Appropriate Relevancy and Reliability of Real-World Data for the Utilization of Regulatory Submission.

The extraction of data that contribute to regulatory approval from real-world data (RWD) is difficult because of the lack of a standardized data format and extraction methodology. Additionally, when real-world evidence (RWE) is used as an external control group, the similarity between internal and external control data is not evaluated. To investigate the data extraction methodology for the external control data of rare molecular subtypes, we have initiated the "REALISE" study.

Vulvar Adenoid Cystic Carcinoma with Squamous Cell Carcinoma Component.

Adenoid cystic carcinoma (ACC) is a major histological type of salivary gland cancer but an uncommon form of vulvar cancer. Salivary gland ACC occasionally dedifferentiates into high-grade carcinoma, resulting in poor prognoses. The dedifferentiated component is usually a poorly differentiated cribriform or solid carcinoma, whereas squamous cell carcinoma (SCC) is exceptional.

Conducting and Writing Quantitative and Qualitative Research.

Comprehensive knowledge of quantitative and qualitative research systematizes scholarly research and enhances the quality of research output. Scientific researchers must be familiar with them and skilled to conduct their investigation within the frames of their chosen research type. When conducting quantitative research, scientific researchers should describe an existing theory, generate a hypothesis from the theory, test their hypothesis in novel research, and re-evaluate the theory.

Trajectory for the Regulatory Approval of a Combination of Pertuzumab Plus Trastuzumab for Pre-treated HER2-positive Metastatic Colorectal Cancer Using Real-world Data.

Utilizing real-world data (RWD) for effective clinical implementation is becoming more and more appealing as the cost of drug development rises, especially for patients with rare diseases and rare molecular subtypes for whom conducting randomized controlled trials is challenging. If a regulatory approval methodology based on RWD as an external control group can be established, drug development for rarer fractions can be accelerated by lowering costs and time, as well as reducing physical and emotional burdens on both patients and healthcare professionals. Since 2017, we have been prospectively collecting the clinical data of standard therapies in patients with rare molecular fractions under the SCRUM-Japan Registry platform, which is a qualified registry utilized as external control data for regulatory submission.

Substantial improvement of histopathological diagnosis by whole-slide image-based remote consultation.

Consultation by subspecialty experts is the most common mode of rendering diagnosis in challenging cases in pathological practice. Our study aimed to highlight the diagnostic benefits of whole-slide image (WSI)-based remote consultation. We obtained diagnostically challenging cases from two institutions from the years 2010 and 2013, with histological diagnoses that contained keywords "probable," "suggestive," "suspicious," "inconclusive," and "uncertain.

Successful embolization of an intrahepatic portosystemic shunt using balloon-occluded retrograde transvenous obliteration: A case report.

Background: A congenital intrahepatic portosystemic shunt (IPSVS) is a rare vascular abnormality that is characterized by an anomalous intrahepatic venous tract that connects the intrahepatic portal vein with the hepatic venous system. Hepatic encephalopathy is an indication for IPSVS embolization, which is technically challenging because rapid blood flow through shunts can induce the migration of embolization material to systemic veins. This case report discusses the efficacy of percutaneous balloon-occluded retrograde transvenous obliteration for treating patients with IPSVSs.

Reduced expression of programmed cell death 1 and programmed cell death ligand 1 in infiltrating inflammatory cells of lichen planus without administration of immune checkpoint inhibitors.

Keratinocytes are the main targets of infiltrating T cells in the pathogenesis of lichen planus. However, the mechanisms of dense inflammatory infiltrates beneath the epidermis remain unknown. The aim of the present study was to clarify the roles of programmed cell death 1 (PD-1) and its ligand (PD-L1) in the pathogenesis of lichen planus.

A Comparison of Outcomes Based on Vessel Type (Native Artery vs. Bypass Graft) and Artery Location (Below-Knee Artery vs. Non-Below-Knee Artery) Using a Combination of Multiple Endovascular Techniques for Acute Lower Limb Ischemia.

Background: To evaluate outcomes of endovascular treatment (EVT) using a combination of multiple endovascular techniques for acute lower limb ischemia (ALLI) and to compare outcomes based on vessel type and artery location.

Methods: A total of 95 consecutive patients with ALLI (mean age, 72.0 years; 65 males; 104 lower limbs) who received emergency EVT using a combination of multiple endovascular techniques including thrombolysis, aspiration thrombectomy, stenting, and balloon angioplasty with or without surgical thromboembolectomy, between January 2005 and December 2017 were included.

Factors associated with the mental health status of medical students during the COVID-19 pandemic: a cross-sectional study in Japan.

Objective: The COVID-19 pandemic had a substantial impact on university students, including those in medical schools, with disruption in routine education causing significant psychological distress. The objective of this study was to evaluate the factors associated with psychological distress among medical students during the period of enforced home quarantine from March through May 2020.

Design: A cross-sectional study.

FMS-like tyrosine kinase 3 (FLT3) amplification in patients with metastatic colorectal cancer.

FMS-like tyrosine kinase 3 (FLT3) plays a key role in hematopoiesis. However, the oncogenic role of FLT3 amplification in patients with metastatic colorectal cancer (mCRC) remains unclear. Here, we aimed to evaluate the characteristics, prognosis, and treatment efficacy of an FLT3 inhibitor (regorafenib) in patients with mCRC with FLT3 amplifications.

Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies.

Comprehensive genomic profiling enables genomic biomarker detection in advanced solid tumors. Here, to evaluate the utility of circulating tumor DNA (ctDNA) genotyping, we compare trial enrollment using ctDNA sequencing in 1,687 patients with advanced gastrointestinal (GI) cancer in SCRUM-Japan GOZILA (no. UMIN000016343), an observational ctDNA-based screening study, to enrollment using tumor tissue sequencing in the same centers and network (GI-SCREEN, 5,621 patients).

Idiopathic Orbital Inflammation Appearing on the Affected Side of Preceding Myasthenia Gravis.

The patient was a 70-year-old man with idiopathic orbital inflammation (IOI) that appeared on the severely affected side of preceding myasthenia gravis (MG). The patient was diagnosed with MG 5 years prior to the onset of IOI. When IOI was diagnosed, an edrophonium test was negative.

Brain metastasis from cutaneous squamous cell carcinoma coexistent with extramammary Paget's disease: A case report.

We report a case of cutaneous squamous cell carcinoma (CSCC), initially coexisting with invasive extramammary Paget's disease (EMPD), in the scrotum of an 84-year-old man. The patient initially had a rash and pruritus before presenting with a pedunculated scrotal mass surrounded by widespread erythema. He underwent total gastrectomy for adenocarcinoma 1 year previously and had been receiving TS-1 (Tegafur/Gimeracil/Oteracil pottasium) orally.

Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms due to lamotrigine differs from that due to other drugs.

Drug-induced hypersensitivity syndrome (DIHS), also referred to as drug reaction with eosinophilia and systemic symptoms (DRESS), is a multi-organ systemic drug reaction characterized by hematological abnormalities and reactivation of human herpesvirus-6 (HHV-6). DIHS/DRESS is typically associated with a limited number of drugs, such as the anticonvulsants. Our group has treated 12 patients for DIHS/DRESS due to lamotrigine (LTG), but their presentation differed from that of patients with DIHS/DRESS caused by other drugs.

A Case of Primary Cutaneous Basal Cell Carcinosarcoma.

A 94-year-old man consulted our hospital due to a rapidly growing tumor on the left cheek. The histological diagnosis of the tumor was basal cell carcinosarcoma, which was composed of intermingled epithelial and mesenchymal components. The former was basal cell carcinoma, while the latter was spindle cell sarcoma.

Feasibility study of cancer genome alterations identified by next generation sequencing: ABC study.

Background: To confirm the feasibility and explore the clinical applicability of amplicon sequencing by next generation sequencing (NGS) of biopsy samples from patients with advanced solid tumors, we conducted a prospective study.

Methods: Patients with unresectable, advanced, or recurrent solid tumors were included. Key eligibility criteria were as follows: 20 years or older, any planned systemic therapy, adequate lesion for biopsy, and written informed consent.

Evaluation of the relationship between hepatocellular carcinoma location and transarterial chemoembolization efficacy.

Aim: To evaluate the relationship between the location of hepatocellular carcinoma (HCC) and the efficacy of transarterial chemoembolization (TACE).

Methods: We evaluated 115 patients (127 nodules), excluding recurrent nodules, treated with TACE between January 2011 and June 2014. TACE efficacy was evaluated according to mRECIST.

Endovascular Treatment Strategy Using Catheter-Directed Thrombolysis, Percutaneous Aspiration Thromboembolectomy, and Angioplasty for Acute Upper Limb Ischemia.

Purpose: To evaluate the usefulness and safety of endovascular treatments for acute upper limb ischemia (AULI) by using multiple techniques, and to compare catheter-directed thrombolysis (CDT) and percutaneous aspiration thromboembolectomy (PAT) as initial procedures.

Materials And Methods: The study included 18 patients (4 men and 14 women) with AULI, who underwent a total of 20 sessions of endovascular treatment using various endovascular techniques between January 2005 and April 2016. The patients were initially treated with CDT [n = 9, CDT-based group (C-G)], PAT [n = 6, PAT-based group (P-G)], or angioplasty (n = 3).

Epidemiology of Adverse Events and Medical Errors in the Care of Cardiology Patients.

Objectives: There have been epidemiological studies of adverse events (AEs) among general patients but those of patients cared by cardiologist are not well scrutinized. We investigated the occurrence of AEs and medical errors (MEs) among adult patients with cardiology in Japan.

Methods: We conducted a cross-sectional study of adult outpatients at a Japanese teaching hospital from February through November 2006.