171 research outputs found

    The Diary Of Anne Frank Playbill

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    Providence College Department of Theatre, Dance & Film Blackfriars Theatre The Diary of Anne Frank, dramatized by Frances Goodrich & Albert Hackett March 30 - April 1 & April 6 - 8, 1984, 8PM Director, Richard Warner Scenic & Lighting Design, Jim Eddy Costume Design, Mary G. Farrell Research Consultant, Rev. Matthew Powell, O.P. Theatre Program Director, John Garrity Cast: Mrs. Van Daan - Lisa Gould; Mr. Van Daan - Mark Enright; Peter Van Daan - John Brewer; Mr. Frank - James H. Maher; Miep - Mary Donovan; Mrs. Frank - Patricia Carver; Margot Frank - Mary Vining; Franz Kraler - Joseph Henderson; Anne Frank - Julie Marrinucci; Mr. Dussel - Fr. John Corbett, O.P.https://digitalcommons.providence.edu/annefrank_pubs/1004/thumbnail.jp

    Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Alter the Gut-Brain Communication

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    This study investigated the anatomical integrity of vagal innervation of the gastrointestinal tract following vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) operations. The retrograde tracer fast blue (FB) was injected into the stomach to label vagal neurons originating from nodose ganglion (NG) and dorsal motor nucleus of the vagus (DMV). Microglia activation was determined by quantifying changes in the fluorescent staining of hindbrain sections against an ionizing calcium adapter binding molecule 1 (Iba1). Reorganization of vagal afferents in the hindbrain was studied by fluorescent staining against isolectin 4 (IB4). The density of Iba1-and IB4-immunoreactivity was analyzed using Nikon Elements software. There was no difference in the number of FB-labeled neurons located in NG and DMV between VSG and VSG-sham rats. RYGB, but not RYGB-sham rats, showed a dramatic reduction in number of FB-labeled neurons located in the NG and DMV. VSG increased, while the RYGB operation decreased, the density of vagal afferents in the nucleus tractus solitarius (NTS). The RYGB operation, but not the VSG procedure, significantly activated microglia in the NTS and DMV. Results of this study show that the RYGB, but not the VSG procedure, triggers microglia activation in vagal structures and remodels gut-brain communication

    Evaluating Medical Devices Remotely: Current Methods and Potential Innovations

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    Objective: We present examples of laboratory and remote studies, with a focus on studies appropriate for medical device design and evaluation. From this review and description of extant options for remote testing, we provide methods and tools to achieve research goals remotely. Background: The FDA mandates human factors evaluation of medical devices. Studies show similarities and differences in results collected in laboratories compared to data collected remotely in non-laboratory settings. Remote studies show promise, though many of these are behavioral studies related to cognitive or experimental psychology. Remote usability studies are rare but increasing, as technologies allow for synchronous and asynchronous data collection. Method: We reviewed methods of remote evaluation of medical devices, from testing labels and instruction to usability testing and simulated use. Each method was coded for the attributes (e.g., supported media) that need consideration in usability studies. Results: We present examples of how published usability studies of medical devices could be moved to remote data collection. We also present novel systems for creating such tests, such as the use of 3D printed or virtual prototypes. Finally, we advise on targeted participant recruitment. Conclusion: Remote testing will bring opportunities and challenges to the field of medical device testing. Current methods are adequate for most purposes, excepting the validation of Class III devices. Application: The tools we provide enable the remote evaluation of medical devices. Evaluations have specific research goals, and our framework of attributes helps to select or combine tools for valid testing of medical devices

    Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: A phase IV, randomized, open-label, controlled study

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    AbstractBackgroundAS03-adjuvanted H5N1 pandemic influenza vaccines have been assessed in an extensive clinical development program conducted in North America, Europe, and Asia including children from 6 months of age, adults, and elderly adults. We evaluated AS03-H5N1 in Korean adults 18 through 60 years of age.MethodsThis Phase IV, randomized, study was conducted to assess the immunogenicity, reactogenicity, and safety of two doses (3.75ÎĽg of hemagglutinin antigen) of A/Indonesia/5/2005 (H5N1) adjuvanted with AS03 given 21 days apart in Korean adults. Antibody responses were assessed using hemagglutination-inhibition (HI) assays against the vaccine strain and a vaccine-heterologous strain (A/Vietnam/1194/2004) 21 days after the second dose. A control group (safety) received a licensed seasonal inactivated trivalent influenza vaccine (TIV). Reactogenicity was assessed for 7 days after each vaccination, and unsolicited adverse events were assessed for 182 days following vaccination in both study groups (NCT01730378).ResultsAS03-H5N1 was immunogenic and elicited robust HI antibody responses with seroconversion rates of 100% for the vaccine strain and 69.1% for the heterologous strain (N=81). HI antibody responses fulfilled the European licensure criteria for immunogenicity (primary endpoint). The incidence of local and systemic solicited adverse events (reactogenicity) was higher with AS03-H5N1 than TIV. There was no apparent difference in the rate of unsolicited adverse events in the AS03-H5N1 and TIV groups.ConclusionThe results indicate that AS03-H5N1 vaccine is immunogenic with reactogenicity and safety findings that are consistent with the established profile of AS03-H5N1 vaccine

    Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years

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    AbstractBackgroundStockpiling vaccine for deployment in the event of an influenza pandemic is an important mitigation strategy. A necessary aspect of stockpiling is to determine the shelf-life of the stored vaccine.MethodsIn this Phase II, open-label study we assessed the immunogenicity and safety of H5N1 A/Indonesia/5/2005 vaccine adjuvanted with AS03A. The AS03A-H5N1 vaccine was prepared from bulk antigen that had been stored for 4 years, and adjuvant that had been stored for 2.5 years. Both the antigen and adjuvant were filled in separate multi-dose vials within 4 months of use, and on the day of vaccination, the contents of antigen and adjuvant vials were mixed. Seventy-eight adults aged 18–64 years were scheduled to receive two doses of hemagglutinin-antigen (3.75μg) given 21 days apart. Antibody responses were assessed by hemagglutination-inhibition (HI) assay according to age (18–30 years, 31–40 years, 41–50 years, and 51–64 years). Reactogenicity was assessed for 7 days after each vaccination, and safety was assessed for 385 days post-vaccination (NCT01416571).ResultsThe vaccine was immunogenic. Twenty-one days after the second dose of vaccine in the overall population, the HI seroconversion rate and seroprotection rate (SPR; titer ≥1:40) was 96.0% and 98.7%, respectively. At Day 182 after vaccination, the SPR was 76.7% in the overall population. Injection site pain was the most frequent solicited adverse event (91.0%), and no safety concerns were raised.ConclusionThe immunogenicity and safety observed with AS03A-H5N1 vaccine formulated with bulk antigen which had been stockpiled before vialing and administration was consistent with that previously observed with newly manufactured AS03A-H5N1 vaccine. This suggests that stockpiling bulk antigen for 4 years does not compromise the immunogenicity or reactogenicity of the vaccine
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