治験一覧
8,963 件中 1981〜2000 件を表示
NTRK遺伝子融合陽性進行性または再発性固形腫瘍、遺伝子の特定の変化によって引き起こされるまれな癌
Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer. In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing. In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The study will include patients of all ages with TRK fusion cancer. In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from: * the patients' medical records * interviews with the patients or their parents or guardians * the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.
アベニールの完全な市販後臨床追跡調査
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.
短腸症候群におけるアプラグルチドの長期安全性を評価するためのオープンラベル延長試験。
The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
食道切除術における組織酸素飽和度
Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy.
進行性または転移性固形癌患者におけるAZD7789の安全性と有効性を評価する研究
This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.
特発性肺線維症患者におけるHZN-825の有効性、安全性および忍容性を評価する多施設共同試験
HZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF). Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase. During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors: 1. Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no 2. Forced vital capacity (FVC) % predicted at Baseline: ≥70% or \<70% Participants who complete the 52-week Double blind Treatment Period of the Core Phase of the trial will be invited to extend their participation in the 52-week Extension Phase of the trial.
進行癌に対する全身治療を受けていないER陽性HER2陰性乳癌患者を対象としたAZD9833＋パルボシクリブとアナストロゾール＋パルボシクリブの比較試験
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
RESTORE - 二次性股関節骨折予防のためのAGN1 LOEPの研究
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.
心不全、肥満、2型糖尿病患者におけるセマグルチドの効果を検証する研究
This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. * At 6 of the visits participants will have blood samples taken. * At 5 of the visits participants will be asked to fill in a questionnaire * At 4 of the visits participants will have to do a 6-minute walking test * At 3 of the visits participants will have a test to check the heart. * participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
原発性免疫性血小板減少症の成人患者におけるエフガルチギモドPH20皮下注射剤の有効性および安全性を評価する研究
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
鼻茸を伴う慢性副鼻腔炎の日本人患者におけるデュピルマブの有効性（SINUS-M52）
This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies. Duration of study period (per participant): * Screening Period (2 to 4 weeks) * Intervention Period (up to 52 weeks±3 days)
HR+/HER2-局所再発手術不能または転移性乳がんに対するペムブロリズマブ（MK-3475）と化学療法の併用とプラセボと化学療法の併用を比較する試験（MK-3475-B49/KEYNOTE-B49）
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1.
成人における RSVpreF の有効性、免疫原性、安全性を評価する研究。
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States and Canada.
骨髄性プロトポルフィリン症（EPP）またはX連鎖性プロトポルフィリン症（XLP）患者における経口デルシメラゴン（MT-7117）の安全性および忍容性を評価するための継続試験
To evaluate the long-term safety and tolerability of oral dersimelagon.
ヒト免疫不全ウイルス1型（HIV-1）感染症患者を対象としたドラビリン/イスラトラビル（DOR/ISL 100 mg/0.75 mg）の非盲検追跡調査（MK-8591A-033）
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
慢性閉塞性肺疾患（COPD）におけるSAR440340/REGN3500/イテペキマブの有効性、安全性、忍容性を評価する試験
Primary Objective: Primary population (former smokers cohort): * Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): * Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD * Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD * Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD * Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) * Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD * Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD * Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD * Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD * Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
アテゾリズマブとベバシズマブによる治療歴のある肝細胞癌患者におけるアテゾリズマブとレンバチニブまたはソラフェニブの併用とレンバチニブまたはソラフェニブ単独の併用を比較する試験
This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.
日常臨床診療における乾癬性関節炎患者を対象としたグセルクマブとインターロイキン-17（IL-17）阻害剤療法の研究
The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).
進展期小細胞肺癌の第一選択治療としてBMS-986012をカルボプラチン、エトポシド、ニボルマブと併用する試験
The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
進行性MTAP遺伝子変異陽性固形腫瘍患者を対象としたAMG 193試験（MTAPESTRY 101）
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the efficacy of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.