• Journal of the Society of Disaster Information
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• v.17 no.4
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• pp.778-785
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• 2021

Purpose: The study is to analyze the current status of international clinical trial information services related to COVID-19 and to find out the impact of disclosing activities of clinical trial registration on the medical and pharmaceutical industry. Method: To achieve the purpose of the study, this study analyzed the current status of 780 registered clinical trials for COVID-19 during March of 2020 by using regression analysis. Result: The analysis of clinical trial research registration information showed and proved its usefulness for the development of related new drugs, treatments, vaccines, predictive and prognostic diagnostic kits and treatments related to the COVID-19 (Corona 19) in the world. Conclusion: The study concludes and urges all medical and pharmaceutical companies to register their trials on CRIS and recommends utilizing this registered data to develop advanced drug to benefits all patients related to COVID-19.

• Proceedings of the Korean Society for Information Management Conference
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• 2017.08a
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• pp.104-104
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• 2017

연구 데이터란 과학적 연구에서 사용된 일차 자료와 연구자에 의해 직접 작성된 연구의 결과로서 수치, 문자, 이미지, 음성 등의 사실적 기록을 의미한다. 이 연구의 주제 분야인 의학은 잠재적 가치와 활용 가능성이 높고 공익적 성격을 가지고 있는 학문 분야로 의학 연구 데이터의 종류와 관리의 필요성을 통해서 그 가치와 공유 의미를 찾아보고자 한다. 또한 연구 데이터의 대표적인 임상 시험 기록과 연구 논문의 발표와 공유 현황에 대해서도 살펴보고 그 안에서 도서관의 역할이 어떤 것인가를 짚어보고자 한다. 의학 연구 데이터는 환자 진료기록, 건강 검진 기록, 임상 기록, 사망 기록, 임상 시험 기록, 유전체 정보, 연구 논문 등 그 종류와 형태가 다양하며 대용량인 경우가 많다. 의학 연구는 개인 정보보호와 윤리적인 문제 등 연구 수행 과정에서 어려운 점이 많은 성격을 가지고 있으나 질병 치료나 예방 나아가 인류의 건강과 직접적으로 관련된 학문 분야로 의학 연구 데이터의 보존과 공개, 공유를 위한 관리는 큰 의미가 있다. 의학 연구 데이터관리는 새로운 연구의 밑받침이 될 뿐만 아니라 중 저개발 국가의 연구자들에게도 큰 기회를 부여하여 세계적인 의학 발전에 기여할 수 있다. 또한 임상 시험 결과에 대한 은폐와 거짓 연구 방지에도 의미가 있어 미국뿐만 아니라 전세계적으로 학술 연구 논문 발표에 사용된 데이터는 등록하도록 규정하고 있다. 임상 시험 등록으로 공인된 사이트는 NIH의 ClinicalTrials.gov, ICTRP의 Primary Registry 등이 있으며, 우리나라에도 질병관리본부 국립보건연구원에서 관리하는 CRIS 등이 있다. 의학 연구자들은 연구의 시작부터 연구 데이터를 수집, 사용, 보존, 공유의 문제를 고려해야 하나 시간적 물리적인 문제 등으로 어려움을 겪고 있으며, 이를 지원하는 서비스는 도서관에서도 관심이 높아지고 있는 분야로 Virginia Commonwealth 대학 도서관과 Emory 대학 도서관 등에서 시도되고 있다. 이 서비스는 연구 과정에서 사서의 지원이 가능한 새로운 기회로 연구자의 데이터관리를 위한 단계별 스토리를 조직하고 DMP 작성 지원 및 교육 등을 통해서 학술 커뮤니케이션에서 새로운 역할자로 자리잡을 수 있을 것이다.

• Radiation Oncology Journal
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• v.26 no.2
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• pp.104-112
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• 2008

Purpose: To assess the toxicity and tumor response induced by $DCVac/IR^{(R)}$ dendritic cell(DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. Materials and Methods: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of $6{\times}10^6$ DCs were packed into a vial($DCVac/IR^{(R)}$, 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses($3{\times}10^6\;to\;12{\times}10^6$ DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. Results: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The $12{\times}10^6$ DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. Conclusion: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The $DCVac/IR^{(R)}$ immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.48 no.3
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• pp.245-254
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• 2022

In this study, we tried to investigate the efficacy of combined light therapy using low-power lasers at 655 nm and LEDs emitting wavelengths at 625 ± 5 nm and 850 ± 10 nm in hair loss and scalp. A total of 33 subjects were enrolled in this clinical trial. Each subject used the LLLT and LED device on the scalp for 10 min on a daily basis for 12 weeks. After 12 weeks of LLLT and LED device use, there were significant improvements in redness, elasticity, and hydration of the scalp. Additionally, hair luster and tensile strength were improved. A remarkable decrease in total shed hairs was observed in all subjects at 4, 8, and 12 weeks without any serious adverse event. Combined light therapy using LLLT and LEDs proved to be an effective treatment for reducing hair loss and improving scalp condition.

• The Korean Nurse
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• v.23 no.3 s.126
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• pp.7-21
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• 1984

한국간호 I. 간호행정제도 및 법규의 변천 1. 간호행정기구 한국의 의료행정은 현대의학의 도입과 더불어 1894년 6월 내부에 위생국을 둔다는 규정이 발표됨으로서 시작되었고 1901년 관제개편에 따라 위생국에 보건과와 의무과가 설치되었다. 그 후 1945년 12월 보건후생부 간호사업국내에 보건간호과 기관간호과 조산 간호과가 설치되었고 각 도에는 간호 사업계가 설치되었다. 1948년부터는 보건사회부 의정국내의 조산간호과가 간호 사업과로 개편되었다. 그후 1970년 간호사업과가 간호사업담당관제로 개편되었으며 1981년부터는 간호사업담당관제도 폐지되어 보건국의 가족보건과나 의정국 지역의료과에서 한 명의 간호원이 참여하는 정도로 간호행정기구가 점차 축소되었다. 2. 간호법규 1)면허 1962년 개정된 의료법에 의하여 간호원의 면허는 문교부장관이 인가한 간호교육기관 졸업자중 간호원 국가시험 합격자로 규정하였다. 조산원의 경우는 1914년 처음으로 조산원 면허등록을 시작하였으며 현재는 간호원 면허를 받은 자로서 보건사회부장관이 지정하는 교육병원에서 1년의 정규 교육과정을 필한자로 그 자격을 명시하고 있다. 2) 자격시험 자격시험은 1916년부터 실시되었으며 1920년 이후는 각 도에서 관할 실시하였다. 그 후 1962년부터는 보건사회부장관의 주도하에 국가시험을 시행하였으며 현재는 국립 보건원에서 간호원을 포함한 의료업자의 국가 시험을 주관하고 있다. 3)간호수가 간호원 조산원에 관한 간호수가 관계 규칙은 1911년에 발표된 것으로 간호원의 경우 출장 시에 출장비와 간호료를 환자가 지불하도록 하는 것이었다. 1925년 5월까지는 각 지역별로 간호수가에 차이가 있었으나 동년 6월부터 수가규정이 전국적으로 통일되었다. 그 후 1953년부터는 국공립병원 간호원들에게도 다른 일반 공직자와 같이 직급을 보함으로서 간호직에 대한 보수가 통일되었으며 1971년부터는 간호직 수당이 제정되었다. II. 간호사업의 분야별 발전 1. 임상간호제도의 발전 1)초기의 임상간호 한국에 서양의학을 기초로 설립된 최초의 병원은 1885년 의사 Allen에 의한 왕립병원이다. 그 후 정부에 의하여 1894년 군부병원이 설립되었고, 1899년 내부병원이 1904년에 적십자 병원이 설립되었다. 당시에 이루어진 현대간호는 일본인 간호원들에 의해 전해진 일본식 간호와 선교사 간호원들에 의해 전해진 서구식 간호방식이 있었는데 이 두 간호방법은 문화적 배경이나 사회적 인습에 의한 많은 차이점을 볼 수 있었다. 2) 일제하의 임상간호 이 당시에 이루어진 일본식 간호방법을 보면 간호원들의 주업무가 환자를 위한 간호보다도 의사 보조에 더 치중한 것을 볼 수 있다. 한편 선교계 병원에서는 입원환자에 대해서는 간호원들이 전인간호를 실시하였으며 병원당국과 의사들의 협조로 많은 간호사업의 발전을 가져올수 있었다. 3) 광복 이후의 임상간호 6.25 동란 후 한국에는 병원이 계속 늘어나 현재 20Bed 이상의 전국의 병원수가 431개소이고 이중 80Bed 이상의 종합병원이 148개소나 된다. 각 병원의 간호사업은 간호사업과 또는 간호사업부의 행정체제로 운영되고 있으며 최근에는 간호과정(Nursing Process)의 개념을 도입하여 문제중심 간호기록인 POMR(Problem Oriented Medical Record) 방법을 시도하고 있다. 또한 면허간호원은 매년 중앙회에서 실시하는 보수교육을 10시간 이상 받고 있다.

• The Korean Journal of Applied Statistics
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• v.19 no.3
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• pp.395-406
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• 2006

Long-term survival rates are the most commonly used outcome measures for patients with cancer. However, traditional long-term survival statistics, which are derived by cohort analysis or complete analysis, essentially reflect the survival expectations of patients diagnosed many years ago. They are often outdated at the time they become available. In this article, we propose a modified product-limit method to obtain up-to-date estimates of long-term survival rates via a period analysis. The proposed method is illustrated with cancer registry data collected from January 1993 to December 1997.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.32 no.2
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• pp.68-93
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• 2019

Objective : This study summarized the characteristics of clinical trials for atopic dermatitis medicines approved by the Ministry of Food and Drug Safety(MFDS). This study may be a reference for the design of clinical trials of atopic dermatitis herbal medicine treatment which may be carried out later. Method : The characteristics of the clinical trial were analyzed for clinical trials registered with ClinicalTrials.gov, CRIS, and the Korea Health Industry Development Institute among the clinical trial approval statuses posted on the website of the MFDS. Result : 1. Clinical trial drugs were developed in various formulations such as oral medicines, injections, dermatologic agents, and similar proportions. Relatively little clinical trials were found for herbal medicine. 2. In the control evaluation test, most of the treatments for the control group were performed with placebo using Vehicle. 3. In most clinical trials, one intervention group was in the form of a parallel assignment with only one treatment. 4. The age of the subjects was 11 out of 28 studies including minors, and clinical trials targeting minors were also found to be significant. 5. In the case of atopic dermatitis, the cases of subacute chronic or atopic dermatitis more than 6 months or more than 1 year were often used. 6. Most clinical trials were divided into mild to moderate atopic dermatitis or moderate to severe atopic dermatitis. The SCORAD index, EASI, IGA, BSA, and NRS were used as the evaluation criteria. 7. Regulations for the drugs used prior to the trial period for the treatment of atopic dermatitis vary somewhat from one clinical trial to another. 8. IGA was used most often as a primary efficacy tool, and SCORAD index, EASI, and NRS were also used.

• Radiation Oncology Journal
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• v.24 no.4
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• pp.263-271
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• 2006

$\underline{Purpose}$: To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. $\underline{Materials\;and\;Methods}$: Our study was open labelled prospective phase IV multi-center study. the study population included patients with more 4 numeric rating scale(NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups; patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief; second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. $\underline{Results}$: Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, p=0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. $\underline{Conclusion}$: Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There was no major side effect.

• The Journal of the Acoustical Society of Korea
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• v.39 no.4
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• pp.303-317
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• 2020

Extracorporeal Shock Wave Therapy (ESWT) is an innovative treatment in chronic musculoskeletal pain management and cardiovascular diseases. In this study, we surveyed the acoustic shock wave outputs from the domestically used focal type ESWT devices. The survey data were collected through 30 technical documents registered to the Ministry of Food and Drug Safety (MFDS), Rep. Korea. The results show that the focusing geometry varies largely, 5 mm to 65 mm in the focal length, 3 mm to 30 mm in focal width, and 4 mm to 108 mm in focal depth. The maximum positive pressure (P+) ranges from 7 MPa to 280 MPa, the focal Energy Flux Density (EFD) from 0.0035 mJ/㎟ to 35 mJ/㎟, and the energy per pulse (E) from 0.737 mJ to 80.86 mJ. All domestic PE-type (five) and one EM-type domestic devices included in the analysis of the correlation between P+ and EFD are shown to be far beyond the usual ranges and do not comply with expected correlation so that the reliability of their data was suspected. For the suspected, post-performance tests are required by a recognized testing agency. MFDS guidelines need to be revised so that the pass criteria for the shock wave acoustic outputs can be based on the clinical tests for indications.

• Korean Journal of Acupuncture
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• v.35 no.2
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• pp.70-81
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• 2018

Objectives : To investigate the association of trial registration status with presence of reporting bias including publication bias and outcome reporting bias in recently published randomized controlled trials (RCTs) of acupuncture. Methods : A PubMed search for RCTs of acupuncture published from March 2016 to February 2017 was conducted. Primary outcomes were identified and the direction of the results was judged as positive (i.e., statistically significant) or negative. The trial registration was identified by manually screening the trial registration number in the main text of the published article and classified into 1) prospective registration; 2) retrospective registration based on the registration date or; 3) no registration. Results : Of the 125 included RCTs, only 40 studies (32.0%) prospectively registered the study protocols. Among 65 RCTs that adequately reported the primary outcome, unregistered trials were more likely to report positive results than the registered ones (p=0.013). Of the 40 prospectively registered studies, 19 trials (47.5%) had the discrepancies between the registered and published primary outcomes and furthermore, 40% of them reported the positive findings. Conclusions : Unregistered trials were more likely to report positive results and the discrepancies between the registered and published primary outcomes were detected in about a half of the prospectively registered studies, 42.1% of which tended to report positive findings. Journal editors and researchers in this field should be alerted to various reporting biases.