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Real World Efficacy and Tolerability of Acotiamide, in Relieving Meal
testinal & in D o i tr g s e Journal of Gastrointestinal & a s t G i v f e o Narayanan et al., J Gastrointest Dig Syst 2018, 8:1 S l y a s n r ISSN: 2161-069Xt Digestive System DOI: 10.4172/2161-069X.1000553 e u m o J Research Article Open Access Real World Efficacy and Tolerability of Acotiamide, in Relieving Meal- related Symptoms of Functional Dyspepsia Varsha Narayanan*, Amit Bhargava and Shailesh Pallewar 1Department of Medical Services and Research, Lupin Ltd., India *Corresponding author: Narayanan V, Department of Medical Services and Research, Lupin Ltd., Mumbai, India, Tel: +912266402222; E-mail: [email protected] Received date: February 09, 2018; Accepted date: February 21, 2018; Published date: February 27, 2018 Copyright: © 2018 Narayanan V, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Background: Functional Dyspepsia (FD) is a highly prevalent clinical condition that imposes negative economic burden on health-care system as well as greatly impairs quality of life. Treatment of non-specific and bothersome meal-related FD symptoms like post-prandial fullness, upper abdominal bloating and early satiety, is a therapeutic challenge for the clinicians as poorly-defined and ill-understood pathogenesis has hampered efforts to develop effective treatments. Acotiamide is first-in-class drug that exerts its gastro-kinetic effect by enhancing acetylcholine release. Though evidence of its efficacy and tolerance are available through randomized clinical trials, real world data from its regular in-clinic use is lacking. -
A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia
Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using The BARRX™ Anorectal Wand (Clinical Protocol 01-2017) AUGUST 31, 2017 Page 1 of 40 Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia PROTOCOL SIGNATURE PAGE I, , Principal Investigator at site , agree to conduct and follow this protocol: PROTOCOL 01-2017: A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for Anal Intraepithelial Neoplasia using the Barrx™ Anorectal Wand as written according to FDA guidelines. I understand that no deviations from the above protocol may be made without written permission from the Protocol Chair(s). _________________________________ _____________________ Signature Date (mm/dd/yyyy) Page 2 of 40 Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia P ROT O COL S U M M ARY Title A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for Anal Intraepithelial Neoplasia using the Barrx™ Anorectal Wand Design Multi-center prospective trial involving up to 70 subjects Subject Population HIV-positive and HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN) containing at least one high- grade squamous intraepithelial lesions (HSIL) involving the squamocolumnar junction (SCJ). Objective Assess the safety, and efficacy of circumferential radiofrequency ablation (RFA) to the anal canal using the FDA cleared Barrx™ Anorectal Wand to eradicate anal -
PN0496-Acotiamide.Pdf
Acotiamide hydrochloride hydrate (Acofide®) 盐酸阿考替胺 Z-338 in Zeria; YM-443 in Astellas Tablet, oral, EQ 100 mg acotiamide Acotiamide is a peripheral acetylcholinesterase inhibitor, indicated for the treatment of functional dyspepsia (FD), which was first-in-class drug to treat FD in the world and approved in 2013 by Japan PMDA. It was originally discovered by Zeria, and co-developed with Astellas. The drug is co-marketing in Japan with a single brand name. The human recommended starting dose is 100 mg at a time, and 3 times a day before meals. Worldwide Key Approvals Global Sales ($Million) Key Substance Patent Expiration 2016-May (US5981557A) 2016-May (EP0870765B1) 2013-Mar (JP) Not available 2021-May (JP3181919B2) 2016-May (CN1063442C) Mechanism of Action Acotiamide hydrochloride hydrate is an acetylcholinesterase (AChE) inhibitor and enhanced the acetylcholine (ACh)-induced contraction and motility of the gastric antrum and the gastric body. Target Binding Selectivity In vitro Efficacy In vivo Efficacy Mixed pattern: Ki1= 0.61 µM Effect dose of contraction in gastric sample: Significantly improved the gastrointestinal motility: Ki2= 2.7 µM ACh-induced: at 1 µM In normal and gastric hypomotility dogs: at 10 mg/kg. Inhibition: IC50= 3 µM Electrical-induced: at 0.3 µM In gastric hypomotility rats: at 100 mg/kg. Pharmacokinetics Parameters Rats Dogs Healthy Humans 3 10 3 10 50 mg 100 mg 200 mg 400 mg 800 mg Dose (mg/kg) (i.v.) (p.o.) (i.v.) (p.o.) (p.o.) (p.o.) (p.o.) (p.o.) (p.o.) Tmax (hr) - 0.08 - 0.5 2.75 2.42 2.08 2.25 2.13 Cmax -
Wtf World Ranking (April 2012) Women's
WTF WORLD RANKING (APRIL 2012) WOMEN'S UNDER 46KG 2012 4th 2012 US 2012 Spanish Total Rank First name Last Name Nation Div 2009 (25%) 2010 (50%) 2011 (75%) Bahrain Open (G- German Open (G- points Open 2) Open 2) 1 RUKIYE YILDIRIM TURKEY F-46 12.15 45.00 48.90 20.00 126.05 2 YVETTE YONG CANADA F-46 13.52 20.00 36.92 20.00 90.44 3 BUTTREE PUEDPONG THAILAND F-46 25.30 20.40 11.34 57.04 4 SOHUI KIM KOREA F-46 0.00 0.00 52.50 52.50 5 ELAIA TORRONTEGUI SPAIN F-46 11.88 18.78 15.84 4.32 50.82 6 ITZEL ADILENE MANJARREZ BASTIDAS MEXICO F-46 0.00 20.00 30.24 50.24 7 ANASTASIA VALUEVA RUSSIA F-46 0.00 0.00 37.94 6.00 43.94 8 ALISON PINTENO FRANCE F-46 7.15 13.80 19.64 40.58 9 KHAYALA GULIYEVA AZERBAIJAN F-46 0.00 1.80 13.44 12.00 12.00 39.24 10 KATIA ARAKAKI BRAZIL F-46 6.97 28.00 2.70 37.67 11 AYA ROBIE EGYPT F-46 0.00 0.00 37.50 37.50 12 ZHAOYI LI CHINA F-46 0.00 0.00 36.00 36.00 13 YULIYA VOLKOVA UKRAINE F-46 2.65 11.16 21.38 35.18 14 DANA HAIDER IZZAT TOURAN JORDAN F-46 0.00 32.78 0.00 32.78 15 SUMEYYE GULEC MANZ GERMANY F-46 1.85 0.00 29.10 30.95 16 CAROLENA CARSTENS PANAMA F-46 0.00 10.00 20.34 30.34 17 SARA KHOSH JAMAL FEKRY IRAN F-46 0.00 19.00 7.50 3.60 30.10 18 KHADY FALL SENEGAL F-46 0.00 15.00 13.50 28.50 19 HSIEN YUNG HUANG CHINESE TAIPEI F-46 2.65 25.00 0.00 27.65 20 SORA HONG KOREA F-46 2.50 25.00 0.00 27.50 21 FRANCISCA VALENTINA INDONESIA F-46 3.12 14.40 7.50 25.02 22 HYOJI PARK KOREA F-46 25.00 0.00 0.00 25.00 22 SEOYEON JEON KOREA F-46 0.00 25.00 0.00 25.00 22 ZEYNEB AMDOUNI TUNISIA F-46 0.00 25.00 0.00 25.00 25 BOLILI MIAMBANZILA -
Buddhist Revivalist Movements Comparing Zen Buddhism and the Thai Forest Movement Buddhist Revivalist Movements Alan Robert Lopez Buddhist Revivalist Movements
Alan Robert Lopez Buddhist Revivalist Movements Comparing Zen Buddhism and the Thai Forest Movement Buddhist Revivalist Movements Alan Robert Lopez Buddhist Revivalist Movements Comparing Zen Buddhism and the Thai Forest Movement Alan Robert Lopez Chiang Mai , Thailand ISBN 978-1-137-54349-3 ISBN 978-1-137-54086-7 (eBook) DOI 10.1057/978-1-137-54086-7 Library of Congress Control Number: 2016956808 © The Editor(s) (if applicable) and The Author(s) 2016 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Cover image © Nickolay Khoroshkov / Alamy Stock Photo Printed on acid-free paper This Palgrave Macmillan imprint is published by Springer Nature The registered company is Nature America Inc. -
Detail Report
Supplemental Update Report CR Number: 2012319113 Implementation Date: 16-Jan-19 Related CR: 2012319113 MedDRA Change Requested Add a new SMQ Final Disposition Final Placement Code # Proposed SMQ Infusion related reactions Rejected After Suspension MSSO The proposal to add a new SMQ Infusion related reactions is not approved after suspension. The ICH Advisory Panel did approve this SMQ topic to go into the development phase and it Comment: underwent testing in three databases (two regulatory authorities and one company). However, there were numerous challenges encountered in testing and the consensus decision of the CIOMS SMQ Implementation Working Group was that the topic could not be developed to go into production as an SMQ. Most notably, in contrast to other SMQs, this query could not be tested using negative control compounds because it was not possible to identify suitable compounds administered via infusion that were not associated with some type of reaction. In addition, there is no internationally agreed definition of an infusion related reaction and the range of potential reactions associated with the large variety of compounds given by infusion is very broad and heterogenous. Testing was conducted on a set of around 500 terms, the majority of which was already included in Anaphylactic reaction (SMQ), Angioedema (SMQ), and Hypersensitivity (SMQ). It proved difficult to identify potential cases of infusion related reactions in post-marketing databases where the temporal relationship of the event to the infusion is typically not available. In clinical trial databases where this information is more easily available, users are encouraged to provide more specificity about the event, e.g., by reporting “Anaphylactic reaction” when it is known that this event is temporally associated with the infusion. -
California Buddhist Centers - Updated January 1, 2007
California Buddhist Centers - Updated January 1, 2007 - www.BuddhaNet.net -------------------------------------------------------------------------------- Abhayagiri Buddhist Monastery Address: 16201 Tomki Road, Redwood Valley, CA 95470 CA Tradition: Theravada Forest Sangha Affiliation: Amaravati Buddhist Monastery (UK) EMail: [email protected] Website: http://www.abhayagiri.org -------------------------------------------------------------------------------- All One Dharma Address: 1440 Harvard Street, Quaker House Santa Monica CA 90404 Tradition: Zen/Vipassana Affiliation: General Buddhism Phone: e-mail only EMail: [email protected] Website: http://www.allonedharma.org Spiritual Director: Group effort Teachers: Group lay people Notes and Events: -------------------------------------------------------------------------------- American Buddhist Meditation Temple Address: 2580 Interlake Road, Bradley, CA 93426 CA Tradition: Theravada, Thai, Maha Nikaya Affiliation: Thai Bhikkhus Council of USA -------------------------------------------------------------------------------- American Buddhist Seminary Temple at Sacramento Address: 423 Glide Avenue, West Sacramento CA 95691 CA Tradition: Theravada EMail: [email protected] Website: http://www.middleway.net Teachers: Venerable T. Shantha, Venerable O.Pannasara Spiritual Director: Venerable (Bhante) Madawala Seelawimala Mahathera -------------------------------------------------------------------------------- American Young Buddhist Association Address: 3456 Glenmark Drive, Hacienda -
BUDDHISM, MEDITATION, and the NEGOTIATION of the PUBLIC SPHERE by Leana Marie Rudolph a Capstone Project Submitted for Graduatio
BUDDHISM, MEDITATION, AND THE NEGOTIATION OF THE PUBLIC SPHERE By Leana Marie Rudolph A capstone project submitted for Graduation with University Honors May 20, 2021 University Honors University of California, Riverside APPROVED Dr. Matthew King Department of Religious Studies Dr. Richard Cardullo, Howard H Hays Jr. Chair University Honors ABSTRACT This capstone serves to map and gather the oral histories of formerly undocumented Buddhist communities pertaining to their lived experiences in the Inland Empire. The ethnographic fieldwork conducted of 11 sites over the period of 12 months explored the intersection of diaspora, economy, and religious affiliation. This research begins to explore this junction by undertaking a qualitative and quantitative study that will map Buddhist life in the Inland Empire today. It will include interviews, providing oral histories, and will be accessible through a GIS map, helping Religious Studies and Anthropologist scholars to locate these sites and have background information on these locations. The Inland Empire represents many heavily populated, post-agricultural, and manufacturing areas in America today, which since the 1970s and especially since 2008 has suffered from many economic and social crises related to suburban poverty, as well as waves of demographic changes. Taking the Inland Empire as a petri dish for broader trends at the intersection of religion, economy, and the social in the American public sphere today, this capstone project hopes to determine how Buddhism forms at these intersections, what new stories about life in the Inland Empire Buddhist sites and communities help illuminate, and what forms of digital interfacing best brings anthropological analyses to the publics it examines. -
Pharmacological Agents Currently in Clinical Trials for Disorders in Neurogastroenterology
Pharmacological agents currently in clinical trials for disorders in neurogastroenterology Michael Camilleri J Clin Invest. 2013;123(10):4111-4120. https://doi.org/10.1172/JCI70837. Clinical Review Esophageal, gastrointestinal, and colonic diseases resulting from disorders of the motor and sensory functions represent almost half the patients presenting to gastroenterologists. There have been significant advances in understanding the mechanisms of these disorders, through basic and translational research, and in targeting the receptors or mediators involved, through clinical trials involving biomarkers and patient responses. These advances have led to relief of patients’ symptoms and improved quality of life, although there are still significant unmet needs. This article reviews the pipeline of medications in development for esophageal sensorimotor disorders, gastroparesis, chronic diarrhea, chronic constipation (including opioid-induced constipation), and visceral pain. Find the latest version: https://jci.me/70837/pdf Review Pharmacological agents currently in clinical trials for disorders in neurogastroenterology Michael Camilleri Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, Minnesota, USA. Esophageal, gastrointestinal, and colonic diseases resulting from disorders of the motor and sensory functions represent almost half the patients presenting to gastroenterologists. There have been significant advances in under- standing the mechanisms of these disorders, through basic and translational research, and in targeting the recep- tors or mediators involved, through clinical trials involving biomarkers and patient responses. These advances have led to relief of patients’ symptoms and improved quality of life, although there are still significant unmet needs. This article reviews the pipeline of medications in development for esophageal sensorimotor disorders, gastropa- resis, chronic diarrhea, chronic constipation (including opioid-induced constipation), and visceral pain. -
PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. -
C:\Users\Kusala\Documents\2009 Buddhist Center Update
California Buddhist Centers / Updated August 2009 Source - www.Dharmanet.net Abhayagiri Buddhist Monastery Address: 16201 Tomki Road, Redwood Valley, CA 95470 CA Tradition: Theravada Forest Sangha Affiliation: Amaravati Buddhist Monastery (UK) EMail: [email protected] Website: http://www.abhayagiri.org All One Dharma Address: 1440 Harvard Street, Quaker House Santa Monica CA 90404 Tradition: Non-Sectarian, Zen/Vipassana Affiliation: General Buddhism Phone: e-mail only EMail: [email protected] Website: http://www.allonedharma.org Spiritual Director: Group effort Teachers: Group lay people Notes and Events: American Buddhist Meditation Temple Address: 2580 Interlake Road, Bradley, CA 93426 CA Tradition: Theravada, Thai, Maha Nikaya Affiliation: Thai Bhikkhus Council of USA American Buddhist Seminary Temple at Sacramento Address: 423 Glide Avenue, West Sacramento CA 95691 CA Tradition: Theravada EMail: [email protected] Website: http://www.middleway.net Teachers: Venerable T. Shantha, Venerable O.Pannasara Spiritual Director: Venerable (Bhante) Madawala Seelawimala Mahathera American Young Buddhist Association Address: 3456 Glenmark Drive, Hacienda Heights, CA 91745 CA Tradition: Mahayana, Humanistic Buddhism Contact: Vice-secretary General: Ven. Hui-Chuang Amida Society Address: 5918 Cloverly Avenue, Temple City, CA 91780 CA Tradition: Mahayana, Pure Land Buddhism EMail: [email protected] Spiritual Director: Ven. Master Chin Kung Amitabha Buddhist Discussion Group of Monterey Address: CA Tradition: Mahayana, Pure Land Buddhism Affiliation: Bodhi Monastery Phone: (831) 372-7243 EMail: [email protected] Spiritual Director: Ven. Master Chin Chieh Contact: Chang, Ei-Wen Amitabha Buddhist Society of U.S.A. Address: 650 S. Bernardo Avenue, Sunnyvale, CA 94087 CA Tradition: Mahayana, Pure Land Buddhism EMail: [email protected] Spiritual Director: Ven. -
Infectious Gastroenteritis Generalised Anxiety Disorder HIV Smoking Associated Cancers
BEST PRACTICE 25 DECEMBER 2009 Infectious gastroenteritis Generalised anxiety disorder HIV bpac nz Smoking associated cancers better medicin e Editorial Team Tony Fraser Professor Murray Tilyard We would like to acknowledge the following people for Clinical Advisory Group their guidance and expertise in developing this edition: Michele Cray Dr Shaun Costello, Dunedin Serena Curtis-Lemuelu Dr Edward Coughlan, Christchurch Dr Rosemary Ikram Professor Tony Dowell, Wellington Dr Cam Kyle Dr Rosemary Ikram, Christchurch Dr Chris Leathart Mr William Pearce, Christchurch Dr Lynn McBain Dr Alan Pithie, Christchurch Adam McRae Dr Gabrielle Ruben, Wellington Janet Maloney-Moni Assoc. Professor Mark Thomas, Auckland Dr Peter Moodie Dr Robyn Toomath, Wellington Associate Professor Jim Reid Dr Neil Whittaker, GP Reviewer, Nelson Associate Professor David Reith Assoc. Professor Michael Williams, Dunedin Professor Murray Tilyard Programme Development Team Rachael Clarke Peter Ellison Best Practice Journal (BPJ) Rebecca Harris Julie Knight ISSN 1177-5645 Noni Richards BPJ, Issue 25, December 2009 Dr Tom Swire Dr AnneMarie Tangney nz Dr Sharyn Willis BPJ is published and owned by bpac Ltd Dave Woods Level 8, 10 George Street, Dunedin, New Zealand. Report Development Team Bpacnz Ltd is an independent organisation that promotes health Justine Broadley care interventions which meet patients’ needs and are evidence Todd Gillies based, cost effective and suitable for the New Zealand context. Lana Johnson We develop and distribute evidence based resources which describe, facilitate and help overcome the barriers to best Web practice. Gordon Smith Bpacnz Ltd is currently funded through contracts with PHARMAC Design and DHBNZ. Michael Crawford Bpacnz Ltd has five shareholders: Procare Health, South Link Management and Administration Health, IPAC, the University of Otago and Pegasus Health.