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未分化リンパ腫キナーゼ(ALK)陽性非小細胞肺癌(NSCLC)を有する日本人患者を対象としたブリガチニブの第2相臨床試験

完了NCT03410108第2相

The purpose of this study is to evaluate efficacy and safety of brigatinib in Japanese participants with anaplastic lymphoma kinase (ALK)-positive NSCLC.

対象疾患:
ALK-positive Advanced NSCLC

中等度から重度のアトピー性皮膚炎患者における抗OX40モノクローナル抗体(KHK4083)の研究

完了NCT03703102第2相

A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

対象疾患:
Atopic Dermatitis

局所進行性切除不能膵臓癌に対する炭素イオン線治療と光子線治療の比較試験

取り下げNCT03536182第3相

To determine if carbon ion radiotherapy improves overall survival versus photon therapy in patients with locally advanced, unresectable pancreatic cancer

対象疾患:
Locally Advanced Pancreatic Adenocarcinoma

再生能力を高めるためのKit陽性細胞を用いた日本のOMI治療

不明NCT03351400第1相

The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.

対象疾患:
Chronic Heart FailureOld Myocardial Infarction

BI 655130 中等度から重度の潰瘍性大腸炎患者における長期治療

完了NCT03648541第2相

To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

対象疾患:
Colitis, Ulcerative

心筋血流および心筋予備能のSPECT測定の実現可能性に関する多施設共同評価

完了NCT03427749

Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically indicated to have an MBF study.

対象疾患:
Coronary Artery Disease

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ための延長試験

実施中(募集終了)NCT03424018第3相

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

対象疾患:
Achondroplasia

2型糖尿病患者における末梢神経障害の有病率と日常生活動作への影響

完了NCT03440203

The trend of diabetes prevalence was increased by comparing these two national surveys in 2009 and 2014. However, the studies only focused on the prevalence and risk of diabetes and non-communicable diseases in Myanmar. The study focused on the common complications of Diabetic Peripheral Neuropathy (DPN) is rare. The studies in other countries showed high prevalence rate and under-diagnosis of DPN. Most of the patients with DPN did not complain about their symptoms because of without prominent symptoms. DPN is the major complication of diabetes. According to the international studies, DPN has the hidden epidemic and is the common causes which can lead to disability and decreased the quality of life in diabetes. Therefore, the study focused on the prevalence of DPN and its impact on the ADLs is obligatory as the descriptive study to explore the actual situation. Nursing care is not only for the patients in the hospital but also for the people in the community. Moreover, the nurses have to focus on all levels of prevention. Diabetes is the lifelong diseases and accessibility of health care for everyone with diabetes is a very important issue in the era with increased prevalence of diabetes. Therefore, we all have to focus not only on the primary prevention but also on the secondary and tertiary prevention of diabetes. The secondary and tertiary prevention in the diabetic patients also means the primary prevention of other diseases and disabilities (the complications of diabetes). For diabetic neuropathic patients, maintaining normal daily living is very important liked everyone. The objective of this study is to evaluate the prevalence of DPN and DPNP in type 2 diabetic patients and impact on the activities of daily living. The descriptive, cross-sectional study design will be used in this study. The inclusion criteria are the person aged over 25 years of age who had already diagnosed type 2 diabetes mellitus, taking any anti-glycemic treatment. The persons who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism will be excluded from this study. The patients who meet the inclusion criteria and come to outpatient diabetic clinics at YGH, NOGH, EYGH, and WYGH will be chosen as a sample after obtaining informed consent. Data collection will be done at this outpatients diabetic clinic of these four hospitals. This study has already obtained ethical clearance from Nursing Science Ethical Review Committee, Graduate School of Health Sciences, Okayama University, Japan with the review number D1605. It will be carrying out after obtaining approval from Department of Medical Research, Myanmar. At the outset, informed consent will be obtained with detailed information about the purpose of research, the part they need to participate, possible benefits and their rights to withdraw.

対象疾患:
Activities of Daily LivingDiabetic Neuropathy Peripheral

多発性骨髄腫の標準治療レジメンと併用した皮下ダラツムマブの効果を評価する研究

完了NCT03412565第2相

The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

対象疾患:
Multiple Myeloma

切除不能な非小細胞肺癌患者における化学放射線療法と併用したデュルバルマブの研究

実施中(募集終了)NCT03519971第3相

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care \[SoC\] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

対象疾患:
Non-Small Cell Lung Cancer

STEMIにおける生分解性ポリマーと耐久性ポリマーエベロリムス溶出ステントの長期治癒に関するランダム化比較

完了NCT03440801該当なし

This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing such as the frequency of malapposed and uncovered stent struts at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.

対象疾患:
STEMI - ST Elevation Myocardial Infarction

顕性ハンチントン病患者における髄腔内投与RO7234292(RG6042)の有効性および安全性を評価する研究

完了NCT03761849第3相

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

対象疾患:
Huntingtons Disease

健康な日本人男性を対象とした、BI 690517の様々な投与量が体内でどのように吸収され、どの程度忍容されるかを検証する研究

完了NCT03608072第1相

The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy Japanese male subjects following oral administration of multiple rising doses over 14 days. Secondary objective is the exploration of the pharmacokinetic(s) (PK) and pharmacodynamic(s) (PD) of BI 690517 in healthy Japanese male subjects after multiple dosing.

対象疾患:
Healthy

HR-pQCTを用いた胃切除後の骨微細構造の評価

不明NCT03398226

Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

対象疾患:
Gastric CancerOsteoporosisSarcopenia

日本人2型糖尿病患者を対象としたLY3209590の研究

完了NCT03603704第1相

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.

対象疾患:
Diabetes Mellitus, Type 2

転移性大腸がんの一次治療における、ニボルマブと標準治療の併用療法と標準治療単独療法を比較する治験免疫療法研究

完了NCT03414983第2/第3相

This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).

対象疾患:
Colorectal Cancer

健康な日本人男性被験者におけるラルテグラビル(MK-0518)の安全性、忍容性、および薬物動態(MK-0518-851)

完了NCT03667547第4相

This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.

対象疾患:
Human Immunodeficiency Virus (HIV) Infection

新型ステントリトリーバー、AIS用VERSIシステム

完了NCT03366818該当なし

To confirm efficacy and safety of VERSI system for acute ischemic stroke

対象疾患:
Acute Ischemic Stroke

成人遅発性ポンペ病患者を対象としたATB200/AT2221とアルグルコシダーゼアルファ/プラセボの比較試験

完了NCT03729362第3相

This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

対象疾患:
Pompe Disease (Late-onset)

喘息患児におけるデュピルマブの安全性と有効性の評価(Liberty Asthma Excursion)

完了NCT03560466第3相

Primary Objective: * To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate the efficacy of dupilumab in children of 6 to \<12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: * To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. * To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: * Systemic exposure. * Anti-drug antibodies (ADAs). * Biomarkers. * To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study * To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: * Systemic exposure, * Anti-drug antibodies (ADAs), * Biomarkers

対象疾患:
Asthma