• Title/Summary/Keyword: pilot human study

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Diagnostic Evaluation of the BioFire® Meningitis/Encephalitis Panel: A Pilot Study Including Febrile Infants Younger than 90 Days (BioFire® Meningitis/Encephalitis Panel의 진단적 유용성 평가: 90일 미만 발열영아에서의 예비 연구)

  • Kim, Kyung Min;Park, Ji Young;Park, Kyoung Un;Sohn, Young Joo;Choi, Youn Young;Han, Mi Seon;Choi, Eun Hwa
    • Pediatric Infection and Vaccine
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    • v.28 no.2
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    • pp.92-100
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    • 2021
  • Purpose: Rapid detection of etiologic organisms is crucial for initiating appropriate therapy in patients with central nervous system (CNS) infection. This study aimed to evaluate the diagnostic value of the BioFire® Meningitis/Encephalitis (ME) panel in detecting etiologic organisms in cerebrospinal fluid (CSF) samples from febrile infants. Methods: CSF samples from infants aged <90 days who were evaluated for fever were collected between January 2016 and July 2019 at the Seoul National University Children's Hospital. We performed BioFire® ME panel testing of CSF samples that had been used for CSF analysis and conventional tests (bacterial culture, Xpert® enterovirus assay, and herpes simplex virus-1 and -2 polymerase chain reaction) and stored at -70℃ until further use. Results: In total, 72 (24 pathogen-identified and 48 pathogen-unidentified) CSF samples were included. Using BioFire® ME panel testing, 41 (85.4%) of the 48 pathogen-unidentified CSF samples yielded negative results and 22 (91.7%) of the 24 pathogen-identified CSF samples yielded the same results (enterovirus in 19, Streptococcus agalactiae in 2, and Streptococcus pneumoniae in 1) as those obtained using the conventional tests, thereby resulting in an overall agreement of 87.5% (63/72). Six of the 7 pathogen-unidentified samples were positive for human parechovirus (HPeV) via BioFire® ME panel testing. Conclusions: Compared with the currently available etiologic tests for CNS infection, BioFire® ME panel testing demonstrated a high agreement score for pathogen-identified samples and enabled HPeV detection in young infants. The clinical utility and cost-effectiveness of BioFire® ME panel testing in children must be evaluated for its wider application.

Diagnostic Availability of Estrogen Receptor Alpha mRNA on Cervical Cancer Tissue (자궁경부암 조직에서 에스트로겐 수용체 알파 mRNA의 진단적 유용성)

  • Kim, Geehyuk;Yu, Kwangmin;Kim, Jungho;Kim, Seoyong;Park, Sunyoung;Ahn, Sungwoo;Lee, Ji-Young;Kim, Sunghyun;Park, Ho-Hyun;Lee, Dongsup
    • Korean Journal of Clinical Laboratory Science
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    • v.50 no.4
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    • pp.449-456
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    • 2018
  • Cervical cancer is the fourth most frequently diagnosed cancer in women worldwide. In lower Human Development Index countries, it has the second highest incidence and mortality among cancer in women. Therefore, better diagnosis and treatment systems are needed. Among them, estrogen receptor alpha ($ER-{\alpha}$) mRNA expression has been analyzed with RT-qPCR since several studies reported that $ER-{\alpha}$ is necessary in the maturation of the uterus and is related to cervical cancer. In this study, $ER-{\alpha}$ quantitative analysis was performed on various lesions and normal tissue samples. Based on the receiver operating characteristic (ROC) curve, its sensitivity and specificity were 85% and 75%, respectively, showing higher or similar results to those of conventional HPV tests. In addition, its expression level was analyzed with clinical information. With regression analysis, the R square value between the $ER-{\alpha}$ mRNA expression level and menopause status was 0.5041, indicating a strong correlation. This study was performed as part of a pilot study and suggests that $ER-{\alpha}$ is related to carcinogenesis. Future studies will examine other hormones and menopausal factors with a larger sample size.

The influence of wearing helmet and cervical spine injury in skiers and snowboarders (스키와 스노우 보드에서 헬멧의 착용이 경추부 손상에 미치는 영향)

  • Kim, Sung Hun;Kim, Tae Kyun;Chun, Keun Churl;Hwang, Jae Sun
    • Journal of Korean Orthopaedic Sports Medicine
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    • v.10 no.2
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    • pp.94-99
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    • 2011
  • Purpose: As the number of people enjoying skiing and snowboarding which are two popular winter sports has been increasing, wearing helmet during doing these sports has been needed for safety. The rates of head or face injury have decreased after using helmet. However the effect that wearing helmet has on cervical damage is not yet to be known. So through this research we intend to be helpful in developing effective program and safety equipment. Materials and Methods: During two seasons from December 2009 to march 2011, cased 658 cervical injuries within 14538 admittance in medical center of major resort due to skiing and snow-boarding injuries. For survey and research model, one year before the research year conducted a pilot study. Admittance were 432 male and 226 female, advanced 273 and 385 novice. We divided them into two groups depending on wearing helmet, measured cervical damage ratio and injury mechanism, and researched the severity of damage and diagnosed injury. Each group used SPSS 12.0 (SPSS Inc., Chicago, IL, USA) to process data statistically. Results: The number of patients was 312 in skier and 346 in snow boarder. Patients wearing helmet were 146 in skier and 127 in snow boarder. Classification of each injuries were confirmed as 292 cases of simple sprain, 359 bruising, 6 cervical fractures and 1 case of dislocation. Classification of injury mechanisms were 287 of human collision, 212 material collision, 108 of slip down by oneself, 39 of falling and 12 cases of etc. In cases wearing helmet ski 78/ snow board 70 were simple sprain, ski 64/ snowboard 68 were shown as bruising, ski 1/ snow board 2 had cervical fracture or dislocation. The ratio of cervical sprain increased in cases of wearing helmet compared to non-wearing cases and there was a statistical significance (p<0.001). The ratio of cervical contusion increased significantly in non-wearing helmet user (p<0.05). However, there was no significant increase in fracture and dislocation compared between helmet user and non-user (p> 0.05). Conclusion: In this study, wearing helmet had no relation to additional cervical injury occurrence or severity among skiers and snow boarders. The ratio of cervical sprain increased significantly in helmet user with person to person accident. However, the cervical contusion decreased. On this ground, further biomechanical studies are required and modified helmet will be necessary.

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Craniofacial morphologic alteration induced by bone-targeted mutants of FGFR2 causing Apert and Crouzon syndrome (어퍼트 및 크루즌 증후군을 유발하는 골조직 특이성 FGFR2 돌연변이에 의한 두개안면 형태의 변화)

  • Lee, Kee-Joon;Nah, Hyun-Duck;Tjoa, Stephen T. J.;Park, Young-Chel;Baik, Hyoung-Seon;Yun, Tae-Min;Song, Jin-Wook
    • The korean journal of orthodontics
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    • v.36 no.4
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    • pp.284-294
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    • 2006
  • Objective: Activating mutations in the fibroblast growth factor receptor-2 (FGFR2) have been shown to cause syndromic craniosynostosis such as Apert and Crouzon syndromes. The purpose of this pilot study was to investigate the resultant phenotypes induced by the two distinctive bone-targeted gene constructs of FGFR2, Pro253Arg and Cys278Phe, corresponding to human Apert and Crouzon syndromes respectively. Methods: Wild type and a transgenic mouse model with normal FGFR2 were used as controls to examine the validity of the microinjection. Micro-CT and morphometric analysis on the skull revealed the following results. Results: Both Apert and Crouzon mutants of FGFR2 induced fusion of calvarial sutures and anteroposteriorly constricted facial dimension, with anterior crossbite present only in Apert mice. Apert mice differed from Crouzon mice and transgenic mice with normal FGFR2 in the anterior cranial base flexure and calvarial flexure angle which implies a possible difference in the pathogenesis of the two mutations. In contrast, the transgenic mice with normal FGFR2 displayed normal craniofacial phenotype. Conclusion: Apert and Crouzon mutations appear to lead to genotype-specific phenotypes, possibly causing the distinctive sites and sequence of synostosis in the calvaria and cranial base. The exact function of the altered FGFR2 at each suture needs further investigation.

A Study on the infringement of privacy of unmanned aircraft : Focusing on the analysis of legislation and US policy (무인항공기의 사생활 침해에 대한 법적 대응 : 미국 정책.입법안 분석을 중심으로)

  • Kim, Sun-Ihee
    • The Korean Journal of Air & Space Law and Policy
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    • v.29 no.2
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    • pp.135-161
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    • 2014
  • An unmanned aerial vehicle (UAV), commonly known as a drone and also referred to as an unpiloted aerial vehicle and a remotely piloted aircraft (RPA) by the International Civil Aviation Organization (ICAO), is an aircraft without a human pilot aboard. ICAO classify unmanned aircraft into two types under Circular 328 AN/190. Unmanned aircraft, which is the core of the development of the aviation industry. However, there are also elements of the legal dispute. Unmanned aircraft are manufactured in small size, it is possible to shoot a record peripheral routes stored in high-performance cameras and sensors without the consent of the citizens, there is a risk of invasion of privacy. In addition, the occurrence of the people of invasion of privacy is expected to use of civilian unmanned aircraft. If the exposure of private life that people did not want for unmanned aircraft has occurred, may occur liability to the operator of unmanned aircraft, this is a factor to be taken into account for the development of unmanned aircraft industry. In the United States, which is currently led by the unmanned aircraft industry, policy related to unmanned aircraft, invasion of privacy is under development, is preparing an efficient measures making. Unmanned aircraft special law has not been enforced. So there is a need for legal measures based on infringement of privacy by the unmanned aircraft. US was presented Privacy Protection Act of unmanned aircraft (draft). However Korea has many laws have been enacted, to enact a new law, but will be able to harm the legal stability, there is a need for the enactment of laws for public safety of life. Although in force Personal Information Protection Law, unmanned aerospace, when the invasion of privacy occurs, it is difficult to apply the Personal Information Protection Law. So, it was presented a privacy protection bill with infringement of privacy of unmanned aircraft in the reference US legislation and the Personal Information Protection Act.

The Importance-Performance Analysis of Bakery Cafe Choice Attributes Perceived by Customers in Seoul (베이커리카페 선택속성의 중요도 및 수행도 분석: 서울지역을 중심으로)

  • Choi, Mi-Kyung;Jung, Jae-Chan
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.35 no.4
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    • pp.456-463
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    • 2006
  • The purposes of this study were to extract choice attributes of bakery cafe customers and to conduct important- performance analysis (IPA) of choice attributes perceived by bakery cafe customers. The questionnaire was developed through literature review and focus group interview, and modified after pilot test. The questionnaires for main survey were distributed to 320 males and females aged 20 and over in Seoul. A total of 275 questionnaires were used for analysis (85.9%) and the statistical analyses were conducted using SPSS Win (12.0) for descriptive analyses, exploratory factor analysis, reliability analysis, and correlation analyses. The main results were as follows. 'Products', 'convenience to use', 'services and price', 'interior environments' 'brand' and 'location' dimensions were extracted as choice attributes dimensions of bakery cafe customers and customers of bakery cafe regarded 'sanitation and cleanness', 'kindness of employees', 'quality of products', 'comfortable and pleasant facilities' and 'taste of bakery products' as more important than other attributes. In addition, the results of IPA showed that marketing managers of bakery cafes should focused on the dimension of 'services and price' in the reason that this dimension was low at performance although customers regarded it very important. Overall, researchers and managers of bakery cafes should understand unique choice attributes of bakery cafe customers, and make efforts to establish marketing strategies that meet bakery cafe customers' needs.