Updated on 2022/05/12

写真a

 
KINOSHITA Fumie
 
Organization
Nagoya University Hospital Date Center Assistant professor of hospital
Title
Assistant professor of hospital

Degree 2

  1. 博士(医学) ( 2022.3   京都府立医科大学 ) 

  2. 修士(薬学) ( 2005.3   大阪大学 ) 

Research Interests 2

  1. データ管理学

  2. 生物統計学

Research Areas 1

  1. Informatics / Statistical science

 

Papers 45

  1. Annual Body Mass Index Gain and Risk of Gestational Diabetes Mellitus in a Subsequent Pregnancy. Reviewed

    Tano S, Kotani T, Ushida T, Yoshihara M, Imai K, Nakano-Kobayashi T, Moriyama Y, Iitani Y, Kinoshita F, Yoshida S, Yamashita M, Kishigami Y, Oguchi H, Kajiyama H

    Frontiers in endocrinology   Vol. 13   page: 815390   2022.3

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    DOI: 10.3389/fendo.2022.815390

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  2. Influence of background characteristics in responders of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence Reviewed

    Yamanishi Tomonori, Ishizuka Osamu, Shimizu Shinobu, Kobayashi Yumiko, Kinoshita Fumie, Yamamoto Tokunori, Mizokami Atushi, Narimoto Kazutaka, Toriyama Kazuhiro, Kamei Yuzuru, Kuwatsuka Yachiyo, Mizuno Masaaki, Gotoh Momokazu

        2022.2

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    DOI: 10.1111/luts.12433

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  3. Safety and efficacy of MIKE-1 in patients with advanced pancreatic cancer: a study protocol for an open-label phase I/II investigator-initiated clinical trial based on a drug repositioning approach that reprograms the tumour stroma. Reviewed

    Mizutani Y, Iida T, Ohno E, Ishikawa T, Kinoshita F, Kuwatsuka Y, Imai M, Shimizu S, Tsuruta T, Enomoto A, Kawashima H, Fujishiro M

    BMC cancer   Vol. 22 ( 1 ) page: 205   2022.2

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    DOI: 10.1186/s12885-022-09272-2

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  4. Assessment of placental abruption with diffusion-weighted imaging Reviewed

    Mizutani Teruyuki, Kotani Tomomi, Kato Noriko, Imai Kenji, Ushida Takafumi, Nakano-Kobayashi Tomoko, Kinoshita Yoshimi, Ito Masato, Kinoshita Fumie, Yamamuro Osamu, Kajiyama Hiroaki

    JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH     2022.2

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    DOI: 10.1111/jog.15183

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  5. Laparoscopic Kasai portoenterostomy can be a standard surgical procedure for treatment of biliary atresia. Reviewed

    Shirota C, Hinoki A, Tainaka T, Sumida W, Kinoshita F, Yokota K, Makita S, Amano H, Nakagawa Y, Uchida H

    World journal of gastrointestinal surgery   Vol. 14 ( 1 ) page: 56 - 63   2022.1

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    DOI: 10.4240/wjgs.v14.i1.56

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  6. Multi-state model for predicting ocular progression in acute Stevens-Johnson syndrome/toxic epidermal necrolysis. Reviewed

    Kinoshita F, Yokota I, Mieno H, Ueta M, Bush J, Kinoshita S, Sueki H, Asada H, Morita E, Fukushima M, Sotozono C, Teramukai S, Japanese Research Committee on Severe Cutaneous Adverse Reaction.

    PloS one   Vol. 16 ( 12 ) page: e0260730   2021.12

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    DOI: 10.1371/journal.pone.0260730

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  7. Comparison of contrast-enhanced transabdominal ultrasonography following endoscopic ultrasonography with GD-EOB-DTPA-enhanced MRI for the sequential diagnosis of liver metastasis in patients with pancreatic cancer Reviewed

    JOURNAL OF HEPATO-BILIARY-PANCREATIC SCIENCES     2021.12

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  8. Annual body mass index gain and risk of hypertensive disorders of pregnancy in a subsequent pregnancy Reviewed

    Tano Sho, Kotani Tomomi, Ushida Takafumi, Yoshihara Masato, Imai Kenji, Nakano-Kobayashi Tomoko, Moriyama Yoshinori, Iitani Yukako, Kinoshita Fumie, Yoshida Shigeru, Yamashita Mamoru, Kishigami Yasuyuki, Oguchi Hidenori, Kajiyama Hiroaki

      Vol. 11 ( 1 ) page: 22519   2021.11

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    DOI: 10.1038/s41598-021-01976-y

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  9. Endobronchial Ultrasonography with a Guide Sheath Transbronchial Biopsy for Diagnosing Peripheral Pulmonary Lesions within or near Fibrotic Lesions in Patients with Interstitial Lung Disease Reviewed

    Ito Takayasu, Okachi Shotaro, Kimura Tomoki, Kataoka Kensuke, Suzuki Yasuhiko, Kinoshita Fumie, Wakahara Keiko, Hashimoto Naozumi, Kondoh Yasuhiro

      Vol. 13 ( 22 )   2021.11

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  10. Poor local control of ulcerative T1 glottic cancer treated with 2.25-Gy per fraction radiotherapy Reviewed

    Oie Yumi, Itoh Yoshiyuki, Kawamura Mariko, Takase Yuuki, Murao Takayuki, Ishihara Shunichi, Nomoto Yoshihito, Hirasawa Naoki, Asano Akiko, Yamakawa Kouji, Ito Junji, Kinoshita Fumie, Naganawa Shinji

    NAGOYA JOURNAL OF MEDICAL SCIENCE   Vol. 83 ( 4 ) page: 811 - 825   2021.11

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    DOI: 10.18999/nagjms.83.4.811

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  11. Is area under the curve the best parameter for carboplatin induced emetic risk stratification? Reviewed

    Ozone Sachiko, Ichikawa Kazuya, Morise Masahiro, Matsui Akira, Kinoshita Fumie, Matsuzawa Reiko, Koyama Junji, Tanaka Ichidai, Hashimoto Naozumi

    NAGOYA JOURNAL OF MEDICAL SCIENCE   Vol. 83 ( 4 ) page: 773 - 785   2021.11

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    DOI: 10.18999/nagjms.83.4.773

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  12. Corticosteroid Pulse Therapy for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Patients With Acute Ocular Involvement Reviewed

    Mieno Hiroki, Ueta Mayumi, Kinoshita Fumie, Teramukai Satoshi, Kinoshita Shigeru, Sotozono Chie

    AMERICAN JOURNAL OF OPHTHALMOLOGY   Vol. 231   page: 194 - 199   2021.11

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    DOI: 10.1016/j.ajo.2021.06.015

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  13. Cross-Sectional Examination of Homocysteine Levels with Sarcopenia and Its Components in Memory Clinic Outpatients Reviewed

    Yamada Yosuke, Umegaki Hiroyuki, Kinoshita Fumie, Huang Chi Hsien, Sugimoto Taiki, Fujisawa Chisato, Komiya Hitoshi, Watanabe Kazuhisa, Nagae Masaaki, Kuzuya Masafumi, Sakurai Takashi

    JOURNAL OF ALZHEIMERS DISEASE   Vol. 82 ( 3 ) page: 975 - 984   2021.8

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    DOI: 10.3233/JAD-210083

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  14. Prediabetes is associated with proteinuria development but not with glomerular filtration rate decline: A longitudinal observational study Reviewed

    Furukawa Mariko, Onoue Takeshi, Kato Kiminori, Wada Takashi, Shinohara Yukito, Kinoshita Fumie, Goto Motomitsu, Arima Hiroshi, Tsushita Kazuyo

    DIABETIC MEDICINE   Vol. 38 ( 8 ) page: e14607   2021.8

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    DOI: 10.1111/dme.14607

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  15. The Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT): The Study Protocol for an 18-Month, Multicenter, Randomized, Controlled Trial Reviewed

    Sugimoto T., Sakurai Takashi, Akatsu H., Doi T., Fujiwara Y., Hirakawa A., Kinoshita F., Kuzuya M., Lee S., Matsuo K., Michikawa M., Ogawa S., Otsuka R., Sato K., Shimada H., Suzuki H., Suzuki H., Takechi H., Takeda S., Umegaki H., Wakayama S., Arai H.

      Vol. 8 ( 4 ) page: 465 - 476   2021.6

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    DOI: 10.14283/jpad.2021.29

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  16. Platelet counts during normal pregnancies and pregnancies complicated with hypertensive disorders Reviewed

    Ushida Takafumi, Kotani Tomomi, Moriyama Yoshinori, Imai Kenji, Nakano-Kobayashi Tomoko, Kinoshita Fumie, Nakamura Noriyuki, Iitani Yukako, Yoshida Shigeru, Yamashita Mamoru, Kajiyama Hiroaki

    PREGNANCY HYPERTENSION-AN INTERNATIONAL JOURNAL OF WOMENS CARDIOVASCULAR HEALTH   Vol. 24   page: 73 - 78   2021.6

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    DOI: 10.1016/j.preghy.2021.02.013

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  17. Autoantibody profiles in patients' sera associated with distribution patterns of dermatomyositis skin symptoms. Reviewed

    Ogawa-Momohara M, Kinoshita F, Muro Y, Kobayashi Y, Takeichi T, Akiyama M

    Journal of the American Academy of Dermatology   Vol. 84 ( 6 ) page: 1720 - 1722   2021.6

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    Language:English   Publishing type:Research paper (scientific journal)  

    DOI: 10.1016/j.jaad.2020.07.131

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  18. Variability measurements provide additional value to shear wave elastography in the diagnosis of pancreatic cancer Reviewed

    SCIENTIFIC REPORTS   Vol. 11 ( 1 ) page: 7409   2021.4

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    DOI: 10.1038/s41598-021-86979-5

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  19. Maternal low birth weight and hypertensive disorders of pregnancy Reviewed

    Ushida Takafumi, Kotani Tomomi, Kinoshita Fumie, Imai Kenji, Nakano-Kobayashi Tomoko, Nakamura Noriyuki, Moriyama Yoshinori, Yoshida Shigeru, Yamashita Mamoru, Kajiyama Hiroaki

    PREGNANCY HYPERTENSION-AN INTERNATIONAL JOURNAL OF WOMENS CARDIOVASCULAR HEALTH   Vol. 23   page: 5 - 10   2021.3

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    DOI: 10.1016/j.preghy.2020.10.010

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  20. Liver transaminase levels during pregnancy: a Japanese multicenter study Reviewed

    Ushida Takafumi, Kotani Tomomi, Kinoshita Fumie, Imai Kenji, Nakano-Kobayashi Tomoko, Nakamura Noriyuki, Moriyama Yoshinori, Yoshida Shigeru, Yamashita Mamoru, Kajiyama Hiroaki

    JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE     2021.2

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  21. Maternal low birth weight and hypertensive disorders of pregnancy. Reviewed

    1. Ushida T, Kotani T, Kinoshita F, Imai K, Nakano-Kobayashi T, Nakamura N, Moriyama Y, Yoshida S, Yamashita M, Kajiyama H.

    Pregnancy Hypertens.   Vol. 23   page: 5 - 10   2020.10

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  22. Genome-wide association meta-analysis identifies GP2 gene risk variants for pancreatic cancer. Reviewed

    Lin Y, Nakatochi M, Hosono Y, Ito H, Kamatani Y, Inoko A, Sakamoto H, Kinoshita F, Kobayashi Y, Ishii H, Ozaka M, Sasaki T, Matsuyama M, Sasahira N, Morimoto M, Kobayashi S, Fukushima T, Ueno M, Ohkawa S, Egawa N, Kuruma S, Mori M, Nakao H, Adachi Y, Okuda M, Osaki T, Kamiya S, Wang C, Hara K, Shimizu Y, Miyamoto T, Hayashi Y, Ebi H, Kohmoto T, Imoto I, Kasugai Y, Murakami Y, Akiyama M, Ishigaki K, Matsuda K, Hirata M, Shimada K, Okusaka T, Kawaguchi T, Takahashi M, Watanabe Y, Kuriki K, Kadota A, Okada R, Mikami H, Takezaki T, Suzuki S, Yamaji T, Iwasaki M, Sawada N, Goto A, Kinoshita K, Fuse N, Katsuoka F, Shimizu A, Nishizuka SS, Tanno K, Suzuki K, Okada Y, Horikoshi M, Yamauchi T, Kadowaki T, Yu H, Zhong J, Amundadottir LT, Doki Y, Ishii H, Eguchi H, Bogumil D, Haiman CA, Le Marchand L, Mori M, Risch H, Setiawan VW, Tsugane S, Wakai K, Yoshida T, Matsuda F, Kubo M, Kikuchi S, Matsuo K

    Nature communications   Vol. 11 ( 1 ) page: 3175   2020.6

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    DOI: 10.1038/s41467-020-16711-w

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  23. Usefulness of endoscopic ultrasound-guided fine-needle biopsy for the diagnosis of autoimmune pancreatitis using a 22-gauge Franseen needle: a prospective multicenter study. Reviewed

    Ishikawa T, Kawashima H, Ohno E, Suhara H, Hayashi D, Hiramatsu T, Matsubara H, Suzuki T, Kuwahara T, Ishikawa E, Shimoyama Y, Kinoshita F, Hirooka Y, Fujishiro M

    Endoscopy     2020.6

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    DOI: 10.1055/a-1183-3583

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  24. A new risk stratification model for intravesical recurrence, disease progression, and cancer-specific death in patients with non-muscle invasive bladder cancer: the J-NICE risk tables. Reviewed

    Miyake M, Matsuyama H, Teramukai S, Kinoshita F, Yokota I, Matsumoto H, Shimada K, Kinjyo M, Shimokama T, Okumura K, Yomenori M, Enokida H, Nakagawa M, Nakai Y, Fujimoto K, Nishinihon Uro-oncology Extensive Collaboration group.

    International journal of clinical oncology     2020.3

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    DOI: 10.1007/s10147-020-01654-5

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  25. Evaluation of pre- and post-surgery reading ability in patients with epiretinal membrane: a prospective observational study. Reviewed

    Mieno H, Kojima K, Yoneda K, Kinoshita F, Mizuno R, Nakaji S, Sotozono C

    BMC ophthalmology   Vol. 20 ( 1 ) page: 95   2020.3

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    DOI: 10.1186/s12886-020-01364-6

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  26. Interleukin-6 secretion by fibroblasts in carpal tunnel syndrome patients is associated with trigger finger and inhibited by tranilast Reviewed

    Kawamoto Hiroya, Iwatsuki Katsuyuki, Kurimoto Shigeru, Yamamoto Michiro, Tatebe Masahiro, Morita Akimasa, Kinoshita Fumie, Hirata Hitoshi

    MUSCLE & NERVE   Vol. 61 ( 3 ) page: 408-415   2020.3

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    DOI: 10.1002/mus.26793

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  27. Sample size estimation and re-estimation of cluster randomized controlled trials for real-time feedback, debriefing, and retraining system of cardiopulmonary resuscitation for out-of-hospital cardiac arrests Reviewed

    Akiko Kada, Akihiro Hirakawa, Fumie Kinoshita, Yumiko Kobayashi, Toshihiro Hatakeyama, Daisuke Kobayashi, Chika Nishiyama, Taku Iwami

    Contemporary Clinical Trials Communications   Vol. 14   page: 100316   2019.6

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    DOI: 10.1016/j.conctc.2019.100316

  28. A Comparative Study of Longitudinal Toxicities of Cytotoxic Drugs, Molecularly Targeted Agents, Immunomodulatory Drugs, and Cancer Vaccines. Reviewed

    Hirakawa A, Sudo K, Yonemori K, Sadachi R, Kinoshita F, Kobayashi Y, Okuma HS, Kawachi A, Tamura K, Fujiwara Y, Rubinstein L, Takebe N

    Clinical pharmacology and therapeutics   Vol. 106 ( 4 ) page: 803-809   2019.5

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    DOI: 10.1002/cpt.1442

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  29. Design of a prospective multicenter randomized controlled trial evaluating the effects of gastric lavage on coffee-ground emesis in neonates: study protocol Reviewed

    Maeda Takashi, Sato Yoshiaki, Hirakawa Akihiro, Nakatochi Masahiro, Kinoshita Fumie, Suzuki Takeshi, Ichimura Shintaro, Ito Ryoichi, Kudo Ryuji, Suzuki Michio, Hoshino Shin, Sugiyama Yuichiro, Muramatsu Hideki, Kidokoro Hiroyuki, Kawada Jun-ichi, Takahashi Yoshiyuki, Hayakawa Masahiro, Kato Yuichi, Oshiro Makoto, Hayashi Seiji, Tachibana Takashi, Ieda Kuniko, Yamamoto Hikaru, Takemoto Koji

    NAGOYA JOURNAL OF MEDICAL SCIENCE   Vol. 81 ( 2 ) page: 227-232   2019.5

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    DOI: 10.18999/nagjms.81.2.227

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  30. Comparison of clinical characteristics of human metapneumovirus and respiratory syncytial virus infection in hospitalized young children. Reviewed

    Taniguchi A, Kawada JI, Go K, Fujishiro N, Hosokawa Y, Maki Y, Sugiyama Y, Suzuki M, Tsuji T, Hoshino S, Muramatsu H, Kidokoro H, Kinoshita F, Hirakawa A, Takahashi Y, Sato Y, Natsume J

    Japanese journal of infectious diseases   Vol. 72 ( 4 ) page: 237-242   2019.2

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    DOI: 10.7883/yoken.JJID.2018.480

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  31. The lipoxygenase-hepoxilin pathway is activated in cutaneous plaque lesions of psoriasis. Reviewed

    5. Takeichi T, Kinoshita F, Tanaka H, Fujita S, Kobayashi Y, Nakatochi M, Sugiura K, Akiyama M.

    Journal of Cutaneous Immunology and Allergy   Vol. 2 ( 1 ) page: 15 - 24   2019.2

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    DOI: 10.1002/cia2.12039

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  32. Cross-sectional survey on disease severity in Japanese patients with harlequin ichthyosis/ichthyosis: Syndromic forms and quality-of-life analysis in a subgroup Reviewed

    Murase Chiaki, Takeichi Takuya, Shibata Akitaka, Nakatochi Masahiro, Kinoshita Fumie, Kubo Akiharu, Nakajima Kimiko, Ishii Norito, Amano Hiroo, Masuda Koji, Kawakami Hiroshi, Kanekura Takuro, Washio Ken, Asano Masayuki, Teramura Kazuya, Akasaka Eijiro, Tohyama Mikiko, Hatano Yutaka, Ochiai Toyoko, Moriwaki Shinichi, Sato Tomotaka, Ishida-Yamamoto Akemi, Seishima Mariko, Kurosawa Michiko, Ikeda Shigaku, Akiyama Masashi

    JOURNAL OF DERMATOLOGICAL SCIENCE   Vol. 92 ( 2 ) page: 127-133   2018.11

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    DOI: 10.1016/j.jdermsci.2018.08.008

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  33. Anticancer Agent-Induced Life-Threatening Skin Toxicities: A Database Study of Spontaneous Reporting Data. Reviewed

    Tanaka R, Yonemori K, Hirakawa A, Kinoshita F, Kobayashi Y, Yamazaki N, Fujimoto M, Tamura K, Fujiwara Y

    The oncologist   Vol. 24 ( 2 ) page: 266-272   2018.9

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    DOI: 10.1634/theoncologist.2017-0511

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  34. Prediction model for pancreatic cancer risk in the general Japanese population Reviewed

    Nakatochi Masahiro, Lin Yingsong, Ito Hidemi, Hara Kazuo, Kinoshita Fumie, Kobayashi Yumiko, Ishii Hiroshi, Ozaka Masato, Sasaki Takashi, Sasahira Naoki, Morimoto Manabu, Kobayashi Satoshi, Ueno Makoto, Ohkawa Shinichi, Egawa Naoto, Kuruma Sawako, Mori Mitsuru, Nakao Haruhisa, Wang Chaochen, Nishiyama Takeshi, Kawaguchi Takahisa, Takahashi Meiko, Matsuda Fumihiko, Kikuchi Shogo, Matsuo Keitaro

    PLOS ONE   Vol. 13 ( 9 ) page: e0203386   2018.9

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    DOI: 10.1371/journal.pone.0203386

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  35. Study protocol for the MEXiletine hydrochloride administration trial: a placebo-controlled, randomised, double-blind, multicentre, crossover study of its efficacy and safety in spinal and bulbar muscular atrophy (MEXPRESS) Reviewed

    Yamada Shinichiro, Hashizume Atsushi, Hijikata Yasuhiro, Inagaki Tomonori, Ito Daisuke, Kinoshita Fumie, Nakatochi Masahiro, Kobayashi Yumiko, Hirakawa Akihiro, Nakamura Tomohiko, Katsuno Masahisa

    BMJ OPEN   Vol. 8 ( 9 ) page: e023041   2018.9

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    DOI: 10.1136/bmjopen-2018-023041

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  36. The rate of neonatal respiratory distress syndrome/transient tachypnea in the newborn and the amniotic lamellar body count in twin pregnancies compared with singleton pregnancies. Reviewed

    Tsuda H, Kotani T, Nakano T, Imai K, Ushida T, Hirakawa A, Kinoshita F, Takahashi Y, Iwagaki S, Kikkawa F

    Clinica chimica acta; international journal of clinical chemistry   Vol. 484   page: 293-297   2018.6

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    DOI: 10.1016/j.cca.2018.06.015

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  37. The impact of fertility treatment on the neonatal respiratory outcomes and amniotic lamellar body counts in twin pregnancies. Reviewed

    Tsuda H, Kotani T, Nakano T, Imai K, Ushida T, Hirakawa A, Kinoshita F, Takahashi Y, Iwagaki S, Kikkawa F

    Clinica chimica acta; international journal of clinical chemistry   Vol. 484   page: 192-196   2018.6

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    DOI: 10.1016/j.cca.2018.05.060

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  38. National survey of quality of life and disease severity in patients with congenital ichthyosis

    Murase C., Takeichi T., Shibata A., Nakatochi M., Kinoshita F., Ikeda S., Kurosawa M., Akiyama M.

    JOURNAL OF INVESTIGATIVE DERMATOLOGY   Vol. 138 ( 5 ) page: S44 - S44   2018.5

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  39. Treatment with Creatine Monohydrate in Spinal and Bulbar Muscular Atrophy: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial. Reviewed

    Hijikata Y, Katsuno M, Suzuki K, Hashizume A, Araki A, Yamada S, Inagaki T, Ito D, Hirakawa A, Kinoshita F, Gosho M, Sobue G

    JMIR research protocols   Vol. 7 ( 3 ) page: e69   2018.3

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    Language:English   Publishing type:Research paper (scientific journal)  

    DOI: 10.2196/resprot.8655

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  40. Potential utility of a longitudinal relative dose intensity of molecularly targeted agents in phase 1 dose-finding trials Reviewed

    Hirakawa Akihiro, Yonemori Kan, Kinoshita Fumie, Kobayashi Yumiko, Okuma Hitomi S., Kawachi Asuka, Tamura Kenji, Fujiwara Yasuhiro, Rubinstein Larry, Harris Pamela Jo, Takebe Naoko

    CANCER SCIENCE   Vol. 109 ( 1 ) page: 207-214   2018.1

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    DOI: 10.1111/cas.13436

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  41. Drug induced Interstitial Lung Disease in Oncology Phase I Trials Reviewed

    Kan Yonemori, Akihiro Hirakawa, Asuka Kawachi, Fumie Kinoshita, Hitomi Ohkuma, Tadaaki Nishikawa, Kenji Tamura, Yasuhiro Fujiwara, Naoko Takebe

    Cancer Science   Vol. 107 ( 12 ) page: 1830-1836   2016.12

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  42. An Analysis of Japanese Patients Enrolled in Multiregional Clinical Trials in Oncology Reviewed

    Akihiro Hirakawa, Fumie Kinoshita

    Therapeutic Innovation & Regulatory Science     2016.10

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    Language:English   Publishing type:Research paper (scientific journal)  

    DOI: 10.1177/2168479016672702

  43. Risk Factors for Developing Skeletal-Related Events in Breast Cancer Patients With Bone Metastases Undergoing Treatment With Bone-Modifying Agents

    Ryota Tanaka, Kan Yonemori, Akihiro Hirakawa, Fumie Kinoshita, Naoki Takahashi, Jun Hashimoto, Makoto Kodaira, Harukaze Yamamoto, Mayu Yunokawa, Chikako Shimizu, Manabu Fujimoto, Yasuhiro Fujiwara, Kenji Tamura

    The Oncologist   Vol. 21 ( 4 ) page: 508-13   2016.3

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    Language:English   Publishing type:Research paper (scientific journal)  

    DOI: 10.1634/theoncologist.2015-0377

  44. The presence of intraductal carcinoma of the prostate in needle biopsy is a significant prognostic factor for prostate cancer patients with distant metastasis at initial presentation. Reviewed

    Kato M,Tsuzuki T,Kimura K,Hirakawa A,Kinoshita F,Sassa N,Ishida R,Fukatsu A,Kimura T,Funahashi Y,Matsukawa Y,Hattori R,Gotoh M

    Modern Pathology   Vol. 29 ( 2 ) page: 166-173   2016.1

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    DOI: 10.1038/modpathol.2015.146.

  45. 抗悪性腫瘍薬の臨床データパッケージ分析からみる今後の課題 Reviewed

    平川晃弘、木下文恵、森由美子、清水忍

    医薬品医療機器レギュラトリーサイエンス   Vol. 46 ( 10 ) page: 714-720   2015.10

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Books 2

  1. 臨床研究アウトプット術

    前田圭介 / 室谷健太  編著他( Role: Sole author)

    中外医学社  2020.2 

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    Language:Japanese Book type:Scholarly book

  2. 臨床試験のためのデータモニタリング委員会

    平川晃弘,浅野淳一,上村鋼平,木下文恵,佐藤宏征,武内亜希子( Role: Joint translator)

    サイエンティスト社  2017.6 

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    Language:Japanese Book type:Scholarly book

Presentations 1

  1. アウトカムにおけるデータエラーのデータクリーニング方法の検討

    木下 文恵、小林 由美子、中杤 昌弘

    日本臨床試験学会 第13回学術集会総会  2022.2.4 

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    Event date: 2022.2

    Language:Japanese   Presentation type:Poster presentation  

KAKENHI (Grants-in-Aid for Scientific Research) 1

  1. 患者レジストリにおける統計学的データエラー管理手法の構築

    Grant number:20K18848  2020.4 - 2023.3

    科学研究費助成事業  若手研究

    木下 文恵

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    Authorship:Principal investigator 

    Grant amount:\3120000 ( Direct Cost: \2400000 、 Indirect Cost:\720000 )

    疾患レジストリは臨床研究の情報源として注目されているが、しばしばデータの品質管理に困難が生じる。本研究ではレジストリのデータエラーに焦点をあて、データマネジメント及び生物統計双方の観点より、統計学的なデータ管理手法の整備を行う。その結果、レジストリ研究に関わる研究者が、一定の品質を保った解析結果を得られるようになり、より高精度な疾患の経過把握や治療法の評価を行えることが期待される。
    本研究は、データエラーの観点から、より効率的なレジストリのデータ管理手順を構築することを目的としている。具体的には、臨床研究において、データエラーが統計解析結果に及ぼす影響を統計学的に検討する。また、レジストリ研究に用いられているデータ管理、解析手法等について調査し、データクリーニングや調査票の設計なども含め、データマネジメントおよび統計解析双方の観点から最適なデータ管理手法を検討する。
    本年度は、臨床研究におけるデータエラーに関する情報を洗い出し、データエラーの内容とエラー数、解析手法との関係等について検討を行った。その結果、生存時間解析においてエラーの発生が多いことを確認した。また並行して、二値アウトカム、生存時間アウトカムにおけるデータエラー発生を想定したシミュレーションプログラムを作成した。作成したデータセットには共変量についても組み込んであり、様々な条件を考慮して検討が可能である。統計解析結果に対するデータエラーの影響を評価するため、想定される効果量、エラー率、症例数等について複数のシナリオを準備し、シミュレーションを行った。また、レジストリ研究についての文献レビューを行い、研究対象、データ管理、評価項目、主な解析手法といった点から情報を整理した。
    今後、文献レビューについて体系的にまとめていくとともに、その結果も反映してシミュレーションのシナリオをさらに整備し、結果を確認する予定である。
    近年レジストリを用いた研究が多く報告されていることから、想定していたより文献レビューに時間が必要であったこと、また厚生労働省よりレジストリの活用に関する基本的考え方が提示されるなど、最新の知見を踏まえて研究の方針を検討する必要があったため、やや予定より遅れている。
    本年度、プログラムの準備や文献レビューができたため、結果について速やかに体系的にまとめていくとともに、具体的な調査票等に関しても当初の予定通り検討を進めていく。