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統合失調症または統合失調感情障害および陰性症状を有する参加者におけるRO6889450(ラルミタロント)の効果を評価する研究

中止NCT03669640第2相

This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.

対象疾患:
Schizophrenia, Schizoaffective Disorder

日本人骨粗鬆症患者における2年間のデノスマブ療法後の他の骨吸収抑制薬の有効性および安全性の検討

募集中NCT03755193第2相

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy: SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months

対象疾患:
Osteoporosis

健康な被験者を対象としたNPF-08の第I/II相臨床試験

完了NCT03423771第1/第2相

Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events and adverse drug reactions observed from the date of administration to 7 days after administration.

対象疾患:
Healthy Volunteers

中等度から重度のアトピー性皮膚炎(湿疹)を有する青年および成人患者におけるウパダシチニブの評価

完了NCT03569293第3相

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

対象疾患:
Atopic Dermatitis

進行固形癌患者を対象とした、抗プログラム細胞死(PD)-1モノクローナル抗体JNJ-63723283の単独療法またはエルダフィチニブとの併用療法における安全性、薬物動態、薬力学、および免疫原性を評価する試験

完了NCT03547037第1相

The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part).

対象疾患:
Neoplasm

中等度から重度のアトピー性皮膚炎の青年に対するトラロキヌマブ単独療法 - ECZTRA 6 (ECZema TRAlokinumab 試験番号 6)。

完了NCT03526861第3相

Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.

対象疾患:
Atopic Dermatitis

遺伝性血管性浮腫症の疫学的分析

完了NCT03558009

An international, multicenter, epidemiological, observational study investigating the prevalence of Hereditary Angioedema (HAE) disease among participants with recurrent episodes of abdominal pain of no obvious etiology.

対象疾患:
Abdominal PainFunctional Abdominal Pain

根治的前立腺摘除術の対象となる高リスク、局所性または局所進行性前立腺癌患者を対象としたアパルタミドの研究

実施中(募集終了)NCT03767244第3相

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

対象疾患:
Prostatic Neoplasms

成人非小細胞肺癌患者を対象とした、ドセタキセルとの併用療法におけるカナキヌマブの有効性および安全性を評価する第III相試験(二次または三次治療として実施)

中止NCT03626545第3相

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

対象疾患:
Non-Small-Cell Lung

季節性アレルギー性鼻炎患者におけるMT-2990の臨床薬理試験

完了NCT03570957第1相

The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.

対象疾患:
Seasonal Allergic Rhinitis

転移性子宮頸癌に対するプラチナ製剤とパクリタキセル、ベバシズマブおよびアテゾリズマブ併用化学療法

実施中(募集終了)NCT03556839第3相

The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity. The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin). This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

対象疾患:
Carcinoma of the Cervix, Stage IVB

MIBC患者におけるデュルバルマブ+ゲムシタビン/シスプラチン(術前治療)およびデュルバルマブ(術後治療)

実施中(募集終了)NCT03732677第3相

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

対象疾患:
Muscle Invasive Bladder Cancer

圧力モニター超音波検査による遠位橈尺関節安定性の定量的評価

不明NCT03658096該当なし

To quantitatively assess distal radio ulnar joint (DRUJ) stability, a pressure-monitor ultrasound system was developed. The objective of this study was to evaluate the force-displacement relationship of DRUJ in patients and normal subjects. Each subject will be imaged sitting with elbow flexed and forearm pronated. The dorsal surface of distal radius and the center of ulnar head will be displayed at DRUJ level. The pressure toward palmar direction will be applied to distal ulna with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm. The distance between the dorsal surface of the ulnar head and the dorsal surface of the distal radius will be measured. At the same time, the pressure to the transducer will be measured.

対象疾患:
Distal Radioulnar Joint SprainTriangular Fibrocartilage Complex Injury

非透析患者における腎性貧血の改善を目的としたモリデュスタットの研究

完了NCT03350321第3相

The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs).

対象疾患:
AnemiaRenal Insufficiency, Chronic

急性骨髄性白血病患者におけるDSP-2033(アルボシジブ)の研究

完了NCT03563560第1相

This is an open label, multi-center, phase 1 study of DSP-2033 (Alvocidib) in combination with cytarabine/mitoxantrone (ACM regimen) or cytarabine/daunorubicin (A+7+3 regimen) in patients with acute myeloid leukemia (AML).

対象疾患:
Acute Myeloid Leukemia

イキサゾミブ、レナリドミド、デキサメタゾンを併用した治療を受けた再発性および/または難治性多発性骨髄腫患者を対象とした研究

完了NCT03433001

The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.

対象疾患:
Relapsed and/or Refractory Multiple Myeloma

再発性および難治性多発性骨髄腫患者を対象とした、BCMA x CD3 T細胞結合抗体CC-93269の研究

中止NCT03486067第1相

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

対象疾患:
Multiple Myeloma

ブレンツキシマブベドチン静脈内投与「未治療のCD30陽性ホジキンリンパ腫」における薬剤使用状況の監視

完了NCT03729609

The purpose of this survey is to monitor and identify the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma participants on concomitant brentuximab vedotin and doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) in routine clinical practice.

対象疾患:
Untreated CD30-Positive Hodgkin's Lymphoma

健康な成人アジア人を対象としたTAK-831の第1相臨床試験

完了NCT03687684第1相

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants.

対象疾患:
Healthy Volunteers

進行性固形腫瘍患者を対象としたニラパリブ単剤療法に関する研究

完了NCT03497429第1相

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Niraparib in Japanese participants with advanced solid tumors.

対象疾患:
Advanced Solid Tumors