bluuebunny/crossref_metadata_2025_split huggingface dataset:
Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease — a randomized controlled trial
Authors: Schuermans Valérie N. E. , Smeets Anouk Y. J. M. , Boselie Toon F. M. , Candel Math J. J. M. , Curfs Inez , Evers Silvia M. A. A. , Van Santbrink Henk 
Published: August 2022

Abstract
Introduction
To date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term.

Methods and analysis
In this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery.

Discussion
High-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.

Trial registration
ClinicalTrials.gov NCT04623593. Registered on 29 September 2020.
The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnea and life quality: a randomized controlled trial
Authors: Ceyhan Yasemin , Tekinsoy Kartin Pınar 
Published: August 2022

Abstract
Background
Severe dyspnea and poor quality of life are common in chronic obstructive pulmonary disease (COPD). The most important reason for this is wrong applications in inhaler treatment. In addition, inhaler treatments that support non-pharmacological methods increase the effectiveness of the drug. The aim of this study was to determine the effects of breathing exercises and inhaler training for chronic obstructive pulmonary disease patients on the severity of dyspnea and life quality.

Methods
The research was a randomized controlled trial. A total of 67 patients with COPD were included. The patients were randomized into two groups. Intervention group 1 were given pursed lip breathing exercise and inhaler training and Intervention group 2 were given only inhaler training. A follow-up after 4 weeks was carried out in both groups. Patient outcomes in both groups were assessed by a COPD assessment test (CAT), the Modified Medical Research Council (mMRC) scale, and the St. George’s Respiratory Questionnaire scale (SGRQ). This study followed the CONSORT checklist for randomized controlled trials. In the data analysis, independent t, Mann-Whitney U, ANOVA, Wilcoxon analysis, and Pearson chi-square tests were used.

Results
The pursed lips exercise and inhaler drug use skills of patients in both groups increased (p<0.001). The median value of the CAT and mMRC scores were statistically significant for both groups (p<0.005). The mean of life quality scores of patients in both groups decreased, and this result was found to be statistically significant in all sub-dimensions and in the total scale score for both groups (p<0.001). Although the increase in the quality of life and the decrease in the severity of dyspnea of the patients in both groups were significant, neither group was superior to the other (p>0.05).

Conclusions
As a result of the study, it was found that the skill of using the inhaler and the life quality of the patients increased, and the severity of dyspnea decreased. Supporting inhaler treatments with non-pharmacological methods can increase drug efficacy and quality of life.

Trial registration
ClinicalTrials.gov NCT04739488. Registered on 21 Feb 2021.
Effect of acupuncture for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized clinical trial
Authors: Qi Ling-Yu , Yang Jing-Wen , Yan Shi-Yan , She Yan-Fen , Hu Hui , Li Ying , Chi Li-Li , Wu Bang-Qi , Tu Jian-Feng , Wang Li-Qiong , Liu Cun-Zhi 
Published: August 2022

AbstractBackgroundDiarrhea-predominant irritable bowel syndrome (IBS-D) is the most common subtype of IBS. Acupuncture is commonly used to treat IBS-D, but its effect is uncertain because of the poor quality of prior studies. This trial aims to evaluate the efficacy and safety of acupuncture treatment for IBS-D through comparisons with sham acupuncture.Methods/designThis is a large-scale, multi-center, randomized, two-arm interventional clinical trial. Participants will take part in a total of 20 weeks of study, which contained 3 phases: 2-week screening, 6-week treatment, and 12-week follow-up. Based on the composite response rate of the primary endpoint in our pilot study (a sham acupuncture response rate of 27% and a true acupuncture of approximately 45%), 280 randomly allocated participants were planned. Eligible participants will be randomly assigned to the true acupuncture group and sham acupuncture group according to a ratio of 1:1, and a total of 15 sessions of treatment overall 6-week treatment period will be brought. The primary endpoint is a composite response rate at week 6, and the responder is defined as who responses in both abdominal pain intensity and stool consistency. Furthermore, composite response rates at other weeks, IBS Symptom Severity Scale, IBS Quality of Life, Adequate Relief scale, and individual IBS symptoms (abdominal pain, bloating, stool frequency) are chosen as secondary endpoints.DiscussionThis trial may provide high-quality evidence for the efficacy and safety of acupuncture in the treatment of IBS-D. The results of this study will be published in peer-reviewed journals.Trial registrationChinese Clinical Trial Registry: ChiCTR2100044762. Registered on 26 March 2021.
Factors associated with reporting of the Prevention of Falls Network Europe (ProFaNE) core outcome set domains in randomized trials on falls in older people: a citation analysis and correlational study
Authors: Korall Alexandra M. B. , Steliga Dawn , Lamb Sarah E. , Lord Stephen R. , Rabbani Rasheda , Sibley Kathryn M. 
Published: August 2022

AbstractBackgroundCore outcome sets are advocated as a means to standardize outcome reporting across randomized controlled trials (RCTs) and reduce selective outcome reporting. In 2005, the Prevention of Falls Network Europe (ProFaNE) published a core outcome set identifying five domains that should be measured and reported, at a minimum, in RCTs or meta-analysis on falls in older people. As reporting of all five domains of the ProFaNE core outcome set has been minimal, we set out to investigate factors associated with reporting of the ProFaNE core outcome set domains in a purposeful sample of RCTs on falls in older people.MethodsWe conducted a systematic citation analysis to identify all reports of RCTs focused on falls in older people that cited the ProFaNE core outcome set between October 2005 and July 2021. We abstracted author-level, study-level, and manuscript-level data and whether each domain of the ProFaNE core outcome set was reported. We used penalized LASSO regression to identify factors associated with the mean percentage of ProFaNE core outcome set domains reported.ResultsWe identified 85 eligible reports of RCTs. Articles were published between 2007 and 2021, described 75 unique RCTs, and were authored by 76 unique corresponding authors. The percentage of ProFaNE core outcome set domains reported ranged from 0 to 100%, with a median of 40% and mean (standard deviation, SD) of 52.2% (25.1). RCTs funded by a non-industry source reported a higher mean percentage of domains than RCTs without a non-industry funding source (estimated mean difference = 17.5%; 95% confidence interval (CI) 1.8–33.2). RCTs examining exercise (15.4%; 95% CI 1.9–28.9) or multi-component/factorial (17.4%; 95% CI 4.7–30.1) interventions each reported a higher mean percentage of domains than RCTs examining other intervention types.ConclusionsWe found that RCTs funded by at least one non-industry source, examining exercise or multi-component/factorial interventions, reported the highest percentages of ProFaNE core outcome set domains. Findings may help inform strategies to increase the impact of the ProFaNE core outcome set. Ultimately, this may lead to enhanced knowledge of the effectiveness and safety of interventions to prevent and/or manage falls in older people.
Biodistribution and dosimetry of the GluN2B-specific NMDA receptor PET radioligand (R)-[11C]Me-NB1
Authors: Rischka Lucas , Murgaš Matej , Pichler Verena , Vraka Chrysoula , Rausch Ivo , Winkler Dietmar , Nics Lukas , Rasul Sazan , Silberbauer Leo Robert , Reed Murray Bruce , Godbersen Godber Mathis , Unterholzner Jakob , Handschuh Patricia , Gryglewski Gregor , Mindt Thomas , Mitterhauser Markus , Hahn Andreas , Ametamey Simon Mensah , Wadsak Wolfgang , Lanzenberger Rupert , Hacker Marcus 
Published: August 2022

Abstract
Background
The NMDA receptor (NMDAR) plays a key role in the central nervous system, e.g., for synaptic transmission. While synaptic NMDARs are thought to have protective characteristics, activation of extrasynaptic NMDARs might trigger excitotoxic processes linked to neuropsychiatric disorders. Since extrasynaptic NMDARs are typically GluN2B-enriched, the subunit is an interesting target for drug development and treatment monitoring. Recently, the novel GluN2B-specific PET radioligand (R)-[11C]Me-NB1 was investigated in rodents and for the first time successfully translated to humans. To assess whether (R)-[11C]Me-NB1 is a valuable radioligand for (repeated) clinical applications, we evaluated its safety, biodistribution and dosimetry.

Methods
Four healthy subjects (two females, two males) underwent one whole-body PET/MR measurement lasting for more than 120 min. The GluN2B-specific radioligand (R)-[11C]Me-NB1 was administered simultaneously with the PET start. Subjects were measured in nine passes and six bed positions from head to mid-thigh. Regions of interest was anatomically defined for the brain, thyroid, lungs, heart wall, spleen, stomach contents, pancreas, liver, kidneys, bone marrow and urinary bladder contents, using both PET and MR images. Time-integrated activity coefficients were estimated to calculate organ equivalent dose coefficients and the effective dose coefficient. Additionally, standardized uptake values (SUV) were computed to visualize the biodistribution.

Results
Administration of the radioligand was safe without adverse events. The organs with the highest uptake were the urinary bladder, spleen and pancreas. Organ equivalent dose coefficients were higher in female in almost all organs, except for the urinary bladder of male. The effective dose coefficient was 6.0 µSv/MBq.

Conclusion
The GluN2B-specific radioligand (R)-[11C]Me-NB1 was well-tolerated without reported side effects. Effective dose was estimated to 1.8 mSv when using 300 MBq of presented radioligand. The critical organ was the urinary bladder. Due to the low effective dose coefficient of this radioligand, longitudinal studies for drug development and treatment monitoring of neuropsychiatric disorders including neurodegenerative diseases are possible.
Trial registration Registered on 11th of June 2019 at https://www.basg.gv.at (EudraCT: 2018-002933-39).
The interstitium at the developing nephron in the fetal kidney during advanced pregnancy — a microanatomical inventory
Authors: Minuth Will W. 
Published: August 2022

AbstractBackgroundA series of noxae can evoke the termination of nephron formation in preterm and low birth weight babies. This results in oligonephropathy with severe consequences for health in the later life. Although the clinical parameters have been extensively investigated, little is known about the initial damage. Previous pathological findings indicate the reduction in width of the nephrogenic zone and the lack of S-shaped bodies. Current morphological investigations suggest that due to the mutual patterning beside the forming nephron, also its structural neighbors, particularly the interjacent interstitium, must be affected. However, beside the findings on integrative and mastering functions, systematic microanatomical data explaining the configuration of the interstitium at the developing nephron in the fetal kidney during advanced pregnancy is not available. Therefore, this work explains the typical features.ResultsThe generated data depicts that the progenitor cells, nephrogenic niche, pretubular aggregate, and mesenchymal-to-epithelial transition are restricted to the subcapsular interstitium. During the proceeding development, only the distal pole of the renal vesicles and comma- and S-shaped bodies stays in further contact with it. The respective proximal pole is positioned opposite the peritubular interstitium at the connecting tubule of an underlying but previously formed nephron. The related medial aspect faces the narrow peritubular interstitium of a collecting duct (CD) ampulla first only at its tip, then at its head, conus, and neck, and finally at the differentiating CD tubule. The lateral aspect starts at the subcapsular interstitium, but then it is positioned along the wide perivascular interstitium of the neighboring ascending perforating radiate artery. When the nephron matures, the interstitial configuration changes again.ConclusionsThe present investigation illustrates that the interstitium at the forming nephron in the fetal kidney consists of existing, transient, stage-specific, and differently far matured compartments. According to the developmental needs, it changes its shape by formation, degradation, fusion, and rebuilding.
Goal management training improves executive control in adults with ADHD: an open trial employing attention network theory to examine effects on attention
Authors: Jensen Daniel A. , Lundervold Astri J. , Stubberud Jan , Halmøy Anne , Haavik Jan , Sørensen Lin 
Published: August 2022

Abstract
Background
Adults with Attention-Deficit/Hyperactivity Disorder (ADHD) typically experience poorer attentional control. According to the attention network theory, attentional control relies on three interacting networks of alerting, orienting, and executive control. In ADHD, it is mainly the alerting and executive control networks that are suggested and found to be compromised.

Methods
In the current study, we investigated if a group-based metacognitive remediation program (Goal Management Training [GMT]) in adults with ADHD would enhance attentional control using an experimental measure of the attention network theory. We expected that GMT would specifically enhance the executive control and alerting networks.

Results
Data from post- and follow up-assessments of 21 adults (age: 39.05 [11.93]) with ADHD who had completed GMT were included. Linear mixed-effects modeling revealed significant improvements in the functioning of the executive control network for the majority of the participants, although a small subset of participants showed a negative development following the intervention. Results also showed an improvement in the orienting network at follow up, but no change in the alerting network.

Conclusion
The results may indicate that improvements in the functioning of the executive control network are central to the positive effects of GMT reported in disorders characterized by impaired attentional control.
Trial registration: The study was retrospectively registered in the ISRCTN (Identifier: ISRCTN91988877) on the 18/01/2021.
Possible clinical implications and future directions of managing bacterial biofilms in cutaneous leishmaniasis wounds
Authors: Kaluarachchi T. D. Jayasena , Campbell Paul M. , Wickremasinghe Renu , Ranasinghe Shalindra , Yasewardene Surangi , De Silva Hiromel , McBain Andrew J. , Weerasekera Manjula 
Published: August 2022

AbstractCutaneous leishmaniasis (CL) lesions are chronic and result in disfiguring scars. The microbiological aspects of these wounds have not been systematically investigated. We have recently reported that 61.5% of CL wounds in a Sri Lankan cohort harboured bacterial biofilms, mainly composed of bacilli, Enterobacteriaceae, and Pseudomonas, which could delay wound healing. We have additionally reported that biofilms were significantly associated patients over 40 years of age, discharge, pain and/or itching of the wound, and high pus cell counts. Using this as background knowledge and other relevant literature, we highlight the importance of investigating the role of biofilms in CL wound healing, clinical indicators, cost-effective laboratory tests involving less invasive sampling techniques for diagnosing biofilms and potential therapeutic options for biofilm-containing CL wounds, such as adjunctive application of wound debridement and antimicrobial treatment along with anti-parasitic drugs.
Numerical analysis of turbulence characteristics in a flat-plate flow with riblets control
Authors: Zhang Yang , Ye Zhixian , Li Binghua , Xie Lan , Zou Jianfeng , Zheng Yao 
Published: August 2022

AbstractA comparative study about riblets-controlled turbulent boundary layers has been performed to investigate the turbulence characteristics associated with drag reduction in a compressive flat-plate flow (where the free-stream Mach number is 0.7) by means of direct numerical simulations (DNSs). With a setting of the triangular riblets (s+ ≈ 30.82, h+ ≈ 15.41) settled on the Reτ ≈ 500 turbulent boundary layer, an effective global drag reduction was achieved. By comparing velocity and its fluctuation distribution, vorticity fluctuation and streaks structures between the smooth and riblets flat-plate cases, two roles of lifting and rectification in terms of riblets drag control are revealed that the micro-scale riblets can lift up logarithmic-law region of the boundary layer, which leads to a smaller wall friction velocity and thus a drag reduction. The streamwise vortices and its fluctuation structures are shifted upward, thus the interactions between them and the wall surface are weakened, which causes the suppressed intensity of Reynolds normal stresses, streamwise vorticity and turbulent kinetic energy production inside the riblets. Moreover, the streaks associated with streamwise velocity or 3D vortices are ruled from the distorted to long and straight structures as they pass through the riblets, indicating an ability of riblets to turn turbulence into a more ordered state.
Conformal gravity: Newton's constant is not universal
Authors: Nesbet R. K. 
Published: August 2022

Abstract
Newton's gravitational constant G has been measured to high accuracy in a number of independent experiments. For currently unresolved reasons, indicated values from different well-designed and thoroughly analyzed experiments differ by more than the sum of estimated errors. It has recently been shown that requiring both Einstein general relativity and the Higgs scalar field model to satisfy conformal symmetry (local Weyl scaling covariance) introduces gravitational effects that explain anomalous galactic rotation, currently accelerating Hubble expansion, and dark galactic halos, without invoking dark matter. This implies different values G

n
and G

p
for neutron and proton, respectively, but retains the Einstein equivalence principle for test objects accelerated by a given gravitational field. Isotopic mass defect μ per nucleon determines independent G

m
. Thus G differs for each nuclear isotope. Several recent measurements are used here to estimate

,

, and

in units

.
AMPK promotes Arf6 activation in a kinase-independent manner upon glucose starvation
Authors: Chen Kuan-Jung , Hsu Jia-Wei , Lee Fang-Jen S. 
Published: August 2022

ABSTRACT
AMP-activated protein kinase (AMPK) is a crucial cellular nutrient and energy sensor that maintains energy homeostasis. AMPK also governs cancer cell invasion and migration by regulating gene expression and activating multiple cellular signaling pathways. ADP-ribosylation factor 6 (Arf6) can be activated via nucleotide exchange by guanine-nucleotide-exchange factors (GEFs), and its activation also regulates tumor invasion and migration. By studying GEF-mediated Arf6 activation, we have elucidated that AMPK functions as a noncanonical GEF for Arf6 in a kinase-independent manner. Moreover, by examining the physiological role of the AMPK–Arf6 axis, we have determined that AMPK activates Arf6 upon glucose starvation and 5-aminoimidazole-4-carboxamide-1-β-D-ribofuranoside (AICAR) treatment. We have further identified the binding motif in the C-terminal regulatory domain of AMPK that is responsible for promoting Arf6 activation and, thus, inducing cell migration and invasion. These findings reveal a noncanonical role of AMPK in which its C-terminal regulatory domain serves as a GEF for Arf6 during glucose deprivation.
Mitochondrial haplogroup association with fasting glucose response in African Americans treated with a thiazide diuretic
Authors: Minniefield Bre , Armstrong Nicole , Srinivasasainagendra Vinodh , Tiwari Hemant , Ballinger Scott , Chong Zechen , Aslibekyan Stella , Arnett Donna , Irvin Marguerite 
Published: August 2022

Background: Hypertensive African Americans have a ~50% response rate to thiazide diuretic treatment. This contributes to a high prevalence of uncontrolled high blood pressure. Here, we examined the role of the mitochondrial genome on thiazide diuretic treatment response in hypertensive African Americans enrolled in a clinical trial. Methods: Participants from the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT, n= 4279) were genotyped using the Illumina Infinium Multi-Ethnic Beadchip. Haplotype groups were called using HaploGrep. We used a linear regression analysis to examine the association between mitochondrial haplogroups (L, M, and N) and changes in blood pressure and fasting glucose over six months and two years, respectively. Results: The analysis revealed a null association between mitochondrial haplogroups M and N versus L for each of the outcomes. In subgroup analysis, the L subclades L1, L2, and L3/L4 (versus L0) were each inversely associated with fasting glucose response (p < 0.05). Conclusions: This discovery analysis suggests the mitochondrial genome has a small effect on fasting glucose response, but not that of blood pressure, to thiazide diuretic treatment in African Americans.