治験一覧
8,963 件中 4401〜4420 件を表示
OTEZLAの市販後調査研究
To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica 1. Planned registration period 2 years 2. Planned surveillance period for 4 years from 6 months after launch
局所進行性または転移性固形腫瘍を有する日本人被験者におけるPD-L1抗体KN035の臨床試験
This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in Japanese patients with advanced and metastatic solid tumor. The dose escalation will follow the widely used 3+3 design.
日本人2型糖尿病患者における経口セマグルチドとプラセボおよびリラグルチドの単剤療法との比較における用量反応、安全性および有効性
This trial is conducted in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes mellitus
レブラミド®カプセルの薬物使用成績調査（再発性または難治性ATLL）
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)). 1. Planned registration period 3 years 2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL
慢性尋常性乾癬患者におけるビメキズマブの長期安全性、忍容性および有効性を評価する研究
This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
高コレステロール血症を伴う急性冠症候群で入院した日本人患者におけるアリロクマブの冠動脈アテローム容積への影響の評価
Primary Objective: To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary atheroma progression (percent change in normalized total atheroma volume \[TAV\]) after 9 months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks prior to randomization, with hypercholesterolemia treated with statin. Secondary Objectives: * To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints including absolute change in percent atheroma volume and normalized TAV after 9 months of treatment. * To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein cholesterol and lipoprotein (a) after 9 months treatment. * To evaluate the safety of alirocumab (Praluent®) including the occurrence of cardiovascular events (coronary heart disease death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) throughout the study.
抗うつ薬療法に十分な反応を示さなかった大うつ病性障害の成人患者における抗うつ薬の補助療法としてのJNJ-42847922の有効性と安全性を評価する研究
The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.
M14-431試験またはM14-433試験を完了したクローン病患者におけるウパダシチニブ（ABT-494）の有効性と安全性を評価する維持試験および長期継続試験
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
進行悪性固形腫瘍を有する日本人患者におけるSAR408701の評価
Primary Objective: * To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors. Secondary Objectives: * To characterize the overall safety profile of SAR408701 monotherapy. * To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites. * To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for main dose escalation part. * To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity. * To assess the potential immunogenicity of SAR408701.
軟骨無形成症の小児におけるBMN 111の有効性と安全性を評価する研究
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia.
生物学的製剤による治療に不十分な反応を示した、または生物学的製剤による治療に不耐性を示した中等度から重度の活動性クローン病患者におけるウパダシチニブ（ABT-494）の有効性および安全性に関する研究
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
L-カルニチンは肝切除患者のアンモニア代謝を改善する
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corresponding tissues of eight normally nourished non-hepatic patients who died after an acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3 (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal injury. In the current study, it is the first clinical interventional research whether L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized patients.
ニンラロカプセル剤の薬剤使用結果調査（全症例サーベイランス）「再発性／難治性多発性骨髄腫」
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
オムロン製デジタル血圧計の臨床評価
The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.
中等度活動性潰瘍性大腸炎の日本人患者におけるE6007の研究
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg), E6007 60 mg or placebo.
日本人を対象とした夜間多尿による夜間頻尿に対するSK-1404の臨床試験
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.
難治性または再発性リンパ腫または多発性骨髄腫患者を対象とした、Mcl-1阻害剤MIK665の第I相試験
The purpose of this first in human study is to assess safety, tolerability, PK and preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as S64315) as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed lymphoma or multiple myeloma.
重症患者における抜管成功の予測因子：多施設共同観察研究
Extubation failure can directly worsen patient outcomes. Therefore, the decision to extubate is a critical moment during an intensive care unit (ICU) stay. The decision to extubate is usually made after a weaning readiness test involving spontaneous breathing on a T-piece or low levels of ventilatory assistance. However, extubation failure still occurs in 10 to 20% of patients. The investigators focused on previously reported physiological risk factors, and were able to obtain from common clinical practice: 1) age, 2) underlying cardiovascular disease, 3) underlying respiratory disease or occurrence of pneumonia, 4) rapid shallow breathing index (RSBI), 5) positive fluid balance during the previous 24 hours, 6) the ratio of arterial oxygen partial pressure to fractional inspired oxygen, 7) Glasgow Coma Scale, 8) respiratory tract secretions. The investigators aimed to assess the incidence and risk factors for extubation failure among critically ill patients who passed the 30 min spontaneous breathing test (SBT) using a low level of pressure support (PS) with positive end-expiratory pressure (PEEP), in a prospective multicenter study.
中等度から重度の尋常性乾癬の維持療法におけるリサンキズマブの安全性と有効性を評価する研究（LIMMITLESS）
The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.
難治性または再発・難治性多発性骨髄腫患者を対象とした、イサツキシマブ、ポマリドミド、デキサメタゾン併用療法とポマリドミド、デキサメタゾン併用療法を比較する多国籍臨床試験
Primary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: * To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. * To compare the Overall Survival (OS) between the two arms. * To evaluate the Time To Progression (TTP) in each arm. * To evaluate the PFS in high risk cytogenetic population in each arm. * To evaluate the Duration of Response (DOR) in each arm. * To evaluate the safety in both treatment arms. * To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. * To evaluate the immunogenicity of isatuximab. * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.