DOCSLIB.ORG

Annual HFHS Publications List 2017 This Bibliography Aims to Recognize

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Annual HFHS Publications List 2017 This Bibliography Aims to Recognize Annual HFHS Publications List 2017 This bibliography aims to recognize the scholarly activity and provide ease of access to journal articles, meeting abstracts, book chapters, books and other works published by Henry Ford Health System personnel. Searches were conducted in PubMed, Embase, Web of Science, and Google Scholar during 2017, and then imported into EndNote for formatting. The searches captured over 1,500 unique publications from Henry Ford Health System authors for 2017. Click the “Full Text” link to view the articles to which Sladen Library provides access. If the full-text of the article is not available, you may request it through ILLiad by clicking on the “Article Request Form,” or by calling us at 313-916-2550. If you would like to be added to the monthly email distribution list to automatically receive a PDF of this bibliography in your inbox, or you have any questions or comments, please contact Angela Cabrera at [email protected]. Administration Omar J, Heidemann DL, Blum-Alexandar B, Uju-Eke C, Alam Z, Willens DE, and Wisdom K. Fresh prescription: Improving nutrition education and access to fresh produce in Detroit J Gen Intern Med 2017; 32(2):S752. PMID: Not assigned. Abstract Administration Smith KL, Fedel P, and Heitman J. Incapacitated surrogates: A new and increasing dilemma in hospital care J Clin Ethics 2017; 28(4):279-289. PMID: 29257763. Article Request Form Allergy Brown KR, Krouse RZ, Calatroni A, Visness CM, Sivaprasad U, Kercsmar CM, Matsui EC, West JB, Makhija MM, Gill MA, Kim H, Kattan M, Pillai D, Gern JE, Busse WW, Togias A, Liu AH, and Khurana Hershey GK. Endotypes of difficult-to-control asthma in inner-city African American children PLoS One 2017; 12(7):e0180778. PMID: 28686637. Full Text Allergy Cassidy-Bushrow AE, Burmeister C, Havstad S, Levin AM, Lynch SV, Ownby DR, Rundle AG, Woodcroft KJ, Zoratti EM, Johnson CC, and Wegienka G. Prenatal antimicrobial use and early-childhood body mass index Int J Obes (Lond) 2017; 42(1):1-7. PMID: 28925412. Article Request Form Allergy Esquivel A, Busse WW, Calatroni A, Togias AG, Grindle KG, Bochkov YA, Gruchalla RS, Kattan M, Kercsmar CM, Khurana Hershey G, Kim H, Lebeau P, Liu AH, Szefler SJ, Teach SJ, West JB, Wildfire J, Pongracic JA, and Gern JE. Effects of omalizumab on rhinovirus infections, illnesses and exacerbations of asthma Am J Respir Crit Care Med 2017; 196(8):985-992. PMID: 28608756. Full Text Allergy Fonseca W, Lucey K, Jang S, Fujimura KE, Rasky A, Ting HA, Petersen J, Johnson CC, Boushey HA, Zoratti E, Ownby DR, Levine AM, Bobbit KR, Lynch SV, and Lukacs NW. Lactobacillus johnsonii supplementation attenuates respiratory viral infection via metabolic reprogramming and immune cell modulation Mucosal Immunol 2017; 10(6):1569-1580. PMID: 28295020. Article Request Form Allergy Havstad S, Sitarik AR, Johnson CC, Zoratti EM, Ownby DR, Levin AM, and Wegienka G. Allergic sensitization in American children of Middle Eastern ethnicity at age 2 Ann Allergy Asthma Immunol 2017; 119(5):464-466. PMID: 28941706. Full Text Allergy Hoch HE, Calatroni A, West JB, Liu AH, Gergen PJ, Gruchalla RS, Hershey KG, Kercsmar CM, Kim H, Lamm CI, Makhija MM, Mitchell HE, Teach SJ, Wildfire JJ, Busse WW, and Szefler SJ. Can we predict fall asthma exacerbations? Validation of the seasonal asthma exacerbation index J Allergy Clin Immunol 2017; 140(4) 1130-1137 e5. PMID: 28238748. Full Text Allergy Krouse RZ, Sorkness CA, Wildfire JJ, Calatroni A, Gruchalla R, Hershey GKK, Kattan M, Liu AH, Makhija M, Teach SJ, West JB, Wood RA, Zoratti EM, and Gergen PJ. Minimally important differences and risk levels for the Composite Asthma Severity Index J Allergy Clin Immunol 2017; 139(3):1052-1055. PMID: 27744028. Full Text Allergy Liu AH, Zoratti EM, Pongracic JA, Babineau DC, Visness CM, Gergen PJ, Togias A, and Busse WW. The multimorbid polysensitized phenotype is associated with the severity of allergic diseases Reply J Allergy Clin Immunol 2017; 139(4):1408-1409. PMID: 28237730 Full Text Allergy Mann ET, Havstad SL, Sitarik A, Bellemore SM, Levin AM, Lynch SV, Ownby DR, Johnson CC, Lukacs NW, Zoratti EM, Woodcroft KJ, and Bobbitt KR. Characterization of basophils in infants in the microbes, allergy, asthma and Pets (MAAP) birth cohort J Allergy Clin Immunol 2017; 139(2):AB168. PMID: Not assigned. Abstract Allergy Orandi D, Havstad S, Sitarik A, Bobbitt K, Jones K, Levin A, Lukacs N, Lynch SV, Wegienka G, Woodcroft K, Ownby D, Johnson C, and Zoratti E. An analysis of potential associations between delivery mode and dog-keeping to basophil FCER1 and activation marker expression during infancy J Allergy Clin Immunol 2017; 139(2):AB167. PMID: Not assigned. Abstract Allergy Sitarik AR, Bobbitt KR, Havstad SL, Fujimura KE, Levin AM, Zoratti EM, Kim H, Woodcroft KJ, Wegienka G, Ownby DR, Joseph CL, Lynch SV, and Johnson CC. Breast milk tgfbeta is associated with neonatal gut microbial composition J Pediatr Gastroenterol Nutr 2017; 65(3):e60-e67. PMID: 28362692. Full Text Allergy Sitarik AR, Bobbitt KR, Havstad SL, Fujimura KE, Levin AM, Zoratti EM, Kim H, Woodcroft KJ, Wegienka G, Ownby DR, Joseph CLM, Lynch SV, and Johnson CC. Breast milk transforming growth factor beta is associated with neonatal gut microbial composition J Pediatr Gastroenterol Nutr 2017; 65(3):e60-e67. PMID: 28827481. Full Text Allergy Sorkness RL, Zoratti E, Kattan M, Gergen PJ, Evans M, and Visness C. Obstructive phenotype as a predictor of asthma control and stability in children Am J Respir Crit Care Med 2017; 195PMID: Not assigned. Abstract Allergy Sorkness RL, Zoratti EM, Kattan M, Gergen PJ, Evans MD, Visness CM, Gill M, Khurana Hershey GK, Kercsmar CM, Liu AH, O'Connor GT, Pongracic JA, Pillai D, Sorkness CA, Togias A, Wood RA, and Busse WW. Obstruction phenotype as a predictor of asthma severity and instability in children J Allergy Clin Immunol 2017;PMID: 29146272. Full Text Allergy Wegienka G, Havstad S, Kim H, Zoratti E, Ownby D, Woodcroft KJ, and Johnson CC. Subgroup differences in the associations between dog exposure during the first year of life and early life allergic outcomes Clin Exp Allergy 2017; 47(1):97-105. PMID: 27562398. Full Text Allergy Wegienka G, Sitarik A, Bassirpour G, Zoratti EM, Ownby D, Johnson CC, and Havstad S. The associations between eczema and food and inhalant allergen-specific IgE vary between black and white children J Allergy Clin Immunol Pract 2017;6(1):292-294 e2. PMID: 28958743. Full Text Anesthesiology Asif A, Malik M, Lundberg KA, Tarabishy A, and Hanna JS. Effectiveness of mexiletine for treatment of neuropathic pain Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract Anesthesiology Bogan J, Saraswat A, Alsaden MR, and Guruswamy J. Neuraxial analgesia in a patient with factor XII deficiency Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract 2 Anesthesiology Calo S, Jaehne AK, Keenan KA, Xu J, Tawil B, Thompson R, Knight RA, Miller J, Lewandowski C, and Tavarekere NN. Deterioration in recombinant tissue plasminogen activator after repeated freezing and thawing cycles for thromboelastography Stroke 2017; 48PMID: Not assigned. Abstract Anesthesiology Cata JP, Guerra CE, Chang GJ, Gottumukkala V, and Joshi GP. Non-steroidal anti-inflammatory drugs in the oncological surgical population: beneficial or harmful? A systematic review of the literature Br J Anaesth 2017; 119(4):750-764. PMID: 29121285. Full Text Anesthesiology Chauhan G, and Garzon-Serrano J. Evaluation of low cost high fidelity USB powered arterial line simulation device for ultrasound guided vascular puncture and cannulation Anesth Analg 2017; 124(5):26-27. PMID: Not assigned. Abstract Anesthesiology Chauhan G, Loomba V, Upadhyay A, and Sibai N. A case report on use of Mexiletine as panacea for opioid induced hyperalgesia Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract Anesthesiology Chauhan G, Patri M, and Loomba V. Cervical myelopathy after neck manipulation in a patient with cervical spondylosis with radiculopathy. Cause and effect or natural progression? Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract Anesthesiology Chauhan G, Patri M, Mordis C, Sandeepram B, and Hehar P. Information Needs Assessment regarding postoperative pain: Gender based analysis of adult population Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract Anesthesiology Davis H, Galusca D, Nanamori M, and Morita Y. Portopulmonary hypertension and atrial fibrillation in liver transplantation Anesthesia and Analgesia 2017; 124:439-439. PMID: Not assigned. Abstract Anesthesiology Gandam Venkata H, Upadhyay AY, and Talari G. Pain as a predictor of disability in elderly population Anesthesiology 2017; 127(6):1038-1039. PMID: 29135554. Full Text Anesthesiology Khanduja S, Larimore K, Loomba V, Sibai N, and Upadhyay A. A retrospective review of mri results for low backache: Are we over investigating? Pain Med 2017; 18(3):602-603. PMID: Not assigned. Abstract Anesthesiology Lencho T, and Morita Y. Modified tricuspid annular plane systolic excursion and its association with postoperative course in heart transpant patients Anesth Analg 2017; 124:111-112. PMID: Not assigned. Abstract Anesthesiology Malik MF, and Alsaden MR. Retrospective analysis of post-operative adductor canal block with epidural anesthesia for total knee replacement Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract Anesthesiology Mbuvah F, and Garzon-Serrano J. Ultrasound guided serratus anterior plane block for thoracic analgesia in a patient with multiple rib fractures Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract Anesthesiology Mbuvah F, Haddad R, Sibai N, and Kataria P. Mexiletine therapy for buerger's disease Reg Anesth Pain Med 2017; 42(6)PMID: Not assigned. Abstract Anesthesiology McCormick ZL, DeFrancesch F, Loomba V, Moradian M, Bathina R, and Rappard G. Diagnostic value, prognostic value, and safety of provocation discography Pain Med 2017;PMID: 28340253.
Load more

Recommended publications
  • 204569Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204569Orig1s000 MEDICAL REVIEW(S) Cross Discipline Team Leader Review 3. CMC/Device Dr. Khairuzzaman found the drug product portion of the NDA to be acceptable, and without need for phase 4 commitments. Dr. Sapru’s review stated that with the exception of a pending issue concerning the control of potential genotoxic impurity (b) (4) the NDA was approvable in terms of drug substance. Dr. Suarez found that the NDA was acceptable from a biopharmaceutics perspective. The Office of Compliance issuance of an acceptable recommendation for drug substance manufacturing and testing facilities was pending at the time of this review. 4. Nonclinical Pharmacology/Toxicology Dr. Richard Siarey completed the primary nonclinical review, and Dr. Lois Freed completed a supervisory memo. Dr. Siarey’s overall conclusion was that from a nonclinical perspective, approval of the suvorexant NDA was recommended. However, he found evidence that catapelxy was observed in dogs exposed to MK-4305 (suvorexant) near Tmax, although he concluded that additional information could have been gained by studying the drug in an experimental model that has been used for diagnosing cataplexy in dogs. Dr. Siarey suggested that since cataplexy occurred in dogs near Tmax, a time at which if used for insomnia patients would ordinarily be in bed, safety concern for humans was reduced. Dr. Siarey also found that the neurobehavioral assessment in the pre- and post-natal developmental study was not complete, as the passive avoidance tests was performed too early in development, while learning/acquisition tests and retention/memory tests were not conducted.
    [Show full text]
  • Anti-Infectives Industry Over the Next 5 Years and Beyond
    Bridging the innovation gap... New Drug Futures: Products that could change the pharma market to 2013 and beyond Over 70 pipeline prospects This new major and insightful 450 page in 8 major therapy areas analysis evaluates, compares and contrasts the are analysed in this report prospects for the development compounds that could revolutionise the pharmaceutical Anti-infectives industry over the next 5 years and beyond. Cardiovascular CNS The report provides: Gastrointestinal Detailed background and market context for Metabolic each therapy area covered: Musculoskeletal Addressable patient population Oncology Current treatments Sales drivers Respiratory Sales breakers Future treatments Market dynamics – winners and losers Key drug launches by 2013 Unique sales forecasts by major product to 2013 Over 70 key products assessed Unique evaluation scores for key areas such as novelty of mechanism, clinical data and competition Critical and detailed appraisal of each product‟s research and development Extensive pipeline listings, putting the profiled products into their competitive context The search – and need – for new products has never been greater and what’s in the development pipeline has never generated more interest. That is why this analysis is so important! GLOBAL PHARMA MARKET IN CONTEXT THE Are there too many prophets of doom ready to write-off the research-based pharma industry in the future? Too few novel There is plenty on which to base such anxiety. The research-based industry products and an must achieve a fair price in the face of greater cost control, while the aggressive generic burden of regulation is setting the bar high for successful product sector are taking introduction.
    [Show full text]
  • The Dual Orexin Receptor Antagonist TCS1102 Does Not Affect Reinstatement of Nicotine- Seeking
    RESEARCH ARTICLE The dual orexin receptor antagonist TCS1102 does not affect reinstatement of nicotine- seeking Shaun Yon-Seng Khoo, Gavan P. McNally, Kelly J. Clemens* School of Psychology, University of New South Wales, Sydney, Australia * [email protected] a1111111111 a1111111111 a1111111111 Abstract a1111111111 a1111111111 The orexin/hypocretin system is important for appetitive motivation towards multiple drugs of abuse, including nicotine. Both OX1 and OX2 receptors individually have been shown to influence nicotine self-administration and reinstatement. Due to the increasing clinical use of dual orexin receptor antagonists in the treatment of disorders such as insomnia, we OPEN ACCESS examined whether a dual orexin receptor antagonist may also be effective in reducing nico- Citation: Khoo SY-S, McNally GP, Clemens KJ tine seeking. We tested the effect of intracerebroventricular (i.c.v.) administration of the (2017) The dual orexin receptor antagonist potent and selective dual orexin receptor antagonist TCS1102 on orexin-A-induced food TCS1102 does not affect reinstatement of nicotine- self-administration, nicotine self-administration and reinstatement of nicotine-seeking in seeking. PLoS ONE 12(3): e0173967. https://doi. org/10.1371/journal.pone.0173967 rats. Our results show that 30 μg of TCS1102 i.c.v. abolishes orexin-A-induced increases in food self-administration but does not reduce nicotine self-administration. Neither i.c.v. 10 μg Editor: Judith Homberg, Radboud University Medical Centre, NETHERLANDS nor 30 μg of TCS1102 reduced compound reinstatement after short-term (15 days) self- administration nicotine, but 30 μg transiently reduced cue/nicotine compound reinstatement Received: November 24, 2016 after chronic self-administration (29 days).
    [Show full text]
  • 2017 Research Annual Report Table of Contents Summaries of 2017
    2017 RESEARCH ANNUAL REPORT TABLE OF CONTENTS SUMMARIES OF 2017 NATIONAL INSTITUTES OF HEALTH AND OTHER FEDERAL GRANTS AWARDED TO HFHS PART I – INTERNAL MEDICINE DEPARTMENT_________________________________ ALLERGY AND IMMUNOLOGY ................................................................................................. 1 CARDIOLOGY/CARDIOVASCULAR RESEARCH…………………………………………….1 ENDOCRINOLOGY AND METABOLISM .................................................................................. 2 GASTROENTEROLOGY ............................................................................................................. .3 HEMATOLOGY/ONCOLOGY…………………………………………………………………...4 HYPERTENSION AND VASCULAR RESEARCH……………………………………………...5 INFECTIOUS DISEASE…………………………………………………………………………..9 PULMONARY……………………………………………………………………………………10 SLEEP MEDICINE ....................................................................................................................... 11 GENERAL INTERNAL MEDICINE…………………………………………………………….13 PART II – ALL OTHER CLINICAL DEPARTMENTS_______________________________ DERMATOLOGY ........................................................................................................................ 14 NEUROLOGY .............................................................................................................................. 15 NEUROSURGERY……………………………………………………………………………….23 ORTHOPAEDICS/BONE & JOINT……………………………………………………………..24 PATHOLOGY ..............................................................................................................................
    [Show full text]
  • Study Protocol
    Confidential Page 1 Protocol No. Everolimus Investigator-initiated Protocol Template RAD001 (Everolimus) Clinical evaluation of everolimus (a rapamycin analog) in restoring salivary gland function to patients treated with radiotherapy for head and neck cancer CRAD001XUS274T Authors: Panayiotis Savvides, MD PhD MPH (Principal Investigator) Kirsten Limesand, PhD (co-Investigator) Denise Roe, DrPH (co-Investigator) Sun Yi, MD (co-Investigator) Julie Bauman, MD (co-Investigator) Daruka Mahadevan, MD PhD (co-Investigator) Version number: 1.2 Release date 06/22/2018 Referenced Investigator Brochure 15, release date 27-April-2016 Edition IRB NUMBER: PHXB-17-0072-70-15 IRB APPROVAL DATE: 07/03/2018 Confidential Page 2 Protocol No. Table of contents Table of contents..................................................................................................................2 List of figures.......................................................................................................................3 List of tables.........................................................................................................................3 List of abbreviations ............................................................................................................4 Glossary of terms.................................................................................................................6 Schema.................................................................................................................................8 1
    [Show full text]
  • Understanding Peptide Binding in Class a G Protein-Coupled Receptors
    Molecular Pharmacology Fast Forward. Published on July 10, 2019 as DOI: 10.1124/mol.119.115915 This article has not been copyedited and formatted. The final version may differ from this version. MOL# 115915 Understanding peptide binding in Class A G protein-coupled receptors Irina G. Tikhonova, Veronique Gigoux, Daniel Fourmy School of Pharmacy, Medical Biology Centre, Queen’s University Belfast, Belfast BT9 7BL, Northern Ireland, United Kingdom, (I.G.T.) INSERM ERL1226-Receptology and Therapeutic Targeting of Cancers, Laboratoire de Physique et Chimie des Nano-Objets, CNRS UMR5215-INSA, Université de Toulouse III, F- 31432 Toulouse, France. (V.G., D.F.) Downloaded from molpharm.aspetjournals.org Keywords: peptides, peptide GPCRs, peptide binding at ASPET Journals on September 30, 2021 1 Molecular Pharmacology Fast Forward. Published on July 10, 2019 as DOI: 10.1124/mol.119.115915 This article has not been copyedited and formatted. The final version may differ from this version. MOL# 115915 Running title page: Peptide Class A GPCRs Corresponding author: Irina G. Tikhonova School of Pharmacy, Medical Biology Centre, 97 Lisburn Road, Queen’s University Belfast, Belfast BT9 7BL, Northern Ireland, United Kingdom Email: [email protected] Tel: +44 (0)28 9097 2202 Downloaded from Number of text pages: 10 Number of figures: 3 molpharm.aspetjournals.org Number of references: 118 Number of tables: 2 Words in Abstract: 163 Words in Introduction: 503 Words in Concluding Remarks: 661 at ASPET Journals on September 30, 2021 ABBREVIATIONS: AT1,
    [Show full text]
  • Annual Report 2007 in Detail
    Annual Report 2007 In Detail WorldReginfo - 954f6161-6bac-48a4-873f-6ee9f4f1d49c Content WorldReginfo - 954f6161-6bac-48a4-873f-6ee9f4f1d49c 01 Marketed Products 04 Summary of Achievements 05 Tracleer® 06 Ventavis® 08 Zavesca® 08 02 Research & Development 10 Drug Discovery 11 Drug Discovery Platforms 11 Therapeutic Areas 12 Clinical Development 18 03 Our Strategy 27 04 Business Development 29 05 Financial Report 32 Corporate Governance 37 Consolidated Financial Statements 49 Holding Company Statements 78 03 WorldReginfo - 954f6161-6bac-48a4-873f-6ee9f4f1d49c 01 Marketed Products WorldReginfo - 954f6161-6bac-48a4-873f-6ee9f4f1d49c Summary of achievements Actelion’s strong commitment to expand Tracleer® into new indications is demonstrated by the comprehensive clini- Actelion continued its strong performance in 2007 and further cal trial program, including the COMPASS trials (combina- built its leadership position in pulmonary arterial hypertension tion therapy), BUILD 3 (idiopathic pulmonary fibrosis) and (PAH) with Tracleer® (bosentan) sales of CHF 1,18 billion, a FUTURE (pediatric indication). growth of 31% compared to the previous year (+32% in lo- cal currencies). This strong performance was seen in all re- Several marketing and life cycle activities were initiated for gions worldwide, including the United States, Europe, and Ventavis® in 2007 to enhance its profile and set it up for con- Japan in particular. It was also the first full year of marketing tinued success in 2008. Ventavis® (iloprost) after the acquisition of CoTherix in the United States. In an increasingly competitive PAH market, Zavesca® (miglustat), Actelion’s second global brand, gener- Ventavis® was able to contribute CHF 78.2 million to our PAH ated sales of CHF 35.3 million, a growth of 39% compared franchise revenues.
    [Show full text]
  • The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances" WHO/EMP/RHT/TSN/2013.1
    INN Working Document 18.435 31/05/2018 Addendum1 to "The use of stems in the selection of International Nonproprietary names (INN) for pharmaceutical substances" WHO/EMP/RHT/TSN/2013.1 Programme on International Nonproprietary Names (INN) Technologies Standards and Norms (TSN) Regulation of Medicines and other health technologies (RHT) World Health Organization, Geneva © World Health Organization 2018 - All rights reserved. The contents of this document may not be reviewed, abstracted, quoted, referenced, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means, without explicit prior authorization of the WHO INN Programme. This document contains the collective views of the INN Expert Group and does not necessarily represent the decisions or the stated policy of the World Health Organization. Addendum1 to "The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances" - WHO/EMP/RHT/TSN/2013.1 1 This addendum is a cumulative list of all new stems selected by the INN Expert Group since the publication of "The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances" 2013. ------------------------------------------------------------------------------------------------------------ -apt- aptamers, classical and mirror ones (a) avacincaptad pegol (113), egaptivon pegol (111), emapticap pegol (108), lexaptepid pegol (108), olaptesed pegol (109), pegaptanib (88) (b) -vaptan stem: balovaptan (116), conivaptan
    [Show full text]
  • A Multicentre Phase II Study of AZD1775 Plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
    Clinical Study Protocol AstraZeneca AZD1775 - D6010C00004 Version 10, 05 September 2018 Clinical Study Protocol Drug Substance AZD1775 Study Code D6010C00004 Version 10 Date 05 September 2018 A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Sponsor: AstraZeneca AB, 151 85 Södertälje, Sweden. EudraCT: 2015-000886-30 CONFIDENTIAL AND PROPRIETARY 1 of 153 Clinical Study Protocol AstraZeneca AZD1775 - D6010C00004 Version 10, 05 September 2018 VERSION HISTORY Version 10.0, 05 September 2018 (Amendment 9) Changes to the protocol are summarised below: ! Specified that patients still receiving AZD1775 after the primary data cut-off will have a Final Protocol Visit (FPV) occurring at their next scheduled visit focused on capturing safety information. Following the FPV, patients may continue to receive treatment with AZD1775 ± chemotherapy as deemed appropriate by the Investigator (see Table 2, footnote ‘bb’, Table 3, footnote ‘cc’, and Section 4.4). The end-of-study treatment visit is not required for patients continuing treatment after the FPV. ! Amended Section 5.6 to add clarification about optional tumour biopsies. ! Clarified that blood samples and optional tumour biopsies for exploratory biomarker research will be collected at treatment discontinuation due to disease progression for subjects that continue taking AZD1775 ± chemotherapy after the FPV (see Section 5.6). ! Clarified how SAEs will be reported after the FPV (see Section 6.4.1 and Section 6.5). ! Clarified that after the FPV pregnancies will be monitored while patients are on treatment and for 30 days after their final dose of AZD1775 ±chemotherapy (Section 6.7).
    [Show full text]
  • Nonpublication of Trial Results for New Neurological Drugs: a Systematic Review
    Nonpublication of Trial Results for New Neurological Drugs: A Systematic Review NOTE: This is an earlier version of the manuscript published in Annals of Neurology 2017. It contains information and data that editors/referees asked us to remove as a condition for acceptance. We strongly disagreed and therefore present those data in this version. Amanda K Hakala1, BSc, Dean Fergusson2, PhD, Jonathan Kimmelman1*, PhD 1 Studies of Translation, Ethics, and Medicine (STREAM), Biomedical Ethics Unit, McGill University, H3A 1X1, Montreal, Canada 2 Centre for Practice Changing Research, Ottawa Hospital Research Institute, University of Ottawa, K1H 8L6, Ottawa, Canada Corresponding author: Jonathan Kimmelman [email protected] (514) 398-3306 Abstract word count: 236 Introduction word count: 302 Discussion word count: 885 Total manuscript body word count: 2996 Number of figures: 3 Number of tables: 3 1 ABSTRACT Objective: To evaluate nonpublication rates among trials of new successful and unsuccessful neurological drugs. Methods: Our ‘licensed’ drug cohort consisted of all novel drugs receiving FDA licensure 2005 to 2012 inclusive in seven neurological disorders. Our cohort of ‘stalled’ drugs included all experimental agents tested in the same domains that had at least one completed phase III trial in the same timeframe but failed to receive FDA approval. Trials of these drugs were included in our sample if their primary outcome collection occurred before October 1, 2010. We determined the publication status of eligible trials using searches of clinicaltrials.gov, Google Scholar, PubMed, Embase, sponsor websites, and direct electronic query of trial contacts and sponsors. The primary outcome was journal publication (or results reporting in other media).
    [Show full text]
  • WO 2017/151816 Al 8 September 2017 (08.09.2017) P O P C T
    (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 WO 2017/151816 Al 8 September 2017 (08.09.2017) P O P C T (51) International Patent Classification: Gilead Apollo, LLC, 333 Lakeside Drive, Foster City, C07D 495/04 (2006.01) A61P 3/00 (2006.01) California 94404 (US). YANG, Xiaowei; c/o Gilead A61K 31/519 (2006.01) A61P 3/06 (2006.01) Apollo, LLC, 333 Lakeside Drive, Foster City, California 94404 (US). (21) International Application Number: PCT/US20 17/020271 (74) Agents: TANNER, Lorna L. et al; Sheppard Mullin Richter & Hampton LLP, 379 Lytton Avenue, Palo Alto, (22) Date: International Filing California 94301-1479 (US). 1 March 2017 (01 .03.2017) (81) Designated States (unless otherwise indicated, for every (25) Filing Language: English kind of national protection available): AE, AG, AL, AM, (26) Publication Language: English AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, (30) Priority Data: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, 62/302,755 2 March 2016 (02.03.2016) US HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, 62/303,237 3 March 2016 (03.03.2016) US KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, (71) Applicant: GILEAD APOLLO, LLC [US/US]; 333 MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, Lakeside Drive, Foster City, California 94404 (US).
    [Show full text]
  • The Use of Physiology-Based PK and PD Modeling in the Discovery of the Dual
    JPET Fast Forward. Published on June 29, 2017 as DOI: 10.1124/jpet.117.241596 This article has not been copyedited and formatted. The final version may differ from this version. JPET #241596 The use of physiology-based PK and PD modeling in the discovery of the dual orexin receptor antagonist ACT-541468 Alexander Treiber, Ruben de Kanter, Catherine Roch, John Gatfield, Christoph Boss, Markus von Raumer, Benno Schindelholz, Clemens Mühlan, Joop van Gerven, Francois Jenck Downloaded from Departments of Preclinical Drug Metabolism and Pharmacokinetics (A.T., R.d.K.), Preclinical Pharmacology (C.R, F.J.), Biology (J.G.), Chemistry (C.B.), Clinical Pharmacology (C.M.) jpet.aspetjournals.org and Preclinical Development (B.S., M.v.R.), Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland. Center for Human Drug Research, Leiden, The Netherlands (J.v.G). at ASPET Journals on September 23, 2021 1 JPET Fast Forward. Published on June 29, 2017 as DOI: 10.1124/jpet.117.241596 This article has not been copyedited and formatted. The final version may differ from this version. JPET #241596 Running title: Role of physiology-based modeling in ACT-541468 discovery Corresponding author: Alexander Treiber Idorsia Pharmaceuticals Ltd Hegenheimermattweg 91 4123 Allschwil Switzerland +41 61 565 65 92 (phone) Downloaded from +41 61 565 89 03 (fax) [email protected] jpet.aspetjournals.org Text pages: 46 Number of tables: 8 Number of figures: 10 at ASPET Journals on September 23, 2021 Number of references: 67 Abstract: 250 words Introduction: 817 words Discussion: 1630 words Recommended section assignment: Drug Discovery and Translational Medicine, Neuropharmacology Abbreviations: ADAM, advanced dissolution, absorption, and metabolism; ADME, absorption, distribution, metabolism, and excretion; AMS, accelerator mass spectrometry; ANOVA, analysis of variance; AUC, area under the plasma concentration vs.
    [Show full text]