治験一覧
8,963 件中 1161〜1180 件を表示
REZILIENT3（EGFR非小細胞肺癌におけるZIpaLertinibの研究）
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.
ゲノム異常のない進行NSCLCに対するDato-DXdとデュルバルマブおよびカルボプラチンの併用療法の第III相非盲検第一選択試験
This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
健康な男性を対象とした、BI 1839100の様々な投与量に対する忍容性を検証する研究（1490-0003）
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1839100 in healthy male subjects following oral administration of single rising doses.
中等度から重度のアトピー性皮膚炎患者12歳以上を対象とした、プラセボと比較した皮下アムリテリマブ単剤療法の有効性と安全性を評価する試験（COAST 2）
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. 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).
ROSA膝関節手術中計画の柔軟性に関する研究
The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.
クレアリーフ：BI 1291583を用いた以前の研究に参加した気管支拡張症患者におけるBI 1291583の長期治療を検証する研究
This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term. Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the AirleafTM or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose. Participants visit the study site 10 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.
日本人PV患者におけるP1101の評価に関する研究
This is a Phase 3 single arm study to investigate efficacy and safety of P1101's rapid titration for adult Japanese patients with PV.
日本における実臨床環境でのEVUSHELD™（チキサゲビマブ／シルガビマブ）曝露前予防に関する観察研究
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan. All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
進行固形腫瘍患者におけるサシツズマブ・ティルモテカン（MK-2870）の単剤療法およびペムブロリズマブとの併用療法（MK-2870-008）
This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in combination with pembrolizumab (MK-3475) or pembrolizumab + carboplatin, in Japanese participants with advanced solid tumors or treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC). Per protocol amendment 04, Arm 3: Pembrolizumab/Carboplatin + sacituzumab tirumotecan Combination Therapy was discontinued, and subsequently all Arm 3 procedures, recruitment, and descriptions were removed.
ファブリー病の日本人患者におけるPRX-102の安全性、薬物動態、病態生理学的変化、および有効性を評価する研究
The aim of this study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease. It is planned of a total of approximately 18-20 male and female Fabry disease patients between the ages of 13 and 60 years to be part of the study. The study is conducted in Japan.
エンリシチドデカノエート（MK-0616経口PCSK9阻害剤）心血管アウトカム試験（MK-0616-015）CORALreefアウトカム
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.
肝細胞癌（HCC）の成人患者を対象に、静脈内（IV）注入によるリブモニプリマブとIV注入によるブディガリマブの併用投与時の有害事象および疾患活動性の変化を評価する研究
Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab. Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), lenvatinib, or sorafenib. Approximately 120 adult participants will be enrolled in the study across 60 sites worldwide. In arm 1 (control), participants will receive the investigator's choice: lenvatinib as an oral capsule or sorafenib as an oral tablet, once daily. In arm 2, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab, every 3 weeks. In arm 3, participants will receive intravenously (IV) infused livmoniplimab (dose B) in combination with IV infused budigalimab, every 3 weeks. The estimated duration of the study is up to 2 years There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
転移性非小細胞肺癌（NSCLC）成人患者を対象とした、ベラヒアルロニダーゼアルファ配合皮下（SC）ペムブロリズマブ（MK-3475A）と静脈内ペムブロリズマブの併用療法（MK-3475A-D77）の試験
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
集中治療室の看護師に対する終末期コミュニケーション戦略の有効性
Burnout among healthcare workers is frequently reported, and one of the factors cited is the stress caused by end-of-life care. It has been reported that nursing staff experience decreased well-being as a result of being involved in end-of-life care, and this is also true in intensive care units. This decrease in well-being is said to lead to lower quality of care, poor communication with patients and their families, absenteeism, and high turnover. Although palliative care interventions such as education and communication tools have been reported to improve the well-being of healthcare professionals involved in end-of-life care, few reports have evaluated the association with burnout. We investigated whether communication-based palliative interventions in end-of-life care in intensive care units (ICUs) improve the risk of burnout among nurses working in ICUs.
全身性重症筋無力症（gMG）の試験参加者によるロザノリキシズマブの自己投与を評価する第3相オープンラベルクロスオーバー試験
The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.
プラチナ製剤、エトポシド、デュルバルマブ併用療法後の進展期小細胞肺癌（ES-SCLC）の第一選択治療におけるタルラタマブとデュルバルマブの併用とデュルバルマブ単独の併用を比較する試験
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
IgG4関連疾患患者を対象としたオベセリマブの第3相試験
この研究は、IgG4関連疾患（IgG4-RD）の再発予防に対するオベセリマブの有効性と安全性を検討することを目的としています。
網膜に異常な血管が成長する眼疾患（未熟児網膜症）を有する早産児におけるアイリーアの使用に関するデータ収集研究
これは、アイリーアによる治療を受ける未熟児網膜症（ROP）の日本人乳児からデータを収集するための観察研究です。観察研究では、特別なアドバイスや介入は行わず、観察のみを行います。 ROPは、早産児にのみ発生する眼疾患です。ROPのほとんどは軽度で、治療なしでも回復しますが、重篤な場合は適切な時期に治療する必要があります。ROPは、「網膜」の血管が異常に増殖することで発生します。網膜は眼の奥にある組織層で、光を捉えて脳に信号を送ります。ROPの乳児では、これらの異常な血管から血が漏れることがあります。これが網膜に損傷を与え、場合によっては網膜の位置がずれて失明などの医学的問題を引き起こすことがあります。 アイリーアは眼球内に注射で投与されます。網膜の血管の異常増殖を引き起こす特定のタンパク質（VEGF）を阻害することで作用します。アイリアは日本で既に販売されており、ROP（尿路上皮腫）の乳児への医師による処方が承認されています。 本研究の参加者は、本研究開始前に医師がアイリアによる治療を決定した日本人のROPの乳児です。既に医師からアイリアを処方されているROPの乳児も対象となります。 本研究の主な目的は、実臨床環境下におけるROPの乳児に対するアイリアによる治療の安全性に関するデータをより多く収集することです。また、本研究のもう一つの目的は、これらの参加者におけるアイリアの有効性に関するデータをより多く収集することです。 アイリアの安全性を検証するため、研究担当医はアイリアによる治療を受けた参加者が抱えるすべての医学的問題を収集します。これらの医学的問題は有害事象と呼ばれます。医師は、治療との関連性がないと考えられる場合でも、発生したすべての有害事象を記録します。 アイリーアの効果を検証するため、治験担当医師は参加者数について以下の点を確認します。 * 治療開始後、活動性ROPがない * 治療開始後6ヶ月以内にROPが再発した 本試験では、治験担当医師は以下のことを行います。 * 医療記録から参加者の過去のデータを収集する * 参加者に聞き取り調査を行う * 定期検診で治療関連データを収集する。試験期間は6ヶ月で、3回の通院が予定されています。1回は治療開始時、1ヶ月後、そして6ヶ月後に通院します。本試験に必要なすべてのデータは、定期検診で収集されます。このデータ収集以外に、本試験では追加の検査や診察は予定されていません。
インスリングラルギン、メトホルミン、SGLT-2阻害薬の併用の有無にかかわらず、2型糖尿病患者におけるオルフォルグリプロン（LY3502970）の有効性を評価する試験
The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.
ADH1患者における標準治療と比較したエンカレレットの有効性と安全性
The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).