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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. -
Management of Poisoning
MOH CLINICAL PRACTICE GUIDELINES December/2011 Management of Poisoning Health Ministry of Sciences Chapter of Emergency College of College of Family Manpower Authority Physicians Physicians, Physicians Academy of Medicine, Singapore Singapore Singapore Singapore Medical Pharmaceutical Society Society for Emergency Toxicology Singapore Paediatric Association of Singapore Medicine in Singapore Society (Singapore) Society Executive summary of recommendations Details of recommendations can be found in the main text at the pages indicated. Principles of management of acute poisoning – resuscitating the poisoned patient GPP In a critically poisoned patient, measures beyond standard resuscitative protocol like those listed above need to be implemented and a specialist experienced in poisoning management should be consulted (pg 55). GPP D Prolonged resuscitation should be attempted in drug-induced cardiac arrest (pg 55). Grade D, Level 3 1 C Titrated doses of naloxone, together with bag-valve-mask ventilation, should be administered for suspected opioid-induced coma, prior to intubation for respiratory insuffi ciency (pg 56). Grade C, Level 2+ D In bradycardia due to calcium channel or beta-blocker toxicity that is refractory to conventional vasopressor therapy, intravenous calcium, glucagon or insulin should be used (pg 57). Grade D, Level 3 B Patients with actual or potential life threatening cardiac arrhythmia, hyperkalaemia or rapidly progressive toxicity from digoxin poisoning should be treated with digoxin-specifi c antibodies (pg 57). Grade B, Level 2++ B Titrated doses of benzodiazepine should be given in hyperadrenergic- induced tachycardia states resulting from poisoning (pg 57). Grade B, Level 1+ D Non-selective beta-blockers, like propranolol, should be avoided in stimulant toxicity as unopposed alpha agonism may worsen accompanying hypertension (pg 57). -
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 -
Early Description of Coronavirus 2019 Disease in Kidney Transplant Recipients in New York
RAPID COMMUNICATION www.jasn.org Early Description of Coronavirus 2019 Disease in Kidney Transplant Recipients in New York The Columbia University Kidney Transplant Program* Department of Medicine, Division of Nephrology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York ABSTRACT Background The novel SARS-CoV-2 virus has caused a global pandemic of coronavirus kidney recipients (80%), with a me- disease 2019 (COVID-19). Although immunosuppressed individuals are thought to be dian time since transplant of 49 at an increased risk of severe disease, little is known about their clinical presentation, (interquartile range, 38–118; range, disease course, or outcomes. 0–232) months (Table 1). All but one Methods We report 15 kidney transplant recipients from the Columbia University patientweretakingtacrolimusatthe kidney transplant program who required hospitalization for confirmed COVID-19, time of COVID-19 diagnosis, and and describe their management, clinical course, and outcomes. most (80%) were also taking either my- cophenolate mofetil or mycophenolic Results Patients presented most often with a fever (87%) and/or cough (67%). Initial acid. Despite our status as an early ste- chest x-ray most commonly showed bilateral infiltrates, but 33% had no acute ra- roid withdrawal center for most trans- diographic findings. Patients were managed with immunosuppression reduction plants, ten patients (67%) were taking and the addition of hydroxychloroquine and azithromycin. Although 27% of our prednisone at the time of COVID-19 patients needed mechanical ventilation, over half were discharged home by the diagnosis. The underlying cause of end of follow-up. ESKD varied. Conclusions Kidney transplant recipients with COVID-19 have presentations that Patients reported symptom onset are similar to that of the general population. -
Use of Fluorescence to Guide Resection Or Biopsy of Primary Brain Tumors and Brain Metastases
Neurosurg Focus 36 (2):E10, 2014 ©AANS, 2014 Use of fluorescence to guide resection or biopsy of primary brain tumors and brain metastases *SERGE MARBACHER, M.D., M.SC.,1,5 ELISABETH KLINGER, M.D.,2 LUCIA SCHWYZER, M.D.,1,5 INGEBORG FISCHER, M.D.,3 EDIN NEVZATI, M.D.,1 MICHAEL DIEPERS, M.D.,2,5 ULRICH ROELCKE, M.D.,4,5 ALI-REZA FATHI, M.D.,1,5 DANIEL COLUCCIA, M.D.,1,5 AND JAVIER FANDINO, M.D.1,5 Departments of 1Neurosurgery, 2Neuroradiology, 3Pathology, and 4Neurology, and 5Brain Tumor Center, Kantonsspital Aarau, Aarau, Switzerland Object. The accurate discrimination between tumor and normal tissue is crucial for determining how much to resect and therefore for the clinical outcome of patients with brain tumors. In recent years, guidance with 5-aminolev- ulinic acid (5-ALA)–induced intraoperative fluorescence has proven to be a useful surgical adjunct for gross-total resection of high-grade gliomas. The clinical utility of 5-ALA in resection of brain tumors other than glioblastomas has not yet been established. The authors assessed the frequency of positive 5-ALA fluorescence in a cohort of pa- tients with primary brain tumors and metastases. Methods. The authors conducted a single-center retrospective analysis of 531 patients with intracranial tumors treated by 5-ALA–guided resection or biopsy. They analyzed patient characteristics, preoperative and postoperative liver function test results, intraoperative tumor fluorescence, and histological data. They also screened discharge summaries for clinical adverse effects resulting from the administration of 5-ALA. Intraoperative qualitative 5-ALA fluorescence (none, mild, moderate, and strong) was documented by the surgeon and dichotomized into negative and positive fluorescence. -
GHS Calcium Lactate Gluconate MSDS.Pdf
Safety Data Sheet (Calcium Lactate Gluconate) DATE PREPARED: 7/9/2015 Section 1. Product and Company Identification Product Name Calcium Lactate Gluconate CAS Number 11116-97-5 Parchem - fine & specialty chemicals EMERGENCY RESPONSE NUMBER 415 Huguenot Street CHEMTEL New Rochelle, NY 10801 Toll Free US & Canada: 1 (800) 255-3924 (914) 654-6800 (914) 654-6899 All other Origins: 1 (813) 248-0585 parchem.com [email protected] Collect Calls Accepted Section 2. Hazards Identification Classification of the substance or mixture Classification according to Directive 67/548/EEC or 1999/45/EC as amended: This preparation does not meet the criteria for classification according to Directive 1999/45/EC as amended. Classification according to Regulation (EC) No 1272/2008 as amended: This mixture does not meet the criteria for classification according to Regulation (EC) 1272/2008 as amended. Hazard and precautionary statements Hazard statements: The substance does not meet the criteria for classification. Precautionary statements: Not available. Appearance & Odor: White powder with no odor. Fire & Explosion Hazards Potential for dust explosion may exist. This product is not defined as flammable or combustible. However, the product may decompose under fire conditions to produce toxic oxides of carbon. Depending upon conditions, dusts may be sensitive to static discharge. Avoid possibility of dry powder and friction causing static electricity in presence of flammables (See NFPA-77, Chpt. 6) Primary Route of Exposure: Skin and eye contact are the primary routes of exposure to this product. Inhalation Acute Exposure: Inhalation of dust may cause mild irritation. Skin Contact - Acute: Skin contact is not expected to cause irritation. -
Tall Man Lettering List REPORT DECEMBER 2013 1
Tall Man Lettering List REPORT DECEMBER 2013 1 TALL MAN LETTERING LIST REPORT WWW.HQSC.GOVT.NZ Published in December 2013 by the Health Quality & Safety Commission. This document is available on the Health Quality & Safety Commission website, www.hqsc.govt.nz ISBN: 978-0-478-38555-7 (online) Citation: Health Quality & Safety Commission. 2013. Tall Man Lettering List Report. Wellington: Health Quality & Safety Commission. Crown copyright ©. This copyright work is licensed under the Creative Commons Attribution-No Derivative Works 3.0 New Zealand licence. In essence, you are free to copy and distribute the work (including other media and formats), as long as you attribute the work to the Health Quality & Safety Commission. The work must not be adapted and other licence terms must be abided. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nd/3.0/nz/ Copyright enquiries If you are in doubt as to whether a proposed use is covered by this licence, please contact: National Medication Safety Programme Team Health Quality & Safety Commission PO Box 25496 Wellington 6146 ACKNOWLEDGEMENTS The Health Quality & Safety Commission acknowledges the following for their assistance in producing the New Zealand Tall Man lettering list: • The Australian Commission on Safety and Quality in Health Care for advice and support in allowing its original work to be either reproduced in whole or altered in part for New Zealand as per its copyright1 • The Medication Safety and Quality Program of Clinical Excellence Commission, New South -
Melphalan) for Injection, for Intravenous Use History of Serious Allergic Reaction to Melphalan Initial U.S
HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------DOSAGE FORMS AND STRENGTHS----------------------- These highlights do not include all the information needed to use For Injection: 50 mg per vial, lyophilized powder in a single-dose vial for EVOMELA safely and effectively. See full prescribing information for reconstitution. (3) EVOMELA. ---------------------------CONTRAINDICATIONS---------------------------------- EVOMELA® (melphalan) for injection, for intravenous use History of serious allergic reaction to melphalan Initial U.S. Approval: 1964 WARNING: SEVERE BONE MARROW SUPPRESSION, ---------------------WARNINGS AND PRECAUTIONS-------------------------- HYPERSENSITIVITY, and LEUKEMOGENICITY See full prescribing information for complete boxed warning. • Gastrointestinal toxicity: Nausea, vomiting, diarrhea or oral mucositis may occur; provide supportive care using antiemetic and antidiarrheal • Severe bone marrow suppression with resulting infection or medications as needed. (2.1, 5.2) bleeding may occur. Controlled trials comparing intravenous (IV) • Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to melphalan to oral melphalan have shown more myelosuppression fetus and to avoid pregnancy . (5.6, 8.1, 8.3) with the IV formulation. Monitor hematologic laboratory • Infertility: Melphalan may cause ovarian function suppression or testicular parameters. (5.1) suppression. (5.7) • Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation -
Wednesday May 26, 1999
5±26±99 Vol. 64 No. 101 Wednesday Pages 28333±28712 May 26, 1999 federal register 1 VerDate 06-MAY-99 21:29 May 25, 1999 Jkt 183247 PO 00000 Frm 00001 Fmt 4710 Sfmt 4710 E:\FR\FM\26MYWS.XXX pfrm03 PsN: 26MYWS II Federal Register / Vol. 64, No. 101 / Wednesday, May 26, 1999 The FEDERAL REGISTER is published daily, Monday through SUBSCRIPTIONS AND COPIES Friday, except official holidays, by the Office of the Federal Register, National Archives and Records Administration, PUBLIC Washington, DC 20408, under the Federal Register Act (44 U.S.C. Subscriptions: Ch. 15) and the regulations of the Administrative Committee of Paper or fiche 202±512±1800 the Federal Register (1 CFR Ch. I). The Superintendent of Assistance with public subscriptions 512±1806 Documents, U.S. Government Printing Office, Washington, DC 20402 is the exclusive distributor of the official edition. General online information 202±512±1530; 1±888±293±6498 Single copies/back copies: The Federal Register provides a uniform system for making available to the public regulations and legal notices issued by Paper or fiche 512±1800 Federal agencies. These include Presidential proclamations and Assistance with public single copies 512±1803 Executive Orders, Federal agency documents having general FEDERAL AGENCIES applicability and legal effect, documents required to be published Subscriptions: by act of Congress, and other Federal agency documents of public Paper or fiche 523±5243 interest. Assistance with Federal agency subscriptions 523±5243 Documents are on file for public inspection in the Office of the Federal Register the day before they are published, unless the issuing agency requests earlier filing. -
UC Irvine UC Irvine Previously Published Works
UC Irvine UC Irvine Previously Published Works Title ACTR-10. A RANDOMIZED, PHASE I/II TRIAL OF IXAZOMIB IN COMBINATION WITH STANDARD THERAPY FOR UPFRONT TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MGMT METHYLATED GLIOBLASTOMA (GBM) STUDY DESIGN Permalink https://escholarship.org/uc/item/2w97d9jv Journal Neuro-Oncology, 20(suppl_6) ISSN 1522-8517 Authors Kong, Xiao-Tang Lai, Albert Carrillo, Jose A et al. Publication Date 2018-11-05 DOI 10.1093/neuonc/noy148.045 Peer reviewed eScholarship.org Powered by the California Digital Library University of California Abstracts 3 dyspnea; grade 2 hemorrhage, non-neutropenic fever; and grade 1 hand- toxicities include: 1 patient with pre-existing vision dysfunction had Grade foot. CONCLUSIONS: Low-dose capecitabine is associated with a modest 4 optic nerve dysfunction; 2 Grade 4 hematologic events and 1 Grade 5 reduction in MDSCs and T-regs and a significant increase in CTLs. Toxicity event(sepsis) due to temozolamide-induced cytopenias. CONCLUSION: has been manageable. Four of 7 evaluable patients have reached 6 months 18F-DOPA-PET -guided dose escalation appears reasonably safe and toler- free of progression. Dose escalation continues. able in patients with high-grade glioma. ACTR-10. A RANDOMIZED, PHASE I/II TRIAL OF IXAZOMIB IN ACTR-13. A BAYESIAN ADAPTIVE RANDOMIZED PHASE II TRIAL COMBINATION WITH STANDARD THERAPY FOR UPFRONT OF BEVACIZUMAB VERSUS BEVACIZUMAB PLUS VORINOSTAT IN TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MGMT ADULTS WITH RECURRENT GLIOBLASTOMA FINAL RESULTS Downloaded from https://academic.oup.com/neuro-oncology/article/20/suppl_6/vi13/5153917 by University of California, Irvine user on 27 May 2021 METHYLATED GLIOBLASTOMA (GBM) STUDY DESIGN Vinay Puduvalli1, Jing Wu2, Ying Yuan3, Terri Armstrong2, Jimin Wu3, Xiao-Tang Kong1, Albert Lai2, Jose A. -
2016 ASCO TRC102 + Temodar Phase 1 Poster
Phase I Trial of TRC102 (methoxyamine HCL) in Combination with Temozolomide in Patients with Relapsed Solid Tumors Robert S. Meehan1, Alice P. Chen1, Geraldine Helen O'Sullivan Coyne1, Jerry M. Collins1, Shivaani Kummar1, Larry Anderson1, Kazusa Ishii1, Jennifer Zlott1, 1 1 2 1 1 2 2 1,3 #2556 Larry Rubinstein , Yvonne Horneffer , Lamin Juwara , Woondong Jeong , Naoko Takebe , Robert J. Kinders , Ralph E. Parchment , James H. Doroshow 1Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892 2Frederick National Laboratory for Cancer Research, Frederick, Maryland 21702; 3Center for Cancer Research, NCI, Bethesda, Maryland 20892 Introduction Patient Characteristics Adverse Events Response • Base excision repair (BER), one of the pathways of DNA damage repair, has been implicated in No. of Patients 34 C3D1 chemoresistance. Age (median) 60 Adverse Event Grade 2 Grade 3 Grade 4 Baseline C3D1 Baseline Range 39-78 Neutrophil count decreased 1 3 2 • TRC102 is a small molecule amine that covalently binds to abasic sites generated by BER, Race Platelet count decreased 2 1 2 resulting in DNA strand breaks and apoptosis; therefore, co-adminstraion of TRC102 is Caucasian 24 African American 6 Lymphocyte count decreased 6 5 anticipated to enhance the antitumor activity of temozolomide (TMZ), which methylates DNA Asian 2 Anemia 9 3 1 at N-7 and O-6 positions of guanine. Hispanic 2 Hypophosphatemia 2 2 Tumor Sites • We conducted a phase 1 trial of TRC102 in combination with TMZ to determine the safety, tolerability, GI 11 Fatigue 3 1 and maximum tolerated dose (MTD) of the combination (Clinicaltrials.gov identifier: NCT01851369) H&N 4 Hypophosphatemia 1 Lung 7 Hemolysis 1 1 1 • First enrollment: 7/16/2013.