治験一覧
8,963 件中 161〜180 件を表示
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.
中等度から重度の尋常性乾癬におけるESK-001の長期安全性と有効性
The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.
進行固形腫瘍患者を対象とした、CBA-1535（T 細胞誘導剤（5T4/CD3/5T4））の第 I 相、初めてのヒト研究。
This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535. The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab. This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.
アルツハイマー型認知症に伴う興奮性行動を示す患者を対象としたONO-2020の試験
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
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.
常染色体優性多発性嚢胞腎（ADPKD）の成人患者におけるABBV-CLS-628の静脈内注入の有害事象および有効性を評価する研究
常染色体優性多発性嚢胞腎（ADPKD）は、腎臓に液体が貯留した嚢胞が形成される腎疾患の最も一般的な遺伝的原因です。本試験の目的は、成人被験者におけるADPKD治療におけるABBV-CLS-628の安全性と有効性を評価することです。 ABBV-CLS-628は、ADPKD治療薬として開発中の治験薬です。被験者は、治療群と呼ばれる4つのグループのいずれかに分けられます。各グループは異なる治療を受けます。被験者がプラセボに割り付けられる確率は4分の1です。世界約100の施設で、約240名のADPKD成人被験者が登録されます。 被験者は、92週間にわたり、4週間ごとにABBV-CLS-628またはプラセボを静脈内投与されます。被験者は最大15週間追跡されます。 この試験の参加者は、標準治療と比較して治療負担が大きくなる可能性があります。試験期間中、参加者は定期的に病院またはクリニックを受診していただきます。治療の効果は、医学的評価、血液検査、副作用の確認、アンケートへの回答によって確認されます。
重症化リスクの高いRSウイルス（RSV）感染の症状のある入院していない成人を対象としたS-337395の試験
The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.
遺伝子変異（PIK3CA）を有する進行乳がん患者を対象としたLY4064809（テルソリシブ）と他の抗がん剤治療の併用試験
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
転移性腎細胞癌における超低分割放射線療法と免疫療法のアブスコパル効果
The goal of this multicenter observational study is to elucidate the clinical and immunological characteristics of the abscopal effect in patients with metastatic renal cell carcinoma (mRCC) receiving immune checkpoint inhibitors (ICI) combined with image-guided ultra-hypofractionated radiotherapy (IGU). The main questions this study aims to answer are: What is the abscopal response rate (ARR) at one year after IGU in patients continuing ICI treatment? What clinical and immunological factors are associated with the occurrence and timing of the abscopal effect? Participants are patients with mRCC who have experienced immune-confirmed stable or progressive disease during ICI therapy and are scheduled to receive IGU to a selected lesion. Researchers will observe tumor responses at irradiated and non-irradiated sites using standard imaging (CT/MRI) and collect clinical and laboratory data at baseline, 3, 6, 9, and 12 months after IGU. Optional exploratory blood samples will be obtained for cytokine analysis (e.g., IFN-β, IFN-γ, TNF-α, IL-6). The primary outcome is the abscopal response rate (ARR) at one year after IGU. Secondary outcomes include tumor shrinkage rate of irradiated and non-irradiated lesions, 1-year overall survival, disease-specific survival, and progression-free survival. This study seeks to establish a foundation for developing combined immunotherapy and ultra-hypofractionated radiotherapy strategies for metastatic renal cell carcinoma. \*This study is led by Prof. Hiroshi Onishi (University of Yamanashi). The registry entry is managed by Dr. Zhe Chen on behalf of the study group.
FSHD患者におけるデルブラックス（AOC 1020とも呼ばれる）の評価研究
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)
中等度から重度の活動性潰瘍性大腸炎患者におけるドゥバキトゥグの有効性と安全性を調査するための導入試験
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
クレオパトラ：トランスサイレチンアミロイド（ATTR）アミロイドーシスによる心不全患者におけるコラミツグ（NNC6019-0001）と呼ばれる薬剤による治療効果を調査する研究
This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.
ステロイド依存性潰瘍性大腸炎患者におけるオザニモドの有効性
The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan
肝細胞癌の第一選択治療として、リルベゴストミグとベバシズマブ（トレメリムマブの有無を問わず）の併用療法の第III相試験
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
再発性/転移性頭頸部癌患者における標準治療薬（SOC）へのアミバンタマブ追加投与とSOC単独投与との比較試験
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.
MTAP欠失ホモ接合体を有する、治療歴のある進行性または転移性非小細胞肺癌（NSCLC）患者を対象としたBMS-986504の試験（MountainTAP-9）
この研究の目的は、以前の治療で病勢進行したホモ接合型 MTAP 欠失を伴う進行性または転移性非小細胞肺癌 (NSCLC) の参加者における BMS-986504 単独療法の安全性と有効性を評価することです。
切除不能肝外胆管癌に対する反復胆管内高周波アブレーション＋デュルバルマブ、ゲムシタビン、シスプラチン
This international, multicenter, open-label randomized controlled trial evaluates whether repeated endobiliary radiofrequency ablation (EB-RFA) improves overall survival in patients with unresectable extrahepatic cholangiocarcinoma undergoing first-line systemic therapy with durvalumab plus gemcitabine and cisplatin (GCD). Eligible patients will be randomized 1:1 to EB-RFA with plastic stent placement or standard plastic stenting alone. A scheduled second endoscopic session will be performed at 3 months in both groups (repeat EB-RFA only in the EB-RFA arm). The primary endpoint is overall survival. Secondary endpoints include time to recurrent biliary obstruction, progression-free survival, adverse events, and technical/clinical success.
非小細胞肺がん（NSCLC）におけるプラットフォーム研究
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
中等度から重度の慢性閉塞性肺疾患患者におけるAZD6793の効果を調査する研究
This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
PODOMOUNT-Basket：BI 764198が様々なタイプの腎臓病を持つ成人および青年に効果があるかどうかを検証する研究
This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.