Background: Avelumab + axitinib was approved for the treatment of advanced renal cell carcinoma (aRCC) in Japan in December 2019. We report long-term real-world subgroup analyses with first-line avelumab + axitinib in patients with aRCC by International Metastatic RCC Database Consortium (IMDC) risk classification from the J-DART2 study in Japan.
Methods: J-DART2 was a multicenter, noninterventional, retrospective study examining characteristics, treatment patterns, and outcomes in patients with aRCC who started first-line avelumab + axitinib in Japan between December 2019 and October 2022.
Introduction: Avelumab + axitinib was approved in Japan in December 2019 for the treatment of curatively unresectable or metastatic renal cell carcinoma (RCC) based on results from the JAVELIN Renal 101 trial.
Materials And Methods: To evaluate the safety and effectiveness of avelumab + axitinib in older patients in general clinical practice in Japan, an ad hoc analysis of data from post-marketing surveillance (PMS) by age group was conducted.
Results: The analysis population included 328 patients who had received ≥1 dose of avelumab and were enrolled between December 2019 and May 2021.
Introduction: Avelumab, an anti-programmed death ligand 1 antibody, was approved in combination with axitinib for curatively unresectable or metastatic renal cell carcinoma (RCC) in Japan in December 2019. Because the pivotal JAVELIN Renal 101 study included a limited number of Japanese patients, post-marketing surveillance (PMS) was required to evaluate outcomes (safety and effectiveness) in patients with RCC who received avelumab + axitinib treatment in clinical practice in Japan.
Materials And Methods: We report data from prospective, noncomparative, multicenter, observational PMS in patients with RCC who received ≥ 1 dose of avelumab.
Objective: Clinical trials have demonstrated the efficacy and safety of avelumab + axitinib in patients with advanced clear cell renal cell carcinoma (ccRCC). However, information is limited regarding the activity of avelumab + axitinib in patients with non-clear cell RCC (nccRCC). In Japan, post-marketing surveillance (PMS) of patients with RCC receiving avelumab + axitinib treatment in general clinical practice was undertaken.
View Article and Find Full Text PDFTraumatic middle meningeal artery aneurysm (TMMA) is a rare condition and a known cause of several different bleeding patterns after head injury. Once detected, they need to be treated as an emergency due to their potential for morbidity and mortality. Generally, recurrence does not occur in surgery for acute epidural hematoma if adequate hemostasis is achieved.
View Article and Find Full Text PDFStud Health Technol Inform
November 2024
Architecture still excludes users despite decades of increased attention towards the designing of built environments to accommodate all. Partially, this grand problem is due to the uncertainty and plurality of future usage, which challenge architects in identifying potentially excluding mechanisms of their designs. Common approaches in responding to these challenges are either top-down assessment of architecture, or bottom-up collection of situated accounts from users.
View Article and Find Full Text PDFStud Health Technol Inform
November 2024
Current studies at the intersection between architecture and disability focus on addressing the immediate needs of disabled individuals and often overlook the potential of built environments to create positive experiences. Additionally, conventional approaches for investigating disabled people's spatial experiences often fail to capture the inherent nuanced sensory and emotional aspects. This paper describes the process of filmmaking and the use of film to explore its contributions and limitations in the understanding on how personal and contextual factors influence individuals' positive spatial experiences.
View Article and Find Full Text PDFBackground: Avelumab + axitinib was approved for advanced renal cell carcinoma (aRCC) in Japan in December 2019. We report long-term real-world outcomes with first-line avelumab + axitinib from the J-DART2 study in Japan.
Methods: J-DART2 was a multicenter, noninterventional, retrospective study examining clinical data from patients with curatively unresectable locally advanced or metastatic RCC who started treatment with first-line avelumab + axitinib in Japan between December 2019 and October 2022.
The main goals of acquired hemophilia A (AHA) therapy are to arrest bleeding using bypass agents and eradicate FVIII inhibitors using immunosuppressive therapy (IST). We treated a total of 25 patients with AHA in the past 10 years at Gunma University Hospital. Fifteen patients (60%) underwent rehabilitation during hospitalization.
View Article and Find Full Text PDFThe choroid plexus is the secretory tissue responsible for cerebrospinal fluid production in the brain. Ischemia of the choroid plexus is rare because of its abundant blood supply from multiple arterial systems, including the anterior and posterior choroidal arterial anastomoses. It is not clear under what circumstances isolated choroid plexus infarction occurs.
View Article and Find Full Text PDFBackground: Carotid artery dissection is a common cause of ischemic stroke, predominantly affecting the internal carotid artery, with rare involvement of the common carotid artery (CCA). The limited literature makes diagnosis and management challenging, particularly in asymptomatic patients. In this report, the authors present a unique case of spontaneous, asymptomatic CCA dissection that resembled a carotid web, shedding light on its clinical spectrum and management.
View Article and Find Full Text PDFSymptomatic cerebellar cyst formation after surgery is rare and the mechanism remains unknown. We describe a cerebellar cyst that gradually expanded, becoming symptomatic, after the removal of a foramen magnum meningioma and discuss the mechanism of cyst formation. A 76-year-old woman with a tumor at the foramen magnum was treated by posterior fossa craniotomy and C1 hemilaminectomy.
View Article and Find Full Text PDFBackground: Neurenteric cysts are relatively rare benign congenital intracranial cystic lesions that enlarge rarely and very slowly. The authors present a case of an enlarging neurenteric cyst at the craniocervical junction with a fluid-fluid level on magnetic resonance imaging (MRI).
Observations: A 34-year-old man with no significant medical history underwent head MRI to investigate mild headaches.
Objectives: The JAVELIN Bladder 100 phase 3 trial showed that avelumab first-line maintenance + best supportive care significantly prolonged overall survival and progression-free survival versus best supportive care alone in patients with advanced urothelial carcinoma who were progression-free following first-line platinum-based chemotherapy. We report findings from J-AVENUE (NCT05431777), a real-world study of avelumab first-line maintenance therapy in Japan.
Methods: Medical charts of patients with advanced urothelial carcinoma without disease progression following first-line platinum-based chemotherapy, who received avelumab maintenance between February and November 2021, were reviewed.
Background: Spontaneous intracranial hypotension (SIH) is a rare condition characterized by positional headache, for which contrast-enhanced magnetic resonance imaging (MRI) is the preferred diagnostic method. Although MRI reveals characteristic findings, head computed tomography (CT) is usually the first diagnostic step, but identifying features of SIH on CT is often difficult. This study was specifically designed to evaluate the utility of head CT in detecting upper cervical epidural venous engorgement as a sign of SIH.
View Article and Find Full Text PDFBiochem Biophys Res Commun
February 2024
Regulated intramembrane proteolysis (RIP) is a two-step processing mechanism for transmembrane proteins consisting of ectodomain shedding (shedding), which removes the extracellular domain through juxtamembrane processing and intramembrane proteolysis, which processes membrane-anchored shedding products within the transmembrane domain. RIP irreversibly converts one transmembrane protein into multiple soluble proteins that perform various physiological functions. The only requirement for the substrate of γ-secretase, the major enzyme responsible for intramembrane proteolysis of type I transmembrane proteins, is the absence of a large extracellular domain, and it is thought that γ-secretase can process any type I membrane protein as long as it is shed.
View Article and Find Full Text PDFBackground: Rasagiline is a monoamine oxidase B inhibitor for the treatment of Parkinson's disease (PD). This study assessed the safety and effectiveness of rasagiline in patients with PD in routine clinical practice in Japan.
Research Design And Methods: This multicenter, prospective, observational study (148 sites) enrolled patients (1 November 2018-31 October 2020) with PD.
We evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LV) to find a new usefulness of low frequency (LF) Raman spectroscopy. LV contained dispersed granules with diameters in the order of several hundred micrometers, which were composed of the active pharmaceutical ingredient (API), as confirmed by infrared (IR) microspectroscopy. On the contrary, the API and inactive pharmaceutical ingredients (non-APIs) were homogeneously distributed in LV tablet (LV) formulations.
View Article and Find Full Text PDFBackground: Twig-like middle cerebral artery (T-MCA) is a rare vascular abnormality characterized by the replacement of the M1 segment of the middle cerebral artery (MCA) with a plexiform arterial network of small vessels. T-MCA is generally regarded as an embryological persistence. Conversely, T-MCA may also be a secondary sequela but no reports of cases of formation exist.
View Article and Find Full Text PDFBackground: Intracranial arachnoid cysts (ACs) are developmental anomalies usually filled with cerebrospinal fluid (CSF), rarely resolving throughout life. Here, we present a case of an AC with intracystic hemorrhage and subdural hematoma (SDH) that developed after a minor head injury before gradually disappearing. Neuroimaging demonstrated specific changes from hematoma formation to AC disappearance over time.
View Article and Find Full Text PDFIntroduction: This ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three doses of vedolizumab.
Methods: Patients were enrolled via a web-based electronic data capture system from approximately 250 institutions.
An 86-year-old Japanese male patient visited a nearby hospital with painful swelling in his left upper and lower limbs 35 days after the second dose of the BNT162b2 mRNA coronavirus disease-2019 (COVID-19) vaccine. He was referred to our hematological department due to a prolonged activated partial thromboplastin time and was urgently admitted. He was diagnosed with acquired hemophilia A (AHA) based on factor VIII (FVIII) activity of 1.
View Article and Find Full Text PDFBackground: Most coronavirus disease 2019 (COVID-19)-related cerebrovascular disorders are ischemic while hemorrhagic disorders are rarely reported. Among these, subarachnoid hemorrhage (SAH) is very rarely reported and nonaneurysmal SAH has been reported in only about a dozen cases. Here, we report a case of nonaneurysmal SAH as the only clinical manifestation of COVID-19 infection.
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