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  • 1
    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 22, No. 6 ( 2020-6-2), p. e18938-
    Abstract: The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. Objective The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. Methods We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. Results We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. Conclusions We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.
    Type of Medium: Online Resource
    ISSN: 1438-8871
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2020
    detail.hit.zdb_id: 2028830-X
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  • 2
    In: International Archives of Allergy and Immunology, S. Karger AG, Vol. 141, No. 3 ( 2006), p. 281-289
    Abstract: 〈 i 〉 Background: 〈 /i 〉 〈 i 〉 Staphylococcus aureus 〈 /i 〉 -producing superantigens (SAgs), such as staphylococcal enterotoxin B (SEB) or toxic shock syndrome toxin-1 (TSST-1), are frequently observed in atopic dermatitis (AD). However, little has been done to establish the association of immune responses to SAgs and the therapeutic response to immunosuppressive drugs in AD. Therefore, we investigated the prevalence and role of SAgs in the pathophysiology and immunosuppressive drug sensitivity in AD patients. 〈 i 〉 Methods: 〈 /i 〉 We classified 29 patients into two groups on the basis of their clinical AD scores: a low-score group (n = 14) corresponding to mild to moderate patients and a high-score group (n = 15) corresponding to severe patients. We estimated the plasma anti-SEB or TSST-1 IgE of these patients and healthy subjects by ELISA. We also estimated individual drug sensitivity by determining drug concentrations that would give 50% inhibition (IC 〈 sub 〉 50 〈 /sub 〉 ) of peripheral-blood mononuclear cell (PBMC) proliferation in vitro. 〈 i 〉 Results: 〈 /i 〉 The levels of plasma anti-SEB or TSST-1 IgE in the severe patients were significantly higher than those in the mild to moderate patients (p 〈 0.05 and p 〈 0.01, respectively). When stimulated with concanavalin A in vitro, PBMCs in the severe patients exhibited low sensitivity to the suppressive efficacy of tacrolimus (FK506) as compared to the mild to moderate patients (p 〈 0.01). Furthermore, there was a significant correlation between the IC 〈 sub 〉 50 〈 /sub 〉 s of FK506 and plasma anti-TSST-1 IgE levels (p 〈 0.01). 〈 i 〉 Conclusions: 〈 /i 〉 We showed that PBMCs in severe AD patients exhibited lower sensitivity to FK506, and had higher plasma levels of anti-TSST-1 IgE as compared to the mild AD patients. SAgs appear to be one of the causes of decreased PBMC sensitivity to FK506, and therefore an alternative treatment would be useful based on the individual drug sensitivity data and anti-TSST-1 IgE levels.
    Type of Medium: Online Resource
    ISSN: 1018-2438 , 1423-0097
    RVK:
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2006
    detail.hit.zdb_id: 1482722-0
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  • 3
    Online Resource
    Online Resource
    JMIR Publications Inc. ; 2019
    In:  Journal of Medical Internet Research Vol. 21, No. 5 ( 2019-05-16), p. e13385-
    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 21, No. 5 ( 2019-05-16), p. e13385-
    Type of Medium: Online Resource
    ISSN: 1438-8871
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2019
    detail.hit.zdb_id: 2028830-X
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  • 4
    In: International Journal of Dermatology, Wiley, Vol. 54, No. 8 ( 2015-08)
    Abstract: Glupearl 19S, an acid‐hydrolyzed wheat protein ( HWP ), is used widely in Japan as a moisturizing ingredient in facial soaps. Since 2010, there has been an increasing number of reports of contact urticaria and wheat allergy resulting from the use of products containing this substance. Case reports Sixty‐one patients who had used HWP ‐containing facial soap visited our hospital. Thirty‐five of these experienced urticaria or anaphylaxis after consuming wheat‐containing food. Results Eighteen of the 35 patients tested positive to 0.01% Glupearl 19S solution. Wheat‐specific IgE and serum gluten‐specific IgE were higher in the patients with HWP allergy than in non‐ HWP allergy patients. Among the patients who tested positive to Glupearl 19S on the skin prick test, nine experienced HWP –wheat‐dependent exercise‐induced anaphylaxis, and four experienced food‐dependent anaphylaxis. Moreover, four of these patients not only experienced food‐dependent anaphylaxis but also a worsening of the symptoms during exercise. Discussion The clinical symptomology was so variable that the patients were classified into six groups. We found that patients with HWP allergy tended to manifest symptoms of both HWP –wheat‐dependent exercise‐induced anaphylaxis and contact urticaria. The etiology of hydrolyzed wheat protein allergy is unknown. Patients with a history of these symptoms need to be informed about the risk of consuming wheat‐containing foods and the importance of excluding such items from their diet.
    Type of Medium: Online Resource
    ISSN: 0011-9059 , 1365-4632
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2015
    detail.hit.zdb_id: 2020365-2
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