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ダウン症候群に伴う眼瞼内反症に対するまつ毛切除術

完了NCT01758718該当なし

Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured.

対象疾患:
Down's Syndrome

多発性硬化症の日本人患者を対象とした経口徐放性ファムプリジン(BIIB041)の安全性および有効性に関する研究

完了NCT01917019第3相

This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind portion of the study is to evaluate the safety and tolerability of prolonged-release Fampridine in this study population. The primary objective of the open-label extension study (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The primary objective of the additional open-label extension (Part C) is to provide participants who complete the study with continued access to prolonged-release fampridine until marketed drug can be used at the applicable site or until sponsor decision to discontinue the study.

対象疾患:
Multiple SclerosisMultiple Sclerosis, Primary ProgressiveMultiple Sclerosis, Remittent ProgressiveRelapsing-Remitting Multiple SclerosisSecondary Progressive Multiple Sclerosis

ステージIV非小細胞肺癌の治療におけるドセタキセルとラムシルマブ併用療法とドセタキセルとプラセボ併用療法の比較研究

完了NCT01703091第2相

The purpose of this study is to evaluate the effects of ramucirumab in combination with docetaxel in participants with Stage IV non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.

対象疾患:
Non-small Cell Lung Cancer Metastatic

胆道癌に対する肝切除術後の補助療法として、ゲムシタビンとS-1を比較する第II相試験

完了NCT01815307第2相

To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.

対象疾患:
Biliary Tract Cancer

アジアにおける関節リウマチ患者を対象としたフォスタマチニブの安全性評価に関する長期研究

中止NCT01640054第2相

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).

対象疾患:
Rheumatoid Arthritis

小児ループス患者を対象としたベリムマブと標準治療併用療法の臨床試験

実施中(募集終了)NCT01649765第2相

This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus

対象疾患:
Systemic Lupus Erythematosus

中等度から重度の関節リウマチに関する研究

完了NCT01710358第3相

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

対象疾患:
Rheumatoid Arthritis

通年性アレルギー性鼻炎の小児患者におけるTAU-284の確認試験

完了NCT01861522第3相

The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.

対象疾患:
Perennial Allergic Rhinitis

FFR検査を受ける患者におけるOCTの観察研究

完了NCT01663896

The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.

対象疾患:
Coronary Artery Disease

肝転移の根治的治療後にレゴラフェニブ補助療法を受けた結腸直腸癌とプラセボ投与を受けた結腸直腸癌を比較した、無作為化二重盲検プラセボ対照第III相試験

中止NCT01939223第3相

To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.

対象疾患:
Colorectal Neoplasms

新規診断多発性骨髄腫患者を対象としたカルフィルゾミブ、メルファラン、プレドニゾン併用療法とボルテゾミブ、メルファラン、プレドニゾン併用療法の第3相試験

完了NCT01818752第3相

The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

対象疾患:
Multiple Myeloma

脳卒中後の痙縮治療のための新世代ボツリヌス毒素A2NTXの研究

不明NCT01910363第2/第3相

To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity. * we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner. * we also assess the safety of A2NTX and compare it to that of BOTOX.

対象疾患:
Lower Limb Spasticity After Stroke

高齢患者におけるデスフルランの最適化

完了NCT01700907第1/第2相

Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing. Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia. The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).

対象疾患:
Postoperative Cognitive Dysfunction

非高齢男性被験者へのASP7991の複数回経口投与

完了NCT01872013第1相

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.

対象疾患:
HealthyPharmacokinetics of ASP7991

COL-1620膣プロゲステロンゲルの有効性および安全性を評価する第3相臨床試験

完了NCT01863680第3相

The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology \[JSOG\] 2009 registry data: 24.3 percent \[%\]). The secondary objectives of this trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.

対象疾患:
Embryo TransferLuteal Hormone Supplementation in In-vitro Fertilization

EVOLVE II QCA:動脈硬化性病変の治療におけるSYNERGYステントシステムの有効性を評価するための前向き多施設共同試験

完了NCT01787799第3相

The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

対象疾患:
Atherosclerotic Lesion(s)

中等度から重度のコントロール不良喘息患者におけるデュピルマブの評価

完了NCT01854047第2相

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma. Secondary Objective: To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to: * Safety and tolerability * Dupilumab systemic exposure and anti-drug antibodies

対象疾患:
Asthma

高リン血症を伴う腹膜透析患者におけるPA21の第III相試験

完了NCT01852682第3相

The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

対象疾患:
HyperphosphatemiaPeritoneal Dialysis

日本人被験者におけるエボロクマブ(AMG 145)の忍容性および有効性を評価するための研究

完了NCT01652703第2相

The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.

対象疾患:
Hypercholesterolemia and High Risk for Cardiovascular Events

進行がんを患う日本人参加者を対象としたLY2940680の研究

完了NCT01919398第1相

The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to the global recommended dose in Japanese participants with advanced solid cancers.

対象疾患:
Neoplasm Metastasis