bluuebunny/crossref_metadata_2025_split huggingface dataset:
Association of Baseline Mitral Valve Area With Procedural and Clinical Outcomes of Mitral Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry
Authors: Mushiake Kazunori , Kubo Shunsuke , Ono Sachiyo , Maruo Takeshi , Nishiura Naoki , Osakada Kohei , Kadota Kazushige , Yamamoto Masanori , Saji Mike , Asami Masahiko , Enta Yusuke , Nakashima Masaki , Shirai Shinichi , Izumo Masaki , Mizuno Shingo , Watanabe Yusuke , Amaki Makoto , Kodama Kazuhisa , Yamaguchi Junichi , Izumi Yuki , Naganuma Toru , Bota Hiroki , Ohno Yohei , Yamawaki Masahiro , Ueno Hiroshi , Mizutani Kazuki , Otsuka Toshiaki , Hayashida Kentaro ,   on behalf of the OCEAN-Mitral Investigators
Published: December 2024

BACKGROUND:
A small mitral valve area (MVA) is one of the challenging anatomies for transcatheter edge-to-edge repair (TEER) for mitral regurgitation, but the relationship between baseline MVA and clinical outcomes remains unknown. This study aimed to evaluate the association of baseline MVA with procedural and clinical outcomes in patients undergoing TEER with MitraClip from the OCEAN-Mitral registry (Optimized Catheter Valvular Intervention-Mitral).

METHODS:

A total of 1768 patients undergoing TEER were divided into 3 groups according to baseline MVA: group 1: <4.0 cm
2
, n=358; group 2: 4.0–5.0 cm
2
, n=493; and group 3: ≥5.0 cm
2
, n=917. The primary end point was a composite of all-cause death and heart failure hospitalization within 2 years of TEER and compared between the 3 groups.

RESULTS:

Patients with smaller MVA had significantly fewer clips implanted and higher postprocedural transmitral mean pressure gradient. There was no significant difference in the acute procedural success rate and postprocedural mitral regurgitation severity between the 3 groups. The incidence of the primary end point was similar in group 1 compared with groups 2 and 3 (35.2% versus 34.5% versus 34.0%;
P
=0.96) and was also similar in patients with MVA <3.5 cm
2
and those with MVA 3.5 to 4.0 cm
2
. The adjusted risk of MVA <4.0 cm
2
relative to MVA of 4.0 to 5.0 cm
2
and MVA ≥5 cm
2
for the primary end point remained insignificant (hazard ratio, 1.06 [95% CI, 0.79–1.41];
P
=0.68; hazard ratio, 0.99 [95% CI, 0.75–1.31];
P
=0.96, respectively). At 1 year, no significant difference in the proportion of residual mitral regurgitation 3+/4+ was observed between the 3 groups (7.2% versus 4.4% versus 6.5%;
P
=0.49).

CONCLUSIONS:

In patients undergoing TEER, a small MVA <4.0 cm
2
may limit the number of clips implanted and increase the transmitral pressure gradient after TEER, but baseline MVA was not associated with mitral regurgitation reduction and clinical outcomes.

REGISTRATION:

URL:
https://center6.umin.ac.jp/cgiope n-bin/ctr/ctr_view.cgi?recptno=R000027188
; Unique identifier: UMIN000023653.
Between Believing and Not Believing
Authors: Barbierato Frederico 
Published: December 2024

Abstract
This article, focusing on the Venetian context, aims to provide an overview of atheism, particularly of a ‘popular’ nature, with a special emphasis on the seventeenth century. By analyzing a few cases and the evolution of historiographical developments on early modern Italy, it seeks to demonstrate that unbelieving and openly atheistic points of view were indeed present in popular, non-academic circles, and that the dynamics of contamination between levels of culture were constant and not always linked to top-down acculturation processes.
Motives for Becoming a Christian in the Second and Third Centuries
Authors: Roukema Riemer 
Published: December 2024

Abstract
Initially a valedictory lecture, this essay discusses the question for which motives people joined the Christians in the second and third centuries. It analyzes the conversion accounts of Justin Martyr, Tatian the Assyrian, Clement of Alexandria, Gregory the Wonderworker, Cyprian of Carthage, and the story about Thecla of Iconium. Next, it pays attention to the role of simple preachers, the Roman persecutions, and especially the love and care that Christians displayed to both fellow-believers and non-Christian friends and neighbors during plagues. With reference to Cyprian of Carthage and Dionysius of Alexandria and in agreement with Rodney Stark it is argued that someone who was supported was more likely to survive the pandemic than those who were abandoned by their relatives and friends. It is likely that therefore such non-Christians have converted thanks to their experiences with Christians.
Association between clinical factors and the choice of palliative care setting among cancer patients: A post-hoc analysis of a cohort study
Authors: Corli Oscar , Porcu Luca , Bosetti Cristina , Recchia Angela , De Giorgi Silvia , Lonati Giada , Rizzi Barbara 
Published: December 2024

Introduction: In the literature, the data about the factors related to the choice of the setting at patient’s first palliative care admission visit are scanty. In fact it seems that the choice between home or hospice care is mainly based on the opinions and needs of patients, families and physicians. This study aims to address the association between the clinical factors detected at the first palliative visit in advanced cancer patients and the choice of palliative care setting (i.e., hospice or home care). Methods: This is a monocentric, prospective cohort study. A total of 1811 consecutive patients with advanced cancer, admitted to the VIDAS Palliative Care service (hospice/ home care), Milan, Italy in 2018-2020 were included. Results: In the univariate analysis, several clinical comorbidities and physiological deficits were associated with hospice admittance; while patients with more severe symptoms of anxiety, asthenia, depression, and pain were associated with home care admittance. In the multivariate logistic analysis, six clinical factors were associated with the risk of hospice admission: anxiety (OR 0.16), brain metastases (OR 1.67), severe sleep-wake rhythm upset (OR 1.79), bone/vertebral fractures (OR 2.12), intestinal occlusion or sub-occlusion (OR 2.16), and cachexia (OR 2.25). The multivariate cluster analysis confirmed the link observed with the previous statistical analyses. Conclusion: The results of this analysis showed that some clinical factors were closely related to the chosen palliative care setting and should be taken into consideration a priori to deciding the most appropriate place of care.
DDT and Its Metabolites in Ethiopian Aquatic Ecosystems: Environmental and Health Implications
Authors: Melake Bealemlay Abebe , Alamirew Tamagnu Sintie , Endalew Salie Mulat 
Published: December 2024

Background: Despite its significant application, DDT and its metabolites pose a potential threat to the environment. Therefore, data on environmental and health concerns must thus be investigated. Objective: The objective of this study was to assess the environmental and human health risks posed by DDT and its metabolites in Ethiopian surface waters. Methods: The total amount of DDT and its metabolites consumed as a sum (∑DDT) is calculated by considering their equivalent toxicity. To calculate the human risk from drinking contaminated water, the maximum concentrations in all of Ethiopia’s surface waterways were pooled. The average concentration values were added to calculate the human risk from consuming fish contaminated with ∑DDT. Similarly, ∑DDT residues in water can be used to predict the potential environmental risk. Results: A higher level of ∑DDT in surface water was detected in Gilgel Gibe I hydroelectric dam reservoir and its tributaries with an average concentration of 640 ng/l. There is no health risk associated with drinking these surface waters because the concentrations of ∑DDT were below the WHO’s recommended level. In fish samples, B. intermedius accumulated a higher level of ∑DDT (21.47 ng/g ww). With the exception of local infants, ∑DDT does not pose a non-carcinogenic risk to any age group. However, consuming fish contaminated with ∑DDT poses an unacceptable risk of cancer to all age categories. The risk posed by ∑DDT on aquatic species is highly likely. The bioaccumulation factor (BAF) value indicates that fish tissue does not absorb ∑DDT directly from the water. Conclusion: The prevalence of ∑DDT would link to both historical pollution and their current application in vector control. Ecosystems are frequently exposed to chemical mixes later in life; thus, rather than focusing on the ideal case of exposure to a single toxin, future studies can examine the mixture toxicity of numerous organic contaminants.
Long-term safety of gantenerumab in participants with Alzheimer's disease: A phase III, open-label extension study (SCarlet RoAD)
Authors: Boada Mercè , Neve Anuja , Das Bibha , Wojtowicz Jakub , Huang Zhiyue , Bullain Szofia , Watkin Michelle , Lott Dominik , Bittner Tobias , Delmar Paul , Klein Gregory , Hofmann Carsten , Kerchner Geoffrey A , Smith Janice , Baudler Monika , Fontoura Paulo , Doody Rachelle S 
Published: December 2024

Background Gantenerumab is a fully human anti-amyloid-β (Aβ) immunoglobulin G1 monoclonal antibody for subcutaneous (SC) administration. The efficacy and safety of low-dose (105 mg or 225 mg) gantenerumab were investigated in SCarlet RoAD (SR; NCT01224106), a Phase III, double-blind (DB), placebo-controlled study in participants with prodromal Alzheimer's disease. Following a pre-planned futility analysis, SR was converted into an open-label extension (OLE) study. Objective To assess the long-term safety and tolerability of SC gantenerumab at doses of up to 1200 mg every 4 weeks (Q4W) in OLE participants who previously received placebo or gantenerumab in the DB part of SR. Methods Participants of the DB part of SR, who met the eligibility criteria for the OLE, were offered the opportunity to receive gantenerumab up-titrated to 1200 mg Q4W according to prespecified titration regimens. Safety and tolerability were assessed using magnetic resonance imaging (MRI), physical and neurologic examinations, and adverse event monitoring. Results Overall, 154 participants were rolled over from the DB part of SR and received at least one dose of gantenerumab in the SR OLE. The median duration of treatment was 2.9 years (152.9 weeks). Forty-seven (30.5%) participants had an amyloid-related imaging abnormalities – edema (ARIA-E) MRI finding, and 51 (33.1%) had an ARIA – hemorrhage MRI finding. Most ARIA-E findings were asymptomatic and manageable by MRI monitoring and dose intervention. There were no unexpected safety findings. Conclusions SC gantenerumab at doses of up to 1200 mg Q4W was well tolerated with no unexpected safety findings in participants with prodromal Alzheimer's disease. Trial registration: ClinicalTrials.gov ID NCT01224106
Count Me In: patient-partnered research to address disparities for rare cancer patients
Authors: Bhakhri Priyanka , Phelps Kolbe , Gómez Tejeda Zañudo Jorge , Gwozdz Erin , Ko Sophia , Hendrickson Taisha , Anastasio Elana , Diehl Diane M. , Painter Corrie A. , McGillicuddy Mary 
Published: December 2024

Background: Approximately 25% of cancer patients are diagnosed with rare cancers and face unique challenges. Decentralized patient-partnered research efforts, like Count Me In provide an avenue for patients to participate in research that overcomes key barriers to address disparities in rare cancer research to accelerate discovery. Objectives: Projects in metastatic breast cancer (The Metastatic Breast Cancer Project; MBCproject) and angiosarcoma (The Angiosarcoma Project; ASCproject) highlight disparities that exist for all cancer patients and underscore those that are compounded for rare cancer patients. Design: Through Count Me In’s research platform, patients visit a website to enroll in the study and complete surveys, which allows us to access their medical records and biospecimens. Clinically annotated sequencing data are de-identified and released on research platforms. Methods: MBCproject and ASCproject data were analyzed to identify differences between patients with a more common and rare cancer, respectively. The analysis included outreach strategies, patient-reported themes, and distance traveled for care. Results: As of September 28, 2023, 3742 patients have enrolled in MBCproject and 491 patients have enrolled in the ASCproject from across the United States and Canada. Outreach strategies were tailored to resource availability. Using survey information, it was observed that patients with a rare cancer (angiosarcoma) traveled longer distances to receive care than those with a more common cancer (metastatic breast cancer) for three major cancer centers. Patients with rare and common cancers highlighted different themes when asked about their disease experience. Themes like misdiagnosis and discontent with resource availability came up more often for rare cancer patients. Data sharing and collaboration in angiosarcoma research enabled rapid discoveries with clinical impact. Conclusion: Count Me In’s platform has led to unprecedented data generation and findings in rare cancer through partnering with patients. Directly engaging with patients to generate and share data while emphasizing collaboration sets the foundation for a more equitable future.
Smoking cessation and harm reduction: a systematic overview of ongoing, randomized controlled trials
Authors: Derissen Mara , Scheliga Sebastian , Clemens Benjamin , Leiding Delia , Kröger Knut , Böhner Hinrich , Habel Ute 
Published: December 2024

Abstract
Background
Smoking remains one of the major public health threats, necessitating substantial scientific and societal interest in further developing and implementing systematic, smoking cessation trials. This review examines ongoing randomized controlled trials (RCTs) on smoking cessation and harm reduction, focusing on adherence to German S3 guidelines for tobacco dependence and identifying areas needing further research and neglected aspects in the implementation of treatment guidelines for tobacco dependence.

Methods
A systematic search was conducted on the International Clinical Trials Registry Platform, comprising multiple trial registries worldwide, to identify ongoing RCTs focusing on smoking cessation and harm reduction. Utilizing the PICOS-scheme, we focused on trials targeting the general population, with biochemical verification, psychological counseling, telemedicine, and nicotine replacement therapy /smoking cessation medication or electronic nicotine delivery systems. Exclusion criteria included trials marked as "completed," "terminated," "unknown," or "withdrawn.".

Results
The review identified 30 ongoing RCTs, with a majority located in North America. A significant number of trials focus on socioeconomically disadvantaged or uninsured populations, while few address cancer survivors or individuals with smoking-related diseases. Nicotine replacement therapy or smoking cessation medication is consistently used across trials, but with varying regimens. Psychotherapeutic interventions are employed in 22 trials, with motivational interviewing being the most common method. Only four trials utilize electronic nicotine delivery systems as a harm reduction strategy. The lack of standardized reporting in trial registries was a significant barrier to synthesizing and categorizing information. Geographic representation is predominantly in North America, suggesting a need for more diverse trial locations.

Conclusions
There is a critical need for more RCTs involving electronic nicotine delivery systems and tailored psychotherapeutic interventions. Expanding trial locations beyond North America and standardizing trial reporting could enhance the global applicability of smoking cessation strategies. Future research should focus on the long-term risks and benefits of electronic nicotine delivery systems, particularly in high-risk populations. This approach will aid in developing more effective and culturally relevant smoking cessation guidelines.
First scientific research to trace the origins of Qin clay sealings
Authors: Guo Houze , Yang Lu 
Published: December 2024

Abstract
Clay sealing represents the key physical example of the document sealing system of the Qin dynasty in ancient China. However, only the inscriptions and aesthetic values of clay sealings have been discussed until now, and the relevant sources have not been traced from the perspective of scientific analysis. A total of 81 clay sealings unearthed in Xi’an were studied via ultra-depth field microscopy, petrographic microstructure analysis and X-ray fluorescence spectroscopy. The relevant methods of tracing and making clay samples are discussed based on the results of the literature investigation and elemental analysis. The composition, technology and spatial links between different clay sealings collected from all over the country show that highly organized sealing materials and systematic processes are important parts of the establishment of unified China. They also provide detailed and effective scientific information that is useful for the future preservation of clay sealings protection and further archaeological research.
Swedish translation and content evaluation of the Empowerment Audiology Questionnaire (EmpAQ—15)
Authors: Larsson Josefina , Karlsson Elin 
Published: December 2024

Abstract
Objective
Translating the newly developed Empowerment Audiology Questionnaire, EmpAQ-15 to Swedish, and performing content validation on the Swedish version.

Design
Best-practice principles using forward and back translations which were revised by a committee prior to field testing. Field testing was conducted by cognitive interviews with hearing-aid users talking through and rating the items in the translated questionnaire. Content validation was assessed by examining equivalence, accessibility, acceptability, comprehensiveness, and relevance of interview data. Questionnaire introduction and scoring instructions were evaluated by Swedish audiologists.

Study sample
Ten adult native speaking Swedish hearing aid users, recruited with purposive sampling. Maximum variation based on age, gender, hearing aid usage, and degree of hearing loss. Seven Swedish audiologists assessing instructions for result calculations.

Results
The conceptual equivalence between the Swedish translation and the English original questionnaire was judged to be high overall. The instructions and majority of items were experienced as accessible, acceptable, comprehensive, and relevant. The audiologists showed that they could follow scoring instructions and reason about the results.

Conclusions
This content validity study was the first step towards a Swedish version of a self- report measure of Empowerment for people with hearing loss.
Performance of different dynamic oxygenation indices incorporating heart rate to predict non-invasive ventilation outcomes in hypoxemic respiratory failure
Authors: Mamdouh Omnia Mohamed , Ahmed Ashraf El Sayed , Hashem Ahmed Zidan Abuzeid , Elshahaat Hadeer Ahmed 
Published: December 2024

Abstract
Background
Non-invasive ventilation (NIV) becomes crucial ventilatory support for respiratory failure patients, but wasting time in high-risk patients for suspected NIV failure and delayed intubation with invasive mechanical ventilation (IMV) is also fatal. Early prediction of NIV succeeded or failed patients is a potentially effective strategy for minimizing mortality and improving outcomes. This study evaluated the predictive power of dynamic change of hypoxemic indices incorporating heart rate (HR) [ROX-HR and POX-HR] in predicting NIV outcomes in hypoxemic acute respiratory failure (ARF), to get the best benefits of NIV and avoiding delayed intubation and IMV aiming to decrease intensive care unit (ICU) mortality risk.

Results
This study enrolled 120 patients who were admitted and initiated NIV at Respiratory ICU and Anesthesia and Surgical ICU at Zagazig University Hospitals for ARF from June 2023 to May 2024. Enrolled patients were 80 males and 40 females with mean ± SD of their age 51.5 ± 13.4yrs. 40 (33.3%) had failed NIV and 80 (66.7%) had succeeded with the mean ± SD of NIV duration being 26.4 ± 15.6 h. Several oxygenation indices in the form of ROX, POX, ROX-HR, and POX-HR were measured at different points of time during NIV (baseline, after 2 h, 12 h, and after 24 h). Patients with failed NIV showed a highly statistically significant drop in ROX, POX, ROX-HR, and POX-HR than patients with succeeded NIV. At all measured time points, indices incorporating heart rate (ROX-HR and POX-HR) had better performance in predicting NIV outcomes. POX-HR had the highest accuracy than other measured indices in early prediction (after 2 h) of NIV outcomes. A ROX-HR index of > 5 and a POX-HR index of > 4 were correlated with a low chance of NIV failure at all time points during the first 24 h, even after applying multivariate regression analysis for confounders.

Conclusions
Heart rate–based indices are more reliable in predicting NIV outcomes. Among the assessed indicators, POX-HR has the highest accuracy in predicting the outcomes of NIV at an early stage.
The Association Between Fluid Management and Intraoperative Blood Pressure and Patients’ Outcome After Complex Spine Surgeries
Authors: Koh Ye Rin , Li Yufei , Koh Joan , Ekrami Elyad , Liu Xiaodan , Argalious Maged Y. , Manlapaz Mariel R. , Troianos Christopher A. , Steinmetz Michael P. , Farag Ehab 
Published: December 2024

BACKGROUND:
Both intraoperative hypotension and excessive fluid administration can lead to detrimental perioperative complications. However, how much fluid is considered excessive and how is intraoperative hypotension related to major postoperative complications?

METHODS:
We conducted a single-center retrospective cohort study in 6243 patients undergoing complex spine surgery at the Cleveland Clinic Foundation between 2012 and 2022 and studied the relationship between intraoperative net fluid administration and intraoperative hypotension with major postoperative complications. The primary outcome was a collapsed composite of postoperative complications including acute kidney injury (AKI), myocardial infarction (MI), stroke, and intensive care unit (ICU) admissions. Secondary outcomes were in-hospital postoperative pulmonary complications, surgical site infections (SSI), and mortality.

RESULTS:
The study consisted of 6998 complex spinal surgery cases from 6243 patients. The median net fluid administration was 2100 mL (Interquartile range: 1450 to 3020 mL), and we found a change point in net fluid administration of 1865 mL (95% Confidence Interval: 1228 to 4710 mL). The odds ratio of developing postoperative complications for every 500 mL increase in net fluid administration was 1.16 (95% confidence interval [CI], 1.11–1.21; P < .0001) above and 0.87 (95% CI, 0.77–0.98; P = .026) below the change point. The odds ratio of developing postoperative pulmonary complications was 1.12 (95% CI, 1.07–1.18; P < .0001) for every 500 mL increase in net fluid administration.
Intraoperative hypotension was detected in 2052 complex spine surgeries (29%). The odds ratio of developing any postoperative complication was 1.57 (95% CI, 1.37–1.80; P < .0001) and 1.30 (95% CI, 1.04–1.61; P = .019) for postoperative pulmonary complications.

CONCLUSIONS:
We discovered a change point in net fluid administration of 1,865mL. Above this change point, higher net fluid administration is associated with increased odds of developing postoperative complications. Intraoperative hypotension in complex spine surgeries was associated with increased postoperative complications.