• 제목/요약/키워드: Clinical trial center

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소아승낙 현황조사와 소아청소년과/소아신경과 전문의를 대상으로 면담조사를 통한 소아승낙서 공통기준 수립 연구 (Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist)

  • 이윤진;이선주;강수진;이대호;배균섭;정종우;김병수;김진석;이명아
    • 대한기관윤리심의기구협의회지
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    • 제6권1호
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    • pp.5-16
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    • 2024
  • Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

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신경성 식욕부진증에 대한 한약치료, 인지행동치료 및 인간중심상담치료 병행 1예 보고 (A Case Report of Concurrent Korean Herbal Medicine Treatment, Cognitive Behavior Therapy, and Person-centered Counseling Therapy for Anorexia Nervosa)

  • 허미숙;김환;서영경;양창섭;이미영;장익순;정인철
    • 동의신경정신과학회지
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    • 제28권3호
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    • pp.195-206
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    • 2017
  • Objectives: To evaluate the effects of concurrent therapy with cognitive behavior therapy and person-centered counseling in addition to general Korean herbal medicine treatment for a patient with anorexia nervosa. Methods: A patient diagnosed with anorexia nervosa was treated with Korean herbal medicine treatment, cognitive behavior therapy, and person-centered treatment. The results were evaluated through a feeding interview, self-checklist, beck depression inventory (BDI) and InBody test. Results: After the treatment period, the treatment effects such as improvement of dietary restriction and elimination behavior, weight gain, and reduced depression were confirmed. Conclusions: This study suggests that concurrent therapy together with cognitive behavior therapy, person-centered counseling, and general Korean herbal medicine treatment is effective on patients with anorexia nervosa.

Serum level changes of long chain-polyunsaturated fatty acids in patients undergoing periodontal therapy combined with one year of omega-3 supplementation: a pilot randomized clinical trial

  • Martinez, Gisele Lago;Koury, Josely Correa;Martins, Marcela Anjos;Nogueira, Fernanda;Fischer, Ricardo Guimaraes;Gustafsson, Anders;Figueredo, Carlos Marcelo S.
    • Journal of Periodontal and Implant Science
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    • 제44권4호
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    • pp.169-177
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    • 2014
  • Purpose: We aimed to investigate the impact of nonsurgical periodontal treatment combined with one-year dietary supplementation with omega (${\omega}$)-3 on the serum levels of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and arachidonic acid (AA). Methods: Fifteen patients with chronic generalized periodontitis were treated with scaling and root planing. The test group consisted of seven patients ($43.1{\pm}6.0$ years) supplemented with ${\omega}$-3, consisting of EPA plus DHA, three capsules, each of 300 mg of ${\omega}$-3 (180-mg EPA/120-mg DHA), for 12 months. The control group was composed of eight patients ($46.1{\pm}11.6$ years) that took a placebo capsule for 12 months. The periodontal examination and the serum levels of DPA, EPA, DHA, and AA were performed at baseline (T0), and 4 (T1), and 12 (T2) months after therapy. Results: In the test group, AA and DPA levels had been reduced significantly at T1 (P<0.05). AA and EPA levels had been increased significantly at T2 (P<0.05). The ${\Delta}EPA$ was significantly higher in the test compared to the placebo group at T2-T0 (P=0.02). The AA/EPA had decreased significantly at T1 and T2 relative to baseline (P<0.05). Conclusions: Nonsurgical periodontal treatment combined with ${\omega}$-3 supplementation significantly increased the EPA levels and decreased the AA/EPA ratio in serum after one year follow-up. However, no effect on the clinical outcome of periodontal therapy was observed.

$Lipiodol-I^{-131}$의 경간동맥 주입에 의한 간암치료의 가능성에 관한 연구 (Therapeutic Feasibility Study and Clinical Trial of Intrahepatic $I^{-131}-Lipiodol$ on Patients with Hepatocellular Carcinoma)

  • 유형식;서정호;이종태;김동익;박창윤;김병수;박찬희
    • 대한핵의학회지
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    • 제20권2호
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    • pp.61-71
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    • 1986
  • An iodized oil such as Ethiodol or Lipiodol was selectively retained in the tumor vessels of the large hepatomas as well as in the small daughter hepatomas for long periods following the intra-arterial hepatic injection of such contrast material. The specific aim of the study is to deliver a high internal radiation dose to hepatocellular carcinoma (HCC) in an attempt to control the disease. We were able to replace a small fraction of the stable iodine (I-127) of the 37% iodine in Lipiodol by the $I^{-131}$ with 100% exchange efficiency. $I^{-131}$ labeled Lipiodol was injected through the super-selected tumor feeding artery under superselection or into the proper hepatic arterial level of patients who have malignant hepatomas confirmed by aspiration cytology serum AFP and various imaging modalities. Clinical traial was performed on 43 cases during recent 6 months and follow-up observation was carried out. No severe complications or other adverse reactions were encountered until nowdays. $I^{-131}-Lipiodol$ was stable in vivo and no significant activity was noted in the thyroid, stomach, blood and urine after the injection. Only small fraction of radioisotope activity was noticed in the both side of lungs. Tumor to normal liver radio was very high. Therefore, $I^{-131}-Lipiodol$ (or P-32-Lipiodol) will be effective delivering high internal radiation dose to the tumor while delivering small radiation doses to normal tissues. Labeling, tumor dose calculation and preliminary findings will be presented.

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노인의 인지감퇴에 미치는 아포지단백 E4와 교육수준의 상호작용 (Interaction of Apolipoprotein E ${\varepsilon}4$ and Education on Cognitive Decline in Korean Elders)

  • 김재민;신일선;김성완;양수진;박상욱;신희영;윤진상
    • 생물정신의학
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    • 제15권1호
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    • pp.29-34
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    • 2008
  • Objectives : This study aimed to test potential modifying effects of education on the association between apolipoprotein E ${\varepsilon}4$ (Apo E4) and cognitive decline. Methods : A community cohort(N=683) aged 65 or over completed the Korean version of Mini-Mental State Examination(MMSE-K) at baseline and two years later(1999-2001). Apo E polymorphisms were genotyped, and classified into that with or without Apo E4. Educational levels were categorized into people with or without education. Covariates included demographic(age, gender), life style(smoking, alcohol drinking), clinical (depression, sleep disorder, vascular risk factors) characteristics. Results : The association between Apo E4 and cognitive decline was significant only in the old persons with no education. The interaction term between education and Apo E4 on cognitive decline was significant(p=0.040). Conclusion : Elders with no education might be more vulnerable to the impact of Apo E4 on cognitive decline, which suggests gene-environment interaction.

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국내의 경근(經筋) 연구동향에 대한 고찰 (An Analysis of the Study Tendency on Meridian Muscle)

  • 이상민;이종수
    • 척추신경추나의학회지
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    • 제4권2호
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    • pp.211-223
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    • 2009
  • Objectives : The aim of this research is to analyze the current trend of the studies about eridian muscle and to provide background for further studies. Methods : Reviewing 33 domestic oriental medical studies about meridian muscle, and comparative analysis was made. These studies were classified by method, theme and subtitle. Results : 1. According to the classification by study method, number of literary studies are 22(67%), which is more than half, number of experimental studies are 5(15%) and clinical studies are 6(18%). 2. According to the classification by study theme in literary study, percentage of 'Structure amp; Movement of Meridian Muscle' took 64%, Theory study of Meridian Muscle' took 14%, 'Application of Concept of Meridian Muscle' took 14%, 'Treatment of Meridian Muscle disorder' took 9% arranged in order. 3. In 'Theory study of Meridian Muscle', there were not only literary approaches but also Deficiency-Excessiveness(虛實) and historical approaches. Study about 'Structure & Movement of Meridian Muscle' includes analysis of muscle and Myofascial pain syndrome. On this background, it is necessary to recognize the linkage and motion analysis of Meridian Muscle. Therefore, studies were changed into interpretation about Anatomy trains, analysis of motion. The study about 'Treatment of Meridian Muscle disorder' provided the various treatment method-Acupuncture, Manual therapy, Ashi(阿是)-point therapy, CHUNA therapy etc.- in literary study. The study about the 'Application of Concept of Meridian Muscle' has been performed in relation to Embedding Therapy, Kyungkuen chuna, Ki-gong therapy. 4. Experimental Studies were all Anatomical Studies. Studies were done in trial of discovering the actual existence, but revealed problem in interpretating the meaning of Meridian Muscle. 5. Clinical Studies based on Ashi(阿是)-point therapy CHUNA Muscles Along Meridians Release Therapy etc, were performed. Experimental studies about Meridian Muscle were assessed as low grade according to Jadad Scale. There were no studies which were based on well-organized Meridian Muscle theory. Conclusions : There needs to be more discussion about concept of Meridian Muscle and proceed more reliable experimental studies with organized Meridian Muscle theory. Further objective studies about treatment of Meridian Muscle should be done.

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성인 아토피 피부염 환자의 삶의 질과 중증도에 대한 상관 연구 (A study on the correlation between quality of life and disease severity in adult patients with atopic dermatitis)

  • 김남권;이동효;조가원;문효;서은성
    • 한방안이비인후피부과학회지
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    • 제24권3호
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    • pp.27-36
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    • 2011
  • Objective : The purpose of this clinical research was to analyze the correlation between disease severity and disease specific quality of life adjusted by general quality of life measure in adult patients with atopic dermatitis attending Wonkwang Univ. Sanbon Oriental Medical Center. Methods : A total of 35 patients participated in atopic dermatitis clinical trial from June 1st, 2010 to June 30th, 2011 were included in this study. SCORing Atopic Dermatitis(SCORAD) index, Dermatologic Life Quality Index(DLQI), Health Utility Index III(HUI-III) and EuroQoL 5-Dimension(EQ-5D) have been estimatied. Baseline statistical analysis and normality test were done by using Student t-test, Shapiro-Wilk test and ladder test. Pearson analysis and Spearman analysis were conducted to examined the correlation of each variables. Hierachial regression analysis was performed using related variables. Statistical significance was achieved if the probability was less than 5%. Results : There were statistically significance between DLQI and SCORAD index, and also between DLQI and EQ-5D. However there was no significant between DLQI and HUI-III. In the hierachial regression analysis, after adjusting for demographic variables (gender, age) and general quality of life (EQ-5D), SCORAD index significantly predict the intensity of disease specific quality of life (DLQI). Conclusions : We confirmed the correlation between SCORAD index and DLQI, and developed the inference for regression equation of DLQI using SCORAD index, EQ-5D and demographic variables.

화침에 대한 국내외 연구 경향 고찰 (Review of Studies on Fire Needle)

  • 문수정;공재철;조동찬;김에스더;송용선;이정한
    • 한방재활의학과학회지
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    • 제21권4호
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    • pp.67-76
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    • 2011
  • Objectives: The aim of this review was to investigate studies on fire needle and to propose for the better method of studies in the future. Methods: Studies related to fire needle were searched with electric database for this study, and 10 domestic and overseas databases were included. Results: 19 clinical studies were analyzed in terms of condition, time of heating, number and frequency of treatment, number of heating, safety procedure or device aid reports of adverse events. Also 3 review studies were summarized. The number of studies was increasing and the kind of diseases to treat with fire noodle were various. Especially musculoskeletal diseases like ligament lesion and lumbago were noticeable. Heating-after-insertion method was recently proposed but the use of term was confusing. The report of adverse events or safety procedure was rare. Also there was an effort to develop more convenient and safer device. Conclusions: High quality clinical trial en fire needle is needed especially to compare 2 methods, heating-after-insertion and heating-before-insertion. And studies need to report safety procedures and adverse events to evaluate the safety of fire needle therapy.

2,450 MHz 온열치료기의 온도분포실험 -Phantom 및 실험동물종양에서- (A Thermoprofile Study of 2,450-MHz Microwave Thermogenerator in Phantom and Animal Tumor)

  • 윤세철;길학준;박용휘;추성실
    • Radiation Oncology Journal
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    • 제4권2호
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    • pp.173-177
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    • 1986
  • 온열요법이 암환자치료에 있어 온열요법 단독 또는 방사선치료나 일부 항암화학요법제와 병행할 때 그 효과가 상승되고 있음은 최근 잘 알려진 사실이다. 가톨릭의대부속 강남성모병원 방사선치료실에서는 온열요법의 동물실험과 더 나아가 임상응용을 목적으로 가정용 전자레인지를 개조하여 극초단파유도관을 제작, 부착시킴으로서, 실험 및 종양부위에 2,450MHz 극초단파를 조사할 수 있는 장치를 제작하였다. 아울러 이 온열치료장치가 온열치료기로서의 적합성을 알아보기 위하여 본 실험을 실시하였다. 실험을 위한 phantom으로, 고기덩어리와 한천을 이용하였으며, 마우스하지에 발생시킨 Sarcom-180고형종양을 또한 이용하여, 이 온열치료기의 전압변동에 따른 온도분포 변화를 측정하였다. 한편 실험동물종양에서는 종양조직내 온도가 주위 정상조직보다 $1\~3^{\circ}C$ 높은 것을 확인할 수 있었다.

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The effect of different micro-osteoperforation depths on the rate of orthodontic tooth movement: A single-center, single-blind, randomized clinical trial

  • Ozkan, Tugba Haliloglu;Arici, Selim
    • 대한치과교정학회지
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    • 제51권3호
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    • pp.157-165
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    • 2021
  • Objective: This study aimed to identify the clinical effectiveness of two different penetration depths of micro-osteoperforations (MOPs) on the rate of orthodontic tooth movement. Methods: Twenty-four patients requiring the removal of the upper first premolar teeth were selected and randomly divided into two groups. The control group participants did not undergo MOPs. Participants in the experimental group underwent three MOPs each at 4-mm (MOP-4) and 7-mm (MOP-7) depths, which were randomly and equally performed to either the left or right side distal to the canine. The retraction amount was measured on three-dimensional digital models on the 28th day of retraction. MOP-related pain was measured using a visual analog scale (VAS). Between-group statistical differences in the VAS scores were determined using an independent t-test and those in canine retraction were determined using analysis of variance and post-hoc Tukey test. Results: No significant difference was found between the MOP-4 (1.22 ± 0.29 mm/month) and MOP-7 (1.29 ± 0.31 mm/month) groups in terms of the canine retraction rate. Moreover, both the groups demonstrated a significantly higher canine movement than the control group (0.88 ± 0.19 mm/month). MOPs did not significantly affect the mesialization of the posterior teeth (p > 0.05). Moreover, the pain scores in the MOP-4 and MOP-7 groups were similar and showed no statistically significant difference. Conclusions: Three MOPs with a depth of 4 mm can be performed as an effective method to increase the rate of tooth movement. However, three MOPs with depths of 4-7 mm does not additionally enhance tooth movement.