治験一覧
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ゲル化剤を使用したピューレ状米と標準的なピューレ状米の比較
The texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. However, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.
重症患者における高タンパク質投与量の影響
The investigator will investigate the effects of higher protein/amino acid dosing (≥2.2 g/kg/d) vs usual protein/amino acid dosing (≤1.2 g/kg/d) on clinical outcomes in nutritionally high risk ill patients.
進行性固形腫瘍を有する日本人患者を対象とした、PARP阻害剤タラゾパリブの第1相臨床試験
This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part. The dose escalation part is open-label, and evaluates safety, preliminary efficacy and PK of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available. In the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs. The expansion part is designed to assess the efficacy, safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations. In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint.
BAY 77-1931口腔内崩壊錠の生物学的同等性試験
The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.
日本における市販後コホート研究
The objectives and endpoints of this study were analyzed in the study population of adults eligible to purchase tobacco products. The study was planned to describe the patterns of use of tobacco and nicotine containing products and self-reported health outcomes and health related events in CC (Cigarette) smokers and IQOS users in Japan. The initial study record (posted on ClinicalTrials.gov) included a clinical sub-study designed to estimate population level differences in the biomarkers of exposure and clinical risk endpoints among IQOS users, CC smokers and never-smokers. However, due to low recruitment and retention of subjects, the clinical sub-study was terminated in May 2017, and for the same reasons the main study was terminated in March 2018. The study protocol was updated to remove the clinical sub-study objectives. The study initially included 18 outcome measures. Due to study termination leading to a shortened follow-up period and a smaller sample size, only 7 of these outcome measures could be assessed and the other outcome measures planned were either unattainable or uninformative.
駆出率が保たれた慢性心不全患者におけるEMPグリフロジンアウトカム試験（EMPEROR-Preserved）
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction. Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine. Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
アルツハイマー病の臨床症状発症リスクのある参加者を対象としたCNP520とプラセボの比較研究
The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.
中等度から重度の慢性閉塞性肺疾患（COPD）を有する日本人被験者におけるPT001の3つの用量の有効性および安全性を評価する研究
The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.
肺がん患者を対象とした、デュルバルマブ + トレメリムマブと化学療法の併用、またはデュルバルマブと化学療法の併用、あるいは化学療法単独の研究 (POSEIDON)。
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
進行性および／または転移性固形腫瘍における、リリルマブとニボルマブの併用療法、またはニボルマブとイピリムマブの併用療法の安全性に関する研究
The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors
食道がん患者におけるOBP-301と放射線療法の併用に関する研究
This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.
全身性膿疱性乾癬または紅皮症性乾癬を有する日本人被験者における、リサンキズマブの2種類の異なる皮下投与レジメンの有効性および安全性を評価する研究
The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).
日本の医療現場におけるてんかん重積状態（痙攣発作）の小児を対象としたミダゾラム塩酸塩口腔粘膜液（MHOS/SHP615）の非盲検試験
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a healthcare setting.
早期大腸内視鏡検査と選択的大腸内視鏡検査の比較
This multi-center, randomized controlled trial study is planned to include 162 outpatients with onset of acute lower gastrointestinal bleeding to compare the rate of identification of stigmata of recent hemorrhage (SRH), and other clinical outcomes, including the 30-day rebleeding rate, between 'early' colonoscopy and 'elective' colonoscopy.
ESA未治療の貧血を伴う慢性腎臓病患者におけるASP1517の間欠的経口投与に関する研究
The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.
全身性エリテマトーデス患者を対象としたBMS-986165の評価に関する臨床試験
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).
軽度または中等度の腎機能障害患者におけるMCI-186の薬物動態試験
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.
硝子体切除術中の術中光干渉断層計による網膜微細構造の評価
We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.
BRCA1またはBRCA2の生殖細胞系列変異保因者を対象とした前向きコホート研究
乳がん感受性遺伝子（BRCA）1/2変異を有する日本人女性における卵巣がん、卵管がん、腹膜がんの発症率および危険因子を明らかにする。
中等度から重度の潰瘍性大腸炎患者を対象とした、オンタマリマブの維持療法としての有効性および安全性に関する研究
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).