• Title/Summary/Keyword: Clinical protocols

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A retrospective study of 16 cats with intermediate- to high-grade alimentary lymphoma

  • Kwak, Dong-Hyuk;Cho, Mun-Ju;Park, Hyung-Jin;Song, Kun-Ho;Seo, Kyoung Won
    • Korean Journal of Veterinary Research
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    • v.61 no.1
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    • pp.8.1-8.10
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    • 2021
  • The purpose of this retrospective study was to describe cases of feline intermediateto high-grade alimentary lymphoma regarding signalment, clinical presentation, laboratory findings, response to therapy (modified 25-week University of Wisconsin-Madison [UW-25] vs. COP [cyclophosphamide, vincristine, prednisone]), toxicosis, and outcomes and to identify prognostic factors. Sixteen cats were treated with chemotherapy protocols. Response rates and survival did not differ statistically between the two protocols. The progression-free interval (PFI) and median survival time (MST) in cats achieving a response to therapy were longer than in those with no response [NR] (complete remission [CR] vs. partial remission [PR] vs. NR; PFI, 124 vs. 49 vs. 12 days, p < 0.001; MST, 361 vs. 118 vs. 16 days, p < 0.001). Clinical stage was another prognostic factor for PFI and MST. The PFI and MST in cats in stage I were longer than in those in other stages (PFI, 107 days vs. 30 days; MST, 193 days vs. 54 days). Hematologic and gastrointestinal toxicosis was mostly low grade. In comparing the modified UW-25 protocol with the COP protocol, there was not much difference in the number of neutropenic episodes and grade levels.

Appearance of nasopalatine duct cysts on dental magnetic resonance imaging using a mandibular coil: Two case reports with a literature review

  • Adib Al-Haj Husain ;Daphne Schonegg ;Silvio Valdec ;Bernd Stadlinger ;Marco Piccirelli ;Sebastian Winklhofer
    • Imaging Science in Dentistry
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    • v.53 no.2
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    • pp.161-168
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    • 2023
  • Nasopalatine duct cysts (NPDCs), the most common non-odontogenic cysts of maxilla, are often incidental findings on diagnostic imaging. When symptomatic, they usually present as a painless swelling with possible fistula. Conventional radiography shows a round-to-ovoid or heart-shaped radiolucency between the roots of central maxillary incisors. While the radiographic features of NPDCs in X-ray-based modalities have been well described, their magnetic resonance imaging (MRI) features have rarely been reported. Developments in dental MRI in recent years and the introduction of various dental MRI protocols now allow a wide range of applications in dental medicine. MRI is becoming an important tool for the detection and diagnosis of incidental or non-incidental dentomaxillofacial cysts. This report presented and discussed the characteristics of 2 NPDC cases visualized on MRI using both conventional and newly implemented specific dental MRI protocols with a novel 15-channel mandibular coil, demonstrating the use of these protocols for radiation-free maxillofacial diagnoses.

Development of a Blood Glucose Control Protocol for Medical ICU Patients (내과 중환자실 환자의 혈당조절 프로토콜 개발)

  • Kim, Eun Sung;Choi-Kwon, Smi
    • Journal of Korean Clinical Nursing Research
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    • v.15 no.3
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    • pp.27-38
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    • 2009
  • Purpose: The purpose of this study was to develop a blood glucose control protocol for medical intensive care unit (ICU) patients. Methods: The blood glucose control protocol was developed through the following process: selection of preliminary protocols, clinical application, and evaluation. The clinical validity of the protocol was measured by application, along with examination of the effects of the Yale and the Mayo blood glucose protocols. Seventeen medical ICU adults patients whose blood glucose levels exceeded 200 mg/dL consecutively participated in the study. The development protocol was evaluated by an expert group. Results: Incidence of normal blood glucose levels (p=.041) increased significantly in the Yale protocol application group. Also, incidence of severe hyperglycemia (p=.029) decreased significantly and time to target range of glucose (p=.023) decreased significantly after application of the Yale protocol. However, there was no significant difference in incidence of hypoglycemia (p=.666) between three groups. Conclusion: Using the developed protocol as a basis for the modified Yale protocol was found to be effective in improving the state of blood glucose control for medical ICU patients and is expected to be used for nursing intervention in critical care.

Survey of Institutional Review Board Risk Level Classification of Clinical Trials Among Korean University Hospitals (임상시험심사위원회(Institutional Review Board)의 임상시험에 대한 위험평가 분류조사연구)

  • Lee, Sun Ju;Kang, Su Jin;Maeng, Chi Hoon;Shin, Yoo Jin;Yoo, Soyoung
    • The Journal of KAIRB
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    • v.4 no.2
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    • pp.36-41
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    • 2022
  • Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

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Scoping Review of Prospective Clinical Studies, Projects, and Clinical Study Protocol for Korean Medicine Treatment on Dementia (국내 치매에 대한 한의치료 전향적 임상연구, 과제, 임상시험 프로토콜의 현황조사)

  • Kim, Je-Beom;Lee, Dong-Yoon;Ha, Da-Jung;Kwon, Chan-Young
    • The Journal of Korean Medicine
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    • v.42 no.3
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    • pp.99-118
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    • 2021
  • Objectives: The aim of this study is to review and analyze the trends in prospective clinical research (PCR), project, clinical study protocol of Korean medicine (KM) for dementia. Methods: We searched PCRs of KM on dementia in six electronical databases, up to January 28, 2021. Moreover, the clinical research protocol and projects of KM for dementia were searched. Results: Total eight PCRs, nine projects, and three clinical study protocols were included. In the PCRs, there were one randomized controlled trial, five before and after study, and two comparative group before-after studies. Four of them used herbal medicine, two used acupuncture, one study used both herbal medicine and acupuncture, and the other one used moxibustion. Jowiseungchung-tang was the most frequently used herbal medicine. BL62, KI6 were used in electro-acupuncture, auricular-Shenmen in auricular acupuncture, and GV20 in moxibustion. The most frequent outcome was Korean-Dementia Rating Scale (K-DRS). One reported significant increase in K-DRS score, one reported 60% improvement, and the other studies mostly reported no significant difference. In the projects including 20 clinical studies of dementia, herbal medicine, integrative medicine and acupuncture were mainly used. In the protocols, herbal medicine, complex KM intervention, and integrative medicine were used. Conclusions: Currently, the number of PCRs of KM for dementia is very scarce. Therefore, the researcher's interest in this field and national research support should be made more, and the quality of clinical research in the future can be further improved by supplementing the limitations of previously published clinical research.

Neuroimaging in Randomized, Multi-Center Clinical Trials of Endovascular Treatment for Acute Ischemic Stroke: A Systematic Review

  • Chong Hyun Suh;Seung Chai Jung;Byungjun Kim;Se Jin Cho;Dong-Cheol Woo;Woo Yong Oh;Jong Gu Lee;Kyung Won Kim
    • Korean Journal of Radiology
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    • v.21 no.1
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    • pp.42-57
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    • 2020
  • Appropriate use and analysis of neuroimaging techniques is an inevitable aspect of clinical trials for patients with acute ischemic stroke. Neuroimaging examinations were recently used to define the core eligibility criteria and outcomes in acute ischemic stroke research. Recent clinical trials for endovascular treatment in acute ischemic stroke have also demonstrated the efficacy or safety of endovascular treatment using various imaging modalities as well as clinical indices. Furthermore, independent imaging reviews and imaging core laboratory assessments are essential to manage and analyze imaging data in order to enhance the reliability of the outcomes. Therefore, we systematically reviewed the use of neuroimaging in recent randomized clinical trials for endovascular treatment of acute ischemic stroke in order to provide a thorough summary, which would serve as a resource guiding the use of appropriate imaging protocols and analyses in future clinical trials for acute ischemic stroke. This review will help researchers select appropriate imaging biomarkers among the various imaging protocols available and apply the selected type of imaging examination for each study in accordance with the academic purpose.

Comparison of concurrent chemoradiotherapy versus sequential radiochemotherapy in patients with completely resected non-small cell lung cancer

  • Kim, Hwan-Ik;Noh, O Kyu;Oh, Young-Taek;Chun, Mison;Kim, Sang-Won;Cho, Oyeon;Heo, Jaesung
    • Radiation Oncology Journal
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    • v.34 no.3
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    • pp.202-208
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    • 2016
  • Purpose: Our institution has implemented two different adjuvant protocols in treating patients with non-small cell lung cancer (NSCLC): chemotherapy followed by concurrent chemoradiotherapy (CT-CCRT) and sequential postoperative radiotherapy (PORT) followed by postoperative chemotherapy (POCT). We aimed to compare the clinical outcomes between the two adjuvant protocols. Materials and Methods: From March 1997 to October 2012, 68 patients were treated with CT-CCRT (n = 25) and sequential PORT followed by POCT (RT-CT; n = 43). The CT-CCRT protocol consisted of 2 cycles of cisplatin-based POCT followed by PORT concurrently with 2 cycles of POCT. The RT-CT protocol consisted of PORT followed by 4 cycles of cisplatin-based POCT. PORT was administered using conventional fractionation with a dose of 50.4-60 Gy. We compared the outcomes between the two adjuvant protocols and analyzed the clinical factors affecting survivals. Results: Median follow-up time was 43.9 months (range, 3.2 to 74.0 months), and the 5-year overall survival (OS), locoregional recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) were 53.9%, 68.2%, and 51.0%, respectively. There were no significant differences in OS (p = 0.074), LRFS (p = 0.094), and DMFS (p = 0.490) between the two protocols. In multivariable analyses, adjuvant protocol remained as a significant prognostic factor for LRFS, favouring CT-CCRT (hazard ratio [HR] = 3.506, p = 0.046) over RT-CT, not for OS (HR = 0.647, p = 0.229). Conclusion: CT-CCRT protocol increased LRFS more than RT-CT protocol in patients with completely resected NSCLC, but not in OS. Further studies are warranted to evaluate the benefit of CCRT strategy compared with sequential strategy.

Stress Testing and Imaging Protocols for Myocardial Perfusion Studies (심근관류영상을 위한 심근부하 방법 및 검사 프로토콜)

  • Kim, Seong-Min
    • Nuclear Medicine and Molecular Imaging
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    • v.43 no.3
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    • pp.179-195
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    • 2009
  • Scince $^{201}$TI was introduced as a myocardial perfusion imaging agent in the early 1970s, scintigraphic evaluation of myocardial perfusion for the diagnosis of coronary artery disease is a valuable noninvasive diagnostic imaging modality. Stress radionuclide myocardial perfusion imaging is widely accepted to have high diagnostic and prognostic use in the assessment of patients with known or suspected coronary artery disease. With wise use of this nonivasive imaging technique, more patients are referred for stress perfusion imaging. Until now various protocols for stress testing and myocardial imaging were developed and used in worldwide. This article presented various protocols of stress testing and myocardial imaging for clinical use.

Treatment packages of persistent allergic rhinitis for developing PRCT protocols : An expert survey (통년성 알레르기 비염의 표준 치료 모델 개발 : 실용임상연구 프로토콜 개발을 위한 기초 연구)

  • Kim, Nam-Kwen;Lee, Dong-Hyo;Seo, Eun-Sung;Choi, Eun-Ji;Jang, Bo-Hyeong;Choi, In-Hwa;Ko, Seong-Gyu
    • Journal of Society of Preventive Korean Medicine
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    • v.17 no.3
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    • pp.143-153
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    • 2013
  • Objective : This study was done to define the treatment protocol of Traditional Korean Medicine for persistent allergic rhinitis, which might be necessary for conducting PRCT study. Methods : Data were collected by questionnaire from Korean Medicine doctors participated in the Conference of The Korean Oriental Medical Ophthalmology & Otolaryngology & Dermatology Society in October 2012. We investigated their treatment procedures for persistent allergic rhinitis in ordinary clinical settings. Their treatment patterns including annual treatment period, frequencies and treatment times were also investigated. Finally, we combined the national insurance covered or out-of-pocket treatments as treatment packages according to the response rates of each contents, and displayed them as treatment protocols for PRCT study. Results : 50 Korean medicine doctors described the informed consent and questionnaire. Response rates of each treatment procedure were listed in Table 2 to Table 5. Treatment periods, frequencies and treatment time of each visit were listed in Table 6. Finally, treatment packages which would be defined for PRCT were listed in Table 7 as treatment package 1(response rates were over 50%), package 2(response rates were over 25%), package 3(response rates were over10%). Conclusion : These results provide the rational background and preliminary sources of defining treatment packages for developing PRCT protocols.

A Clinical Protocol Development Methodology for Ubiquitous Healthcare Service (유비쿼터스 헬스케어 서비스를 위한 태스크 중심의 임상 프로토콜 개발 방법론)

  • Hwang, Kyoung-Soon;Kim, Wun-Jea;Lee, Chan-Hee;Lee, Keon-Myung
    • Journal of the Korean Institute of Intelligent Systems
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    • v.20 no.1
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    • pp.66-75
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    • 2010
  • With the advances in ubiquitous service infrastructure, healthcare services have drawn attention as one of promising application domains. In ubiquitous healthcare services, patients or care-givers as well as medical personnel are asked to play their roles and, in addition, the information system is supposed to have active roles. In medicine, clinical protocols have been developed and put into practice in order to reduce treatment variances and assure the service quality. In the same token, clinical protocols on ubiquitous service practices are need to be developed which takes into account both the clinical details and the ubiquitous service functionality. This paper introduces a clinical protocol modeling methodology which pays attention to participants and their tasks including contextual information. The proposed method has been successfully applied to a real application domain, OAB(overactive bladder) syndrome patient care to see how it builds a clinical protocol.