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転移性胃癌患者におけるTAS-102またはプラセボ+BSCの試験

完了NCT02500043第3相

The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

対象疾患:
Refractory Metastatic Gastric Cancer

6ヶ月間のコアスタディで治療を完了したサルコペニアの高齢者を対象とした、24週間の薬剤非投与延長試験

完了NCT02468674第2相

This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study and the main objective was to determine the long-term durability of bimagrumab (BYM338) effect after a 6-month treatment period.

対象疾患:
Sarcopenia

単球由来細胞を個々の薬剤効果および肝毒性の代替マーカーとして用いる

不明NCT02353455

Drug metabolism in the liver is subject to large fluctuations (differences between women and men, people of different ethnic backgrounds, children and adults). These large differences are responsible for very different drug effects and side-effects (and especially liver damage caused by drugs) between individuals. Recent scientific findings suggest that blood derived cells can be used to model individual effects of drugs on the liver reflect inter-individual differences. Since liver damage caused by drugs is a diagnosis of exclusion, the aforementioned cells can be used to identify patients that show higher sensitivity to hepatotoxic side-effects and - in case several drugs are involved - identify the causal agent or possible interactions.

対象疾患:
Adverse Reaction to DrugDrug-induced Disorder of Liver

健康な日本人男性被験者におけるAZD0585の総EPAおよび総DHAの薬物動態に対する食事の影響を調査する研究

完了NCT02372344第1相

The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.

対象疾患:
Healthy

全身性膿疱性乾癬または紅皮症性乾癬患者を対象としたCNTO1959(グセルクマブ)の有効性および安全性に関する研究

完了NCT02343744第3相

The purpose of this study is to examine descriptively the efficacy of CNTO 1959 in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

対象疾患:
Pustular Psoriasis

中等度から重度の活動性関節リウマチを有する日本人患者における、メトトレキサート(MTX)にサリルマブを追加投与した場合の有効性および安全性を評価する研究(SARIL-RA-KAKEHASI)

完了NCT02293902第3相

Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX. Secondary Objective: -To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

対象疾患:
Rheumatoid Arthritis

MT-2412の日本人2型糖尿病患者における検証的試験(テネリグリプチンの併用試験)

完了NCT02354222第3相

The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

対象疾患:
Type 2 Diabetes Mellitus

SYR-472 25mg錠および50mg錠の第1相生物学的同等性試験

完了NCT02372097第1相

The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.

対象疾患:
Healthy

肝細胞癌患者におけるDCビーズの市販後調査

完了NCT02269995

This surveillance's objectives are: 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Factors considered to have effect to safety and effectiveness

対象疾患:
Hepatocellular Carcinoma

ペルツズマブ治療歴のあるHER2陽性進行乳がんにおけるペルツズマブ再治療の第III相試験

完了NCT02514681第3相

The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer patients for previously treated with pertuzumab

対象疾患:
HER2-positive Locally Advanced or Metastatic Breast Cancer

特発性網膜上膜を伴う症例における、25ゲージ硝子体切除術と白内障手術の併用、およびトーリック眼内レンズ挿入術。

不明NCT02328157該当なし

Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative corneal astigmatism. Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival sutureless vitrectomy, resulting in good visual recovery. So far, however, limited information is available on the the stability of axis rotation, astigmatism correction, and improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a 25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal and refractive astigmatism up to 6 months postoperatively. We are expecting to show that postoperative IOL axis stability is similar to that reported for cataract surgery alone in vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.

対象疾患:
CataractCorneal AstigmatismEpiretinal Membrane

網膜静脈分枝閉塞症による黄斑浮腫に対するラニビズマブのPRN投与レジメンの有用性の評価

完了NCT02478515第4相

Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is expected that similar results could be obtained by less frequent IVR. The purpose of this study is to investigate if IVR by PRN is as effective as by monthly. In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area.

対象疾患:
Branch Retinal Vein Occlusion

膵臓癌に対するゲムシタビンとナブパクリタキセルを併用した化学放射線療法の研究

完了NCT02272738第1相

The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.

対象疾患:
Pancreatic Cancer

幹細胞移植(SCT)を受けていない新規診断多発性骨髄腫(NDMM)患者を対象とした経口イキサゾミブ維持療法に関する研究

完了NCT02312258第3相

The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to initial therapy and who have not undergone SCT.

対象疾患:
Multiple Myeloma

健康な女性におけるレボノルゲストレル(LNG)含有膣内リングの1年間の安全性と避妊効果

完了NCT02403401第3相

Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.

対象疾患:
Contraception

尋常性乾癬患者を対象としたGSK2894512クリームの用量探索試験

完了NCT02564042第2相

This study will evaluate the efficacy and safety of two concentrations (0.5 percent \[%\] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in subjects with plaque psoriasis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and dosing frequency in future clinical safety and efficacy studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all psoriasis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. Approximately 270 adult males and females subjects with plaque psoriasis will be screened in order to have at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to achieve at least 24 evaluable Japanese subjects.

対象疾患:
Psoriasis

グルカゴン様ペプチド-1欠乏症は、冠動脈疾患における残存リスクなのか?

完了NCT02280837

In this study, the investigators hypothesized that significant proportion of patients with coronary artery disease (CAD) has reduced capacity of glucagon-like peptide-1 (GLP-1) secretion, which is detectable as blunted response of plasma active GLP-1 level to oral glucose loading and that reduced GLP-1 secretory function is associated with increased severity of coronary artery stenosis but not with classic risk factors for CAD. To test this hypothesis, the investigators will analyze correlation between GLP-1 secretory capacity and severity of coronary artery stenosis determined by Gensini Score (GS), an established score system for coronary artery stenoses. Additionally, the investigators will analyze relationship between level of "total" GLP-1 and severity of coronary artery stenosis to determine how it is different from the active GLP-1 - coronary stenosis relationship.

対象疾患:
Coronary Artery Disease

X3搭載ナビゲーションと非搭載ナビゲーションの比較研究

完了NCT02543463該当なし

The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.

対象疾患:
Degenerative Joint Disease

SpyGlass AMEAレジストリ

完了NCT02281019

The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

対象疾患:
Biliary Obstruction Due to Common Bile Duct StoneBiliary StrictureHemobiliaPeriampullary Tumor

2型糖尿病および微量アルブミン尿症患者を対象としたTAK-272の第2相用量探索試験

完了NCT02332824第2相

The purpose of this study is to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272.

対象疾患:
Type 2 Diabetes Mellitus and Microalbuminuria