治験一覧
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HER2発現進行乳がん成人患者におけるジシタマブ・ベドチンの研究
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer). This study is seeking participants who: * have breast cancer that is hard to treat and has spread in the body (advanced cancer) * have tumors that have HER2 on them * have received previous treatment for their advanced breast cancer All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein). Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks. The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.
ADHDの成人患者を対象としたEB-1020の長期試験
The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan
オフィスワーカーの腰痛に効くランバーサポートベルト
Background: Low-back pain (LBP) is common among office workers and can reduce productivity and quality of life. Lumbar support belts are commonly used to manage LBP, but their effectiveness specifically for office workers remains uncertain. Aim: This study investigates whether wearing a commercially available lumbar support belt (Guardner Belt) can reduce low-back pain, decrease physical fatigue during computer work, and improve perceived work performance among office workers with chronic low-back pain. Methods: Thirty office workers with chronic nonspecific low-back pain were randomly assigned to either wear the lumbar support belt during work hours for four weeks or continue usual activities without the belt. Participants' pain, fatigue, and work performance were assessed before and after the intervention period.
体性感覚活動の自己調節による人間の感覚運動統合の強化
The purpose of this study is to examine the functional and structural modification effects on the brain of a non-invasive experimental device applied to the head and forearms of healthy subjects during motor recall training. The experimental device used in this study is the Brain-Machine Interface (hereinafter referred to as BMI), which is under development in the principal investigator's laboratory. The BMI consists of an arithmetic unit that processes the results in real time using a personal computer, a depth ray that displays the results, a transcutaneous electrical stimulator that is driven based on the results of the arithmetic, and an exoskeletal motor assist device that is driven based on the results of the arithmetic.
ホモ接合MTAP欠失を有する転移性非小細胞肺癌の一次治療患者におけるBMS-986504とペムブロリズマブおよび化学療法の併用とプラセボとペムブロリズマブおよび化学療法の併用を比較する試験
The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion
リチウム、バルプロ酸、またはラモトリギンを服用している双極性I型障害患者における、混合症状の有無にかかわらず躁病の治療におけるKarXTの補助的有効性と安全性を評価する研究
この研究の目的は、双極性I型障害の参加者の躁病治療における補助的なKarXTの有効性と安全性を評価することです。
肺動脈性高血圧症患者を対象としたソタテルセプト(MK-7962)の臨床試験(MK-7962-031/LIGHTRAY EXTENSION)
Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH. A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight. This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.
EGFRチロシンキナーゼ(EGFR TKI)療法が奏効しなかったEGFR変異非小細胞肺癌に対するイザロンタマブ・ブレンギテカン(BMS-986507)とプラチナ製剤ペメトレキセドの併用療法を比較する試験(IZABRIGHT-Lung01)
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
重度の活動性GPAまたはMPA患者を対象としたラプカブタゲンオートロイセルを評価する第2相試験
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
栄養失調リスクのある高齢者を含む高齢者を対象としたPF-07258669と呼ばれる研究薬について知るための研究
The purpose of this study is to look at safety, tolerability, and pharmacodynamic effects (i.e. how the study drug affects your body) of PF-07258669 in older participants ((60 years to \<90 years) including those at risk of malnutrition. The study medicine PF-07258669 is being developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss. This is approximately a 26-week-long study with 9 visits to the study doctor and 4 telehealth visits (ie. visits by phone call). The study will include * Screening period for up to 4 weeks * Pre-treatment period of 2 weeks * Treatment period of 16 weeks : study drug (PF-07258669 or matching placebo) * Follow-up period of 4 weeks The study requires answering questionnaires and use of digital devices at home to measure blood pressure and physical activity. The study team will monitor how each participant is doing during the study
既治療進展期小細胞肺がん患者におけるサシツズマブ・ゴビテカンと標準治療の比較試験
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).
進行固形腫瘍患者におけるBMS-986504の安全性、忍容性および薬物濃度を評価する研究
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986504 in participants with advanced solid tumors.
CIDPの成人患者におけるエンパシプルバートとIVIgの有効性と安全性を評価する研究
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).
関節リウマチ患者における皮下MTX療法中のMTX-PG濃度の変化(COSMOS研究)
Methotrexate is known to exist intracellularly as methotrexate polyglutamate, which is formed by the addition of glutamic acid after absorption into the body. The objective of this study is to measure the concentration of methotrexate polyglutamate in red blood cells and peripheral blood mononuclear cells after initiating methotrexate treatment in patients with rheumatoid arthritis who have no prior history of using methotrexate (either subcutaneous or oral formulations). Additionally, we aim to examine changes in methotrexate polyglutamate concentrations when switching from oral methotrexate to subcutaneous Metoject, as well as to investigate the relationship between methotrexate polyglutamate concentration and the efficacy and safety of the treatment. Another objective of this study is to evaluate whether switching to subcutaneous Metoject allows for an increased maximum tolerable dosage while maintaining safety.
新潟県における心血管疾患患者の予後予測に関する研究
The goal of this observational study is to investigate the prognosis of cardiovascular disease in Niigata Prefecture. Specifically, it aims to clarify the current status of medical treatment for cardiovascular disease patients in regional cities in Japan, where the population is aging. With patient consent, the study will track long-term medical treatment progress using health insurance claim data recorded in Japan's unique social security system.
軽度から中等度のアルツハイマー病患者を対象としたONO-2020の研究
This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with mild to moderate Alzheimer's disease (AD). This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition in individuals with Alzheimer's disease dementia.
ビカドロスタット(BI 690517)とエンパグリフロジンの併用が心不全および左心室のポンプ機能低下患者に有効かどうかを検証する研究
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between 1 and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, must go to hospital due to heart failure, or die during the study. The time until these events are observed is compared between the treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
LY4268989(MORF-057)を中等度から重度の活動性潰瘍性大腸炎の成人患者にミリキズマブと併用投与した場合:
The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
局所進行子宮頸部腺癌に対する炭素イオン線治療と併用および併用後のペムブロリズマブ投与
The goal of this clinical trial is to learn if pembrolizumab works for cervical adenocarcinoma treat with concurrent chemo-carbon-ion radiaotherapy (CIRT). The main questions it aims to answer are: • Does concurrent chemo-CIRT with pembrolizumab improves 2-year progression-free survival (PFS), compared with concurrent chemoradiotherapy with conventional X-rays?
軟骨無形成症患者におけるKK8398の有効性と安全性の評価(AOBA試験)
This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia