治験一覧
8,963 件中 1561〜1580 件を表示
造血幹細胞移植（HSCT）または固形臓器移植（SOT）を受けた小児および青年におけるサイトメガロウイルス（CMV）感染症の治療におけるマリバビルの安全性、忍容性、薬物動態、および抗ウイルス活性を評価する研究
The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.
抗レトロウイルス療法（ART）によりウイルス学的抑制が得られたヒト免疫不全ウイルス1型（HIV-1）患者におけるドラビリン/イスラトラビル（DOR/ISL）への切り替え（MK-8591A-051）
The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.
オックスフォードリスク因子と非侵襲的画像診断研究
ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.
プログラム細胞死タンパク質1（PD-1）/プログラム細胞死リガンド1（PD-L1）治療歴のある進行食道がん患者を対象に、ペンブロリズマブ（MK-3475）併用の有無における治験薬の評価試験（MK-3475-06B）
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
視神経脊髄路症候群（NMOSD）の小児患者を対象としたラブリズマブIVの有効性と安全性に関する研究
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
アトピー性皮膚炎患者を対象とした研究薬（CIBINQO）について知るための研究。
The purpose of this study is to learn about the safety and effectiveness (how well the study treatment works) of the study medicine (CIBINQO) for the potential treatment of atopic dermatitis in people under Japanese medical practice.
統合失調症患者を対象としたSEP-363856の長期安全性および忍容性を評価する臨床試験
A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.
2歳から18歳未満の全身性重症筋無力症の小児におけるニポカリマブの試験
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.
日本人健康男性被験者に単回投与および反復投与した場合の、治験薬BAY2395840の安全性、身体への影響、および体内への侵入、体内通過、体外への排出経路を調べる研究
Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP). DNP is pain due to damage to the nerves in the extremities that can occur in patients with diabetes as a result of blood sugar levels being too high for too long. BAY2395840 works by blocking specific receptors. A receptor is a protein inside or on the surface of a cell that binds to a specific substance and causes a specific effect in the cell. BAY2395840 specifically blocks so-called bradykinin B1 receptor, whose activation is involved in inflammatory responses. This blockage may help to relieve pain and inflammation. BAY2395840 has already been studied in clinical studies with European people. However, data for Japanese people are still missing. The participants of this study do not benefit from this study. However, the study will provide information on how to use BAY2395840 in later studies with Japanese people. The main purpose of this study is to learn how safe the study drug BAY2395840 is and how it affects the body if given in single and in repetitive doses to Japanese healthy male participants. To answer this question, the researchers will collect and analyze the medical problems the participants have after taking BAY2395840 and that may or may not be related to the study treatments. These medical problems are also known as "adverse events". In addition, the study team will learn how BAY2395840 moves into, through and out of the body if given in single and in repetitive doses to Japanese healthy male participants. For this, the researchers will collect data on: * the (average) highest level of BAY2395840 in the blood (also referred to as Cmax) * the (average) total level of BAY2395840 in the blood (also referred to as AUC) during the treatment period with the study drug on day 1 and for the repetitive dose group only (see below), on day 7. Subsequently, the study team will compare the data between those participants who received the study drug BAY2395840 (from different dosing groups) and those participants who received placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. All study participants will be randomly (by chance) assigned to 1 of 5 treatment groups. Dependent on the treatment group, the participants will either take: * a single dose of the lowest, middle and highest BAY2395840 dose (treatment groups 1 to 3) * repetitive doses of the highest BAY2395840 dose (treatment group 4) or * placebo (treatment group 5). The participants will take their treatments as dosage form 1 after diet 1. The treatment period with repetitive doses of BAY2395840 will be 7 subsequent days. The participants from treatment groups 1 to 3 will have an in house-period of 8 days including 7 overnight stays. The participants from treatment group 4 will have an in house-period of 12 days including 11 overnight stays. The study duration will be approximately 6 weeks per participant for dose groups 1 to 3 and approximately 7 weeks per participant for dose group 4. During the study, the study team will: * take blood and urine samples * do physical examinations * check the vital signs such as blood pressure, heart rate, body temperature * examine heart health using electrocardiogram (ECG). About 10 to 14 days after the participants take their last treatment, the study doctors and their team will check the participants' health.
統合失調症の症状が十分にコントロールされていない被験者における補助的KarXTの有効性と安全性を評価する研究
This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
HER2陽性進行性または転移性胃癌および食道癌患者におけるザニダタマブと化学療法の併用とティスレリズマブの併用に関する研究
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
進行性肺腺癌の非喫煙者におけるLP-300とカルボプラチンおよびペメトレキセドの併用療法の研究
The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.
全身性重症筋無力症の成人患者におけるALXN1720の安全性と有効性
The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).
マルチモーダル時代における治療アプローチレジストリ
The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: * surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) * the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) * drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: * How many patients receive a given kind of treatment? * How do expert centers combine the different treatments? * Are patients doing better after they receive a given kind of treatment? * How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.
高レベルのα-フェトプロテインを産生する胆嚢の印環細胞を伴う低分化腺癌：症例報告
Alpha-fetoprotein (AFP) can become elevated in hepatocellular carcinoma (HCC), yolk sac tumors and other malignant tumors of various organs. Herein, the investigator present a case of AFP-producing gallbladder carcinoma with signet ring cells successfully treated with laparoscopic whole-layer cholecystectomy.
閉塞性睡眠時無呼吸マスタープロトコルGPIF：閉塞性睡眠時無呼吸患者におけるチルゼパチド（LY3298176）の研究
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.
慢性腎臓病患者における植物性タンパク質食の有効性
The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease.
フェニルケトン尿症患者を対象としたPTC923の長期安全性試験
The main purpose of this study is to evaluate the long-term safety of PTC923 in participants with phenylketonuria, and to evaluate the changes from baseline in dietary phenylalanine (Phe)/protein consumption.
肺炎球菌ワクチン接種経験のある成人におけるV116の安全性、忍容性、および免疫原性を評価するための研究（V116-006、STRIDE-6）
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
癌関連静脈血栓塞栓症（VTE）の治療におけるアベラシマブとアピキサバンの比較試験
This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)