• Title/Summary/Keyword: institutional review board (IRB)

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Randomized, Double-blind, and Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Humulus japonicus Extract Powder on Child Height Growth: Study Protocol (소아 키 성장에 미치는 한삼덩굴추출분말의 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜)

  • Jang Subi;Choi Bom;Cheon Jin Hong;Kim Ki Bong
    • The Journal of Pediatrics of Korean Medicine
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    • v.37 no.3
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    • pp.121-132
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    • 2023
  • Objectives We aimed to confirm whether Humulus japonicus Extract Powder can enhance child height growth significantly and safely compared with a placebo. Methods A total of 150 children between the 3rd and 25th percentiles in height and between the ages of 6 and 9 years will be recruited to participate in this randomized, double-blind, placebo-controlled clinical trial. The participants will be randomly assigned to the treatment or placebo group. Participants in the treatment group will take one pack per day (700 mg of Humulus japonicus Extract Powder) for 24 weeks. Participants in the placebo group will take one package of placebo per day (0 mg of Humulus japonicus Extract Powder) for 24 weeks. The primary outcome will be a change in height after 12 weeks, and the secondary outcomes will be the height after 24 weeks, growth rate, height standard deviation, growth hormone, insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), bone alkaline phosphatase (BALP), and osteocalcin after 12 and 24 weeks. Results This protocol was approved by the Institutional Review Board (IRB) of the Korean Medicine Hospital of Busan University (IRB No. PNUKHIRB-2023-03-002). Research participants will be recruited from June 2023 to December 2023. Conclusions The results of this study provide clinical information regarding the effectiveness and safety of the Humulus japonicus Extract Powder in increasing child height.

Study on the Clinical Trial Practice of Drugs at the Designated Hospitals (국내 임상시험 실시기관의 의약품 임상시험 관리현황 분석)

  • Lee Eui-Kyoung;Jang Sun-Mee;Huh Soon-Im
    • Korean Journal of Clinical Pharmacy
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    • v.5 no.2
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    • pp.33-49
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    • 1995
  • The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

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Relationship between safety and health activities of clinical dental hygienists (일부 임상치과위생사의 안전과 보건활동 관련성)

  • Choi, Hye-Jung;Park, Kyung-Hwa
    • Journal of Korean society of Dental Hygiene
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    • v.16 no.5
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    • pp.717-723
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    • 2016
  • Objectives: The purpose of the study is to investigate the relationship between safety and health activities of clinical dental hygienists. Methods: A self-reported questionnaire was completed by 208 dental hygienists in Seoul, Gyeonggido, and Incheon from May 9 to June 30, 2016. The study was approved by institutional review board (IRB). The questionnaire consisted of general characteristics of the subjects (9 items) and safety activities (15 items), and health activities (17 items) by Likert 5 point scale. Except two incomplete answers, data were analyzed using SPSS 22.0 program. Results: The mean of safety activities and health activities was 3.04 and 3.55, respectively. A significant difference was shown in staff safety, facility safety, environmental safety, infection control, and dental technique control (p<0.001). Conclusions: A significant association was shown in safety and health activities of clinical dental hygienists. It is necessary to promote the safety and health activities for the clinical dental hygienists.

Needs of revision of dental hygienist-related medical law (치과위생사의 제도와 업무 관련 의료법 개정에 대한 요구도)

  • Kim, Sun-Il;Jun, Mi Kyoung;Lee, Sun-Mi
    • Journal of Korean society of Dental Hygiene
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    • v.16 no.5
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    • pp.677-685
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    • 2016
  • Objectives: The purpose of the study was to investigate the basic materials required for law revision regarding dental hygienists through perceptions and opinions of legislation amendments. Methods: The study was conducted from April 23, 2016. A self-reported questionnaire was completed by 797 dental hygienists in Seoul and Gyeonggido after receiving informed consent from institutional review board (IRB No. PO1-201602-23-001). Results: Necessity for dental hygienist-related medical law revision accounted for 92.4% and 85.4% of dental hygienists replied that specialized dental hygienist system must be established. The reasons for medical law revision were as follows; roles and education of medical technicians (60.6%), settlement of medical legal problems (48.0%), cooperation with other organizations (29.0%), political negotiations (17.4%), and national consensus (9.5%). The score for 'possible to get legal protection by the system establishment of roles and work scope of dental hygienists' was 4.11 of 5 points. Conclusions: It is important to establish the job scope of dental hygienist. The revision of dental hygienist-related law will help to enhance the status of dental hygienists as professional medical technicians in the future.

Sa-am Five-element Acupuncture and Hwangyeon-haedoktang Pharmacopuncture Treatment for an Essential Tremor: Three Case Reports

  • Jeong, Jong-Jin;Sun, Seung-Ho
    • Journal of Pharmacopuncture
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    • v.16 no.4
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    • pp.49-53
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    • 2013
  • The purpose of this study was to report the effect of a combination of Sa-am five-element acupuncture and eight-principle pharmacopuncture (EPP) for the treatment of an essential tremor (ET). This study reviewed the medical records treated at OO Korean medical hospital for ET by using diverse types of acupuncture without herbal medicine, other types of physical therapy, and western medication related ET or Parkinson's disease and was performed after the approval of the institutional review board (IRB). The three cases that were finally selected were then extracted and reviewed. The three cases that were finally selected involved three women in their 70s to 80s. The evaluation of the progress was made by using the numeric rating scale. A combined treatment, the method of liver excess (肝乘格), from among Sa-am five-element acupuncture, and Hwangyeonhaedoktang EPP at CV23 and CV17, was applied to all cases. In all three cases, the ET was improved, and recurred ETs improved with the same treatment. The results suggest that the combined treatment of Sa-am five-element acupuncture and Hwangyeon-haedoktang EPP may be effective for treating an ET, even though this conclusion is based on only three cases.

Current status and improvement strategies of emergency medical counseling service for overseas koreans (재외국민 응급의료상담 서비스의 이용 실태 및 서비스 향상방안)

  • Hyeon-Jeong Ko;Eun-Sook Choi
    • The Korean Journal of Emergency Medical Services
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    • v.28 no.1
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    • pp.77-95
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    • 2024
  • Purpose: This study aimed to analyze the counseling status of overseas Koreans using emergency medical counseling services, identify frequently occurring types of diseases, explore approaches to emergency treatment guidance, and protect overseas Koreans from medical blind spots, thereby enhancing the quality of emergency medical counseling services. Methods: This study was approved by the Institutional Review Board of Kongju National University (KNU_IRB_2023-31), and data were collected and analyzed from 10,951 cases of emergency medical counseling services utilized by overseas Koreans from the National Fire Agency from 2018 to 2022. Results: Emergency medical consultation services for overseas Koreans included a majority of non-trauma patients, with medical consultations being predominant. Terrestrial patients commonly seek advice for internal medical symptoms, whereas maritime patients frequently present with trauma-related symptoms, with a higher incidence of cardiac arrest and altered consciousness cases at sea. The development of self-diagnostic tests based on internal medicine symptoms is necessary for terrestrial patients, whereas stakeholder education is required for maritime patients. Conclusion: Due to the different types of diseases occurring in terrestrial and maritime patients, emergency medical consultation services for overseas Koreans should be implemented according to the specific characteristics of each patient. Therefore, it is necessary to develop and disseminate response manuals that are tailored to medical and trauma-related symptoms.

An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers (의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석)

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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The Domestic Trends of Acupuncture Treatment on Lateral Epicondylitis : A literature review (주관절 외측상과염의 침치료에 대한 국내 연구 동향 분석)

  • Kim, Hyunseok;Lee, Chiho;Oh, Minseok
    • Journal of Haehwa Medicine
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    • v.25 no.1
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    • pp.1-13
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    • 2016
  • Objectives : Lateral epicondylitis on elbow is one of the most common causes of elbow pain. Lateral epicondylitis can be managed with acupuncture, but the evidence for its effectiveness is uncertain. The purpose of this review is to investigate the trends of acupuncture treatments on lateral epicondylitis. Methods : We investigated the studies about acupuncture treatments for lateral epicondylitis via searching 5 Korean web databases(KTKP, RISS, OASIS, KCI, Kisti) The key search terms were 'Lateral epicondylitis', 'Tennis elbow', 'External epicondylitis'. 12 research papers(10 case reports, 1 RCT, 1NRCT) were found to be analyzed according to their published year, the titles of journals, published institution, the types of study, the number of cases, the types of treatments, the instruments for assessment and ethical approvals. The effectiveness of acupuncture treatment was classified. Results : 12 papers were published since 2003. The studies on acupuncture treatments about lateral epicondylitis were mainly published in The journal of pharmacopuncture. 10 case reports, 1 non-randomized controlled trials, 1 randomized controlled trials had been under research. In most of the research, the number of the cases were not enough. In 9 cases of the studies, various korean medicine treatments including acupuncture were used to treat the symptoms. In 3 cases of the studies single method was used to treat the symptoms. Visual analogue scale(VAS) and range of motion(ROM), grip strength were used as primary assessments. Among 12 clinical studies, 1 of them were accepted by institutional review board(IRB). Conclusions : In this study, we analyzed the trends of acupuncture treatments on lateral epicondylitis. Reviewing the domestic trends of studies on acupuncture treatments for lateral epicondylitis and examining the strong and weak points of those treatments are essential for the future studies.

Analyzing intervention research trends in animal-assisted therapy: a review on the Korean experimental researches from 1998 to 2022

  • Taeyoung Kil
    • Journal of Animal Science and Technology
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    • v.65 no.6
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    • pp.1111-1123
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    • 2023
  • This study aims to present a more systematic and developmental research direction by classifying animal-mediation related research trends published in Korea. We analyzed the research trends of 68 domestic animal-mediation programs published in 26 journals over the past 24 years under the premise of the necessity of animal-assisted therapy, which considered a very effective intervention method in the practice areas of various subjects. Therefore, this study examines the year of publication of animal-mediation related research conducted in various academic fields from 1998 to 2022, research data sources, characteristics of research subjects, types of interventions and research topics, research design and intervention sessions, intervention methods, and ethical consideration statements. The results of this study are as follows: First, in the source of research and research trends by year, the number of papers published in animal-related societies was the highest at 34 (50%); the number of studies has been steadily increasing since the mid-2000s. Second, regarding research trends by subject, 45 (66%) were general subjects, 23 (34%) were medically diagnosed, 60 (88%) were selected through pre-evaluation, and 8 (12%) were requested. Third, regarding research trends by method, 27 (40%) of the pretests were conducted before and after the experiment-control group, and only 3 (4%) of the 68 papers were examined later. Fourth, regarding research trends by content, depression (25%) was the most frequently applied variable, and regarding intervention sessions, 53 (78%) were less than 12 sessions. Fifth, regarding research trends and ethical consideration statements by treatment approach method, 58 cases (85%) of individual treatment approaches and 10 cases (15%) of intervention approaches integrated with individual treatment approaches, and 23 cases (34%) of studies with ethical consideration statements or the Institutional Review Board's (IRB) approval. Based on the study results, the implications and research directions of animal-assisted therapy related research are discussed.

Korean Standard Classification of Diseases of Early Postpartum Women in a Korean Medicine Hospital (일개 한방병원에 내원한 산욕초기 산모의 한국표준질병·사인분류 분석)

  • Kim, Pyung-Wha
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.1
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    • pp.73-84
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    • 2019
  • Objectives: The purpose of this study is to collect and analyze the KCD codes applied to the treatment of 27 postpartum women who had been treated with Korean traditional medicine in a Korean medicine hospital, so that this study may be used as a basic data for setting the direction of postpartum Korean medical treatment research. Methods: It was approved by the Institutional Review Board (IRB) of ${\bigcirc}{\bigcirc}$ University medical center (IRB approval number : WSOH IRB H1708-02-01). Twenty-seven postpartum women who had been treated at ${\bigcirc}{\bigcirc}$ University medical center were received outpatient treatment for two weeks (from September 27, 2017 to January 5, 2018), and the KCD codes applied to the mothers were collected after obtaining the consent. On the day of registration of the study, the fertility, obstetric history and high-risk pregnancies were identified through an interview. Results: 1. The mean age of the 27 subjects was $33.33{\pm}3.99\;years$ old. Among the subjects, 17 mothers (63.0%) were high-risk pregnancy and 10 mothers (37.0%) were normal. 2. Among the 22 major disease categories, 8 categories were used. M code (musculoskeletal system) was used 243 times (70.85%), followed by R code (unclassified symptom) of 51 times (14.87%) and U code (special purpose code) of 23 times (6.71%). 3. The most commonly used code among the ten frequently used codes was M25.57 (joint pain, ankle and foot), a total of 47 times. Of the remaining nine codes, except for R60.1 (systemic edema) and U68.4 (The deficiency of yang in Bi), all codes were M codes (musculoskeletal system). 4. The M code (musculoskeletal system) was the most used major disease category in high-risk group, a total of 159 times. But in specific categories, the most commonly used code was R60.1 (systemic edema), a total of 28 times. 5. In normal group, the M code (musculoskeletal system) was the most used major disease category, a total of 84 times. Also, in specific categories, the most commonly used code was M25.57 (joint pain, ankle and foot), total 29 times. 6. The U code, corresponding to 'the diagnosis of childbirth and other obstetrical medical use', was used 23 times (6.71%), O code three times (0.87%) and Z code two times (0.58%), which was less than 10% of the total number of codes used. Conclusion: When analyzing KCD codes related to Korean medicine treatment for postpartum diseases, it is important to select the KCD codes that reflect the actual clinical state.