999 resultados para Marine safety.
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Agency Performance Report
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Agency Performance Report
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Agency Performance Report
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Agency Performance Report
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Agency Performance Report
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Yearly administration of the influenza vaccine is the main strategy to prevent influenza in immunocompromised patients. Here, we reviewed the recent literature regarding the clinical significance of the influenza virus infection, as well as the immunogenicity and safety of the influenza vaccine in HIV‑infected individuals, solid-organ and stem-cell transplant recipients and patients receiving biological agents. Epidemiological data produced during the 2009 influenza pandemic have confirmed that immunocompromised patients remain at high risk of influenza-associated complications, namely viral and bacterial pneumonia, hospitalization and even death. The immunogenicity of the influenza vaccine is overall reduced in immunocompromised patients, although a significant clinical protection from influenza is expected to be obtained with vaccination. Influenza vaccination is safe in immunocompromised patients. The efficacy of novel strategies to improve the immunogenicity to the vaccine, such as the use of adjuvanted vaccines, boosting doses and intradermal vaccination, needs to be validated in appropriately powered clinical trials.
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Agency Performance Report
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Agency Performance Report
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BACKGROUND AND PURPOSE: Intravenous thrombolysis for acute ischemic stroke is beneficial within 4.5 hours of symptom onset, but the effect rapidly decreases over time, necessitating quick diagnostic in-hospital work-up. Initial time strain occasionally results in treatment of patients with an alternate diagnosis (stroke mimics). We investigated whether intravenous thrombolysis is safe in these patients. METHODS: In this multicenter observational cohort study containing 5581 consecutive patients treated with intravenous thrombolysis, we determined the frequency and the clinical characteristics of stroke mimics. For safety, we compared the symptomatic intracranial hemorrhage (European Cooperative Acute Stroke Study II [ECASS-II] definition) rate of stroke mimics with ischemic strokes. RESULTS: One hundred stroke mimics were identified, resulting in a frequency of 1.8% (95% confidence interval, 1.5-2.2). Patients with a stroke mimic were younger, more often female, and had fewer risk factors except smoking and previous stroke or transient ischemic attack. The symptomatic intracranial hemorrhage rate in stroke mimics was 1.0% (95% confidence interval, 0.0-5.0) compared with 7.9% (95% confidence interval, 7.2-8.7) in ischemic strokes. CONCLUSIONS: In experienced stroke centers, among patients treated with intravenous thrombolysis, only a few had a final diagnosis other than stroke. The complication rate in these stroke mimics was low.
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Agency Performance Plan, Iowa Department of Public Safety
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This report outlines the strategic plan for Iowa Department of Public Safety, goals and mission.
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BACKGROUND: Present combination antiretroviral therapy (cART) alone does not cure HIV infection and requires lifelong drug treatment. The potential role of HIV therapeutic vaccines as part of an HIV cure is under consideration. Our aim was to assess the efficacy, safety, and immunogenicity of Vacc-4x, a peptide-based HIV-1 therapeutic vaccine targeting conserved domains on p24(Gag), in adults infected with HIV-1. METHODS: Between July, 2008, and June, 2010, we did a multinational double-blind, randomised, phase 2 study comparing Vacc-4x with placebo. Participants were adults infected with HIV-1 who were aged 18-55 years and virologically suppressed on cART (viral load <50 copies per mL) with CD4 cell counts of 400 × 10(6) cells per L or greater. The trial was done at 18 sites in Germany, Italy, Spain, the UK, and the USA. Participants were randomly assigned (2:1) to Vacc-4x or placebo. Group allocation was masked from participants and investigators. Four primary immunisations, weekly for 4 weeks, containing Vacc-4x (or placebo) were given intradermally after administration of adjuvant. Booster immunisations were given at weeks 16 and 18. At week 28, cART was interrupted for up to 24 weeks. The coprimary endpoints were cART resumption and changes in CD4 counts during treatment interruption. Analyses were by modified intention to treat: all participants who received one intervention. Furthermore, safety, viral load, and immunogenicity (as measured by ELISPOT and proliferation assays) were assessed. The 52 week follow-up period was completed in June, 2011. For the coprimary endpoints the proportion of participants who met the criteria for cART resumption was analysed with a logistic regression model with the treatment effect being assessed in a model including country as a covariate. This study is registered with ClinicalTrials.gov, number NCT00659789. FINDINGS: 174 individuals were screened; because of slow recruitment, enrolment stopped with 136 of a planned 345 participants and 93 were randomly assigned to receive Vacc-4x and 43 to receive placebo. There were no differences between the two groups for the primary efficacy endpoints in those participants who stopped cART at week 28. Of the participants who resumed cART, 30 (34%) were in the Vacc-4x group and 11 (29%) in the placebo group, and percentage changes in CD4 counts were not significant (mean treatment difference -5·71, 95% CI -13·01 to 1·59). However, a significant difference in viral load was noted for the Vacc-4x group both at week 48 (median 23 100 copies per mL Vacc-4x vs 71 800 copies per mL placebo; p=0·025) and week 52 (median 19 550 copies per mL vs 51 000 copies per mL; p=0·041). One serious adverse event, exacerbation of multiple sclerosis, was reported as possibly related to study treatment. Vacc-4x was immunogenic, inducing proliferative responses in both CD4 and CD8 T-cell populations. INTERPRETATION: The proportion of participants resuming cART before end of study and change in CD4 counts during the treatment interruption showed no benefit of vaccination. Vacc-4x was safe, well tolerated, immunogenic, seemed to contribute to a viral-load setpoint reduction after cART interruption, and might be worth consideration in future HIV-cure investigative strategies. FUNDING: Norwegian Research Council GLOBVAC Program and Bionor Pharma ASA.
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The end-Permian mass extinction greatly diminished marine diversity and brought about a whole-scale restructuring of marine ecosystems; these ecosystem changes also profoundly affected the sedimentary record. Data presented here, attained through facies analyses of strata deposited during the immediate aftermath of the end-Permian mass extinction (southern Turkey) and at the close of the Early Triassic (southwestern United States), in combination with a literature review, show that sedimentary systems were profoundly affected by: (1) a reduction in biotic diversity and abundance and (2) long-term environmental fluctuations that resulted from the end-Permian crisis. Lower Triassic strata display widespread microbialite and carbonate seafloor fan development and contain indicators of suppressed infaunal bioturbation such as flat-pebble conglomerates and wrinkle structures (facies considered unusual in post-Cambrian subtidal deposits). Our observations suggest that depositional systems, too, respond to biotic crises, and that certain facies may act as barometers of ecologic and environmental change independent of fossil assemblage analyses. Close investigation of facies changes during other critical times in Earth history may serve as an important tool in interpreting the ecology of metazoans and their environment.
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The stratigraphic basis of this work has allowed the use of larger foraminifers in the biostratigraphic characterisation of the new Shallow Benthic Zones (SBZ). This part of the volume presents a description of the sedimentary cycles formed by the transgressive-regressive systems of the Lutetian and Bartonian in the southeastern sector of the Ebro Foreland Basin. Concerning the Lutetian deposits studied in the Amer-Vic and Empordà areas, four sedimentary cycles have been characterised. The first and second are found within the Tavertet/Girona Limestone Formation (Reguant, 1967; Pallí, 1972), while the third and fourth cycles cover the Coll de Malla Marl Formation (Clavell et al., 1970), the Bracons Formation (Gich, 1969, 1972), the Banyoles Marl Formation (Almela and Ríos, 1943), and the Bellmunt Formation (Gich, 1969, 1972). In the Bartonian deposits studied in the Igualada area, two transgressive-regressive sedimentary cycles have been characterised in the Collbàs Formation (Ferrer, 1971), the Igualada Formation (Ferrer, 1971), and the Tossa Formation (Ferrer, 1971). The Shallow Benthic Zones (SBZs) recognised within the Lutetian are the following: SBZ 13, from the Early Lutetian, in the transgressive system of the first cycle; SBZ 14, from the Middle Lutetian, in the second cycle and the lower part of the transgressive system of the third cycle; SBZ 15, from the Middle Lutetian, in the remaining parts of the third system; SBZ 16, from the Late Lutetian, throughout the fourth cycle. The association of larger foraminifers in the first and second cycles of the Bartonian in the Igualada area has been used as the basis for the definition of SBZs 17 and 18 recognised in the Bartonian of the western Tethys.
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In the southeastern Ebro Foreland Basin, the marine deposits of Lutetian and Bartonian age show excellent outcrop conditions, with a great lateral and horizontal continuity of lithostratigraphic units. In addition, the rich fossil record -mainly larger foraminifers-, provides biostratigraphic data of regional relevance for the whole Paleogene Pyrenean Basin, that can be used for the Middle Eocene biocorrelation of the western Tethys. This contribution is a sedimentary and biostratigraphic synthesis of the basic outcrops and sections of the Lutetian andBartonian marine and transitional deposits in the southeastern sector of the Ebro Foreland Basin.