治験一覧
8,963 件中 5401〜5420 件を表示
抗VEGF療法後のBRVOにおける網膜感受性
The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.
進行がんを患う日本人参加者を対象としたオララツマブの研究
This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate safety and side effects of olaratumab in combination with doxorubicin in Japanese participants with a group of rare cancers (advanced solid tumors, especially advanced soft tissue sarcoma \[STS\].) The main purpose of Part B is to evaluate how much olaratumab gets into the blood stream of Japanese participants with advanced solid tumors and how long it takes the body to get rid of it.
ステージIVの非扁平上皮非小細胞肺癌（NSCLC）患者を対象とした、アテゾリズマブとカルボプラチン＋パクリタキセル（＋）の併用療法（ベバシズマブ併用または非併用）とカルボプラチン＋パクリタキセル＋ベバシズマブの併用療法との比較研究
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
再発性または難治性の多発性骨髄腫に対するダラツムマブによる早期アクセス治療
The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.
トホグリフロジンGLP-1アナログ併用療法試験
An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.
日本人健康成人男性を対象としたリバーロキサバンの生物学的同等性試験
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.
ALN-TTR02（パチシラン）による治療歴のある被験者を対象とした、トランスサイレチン（TTR）介在性アミロイドーシス治療のための治験薬パチシラン（ALN-TTR02）の研究
The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
血液悪性腫瘍患者におけるベネトクラクスの評価に関する研究
This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
思春期特発性側弯症の進行を予測する新たなモデルに関する多施設共同前向き評価
Scoliosis is a three-dimensional deformity affecting the orientation and position of the spine. Locally, the shape of the vertebra is also affected. The most common form is adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young adolescent females. AIS can either be treated using a brace and in some cases necessitate surgical correction to prevent progressive deformity. Risk factors for progression include female gender, curve magnitude and location, skeletal maturity and growth velocity. However, these risk factors have been shown to be inconsistent in predicting curve progression. Over the past 6 years, the investigators have developed a predictive model of the final Cobb angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195 patients that were enrolled upon their initial visit and followed until maturity. This predictive model has a determination coefficient of 0.702. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study. The objective of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. Three-dimensional reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral disks at each level as well as the geometry of the pelvis. A series of local and regional parameters will then be calculated from these 3D reconstructions. Correlation analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation or pelvic geometry can be used as early predictors of curve progression in AIS. Identifying a new 3D measure of scoliosis associated with rapid curve progression could help predict which curves need early treatment to prevent further progression. The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.
日本人の腺癌サブタイプ非小細胞肺癌患者における第一選択化学療法不成功後のニンテダニブとドセタキセルの併用療法
To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area (BSA) \<1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (NSCLC) after failure of first line platinum- based chemotherapy
進行肝細胞癌におけるデュルバルマブまたはトレメリムマブ単独療法、あるいはデュルバルマブとトレメリムマブまたはベバシズマブの併用療法の研究
This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.
高齢2型糖尿病患者におけるイプラグリフロジン治療に関する調査
The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.
急性骨髄性白血病患者を対象としたSGI-110の第1相臨床試験
To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously to Japanese patients with acute myeloid leukemia (AML).
1型糖尿病患者におけるASP1941の薬力学、薬物動態、および安全性
The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2 weeks.
MLN1202の単回皮下投与に関する第1相試験
The objective of the study is to investigate the safety, pharmacokinetics, and pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.
ラベプラゾールと低用量アスピリンの長期併用療法に関する臨床経験調査
To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.
重症肺気腫に対するOL-BF-001の安全性と有効性を評価するための前向き多施設臨床試験
This is a multicenter,single-arm,open-label study designed to evaluate improvement of lung function and safety after treatment with OL-BF-001 for severe emphysema. OL-BF-001 consists of a bronchial valve, deployment catheter, loader and airway sizing kit. A bronchial valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.
京都心不全研究
The purpose of this study is to investigate the patient characteristics, selection of treatment, and factors associated with clinical outcomes in Japanese patients with acutely decompensated congestive heart failure.
切除不能な転移性大腸癌におけるレゴラフェニブ誘発性疲労／倦怠感に対する経口ステロイド療法（KSCC1402/HGCSG1402）
The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from regorafenib treatment, as well as to assess treatment continuation of regorafenib.
体外受精（IVF）／卵細胞質内精子注入法（ICSI）治療を受ける日本人女性を対象としたFE 999049の用量反応試験
This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.