Publications by authors named "Manabu Kano"

Background: The present study investigated the acute mucosal reaction (AMR) after high-dose-rate interstitial brachytherapy at 54 Gy/9 fractions (HDR54) as monotherapy administered twice a day for tongue cancer in 13 patients, and attempted to validate HDR54 by comparing the AMR with that of our previously reported HDR at 60 Gy/10 fractions (HDR60), and low-dose-rate interstitial brachytherapy at approximately 70 Gy (LDR70).

Methods: The European Organization for Research on Treatment of Cancer/ Radiation Therapy Oncology Group scoring system with modifications (score: 1-4.5) was used to evaluate AMR.

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Article Synopsis
  • The study investigates the use of a heart rate variability (HRV) index derived from machine learning as a biomarker for drug-induced convulsions, focusing on its effectiveness with various convulsants.
  • Different doses of convulsants and non-convulsants were administered to telemetry-implanted male subjects, and the convulsive potential was analyzed using HRV data and statistical methods.
  • Findings suggested that the convulsive index increased for certain convulsants at lower doses, while the methodology has potential for predicting autonomic nervous activity fluctuations, although it may produce false positives.
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In continuous pharmaceutical manufacturing processes, it is crucial to control the powder flow rate. The feeding process is characterized by the amount of powder delivered per screw rotation, referred to as the feed factor. This study aims to develop models for predicting the feed factor profiles (FFPs) of two-component mixed powders with various formulations, while most previous studies have focused on single-component powders.

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Mathematical formulas play a prominent role in science, technology, engineering, and mathematics (STEM) documents; understanding STEM documents usually requires knowing the difference between equation groups containing multiple equations. When two equation groups can be transformed into the same form, we call the equation groups equivalent. Existing tools cannot judge the equivalence of two equation groups; thus, we develop an algorithm to judge such an equivalence using a computer algebra system.

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Article Synopsis
  • The design space (DS) is a key scientific concept used in drug product regulatory filings to ensure quality by analyzing process parameters and material attributes through a high-dimensional statistical model.* -
  • This study proposes a greedy approach to simplify the DS, making it more visually manageable while still retaining comprehensive understanding of the processes involved.* -
  • By fixing non-critical parameters and focusing on critical ones, the study shows that this new approach can effectively support pharmaceutical manufacturing process development.*
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Objective: Easily detecting patients with undiagnosed sleep apnea syndrome (SAS) requires a home-use SAS screening system. In this study, we validate a previously developed SAS screening methodology using a large clinical polysomnography (PSG) dataset (N = 938).

Methods: We combined R-R interval (RRI) and long short-term memory (LSTM), a type of recurrent neural networks, and created a model to discriminate respiratory conditions using the training dataset (N = 468).

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Although medical checkup data would be useful for identifying unknown factors of disease progression, a causal relationship between checkup items should be taken into account for precise analysis. Missing values in medical checkup data must be appropriately imputed because checkup items vary from person to person, and items that have not been tested include missing values. In addition, the patients with target diseases or disorders are small in comparison with the total number of persons recorded in the data, which means medical checkup data is an imbalanced data analysis.

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Soft sensors are powerful tools for the implementation of process analytical technology (PAT). They are categorized into white-box (first-principle), black-box (statistical), and gray-box models. Gray-box models integrate white-box and black-box models to address each drawback, i.

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In petroleum refineries, naphtha reforming units produce reformate streams and as a by-product, hydrogen (H). Naphtha reforming units traditionally deployed are designed as packed bed reactors (PBR). However, they are restrained by a high-pressure drop, diffusion limitations in the catalyst, and radial and axial gradients of temperature and concentration.

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Soft sensors play a crucial role as process analytical technology (PAT) tools. They are classified into physical models, statistical models, and their hybrid models. In general, statistical models are better estimators than physical models.

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Heart rate variability, which is the fluctuation of the R-R interval (RRI) in electrocardiograms (ECG), has been widely adopted for autonomous evaluation. Since the HRV features that are extracted from RRI data easily fluctuate when arrhythmia occurs, RRI data with arrhythmia need to be modified appropriately before HRV analysis. In this study, we consider two types of extrasystoles-premature ventricular contraction (PVC) and premature atrial contraction (PAC)-which are types of extrasystoles that occur every day, even in healthy persons who have no cardiovascular diseases.

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We presented a control strategy for tablet manufacturing processes based on continuous direct compression. The work was conducted by the experts of pharmaceutical companies, machine suppliers, academia, and regulatory authority in Japan. Among different items in the process, the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch manufacturing.

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The present study investigates the factors of "Weekday sleep debt (WSD)" by comparing activity data collected from persons with and without WSD. Since it has been reported that the amount of sleep debt as well the difference between the social clock and the biological clock is associated with WSD, specifying the factors of WSD other than chronotype may contribute to sleep debt prevention. We recruited 324 healthy male employees working at the same company and collected their 1-week wrist actigraphy data and answers to questionnaires.

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Purpose: Sleep apnea syndrome (SAS) is a prevalent sleep disorder in which apnea and hypopnea occur frequently during sleep and result in increase of the risk of lifestyle-related disease development as well as daytime sleepiness. Although SAS is a common sleep disorder, most patients remain undiagnosed because the gold standard test polysomnography (PSG), is high-cost and unavailable in many hospitals. Thus, an SAS screening system that can be used easily at home is needed.

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Orthostatic hypotension (OH) caused by autonomic dysfunction is a common symptom in older people and patients with idiopathic rapid eye movement sleep behavior disorder (iRBD). The orthostatic challenge test is a standard autonomic function test that measures a decrease of blood pressure during a postural change from supine to standing positions. Although previous studies have reported that changes in heart rate variability (HRV) are associated with autonomic dysfunction, no study has investigated the relationship between HRV before standing and the occurrence of OH in an orthostatic challenge test.

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As a result of the research activities of the Japan Agency for Medical Research and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology transfer, process control, and quality control used in the current commercial batch manufacturing would be effective also in continuous manufacturing, while there are differences in the process development using continuous manufacturing and batch manufacturing. This document introduces an example of the way of thinking for establishing a control strategy for continuous manufacturing processes.

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In-line monitoring of granule water content during fluid bed granulation is important to control drug product qualities. In this study, a practical scale-free soft sensor to predict water content was proposed to cope with the manufacturing scale changes in drug product development. The proposed method exploits two key ideas to construct a scale-free soft sensor.

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A warning prior to seizure onset can help improve the quality of life for epilepsy patients. The feasibility of a wearable system for predicting epileptic seizures using anomaly detection based on machine learning is evaluated. An original telemeter is developed for continuous measurement of R-R intervals derived from an electrocardiogram.

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A considerable amount of health record (HR) data has been stored due to recent advances in the digitalization of medical systems. However, it is not always easy to analyze HR data, particularly when the number of persons with a target disease is too small in comparison with the population. This situation is called the imbalanced data problem.

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Article Synopsis
  • Sleep apnea syndrome (SAS) is common and leads to daytime fatigue and higher risk of health issues, but many are undiagnosed due to testing difficulties.
  • The research introduces a new screening method using heart rate variability (HRV) and long short-term memory (LSTM) neural networks.
  • The new algorithm shows excellent performance, accurately identifying patients versus healthy individuals with 100% sensitivity and specificity.
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Sleep spindles are important electroencephalographic (EEG) waveforms in sleep medicine; however, it is burdensome even for experts to detect spindles, so automatic spindle detection methodologies have been investigated. Conventional methods utilize waveforms template matching or machine learning for detecting spindles. In the former approach, it is necessary to tune thresholds for individual adaptation, while the latter approach has the problem of imbalanced data because the amount of sleep spindles is small compared with the entire EEG data.

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Objective: Obstructive sleep apnea (OSA) is a common sleep disorder; however, most patients are undiagnosed and untreated because it is difficult for patients themselves to notice OSA in daily living. Polysomnography (PSG), which is the gold standard test for sleep disorder diagnosis, cannot be performed in many hospitals. This fact motivates us to develop a simple system for screening OSA at home.

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Steam methane reforming (SMR) is a dominant technology for hydrogen production. For the highly energy-efficient operation, robust energy analysis is crucial. In particular, exergy analysis has received the attention of researchers due to its advantage over the conventional energy analysis.

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Entrained flow gasification is a commonly used method for conversion of coal into syngas. A stable and efficient operation of entrained flow coal gasification is always desired to reduce consumption of raw materials and utilities, and achieve higher productivity. However, uncertainty in the process hinders the stability and efficiency.

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A focal brain cooling system for treatment of refractory epilepsy that is implantable and wearable may permit patients with this condition to lead normal daily lives. We have developed such a system for cooling of the epileptic focus by delivery of cold saline to a cooling device that is implanted cranially. The outflow is pumped for circulation and cooled by a Peltier device.

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