治験一覧
8,963 件中 5461〜5480 件を表示
早期パーキンソン病患者を対象としたTVP-1012（1mg）の第3相長期延長試験
The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in Japanese participants with early Parkinson's disease.
AVJ-514 日本トライアル
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.
慢性便秘（CC）患者を対象としたKWA-0711の第II相臨床試験
The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic Constipation (CC) patients.
日本人骨粗鬆症患者におけるデノスマブおよび／またはテリパラチド治療後の骨代謝マーカーおよび骨密度の変化
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.
中等度から重度の尋常性乾癬を有する日本人患者におけるアプレミラスト（CC-10004）2用量の有効性および安全性に関する研究
This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.
BAX 855 続き
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
バイオクリーンファーストケアEXとバイオフィニティレンズの併用
To determine if patients are unreactive to the lens care solution / Biofinity combination.
光干渉断層撮影（OCT）規範データ収集研究（S-2013-2）
This study is being initiated to create a normal database including measures of optic nerve head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg Spectralis OCT device. The range will be determined for each structural parameter across normal eyes in Japanese subjects, and the measurements stratified according to age.
RS-3000 Lite契約に関する調査
The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.
ボツリヌス毒素B型（ネルブロック）投与後の市販後調査－ボツリヌス毒素A型投与から変化した患者における臨床状態の調査
Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)
糖尿病性腎症患者における低用量MT-3995の安全性、忍容性および薬物動態に関する研究
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.
麻酔薬と肝切除手術後の急性腎障害
* It has been shown that patients who undergo liver resection surgery are at high risk for postoperative acute kidney injury (AKI). * Sevoflurane may increase the risk for postoperative AKI because of production of compound-A. * Therefore, we have planned to investigate the effects of different anesthetic agents on postoperative renal function. * Patients undergoing liver resection surgery are randomized into 2 groups. * One of the groups receives sevoflurane and the other group receives desflurane. * Blood and urine specimen are sampled both pre- and postoperatively, and several biomarkers are compared between the groups.
心筋虚血の動脈硬化性決定因子のコンピュータ断層撮影評価
The study seeks to determine the accuracy of using anatomic and physiologic information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve. The hypothesis of this proposal is that integrating anatomic plaque features with physiologic fractional flow reserve-CT will optimize identification of coronary lesions that are ischemia-causing by computed tomography .
胆道癌治療におけるMEK阻害剤トラメチニブ単剤療法の第IIa相試験
This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and safety of orally administered MEK inhibitor trametinib as the second line in subjects with advanced or metastatic biliary tract cancers (BTC) in Japanese population. The primary endpoint of this study is 12 week non-progressive disease (PD) rate defined as the percentage of subjects without progression at Week 12. As a sub-study, pharmacokinetics (PK) of four tablets of 0.5 milligram (mg) tablet, or one tablet of 2 mg tablet to achieve 2 mg daily regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese population. Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose of 2 mg every day as one 2 mg tablet or four 0.5 mg tablets on Day 1. From Day 2 until disease progression or withdrawal from the study treatment, all subjects will receive one tablet of 2 mg trametinib . Disease assessment will be performed every 8 week. Translational research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers for biological activity, and sensitivity or resistance to treatment with trametinib .
日本人2型糖尿病患者を対象とした、セマグルチド週1回投与とシタグリプチン1日1回投与の安全性および有効性を比較する臨床試験
This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.
レゴラフェニブ点眼薬：新生血管性加齢黄斑変性における有効性および安全性の検討
Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate the safety and tolerability of the regorafenib eye drops. Part B (Phase IIb): Primary objectives: The study part B is designed to investigate: * how often the regorafenib eye drops need to be given per day * whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.
進行性固形悪性腫瘍を有する成人患者におけるCLR457の経口投与に関する研究
To estimate the maximum tolerated dose (MTD) or recommended dose for phase II (RP2D) of CLR457 and to investigate the anti-tumor activity of CLR457
ノバルティスがスポンサーとなったドビチニブ単剤試験において、主要目的の要件を満たしたドビチニブ（TKI258）による治療を継続している固形腫瘍患者におけるドビチニブの長期安全性／忍容性を評価するための非盲検多施設共同延長試験
The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.
C13-CAC呼気検査と24時間胃内pHモニタリングの比較研究
The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers
アログリプチン錠 特別薬物使用監視 2型糖尿病：スルホニル尿素との併用療法
The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.