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脂質異常症患者を対象としたAZD8233の研究。

完了NCT04823611第1/第2相

A Phase 1 and 2 Study of AZD8233 in Participants with Dyslipidemia and this study consists of Part A , Part B and Part C. Part A is designed as a randomized, single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study. Part B is designed as a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study. Part C is designed as a randomized , single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study.

対象疾患:
Dyslipidemia

GORE® VIABAHN® 人工関節の市販後調査研究(JPS 16-03)

完了NCT04706273

This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.

対象疾患:
Peripheral Arterial Disease

がん治療のための人工知能を用いた臨床意思決定支援システムの開発

募集中NCT04675138

Clinical Decision Support Systems (CDSSs) to augment clinical care and decision making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information. In view of the benefit of developing a CDSS, we sought to develop an alternative CDSS for oncologic therapy selection through a partnership with Ping An Technology (Shenzhen, China), beginning with gastric and oesophagal cancer. This would be done in a piecemeal fashion, with the prototype platform utilizing only international guidelines and high-quality published evidence from journals to arrive at case-specific treatment recommendations. This platform would then be evaluated by comparing its recommendations with that from the multidisciplinary tumour boards of several tertiary care institutions to determine the concordance rate.

対象疾患:
Esophageal CancerEsophagogastric Junction CancerGastric Cancer

外来成人におけるCOVID-19治療薬AZD7442の第III相臨床試験

完了NCT04723394第3相

This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death.

対象疾患:
COVID-19

INCB054707の安全性、忍容性および薬物動態を評価するための研究

完了NCT05068466第1相

This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.

対象疾患:
Healthy Participants

NNC0385-0434錠が心臓病患者または心臓病リスクの高い人の血中コレステロールを低下させる仕組みを調査する研究

完了NCT04992065第2相

This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as an injection (a medicine that doctors can already prescribe). Which treatment participants get is decided by chance. If participants get NNC0385-0434 or placebo participants will need to take 1 tablet every morning. If participants get evolocumab participants will need to take 1 injection every 2 weeks. The study will last for about 22 weeks. About 255 people will participate in the study. Participants will have 9 visits to the clinic and 2 phone calls with the study doctor. Some people will be invited to participate in a sub-study and will have 4 extra visits (13 visits in total). Participants will have blood samples taken at all visits to the clinic (except visit 0). At 4 clinic visits, participants will have an electrocardiogram (ECG). This is a test to check your heart. Women can only take part in the study if they are not able to become pregnant.

対象疾患:
Atherosclerotic Cardiovascular Disease

心不全患者におけるiPS細胞由来心筋細胞スフェロイド(HS-001)の研究(LAPiS研究)

実施中(募集終了)NCT04945018第1/第2相

The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.

対象疾患:
Heart FailureIschemic Heart Disease

日本、韓国、台湾における60歳以上の肺炎球菌ワクチン未接種成人を対象とした20価肺炎球菌結合型ワクチンの安全性および免疫原性に関する研究

完了NCT04875533第3相

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japan, Korea, and Taiwan

対象疾患:
Pneumococcal Disease

肥満症患者を対象としたチルゼパチド(LY3298176)の研究

完了NCT04844918第3相

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

対象疾患:
Obesity

5-FU、オキサリプラチン、およびドセタキセルを用いた食道癌治療の安全性と有効性を評価する前向き試験

不明NCT04699994第2相

The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.

対象疾患:
Esophageal Squamous Cell Carcinoma

再発性または難治性の多発性骨髄腫患者を対象としたテクリスタマブの日本人被験者を対象とした試験

実施中(募集終了)NCT04696809第1/第2相

The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.

対象疾患:
造血悪性腫瘍

クローン病患者におけるダルバドストロセルの調査

募集中NCT05113095

This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.

対象疾患:
Crohn's Disease

先天性心疾患を有する成人における患者報告アウトカムのパターン評価 - 国際研究II

完了NCT04902768

This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

対象疾患:
Congenital Heart Disease

肺がんにおけるアテゾリズマブ併用療法の前向き多施設観察研究におけるバイオマーカー探索的研究(J-TAIL-2)

完了NCT04818983

This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.

対象疾患:
Extensive Disease Small Cell Lung CancerNon-small Cell Lung Cancer

全身性強皮症患者におけるグセルクマブの研究

完了NCT04683029第2相

The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).

対象疾患:
Scleroderma, Systemic

非小細胞肺癌(NSCLC)患者を対象とした手術または放射線治療後のセルペルカチニブに関する研究

実施中(募集終了)NCT04819100第3相

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

対象疾患:
Carcinoma, Non-Small-Cell Lung

HIV/HCV感染および血友病を合併した肝硬変患者におけるOP-724の安全性および忍容性に関する研究。

完了NCT04688034第1相

To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.

対象疾患:
Liver Cirrhosis

ROS1陽性NSCLCを対象としたタレトレクチニブの第2相国際共同試験

実施中(募集終了)NCT04919811第2相

The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.

対象疾患:
Non Small Cell Lung Cancer

臨床現場における卵巣癌患者に対するニラパリブの研究

実施中(募集終了)NCT05021562

The main aim of this study is to check for side effects from treatment with niraparib. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.

対象疾患:
Ovarian Cancer

慢性炎症性脱髄性多発根神経炎(CIDP)および多巣性運動神経障害(MMN)の日本人患者を対象としたTAK-771の試験

実施中(募集終了)NCT05084053第3相

The main aim of the study is to check for side effects from TAK-771, and to check how well TAK-771 controls symptoms in Japanese participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) The participants will be treated with TAK-771 for 45 months as a maximum. There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 2, 3, or 4 weeks).

対象疾患:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Multifocal Motor Neuropathy (MMN)