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  1. Article ; Online: Interpretation of Guidance for the Design and Implementation of Drug Clinical Studies

    BAI Xiaoyin / YANG Hong

    Xiehe Yixue Zazhi, Vol 14, Iss 1, Pp 81-

    Based on E8 (R1): General Considerations for Clinical Trials

    2023  Volume 85

    Abstract: As clinical research and drug development in China continue to advance, greater attention has been paid to the value of clinical research guidelines. The first revision of the original E8 recommendations (R1), 'General Considerations for Clinical ... ...

    Abstract As clinical research and drug development in China continue to advance, greater attention has been paid to the value of clinical research guidelines. The first revision of the original E8 recommendations (R1), 'General Considerations for Clinical Research' was made by the International Council for Harmonization in October 2021. Our National Medical Products Administration has recently opted to implement the rules beginning from July 2023. In order to provide useful references for improved design and execution of drug clinical studies in China, this paper primarily interprets the fundamental background and revision of E8 (R1) from the perspective of clinical workers. It also analyzes and discusses the application of the current clinical study guidelines in China.
    Keywords drug research and development ; clinical research ; guideline ; study design ; interpretation ; Medicine ; R
    Subject code 610
    Language Chinese
    Publishing date 2023-01-01T00:00:00Z
    Publisher Editorial Office of Medical Journal of Peking Union Medical College Hospital
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Antioxidant, selenium and risk of nonalcoholic fatty liver disease, more than causality.

    Mi, Jiarui / Wang, Fang / Liu, Zhengye / Bai, Xiaoyin

    Hepatology international

    2023  Volume 18, Issue 1, Page(s) 289–291

    MeSH term(s) Humans ; Non-alcoholic Fatty Liver Disease ; Antioxidants/therapeutic use ; Selenium
    Chemical Substances Antioxidants ; Selenium (H6241UJ22B)
    Language English
    Publishing date 2023-02-23
    Publishing country United States
    Document type Letter
    ZDB-ID 2270316-0
    ISSN 1936-0541 ; 1936-0533
    ISSN (online) 1936-0541
    ISSN 1936-0533
    DOI 10.1007/s12072-023-10500-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Comparative effectiveness and safety of ustekinumab at different intervals of maintenance phase in inflammatory bowel disease: a systematic review and meta-analysis.

    Bai, Yaqing / Sun, Yinghao / He, Qi / Bai, Xiaoyin / Yang, Hong

    European journal of gastroenterology & hepatology

    2024  Volume 36, Issue 4, Page(s) 359–370

    Abstract: Ustekinumab has two alternative drug maintenance intervals for inflammatory bowel disease (IBD), every 8 weeks (Q8W) and every 12 weeks (Q12W). The current study aimed at evaluating the comparative efficacy and safety of the two maintenance intervals in ... ...

    Abstract Ustekinumab has two alternative drug maintenance intervals for inflammatory bowel disease (IBD), every 8 weeks (Q8W) and every 12 weeks (Q12W). The current study aimed at evaluating the comparative efficacy and safety of the two maintenance intervals in patients with IBD. A systematic search on PubMed, Web of Science, Cochrane Library, and EMBASE was carried out. The relative risk (RR) was pooled for efficacy and safety outcomes between the two intervals at various follow-up time points, categorized as short term (less than 44 weeks), medium term (about 92 weeks), and long term (about 152 weeks). A total of 14 studies with 1448 patients were included. Q8W didn't result in a remarkably higher proportion of clinical remission compared to Q12W at short term (RR, 0.99; 95% CI, 0.83-1.16), medium term (RR, 1.05; 95% CI, 0.91-1.20), and long term (RR, 1.07; 95% CI, 0.91-1.26). Similarly, no substantial differences exist at short term in clinical response (RR, 1.00; 95% CI, 0.85-1.17), endoscopic remission (RR, 0.97; 95% CI, 0.26-3.69), and histologic improvement (RR, 1.13; 95% CI, 0.93-1.36) between the two intervals. For safety outcomes, the RR values for any adverse events in the short, medium, and long term were 1.10 (95% CI, 1.00-1.21), 1.14 (95% CI, 1.08-1.20), and 1.12 (95% CI, 1.07-1.17) for Q8W versus Q12W. Finally, we conclude that ustekinumab maintenance therapy administered every 8 and 12 weeks showed similar effectiveness in achieving efficacy outcomes in IBD patients, and most safety outcomes were significantly better for Q12W during the maintenance phase.
    MeSH term(s) Humans ; Ustekinumab/adverse effects ; Crohn Disease/drug therapy ; Remission Induction ; Inflammatory Bowel Diseases/drug therapy ; Chemoprevention
    Chemical Substances Ustekinumab (FU77B4U5Z0)
    Language English
    Publishing date 2024-02-16
    Publishing country England
    Document type Meta-Analysis ; Systematic Review ; Journal Article
    ZDB-ID 1034239-4
    ISSN 1473-5687 ; 0954-691X
    ISSN (online) 1473-5687
    ISSN 0954-691X
    DOI 10.1097/MEG.0000000000002718
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 2932: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (2.OG)
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  4. Article: Spatial Shifts of Reflected Light Beam on Hexagonal Boron Nitride/Alpha-Molybdenum Trioxide Structure.

    Bai, Song / Li, Yubo / Cui, Xiaoyin / Fu, Shufang / Zhou, Sheng / Wang, Xuanzhang / Zhang, Qiang

    Materials (Basel, Switzerland)

    2024  Volume 17, Issue 7

    Abstract: This investigation focuses on the Goos-Hänchen (GH) and Imbert-Fedorov (IF) shifts on the surface of the uniaxial hyperbolic material hexagonal boron nitride (hBN) based on the biaxial hyperbolic material alpha-molybdenum (α- ... ...

    Abstract This investigation focuses on the Goos-Hänchen (GH) and Imbert-Fedorov (IF) shifts on the surface of the uniaxial hyperbolic material hexagonal boron nitride (hBN) based on the biaxial hyperbolic material alpha-molybdenum (α-MoO
    Language English
    Publishing date 2024-04-02
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2487261-1
    ISSN 1996-1944
    ISSN 1996-1944
    DOI 10.3390/ma17071625
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: The culprit of turbulent lower gastrointestinal bleeding: The appendiceal ulcer.

    Liu, Zhaoshi / Hou, Rui / Bai, Xiaoyin

    Asian journal of surgery

    2022  Volume 45, Issue 12, Page(s) 2761–2762

    MeSH term(s) Humans ; Ulcer/complications ; Appendix/surgery ; Gastrointestinal Hemorrhage/etiology ; Gastrointestinal Hemorrhage/surgery
    Language English
    Publishing date 2022-06-16
    Publishing country China
    Document type Letter
    ZDB-ID 1068461-x
    ISSN 0219-3108 ; 1015-9584
    ISSN (online) 0219-3108
    ISSN 1015-9584
    DOI 10.1016/j.asjsur.2022.06.023
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.B 2831: Show issues Location:
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  6. Article ; Online: A remote attack to the distal colon from the acute necrotizing pancreatitis.

    Bai, Xiaoyin / Zou, Linfeng / Wang, Qiang / Yang, Aiming

    Asian journal of surgery

    2022  Volume 46, Issue 3, Page(s) 1307–1308

    MeSH term(s) Humans ; Pancreatitis, Acute Necrotizing/diagnosis ; Pancreatitis, Acute Necrotizing/surgery ; Colon/surgery
    Language English
    Publishing date 2022-08-27
    Publishing country China
    Document type Letter
    ZDB-ID 1068461-x
    ISSN 0219-3108 ; 1015-9584
    ISSN (online) 0219-3108
    ISSN 1015-9584
    DOI 10.1016/j.asjsur.2022.08.080
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.B 2831: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    ab Jg. 2022: Lesesaal (EG)

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  7. Article: Neostigmine for non-mild acute pancreatitis: A systematic review and meta-analysis of randomized controlled trials.

    He, Kun / Wang, Yabing / Li, Jianing / Bai, Xiaoyin / Yang, Zihan / Han, Xianlin / Wu, Dong

    Frontiers in pharmacology

    2023  Volume 14, Page(s) 1131974

    Abstract: Background: ...

    Abstract Background:
    Language English
    Publishing date 2023-02-28
    Publishing country Switzerland
    Document type Systematic Review
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2023.1131974
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Pancreatic carcinoma disguised as type 1 autoimmune pancreatitis with a mass-forming appearance: a clinical dilemma.

    Yan, Zhiyu / Chang, Xiaoyan / Bai, Xiaoyin / Han, Xianlin / Feng, Yunlu / Yang, Aiming

    Hepatobiliary surgery and nutrition

    2023  Volume 12, Issue 6, Page(s) 997–1000

    Language English
    Publishing date 2023-11-15
    Publishing country China (Republic : 1949- )
    Document type Case Reports
    ZDB-ID 2812398-0
    ISSN 2304-389X ; 2304-3881
    ISSN (online) 2304-389X
    ISSN 2304-3881
    DOI 10.21037/hbsn-23-436
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  9. Article ; Online: ST2 and CSF‐1 as potential druggable targets of inflammatory bowel diseases

    Jiarui Mi / Xia Wu / Xiaoyin Bai / Yang Yang / Hong Yang

    Clinical and Translational Science, Vol 16, Iss 2, Pp 236-

    Results from two‐sample Mendelian randomization study

    2023  Volume 245

    Abstract: Abstract Novel druggable targets are warranted for inflammatory bowel disease (IBD) treatment. We aimed to identify novel circulating proteins with causal associations with the risk of IBDs and provide potential therapeutic targets for IBD treatment. We ... ...

    Abstract Abstract Novel druggable targets are warranted for inflammatory bowel disease (IBD) treatment. We aimed to identify novel circulating proteins with causal associations with the risk of IBDs and provide potential therapeutic targets for IBD treatment. We performed a two‐sample Mendelian randomization (MR) study to explore the associations of 55 circulating biomarkers on the risk of IBD, Crohn's disease (CD), and ulcerative colitis (UC) by leveraging the summary statistics from large genomewide association studies and protein quantitative trait loci studies. The individual estimate was pooled together by meta‐analyses to estimate the causal effects of each outcome. In univariable MR, we identified several circulating proteins showed potential correlation with IBD, UC, and CD. Of note, we observed that a genetically proxied increased level of suppression of tumorigenicity 2 (ST2) was associated with an elevated risk of IBD (odds ratios [ORs] 1.133, 95% confidence interval [CI] 1.091–1.176, p < 0.0001), CD (ORs 1.188, 95% CI 1.103–1.281, p < 0.0001), and UC cohorts (ORs 1.087, 95% CI 1.050–1.125, p < 0.0001). Additionally, we observed a consistent positive correlation between the level of CSF‐1 and the increased risk of IBD in individual MR, with statistically significant causal associations in the meta‐analyses with ORs equal to 1.217 (IBD, 95% CI 1.115–1.328, p < 0.0001), 1.223 (CD, 95% CI 1.082–1.382, p = 0.0013), and 1.179 (UC, 95% CI 1.055–1.317, p = 0.0037). This study provided evidence for potential casual associations between circulating ST2 and CSF‐1 levels, and increased risks of IBD, UC, and CD, implicating potential treatment targets for IBD and subtypes.
    Keywords Therapeutics. Pharmacology ; RM1-950 ; Public aspects of medicine ; RA1-1270
    Subject code 610
    Language English
    Publishing date 2023-02-01T00:00:00Z
    Publisher Wiley
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: One-step preparation of lignin-based magnetic biochar as bifunctional material for the efficient removal of Cr(VI) and Congo red: Performance and practical application.

    Sun, Yongchang / Wang, Tingting / Han, Caohui / Bai, Lu / Sun, Xiaoyin

    Bioresource technology

    2022  Volume 369, Page(s) 128373

    Abstract: The lignin-based magnetic biochar (LMB) was fabricated with a facile one-step solvothermal method. The spherical ... ...

    Abstract The lignin-based magnetic biochar (LMB) was fabricated with a facile one-step solvothermal method. The spherical Fe
    Language English
    Publishing date 2022-11-21
    Publishing country England
    Document type Journal Article
    ZDB-ID 1065195-0
    ISSN 1873-2976 ; 0960-8524
    ISSN (online) 1873-2976
    ISSN 0960-8524
    DOI 10.1016/j.biortech.2022.128373
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Bonn / Germany

    Z 3258: Show issues

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