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XIENCE PRIME 日本における市販後調査(PMS)

完了NCT01721096

The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

対象疾患:
AnginaCoronary Artery DiseaseCoronary Artery StenosisCoronary OcclusionMyocardial Ischemia

増殖性糖尿病網膜症に対する小径硝子体切除術と従来型硝子体切除術の比較

完了NCT01758757該当なし

Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.

対象疾患:
Proliferative Diabetic Retinopathy

再発・難治性多発性骨髄腫の治療薬としてSyB L-0501を研究する

完了NCT01849848第2相

The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m\^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.

対象疾患:
Relapsed/Refractory Multiple Myeloma

ドライアイ症候群患者を対象としたKCT-0809の後期第II相臨床試験

完了NCT01890941第2相

The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

対象疾患:
Dry Eye Syndromes

心筋梗塞後患者における安定型冠動脈疾患の長期リスク、臨床管理、および医療資源の利用

中止NCT01866904

THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

対象疾患:
Stable Coronary Artery Disease (CAD), Myocardial Infarction

高アルファリポタンパク血症患者におけるCETP欠損と動脈硬化症の関係

不明NCT01916512

The aim of this study is to determine whether high high density lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP) activity is atherogenic or not in subjects who received health checkups. We investigate the association between CETP activities and the severity of atherosclerosis assessed by intima-media thickness (IMT) and compare the atherogenic change between in subjects with high HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining the morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG) change, Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and various serum atherogenic markers. And we also examine the correlation between normal lipid profile and concentration, activity and function of surface lipoprotein in subjects with variety of lipoprotein levels, including patients with hyper-LDL-cholesterolemia, hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.

対象疾患:
CETP DeficiencyHigh Level of Remnant CholesterolHyper-LDL-cholesterolemiaHyperalphalipoproteinemiaLow CETP Activity

慢性閉塞性肺疾患の急性増悪に対するリゾチームの効果:無作為化プラセボ対照試験

完了NCT01645800第4相

The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.

対象疾患:
COPD

統合失調症患者におけるスルフォラファンを豊富に含むブロッコリースプラウト抽出物の非盲検試験

完了NCT01716858第2相

Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.

対象疾患:
Schizophrenia

TMC435を投与された健康な男性被験者における食事の影響を評価するための薬物動態学的研究

完了NCT01799603第1相

The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.

対象疾患:
Healthy

オキサリプラチン化学療法で以前に治療を受けた転移性結腸直腸癌患者における、FOLFIRI療法と併用したアフリベルセプトとプラセボの比較試験

完了NCT01661270第3相

Primary Objective: To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo in participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment for metastatic disease. Secondary Objectives: To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers.

対象疾患:
Colorectal Cancer Metastatic

関節リウマチ患者におけるプログラフカプセルの特殊薬剤使用結果調査

完了NCT01870908

This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.

対象疾患:
Rheumatoid Arthritis

ALK遺伝子再構成を有する未治療の非小細胞肺癌患者におけるLDK378と化学療法との比較

完了NCT01828099第3相

To compare the efficacy and safety of ceritinib with standard first-line chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with stage IIIB (not candidates for definitive multimodality therapy) or stage IV, non-squamous non-small cell lung cancer (NSCLC) harboring a confirmed anaplastic lymphoma kinase (ALK) rearrangement, using the Ventana immunohistochemistry (IHC) test.

対象疾患:
Non-Small Cell Lung Cancer

先進心臓再同期療法(CRT)レジストリ

完了NCT01805154

The intent of this registry is to understand comprehensive clinical care strategies for Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world clinical practice.

対象疾患:
Heart Failure

中等度から重度の慢性尋常性乾癬患者におけるセクキヌマブの有効性および安全性に関する4年間の延長試験

完了NCT01640951第3相

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

対象疾患:
Moderate to Severe Chronic Plaque-Type Psoriasis

高リン血症を伴う血液透析患者におけるPA21の第III相試験

完了NCT01850602第3相

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

対象疾患:
HemodialysisHyperphosphatemia

慢性大うつ病患者の家族を対象とした短期多家族心理教育

完了NCT01734291該当なし

The purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning.

対象疾患:
Major Depressive Disorder

重症難治性喘息患者におけるメポリズマブ補助療法の有効性および安全性に関する研究

完了NCT01691521第3相

This study will evaluate two dose regimens of mepolizumab \[75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks\] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events. This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC. Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

対象疾患:
Asthma

胆道癌に対するCDDPとGEM併用化学療法における短期的な水分補給のための経口補水療法

完了NCT01917617第2相

The objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including gemcitabine and cisplatin.

対象疾患:
Biliary Tract Cancer

初回入院統合失調症患者における共同意思決定

完了NCT01869660第2/第3相

To determine whether shared decision making (SDM) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.

対象疾患:
Schizophrenia

2型糖尿病に対するインスリン療法にシタグリプチンを追加した場合の安全性と有効性

完了NCT01855087

There is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.

対象疾患:
Type 2 Diabetes