PMDA Perspective on Use of Real-World Data and Real-World Evidence as an External Control: Recent Examples and Considerations.

Recent discussions about the utilization of real-world data (RWD) and real-world evidence (RWE) have been more focused on drug development for regulatory approval rather than during the post-marketing stage. In Japan, RWD/RWE have been practically utilized as an external control for drug approval. Most cases were related to orphan diseases where the feasibility of conducting randomized controlled clinical trials was generally low.

Bipolar and Laplacian montages are suitable for high-gamma modulation language mapping with stereoelectroencephalography.

Objective: To determine the optimal montage and vocalization conditions for high-gamma language mapping using stereoelectroencephalography.

Methods: We studied 12 epilepsy patients who underwent invasive monitoring with depth electrodes and measurement of auditory-naming related high-gamma modulations. We determined the effects of electrode montage and vocalization conditions of the response on the high-gamma (60-140 Hz) amplitudes.

Feasibility of decoding covert speech in ECoG with a Transformer trained on overt speech.

Several attempts for speech brain-computer interfacing (BCI) have been made to decode phonemes, sub-words, words, or sentences using invasive measurements, such as the electrocorticogram (ECoG), during auditory speech perception, overt speech, or imagined (covert) speech. Decoding sentences from covert speech is a challenging task. Sixteen epilepsy patients with intracranially implanted electrodes participated in this study, and ECoGs were recorded during overt speech and covert speech of eight Japanese sentences, each consisting of three tokens.

Increased risk of incisional hernia after stoma closure in patients with colorectal cancer.

Purpose: Stoma construction and closure are common surgical strategies in patients with colorectal cancer. The present study evaluated the influence of multiple incisional sites resulting from stoma closure on incisional hernia after colorectal cancer surgery.

Methods: The study included 1681 patients who underwent colorectal cancer surgery.

Seizure onset zone identification using phase-amplitude coupling and multiple machine learning approaches for interictal electrocorticogram.

Automatic seizure onset zone (SOZ) localization using interictal electrocorticogram (ECoG) improves the diagnosis and treatment of patients with medically refractory epilepsy. This study aimed to investigate the characteristics of phase-amplitude coupling (PAC) extracted from interictal ECoG and the feasibility of PAC serving as a promising biomarker for SOZ identification. We employed the mean vector length modulation index approach on the 20-s ECoG window to calculate PAC features between low-frequency rhythms (0.

Clinical Significance of Controlling Nutritional Status (CONUT) Score in Patients With Colorectal Liver Metastases After Hepatectomy.

Background/aim: The prognostic outcome of the controlling nutritional status (CONUT) score in patients with colorectal liver metastases (CRLM) who underwent hepatectomy has not been investigated. The aim of this study was to investigate the prognostic value of preoperative CONUT score and other systemic inflammation-related biomarkers in patients who underwent hepatectomy for CRLM.

Patients And Methods: The subjects included 145 patients with CRLM who underwent hepatectomy and retrospectively investigated the association of preoperative CONUT score with disease-free survival (DFS), surgical failure-free survival (SFS), and overall survival (OS) using univariate and multivariate analyses.

Effect of vagus nerve stimulation against generalized seizure and status epilepticus recurrence.

Objective: Vagus nerve stimulation (VNS) is a palliative surgery for drug-resistant epilepsy. The two objectives of this study were to (1) determine the seizure type most responsive to VNS and (2) investigate the preventive effect on status epilepticus (SE) recurrence.

Methods: We retrospectively reviewed 136 patients with drug-resistant epilepsy who underwent VNS implantation.

Causal Connectivity Network Analysis of Ictal Electrocorticogram With Temporal Lobe Epilepsy Based on Dynamic Phase Transfer Entropy.

Temporallobe epilepsy (TLE) has been conceptualized as a brain network disease, which generates brain connectivity dynamics within and beyond the temporal lobe structures in seizures. The hippocampus is a representative epileptogenic focus in TLE. Understanding the causal connectivity in terms of brain network during seizures is crucial in revealing the triggering mechanism of epileptic seizures originating from the hippocampus (HPC) spread to the lateral temporal cortex (LTC) by ictal electrocorticogram (ECoG), particularly in high-frequency oscillations (HFOs) bands.

High-output stoma is a risk factor for stoma outlet obstruction in defunctioning loop ileostomies after rectal cancer surgery.

Purpose: Defunctioning loop ileostomy has been reported to reduce symptomatic anastomotic leakage after rectal cancer surgery; however, stoma outlet obstruction (SOO) is a serious postileostomy complication. We, therefore, explored novel risk factors for SOO in defunctioning loop ileostomy after rectal cancer surgery.

Methods: This is a retrospective study that included 92 patients who underwent defunctioning loop ileostomy with rectal cancer surgery at our institution.

Proper Therapy Selection Improves Epilepsy Outcomes in Patients With Multilobar Sturge-Weber Syndrome.

Background: Hemispherectomy is an optimal treatment for patients with Sturge-Weber syndrome (SWS) affecting the whole hemisphere; however, a consensus has not been reached regarding therapeutic choices for those with involvement of two to three lobes. In this study, we compared seizure and cognitive outcomes between medical and surgical treatment groups in patients with multilobar involvement.

Methods: We evaluated 50 patients with multilobar involvement.

An integrated genetic analysis of epileptogenic brain malformed lesions.

Focal cortical dysplasia is the most common malformation during cortical development, sometimes excised by epilepsy surgery and often caused by somatic variants of the mTOR pathway genes. In this study, we performed a genetic analysis of epileptogenic brain malformed lesions from 64 patients with focal cortical dysplasia, hemimegalencephy, brain tumors, or hippocampal sclerosis. Targeted sequencing, whole-exome sequencing, and single nucleotide polymorphism microarray detected four germline and 35 somatic variants, comprising three copy number variants and 36 single nucleotide variants and indels in 37 patients.

[A Report on Health Resource Use of Internal Radiation Therapy with I-MIBG (2 Survey)].

Internal radiation therapy using Iodine-131 metaiodobenzylguanidine (I-MIBG) for neuroblastoma has been discussed whether a special application scheme for off-labeled drugs called "Kouchi-Shinsei" could be applied to neuroblastoma or not by the Evaluation Committee on Unapproved or Off-labeled Drug with High Medical Needs (the Committee); if the Committee determines that Kouchi-Shinsei is applicable, neuroblastoma indication is expected to be regulatory approved within a year. Since a NHI medical technical fee is not yet set for neuroblastoma, the Japanese Society of Nuclear Medicine surveyed health resource use via a questionnaire survey of medical institution that has conducted a Japanese Advanced Medical Care B clinical study in neuroblastoma. Results showed that the necessary total cost per patient is 1,847,451 JPY when calculated based on the Draft Proposal for Medical Examination Value (Ver.

Chronological changes in phase-amplitude coupling during epileptic seizures in temporal lobe epilepsy.

Objective: To analyze chronological changes in phase-amplitude coupling (PAC) and verify whether PAC analysis can diagnose epileptogenic zones during seizures.

Methods: We analyzed 30 seizures in 10 patients with mesial temporal lobe epilepsy who had ictal discharges with preictal spiking followed by low-voltage fast activity patterns on intracranial electroencephalography. We used the amplitude of two high-frequency bands (ripples: 80-200 Hz, fast ripples: 200-300 Hz) and the phase of three slow wave bands (0.

Epileptic seizure focus detection from interictal electroencephalogram: a survey.

Electroencephalogram (EEG) is one of most effective clinical diagnosis modalities for the localization of epileptic focus. Most current AI solutions use this modality to analyze the EEG signals in an automated manner to identify the epileptic seizure focus. To develop AI system for identifying the epileptic focus, there are many recently-published AI solutions based on biomarkers or statistic features that utilize interictal EEGs.

[Implanted Electrical Stimulation].

Neuromodulation therapy for epilepsy is the third treatment option after medical treatment with antiepileptic drugs and surgical treatment, such as epileptic focal resection. In addition to vagus nerve stimulation(VNS), deep brain stimulation(DBS)and responsive neurostimulation(RNS)have been approved in several countries. These therapies consist of an implantable device and stimulating electrodes.

Epileptic seizure detection by using interpretable machine learning models.

Accurate detection of epileptic seizures using electroencephalogram (EEG) data is essential for epilepsy diagnosis, but the visual diagnostic process for clinical experts is a time-consuming task. To improve efficiency, some seizure detection methods have been proposed. Regardless of traditional or machine learning methods, the results identify only seizures and non-seizures.

Seizure onset zone classification based on imbalanced iEEG with data augmentation.

. Identifying the seizure onset zone (SOZ) in patients with focal epilepsy is the critical information required for surgery. However, collecting this information is challenging, time-consuming, and subjective.

Short-term Postoperative Outcomes of Colorectal Cancer Patients With Chronic Renal Failure on Dialysis.

Background/aim: Surgery for dialysis patients requires special attention because of their physical characteristics. This study aimed to investigate the short-term postoperative outcomes of colorectal cancer patients with chronic renal failure (CRF) on dialysis and aimed to investigate safer treatment options for these patients.

Patients And Methods: A total of 1,504 colorectal cancer patients who underwent primary resection between January 2008 and December 2018 were included.

Satelight: self-attention-based model for epileptic spike detection from multi-electrode EEG.

Because of the lack of highly skilled experts, automated technologies that support electroencephalogram (EEG)-based in epilepsy diagnosis are advancing. Deep convolutional neural network-based models have been used successfully for detecting epileptic spikes, one of the biomarkers, from EEG. However, a sizeable number of supervised EEG records are required for training.

[Reactivation of latent viruses in Neurology].

After establishing latent infection, some viruses can be reactivated by the alteration of host immunological conditions. First, we reviewed viruses that can cause neuronal damage by reactivation. Then we focused on the herpes simplex virus (HSV).