治験一覧
8,963 件中 3841〜3860 件を表示
レジリエント：日本の地域臨床現場における2型糖尿病患者に対するRyzodeg®の効果を検証する研究
The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.
ALK陽性非小細胞肺癌患者における術後補助化学療法としてのアレクチニブとプラチナ製剤併用化学療法の比較研究
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
胃癌に対する一次化学療法としてのペムブロリズマブ（MK-3475）とTS-1+シスプラチンまたはTS-1+オキサリプラチンの併用療法の安全性および有効性（MK-3475-659/KEYNOTE-659）
The purpose of this study is to estimate objective response rates (ORRs) of pembrolizumab + oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, as first-line treatment for gastric cancer in programmed death-ligand 1 (PD-L1) positive, human epidermal growth factor receptor 2 (HER2/neu)-negative participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
人工呼吸器関連肺炎に対するグラム染色誘導型抗生物質選択試験（GRACE-VAP試験）
Background: Optimising the use of antibiotic agents is a pressing challenge to overcoming the rapid emergence and spread of multidrug-resistant pathogens in intensive care units (ICUs). Although Gram staining may possibly provide immediate information for predicting pathogenic bacteria, Gram stain-guided initial antibiotic treatment is not well established in the ICU setting. The investigators planned the GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial to investigate whether Gram staining can safely restrict the use of broad-spectrum antibiotics in patients with ventilator-associated pneumonia (VAP), which is one of the most common hospital-acquired infections in ICUs. Methods/Design: The GRACE-VAP trial is a multicenter, randomised, open-label parallel-group trial to assess the non-inferiority of Gram stain-guided initial antibiotic treatment to guidelines-based initial antibiotic treatment for the primary endpoint of clinical cure rate in patients with VAP. Secondary endpoints include the coverage rates of initial antibiotic therapies, the selected rates of anti-pseudomonal agents and anti-methicillin-resistant Staphylococcus aureus (MRSA) agents as initial antibiotic therapies, 28-day all-cause mortality, ICU-free days, ventilator-free days, and adverse events. Participants are randomly assigned to receive Gram stain-guided treatment or guidelines-based treatment at a ratio of 1:1. In the Gram stain group, results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics. In the guidelines group, the combination of an anti-pseudomonal agent and anti-MRSA agent are administered. A total sample size of 200 was estimated to provide a power of 80% with a 1-sided alpha level of 2.5% and a non-inferiority margin of 20%, considering 10% non-evaluable participants. Discussion: The GRACE-VAP trial is expected reveal whether Gram staining can reduce the use of broad-spectrum antibiotics without impairing patient outcomes and thereby provide evidence for an antibiotics selection strategy in patients with VAP.
H1抗ヒスタミン薬で十分な効果が得られない青年および成人の慢性蕁麻疹に対するリゲリズマブの第III相試験および有効性。
The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
中等度から重度の慢性尋常性乾癬の成人患者におけるビメキズマブの有効性と安全性を評価する研究
This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).
ベングルスタットがADPKD患者の将来的な治療法となり得るかどうかを判断するために設計された医学研究
Primary Objective: To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2). Secondary Objectives: * To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2). * To evaluate the pharmacokinetics (PK) of venglustat in ADPKD participants (Stages 1 and 2). * To determine the effect of venglustat on pain and fatigue, based on participant reported diary (Stages 1 and 2). * Safety/tolerability objectives: * To characterize the safety profile of venglustat (Stages 1 and 2). * To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2). * To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).
進行性悪性腫瘍患者を対象とした、NZV930単剤療法およびPDR001および/またはNIR178との併用療法に関する第I/Ib相試験。
The purpose of this study was to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers
血友病AおよびB患者（阻害因子の有無を問わず）を対象とした、通常治療中の追跡調査（Explorer™6）
This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.
活動性非分節型白斑患者におけるPF-06651600およびPF-06700841の有効性および安全性プロファイルを評価する第2b相試験
This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week Follow up Period.
再発または難治性の急性骨髄性白血病（AML）を有する日本人患者におけるミラデメタンの有効性に関する研究
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the milademetan dose will be made in the same participant. Dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a modified continuous reassessment method (mCRM).
再発性または難治性の小細胞肺癌患者を対象とした、ABBV-011単剤療法およびブジガリマブ（ABBV-181）との併用療法に関する研究
This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.
日本人患者を対象としたMEDI9447（オレクルマブ）の第I相臨床試験
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MEDI9447 in Japanese patients with advanced solid malignancies.This study consists of 2 cohorts. Cohort 1 (dose level 1) and Cohort 2 (dose level 2). At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in each cohort.
急性冠症候群患者を対象としたCSL112の有効性を調査する研究
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events \[MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke\] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
糖尿病性腎症患者におけるカナグリフロジン（TA-7284）の有効性と安全性
The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo
進行性肝細胞癌を有する日本人患者を対象としたカボザンチニブの第2相試験
The purpose of this study is to evaluate the efficacy and safety of cabozantinib in Japanese participants with advanced hepatocellular carcinoma (HCC) who have received prior systemic anticancer therapy.
腹部手術後の回復を評価するための患者報告アウトカム尺度の開発
As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is currently precluded by the lack of PRO measures specifically developed and validated in the context of postoperative recovery. The core goal of this research project is to develop a PRO measure aimed to assess postoperative recovery from the perspective of patients undergoing abdominal surgery. This project complies with the US Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be conducted in three phases: Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate relevant items. Phase 2: Use of Rasch Analysis for item-reduction and scale formation. Phase 3: Further assessment of measurement properties based on traditional psychometric methods.
重症インフルエンザで入院中の患者を対象に、バロキサビルマルボキシルと標準治療のノイラミニダーゼ阻害剤を併用した場合の有効性および安全性を評価する研究
This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.
日本カテーテルアブレーション登録
Japanese Cather Ablation (J-AB) Registry is a voluntary nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The objectives of this registry are to observe and describe developments in the catheter ablation treatment of arrhythmia in Japan and to provide reliable information on the type of activity performed and the facilities available in Japanese arrhythmia units.
深部粘膜下層浸潤の予測精度
The main aim of this study is to determine whether the assessment of the invasive pattern based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment based on white light endoscopy (WLE), carried out by trained endoscopists.