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Risk management for drugs and biologics in the united states

Chapter 16 Risk Management for Drugs and Biologics in the United States Chapter 16RISK MAnAgEMEnT FOR DRugS AnD bIOLOgICS In THE unITED STATES Arcoxia, Vioxx, Acomplia, Zelnorm, and Tysabri; Aranesp, Procrit, Avandia, and Lucentis —all of these prominent drugs, and others, have been in the news often over the past year.1 The concerns raised about them illustrate the unprecedented combined focus on both drug safety and costs, not only by the Food and Drug Administration (FDA), but also by Congress and the Centers for Medicare and Medicaid Services (CMS).

For which strategies of suicide prevention is there evidence of effectiveness?

For which strategies of suicide prevention is there evidence of effectiveness? ABSTRACT This Health Evidence Network (HEN) synthesis report notes that suicide rates among adolescents and young adults have increased considerably over the last decades. In addition, many widely-used suicide prevention programmes have never been scientifically assessed, thus making it uncertain which are effective. Due to the limited evidence and the heterogeneity of the interventions, it is not possible to determine if onesingle intervention was more effective than another. A broad array of suicide preventive interventionsaddressing different risk factors at various levels will be required. HEN, initiated and coordinated by the WHO Regional Office for Europe, is an information service for public health and health care decision-makers in the WHO European Region. Other interested parties mightalso benefit from HEN. This HEN evidence report is a commissioned work and the contents are the responsibility of the authors.They do not necessarily reflect the official policies of WHO/Europe. The reports were subjectedto international review, managed by the HEN team. When referencing this report, please use the following attribution: Guo B, Harstall C (2004) For which strategies of suicide prevention is there evidence of effectiveness?Copenhagen, WHO Regional Office for Europe (Health Evidence Network report;, accessed 15 July 2004).

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 Bienvenido Unidad de Endotelio, Riesgo Cardiovascular y Salud Cardiometabólica Bienvenido al Servicio de la Unidad de Endotelio, Riesgo Cardiovascular y Salud Cardiometabólica. La Unidad Endotelio dependiente del Servicio de Medicina Interna del Hospital Ramón y Cajal, fue concebida en el año 1998, el mismo año en el que fueron concedidos los premios Nóbel de Medicina a los principales investigadores sobre el endotelio, considerado en la medicina actual el barómetro de la enfermedad cardiovascular. Actualmente la Unidad se compone de un grupo multidisciplinar de profesionales, integrada por médicos, enfermeras, nutricionistas, genetistas, biólogos, bioquímicos e ingenieros. Perspectiva histórica En 1980 fue fundada la "Unidad de Diabetes", pionera en su género en España dentro de los Servicios de Medicina Interna y a la que se le fueron incorporando patologías monográficas como la "hipertensión arterial", "dislipemia" y "obesidad", no sólo en el plano asistencial sino también en el de la investigación, participando en multitud de ensayos clínicos, hasta configurarse en 1990 una estructura de "Unidad de Riesgo Cardiovascular" que fue de las primeras en asentarse como tal en nuestro país. Como consecuencia de los cambios experimentados en la patología cardiovascular aterosclerótica y sobre todo como consecuencia del protagonismo creciente del endotelio como "capa funcionalmente activa" y no solo como "capa de revestimiento" en 1998 se presenta un proyecto de cambio a Unidad de Patología Endotelial que se puso en marcha en el año 2000. Sus inicios fueron lentos pero firmes y fructíferos, practicándose desde entonces una medicina moderna en todos sus matices: preventiva, predictiva, participativa, personalizada y traslacional. El comienzo La Unidad de Endotelio, Riesgo Cardiovascular y Salud Cardiometabólica del Hospital Ramón y Cajal, antigua Unidad de Patología Endotelial, fue fundada en el año 2000 como una "sección funcional" del Servicio de Medicina Interna por los entonces responsables del Servicio y del Hospital, bajo el auspicio de la Consejería de Sanidad de la Comunidad de Madrid. Dicha unidad fue a su vez la evolución natural de unidades previas del Servicio de Medicina Interna, servicio que como citado previamente siempre ha mantenido una línea cardiometabólica cuando todavía, ni siquiera, se había acuñado el término. Nuestra trayectoria hasta la actualidad En 2008 la Consejería apuesta de una forma decidida por la Unidad y culmina en unas nuevas instalaciones con un amplio surtido de novedades tecnológicas y bioquímicas para un mejor diagnóstico y manejo del enfermo vascular, claramente diferenciador de las Unidades de Riesgo Vascular de otros Hospitales de la Comunidad de Madrid. La Unidad fue dotada de recursos humanos y materiales en función del número de pacientes incorporados en aquella fecha (400). Las previsiones se quedaron cortas y hoy la Unidad de Endotelio, Riesgo Cardiovascular y Salud Cardiometabólica sobrepasa los 2000 pacientes con una tasa de seguimiento a los 5 años superior al 95%.

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ReviewAzithromycin-chloroquine and the intermittent preventive treatment of malaria in pregnancyR Matthew Chico*1, Rudiger Pittrof2, Brian Greenwood1 and Daniel Chandramohan1 Address: 1Department of Infectious and Tropical Disease, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK and 2Enfield Town Clinic, Wenlock House, 33 Eaton Road, Enfield, EN1 1NJ, UK

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Plate-forme Mineurs en exil – Platform Kinderen op de vlucht Rue du marché aux poulets – Kiekenmarkt, 30 1000 Bruxelles – Brussel Tél. : 02/210.94.91. Fax : 02/209.61.60 DÉTENTION DES ENFANTS EN FAMILLE EN BELGIQUE : ANALYSE DE LA THÉORIE ET DE LA PRATIQUE Le présent rapport a été réalisé par le groupe de travail « Détention » de la Plate-forme Mineurs en exil. Ce groupe de travail, composé de membres de la Plate-forme, suit de près les actualités en matière de détention d'enfants mineurs, accompagnés ou non. La Plate-forme est un réseau national bilingue et regroupe 38 organisations qui travaillent avec les familles des enfants mineurs en séjour précaire ou irrégulier, et avec les mineurs étrangers non accompagnés. Pour plus d'informations, consultez le sit

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07 de Julio del 2009 Ref.: Documento Institucional Secretaria de Planificación en Salud – Médicos del Mundo Argentina Epidemia de Gripe A h1n1-ETI– IRAS en Argentina: Mitos y Realidades en Sistema de Salud, Información Epidemiológica y Determinantes socio-económicos Breve Reseña - ANTECEDENTES La epidemia de Influenza (Gripe A-H1N1 y Gripe estacional) e Infecciones Respiratorias Aguadas-IRAS (Bronquitis, Bronquiolitis, Neumonías, etc) que claramente desborda en demanda a los servicios públicos de salud, al subsector privado y de seguridad social, resulta ser una amenaza a la Salud Colectiva. A su vez, se generó un caos des-informativo, se potenció la descoordinación y fragmentación imperante en los criterios de intervención en el sistema de salud debido a la ausencia de rectoría del Estado nacional, entre otros problemas. La Organización Mundial de la Salud (OMS) declaró el ingreso a la Fase 6 de Influeza A (H1N1) instalando la máxima alerta epidemiológica a nivel internacional y activando las medidas, protocolos y acciones pertinentes frente a este estadio de la enfermedad. A nivel nacional en nuestro país el Ministerio de Salud de la Nación llevó adelante los protocolos internacionales de la OMS y las medidas que se tenían establecidas para la potencial pandemia de Gripe Aviar (que nunca ocurrió), dio por terminada así la fase de contención cuando comenzaron los contagios de persona-persona en nuestro territorio y se encuentra en la etapa de mitigación con lo se aplicará principal atención a los grupos vulnerables y en riesgo, se recomendó auto-aislamiento en caso de tener los síntomas de gripe, el cierre de escuelas-universidades, la no realización de eventos u actividades masivas donde exista presencia de personas en lugares cerrados, y la no asistencia de Hospitales-Unidades sanitarias si no se tiene síntomas de la enfermedad, la universalización del tratamiento de profilaxis con el antiviral (oseltamivir – zanamivir) en los casos sospechosos de Gripe A, entre otras medidas. La situación epidemiológica y sanitaria en Argentina actualmente se ubica como el 7to país con más casos de Influenza A (H1N1) en el mundo -segundo en América del Sur- con 2409 casos confimados por el Instituto Malbrán, donde hasta el momento hubo 60 muertes en diferentes puntos de la Ciudad, Provincia de Buenos Aires, Sante Fe, San Juan, Neuquén y Misiones por dicha influenza A (H1N1). Aunque la cantidad real de enfermos puede llegar a más de 100.000 según propias inferencias del Ministerio de Salud de la Nación ya que solo se reporta con prueba diagnóstica por laboratorio los casos severos y mortales, mientras que los leves se tratan directamente como sospechosos sin confirmación por laboratorio. Esta estimación se basa en el supuesto que hubo hasta el momento por lo menos 110.000 casos de Enfermedad Tipo Influenza (ETI) registrados por demanda a los servicios de salud y teniendo en cuenta que se estima que "el 85 o 90 por ciento del virus que circula es A – H1N1 (según centros centinelas), se tomó esta proporción para inferir dicha cifra que justamente daría 100.000. Como se reconoce en esta época del año, en nuestro país se producen 3200 muertes ligadas a la Gripe Estacional obviamente afectando a aquellos con patologías de base o en situación de vulnerabilidad social. Las Infecciones Respiratorias Agudas-IRAS (Neumonías/ Bronquiolitis) la sufren cientos de miles de chicos-adultos-adultos mayor, donde anualmente mueren 19.000 personas y 566 chicos menores de 5 año por dicha situación. En Argentina durante el 2008 se notificó un total de 1.186.997 casos de Enfermedad Tipo Influenza (ETI) en todo el país; mientras que el número de casos notificados de Neumonía en

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IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION Reported Pregnancies per 100 Women per Year Combination pill less than 1 to 2 NUVARING® Contraceptive vaginal ring etonogestrel/ethinyl estradiol slow release vaginal ring Intrauterine device (IUD) less than 1 to 6 Condom with spermicidal foam or gel CONTRACEPTIVE VAGINAL RING

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Best Practices in Nursing Care to Older Adults From The Hartford Institute for Geriatric Nursing, New York University, College of Nursing, and the Alzheimer's Association Issue Number D8, Revised 2013 Editor-in-Chief: Sherry A. Greenberg, PhD(c) MSN, GNP-BC New York University College of Nursing Assessing and Managing Delirium in Older Adults with Dementia

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Plant Biology ISSN 1435-8603 Tetracycline accumulates in Iberis sempervirens L. throughapoplastic transport inducing oxidative stress and growthinhibitionG. Di Marco1, A. Gismondi1, L. Canuti1, M. Scimeca2, A. Volpe2 & A. Canini11 Department of Biology, University of Rome ‘Tor Vergata', Rome, Italy2 Department of Biomedicine and Prevention, University of Rome ‘Tor Vergata', Rome, Italy

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Parkinson's Disease: YOUR QUESTIONS ANSWERED What is Parkinson's disease (PD)? How did I get PD and who usually gets it? PD is a disease that affects a specific type of cell in No one knows how PD develops for any given individual, the brain. These cells normally make a substance but the risk of getting PD seems to be affected by

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This article appeared in a journal published by Elsevier. The attached copy is furnished to the author for internal non-commercial research and education use, including for instruction at the authors institution and sharing with colleagues. Other uses, including reproduction and distribution, or selling or licensing copies, or posting to personal, institutional or third party

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esthetic medicine & age prevention Was ist Mesotherapie? Längst lassen sich Gesundheit und Schönheit nicht mehr voneinander trennen - und so rücken auch Medizin, Pharmazie, Ernährung und Kosmetik immer dichter zusammen. Neuester Hype in diesem Bereich ist die Mesotherapie. Die griechische Vorsilbe "Meso" bezieht sich auf den mesodermalen Ursprung von Haut- und Bindegewebe in der embryonalen Entwicklung des Menschen. Mit pharmakologisch wirksamen Schönheitscocktails bietet sie bei zahlreichen Schönheitswünschen eine schnel e, lang anhaltende und vor al em bezahlbare Hilfe, die einen gesunden Lebensstil optimal ergänzt.

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Journal of Antimicrobial Chemotherapy (2002) 49, 999–1005DOI: 10.1093/jac/dkf009 Risk factors associated with nosocomial methicillin-resistant Staphylococcus aureus (MRSA) infection including previous use of antimicrobials Eileen M. Graffunder* and Richard A. Venezia Department of Epidemiology MC-45, Albany Medical Center Hospital, 43 New Scotland Avenue, Albany,

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No recuerdo si lo hice- def:maeva 30/8/13 13:50 Página 7 ÁLVARO ABELLA VILLAR No recuerdo si lo hice- def:maeva 30/8/13 13:40 Página 9 Para Alice Gervase O'Neill LaPlante No recuerdo si lo hice- def:maeva 30/8/13 13:40 Página 11 No recuerdo si lo hice- def:maeva 30/8/13 13:40 Página 13 Ha pasado algo. Siempre se sabe. Recuperas la consciencia y descubres el destrozo: una lámpara rota, un rostro humanodesolado que se difumina justo cuando estás a punto de reco-nocerlo. A veces, es alguien con un uniforme: un paramédico,una enfermera. Una mano extendida con una pastilla. O dis-puesta a clavar una aguja.

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Anthony N. Lawrence, III Tony Lawrence was born in Pascagoula, Mississippi on April 3, 1965. He is the son of Anthony & Darla Lawrence of Pascagoula. He graduated from Our Lady of Victories High School in 1983. He attended The University of Southern Mississippi, receiving a Bachelor of Science Degree in History and Political Science in 1987. He attended The University of Mississippi School of Law, receiving his Juris Doctor Degree in 1990. He was admitted to the practice of law that year. He also is admitted to practice law in all courts in the State of Alabama. Mr. Lawrence began his practice in a general litigation firm and tried civil lawsuits in both Mississippi and Alabama. He served as Assistant District Attorney from 1996 to 1999 in the Nineteenth Circuit Court District and as a Special Prosecutor in other Circuit Court Districts in the State of Mississippi. He joined the law firm of Colingo, Williams, Heidelberg, Steinberger, & McElhaney on September 20, 1999, and practiced primarily in the area of medical malpractice defense. Mr. Lawrence was elected District Attorney for Jackson, George, and Greene Counties in November 2003 and is presently serving in that position, having been reelected in 2007 and 2011. Mr. Lawrence is a member of the Mississippi Bar, Alabama Bar, Jackson County Bar, the National District Attorneys Association, the Mississippi Prosecutors Association and the Association of Government Attorneys in Capital Litigation. He has served as Special Judge in the Jackson County Youth Court. Mr. Lawrence has served as Vice-President, President-Elect and President of the Mississippi Prosecutor's Association and on the Board of Directors for 7 years. He was appointed by Governor Haley Barbour to serve on the Children's Justice Act Task Force. Mr. Lawrence has been an Adjunct Instructor of Criminal Investigations at the Mississippi Gulf Coast Community College – Jackson County Campus and the University of Southern Mississippi at the Long Beach campus. Mr. Lawrence was appointed by Governor Phil Bryant to the Judicial Appointment Governor Advisory Committee and the Governor's Teen Pregnancy Task Force. He has served as President of the Singing River Soccer Club, and was a founding officer in the Mississippi Coast Futbol Club. He has coached youth sports for approximately 27 years and served as coach for the Resurrection High School Varsity Girls Soccer Team for 8 years and as head coach for Resurrection Varsity Boys Soccer Team for 5 years. He coached Resurrection High School Mock Trial Team for over 15 years and volunteers as a Guest Lecturer in area schools. He is married to Anita Lawrence, the former Anita Williamson, and they have two children, Taylor age 23, and Bay age 19. They attend Our Lady of Victories Catholic Church.

Abstracts 201

Computerassistierte Implantologie: Entwicklung und state oft the art Autor: G. Widmann Co-Autor: W. Puelacher Kontakt: Universtitätsklinik für Radiologie I, Department Radiologie, Medizinische Universität Innsbruck Adresse: Anichstr. 35, 6020 Innsbruck Email: gerlig.widmann@i-med.ac.at Zielstellung: Die computerassistierte Implantologie hat in den letzen 10 Jahren zunehmend an

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[12] UNNI 4-19-12.DOC (DO NOT DELETE) 9/10/2012 3:01 PM Indian Patent Law and TRIPS: Redrawing the Flexibility Framework in the Context of Public Policy and Health V.K. Unni Presented in March 2011 at the University of the Pacific, McGeorge School of Law Symposium on The Global Impact and Implementation of Human Rights Norms. TABLE OF CONTENTS

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Table of Contents 2006 05+ Mustang (197)Owners Guide (post-2002-fmt)USA (fus) Table of Contents 2006 05+ Mustang (197)Owners Guide (post-2002-fmt)USA (fus) Table of Contents All rights reserved. Reproduction by any means, electronic or mechanicalincluding photocopying, recording or by any information storage and retrievalsystem or translation in whole or part is not permitted without writtenauthorization from Ford Motor Company. Ford may change the contents withoutnotice and without incurring obligation.

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Medicines Partnership of Australia Packaging and labelling of pharmaceuticals and consumer safety – a survey of the literature Elizabeth de Somer, Ivan Trofimov Medicines Australia Ltd Introduction Inadequate and ambiguous packaging and label ing of medications is widely perceived as a

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Comunicati Care Maestre, cari Maestri, cari Consoli Regionali e Provinciali mi appello al vostro radicato spirito associativo, alla vostra sensibilità Appello alle lettrici e ai lettori per richiamare l'attenzione di tutti sul XXXIV Convegno Nazio- di Silvio Manfredi nale di Ascoli Piceno che si terrà nei giorni 9 e 10 maggio p.v. Dobbiamo essere numerosi e coesi, dobbiamo dare prova che an-

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Wie gründe ich eine Selbsthilfegruppe? – Ein praktischer Ratgeber Einleitung: Die Diagnose Multiples Myelom/Plasmozytom ist eine große Herausforderung. Dabei handelt es sich um eine seltene und komplizierte Krankheit. Die Diagnose ist häufig nicht eindeutig, und die empfohlene Behandlung kann von Arzt zu Arzt variieren. Dies trägt nicht gerade dazu bei, neu erkrankten Patienten ein Gefühl von Sicherheit zu vermitteln. Dennoch, mit geeigneten Testverfahren und Untersuchungen kann eine eindeutige Diagnose gestellt werden. Patienten ohne Symptome können durch regelmäßige Kontrolluntersuchungen ohne aggressive Therapien behandelt werden. Patienten mit Symptomen kann mit einer Therapie geholfen werden, durch die die Krankheit höchstwahrscheinlich für Jahre eingedämmt wird. Darüber hinaus kann der Einsatz von neuen Therapieformen in Erwägung gezogen werden, um eventuell den Krankheitsverlauf langfristig zu kontrollieren oder sogar eine Heilung zu erreichen. Damit Patienten, deren Angehörige und Freunde das Leben mit Multiplem Myelom/Plasmozytom erfolgreich meistern können, ist es sehr wichtig, dass sie bei der Krankheitsbewältigung unterstützt werden. Dies geschieht durch die Vermittlung von Wissen, einer positiven Einstellung und Fähigkeiten zur Krankheitsbewältigung. Für Patienten und betreuende Personen, die sich mit der Diagnose Multiples Myelom/Plasmozytom konfrontiert sehen, ist diese Hilfe unerlässlich. Selbsthilfegruppen können dabei eine Richtung vorgeben und Informationen aus erster Hand liefern: Die gegenseitige Unterstützung und der Informationsaustausch mit Menschen, die sich in einer ähnlichen Situation befinden, können dazu beitragen, dass Patienten sich weniger allein gelassen fühlen. Myeloma Euronet ist ein neuer zwangloser Zusammenschluss von nationalen Organisationen, die Menschen mit Multiplem Myelom/Plasmozytom und deren Angehörige und Freunde bestmöglich unterstützen möchten. Sämtliche Mitgliedsorganisationen sind mit der Gründung und Leitung von Selbsthilfegruppen bestens vertraut. Mit ihrem Wissen und ihrer Erfahrung haben sie zur Erstellung dieser Broschüre beigetragen. Mit diesem Ratgeber möchten wir Ihnen eine Anleitung zur Gründung Ihrer eigenen Selbsthilfegruppe geben. Die emotionale und soziale Unterstützung von Menschen mit Multiplem Myelom/Plasmozytom ist ebenso wichtig wie deren medizinische Betreuung. Mit Ihrer eigenen Selbsthilfegruppe können Sie die Betroffenen beim Umgang mit Angst und Frustration unterstützen und ihnen letztendlich zu einem bewussteren Leben verhelfen.

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Survey Results & analysis for Global survey of models of preclinical TB drug testing This report contains a detailed statistical analysis of the results to the survey titled Global survey of models of preclinical TB drug testing . The results analysis includes answers from all respondents who took the survey (30 completed responses were received to the survey up to this time)

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BMC Molecular Biology Research articleHin-mediated DNA knotting and recombining promote replicon dysfunction and mutationRichard W Deibler†1,2,3, Jennifer K Mann†2,4, De Witt L Sumners4 and Lynn Zechiedrich*1,2,4 Address: 1Interdepartmental Program in Cell and Molecular Biology, Baylor College of Medicine, Houston, Texas 77030-3411 USA, 2Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas 77030-3411 USA, 3Department of Systems Biology, Harvard Medical School, Boston, Massachusetts 02115 USA and 4Department of Mathematics, Florida State University, Tallahassee, Florida 32306-4510 USA

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Medical Technology SA Volume 25 No. 1 June 2011 Peer reviewed rEviEW PATHOGENESIS AND FUTURE TREATMENTS OF SYSTEMIC LUPUS ERYTHEMATOSUS: THE ROLE OF CYTOKINES AND ANTI-CYTOKINES?W. J. MauleUniversity of Johannesburg, Department of Biomedical Technology, Faculty of Health Sciences, South Africa.email: warrenm@uj.ac.za tel: +27 (0)11 559 6265 fax: +27 (0)11 559 6558

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High Performance Alarm Release 02 Congratulations on your choice of a MetaSystem product! We would like to ask you to read the instructions in this manual carefully as you will find it contains useful information to get acquainted with the many possibilities that the H.P.A (High Performance Alarm) range of products is able to offer. After you have installed the product according to the "installation instructions" supplied with the product, and which

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Am J Physiol Gastrointest Liver Physiol 306: G796–G801, 2014.First published March 13, 2014; doi:10.1152/ajpgi.00130.2013. Prokinetic effects of mirtazapine on gastrointestinal transit Jieyun Yin,1 Jun Song,1 Yong Lei,3 Xiaohong Xu,3 and Jiande D. Z. Chen1,2,31Division of Gastroenterology, University of Texas Medical Branch, Galveston, Texas; 2Ningbo Pace Translational MedicalResearch Center, Ningbo, China; and 3Veterans Research and Education Foundation, VA Medical Center, Oklahoma City,Oklahoma

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Rapid oscillometric blood pressure measurement compared toconventional oscillometric measurementSteven A. Yarowsa, Ketul Patelb and Robert Brooka Background There have been few reports studying the necessary interval between blood pressure Oscillometric blood pressure measurement has largely measurements, after the initial rest period.

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(April-September, FY2013) Board of Directors Advancing Towards Legalizing MiCare Presence in Manila The FSM Assistant Attorney, Mr. Joses Gallen accompanied by the MiCare Administrator, Nena S. Nena met with a Makati based law firm last October 14, 2013 to discuss the possibility of extending legal as- FSM National Government sistance to MiCare. There is a need to register in the

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ICT implants in the human body : a review 21 December 2004 Fabienne NSANZE Introduction Present day uses such as heart pacemakers, cochlear implants and neurostimulators are not the focus of this paper. Rather, attention is given to implants that use computer technology either for control/surveillance or enhancement purposes. Apart from one example (the subdermal RFID device, Verichip™, see below), all of these ICT implantations are active implantable devices for "functional electrical stimulation". They partially replace the neural functions of the body by means of electrodes that establish a direct contact to nerves. http://www.medics-network.com/download/schneidersteiglitz_jf04.pdf "Over the last 50 years, we have seen evolution of pacemaker technologies, as an accepted form of intrusion into human body." This is confirmed by the recent U.S. Food and Drug Administration approval of implantable ID chips in humans, for security, financial and personal identification or safety applications. Besides medical purposes, "for [healthy] beneficiaries, implant technologies involve possibly some future advantages, like rapid math, memory capacity or communication by thought. " [quoted from http://www.unido.org/file-storage/download/?file_id=10499] Categorisation of Implantable Devices Implantable devices can be categorised as medical or non-medical devices, both either passive or active devices.