治験一覧
8,963 件中 3981〜4000 件を表示
ALK陽性NSCLC患者の第一選択治療におけるロルラチニブとクリゾチニブの比較試験
A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population
クローン病患者におけるリサンキズマブの有効性と安全性に関する研究
The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; * Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; * Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
軸性脊椎関節炎（axSpA）患者を対象としたブロダルマブの研究
To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis \[AS\] and non-radiographic axial spondyloarthritis \[nr-axSpA\]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.
OAC逆転の医学的必要性
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
早期乳がんに対する補助アロマターゼ阻害剤投与中の女性におけるデノスマブの正常骨密度に対する有効性
This multicenter, randomized, comparative study will evaluate the efficacy of denosumab to prevent the adjuvant therapy of aromatase inhibitors-induced loss of bone mineral density (BMD) in breast cancer patients with normal BMD. Investigators will compare the inhibitory effects of denosumab on bone loss between participants with normal BMD to whom Letrozole or Arimidex will be administered as postoperative endocrine therapy for stage I-IIIA postmenopausal hormone-sensitive breast cancer and controls.
地域社会におけるてんかん重積状態（痙攣発作）の小児患者に対するミダゾラム塩酸塩口腔粘膜溶液（MHOS/SHP615）の研究
The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is safe and effective in children with status epilepticus (SE) (convulsive) in the community setting. This study is open-label extension for patients who completed the SHP615-301 study and who tolerated and responded to MHOS/SHP615 treatment in the hospital setting.
強力な化学療法が適応とならない急性骨髄性白血病の未治療患者におけるベネトクラックスと低用量シタラビンの併用と低用量シタラビン単独の比較試験
The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).
スピリーバ・レスピマット®の喘息患者における特定用途での効果
The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use
卵巣がんに対する横断的アプローチの特徴づけ：BRCA遺伝子検査
The multi-centered, cross-sectional investigations shall be conducted in this study with the objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
ジェネンテック社および/またはF.ホフマン・ラ・ロシュ社がスポンサーとなったアテゾリズマブ研究（IMbrella A）に以前登録された参加者を対象とした研究
This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.
日本人2型糖尿病患者におけるデュラグルチド（LY2189265）の血糖動態効果に関する研究
The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.
2型糖尿病患者を対象としたLY900014とインスリンリスプロの比較研究
The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).
HTLV-1関連脊髄症（HAM）患者を対象としたKW-0761の研究
The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan.
ペマフィブラートは糖尿病患者のトリグリセリド値を低下させることで心血管疾患の転帰を改善する（PROMINENT）
The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: * nonfatal Myocardial Infarction (MI) * nonfatal ischemic stroke * coronary revascularization; or * Cardio Vascular (CV) death.
成長ホルモン欠乏症の既往歴のある日本人成人を対象に、ソマパシタン（NNC0195-0092）の週1回投与とノルディトロピン®フレックスプロ®の毎日投与を52週間併用した場合の安全性を評価する試験
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.
進行性核上性麻痺（PSP）患者におけるABBV-8E12の有効性、安全性、忍容性、および薬物動態を評価するための研究
The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
進行期古典的ホジキンリンパ腫で再発/難治性または自家幹細胞移植の適応とならない患者におけるニボルマブ＋ブレンツキシマブベドチンとブレンツキシマブベドチンの併用療法とブレンツキシマブベドチン単独療法との比較研究
The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant
乳がん患者における手術後の内分泌療法（アベマシクリブ（LY2835219）併用の有無）
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
悪性末梢神経鞘腫瘍の多施設レジストリ
まず、研究者らは、神経線維腫症（NF）1関連悪性末梢神経鞘腫瘍（MPNST）および前駆病変（例：非定型または結節性叢状神経線維腫）の臨床的全体像を明らかにするため、後ろ向き解析を行う予定です。NF1関連癌の専門知識を持つ世界中のセンターから、組織学的、免疫組織化学的、分子生物学的、放射線学的、治療学的、および関連する臨床データを標準化された方法で収集し、世界規模のデータベースを構築します。このレジストリは本質的に後ろ向きではありますが、INFACTの取り組みの結果と同様に、これまで予期されていなかったパターンが明らかになる可能性があります。このレジストリにより、関連バンクで収集されたMPNST生体試料（凍結またはパラフィン包埋された生殖細胞系列（または正常組織DNA）サンプル、および集計解析のための体細胞全エクソームまたは全ゲノムシーケンスデータ）に関連するデータを取得できるようになります。第二に、研究者らは、解析のためにMPNSTサンプルを前向きに収集するため、患者を機関バンクに共同登録する予定です。これらの患者は、上記の情報の収集、腫瘍組織の保管、および腫瘍のゲノム特性評価を含む将来の研究について同意を得ることになります。
アジア太平洋地域におけるループス低疾患活動性状態（LLDAS）の妥当性検証
Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE). SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time. The diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease. In this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.