bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of Udenafil on Echocardiographic Indices of Single Ventricle Size and Function in FUEL Study Participants
Authors: Di Maria Michael V. , Goldberg David J. , Zak Victor , Hu Chenwei , Lubert Adam M. , Dragulescu Andreea , Mackie Andrew S. , McCrary Andrew , Weingarten Angela , Parthiban Anitha , Goot Benjamin , Goldstein Bryan H. , Taylor Carolyn , Lindblade Christopher , Petit Christopher J. , Spurney Christopher , Harrild David M. , Urbina Elaine M. , Schuchardt Eleanor , Beom Kim Gi , Kyoung Yoon Ja , Colombo Jamie N. , Files Matthew D. , Schoessling Megan , Ermis Peter , Wong Pierre C. , Garg Ruchira , Swanson Sara K. , Menon Shaji C. , Srivastava Shubhika , Thorsson Thor , Johnson Tiffanie R. , Krishnan Usha S. , Paridon Stephen M. , Frommelt Peter C. ,   for the Pediatric Heart Network
Published: November 2022

Background:
The FUEL trial (Fontan Udenafil Exercise Longitudinal) demonstrated statistical improvements in exercise capacity following 6 months of treatment with udenafil (87.5 mg po BID). The effect of udenafil on echocardiographic measures of single ventricle function in this cohort has not been studied.

Methods:
The 400 enrolled participants were randomized 1:1 to udenafil or placebo. Protocol echocardiograms were obtained at baseline and 26 weeks after initiation of udenafil/placebo. Linear regression compared change from baseline indices of single ventricle systolic, diastolic and global function, atrioventricular valve regurgitation, and mean Fontan fenestration gradient in the udenafil cohort versus placebo, controlling for ventricular morphology (left ventricle versus right ventricle/other) and baseline value.

Results:

The udenafil participants (n=191) had significantly improved between baseline and 26 weeks visits compared to placebo participants (n=195) in myocardial performance index (
P
=0.03, adjusted mean difference [SE] of changes between groups −0.03[0.01]), atrioventricular valve inflow peak E (
P
=0.009, 3.95 [1.50]), and A velocities (
P
=0.034, 3.46 [1.62]), and annular Doppler tissue imaging-derived peak e′ velocity (
P
=0.008, 0.60[0.23]). There were no significant differences in change in single ventricle size, systolic function, atrioventricular valve regurgitation severity, or mean fenestration gradient. Participants with a dominant left ventricle had significantly more favorable baseline values of indices of single ventricle size and function (lower volumes and areas, E/e′ ratio, systolic:diastolic time and atrioventricular valve regurgitation, and higher annular s′ and e′ velocity).

Conclusions:
FUEL participants who received udenafil demonstrated a statistically significant improvement in some global and diastolic echo indices. Although small, the changes in diastolic function suggest improvement in pulmonary venous return and/or augmented ventricular compliance, which may help explain improved exercise performance in that cohort.

Registration:

URL:
https://clinicaltrials.gov
; Unique Identifier: NCT02741115.
Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative
Authors: Bergmark Brian , Dallan Luis A.P. , Pereira Gabriel T.R. , Kuder Julia F. , Murphy Sabina A. , Buccola Jana , Wollmuth Jason , Lopez John , Spinelli Joia , Meinen Jennifer , West Nick E.J. , Croce Kevin ,   on behalf of the LightLab Initiative Investigators
Published: November 2022

BACKGROUND:
Use of intracoronary imaging is associated with improved outcomes in patients undergoing percutaneous coronary intervention (PCI). Yet, the impact of intracoronary imaging on real-time physician decision-making during PCI is not fully known.

METHODS:
The LightLab Initiative is a multicenter, prospective, observational study designed to characterize the use of a standardized optical coherence tomography (OCT) workflow during PCI. Participating physicians performed pre-PCI and post-PCI OCT in accordance with this workflow and operator assessments of lesion characteristics and treatment plan were recorded for each lesion based on angiography alone and following OCT. Physicians were categorized as having low (n=15), intermediate (n=13), or high (n=14) OCT use in the year preceding participation.

RESULTS:
Among 925 patients with 1328 lesions undergoing PCI, the prescribed OCT workflow was followed in 773 (84%) of patients with 836 lesions. Operator lesion assessment and decision-making during PCI changed with OCT use in 86% (721/836) of lesions. Pre-PCI OCT use changed operator decision-making in 80% of lesions, including lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%), and stent length (36%). Post-PCI OCT changed stent optimization decision-making in 31% of lesions. These findings were consistent across strata of physician prior OCT experience.

CONCLUSIONS:
A standardized OCT workflow impacted PCI decision-making in 86% of lesions, with a predominant effect on pre-PCI lesion assessment and planning of treatment strategy. This finding was consistent regardless of operator experience level and provides insight into mechanisms by which intravascular imaging might improve PCI outcomes.
Improvements and Maintenance of Clinical and Functional Measures Among Rural Women: Strong Hearts, Healthy Communities-2.0 Cluster Randomized Trial
Authors: Seguin-Fowler Rebecca A. , Eldridge Galen D. , Rethorst Chad D. , Graham Meredith L. , Demment Margaret , Strogatz David , Folta Sara C. , Maddock Jay E. , Nelson Miriam E. , Ha Seungyeon 
Published: November 2022

Background:
Cardiovascular disease is the leading cause of death in the United States; however, women and rural residents face notable health disparities compared with male and urban counterparts. Community-engaged programs hold promise to help address disparities through health behavior change and maintenance, the latter of which is critical to achieving clinical improvements and public health impact.

Methods:
A cluster-randomized controlled trial of Strong Hearts, Healthy Communities-2.0 conducted in medically underserved rural communities examined health outcomes and maintenance among women aged ≥40 years, who had a body mass index >30 or body mass index 25 to 30 and also sedentary. The multilevel intervention provided 24 weeks of twice-weekly classes with strength training, aerobic exercise, and skill-based nutrition education (individual and social levels), and civic engagement components related to healthy food and physical activity environments (community, environment, and policy levels). The primary outcome was change in weight; additional clinical and functional fitness measures were secondary outcomes. Mixed linear models were used to compare between-group changes at intervention end (24 weeks); subgroup analyses among women aged ≥60 years were also conducted. Following a 24-week no-contact period, data were collected among intervention participants only to evaluate maintenance.

Results:

Five communities were randomized to the intervention and 6 to the control (87 and 95 women, respectively). Significant improvements were observed for intervention versus controls in body weight (mean difference: −3.15 kg [95% CI, −4.98 to −1.32];
P
=0.008) and several secondary clinical (eg, waist circumference: −3.02 cm [−5.31 to −0.73],
P
=0.010; systolic blood pressure: −6.64 mmHg [−12.67 to −0.62],
P
=0.031; percent body fat: −2.32% [−3.40 to −1.24];
P
<0.001) and functional fitness outcomes; results were similar for women aged ≥60 years. The within-group analysis strongly suggests maintenance or further improvement in outcomes at 48 weeks.

Conclusions:
This cardiovascular disease prevention intervention demonstrated significant, clinically meaningful improvements and maintenance among rural, at-risk older women.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT03059472.
Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial
Authors: Knoepke Christopher E. , Wallace Bryan C. , Allen Larry A. , Lewis Carmen L. , Gupta Sanjaya K. , Peterson Pamela N. , Kramer Daniel B. , Brancato Scott C. , Varosy Paul D. , Mandrola John M. , Tzou Wendy S. , Matlock Daniel D. 
Published: November 2022

Background:
Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians’ experience implementing and using the DAs.

Methods:
This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method.

Results:
We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA’s, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions.

Conclusions:
Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique Identifier: NCT03374891.
Beyond Oral and Written Prophecy
Authors: Stell Elizabeth 
Published: November 2022

Abstract
This article examines performance as part of the prophetic and revelatory in ancient Jewish literature. The body of the article centres on the so-called “prophetic actions” within the biblical corpus. Scholarship’s use of this category has highlighted nonverbal performance as a part of prophecy but raises questions regarding the efficacy of these varied actions as well as their distinction from written or spoken prophecy. Here I reapply J.L. Austin’s speech act theory to further examine their function. Isaiah 20:1–6 and Jeremiah 51:59–64, my central case studies, demonstrate not only the variety among these performances but also how interwoven they are with prophetic biography, writing, and speech. Exploring such phenomena through this more flexible lens further illuminates the continued significance of performance and prophecy in the Second Temple period, which the article demonstrates using 11QPsalmsa and the Exagoge of Ezekiel.
Approaches to Understanding Decadal and Long-Term Shifts in Observed Precipitation Distributions in Victoria, Australia
Authors: Tolhurst Gen , Hope Pandora , Osburn Luke , Rauniyar Surendra 
Published: November 2022

Abstract
Over the past century, precipitation totals in Australia’s southeastern state of Victoria have shown multidecadal variability without clear trends. This has impacted agriculture, water security, ecosystem services, and flood hazards. Hydrological and meteorological evidence suggests that Victorian precipitation regimes have changed since the beginning of the Millennium Drought in 1997. Until now, Victorian precipitation intensity distributions have not been assessed in detail. We assess the time-varying aspect of observed precipitation intensity distributions by identifying temporal shifts in Victorian precipitation and using those different epochs to assess multidecadal changes in precipitation characteristics. We used 788 manual rain gauges and 49 automatic weather stations to analyze subdaily-to-multiday precipitation distributions from 1900 to 2020 for three Victorian regions and four seasons. Distributions are significantly different for the three epochs (1900–45, 1946–96, and 1997–2020). We summarized precipitation distributions by categorizing precipitation intensities, calculating histograms, and fitting gamma distributions. This study provides evidence that Victorian precipitation distributions have shifted over decades and that distributions depend on regional and seasonal differences. Recent precipitation declines are mostly due to decreasing light and moderate precipitation, despite increasing heavy precipitation. Heavy precipitation has shown a tendency to increase in frequency since 1997. Increases were greatest for 6-h springtime and summertime precipitation in northern Victoria and wintertime precipitation in southern and eastern Victoria. Observed precipitation distributions show changes that are consistent with climate projections. To better understand processes driving observed and projected changes to precipitation distributions globally, interdecadal shifts, seasonal variations, and regional climates need to be considered.

Significance Statement
Our research investigated how different rainfall intensities have contributed to changing rainfall totals over the last century in Victoria, Australia. This is important because different rainfall intensities have various impacts on farms, rivers, catchments, and infrastructure. In Victoria, we found three multidecade periods with different average rainfall intensity distributions. Early-twentieth-century rainfall is close to the observed average, 1946–96 was very wet, and 1997–2020 was drier. Recent years were drier because of fewer light and moderate rainfall events. Changes in heavy rainfall depend on the season and subregional factors. This may indicate that weather processes have changed. Decreasing light-to-moderate rainfall intensities will affect stakeholders by decreasing soil moisture, runoff, and streamflow.
Changes in insulin resistance following antidepressant treatment mediate response in major depressive disorder
Authors: Rashidian Houman , Subramaniapillai Mehala , Park Caroline , Lipsitz Orly , Zuckerman Hannah , Cao Bing , Lee Yena , Gill Hartej , Rodrigues Roger Nelson , Di Vincenzo Joshua D. , Iacobucci Michelle , Jaberi Saja , Rosenblat Joshua D. , McIntyre Roger S. , Mansur Rodrigo B. 
Published: November 2022

Background: Insulin resistance (IR) is a potential predictor of antidepressant treatment response. Aims: We assess changes in IR after antidepressant treatment and whether these changes have any effect on treatment response. Also, to see whether changes in IR mediates relationship between C-reactive protein (CRP) and antidepressant efficacy. Methods: This is a secondary analysis of an 8-week, open-label clinical trial with 95 adults experiencing a major depressive episode. Response to vortioxetine was measured using the Montgomery–Åsberg Depression Rating Scale (MADRS). Generalized estimating equation models were utilized for this intent-to-treat analysis. Results: When adjusted for age, sex, and body mass index, there was a significant increase in IR following treatment in the overall sample (p = 0.035). This finding was detected in treatment non-responders (p = 0.019), whereas it was not observed in responders (p = 0.329). Mediation analysis revealed that change in IR during treatment was responsible for change in MADRS as well as the relationship between baseline CRP and treatment response. Conclusions: Exacerbation of IR during antidepressant treatment mediated non-response. Conversely in treatment responders IR reduced. Like previous studies, baseline CRP moderated treatment response. This relationship was also mediated by changes in IR. These findings further elucidate the role of IR in terms of antidepressant response as well as potentially explain inflammation’s relationship with the latter.
Virological outcomes and metabolic effects after switching from ritonavir-boosted protease inhibitors to a dolutegravir-based regimen in virologically suppressed patients living with HIV
Authors: Sribenjalux Wantin , Nuntawit Tharatorn , Meesing Atibordee , Chetchotisakd Ploenchan 
Published: November 2022

Background A ritonavir-boosted protease inhibitor (PI)-based antiretroviral therapy (ART) regimen can cause abnormal lipid levels and increased incidence of cardiovascular disease. Switching to a dolutegravir (DTG)-based regimen has been shown to improve blood lipid levels, but data in the Thai population are limited. Method A prospective cohort study was conducted at Srinagarind Hospital between April 28, 2021, and April 30, 2022. Patients were eligible if they (1) were over 18 years of age, 2) had received a ritonavir-boosted PI-based regimen for at least three months, and 3) had documented plasma HIV RNA levels below 50 copies/mL within six months before the enrollment. All eligible patients included in the study switched from a ritonavir-boosted PI-based ART regimen to a DTG-based regimen. The primary outcome was changes in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 24. Results Forty-six eligible patients were enrolled, 71.7% of whom were male, with a mean age of 49.4 years. Mean body weight was 62.7 kg and body mass index (BMI) was 22.86 kg/m2. The majority of patients had been on a regimen of boosted atazanavir (ATV/r; 60.9%), followed by boosted lopinavir (LPV/r; 37.0%). Six patients were withdrawn from the study. At week 24 after switching to DTG, LDL-C was significantly lower than at baseline, with a difference of −15.1 mg/dL (95% confidence interval [CI; −23.3 to −6.8]; p-value < 0.001), as were total cholesterol and triglycerides, with differences of −22.1 mg/dL (95% CI [−33.3 to −10.8]; p-value <0.001) and −67.7 mg/dL, (95% CI [−88.3 to −47.0]; p-value 0.001), respectively. There were no significant changes in body weight (0.51 kg; 95% CI [−0.37 to 1.38]; p-value 0.251) or BMI (0.17 kg/m2; 95% CI [−0.14 to 0.48]; p-value 0.284) from baseline to week 24. In addition, 39 of 40 patients (97.5%) maintained virological suppression (HIV RNA <50 copies/mL), with only one patient (2.5%) developing virological failure. Three grade 3 adverse events were observed. Conclusion Switching from a boosted PI-based ART regimen to a DTG-based regimen in people living with HIV/AIDS who had attained prior virological suppression resulted in a significant reduction in total cholesterol, LDL-C, and triglyceride levels, but did not increase the patient’s body weight at 24 weeks of follow-up. Furthermore, the DTG-based regimen was also highly effective in maintaining virological suppression. Trial Registration Thai Clinical Trials Registry, TCTR20210625004.
Lanzhou Lily polysaccharide fragment protects human umbilical vein endothelial cells from radiation-induced DNA double-strand breaks
Authors: Kang S , Guo Z , Zhao F , Song L , Lu L , Wang C , Liu Z , Zhao J 
Published: November 2022

Background Radiotherapy is widely used in the treatment of tumors. However, while killing tumor cells, radiation may also cause damage to the surrounding normal tissues. Therefore, it is very important to find safe and effective radiation protection agents. Purpose To investgate the radiation protection effect of Lanzhou Lily polysaccharide fragments (LLP). Methods: The crude polysaccharides of Lanzhou Lily were extracted from the dried bulb powder of Lilium lilium by ultrasonic-assisted hot water method, and then five different fragments were separated from the polysaccharides by DEAE-52-cellulose column. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-2H-tetrazolium bromide assay, neutral comet and immunofluorescent staining were used to investigate the effect of LPe fragment on Human Umbilical Vein Endothelial Cells (HUVEC) survival and the possible radioprotective mechanism. Results The LPe fragment (composing of mannose and glucose, with a ratio of 5.5:2.9, and the average molecular weight is 8629.8 Da), significantly promoted the proliferation of HUVECs and protected cells from X-ray-induced double-strand breaks (DSBs) in DNA, in which pretreatment with the LPe fragment at 100 μg/mL showed the most pronounced protection. In addition, the occurrence of X-ray-induced γH2AX foci was significantly reduced by treatment with the LPe fragment at 50, 100, and 200 μg/mL. Furthermore, caffeine or wortmannin in combination with the LPe fragment at 25 μg/mL significantly reduced the number of X-ray-induced γH2AX foci, indicating phosphoinositide-3 kinases (PI3K) is involved in H2AX phosphorylation in HUVECs. Conclusion These results indicate the LPe fragment has a protective effect against radiation-induced DSBs and may be used as a natural antioxidant agent.
Direct Ischemic Postconditioning After Carotid Endarterectomy in the Prevention of Postoperative Cerebral Ischemic Complications—Observational Case–Control Study
Authors: Ilijevski Nenad , Atanasijević Igor , Lozuk Branko , Gajin Predrag , Matić Predrag , Babić Srđan , Sagić Dragan , Unić-Stojanović Dragana , Tanasković Slobodan 
Published: November 2022

Introduction: Ischemic postconditioning (IPCT) represents one of the several therapeutic strategies to attenuate ischemic reperfusion injury (IR) after carotid endarterectomy (CEA). We here present the first in-human study of IPCT in carotid surgery. Methods: The study represents an observational case-control study, with the data collected in our Institution carotid database. From December 2015 to December 2020, a total of 300 patients were included in our study; IPCT group consisted of 148 patients in whom ischemic postconditioning was performed while control group consisted of 152 patients in whom IPCT was not performed. Indications for IPCT technique were: severe unilateral internal carotid artery (ICA) stenosis (>90%), severe bilateral ICA stenosis (>80%), severe ICA stenosis (>80%) with contralateral ICA occlusion and ICA subocclusion. IPCT was performed by applying 6 cycles of 30 sec reperfusion (declamping of ICA)/30 sec ischemia (clamping of ICA) after finishing the procedure and initial declamping. Two groups of patients were compared in terms of occurrence of intrahospital and early postoperative stroke, TIA (transient ischemic attack) and neurologic morbidity. Results: Cumulative incidence of intrahospital postoperative stroke or TIA was significantly higher in the control group (5.3% vs 0.7%, P = .036). According to carotid plaque characteristics, patients in the IPCT group had significantly more frequent presence of heterogenous plaque, as well as ulcerated plaque, which was associated with the absence of postoperative stroke and significantly lower cumulative rate of TIA/stroke when compared to the control group (43.9% vs 8% and 47.3% vs 1.5%). During the follow-up period of 1 month after the surgery, there were no cases of stroke, TIA and deaths due to neurological causes in both groups of patients. Conclusion: Our results showed that IPCT significantly reduced the incidence of postoperative cerebral ischemic complications after CEA in high-risk patients for IR injury when compared to the control group.