Yukari Uemura
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View article: HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy
HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy Open
View article: HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy
HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy Open
Older adults with HER2-positive early breast cancer are underrepresented in clinical trials, and the benefit of chemotherapy in this population remains uncertain. We evaluated the HER2DX genomic assay within the randomized RESPECT trial (N…
View article: Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: final report of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06)
Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: final report of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06) Open
Introduction Although bone anabolic agents such as teriparatide are effective for osteoporosis, satisfaction and adherence may vary by regimen. This multicenter study assessed long-term satisfaction, persistence, efficacy, and safety in po…
View article: Electronic Patient-Reported Outcomes With Vital Sign Monitoring During Trastuzumab Deruxtecan Therapy
Electronic Patient-Reported Outcomes With Vital Sign Monitoring During Trastuzumab Deruxtecan Therapy Open
Importance Patients with ERBB2 (formerly HER2 or HER2/neu)-positive metastatic breast cancer (MBC) receiving trastuzumab deruxtecan (T-DXd), a new standard of care, may experience specific adverse events affecting their quality of life (QO…
View article: Accuracy of classification of urinary Gram-stain findings by a computer-aided diagnosis app compared with microbiology specialists
Accuracy of classification of urinary Gram-stain findings by a computer-aided diagnosis app compared with microbiology specialists Open
Introduction. Timely and accurate diagnosis of bacterial infections enables early administration of appropriate antimicrobial treatment and improved outcomes. Hypothesis/Gap Statement. The accuracy of computer-aided diagnosis (CAD) for ide…
View article: Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: Interim report (end of 52-week treatment) of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06)
Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: Interim report (end of 52-week treatment) of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06) Open
View article: Inflammatory and Coagulation Marker Changes in PMX-DHP-Treated COVID-19 Patients
Inflammatory and Coagulation Marker Changes in PMX-DHP-Treated COVID-19 Patients Open
View article: OXYTOCIN-INDUCED INCREASES IN CYTOKINES AND CLINICAL EFFECT ON THE CORE SOCIAL SYMPTOMS OF AUTISM
OXYTOCIN-INDUCED INCREASES IN CYTOKINES AND CLINICAL EFFECT ON THE CORE SOCIAL SYMPTOMS OF AUTISM Open
Background Oxytocin may provide a novel treatment for the core symptoms of autism spectrum disorder (ASD). However, previous results regarding the efficacy of repeated or higher dose oxytocin are controversial, and the underlying mechanism…
View article: P-1395. Safety and Effectiveness of LC16m8 for Pre-Exposure Prophylaxis Against mpox in High-Risk Population: An Open-Label Randomized Trial
P-1395. Safety and Effectiveness of LC16m8 for Pre-Exposure Prophylaxis Against mpox in High-Risk Population: An Open-Label Randomized Trial Open
Background Since May 2022, the incidence of mpox cases has surged outside endemic regions. Although vaccination remains pivotal in mpox prevention, data on LC16m8, a third-generation smallpox vaccine, are scant. We provided LC16m8 pre-expo…
View article: Predictors of rituximab efficacy in systemic sclerosis-associated interstitial lung disease: machine-learning analysis of the DESIRES trial
Predictors of rituximab efficacy in systemic sclerosis-associated interstitial lung disease: machine-learning analysis of the DESIRES trial Open
Objectives Rituximab is emerging as a promising therapeutic option for systemic sclerosis-associated interstitial lung disease (SSc-ILD). However, little is known about factors that predict the efficacy of rituximab in SSc-ILD. Methods A p…
View article: Physical, but not laboratory, treatment‐related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis
Physical, but not laboratory, treatment‐related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis Open
Background While the occurrence of immune‐related adverse events has been recognized as a prognostic marker in patients receiving immune checkpoint inhibitors, the prognostic significance of treatment‐related adverse events (trAEs) in pati…
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: Low CD86 expression is a predictive biomarker for clinical response to the therapeutic human papillomavirus vaccine IGMKK16E7: results of a post hoc analysis
Low CD86 expression is a predictive biomarker for clinical response to the therapeutic human papillomavirus vaccine IGMKK16E7: results of a post hoc analysis Open
Background Although therapeutic human papillomavirus vaccines could offer a noninvasive treatment for patients with cervical intraepithelial neoplasia, none has been clinically implemented. Oral administration of the therapeutic human papi…
View article: Efficacy of first‐line immune checkpoint inhibitor and anti‐angiogenic agent combination therapy for Kirsten rat sarcoma viral antigen‐mutant advanced non‐small‐cell lung cancer: a systematic review and network meta‐analysis
Efficacy of first‐line immune checkpoint inhibitor and anti‐angiogenic agent combination therapy for Kirsten rat sarcoma viral antigen‐mutant advanced non‐small‐cell lung cancer: a systematic review and network meta‐analysis Open
Background Recent advancements in advanced non‐small‐cell lung cancer (NSCLC) treatment have significantly improved primary therapy outcomes owing to the emergence of various molecular targeted therapies and immune checkpoint inhibitors (I…
View article: Physical, but not laboratory, treatment-related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis
Physical, but not laboratory, treatment-related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis Open
Background While the occurrence of immune-related adverse events has been recognized as a prognostic marker in patients receiving immune checkpoint inhibitors, the prognostic significance of treatment-related adverse events (trAEs) in pati…
View article: Integrated impact of multiple body composition parameters on overall survival in gastrointestinal or genitourinary cancers: A descriptive cohort study
Integrated impact of multiple body composition parameters on overall survival in gastrointestinal or genitourinary cancers: A descriptive cohort study Open
Background This study aimed to evaluate if combining low muscle mass with additional body composition abnormalities, such as myosteatosis or adiposity, could improve survival prediction accuracy in a large cohort of gastrointestinal and ge…
View article: A crossover comparison of patient satisfaction with two teriparatide regimens: primary results of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06)
A crossover comparison of patient satisfaction with two teriparatide regimens: primary results of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06) Open
Introduction This study aimed to compare treatment satisfaction with two dosing regimens (two teriparatide [TPTD] self-injection systems) in osteoporosis patients at high risk of fracture. Materials and methods In this open-label crossover…
View article: Safety and Effectiveness of LC16m8 for Pre-Exposure Prophylaxis against mpox in a High-Risk Population: An Open-Label Randomized Trial
Safety and Effectiveness of LC16m8 for Pre-Exposure Prophylaxis against mpox in a High-Risk Population: An Open-Label Randomized Trial Open
Background The incidence of mpox cases has surged outside endemic regions since May 2022. However, data regarding the safety and efficacy of the LC16m8 vaccine are limited. This study provided opportunities for LC16m8 pre-exposure prophyla…
View article: Blood perfusion with polymyxin B immobilized columns in patients with COVID-19 requiring oxygen therapy
Blood perfusion with polymyxin B immobilized columns in patients with COVID-19 requiring oxygen therapy Open
View article: Internet of things‐based approach for glycemic control in people with type 2 diabetes: A randomized controlled trial
Internet of things‐based approach for glycemic control in people with type 2 diabetes: A randomized controlled trial Open
Aims The utilization of long‐term effect of internet of things (IoT) on glycemic control is controversial. This trial aimed to examine the effect of an IoT‐based approach for type 2 diabetes. Materials and Methods This randomized controlle…
View article: A non-inferiority trial comparing the accuracy of classifying urinary gram-stain findings between an artificial intelligence smartphone-based application and microbiology specialists
A non-inferiority trial comparing the accuracy of classifying urinary gram-stain findings between an artificial intelligence smartphone-based application and microbiology specialists Open
Background Gram staining results interpreted by microbiology specialists (MS) were compared to a developed computer-aided diagnosis system (CAD) using artificial intelligence for interpretation. Methods Using a non-inferiority study, CAD-p…
View article: The development and analysis of a Japanese modern comprehensive clinical data management training program
The development and analysis of a Japanese modern comprehensive clinical data management training program Open
View article: Associations of concomitant medications with immune-related adverse events and survival in advanced cancers treated with immune checkpoint inhibitors: a comprehensive pan-cancer analysis
Associations of concomitant medications with immune-related adverse events and survival in advanced cancers treated with immune checkpoint inhibitors: a comprehensive pan-cancer analysis Open
Background While concomitant medications can affect the efficacy of immune checkpoint inhibitors (ICIs), few studies have assessed associations of concomitant medications with the occurrence and profile of immune-related adverse events (ir…
View article: Comparative effectiveness of tocilizumab vs standard care in patients with severe COVID-19-related pneumonia: a retrospective cohort study utilizing registry data as a synthetic control
Comparative effectiveness of tocilizumab vs standard care in patients with severe COVID-19-related pneumonia: a retrospective cohort study utilizing registry data as a synthetic control Open
View article: Myocardial DNA Damage Predicts Heart Failure Outcome in Various Underlying Diseases
Myocardial DNA Damage Predicts Heart Failure Outcome in Various Underlying Diseases Open
DNA damage determines the consequences of human heart failure. Assessment of DNA damage is useful to predict treatment efficacy and prognosis of heart failure patients with various underlying etiologies.
View article: Myocardial DNA damage combined with genotype predicts heart failure outcome in various underlying diseases
Myocardial DNA damage combined with genotype predicts heart failure outcome in various underlying diseases Open
Background Reliable predictors of treatment efficacy in heart failure have been long awaited. DNA damage has been implicated as a cause of heart failure. Purpose To investigate the association of DNA damage in myocardial tissue with treatm…
View article: Phase I and II randomized clinical trial of an oral therapeutic vaccine targeting human papillomavirus for treatment of cervical intraepithelial neoplasia 2 and 3
Phase I and II randomized clinical trial of an oral therapeutic vaccine targeting human papillomavirus for treatment of cervical intraepithelial neoplasia 2 and 3 Open
Background Although many human papillomavirus (HPV)–targeted therapeutic vaccines have been examined for efficacy in clinical trials, none have been translated into clinical use. These previous agents were mostly administered by intramuscu…
View article: Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial
Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial Open
Background Mycoplasma genitalium is an emerging sexually transmitted pathogen associated with increasing antibiotic resistance. The current treatment guidelines recommend moxifloxacin-sequential therapy for macrolide-resistant Mgenitalium …
View article: Neutralization against Omicron sublineages (BA.2/BA.5/BQ.1.1/XBB/XBB.1.5) in bivalent BNT162b2-vaccinated HCWs with or without risk factors, or following BT infection with Omicron
Neutralization against Omicron sublineages (BA.2/BA.5/BQ.1.1/XBB/XBB.1.5) in bivalent BNT162b2-vaccinated HCWs with or without risk factors, or following BT infection with Omicron Open
View article: Efficacy of Lactococcus lactis strain Plasma on clearance of anal HPV infection in men who have sex with men: A single-center, double-blinded, randomized placebo-controlled trial (CLEAR HPV study)
Efficacy of Lactococcus lactis strain Plasma on clearance of anal HPV infection in men who have sex with men: A single-center, double-blinded, randomized placebo-controlled trial (CLEAR HPV study) Open
Background: Anal cancer is a human papillomavirus-related cancer; specifically, it is preceded by high-grade squamous intraepithelial lesions, which are less likely to regress spontaneously than low-grade intraepithelial lesions. Although …