bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of reporting trends in the MAUDE Database: 1991 to 2022
Authors: Mishali Meital , Sheffer Nadav , Mishali Oren , Negev Maya 
Published: January 2025

Adverse event reporting for medical devices is critical for risk mitigation. The Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database serves as a key tool for post-market surveillance, receiving reports from various sources. Ensuring information integrity, especially across diverse reporting sources, is paramount. Periodic regulatory updates aim to enhance reporting. Objective Analyze reporting patterns, assess the potential contribution of 2015 and 2018 regulatory updates on reporting rates for varies reporters. Additionally, evaluating reporting schedule compliance by comparing average reporting times to regulatory requirements for these reporters. Methods Data from 1991–2022 was retrieved from the MAUDE database. Annual report counts were filtered by reporter and event type. Average reporting time was calculated as the difference between received and awareness dates. Results The 2018 Voluntary Malfunction Summary Reporting (VMSR) program correlated with an increase in manufacturers’ event reporting, peaking at 3,135,501 events in 2022. Distributors’ reports surged post-2018, while voluntary reports steadily increased since 1997, spiking notably in 2015 with the Electronic Medical Device Reporting (eMDR) submission update. Reporting times for deaths averaged 80 days for manufacturers, far exceeding regulatory requirements, compared to 40 days for distributors and 46 days for user facilities. Malfunction events had longer average reporting times for manufacturers (89 days) compared to distributors (44 days). Conclusions Changes in reporting trends around 2015 and 2018 may be linked to regulatory updates. Tailoring regulatory changes for each reporter type, like user-friendly electronic forms, new reporting programs, and exemptions cancelations, can improve reporting. Balancing the volume of reports among different reporters is crucial for enhancing database integrity, transparency, and overall health outcomes.
A Study of Tenecteplase in Acute Ischaemic Stroke: A Descriptive Real World Single Centre Experience from a Public Tertiary Care Hospital in Western India
Authors: Nagendra Shashank , Chaudhary Gaurav , Ojha Pawan , Jagiasi Kamlesh , Singh Rakesh , Singh Rakesh K. , Chheda Akash , Shah Arjun , Mahto Anuradha , Aipu Bilia K , Goud Survi Karthik , Bagadia Harshil , Gutte Avinash Angad , Radhakrishnan Rahul , Deshmukh Narayan 
Published: January 2025

Background This study evaluates the efficacy and safety of tenecteplase, a newer thrombolytic agent, in acute ischaemic stroke (AIS) at a tertiary public care centre in Western India. Methods This retrospective study analysed 30 patients with AIS treated with tenecteplase, presenting within 4.5 hours from onset and receiving 0.25 mg/kg of tenecteplase. Primary outcomes were patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90 days and those showing an improvement of the National Institutes of Health Stroke Scale (NIHSS) by 4 after 24 hours of thrombolysis. The secondary outcome was patients showing an improvement of NIHSS by 2 after 24 hours of thrombolysis and the number of patients showing an mRS score of 0-2 at 90 days. Safety outcomes were symptomatic intracerebral haemorrhage (ICH), all intracranial bleeding occurring within 24 hours, and in-hospital mortality. The impact of age and sex on outcomes was assessed. Results The mean age was 55.86 years. The mean symptom onset-to-hospital arrival time was 111.4 minutes and the mean door-to-needle time was 64.66 minutes. Out of all patients, 22 were male, and 8 were female. The mean NIHSS was 11.86 at presentation and 7.97 at 24 hours. The primary outcome of mRS 0-1 at 3 months was achieved in 19 patients; change in NIHSS ≥4 at 24 hours was in 7 patients. For secondary outcome, NIHSS change of 2 at 24 hours occurred in 13 patients, while 25 patients achieved mRS 0-2 at 3 months. Symptomatic ICH occurred in 1 patient, any ICH occurred in 7, while 2 patients had in-hospital mortality. Conclusion Tenecteplase is a safe and effective option for patients with AIS presenting within 4.5 hours.
The blood transcriptional response in patients developing intensive care unit-acquired pneumonia
Authors: de Brabander Justin , Michels Erik H.A. , Butler Joe M. , Reijnders Tom D.Y. , van Engelen Tjitske S.R. , Leite Giuseppe G.F. , Paling Fleur P. , Klarenbeek Augustijn M. , Sie Daoud L.S. , Boyer Roxane E. , Sweeney Timothy E. , Bonten Marc J.M. , Timbermont Leen , Malhotra-Kumar Surbhi , Kluytmans Jan A.J.W. , Peters-Sengers Hessel , van der Poll Tom 
Published: January 2025

IntroductionImmune response dysregulation has been implicated in the development of intensive care unit (ICU)-acquired pneumonia. We aimed to determine differences in the longitudinal blood transcriptional response between patients who develop ICU-acquired pneumonia (cases) and those who do not (controls).MethodsWe performed a case-cohort study in mechanically ventilated trauma and surgery patients with ICU stays >2 days, enrolled in 30 hospitals across Europe. We collected blood for RNA sequencing at baseline, day 7 and (in cases) the day of pneumonia diagnosis. We performed gene set enrichment analysis and analysed longitudinal gene expression changes using linear mixed models. External validation was performed using an independent trauma cohort.ResultsWe enrolled 113 cases and 115 controls, with similar baseline characteristics. At baseline (median 2 days after ICU admission), cases showed upregulated gene pathways relating to innate immunity, hemostasis and metabolism, and downregulated adaptive immune pathways. These changes persisted at the day of pneumonia diagnosis (median 6 days, compared to day 7 in controls). In the longitudinal comparison, cases exhibited enhanced upregulation of innate immunity, adaptive immunity and hemostasis pathways, along with enhanced downregulation of metabolism pathways relative to controls (all p<0.00001, except hemostasis p<0.05). These findings were largely externally validated. Cases had higher quantitative sepsis response signature scores (p<0.001), reflective of immune dysregulation.ConclusionPatients developing ICU-acquired pneumonia exhibit distinct blood transcriptional responses shortly after ICU admission and in the subsequent path to pneumonia, suggestive of broad immune dysfunction with both immunosuppressive and inflammatory features.
Development and external validation of a model for lung transplantation-free survival prediction of primary Sjögren's syndrome-associated interstitial lung disease: a prospective cohort study
Authors: Meng Wenyan , Zhang Xinran , Zhang Shu , Xie Bingbing , Ren Yanhong , Wang Shiyao , Geng Jing , Guo Xiaojuan , Liu Min , Xie Sheng , Zhao Ling , Wang Chen , Dai Huaping 
Published: January 2025

BackgroundThe primary Sjögren's Syndrome-associated Interstitial Lung Disease (pSS-ILD) patients have a worse prognosis than pSS patients without pulmonary involvement. This study aims to establish a prediction nomogram for early prediction of lung transplantation (LTx)-free survival in pSS-ILD patients.MethodsThe training cohort comprised 260 patients from China-Japan Friendship Hospital between January 1, 2016, and June 30, 2022, while the external validation cohort consisted of 135 patients from Beijing Chaoyang Hospital between January 1, 2007, and December 31, 2012. Univariable Cox regression analysis and least absolute shrinkage and selection operator (LASSO) were employed for variable selection, and a nomogram model was developed to predict the 1 -, 3 -, 5-year LTx-free survival. Both discrimination and calibration of the nomogram were assessed using concordance index (C-index), area under the curve (AUC), calibration curve and decision curve analysis (DCA).ResultsMultivariable Cox regression demonstrated that elevated age, oxygenation index, CA125 and fibrosis score were independent risk factors for LTx-free survival in pSS-ILD patients. The C-index displayed of the training and validation cohorts were 0.812 and 0.809. The 1-, 3-, 5-year AUC values in training and validation cohorts were 0.781, 0.874, 0.909 and 0.793, 0.826, 0.863 respectively. Bias-corrected curve is close to the ideal curve and revealed a strong consistency between actual observation and prediction.
Social support and recovery in ARDS survivors: a prospective cohort study
Authors: Szymczak Hermann , Brandstetter Susanne , Blecha Sebastian , Dodoo-Schittko Frank , Rohr Magdalena , Bein Thomas , Apfelbacher Christian 
Published: January 2025

BackgroundSocial support (SS) may contribute to the long-term recovery of critical illness survivors. This study focuses on survivors of the acute respiratory distress syndrome (ARDS) to investigate the causal relationship between SS and health related quality of life (HRQoL) and healthcare utilization in critically ill patients.MethodsA cohort study with N=877 ARDS survivors in 61 ICUs was conducted in Germany, between 2014 and 2019. SS (F-SozU K-14) and HRQoL (Physical and Mental Component Scale: PCS, MCS of the SF-12) were assessed at 3, 6, 12, and 24 months after ICU discharge. Healthcare utilization was assessed after 12 and 24 months. To identify confounders and allow for causal inferences, a directed acyclic graph (DAG) was developed.ResultsAdjusted regression models demonstrated significant positive impact of SS on mental HRQoL after three months onward (all ßs >0.15, allps <0.05). This influence increases over time. In contrast, the influence of SS on physical HRQoL and healthcare utilization remained inconclusive (only one significant association for physical HRQoL at 12 months: β=0.128, p<0.05, otherwise allps >0.05).ConclusionResults indicate SS plays an important and unique role in the long-term recovery of survivors of critical illness in the mental area. It appears that the more distal mechanism of SS unfolds progressively over time, perhaps as the immediate sequelae of critical illness after discharge subside. In contrast, SS does not appear to exert a substantial causal impact on physical HRQoL and healthcare utilization.
Strains of a virtuoso: pacemaker infection and ventricular tachycardia in a violinist
Authors: Chen Yuanguo , Zhang Haibo , Qiao Qi , Ma Lian 
Published: January 2025

Abstract

Purpose
Pacemaker-related infections are serious complications of cardiac implantable electronic devices (CIEDs). This case report aims to describe the occurrence of pacemaker pocket infection and recurrent ventricular tachycardia (VT) in a Chinese amateur violinist with sick sinus syndrome (SSS), and to explore the possible connection between occupational habits and the infection, as well as VT.

Methods
A 76-year-old male violinist with a Biotronik Evia DR dual-chamber pacemaker presented with syncope and signs of a pacemaker pocket infection three years after implantation. Despite initial antibiotic treatment, the infection persisted with slightly elevated C-reactive protein (CRP) and negative cultures. The VT originated from the right ventricular outflow tract (RVOT), as confirmed by echocardiography and ECG findings. The infection was treated with debridement and extraction of the pacemaker and leads.

Results
Debridement and extraction of the pacemaker and leads successfully resolved both the VT and the infection. The VT was likely linked to the infected lead, while the pacemaker infection was attributed to the patient’s violin playing, which caused mechanical stress and skin damage at the pacemaker site. Postoperative recovery was uneventful, with no recurrence of infection or arrhythmias at follow-up.

Conclusion
This case highlights the importance of considering a patient’s occupational habits when selecting pacemaker pocket sites to prevent infections and complications. In this case, the patient’s violin playing likely contributed to mechanical stress at the pacemaker site, leading to infection. Early identification and appropriate management, including device removal, are crucial to prevent further complications.
Role of regular medical visits in mitigating increased suicide risk during the early COVID-19 pandemic in Kobe, Japan
Authors: Miyamori Daisuke , Nagasaki Yasushi , Yoshida Shuhei , Kashima Saori , Omori Wataru , Itagaki Kei , Ito Masanori 
Published: January 2025

Abstract

Background
Japan has one of the lowest COVID-19 death rates, while the annual suicide rate in 2020 has risen for the first time since 2007. This study aimed to identify high-risk populations and assess the impact of medical visits on suicide trends post-COVID-19 pandemic in Japan.

Method
This quasi-experimental study analyzed a population-based database from Hyogo Prefecture (2012–2022). Interrupted time-series analyses identified level and trend changes in monthly suicide rates per 1 million population during the exposure period (2020–2022) versus the control period (2012–2019). Regular visits to primary care and psychiatry stratified analysis.

Results
2181 cases were analyzed, with two-thirds male and a median age of 54. Primary care physicians and psychiatric history were present in 69% and 40% of patients. The study found significant level changes in suicide rates overall (4.14, 95% CI: 1.70, 6.58) among individuals without regular primary care physician visits (2.83, 95% CI: 1.35, 4.32) and without psychiatric visits (2.85, 95% CI: 0.56, 5.14). In contrast, no significant changes were observed in individuals with regular primary care (0.99, 95% CI: -0.78, 2.76) or regular psychiatric visits (0.59, 95% CI: -0.98, 2.16). The trend changes were not significant in any of the groups.

Conclusion
This study suggests that a history of attending a medical institution may have prevented the rapid increase in suicides during the early stages of the COVID-19 pandemic.
Enhanced detection of mild cognitive impairment in Alzheimer’s disease: a hybrid model integrating dual biomarkers and advanced machine learning
Authors: Alex John Sahaya Rani , Roshini R. , Maneesha G. , Aparajeeta Jeetashree , Priyadarshini B. , Lin Chih-Yang , Lung Chi-Wen 
Published: January 2025

Abstract
Alzheimer's disease (AD) is a complex, progressive, and irreversible neurodegenerative disorder marked by cognitive decline and memory loss. Early diagnosis is the most effective strategy to slow the disease's progression. Mild Cognitive Impairment (MCI) is frequently viewed as a crucial stage before the onset of AD, making it the ideal period for therapeutic intervention. AD is marked by the buildup of amyloid-beta (Aβ) plaques and tau neurofibrillary tangles (NFTs), which are believed to cause neuronal loss and cognitive decline. Both Aβ plaques and NFTs accumulate for many years before the clinical symptoms become apparent in AD. As a result, in this study, CerebroSpinal Fluid (CSF) biomarker information is combined with hippocampal volumes to differentiate between MCI and AD. For this, a novel two-stage hybrid learning model that leverages 3D CNN and the notion of a Fuzzy and Machine learning model is proposed. A 3D-CNN architecture is employed to segment the hippocampus from the structural brain 3D-MR images and quantify the hippocampus volume. In stage 1, the hippocampus volume is passed through thirteen machine learning models and fuzzy clustering for classifying symptomatic AD and healthy brain (Normal Control - NC). The CSF data is fuzzified to capture the inherent uncertainty and overlap in clinical data. The identified symptomatic AD data in the stage1 are further classified into MCI and AD with the aid of a fuzzified CSF biomarker in stage 2. The experimental work presented in this study utilized the Alzheimer's Disease Neuroimaging Initiative (ADNI) dataset. The proposed hybrid model achieved an average accuracy of 93.6% for distinguishing between NC and symptomatic AD and 93.7% for discriminating between MCI and AD. This approach enhances diagnostic accuracy and provides a more comprehensive assessment, allowing for earlier and more targeted therapeutic interventions.
Prevalence of obsessive-compulsive symptoms in patients with schizophrenia treated with clozapine: a scoping review
Authors: Moreno Tarazona Evelyn , Orozco Gonzalez Mauricio , La Rosa Giron Andrea , Ruiz-Grosso Paulo , Lazo-Porras Maria 
Published: January 2025

Abstract

Background
Schizophrenia is a complex psychiatric disorder, and in patients treated with clozapine, it may induce or exacerbate obsessive-compulsive symptoms (OCS), which negatively affect patients’ quality of life, functionality and treatment adherence. Despite its clinical relevance, the reported prevalence and characteristics of clozapine associated OCS vary widely, limiting effective management.

Objective
This scoping review synthesizes evidence on the prevalence of OCS in patients with schizophrenia treated with clozapine and explores treatment characteristics (types, severity, dose, and time to onset/exacerbation).

Methods
The PRISMA-ScR methodology guided the search in PubMed, LILACS, Embase, and Scielo. Observational studies in Spanish, English, Portuguese, and French reporting prevalence, incidence, or frequency of OCS in patients over 18 years with schizophrenia treated with clozapine were included. Clinical, qualitative studies, and those with access restrictions were excluded. Risk of bias was assessed using JBI tools.

Results
Fourteen studies were included, reporting OCS prevalence between 20% and 76%, and de novo OCS between 4.8% and 46.4%. Clozapine dose ranged from 196 to 525 mg/day, and treatment duration from 5 to 210 months. The most common obsessions were aggression and checking, with severity ranging from mild to moderate.

Conclusions
The prevalence of OCS in patients treated with clozapine varies widely. Further research is needed to clarify the relationship between dose, treatment duration, and the onset/exacerbation of OCS.
Histopathology of the tongue in a hamster model of COVID-19
Authors: Coggins John , Saito Marina Hosotani , Cook Rebecca , Urata Shinji , Urata Megumi , Harsell Nantian Lin , Tan Wilhelmina Nanrui , Figueira Bibiana Toro , Bradley Megan , Quadri Nadia Z. , Saripada Janisah Amirah I. , Reyna Rachel A. , Maruyama Junki , Paessler Slobodan , Makishima Tomoko 
Published: January 2025

Abstract

Objective
With altered sense of taste being a common symptom of coronavirus disease 2019 (COVID-19), the main objective was to investigate the presence and distribution of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) within the tongue over the course of infection.

Methods
Golden Syrian hamsters were inoculated intranasally with SARS-CoV-2 and tongues were collected at 2, 3, 5, 8, 17, 21, 35, and 42 days post-infection (dpi) for analysis. In order to test for gross changes in the tongue, the papillae of the tongue were counted. Paraffin-embedded thin sections of the tongues were labeled for the presence of SARS-CoV-2 antigen.

Results
There was no difference in fungiform or filiform papillae density throughout the course of infection. SARS-CoV-2 antigen was observed in the vallate papillae taste buds (3–35 dpi) and autonomic ganglia (5–35 dpi), as well as in the serous and mucous salivary glands of the posterior tongue (2–42 dpi).

Conclusion
The presence and distribution of SARS-CoV-2 suggest that the virus could cause taste disturbance by infecting the vallate papillae taste buds. This effect could be exacerbated by a diminished secretion of saliva caused by infection of the serous salivary glands and the autonomic ganglia which innervate them.
Improving the healthcare user experience: an optimization model grounded in patient-centredness
Authors: Peruzzo Elisa , Seghieri Chiara , Vainieri Milena , De Rosis Sabina 
Published: January 2025

Abstract

Background
Patient satisfaction and experience are key outcomes of healthcare and can be computed as powerful measures of service quality. Understand what affects them is essential for service quality improvement. Investigating whether the care setting (i.e., medical or surgical) can impact the patients’ perception of the quality can be also important for the actionability of this data. The aim is to explore which experiential factors should be prioritized to improve patient satisfaction with hospitalization service, using experience items as intermediate results and considering different settings.

Methods
Patient-reported experience measures are used in an Italian region. This study uses the optimization approach to identify factors of healthcare user experience affecting and enhancing satisfaction.

Results
The results confirm that, among the significant determinants of satisfaction, some specific experiential aspects emerged as the potential primary focus to be prioritized in improvement actions. These aspects vary according to the specific departmental area.

Conclusions
The study presents an optimization model directly informed by healthcare service users, utilizing their insights to drive healthcare delivery improvements. It emphasizes the necessity of not only collect patient perspectives but also applying different methodologies to understand what matters to patients and what interventions could be prioritized, and to strategically use diverse insights to enhance the delivery of healthcare services and patient experience and satisfaction.
Understanding malaria treatment patronage from informal healthcare providers in Nigerian urban settlements: insights from community members and providers
Authors: Bamgboye Eniola A , Ogunwale Akintayo Olamide , Al-Mukhtar Adamu , Musa Bello , Mhlanga Laurette , Olawuwo Morenikeji , Fagbamigbe Adeniyi , Akinyemi Joshua , Ajayi IkeOluwapo , Ozodiegwu Ifeoma D 
Published: January 2025

Abstract

Background
Informal Healthcare Providers (IHCPs), including Proprietary Patent Medicine Vendors (PPMVs), drug peddlers, traditional healers, and herbal drug sellers are often the first choice for malaria treatment, especially in urban slums. Unplanned urbanization significantly impacts malaria transmission by creating cities with inadequate safety nets and healthcare access, increasing reliance on IHCPs. While the World Health Organization recognizes IHCP’s crucial role and emphasizes integrating them into formal healthcare for improved malaria care, they lack requisite training in malaria management and operate outside official regulations, raising concerns about the quality of care they provide. Understanding IHCPs' perceptions and practices is essential for their proper integration. This study explored the perceived malaria burden, IHCPs’ competence in malaria treatment, and reasons for visiting IHCPs in various urban settlements from both community member and provider perspectives.

Methods
This qualitative cross-sectional study was carried out in Ibadan and Kano metropolises. Eighteen Focus Group Discussions among 157 adult community members and twelve Key-Informant Interviews among PPMVs, drug peddlers, traditional healers and herbal drug sellers were conducted in these cities. Participants were drawn purposively from settlements—designated as formal, informal, and slum based on local definitions—in selected wards within the cities. Data were collected using pre-tested guides and analysed thematically.

Results
This study reveals that malaria remains a significant health problem in these Nigerian cities. Patronage of IHCPs generally is driven by affordable treatment, perceived mildness of illness, and access to credit facilities. However, cultural belief was key to patronage of traditional healers and herbal drug sellers, largely among informal and slum residents. Furthermore, while IHCPs had a strong perceived competence in managing malaria cases, inadequate diagnosis and treatment were standard practices.

Conclusions
IHCPs remain consistently patronized across urban settlements. IHCPs are continuously patronized in all urban settlement. Educating and equipping IHCPs with diagnostic tools, enhancing access to affordable healthcare, and raising public awareness is crucial for proper malaria management and promoting collaborations with formal healthcare providers.