• Title/Summary/Keyword: medical contract

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Child health promotion program in South Korea in collaboration with US National Aeronautics and Space Administration: Improvement in dietary and nutrition knowledge of young children

  • Lim, Hyunjung;Kim, JiEun;Wang, Youfa;Min, Jungwon;Carvajal, Nubia A.;Lloyd, Charles W.
    • Nutrition Research and Practice
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    • v.10 no.5
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    • pp.555-562
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    • 2016
  • BACKGROUND/OBJECTIVES: Childhood obesity has become a global epidemic. Development of effective and sustainable programs to promote healthy behaviors from a young age is important. This study developed and tested an intervention program designed to promote healthy eating and physical activity among young children in South Korea by adaptation of the US National Aeronautics and Space Administration (NASA) Mission X (MX) Program. SUBJECTS/METHODS: The intervention program consisted of 4 weeks of fitness and 2 weeks of nutrition education. A sample of 104 subjects completed pre- and post- surveys on the Children's Nutrition Acknowledgement Test (NAT). Parents were asked for their children's characteristics and two 24-hour dietary records, the Nutrition Quotient (NQ) at baseline and a 6-week follow-up. Child weight status was assessed using Korean body mass index (BMI) percentiles. RESULTS: At baseline, 16.4% (boy: 15.4%; girl: 19.2%) of subjects were overweight or obese (based on $BMI{\geq}85%tile$). Fat consumption significantly decreased in normal BMI children ($48.6{\pm}16.8g$ at baseline to $41.9{\pm}18.1g$ after intervention, P < 0.05); total NQ score significantly increased from 66.4 to 67.9 (P < 0.05); total NAT score significantly improved in normal BMI children (74.3 at baseline to 81.9 after the program), children being underweight (from 71.0 to 77.0), and overweight children (77.1 at baseline vs. 88.2 after intervention, P < 0.001). CONCLUSIONS: The 6-week South Korean NASA MX project is feasible and shows favorable changes in eating behaviors and nutritional knowledge among young children.

Medicolegal Study on Human Biological Material as Property (인체 유래 물질의 재산권성에 대한 의료법학적 고찰)

  • Lee, Ung-Hee
    • The Korean Society of Law and Medicine
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    • v.10 no.2
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    • pp.455-492
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    • 2009
  • (Background) Recent biotechnological breakthroughs are shedding new lights on various ethical and legal issues about human biological material. Since Rudolph Virchow, a German pathologist, had founded the medical discipline of cellular pathology, issues centering around human biological materials began to draw attention. The issues involving human biological materials were revisited with more attention along with series concerns when the human genome map was finally completed. Recently, with researches on human genes and bioengineering reaping enormous commercial values in the form of material patent, such changes require a society to reassess the present and future status of human tissue within the legal system. This in turn gave rise to a heated debate over how to protect the rights of material donors: property rule vs. no property rule. (Debate and Cases) Property rule recognizes the donors' property rights on human biological materials. Thus, donors can claim real action if there were any bleach of informed consent or a donation contract. Donors can also claim damages to the responsible party when there is an infringement of property rights. Some even uphold the concept of material patents overtaking. From the viewpoint of no property rule, human biological materials are objects separated from donors. Thus, a recipient or a third party will be held liable if there were any infringement of donor's human rights. Human biological materials should not be commercially traded and a patent based on a human biological materials research does not belong to the donor of the tissues used during the course of research. In the US, two courts, Moore v. Regents of the University of California, and Greenberg v. Miami Children's Hospital Research Institute, Inc., have already decided that research participants retain no ownership of the biological specimens they contribute to medical research. Significantly, both Moore and Greenberg cases found that the researcher had parted with all ownership rights in the tissue samples when they donated them to the institutions, even though there was no provision in the informed consent forms stating either that the participants donated their tissue or waived their rights to ownership of the tissue. These rulings were led to huge controversy over property rights on human tissues. This research supports no property rule on the ground that it can protect the human dignity and prevent humans from objectification and commercialization. Human biological materials are already parted from human bodies and should be treated differently from the engineering and researches of those materials. Donors do not retain any ownership. (Suggestions) No property rule requires a legal breakthrough in the US in terms of donors' rights protection due to the absence of punitive damages provisions. The Donor rights issue on human biological material can be addressed through prospective legislation or tax policies, price control over patent products, and wider coverage of medical insurance. (Conclusions) Amid growing awareness over commercial values of human biological materials, no property rule should be adopted in order to protect human dignity but not without revamping legal provisions. The donors' rights issue in material patents requires prospective legislation based on current uncertainties. Also should be sought are solutions in the social context and all these discussions should be based on sound medical ethics of both medical staffs and researchers.

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Preparation of Reproducible and Responsive Scar Model and Histology Analysis

  • Kim, Sang-Cheol;ChoLee, Ae-Ri
    • Journal of Pharmaceutical Investigation
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    • v.40 no.1
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    • pp.45-49
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    • 2010
  • Unlike human, with some exceptions, animals do not heal with excessive scar. The lack of suitable animal model has hindered the development of effective scar therapy. We previously reported that partial thickness rabbit ear wound model resembles human wound heal process. This study was designed to prepare a hypertropic scar wound model which can be employed for testing anti-scar therapy. Four wounds were created down to the bare cartilage on the anterior side of each rabbit ear using 8-mm dermal biopsy punch and histology analysis at post operation day (POD) 5, 28 and 48 were performed. As the outcome of scar formation is largely determined by the early inflammatory response to the wounding and the degree and the duration of occlusion, cephalodin(50 mg/kg) was injected daily and medical occlusive dressings were applied. Five micro wound and scar sections were stained with hematoxylin and eosin for quantification of epidermal regeneration and scar hypertrophy. Sections were also stained using Masson's trichrome and Sirius red to evaluate collagen organization and rete ridge formation. Wound closure process was assessed to 7wks post wounding. Complete removal of the epidermis, dermis and perichondrial layer caused delayed epithelialization, which results in hypertropic scarring. The inability of the wounds to contract and the delay in epithelialization in rabbit ear was likely due to cartilage and it created scar elevation. The results suggest that full thickness surgical punch wound model in rabbit ear could be employed as a reliable and reproducible scar wound model for testing anti-scar therapy.

The Comparative of Inhibitory Effect of Various Solvent Extracts from Aloe arborescens and Aloe vera on Tumor Cell Lines Using Clonoginic Assay (Clonogenic Assay를 이용한 Aloe arborescens와 Aloe vera 용매 추출물의 종양세포 억제효과의 비교)

  • Hong, Hee-Sun;Lee, Keyong-Ho;Kim, Jeong-Hwan;Kang, Hee-Gon;Cho, Choa-Hyoung;Kim, Chang-Han
    • Korean Journal of Pharmacognosy
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    • v.30 no.3
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    • pp.275-279
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    • 1999
  • The solvent extracts from Aloe arborescens and Aloe vera were randomly screened for inhibitory effects on the growth of tumor cell lines. In case of Aloe vera extracts, butyl alcohol extract and ethyl alcohol extract showed antitumor activity at $100\;{\mu}g/ml$ on lung cell lines(A427, Sk-mes-1, Calu-3 and 3LL). In Aloe arborescens extracts, butyl alcohol extract and ethyl alcohol extract exerted high activity at $100\;{\mu}g/ml$ on breast cell line(Hs-578T) and lung cell line(Sk-mes-1), respectively. The solvent extracts from Aloe vera exerted antitumor activity broadly on various tumor cell lines. In contract, the solvent extracts from Aloe arborescens exerted specific antitumoricity on a few tumor cell lines.

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A Study on System for International Standard(IS) based Clinical Information Management (국제표준 기반의 임상정보 관리체계 구축에 관한 연구)

  • Choi, Yongjung
    • Proceedings of the Korean Society of Computer Information Conference
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    • 2014.01a
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    • pp.429-432
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    • 2014
  • 국내 제약산업의 경쟁력을 제고시키기 위해서는 신약의 심사/허가 기간을 단축시켜 급변하게 변하는 글로벌 제약시장에서 경쟁 우위적 위치를 선점할 수 있도록 기회를 제공할 수 있도록 체계 개선이 시급하다. 신약허가를 위해서는 임상시험 결과에 대한 안전성과 유효성 등에 대한 심사가 수행되게 된다. 하지만 현재 신약허가를 위해서 제약사와 임상시험수탁기관(Contract Research Organization, CRO)에서 데이터 정보체계인 Domain, Variable 및 Parameter 등의 표준을 따르지 않고 다양한 유형의 임상정보데이터를 심사기관에 제출하고 있어 이로 인한 심사기간 증가와 심사업무 비효율성을 야기시키고 있다. 따라서 본 연구에서는 국제민간기구인 CDISC (Clinical Data Interchange Standards Consortium)에서 제정한 글로벌 임상데이터 표준인 CDISC 표준을 준용한 국내 임상시험정보관리 체계 (eCTD 시스템)및 의약품 전주기적 관리체계를 제시하고자 하며, 본 연구를 통한 기대효과로는 국제표준의 임상정보관리 인프라 구축으로 인한 국내 신약개발 및 해외 진출 환경을 마련하여 글로벌 시장선점의 기회를 제공할 수 있고, 규제기관 차원에서는 의약품 허가, 심사업무의 효율성 증가는 물론 전주기적 의약품 안전관리체계를 마련할 수 있을 것으로 사료된다.

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A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine - Historical Evidence-Based Medicine II - (한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고 - 역사적 근거 발굴부터 천연물신약 임상시험계획승인신청까지 -)

  • Eom, Seok-ki;Kim, Se-hyun;Kim, Kyung-suk;Park, Sang-jae;Eo, Wan-kyu;Choi, Won-cheol
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.63-102
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    • 2010
  • Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

Review of 2017 Major Medical Decisions (2017년 주요 의료판결 분석)

  • Lee, Jung Sun;Lee, Dong Pil;Yoo, Hyun Jung;Jeong, Hye Seung;Park, Tae Shin
    • The Korean Society of Law and Medicine
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    • v.19 no.1
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    • pp.207-254
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    • 2018
  • The major court rulings delivered in 2017 include the ruling that separated the legal character of denture production agreement signed together with medical care agreement and found a subcontracting dimension in the former, and the ruling that overcame the limitations of the theory of entire appearance of a fetus as discussed in civil law by using the legal principle of insurance which suggests that unborn child insurance takes effect after the contract is signed and the first installment of the premium is paid in. As more court rulings find the medical specialists responsible for accidents and injuries from drugs, some argue that medication counseling by the druggist who makes and dispenses drugs should be upgraded. And with respect to a court ruling that denied the hospital's responsibility for an infection-involving accident even if there were no records on specific measures taken in infection management, some criticized the court for being too conservative in recognizing responsibilities. And with respect to infectious disease management, some criticized the court for its interpretation and application of the facts in the direction of denying the negligence. In addition, some claimed that it is necessary to establish institutional system for hospital infection control and its aid for victims, and to improve the system including the reversal of the burden of proof given the special nature of hospital infections. A number of rulings on the duty to disclose included the one which stated that the specific matter did not require a doctor's explanation as it was explained or the specific medical service would have been performed even if no explanation had been given. There was a greatly controversial ruling over the scope of indemnification, which accepted the occurrence of multiple scars and deformation as disorders while regarding breast as a thoracic organ. And a Supreme Court ruling over interpreting Medical Service Act was criticized as overstepping the boundary allowed in the law.

The Qualification of Dentist for Sedation : BLS and ACLS (진정법을 준비하는 치과의사의 자격요건 : 기본생명구조술과 전문심장구조술)

  • Kim, Jongbin;Yoo, Seunghoon;Kim, Jongsoo
    • Journal of the korean academy of Pediatric Dentistry
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    • v.42 no.1
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    • pp.80-86
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    • 2015
  • Dentists who want to perform sedation must have abilities to control any emergent situation that may occur during treatment procedures. In the 2010 guideline for the use of sedation by dentists, he/she must has valid certifications for basic life support (BLS) and for advanced cardiovascular life support (ACLS). The Korean Association of Cardiopulmonary Resuscitation (KACPR) has made a contract with the American Heart Association for education and certification. From 2004, they have held many courses for BLS and ACLS providers and instructors. The author of this research participated in the above mentioned courses and qualified as a BLS provider, BLS instructor and ACLS provider. The present paper was intended as an introduction to and arrangement of BLS and ACLS courses for health care providers through a year of experience. However, the previous course of the ACLS provider was focused more toward medical doctors. It is necessary to develop a new advanced course for dentists who employ sedation in their medical practices.

Study of Usage of Underwriting under Shared Policy Contract (계약정보 공유에 따른 언더라이팅 활용에 대한 고찰)

  • Bae, Young-Hie
    • The Journal of the Korean life insurance medical association
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    • v.22
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    • pp.121-137
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    • 2003
  • 현행 생명보험업계는 중복가입계약에 대한 정보교환제도를 시행함으로써 잠재적 위험에 대한 위험평가를 하고는 있으나 실제 언더라이팅 과정에서는 효율적인 활용을 못하고 있다. 따라서 언더라이팅 실무 입장에서 현행 정보교환제도의 문제점을 파악하고 각 보험회사가 취할 수 있는 효율적인 대응방안을 제시할 필요성이 대두되고 있다. 현행 정보교환제도의 문제점을 크게 몇가지로 나눌 수 있다. - 교환기준에 미달하는 다수의 계약건을 가입한 경우 위험평가 불가 - 위험평가상 고지의무에 충실한 계약자의 상대적 불리 - 정해진 기준과 다른 임의적 기준적용 등 선별적 자료교환으로 위험선택에서 배제된 잠재적 위험들의 계속적인 계약 및 지급 등 역선택 방조기능 - 실시간 반영된 정보부재 및 교환된 자료만으로 one-stop 위험평가를 할 수 없는 어려움 내재 - 정보교환에 대한 전체적 참여노력 부족 및 자기정보에 대한 방어와 자체 활용 이런 문제점들을 인식하고 이에 대한 효율적 대응방안을 제시해 본다. - 언더라이팅 측면에서 판매채널 다변화, 업무겸업화 둥 대외 환경변화에 따른 위험분석 및 평가, 위험분산을 위한 multi-player로서의 언더라이터 양성 필요 - 지급, 조사건의 분석 및 통계화 등 feed back 기능 강화통한 언더라이팅 활용 - 방문진단 통한 적부기능 활용 또는 모집자 사정평점제 등 언더라이팅 과정에서 활용할 수 있는 위험평가 자료축적 - 영업환경적 측면에서 고보장 상품의 경쟁적인 개발제한 - 정보교환제도 측면에서 정보교환 기준 변경 및 교환내용 추가 및 공동의 계약인수 guideline 필요 - 진단거절체, 표준미달체, 사절체 등 새로운 정보교환의 추진 필요 - 종합적인 피보험자의 정보를 획득할 수 있는 피보험자 종합정보의 데이터 구축 및 활용 효율적인 위험관리 외에도 각 보험회사별로 역선택 위험에 대한 심각성을 인식하고 업계간 정보교환에 적극적인 참여와 노력이 필요하며 잠재적 위험평가를 하는데 있어 계약자에게는 객관적 근거없이 불편을 갖지 않도록 언더라이팅 서비스하는 것 또한 중요하다. 지속적인 피보험자의 위험통계축적으로 잠재위험에 대한 보다 객관화된 위험평가를 할 수 있는 언더라이팅 기법을 체득함으로써 언더라이팅 경쟁력을 갖을 수 있다.

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Standing Issues and Policy Tasks of the Korean Dental Community - The direction of reforming the country's health insurance system (치과의료계의 현안과 정책과제 - 건강보험제도의 현안과 발전방향 모색)

  • Lee, Soo-Ku
    • The Journal of the Korean dental association
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    • v.48 no.1
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    • pp.6-11
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    • 2010
  • Amid the rapid transitions in both local and international markets, the Korean dental industry is facing more challenges than at any time in its history. This paper tried to address some of the key issues faced by the industry as well as the policy issues and I direction of implementation that the Korean Dental Association (KDA) is expected to tackle. First, the direction of reforming the country's health insurance system was examined with emphasis on the expected changes in and improvement of the fee-for-service reimbursement system (FFSRS) and medical reimbursement system (MRS). With FFSRS, the most urgent issue would be ameliorating the current lop-sided, unreasonable reimbursement system that prevents suppliers from voicing their opinions. To help achieve that goal, the limited authority and responsibility of the president of National Health Insurance Corporation (NHIC) as one of the contract-making parties must be clarified. In addition, the functions of NHIC's Health Insurance Finance Committee must be restricted; at the same time, the panel organization of the Health Insurance Policy Review Committee needs to be reformed to embrace greater democracy. As with MRS, the government is considering a block budget bill to help promote efficiency in employing and managing the health insurance fund. Policymakers must understand that the implementation of such proposal could exacerbate an already dire situation. Improving MRS requires meeting the following preconditions: (a) the structurally vicious cycle of small charge-small salary needs to be resolved, and a certain percentage of fee raise must be guaranteed on a yearly basis to help adjust the fee system to a more realistic level; (b) the supply-and-demand balance in producing health care professionals must be improved including the prevention of oversupply of doctors, nurses, etc., and; (c) institutional strategies must be provided to enhance the quality of medical care and ensure academic advancement in health care disciplines.