313 Needs Assessment for an Infant and Toddler Food Allergy
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Pediatric Institute & Cleveland Clinic Children's
Pediatric Institute & Cleveland Clinic Children’s This project would not have been possible without the commitment and expertise of a team led by Dr. Vera Hupertz, Anne Shi, and Allan Cohn. Graphic design and photography were provided by Cleveland Clinic’s Center for Medical Art and Photography. © The Cleveland Clinic Foundation 2017 9500 Euclid Avenue, Cleveland, OH 44195 clevelandclinic.org 2016 Outcomes 17-OUT-420 108373_CCFBCH_17OUT420_ACG.indd 1-3 9/7/17 1:42 PM Measuring Outcomes Promotes Quality Improvement Clinical Trials Cleveland Clinic is running more than 2200 clinical trials at any given time for conditions including breast and liver cancer, coronary artery disease, heart failure, epilepsy, Parkinson disease, chronic obstructive pulmonary disease, asthma, high blood pressure, diabetes, depression, and eating disorders. Cancer Clinical Trials is a mobile app that provides information on the more than 200 active clinical trials available to cancer patients at Cleveland Clinic. clevelandclinic.org/cancertrialapp Healthcare Executive Education Cleveland Clinic has programs to share its expertise in operating a successful major medical center. The Executive Visitors’ Program is an intensive, 3-day behind-the-scenes view of the Cleveland Clinic organization for the busy executive. The Samson Global Leadership Academy is a 2-week immersion in challenges of leadership, management, and innovation taught by Cleveland Clinic leaders, administrators, and clinicians. Curriculum includes coaching and a personalized 3-year leadership development plan. clevelandclinic.org/executiveeducation Consult QD Physician Blog A website from Cleveland Clinic for physicians and healthcare professionals. Discover the latest research insights, innovations, treatment trends, and more for all specialties. consultqd.clevelandclinic.org Social Media Cleveland Clinic uses social media to help caregivers everywhere provide better patient care. -
Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models. -
Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products. -
Atopic Dermatitis (AD)
This activity is provided by PRIME Education. There is no fee to participate. This activity is supported by education grants from AbbVie, Inc., Sanofi Genzyme and Regeneron Pharmaceuticals. © 2019 PRIME® Education, LLC. All Rights Reserved.. Overview This downloadable fact‐sheet provides an easy‐to‐follow collection of the latest evidence shaping the treatment and management of psoriasis (PsO) and atopic dermatitis (AD). Learn about validated tools, evidence‐based strategies, and new and emerging targeted therapies that can be incorporated in daily practice to improve outcomes for patients with these conditions. © 2019 PRIME® Education, LLC. All Rights Reserved.. 2 1 Learning Objectives • Identify major barriers to evidence‐based treatment and management in federal and public sectors • Implement appropriate methods for diagnosis and assessment of disease activity • Assess current evidence on targeted biologic and small‐molecule therapies to guide treatment decisions for patients with moderate to severe disease • Monitor treatment responses according to treat‐to‐target principles and methods • Apply current evidence and guidelines to inform treatment decisions for patients with inadequate responses to initial therapies • Incorporate patient‐reported outcomes and shared decision‐making into clinical practice • Apply effective strategies for multidisciplinary care coordination and shared patient management © 2019 PRIME® Education, LLC. All Rights Reserved.. 3 Accreditation In support of improving patient care, PRIME® is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 2.25 Interprofessional Continuing Education (IPCE) credits for learning and change. -
Smoldering Inflammation in Cardio-Immune-Metabolic Disorders
EDITORIAL published: 19 March 2021 doi: 10.3389/fphys.2021.651946 Editorial: Smoldering Inflammation in Cardio-Immune-Metabolic Disorders Gilda Varricchi 1,2,3*, Nazareno Paolocci 4,5, Felice Rivellese 6 and Giuseppe Rengo 1,7 1 Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy, 2 Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy, 3 Institute of Experimental Endocrinology and Oncology (IEOS), National Research Council, Naples, Italy, 4 Division of Cardiology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States, 5 Department of Biomedical Sciences, University of Padova, Padova, Italy, 6 Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom, 7 Istituti Clinici Scientifici Maugeri SpA Società Benefit, Telese Terme, Italy Keywords: allergic disorders, diabetes, obesity, low grade inflammation, sinovitis, IL-5, mast cells, Alzheimer’s disease Editorial on the Research Topic Smoldering Inflammation in Cardio-Immune-Metabolic Disorders “If many remedies are prescribed for an illness, you may be certain that the illness has no cure.” Anton Chekhov - The Cherry Orchard - Smoldering or low-grade inflammation plays a pivotal role in both physiological and pathological conditions (Calder et al., 2017; Zelechowska et al., 2018; Ronnback and Hansson, 2019). Aging is accompanied by -
Increasing Prevalence of Bronchial Hyperresponsiveness in Three Selected Areas in East Germany
Copyright #ERS Journals Ltd 2001 Eur Respir J 2001; 18: 451–458 European Respiratory Journal Printed in UK – all rights reserved ISSN 0903-1936 Increasing prevalence of bronchial hyperresponsiveness in three selected areas in East Germany C. Frye*, J. Heinrich*, M. Wjst*, H-E. Wichmann*,#, for the Bitterfeld study group Increasing prevalence of bronchial hyperresponsiveness in three selected areas in East *GSF - Forschungszentrum fu¨r Um- Germany. C. Frye, J. Heinrich, M. Wjst, H-E. Wichmann, for the Bitterfeld study welt und Gesundheit, Institut fur # Epidemiologie, Ingolstaedter Land- group. ERS Journals Ltd 2001. # ABSTRACT: The prevalence of asthma, bronchial hyperresponsiveness (BHR) and strabe 1, Neuherberg, Germany. Lehr- stuhl fu¨r Epidemiologie, Institut fu¨r allergic rhinitis in children was lower in East Germany compared to West Germany. medizinische Informationsverarbei- The reasons for this difference are still not understood. This study tested the hypothesis tung, Biometrie und Epidemiologie that prevalence of BHR increased in East German children after reunification. der Ludwig-Maximilians-Universita¨t Two consecutive cross-sectional surveys of schoolchildren aged 8–14 yrs from three Mu¨nchen, Neuherberg, Germany. communities in East Germany were carried out in 1992–1993 and 1995–1996. A subsample of 530 and 790 children with complete lung function and cold air challenge Correspondence: J. Heinrich, GSF - data was analysed. Forschungszentrum fu¨r Umwelt und The prevalence of BHR increased from 6.4% in 1992–1993 to 11.6% in 1995–1996 Gesundheit, Institut fur Epidemiologie, Ingolstaedter Landstrabe 1, D-85764 (odds ratio (OR): 2.0, 95% confidence interval (CI): 1.3–3.0, adjusted for age, sex, Neuherberg, Germany. -
Environmental Determinants of Allergy and Asthma in Early Life
Clinical reviews in allergy and immunology Environmental determinants of allergy and asthma in early life Allison J. Burbank, MD,* Amika K. Sood, MD,* Matthew J. Kesic, PhD, David B. Peden, MD, MS, and Michelle L. Hernandez, MD Chapel Hill, NC INFORMATION FOR CATEGORY 1 CME CREDIT Credit can now be obtained, free for a limited time, by reading the review List of Design Committee Members: Allison J. Burbank, MD, Amika articles in this issue. Please note the following instructions. K. Sood, MD, Matthew J. Kesic, PhD, David B. Peden, MD, MS, and Mi- Method of Physician Participation in Learning Process: The core ma- chelle L. Hernandez, MD terial for these activities can be read in this issue of the Journal or online at Disclosure of Significant Relationships with Relevant Commercial the JACI Web site: www.jacionline.org. The accompanying tests may only Companies/Organizations: M. L. Hernandez has received grants from be submitted online at www.jacionline.org. Fax or other copies will not be the American Academy of Allergy, Asthma & Immunology Foundation. accepted. The rest of the authors declare that they have no relevant conflicts of interest. Date of Original Release: July 2017. Credit may be obtained for these Activity Objectives: courses until June 30, 2018. 1. To describe the effect of microbial exposure and childhood infec- Ó Copyright Statement: Copyright 2017-2018. All rights reserved. tions on the risk of allergic disease. Overall Purpose/Goal: To provide excellent reviews on key aspects 2. To understand the link between indoor allergen exposure and the risk of allergic disease to those who research, treat, or manage allergic of atopy. -
Food Allergy in Children and Young People Diagnosis and Assessment of Food Allergy in Children and Young People in Primary Care and Community Settings
Issue date: February 2011 Food allergy in children and young people Diagnosis and assessment of food allergy in children and young people in primary care and community settings NICE clinical guideline 116 Developed by the Centre for Clinical Practice at NICE Update information Minor changes since publication October 2018: After a surveillance review, links to other NICE guidance have been updated as needed and new links added in some recommendations. Some terminology has also been updated. These changes can be seen in the short version of the guideline at http://www.nice.org.uk/guidance/cg116 NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales. This guidance represents the view of NICE, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering. Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. -
Looking for Therapeutic Antibodies in Next Generation Sequencing Repositories
bioRxiv preprint doi: https://doi.org/10.1101/572958; this version posted March 10, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. Title: Looking for Therapeutic Antibodies in Next Generation Sequencing Repositories. Authors: Konrad Krawczyk1*, Matthew Raybould2, Aleksandr Kovaltsuk2, Charlotte M. Deane2 1 NaturalAntibody, Hamburg, Germany 2 Oxford University Department of Statistics, Oxford, UK *Correspondence to [email protected] Abstract: Recently it has become possible to query the great diversity of natural antibody repertoires using Next Generation Sequencing (NGS). These methods are capable of producing millions of sequences in a single experiment. Here we compare Clinical Stage Therapeutic antibodies to the ~1b sequences from 60 independent sequencing studies in the Observed Antibody Space Database. Of the 242 post Phase I antibodies, we find 16 with sequence identity matches of 95% or better for both heavy and light chains. There are also 54 perfect matches to therapeutic CDR-H3 regions in the NGS outputs, suggesting a nontrivial amount of convergence between naturally observed sequences and those developed artificially. This has potential implications for both the discovery of antibody therapeutics and the legal protection of commercial antibodies. Introduction Antibodies are proteins in jawed vertebrates that recognize noxious molecules (antigens) for elimination. An organism expresses millions of diverse antibodies to increase the chances that some of them will be able to bind the foreign antigen, initiating the adaptive immune response. -
What You Need to Know About the New Guidelines for the Diagnosis and Management of Food Allergy in the U.S
Allergy guidelines insert_Layout 1 9/26/11 1:36 PM Page 1 What you need to know about the new guidelines for the diagnosis and management of food allergy in the U.S. V OLUME 126, N O . 6 D ECEMBER 2010 • Tests for food-specific IgE are recom- Overview www.jacionline.org • The Guidelines, sponsored by the NIH Supplement to mended to assist in diagnosis, but should (NIAID), are based upon expert opinion THE JOURNAL OF not be relied upon as a sole means to di- Allergy ANDClinical and a comprehensive literature review. Immunology agnose food allergy. The medical history/ AAP had input on the document.1,2 exam are recommended to aid in diag- nosis. A medically monitored feeding Guidelines for the Diagnosis and Management Definitions of Food Allergy in the United States: Report of the (food challenge) is considered the most NIAID-Sponsored Expert Panel • Food allergy was defined as an adverse definitive test for food allergy. health effect arising from a specific im- • Food-specific IgE testing has numerous mune response. limitations; positive tests are not intrin- • Food allergies result in IgE-mediated sically diagnostic and reactions some- immediate reactions (e.g., anaphylaxis) OFFICIAL JOURNAL OF times occur with negative tests. These and several chronic diseases (e.g., ente- Supported by the Food Allergy Initiative issues are also reviewed in an AAP Clini - rocolitis syndromes, eosinophilic esopha - cal Report.3 Testing “food panels” with- gitis, etc), in which IgE may not play an important role. out considering history is often mis - leading. Tests selected to evaluate food allergy should be Epidemiology and Natural History based on the patient’s medical history and not comprise • Food allergy is more common in children than adults, large general panels of food allergens. -
The Two Tontti Tudiul Lui Hi Ha Unit
THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int . -
Asthma in Children
ISSN: 2573 - 9611 Research article Journal of Pediatrics & Neonatal Biology Asthma in Children Siniša Franjić Independent Researcher *Corresponding author Siniša Franjić, Independent Researcher Submitted: 29 Jan 2021; Accepted: 07 Feb 2021; Published: 12 Feb 2021 Citation : Siniša Franjić (2021) Asthma in Children J Pediatr Neonatal Biol, 6: 01-04 Abstract Asthma is one of the most common chronic diseases of the airways, characterized by allergic inflammation in the air- ways, often as a result of exposure to allergens, cold air, tobacco smoke, exercise, or emotional stress. The most common asthma symptoms in children are: cough, shortness of breath with wheezing, chest pressure and shortness of breath. Asthma is an incurable disease, but its symptoms, which range from mild to life-threatening, can be controlled with medication and lifestyle, thus ensuring a full and normal life for the child. Keywords: Asthma, Disease, Children, Management Introduction Asthma is a disorder affecting conducting airways in which in- Asthma is a condition characterised by airway obstruction due to flammation interacts with structural changes to cause variable air- bronchial smooth muscle constriction and inflammation that is at flow limitation [3]. Conventional treatment of established asthma least partly reversible [1]. Any asthmatic is susceptible to suffering is highly effective in controlling symptoms and improving quality from an exacerbation (‘asthma attack’), which may be caused by of life. With the possible exception of immunotherapy, however, allergic triggers (e.g. pollen, mould), respiratory infection, med- no treatment has been shown to modify long-term outcomes and ications (e.g. NSAIDs or β-blockers) or lack of compliance with no cure has been identified.