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FYU-981の臨床薬理(肝機能不全患者)

完了NCT03306667第1相

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.

対象疾患:
HealthyHepatic Insufficiency

CM Asia Nail(AS2使用、AS2不使用)(AS2研究)

完了NCT03196193該当なし

The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months.

対象疾患:
Trochanteric Fracture of Femur

進行性肝細胞癌におけるアベルマブとアキシチニブの併用療法に関する研究(VEGF Liver 100)

完了NCT03289533第1相

To evaluate the safety, efficacy and PK of avelumab in combination with axitinib as first line treatment in patients with advanced HCC

対象疾患:
Carcinoma, Hepatocellular

肺高血圧症患者におけるバルドキソロンメチルの長期安全性を評価するための拡張アクセスプログラム RANGER

中止NCT03068130第3相

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

対象疾患:
Pulmonary Hypertension

血友病A患者を対象に、4週間ごとにエミシズマブを投与した場合の有効性、安全性、薬物動態、および薬力学を評価する研究

完了NCT03020160第3相

This multicenter, open-label, non-randomized study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part.

対象疾患:
Hemophilia A

中等度から重度のアトピー性皮膚炎患者におけるバリシチニブ(LY3009104)の研究

完了NCT03334396第3相

The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

対象疾患:
Atopic Dermatitis

冠動脈疾患患者におけるBuMA Supreme™薬剤コーティング冠動脈ステントの安全性と有効性を評価するPIONEER III試験

完了NCT03168776該当なし

The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents. This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years.

対象疾患:
Coronary Artery Disease

PIK3CA/AKT1/PTEN遺伝子変異を有する局所進行性または転移性のトリプルネガティブ乳がん、あるいはホルモン受容体陽性HER2陰性乳がん患者を対象とした、イパタセルチブとパクリタキセルの併用療法に関する研究

完了NCT03337724第3相

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

対象疾患:
Breast Cancer

胸部手術における片肺換気中の高PEEPと低PEEPによる保護換気

完了NCT02963025該当なし

One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP). Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV. Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.

対象疾患:
One-Lung Ventilation

逆流性食道炎に伴う睡眠障害に対するボノプラザンの効果を調査する研究 - 探索的評価

完了NCT03116841第4相

The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on sleep disturbance of patients with reflux esophagitis, who have heartburn and/or regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the maintenance treatment with PPI other than vonoprazan.

対象疾患:
Reflux Esophagitis

オルメサルタンの脳グルコース代謝、血管炎症および脂肪組織に対する有効性

不明NCT02996916第4相

Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a major target of the damaging effects of hypertension. Hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. Although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.

対象疾患:
Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

初期アルツハイマー病認知症におけるラナベセスタット(LY3314814)の研究

中止NCT02972658第3相

This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.

対象疾患:
Alzheimer's Disease

FLT3/内部タンデム重複(ITD)急性骨髄性白血病(AML)患者に対する同種移植後の維持療法として投与されるFMS様チロシンキナーゼ3(FLT3)阻害剤ギルテリチニブの臨床試験

完了NCT02997202第3相

The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

対象疾患:
Acute Myeloid Leukemia

進行性固形腫瘍患者を対象としたブジガリマブ(ABBV-181)の臨床試験

完了NCT03000257第1相

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.

対象疾患:
Advanced Solid Tumors

バイオリムスA9溶出ステント留置におけるPCIガイダンスにおけるOFDIとIVUSの比較

不明NCT03292081第2相

The aim of this study is to assess clinical safety and efficacy of percutaneous coronary intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.

対象疾患:
Coronary Artery Disease

クロストリジウム・ディフィシルワクチンの有効性試験

完了NCT03090191第3相

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

対象疾患:
Clostridium Difficile Infection

切除不能な悪性遠位総胆管狭窄症患者におけるEUSガイド下胆管十二指腸吻合術と被覆金属ステントを用いたERCPの比較

完了NCT03000855第2/第3相

EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain. The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.

対象疾患:
Malignant Biliary Obstruction

進行固形腫瘍患者を対象とした免疫療法薬ABBV-927およびABBV-181の試験

実施中(募集終了)NCT02988960第1相

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

対象疾患:
Advanced Solid Tumors Cancer

局所進行性または転移性固形腫瘍患者におけるABBV-368の単剤療法および併用療法としての安全性、忍容性および薬物動態に関する研究

完了NCT03071757第1相

The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.

対象疾患:
Advanced Solid Tumors Cancer

母子の継続的なケアにおける非感染性疾患のサービスの統合

完了NCT03145155該当なし

このクラスターランダム化比較試験の目的は、継続的ケア(CoC)カードの利用と健康教育を組み合わせた介入が母親のCoCサービスの完了に及ぼす影響、およびNCDと栄養に関する健康教育が母親のNCDと栄養に関する知識に及ぼす影響を調査することです。 妊娠12~20週の妊婦が募集され、介入群(n=600)と対照群(n=600)に割り当てられます。 介入パッケージは、(1)CoCカードの利用、および(2)母子保健(MNCH)、NCD、栄養におけるCoCに関する健康教育の2つの要素で構成されます。 CoCカードには、最初の産前ケア(ANC)から最後の産後ケア(PNC)までのCoCサービスが含まれており、4回のANC、熟練出産介助(SBA)、4回のPNCと必須サービスが含まれます。 上記のサービスを受けた妊婦にはステッカーが配布されます。 健康教育は妊娠中に3回、産後に1回実施されます。健康教育には、MNCHサービス、NCD、栄養に関する継続的な利用の重要性が含まれます。成果は、CoCサービスの完了率とNCDおよび栄養に関する知識です。

対象疾患:
継続的なケア非感染性疾患