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  1. Article ; Online: Gender Eligibility Descriptions for Clinical Trials-Reply.

    Mohan, Swapna / Tse, Tony

    JAMA

    2024  Volume 331, Issue 16, Page(s) 1416–1417

    MeSH term(s) Humans ; Clinical Trials as Topic/standards ; Female ; Male ; Patient Selection ; Eligibility Determination ; Sex Factors
    Language English
    Publishing date 2024-03-25
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2024.0692
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Shedding light on data monitoring committee charters on ClinicalTrials.gov.

    Fine, Anna M / Golfinopoulos, Elisa / Tse, Tony

    Clinical trials (London, England)

    2023  Volume 21, Issue 2, Page(s) 260–261

    MeSH term(s) Humans ; Clinical Trials Data Monitoring Committees
    Language English
    Publishing date 2023-11-04
    Publishing country England
    Document type Letter ; Research Support, N.I.H., Intramural ; Comment
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/17407745231203393
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5831: Show issues Location:
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  3. Article ; Online: Characterizing Gender Eligibility Descriptions for Clinical Trials Registered on ClinicalTrials.gov.

    Burton, Amanda / Mohan, Swapna / Puplampu-Dove, Yvonne / Tse, Tony

    JAMA

    2023  Volume 330, Issue 20, Page(s) 2019–2021

    MeSH term(s) Eligibility Determination ; Registries ; Research Design ; Sex Factors ; Clinical Trials as Topic
    Language English
    Publishing date 2023-11-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2023.19517
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Assessing the Turning Ability during Walking in People with Stroke Using L Test.

    Ng, Shamay S M / Tse, Mimi M Y / Chen, Peiming / Lam, Tony P S / Yeung, Tony H T / Liu, Tai-Wa / So, Billy C L

    International journal of environmental research and public health

    2023  Volume 20, Issue 4

    Abstract: Background: The L Test of Functional Mobility (L Test) was developed to assess the advanced mobility, which includes both turning and walking ability. This study aimed to evaluate (1) the intra-rater reliability of the L Test in four turning conditions, ...

    Abstract Background: The L Test of Functional Mobility (L Test) was developed to assess the advanced mobility, which includes both turning and walking ability. This study aimed to evaluate (1) the intra-rater reliability of the L Test in four turning conditions, (2) the correlation with other stroke-specific impairment for community-dwelling older adults with stroke, and (3) the optimal cut-off completion time of the L Test to distinguish the difference of performance between healthy older adults and people with stroke.
    Methods: This is a cross-sectional design. Thirty older adults with stroke and healthy older adults were included. The subjects were assessed by L Test along with other stroke-specific outcomes.
    Results: The L Test showed excellent intra-rater reliability (ICC = 0.945-0.978) for the four turning conditions. There were significant correlations between L Test completion times and Fugl-Meyer Assessment-Lower Extremity (FMA-LE) scores, Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores, Berg Balance Scale (BBS) score, and Timed Up and Go (TUG) Test scores. The cut-off of the L Test was established as 23.41-24.13 s.
    Conclusion: The L Test is an easy-to-administer clinical test for assessing the turning ability of people with stroke.
    MeSH term(s) Humans ; Aged ; Stroke Rehabilitation ; Reproducibility of Results ; Cross-Sectional Studies ; Disability Evaluation ; Stroke ; Walking ; Postural Balance
    Language English
    Publishing date 2023-02-17
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2175195-X
    ISSN 1660-4601 ; 1661-7827
    ISSN (online) 1660-4601
    ISSN 1661-7827
    DOI 10.3390/ijerph20043618
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type.

    Nelson, Julianne T / Tse, Tony / Puplampu-Dove, Yvonne / Golfinopoulos, Elisa / Zarin, Deborah A

    JAMA

    2023  Volume 329, Issue 16, Page(s) 1404–1406

    MeSH term(s) Clinical Trials as Topic/economics ; Clinical Trials as Topic/standards ; Databases, Factual ; Information Sources/economics ; Information Sources/standards ; Publishing/economics ; Publishing/standards ; PubMed ; Registries ; Research Support as Topic ; Disclosure/standards
    Language English
    Publishing date 2023-03-30
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2023.2351
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.

    Gelinas, Luke / Morrell, Walker / Tse, Tony / Glazier, Ava / Zarin, Deborah A / Bierer, Barbara E

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e185

    Abstract: Introduction: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We ... ...

    Abstract Introduction: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov.
    Methods: We downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (
    Results: Of the 102 trial records, 76 had identifiable KI sections that were, on average, 10% of the total length of full ICF documents. KI readability grade level was not notably different from other sections of ICFs. Most KI sections were distinguished by section headers and included lists but contained few other formatting elements. Most KI sections included a subset of topics consistent with the basic elements of informed consent specified in the Common Rule.
    Conclusion: Many of the KI sections in the study sample aligned with practices suggested in the preamble to the revised Common Rule. Further, our results suggest that some KI sections were tailored in study-specific ways. Nevertheless, guidelines on how to write concise and comprehensible KI sections would improve the utility and readability of KI sections.
    Language English
    Publishing date 2023-08-14
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.605
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Translating mesenchymal stem cell and their exosome research into GMP compliant advanced therapy products: Promises, problems and prospects.

    Ma, Chui-Yan / Zhai, Yuqing / Li, Chung Tony / Liu, Jie / Xu, Xiang / Chen, Hao / Tse, Hung-Fat / Lian, Qizhou

    Medicinal research reviews

    2023  Volume 44, Issue 3, Page(s) 919–938

    Abstract: Mesenchymal stem cells (MSCs) are one of the few stem cell types used in clinical practice as therapeutic agents for immunomodulation and ischemic tissue repair, due to their unique paracrine capacity, multiple differentiation potential, active ... ...

    Abstract Mesenchymal stem cells (MSCs) are one of the few stem cell types used in clinical practice as therapeutic agents for immunomodulation and ischemic tissue repair, due to their unique paracrine capacity, multiple differentiation potential, active components in exosomes, and effective mitochondria donation. At present, MSCs derived from tissues such as bone marrow and umbilical cord are widely applied in preclinical and clinical studies. Nevertheless, there remain challenges to the maintenance of consistently good quality MSCs derived from different donors or tissues, directly impacting their application as advanced therapy products. In this review, we discuss the promises, problems, and prospects associated with translation of MSC research into a pharmaceutical product. We review the hurdles encountered in translation of MSCs and MSC-exosomes from the research bench to an advanced therapy product compliant with good manufacturing practice (GMP). These difficulties include how to set up GMP-compliant protocols, what factors affect raw material selection, cell expansion to product formulation, establishment of quality control (QC) parameters, and quality assurance to comply with GMP standards. To avoid human error and reduce the risk of contamination, an automatic, closed system that allows real-time monitoring of QC should be considered. We also highlight potential advantages of pluripotent stem cells as an alternative source for MSC and exosomes generation and manufacture.
    MeSH term(s) Humans ; Exosomes ; Cell Differentiation ; Mesenchymal Stem Cells ; Stem Cells ; Cell Proliferation
    Language English
    Publishing date 2023-12-14
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 603210-2
    ISSN 1098-1128 ; 0198-6325
    ISSN (online) 1098-1128
    ISSN 0198-6325
    DOI 10.1002/med.22002
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    Zs.A 1764: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (1.OG)
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  8. Article ; Online: Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.

    Tse, Tony / White, Sarah / Gelinas, Luke / Morrell, Walker / Bierer, Barbara / Zarin, Deborah A

    JAMA network open

    2021  Volume 4, Issue 11, Page(s) e2135146

    MeSH term(s) Clinical Trials as Topic/economics ; Clinical Trials as Topic/statistics & numerical data ; Consent Forms/statistics & numerical data ; Consent Forms/trends ; Cross-Sectional Studies ; Forecasting ; Humans ; Informed Consent/statistics & numerical data ; Research Support as Topic/statistics & numerical data ; Research Support as Topic/trends ; United States
    Language English
    Publishing date 2021-11-01
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Intramural
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2021.35146
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  9. Article ; Online: Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS).

    Zarin, Deborah A / Tse, Tony

    PLoS medicine

    2016  Volume 13, Issue 1, Page(s) e1001946

    MeSH term(s) Clinical Trials as Topic/methods ; Clinical Trials as Topic/standards ; Databases, Factual/standards ; Drug Industry/methods ; Drug Industry/standards ; Humans ; Information Dissemination/methods
    Language English
    Publishing date 2016-01
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Intramural ; Review
    ZDB-ID 2185925-5
    ISSN 1549-1676 ; 1549-1277
    ISSN (online) 1549-1676
    ISSN 1549-1277
    DOI 10.1371/journal.pmed.1001946
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    Zs.A 6042: Show issues Location:
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  10. Article ; Online: Trialists' Intent to Share Individual Participant Data as Disclosed at ClinicalTrials.gov.

    Bergeris, Annice / Tse, Tony / Zarin, Deborah A

    JAMA

    2018  Volume 319, Issue 4, Page(s) 406–408

    MeSH term(s) Clinical Trials as Topic ; Databases, Factual ; Disclosure ; Humans ; Information Dissemination ; Intention ; Research Personnel
    Language English
    Publishing date 2018-01-20
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Intramural
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2017.20581
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