positive stool culture or sequelae compatible with poliomyelitis appearing up to 60 days after the beginning of motor impairment.
The association of hepatitis C virus infection and the hepatosplenic form of schistosomiasis mansoni has been claimed to result in the concomitant evolution of the two pathologies, with a poor prognosis due to aggravated liver disease. Recently, however, some authors have begun to reject the hypothesis of a higher susceptibility of hepatosplenic schistosomal patients to HCV. The aim of the present transverse study carried out between July and August 1990 was to determine the possible association between SM and HCV markers in residents of Catolândia, Bahia State.
View Article and Find Full Text PDFThis study aimed to determine the clinical epidemiological profile of the snake bites attended at the reference hospital of Acre. One hundred-forty four patients were studied prospectively, from January to December 2002. One hundred-thirteen (78.
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