• Title/Summary/Keyword: Safety grade

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Phase II Study on Pemetrexed-based Chemotherapy in Treating Patients with Metastatic Gastric Cancer not Responding to Prior Palliative Chemotherapy

  • Wei, Guo-Li;Huang, Xin-En;Huo, Jie-Ge;Wang, Xiao-Ning;Tang, Jin-Hai
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.5
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    • pp.2703-2706
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    • 2013
  • Purpose: This study was to determine the efficacy and safety of pemetrexed based chemotherapy in treating patients with metastatic gastric cancer who failed to respond to first and (or) second line chemotherapy. Patients and Methods: Metastatic gastric cancer patients who failed first and (or) second line chemotherapy, were enrolled. All patients were recruited from Jiangsu Cancer Hospital & Research Institute, and were treated with pemetrexed $500mg/m2$ (intravenous; on day 1), and a platinum (or irinotecan) every 3 weeks until disease progression, or intolerable toxicity. Evaluation on efficacy was conducted after two cycles of chemotherapy using the Response Evaluation Criteria for Solid Tumors. Toxicity was recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Results: From Jun 2011 to May 2013, 23 patients were enrolled. All eligible 23 patients completed at least 2 cycles of chemotherapy with pemetrexed based chemotherapy, and were evaluable. Their median age was 55 years (range 40 to 78 years). Seventeen patients were male and 6 female. Three patients (13%) achieved partial response, five patients (22%) stable, 15 patients (65%) with disease progression, and none with complete response. Grade 2 neutrophil suppression occurred in 4.3%, grade 3 in 13% of patients, and no grade 4 was reported. Thrombocytopenia was encountered as follows: 4.3% grade 2, 4.3% grade 3 and 4.3% grade 4. Incidence of anemia was 34.8% in grade 2, 8.7% grade 3 and 0% grade 4. Only 4.3% of patients required packed red blood cell infusion. Elevated transaminase were 4.3% in grade 2 and 0% in grade 3 or 4. Other toxicity included oral mucositis. Conclusions: Pemetrexed based chemotherapy is mildly effective in treating patients with metastatic gastric cancer with tolerable toxicity.

Allogeneic clonal mesenchymal stem cell therapy for refractory graft-versus-host disease to standard treatment: a phase I study

  • Yi, Hyeon Gyu;Yahng, Seung-Ah;Kim, Inho;Lee, Je-Hwan;Min, Chang-Ki;Kim, Jun Hyung;Kim, Chul Soo;Song, Sun U.
    • The Korean Journal of Physiology and Pharmacology
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    • v.20 no.1
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    • pp.63-67
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    • 2016
  • Severe graft-versus-host disease (GVHD) is an often lethal complication of allogeneic hematopoietic stem cell transplantation (HSCT). The safety of clinical-grade mesenchymal stem cells (MSCs) has been validated, but mixed results have been obtained due to heterogeneity of the MSCs. In this phase I study, the safety of bone marrow-derived homogeneous clonal MSCs (cMSCs) isolated by a new subfractionation culturing method was evaluated. cMSCs were produced in a GMP facility and intravenously administered to patients who had refractory GVHD to standard treatment resulting after allogeneic HSCT for hematologic malignancies. After administration of a single dose ($1{\times}10^6cells/kg$), 11 patients were evaluated for cMSC treatment safety and efficacy. During the trial, nine patients had 85 total adverse events and the rate of serious adverse events was 27.3% (3/11 patients). The only one adverse drug reaction related to cMSC administration was grade 2 myalgia in one patient. Treatment response was observed in four patients: one with acute GVHD (partial response) and three with chronic GVHD. The other chronic patients maintained stable disease during the observation period. This study demonstrates single cMSC infusion to have an acceptable safety profile and promising efficacy, suggesting that we can proceed with the next stage of the clinical trial.

Study on Seismic Performance Evaluation and Verification of Seismic Safety for Power Cable Tunnels (개착식 전력구의 내진성능 평가 및 내진 안전성 검증)

  • Hwang, Kyeong-min;Chun, Nak-hyun;Chung, Gil-young;Park, Kyung-sung
    • KEPCO Journal on Electric Power and Energy
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    • v.6 no.4
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    • pp.439-445
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    • 2020
  • In this paper, the seismic performance evaluation was performed on 100 existing open-cut power cable tunnels, including ones that did not consider seismic design, in order to verify that the government's demand level (seismic special grade, 0.22 g). The results of the seismic performance evaluation show that most of the tunnels have seismic performance of 0.3 to 1 g, satisfying the level of the seismic special grade and securing the seismic safety. Meanwhile, the earthquake response analysis and structural test were performed to verify the validity of the method and the results of the seismic performance evaluation of the tunnels by the response displacement method, and to verify their seismic safety. As a result, the relative displacement due to the response displacement method under the 0.22 g earthquake was conservative than the results of the earthquake response analysis, and the results of load-displacement curves and response modification coefficient calculation by real scale structural tests showed the safety of the tunnels.

The Clinical Efficacy and Safety of Four-Weekly Docetaxel as First-Line Therapy in Elderly Lung Cancer Patients with Squamous Cell Carcinoma

  • Choi, Jong Hyun;Choi, Juwhan;Chung, Sang Mi;Oh, Jee Youn;Lee, Young Seok;Min, Kyung Hoon;Hur, Gyu Young;Shim, Jae Jeong;Kang, Kyung Ho;Lee, Hyun Kyung;Lee, Sung Yong
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.3
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    • pp.211-216
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    • 2019
  • Background: Docetaxel is one of the standard treatments for advanced non-small cell lung cancer. Docetaxel is usually administered in a 3-week schedule, but there is significant toxicity. In this phase II clinical study, we investigated the efficacy and safety of a 4-weekly schedule of docetaxel monotherapy, as first-line chemotherapy for advanced squamous cell carcinoma in elderly lung cancer patients. Methods: Patients with stage IIIB/ IV lung squamous-cell carcinoma age 70 or older, that had not undergone cytotoxic chemotherapy were enrolled. Patients received docetaxel $25mg/m^2$ on days 1, 8, and 15, every 4 weeks. Primary endpoint was the objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity profiles. Results: A total of 19 patients were enrolled. Among 19 patients, 17 were for evaluated efficacy and safety. In the intent-to-treat population, ORR and disease control rate (DCR) were 11.8% and 47.1%, respectively. In the response evaluable population, ORR was 16.7% and DCR was 66.7%. Median PFS and OS were 3.1 months and 3.3 months, respectively. There were three adverse grade 3/4 events. Grade 1 neutropenia was reported in one patient. Conclusion: Our data failed to demonstrate efficacy of a 4-weekly docetaxel regimen, in elderly patients with a poor performance status. However, incidence of side effects, including neutropenia, was lower than with a 3-week docetaxel regimen, as previously reported.

Analysis of Relationship between Construction Accidents and Particulate Matter using Big Data

  • Lee, Minsu;Jeong, Jaewook;Jeong, Jaemin;Lee, Jaehyun
    • International conference on construction engineering and project management
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    • 2022.06a
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    • pp.128-135
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    • 2022
  • Because construction work is conducted outdoors, construction workers are affected by harmful environmental factor. Especially, Particulate Matter (PM10) is one of the harmful environmental factors with a diameter of 10㎍/m3 or less. When PM10 is inhaled by human, it can cause fatal impact on the human. Contrary to the various analyses of health impact on PM10, the research on the relationship between construction accidents and PM10 are few. Therefore, this study aims to conduct the relative frequency analysis which find out the correlation between construction accidents and PM10, and the modified PM10 grade is suggested to expect accidents probability caused by PM10 in the construction industry. This study is conducted by four steps. i) Establishment of the database; ii) Classification of data; iii) Analysis of the Relative Frequency of accidents in the construction industry by PM10 concentration; iv) Modified PM10 groups to classify the impact of PM10 on accident. In terms of frequency analysis, the most accidents were occurred in the average concentration of PM10 (32㎍/m3). However, we found that the relative frequency of accident was increased as the concentration of PM10 increased. This means the higher PM10 concentration can cause more accidents during construction. In addition, PM10 concentration was divided as 6 groups by the WHO, but the modified PM10 grade by the relative frequency on accident was suggested as 3 groups.

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The Effectiveness of a Participatory Road Traffic Safety Education Program for the Elementary School Students (참여 중심 어린이 교통안전교육 프로그램 효과 평가)

  • Shon, Ju-Hyun;Lee, Myung-Sun
    • Korean Journal of Health Education and Promotion
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    • v.27 no.1
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    • pp.49-60
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    • 2010
  • Objectives: The purpose was to evaluate the effectiveness of participatory road safety education program for the lower grade in elementary schools. This program was developed based on the Activated Health Education model. Methods: Study design was compromise experimental group pre-post design. 456 students in 8 schools were nonrandomly assigned to study group(n=224) or control(n=232). The students finished self-administered questionnaire before and after education. Collected data was analyzed by using the SPSS. Results: 1. The common relevant factors in road safety knowledge and attitude were 'residential state' and 'experience of traffic accident'. 2. The knowledge showed that the case and control scored at 6.48 and 6.41 points before. After this intervention, the case and control scored at 8.38 and 6.51. The difference of the case was significant(p<0.001). 3. The attitude showed that the case and control scored at 19.67 and 19.63 before. After this, the case and control scored at 19.86 and 19.63. The difference of the case was significant(p<0.05). Conclusion: In order to implement the road safety education, children's socio-demographic characteristics were considered. Because this education was effective in both improving knowledge and attitude and bringing interest, various participatory program will be applied in road safety education for children.

Analysis of Latent profiles and Inter-individual Differences in Disaster Safety Awareness of High school

  • Lee, Soon-Beom;Kim, Eun-Mi;Kong, Ha-Sung
    • International Journal of Internet, Broadcasting and Communication
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    • v.14 no.2
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    • pp.171-182
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    • 2022
  • In this study, by classifying latent groups for disaster safety awareness focusing on the four sub-factors of the developed disaster awareness scale of high school students, the characteristics of each group were examined, and the differences between latent classes according to inter-individual differences were investigated. As a result of analysis based on the data of a total of 1054 high school students, the disaster safety awareness of high school students was classified into three latent groups. Each latent group was named 'High Safety Awareness Type(SAT)', 'Normal SAT', and 'Low SAT' according to its characteristics. In all four fire safety awareness sub-factors, 'High SAT', which had a high score, accounted for 56.5% of the total, and 'Normal SAT', which had a moderate score in the sub-factors, had the lowest ratio at 20.3%. There were no significant differences by gender, grade, and academic achievement of the latent group. These results are not only meaningful as the first study of the latent profile analysis of high school students on disaster safety awareness, but also help to identify the characteristics of individuals in each latent group with more subdivisions and provide useful data for disaster safety awareness education according to individual differences. The implications of this study and suggestions for follow-up studies were discussed.

Preparation of Spacer for Safety Improvement of Architecture (건축물의 안전성 향상을 위한 Spacer의 제조)

  • 홍성수;강기준;한지원
    • Journal of the Korean Society of Safety
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    • v.13 no.3
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    • pp.45-50
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    • 1998
  • The low grade domestic kaoline, such as pink-C and white-D, was converted to metakaoline, which has pozzolanic reactivity by heat treatment in the temperature range of $600^{\circ}C$ to 100$0^{\circ}C$ for preparing the spacer. The spacer was used for supporting the reinforced steel rod during construction to improve the safety of architecture. Pink-C and white-D were completely dehydroxylated when burnt at 80$0^{\circ}C$ for 1 hour and converted to metakaoline. The compressive strengths of specimens added calcined pink-C were lower than those of press molding mortar products inspite of calcining conditions. When white-D with calcined 80$0^{\circ}C$ and 100$0^{\circ}C$ for 1 hour was mixed 30% in the weight ratio of cement, the specimens cured 28 days had 338 $kg/cm^2$ and 347 $kg/cm^2$ of compressive strengths, respectively.

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Safety and Efficacy of a Mouth-Rinse with Granulocyte Colony Stimulating Factor in Patients with Chemotherapy-Induced Oral Mucositis

  • Wang, Lin;Huang, Xin-En;Ji, Zhu-Qing;Liu, Meng-Yan;Qian, Ting;Li, Li
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.1
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    • pp.413-418
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    • 2016
  • Objective: To assess the safety and effectiveness of a mouth-rinse with G-CSF (JiSaiXin, produced by NCPC Biotechnology Co., Ltd) in treating patients with chemotherapy-induced oral mucositis (CIM). Method: A consecutive cohort of patients with advanced cancers and CIM were treated with mouth-rinse G-CSF. All chemotherapy for patients with advanced cancers was adopted from regimens suggested by NCCN guidelines. The mouth-rinse with G-CSF at a dose of 150-300ug plus 100ml-500ml normal saline was started from the time of oral mucositis was confirmed and continuously used for at least 7 days as one course. After at least two courses of treatment, safety and efficacy were evaluated. Results: There were 7 female and 7 male patients with advanced cancer and CIM recruited into this study, including 5 with colorectal, 2 with lung, 1 patient with gastric, 1 with cervical and 1 with pancreatic cancer, as well as 2 patients with diffuse large B cell lymphomas, 1 with nasopharyngeal and 1 with gastric cancer. The median age was 57 (41-79) years. Grade 1 to 2 myelosuppression was observed in 3/14 patients, and Grade 4 myelosuppression in 1/14. Adverse effects on the gastrointestinal tract were documented in 5/14 patients, and were Grade 1 to Grade 3. No treatment related death was documented. Regarding CIM, the median response time to mouth rinse of G-CSF was 2 (1-5) days, and all patients with CIM demonstrated a positive response. Conclusions: Mouth-rinse with G-CSF proved to be safe and effective in treating patients with advanced cancers and CIM. However, further randomized controlled studies should be conducted to clarify the effectiveness of this treatment with other lesions.