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WO 2017/048702 Al
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date W O 2017/048702 A l 2 3 March 2017 (23.03.2017) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 487/04 (2006.01) A61P 35/00 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/519 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (21) International Application Number: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US20 16/05 1490 HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (22) International Filing Date: KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 13 September 2016 (13.09.201 6) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (25) Filing Language: English SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (26) Publication Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 62/218,493 14 September 2015 (14.09.2015) US (84) Designated States (unless otherwise indicated, for every 62/218,486 14 September 2015 (14.09.2015) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (71) Applicant: INFINITY PHARMACEUTICALS, INC. -
Project Protocol
CADTH Health Technology Assessment June 2016 (Update Drugs for the management of rheumatoid May 2017) arthritis: clinical evaluation – project protocol PROSPERO Registration Number: CRD42016041498 1 Cite as: Drugs for the management of rheumatoid arthritis: clinical evaluation – project protocol. Ottawa: CADTH; 2016 Jun; updated 2017 April. This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH) in collaboration with the Canadian Institutes of Health Research (CIHR) Drug Safety and Effectiveness Network (DSEN). This report contains a comprehensive review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) available to CADTH at the time it was prepared, and its creation was guided by expert input and advice throughout its preparation. The information in this report is intended to help health care decision-makers, patients, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment in respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this report to ensure that its contents are accurate, complete, and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or as a result of the use (or misuse) of any information contained in or implied by the information in this report. -
State Operations Manual Appendix X – Guidance to Surveyors: Organ Transplant Programs
State Operations Manual Appendix X – Guidance to Surveyors: Organ Transplant Programs Table of Contents (Rev. 200, Issued: 02-21-20) Transmittals for Appendix X Part I – The Standard Organ Transplant Program Survey Protocol I. Introduction II. Survey Protocol Tasks Task 1 - Pre-survey: off-site Preparation Task 2 - Entrance Activities Task 3 - Sample Selection Task 4 - Tracer for Selected Patients and Living Donors including Observations of Care, Interviews and Medical Record Review Task 5 – Administrative Review Task 6 – Personnel Record Review (If Indicated) Task 7 – Pre-exit Task 8 – Exit Conference Task 9 - Post Survey Activities III. Alternate Survey Protocol: Pediatric Heart Program Task 1 - Pre-survey: off-site Preparation Task 2 - Entrance Activities Task 3 - Sample Selection Task 4 – Review of Transplant Patient Medical Records Task 5 – Staff Interview Task 6 – Personnel Record Review Task 7 – Administrative Review Task 8 – Pre-exit Task 9 – Exit Conference Task 10 - Post Survey Activities Part II – Interpretive Guidelines for Organ Transplant Surveys 42 C.F.R. 482.72 OPTN Membership 42 C.F.R. 482.74 Notification to CMS 42 C.F.R. 482.76 Pediatric Transplants 42 C.F.R. 482.78 Emergency preparedness for Transplant Programs 42 C.F.R. 482.80 Data Submission, Clinical Experience and Outcome Requirements for Initial Approval 42 C.F.R. 482.82 Data Submission, Clinical Experience and Outcome Requirements Re-approval 42 C.F.R. 482.90 Patient and Living Donor Selection 42 C.F.R. 482.92 Organ Recovery and Receipt 42 C.F.R. 482.94 Patient and Living Donor Management 42 C.F.R. -
Partnering with Your Transplant Team the Patient’S Guide to Transplantation
Partnering With Your Transplant Team The Patient’s Guide to Transplantation U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration This booklet was prepared for the Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation by the United Network for Organ Sharing (UNOS). PARTNERING WITH YOUR TRANSPLANT TEAM THE PATIENT’S GUIDE TO TRANSPLANTATION U.S. Department of Health and Human Services Health Resources and Services Administration Public Domain Notice All material appearing in this document, with the exception of AHA’s The Patient Care Partnership: Understanding Expectations, Rights and Responsibilities, is in the public domain and may be reproduced without permission from HRSA. Citation of the source is appreciated. Recommended Citation U.S. Department of Health and Human Services (2008). Partnering With Your Transplant Team: The Patient’s Guide to Transplantation. Rockville, MD: Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation. DEDICATION This book is dedicated to organ donors and their families. Their decision to donate has given hundreds of thousands of patients a second chance at life. CONTENTS Page INTRODUCTION.........................................................................................................................1 THE TRANSPLANT EXPERIENCE .........................................................................................3 The Transplant Team .......................................................................................................................4 -
A PILOT RANDOMIZED CONTROLLED TRIAL of DE NOVO BELATACEPT-BASED IMMUNOSUPPRESSION in LUNG TRANSPLANTATION Howard J. Huang, MD Ra
A PILOT RANDOMIZED CONTROLLED TRIAL OF DE NOVO BELATACEPT-BASED IMMUNOSUPPRESSION IN LUNG TRANSPLANTATION Howard J. Huang, MD Ramsey R. Hachem, MD Study ID: IM103-387 Draft: v 6.0 Date: 8 December 2017 ! 1 TABLE OF CONTENTS Section Page 1. List of Abbreviations 3 2. Protocol Summary 4 3. Study Schematic 4 4. Key Roles 5 5. Introduction 6 6. Objectives and Purpose 7 7. Study Design and Endpoints 7 8. Study Enrollment 8 9. Study Agent 11 10. Study Procedures and Schedule 11 11. Safety Considerations 13 12. Statistical Considerations 18 13. References 19 ! 2 LIST OF ABBREVIATIONS ACR Acute Cellular Rejection AE Adverse Event AMR Antibody-Mediated Rejection ATG Anti-Thymocyte Globulin ATS American Thoracic Society BAL Bronchoalveolar Lavage BELA Belatacept BMS Bristol-Myers Squibb BOS Bronchiolitis Obliterans Syndrome CARV Community-Acquired Respiratory Virus/Viral CBC Complete Blood Counts CFR Code of Federal Regulations CIP Cellular Immunophenotyping CKD Chronic Kidney Disease CLAD Chronic Lung Allograft Dysfunction CMP Comprehensive Metabolic Panel CMV Cytomegalovirus CNI Calcineurin Inhibitor DCC Data Coordinating Center DSA Donor-Specific HLA Antibodies DSMB Data Safety and Monitoring Board EBV Epstein-Barr Virus ECLS Extra-Corporeal Life Support ECMO Extra-Corporeal Membrane Oxygenation FOB Fiberoptic Bronchoscopy GCP Good Clinical Practice HIV Human Immunodeficiency Virus HLA Human Leukocyte Antigens HSV Herpes Simplex Virus IgG Immunoglobulin G IP Investigational Product IRB Institutional Review Board IS Immunosuppression ISHLT International -
Flesh Is Heir
cover story 125 Years of r e m o v i n g a n d Preventing t h e i l l s t o w h i c h fleSh is heiR b y b arbara I. Paull, e r I c a l l o y d , e d w I n K I ester Jr., J o e m ik s c h , e l a I n e v I t o n e , c h u c K s ta r e s I n I c , a n d sharon tregas ki s lthough the propriety of establishing a medical school here has been sharply questioned by some, “ we will not attempt to argue the question. Results will determine whether or not the promoters of the enterprise were mistaken in their judgment Aand action. The city, we think, offers ample opportunity for all that is desirable in a first-class medical school, and if you will permit me to say it, the trustees and faculty propose to make this a first-class school.” —John Milton Duff, MD Professor of Obstetrics, September 1886 More than three decades after the city’s first public hospital was established, after exhausting efforts toward a joint charter, Pittsburgh physicians founded an indepen- dent medical college, opening its doors in September 1886. This congested industrial city—whose public hospital then performed more amputations and saw more fatal typhoid-fever cases per capita than any other in the country—finally would have its own pipeline of new physicians for its rising tide of diseased and injured brakemen, domestics, laborers, machinists, miners, and steelworkers from around the world, as well as the families of its merchants, professionals, and industry giants. -
Djokovic, Kenin Defend Titles but No Federer at Unique Australian Open
Sports Sunday, February 7, 2021 13 beIN SPORTS to broadcast Djokovic, Kenin defend titles but no Australian Open exclusively Federer at unique Australian Open across MENA DPA TRIBUNE NEWS NETWORK BERLIN The coronavirus has made the Australian Open a massive challenge DOHA THE contrast to 2020 could for tennis players and organizers alike but the best in the world – BEIN MEDIA GROUP, the hardly be starker when the global sports and entertain- Australian Open starts Mon- ment broadcaster and its day with Novak Djokovic and most of them – are now ready to take to the court in Melbourne. flagship sports channel beIN Sofia Kenin defending the ti- SPORTS will broadcast the tles they won 13 months ago in long awaited 2021 Australian Melbourne. Open live and exclusively for Those wins heralded the its viewers and subscribers start of a tennis season which across the Middle East and would soon be halted by the North Africa (MENA) – in- coronavirus pandemic and cluding exclusive footage of then resumed in limited fash- Tunisian star Ons Jabeur and ion only months later, after Egyptian talent Mayar Sherif. the cancellation of Wimble- The date for the start of don, and with a completely re- the 2021 Australian Open was worked schedule. previously scheduled to begin The global health situation in January but was postponed has forced Australian Open to February (8-21) due to the organizers to delay their tour- COVID-19 pandemic. The nament from its usual slot by 2021 Australian Open men’s three weeks from the intended qualifying was successfully January 18 start. -
35Th Anniversary Vol
Published for Members of the American Society of Transplant Surgeons 35th Anniversary Vol. XV, No. 1 Summer 2009 President’s Letter 4 Member News 6 Regulatory & Reimbursement 8 Legislative Report 10 OPTN/UNOS Corner 12 35th Anniversary of ASTS 14 Winter Symposium 18 Chimera Chronicles 19 American Transplant Congress 2009 20 Beyond the Award 23 ASTS Job Board 26 Corporate Support 27 Foundation 28 Calendar 29 New Members 30 www.asts.org ASTS Council May 2009–May 2010 PRESIDENT TREASURER Charles M. Miller, MD (2011) Robert M. Merion, MD (2010) Alan N. Langnas, DO (2012) Cleveland Clinic Foundation University of Michigan University of Nebraska Medical Center 9500 Euclid Avenue, Mail Code A-110 2922 Taubman Center PO Box 983280 Cleveland, OH 44195 1500 E. Medical Center Drive 600 South 42nd Street Phone: 216 445.2381 Ann Arbor, MI 48109-5331 Omaha, NE 68198-3280 Fax: 216 444.9375 Phone: 734 936.7336 Phone: 402 559.8390 Email: [email protected] Fax: 734 763.3187 Fax: 402 559.3434 Peter G. Stock, MD, PhD (2011) Email: [email protected] Email: [email protected] University of California San Francisco PRESIDENT -ELECT COUNCILORS -AT -LARGE Department of Surgery, Rm M-884 Michael M. Abecassis, MD, MBA (2010) Richard B. Freeman, Jr., MD (2010) 505 Parnassus Avenue Northwestern University Tufts University School of Medicine San Francisco, CA 94143-0780 Division of Transplantation New England Medical Center Phone: 415 353.1551 675 North St. Clair Street, #17-200 Department of Surgery Fax: 415 353.8974 Chicago, IL 60611 750 Washington Street, Box 40 Email: [email protected] Phone: 312 695.0359 Boston, MA 02111 R. -
Allotransplantation, from Dream to Realty
allotransplantation, froM dreaM to realtY DENYS MONTANDON, MD Switzerland In the vegetal world, grafting can be defined as the natural or deliberate fusion Later, St. John obtained by praying his cut hand, touched it to his wrist and of plant parts so that vascular continuity is established between them, and kneeled in front of the icon of the Virgin Mary. After a long prayer, he felt thus the resulting genetically composite organism functions as a single plant. asleep and dreamed of the Virgin Mary who Vegetal grafts have been performed since antiquity, particularly around the told him “Your hand is healed because you Mediterranean Basin. No wonder, the idea of grafting a portion of tissue, an wrote in defense of God.” When St. John organ or a limb from one individual to another has been a conscious or an awoke, he saw his cured hand and to express unconscious dream for centuries. We are speaking here not only of implanting his gratitude to the Virgin Mary he ordered a foreign body in a living creature, but to graft living material which will be to put on the icon a silver copy of the cut re-vascularized so as to become an integral part of the recipient host. hand. That’s why the icon is called the Three Handed Virgin. (Fig. 3) myThS ANd mIrACleS Hybrid monsters made of different ANeCdoTeS animal or human parts are not rare in During the Renaissance, the possibility of the myths of several civilizations. One reconstructing a nose with the person’s of the best known in Greek mythology own flesh, as initiated by the Branca family is the Centaur Chiron who had the in Catania (Sicily), and later described and Figure3 - Three Hands Icon of Virgin head and torso of a man and the illustrated in detail by Gaspare Tagliacozzi Mary body of a horse (Fig. -
2021 Hydropower Status Report Sector Trends and Insights
2021 Hydropower Status Report Sector trends and insights | 1 Contents REGISTER FOR THE VIRTUAL Foreword 4 Executive summary 5 Hydropower installed capacity in 2020 7 Hydropower growth in context 8 Where was capacity added in 2020? 9 Regional developments 10 Sector developments 12 Feature: A defining year for pumped storage 12 Clean energy systems 14 Finance and modernisation 16 Water and climate change 18 Sustainability assessments 19 The planet’s premier hydropower event Feature: The new global sustainability standard 20 is now online and open to all Regions in focus 22 Registration has opened for the 2021 World North and Central America 22 Hydropower Congress, the globe’s premier 7-24 SEPTEMBER 2021 South America 26 gathering of influencers and innovators REGISTER NOW FOR FREE dedicated to advancing sustainable Europe 30 HYDROPOWER.ORG/CONGRESS hydropower. Africa 34 For the first time ever, access to the World South and Central Asia 38 Hydropower Congress is free of charge and East Asia and Pacific 42 open to all. Virtual events will be broadcast Data tables: capacity and generation 2020 46 online across multiple timezones, with video on-demand services available for all registrants. Hosted by With support from Hosting partner Organised by Over 150 speakers will address more than 30 virtual events over three weeks between 7-24 September 2021. Strategic partners Supporting partners Event sponsor 2 | International Hydropower Association | Hydropower Status Report 2021 | |1 1 We are the voice of sustainable hydropower Secure hydropower’s place in the energy transition by joining the International Hydropower Association today The International Hydropower Association When delivered responsibly, hydropower offers (IHA) represents organisations and individuals clean, affordable and reliable electricity, while committed to sustainable hydropower. -
Announcer Andy Taylor. 2021 Qatar Total Open Champions And
MOST QATAR TOTAL OPEN TITLES MOST QATAR TOTAL OPEN FINALS 2 - Petra Kvitova (CZE) 3 - Petra Kvitova (CZE) 2 - Victoria Azarenka (BLR) 3 - Victoria Azarenka (BLR) 2 - Maria Sharapova (RUS) 2 - Simona Halep (ROU) 2 - Anastasia Myskina (RUS) 2 - Caroline Wozniacki (DEN) 2 - Vera Zvonareva (RUS) 2 - Maria Sharapova (RUS) 2 - Svetlana Kuznetsova (RUS) 2 - Anastasia Myskina (RUS) Qatar Total Open - Singles Champions and Finalists LEVEL YEAR CHAMPION Titles Finals FINALIST Titles Finals WTA 500 2021 Petra Kvitova (CZE) 2 3 Garbiñe Muguruza (ESP) 0 2 Premier 5 2020 Aryna Sabalenka (BLR) 1 1 Petra Kvitova (CZE) 1 2 Premier 2019 Elise Mertens (BEL) 1 1 Simona Halep (ROU) 1 2 Premier 5 2018 Petra Kvitova (CZE) 1 1 Garbiñe Muguruza (ESP) 0 1 Premier 2017 Karolina Pliskova (CZE) 1 1 Caroline Wozniacki (DEN) 0 2 Premier 5 2016 Carla Suarez Navarro (ESP) 1 1 Jelena Ostapenko (LAT) 1 1 Premier 2015 Lucie Safarova (CZE) 1 1 Victoria Azarenka (BLR) 2 3 Premier 5 2014 Simona Halep (ROU) 1 1 Angelique Kerber (GER) 0 1 Premier 5 2013 Victoria Azarenka (BLR) 2 2 Serena Williams (USA) 0 1 Premier 5 2012 Victoria Azarenka (BLR) 1 1 Sam Stosur (AUS) 0 1 Premier 2011 Vera Zvonareva (RUS) 1 2 Caroline Wozniacki (DEN) 0 1 WTA Finals 2010 Kim Clijsters (BEL) Caroline Wozniacki (DEN) WTA Finals 2009 Serena Williams (USA) Venus Williams (USA) WTA Finals 2008 Venus Williams (USA) Vera Zvonareva (RUS) Tier I 2008 Maria Sharapova (RUS) 2 2 Vera Zvonareva (RUS) 0 1 Tier II 2007 Justin Henin (BEL) 1 1 Svetlana Kuznetsova (RUS) 0 2 Tier II 2006 Nadia Petrova (RUS) 1 1 Amelie Mauresmo (FRA) 0 1 Tier II 2005 Maria Sharapova (RUS) 1 1 Alicia Molik (AUS) 0 1 Tier II 2004 Anastasia Myskina (RUS) 2 2 Svetlana Kuznetsova (RUS) 0 1 Tier III 2003 Anastasia Myskina (RUS) 1 1 Elena Likhovtseva (RUS) 0 1 Tier III 2002 Monica Seles (USA) 1 1 Tamarine Tanasugarn (THA) 0 1 Tier III 2001 Martina Hingis (SUI) 1 1 Sandrine Testud (FRA) 0 1 Doha hosted the WTA Finals | In 2009 and 2010, the Qatar Total Open was not held. -
Natera Announces Publication of Analytical Validation Study Demonstrating Superior Precision of Its Kidney Transplant Rejection Assay
Natera Announces Publication of Analytical Validation Study Demonstrating Superior Precision of Its Kidney Transplant Rejection Assay February 22, 2019 Core Technology Delivers Superior Analytical Performance, Underpins Outstanding Clinical Performance SAN CARLOS, Calif., Feb. 22, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA, today announced analytical validation study results to be published online in the journal Transplantation demonstrating the superior performance of its donor-derived cell-free DNA (dd-cfDNA) test for detecting active rejection in kidney transplant recipients.1 The study showed superior assay precision with coefficient of variation up to five times better than previously published studies.1,2 Natera's analytical validation was based on the analysis of 1,064 replicate samples from both related and non-related donor-recipient pairs. Conducted according to rigorous guidelines from the Clinical & Laboratory Standards Institute, the validation study measured key properties of the assay, including lower limit of detection, linearity, and precision. The assay's precision was particularly strong, showing a coefficient of variation up to five times better than that of a competitive dd-cfDNA assay (1.85% vs. 9.2% within run; 1.99% vs. 4.5% across runs) in repeatability and reproducibility studies.1,2 Previously published analytical studies using other dd-cfDNA assays did not include related donor-recipient cases (such as parents or siblings), which is notable given the technical challenge of differentiating DNA patterns from close relatives. It has been estimated that 52 percent of live kidney donations originate from biologically related donors.3 Natera has leveraged its deep experience using single-nucleotide polymorphism (SNP)-based methods to analyze fetal DNA in maternal blood to achieve high accuracy in these cases.