• Title/Summary/Keyword: Clinical protocols

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Review of Clinical Acupuncture Research Protocols on Cancer in the USA (미국의 암 관련 침 임상 연구 프로토콜 분석)

  • Dobs, Adrian S;Lee, Sang-Hoon
    • The Journal of Korean Medicine
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    • v.28 no.3 s.71
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    • pp.116-125
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    • 2007
  • Objective : To overview the protocols of clinical acupuncture research on cancer in the USA. Methods : Using 'acupuncture' and 'cancer' as keyword search terms in Clinical Trials. gov, 28 clinical studies were found. Three studies by non-American institutions were excluded and 25 studies were analyzed. Analytic parameters were cancer condition, primary outcome, research institution, study design, and acupuncture intervention. Results : Breast cancer was the most frequent single condition in the searched protocols. Pain and quality of life were the primary outcomes in many studies. Memorial Sloan-Kettering Cancer Centerin New York has performed the largest number of acupuncture cancer studies. The majority of studies were randomized controlled trials with active controls or placebo/sham controls. Total enrollment varied between the range of 10 and 700 subjects and ages of these subjects were at least above 18 years old (except one protocol). Most protocols had strict exclusion criteria for acupuncture needling such as bleeding disorders, infection, heart disorder, and central nervous system disorder. Conclusions : Clinical acupuncture studies for cancer patients have focused on pain, quality of life, and side effects induced by anti-cancer therapies. Re-evaluation and cautions for strict exclusion criteria in foreign countries are required to perform multi-national acupuncture trials.

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Current Evidence of Acupuncture in the Cochrane Databse of Systematic Reviews: an Overview (코크란 체계적 문헌고찰 내의 침구치료 임상근거 현황고찰)

  • Kim, Kun-Hyung;Noh, Seung-Hee;Lee, Myeong-Soo;Yang, Gi-Young;Shin, Byung-Cheul;Kim, Jae-Kyu;Lee, Byung-Ryul
    • Journal of Acupuncture Research
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    • v.28 no.4
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    • pp.57-64
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    • 2011
  • Objectives : The aim of this study is to overview the current status of Cochrane systematic review of acupuncture. Methods : Published Cochrane systematic reviews and protocols for evaluating acupuncture and/or moxibustion were searched by the terms 'acupuncture' and 'moxibustion' in Issue 1, Cochrane Library, 2011. Only reviews or protocols that regarded acupuncture or moxibustion as primary methods of intervention in their reviews were included. Data regarding first author national affiliation, intervention and disease, as well as the number of reviews or protocols that included Korean, Chinese, or Japanese databases in search strategies were obtained. Results : We found 92 hits at screening, and 59 studies were eligible for this review. Included interventions were acupuncture (n=56), auricular acupuncture (n=2), and moxibustion (n=1) for various diseases and conditions. The number of publications of Cochrane systematic reviews or protocols increased gradually from 2002 to 2011. First authors' affiliations were located in China (n=32), Australia (n=8), UK (n=7), Canada (n=4), U.S. (n=4), Germany (n=2), Norway, (n=1) and Korea (n=1). 44, four and four Cochrane reviews adopted Chinese, Korean and Japanese databases, respectively. Conclusions : Search strategies in a substantial number of Cochrane reviews or protocols for acupuncture and moxibustion heavily relied on Chinese databases. Korean databases were underused in existing Cochrane reviews and protocols, and Korean authors were much less involved in the Cochrane systematic reviews or protocols than Chinese authors. Further studies need to be conducted in order to incorporate evidence of acupuncture reported in Korean databases into the Cochrane systematic reviews.

Analysis on Clinical Characteristics and Influencing Factors of Patients with Locoregionally Advanced Nasopharyngeal Carcinoma

  • Zheng, Wei;Xu, Yuan-Ji;Qiu, Su-Fang;Zong, Jing-Feng;Huang, Ling-Ling;Huang, Chao-Bin;Lin, Shao-Jun;Pan, Jian-Ji
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.10
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    • pp.4393-4399
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    • 2015
  • Background: To explore the independent prognostic factors for the recurrence/metastasis of patients with locoregionally advanced nasopharyngeal carcinoma (LANPC). Materials and Methods: A total of 604 patients initially diagnosed as LANPC by pathohistology in Fujian Provincial Cancer Hospital were selected to analyze the relationship between the clinical pathological patterns, therapeutic protocols and clinical stages with the recurrence/metastasis of LANPC. Results: The 1-, 3- and 5-year locoregionally recurrent rates of LANPC patients were 2.0%, 9.5% and 12.9% respectively, with average recurrent period being 78 months. Univariate analysis results indicated that clinical stages had certain influence on the recurrent period of LANPC patients. However, COX regression models showed that ages, genders and clinical stages were not the independent prognostic factors influencing the recurrence. The 1-, 3- and 5-year metastatic rates of LANPC patients were 6.6%, 17.5% and 18.8% respectively, with average metastatic period of 73 months. Univariate analysis results demonstrated that ages, N stages, clinical stages, locations of lymph node, retropharyngeal lymph node and extracapsular invasion of lymph node had certain influence on the metastatic period of LANPC patients. Additionally, further COX regression analysis results suggested that T stages, reduction protocols and extracapsular invasion of lymph node were the independent prognostic factors influencing the metastasis of patients with LANPC, in which T stages and extracapsular invasion of lymph node were the pestilent factors while reduction protocols the protective factor. Conclusions: Induction chemotherapy is beneficial to LANPC patients with initial treatment, and the metastatic rate decreases greatly after the application of reduction chemotherapy.

Regional Differences in Access to Clinical Trials for Cancer in Korea

  • Kim, Woorim;Jang, Seongkyeong;Chang, Yoon Jung
    • Quality Improvement in Health Care
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    • v.27 no.1
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    • pp.20-25
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    • 2021
  • Purpose: The ability to access clinical trials for cancer treatment is important. This study investigated whether regional differences exist in oncologic clinical trial protocols conducted in South Korea. Methods: Records of all approved oncologic clinical trials conducted in 2019 were downloaded from the Republic of Korea Ministry of Food and Drug Safety. The study covered Seoul, the capital area, other metropolitan cities, and provincial areas. Descriptive statistics summarized the distribution patterns of clinical trials by region. Results: A total of 202 oncologic clinical trials were conducted in 63 institutions in 2019. Of these protocols, 186 (92%) were available in Seoul, 120 (59%) in the capital area, 64 (32%) in metropolitan cities, and 66 (33%) in provincial areas. More regional differences in protocol availability were observed in domestic trials, investigator-initiated trials, phase 1 and 2 trials, and smaller-scale trials. Conclusion: Most oncologic clinical trials were conducted in medical institutions located in Seoul, with the rest conducted in the capital area, metropolitan cities, and provincial areas. The findings reveal clear differences in protocol availability between Seoul and the other regions. Measures designed to improve geographical access to oncologic clinical trials may be needed given their growing importance in cancer treatment.

Assessing Methodological Quality of Acupuncture Clinical Trials of Korea (한국 침 임상시험의 질 평가 및 분석)

  • Park, Ji-Eun;Kang, Kyung-Won;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.24 no.1
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    • pp.127-135
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    • 2007
  • Objectives: To evaluate the methodological quality of Korean Acupuncture Clinical trials Methods : Two independent researchers reviewed 12 protocols of Acupuncture clinical trials which were conducted in Korea 2006. Also, Survey Principal Investigator of those was conducted. We compare the results of protocol review with investigator reponses of actual practice. Quality assessment consisted of 5 items including random sequence generation, randomization method, allocation concealment, subject blinding, assessor blinding. Results : Randomization was performed using the proper procedure to insure that treatment assignment is unbiased and concealed from subjects in all clinical trials, According to protocols, 6(50%) of 12 clinical trials used computer-generated random numbers, 6(50%) remaining trials didn't describe the randomization method. Also all trials used appropriate randomization methods on the basis of the survey results: 8 trials used computer-generated random number, 2 used random table. Of 7 protocols in which allocation concealment was stated, 5(71%) reported appropriate method (Calling a central office or statisticians, Sealed opaque envelopes). However according to survey, 5(42%) of 12 trials used inappropriate allocation concealment (Keeping a master randomization list and referring to when subject entered the trial). In addition, the result of protocol review and survey response was not coincident in 5(42%) trials. Subject blinding was conducted in all except 1 clinical trials. Although 11(92%) of 12 trials were conducted using assessor blinding in actual practice, only 7(58%) reported that in protocol. Conclusion : Although randomization and blinding were conducted adequately, allocation concealment was used inadequately, Not only appropriate allocation concealment, but also every quality assessment item including randomization, blinding should be stated in more detail in protocol.

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Protocols of Myocardial Perfusion SPECT (심장관류SPECT 검사 프로토콜)

  • Kim, Seong-Min
    • The Korean Journal of Nuclear Medicine
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    • v.39 no.2
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    • pp.82-86
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    • 2005
  • In myocardial perfusion scintigraphy, the results of this evalution now confront the practitioner of nuclear medicing with methodologic options. Most nuclear cardiologic studies are performed using thallium-201, Tc-99m sestamibi and Tc-99m tetrofosmin. Some part of these studies use some form of pharmacologic stress test. While tailoring each test to the individual is ideal, this may be impractical for a busy department. Accordingly, established protocols to be used for patients with similar clinical presentations will be helpful. The following review presents methodology of various imaging protocols mainly according to the guidelines of nuclear cardiology procedures in American Society of Nuclear Cardiology.

Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline (침구임상시험 가이드라인 개발과정에서 IRB의 윤리적·과학적 지적사항 사례 조사 연구)

  • Leem, Jung Tae;Lee, Seung Hoon;Han, Ga Jin;Kim, Eun Jung;Seo, Byung Kwan;Kim, Tae Hun;Lee, Seung Deok;Kim, Jong Uk;Yu, A Mi;Nam, Dong Woo;Lee, Jun Hee
    • Journal of Acupuncture Research
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    • v.32 no.2
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    • pp.11-21
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    • 2015
  • Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

Three states of stromal cells-solid, liquid, and aerosol-and innovative delivery methods not previously reported

  • Copcu, Hasim Eray
    • Archives of Plastic Surgery
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    • v.48 no.5
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    • pp.549-552
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    • 2021
  • Clinical applications of stromal cells obtained mechanically from adipose tissue are quite popular methods. However, generally accepted protocols still do not exist. In this study, three new delivery methods using different protocols are presented as innovative methods in accordance with an approach called "Indication-based protocols." In mechanical methods, before cutting the fat tissue with ultra-sharp blades, which we define as "Adinizing," mixing it with different liquids such as saline or plasma provides the stromal cells in liquid form with high number and viability as a final product. At the same time, since stromal cells and extracellular matrix are preserved by mechanical methods, it was deemed appropriate to use the term total stromal cells (TOST) instead of stromal vascular fraction for this final product, unlike the product obtained with the enzyme. TOST can be combined with plasma and used for dermal filling in "solid" form. In addition to this filling effect, it will also cause a change in the tissue regeneratively. Finally, the stromal cells obtained from liquid can be applied clinically in aerosol form with the help of nebulizer. We believe that three innovative delivery methods can be used successfully in the treatment of many clinical situations in the future.

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.