治験一覧
8,963 件中 6001〜6020 件を表示
日本人重症高血圧患者におけるLCZ696の安全性、忍容性および有効性
This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients
2型糖尿病患者におけるリナグリプチンによる心血管および腎微小血管アウトカム試験（CARMELINA）
The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.
横行結腸癌および下行結腸癌患者における腹腔鏡手術と開腹手術のランダム化比較試験
The long-term results of several large-scale prospective randomized trials that compared laparoscopic-assisted and open colectomy for colon cancer were published in the past decade. The oncologic outcomes were nearly similar in patients who underwent laparoscopic or open surgery. In Japan, the Japan Clinical Oncology Group (JCOG) conducted a randomized trial to compare oncological outcomes between patients who underwent laparoscopic or open surgery for advanced colon cancer and recto-sigmoid cancer. However, the exclusion criterion were concerning tumor site in transverse and descending colon. The reason of exclusion was that laparoscopic procedure was difficult in transverse and descending colon cancers. However, laparoscopic surgery for transverse and descending colon cancer was performed clinically. We conducted a randomized trial that compared laparoscopic surgery and conventional open surgery in in transverse and descending colon cancer. The purpose of the present study was to clarify the safety and feasibility of laparoscopic surgery on in transverse and descending colon cancer patients.
標準リスクの小児再発性ALLの治療に関する国際研究2010
The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.
日本人アルツハイマー病患者を対象としたガンテネルマブの複数回投与試験
Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.
KIF5B-RET陽性肺腺癌患者におけるレンバチニブ（E7080）の安全性および有効性に関する研究
This is a Phase 2, open-label, safety and activity study of lenvatinib in subjects with KIF5B-RET-positive adenocarcinoma of the lung and other confirmed RET translocations. At least 20 subjects with KIF5B-RET and other RET translocations will be treated and will receive lenvatinib at a starting dose of 24 mg orally, once per day. The study will consist of 3 phases: The Pretreatment Phase, The Treatment Phase and the Extension Phase. The Pretreatment Phase will include screening procedures and eligibility assessments. The Pretreatment Phase consists of a Screen 1, Screen 2 and Baseline Period. The Treatment Phase will begin when the subject has met all eligibility criteria on Day 1 of the first Treatment Cycle. The Treatment Phase contains the Treatment and Follow-up Periods. The Extension Phase will begin for subjects who received treatment in the study (either in the Treatment Period or Follow-up Period) at the time of database cutoff.
臨床優先プログラム - 骨感染症登録
Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include: 1. baseline patient attributes; 2. surgical approach, implants and technology; 3. hospital course; 4. surgeon and institutional characteristics; 5. longitudinal patient outcome, 6. post-procedure complications and revisions, 7. serum/tissue/drainage samples.
ステージIV扁平上皮非小細胞肺癌（NSCLC）の一次治療におけるネシツムマブの研究
The purpose of the Phase 1b portion of the study is to investigate how the body tolerates necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose for the subsequent Phase 2 portion of the study. The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV squamous NSCLC in a first-line setting.
アトピー性皮膚炎の小児患者を対象としたTAU-284の確認試験
The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.
経口ステロイド治療にもかかわらず活動性水疱性類天疱瘡を有する患者におけるQGE031とプラセボの安全性、有効性およびPK/PDの比較
To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is broken down by the body and the impact it has on different blood and tissue markers will also be explored.
HCV遺伝子型1bの治療歴のない患者、またはペグインターフェロンアルファ＋リバビリン（アルファ＋RBV）療法後に再発した患者における、ペグインターフェロンラムダ-1a＋リバビリン＋ダクラタスビル（ラムダ＋RBV＋DCV）併用療法の有効性および安全性評価
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
進行性古典的ホジキンリンパ腫患者を対象とした第一線治療試験
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin \[Adriamycin\], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin \[Adriamycin\],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
切除不能または転移性NRAS変異陽性黒色腫におけるMEK162とダカルバジンの有効性を比較する研究
Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival
喘息患者におけるメポリズマブの長期安全性を判定するための研究
This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.
アジア人患者を対象としたLEE011の第I相臨床試験
This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
PCI-32765（イブルチニブ）の長期継続試験
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
網膜色素変性症治療薬UF-021の第III相有効性および安全性臨床試験
This study is a multicenter trial performed in Japan, consisting of a comparative study period and a continuous administration period. Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study in patients with retinitis pigmentosa. The safety of same eye drops will also be examined in 52 weeks continuous administration period, in all the patients who completed the comparative study period.
子宮内膜症患者を対象としたKLH-2109の第II相無作為化非盲検試験
The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.
ピオグリタゾンは内臓脂肪代謝を低下させる
Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.
広範囲尋常性乾癬の日本人患者におけるLEO 90105（カルシポトリオール水和物＋ベタメタゾンジプロピオン酸エステル）の薬物動態
The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.