治験一覧
8,963 件中 4161〜4180 件を表示
本態性振戦に対するExAblate MRgFUSの有効性と安全性を評価する研究
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET). The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.
3T MRI CIEDの市販後調査
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).
活動性強直性脊椎炎の成人患者におけるウパダシチニブの安全性と有効性を評価する研究
The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
重度大動脈弁狭窄症患者におけるSYM-SV/DS-002の安全性および有効性
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
日本特発性間質性肺炎登録
An objective of JIPS Registry is to examine disease behavior of idiopathic interstitial pneumonias (IIPs), considering classification, background, and diagnostic methods based on American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the ATS/ERS classification of 2002 and 2013.
中等度から重度の潰瘍性大腸炎患者を対象とした、導入療法としてのSHP647の有効性および安全性に関する研究
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
阻害因子を持たない重症血友病A患者におけるコンシズマブの予防的投与の有効性および安全性を評価する臨床試験
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.
健康な成人男性におけるASC-01（アリピプラゾール／セルトラリン配合剤）の単回投与とアリピプラゾールおよびセルトラリンの同時単回投与の生物学的同等性、ならびにASC-01の薬物動態に対する食事の影響
To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1). To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).
難治性小細胞肺癌患者におけるペムブロリズマブとアムルビシンの併用療法
To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus amurubicin (AMR).
二次性副甲状腺機能亢進症を伴う血液透析患者におけるSK-1403の用量調整試験
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
進行固形腫瘍におけるクアボンリマブ（MK-1308）とペムブロリズマブ（MK-3475）の併用試験（MK-1308-001）
This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.
中等度から重度の疼痛を伴う変形性関節症患者におけるMT-5547の有効性と安全性
The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.
超未熟児における気管支肺異形成症の予防におけるOHB-607の臨床的有効性と安全性に関する研究
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.
視覚機能評価方法の開発
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
進行性肝細胞癌患者におけるPDR001とソラフェニブの併用療法の安全性および忍容性に関する研究、ならびにこの併用療法における最大耐用量および／または第2相試験用量の特定
A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.
急性脳卒中患者における血管内血栓除去術の適応患者選択のための頸動脈二重超音波検査
The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular imaging for selecting acute stroke patients for endovascular thrombectomy.
胃腸びらんおよび／または潰瘍に対するプロトンポンプ阻害薬の有効性
The aim of this study is to collect the data of clinical efficacy and safety after the usage of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.
マイクロバイオーム非侵襲診断ツールの開発
Although the endometrium tissue has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. In a pilot study conducted by our research team, the microorganisms present in the endometrium were analysed in samples of endometrial fluid (EF) using next generation sequencing (NGS).Consistent with previously published studies, in normal conditions the endometrium is mainly composed of different species of the genus Lactobacillus. It was further noted that the presence of other pathogenic bacteria such as Streptococcus, and/or Gardnerella may alter the endometrial microbiome and can disrupt the uterine environment, affecting implantation rates and pregnancy success. This project aims to validate the microbiome found in the endometrium of women of reproductive age and try to corroborate the relationship between the endometrial microbiome and the reproductive outcomes in patients undergoing assisted reproduction treatment (ART). The use of Endometrial Receptivity Analysis (ERA) tool, together with the analysis of the endometrial flora before the embryo transfer will allow to evaluate the impact of the presence of endometrial pathogens on implantation in receptive patients. Therefore, the focus of this project is the development and clinical validation of a non-invasive diagnosis tool to analyse the microbiota, adding the microbiome study to the ERA analysis.
日本の夜間在宅睡眠モニタリング調査
The investigators hypothesized that depression is associated with home sleep EEG, subjective sleepiness and insomnia symptoms. To test this, the investigators plan to perform sleep examination with single channel EEG, in combination with questionnaire survey for insomnia, sleepiness, depression and job stress to Koka city government employees.
SIADHに伴う低ナトリウム血症患者におけるトルバプタンの有効性と安全性を調査する多施設共同試験
The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.