治験一覧
8,963 件中 1141〜1160 件を表示
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.
中等度から重度のアトピー性皮膚炎患者（生後6ヶ月から18歳未満）を対象としたレブリキズマブ（LY3650150）の長期安全性および有効性を評価する試験
The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.
アレクシオンC5阻害剤による治療を受けたAQP4+ NMOSD患者登録
Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.
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.
3Dプリンティング技術学習プログラムの効果
3D printing technology helps rehabilitation professionals make an order-made assistive device (AD). However, most have not learned how to use the technology for clinical practice. The study is aimed to evaluate a 3D printing technology learning program for rehabilitation professionals. Eligible participants who have a licence for physical, occupational or speech-language therapy and have not experienced learning any 3D printing technology. The learning program was conducted in accordance with Kolb's Experiential Learning Theory (Morris TH, 2020). The program was conducted over eight weeks. The outcome measure included the Japanese version of the modified Technology Acceptance Model questionnaire (TAM-J). It consists of 13 items and four scales; Perception of usefulness (28 points total), Perception of ease of use (35 points total), Attitude toward use (14 points total) and Intention to use (14 points total). Within-group analyses were performed using the Wilcoxon signed-rank test for the TAM-J between different time points.
PSMA陽性OMPCにおけるルテチウム（177Lu）ビピボチドテトラキセタンと観察を比較するオープンラベル試験。
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
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.
カルメット・ゲラン菌（BCG）投与後の再発性高リスク非筋層浸潤性膀胱癌（HR-NMIBC）患者におけるTAR-200と膀胱内化学療法の比較試験
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.
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.
胆道癌切除後の補助療法としてのリルベゴストミグ＋化学療法（ARTEMIDE-Biliary01）
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
肺炎球菌感染症リスク増加成人におけるV116の安全性と免疫原性（V116-008）
The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.
ニルセビマブ2回投与後の安全性、薬物動態、抗薬物抗体および抗RSV抗体を評価する研究
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months. Study details include * The study duration is approximately 21 months with a 2-month enrollment period. * Study intervention is 2 doses administered 5- 6 months apart. * The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.
非再発性二次進行性多発性硬化症の成人患者におけるフレキサリマブ（SAR441344）の有効性および安全性試験
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.
HIV-1抗レトロウイルス治療未経験者におけるDOR/ISL（MK-8591A-053）
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
慢性副甲状腺機能低下症患者におけるエネボパラチド（AZP-3601）の安全性と有効性の評価
This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not know which group each patient has been randomized to. All patients will start with a fixed dose of study treatment (eneboparatide or placebo), administered subcutaneously with a pre-filled pen. Study treatment will be individually titrated. After completion of the first 24 weeks, patients will be treated in the open label extension part of the study for 132 weeks. During this phase, all patients (including patients that were in the placebo group) will receive eneboparatide.
近視性脈絡網膜萎縮症（PAMyCA）患者を対象としたPAL-222の臨床試験
The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy. The main question it aims to answer are: • Percentage of changes in the chorioretinal atrophic area Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy. Researchers will compare non-therapeutic eye to see if the changes is significant different.
イムフィンジ/イムジュドuHCC日本PMS_日本市販後調査（PMS）研究
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting.
プラチナ製剤抵抗性、高悪性度卵巣がん、原発性腹膜がん、または卵管がん患者におけるラルドタトゥグ・デルクステカン（R-DXd）の研究
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
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).
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).