治験一覧
8,963 件中 1421〜1440 件を表示
エザベンリマブと併用したオブリキスタミグ（BI 764532）の異なる用量が、DLL3陽性の小細胞肺がんおよびその他の神経内分泌腫瘍の患者にどの程度忍容されるかを検証する研究
This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of obrixtamig that people can tolerate when taken together with another medicine called ezabenlimab. Obrixtamig and ezabenlimab may help the immune system fight cancer. Participants get obrixtamig and ezabenlimab as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.
メタバース空間を利用した運動動画配信の若年成人における有効性
This study explored whether exercise video distribution using metaverse space is effective in increasing physical activity among young people, along with mental health and locomotive function. This is a randomized parallel-group study. Participants will be assigned to 3 groups: a metaverse group, a YouTube group, and a control group. The metaverse group will receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will receive access to the same exercise videos as the metaverse group. The control group was given no specific instructions. The intervention period was 8 weeks, and physical activity and other items were measured before and after the intervention. These pre- and post-intervention measurements will be used to determine whether the delivery of exercise videos via Metaverse is effective in increasing physical activity in young adults.
DAREON™-5：BI 764532の異なる用量が小細胞肺がんやその他の神経内分泌がんの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 small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 2 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2, all participants receive the same dose of BI 764532. Part 2 is open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma. All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.
X連鎖性網膜色素変性症の日本人患者に対するAAV5-hRKp.RPGRの治療研究
The purpose of the study is to assess the safety and tolerability of bilateral subretinal delivery of adeno-associated virus vector with a serotype 5 capsid human rhodopsin kinase promoter. retinitis pigmentosa guanosine triphosphatase regulator (AAV5-hRKp.RPGR).
局所進行または転移性チロシンキナーゼ阻害剤（TKI）未治療のROS1陽性非小細胞肺癌（NSCLC）患者を対象としたレポトレクチニブとクリゾチニブの比較試験（TRIDENT-3）
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
肥大型心筋症患者の健康関連QOLを評価する研究
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.
進行KRAS G12C変異非小細胞肺癌患者におけるオロモラシブ（LY3537982）とペムブロリズマブの併用療法（化学療法併用または非併用）の第一選択薬としての研究
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
日本人および外国人男性を対象とした新薬NNC0519-0130の調査研究
NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.
重症喘息の5歳から12歳未満の小児におけるテゼペルマブの有効性と安全性をプラセボと比較する試験
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
骨髄増殖性腫瘍患者におけるINCA033989の単独療法またはルキソリチニブとの併用療法を評価する研究
This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
ループス腎炎の青年および小児患者におけるボクロスポリン長期治療
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric subjects with lupus nephritis.
SEP-363856が全般性不安障害の成人にどの程度効果があり、どの程度安全であるかを測定する臨床試験
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.
ヒドロキシウレア（MK-3543-006）に対する反応不十分または不耐性を有する本態性血小板血症患者におけるボメデムスタット（IMG-7289/MK-3543）と最善の利用可能な治療法（BAT）の比較試験
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
活動性シェーグレン症候群の成人患者におけるデュクラバシチニブの有効性と安全性を評価する研究
この研究の目的は、活動性シェーグレン症候群の成人参加者におけるデュクラバシチニブの2回投与の安全性と有効性を評価することです。
白斑治療におけるMK-6194の臨床試験（MK-6194-007）
Researchers are looking for a new way to treat people with non-segmental vitiligo (NSV). The goal of this study is to learn about the safety of MK-6194 and how well people tolerate it. Researchers also want to learn if people who take MK-6194 have more of a decrease in the amount of vitiligo on their face compared to people who take placebo.
EGFR遺伝子変異またはその他のゲノム異常を有する、既治療の進行または転移性非扁平上皮非小細胞肺癌（NSCLC）におけるサシツズマブ チルモテカン（MK-2870）と化学療法の比較（MK-2870-004）
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
肥満症を患う日本人患者にサボデュチドが効果があるかどうかを検証する研究
This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 35 kg/m² or more and at least one health problem related to their weight, or * a BMI of 27 kg/m² or more and at least two health problems related to their weight. People who have either type 2 diabetes, high blood pressure, or increased blood lipids can take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with obesity disease to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.
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.
イムフィンジ/イムジュドNSCLC日本PMS_日本市販後調査（PMS）研究 - CEI/SCEI
To collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer who receive combination therapy of IMJUDO, IMFINZI and other platinum-based anti-cancer agents under actual use in the postmarketing setting.
日本の中等症から重症の潰瘍性大腸炎（UC）成人患者を対象としたリンヴォックの疾患活動性および有害事象の変化を評価する観察研究
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective Rinvoq is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Rinvoq is a drug approved for the treatment of ulcerative colitis (UC). All study participants will receive Rinvoq as prescribed by their study doctor in accordance with approved local label. Approximately 300 adult participants will be enrolled in Japan. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 60 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.