bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials
Authors: Deodhar Atul , Blauvelt Andrew , Lebwohl Mark , Feely Meghan , Kronbergs Andris , Eberhart Nadezhda , Zhu Danting , Inman Elsa , Grace Elsie , Holzkaemper Thorsten , Rahman Proton , Marzo-Ortega Helena , Papp Kim A. , Merola Joseph F. , Gottlieb Alice B. , Schwartzman Sergio 
Published: February 2024

Abstract
Background
We report long-term, end-of-study program safety outcomes from 25 randomized clinical trials (RCTs) in adult patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) [including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)] who received ≥ 1 dose of Ixekizumab (IXE) over 5 years (PsO) or up to 3 years (PsA, axSpA).

Methods
This integrated safety analysis consists of data from patients who received any dose of IXE, across 25 RCTs (17 PsO, 4 PsA, 4 axSpA). Rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and selected adverse events (AEs) of interest were analyzed for all pooled studies by years of therapy and overall, through March 2022. Results were reported as exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) overall and at successive year intervals.

Results
Six thousand eight hundred ninety two adult patients with PsO, 1401 with PsA, and 932 with axSpA (including AS and nr-axSpA), with a cumulative IXE exposure of 22,371.1 PY were included. The most commonly reported TEAE across indications was nasopharyngitis (IRs per 100 PY: 8.8 (PsO), 9.0 (PsA), 8.4 (axSpA)). SAEs were reported by 969 patients with PsO (IR 5.4), 134 patients with PsA (IR 6.0), and 101 patients with axSpA (IR 4.8). Forty-five deaths were reported (PsO, n = 36, IR 0.2; PsA, n = 6, IR 0.3; axSpA, n = 3, IR 0.1). TEAEs did not increase during IXE exposure: IRs per 100 PY, PsO: 88.9 to 63.2 (year 0–1 to 4–5), PsA: 87 to 67.3 (year 0–1 to 2–3), axSpA: 82.1 to 55.4 (year 0–1 to >  = 2). IRs per 100 PY of discontinuation from IXE due to AE were 2.9 (PsO), 5.1 (PsA), and 3.1 (axSpA). IRs per 100 PY of injection site reactions were 5.9 (PsO), 11.6 (PsA) and 7.4 (axSpA); Candida: 1.9 (PsO), 2.0 (PsA), and 1.2 (axSpA); depression, major adverse cerebro-cardiovascular events and malignancies: ≤ 1.6 across all indications. Adjudicated IRs per 100 PY of inflammatory bowel disease were ≤ 0.8 across indications (0.1 [PsO]; 0.1 [PsA]; 0.8 [axSpA]).

Conclusions
In this integrated safety analysis, consisting of over 22,000 PY of exposure, the long-term safety profile of IXE was found to be consistent with previous, earlier reports, with no new safety signals identified.

Trial registration
NCT registration numbers for RCTs included in this integrated analysis can be found in Additional File 1.
Relationship between maximal oxygen uptake, within-set fatigue and between-set recovery during resistance exercise in resistance-trained men and women
Authors: Lundberg Tommy R. , Larsson Gustav , Alstermark Rasmus , Mandić Mirko , Fernandez-Gonzalo Rodrigo 
Published: February 2024

Abstract
Background
The primary aim of this study was to examine the relationship between maximal oxygen update (V̇O2max) and within-set fatigue and between-set recovery during resistance exercise in men and women.

Methods
We examined the relationship between V̇O2max and various indices of fatigue and recovery during parallel squats (3 sets, 90 s rest, 70% of 1RM to failure) and isokinetic knee extensions (3 × 10 maximal repetitions at 60 deg/s, 45 s rest) in 28 (age 27.0 ± 3.6 years) resistance-trained subjects (14 men and 14 women). We also examined whether there were sex differences in within-set fatigue and between-set recovery.

Results
V̇O2max was weakly related to recovery and fatigue in both men and women (range of P-values for V̇O2max as a covariate; 0.312–0.998, range of R-values, 0.005–0.604). There were no differences between the sexes in fatigue within a set for the squat, but men showed less within-set fatigue than women in the first set of the isokinetic knee extension exercise (~ 8% torque loss difference, main effect of sex P = 0.034). Regarding recovery between sets, men showed greater relative peak power (P = 0.016) and peak torque (P = 0.034) loss between sets in both exercises, respectively, compared to women. Women also tended to complete more repetitions than men (main effect of sex, P = 0.057). Loss of peak torque between sets in knee extension was evident in both absolute and relative (%) values in men but not in women.

Conclusions
Our study suggests that aerobic capacity is weakly associated with within-set fatigue and between-set recovery in resistance training in both men and women. Women and men show comparable levels of within-set fatigue in the multi-joint squat, but women show more within-set fatigue during the single-joint isokinetic knee extension compared with men. In contrast, women recover better than men between sets in both exercises.
Pneumocystis jirovecii pneumonia: a case report
Authors: Gri Jacqueline , Jain Varun 
Published: February 2024

Abstract
Introduction and importance
Pneumocystis jirovecii (PJP) pneumonia is a serious life-threatening condition in immunocompromised individuals and is often associated with human immunodeficiency virus (HIV) + patients. We describe a case of PJP pneumonia which provided a diagnostic challenge in a patient who presented with no known risk factors leading to a delay in initiation of appropriate antibiotic therapy.

Case presentation
A 71-year-old previously healthy white/Caucasian male presented with subacute hypoxic respiratory failure due to multifocal pneumonia with diffuse bilateral ground glass opacities with consolidations despite prior treatment with antibiotics and steroids. He was admitted and started on intravenous broad-spectrum antibiotics but continued to deteriorate, eventually requiring intubation and transfer to the ICU. Bronchoscopy revealed PJP and treatment was initiated, but the patient developed refractory shock and multiorgan failure, and ultimately died. It was later discovered that he was HIV-1 positive.

Clinical discussion
PJP, as a potential cause of his presentation, was not considered given that our patient lacked any overt risk factors for PJP pneumonia. He continued to worsen despite broad spectrum antibiotic therapy and hence bronchoscopy was pursued. His clinical profile, in hindsight, was suspicious for PJP pneumonia and early PJP-directed antibiotic therapy may have prevented a fatal outcome, as in this case. There was an element of cognitive bias across multiple providers which may have contributed to the delay in treatment despite his rapid clinical decline while on conventional pneumonia treatment protocol. His diagnosis was later evident when his BAL-DFA grew PJP in addition to his low levels of CD4 and CD8 cells. He was found to be HIV-1 positive five days after his death; there was a delay in this diagnosis since all positive HIV tests from the hospital are reported as ‘pending’ until the presumptive positive sample goes to the Connecticut Department of Public Health State laboratory for the confirmatory test. PJP-targeted therapies were initiated later in our patient’s hospital course when the infection had progressed to refractory septic shock with multiorgan failure and eventual death.

Conclusion
PJP pneumonia is a fatal disease if not recognized early in the course of illness, and the patient usually undergoes multiple antibiotic regimens before they are diagnosed and receive appropriate clinical care. The gold standard of diagnostic testing for PJP is by obtaining bronchial washings through a flexible bronchoscopy and the turnaround time for such results may take a few days to result. A significant proportion of patients may not have any overt risk factors of immunosuppression and early empiric treatment for PJP may be clinically appropriate as the delay in diagnosis may be associated with significant morbidity and mortality risk.
Abnormal protein post-translational modifications induces aggregation and abnormal deposition of protein, mediating neurodegenerative diseases
Authors: Li Wei , Li Hong-Lian , Wang Jian-Zhi , Liu Rong , Wang Xiaochuan 
Published: February 2024

AbstractProtein post-translational modifications (PPTMs) refer to a series of chemical modifications that occur after the synthesis of protein. Proteins undergo different modifications such as phosphorylation, acetylation, ubiquitination, and so on. These modifications can alter the protein’s structure, function, and interaction, thereby regulating its biological activity. In neurodegenerative diseases, several proteins undergo abnormal post-translational modifications, which leads to aggregation and abnormal deposition of protein, thus resulting in neuronal death and related diseases. For example, the main pathological features of Alzheimer’s disease are the aggregation of beta-amyloid protein and abnormal phosphorylation of tau protein. The abnormal ubiquitination and loss of α-synuclein are related to the onset of Parkinson’s disease. Other neurodegenerative diseases such as Huntington’s disease, amyotrophic lateral sclerosis, and so on are also connected with abnormal PPTMs. Therefore, studying the abnormal PPTMs in neurodegenerative diseases is critical for understanding the mechanism of these diseases and the development of significant therapeutic strategies. This work reviews the implications of PPTMs in neurodegenerative diseases and discusses the relevant therapeutic strategies.
Estimation of the effect of vaccination in critically ill COVID-19 patients, analysis using propensity score matching
Authors: Havaldar Amarja Ashok , Selvam Sumithra 
Published: February 2024

Abstract
Background
Vaccination helped in reducing mortality and disease severity due to COVID-19. Some patients can develop breakthrough infections. The effect of vaccination in critically ill patients admitted with breakthrough infections is not well studied. We designed a study to estimate the effect of vaccination on ICU mortality in critically ill COVID-19 patients by using propensity score matching.

Methods
We included patients from 15th June 2020 to 31st December 2021. Inclusion criteria were unvaccinated and vaccinated COVID-19 patients requiring intensive care unit (ICU) admission. The institutional ethics committee approval was obtained (institutional ethics committee, IEC 08/2023, Clinical trial registry, India CTRI/2023/01/049142). The primary outcome was ICU mortality. The secondary outcomes were the length of ICU stay and duration of mechanical ventilation. We used multivariable logistic regression (MLR) and propensity score matching (PSM) for the statistical analysis.

Results
Total of 667 patients (79.31%) were unvaccinated and 174 (20.68%) vaccinated. The mean age was 57.11 [standard deviation (SD) 15.13], and 70.27% were males. The ICU mortality was 56.60% [95% confidence interval (CI) 53.24–60%]. The results of MLR and PSM method showed that vaccinated patients were less likely to be associated with mortality [adjusted odds ratio (AOR), 95% CI using logistic regression: 0.52 (0.29, 0.94), and by propensity score matching: 0.83 (0.77, 0.91)].

Conclusion
The findings of this study support COVID-19 vaccination as an effective method for reducing case fatality not only in the general population but also in critically ill patients, and it has important public health implications.
Hip prosthesis and colon surgery, a decade of surveillance on surgical site infections in Italy, a prospective cohort study: rates, trends, and disease burden in DALYs
Authors: Bordino Valerio , Vicentini Costanza , Cornio Alessandro Roberto , Gianino Maria Michela , Zotti Carla Maria 
Published: February 2024

Abstract
Background
Surveillance programs are a key element of interventions aiming to reduce rates of surgical site infections (SSIs). The aim of this study was to evaluate rates and trends of SSIs following hip arthroplasty and colon surgery procedures in Piedmont, a region in North-western Italy, from 2010 to 2019. Further, we aimed to assess the burden of SSIs in terms of Disability-Adjusted Life-Years (DALYs).

Methods
A prospective cohort study was conducted among 42 hospitals participating in the surveillance system. Procedure-specific SSI rates were calculated and the 2010 - 2019 trend was evaluated using Spearman's Rho test. Patients were stratified according to age, sex and infection risk index according to life expectancy in order to calculate DALYs, using a modified version of the ECDC’s BCoDE toolkit: disease models for both procedure types were adapted to incorporate long-term disability associated with SSIs.

Results
Overall, 20,356 hip arthroplasty and 11,011 colon surgery procedures were monitored over 10 years and were included in our analyses. Hip arthroplasty and colon surgery cumulative SSIs rates were 1.5% and 8% respectively. Using the Spearman’s Rho test, we evaluated a significant downward trend from 2010 to 2019 for colon surgery interventions (Rs − 0.7, p < 0.05), while there was no difference for hip arthroplasty. (Rs − 0.04, p > 0.05).
Regarding disease burden, a total of 955.3 (95%CI 837.7–1102.98) and 208.65 (95%CI 180.87–240.90) DALYs were calculated for SSIs following hip arthroplasty, whilst 76.58 (95%CI 67.15–90.71) and 38.62 (95% CI 33.09–45.36) DALYs for SSIs in colon surgery, in 2010 and 2019, respectively.

Conclusions
The significant decrease both in terms of incidence and DALYs found in this study for colon surgery and the stability for hip arthroplasty support the role of surveillance networks in improving quality of care. Despite the smaller SSI rate, the burden associated with SSIs following hip arthroplasty was higher, which is important to consider in light of the aging population in Italy.
Dynamic changes in the gut microbiota during three consecutive trimesters of pregnancy and their correlation with abnormal glucose and lipid metabolism
Authors: Gao Yiyang , Zhang Jinjia , Chen Haiying , Jin Xiaohui , Lin Zhenyu , Fan Chenling , Shan Zhongyan , Teng Weiping , Li Jing 
Published: February 2024

Abstract
Introduction
During normal pregnancy, changes in the gut microbiota (GM) in response to physiological alterations in hormonal secretion, immune functions and homeostasis have received extensive attention. However, the dynamic changes in the GM during three consecutive trimesters of pregnancy and their relationship with glucose and lipid metabolism have not been reported. In this study, we aimed to investigate the dynamic changes in the diversity and species of the GM during three consecutive trimesters in women who naturally conceived, and their relationships with abnormal fasting blood glucose (FBG) and serum lipid levels.

Methods
A total of 30 pregnant women without any known chronic or autoimmune inflammatory disease history before pregnancy were enrolled during the first trimester. Serum and stool samples were collected during the first trimester, the second trimester, and the third trimester. Serum samples were tested for FBG and blood lipid levels, and stool specimens were analyzed by 16S rDNA sequencing.

Results
The abundance ratio of bacteroidetes/firmicutes showed an increasing tendency in most of the subjects (19/30, 63.3%) from the first to the third trimester. LEfSe analysis showed that the abundance of Bilophila was significantly increased from the first to the third trimester. In addition, at the genus level, the increased relative abundance of Mitsuokella, Clostridium sensu stricto and Weissella were potentially involved in the development of high FBG during pregnancy. The raised relative abundance of Corynebacterium, Rothia and Granulicatella potentially contributed to the occurrence of dyslipidemia during pregnancy.

Conclusions
There are dynamic changes in the GM during the three trimesters, and the alterations in some bacterium abundance may contribute to the development of high FBG and dyslipidemia during pregnancy. Monitoring enterotypes and correcting dysbiosis in the first trimester may become new strategies for predicting and preventing glucolipid metabolism disorders during pregnancy.
Indoor air pollutants and their seasonal monitoring in European museums
Authors: Kraševec Ida , Markelj Jernej , Elnaggar Abdelrazek , Cigić Irena Kralj 
Published: February 2024

Abstract
The monitoring of indoor air pollutants is an important part of the management of heritage collections. In this work, acetic acid, formic acid, formaldehyde, acetaldehyde and NO2 were measured with passive samplers along with temperature and relative humidity once per season in seven European institutions of different sizes with different types of objects. The measurements were carried out in a variety of locations, from modern and old display cases in exhibition rooms of different sizes to storage rooms and their enclosures for different types of objects. The results were evaluated based on the characteristics of the sampling locations and the extent to which the changing seasons affect pollutant concentrations were estimated. The dataset obtained from this study can be a valuable asset as a snapshot of the current state of the environment in European heritage collections.
The effect of micro-osteoperforations on the rate of maxillary incisors' retraction in orthodontic space closure: a randomized controlled clinical trial
Authors: Mordente Carolina Morsani , Oliveira Dauro Douglas , Palomo Juan Martin , Cardoso Polyana Araújo , Assis Marina Araújo Leite , Zenóbio Elton Gonçalves , Souki Bernardo Quiroga , Soares Rodrigo Villamarim 
Published: February 2024

Abstract
Background
This single-centered randomized controlled clinical trial aimed to evaluate the effectiveness of micro-osteoperforations (MOPs) in accelerating the orthodontic retraction of maxillary incisors.

Methods
Forty-two patients aged 16–40 were recruited and randomly assigned into two groups, one which underwent MOPs (MOPG) in the buccal and palatal region of all maxillary incisors immediately before the start of retraction and one which did not (CG). Eligibility criteria included the orthodontic need for maxillary first premolars extraction and space closure in two phases. The primary outcome of the study consisted of measuring the rate of space closure and, consequently, the rate of incisors’ retraction using digital model superimposition 14 days later and monthly thereafter for the next 4 months. The secondary outcomes included measuring anchorage loss, central incisors’ inclination, and root length shortening, analyzed using cone beam computed tomography scans acquired before retraction and 4 months after retraction. Randomization was performed using QuickCalcs software. While clinical blinding was not possible, the image’s examinator was blinded.

Results
Twenty-one patients were randomly assigned to each group. However, due to various reasons, a total of 37 patients (17 male and 20 female) were analyzed (mean age: 24.3 ± 8.1 years in the MOPG; 22.2 ± 4.2 years in the CG) during the trial. No statistically significant difference was found between the MOPG and the CG regarding the incisors’ retraction measured at different time points at the incisal border (14 days, 0.4 mm vs. 0.5 mm; 1 month, 0.79 mm vs. 0.77 mm; 2 months, 1.47 mm vs. 1.41 mm; 3 months, 2.09 mm vs. 1.88 mm; 4 months, 2.62 mm vs. 2.29 mm) and at the cervical level (14 days, 0.28 mm vs. 0.30 mm; 1 month, 0.41 mm vs. 0.32 mm; 2 months, 0.89 mm vs. 0.61 mm; 3 months, 1.36 mm vs. 1.10 mm; 4 months, 1.73 mm vs. 1.39 mm). Similarly, no statistically significant differences were detected in the space closure, anchorage loss, central incisors’ inclination, and radicular length between groups. No adverse effect was observed during the trial.

Conclusions
MOPs did not accelerate the retraction of the maxillary incisors, nor were they associated with greater incisor inclination or root resorption.
Trial registration ClinicalTrials.gov NCT03089996. Registered 24 March 2017—https://clinicaltrials.gov/ct2/show/NCT03089996.
Translation and cross-cultural adaptation of seventeen widely-used assessment instruments for child and adolescent mental health in Greece
Authors: Karagiorga Vasiliki Eirini , Schafer Julia Luiza , Marchionatti Lauro Estivalete , Caye Arthur , Serdari Aspasia , Kotsis Konstantinos , Basta Maria , Balikou Panagiota , Kapsimalli Efstathia , Mitropoulou Andromachi , Klavdianou Nikanthi , Zeleni Domna , Mitroulaki Sotiria , Botzaki Anna , Gerostergios Giorgos , Samiotakis Giorgos , Simioni André , Georgiades Katholiki , Salum Giovanni Abrahão , Koumoula Anastasia 
Published: February 2024

Abstract
Background
In the context of Greece, many instruments measuring constructs pertinent to child and adolescent mental health lacked a locally-validated, freely-available version. As part of a nationwide survey, we translated and cross-culturally adapted a collection of seventeen brief, largely-employed assessment tools that can be used at scale.

Methods
This study is part of the Child and Adolescent Mental Health Initiative in Greece (CAMHI), a capacity-building program focusing on enhancing mental health care for children and adolescents living in Greece. We conducted a nationwide survey assessing mental health symptoms, parenting practices, service availability and quality, mental health literacy and stigma, and professional practices within the country. As part of this process, we selected outcomes and instruments after consulting the International Consortium for Health Outcomes Measurement (ICHOM) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). From our selection, we identified 17 instruments that did not have a Greek-validated version available for use. These instruments were translated and cross-culturally adapted following a structured procedure, including independent back-and-forth translations, synthesis of versions, expert revision, and pilot testing. Some instruments were slightly modified to meet CAMHI survey purposes.

Results
A cross-culturally adapted version in Greek was made available for the following instruments: Pediatric Symptoms Checklist (PSC); Deliberate Self Harm Inventory (DSH) (modified); Child and Adolescent Trauma Screen-2 (CATS-2); ABCD Screen Use (modified); Swanson, Nolan, and Pelham-IV (SNAP-IV); Parent Behavior Inventory (PBI); Mental Health Literacy Scale (MHLS)—(modified); Australian Mental Health Vignettes; Reported and Intended Behavior Scale (RIBS); Barriers to Access to Care (BACE) (modified); Experience of Service Questionnaire (ESQ) (modified); and Multitheoretical List of Therapeutic Interventions (MULTI-30) (modified).

Conclusion
A collection of these widely-used assessment tools is now adapted for the local context and freely accessible at [https://osf.io/crz6h/]. Researchers and health professionals in Greece can utilize this resource to screen, evaluate, and monitor various constructs related to mental health in accordance with the most effective practices.
Training of a robot-based psychological intervention program to prevent inappropriate touching of children
Authors: Tahan Mohammad , Afrooz Gholamali , Bolhari Jafar 
Published: February 2024

Abstract
Background
This study aimed to evaluate the effect of a robot-based psychological intervention on the prevention of inappropriate touching of children. The trial was registered in the International Clinical Trial Registry Platform with the registration id of ISRCTN17186302.

Results
In this study, the intervention had a positive effect on inappropriate sexual care in elementary school children (P < 0.01). Moreover, education on sexual care heightened children’s knowledge about inappropriate touch (P < 0.01).

Conclusion
According to the results, the robot-based psychological intervention had an impact on children’s sexual care. It is suggested that this method be applied by counselors and psychologists as a therapeutic approach.