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2. A randomized double blind placebo-controlled clinical trial of Hochuekkito, a traditional herbal medicine, in the treatment of elderly patients with weakness N of one and responder restricted design

Author

Satoh, N., Sakai, S., Kogure, T., Tahara, E., Origasa, H., Shimada, Y., Kohoda, K., Okubo, T., and Terasawa, K.

Subjects
Aged -- Health aspects -- Research, Medicine, Chinese -- Research -- Health aspects, Clinical trials -- Research -- Health aspects, Biological sciences, Health, Science and technology
Abstract

Abstract Objective: To evaluate the effects of Hochuekkito, a traditional Japanese and Chinese medicine, in the treatment of elderly patients with general weakness. To devise a suitable study design for [...]

Published
2005

5. Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

Author

Isomura, T, Suzuki, S, Origasa, H, Hosono, A, Suzuki, M, Sawada, T, Terao, S, Muto, Y, and Koga, T

Subjects
Green tea -- Health aspects, Liver -- Health aspects, Food/cooking/nutrition, Health
Abstract

There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5-9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare. European Journal of Clinical Nutrition (2016) 70, 1221-1229; doi: 10.1038/ejcn.2016.78; published online 18 May 2016, Author(s): T Isomura [1, 2, 3, 4]; S Suzuki [3]; H Origasa [4]; A Hosono [3]; M Suzuki [1]; T Sawada [1]; S Terao [1]; Y Muto [1]; T Koga [...]

Published
2016
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10. Primary and secondary prevention of stroke and systemic embolism with rivaroxaban in patients with non-valvular atrial fibrillation (sub-analysis of the expand study)

Author

Uchiyama, S., primary, Hirotsugu, A., additional, Inoue, H., additional, Kitazono, T., additional, Shimizu, W., additional, Yamashita, T., additional, Ikeda, T., additional, Kamouchi, M., additional, Kaikita, K., additional, Fukuda, K., additional, Origasa, H., additional, and Shimokawa, H., additional

Published
2017
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14. THU0157 Clinical Outcomes at Week 104 and Analysis of Associated Baseline Factors after An Initial 1 Year of Certolizumab Pegol and MTX Treatment in MTX-Naïve Patients with Early RA: Results from The Second Year of The C-Opera Study

Author

Atsumi, T., primary, Yamamoto, K., additional, Takeuchi, T., additional, Yamanaka, H., additional, Ishiguro, N., additional, Tanaka, Y., additional, Eguchi, K., additional, Watanabe, A., additional, Origasa, H., additional, Shoji, T., additional, Togo, O., additional, Okada, T., additional, van der Heijde, D., additional, Miyasaka, N., additional, and Koike, T., additional

Published
2016
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17. SAT0173 Baseline Parameters Identified in Early, Methotrexate-Naïve Rheumatoid Arthritis Patients with Better Outcomes with Certolizumab Pegol+Methotrexate Compared to Placebo+Methotrexate: Post-Hoc Analyses of C-OPERA, A Randomized, Controlled, Phase 3 Study

Author

Atsumi, T., primary, Yamamoto, K., additional, Takeuchi, T., additional, Yamanaka, H., additional, Ishiguro, N., additional, Tanaka, Y., additional, Eguchi, K., additional, Watanabe, A., additional, Origasa, H., additional, Shoji, T., additional, Togo, O., additional, Okada, T., additional, van der Heijde, D., additional, Miyasaka, N., additional, and Koike, T., additional

Published
2015
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19. FRI0278 The First Early Rheumatoid Arthritis, Certolizumab Pegol, Multicenter, Double-Blind, Randomized, Parallel-Group Study: C-Opera, in Patients Fulfilling the 2010 Acr/Eular Classification Criteria, Demonstrates Inhibition of Joint Damage Progression

Author

Atsumi, T., primary, Yamamoto, K., additional, Takeuchi, T., additional, Yamanaka, H., additional, Ishiguro, N., additional, Tanaka, Y., additional, Eguchi, K., additional, Watanabe, A., additional, Origasa, H., additional, Shoji, T., additional, Okada, T., additional, van der Heijde, D., additional, Miyasaka, N., additional, and Koike, T., additional

Published
2014
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21. Gemcitabine and vinorelbine followed by docetaxel in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial of nonplatinum sequential triplet combination chemotherapy (JMTO LC00-02)

Author

Shigeto Hosoe, Harada H, Ohsaki Y, Morioka T, Masaaki Kawahara, Y. Iwamoto, Kiyoyuki Furuse, Mitsuo Fukushima, Kazuhiko Shibata, Origasa H, and K Komuta

Subjects
Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, endocrine system diseases, Paclitaxel, medicine.medical_treatment, nonplatinum regimen, Phases of clinical research, Docetaxel, Vinorelbine, Vinblastine, Deoxycytidine, Drug Administration Schedule, chemistry.chemical_compound, Clinical, Internal medicine, Carcinoma, Non-Small-Cell Lung, advanced non-small-cell lung cancer, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Survival rate, Aged, Aged, 80 and over, Chemotherapy, business.industry, Combination chemotherapy, Middle Aged, Survival Analysis, Gemcitabine, Carboplatin, Surgery, chemistry, Female, Taxoids, sequential-triplet chemotherapy, business, medicine.drug
Abstract

To evaluate the efficacy and toxicity of the sequential nonplatinum combination chemotherapy consisting of gemcitabine (GEM) and vinorelbine (VNR) followed by docetaxel (DOC) in patients with advanced non-small-cell lung cancer (NSCLC), we conducted the multiinstitutional phase II study. A total of 44 chemotherapy-naive patients with advanced NSCLC were treated with GEM 1000 mg m(-2) and VNR 25 mg m(-2) intravenously on days 1 and 8 every 3 weeks for three cycles. DOC 60 mg m(-2) was then administrated intravenously at 3-week intervals for three cycles. Patients were evaluated for response and toxicity with each cycle of the treatment. The major objective response rate was 47.7% (95% confidence interval (CI), 33.8-62.1%). Median survival time (MST) was 15.7 months and 1-year survival rate was 59%. In the GEM/VNR cycle, grade 3/4 neutropenia occurred in 36.3%, grade 3/4 anaemia in two patients (4.5%) and grade 3 thrombocytopenia in one patient (2.3%). Grade 3 pneumonitis occurred in two patients (4.5%) in GEM/VNR cycles. In the DOC cycles, grade 3/4 neutropenia occurred in 39.4% but no patient experienced grade 3/4 anaemia or thrombocytopenia. Of the 44 eligible patients, 33 patients completed three cycles of GEM/VNR and 22 patients completed six cycles of planned chemotherapy (three cycles of GEM/VNR followed by three cycles of DOC). The sequential triplet nonplatinum chemotherapy consisted of GEM/VNR followed by DOC, and was very active and well tolerated. This study forms the basis for an ongoing phase III trial that compares this nonplatinum triplet and standard platinum doublet combination (carboplatin/paclitaxel).

Published
2003

23. AB0468 Improved physical function, pain, and health related quality of life with certolizumab pegol in japanese rheumatoid arthritis patients with an inadequate response to methotrexate: Results from the jrapid study

Author

Yamanaka, H., primary, Yamamoto, K., additional, Takeuchi, T., additional, Ishiguro, N., additional, Tanaka, Y., additional, Eguchi, K., additional, Watanabe, A., additional, Origasa, H., additional, Shoji, T., additional, Sakamaki, Y., additional, Miyasaka, N., additional, and Koike, T., additional

Published
2013
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24. THU0199 Week 12 Clinical Response to Certolizumab Pegol Predicts Long-Term Outcomes Regardless of Concomitant Medications and Baseline Disease Characteristics in Japanese Patients with Active Rheumatoid Arthritis

Author

Yamanaka, H., primary, Yamamoto, K., additional, Takeuchi, T., additional, Ishiguro, N., additional, Tanaka, Y., additional, Eguchi, K., additional, Watanabe, A., additional, Origasa, H., additional, Shoji, T., additional, Onodera, S., additional, Miyasaka, N., additional, and Koike, T., additional

Published
2013
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26. FRI0201 Immunogenicity of certolizumab pegol without concomitant methotrexate and clinical response in rheumatoid arthritis patients: post-hoc analysis of the hikari study

Author

Takeuchi, T., primary, Yamamoto, K., additional, Yamanaka, H., additional, Ishiguro, N., additional, Tanaka, Y., additional, Eguchi, K., additional, Watanabe, A., additional, Origasa, H., additional, Wada, Y., additional, Shoji, T., additional, Miyasaka, N., additional, and Koike, T., additional

Published
2013
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27. AB0469 Improved physical function, pain, and health related quality of life with certolizumab pegol in japanese rheumatoid arthritis patients without methotrexate co-administration: Results from the hikari study

Author

Yamanaka, H., primary, Yamamoto, K., additional, Takeuchi, T., additional, Ishiguro, N., additional, Tanaka, Y., additional, Eguchi, K., additional, Watanabe, A., additional, Origasa, H., additional, Iwai, K., additional, Sakamaki, Y., additional, Miyasaka, N., additional, and Koike, T., additional

Published
2013
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29. 77 EFFECTS OF PA ON THE RISK OF CORONARY ARTERY DISEASE IN HYPERCHOLESTEROLEMIC PATIENTS IN RELATED WITH NONATTAINMENT THE LIPID MANAGEMENT GOALS FOR LDL-C OR NON HDL-C: SUB-ANALYSIS OF THE JELIS

Author

Sasaki, J., primary, Yokoyama, M., additional, Matsuzaki, M., additional, Saito, Y., additional, Origasa, H., additional, Ishikawa, Y., additional, Oikawa, S., additional, Itakura, H., additional, Hishida, H., additional, Kita, T., additional, Kitabatake, A., additional, Nakaya, N., additional, Sakata, T., additional, Shimada, K., additional, Shirato, K., additional, and Matsuzawa, Y., additional

Published
2011
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32. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis

Author

Yokoyama, M., Origasa, H., and Marsuzaki, M.

Subjects
Coronary heart disease -- Research, Eicosanoic acid -- Research -- Health aspects, Omega-3 fatty acids -- Health aspects -- Research, Hypercholesterolemia -- Research, Health, Research, Health aspects
Abstract

BACKGROUND: Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease. We aimed to test the hypothesis that long-term [...]

Published
2007

33. Phase III randomized study of vinorelbine (V), gemcitabine (G) followed by docetaxel (D) (VGD) versus paclitaxel (P) and carboplatin (C) (PC) in patients (pts) with advanced non-small cell lung cancer (NSCLC) (Japan Multinational Trial Organization LC00–03)

Author

Kawahara, M., primary, Ogawara, M., additional, Nishiwaki, Y., additional, Kubota, K., additional, Komuta, K., additional, Minato, K., additional, Fujita, Y., additional, Origasa, H., additional, Fukushima, M., additional, and Furuse, K., additional

Published
2006
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35. Phase III randomized study of vinorelbine (V), gemcitabine (G) followed by docetaxel (D) (VGD) versus paclitaxel (P) and carboplatin (C) (PC) in patients (pts) with advanced non-small cell lung cancer (NSCLC) (Japan Multinational Trial Organization LC00–03)

Author

Kiyoyuki Furuse, M Ogawara, Koichi Minato, Mitsuo Fukushima, Kaoru Kubota, Masaaki Kawahara, Yuka Fujita, Yutaka Nishiwaki, Origasa H, and Kiyoshi Komuta

Subjects
Oncology, Cancer Research, medicine.medical_specialty, business.industry, non-small cell lung cancer (NSCLC), Phases of clinical research, medicine.disease, Vinorelbine, Gemcitabine, Carboplatin, chemistry.chemical_compound, Paclitaxel, chemistry, Docetaxel, Internal medicine, medicine, business, Survival rate, medicine.drug
Abstract

7013 Background: Our phase II study of non-platinum VGD for advanced NSCLC demonstrated excellent results with the median survival time (MST) of 15.7 mos and a 1-year survival rate of 59% (Brit J Cancer 88:42,2003). A phase III trial was performed to determine the survival benefit of VGD compared with PC for advanced NSCLC as a Japan-SWOG Lung Cancer Common Arm Trial. Methods: Between Mar 2001 and Apr 2005, 401 chemo-naïve NSCLC pts with Stage IIIB with pleural effusion or Stage IV without brain metastasis, who had ECOG PS 0–1, were randomized to VGD; V 25 mg/m2 iv and G 1000 mg/m2 iv, days 1, 8, every 21 days for 3 cycles followed by D 60 mg/m2 iv, d1, every 21 days for 3 cycles or PC; C AUC=6 iv and P 225 mg/m2 iv, day 1, every 21 days for 6 cycles. The primary endpoint was overall survival (OS). For a two-sided test at the 5% level of significance and power of 85%, the number of pts required to detect a 40% difference in MST was 400. Results: 393 pts (196 VGD, 197 PC) were evaluable for response, OS and toxicity. Baseline demographics were balanced (VGD vs PC): median age 65 yrs(both arms);male(74 vs 69%); PS 0 40%(both arms);Stage IIIB (17 vs 18%); Ad/Sq (66%/23% vs 76%/15%). There were 238 deaths with a median follow-up of 23 mos. 49% in VGD and 29% in PC arm completed 6 cycles (p=0.00005). Response rates in arms VGD/PC were 23% vs 36% (p= 0.008). There were no significant differences in progression free survival, OS, 1- and 2-yr survivals between VGD and PC arms: 5.9 vs 6.0 mos (p=0.95, Log rank), 13.1 vs 13.8 mos (MST, p=0.28, Log rank), 55.6 vs 55.5%, and 27.6 vs 31.8%. Grade 3/4 toxicities in arms VGD/PC were: neutropenia (G4) (30 vs 54%, p No significant financial relationships to disclose.

Published
2006

36. Gemcitabine and vinorelbine followed by docetaxel in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial of nonplatinum sequential triplet combination chemotherapy (JMTO LC00-02)

Author

Hosoe, S, primary, Komuta, K, additional, Shibata, K, additional, Harada, H, additional, Iwamoto, Y, additional, Ohsaki, Y, additional, Morioka, T, additional, Origasa, H, additional, Fukushima, M, additional, Furuse, K, additional, and Kawahara, M, additional

Published
2003
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39. Evaluation of long-term efficacy of antiarrhythmic drug : An interium report of Japanese Antiarrhythmics Long-term Trial (JALT-1)

Author

Iinuma, H., primary, Harumi, K., additional, Sugimoto, T., additional, Hayakawa, K., additional, Matsuo, H., additional, Miyahara, H., additional, Kasanuki, K., additional, Ohe, T., additional, Ogawa, S., additional, Tanabe, A., additional, Kato, T., additional, Inoue, H., additional, Uoi, T., additional, Origasa, H., additional, and Maeda, H., additional

Published
1995
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50. Quality-of-life evaluation for advanced non-small-cell lung cancer: a comparison between vinorelbine plus gemcitabine followed by docetaxel versus paclitaxel plus carboplatin regimens in a randomized trial: Japan Multinational Trial Organization LC00-03 (BRI LC03-01)

Author

Shinkai Tetsu, Kubota Kaoru, Origasa Hideki, Teramukai Satoshi, Tokoro Akihiro, Tada Harue, Kawahara Masaaki, Fukushima Masanori, and Furuse Kiyoyuki

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background A randomized trial of vinorelbine plus gemcitabine followed by docetaxel (VGD) versus paclitaxel plus carboplatin (PC) in patients with advanced non-small-cell lung cancer showed no difference in overall survival (median survival time: 13.6 versus 14.1 months) between the two treatment groups. We report here the results of quality-of-life (QOL) study initiated in the mid-course of this randomized trial. Methods The patients themselves assessed the Functional Assessment of Cancer Therapy (FACT)-Lung (FACT-L), FACT-Taxane and the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) QOL instruments at baseline and 6, 12 and 18 weeks after the treatment. The primary endpoint was a comparison of total QOL score for each assessment instrument between the two groups. Results Sixty-eight patients from the trial (VGD, 34; PC, 34) who submitted baseline questionnaires and at least one questionnaire over the course of treatment were eligible. Longitudinal analysis showed a significant difference in slope of the FACT-Taxane score (p = 0.004) between treatment regimens over time, but no difference was found in FACT-L score (p = 0.311) and FACIT-Sp score (p = 0.466) between the two groups. Conclusions The significant difference in slope of FACT-Taxane score favored the VGD regimen. These data should be considered in treatment decision-making for patients with advanced non-small-cell lung cancer. Trial registration NCT00242983.

Published
2011
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