• 제목/요약/키워드: Clinical protocol

검색결과 832건 처리시간 0.03초

냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발 (Development of Clinical Protocol for Acquisition of Change of Radial Pulse Wave Signal in the Cold-Heat Intervention: Explanatory, Randomized, 2×2 cross-over design)

  • 유하나;김지혜;구본초;김현호;전영주
    • 대한한의진단학회지
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    • 제19권2호
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    • pp.91-100
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    • 2015
  • Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

Single-session associative protocol for dentin hypersensitivity management: a 1-year randomized, blinded clinical study

  • Thayna Carolina Zeni;Poliana Maria de Faveri Cardoso;Rafael da Silva Vanolli;Marcio Jose Mendonca;Julio Katuhide Ueda;Veridiana Camilotti
    • Restorative Dentistry and Endodontics
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    • 제49권2호
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    • pp.15.1-15.11
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    • 2024
  • Objectives: This study aimed to establish a single-session associative protocol for nonrestorative management of dentin hypersensitivity (DH). Materials and Methods: Twenty-four individuals with DH and a minimum sensitivity level of 4 on the visual analog scale (VAS) were selected. The study was conducted in a split-mouth design, with each participant (n = 20) having at least 1 affected tooth in all quadrants. The management protocols consisted of control group: universal adhesive, Neural Desensitizing Protocol group: 5% potassium nitrate, Mixed Desensitizing Protocol (PAM) group: 5% sodium fluoride and 5% potassium nitrate, Remineralizing Desensitizing Protocol (PDR) group: surface-partially reacted glass technology photopolymerizable varnish. Evaluations were performed immediately after application, at 1 week, 1 month, 2 months, and 12 months using the VAS sensitivity test. Results: The scores were subjected to statistical analysis using the Friedman test (p < 0.05), Durbin-Conover test (p < 0.05), and Wilcoxon test (p < 0.05). At the 12-month evaluation, all groups showed statistically significant differences compared to the initial assessment. For the evaluation after 12 months, there was a statistically significant difference between the PAM group, the control group, and the PDR group. Conclusions: It can be concluded that all groups were effective in controlling DH, but there were significant results in the control group and PDR group. The clinical relevance of this study is to demonstrate that the application of single-session desensitizing protocols can be effective in controlling DH for up to 12 months.

Preoperative N Staging of Gastric Cancer by Stomach Protocol Computed Tomography

  • Kim, Se Hoon;Kim, Jeong Jae;Lee, Jeong Sub;Kim, Seung Hyoung;Kim, Bong Soo;Maeng, Young Hee;Hyun, Chang Lim;Kim, Min Jeong;Jeong, In Ho
    • Journal of Gastric Cancer
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    • 제13권3호
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    • pp.149-156
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    • 2013
  • Purpose: Clinical stage of gastric cancer is currently assessed by computed tomography. Accurate clinical staging is important for the tailoring of therapy. This study evaluated the accuracy of clinical N staging using stomach protocol computed tomography. Materials and Methods: Between March 2004 and November 2012, 171 patients with gastric cancer underwent preoperative stomach protocol computed tomography (Jeju National University Hospital; Jeju, Korea). Their demographic and clinical characteristics were reviewed retrospectively. Two radiologists evaluated cN staging using axial and coronal computed tomography images, and cN stage was matched with pathologic results. The diagnostic accuracy of stomach protocol computed tomography for clinical N staging and clinical characteristics associated with diagnostic accuracy were evaluated. Results: The overall accuracy of stomach protocol computed tomography for cN staging was 63.2%. Computed tomography images of slice thickness 3.0 mm had a sensitivity of 60.0%; a specificity of 89.6%; an accuracy of 78.4%; and a positive predictive value of 78.0% in detecting lymph node metastases. Underestimation of cN stage was associated with larger tumor size (P<0.001), undifferentiated type (P=0.003), diffuse type (P=0.020), more advanced pathologic stage (P<0.001), and larger numbers of harvested and metastatic lymph nodes (P<0.001 each). Tumor differentiation was an independent factor affecting underestimation by computed tomography (P=0.045). Conclusions: Computed tomography with a size criterion of 8 mm is highly specific but relatively insensitive in detecting nodal metastases. Physicians should keep in mind that computed tomography may not be an appropriate tool to detect nodal metastases for choosing appropriate treatment.

소아심장외과 중환자실 장관영양 프로토콜 개발 및 효과평가 (Development and Implementation of a Feeding Protocol for Infants in a Pediatric Cardiac Intensive Care Unit)

  • 엄주연;이효진
    • Child Health Nursing Research
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    • 제22권4호
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    • pp.326-335
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    • 2016
  • Purpose: It is crucial to provide adequate enteral nutrition for postoperative recovery, wound healing and normal growth in infants in pediatric cardiac ICUs. This study was done to develop a feeding protocol using the vaso-active inotropic (VAI) score and to evaluate the impact of nutritional outcomes following the new feeding protocol for infants who underwent cardiac surgery. Methods: This study consisted of three phases. First, a feeding protocol was developed based on a literature review. Second, ten experts rated the content validity. Third, a comparison study was conducted to evaluate the impact of the new feeding protocol. Data were analyzed using SPSS Version 20. Results: Twenty-nine infants were enrolled in the pre-protocol group, and 22 infants in the post-protocol group. Patients in the 2 groups were similar. Time to reach feeding goal was significantly decreased from 56.0 (27-210) hours to 28.5 (10-496) hours in the post-protocol group (Z=-4.22, p<.001). Level of enteral feeding knowledge among nurses increased significantly after implementation of the protocol. Conclusion: The feeding protocol using VAI score facilitates the achievement feeding goal to decrease feeding interruptions and help nurses in their practice. Larger studies are necessary to examine clinical outcomes following the implementation of this feeding protocol.

기관내흡인에 대한 개념분석 (Concept Analysis of Endotracheal Suctioning(ETS))

  • 안영미
    • 대한간호학회지
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    • 제35권2호
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    • pp.292-302
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    • 2005
  • Purpose: Concept analysis was performed on the behavioral concept of endotracheal suctioning (ETS), to identify the goal, to develop astandardized clinical protocol, to identify the antecedents and consequences, and to differentiate the improper use of ETS. Method: Walker & Avant's concept analysis was employed using clinical guidelines, books and review articles in which the procedures of ETS were written in detail and published in Pubmed within the last 20 years. Result: The macro-goal of ETS was to remove accumulated respiratory secretions. Three defining attributes of ETS were identified; catheter, suctioning and asepsis. Each attribute involved empirical referents, such as the size and depth of the catheter, the suction pressure, duration and method for suctioning. The antecedents of ETS were identical to the clinical evidences for the need of ETS such as the nursing assessment data. The consequences of ETS serve as an evaluation criteria on the effectsof ETS based on the goal of ETS. Conclusion: The concept analysis of ETS demonstrates an example of considering a specific nursing protocol of ETS as a behavioral concept, applying concept analysis to it to identify it's key behavioral components as defining attributes and empirical referents and then developing and applying the standard ETS protocol.

얼굴마비의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구 (Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy)

  • 공나경;서은성;선지혜;김남권
    • 대한한의학회지
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    • 제38권1호
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    • pp.46-55
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    • 2017
  • Objectives: The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy. Methods: Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated. Results: As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study. Conclusions: We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.

갱년기 여성의 안면홍조에 대한 침치료 다기관 임상시험 : 프로토콜 (The effect of acupuncture on hot flushes : A study protocol of multi-center randomized controlled clinical trial)

  • 박지은;오달석;강경원;김동일;최선미
    • Korean Journal of Acupuncture
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    • 제24권3호
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    • pp.33-45
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    • 2007
  • Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

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아토피 피부염의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구 (Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Atopic Dermatitis)

  • 권지예;선지혜;윤화정;김남권
    • 한방안이비인후피부과학회지
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    • 제30권1호
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    • pp.17-28
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    • 2017
  • Objectives : The aim of this study is reviewing the literature to extracting the key parameter and finding the calibration parameter for the clinical study with economical assessment protocol on atopic dermatitis. Methods : Literature search is performed using PUBMED for literature published from Janurary 2000 to December 2016. We included randomized controlled trials(RCTs) with economic assessment in which human participants. Results : Among the articles published from January 2000 to December 2016, The 1464 articles were found. After reviewing the title, abstract and full text, the five articles were selected. Selected articles are classified 3 CEA(cost effective analysis)study, 1 CMA(cost minimizing analysis)study and 1 cost analysis study. Conclusions : We found highly reliable key parameters and calibration parameters, which might be necessary factors for developing research protocol of economic evaluation alongside clinical trial about atopic dermatitis patients.

여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜 (A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial)

  • 서영경;이은희;김환;이지윤;박채린;최선영;장은수;권오진;김형준;정인철
    • 동의신경정신과학회지
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    • 제29권1호
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.