• 제목/요약/키워드: Background registration

검색결과 120건 처리시간 0.021초

물질안전보건자료 및 표시제도의 개선 방향 제안(2) - 유럽연합의 CLP 제도 고찰에 근거하여 (How to Improve the Reliability of MSDS and Labels?(2): A Review on the EU CLP(REGULATION(EC) No 1272/2008))

  • 김신범;이윤근;최영은
    • 한국산업보건학회지
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    • 제25권2호
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    • pp.115-125
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    • 2015
  • Objectives: The major objectives of this study are to review the EU CLP Regulations to propose ways of improving the reliability of MSDS and labels. Methods: To review the EU CLP Regulations, we used EU documents including directives and regulations on chemical management. In addition, we used EU governmental agency reports to illuminate the history and background of the CLP. We found the EU CLP's instruments for reliable hazard communication and evaluated the operations of the instruments. Results: EU CLP Regulations have four instruments for the EU CLP Regulations to make hazard communication reliable. These instruments are GHS, the harmonized CMR and respiratory sensitive substances classification list, C&L inventory and restriction of trade secrets. These are highly useful for achieving the objectives of REACH and CLP(no data-no market and changing the burden of proof). Conclusions: Changing the burden of proof is a key principle for achieving a society safe from hazardous chemicals. Chemical manufacturers and importers alone should bear the responsibility for reliable MSDS. We recommend benchmarking the EU CLP Regulations in order to change efficiently the burden of proof. Trade secrets should be limited to low-hazard substances and be approved by the government before the chemical product is on the market. Like the C&L inventory, chemical product information including substances identification and hazard properties should be notified, aggregated and be opened to public on the Internet. Finally, we recommend a MSDS registration system once again.

Effects of Lumbar Mobilization for Lower Limb Strength in Healthy Individuals: A Protocol for Systematic Review and Meta-Analysis

  • Choi, Wansuk;Choi, Taeseok;An, Hojung;Kim, Jisung;Heo, Seoyoon
    • 국제물리치료학회지
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    • 제11권2호
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    • pp.2096-2101
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    • 2020
  • Background: The effect of mobilization on lumbar back pain has been fully described in several clinical aspects, but evidence for muscle strength would be still less clear. Objective: To assess the effect of lumbar mobilization on lower limb strength in healthy individuals. Methods and Analysis: Healthy people aged 18-65 will be included regardless of race or sex. Original peer-reviewed primary reporting randomized controlled trials (RCTs) will be included. Electronic databases, such as MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, Pedro, CINAHL, ClinicalTrials.gov will be searched from inception until July 30. Only studies published in English will be included in this review. Two reviewers will complete the screening for eligibility independently, and the other two reviewers will also complete the risks of data extraction and bias assessment independently. Lower Limb strength will be assessed as primary outcome, and particular intervention or participant characteristics will be assessed as the secondary outcomes. Meta-analysis will be conducted using Review Manager 5.3.3, and evidence level will be assessed using the method for Grading of Recommendations Assessment, Development and Evaluation. Outcomes will be presented as the weighted mean difference or standardized mean difference with 95% CI. If I2 ≤ 50%, P>.1, the fixed effect model will be used, otherwise, random-effects model will be used. Ethics and dissemination: This review might not be necessary ethical approval because it does not require individual patient's data; these findings will be published in conference presentations or peer-reviewed journal articles. PROSPERO registration number: CRD42020150144.

Optimal Timing of Zoster Vaccination After Shingles: A Prospective Study of the Immunogenicity and Safety of Live Zoster Vaccine

  • Lee, Eunyoung;Chun, June Young;Song, Kyoung-Ho;Choe, Pyoeng Gyun;Bang, Ji Hwan;Kim, Eu Suk;Kim, Hong Bin;Park, Sang Won;Kim, Nam Joong;Park, Wan Beom;Oh, Myoung-don
    • Infection and chemotherapy
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    • 제50권4호
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    • pp.311-318
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    • 2018
  • Background: Zoster vaccination is recommended for people with a history of herpes zoster (HZ), but the most effective timing of vaccine administration after zoster illness is unresolved. This prospective observational study compared the immunogenicity and safety of administering HZ vaccine at 6-12 months and 1-5 years after zoster illness. Materials and Methods: Blood samples were collected before the administration of live zoster vaccine and 6 weeks after vaccination. Varicella-zoster virus (VZV) IgG concentrations and T-cell responses were assessed by glycoprotein enzyme-linked immunosorbent assay and interferon-${\gamma}$ enzyme-linked immunospot assay (ELISPOT), respectively. Results: The baseline geometric mean value (GMV) of VZV IgG was higher in the 6-12 months group than in the 1-5 years group (245.5 IU/mL vs. 125.9 IU/mL; P = 0.021). However, the GMV increased significantly in both groups (P = 0.002 in the 6-12 months group; P <0.001 in the 1-5 years group). The results of the ELISPOT assay were not significant for differences of the GMV between baseline and 6-week post-vaccination groups, while the GMV increased significantly in both groups (P = 0.001 in the 6-12 months group; P <0.001 in the 1-5 years group). Conclusion: The immunogenicity of zoster vaccine may be similar whether administered 6-12 months, or >1 year after zoster illness. Trial Registration: ClinicalTrials.gov Identifier: NCT02704572

A Korean nationwide investigation of the national trend of complex regional pain syndrome vis-à-vis age-structural transformations

  • Lee, Joon-Ho;Park, Suyeon;Kim, Jae Heon
    • The Korean Journal of Pain
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    • 제34권3호
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    • pp.322-331
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    • 2021
  • Background: The present study employed National Health Insurance Data to explore complex regional pain syndrome (CRPS) updated epidemiology in a Korean context. Methods: A CRPS cohort for the period 2009-2016 was created based on Korean Standard Classification of Diseases codes alongside the national registry. The general CRPS incidence rate and the yearly incidence rate trend for every CRPS type were respectively the primary and secondary outcomes. Among the analyzed risk factors were age, sex, region, and hospital level for the yearly trend of the incidence rate for every CRPS. Statistical analysis was performed via the chi-square test and the linear and logistic linear regression tests. Results: Over the research period, the number of registered patients was 122,210. The general CRPS incidence rate was 15.83 per 100,000, with 19.5 for type 1 and 12.1 for type 2. The condition exhibited a declining trend according to its overall occurrence, particularly in the case of type 2 (P < 0.001). On the other hand, registration was more pervasive among type 1 compared to type 2 patients (61.7% vs. 38.3%), while both types affected female individuals to a greater extent. Regarding age, individuals older than 60 years of age were associated with the highest prevalence in both types, regardless of sex (P < 0.001). Conclusions: CRPS displayed an overall incidence of 15.83 per 100,000 in Korea and a declining trend for every age group which showed a negative association with the aging shift phenomenon.

Quality Over Volume: Modeling Centralization of Gastric Cancer Resections in Italy

  • Lorenzon, Laura;Biondi, Alberto;Agnes, Annamaria;Scrima, Ottavio;Persiani, Roberto;D'Ugo, Domenico
    • Journal of Gastric Cancer
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    • 제22권1호
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    • pp.35-46
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    • 2022
  • Background: The correlation between hospital volume and postoperative outcomes has led to the centralization of complex procedures in several countries. However, the results reported in relation to gastric cancer (GC) are contradictory. This study aimed to analyze GC surgical volumes and 30-day postoperative mortality in Italy and to provide a simulation for modeling centralization of GC resections based on district case volumes. Methods: A national registry was used to identify all GC resections, record mortality rates, and track the national in-border GC resection health travel. Hospitals were grouped according to caseload. Centralization of all GC procedures performed within the same district was modeled. The outcome measures were a minimal volume of 25 GC resections/year and the 30-day postoperative mortality. Results: In 2018, 5,873 GC resections were performed in 498 Italian hospitals (mean resections per hospital per year: 11.8); the postoperative mortality rate (5.51%) was tracked from 2016-2018. GC resection health travel ranged from 2% to 50.5%, with a significant (P<0.001) difference between northern and central/southern Italy. The mean mortality rate was 7.7% in hospitals performing one to 3 GC resections per year, compared with 4.7% in those with >17 GC resections/year (P≤0.01). Most Italian districts achieved 25 procedures/year after centralization; however, 66.3% of GC cases in southern Italy vs. 42.2% in central and 52.7% in the northern regions (P<0.001) required reallocation. Conclusion: Postoperative mortality after GC resection correlated with hospital volume. Despite health travel, most Italian districts can reach a high-volume threshold, but discrepancies in mortality rates are alarming.Trial RegistrationResearch Registry Identifierresearchregistry6869

Efficacy of Commiphora myrrha and Honey in Primary Dysmenorrhea: A Randomized Controlled Study

  • Aneesa K, Haleema;Roqaiya, Mariyam;Quadri, Mohd Aqil
    • 셀메드
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    • 제11권4호
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    • pp.19.1-19.8
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    • 2021
  • Background: Dysmenorrhea is the most common menstrual complaint in young women with a prevalence as high as 90% and is responsible for substantial repeated short-term absenteeism from school and work in young women. The objective of this study was to compare the efficacy of Commiphora myrrha and honey with mefenamic acid in primary dysmenorrhea. Materials and Methods: This prospective standard controlled trial was conducted at Luqman Unani Medical College Hospital and Research Center Vijayapura, India where 40 diagnosed patients of primary dysmenorrhea were randomly assigned to receive test drug (powdered Commiphora myrrha gum resin10g with 30g honey in two divided doses) or active control drug (mefenamic acid 250mg TID) for first 3days of menstruationfor two consecutive cycles. The primary outcome measure was reduction in severity of pain assessed by numerical pain rating scale (NPRS), and secondary outcome measures were improvement in quality of life (QOL) assessed by SF-36 and reduction in perceived stress score (PSS). Results: During first cycle treatment no significant difference was found in NPRS score (p=0.085) between the groups however significant difference in NPRS score (p<0.001) was seen during 2nd treatment cycle. Significant reduction (p=0.022) in the perceived stress score was noted and overall quality of life was markedly improved after treatment in both the groups. Conclusion: These data suggest that Commiphora myrrha gum resin with honey is an effective herb in reducing symptoms of primary dysmenorrhea. These results need to be confirmed by a properly designed trial with a larger sample size. Trial registration: Clinical Trial Registry India CTRI/2017/09/009596.

가습기 살균제 참사와 관련된 당시 생활화학물질 관리 법령에 대한 비판적 고찰 (Critical Review of the Former Korean Regulations for Consumer Chemicals and the Humidifier Disinfectant Disaster)

  • 조대환;조경이;박태현;최예용;박동욱
    • 한국환경보건학회지
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    • 제48권3호
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    • pp.183-194
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    • 2022
  • Background: No study has examined the regulatory factors associated with fatal health problems due to the use of humidified disinfectants (HD) in South Korea. Objectives: This study aimed to identify and discuss the deficiencies and limitations found in the Toxic Chemical Control Acts (TCCA) that failed to prevent the health risk of chemicals in HD products. Methods: The South Korean TCCA was reviewed focusing on acts in operation from 1994 through the end of 2011, the period when HD was allowed in manufacturing and marketing. Results: The TCCA was the act intended to regulate the toxicity of chemicals in HD products. We found the TCCA to lack three key legal clauses which would have been essential to controlling the health risk of HD. First, there was the exemption of toxic and hazard testing for existing chemicals, including chloromethylisothiazolinone (CMIT), methylisothiazolinone (MIT), and benzalkonium chloride (BKC). Secondly, there were no articles requiring industry to provide animal inhalation test result for polymers such as polyhexamethylene guanidine (PHMG) and Oligo(2-)ethoxyethoxyethyl guanidine chloride (PGH). Finally, there was a lack of articles on examining the risk of products as well as on addressing changes in the usage of products. These articles were found to be generally provided in the US Toxic Substance Chemical Act (TSCA) and the EU Registration, Evaluation and Authorization of Chemicals (REACH). Conclusions: In conclusion, the Ministry of Environment of South Korea had not updated key articles for regulating hazardous chemicals, causing large-scale health problems due to HD which had been fundamentally addressed in chemical-related acts in other countries.

지역소멸수준과 지역의 총 의료이용 간의 관계 (Relationship between the Level of Local Extinction and Total Medical Service Uses)

  • 박지해;오재환;강제구;정윤지;이광수
    • 보건행정학회지
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    • 제33권3호
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    • pp.253-263
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    • 2023
  • Background: The purpose of this study was to explore the relationship between the local extinction index and total medical service utilization. Methods: A fixed effects model in panel analysis was performed for the 228 administrative districts in Korea. The statistical yearbook on the usage of medical services by region and Korean Statistical Information Service data were used from 2010 to 2019 for analysis. Medical service utilization was represented by the number of visits day, the number of inpatient days, and medical charges. Control variables were selected by using an Anderson model. The local extinction index was calculated using resident registration population data. Results: Descriptive statistics showed that the number of areas at risk of extinction increased from 61 to 95 for the study years. In addition, the number of visits, the number of inpatient days, and medical charges all increased during the study years. After controlling for variables affecting medical service utilization and doing a panel fixed effects model, the result suggested that a one-step increase in the local extinction index was significantly associated with a 12.29% decrease in medical charges of inpatients, a 7.33% decrease in medical charge of outpatient, a 5.21% decrease in the number of inpatient day, and a 5.54% decrease in the number of visits day. Conclusion: This study showed that the higher the region's extinction risks, the higher the region's total medical service utilization. The results of this study suggested that there was a disparity in medical service utilization between areas at risk of extinction and areas not at risk of extinction, so measures should be taken to address this disparity.

우리나라 주요 FTA협정의 수산물 원산지 규정에 관한 비교 연구 - 한·미 및 유럽권 협정을 중심으로 - (A Comparative Study on the Rules of Origin of Fishery Products in South Korea's Major FTAs : Focused on the Korea-US FTA and European Agreements)

  • 박진우;박명섭;최두원
    • 무역학회지
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    • 제41권5호
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    • pp.213-233
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    • 2016
  • FTA 원산지 규정은 품목의 특성에 맞게 산업별 특성 및 양 당사국간의 상황을 고려하여 양 당사국간의 협상에 의해 정해지고 협정문을 통해 규정하고 있으며, 수산물의 원산지결정기준은 크게 완전생산기준을 적용하는 협정과 2단위 세번변경기준을 적용하는 협정으로 나눌 수 있다. 수산물은 HS code Chapter 3에 속하며, 일반적으로 양식 또는 어획에 의한 획득을 통해서 생산된다. 본 연구에서는 이러한 관점에서 각 협정을 비교 하였다. 어획된 수산물의 경우 공해어업과 관련한 배경 지식이 없는 상황에서 업무상 판단 오류가 발생 할 수 있다. 원산지 판정을 위한 선박의 인정 요건과 관련하여 국제 협정에 의해 선박은 등록국의 국기를 게양하고 항행 할 수 있으므로, FTA 원산지규정에 적용할 수 있도록 하는 기국주의 등에 대한 연구를 진행하였다.

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노인장기요양 등급 및 급여 특성이 의료이용에 미치는 영향 (The Effect of Long-Term Care Ratings and Benefit Utilization Characteristics on Healthcare Use)

  • 손강주;오성진;윤종민
    • 보건행정학회지
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    • 제33권3호
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    • pp.295-310
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    • 2023
  • Background: The long-term care (LTC) group has higher rates of chronic disease and disability registration compared to the general older people population. There is a need to provide integrated medical services and care for LTC group. Consequently, this study aimed to identify medical usage patterns based on the ratings of LTC and the characteristics of benefits usage in the LTC group. Methods: This study employed the National Health Insurance Service Database to analyze the effects of demographic and LTC-related characteristics on medical usage from 2015 to 2019 using a repeated measures analysis. A longitudinal logit model was applied to binary data, while a linear mixed model was utilized for continuous data. Results: In the case of LTC ratings, a positive correlation was observed with overall medical usage. In terms of LTC benefit usage characteristics, a higher overall level of medical usage was found in the group using home care benefits. Detailed analysis by medical institution classification revealed a maintained correlation between care ratings and the volume of medical usage. However, medical usage by classification varied based on the characteristics of LTC benefit usage. Conclusion: This study identified a complex interaction between LTC characteristics and medical usage. Predicting the requisite medical services based on the LTC rating presented a challenge. Consequently, it becomes essential for the LTC group to continuously monitor medical and care needs, even after admission into the LTC system. To facilitate this, it is crucial to devise an LTC rating system that accurately reflects medical needs and to broaden the implementation of integrated medical-care policies.