Akihiro Hirakawa
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View article: Gastric lavage for neonates with coffee-ground hematemesis in early postnatal period: Randomized controlled trial
Gastric lavage for neonates with coffee-ground hematemesis in early postnatal period: Randomized controlled trial Open
GL did not significantly reduce the incidence of FI in neonates with coffee-ground hematemesis and thus it cannot be considered superior based on current results. However, it was well tolerated, and the study may have been underpowered. Ex…
View article: <scp>BOIN</scp> ‐ <scp>MEM</scp> : A Two‐Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Oncology Phase I/ <scp>II</scp> Trials
<span>BOIN</span> ‐ <span>MEM</span> : A Two‐Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Oncology Phase I/ <span>II</span> Trials Open
The launch of Project Optimus has shifted a paradigm in oncology early‐phase trials toward identifying the optimal biological dose (OBD), considering both the drug's toxicity and efficacy. Conventional two‐stage designs for dose optimizati…
View article: Correction: Study protocol of the ASTOP trial: A multicenter, randomized, double-blind, placebo-controlled trial of presurgical aspirin administration for the prevention of thromboembolic complications of coil embolization for ruptured aneurysms
Correction: Study protocol of the ASTOP trial: A multicenter, randomized, double-blind, placebo-controlled trial of presurgical aspirin administration for the prevention of thromboembolic complications of coil embolization for ruptured aneurysms Open
[This corrects the article DOI: 10.1371/journal.pone.0310906.].
View article: Association between diaphragm excursion and whole-body muscle mass in older adults: an observational study
Association between diaphragm excursion and whole-body muscle mass in older adults: an observational study Open
View article: Correction: Shinohara et al. Relationship Between Diaphragm Function and Sarcopenia Assessed by Ultrasound: A Cross-Sectional Study. Diagnostics 2025, 15, 90
Correction: Shinohara et al. Relationship Between Diaphragm Function and Sarcopenia Assessed by Ultrasound: A Cross-Sectional Study. Diagnostics 2025, 15, 90 Open
Upon reviewing our original publication [...]
View article: Proposed Diagnostic Criteria for Invasive Pulmonary Aspergillosis in Patients with Autoimmune Inflammatory Rheumatic Diseases: A Proof-of-Concept Study
Proposed Diagnostic Criteria for Invasive Pulmonary Aspergillosis in Patients with Autoimmune Inflammatory Rheumatic Diseases: A Proof-of-Concept Study Open
The EORTC/MSGERC definition lacks sufficient sensitivity for diagnosing invasive pulmonary aspergillosis (IPA) in patients with autoimmune inflammatory rheumatic diseases (AIIRDs). We hypothesized that the partial fulfillment of the EORTC/…
View article: Tumor burden and heterogenous treatment effect of apalutamide in metastatic castration‐sensitive prostate cancer
Tumor burden and heterogenous treatment effect of apalutamide in metastatic castration‐sensitive prostate cancer Open
Background Investigation remains incomplete regarding potential variations in the effect of androgen receptor pathway inhibitors, including apalutamide, based on baseline tumor burden in patients with metastatic castration‐sensitive prosta…
View article: Prospective observational study on the relationships between genetic alterations and survival in Japanese patients with metastatic castration-sensitive prostate cancer: the impact of IDC-P
Prospective observational study on the relationships between genetic alterations and survival in Japanese patients with metastatic castration-sensitive prostate cancer: the impact of IDC-P Open
Background Intraductal Carcinoma of the Prostate (IDC-P) is a significant prognostic indicator for prostate cancer, which demonstrates significant associations with homologous recombination repair gene mutations (HRRm) and alterations in t…
View article: Exploring the association between happy hypoxia and Coronavirus disease 2019 in the triage phase
Exploring the association between happy hypoxia and Coronavirus disease 2019 in the triage phase Open
317 patients were analyzed. Multivariate logistic regression analysis, including all vital signs, demonstrated that the respiratory rate was not statistically associated with COVID-19 (odds ratio, 0.94, p = 0.058), suggesting that happy hy…
View article: Bayesian Hierarchical Model with Adaptive Similarity Evaluation of Treatment Effects in Oncology Basket Trials
Bayesian Hierarchical Model with Adaptive Similarity Evaluation of Treatment Effects in Oncology Basket Trials Open
We developed a novel Bayesian hierarchical model (BHM) that incorporates a similarity measure calculated using the standardized Chi-square test statistic to evaluate the heterogeneity of response rates between two cancer types of interest …
View article: Relationship Between Diaphragm Function and Sarcopenia Assessed by Ultrasound: A Cross-Sectional Study
Relationship Between Diaphragm Function and Sarcopenia Assessed by Ultrasound: A Cross-Sectional Study Open
Background/Objectives: The diaphragm is important for respiration, but the effects of age-related muscle loss and sarcopenia on diaphragm function are unclear. We evaluated the associations of sarcopenia and skeletal muscle mass (SMM) with…
View article: Clinical and Economic Outcomes of Intradiscal Injection of Condoliase for a Treatment of Lumbar Disc Herniation with Severe Low Back Pain: A Multicenter Study
Clinical and Economic Outcomes of Intradiscal Injection of Condoliase for a Treatment of Lumbar Disc Herniation with Severe Low Back Pain: A Multicenter Study Open
This retrospective multicenter study revealed that patients with LDH with severe LBP frequently experienced improvement in radicular pain and LBP, which is similar to LDH cases without severe LBP.
View article: BUPD: A Bayesian under-parameterized basket design with the unit information prior in oncology trials
BUPD: A Bayesian under-parameterized basket design with the unit information prior in oncology trials Open
Basket trials in oncology enroll multiple patients with cancer harboring identical gene alterations and evaluate their response to targeted therapies across cancer types. Several existing methods have extended a Bayesian hierarchical model…
View article: Planning and Implementing Master Protocol Trials in Japan: Key Considerations of the Japanese Guideline
Planning and Implementing Master Protocol Trials in Japan: Key Considerations of the Japanese Guideline Open
The importance of master protocol trials, which encompass basket, umbrella, and platform trials, has been increasingly recognized worldwide for their efficiency in evaluating multiple drugs or diseases within a single trial. While the US F…
View article: Safety of local nasal immunotherapy using hypoallergenic birch pollen ointment in patients with pollen-food allergy syndrome: A preliminary study of five cases
Safety of local nasal immunotherapy using hypoallergenic birch pollen ointment in patients with pollen-food allergy syndrome: A preliminary study of five cases Open
View article: Efficacy and safety of estetrol (15 mg)/drospirenone (3 mg) combination in a cyclic regimen for the treatment of primary and secondary dysmenorrhea: a multicenter, placebo-controlled, double-blind, randomized study
Efficacy and safety of estetrol (15 mg)/drospirenone (3 mg) combination in a cyclic regimen for the treatment of primary and secondary dysmenorrhea: a multicenter, placebo-controlled, double-blind, randomized study Open
View article: JAK1/2 inhibitor ruxolitinib for the treatment of systemic chronic active Epstein-Barr virus disease: a phase 2 study
JAK1/2 inhibitor ruxolitinib for the treatment of systemic chronic active Epstein-Barr virus disease: a phase 2 study Open
Systemic chronic active Epstein-Barr virus disease (sCAEBV) is a rare intractable EBV-positive T-cell or natural killer (NK)-cell lymphoid neoplasm with systemic inflammation. The only curative treatment is allogeneic hematopoietic stem ce…
View article: Evaluating endoscopic ultrasound-guided tissue acquisition for diagnosis of small pancreatic neuroendocrine neoplasms
Evaluating endoscopic ultrasound-guided tissue acquisition for diagnosis of small pancreatic neuroendocrine neoplasms Open
Background and study aims Although small hypervascular tumors are suspected to be pancreatic neuroendocrine tumors (p-NENs), their diagnosis and treatment are challenging. This study evaluated the usefulness of endoscopic ultrasound-guided…
View article: Study protocol of the ASTOP trial: A multicenter, randomized, double-blind, placebo-controlled trial of presurgical aspirin administration for the prevention of thromboembolic complications of coil embolization for ruptured aneurysms
Study protocol of the ASTOP trial: A multicenter, randomized, double-blind, placebo-controlled trial of presurgical aspirin administration for the prevention of thromboembolic complications of coil embolization for ruptured aneurysms Open
Rationale Thromboembolism is a serious complication of endovascular treatment for ruptured cerebral aneurysms. The administration of antiplatelet agents before endovascular treatment for ruptured cerebral aneurysms may reduce the risk of t…
View article: Supplementary Figure S1 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Figure S1 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
MASTER KEY PROJECT
View article: Supplementary Figure S5 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Figure S5 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Correlation between the MDM2 copy number and tumor shrinkage
View article: Supplementary Table S5A from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S5A from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Whole-exome sequencing and RNA sequencing analyses of archived tumor tissue samples
View article: Supplementary Figure S4B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Figure S4B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Anti-tumor activity
View article: Supplementary Table S5B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S5B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Whole-exome sequencing and RNA sequencing analyses of tumor tissue samples at pre-and post-treatment
View article: Supplementary Table S5B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S5B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Whole-exome sequencing and RNA sequencing analyses of tumor tissue samples at pre-and post-treatment
View article: Supplementary Table S2 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S2 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Patient characteristics
View article: Supplementary Table S1 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S1 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Representativeness of study participant
View article: Supplementary Table S7 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S7 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Criteria for modifying treatment
View article: Supplementary Table S1 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S1 from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Representativeness of study participant
View article: Supplementary Table S3A-B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study
Supplementary Table S3A-B from Clinical activity and exploratory resistance mechanism of milademetan, an MDM2 inhibitor, in intimal sarcoma with MDM2 amplification: an open-label phase 1b/2 study Open
Pharmacokinetics