タイトル(別表記) Data management in clinical research
著者 樋之津 史郎|
キーワード 臨床研究 倫理指針 ICH-GCP
備考 特集 臨床研究品質確保体制整備事業 (Feature Article : Project for Securing High Quality Clinical Research)
出版物タイトル 岡山医学会雑誌
発行日 2017-08-01
129巻
2号
出版者 岡山医学会
出版者(別表記) Okayama Medical Association
開始ページ 123
終了ページ 127
ISSN 0030-1558
NCID AN00032489
資料タイプ 学術雑誌論文
関連URL https://doi.org/10.4044/joma.129.123
言語 Japanese
著作権者 Copyright (c) 2017 岡山医学会
論文のバージョン publisher
査読 有り
DOI 10.4044/joma.129.123
Sort Key 10
Eprints Journal Name joma
参考文献 1 ) 厚生労働省 : 研究に関する指針について. http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hokabunya/kenkyujigyou/i-kenkyu/ (2017年5月閲覧) 2 ) 医薬品医療機器総合機構 : ICH-E6 GCP (医薬品の臨床試験の実施基準) . https://www.pmda.go.jp/int-activities/intharmony/ich/0028.html (2017年5月閲覧)
JaLCDOI 10.18926/AMO/54607
フルテキストURL 70_5_425.pdf
著者 Tamura, Tomoki| Hirata, Taizo| Tabata, Masahiro| Hinotsu, Shiro| Hamada, Akinobu| Motoki, Takayuki| Iwamoto, Takayuki| Mizoo, Taeko| Nogami, Tomohiro| Shien, Tadahiko| Taira, Naruto| Matsuoka, Junji| Doihara, Hiroyoshi|
抄録 Docetaxel is a standard treatment for patients with advanced or recurrent breast cancer. The recommended dose is 60 to 100 mg/m2. Previous study have shown that the tumor response rates of patients who received docetaxel monotherapy at doses of 60, 75, and 100 mg/m2 were 22.1% , 23.3% , and 36.0% , respectively, and there was a significant relationship between the dose and response. In Europe and the United States, docetaxel is approved at a dose of 100 mg/m2, and Japanese guidelines also recommend a dose of 100 mg/m2. However, the approved dose in Japan is up to 75 mg/m2. We have launched a phase I trial evaluating 100 mg/m2 docetaxel in patients with advanced or relapsed breast cancer. The major eligibility criteria are as follows: age ≥20 years, pathologically diagnosed breast cancer, recurrent or advanced breast cancer, a good performance status, and HER2 [human epidermal growth factor receptor 2] negative. The primary endpoint is demonstrated safety of 100 mg/m2 docetaxel. This study will clarify whether 100mg/m2 docetaxel can be administrated safely in Japanese patients with advanced or recurrent breast cancer.
キーワード breast cancer phase I trial docetaxel
Amo Type Clinical Study Protocols
発行日 2016-10
出版物タイトル Acta Medica Okayama
70巻
5号
出版者 Okayama University Medical School
開始ページ 425
終了ページ 427
ISSN 0386-300X
NCID AA00508441
資料タイプ 学術雑誌論文
言語 English
OAI-PMH Set 岡山大学
著作権者 CopyrightⒸ 2016 by Okayama University Medical School
論文のバージョン publisher
査読 有り
Submission Path amo/vol70/iss5/18
PubMed ID 27777441
Web of Sience KeyUT 000388098700018
JaLCDOI 10.18926/AMO/54601
フルテキストURL 70_5_401.pdf
著者 Kuroda, Shinji| Kikuchi, Satoru| Nishizaki, Masahiko| Kagawa, Shunsuke| Hinotsu, Shiro| Fujiwara, Toshiyoshi|
抄録 Although intermittent pneumatic compression (IPC) has become common as perioperative prophylaxis for venous thromboembolism (VTE) consisting of pulmonary thromboembolism (PE) and deep vein thrombosis (DVT), the prophylactic effect against VTE, especially lethal PE, is not yet satisfactory. Therefore, pharmacologic prophylaxis, such as with enoxaparin, is desirable. While the efficacy and safety of enoxaparin have been proven in several clinical trials, concern about bleeding with longterm (at least 7 days) use have potentially decreased its widespread adoption. We have launched a phase II study to evaluate the efficacy and safety of short-term (3 days) enoxaparin, in which a total of 70 gastric cancer patients undergoing gastrectomy will be recruited, and the primary endpoint is the incidence of DVT. This study could contribute to making pharmacologic prophylaxis for VTE more common.
キーワード venous thromboembolism enoxaparin short-term use gastric cancer surgery
Amo Type Clinical Study Protocols
発行日 2016-10
出版物タイトル Acta Medica Okayama
70巻
5号
出版者 Okayama University Medical School
開始ページ 401
終了ページ 404
ISSN 0386-300X
NCID AA00508441
資料タイプ 学術雑誌論文
言語 English
OAI-PMH Set 岡山大学
著作権者 CopyrightⒸ 2016 by Okayama University Medical School
論文のバージョン publisher
査読 有り
Submission Path amo/vol70/iss5/12
PubMed ID 27777435
Web of Sience KeyUT 000388098700012
JaLCDOI 10.18926/AMO/54514
フルテキストURL 70_4_327.pdf
著者 Watanabe, Mototsugu| Yamamoto, Hiromasa| Eikawa, Shingo| Shien, Kazuhiko| Shien, Tadahiko| Soh, Junichi| Hotta, Katsuyuki| Wada, Jun| Hinotsu, Shiro| Fujiwara, Toshiyoshi| Kiura, Katsuyuki| Doihara, Hiroyoshi| Miyoshi, Shinichiro| Udono, Heiichiro| Toyooka, Shinichi|
抄録 A study to evaluate the effect of metformin on the immune system was commenced in July 2014. Metformin is one of the most commonly prescribed drugs for type 2 diabetes, and previous studies have reported that metformin has an anti-tumor effect. The aim of this study is to evaluate the efficacy of metformin on the immune system in human cancer patients in vivo. The primary outcome parameter will be the rate change in the population of CD8+ T cells, which produce multiple cytokines.
キーワード metformin CD8+ T cells cancer immunology
Amo Type Clinical Study Protocols
発行日 2016-08
出版物タイトル Acta Medica Okayama
70巻
4号
出版者 Okayama University Medical School
開始ページ 327
終了ページ 330
ISSN 0386-300X
NCID AA00508441
資料タイプ 学術雑誌論文
言語 English
OAI-PMH Set 岡山大学
著作権者 CopyrightⒸ 2016 by Okayama University Medical School
論文のバージョン publisher
査読 有り
Submission Path amo/vol70/iss4/18
PubMed ID 27549683
Web of Sience KeyUT 000384748600018