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脳挫傷患者におけるBIIB093の有効性および安全性を評価する研究

中止NCT03954041第2相

The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

対象疾患:
Brain Contusion

ブレンツキシマブベドチン静脈内投与に関する特別薬物使用監視:「再発性または難治性のCD30陽性末梢性T細胞リンパ腫または小児ホジキンリンパ腫」

完了NCT04213209

The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) in the actual use of on concomitant Brentuximab Vedotin in routine clinical practice.

対象疾患:
Pediatric Hodgkin LymphomaPeripheral T Cell Lymphoma

がんに伴う神経因性疼痛患者を対象としたNPC-06の第II相臨床試験

中止NCT03773055第2相

The purpose of this trial is to investigate the efficiency of pain relief and the safety of NPC-06 for the neuropathic pain associated with cancer, in addition to explore the effective concentration of NPC-06.

対象疾患:
Neuropathic Pain in Cancer

日本における慢性閉塞性肺疾患急性増悪(AECOPD)の原因

完了NCT03957577

The purpose of this prospective, epidemiological, cohort study is to evaluate the lung microbiome in stable-state chronic obstructive pulmonary disease (COPD) in Japanese participants

対象疾患:
Pulmonary Disease, Chronic Obstructive

健康な日本人乳幼児におけるV114の安全性、忍容性、および免疫原性(V114-028)

完了NCT03848065第1相

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).

対象疾患:
Pneumococcal Infections

進行悪性腫瘍患者を対象としたティスレリズマブ、パミパリブ、およびその他の治験薬の研究

招待制NCT04164199第3相

This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene investigational drugs in participants with advanced malignancies who participated in a prior BeiGene-sponsored clinical study (parent study).

対象疾患:
Advanced Malignancies

TRK融合遺伝子陽性の局所進行癌または原発巣から体内の他の部位に転移した癌患者におけるVITRAKVIの日常使用における安全性と有効性についてさらに詳しく知るための研究

募集中NCT04142437

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

対象疾患:
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

進行性黒色腫患者におけるGEN0101とペムブロリズマブの併用療法 PIb/PII

不明NCT03818893第2相

This is a multi-center, open-labeled, non-randomized, single arm investigator-initiated trial to evaluate the safety and efficacy of GEN0101 and Pembrolizmub combination in patients with advanced melanoma.

対象疾患:
Advanced Melanoma

PD-L1陽性ステージIB~IIIA肺癌に対するペムブロリズマブ+ラムシルマブの術前補助療法(EAST ENERGY試験)

不明NCT04040361第2相

The efficacy and safety of the neoadjuvant therapy of pembrolizumab+ ramucirumab

対象疾患:
Non-small Cell Lung Cancer Stage IBNon-small Cell Lung Cancer Stage IINon-small Cell Lung Cancer Stage ⅢA

リネリキシバット長期安全性および忍容性試験

実施中(募集終了)NCT04167358第3相

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 \[NCT01899703\], 201000 GLIMMER \[NCT02966834\] (group 1) or 212620 GLISTEN \[NCT00210418\]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

対象疾患:
胆汁うっ滞

進行性固形腫瘍を有する日本人被験者を対象としたINCMGA00012、INCB001158、およびこれらの併用療法に関する研究

完了NCT03910530第1相

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.

対象疾患:
Advanced Solid TumorsMetastatic Solid Tumors

固形腫瘍患者を対象としたLY3435151の研究

中止NCT04099277第1相

The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

対象疾患:
Cervical CarcinomaGastric AdenocarcinomaHead and Neck Squamous Cell CarcinomaHepatocellular CarcinomaHigh Grade Serous Ovarian Carcinoma4

肺炎性急性呼吸窮迫症候群に対するHLCM051(MultiStem®)の有効性および安全性に関する研究

完了NCT03807804第2相

The primary object of this clinical study is to investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonitis.

対象疾患:
Respiratory Distress Syndrome, Adult

BI 1358894の異なる投与量が体内でどのように吸収され、健康な日本人男性にどの程度忍容されるかについての研究

完了NCT03875001第1相

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses.

対象疾患:
Healthy

胃がん診断における人工知能と専門内視鏡医の比較

完了NCT04040374該当なし

Title: A single-center, retrospective randomized controlled trial of artificial intelligence (AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy. Précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (IOU), and the detection rate of diagnosis of early and advanced gastric cancer. Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in Japan. Describe the Intervention: AI-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images. Study Duration: 3 months.

対象疾患:
Gastric Cancer

中等度から重度の乾癬を有する日本人被験者を対象とした、治験薬BMS-986165の評価に関する臨床試験

完了NCT03924427第3相

The purpose of this study is to investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis.

対象疾患:
Psoriasis

ホルモン受容体陽性かつHER2陰性の局所進行性切除不能または転移性乳がん患者を対象とした、イパタセルチブ+パルボシクリブ+フルベストラント療法とプラセボ+パルボシクリブ+フルベストラント療法の比較試験

中止NCT04060862第1相

The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.

対象疾患:
Breast Cancer

過去にバイエル社がスポンサーとなったレゴラフェニブ臨床試験で治療を受けた被験者を対象としたレゴラフェニブの臨床試験

完了NCT03890731第2相

The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.

対象疾患:
Solid Cancer

アトピー性皮膚炎症候群の成人患者におけるOPA-15406軟膏の比較試験

完了NCT03908970第3相

To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in adult patients with AD.

対象疾患:
Atopic Dermatitis

心不全の小児患者におけるサクビトリル/バルサルタンの長期安全性を評価するためのオープンラベル延長試験

完了NCT03785405第3相

The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2 as per protocol.

対象疾患:
Heart Failure