Search Results (310)

The scientific study of emotion remains fraught with conceptual ambiguity, methodological limitations, and epistemological blind spots. This theoretical paper argues that existing paradigms frequently capture synthetic rather than natural emotional states—those shaped by social expectations, cognitive scripting, and performance under observation. We propose a conceptual framework that distinguishes natural emotion—spontaneous, embodied, and interoceptively grounded—from synthetic forms that are adaptive, context-driven, and often unconsciously rehearsed. These reactions often involve emotional scripts rather than genuine, spontaneous affective experiences. Drawing on insights from affective neuroscience, psychological measurement, artificial intelligence, and neurodiversity, we examine how widely used tools such as EEG, polygraphy, and self-report instruments may capture emotional conformity rather than authenticity. We further explore how affective AI systems trained on socially filtered datasets risk replicating emotional performance rather than emotional truth. By recognizing neurodivergent expression as a potential site of emotional transparency, we challenge dominant models of emotional normalcy and propose a five-step agenda for reorienting emotion research toward authenticity, ecological validity, and inclusivity. This post-synthetic framework invites a redefinition of emotion that is conceptually rigorous, methodologically nuanced, and ethically inclusive of human affective diversity. Full article

Background/Objectives: Pharmacovigilance aims to identify, assess, and minimize drug risks, with spontaneous reporting playing a central role. However, the high level of underreporting and the varying data quality are limitations that should be minimized through prospective cohort studies. Methods: Spontaneous reports reported to the Drug Commission of the German Medical Association (AkdÄ) over one year were compared with the adverse drug reaction (ADR) cases systematically recorded in hospital emergency departments. The frequencies of the demographic patient characteristics and the odds ratios, as the relationship between suspected and concomitant medication, were calculated. Results: In the spontaneous reports, cases were reported by patients a median of 12 years younger, and the group of older patients was less represented (10.8% versus 27.3% in the prospective cohort study). Within the study, cases with polypharmacy were documented significantly more often (a median of seven drugs [IQR 3;10] versus a median of two drugs [IQR 1;5] in the spontaneous reports). New drugs and drugs discussed in the media were frequently reported as causing ADRs, whereas drugs with an effect on the central nervous system were more often suspected in the emergency department setting. Conclusions: Both sources for ADRs provide complementary information that improves the detection of risk signals. The aim for the future is to further increase the awareness of spontaneous reports and to answer specific questions with the help of structured investigations. It is important to compare and validate the findings of spontaneous reports and investigations in regular intervals to improve drug safety. Full article

Background: Temporomandibular joint (TMJ) injections and arthrocentesis are commonly used minimally invasive methods for treating temporomandibular disorders (TMDs). Although considered safe, they can cause neurological complications. The aim of this systematic review was to synthesize all identified evidence for neurological adverse events following intra-articular TMJ interventions. Methods: This review was based on a systematic search with BASE, DOAJ, PubMed, SciELO, and Semantic Scholar on 28 May 2025. It included primary studies involving patients diagnosed with TMDs who underwent intra-articular injections into the TMJ or were treated with arthrocentesis, and in whom neurological adverse effects associated with the intra-articular intervention were reported. Studies reporting non-specific symptoms or unrelated systemic conditions were excluded. The risk of bias was assessed using the Joanna Briggs Institute’s critical appraisal tools. Results were presented in summary tables. Results: The search yielded five eligible studies comprising 319 patients, of whom 320 neurological adverse events were reported. Included studies comprised a randomized controlled trial, two retrospective studies, and two case reports. Four studies had a low risk of bias, and one had a moderate risk of bias according to the Joanna Briggs Institute appraisal tools. The proportion of patients affected ranged from 14% to 65% depending on the study design and intervention type. The most common adverse event was transient facial nerve (cranial nerve VII) paralysis, mainly involving the temporal and zygomatic branches. Less commonly reported complications involved the trigeminal nerve branches (V1, V3). There is also a single case of epidural hematoma with palsy of the oculomotor nerve (III). Most symptoms resolved spontaneously within a few hours to a few days. The use of local anesthesia and large volumes of irrigation (60 mL) during arthrocentesis increases the risk of complications. Attempts to explain the mechanisms of complications include local anesthetic diffusion, compression neuropraxia due to lavage fluid leakage, and corticosteroid neurotoxicity. One of the limitations of the study is the scarcity of data. Conclusions: Although most adverse events are mild and reversible, these findings highlight that precise, real-time guided injection and careful control of lavage volumes can minimize extra-articular spread of anesthetics or fluids, thereby reducing the likelihood of neurological complications. This study received no funding. PROSPERO ID number: CRD420251088170. Full article

Background: Cutis marmorata telangiectatica congenita (CMTC) is a rare congenital vascular anomaly characterized by a persistent, violaceous, reticulated skin pattern. It may present as a benign isolated lesion or as part of a broader syndrome with systemic anomalies such as limb asymmetry, glaucoma, or neurological impairment. Methods: We report a case series of three neonates with CMTC, each representing a distinct clinical pattern: localized, segmental, and generalized. All patients underwent comprehensive clinical assessment, including dermatologic, neurologic, and ophthalmologic evaluations. Additionally, a systematic literature review was conducted using PubMed, Scopus, and Web of Science databases, covering publications from 2012 to 2025. Results: Case 1 involved a localized lesion of the calf; Case 2 had segmental involvement of the forearm and leg; Case 3 presented with generalized CMTC covering over 85% of the body surface, accompanied by dysmorphism and bilateral persistent fetal vasculature (PFV). Literature findings highlighted significant clinical variability and a stronger association of generalized forms with systemic abnormalities. Conclusions: CMTC exhibits a broad clinical spectrum. While localized cases often resolve spontaneously, generalized forms may require multidisciplinary evaluation. Early recognition and systemic screening are crucial for optimal management. Full article

Background: Spontaneous intracerebral hemorrhage (ICH) has the highest case fatality of all stroke types, yet recent epidemiological and outcome data from Central and Eastern Europe remain limited. Methods: We retrospectively analyzed prospectively collected data for 601 consecutive adults with primary ICH admitted to Sibiu County Clinical Emergency Hospital, Romania (2017–2023). Demographics, Glasgow Coma Scale (GCS), CT-derived hematoma volume (ABC/2), anatomical site, intraventricular extension (IVH), treatment, comorbidities, and in-hospital death were reported with exact counts and percentages; no imputation was performed. Results: Mean age was 68.4 ± 12.9 years, and 59.7% were male. Mean hematoma volume was 30.4 mL, and 23.0% exceeded 30 mL. IVH occurred in 40.1% and doubled mortality (50.6% vs. 16.7%). Overall case fatality was 29.6% and climbed to 74.5% for brain-stem bleeds. Men, although younger than women (66.0 vs. 71.9 years), died more often (35.4% vs. 21.1%; risk ratio 1.67, 95% CI 1.26–2.21). Systemic hazards amplified death risk: Oral anticoagulation, 44.2%; chronic alcohol misuse, 51.4%; thrombocytopenia, 41.0%; chronic kidney disease, 42.3%. Conservative management (74.9%) yielded 27.8% mortality overall and ≤15 for small-to-mid lobar or capsulo-lenticular bleeds; lobar surgery matched this (13.4%) only in large clots. Thalamic evacuation was futile (82.3% mortality), and cerebellar decompression performed late still carried 54.5% mortality versus 16.6% medically. Multivariable analysis confirmed that low GCS, IVH, large hematoma volume, thrombocytopenia, and chronic alcohol use independently predicted in-hospital mortality. Limitations: This retrospective study lacked post-discharge functional outcome data (e.g., mRS at 90 days). Conclusions: This study presents the largest Romanian single-center ICH cohort, establishing national benchmarks and underscoring modifiable risk factors. Early ICH lethality aligns with Western data but is amplified by exposures such as alcohol misuse, anticoagulation, thrombocytopenia, and CKD. Priorities include preventive strategies, timely surgical access, wider adoption of minimally invasive techniques, and development of a prospective regional registry. Full article

People with cystic fibrosis may experience polypharmacy, which can increase the risk of drug induced complications such as adverse events and drug–drug interactions. This study aimed to examine the prevalence of adverse events and to identify potential drug–drug interactions associated with elexacaftor/tezacaftor/ivacaftor (ETI). Three databases, the Australian Therapeutic Goods Administration Database of Adverse Event Notification (TGA DAEN), the Canada Vigilance Adverse Reaction Online Database (CVAROD), and the USA Food and Drug Administration Adverse Event Reporting System (FAERS) Database were searched for spontaneous ETI adverse events between 2019 and 2024. Descriptive analysis of the data was undertaken. The FAERS database was analysed to identify adverse events of interest such as anxiety and depression and concomitant drugs prescribed with ETI. A total of 10,628 ETI associated adverse events were identified in all system organ classes. The incidence of psychiatric adverse events ranged from 7 to 15% across the three databases. Potential drug–drug interactions with CYP 3A4/5 strong inhibitors and strong inducers were identified from the FAERS database and azole antifungals were implicated in several ETI dose modifications. The prevalence and types of ETI adverse events were varied and use of concomitant drugs with potential drug interactions was significant, requiring more research to manage them. Full article

Taconis oscillations represent spontaneous excitation of acoustic modes in tubes with large temperature gradients in cryogenic systems. In this study, Taconis oscillations in hydrogen and helium systems are enhanced with a porous material resulting in a standing-wave thermoacoustic engine. A theoretical model is developed using the thermoacoustic software DeltaEC, version v6.4b2.7, to predict system performance, and an experimental apparatus is constructed for engine characterization. The low-amplitude thermoacoustic model predicts the pressure amplitude, frequency, and temperature gradient required for excitation of the standing-wave system. Experimental measurements, including the onset temperature ratio, acoustic pressure amplitudes, and frequencies, are recorded for different stack materials and geometries. The findings indicate that, independent of stack, hydrogen systems excite at smaller temperature differentials than helium (because of different properties such as lower viscosity for hydrogen), and the stack geometry and material affect the onset temperature ratio. However, pressure amplitude in the excited states varies minimally. Initial measurements are also conducted in a cooling setup with an added regenerator. The configuration with stainless-steel mesh screens produces a small cryogenic refrigeration effect with a decrease in temperature of about 1 K. The reported characterization of a Taconis-based thermoacoustic engine can be useful for the development of novel thermal management systems for cryogenic storage vessels, including refrigeration and pressurization. Full article

Haemophilic arthropathy is caused by repeated joint bleeding episodes, primarily affecting knees, ankles and elbows. Conservative options should be considered prior to surgery, as well as postural evaluation, since any functional overload promotes the development of new bleeding. The aim of this study is to verify the use of foot orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas. In total, 15 patients were enrolled and randomly divided into two groups: 8 in group A, composed of patients who were prescribed foot orthoses and a 20-session rehabilitation program, and 7 in group B, composed of patients who were instructed to use foot orthoses only. All patients were evaluated at baseline (T0), at 3 months (T1—end of the rehabilitation program), and at 12 months (T2), using the following scales: Functional Independence Score in Haemophilia (FISH), Haemophilia Joint Health Score (HJHS) and Numerical Rating Scale (NRS). During the 12 months between the first and the last assessment, no patient in group A developed hemarthroses or hematomas, while one case of hemarthrosis was recorded in group B. The HJHS improved significantly (≤0.05) in group A at both T1 and T2, while in group B it improved significantly only in T2. As for FISH, it showed significant improvements in both groups at T1 and T2. NRS showed a significant reduction only at T2 in both groups (p-value T0–T1 0.3 in group A e 0.8 in group B). No patient reported any adverse effects from the use of orthotic insoles. The combination of postural rehabilitation, the use of foot orthoses and pharmacological prophylaxis could improve functioning and joint status in patients affected by haemophilic arthopathy, delaying or preventing new hemarthroses by improving the distribution of joint loads and the modification of musculoskeletal system’s characteristics. Full article

Heart rate (HR) is strongly affected by the autonomic nervous system (ANS), while its spontaneous fluctuations, called heart rate variability (HRV), report about the dynamics of the complex, vegetative regulation of the heart rhythm. Hence, HRV is widely considered an important marker of the ANS effects on the cardiac system, and as such, a crucial diagnostic tool in cardiology. In order to obtain nontrivial results from HRV analysis, it would be desirable to establish exact, universal interrelations between the typical HRV parameters and HR itself. That, however, has not yet been fully accomplished. Hence, our aim was to perform a comparative statistical analysis of ECG recordings from a public database, with a focus on the HR dependence of typical HRV parameters. We revealed their fundamental connections, which were substantiated by basic mathematical considerations, and were experimentally demonstrated via the analysis of 24 h of ECG recordings of more than 200 healthy individuals. The large database allowed us to perform unique age-cohort analyses. We confirmed the HR dependence of typical time-domain parameters, such as RMSSD and SDNN, frequency-domain parameters such as the VLF, LF, and HF components, and nonlinear indices such as sample entropy and DFA exponents. In addition to shedding light on their relationship, we are the first, to our knowledge, to identify a new, diffuse structure in the VHF regime as an important indicator of SNS activity. In addition, the demonstrated age dependence of the HRV parameters gives important new insight into the long-term changes in the ANS regulation of the cardiac system. As a possible molecular physiological mechanism underlying our new findings, we suggest that they are associated with Piezo2 channel function and its age-related degradation. We expect our results to be utilized in HRV analysis related to both medical research and practice. Full article

VisRep (Visualisation Report) is an AI-powered system for capturing and structuring the early stages of the visualisation design process. It addresses a critical gap in predesign: the lack of tools that can naturally record, organise, and transform raw ideation, spoken thoughts, sketches, and evolving concepts into polished, shareable outputs. Users engage in talk-aloud sessions through a terminal-style interface supported by intelligent transcription and eleven structured questions that frame intent, audience, and output goals. These inputs are then processed by a large language model (LLM) guided by markdown-based output templates for reports, posters, and slides. The system aligns free-form ideas with structured communication using prompt engineering to ensure clarity, coherence, and visual consistency. VisRep not only automates the generation of professional deliverables but also enhances reflective practice by bridging spontaneous ideation and structured documentation. This paper introduces VisRep’s methodology, interface design, and AI-driven workflow, demonstrating how it improves the fidelity and transparency of the visualisation design process across academic, professional, and creative domains. Full article

Background: Electroencephalography (EEG) systems based on textile electrodes are increasingly being developed to address the need for more wearable sensor systems for brain function monitoring. Blink-related oscillations (BROs) are a new measure of brain function that corresponds to brainwave responses occurring after spontaneous blinking, and indexes neural processes as the brain evaluates new visual information appearing after eye re-opening. Prior studies have reported BRO utility as both a clinical and non-clinical biomarker of cognition, but no study has demonstrated BRO measurement using textile-based EEG devices that facilitate user comfort for real-world applications. Methods: We investigated BRO measurement using a four-channel EEG system with textile electrodes by extracting BRO responses using existing, publicly available EEG data (n = 9). We compared BRO effects derived from textile-based electrodes with those from standard dry Ag/Ag-Cl electrodes collected at the same locations (i.e., Fp1, Fp2, F7, F8) and using the same EEG amplifier. Results: Results showed that BRO effects measured using textile electrodes exhibited similar features in both time and frequency domains compared to dry Ag/Ag-Cl electrodes. Data from both technologies also showed similar performance in artifact removal and signal capture. Conclusions: These findings provide the first demonstration of successful BRO signal capture using four-channel EEG with textile electrodes, providing compelling evidence toward the development of a comfortable and user-friendly EEG technology that uses the simple activity of blinking for objective brain function assessment in a variety of settings. Full article

Background/Objectives: The combination drug sulfamethoxazole/trimethoprim (ST) is a broad-spectrum antibiotic used against various infections; however, it is associated with several serious adverse events. The ST package inserts contain warnings about these adverse events. However, warnings vary internationally, and specific measures to address ST-related adverse events are unclear. Therefore, we aimed to comprehensively evaluate ST-related adverse events using the Japanese Adverse Drug Event Report (JADER) database and analyze the onset time for each event. Methods: Adverse events due to ST were analyzed using the JADER database between April 2004 and June 2023. The reported odds ratio and 95% confidence interval (95% confidence interval [CI]) were calculated, with a signal detected if the 95% CI lower limit exceeded 1. The Weibull distribution was used to characterize the onset time of adverse events with detected signals. Results: The total number of cases in the JADER database during the study period was 862,952, and the number of adverse events involving ST as a suspected drug was 4203. Adverse events associated with ST include hyperkalemia, syndrome of inappropriate antidiuretic hormone secretion, hematopoietic cytopenia, acute renal failure, hypoglycemia, disseminated intravascular coagulation syndrome, hepatic disorder, and the Stevens–Johnson syndrome/toxic epidermal necrolysis. Conclusions: Weibull analysis indicated an early failure-type onset time for all adverse events, suggesting the need for intensive adverse event monitoring of ST, especially in the first month of use. These findings may support revising drug package inserts in Japan to better reflect the identified risks. Full article

Background and Objectives: The spontaneous reporting (SR) of adverse drug events (ADEs) is a cornerstone of pharmacovigilance and a critical mechanism for safeguarding patient safety. However, underreporting remains a persistent global challenge. In Korea, despite the widespread use of herbal medicines (HMs), adverse event reports from traditional Korean medicine doctors (KMDs) are remarkably scarce. This study aimed to assess the knowledge, attitudes, and experiences of KMDs regarding SR, identify key barriers, and suggest strategies to strengthen the safety culture within traditional Korean medicine. Materials and Methods: A cross-sectional, anonymous online survey was distributed to licensed KMDs registered with the Association of Korean Medicine. The questionnaire collected information on respondents’ sociodemographic characteristics and assessed their knowledge, attitudes, and experiences related to ADE reporting. Descriptive statistics and multivariate logistic regression were used to analyze the associations between the variables. Results: Of the 1021 KMDs who completed the survey, the vast majority acknowledged the importance of SR and recognized their role in pharmacovigilance. Nevertheless, only 5% had ever submitted an ADE report. A widespread lack of awareness about the national spontaneous reporting system (SRS), particularly its inclusion of licensed HMs, was evident. Although many respondents expressed support for expanding the scope of SR to cover all HMs, significant gaps in pharmacovigilance knowledge and limited access to relevant training were major barriers. KMDs affiliated with academic institutions or specialist groups showed higher levels of awareness, education, and reporting behavior. Conclusions: While KMDs exhibit positive attitudes toward patient safety and understand the importance of SR, their participation in it remains low due to knowledge deficits and insufficient training. Addressing these gaps through targeted education and expanding the national SRS to comprehensively include herbal medicines are essential steps toward enhancing pharmacovigilance and cultivating a proactive safety culture in Korean medicine. Full article

Backgrounds and Objectives: This study aims to characterize the prevalence and severity of antidepressant-associated adverse drug events (ADEs) and to identify predictors strongly associated with serious adverse events (SAEs). Materials and Methods: Disproportionality analysis on antidepressant-related ADEs spontaneously reported to the Korea Adverse event Reporting System (KIDS KAERS DB) from 2014 to 2023 was performed. Multiple logistic regression was conducted to identify predictors associated with SAEs. Sensitivity analysis was performed to validate the overall findings and assess the robustness of associations across subgroups defined by completeness of demographic data (age and sex), elderly age-stratification, and causality assessment. The study protocol was approved by the Kyung Hee University institutional review board. Results: Among 21,103 antidepressant-related ADEs, duloxetine was the most etiologic medication, followed by amitriptyline and escitalopram. Fluoxetine is the only agent with a high likelihood of reporting SAEs. ADEs involving vascular (extracardiac) disorders (ROR 42.42, 95% CI 13.19–136.42) and liver and biliary system disorders (ROR 7.84, 95% CI 3.77–16.29) were most likely to be SAEs. The predictors associated with substantial increased SAE risk were fluoxetine use (OR 2.71, 95% CI 1.68–4.39), male sex (OR 1.48, 95% CI 1.11–1.98), and concomitant administration of antiparkinsonian treatment (OR 8.29, 95% CI 3.61–19.06) and antidementia treatment (OR 2.94, 95% CI 1.34–6.05). Sensitivity analyses demonstrated similar and consistent findings. However, reversed trends in the association between SOC-based ADEs and sex were observed in the sensitivity analysis restricted to cases with “certain” and “probable” causality. Conclusions: The type of antidepressant, concomitant medications, and sex are major predictors for SAE risk. Further controlled studies on the impact of comorbidities and polypharmacy on antidepressant-related SAEs are warranted. Full article

Background: Respiratory syncytial virus (RSV) poses a significant health burden in children, being the major cause of lower respiratory tract infection (LRTI), including bronchiolitis. During the 2023–2024 RSV season, Spain introduced nirsevimab, a monoclonal antibody for universal RSV prophylaxis in infants. This study reviews the safety of nirsevimab through post-marketing surveillance. Material and Methods: A descriptive pharmacovigilance study was made based on spontaneous reporting data of suspected adverse events (SAEs) from the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H) and industry reports. SAEs reported between September 2023 and May 2024 were extracted from the Spanish Pharmacovigilance Adverse Reactions Data (FEDRA) database. Cases were analysed by sex, age, severity, and SAEs classification using the Preferred Terms (PT) level of the Medical Dictionary for Regulatory Activities (MedDRA). Reporting rates were estimated based on immunization coverage and birth data. Results: Sixty-seven cases reported 141 SAEs, yielding an overall rate of 23.1 cases per 100,000 doses. Common events included rash (8.51%), drug ineffectiveness (7.09%), and pyrexia (7.09%). Serious events constituted 53.70% of reports, including two fatalities (3.00%). No new safety signals or unexpected risks, such as antibody-dependent enhancement (ADE), were identified. Discussion: SAEs reported peaked early in the campaign, reflecting heightened reporting in new immunization programs. The safety profile aligns with clinical trial findings and regulatory expectations, confirming nirsevimab’s benefit–risk balance. Continued pharmacovigilance is critical for maintaining public trust in RSV prophylaxis. Nirsevimab demonstrated a favorable safety profile during Spain’s initial universal RSV immunization campaign in infants, supporting its continued use in reducing RSV-related morbidity. Full article