Search results for "Safety"
showing 10 items of 1959 documents
Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in h…
2021
A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60–64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccinat…
Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in De…
2020
Background: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. Objective: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. Methods: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Results: O…
Abemaciclib: safety and effectiveness of a unique cyclin-dependent kinase inhibitor
2020
Introduction: The discovery and the clinical availability of novel cyclin-dependent kinases 4 and 6 inhibitors have profoundly changed the therapeutic scenario of metastatic hormone receptor-positive breast carcinoma. Among these inhibitors, abemaciclib can induce potent and sustained cell cycle arrest and immune system stimulation. Areas covered: This review summarizes the safety profile and clinical efficacy data on abemaciclib alone or in combination with aromatase inhibitors or fulvestrant in metastatic hormone receptor-positive breast carcinoma. The management of patients treated with abemaciclib is the object of this paper. Expert opinion: As shown in phase 2 and 3 clinical trials on …
Positron production using a 9 MeV electron linac for the GBAR experiment
2020
For the GBAR (Gravitational Behaviour of Antihydrogen at Rest) experiment at CERN's Antiproton Decelerator (AD) facility we have constructed a source of slow positrons, which uses a low-energy electron linear accelerator (linac). The driver linac produces electrons of 9 MeV kinetic energy that create positrons from bremsstrahlung-induced pair production. Staying below 10 MeV ensures no persistent radioactive activation in the target zone and that the radiation level outside the biological shield is safe for public access. An annealed tungsten-mesh assembly placed directly behind the target acts as a positron moderator. The system produces $5\times10^7$ slow positrons per second, a performan…
Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study
2016
Purpose The PRAME tumour antigen is expressed in several tumour types but in few normal adult tissues. A dose-escalation phase I/II study (NCT01149343) assessed the safety, immunogenicity and clinical activity of the PRAME immunotherapeutic (recombinant PRAME protein (recPRAME) with the AS15 immunostimulant) in patients with advanced melanoma. Here, we report the phase I dose-escalation study segment. Patients and methods Patients with stage IV PRAME-positive melanoma were enrolled to 3 consecutive cohorts to receive up to 24 intramuscular injections of the PRAME immunotherapeutic. The RecPRAME dose was 20, 100 or 500 µg in cohorts 1, 2 and 3, respectively, with a fixed dose of AS15. Advers…
Towards CCTV-aware Routing and Navigation for Privacy, Anonymity, and Safety - Feasibility Study in Jyväskylä
2021
AbstractIn order to withstand the ever-increasing invasion of privacy by CCTV cameras and technologies, on par CCTV-aware solutions must exist that provide privacy, safety, and cybersecurity features. We argue that a first important step towards such CCTV-aware solutions must be a mapping system (e.g., Google Maps, OpenStreetMap) that provides both privacy and safety routing and navigation options. Unfortunately, to the best of our knowledge, there are no mapping nor navigation systems that support CCTV-privacy and CCTV-safety routing options. At the same time, in order to move the privacy vs. safety debate related to CCTV surveillance cameras from purely subjective to data-driven and evide…
Polyphenols and Pharmacological Screening of a Monarda fistulosa L. dry Extract Based on a Hydrodistilled Residue By-Product
2021
This study aimed to determine the composition and content of polyphenols in the dry extract obtained from the hydrodistilled residue by-product of the wild bergamot (Monarda fistulosa L., Lamiaceae Martinov family) herb (MFDE) and to evaluate its safety and pharmacological properties. The total phenolic content (TPC) in the MFDE was 120.64 mg GAE/g. The high-performance liquid chromatography (HPLC) analysis showed the presence of a plethora of phenolic compounds, including hydroxycinnamic acids and flavone derivatives in the MFDE, with rosmarinic acid and luteolin-7-O-glucoside being the main components. With an IC50 value of 0.285 mg/mL, it was found to be a strong DPPH radical scavenger. …
A sustainable city environment through child safety and mobility:A challenge based on ITS?
2012
Our cities should be designed to accommodate everybody, including children. We will not move toward a more sustainable society unless we accept that children are people with transportation needs, and ‘bussing’ them around, or providing parental limousine services at all times, will not lead to sustainability. Rather, we will need to make our cities walkable for children, at least those above a certain age. Safety has two main aspects, traffic safety and personal safety (risk of assault). Besides being safe, children will also need an urban environment with reasonable mobility, where they themselves can reach destinations with reasonable effort; else they will still need to be driven. This p…
Forensic Analysis of Fire in a Substation of a Commercial Center
2020
In this article, the authors discuss the legal liabilities of the professional engineer as both the engineer of record of a project and the construction site manager. In particular, this article analyzes the case of a fire at the end-user medium voltage–low-voltage (MV–LV) substation of a shopping center in Italy, which occurred a few years after the maintenance works on the electrical installation. The professional engineer who had designed and overseen the construction of the substation was accused of professional negligence. The authors through the examination of applicable technical standards, as well as of safety regulations, demonstrate that the professional engineer had acted diligen…
Safety and immunogenicity of the therapeutic vaccine TG1050 in chronic hepatitis B patients: a phase 1b placebo-controlled trial
2020
Funding: Transgène; International audience; Treatment of chronic hepatitis B (CHB) typically requires life-long administration of drugs. Cohort and pre-clinical studies have established the link between a functional T-cell-mounted immunity and resolution of infection. TG1050 is an adenovirus 5-based vaccine that expresses HBV polymerase and domains of core and surface antigen and has shown immunogenicity and antiviral effects in mice. We performed a phase 1 clinical trial to assess safety and explore immunogenicity and early efficacy of TG1050 in CHB patients. This randomized, double blind, placebo-controlled study included two sequential phases: one single dose cohort (SD, n = 12) and one …