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  1. Article ; Online: Commentary: "Emergency Use Authorization for Remdesivir: A Pediatric Perspective".

    Noel, Gary J / Connor, Edward

    The Pediatric infectious disease journal

    2020  Volume 39, Issue 9, Page(s) e234

    MeSH term(s) Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; Clinical Trials as Topic ; Emergency Treatment ; Humans ; Pediatrics ; United States ; United States Food and Drug Administration
    Chemical Substances Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
    Keywords covid19
    Language English
    Publishing date 2020-07-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 392481-6
    ISSN 1532-0987 ; 0891-3668
    ISSN (online) 1532-0987
    ISSN 0891-3668
    DOI 10.1097/INF.0000000000002799
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Neisseria gonorrhoeae

    Cardenas, Amaris J / Thomas, Keena S / Broden, Mary W / Ferraro, Noel J / Pires, Marcos M / John, Constance M / Jarvis, Gary A / Criss, Alison K

    mBio

    2024  , Page(s) e0011924

    Abstract: Gonorrhea, caused by the bacterium : Importance: Neisseria ... ...

    Abstract Gonorrhea, caused by the bacterium
    Importance: Neisseria gonorrhoeae
    Language English
    Publishing date 2024-04-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2557172-2
    ISSN 2150-7511 ; 2161-2129
    ISSN (online) 2150-7511
    ISSN 2161-2129
    DOI 10.1128/mbio.00119-24
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Neisseria gonorrhoeae

    Cardenas, Amaris J / Thomas, Keena S / Broden, Mary W / Ferraro, Noel J / John, Constance M / Pires, Marcos M / Jarvis, Gary A / Criss, Alison K

    bioRxiv : the preprint server for biology

    2024  

    Abstract: Gonorrhea, caused by the ... ...

    Abstract Gonorrhea, caused by the bacterium
    Language English
    Publishing date 2024-01-18
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2024.01.17.576097
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Book: Pediatric infectious diseases

    Noel, Gary J. / Stavola, Joseph J. / Schauf, Victoria

    a comprehensive guide to the subspecialty

    1997  

    Author's details Gary J. Noel ; Joseph J. Stavola ; Victoria Schauf
    Keywords Communicable Diseases / in infancy & childhood / outlines ; Communicable Diseases / examination questions
    Language English
    Size XIV, 361 S. : Ill., graph. Darst., Kt.
    Publisher Johns Hopkins Univ. Press
    Publishing place Baltimore u.a.
    Publishing country United States
    Document type Book
    HBZ-ID HT008085139
    ISBN 0-8018-5563-2 ; 0-8018-5564-0 ; 978-0-8018-5563-4 ; 978-0-8018-5564-1
    Database Catalogue ZB MED Medicine, Health

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  5. Article ; Online: Ensuring continued progress for development of COVID-19 therapeutics in children.

    Noel, Gary J / DeBiasi, Roberta L / Crandall, Wallace / Connor, Edward M

    Pediatric research

    2021  Volume 90, Issue 6, Page(s) 1112–1114

    MeSH term(s) Adolescent ; Age Factors ; Antiviral Agents/adverse effects ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; COVID-19/virology ; Child ; Drug Development ; Host-Pathogen Interactions ; Humans ; Patient Safety ; Risk Assessment ; Risk Factors ; SARS-CoV-2/drug effects ; SARS-CoV-2/pathogenicity ; Treatment Outcome
    Chemical Substances Antiviral Agents
    Language English
    Publishing date 2021-02-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 4411-8
    ISSN 1530-0447 ; 0031-3998
    ISSN (online) 1530-0447
    ISSN 0031-3998
    DOI 10.1038/s41390-021-01384-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Advancing Pediatric Antibacterial Drug Development: A Critical Need to Reinvent our Approach.

    Noel, Gary J / Nambiar, Sumathi / Bradley, John

    Journal of the Pediatric Infectious Diseases Society

    2018  Volume 8, Issue 1, Page(s) 60–62

    Abstract: The Clinical Trials Transformation Initiative convened with several groups in the pediatric antibacterial drug development community with the goal of identifying challenges and recommending ways to improve current practice. Attention to 5 major areas ... ...

    Abstract The Clinical Trials Transformation Initiative convened with several groups in the pediatric antibacterial drug development community with the goal of identifying challenges and recommending ways to improve current practice. Attention to 5 major areas hold the promise of making new antibiotics available for use in children as soon as possible after they are approved for use in adults.
    MeSH term(s) Anti-Bacterial Agents ; Child ; Clinical Protocols ; Clinical Trials as Topic ; Drug Development/organization & administration ; Drug Resistance, Bacterial ; Humans ; Informed Consent ; Research Design ; Stakeholder Participation ; United States
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2018-02-03
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2668791-4
    ISSN 2048-7207 ; 2048-7193
    ISSN (online) 2048-7207
    ISSN 2048-7193
    DOI 10.1093/jpids/piy001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Key clinical research priorities for the pediatric community during the COVID-19 pandemic.

    Noel, Gary J / Davis, Jonathan M / Ramilo, Octavio / Bradley, John S / Connor, Edward

    Pediatric research

    2020  Volume 89, Issue 4, Page(s) 730–732

    MeSH term(s) Adolescent ; COVID-19/epidemiology ; COVID-19/therapy ; COVID-19/virology ; Child ; Child, Preschool ; Humans ; Infant ; Infant, Newborn ; Pandemics ; Pediatrics ; Research ; SARS-CoV-2/isolation & purification
    Keywords covid19
    Language English
    Publishing date 2020-05-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 4411-8
    ISSN 1530-0447 ; 0031-3998
    ISSN (online) 1530-0447
    ISSN 0031-3998
    DOI 10.1038/s41390-020-0962-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Tolerability of Olaparib Combined with Abiraterone in Patients with Metastatic Castration-resistant Prostate Cancer: Further Results from the Phase 3 PROpel Trial.

    Saad, Fred / Armstrong, Andrew J / Oya, Mototsugu / Vianna, Karina / Özgüroğlu, Mustafa / Gedye, Craig / Buchschacher, Gary L / Lee, Ji Youl / Emmenegger, Urban / Navratil, Jiri / Virizuela, Juan Antonio / Salazar, Anibal / Maillet, Denis / Uemura, Hiroji / Kim, Jeri / Oscroft, Emma / Barker, Laura / Degboe, Arnold / Clarke, Noel W

    European urology oncology

    2024  

    Abstract: Background: The PROpel study (NCT03732820) demonstrated a statistically significant progression-free survival benefit with olaparib plus abiraterone versus placebo plus abiraterone in the first-line metastatic castration-resistant prostate cancer (mCRPC) ...

    Abstract Background: The PROpel study (NCT03732820) demonstrated a statistically significant progression-free survival benefit with olaparib plus abiraterone versus placebo plus abiraterone in the first-line metastatic castration-resistant prostate cancer (mCRPC) setting, irrespective of homologous recombination repair mutation status.
    Objective: We report additional safety analyses from PROpel to increase clinical understanding of the adverse-event (AE) profiles of olaparib plus abiraterone versus placebo plus abiraterone.
    Design, setting, and participants: A randomised (1:1), double-blind, placebo-controlled trial was conducted at 126 centres in 17 countries (October 2018-January 2020). Patients had mCRPC and no prior systemic mCRPC treatment.
    Intervention: Olaparib (300 mg bid) or placebo with abiraterone (1000 mg od) plus prednisone/prednisolone (5 mg bid).
    Outcome measurements and statistical analysis: The data cut-off date was July 30, 2021. Safety was assessed by AE reporting (Common Terminology Criteria for Adverse Events v4.03) and analysed descriptively.
    Results and limitations: The most common AEs (all grades) for olaparib plus abiraterone versus placebo plus abiraterone were anaemia (46.0% vs 16.4%), nausea (28.1% vs 12.6%), and fatigue (27.9% vs 18.9%). Grade ≥3 anaemia occurred in 15.1% versus 3.3% of patients in the olaparib plus abiraterone versus placebo plus abiraterone arm. The incidences of the most common AEs for olaparib plus abiraterone peaked early, within 2 mo, and were managed typically by dose modifications or standard medical practice. Overall, 13.8% versus 7.8% of patients discontinued treatment with olaparib plus abiraterone versus placebo plus abiraterone because of an AE; 3.8% versus 0.8% of patients discontinued because of anaemia. More venous thromboembolism events were observed in the olaparib plus abiraterone arm (any grade, 7.3%; grade ≥3, 6.8%) than in the placebo plus abiraterone arm (any grade, 3.3%; grade ≥3, 2.0%), most commonly pulmonary embolism (6.5% vs 1.8% for olaparib plus abiraterone vs placebo plus abiraterone).
    Conclusions: Olaparib plus abiraterone has a manageable and predictable safety profile.
    Patient summary: The PROpel trial showed that in patients who had not received any previous treatment for metastatic castration-resistant prostate cancer, olaparib combined with abiraterone was more effective in delaying progression of the disease than abiraterone alone. Most side effects caused by combining olaparib with abiraterone could be managed with supportive care methods, by pausing olaparib administration for a short period of time and/or by reducing the dose of olaparib.
    Language English
    Publishing date 2024-04-05
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2588-9311
    ISSN (online) 2588-9311
    DOI 10.1016/j.euo.2024.03.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Key clinical research priorities for the pediatric community during the COVID-19 pandemic

    Noel, Gary J / Davis, Jonathan M / Ramilo, Octavio / Bradley, John S / Connor, Edward

    Pediatr. res

    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #266076
    Database COVID19

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