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NLAツールの実現可能性に関する臨床研究

完了NCT01985282

The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.

対象疾患:
Healthy Elder People

視神経脊髄炎(NMO)および視神経脊髄炎スペクトラム障害(NMOSD)患者に対するサトラリズマブ(SA237)の併用療法としての有効性および安全性に関する研究

完了NCT02028884第3相

The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.

対象疾患:
NMO Spectrum Disorder (NMOSD)Neuromyelitis Optica (NMO)

急性胆嚢炎に対するEGBDとPCのランダム化比較試験。

完了NCT02212717第2/第3相

Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in treatment of this condition has been demonstrated but how the two procedures compare to one another is uncertain. The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.

対象疾患:
Acute Cholecystitis

RSV感染で入院した乳児におけるALS-008176の研究

完了NCT02202356第1相

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

対象疾患:
Respiratory Syncytial Virus Infections

血液透析を受けている慢性腎臓病(CKD)患者におけるエポエチンアルファ/ベータ療法とBAY85-3934療法による慢性腎臓病に伴う貧血の維持療法の比較

完了NCT01975818第2相

Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day

対象疾患:
AnemiaRenal Insufficiency, Chronic

腹膜透析を受けている患者における二次性副甲状腺機能亢進症に対するKHK7580の研究

完了NCT02143271第1相

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.

対象疾患:
Secondary Hyperparathyroidism

慢性腎臓病に伴う貧血を有する日本人血液透析患者におけるGSK1278863の安全性、有効性および薬物動態を評価する研究

完了NCT02019719第2相

This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD). It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a follow-up visit approximately 4 weeks after completing treatment.

対象疾患:
Anaemia

統合失調症患者における三角筋への反復注射によるアリピプラゾールIMデポ製剤(OPC-14597 IMD)投与時の薬物動態および安全性を検討する多施設共同非盲検試験

完了NCT02220712第1相

To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

対象疾患:
Schizophrenia

口臭を軽減するための口腔衛生手順

完了NCT02113137第4相

The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

対象疾患:
Halitosis

ファブリー病患者におけるミガラスタット塩酸塩の長期効果に関する非盲検延長試験

完了NCT02194985第3相

This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.

対象疾患:
Fabry Disease

リセドロン酸ナトリウム錠 - 骨パジェット病患者における特別な薬剤使用監視(全症例監視) - 48週間監視 -

完了NCT02106455

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.

対象疾患:
Osseous Paget's Disease

非小細胞肺癌(NSCLC)患者におけるMEDI4736(抗PD-L1抗体)とゲフィチニブの併用療法。

完了NCT02088112第1相

This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects

対象疾患:
Carcinoma, Non-Small-Cell Lung

アルツハイマー病による軽度認知障害および軽度アルツハイマー病患者を対象とした、BAN2401の反復静脈内投与の安全性、忍容性、薬物動態、免疫原性、および薬力学的反応を評価するための無作為化二重盲検プラセボ対照試験

完了NCT02094729第1相

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.

対象疾患:
Alzheimer's Disease

銀フレックスの日本における市販後調査

完了NCT02254356該当なし

Japanese post market clinical study of the Zilver Flex device.

対象疾患:
Peripheral Arterial Disease (PAD)

中等度から重度の潰瘍性大腸炎の小児患者におけるアダリムマブの有効性と安全性

完了NCT02065557第3相

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

対象疾患:
Ulcerative Colitis

TP53wt遺伝子変異を有する特定の進行性腫瘍患者におけるHDM201の安全かつ忍容性の高い投与量を決定および評価するための研究

完了NCT02143635第1相

To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

対象疾患:
Advanced Solid and Hematological TP53wt Tumors

デスフルラン誘発性心筋保護

不明NCT02019797第4相

This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.

対象疾患:
Aortic Valve Stenosis

喘息におけるモンテルカストの気道制御性T細胞への影響

不明NCT01951898第2/第3相

Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.

対象疾患:
Asthma

日本における慢性変形性関節症および膝痛患者を対象としたデュロキセチン(LY248686)の臨床試験

完了NCT02248480第3相

The main purpose of this study is to evaluate the efficacy of the study drug known as duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.

対象疾患:
Osteoarthritis of the Knee

近視性脈絡膜新生血管に対するEYLEAの特別薬物使用調査

完了NCT02260687

The objectives of this study are to investigate the safety and effectiveness of EYLEA.

対象疾患:
Choroidal Neovascularization