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SLE患者におけるVAY736とCFZ533の有効性と安全性の研究

完了NCT03656562第2相

This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to enable further development of these compounds as treatment in this disease population

対象疾患:
Systemic Lupus Erythematosus (SLE)

レビー小体型認知症患者におけるHTL0018318の安全性、忍容性、および有効性を評価するための研究

取り下げNCT03592862第2相

To establish the safety and efficacy of HTL0018318 compared with placebo when administered once daily for 12 weeks to patients with dementia with Lewy bodies.

対象疾患:
Dementia With Lewy Bodies

進行子宮内膜がん患者におけるレンバチニブとペムブロリズマブの併用と医師選択治療の比較(MK-3475-775/E7080-G000-309 Merck Standard Convention [KEYNOTE-775])

完了NCT03517449第3相

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

対象疾患:
Endometrial Neoplasms

統合失調症の日本人男性および女性被験者におけるSEP-363856の安全性、忍容性および薬物動態を評価する研究(パート1およびパート2)。

完了NCT03370640第1相

This is a multiple oral dose, open-label study to assess the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.

対象疾患:
Schizophrenia

包括的生理学的評価に関する国際協力

完了NCT03690713

The current study evaluated prognostic implication of comprehensive physiologic assessment using fractional flow reserve, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR).

対象疾患:
Non-ST Elevation Myocardial InfarctionST-segment Elevation Myocardial InfarctionStable AnginaUnstable Angina

鉄サプリメントのMT-6548の薬物動態への影響

完了NCT03645863第3相

The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.

対象疾患:
Healthy

活動性全身性エリテマトーデスの成人被験者におけるプラセボと比較したセネリモド4用量の有効性と安全性

完了NCT03742037第2相

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

対象疾患:
Systemic Lupus Erythematosus

A-Health RCT:参加型アート活動が地域在住高齢者の健康に及ぼす影響

完了NCT03679715該当なし

The overall objective of the study is to examine the effects of the Montreal Museum of Fine Arts (MMFA) participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers. Aging is often associated with worsening health and withdrawal from social activities, both increasing the risk of a poor quality of life. It has been reported that the practice of art, especially participatory art-based activity enhances wellbeing, quality of life and health condition of patients and older adults. Since October 2015, the Montreal Museum of Fine Arts (MMFA; Quebec, Canada) has successfully initiated a participatory art-based activity known as "Les Beaux-Jeudis" for older community dwellers living in Montreal. Recently, the investigator demonstrated that the MMFA participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.

対象疾患:
Health, SubjectiveQuality of LifeSocial Interaction

OPC-61815の第I相試験

完了NCT03510663第1相

To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects

対象疾患:
Congestive Heart Failure

発作性心房細動の治療における高解像度マッピングを備えたオープン灌流アブレーションカテーテルの前向き評価

完了NCT03729830

To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).

対象疾患:
Paroxysmal Atrial Fibrillation

大うつ病性障害(MDD)患者におけるラパスティネル単剤療法の研究

中止NCT03675776第3相

The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

対象疾患:
Depressive Disorder, Major

フェブキソスタットを対照とした、痛風の有無にかかわらず高尿酸血症患者を対象としたFYU-981の二重盲検比較試験

完了NCT03372200第3相

FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

対象疾患:
Hyperuricemia With or Without Gout

健康な日本人被験者を対象とした、ペランパネル微顆粒剤4mgとペランパネル錠4mgの生物学的同等性試験

完了NCT03399734第1相

This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.

対象疾患:
Healthy Participants

ファセンラ SCEI 長期使用

完了NCT03588546

The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

対象疾患:
Asthma

ピルビン酸キナーゼ欠損症(PKD)を有する、定期的な輸血を受けていない成人参加者におけるAG-348の有効性および安全性を評価する研究

完了NCT03548220第3相

Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.

対象疾患:
Anemia, HemolyticPyruvate Kinase Deficiency

糖尿病性末梢神経障害患者における運動療法の有効性

完了NCT03450200該当なし

Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic patients. Moreover, it will lead to another complication as disabilities and difficulties in activities of daily living (ADL). Most of the intervention for diabetes and diabetic neuropathic patients are mostly focusing on the prevention of foot ulcer. Diabetic foot care can prevent only for diabetes-related foot ulcer and foot amputation. It cannot be reduced DPN and cannot be improved the activities of daily living of the patient with DPN. Moreover, there is the restriction of weight-bearing exercise on the recommendation of exercises for the patients with DPN. Therefore, exercise program which may be suitable for all the patients with DPN was introduced in this study to improve ADL and decrease the neuropathic symptoms in the diabetic patients. Compliance with exercise or intervention is not only critical to get adherence but also for the long-term use of its. Easy to do exercise in the short duration which can able to do on their own in their home promote their compliance and adherence to the exercises. In this study, the effectiveness of exercises in the patients with diabetic peripheral neuropathy was examined to fulfill the requirement of exercises which is simple and can be done in a short time. The objective of the study is to examine the effectiveness of exercise in the patients with diabetic peripheral neuropathy.

対象疾患:
Diabetic Peripheral Neuropathy

ヒト上皮成長因子受容体2(HER2)発現大腸癌におけるDS-8201a(DESTINY-CRC01)

完了NCT03384940第2相

The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

対象疾患:
Colorectal Neoplasm

再発・難治性多発性骨髄腫(RRMM)患者を対象とした、CC-92480単剤療法およびデキサメタゾンとの併用療法における安全性、薬物動態および有効性に関する研究

実施中(募集終了)NCT03374085第1/第2相

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy.

対象疾患:
Multiple Myeloma

呼吸器合胞体ウイルスに感染した非入院成人被験者におけるJNJ-53718678の2つの投与量レベルでの抗ウイルス活性、臨床転帰、安全性、忍容性、および薬物動態を調査する研究

完了NCT03379675第2相

The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams \[mg\] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

対象疾患:
Respiratory Syncytial Virus Infections

びまん性皮膚全身性硬化症におけるレナバサムの有効性および安全性を評価するための臨床試験

中止NCT03398837第3相

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

対象疾患:
Diffuse Cutaneous Systemic Sclerosis