治験一覧
8,963 件中 321〜340 件を表示
肺動脈性高血圧症患者を対象としたソタテルセプト（MK-7962）の臨床試験（MK-7962-031/LIGHTRAY EXTENSION）
Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH. A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight. This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.
急性精神病を呈する統合失調症の日本人成人患者におけるKarXTの有効性と安全性を評価する研究
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
HeFH患者におけるAZD0780のLDL-Cに対する効果を評価する第III相試験
This is a study to evaluate the efficacy and safety of AZD0780 in adults with HeFH and elevated LDL-C, either with clinical ASCVD and LDL-C levels of 55 mg/dL or higher or without clinical ASCVD and LDL-C levels of 70 mg/dL or higher. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.
心不全患者における左室肥大および左室駆出率低下/軽度低下の心臓の構造と機能に対するCDR132Lとプラセボの比較研究
This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.
分化型甲状腺癌患者を対象としたAf-001の第I相試験
This trial consists of 2 parts, i.e., Part Ia and Ib. The Part Ia is to evaluate the safety and tolerability of a single intravenous dose of af-001 in patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) refractory to or intolerant of standard-of-care therapy, who have received total thyroidectomy, and to determine the MTD (Maximum tolerated dose). Part Ib is to evaluate the efficacy and safety of af-001 mutiple doses to patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma), who have received total thyroidectomy and are RAI naïve, randomized into two arms at the determined MTD or the MTD-1 dose level, and to determine the recommended Phase II dose (RP2D)
胆道癌の第一選択治療におけるリルベゴストミグまたはデュルバルマブと化学療法の併用試験（ARTEMIDE-Biliary02）
The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
動脈硬化性心血管疾患および/または慢性腎臓病の成人における心血管アウトカムに対するオルフォルグリプロン（LY3502970）の研究（ATTAIN-Outcomes）
The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.
プラチナ製剤感受性再発卵巣癌患者におけるサシツズマブ・ティルモテカン（MK-2870）治療と標準治療の有効性と安全性を評価する試験（MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103）
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
重度の活動性GPAまたはMPA患者を対象としたラプカブタゲンオートロイセルを評価する第2相試験
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
アトピー性皮膚炎の成人患者を対象とした、1% OPA-15406フォームの基剤に対する優位性を実証する第3相試験
To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).
子宮内膜症患者におけるKLH-2109の臨床試験
To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic pain.
高リスク非筋層浸潤性膀胱癌患者におけるTAR-210と膀胱内化学療法の比較研究
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
治癒的治療の対象となる非小細胞肺がん患者における微小残存病変の検出、モニタリング頻度、および予後との関係を調査する前向き研究。
Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. However, there is currently no adequate method to determine which patients should receive these adjuvant therapies. Identifying those with a good prognosis without adjuvant therapy could reduce the risk of adverse events, lessen the burden of clinic visits, and reduce healthcare costs. Among various approaches, ctDNA-based MRD (minimal residual disease) analysis is highly anticipated and has already been introduced into clinical practice for hematologic malignancies. However, solid tumors' development as a companion diagnostic has been limited, and regulatory approval is mainly being considered based on performance evaluation data. In this study, we will conduct a performance evaluation of MRD analysis using Signatera™ in patients with stage I-III NSCLC while also collecting other prognostic factors based on clinicopathological information and survival data.
肺線維症の家族歴を持つ人々の肺の変化をネランドミラストが遅らせるのに役立つかどうかを検証する研究
This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis. Participants are put into one of 2 groups randomly, which means the group is chosen by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo. Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months. Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.
原発性アルドステロン症患者におけるバクスドロスタットの有効性と安全性を評価する研究
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries.
中大脳動脈M2部閉塞を伴う急性虚血性脳卒中に対する血管内治療のランダム化臨床試験
RESCUE-M2O trial is a prospective, open label, blinded endpoint (PROBE), two-arm, randomized, controlled, post-market study to assess the efficacy and safety of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
健常者におけるCT-P55とコセンティクスの薬物動態、安全性および免疫原性を比較する
This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects
歯周靭帯インプラントの有効性と安全性の評価研究
The goal of this clinical trial is to evaluate the efficacy and safety of periodontal ligament-integrated implants placed via residual periodontal ligament tissue in extraction sockets in adult patients (aged 18 and older) requiring extraction of a single-rooted tooth. The main questions it aims to answer are: * Does the periodontal ligament-integrated implant achieve stable integration with the jawbone at 24 weeks after placement? * Can this implant reproduce physiological tooth mobility and sensory function similar to natural teeth while maintaining periodontal health? This is a multicenter, single-arm, exploratory study with approximately six participants. Participants will: * Undergo tooth extraction of one single-rooted tooth that meets eligibility criteria. * Receive immediate placement of a periodontal ligament-integrated implant into the extraction socket. * Attend scheduled follow-up visits over 48 weeks for assessments including: * Dental X-rays and clinical examinations to evaluate bone healing, periodontal ligament formation, and implant stability. * Measurements of tooth mobility, pocket depth, and pain levels. * Quality of life assessments using a standardized oral health questionnaire. Researchers will monitor participants for implant integration, safety outcomes, and physiological function restoration over the study period.
プラチナ製剤感受性卵巣癌再発患者におけるプラチナ製剤併用化学療法（2L）後の維持療法におけるリナSプラス標準治療の有効性と安全性を標準治療と比較評価する試験
この第3相試験は、世界各国で最大約528名の参加者を対象に実施されます。 本試験の目的は、卵巣がんに対して既に承認され使用されている標準治療と併用した場合のRina-Sの有効性を評価することです。 参加者は、Rina-S単独療法（単独）、Rina-Sとベバシズマブの併用、ベバシズマブ（標準治療）単独、または無治療（モニタリングのみ、標準治療も併用）のいずれかを受けます。プラセボは投与されません。参加者は2つの群のいずれかに参加します。 治療期間は参加者ごとに異なります。参加者のがんが変わらず、または改善し、深刻な問題がない場合、参加者は試験期間中、試験治療を継続できます。 参加者は、1サイクルごとに1～3回の試験実施医療機関への通院を求められます（1サイクルの期間は3週間です）。来院時には、治験薬の安全性と有効性をモニタリングするために、様々な検査（採血など）や処置（心臓活動の記録や画像診断など）が行われます。治験全体の期間（スクリーニング、治療、フォローアップを含む）は、参加者ごとに異なります。
日本におけるTBEゾーン2 PMS
The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.