• Title/Summary/Keyword: Clinical Trial Protocol

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Clinical comparison of resorbable and nonresorbable Barrier in guided tissue regeneration of human intrabony defects (흡수성 차폐막을 이용한 조직유도재생술의 임상적 효과)

  • Hur, Yin-Shik;Kwon, Young-Hyuk;Lee, Man-Sup;Park, Joon-Bong;Herr, Yeek
    • Journal of Periodontal and Implant Science
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    • v.29 no.1
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    • pp.193-207
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    • 1999
  • The purpose of this study was to compare the clinical results of guided tissue regeneration(GTR) using a resorbable barrier manufactured from an copolymer of polylactic acid (PLA) and polylaetic-glycolic acid(PLGA) with those of nonresorbable ePTFE barrier. Thirty two patients(25 to 59 years old) with one radiographically evident intrabony lesion of probing depth ${\geq}$6mm participated in a 6-month controlled clinical trial. The subjects were randomly divided into three independent groups. The first group(n=8) received a ePTFE barrier. The second group (n=12) received a resorbable PLA/PLGA barrier. The third group (n=12) received a resorbable PLA/PLGA barrier combined with an alloplastic bone graft. Plaque index (PI), gingival index(GI), probing depth(PD), gingival recession, clinical attachment level(CAL), and tooth mobility were recorded prior to surgery and at 3, 6 months postsurgery, Statistical tests used to analyze these data included independent t-test, paired t-test, one-way ANOVA. The results were as follows : 1. Probing depth was significantly reduced in all groups at 3, 6 months postsurgery and there were not significant differences between groups. 2. Clinical attachment level was significantly increased in all groups at 3, 6 months postsurgery and there were not significant differences between groups. 3. There were not significant differences in probing depth, clinical attachment level, gingival recession, tooth mobility between second group (PLA/PLGA barrier) and third group (PLA/PLGA barrier combined with alloplastic bone graft) 4. Tooth mobility was not significantly increased in all groups at 3, 6 months postsurgery and there were not significant differences between groups. In conclusion, PLA/PLGA resorbable barrier has similar clinical potential to eP'IFE barrier in GTR procedure of intrabony pockets under the present protocol.

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The Review of Clinical Studies Published in The Journal of Korean Medical Ophthalmology & Otolaryngology & Dermatology (한방안이비인후피부과학회지에 게재된 임상실험연구에 대한 고찰)

  • Kim, Chul-Yun;Seo, Hyung-Sik;Kim, Nam-Kwen;Lee, Dong-Jin;Kwon, Kang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.1-15
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    • 2014
  • Objective : This study was carried out to analyze the quality and quantity of Clinical Trials that have been published in the journal of korean medical ophthalmology, otolaryngology, dermatology(JKOOD). Methods : We analyzed 25 clinical trials that published in JKOOD from 1988 to 2014. We excluded case reports, protocol and retrospective studies and classified searched papers into three categories; Randomized Clinical Trials(RCT), Non Randomized Clinical Trials(NRCT), Before After Study(BAS) by using study Design Algorithm for Medical literature of Intervention(DMAI). All articles were analyzed according to diagnosis, statistics program and intervention period. The bias of RCTs were evaluated by Cochrane Risk of Bias(RoB). Result : 1. The number of searched journals is 25 papers; 13 RCT, 2 NRCT, 10 BAS 2. Distribution of clinical trial; 'Atopic dermatitis' ranked the highest(44%) in disease, 'External application' raked the highest(71%) in treatment method. 3. 'allocation sequence' and 'prevention of allocated intervent to patients and therapists' are graded 'Low' but 'incomplete outcome date' and 'selective outcome' are graded 'Uncertain'. Conclusions : It is necessary to study more RCT. It will be helpful to study systematic reviews and meta analysis in JKOOD.

Mesenchymal Stem Cell Lines Isolated by Different Isolation Methods Show Variations in the Regulation of Graft-versus-host Disease

  • Yoo, Hyun Seung;Yi, TacGhee;Cho, Yun Kyoung;Kim, Woo Cheol;Song, Sun U.;Jeon, Myung-Shin
    • IMMUNE NETWORK
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    • v.13 no.4
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    • pp.133-140
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    • 2013
  • Since the discovery of the immunomodulation property of mesenchymal stem cells (MSCs) about a decade ago, it has been extensively investigated whether MSCs can be used for the treatment of immune-related diseases, such as graft versus-host disease (GvHD). However, how to evaluate the efficacy of human MSCs for the clinical trial is still unclear. We used an MHC-mismatched model of GvHD (B6 into BALB/c). Surprisingly, the administration of the human MSCs (hMSCs) could reduce the GvHD-related mortality of the mouse recipients and xenogeneically inhibit mouse T-cell proliferation and $IFN-{\gamma}$ production in vitro. We recently established a new protocol for the isolation of a homogeneous population of MSCs called subfractionation culturing methods (SCM), and established a library of clonal MSC lines. Therefore, we also investigated whether MSCs isolated by the conventional gradient centrifugation method (GCM) and SCM show different efficacy in vivo. Intriguingly, clonal hMSCs (hcMSCs) isolated by SCM showed better efficacy than hMSCs isolated by GCM. Based on these results, the MHC-mismatched model of GvHD may be useful for evaluating the efficacy of human MSCs before the clinical trial. The results of this study suggest that different MSC lines may show different efficacy in vivo and in vitro.

An Interview Survey for Developing Clinical Trial Protocol on Individualized Acupuncture Treatment for Knee Osteoarthritis (퇴행성 슬관절염의 맞춤형 침구 임상시험 프로토콜 개발을 위한 면접조사)

  • Lee, Sang-Hoon;Seo, Byung-Kwan;Seo, Jung-Chul;Lee, Seung-Deok;Kim, Sun-Woong;Choi, Sun-Mi;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.22 no.6
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    • pp.189-199
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    • 2005
  • Objectives : This interview survey was carried out to identify how Korean medical doctors make acupuncture prescriptions for knee osteoarthritis in clinics. Methods : Survey questions were developed based on a consensus of acupuncture professors at Kyung Hee University, Dongguk University, Daegu Haany University. The interviews were conducted to 72 members of the Korea Oriental Medical Association who answered to prefer remote acupuncture prescription at previous telephone survey. Results : Korean medical doctors prefer to use five shu acupuncture points, especially 'hyung' or , 'shu' points, on the contralateral side of lesion and that the first target organ is liver. Five element points theory was mainly based on 'Nanjing' and 'Hwangdi Neijing'. The De-qi sensation of both doctor and patients was emphasized. Diagnosis and evaluation generally depend on subjective evaluation rather than objective scale. Conclusion : This study showed that Koran medical doctors prefer to follow the Korean traditional acupuncture methods respecting the old classic principles. And these results can guide us to develop advanced clinical trial protocols more close to our acupuncture practice.

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A Systematic Review of Clinical Researches of Korean Medicine for Alopecia (탈모증의 한약제제 치료효과에 대한 체계적 문헌 고찰)

  • Ryu, Deok-Hyun;Roh, Seok-Sun
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.30 no.2
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    • pp.1-18
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    • 2017
  • Objectives : This review aims to evaluate a risk of bias by risk of bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.

Analysis of the Effects of Red Ginseng Ingredient-based 'SSR' in Decreasing Fatigue and Inducing Changes in Blood Composition through a Clinical Trial (인체적용시험을 통한 홍삼기반 'SSR'이 인체 피로도 감소 및 혈액성분 변화에 미치는 영향분석)

  • Shin, Keong Sub;Lee, Hong Gi;Park, Sun Mi
    • The Korean Journal of Food And Nutrition
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    • v.34 no.2
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    • pp.196-206
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    • 2021
  • The main purpose of this study was to examine the correlation between the consumption of red ginseng-based 'SSR' for 30 days and the reduction in human fatigue, blood component changes, and immune cell activity in 35 human subjects. 'SSR' is composed of zinc oxide, folic acid, and D-α-tocopherol with red ginseng as the main component. According to the protocol criteria of the study, 35 subjects who understood the purpose of the study and signed an informed consent form were selected. The fatigue survey was conducted through a questionnaire, and after taking 'SSR', a decreased tendency of physical, mental, and neurosensory fatigue was observed. In hematological analysis, no significant changes were observed in the levels of WBC, RBC, and hemoglobin; however, AST (SGOT) and ALT (SGPT) levels were statistically significantly decreased. In immunological analysis, it was observed that the proliferative effect of T cells (CD3+CD4+) was greater than that of NK cells (CD16+CD56+). The collected data were subjected to t-test analysis using the SPSS 25.0 statistical program. The result from this study proposes that 'SSR' can be used as a functional food material as it reduces human fatigue and enhances immune function.

Effectiveness of low-level laser therapy in facilitating maxillary expansion using bone-borne hyrax expander: A randomized clinical trial

  • Abdelwassie, Sara Hassan;Kaddah, Mohammed Amgad;El-Dakroury, Amr Emad;El-Boghdady, Dalia;Abd El-Ghafour, Mohamed;Seifeldin, Nouran Fouad
    • The korean journal of orthodontics
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    • v.52 no.6
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    • pp.399-411
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    • 2022
  • Objective: The objective of this randomized clinical trial was to study the skeletal and dental effects of low-level laser therapy (LLLT) along with a miniscrew-assisted expander (Hyrax) after six months of retention. Methods: After sequence generation, concealed allocation, and implementation, 24 female patients were randomly divided (1:1) into two-groups: bone-borne rapid palatal expansion (BBE) without LLLT (n = 12) and BBE with LLLT (n = 12). Eligibility criteria included female patients aged 10-13 years old with bilateral posterior crossbites. Intraoral and extraoral photographs, cone-beam computed tomography images, and digital study models were obtained before expansion and six months after retention. The 7 mm Hyrax appliance was anchored to four palatal mini-screws, which were activated twice daily for 15 days, then locked and kept in place as a retainer. LLLT was performed in the laser group during expansion and retention, according to the guidelines provided. Results: The records of 24 patients were analyzed. According to the post-retention measurements, both groups showed a significant increase in nasal and maxillary widths and total facial height. In the laser group, the Sella-Nasion-Point A and Point A-Nasion-Point B angles and the interpremolar apical distance were significantly increased. Conclusions: Within the limitations of this study, the results suggest that the parameters and protocol of LLLT do not clinically affect the efficiency of BBE in prepubertal and pubertal patients.

Impact of Dual-Hemisphere Transcranial Direct Current Stimulation Combined with Modified Constraint-Induced Movement Therapy on Upper Limb Function in Chronic Stroke: A Single Blinded Randomized Controlled Trial (수정된 강제 유도 운동치료와 결합된 이중 반구 경두개 직류 자극이 만성 뇌졸중의 팔 기능에 미치는 영향 : 단일 맹검 무작위 통제 시험)

  • Kim, Sunho
    • Journal of The Korean Society of Integrative Medicine
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    • v.8 no.2
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    • pp.11-20
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    • 2020
  • Purpose : The purpose of this study was to research the effects of dual-hemisphere transcranial direct current stimulation (dual tDCS) and modified constraint-induced movement therapy (mCIMT) to improve upper extremity motor function after stroke. Methods : The study period was from August 2019 to November 2019, and included 24 patients who met the selection criteria. Participants were divided into 2 groups: dual tDCS and mCIMT, and sham dual tDCS and mCIMT group. Dual tDCS and mCIMT group performed mCIMT immediately after applying dual tDCS for 20 minutes, and sham dual tDCS and mCIMT group performed mCIMT immediately after applying sham tDCS for 20 minutes without turning on the power source. Total interventions were conducted 5 times per week for 4 weeks, and mCIMT was conducted for 30 minutes per session for both experimental and control groups. Fugl-Meyer assessment (FMA) and Motor Activity Log scale (MAL) were analyzed before and after 4 weeks of intervention. Results : Both experimental and control groups showed significant changes in FMA, Amount of Use (AOU), and Quality of Movement (QOM) of MAL. When the differences between groups was compared using ANCOVA, the experimental group showed a greater improvement in FMA and AOU of MAL than the control group. Conclusion : In order to enhance the effect of improving upper limb function of stroke patients, dual tDCS could be applied to provide more effective treatment in the clinical setting. Further studies will be needed in larger groups of stroke patients, including long-term follow-up, and multi-group comparisons through the establishment of anodal tDCS and mCIMT, cathodal tDCS, and mCIMT groups to clarify the effects of dual tDCS. In addition, research is needed to establish a protocol for tDCS, and this evidence-based intervention protocol is expected to be used in the clinical setting as an interventional method for various purposes.

Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol

  • Kim, Jihye;Kim, Hyunho;Kim, Keun Ho
    • Integrative Medicine Research
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    • v.6 no.3
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    • pp.317-324
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    • 2017
  • Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

A Review on Clinical Research Trends in the Treatment of Hatha-Style Yoga for Post Traumatic Stress Disorder (외상후 스트레스장애에 대한 하타 스타일 요가 치료의 해외 임상연구 동향)

  • Hong, Hee-Yeon;Hong, Min-Ho;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.31 no.1
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    • pp.13-23
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    • 2020
  • Objectives: The purpose of this study was to review the research trends in the treatment of hatha-style yoga on Post Traumatic Stress Disorder (PTSD). Methods: We searched articles in Pubmed and the China National Knowledge Infrastructure (CNKI) January 2010-December 2019, for studies to treat PTSD using hatha-style yoga. Selected studies were evaluated by the CLEAR-NPT (A Checklist to Evaluate a Report of a Non-pharmacological Trial). Results: Seven randomized controlled clinical trials were selected. PSS-I (PTSD Symptom Scale-Interview) was the most frequently used as diagnostic criteria. The PCL (PTSD Checklist) was also the most commonly used outcome measurement. Of the seven articles, most studies reported that hatha-style yoga was effective to reduce symptoms of PTSD. Conclusions: Hatha-style yoga practice intervention can be used to relieve symptoms of PTSD. More studies should be conducted to make hatha-style yoga as protocol (complementary therapy) for PTSD patients.