Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection.

Background: Chronic hepatitis C virus (HCV) infection with genotypes (GT) 1 and 2 accounts for over 50% of HCV infections globally, including over 97% of all HCV infections in Japan. Here, we report an integrated analysis of efficacy and safety of 8-week treatment with the all-oral, fixed-dose combination of the direct acting antivirals (DAA), glecaprevir and pibrentasvir (G/P), in DAA-naïve Japanese and overseas patients without cirrhosis and with HCV GT1 or GT2 infection.

Methods: Data from 899 DAA-naïve patients without cirrhosis and with HCV GT1 or GT2 infection treated with G/P (300/120 mg) for 8 weeks in the six Phase 2 or 3 overseas or Japan-only clinical trials were included.

Most Important Prognostic Values to Predict Major Adverse Cardiovascular, Cerebrovascular, and Renal Events in Patients with Chronic Kidney Disease Including Hemodialysis for 2 Years.

Patients with chronic kidney disease (CKD) have an increased risk of adverse cardiovascular/cerebrovascular events. The aim of this study is to clarify whether stress myocardial perfusion single-photon emission computed tomography (SPECT) could predict cardiovascular/cerebrovascular events. In the Gunma-CKD SPECT Study, a multicenter prospective cohort trial, 311 patients with CKD (estimated glomerular filtration rate < 60 min/mL/1.

Adenosquamous Carcinoma of the Choledochus.

The patient was an 86-year-old man who was admitted with obstructive jaundice. Computed tomography revealed a tumor in the hilar choledochus with peripheral hepatic duct dilatation. Endoscopic cholangiography (ERC) demonstrated the defect in the choledochus.

Local recurrence of diminutive colorectal polyps after cold forceps polypectomy with jumbo forceps followed by magnified narrow-band imaging: a multicenter prospective study.

Background: Cold polypectomy has been increasingly used to remove diminutive colorectal polyps. We evaluated the local recurrence rate of diminutive polyps at the 1-year follow-up after cold forceps polypectomy (CFP).

Methods: In a prospective, multicenter, observational cohort study, patients with diminutive colorectal polyps ( ≤ 5 mm) were treated by CFP using jumbo forceps followed by magnified narrow-band imaging (NBI).

β-Hydroxy-β-methyl Butyrate/L-Arginine/L-Glutamine Supplementation for Preventing Hand-Foot Skin Reaction in Sorafenib for Advanced Hepatocellular Carcinoma.

Background/aim: Sorafenib is standard treatment for advanced hepatocellular carcinoma (HCC). Hand-foot skin reaction (HFSR) is a notorious side-effect of this therapy. This study evaluated prophylactic benefits of an oral nutritional supplement (ONS) on sorafenib-associated HFSR in advanced HCC.

The impact of histology and ground-glass opacity component on volume doubling time in primary lung cancer.

Background: Correlations between volume doubling time (VDT) of primary lung cancer (PLC), histology, and ground glass opacity (GGO) components remain unclear. The purpose of this study was to evaluate and compare VDT of PLC in terms of histology and presence or absence of GGO components.

Methods: A total of 371 surgically resected PLCs from 2003 to 2015 in our institute were retrospectively reviewed.

Prognostic significance of PD-L1 expression and tumor infiltrating lymphocytes in large cell neuroendocrine carcinoma of lung.

Objectives: Since large cell neuroendocrine carcinoma (LCNEC) is a relatively rare histologic type of primary lung cancer, little is known about the immunological status of patients with LCNEC. We aimed to clarify the expression and prognostic impact of programmed cell death ligand 1 (PD-L1), CD8, CD4, and Forkhead box protein P3 (Foxp3) in LCNEC.

Methods: We retrospectively analyzed PD-L1, CD8, CD4, and Foxp3 expressions in 95 surgically resected LCNEC.

Mandibular Reconstruction with Free Vascularized Fibular Graft.

An iliac block graft is the most commonly used biomaterial for reconstruction following resection of the mandible. Its use has some disadvantages, however, including limitations on the amount of bone that may be harvested, and the subsequent increase in burden on the iliac bone. Therefore, recently, free vascularized fibular grafts have been used as an alternative in some cases.

An electrical scalpel conization versus Shimodaira-Taniguchi conization procedure for cervical intraepithelial neoplasia.

The incidence of cervical intraepithelial neoplasia(CIN) among reproductive-aged women has increased in Japan. Cervical conization is commonly applied for local cervical treatment to preserve fertility. The Shimodaira-Taniguchi (S-T) conization procedure is widely used in Japan.

Intratumoral Hemorrhage of Liver Metastasis from a Rectal Neuroendocrine Tumor.

A 56-year-old healthy woman was referred to our hospital for abdominal pain. Contrast-enhanced computed tomography (CT) showed a 14-cm-diameter liver tumor with intratumoral hemorrhage. We performed emergent transcatheter arterial embolization.

Utilizing a low-cost desktop 3D printer to develop a "one-stop 3D printing lab" for oral and maxillofacial surgery and dentistry fields.

Background: In the oral and maxillofacial surgery and dentistry fields, the use of three-dimensional (3D) patient-specific organ models is increasing, which has increased the cost of obtaining them. We developed an environment in our facility in which we can design, fabricate, and use 3D models called the "One-stop 3D printing lab". The lab made it possible to quickly and inexpensively produce the 3D models that are indispensable for oral and maxillofacial surgery.

[Charcot-Marie-Tooth disease showing transient central nervous system lesions after a large amount of alcohol intake: A case report].

A 23-year-old man experienced numbness in the perioral region and right arm, and right leg weakness on the second day after drinking a large amount of alcohol during foreign travel. His symptoms disappeared but then reappeared repetitively. Cerebral MRI performed on the third day after onset showed multiple white matter lesions; however, these lesions disappeared 26 days after onset.

Use of a Total Variation Minimization Iterative Reconstruction Algorithm to Evaluate Reduced Projections during Digital Breast Tomosynthesis.

Purpose: We evaluated the efficacies of the adaptive steepest descent projection onto convex sets (ASD-POCS), simultaneous algebraic reconstruction technique (SART), filtered back projection (FBP), and maximum likelihood expectation maximization (MLEM) total variation minimization iterative algorithms for reducing exposure doses during digital breast tomosynthesis for reduced projections.

Methods: Reconstructions were evaluated using normal (15 projections) and half (i.e.

What Is the Appropriate Reference for Evaluating the Recovery of Supraspinatus Muscle Atrophy After Arthroscopic Rotator Cuff Repair? The Occupation Ratio of the Supraspinatus May Change After Rotator Cuff Repair Without Volumetric Improvement.

Background: Supraspinatus muscle atrophy is typically assessed by the occupation ratio of the cross-sectional area of the muscle belly to the supraspinatus fossa at the medial border of the coracoid process in a slice along the oblique-sagittal plane on MRI. Previous studies have shown that the occupation ratio of the supraspinatus changed soon after rotator cuff repair compared with before surgery. However, no studies have examined the perioperative change in the muscle volume assessed with 3-dimensional measurement.

Expansions of intronic TTTCA and TTTTA repeats in benign adult familial myoclonic epilepsy.

Epilepsy is a common neurological disorder, and mutations in genes encoding ion channels or neurotransmitter receptors are frequent causes of monogenic forms of epilepsy. Here we show that abnormal expansions of TTTCA and TTTTA repeats in intron 4 of SAMD12 cause benign adult familial myoclonic epilepsy (BAFME). Single-molecule, real-time sequencing of BAC clones and nanopore sequencing of genomic DNA identified two repeat configurations in SAMD12.

Potent viral suppression and improvements in alpha-fetoprotein and measures of fibrosis in Japanese patients receiving a daclatasvir/asunaprevir/beclabuvir fixed-dose combination for the treatment of HCV genotype-1 infection.

Background: In the UNITY-3 study, 96% sustained virologic response (SVR12) rate was observed in Japanese patients with hepatitis C virus (HCV) genotype (GT)-1 infection treated for 12 weeks with fixed-dose daclatasvir, asunaprevir, and beclabuvir (DCV-TRIO). As HCV clearance may improve liver outcomes, we assessed hepatic fibrosis and alpha-fetoprotein (AFP), a hepatocellular carcinoma risk marker, pre- and post-treatment in UNITY-3.

Methods: Treatment-naive or interferon-experienced UNITY-3 patients with HCV GT-1 who received twice-daily DCV-TRIO were assessed for fibrosis [FibroTest; FibroScan; fibrosis-4 index (FIB-4), aspartate-aminotransferase-to-platelet-ratio index] and AFP at baseline and Weeks 4 (FIB-4 only), 12 or 24 post-treatment.

Phase II Study of S-1 plus Trastuzumab for HER2-positive Metastatic Breast Cancer (GBCCSG-01).

Aim: Treatment strategies for patients with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer (MBC) have significantly progressed. The use of trastuzumab, a monoclonal antibody targeting the HER2 (human epidermal growth factor 2) protein, in combination with chemotherapy improves survival in patients with HER2-positive breast cancer. S-1, an oral combination of fluorouracil derivatives, is widely used in Japan and is more convenient than intravenous drugs.

Clinical Outcome of Arthroscopic Remplissage as Augmentation During Arthroscopic Bankart Repair for Recurrent Anterior Shoulder Instability.

Purpose: We aimed to assess functional outcomes and postoperative recurrence rate associated with the remplissage procedure used for bone augmentation with Bankart repair in patients with Hill-Sachs lesions after shoulder dislocation.

Methods: Preoperative computed tomography was performed to check for bony Bankart lesions,calculate the bone defect rate, and estimate the risk for re-dislocation. Functional and clinical scores were assessed preoperatively and at three months, six months, and one year postoperatively.

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

Aim: The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out.

Methods: Subjects with grade I or II HE and hyperammonemia were enrolled.

Systemic metabolism and energy consumption after microsurgical clipping and endovascular coiling for aneurysmal subarachnoid hemorrhage.

Background: The postoperative metabolic states of subarachnoid hemorrhage (SAH) patients were investigated using indirect calorimetry (IDC) and various nutritional evaluations to establish any difference in perioperative metabolic and nutritional states between microsurgical and endovascular treatment.

Methods: This study included 30 acute aneurysmal SAH patients with ruptured intracranial aneurysms treated by surgical clipping (n = 16) or coil embolization (n = 14) at a single institute. The resting energy expenditure (REE) and respiratory quotient were measured using IDC on days 1, 4, 7, 10, 14, and 17-21 after the operation.

Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis.

Background: The once-daily, all oral, RBV-free, pangenotypic direct-acting anti-viral regimen consisting of co-formulated NS3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir (G/P), demonstrated high rates of sustained virologic response (SVR) in phase 2 and 3 studies outside Japan.

Methods: CERTAIN-1 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in Japanese patients with chronic HCV GT1 infection. Patients without cirrhosis received 8 weeks of G/P or 12 weeks of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r, 25/150/100 mg); patients with cirrhosis received G/P for 12 weeks.

Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection.

Glecaprevir (nonstructural protein 3/4A protease inhibitor) and pibrentasvir (nonstructural protein 5A inhibitor) (G/P), a coformulated once-daily, all oral, ribavirin (RBV)-free, direct-acting antiviral regimen, was evaluated for safety and efficacy in hepatitis C virus genotype 2 (GT2)-infected Japanese patients, including those with compensated cirrhosis. CERTAIN-2 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in treatment-naive and interferon ± RBV treatment-experienced Japanese patients without cirrhosis but with GT2 infection. Patients were randomized 2:1 to receive 8 weeks of G/P (arm A) or 12 weeks of sofosbuvir (400 mg once daily) + RBV (600-1000 mg weight-based, twice daily) (arm B).

Segmental Aplasia of Bilateral Internal Carotid Arteries Accompanied by Intracranial Aneurysms: A Case Report.

A 68-year-old woman presented with segmental aplasia of bilateral internal carotid arteries accompanied by unruptured intracranial aneurysms. The abnormality was discovered incidentally at the age of 44 years. Cerebral angiography showed occlusion of bilateral internal carotid arteries, and the carotid territory was supplied by each posterior communicating artery with small intracranial aneurysms.

Elevated serum uric acid level was a notable adverse event during combination therapy with sofosbuvir and ribavirin.

Aim: Combination therapy with sofosbuvir and ribavirin (SOF/RBV) has been recently available for chronic hepatitis C patients with genotype 2 (CHG2) in Japan. The domestic phase III clinical trial showed a high antiviral effect with a relatively safe adverse event (AE) profile. Our aim was to report an important AE detected during treatment.