治験一覧
8,963 件中 3121〜3140 件を表示
慢性副甲状腺機能低下症の日本人患者を対象としたrhPTH(1-84)治療の臨床研究
This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH\[1-84\]) in Japanese participants with chronic hypoparathyroidism for a 26-week period.
研究20090の被験者の長期的転帰を評価するための延長研究
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
進行性および/または切除不能胆道癌（BTC）の一次治療におけるペムブロリズマブ（MK-3475）+ゲムシタビン/シスプラチンとプラセボ+ゲムシタビン/シスプラチンの比較（MK-3475-966/KEYNOTE-966）
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
B細胞悪性腫瘍患者におけるザヌブルチニブ（BGB-3111）療法の長期継続試験
The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.
慢性B型肝炎ウイルス感染症の治療におけるJNJ-73763989および/またはJNJ-56136379を含む様々な併用療法に関する研究
The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.
HVPG測定の周術期管理（CHESS1904）：国際多施設共同調査
Hepatic venous pressure gradient (HVPG) is an invasive test and requires technical skills of the operator and specialized instruments. HVPG measurement and anesthesia can cause stress responses in the body, which in turn lead to inflammatory response and immune function suppression. Thus, the perioperative care for patients undergoing HVPG measurement is crucial. This research trial studies comprehensive patient and medical worker questionnaires in predicting complications in patients with cirrhosis undergoing HVPG measurement. Comprehensive patient and medical worker questionnaires may help identify complications, such as the need for assistance in taking medication, decreased mobility and released tension that may improve outcomes.
片頭痛を患う6歳から17歳の小児を対象としたラスミジタン（LY573144）の研究
The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. The study will last about 6 weeks, and includes 4 visits.
転移性非扁平上皮非小細胞肺癌（NSCLC）の一次治療（1L）におけるペムブロリズマブと維持療法オラパリブまたは維持療法ペメトレキセドの併用試験（MK-7339-006、KEYLYNK-006）
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
2型糖尿病および慢性腎臓病患者におけるセマグルチドの有効性をプラセボと比較する研究
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.
パルスフィールドアブレーションによる組織への不可逆的な電気穿孔と心房細動の治療
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.
重度または非常に重度の円形脱毛症の成人患者を対象としたバリシチニブ（LY3009104）の研究
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
ASP-1929光免疫療法（PIT）試験：少なくとも2種類の治療に失敗した再発性頭頸部がん患者を対象とした研究
A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy
原発性免疫血小板減少症（ITP）の成人患者におけるエフガルティギモドの有効性と安全性を評価する研究。
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
特定の悪性腫瘍におけるTNO155とスパルタリズマブまたはリボシクリブの併用療法の第Ib相試験
This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.
中等度から重度の潰瘍性大腸炎患者におけるデュクラバシチニブの安全性と有効性
The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
膵臓がん成人患者におけるゾルベツキシマブ（IMAB362）の研究
Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Zolbetuximab is a potential treatment for people with pancreatic cancer. There is an unmet medical need to treat people with pancreatic cancer. This study will help find the dose of zolbetuximab to be used with chemotherapy and provide more information on this treatment in adults with metastatic pancreatic cancer. The study is currently ongoing globally. People in this study will be treated with either zolbetuximab and chemotherapy or chemotherapy by itself. The study's main aims are to find a suitable dose of zolbetuximab to be used with chemotherapy in the second part of this study, to check if zolbetuximab and chemotherapy compared to chemotherapy by itself can improve the survival of people with pancreatic cancer, and to check the safety of zolbetuximab when given with chemotherapy and how well people cope with medical problems during the study. Adults with metastatic pancreatic cancer can take part. Their cancer is metastatic, has the CLDN18.2 marker in a tumor sample and has not previously been treated with chemotherapy. Metastatic means the cancer has spread to other parts of the body. People cannot take part are if they have recently had radiotherapy and have not recovered, need to take medicines to suppress their immune system, have history of nervous system metastases from their pancreatic cancer, or they have other active cancers that need treatment. People who have a specific heart condition or infections also cannot take part. This study will be in 2 parts. Part 1 is called the Safety Lead-in Phase. Groups of people will receive 1 of 2 different doses of zolbetuximab: a lower dose or a higher dose, both together with chemotherapy. A medical expert panel will check the results and decide the dose to use in Part 2. Part 2 is called the Randomization Phase. People will be put in 1 of 2 groups by chance and will be given different treatments either zolbetuximab and chemotherapy or chemotherapy by itself. The chance of receiving zolbetuximab and chemotherapy is twice as high as receiving chemotherapy by itself. In both parts of the study, zolbetuximab and chemotherapy or chemotherapy by itself will be given through a vein. This is called an infusion. Each treatment cycle is 4 weeks (28 days) long and people will have either 2 infusions of zolbetuximab and 3 infusions of chemotherapy or 3 infusions of chemotherapy by itself during each treatment cycle. People will visit the clinic on certain days during their treatment. The study doctors will check for any medical problems from zolbetuximab. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken before treatment if a previous sample is not available. People will have the option of giving a tumor sample after treatment has finished. People will visit the clinic after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
健康な日本人男性におけるヒトサイトメガロウイルス（CMV）ワクチン（V160）の安全性および免疫原性（V160-003）
The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
ステージIII-IVまたは再発性子宮内膜がんにおける通常の化学療法（パクリタキセルおよびカルボプラチン）への免疫療法薬ペンブロリズマブの追加試験
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.
小さく生まれた子供と小さくなり続けた子供を対象とした研究。ソマパシタン週1回投与とノルディトロピン®1日1回投与を比較
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.
マシテンタンが慢性血栓塞栓性肺高血圧症（CTEPH）の日本人患者において有効かつ安全であるかどうかを検証する臨床試験。
The endothelin receptor antagonist macitentan showed significant improvement compared with placebo in pulmonary vascular resistance (PVR) and 6-minute walking distance (6MWD) in inoperable CTEPH patients in the phase II MERIT-1 trial (AC-055E201, NCT02021292). However, in the MERIT-1 trial Japanese patients were not included. Therefore, in line with Japan's medical environment, this phase III study is to confirm the efficacy and safety of macitentan in Japanese CTEPH patients.