治験一覧
8,963 件中 5581〜5600 件を表示
エベロリムスをベースとした治療法による腎移植の有効性と安全性の向上（TRANSFORM）
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
長時間にわたる脳神経外科手術における、全静脈麻酔法からデスフルラン麻酔法への切り替え
Since neurological testing during neurosurgery, such as somato-sensory evoked potentials, motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well maintained their wave-form reactivity with total intravenous anaesthesia technique better than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the evoked potential responses during surgery, facilitation of recovery from general anesthesia is getting important, because the real neurological physical examination is much more sensitive than above electrical evoked potentials to evaluate the results of surgical operation. We propose to evaluate the recovery parameters after conversion from total intravenous anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The conversion will be initiated upon completion of the neurophysiological electric evoked potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize that recovery after conversion to Desflurane will be faster compared to recovery after total intravenous anaesthesia alone.
骨髄異形成症候群または慢性骨髄単球性白血病の日本人患者におけるボラセルチブとアザシチジンの併用療法
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability, pharmacokinetics and the preliminary efficacy of this combination.
レノックス・ガストー症候群患者におけるイノベロン錠の長期投与に関する市販後調査
This surveillance's objectives are 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Efficacy during long-term administration 4. Factors considered to have effect to safety and effectiveness 5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)
糖尿病性黄斑浮腫患者における硝子体内ラニビズマブ投与、局所/グリッドレーザー治療、および汎網膜光凝固術の併用療法
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.
カンデサルタンシレキセチル／ヒドロクロロチアジド配合錠 特別薬物使用監視：長期使用（12ヶ月）
The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD\&HD in hypertensive patients in the routine clinical setting
未治療の血友病A患者におけるツロクトコグアルファペゴル（N8-GP）の安全性と有効性
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
網膜静脈閉塞症に伴う黄斑浮腫の病態生理を解明することによる硝子体内ラニビズマブの開発
The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. In particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.
閉経後女性における骨粗鬆症診断キットを用いた治療戦略
The frequency of osteoporosis in Japan is increasing. Also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are several problems in this issue from the medical site and the patient site. The aim of this study is, from the patient site, to increase the motivation of postmenopausal women for osteoporosis using osteoporotic diagnostic kit.
非弁膜性心房細動と診断された日本人患者を対象とした全国規模のコホート研究における、脳卒中および全身性塞栓症予防のためのXa阻害薬の有効性および安全性の評価
The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.
進行期パーキンソン病で、既存の抗パーキンソン病薬による最適化された治療にもかかわらず運動合併症が持続する患者におけるABT-SLV187の安全性、忍容性、有効性を評価するための延長試験
This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.
健康な成人を対象としたTAK-850の筋肉内注射に関する第1/2相臨床試験
This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants
糖尿病予備軍の被験者におけるブルーベリー乾燥粉末の血糖値への影響
The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.
慢性腎臓病に伴う貧血を有する血液透析患者におけるGSK1278863の用量反応関係、安全性および有効性の評価
This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
潰瘍性大腸炎の治療におけるMLN0002（300mg）の第III相試験
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
中等度から重度のアトピー性皮膚炎患者におけるアプレミラストの有効性および安全性に関する研究
A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis
セルメチニブ（AZD6244、ARRY-142886）J-BTC第1相試験
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC). In addition, the pharmacokinetic (PK) profile of selumetinib and chemotherapies will be investigated. Also, the Maximum tolerated dose (MTD) of selumetinib in combination with chemotherapies for Japanese BTC patients will be identified, if possible.
多極冠状静脈洞リードファミリーACUITY® X4を使用したCRT配信の最大化 - RALLY X4研究
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting. It is a prospective, non-randomized, observational multicenter study evaluating standard of care. For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant. Study endpoints: Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.
再現性試験においてSS-1000とPentacamの精度と一致性を調査する
This study is to support the substantial equivalence of the SS-1000 to the predicate device Pentacam. Primary Objective -The primary objective of the trial is to evaluate the precision of the SS-1000 and Pentacam in measuring the anterior segment parameters in an eye, including Corneal Curvature, Corneal Thickness, Anterior Chamber Depth and Cornea Volume. Secondary Objectives * To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye * To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in measuring the anterior segment parameters in an eye * To investigate the agreement between SS-1000 and Pentacam in measuring the anterior segment parameters in an eye Study design -The trial design is a prospective precision trial with the following factors: The trial will be conducted at one investigational site. The site will have three SS-1000 devices and three Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are confounded with instrument effect. All participants will have one visit and undergo the same set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).
脊髄小脳変性症（SCD）患者におけるKPS-0373の確認試験
The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.