治験一覧
8,963 件中 2201〜2220 件を表示
重症RSウイルス感染症（RSV）リスクの高い乳児および小児におけるクレスロビマブ（MK-1654）（MK-1654-007）
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
1型糖尿病患者を対象に、新しい週1回投与インスリン「インスリン・イコデック」と既存の1日1回投与インスリン「インスリン・デグルデック」を食事時インスリンと併用した場合の効果を比較する研究（ONWARDS 6）
This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken. At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
神経変性疾患患者における咽喉機能の系統的評価
This is a non-interventional observational study designed to systematically record the results of routine laryngeal examinations and specific characteristics of dysphagia in patients with neurodegenerative disorders. The results of a fiberoptic / flexible endoscopic evaluation of swallowing (FEES) while performing a structured task protocol will be recorded. If available, laryngeal electromyography (EMG) results will also be recorded. In addition to the examination results, demographic and disease-specific data are collected, and two questionnaires, the Swallowing Disturbance Questionnaire for Parkinson's Disease (SDQ-PD) and the swallowing specific Quality Of Life Questionnaire (SWALQOL), are administered.
インスリン・イコデックとセマグルチドの配合剤である新しい週1回服用薬イコセマが、インスリン・アスパルトと併用して毎日服用するインスリン・グラルギンと比較して、2型糖尿病患者の血糖値をどの程度コントロールできるかを調査する研究（COMBINE 3）
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
原発性シェーグレン症候群（pSS）の成人患者におけるニポカリマブの研究
The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.
iNHL患者を対象としたザンデリシブ（ME-401）とリツキシマブの併用療法に関する第3相試験 - (COASTAL)
This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
日本人を対象としたJNJ-75220795の研究
The purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants.
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.
原発性自然気胸患者の術後再発を減らすための最も予防可能な外科的選択肢：前向きコホート研究
To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.
粘膜下層への注入にゲルとグリセロールを用いた内視鏡的粘膜下層剥離術
The EPSILON study aims to comparatively evaluate the submucosal injection using ORISETM gel and glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
進行性褐色細胞腫/傍神経節腫（PPGL）、膵神経内分泌腫瘍（pNET）、フォン・ヒッペル・リンドウ（VHL）病関連腫瘍、進行性消化管間質腫瘍（wt GIST）、またはHIF-2α関連遺伝子変異を伴う固形腫瘍の治療のためのベルズチファン/MK-6482（MK-6482-015）
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
進行がん（NRAS/KRAS遺伝子変異陽性）の様々な病型を有する日本人を対象に、BI 3011441の異なる投与量を試験する研究
This study is open to Japanese adults with different types of advanced cancer that are positive for NRAS/KRAS mutations. This is a study in people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find the highest dose of BI 3011441 that Japanese people with advanced cancer can tolerate. BI 3011441 is a medicine that may turn off a signal by NRAS/KRAS that makes tumours grow. Participants take BI 3011441 as capsules once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors collect information on any health problems of the participants.
臨床現場における卵巣癌患者に対するニラパリブの研究
The main aim of this study is to check for side effects from treatment with niraparib. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.
進行性または転移性胃がんまたは食道がんの治療歴のある患者を対象としたアミバンタマブの研究
The purpose of this study is to investigate the activity of amivantamab in gastric cancer (GC) and esophageal cancer (EC) participants (Phase 2a), and to characterize the preliminary antitumor activity of amivantamab in selected GC and EC population (Phase 2b).
進行・再発大腸がん患者を対象としたPARADIGM探索研究（NCT02394834）のデータの追加解析
The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer. In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.
長野県立小児病院における家族中心ケアコホート研究1
An observational cohort study to show the effect of parents' presence beside their infants, skin-to-skin contact (SCC), participation in infant care, or any interaction with their infants on parents' and infants' short- and long-term outcomes. Investigators create a hypothesis that longer parents' presence, SCC, participation in infant care, and any interaction with their infants affect outcomes of infants and parents by preventing parents' depression and promoting parent-infant bonding and, in addition, by shortening the length of stay, promoting growth, promoting establishment breastfeeding, and improving developmental outcomes. Parents are asked to make a record of the length of their presence, SCC, participation in infant care, and any interaction with their infants, which are quantitative measurements of family centered care (FCC). Investigators also collect the data related to the background information of the family, delivery, the clinical course of infants, and the outcome measures of the infants and parents. No intervention is included in this research. The study setting is a level IV neonatal intensive care unit (NICU) at Nagano Children's Hospital in Nagano, Japan. Eligible infants are those who are born at 34 weeks of gestation or earlier from Japanese parents in Nagano Children's Hospital and need admission into NICU in the same hospital. Infants are excluded from this study if they have any major anomalies including suspicion of chromosomal disorder on admission, if at least one parent is Not Japanese, or if they do not survive until discharge home. The primary outcomes are the EPDS and Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) of the parents. The secondary outcomes are the followings; (1) length of stay (days), (2) physical measurements at 36 weeks (g or cm) and growth rate from birth to discharge home (g or cm /d), (3) breastmilk-feeding (exclusive, partial, or no breast milk) and the frequency of breastfeeding directly from breast at 36 weeks PMA and at discharge (average frequency per day), and for the infants whose birth weight \<1500g only, (4) developmental quotient (DQ) at 6 and 18 months of corrected age, and 3 years old assessed by Kyoto Scale of Psychological Development (KSPD).
日本における転移性去勢抵抗性前立腺癌に対する177Lu-PSMA-617の研究
The purpose of this study is to assess the efficacy, tolerability, safety, pharmacokinetic (PK) and dosimetry of 177Lu-PSMA-617, in participants with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in Japan. Furthermore, the safety, PK and dosimetry of 68Ga-PSMA-11 (PSMA imaging agent) are assessed in the same study. Another purpose of this study is to provide humanistic perspective access to study treatment (68Ga-PSMA-11 and 177Lu-PSMA-617) for the eligible patients with PSMA-positive mCRPC until marketed products are available in Japan. Furthermore, if data availability PK and dose rate of 177 Lu-PSMA-617 will be evaluated to refine discharge criteria in Japan. After obtaining manufacturing and marketing approval in Japan, this clinical trial will continue as a post marketing trial.
治療に反応した後に再発した多発性骨髄腫患者、または治療に反応しなかった患者を対象に、治験薬（エルラナタマブ）について知るための研究
The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.
慢性炎症性脱髄性多発根神経炎（CIDP）および多巣性運動神経障害（MMN）の日本人患者を対象としたTAK-771の試験
The main aim of the study is to check for side effects from TAK-771, and to check how well TAK-771 controls symptoms in Japanese participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) The participants will be treated with TAK-771 for 45 months as a maximum. There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 2, 3, or 4 weeks).
ウィルソン病の小児患者を対象としたALXN1840と標準治療の比較研究
This study is being conducted to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease (WD).