治験一覧
8,963 件中 1〜20 件を表示
青年期の統合失調症および自閉症関連易刺激性の治療におけるKarXTおよびKarX-ECの長期安全性および忍容性を評価する研究
The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively
アラジール症候群（ALGS）および進行性家族性肝内胆汁うっ滞症（PFIC）患者を対象としたマラリキシバット（TAK-625）のデータベース研究
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). The main aim of the study is to evaluate the risk of liver disorder during the use of maralixibat in Japanese patients with ALGS or PFIC. This database study will conduct in use of medical database called Comprehensive and Informative Registry system for Childhood Liver Disease (CIRCLe).
高血圧が十分にコントロールされておらず、心血管疾患の既往または心血管疾患の高リスクを有する患者におけるジレベシラン
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
人工心肺（CPB）を用いた複雑な心血管手術を受ける成人患者における4F-PCC（4因子プロトロンビン複合体濃縮物）の有効性と安全性
This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular surgery with CPB. The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing complex cardiovascular surgery with CPB.
人工膝関節全置換術後の膝の体の知覚と痛み
This observational study aims to better understand how knee pain and knee-specific body perception are related over time after total knee arthroplasty (knee replacement) for knee osteoarthritis. Although most people improve after surgery, some continue to experience ongoing pain. Disturbed body perception such as feeling that the knee is less clear, less familiar, or difficult to "sense" or "control" as usual-has been linked to chronic musculoskeletal pain, but the timing of its relationship with postoperative pain after knee replacement is not well understood. Adults undergoing primary total knee arthroplasty at Fukuoka Orthopaedic Hospital will be invited to participate. Participants will be asked to complete brief self-report questionnaires about (1) knee pain intensity during movement, (2) knee pain intensity at rest, and (3) knee-specific body perception (how the knee feels and is perceived). Pain intensity will be recorded using 100-mm visual analogue scales, and knee-specific body perception will be assessed using a validated questionnaire. Questionnaires will be completed before surgery (within one week prior) and at 1, 3, 6, and 12 months after surgery. All surgical and rehabilitation care will be provided as part of usual clinical practice. Participation in this study involves completing questionnaires only and does not change clinical care. The study will examine whether within-person changes in knee body perception are associated with later changes in pain intensity across the first postoperative year, while also accounting for stable differences between individuals. Information from this study may help identify potentially modifiable factors associated with persistent pain after knee replacement and may inform future research on rehabilitation strategies that target body perception and related sensorimotor processes. Study data will be handled confidentially in accordance with institutional policies, and analyses will be conducted on de-identified data whenever possible.
統合失調症の成人患者を対象としたブレニパチドの研究
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia. The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.
BI 3000202の異なる用量が全身性エリテマトーデス（SLE）患者に効果があるかどうかを検証する研究
This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.
週1回のインクレチン投与を受けている持続性肥満患者におけるエロラリンタイド（LY3841136）の試験
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.
固形腫瘍またはリンパ腫を有する日本人小児患者およびメルケル細胞癌を有する日本人成人患者を対象としたペムブロリズマブの試験（MK-3475-G21/KEYNOTE-G21）
Researchers are looking for new ways to treat people with solid tumors, lymphomas (blood cancers), and a certain type of skin cancer. The goals of this study are to learn: * About the safety of pembrolizumab (the study medicine) and if people tolerate it * What happens to different doses of pembrolizumab in a person's body over time * How the cancer responds (gets smaller or goes away) to treatment
TAMBEジャパン市販後調査
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
急性精神病性統合失調症患者におけるSEP-363856の有効性と安全性の試験
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
J-Valve経大腿動脈ピボタル研究
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.
既治療の局所進行性または転移性胆管癌患者におけるイボシデニブの早期アクセス試験
A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.
2型糖尿病患者における薬剤NNC0662-0419の異なる投与量による血糖値低下効果を比較した研究
This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
中等度から重度の活動性潰瘍性大腸炎の成人におけるLY4268989
The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.
MDT-0123 日本研究
The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two levels (ALIF or OLIF) due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1) for intervertebral support and correction with the aim of stabilizing the spine.
大うつ病性障害の成人患者を対象としたブレニパチドの研究
This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
GIST治療におけるEFTRとSTERのRCT
Endoscopic resection has been increasing utilized as the treatment for small size gastrointestinal stromal tumors (GIST), of which the best resection method has not been identified. We aim to compare the outcomes of endoscopic full thickness resection (EFTR) versus submucosal tunnelling endoscopic resection (STER) for clinical small gastric GIST. We hypothesize that EFTR could achieve better complete margin negative resection than STER without increase in adverse event. This is an international multi-center double blinded randomized controlled trial involving four high volume centers from Hong Kong, mainland China, India and Japan. Adult patients with clinical 1.0-3.Scm gastric GIST undergoing endoscopic resection would be recruited. Patients would be randomized to undergo EFTR (intervention) or STER (Control) by expert endoscopists under general anaesthesia according to well published methods.
中等度から重度のアトピー性皮膚炎患者を対象としたJNJ-95597528の研究
The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD).
ゾダシランの第3相臨床試験（ヨセミテ試験）
This multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of zodasiran subcutaneous (SC) injection in subjects 12 years of age and older with genetically or clinically diagnosed Homozygous familial hypercholesterolemia (HoFH). After completion of the double blind (DB) treatment period subjects will be eligible to continue in the optional open-label extension (OLE) period of the study. All placebo subjects who opt to continue will transition to active drug during the OLE Period.