• Title/Summary/Keyword: Safety Guideline

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Current Perspectives on Emerging CAR-Treg Cell Therapy: Based on Treg Cell Therapy in Clinical Trials and the Recent Approval of CAR-T Cell Therapy (장기이식 거부반응과 자가면역질환 치료제로서의 CAR Treg 세포치료제의 가능성: Treg 세포치료제 임상시험 현황과 CAR T 세포치료제 허가 정보를 바탕으로)

  • Kang, Koeun;Chung, Junho;Yang, Jaeseok;Kim, Hyori
    • Korean Journal of Transplantation
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    • v.31 no.4
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    • pp.157-169
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    • 2017
  • Regulatory T cells (Treg) naturally rein in immune attacks, and they can inhibit rejection of transplanted organs and even reverse the progression of autoimmune diseases in mice. The initial safety trials of Treg against graft-versus-host disease (GVHD) provided evidence that the adoptive transfer of Treg is safe and capable of limiting disease progression. Supported by such evidence, numerous clinical trials have been actively investigating the efficacy of Treg targeting autoimmune diseases, type I diabetes, and organ transplant rejection, including kidney and liver. The limited quantity of Treg cells harvested from peripheral blood and subsequent in vitro culture have posed a great challenge to large-scale clinical application of Treg; nevertheless, the concept of CAR (chimeric antigen receptor)-Treg has emerged as a potential resolution to the problem. Recently, two CAR-T therapies, tisagenlecleucel and axicabtagene ciloleucel, were approved by the US FDA for the treatment of refractory or recurrent acute lymhoblastic leukemia. This approval could serve as a guideline for the production protocols for other genetically engineered T cells for clinical use as well. The phase I and II clinical trials of these agents has demonstrated that genetically engineered and antigen-targeting T cells are safe and efficacious in humans. In conclusion, both the promising results of Treg cell therapy from the clinical studies and the recent FDA approval of CAR-T therapies are paving the way for CAR-Treg therapy in clinical use.

Analysis of Institutional Limitations on Evacuation of Urban Railway Station Facilities and Guidelines (도시철도역 시설의 피난에 대한 제도적 한계점 분석과 가이드라인)

  • Yekyeong Shin;Okkyung Yuh
    • Journal of Korean Society of Disaster and Security
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    • v.15 no.4
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    • pp.1-9
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    • 2022
  • This study analyzes the institutional status related to 'evacuation' and 'firefighting' in underground subway stations, derives institutional limitations for 'evacuation' in underground subway stations, and proposes guidelines in terms of architectural space based on this. As a result of the study, the following points were derived. First, since similar standards are separately enacted in individual laws and it is difficult to grasp the standards and they are dualized, it is necessary to standardize and regulate the space where users stay according to the movement of urban railway users, limited to urban railways. Second, in order to use trains, a special procedure called 'ticketing' must be considered, and regulations on evacuation safety zones and evacuation stairs between the waiting room and the platform are required. Finally, if there is a platform at a depth of more than 30m underground, it is necessary to install an evacuation floor in accordance with standards similar to the current building law.

A New Perspective on the Advanced Microblade Cutting Method for Reliable Adhesion Measurement of Composite Electrodes

  • Song, Jihun;Shin, Dong Ok;Byun, Seoungwoo;Roh, Youngjoon;Bak, Cheol;Song, Juhye;Choi, Jaecheol;Lee, Hongkyung;Kwon, Tae-Soon;Lee, Young-Gi;Ryou, Myung-Hyun;Lee, Yong Min
    • Journal of Electrochemical Science and Technology
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    • v.13 no.2
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    • pp.227-236
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    • 2022
  • The microblade cutting method, so-called SAICAS, is widely used to quantify the adhesion of battery composite electrodes at different depths. However, as the electrode thickness or loading increases, the reliability of adhesion values measured by the conventional method is being called into question more frequently. Thus, herein, a few underestimated parameters, such as friction, deformation energy, side-area effect, and actual peeing area, are carefully revisited with ultrathick composite electrodes of 135 ㎛ (6 mAh cm-2). Among them, the existence of side areas and the change in actual peeling area are found to have a significant influence on measured horizontal forces. Thus, especially for ultrahigh electrodes, we can devise a new SAICAS measurement standard: 1) the side-area should be precut and 2) the same actual peeling area must be secured for obtaining reliable adhesion at different depths. This guideline will practically help design more robust composite electrodes for high-energy-density batteries.

Two-stage damage identification for bridge bearings based on sailfish optimization and element relative modal strain energy

  • Minshui Huang;Zhongzheng Ling;Chang Sun;Yongzhi Lei;Chunyan Xiang;Zihao Wan;Jianfeng Gu
    • Structural Engineering and Mechanics
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    • v.86 no.6
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    • pp.715-730
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    • 2023
  • Broad studies have addressed the issue of structural element damage identification, however, rubber bearing, as a key component of load transmission between the superstructure and substructure, is essential to the operational safety of a bridge, which should be paid more attention to its health condition. However, regarding the limitations of the traditional bearing damage detection methods as well as few studies have been conducted on this topic, in this paper, inspired by the model updating-based structural damage identification, a two-stage bearing damage identification method has been proposed. In the first stage, we deduce a novel bearing damage localization indicator, called element relative MSE, to accurately determine the bearing damage location. In the second one, the prior knowledge of bearing damage localization is combined with sailfish optimization (SFO) to perform the bearing damage estimation. In order to validate the feasibility, a numerical example of a 5-span continuous beam is introduced, also the noise robustness has been investigated. Meanwhile, the effectiveness and engineering applicability are further verified based on an experimental simply supported beam and actual engineering of the I-40 Bridge. The obtained results are good, which indicate that the proposed method is not only suitable for simple structures but also can accurately locate the bearing damage site and identify its severity for complex structure. To summarize, the proposed method provides a good guideline for the issue of bridge bearing detection, which could be used to reduce the difficulty of the traditional bearing failure detection approach, further saving labor costs and economic expenses.

Development of Guideline for Heuristic Based Usability Evaluation on SaMD (SaMD에 대한 휴리스틱 기반 사용적합성 평가 가이드라인 개발)

  • Jong Yeop Kim;Junghyun Kim;Zero Kim;Myung Jin Chung
    • Journal of Biomedical Engineering Research
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    • v.44 no.6
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    • pp.428-442
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    • 2023
  • In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

COVID-19 vaccine-induced immune thrombotic thrombocytopenia: a review

  • Siti Nur Atikah Aishah Suhaimi;Izzati Abdul Halim Zaki;Zakiah Mohd Noordin;Nur Sabiha Md Hussin;Long Chiau Ming;Hanis Hanum Zulkifly
    • Clinical and Experimental Vaccine Research
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    • v.12 no.4
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    • pp.265-290
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    • 2023
  • Rare but serious thrombotic incidents in relation to thrombocytopenia, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), have been observed since the vaccine rollout, particularly among replication-defective adenoviral vector-based severe acute respiratory syndrome coronavirus 2 vaccine recipients. Herein, we comprehensively reviewed and summarized reported studies of VITT following the coronavirus disease 2019 (COVID-19) vaccination to determine its prevalence, clinical characteristics, as well as its management. A literature search up to October 1, 2021 using PubMed and SCOPUS identified a combined total of 720 articles. Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline, after screening the titles and abstracts based on the eligibility criteria, the remaining 47 full-text articles were assessed for eligibility and 29 studies were included. Findings revealed that VITT cases are strongly related to viral vector-based vaccines, which are the AstraZeneca COVID-19 vaccine (95%) and the Janssen COVID-19 vaccine (4%), with much rarer reports involving messenger RNA-based vaccines such as the Moderna COVID-19 vaccine (0.2%) and the Pfizer COVID-19 vaccine (0.2%). The most severe manifestation of VITT is cerebral venous sinus thrombosis with 317 cases (70.4%) and the earliest primary symptom in the majority of cases is headache. Intravenous immunoglobulin and non-heparin anticoagulant are the main therapeutic options for managing immune responses and thrombosis, respectively. As there is emerging knowledge on and refinement of the published guidelines regarding VITT, this review may assist the medical communities in early VITT recognition, understanding the clinical presentations, diagnostic criteria as well as its management, offering a window of opportunity to VITT patients. Further larger sample size trials could further elucidate the link and safety profile.

Transarterial Chemoembolization for Hepatocellular Carcinoma: 2023 Expert Consensus-Based Practical Recommendations of the Korean Liver Cancer Association

  • Yuri Cho;Jin Woo Choi;Hoon Kwon;Kun Yung Kim;Byung Chan Lee;Hee Ho Chu;Dong Hyeon Lee;Han Ah Lee;Gyoung Min Kim;Jung Suk Oh;Dongho Hyun;In Joon Lee;Hyunchul Rhim;Research Committee of the Korean Liver Cancer Association
    • Korean Journal of Radiology
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    • v.24 no.7
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    • pp.606-625
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    • 2023
  • Transarterial chemoembolization (TACE) was introduced in 1977 with the administration of chemotherapeutic agent to gelatin sponge particles through the hepatic artery in patients with hepatocellular carcinoma (HCC) and was established as conventional TACE using Lipiodol in the 1980s. In the 2000s, drug-eluting beads were developed and applied clinically. Currently, TACE is a commonly used non-surgical treatment modality for patients with HCC who are unsuitable for curative treatment. Considering the vital role of TACE in the management of HCC, it is crucial to organize current knowledge and expert opinions regarding patient preparation, procedural techniques, and post-treatment care in TACE, which can enhance therapeutic efficacy and safety. A group of 12 experts in the fields of interventional radiology and hepatology, convened by the Research Committee of the Korean Liver Cancer Association (KLCA), has developed expert consensus-based practical recommendations in TACE. These recommendations have been endorsed by the Korean Society of Interventional Radiology and provide useful information and direction in performing TACE procedure as well as pre- and post- procedural patient care.

A Bibliometric Analysis of Research Trends in Domestic Integrative Medicine Journals : Focused on Integrative Medicine Research (국내 통합의학 저널의 연구 동향에 대한 계량서지학적 분석 : Integrative Medicine Research를 중심으로)

  • Dae-Jin Kim;Tae-Hyung Yoon;Jong-Rok Lee;Byung-Hee Choi
    • Journal of The Korean Society of Integrative Medicine
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    • v.12 no.2
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    • pp.197-210
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    • 2024
  • Purpose : This study aimed to analyze research trends in the field of integrative medicine through a bibliometric analysis of articles published in Integrative Medicine Research (IMR) journal from 2017 to 2022. Methods : Articles published in IMR journal between 2017 and 2022 were searched using the Web of Science database on August 22, 2023. The analysis was performed using the Bibliometrix and Biblioshiny tools in R (version 4.3.1) and VOSviewer (version 1.6.19). Results : The key findings were as follows: average citations per article (9.41), total authors (1,142), single-authored articles (12), average articles per author (0.27), average co-authors per article (5.27), and rate of international co-authorships (15.69 %). The most-cited article was on the cryopreservation of cells or tissues and their clinical applications. The top keyword analysis by author keywords showed that "acupuncture" was the most frequently used keyword (33 times). Co-occurrence network analysis showed 85 high-frequency keywords that appeared five or more times, and the top five keywords by total link strength were "acupuncture," "herbal medicine," "prevalence," "alternative medicine," and "complementary." The study found that, contrary to the trend in complementary and alternative medicine research in Korea, the IMR journal actively conducts intervention studies to provide clinical evidence. Conclusion : In the IMR journal, "acupuncture" was the most frequent of author keywords. The analysis of keyword trend topics over time showed that the keyword "systematic review" continued to appear from 2020 to 2022, and the keyword "clinical practice guideline" appeared for the first time in 2021. In particular, the co-occurrence network analysis highlighted keywords related to intervention research, in contrast to domestic research trends. While this study analyzed only one journal, future studies expanding the category of integrative medicine and increasing the number of journals analyzed may provide further insights.

Local Ablation for Hepatocellular Carcinoma: 2024 Expert Consensus-Based Practical Recommendations of the Korean Liver Cancer Association

  • Seungchul Han;Pil Soo Sung;Soo Young Park;Jin Woong Kim;Hyun Pyo Hong;Jung-Hee Yoon;Dong Jin Chung;Joon Ho Kwon;Sanghyeok Lim;Jae Hyun Kim;Seung Kak Shin;Tae Hyung Kim;Dong Ho Lee;Jong Young Choi
    • Korean Journal of Radiology
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    • v.25 no.9
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    • pp.773-787
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    • 2024
  • Local ablation for hepatocellular carcinoma (HCC), a non-surgical option that directly targets and destroys tumor cells, has advanced significantly since the 1990s. Therapies with different energy sources, such as radiofrequency ablation, microwave ablation, and cryoablation, employ different mechanisms to induce tumor necrosis. The precision, safety, and effectiveness of these therapies have increased with advances in guiding technologies and device improvements. Consequently, local ablation has become the first-line treatment for early-stage HCC. The lack of organized evidence and expert opinions regarding patient selection, pre-procedure preparation, procedural methods, swift post-treatment evaluation, and follow-up has resulted in clinicians following varied practices. Therefore, an expert consensus-based practical recommendation for local ablation was developed by a group of experts in radiology and hepatology from the Research Committee of the Korean Liver Cancer Association in collaboration with the Korean Society of Image-guided Tumor Ablation to provide useful information and guidance for performing local ablation and for the pre- and post-treatment management of patients.

Adsorption and Metabolism of [14C]butachlor in Rice Plants Under Pot Cultivation ([14C]Butachlor의 벼에 대한 흡수 및 대사)

  • Kim, Ju-Hye;Kim, Jong-Hwan;Kim, Dae-Wook;Lee, Bong-Jae;Kim, Chansub;Ihm, Yangbin;Seo, Jong-Su
    • The Korean Journal of Pesticide Science
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    • v.19 no.3
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    • pp.174-184
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    • 2015
  • In the present study, the metabolism of [$^{14}C$]butachlor was investigated in rice plant according to the OECD test guideline No. 501. [$^{14}C$]Butachlor was treated as granule to paddy water by application of 1.5 kg ingredient (a.i.)/ha at the 3~4 leave stage of rice plant. At 85 days after treatment (DAT), samples of panicle, foliage, and roots were taken for radioactivity analysis. Upon harvest at 126 DAT, rice plants were separated into brown rice, husk, straw, and root parts. Amounts of total radioactivity absorbed by rice plant ranged from 8.6 to 9.8% of applied radioactivity (AR). Total radioactive residues (TRRs) of rice plant at 126 DAT was the highest as 4.0421 mg/kg (7.3% AR) in the straw followed by 1.4595 mg/kg (2.4% AR) in the root, 0.7257 mg/kg (0.1% AR) in the husk. The lowest level recording 0.1020 mg/kg (0.1% AR) was found in brown rice. Each part was extracted with various solvents and solvent/water mixtures. Greater than 70% of TRRs was readily extractable from foliage, panicle, husk and straw. Only 34.0% of the brown rice and 43% of root based on TRRs were extractable showing that the residues were completely assimilated in the plant tissue. The level of non-extractable radioactivity was ranged from 26.2 to 66.0% of TRRs. From this study, five tentative major metabolites (M1, M2, M3, M4 and M5) were observed in rice extracts. Among the metabolites, 2,6-diethylaniline assigned as M4 was identified in rice plant by comparing to retention time of reference standard. Un-metabolized butachlor was not detected in any fractions. In soil extracts, N-(butoxymethyl)-N-(2,6-diethyl phenyl)acetamide, 2,6-diethylaniline, M2, M3 and M5 were observed. And the concentration of butachlor was low level (ca. 0.03 mg/kg).