治験一覧
8,963 件中 601〜620 件を表示
日常診療におけるブデソニド/グリコピロニウム/フォルモテロール（BGF）の単群試験の統合解析
The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.
ヒト上皮成長因子受容体2（HER2）の変異を有する固形腫瘍患者におけるセバベルチニブ（BAY 2927088）錠の治療効果と安全性についてさらに詳しく知るための研究
研究者たちは、HER2活性化変異を有する固形腫瘍患者に対するより良い治療法を模索しています。治療薬が承認される前に、研究者たちはその安全性と作用機序をより深く理解するために臨床試験を実施します。 この試験では、BAY2927088（セバベルチニブ）が、HER2変異を有する様々な種類の固形腫瘍患者においてどれほど有効であるかを明らかにしようとしています。これらの腫瘍には、結腸または直腸、子宮および子宮頸部（子宮の下部）、乳房、膀胱、胆道（胆嚢および胆管を含む）の腫瘍に加え、進行非小細胞肺がん（NSCLC）患者を除く他の種類の固形腫瘍が含まれます。 固形腫瘍では、ヒト上皮増殖受容体2（HER2）と呼ばれる遺伝子に特定の変化または変異がみられることがあります。これにより、がん細胞内で異常なHER2タンパク質が形成され、細胞の増殖が促進されます。治験薬であるBAY2927088は、がんの転移を阻止する可能性のある異常なHER2タンパク質を阻害することが期待されています。 この治験には、18歳以上の約111名の参加者が参加します。参加者全員がBAY2927088を20mgの錠剤として経口服用します。 参加者は3週間ごとのサイクルで治療を受けます。この3週間のサイクルは、治験期間中繰り返されます。参加者は、がんが悪化するまで、医学的な問題が発生するまで、または治験から離脱するまで、BAY2927088を服用することができます。 治験中、医師はがんの転移を調べるために体の様々な部位の画像スキャンを行い、心エコー図または心臓磁気共鳴画像（MRI）と心電図（ECG）を用いて心臓の健康状態を確認します。また、医師は参加者の健康状態を確認するために、血液と尿のサンプルを採取し、身体検査を行います。医師は、参加者の体調や医学的な問題の有無について質問します。
片頭痛患者を対象とした経口アトゲパント錠の安全性と有効性を評価する試験
A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24). There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.
第三大臼歯手術における手術部位感染予防効果
The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration.
60歳以上の個人におけるアブリスボの特別調査
This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.
進行性転移性去勢抵抗性前立腺癌患者を対象とした、ザリタミグとカバジタキセルまたは二次アンドロゲン受容体標的療法との比較第3相試験（XALute）
The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).
アンジェルマン症候群（AS）の小児患者を対象としたGTX-102の第3相有効性および安全性試験
この研究の主な目的は、欠失型アンジェルマン症候群 (AS) の参加者の認知機能に対する GTX-102 の効果を評価することです。
急性冠症候群の症状を有する参加者を対象としたElecsys® Troponin T hs Gen 6の研究
This prospective, non-interventional, single arm, longitudinal cohort multicenter study will recruit approximately 5600 consecutive all-comers, consisting of patients with signs and symptoms of acute coronary syndromes (ACS) who present in the emergency department (ED). The main objective of the study is to determine the clinical performance of Elecsys Troponin T hs Gen 6 versus the centrally adjudicated clinical diagnosis at various time points after ED presentation using the previously determined clinical cut-off of a universal 99th percentile upper reference limit.
日本の日常臨床診療において、経口ベネトクラックス錠±静脈内（IV）注入によるリツキシマブを投与された慢性リンパ性白血病（CLL）成人患者における検出限界以下の微小残存病変（uMRD）の頻度を評価する研究
Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan. Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan. Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.
遠隔転移のない頭頸部局所再発扁平上皮癌の第一選択治療におけるASP-1929光免疫療法とペンブロリズマブの併用に関する研究
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab. Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm). The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.
双極性I型またはII型障害の成人患者における有害事象および疾患活動性の変化を評価するための経口ABBV-932の試験
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder. ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide. Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
重症眼筋無力症の成人患者におけるエフガルチギモドPH20皮下注射の有効性と安全性を評価する試験
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.
BI 1815368の様々な投与量に対する耐性および健康な日本人男性の体内へのBI 1815368の取り込みを検証する研究
The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.
ブリギマドリンを用いた過去の研究に参加した固形腫瘍患者におけるブリギマドリンの長期治療を検証する研究
This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that was being developed to treat cancer. All participants take brigimadlin as tablets once every 3 weeks at the study site. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.
転移性去勢抵抗性前立腺がんの男性における PF-06821497 (メブロメトスタット) の効果を調べる研究。
この研究では、ARSiまたはアビラテロン未治療のmCRPC患者において、治験薬PF-06821497とエンザルタミドの併用がエンザルタミド単独よりも効果的かどうかを調査します。
大腸がん患者に対する第一選択治療としてのONO-7913、ONO-4538および標準治療の比較研究
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
乳幼児を対象としたRSウイルスワクチンの有効性、免疫原性、安全性試験
本試験は、生後6ヶ月から22ヶ月未満の小児約6,300名を対象に実施される、第III相、無作為化、観察者盲検、プラセボ対照、多国籍、多施設共同試験です。本試験の目的は、鼻腔内投与によるRSウイルス幼児（RSVt）ワクチンの有効性、免疫原性、および安全性をプラセボと比較評価することです。 対象となる参加者は、RSVtワクチンまたはプラセボのいずれかを2回鼻腔内投与されるよう、1:1の比率で無作為に割り付けられます。 試験期間は参加者ごとに24ヶ月です。安全性の追跡調査は、初回接種後から試験終了まで実施されます。
進行固形腫瘍患者を対象としたPF-07820435の単剤および併用療法の試験
This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.
肺がんに対する化学療法および他の治験薬との併用におけるBNT327の安全性、有効性、および薬物動態
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
肥満または過体重の日本人被験者を対象としたLY3841136の研究
The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.