Gastrointestinal symptoms in patients receiving imeglimin in combination with metformin: A post-hoc analysis of imeglimin clinical trial data.

Introduction: An increased rate of gastrointestinal (GI) symptoms is reported in patients with type 2 diabetes receiving imeglimin plus metformin vs monotherapy or in combination with other antidiabetic drugs. This post-hoc analysis explored GI symptom incidence, risk factors for their occurrence, and the impact on therapeutic efficacy during imeglimin and metformin combination therapy.

Materials And Methods: Data were derived from the 52-week, open-label, phase 3 TIMES-2 trial in Japanese type 2 diabetes patients.

Differences in imeglimin response in subgroups of patients with type 2 diabetes stratified by data-driven cluster analysis: A post-hoc analysis of imeglimin clinical trial data.

Aim: To explore differences in imeglimin response among type 2 diabetes (T2D) patient clusters using data-driven cluster analysis.

Methods: Data-driven cluster analysis (non-hierarchical k-means clustering) was performed on randomized, double-blind, imeglimin monotherapy and adjunctive (to insulin) therapy trials based on four baseline variables: (1) disease duration; (2) body mass index (BMI); (3) HbA1c; and (4a) homeostatic model assessment of β-cell function (HOMA-β) (monotherapy trials) or (4b) insulin total daily dose (adjunctive trial).

Results: Four clusters were identified with distinct clinical characteristics in both monotherapy (1-4) and adjunctive therapy (I-IV) trials; clusters 1 and I had lower values across all four indices versus the overall population, clusters 2 and II had a longer diabetes duration, cluster 3 had higher baseline BMI and HOMA-β, and cluster III had higher baseline BMI and insulin total daily dose, while clusters 4 and IV had higher baseline HbA1c.

Factors contributing to the clinical effectiveness of imeglimin monotherapy in Japanese patients with type 2 diabetes mellitus.

Aims/introduction: To investigate the effect of patient characteristics on imeglimin effectiveness in Japanese patients with type 2 diabetes mellitus.

Materials And Methods: Data were pooled from two randomized, placebo-controlled, 24-week, double-blind studies of imeglimin monotherapy in Japanese adults with type 2 diabetes mellitus, with the proportion of responders (glycated hemoglobin [HbA1c] < 7.0%) and sustained responders (i.

Oral Intake Difficulty and Aspiration Pneumonia Assessment Using High-Resolution Manometry.

Objective: The sequential generation of swallowing pressure (SP) from the nasopharynx to the proximal esophagus is important for the bolus to pass from the oral cavity to the esophagus. The purpose of this study was to investigate the correlation of the SP sequence mode on high-resolution manometry (HRM) with oral intake difficulty and aspiration pneumonia.

Methods: Consecutive patients with dysphagia who were admitted to our dysphagia clinic between November 2016 and November 2020 were enrolled in this cross-sectional study.

The dynamics of deglutition during head rotation using dynamic 320-row area detector computed tomography.

Objective: We aimed to elucidate the dynamics of deglutition during head rotation by acquiring 320-row area detector computed tomography (320-ADCT) images and analyzing deglutition during head rotation.

Methods: This study included 11 patients experiencing globus pharyngeus. A 320-ADCT was used to acquire images in two types of viscosity (thin and thick), with the head rotated to the left.

Effect of patient characteristics on the efficacy and safety of imeglimin monotherapy in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of two randomized, placebo-controlled trials.

Aims/introduction: Substantial variability in demographic and clinical characteristics exists among patients with type 2 diabetes mellitus, which may impact treatment. This post-hoc analysis evaluated the efficacy and safety of imeglimin 1,000 mg twice daily (BID) monotherapy in type 2 diabetes mellitus patients according to demographic and clinical characteristics.

Materials And Methods: Data were pooled from two placebo-controlled, 24 week, randomized, double-blind studies in adults with type 2 diabetes mellitus.

Effects of the Intensity and Activity Time of Early Rehabilitation on Activities of Daily Living Dependence in Mechanically Ventilated Patients.

Objectives: The aim of this study was to investigate the association between the Rehabilitation Activity Time score (RATs)-a score based on the level and duration of rehabilitation activities-of ventilated patients in the intensive care unit (ICU) and activities of daily living (ADL) dependence at discharge.

Methods: This retrospective, single-center study evaluated patients aged >18 years who underwent mechanical ventilation in the ICU for at least 48 h. The patients were categorized into the low- and high-dose rehabilitation groups based on the median RATs.

Zonisamide improves axial symptoms in dementia with Lewy bodies with parkinsonism: Post hoc analysis of clinical trials.

Patients with dementia with Lewy bodies (DLB) experience worsening axial symptoms with disease progression, which can negatively affect quality of life. Previous phase 2 and 3 clinical trials conducted in Japan showed that zonisamide improved parkinsonism in patients with DLB. In the present study, we performed a post hoc analysis of pooled data from the previous phase 2 and 3 trials to examine the effect of zonisamide on axial symptoms in this patient group.

Efficacy and Safety of Zonisamide in Dementia with Lewy Bodies Patients with Parkinsonism: A Post Hoc Analysis of Two Randomized, Double-Blind, Placebo-Controlled Trials.

Background: Although previous phase II and III clinical trials conducted in Japan showed that zonisamide improved parkinsonism in patients with dementia with Lewy bodies (DLB), some differences in efficacy outcomes were observed between the trials.

Objective: We aimed to further examine the efficacy and safety of zonisamide in DLB patients with parkinsonism in a post hoc analysis of pooled data from the previous phase II and III trials.

Methods: Both trials featured a 4-week run-in period followed by a 12-week treatment period with a double-blind, placebo-controlled, parallel-group, randomized, multicenter trial design.

Fundamentally altered global- and microstate EEG characteristics in Huntington's disease.

Objective: Huntington's disease (HD) is characterized by psychiatric, cognitive, and motor disturbances. The study aimed to determine electroencephalography (EEG) global state and microstate changes in HD and their relationship with cognitive and behavioral impairments.

Methods: EEGs from 20 unmedicated HD patients and 20 controls were compared using global state properties (connectivity and dimensionality) and microstate properties (EEG microstate analysis).

Exercise-based cardiac rehabilitation for patients with catheter ablation for persistent atrial fibrillation: A randomized controlled clinical trial.

Aims: The efficacy and safety of cardiac rehabilitation for patients with persistent atrial fibrillation who restored sinus rhythm after catheter ablation remains unclear. The aim of the present study was to evaluate the effects of cardiac rehabilitation on exercise capacity, inflammatory status, cardiac function, and safety in patients with persistent atrial fibrillation who had catheter ablation.

Methods: In this randomized controlled study, 61 patients treated with catheter ablation for persistent atrial fibrillation (male, 80%; mean age, 66 ± 9 years) were analyzed.

Chemical pleurodesis with autologous blood and freeze-dried concentrated human thrombin improved spontaneous pneumothorax and thoracic endometriosis: The first case involving a pregnant woman.

Objective: Spontaneous pneumothorax combined with thoracic endometriosis is a rare condition during pregnancy. We present a case of chemical pleurodesis with autologous blood and freeze-dried concentrated human thrombin during pregnancy.

Case Report: This report presents a case of spontaneous pneumothorax combined with thoracic endometriosis that arose at 22 weeks' gestation in a 35-year-old female.

The EEG microstate topography is predominantly determined by intracortical sources in the alpha band.

Human brain electric activity can be measured at high temporal and fairly good spatial resolution via electroencephalography (EEG). The EEG microstate analysis is an increasingly popular method used to investigate this activity at a millisecond resolution by segmenting it into quasi-stable states of approximately 100 ms duration. These so-called EEG microstates were postulated to represent atoms of thoughts and emotions and can be classified into four classes of topographies A through D, which explain up to 90% of the variance of continuous EEG.

Trends in antipsychotic prescriptions for Japanese outpatients during 2006-2012: a descriptive epidemiological study.

Purpose: This study aimed to assess the trends in antipsychotic prescriptions for outpatients in Japan, where a community-based approach to mental healthcare is emphasized.

Methods: This descriptive epidemiological study used claims data from 1038 community pharmacies across Japan. Outpatients who were ≥18 years old and receiving their initial antipsychotic prescription during 2006-2012 were evaluated.

Case of pituitary stalk transection syndrome ascertained after breech delivery.

Pituitary stalk transection syndrome (PSTS) is a rare complication that can accompany breech delivery. Early diagnosis of this syndrome is difficult, and it may cause a serious delay in the diagnosis. We present a case of PSTS ascertained after breech delivery.

The functional significance of EEG microstates--Associations with modalities of thinking.

The momentary, global functional state of the brain is reflected by its electric field configuration. Cluster analytical approaches consistently extracted four head-surface brain electric field configurations that optimally explain the variance of their changes across time in spontaneous EEG recordings. These four configurations are referred to as EEG microstate classes A, B, C, and D and have been associated with verbal/phonological, visual, subjective interoceptive-autonomic processing, and attention reorientation, respectively.

Zonisamide improves wearing-off in Parkinson's disease: A randomized, double-blind study.

Background: Previously, we reported 50 mg/d zonisamide improved wearing-off without increasing dyskinesia in patients with Parkinson's disease (PD).

Methods: To determine the efficacy of zonisamide for treatment of "off" time in PD patients, we conducted a multicenter, randomized, double-blind, parallel-group, placebo-controlled study in Japan. Patients with PD and wearing-off received placebo for 4 weeks and then were treated for 12 weeks with zonisamide 25 or 50 mg/d or placebo, in addition to their previous therapy.

Zazen meditation and no-task resting EEG compared with LORETA intracortical source localization.

Meditation is a self-induced and willfully initiated practice that alters the state of consciousness. The meditation practice of Zazen, like many other meditation practices, aims at disregarding intrusive thoughts while controlling body posture. It is an open monitoring meditation characterized by detached moment-to-moment awareness and reduced conceptual thinking and self-reference.

Functionally aberrant electrophysiological cortical connectivities in first episode medication-naive schizophrenics from three psychiatry centers.

Functional dissociation between brain processes is widely hypothesized to account for aberrations of thought and emotions in schizophrenic patients. The typically small groups of analyzed schizophrenic patients yielded different neurophysiological findings, probably because small patient groups are likely to comprise different schizophrenia subtypes. We analyzed multichannel eyes-closed resting EEG from three small groups of acutely ill, first episode productive schizophrenic patients before start of medication (from three centers: Bern N = 9; Osaka N = 9; Berlin N = 12) and their controls.

Manno-oligosaccharide-binding ability of mouse RegIV/GST-fusion protein evaluated by complex formation with the carbohydrate-containing polyamidoamine dendrimer.

The carbohydrate-binding properties of the C-type lectin-like mouse RegIV and glutathione S-transferase-fusion protein (GST-mRegIV) were examined using carbohydrate-containing polyamidoamine dendrimers (PD). GST-mRegIV showed affinity for mannan- and manno-oligosaccharide containing PD. Binding was inhibited by manno-oligosaccharides but not by mannose or other tested carbohydrates, suggesting that the binding site may have an extended structure in contrast with typical C-type lectins.

Assessing direct paths of intracortical causal information flow of oscillatory activity with the isolated effective coherence (iCoh).

Functional connectivity is of central importance in understanding brain function. For this purpose, multiple time series of electric cortical activity can be used for assessing the properties of a network: the strength, directionality, and spectral characteristics (i.e.

sLORETA intracortical lagged coherence during breath counting in meditation-naïve participants.

We investigated brain functional connectivity comparing no-task resting to breath counting (a meditation exercise but given as task without referring to meditation). Functional connectivity computed as EEG coherence between head-surface data suffers from localization ambiguity, reference dependence, and overestimation due to volume conduction. Lagged coherence between intracortical model sources addresses these criticisms.