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非小細胞肺がん(NSCLC)における新規併用療法の研究

募集中NCT07098338第2相

This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.

対象疾患:
非小細胞肺がん

REVEAL: アンジェルマン症候群におけるION582の第3相試験

募集中NCT06914609第3相

The purpose of this study is to evaluate the efficacy and safety of ION582 in children and adults with Angelman syndrome caused by a deletion or mutation of the UBE3A gene.

対象疾患:
アンジェルマン症候群

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

募集中NCT06803823第2相

To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.

対象疾患:
Agitation Associated With Alzheimer's Disease Dementia

切除済みまたは切除不能なKRAS G12C変異非小細胞肺癌患者におけるオロモラシブ(LY3537982)と標準治療の併用試験

募集中NCT06890598第3相

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

対象疾患:
非小細胞肺癌

転移性前立腺癌患者におけるイフィナタマブ デルクステカン(I-DXd)の臨床試験(MK-2400-001)

募集中NCT06925737第3相

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,

対象疾患:
前立腺がん前立腺腫瘍

成人T細胞白血病/リンパ腫患者を対象としたOJP-001の第I/II相試験

募集中NCT07075328第1/第2相

This study aims to evaluate the tolerability of OJP-001, a therapeutic system combining photodynamic therapy (PDT) using OMD-001 and extracorporeal circulation therapy using OJE-001 and OJC-001, in patients with adult T-cell leukemia/lymphoma (ATL). The study will also investigate the recommended dose and pharmacokinetics of OMD-001, as well as the efficacy and safety of OJP-001.

対象疾患:
Adult T-Cell Leukemia/Lymphoma (ATLL)

中等度から重度の活動性潰瘍性大腸炎(UC)患者におけるRO7837195の有効性、安全性、および薬物動態(PK)を評価する研究

募集中NCT06979336第2相

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

対象疾患:
潰瘍性大腸炎

成人における全膝関節置換術後の血栓予防におけるREGN7508とアピキサバンおよびエノキサパリンの比較

募集中NCT07015905第3相

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after total knee replacement surgery. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

対象疾患:
静脈血栓塞栓症(VTE)

FRα高発現卵巣癌におけるAZD5335とミルベツキシマブ・ソラビタンシン、およびFRα低発現卵巣癌におけるAZD5335と化学療法の比較

募集中NCT07218809第3相

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

対象疾患:
Epithelial Ovarian Cancer

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

募集中NCT07347665該当なし

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.

対象疾患:
Acute Ischemic StrokeAcute Ischemic Stroke (AIS) Related to a Distal OcclusionEndovascular Therapy

薬剤耐性肺結核の治療におけるクアボデピスタット含有レジメンの研究

募集中NCT07209761第3相

This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.

対象疾患:
Pulmonary Tuberculosis

KMT2Ar、NPM1m、またはHOX過剰発現に関連する他の遺伝子型を有する進行性血液悪性腫瘍患者におけるAZD3632単独療法または抗癌剤との併用療法の研究

募集中NCT07155226第1/第2相

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.

対象疾患:
Acute Lymphoblastic LeukaemiaAcute Myeloid LeukaemiaHigher-risk Myelodysplastic Syndromes

臨床的にASCVDを発症した患者または初回ASCVD発症リスクのある患者におけるAZD0780のLDL-Cに対する効果を評価する第III相試験

実施中(募集終了)NCT07000123第3相

This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C. 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.

対象疾患:
Cardiovascular Disease

血液透析患者を対象としたTS-172の非盲検薬物動態試験

完了NCT06849778第1相

A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis

対象疾患:
Patients on Hemodialysis

喫煙を止め、再発を避けたい成人を対象としたブレニパチドの研究

募集中NCT07223840第2相

This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. Study participation will last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period. .

対象疾患:
Smoking

パイロットスタディ:CCP介入がNICU環境と早産児の発達に及ぼす影響

募集中NCT07306000該当なし

Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.

対象疾患:
Preterm Infant DevelopmentPreterm Infant Health

進行期小細胞肺癌患者を対象としたALPS12の第I相試験

募集中NCT07107490第1相

This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.

対象疾患:
Extensive Stage Small Cell Lung Cancer

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。

募集中NCT07016997第1相

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.

対象疾患:
Refractory CancerSolid Tumors

BI 764198が巣状分節性糸球体硬化症(FSGS)と呼ばれる腎臓疾患の成人および青年に効果があるかどうかを調べる研究

募集中NCT07220083第3相

This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS. Participants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. 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 up to 2 years. All participants also continue their standard medication for FSGS. Participants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. 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.

対象疾患:
局所性分節性糸球体硬化症

代謝機能障害関連脂肪肝疾患の成人における多剤併用療法のマスタープロトコル(SYNERGY-Outcomes)

募集中NCT07165028第3相

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.

対象疾患:
Metabolic Dysfunction-Associated Steatotic Liver Disease