• Title/Summary/Keyword: Trial Division

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Feasibility Study of Docetaxel and Cyclophosphamide Six- Cycle Therapy as Adjuvant Chemotherapy for Japanese Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer Patients

  • Abe, Hajime;Mori, Tsuyoshi;Kawai, Yuki;Tomida, Kaori;Kubota, Yoshihiro;Umeda, Tomoko;Tani, Tohru
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.8
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    • pp.4835-4838
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    • 2013
  • Background: We compared treatment completion rates and safety of docetaxel and cyclophosphamide sixcycle therapy (TC6) with docetaxel followed by 5FU, epirubicin and cyclophosphamide (T-FEC) therapy in Japanese patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Materials and Methods: We administered TC6 q3w or T-FEC q3w to HER2-negative breast cancer patients. The primary endpoint of this trial was toxicity. As second endpoints, the treatment completion rate and relative dose intensity were evaluated. Results: The TC6 and T-FEC group consisted of 22 and 21 patients, respectively. Concerning hematological toxicity, grade 3 or higher adverse reactions included neutropenia and febrile neutropenia. As non-hematological adverse events, exanthema and peripheral neuropathy were frequently reported in the TC6 group, whereas more patients of the T-FEC group reported nausea and vomiting. In TC6, the treatment completion rate was 86.4% and the relative dose intensity of docetaxel was 93.2%. In T-FEC, the values were 95.2% and 98.9%, respectively. Conclusions: These results suggest that TC6 is tolerable in Japanese, and that this regimen can also be performed in outpatient clinics. However, with the TC6 regimen, the compliance was slightly lower than with the T-FEC regimen, and supportive therapy needs to be managed appropriately.

Feasibility of No Prophylactic Antibiotics Use in Patients Undergoing Total Laparoscopic Distal Gastrectomy for Gastric Carcinoma: a Propensity Score-Matched Case-Control Study

  • Na, Yongmin;Kang, Ji Hoon;Jung, Mi Ran;Ryu, Seong Yeob;Jeong, Oh
    • Journal of Gastric Cancer
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    • v.19 no.4
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    • pp.451-459
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    • 2019
  • Purpose: Laparoscopic surgery is associated with lower surgical site infection (SSI) rates due to minimal skin incision and non-exposure of visceral organs. Most previous studies have analyzed the efficacy of prophylactic antibiotic use in open surgery. Here, we investigated the feasibility of total laparoscopic distal gastrectomy (TLDG) for gastric carcinoma without prophylactic antibiotic use. Materials and Methods: Seventy-one patients who underwent TLDG without prophylactic antibiotic use were 1:1 propensity score matched with 393 patients who underwent TLDG with antibiotic prophylaxis. The short-term surgical outcomes, including SSI rates, were compared between the groups. Results: After matching, 65 patients were selected in each group. The baseline clinicopathological characteristics were well balanced in the matched sample. In the matched group, there was no significant increase in postoperative morbidity in the non-prophylactic group compared with the prophylactic group (18.5% vs. 15.4%, P=0.640), and there were no grade 3≤ complications (1.4% vs. 0%, respectively; P=1.000). The SSI rates in the non-prophylactic and prophylactic groups were 3.1% and 1.5%, respectively (P=0.559). The time to gas passage, diet initiation, and mean hospital stay were not significantly different between the 2 groups. The SSI rate did not increase in the non-prophylactic group in the different subgroups based on different clinicopathological characteristics. Conclusions: Postoperative morbidity, including SSI rates, did not significantly increase in patients undergoing TLDG without prophylactic antibiotic use. A large prospective randomized trial is warranted to reappraise the efficacy of prophylactic antibiotic use in patients undergoing TLDG.

Value of KRAS, BRAF, and PIK3CA Mutations and Survival Benefit from Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

  • Sasaki, Yusuke;Hamaguchi, Tetsuya;Yamada, Yasuhide;Takahashi, Naoki;Shoji, Hirokazu;Honma, Yoshitaka;Iwasa, Satoru;Okita, Natsuko;Takashima, Atsuo;Kato, Ken;Nagai, Yushi;Taniguchi, Hirokazu;Boku, Narikazu;Ushijima, Toshikazu;Shimada, Yasuhiro
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.2
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    • pp.539-543
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    • 2016
  • Background: It is well known that peritoneal carcinomatosis (PC) from colorectal cancer (CRC) is associated with a poor prognosis. However, data on the prognostic significance of modern chemotherapy containing bevacizumab, cetuximab or panitumumab are not available. Materials and Methods: This retrospective review concerned 526 patients with metastatic CRC who were classified into two groups according to the presence or absence of PC, and were treated with systemic chemotherapy, with or without bevacizumab or anti-EGFR antibodies. The genetic background, in particular KRAS, BRAF, and PIK3CA gene mutations, and overall survival (OS) were compared between the two groups. Results: The median OS values were 23.3 and 29.1 months for PC and non-PC patients, respectively (hazard ratio [HR]=1.20; p=0.17). Among all patients, tumor location, number of metastatic sites and BRAF mutation status were significant prognostic factors, whereas the presence of PC was not. In the PC group, chemotherapy with bevacizumab resulted in a significantly longer OS than forchemotherapy without bevacizumab (HR=0.38, p<0.01), but this was not the case in the non-PC group (HR=0.80, p=0.10). Furthermore, the incidence of the BRAF V600E mutation was significantly higher in PC than in non-PC patients (27.7% versus 7.3%, p<0.01). BRAF mutations displayed a strong correlation with shorter OS in non-PC (HR=2.26), but not PC patients (HR=1.04). Conclusions: Systemic chemotherapy, especially when combined with bevacizumab, improved survival in patients with PC from CRC as well as non-PC patients. While BRAF mutation demonstrated a high frequency in PC patients, but it was not associated with prognosis.

A Comparative Study of Sea Trials and Production Processes for Propulsion Type Working Boats with a Tuna Purse Seiner (다랑어 선망어선 탑재용 보조 작업선의 추진기 형태 변화에 대한 제작과정 및 해상시운전 비교 연구)

  • Ha, Seoung-Mu;Jang, Ho-Yun;Seo, Hyoung-Seock;Seo, Kwan-Cheol
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.23 no.5
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    • pp.595-602
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    • 2017
  • In Korea, much research and development have occurred to enhance the technological competitiveness of tuna purse seining fisheries. Due to these efforts, fishing efficiency has been improved with the development of radar, sonar and global positioning systems for fish detection and revisions to the hull forms of tuna purse seiners. However, for skiff boats, net boats and speed boats, which are auxiliary working boats mounted on tuna purse seiners, technology has lagged behind relative to the modernization of the main vessel. In this study, the hull of an existing propeller-based net boat with steel wire net to protect tuna was changed to the hull of a water jet propulsion vehicle to reduce resistance and improve maneuverability. As a result, a prototype of a water jet propulsion option was produced according to the aluminum structure strength standards specified by the Ministry of Oceans and Fisheries, and safety was confirmed by performing a drop test. Moreover, through a sea trial test, an existing net boat was shown to have a speed of 12.0knots and a towing force of 2,545 kgf at 2,500 RPM. The prototype had a speed of 26.7 knots and a towing force of 2,011 kgf at 3,200 RPM, which satisfied the towing capacity standards of auxiliary working boats mounted on tuna purse seiners.

Acupuncture, an Adjunct Therapy for Asthma: a Pilot Study Protocol of Randomized Controlled Trial (본 임상시험을 대비한 천식 침치료 무작위 대조군 예비 임상시험 프로토콜)

  • Choi, Jun-Yong;Oh, Dal-Seok;Roh, Young-Lae;Jung, Hee-Jae;Jung, Sung-Ki;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.25 no.3
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    • pp.43-51
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    • 2008
  • 배경 : 최근까지 이루어진 천식의 침치료 무작위 대조군 연구들에 의한 결과는 뚜렷한 효과를 보여주지 못하고 있다. 이러한 요인의 하나로 적절한 피험자 수를 정하기 위한 예비 임상시험의 부재가 거론되고 있다. 따라서 천식에 대한 침치료의 본 임상시험에 앞서 이의 실행 가능성 및 규모를 예측하는 예비임상시험이 필요한 상황이다. 목적 : 예비임상시험을 통해 서양의학적 치료를 받고 있는 천식환자들에 대한 침치료의 부가적 효과를 검증하기 위한 본 임상시험의 실현 가능성을 예측하기 위함. 방법 : 본 시험은 무작위 단일 맹검 대조군 평행 설계 예비 임상시험이다. 1차 평가변수는 최대 호기량 검사기로 집에서 아침, 저녁으로 매일 측정한 수치로 구해진 최대 호기 유속 일중 변동률의 1주간 평균치 변화이며 2차 평가변수는 의료기관에서 시행하는 폐기능 검사, 기준시점 호흡곤란 지수, 호흡곤란 변화에 대한 지수, 천식환자들의 삶의 질 평가를 위한 설문 등이다. 피험자 수는 총 45명으로 선정 및 제외기준을 통해서 참여하게 되며 1주간의 최대 호기 유속 기저치 평가 기간을 거친 후 진짜침 처치 군, 가짜침 처치 군, 대기군 세 군에 각각 무작위로 15명씩 할당된다. 모든 피험자에게 기존의 천식관련 약물의 사용을 허용하며, 진짜침 처치군 및 가짜침 처치군은 주 3회 4주간 해당 처치를 받고 2주 후에 각 평가 항목에 대하여 추적, 관찰하게 된다. 대기군은 기존의 천식관리를 유지하면서 2주마다 방문하여 총 6주간 평가를 받고 진짜침 처치를 4주간 받게 된다. 고찰 : 본 연구는 국내에서 최초로 이루어지는 천식에 대한 침 무작위 대조군 예비 임상시험으로 향후 적절한 피험자 수와 실행가능성을 예측할 수 있으리라 기대된다.

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A study on the current status and development of the new health technology assessment of Korean medicine field (한의 신의료기술 평가 활성화 방안 제언)

  • Park, Minjung;Jung, Youjin;Son, Soo Kyung;Kwon, Soohyun;Kim, Nankwen;Kim, Jong Woo;Park, Dong Ah;Chung, Seok-Hee
    • The Journal of Korean Medicine
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    • v.40 no.3
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    • pp.59-75
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    • 2019
  • Objectives: The purpose of this study is to examine the current status of Korean medicine health technology assessment and explore realistic plans to activate it. Methods: We investigated all the applications for new health technology assessment related to Korean medicine from 2007 to 2016. The several expert meetings were held to draw out the barriers and improvement strategies of the new health technology assessment of Korean medicine field. Results: There were 31 cases in total except for duplications or reapplies falling into 3 main types. First, 19 of them were to try to enter a medical market and be covered by National Health Insurance. Eight cases were to apply western medicine technology as new health technology in Korean medicine area. The rest was 4 cases, which were totally not appropriate for the purpose of new health technology assessment system. According to the expert opinion, the obstacles of activation in new health technology assessment of Korean medicine were application of unstandardized technology, lack of understanding and experience, lack of clinical trial supporting system for Korean medicine, lack of committee members within the nHTA(new Health Technology Assessment) review board, ambiguous definition of medical practice and sharp conflict between western medicine and Korean medicine. Conclusions: Several suggestions were derived. First of all, to activate Korean medicine in the nHTA system, the existing system should be used sufficiently, and multifaceted efforts are needed to upgrade the system, if necessary. Also, self-help efforts, Korean medicine clinical trial supporting system and increasing R&D investment, establishing extra-committee for Korean medicine in nHTA could be needed. Finally, long-term strategy for improving collaboration between Korean medicine and western medicine should be considered.

Development of an Eye Cure Protocol for ICU Patients (중환자실 입원 환자의 눈 간호를 위한 근거기반 지침 개발)

  • Yoo, Ji-Soo;Lee, Won-Hee;Kim, So-Sun;Ko, Il-Sun;Oh, Eui-Geum;Chu, Sang-Hui;Lee, Ju-Hee;Kang, Se-Won;Song, Eun-Kyeung;Chang, Soo-Jung;Kim, Bok-Hee;Lee, Jung-Eun
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.15 no.1
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    • pp.34-44
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    • 2008
  • Purpose: The purpose of this study was to develop an eye care protocol for intensive care unit (ICU) patients. Method: A systematic review was conducted to develop an eye care protocol for ICU patients. Searches were performed using computerized databases (CINAHL, MEDLINE, EBM Review) and citation search from 1996 to January 2007. For the keywords, "eye care", and "randomized controlled trial" were used to identify experimental studies regarding eye care for ICU patients. After reviewing the collected studies, a preliminary eye care protocol algorithm was created. Then, content validity was examined with ophthalmologists and ICU nurses. Results: Six studies were included to serve as a basis for framing of the preliminary algorithm. The final eye care protocol was completed after verifying the preliminary algorithm's content validity. The final eye care protocol was organized in the following manner: 3 items in the assessment stage, 7 items in the no-risk stage, 4 items in the low-risk stage, and 5 items in the high-risk stage. Conclusion: The results indicate that, for ICU patients, nurses can broaden their knowledge regarding ocular diseases, as well as improve their practice-based eye care nursing performance.

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Hominis Placental Pharmacoacupuncture, a Promising Asthma Therapy (자하거(紫河車) 약침의 기관지 천식 치료 가능성에 대한 소고(小考))

  • Choi, Jun-Yong;Oh, Dal-Seok;Jung, Hee-Jae;Choi, Sun-Mi;Jung, Sung-Ki
    • Korean Journal of Acupuncture
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    • v.25 no.2
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    • pp.87-94
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    • 2008
  • Objectives : The aim of this study was to find out some rationales for using Hominis placental extract(HPE) pharmaco-acupuncture on asthmatic patients, and to suggest an appropriate clinical research of HPE pharmaco-acupuncture on asthma. Methods : Articles regarding immunologic experiments about HPE and clinical reports about HPE-contained pharmaco-acupuncture on asthmatic patients were reviewed by on-line and off-line searching. Results and Conclusions : HPE is suggested to have several pharmacological effects on allergic diseases including asthma as well as autoimmune diseases. There are some observational studies of HPE-contained pharmaco-acupuncture on asthmatic patients. However, the designs of these studies are not sufficient to investigate the exact effect of HPE pharmaco-acupuncture on asthma. To investigate HPE pharmaco- acupuncture as a novel asthma therapy, it will be needed to perform further experiments about HPE's pharmacological mechanism on asthma and to try further advanced clinical researches such as well-designed randomized controlled trial of HPE pharmaco-acupuncture.

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Analysis and Design of a Passive Harmonic Filter for a Three-Phase Rectifier (3상 정류기부하에 대한 수동 고조파필터의 해석 및 설계)

  • Cho, Young-Sik;Cha, Han-Ju
    • The Transactions of the Korean Institute of Electrical Engineers P
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    • v.58 no.3
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    • pp.316-322
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    • 2009
  • This paper presents an analytical design method of a passive harmonic filter for a three-phase diode rectifier and uses a new transfer function approach in the analysis and design. The transfer function approach derives an analytical formulation of an utility system including passive filters with a basis of Laplace transform and provides a graphical formulation so that a visualized insight into an interaction between individual filter and system response can be attainted. Harmonic impedance, voltage division and current division transfer function are used as a design tool, which makes a calculated filter parameters to satisfy IEEE-519 distortion limits. A simple five-step design procedure is introduced in the filter design, which consists of system analysis, selection of PCC(Point of Common Coupling), filter specification calculation, appropriate filter design for system and filter implementation. Philosophy governing the design procedure is based on a numerical/graphical iterative solution, trial and error with visualization feed-back based on "algebra on the graph". Finally, performance of the designed passive harmonic filter is verified by experiment and shows that 5th, 7th, 9th, 11th and 13th harmonics are decreased within IEEE-519 distortion limits, respectively.

Effects of Inclusion Levels of Dietary Vitamins and Trace Minerals on Growth Performance and Pork Stability in Finishing Pigs

  • Chae, B.J.;Choi, S.C.;Cho, W.T.;Han, In K.;Sohn, K.S.
    • Asian-Australasian Journal of Animal Sciences
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    • v.13 no.10
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    • pp.1445-1449
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    • 2000
  • A total of one hundred twenty pigs ($L{\times}Y{\times}D$, $50{\pm}0.78kg$) were employed for a 7-week feeding trial to determine the effect of inclusion levels of vitamin and mineral (VTM) premixes on growth performance, nutrient digestibility and pork stability in finishing pigs. Treatments were 100% (Control), 150%, 200%, and 250% of NRC (1998) requirements. Increasing dietary VTM premixes in finishing pigs had a linear (p<0.05) effect on ADG. It also had a linear effect (p<0.05) on the digestibility of calcium and a linear and quadratic effect (p<0.05) on the digestibility of phosphorus. As dietary VTM levels were increased from 100 to 250% NRC (1998), TBARS values of pork samples were linearly (p<0.05) lowered when stored at $1^{\circ}C$ for 2 or 3 weeks. There was also a trend reducing POV of pig meat as dietary VTM level was increased. In conclusion, it would appear that inclusion of VTM premixes at the level of 200-250% of NRC (1998) requirements gave positive effects on growth performance and pork stability in finishing pigs.