bluuebunny/crossref_metadata_2025_split huggingface dataset:
NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials
Authors: Hegazi Omar E. , Alalalmeh Samer O. , Alnuaimi Ghala Rashid Humaid , Shahwan Moyad , Jairoun Ammar Abdulrahman , Alorfi Nasser M. , Majrashi Shaker A. , Alkhanani Mustfa Faisal , Alkhattabi Abdullah , Alourfi Mansour M. , Alsolami Faris A. , Alsharif Saeed , Alshahrani Hatim 
Published: August 2023

BackgroundNonalcoholic Fatty Liver Disease (NAFLD) has become a significant public health concern, affecting approximately one-fourth of the population. Despite its prevalence, no FDA-approved drug treatments specifically target NAFLD.AimTo provide a review of clinical trials investigating the use of herbal remedies and dietary supplements in NAFLD management, utilizing the ClinicalTrials.gov database.MethodsThis review evaluates the current evidence by examining completed phase III and IV clinical trials registered on ClinicalTrials.gov. An exhaustive search was performed on April 17, 2023, using the terms “Nonalcoholic Fatty Liver Disease” and “NAFLD.” Two independent reviewers appraised eligible trials based on pre-defined inclusion and exclusion criteria.ResultsAn initial search yielded 1,226 clinical trials, with 12 meeting the inclusion criteria after filtration. The majority of trials focused on Omega-3 fatty acids (20.0%) and vitamin D (26.7%), followed by caffeine, chlorogenic acid, ginger, phosphatidylcholine, Trigonella Foenum-graecum seed extract, vitamin C, and vitamin E (each 6.7%). Most studies were Phase 3 (75.0%) and used a parallel assignment model (91.7%). Quadruple masking was the most prevalent technique (58.3%), and Iran was the leading country in terms of trial locations (25.0%). These interventions constitute two herbal interventions and nine supplement interventions.ConclusionThis reveals a diverse range of nutraceuticals, with Omega-3 fatty acids and vitamin D being predominant in the management of NAFLD. The global distribution of trials highlights the widespread interest in these therapeutics. However, more rigorous, large-scale trials are needed to establish safety, efficacy, and optimal dosages.
Genetic characteristics and integration specificity of Salmonella enterica temperate phages
Authors: Sun Siqi , Zhang Xianglilan 
Published: August 2023

IntroductionTemperate phages can engage in the horizontal transfer of functional genes to their bacterial hosts. Thus, their genetic material becomes an intimate part of bacterial genomes and plays essential roles in bacterial mutation and evolution. Specifically, temperate phages can naturally transmit genes by integrating their genomes into the bacterial host genomes via integrases. Our previous study showed that Salmonella enterica contains the largest number of temperate phages among all publicly available bacterial species. S. enterica is an important pathogen that can cause serious systemic infections and even fatalities.MethodsInitially, we extracted all S. enterica temperate phages from the extensively developed temperate phage database established in our previous study. Subsequently, we conducted an in-depth analysis of the genetic characteristics and integration specificity exhibited by these S. enterica temperate phages.ResultsHere we identified 8,777 S. enterica temperate phages, all of which have integrases in their genomes. We found 491 non-redundant S. enterica temperate phage integrases (integrase entries). S. enterica temperate phage integrases were classified into three types: intA, intS, and phiRv2. Correlation analysis showed that the sequence lengths of S. enterica integrase and core regions of attB and attP were strongly correlated. Further phylogenetic analysis and taxonomic classification indicated that both the S. enterica temperate phage genomes and the integrase gene sequences were of high diversities.DiscussionOur work provides insight into the essential integration specificity and genetic diversity of S. enterica temperate phages. This study paves the way for a better understanding of the interactions between phages and S. enterica. By analyzing a large number of S. enterica temperate phages and their integrases, we provide valuable insights into the genetic diversity and prevalence of these elements. This knowledge has important implications for developing targeted therapeutic interventions, such as phage therapy, to combat S. enterica infections. By harnessing the lytic capabilities of temperate phages, they can be engineered or utilized in phage cocktails to specifically target and eradicate S. enterica strains, offering an alternative or complementary approach to traditional antibiotic treatments. Our study has implications for public health and holds potential significance in combating clinical infections caused by S. enterica.
Identification and quantitative assessment of motor complications in Parkinson’s disease using the Parkinson’s KinetiGraph™
Authors: Qu Yan , Zhang Tingting , Duo Yunyan , Chen Liling , Li Xiaohong 
Published: August 2023

IntroductionEffective management and therapies for the motor complications of Parkinson’s disease (PD) require appropriate clinical evaluation. The Parkinson’s KinetiGraph™ (PKG) is a wearable biosensor system that can record the motion characteristics of PD objectively and remotely.ObjectiveThe study aims to investigate the value of PKG in identifying and quantitatively assessing motor complications including motor fluctuations and dyskinesia in the Chinese PD population, as well as the correlation with the clinical scale assessments.MethodsEighty-four subjects with PD were recruited and continuously wore the PKG for 7 days. Reports with 7-day output data were provided by the manufacturer, including the fluctuation scores (FS) and dyskinesia scores (DKS). Specialists in movement disorders used the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale-IV (MDS-UPDRS IV), the wearing-off questionnaire 9 (WOQ-9), and the unified dyskinesia rating scale (UDysRS) for the clinical assessment of motor complications. Spearman correlation analyses were used to evaluate the correlation between the FS and DKS recorded by the PKG and the clinical scale assessment results. Receiver operating characteristic (ROC) curves were generated to analyze the sensitivity and specificity of the FS and DKS scores in the identification of PD motor complications.ResultsThe FS was significantly positively correlated with the MDS-UPDRS IV motor fluctuation (items 4.3–4.5) scores (r = 0.645, p &lt; 0.001). ROC curve analysis showed a maximum FS cut-off value of 7.5 to identify motor fluctuation, with a sensitivity of 74.3% and specificity of 87.8%. The DKS was significantly positively correlated with the UDysRS total score (r = 0.629, p &lt; 0.001) and the UDysRS III score (r = 0.634, p &lt; 0.001). ROC curve analysis showed that the maximum DKS cut-off value for the diagnosis of dyskinesia was 0.7, with a sensitivity of 83.3% and a specificity of 83.3%.ConclusionThe PKG assessment of motor complications in the PD population analyzed in this study has a significant correlation with the clinical scale assessment, high sensitivity, and high specificity. Compared with clinical evaluations, PKG can objectively, quantitatively, and remotely identify and assess motor complications in PD, providing a good objective recording for managing motor complications.
Perfusion-weighted software written in Python for DSC-MRI analysis
Authors: Fernández-Rodicio Sabela , Ferro-Costas Gonzalo , Sampedro-Viana Ana , Bazarra-Barreiros Marcos , Ferreirós Alba , López-Arias Esteban , Pérez-Mato María , Ouro Alberto , Pumar José M. , Mosqueira Antonio J. , Alonso-Alonso María Luz , Castillo José , Hervella Pablo , Iglesias-Rey Ramón 
Published: August 2023

IntroductionDynamic susceptibility-weighted contrast-enhanced (DSC) perfusion studies in magnetic resonance imaging (MRI) provide valuable data for studying vascular cerebral pathophysiology in different rodent models of brain diseases (stroke, tumor grading, and neurodegenerative models). The extraction of these hemodynamic parameters via DSC-MRI is based on tracer kinetic modeling, which can be solved using deconvolution-based methods, among others. Most of the post-processing software used in preclinical studies is home-built and custom-designed. Its use being, in most cases, limited to the institution responsible for the development. In this study, we designed a tool that performs the hemodynamic quantification process quickly and in a reliable way for research purposes.MethodsThe DSC-MRI quantification tool, developed as a Python project, performs the basic mathematical steps to generate the parametric maps: cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), signal recovery (SR), and percentage signal recovery (PSR). For the validation process, a data set composed of MRI rat brain scans was evaluated: i) healthy animals, ii) temporal blood–brain barrier (BBB) dysfunction, iii) cerebral chronic hypoperfusion (CCH), iv) ischemic stroke, and v) glioblastoma multiforme (GBM) models. The resulting perfusion parameters were then compared with data retrieved from the literature.ResultsA total of 30 animals were evaluated with our DSC-MRI quantification tool. In all the models, the hemodynamic parameters reported from the literature are reproduced and they are in the same range as our results. The Bland–Altman plot used to describe the agreement between our perfusion quantitative analyses and literature data regarding healthy rats, stroke, and GBM models, determined that the agreement for CBV and MTT is higher than for CBF.ConclusionAn open-source, Python-based DSC post-processing software package that performs key quantitative perfusion parameters has been developed. Regarding the different animal models used, the results obtained are consistent and in good agreement with the physiological patterns and values reported in the literature. Our development has been built in a modular framework to allow code customization or the addition of alternative algorithms not yet implemented.
Vacuum-assisted biopsy system for breast lesions: a potential therapeutic approach
Authors: Zhu Yue , Chen Xingyan , Dou He , Liu Yuqi , Li Fucheng , Wang Youyu , Xiao Min 
Published: August 2023

PurposeThe primary objective is to optimize the population eligible for Mammotome Minimally Invasive Surgery (MIS) by refining selection criteria. This involves maximizing procedure benefits, minimizing malignancy risk, and reducing the rate of malignant outcomes.Patients and methodsA total of 1158 female patients who came to our hospital from November 2016 to August 2021 for the Mammotome MIS were analyzed retrospectively. Following χ2 tests to screen for risk variables, binary logistic regression analysis was used to determine the independent predictors of malignant lesions. In addition, the correlation between age and lesion diameter was investigated for BI-RADS ultrasound (US) category 4a lesions in order to better understand the relationship between these variables.ResultsThe malignancy rates of BI-RADS US category 3, category 4a and category 4b patients who underwent the Mammotome MIS were 0.6% (9/1562), 6.4% (37/578) and 8.3% (2/24) respectively. Malignant lesions were more common in patients over the age of 40, have visible blood supply, and BI-RADS category 4 of mammography. In BI-RADS US category 4a lesions, the diameter of malignant tumor was highly correlated with age, and this correlation was strengthened in patients over the age of 40 and with BI-RADS category 4 of mammography.ConclusionThe results of this study demonstrate that the clinical data and imaging results, particularly age, blood supply, and mammography classification, offer valuable insights to optimize patients’ surgical options and decrease the incidence of malignant outcomes.
Vein of Galen aneurysmal malformation in newborns: a retrospective study to describe a paradigm of treatment and identify risk factors of adverse outcome in a referral center
Authors: Buratti Silvia , Mallamaci Marisa , Tuo Giulia , Severino Mariasavina , Tortora Domenico , Parodi Costanza , Rossi Andrea , Pasetti Francesco , Castellan Lucio , Capra Valeria , Romano Ferruccio , De Marco Patrizia , Pavanello Marco , Piatelli Gianluca , Paladini Dario , Calevo Maria Grazia , Moscatelli Andrea 
Published: August 2023

BackgroundVein of Galen aneurysmal malformation (VGAM) is a rare cerebral vascular malformation associated with significant morbidity and mortality. Newborns with VGAM without adequate treatment may develop rapidly deteriorating high output heart failure (HOHF) and are at risk for severe neurological outcomes.ObjectiveTo describe the clinical course and management of newborns with VGAM, and identify which echocardiographic and neuroradiologic factors may be associated with severe heart failure at birth and adverse short term outcomes.MethodsThis is a single center retrospective cohort study including all consecutive newborns with VGAM admitted to Gaslini Children's Hospital between 2009 and 2022. We reviewed clinical data, intensive care support, fetal and neonatal cardiologic and neuroradiologic findings and we studied the association with severe HOHF, endovascular complications and death.ResultsOut of 40 newborns, 17 (42.5%) developed severe HOHF requiring early endovascular procedures. Medical treatment was focused on the main components of HOHF by providing inotropic support and peripheral vasodilation. Pulmonary vasodilators were avoided to reduce the negative effects of pulmonary overflow and prevent vascular remodeling. Reduction of the obligatory left to right shunt through the VGAM was possible only through endovascular treatment. Fetal cardiothoracic ratio was significantly associated with severe HOHF at birth and death. Cardiologic parameters of right ventricular overload, pulmonary hypertension and systemic steal were the leading findings associated with haemodynamic compromise at birth. The mediolateral diameter of the straight or falcine sinus at its shortest section (SS-MD), and arterial pseudofeeders were significantly associated with severe HOHF at birth in prenatal and postnatal assessments. None of the postnatal echocardiographic and MRI variables, nor a higher inotropic support were associated with major periprocedural complications or death. Mortality was due to palliation for congenital severe brain damage (4/40, 10%), or major periprocedural complications (3/40, 7.5%). None of the patients died due to HOHF and multiorgan failure. Overall survival at discharge was 82.5% (33/40).ConclusionsThe complexity of neonatal VGAM pathophysiology requires a multidisciplinary approach, specialized intensive care management, and early endovascular treatment to reduce mortality and optimize clinical outcomes. Cardiologic and neuroradiologic parameters are key to define risk stratification and treatment strategies.
A phase 1 study of dimdazenil to evaluate the pharmacokinetics, food effect and safety in Chinese healthy subjects
Authors: Wang Fei , He Jingjing , Zhou Yanling , Ye Lijun , Li Bei , Ma Zhiyuan , Chen Chunyan , Zhang Ruoxi , Lin Zhaocun , Tang Jinshan , Jin Zhiping , Jiang Yu , Lin Nengming 
Published: August 2023

Background and objective: As a partial positive allosteric modulator of the gamma-aminobutyric acid A (GABAA) receptor, dimdazenil was used for the treatment of insomnia with the potential to alleviate associated side effects compared to full agonists. The objective of this trial is to assess the safety, tolerability, food effect and pharmacokinetics following single and multiple doses of dimdazenil in Chinese healthy subjects.Methods: In this phase 1 trial, 36 healthy subjects aged ≥18 years were assigned to receive a single dose of 1.5, 2.5, or 5 mg dimdazenil, with each dose cohort consisting of 12 subjects, and 14 subjects were assigned to receive a multiple 2.5 mg daily dose of dimdazenil for 5 days. Safety, tolerability, and pharmacokinetic characteristics were evaluated.Results: Of the 50 subjects enrolled and 49 completed the trial, the incidences of treatment-emergent adverse events (AEs) in the single-dose groups of 1.5, 2.5, and 5 mg were 16.7%, 58.3% and 66.7% respectively, while 61.5% in the multiple-dose group. There were no serious AEs, deaths, AEs leading to discontinuation or AEs of requiring clinical intervention in any treatment groups. The most treatment-emergent AEs were dizziness (n = 4, 8.2%), hyperuricemia (n = 2, 6.1%), upper respiratory tract infection (n = 2, 6.1%), diastolic blood pressure decreased (n = 2, 6.1%), blood TG increased (n = 2, 6.1%) and RBC urine positive (n = 2, 6.1%). All AEs were mild-to-moderate and transient, and no severe AEs were documented in any study phase. The PK profile of dimdazenil and its active metabolite Ro46-1927 was linear across 1.5–5 mg oral doses in humans. The median Tmax for dimdazenil was in the range of 0.5–1.5 h, and the apparent terminal t1/2z ranged from 3.50 to 4.32 h. Taking Dimdazenil with food may delay Tmax and decrease Cmax, without affecting the total exposure (AUC). No relevant accumulations of dimdazenil and Ro 46–1927 were observed in multiple-dose group.Conclusion: Dimdazenil was generally well tolerated in healthy Chinese subjects after single and 5 days-multiple dosing. The pharmacokinetic properties of dimdazenil are compatible with a drug for the treatment of insomnia.Clinical Trial Registration: chinadrugtrials.org.cn, identifier CTR20201978
Item response theory approach to ethnocentrism
Authors: Monaghan Conal , Bizumic Boris 
Published: August 2023

IntroductionAlthough ethnocentrism is one of the fundamental concepts in the social sciences, its study has been impeded by a diversity of conceptualizations and measures. In recent years, a growing number of political scientists and psychologists have undertaken in-depth research into ethnocentrism. In addition, researchers have recently proposed a comprehensive reconceptualization of ethnocentrism and developed a new Ethnocentrism scale. There is strong evidence for this scale's reliability and validity in indexing ethnocentrism, but like most measures in psychology and political science, this scale is based on classical test theory. Item response theory (IRT) is a powerful psychometric technique that can provide a much more sophisticated test of test performance and is currently under-utilized in research.MethodsWe performed IRT to assess the psychometric properties of the Ethnocentrism scale on a sample of 4,187 participants.ResultsThe scale's items had strong psychometric properties to capture the ethnocentrism latent construct, particularly in the below average to above average range. Men required marginally lower levels of ethnocentrism to endorse less socially acceptable items than women (items relating to superiority, purity, or exploitativeness). When compared to liberals, conservatives responded more readily to nearly all ethnocentrism items. Given this variation, the IRT approach highlighted that future measurements must adjust for differential item functioning, albeit more for political orientation than gender identity.DiscussionThe findings detail how IRT can enhance measurement in political science and demonstrate the implications for how gender and political ideology may affect the differential performance of items.
Problematic smartphone use and sleep disturbance: the roles of metacognitions, desire thinking, and emotion regulation
Authors: Akbari Mehdi , Seydavi Mohammad , Sheikhi Sonay , Spada Marcantonio M. 
Published: August 2023

BackgroundThe association between problematic Smartphone use (PSU) and sleep disturbance is evidenced in the literature, but more research is required to investigate the potential factors that may influence the effect of PSU on sleep disturbance. Given the considerable prevalence of PSU (9.3 to 36.7%) and sleep disturbance (55.2%) in Iran, the current study sought to examine an interactional model to test whether metacognitions about Smartphone use, desire thinking (verbal perseveration and imaginal prefiguration), and emotion regulation (expressive suppression and cognitive reappraisal) could have a moderating effect on the above-mentioned association.MethodThis present study is a cross-sectional, observational study that was conducted between June and September 2022 in a convenience sample of Iranians (n = 603, Female = 419, Age = 24.61 ± 8).ResultsDespite the significant association between metacognitions about the Smartphone use, PSU, and sleep disturbance, metacognitions failed to predict sleep disturbance above PSU. A slope analysis showed, however, that a high (not low or moderate) levels of imaginal prefiguration strengthen the association between PSU and sleep disturbance, while a high (not low or moderate) level of cognitive reappraisal and expressive suppression dampen the PSU-sleep disturbance association. We also found that verbal perseveration and expressive suppression were unique predictors of sleep disturbance, while imaginal prefiguration and reappraisal only predicted sleep disturbance if they interacted with PSU.ConclusionTheoretically, findings suggest that enhancing cognitive reappraisal (by 1 SD) and reducing imaginal prefiguration (by 1 SD), might protect against sleep disturbance by reducing its association with PSU. Limitations and future directions are discussed.
The acceptability of homebased exercise snacking and Tai-chi snacking amongst high and low function UK and Taiwanese older adults
Authors: Liang Ian Ju , Francombe-Webb Jessica , McGuigan Polly M. , Perkin Oliver J. , Thompson Dylan , Western Max J. 
Published: August 2023

Introduction: Exercise “snacking” and Tai-chi ‘snacking’ protocols are designed to overcome typical barriers to older adults’ participation in muscle strength and balance exercise, using short bouts of home-based exercise. This study aimed to investigate the acceptability of homebred exercise- and Tai-chi snacking in British and Taiwanese older adults of high and low physical function.Methods: Thirty-three British and Thirty Taiwanese older adults took part in semi-structured interviews, after trying 1-week of exercise- and Tai-chi snacking. The interview schedule and deductive framework analysis was based on the seven components of the Theoretical Framework of Acceptability (TFA). Differences between the Taiwanese and United Kingdom participants and those considered high versus low physical function were also analysed.Results: Both snacking regimes were found to be convenient and easy to implement. Participants reported that no activity had to be given up, and considered the programmes would be beneficial to their physical and mental health. Interestingly, more UK-based participants preferred the elegant and relaxing movements of Tai-chi snacking, yet participants with low physical function experienced difficulties when mastering Tai-chi movements. A few high physical function participants perceived exercise snacking to be tedious.Discussion: Overall, the snacking exercise was found to be acceptable and useful. Personal affective attitude and different cultural backgrounds may affect exercise participation. Nevertheless, it is important to consider individuals’ physical function when designing exercise regime. The findings indicate that making Tai-chi snacking easier to master initially, building in progression and adding some upper body movements in the exercise snacking may further enhance acceptability.