治験一覧
8,963 件中 2301〜2320 件を表示
早期アルツハイマー病患者におけるセマグルチドの有効性に関する研究（EVOKE Plus）
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
発作性夜間ヘモグロビン尿症患者におけるイプタコパンの長期安全性および忍容性
This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan
INCB054707の安全性、忍容性および薬物動態を評価するための研究
This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.
進歩：臨床監視またはTAVRによる中等度大動脈弁狭窄症の管理
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
転移性大腸癌（mCRC）の2L治療におけるNIS793とその他の新規治験薬とSOC抗癌剤の併用療法に関する研究
The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC. This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.
慢性リンパ性白血病（CLL）/小リンパ球性リンパ腫（SLL）の未治療患者におけるピルトブルチニブ（LOXO-305）とベンダムスチン+リツキシマブ（BR）の併用療法を比較する試験
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
健康な日本人成人を対象としたTAK-919の臨床試験（COVID-19）
TAK-919 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-919 can protect people from Covid-19 and to check for side effects from TAK-919. At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-919 or a placebo in their arm. In this study, a placebo will look like the TAK-919 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-919 than placebo. Participants will receive 2 injections of TAK-919 or placebo, 28 days apart. Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection. During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have visited their clinic 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19. The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-919 or the placebo.
発作のある小児および青年におけるブリバラセタムの安全性と忍容性を試験する研究
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
慢性腎臓病患者におけるアベンシグアト（BI 685509）の異なる投与量が腎機能に及ぼす影響を検証する研究
This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.
ジンマーバイオメット肩関節形成術 PMCF
The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.
AZD7442の第I相二重盲検プラセボ対照試験
AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.
高安動脈炎（TAK）患者を対象としたウステキヌマブの研究
The purpose of this study is to evaluate the efficacy of ustekinumab compared to placebo, in combination with oral glucocorticoid (GC) taper regimen, in participants with relapsing Takayasu Arteritis (TAK).
心不全患者における超音波腎神経遮断システムの臨床研究
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
慢性腎臓病（CKD）および高カリウム血症を有する、または高カリウム血症のリスクがある参加者におけるジルコニウムシクロケイ酸ナトリウムの慢性腎臓病（CKD）進行に対する効果を評価する研究
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate \[eGFR\] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.
COMIRNATY筋注の薬物使用調査
Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.
ROS1陽性NSCLCを対象としたタレトレクチニブの第2相国際共同試験
The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
皮膚筋炎の成人患者におけるラブリズマブとプラセボの比較
This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).
健康な日本人男性におけるセマグルチドと併用した薬剤NNC0480-0389の体内での作用に関する研究
This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).The study includes blood sampling.
終末期の話し合いを早期に開始するための共感的コミュニケーション促進プログラム
Background: The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: palliative care recommends discussing advance care planning (ACP) when patients' estimated life expectancy is reduced from a year to months. Discussions about ACP focus on communication among patients, their caregivers, and healthcare providers to achieve cancer-related treatment and care consistent with the patient's preferences based on their values and goals. ACP can improve outcomes for patients and caregivers; however, provision of ACP to patients remain low. This may be because of the complexity of ACP in clinical practice. A Question Prompt List (QPL) is a structured question list encouraging patients to put forward their queries to physicians and promote discussion between patients and physicians during medical consultations. Our preliminary study found that for patients with advanced cancer after standard chemotherapy, face-to-face interventions by nurses or clinical psychologists using a QPL about treatment and care, which is consistent with the patient's preferences based on their values and goals promoted empathetic communication between patients and their physicians. In recent years, however, ensuring adequate time during outpatient visits has become difficult due to increased numbers of outpatients and shortages of corresponding medical personnel. Therefore, intervention methods not restricted by location or time are needed. Thus, the investigators develop a mobile-based empathetic communication support program, including a QPL, to facilitate discussions about patients' values and goals with their physicians. Purpose: This study examines whether a mobile-based empathetic communication support program, which intends to promote ACP discussions in earlier stages of advanced cancer treatment, improves such communication behaviors of patients with advanced cancer and their physicians. Main contents of the intervention: Patients in the intervention group are provided a mobile-based empathetic communication support program-a mobile application (app). The app comprises a QPL (46 questions in eight categories) and questions about the patient's preferred treatment and end-of-life care based on their values and goals. After registering on the app, patients are first given a program overview and instructions for using the app. Then, they proceed with the content themselves, at home or anywhere else, at any time. Between app registration and the next outpatient visit, the patient is interviewed (by phone or in person) by a nurse or a clinical psychologist, who helps them prepare for the discussion with the physician and asks questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, patients and their physicians are provided feedback based on the interview. Study participants: Overall, 264 patients with advanced or recurrent cancer are recruited from four departments (respiratory medicine, gastroenterology, hepatobiliary medicine, and oncology) in the outpatient clinic of the National Cancer Center Hospital, Japan. Outcome measurement: The primary outcome of this trial is the Reassurance and Emotional support score of physician behavior measured using the SHARE model at the first visit after the intervention. SHARE is a conceptual communication skills model comprising 26 items and four subscales, categorized as S: Supportive environment, H: How to deliver bad news, A: Additional information, and RE: Reassurance and Emotional support. Reassurance and Emotional support assesses physicians' behavior in providing reassurance and addressing patients' emotions with empathetic responses (e.g., remaining silent out of concern for patient's feelings or accepting patient's expression of emotions). The conversation between patients and the physicians is audio-recorded, and a third person's impression of the physician's communication behavior during the outpatient consultation is scored on a 5-point scale from 0: not applicable at all to 4: strongly applicable. Scoring will be conducted by multiple raters blinded to the assignment. Raters are trained in conversation analysis with a manual, and inter- and intra-rater agreements will be checked in advance. Secondary outcomes are as follows: 1) the patient-physician behavioral assessment based on the conversation analysis manual, 2) number of conversations about ACP, 3) psychological distress, 4) quality of life, 5) medical care use, 6) app use, 7) feasibility of intervention program, 8) patients' satisfaction of the consultation, 9) care goals, and 10) preferred place for future care. The investigators chose these outcomes for their comparability with previous studies.
局所進行性または転移性固形腫瘍（増殖を伴う）患者における LUNA18 の用量漸増試験。
This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18 when administered as a single agent or in combination with other anti-cancer drugs in patients with locally advanced or metastatic solid tumors.