JaLCDOI 10.18926/AMO/54601
FullText URL 70_5_401.pdf
Author Kuroda, Shinji| Kikuchi, Satoru| Nishizaki, Masahiko| Kagawa, Shunsuke| Hinotsu, Shiro| Fujiwara, Toshiyoshi|
Abstract 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.
Keywords venous thromboembolism enoxaparin short-term use gastric cancer surgery
Amo Type Clinical Study Protocols
Published Date 2016-10
Publication Title Acta Medica Okayama
Volume volume70
Issue issue5
Publisher Okayama University Medical School
Start Page 401
End Page 404
ISSN 0386-300X
NCID AA00508441
Content Type Journal Article
language 英語
Copyright Holders CopyrightⒸ 2016 by Okayama University Medical School
File Version publisher
Refereed True
PubMed ID 27777435
Web of Sience KeyUT 000388098700012
JaLCDOI 10.18926/AMO/54514
FullText URL 70_4_327.pdf
Author 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|
Abstract 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.
Keywords metformin CD8+ T cells cancer immunology
Amo Type Clinical Study Protocols
Published Date 2016-08
Publication Title Acta Medica Okayama
Volume volume70
Issue issue4
Publisher Okayama University Medical School
Start Page 327
End Page 330
ISSN 0386-300X
NCID AA00508441
Content Type Journal Article
language 英語
Copyright Holders CopyrightⒸ 2016 by Okayama University Medical School
File Version publisher
Refereed True
PubMed ID 27549683
Web of Sience KeyUT 000384748600018
Title Alternative Data management in clinical research
Author Hinotsu, Shiro|
Keywords 臨床研究 倫理指針 ICH-GCP
Publication Title Journal of Okayama Medical Association
Published Date 2017-08-01
Volume volume129
Issue issue2
Start Page 123
End Page 127
ISSN 0030-1558
Related Url https://doi.org/10.4044/joma.129.123
language 日本語
Copyright Holders Copyright (c) 2017 岡山医学会
File Version publisher
DOI 10.4044/joma.129.123
JaLCDOI 10.18926/AMO/54607
FullText URL 70_5_425.pdf
Author 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|
Abstract 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.
Keywords breast cancer phase I trial docetaxel
Amo Type Clinical Study Protocols
Published Date 2016-10
Publication Title Acta Medica Okayama
Volume volume70
Issue issue5
Publisher Okayama University Medical School
Start Page 425
End Page 427
ISSN 0386-300X
NCID AA00508441
Content Type Journal Article
language 英語
Copyright Holders CopyrightⒸ 2016 by Okayama University Medical School
File Version publisher
Refereed True
PubMed ID 27777441
Web of Sience KeyUT 000388098700018