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トランスフェクション中に再編成される遺伝子(RET)活性化を伴う癌の治療に対するアクセス拡大

承認済み・市販化NCT03906331

Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

対象疾患:
Breast CancerColon CancerMedullary Thyroid CancerNon Small Cell Lung CancerOther Solid Tumors With Evidence of Activating RET Alteration2

腸管外病原性大腸菌2型による侵襲性疾患に関する情報を収集するための研究(EXPECT-2)

完了NCT04117113

The purpose of this study is to collect information from study participants who are hospitalized with an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC). This information will be used to support the development of a new vaccine to prevent Extraintestinal pathogenic Escherichia coli (ExPEC). E. coli bacteria are a leading cause of serious infections. Especially adults older than 60 years have a higher risk of developing such infections. To date, there is no vaccine available to prevent E. coli infections. To support the development of a vaccine, more information about E. coli infections is first needed. This information will be collected in the current study, such as: * Medical information such as medical history, diagnosis, duration of hospitalization * Treatment and outcome of the Extraintestinal pathogenic Escherichia coli (ExPEC) * Laboratory information

対象疾患:
E. Coli Infection

ビンダケルカプセル特別調査(ATTR-CM)

完了NCT04108091

Secondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan. This study is conducted in accordance with the protocol even when Vynmac is used, and information the use of Vynmac during the observation period is also collected.

対象疾患:
Transthyretin (TTR) Amyloid Cardiomyopathy

再発性および難治性の慢性リンパ性白血病(小リンパ球性白血病を含む)を有する日本人患者におけるベネトクラクスの安全性および有効性に関する研究

完了NCT04198415

This study will collect real-world safety and efficacy data from Japanese relapse/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) participants treated with venetoclax.

対象疾患:
CancerChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Leukemia (SLL)

局所進行性または転移性胆道がん(胆管がんおよび胆嚢がん)に対する二次治療(2L)におけるM7824単剤療法

完了NCT03833661第2相

The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

対象疾患:
Biliary Tract CancerCholangiocarcinomaGallbladder Cancer

女性における単一動脈グラフトと複数動脈グラフトの結果の比較

募集中NCT04124120該当なし

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

対象疾患:
冠動脈バイパス移植冠動脈疾患心臓病

反復性片頭痛の小児患者におけるエレヌマブの有効性と安全性

実施中(募集終了)NCT03836040第3相

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

対象疾患:
Migraine

進行性または転移性の特定の消化器系腫瘍患者におけるPF-07062119の安全性および忍容性を試験する研究。

中止NCT04171141第1相

A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

対象疾患:
Colorectal AdenocarcinomasEsophageal AdenocarcinomasGastric AdenocarcinomasGastrointestinal Tumors

日本人肥満2型糖尿病患者におけるコタデュチドの安全性および忍容性に関する研究

完了NCT04208620第1相

This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382 (Cotadutide) in Japanese T2DM patients.

対象疾患:
Type 2 Diabetes

リンパ腫治療におけるSyB L-0501RIとリツキシマブの併用療法に関する第I/II相試験

完了NCT03900377第1/第2相

For SyB L-0501RI administered by an intravenous rapid infusion in combination with rituximab, the safety will be investigated in previously untreated patients with low-grade B-cell non-Hodgkin's lymphoma (Lg-B-NHL) or mantle cell lymphoma (MCL), and the safety and tolerability will be investigated in patients with recurrent/refractory diffuse large B-cell lymphoma (DLBCL).

対象疾患:
Lymphoma, B-cell, Diffuse

SK-1403の第3相臨床試験

完了NCT03801980第3相

To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

対象疾患:
Secondary Hyperparathyroidism

DETERMINE-reduced - 駆出率低下型心不全患者における6分間歩行テストを用いたダパグリフロジンの運動能力への影響

完了NCT03877237第3相

International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Reduced Ejection Fraction (HFrEF)

対象疾患:
Heart Failure With Reduced Ejection Fraction (HFrEF)

中等度から進行期の糖尿病性腎症患者におけるセロンセルチブの有効性および安全性を評価する研究

完了NCT04026165第2相

The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).

対象疾患:
Diabetic Kidney Disease

オナセムノゲンアベパルボベック-xioi投与患者の長期追跡調査

実施中(募集終了)NCT04042025第3相

This is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.

対象疾患:
SMASpinal Muscular Atrophy Type ISpinal Muscular Atrophy Type IISpinal Muscular Atrophy Type III

全身性重症筋無力症患者におけるジルコプランの安全性、忍容性および有効性

完了NCT04115293第3相

The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.

対象疾患:
Myasthenia Gravis, Generalized

化学療法および放射線療法を受けている食道癌患者を対象とした、ペムブロリズマブ(MK-3475)とプラセボの比較試験(MK-3475-975/KEYNOTE-975)

実施中(募集終了)NCT04210115第3相

The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants

対象疾患:
Esophageal Adenocarcinoma (EAC)Esophageal Squamous Cell Carcinoma (ESCC)Gastroesophageal Junction Carcinoma (GEJC)

エリクサーバイオアダプターとオニキスステントの併用による冠動脈新生における比較

実施中(募集終了)NCT04192747該当なし

The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions

対象疾患:
Coronary Artery DiseaseCoronary Artery StenosisCoronary DiseaseCoronary Stenosis

パーキンソン病治療における経頭蓋MR誘導集束超音波の安全性と初期効果

完了NCT04002596該当なし

Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.

対象疾患:
Parkinson Disease

慢性腎臓病(CKD)患者を対象とした、治療経験とパターン、治療効果、患者の転帰、および患者の生活の質を評価する研究

完了NCT04034992

DISCOVER CKD is an international observational cohort study in patients with CKD, comprising both prospective and retrospective patient cohorts. The study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care.

対象疾患:
Chronic Kidney Disease

アトピー性皮膚炎の小児患者におけるOPA-15406軟膏の比較試験

完了NCT03911401第3相

To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 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 pediatric patients with Atopic Dermatitis (AD).

対象疾患:
Atopic Dermatitis