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心臓手術における換気

不明NCT03255356

The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

対象疾患:
Anesthesia, GeneralBypass, CardiopulmonaryRespiration, ArtificialRespiratory Complication

SLE患者を対象としたM2951の第II相試験

中止NCT02975336第2相

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

対象疾患:
Systemic Lupus Erythematosus

肉眼的血尿を呈する患者の膀胱癌を評価するための新規マルチプレックスELISAアッセイ

実施中(募集終了)NCT03193528

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

対象疾患:
膀胱がん

日本人喘息患者を対象としたQMF149の長期安全性試験

完了NCT03100500第3相

The purpose of this study was to provide long term safety data of QMF149 in Japanese participants with inadequately controlled asthma for the registration of QMF149 in Japan.

対象疾患:
Asthma

再発性または難治性多発性骨髄腫患者におけるダラツムマブの皮下投与と静脈内投与の比較試験

完了NCT03277105第3相

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).

対象疾患:
Multiple Myeloma

非扁平上皮非小細胞肺癌におけるONO-4538の臨床試験(TASUKI-52)

完了NCT03117049第3相

The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.

対象疾患:
Non-Small Cell Lung Cancer

アジアにおける肝細胞癌登録:INSIGHTレジストリ

完了NCT03233360

The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific') registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years.

対象疾患:
Hepatocellular Carcinoma

健康被験者および潰瘍性大腸炎患者を対象としたKHK4083の第1相試験

完了NCT02985593第1相

The objectives of this study are to evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a placebo-controlled, single-blind comparative study, and to evaluate the safety and tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an open-label study.

対象疾患:
Healthy Men and Subjects With Ulcerative Colitis

非アルコール性脂肪性肝炎(NASH)および架橋線維症(F3)を有する成人におけるセロンセルチブの安全性および有効性

中止NCT03053050第3相

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

対象疾患:
Nonalcoholic Steatohepatitis

コパキソン皮下注射用シリンジ特殊医薬品使用結果調査(全症例調査)「多発性硬化症の再発予防」

完了NCT03209479

The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.

対象疾患:
Multiple Sclerosis

進行性黒色腫患者を対象とした、BMS-986205とニボルマブの併用療法とニボルマブ単独療法との比較に関する治験免疫療法研究

完了NCT03329846第3相

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

対象疾患:
MelanomaSkin Cancer

AcrySof® IQ PanOptix™ IOLの臨床研究

完了NCT03090256該当なし

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

対象疾患:
Cataract

悪性胸膜中皮腫患者におけるYS110の臨床試験

完了NCT03177668第1/第2相

The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.

対象疾患:
Malignant Pleural Mesothelioma

進行性再発性小細胞肺癌の日本人患者におけるロバルピツズマブ・テシリンの安全性および忍容性に関する研究

完了NCT03086239第1相

This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).

対象疾患:
Small Cell Lung Cancer

軟部組織肉腫患者における安全性と有効性に関する研究

完了NCT03058406

The purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.

対象疾患:
Sarcoma, Soft Tissue

「閉経前乳がん」におけるリュープロレリン注射剤キット22.5mgの特別薬物使用監視

完了NCT03209518

The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.

対象疾患:
Premenopausal Breast Cancer

日本人新生血管型加齢黄斑変性症患者におけるアビシパーペゴル硝子体内注射の安全性および薬物動態

完了NCT03335852第1相

This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).

対象疾患:
Macular Degeneration

日本人アルツハイマー病患者を対象としたKHK6640の反復投与試験

完了NCT03093519第1相

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's Disease.

対象疾患:
Alzheimer Disease

アトピー性皮膚炎の小児患者を対象としたOPA-15406軟膏の第2相臨床試験

完了NCT03018691第2相

To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.

対象疾患:
Atopic Dermatitis

骨粗鬆症に対する経口イバンドロン酸の有効性

不明NCT03186131第2相

There has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin D

対象疾患:
Osteoporosis