治験一覧
8,963 件中 5601〜5620 件を表示
25G EUS穿刺吸引（FNA）装置と20G EUSの比較
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.
ノバルティスがスポンサーとなっている研究において、エベロリムス治療を受けており、治験責任医師の判断で治療効果が得られている患者を対象に、エベロリムスの長期安全性に関するデータを収集および評価する研究。
The purpose of this study was to collect and assess long-term safety of everolimus in patients who were currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD\&MA study that had reached its study objectives, were not progressing on the current study treatment as defined by the parent protocol, and were unable to access everolimus treatment outside of a clinical study. Parent studies eligible to participate in the roll-over study were decided by Novartis. Investigator initiated trials (IITs) were not included. The primary objective of the parent study must have been reached and the parent study must have been in the process of being completed and reported.
MG-1を用いたバンカート修復後の追跡調査
Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.
健康な日本人男性および白人男性を対象とした、セマグルチドの薬物動態、薬力学、安全性および忍容性を評価するための臨床試験
This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.
日本人の健康な高齢男性における、異なる適用部位および適用間隔でのE2022テープ製剤（オーバーレイ一体型E2022 18mgテープ製剤）の有効性に関する研究
This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to administer one E2022 tape to designated sites.
筋肉内投与ASP7374の評価に関する研究
The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.
生殖細胞系列 BRCA1/2 変異を有する転移性乳がん患者の治療におけるオラパリブ単独療法と医師選択化学療法の有効性と安全性の評価。
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
乳がんにおける介入的維持内分泌療法を用いたベバシズマブ＋パクリタキセル最適化研究
To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.
GAPP 1調査：糖尿病に対するインスリン療法に関する患者と医師の世界的な意識
This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.
2型糖尿病患者におけるリキシセナチド単剤療法の安全性および忍容性
Primary Objective: To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan Secondary Objective: To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on: * HbA1c (Glycated hemoglobin A1c) reduction; * Fasting plasma glucose; * Body weight.
UNITY 3：遺伝子型1型慢性C型肝炎患者を対象としたダクラタスビル／アスナプレビル／BMS-791325の第3相臨床試験（日本）
The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA \< LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).
AMG 162（デノスマブ）の第3相試験（DESIRABLE試験）：疾患修飾性抗リウマチ薬（DMARDs）治療を受けている関節リウマチ患者を対象とした試験
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.
日本人11～12歳青少年を対象とした、筋肉内投与SP306と皮下投与DTの比較研究
The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan. Primary objectives: * To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. * To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. Secondary objectives: * To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens. * To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.
E2022の既存および新規パッチ製剤の第1相比較試験
The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.
既治療KRAS変異肺がん患者におけるアベマシクリブ（LY2835219）の研究
The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.
正常眼圧緑内障患者におけるトラボプロスト点眼液の眼圧（IOP）低下効果の検討
The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.
日本人成人男性を対象とした、E6011単回皮下投与の第1相臨床試験
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.
再発性および／または難治性の血液悪性腫瘍を有する日本人患者を対象としたLGH447の用量漸増試験
This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese patients with relapsed and/or refractory multiple myeloma for which no standard effective treatment options exist. The study consists of a dose escalation part to estimate the maximum tolerated dose and/or the recommended dose for expansion and a dose expansion part to further assess safety and preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the recommended dose for expansion.
冠動脈ステント留置術を受けた心房細動患者におけるリバーロキサバンとワルファリン併用療法の評価研究（REWRAPS）
Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the prevention of cardiogenic embolism including cerebral infarction in AF patients. However, the combined antithrombotic therapy has been reported to increase the risk of major bleeding for AF patients after coronary stenting, New anticoagulant drugs that hardly interact with other drugs and do not need frequent blood tests have become commonly used. The purpose of this study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the efficacy and safety for AF patients after coronary stenting
日本人健康被験者におけるCR8020の安全性、薬物動態および免疫原性を評価するための研究
The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR8020 in japanese healthy participants