治験一覧
8,963 件中 4461〜4480 件を表示
経静脈栄養を必要とする短腸症候群（SBS）の日本人小児患者を対象とした研究
The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).
小細胞肺癌（SCLC）成人患者におけるタルラタマブの安全性、忍容性および薬物動態（PK）を評価する研究
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
心不全および突然心臓死日本登録
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States. Selected Subject Cohorts: 1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment. 2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment. 3. Selected subject cohort who are clinically expected to require \>40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades). 4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P. The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing \[ATP\] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort. The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort. The all-cause mortality will be assessed in the non-implanted subject cohort.
日本人健康成人男性を対象としたE6130の単回投与試験
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.
活動性クローン病患者を対象としたミリキズマブ（LY3074828）の臨床試験
The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.
健康な日本人成人を対象とした、ExPEC4V（JNJ-63871860）の異なる用量における安全性および免疫原性を評価する研究
The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to \[\> =\] 20 years of age.
腎機能障害患者および腎機能正常被験者における薬物動態試験
The objective of this study is to compare the pharmacokinetics of ASP015K in patients with impaired renal function and subjects with normal renal function.
治療抵抗性うつ病の日本人患者における固定用量の鼻腔内エスケタミン投与の有効性、安全性および忍容性を評価する研究
The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD), in improving depressive symptoms.
多施設共同研究における小児蘇生の質
This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests. The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes.
アルツハイマー病（AD）またはADによる記憶障害のある参加者を対象としたLY3002813の研究
The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD. The study involves 3 parts. * Part A in which participants will receive a single dose of LY3002813 or placebo (no drug). * Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks. * Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks. Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.
脊髄小脳変性症（SCD）患者におけるKPS-0373の追加確認試験
The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.
結節性硬化症（TSC）患者の皮膚病変に対するシロリムス外用製剤の第III相臨床試験
The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in patients with tuberous sclerosis complex (TSC)
潰瘍性大腸炎の維持療法としてのベドリズマブ皮下投与（SC）の有効性と安全性
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
UCART19投与歴のある進行リンパ性白血病患者の長期安全性を評価する研究
The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.
TAK-385最終製剤の食品影響に関する研究
The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.
日本人成人慢性腰痛患者を対象としたタネズマブの長期安全性および有効性に関する研究
This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5 mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7 administrations).
GSKバイオロジカルズのヒトロタウイルス（HRV）ワクチン（444563）2製剤の免疫原性および安全性評価（生後6～12週の健康な乳児を対象に実施）
The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.
転移性腫瘍研究・転帰ネットワーク
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
オレンシア®皮下注射剤125mgシリンジ1mLの使用結果調査
The purpose of this study to collect information on the safety, especially localized injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in patients with rheumatoid arthritis.
好酸球性慢性副鼻腔炎患者におけるベンラリズマブ（KHK4563）の研究
The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily.