治験一覧
8,963 件中 901〜920 件を表示
ONO-2017 試験：原発性全般強直間代発作のある日本人患者
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
肥満または過体重で、少なくとも1つの体重関連合併症を有する参加者を対象とした研究
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity
50歳以上の成人を対象としたmRNA-1083ワクチン（SARS-CoV-2 [COVID-19] およびインフルエンザ）の免疫原性、反応原性、および安全性を調査する研究
The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).
葉酸受容体α陽性進行卵巣がんおよびその他の固形腫瘍を有する成人被験者を対象としたTAK-853の試験
The main aim of this study are to check for side effects from TAK-853, check how much TAK-853 participants can receive without getting side effects from it, check how well TAK-853 controls symptoms, and to check how much TAK-853 stays in their blood over time. The study will be conducted in two phases including Phase 1 Part and Phase 2 Part. In Phase 1 Part, the participants will stay in the hospital for 3 days at least after their 1st injection for some tests and to check for any side effects from their treatment. In Phase 2 Part, participants will visit their study hospital for multiple times. In both phases, the participants will receive TAK-853 on the first days of each 3-week cycle. The participant will be in the study for about 9 months in Phase 1 Part and for about 24 months in Phase 2 Part. The study doctors will check for side effects from the study treatments.
バングラデシュの三次医療機関における集中治療室におけるエビデンスに基づく実践と看護師の行動変容によるケアの質への影響：人工呼吸器関連肺炎に焦点を当てて
Quality of care is crucial for preventing adverse events such as infection in the intensive care units (ICUs). The most common ICU-acquired infections include pneumonia such as ventilator-associated pneumonia (VAP), Central Line Bloodstream Infection (CLABSI), catheter-associated urinary tract in, Medical Device Related Pressure Ulcer (MDRPU) and Pressure Ulcer (PU). This study explores the patient outcome in ICU by examining the causes and prevalence of ICU-acquired infection. The implementation of evidence-based practice (EBP) to reduce infection and change the nurses practice (behavioral changes) to adhere with EBP based on simulation-based training. General objective: To evaluate the effect of EBP by using recent technologies-based equipment to prevent VAP and promote behavior change among nurses for better outcome of the patient in ICU. Specific Objectives: 1. To determine the incidence of adverse events (VAP rate, MDRPU rate, PU rate, CLABSI rate), length of stay and survival rate in ICU. 2. To evaluate the effectiveness of EBP education by changing nurses' behavior and determine its impact on improving patient outcomes in the ICU. 3. To evaluate the effectiveness of EBP including proper equipment use and changed nurses behavior acquired through the training for better patient outcome (VAP ratio) in the ICU. 4. To examine the feasibility of evaluation process and outcomes and successful implementation of EBP in ICU. Hypothesis: It is hypothesize that implementing EBP in ICU, including new equipment use and nurses training, will improve patient outcome. These research consist of three studies: Phase 1: Incidence of adverse events (VAP rate, MDRPU rate, PU rate, CLABSI rate), length of stay and survival rate in ICU. The patients of General ICU will be followed up after admission up to discharge or death at ICU. The investigators use the study findings for our subsequent intervention study 3 as historical data. Phase 2: A pre- and post- quasi-experimental study will be conducted for 6 months to evaluate the nurse's competency on EBP after getting 1-month EBP training. This study has 3 steps: (1) Pre-observation period to measure nurse's competency level for 2-month, (2) nurse's EBP training period with preparation for 1 month, and (3) post-implementation period to measure nurse's competency and implementation of EBP practice for 2 months. Study nurses will receive EBP training, EBP and proper equipment for patient management. The nurses will receive EBP education and training with necessary equipment, such as a close suction catheter, an endotracheal tube, a suction device, and a mouth care brush. In this study, use global standard equipment for the patients safety. Phase 3: A pre- and post- quasi-experimental study will be implemented to evaluate the efficacy of EBP implementation. The investigators use new equipment and implement EBP for patients and assess the patient outcomes. The investigators compare the findings from study 1 (as historical data) with the data from this study 3. The investigators will compare the VAP infection prevalence and patients' outcomes related to ICU-acquired infection between pre- and post- test phase.
低リスクまたは中等度リスク1の早期PMFまたは顕性PMF患者の治療におけるP1101
This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk. Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.
中等度から重度のクローン病患者におけるトゥリソキバート（MK-7240）の有効性と安全性を評価する試験（MK-7240-008）
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
非アルコール性脂肪性肝疾患に対するペマフィブラートの有効性と安全性
This is a study to evaluate the effect of pemafibrate on fatty liver in patients with hypertgemia combined with NAFLD, using fenofibrate as a control.
健康な成人男性ボランティアを対象としたMT-3534の臨床薬理試験
This study is planned to investigate the safety, tolerability, and pharmacokinetics when a single intravenous dose of MT-3534 or a placebo is given to healthy adult male volunteers.
ステロイド抵抗性天疱瘡患者を対象としたONO-4059試験
ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus
早期乳がんに対する新規治療法開発のための持続的かつ効率的なプラットフォーム試験
Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.
中等度から重度の活動性全身性エリテマトーデス患者を対象としたダピロリズマブペゴルの有効性と安全性を評価する試験
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
慢性腎臓病患者における腎障害軽減効果を薬剤NNC0519-0130の異なる投与量で比較する研究
The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.
18歳以上の男女を対象に、デュピルマブ注射とプラセボを比較した慢性単純性苔癬の掻痒改善効果を調査する研究（STYLE 1）
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC. Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.
12歳以上の中等度から重度のアトピー性皮膚炎患者（背景：外用コルチコステロイド）における皮下アムリテリマブの有効性と安全性を評価する試験
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).
フィラデルフィア陰性B前駆細胞急性リンパ性白血病（B-ALL）と新規診断された日本人成人患者を対象とした、静脈内ブリナツモマブの有効性を評価する試験
The main objective of the study is to evaluate safety and tolerability of blinatumomab in adult Japanese participants with newly diagnosed B-ALL.
健康な被験者におけるオルフォルグリプロン（LY3502970）の単回投与と複数回投与を比較する試験
The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.
健康なボランティアを対象としたTRN501の第I相試験
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TRN501 following a single administration of TRN501 or placebo to healthy adult male volunteers.
特発性炎症性ミオパチー（多発性筋炎および皮膚筋炎）の成人患者を対象に、皮下注射で投与し標準治療に追加したアニフロルマブの有効性と安全性を、標準治療に追加したプラセボと比較検討する試験
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.
骨形成不全症の小児日本人被験者におけるセトルスマブ
The primary objective of the study is to evaluate the effect of setrusumab on reduction in fracture rate, including morphometric vertebral fractures.