bluuebunny/crossref_metadata_2025_split huggingface dataset:
REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol
Authors: McKechnie Tyler , Kazi Tania , Wang Austine , Zhang Sophia , Thabane Alex , Nanji Keean , Doumouras Aristithes G , Eskicioglu Cagla , Thabane Lehana , Parpia Sameer , Bhandari Mohit 
Published: April 2024

IntroductionThe aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials.Methods and analysisA comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items.Ethics and disseminationThis is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.
Comparison of the dural puncture epidural and the standard epidural techniques in patients having labor analgesia maintained using programmed epidural boluses: a prospective double-blinded randomized clinical trial
Authors: Yao Han-Qing , Qian Jing , Dong Fang Yu , Liu Lin , Qian Xing-Hua , Wang Li-Zhong , Xiao Fei 
Published: April 2024

BackgroundThe dural puncture epidural technique has been shown in some studies to improve the onset and quality of the initiation of labor analgesia compared with the standard epidural technique. However, few studies have investigated whether this technique confers advantages during the maintenance of analgesia. This randomized double-blinded controlled study compared dural puncture epidural analgesia with standard epidural analgesia when analgesia was maintained using programmed intermittent epidural boluses.Methods400 parturients requesting epidural labor analgesia were randomized to have analgesia initiated with a test dose of 3 mL lidocaine 1.5% with epinephrine 15 µg, followed by 12 mL ropivacaine 0.15% mixed with sufentanil 0.5 µg/mL using the dural puncture epidural or the standard epidural technique. After confirming satisfactory analgesia, analgesia was maintained with ropivacaine 0.1% and sufentanil 0.5 µg/mL via programmed intermittent epidural boluses (fixed volume 8 mL, intervals 40 min). We compared local anesthetic consumption, pain scores, obstetric and neonatal outcomes and patient satisfaction.ResultsA total of 339 patients completed the study and had data analyzed. There were no differences between the dural puncture epidural and standard epidural groups in ropivacaine consumption (mean difference −0.724 mg, 95% CI of difference −1.450 to 0.001 mg, p=0.051), pain scores, time to first programmed intermittent epidural bolus, the number of programmed intermittent epidural boluses, the number of manual epidural boluses, obstetric outcome or neonatal outcome. Patient satisfaction scores were statistically higher in the dural puncture epidural group but the absolute difference in scores was small.ConclusionOur findings suggest that when labor analgesia is maintained using the programmed intermittent epidural bolus method, there is no significant advantage to initiating analgesia using the dural puncture epidural compared with the standard epidural technique.Trial registration numberChiCTR2200062349.
Menthol and filter ventilation in cigarettes: prevalence estimates and relationships with harm perception and smoking exposure
Authors: Carroll Dana Mowls , Bittencourt Lorna , Tessier Katelyn M , Usman Ayaantuu , Stepanov Irina , Hatsukami Dorothy K 
Published: April 2024

IntroductionMenthol and filter ventilation (FV) contribute to cigarette appeal. This observational study examines the US prevalence of menthol versus non-menthol cigarette use by FV and how harm perceptions, cigarettes per day and biomarkers of exposure vary.MethodsPopulation Assessment of Tobacco and Health Study (2013–2014) was merged with FV levels of cigarettes and restricted to daily smoking adults who had a usual cigarette variety and did not regularly use other tobacco (N=1614). Weighted descriptive statistics identified the prevalence of menthol and non-menthol use by low (0.02%–10.04%), moderate (10.05%–23.40%), high (23.41%–28.12%) and very high FV (28.13%–61.10%). Weighted linear regression was used to examine differences in outcomes by menthol/FV adjusted for potential confounders.ResultsThe prevalence of a usual brand that was non-menthol, low FV was the lowest at 2.91%. Using non-menthol cigarettes with high and very high FV (≥23.4%) vs low FV (≤10.04%) was associated with a greater likeliness of misperceiving one’s cigarette variety to be less harmful than other varieties (p values<0.05). Total nicotine equivalent, biomarker for nicotine exposure, was elevated (p values<0.05) among three non-menthol groups (low, moderate and very high FV) compared with two menthol groups (moderate, very high FV).ConclusionThe well-documented harm misperception linked to higher FV is more apparent in those using non-menthol than menthol cigarettes. Increased exposures were observed among some non-menthol cigarette users compared with some menthol cigarette users. These results should by no means delay a menthol ban but rather motivate concerted public health efforts to accompany the menthol ban to maximise smoking cessation.
Digital quantum simulation of gravitational optomechanics with IBM quantum computers
Authors: Carmona Rufo Pablo Guillermo , Mazumdar Anupam , Bose Sougato , Sabín Carlos 
Published: April 2024

AbstractWe showcase the digital quantum simulation of the action of a Hamiltonian that governs the interaction between a quantum mechanical oscillator and an optical field, generating quantum entanglement between them via gravitational effects. This is achieved by making use of a boson-qubit mapping protocol and a digital gate decomposition that allow us to run the simulations in the quantum computers available in the IBM Quantum platform. We present the obtained results for the fidelity of the experiment in two different quantum computers, after applying error mitigation and post-selection techniques. The achieved results correspond to fidelities over 90%, which indicates that we were able to perform a faithful digital quantum simulation of the interaction and therefore of the generation of quantum entanglement by gravitational means in optomechanical systems.
Launching and Positioning of Amul Camel Milk
Authors: Patel Naresh K. 
Published: April 2024

Amul is known globally for its cooperative model and it enjoys a healthy market share in the organized milk market of the country. Post-independence Amul plays a vital role in providing food security to marginalized milk-producing farmers and serving urban customers. Amul is also known for continuous improvement and product development. Amul launched camel milk in the Indian market in selected cities of Gujarat in January 2019 and emerged as the first to launch camel milk. Camel milk has many health-related benefits, particularly for diabetics, Autism, Food allergies, and other autoimmune diseases. Amul is also expecting to demand camel milk due to the increased health consciousness of the urban consumers’ segment. Amul camel milk got an excellent response initially. As per the MD of Amul, Mr. R. S. Shodhi, the major challenge is milk procurement. Being socially committed, Amul is closely working with camel breeders and also having social upliftment behind starting the camel milk. In the initial stage, they have the struggle to establish the entire supply chain of camel milk. And the primary issue is shelf life and awareness of camel milk.
Warburg Effect Reshapes Tumor Immunogenicity
Authors: Enríquez José A. , Mittelbrunn María 
Published: April 2024

Abstract
Tumor cells rewire their metabolism to fulfill the demands of highly proliferative cells. This changes cellular metabolism to adapt to fuel and oxygen availability for energy production and to increase the synthesis capacity of building blocks for cell division and growth. In addition, the metabolic shift modulates the immunogenicity of the tumor cells. Recently, Mahmood and colleagues reported a connection between mitochondrial DNA mutations in cancer cells and their response to immunotherapy in a mouse model of melanoma.
Red Blood Cell Polyunsaturated Fatty Acids and Mortality Following Breast Cancer
Authors: Parada Humberto , Wu Tianying , Hoh Eunha , Rock Cheryl L. , Martinez Maria E. 
Published: April 2024

Abstract

Background:
Intake of polyunsaturated fatty acids (PUFA) may affect mortality following breast cancer; however, epidemiological studies have relied on the self-reported assessment of PUFA intake. Herein, we examined the associations between red blood cell (RBC) PUFAs and mortality.

Methods:
This nested case–control study included 1,104 women from the Women’s Healthy Eating and Living study, a multistate randomized controlled trial. Cases (n = 290) comprised women who died from 1995 to 2006. Matched controls (n = 814) comprised women who were alive at the end of follow-up. PUFAs were measured in baseline RBC samples and included four ω-3 and seven ω-6 PUFAs. We examined each PUFA individually and principal components factor analysis (PCFA)-derived scores in association with all-cause mortality (ACM) and breast cancer–specific mortality (BCM) using conditional logistic regression to estimate ORs and 95% confidence intervals (CIs).

Results:
In fully adjusted models, ACM ORs were elevated among women with PUFAs above the median (&gt;median) versus at the median or below (≤median) for α-linolenic acid (ALA; OR = 1.63, 95% CI, 1.18–2.24) and linolenic acid (LA; OR = 1.56, 95% CI, 1.16–2.09). BCM ORs were elevated for ALA (OR = 1.83, 95% CI, 1.27–2.63), LA (OR = 1.70, 95% CI, 1.23–2.37), and γ-linolenic acid (GLA; OR = 1.50, 95% CI, 1.04–2.16). PCFA Factor 1 (arachidonic acid–adrenic acid–docosapentaenoic acid) scores above the median (vs. ≤median) were associated with lower odds of ACM (OR = 0.71, 95% CI, 0.52–0.97) and BCM (OR = 0.69, 95% CI, 0.49–0.97). PCFA Factor 4 (ALA/GLA) scores above the median (vs. ≤median) were associated with increased odds of BCM (OR = 1.47, 95% CI, 1.04–2.09).

Conclusions:
RBC ALA, LA, and GLA may be prognostic indicators among breast cancer survivors.

Impact:
These results are important for understanding the associations between a biomarker of PUFA intake and mortality among BC survivors.
Gene Expression Assays to Tailor Adjuvant Endocrine Therapy for HR+/HER2− Breast Cancer
Authors: Bottosso Michele , Miglietta Federica , Vernaci Grazia Maria , Giarratano Tommaso , Dieci Maria Vittoria , Guarneri Valentina , Griguolo Gaia 
Published: April 2024

Abstract
Adjuvant endocrine therapy (ET) represents the standard of care for almost all hormone receptor (HR)+/HER2− breast cancers, and different agents and durations are currently available. In this context, the tailoring and optimization of adjuvant endocrine treatment by reducing unnecessary toxic treatment while taking into account the biological heterogeneity of HR+/HER2− breast cancer represents a clinical priority. There is therefore a significant need for the integration of biological biomarkers in the choice of adjuvant ET beyond currently used clinicopathological characteristics. Several gene expression assays have been developed to identify patients with HR+/HER2− breast cancer who will not derive benefit from the addition of adjuvant chemotherapy. By enhancing risk stratification and predicting therapeutic response, genomic assays have also shown to be a promising tool for optimizing endocrine treatment decisions. In this study, we review evidence supporting the use of most common commercially available gene expression assays [Oncotype DX, MammaPrint, Breast Cancer Index (BCI), Prosigna, and EndoPredict] in tailoring adjuvant ET. Available data on the use of genomic tests to inform extended adjuvant treatment choice based on the risk of late relapse and on the estimated benefit of a prolonged ET are discussed. Moreover, preliminary evidence regarding the use of genomic assays to inform de-escalation of endocrine treatment, such as shorter durations or omission, for low-risk patients is reviewed. Overall, gene expression assays are emerging as potential tools to further personalize adjuvant treatment for patients with HR+/HER2− breast cancers.
First-in-Human Stage III/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0
Authors: Markowitz Joseph , Shamblott Michael , Brohl Andrew S. , Sarnaik Amod A. , Eroglu Zeynep , Khushalani Nikhil I. , Dukes Christopher W. , Chamizo Alejandra , Bastawrous Marina , Garcia Edward T. , Dehlawi Ashraf , Chen Pei-Ling , De Aquino Deanryan B. , Sondak Vernon K. , Tarhini Ahmad A. , Kim Youngchul , Lawman Patricia , Pilon-Thomas Shari 
Published: April 2024

Abstract
IFx-Hu2.0 was designed to encode part of the Emm55 protein contained within a plasmid in a formulation intended for transfection into mammalian cells. IFx-Hu2.0 promotes both adaptive and innate immune responses in animal studies. Furthermore, previous studies have demonstrated safety/efficacy in equine, canine, and murine species. We present the first-in-human study of IFx-Hu2.0, administered by intralesional injection into melanoma tumors of seven patients with stage III/IV unresectable melanoma. No dose-limiting toxicities attributable to IFx-Hu2.0 were observed. Grade 1/2 injection site reactions were observed in five of seven patients. IgG and IgM responses to Emm55 peptides and known melanoma antigens were seen in the peripheral blood, suggesting that IFx-Hu2.0 acts as an individualized “in situ vaccine.” Three of four patients previously refractory to anti-PD1 experienced clinical benefit upon subsequent anti-PD1–based treatment. Therefore, this approach is feasible, and clinical/correlative outcomes warrant further investigation for treating patients with metastatic melanoma with an immune priming agent.
Epithelial Expressed B7-H4 Drives Differential Immunotherapy Response in Murine and Human Breast Cancer
Authors: Wescott Elizabeth C. , Sun Xiaopeng , Gonzalez-Ericsson Paula , Hanna Ann , Taylor Brandie C. , Sanchez Violeta , Bronzini Juliana , Opalenik Susan R. , Sanders Melinda E. , Wulfkuhle Julia , Gallagher Rosa I. , Gomez Henry , Isaacs Claudine , Bharti Vijaya , Wilson John T. , Ballinger Tarah J. , Santa-Maria Cesar A. , Shah Payal D. , Dees Elizabeth C. , Lehmann Brian D. , Abramson Vandana G. , Hirst Gillian L. , Brown Swigart Lamorna , van ˈt Veer Laura J. , Esserman Laura J. , Petricoin Emanuel F. , Pietenpol Jennifer A. , Balko Justin M. 
Published: April 2024

Abstract

Combinations of immune checkpoint inhibitors (ICI, including anti-PD-1/PD-L1) and chemotherapy have been FDA approved for metastatic and early-stage triple-negative breast cancer (TNBC), but most patients do not benefit. B7-H4 is a B7 family ligand with proposed immunosuppressive functions being explored as a cancer immunotherapy target and may be associated with anti-PD-L1 resistance. However, little is known about its regulation and effect on immune cell function in breast cancers. We assessed murine and human breast cancer cells to identify regulation mechanisms of B7-H4 in vitro. We used an immunocompetent anti-PD-L1–sensitive orthotopic mammary cancer model and induced ectopic expression of B7-H4. We assessed therapy response and transcriptional changes at baseline and under treatment with anti-PD-L1. We observed B7-H4 was highly associated with epithelial cell status and transcription factors and found to be regulated by PI3K activity. EMT6 tumors with cell-surface B7-H4 expression were more resistant to immunotherapy. In addition, tumor-infiltrating immune cells had reduced immune activation signaling based on transcriptomic analysis. Paradoxically, in human breast cancer, B7-H4 expression was associated with survival benefit for patients with metastatic TNBC treated with carboplatin plus anti-PD-L1 and was associated with no change in response or survival for patients with early breast cancer receiving chemotherapy plus anti-PD-1. While B7-H4 induces tumor resistance to anti-PD-L1 in murine models, there are alternative mechanisms of signaling and function in human cancers. In addition, the strong correlation of B7-H4 to epithelial cell markers suggests a potential regulatory mechanism of B7-H4 independent of PD-L1.

Significance:
This translational study confirms the association of B7-H4 expression with a cold immune microenvironment in breast cancer and offers preclinical studies demonstrating a potential role for B7-H4 in suppressing response to checkpoint therapy. However, analysis of two clinical trials with checkpoint inhibitors in the early and metastatic settings argue against B7-H4 as being a mechanism of clinical resistance to checkpoints, with clear implications for its candidacy as a therapeutic target.
Outcome of Pediatric Large Vessel Occlusion Stroke in Denmark
Authors: Bindslev Julie Brix , Hansen Klaus , Matoor Nicol Dara , Stavngaard Trine , Hoei‐Hansen Christina Engel , Truelsen Thomas 
Published: April 2024

Background
We performed a nationwide study to examine clinical outcome in children with large‐vessel occlusion (LVO) stroke treated with mechanical thrombectomy (MT) or conservatively.

Methods
Study participants were enrolled by 2 methods: (1) registration of children assessed through a pediatric stroke triage‐setup from January 2021 to June 2023 and (2) identification of children registered with a stroke or stroke‐related diagnosis in the Danish National Registry of Patients between January 2011 and December 2020. Medical records were reviewed to validate possible stroke events. Children aged 29 days to 17 years with arterial ischemic stroke were included. The children were followed up for cause of stroke, site of vessel occlusion, treatment characteristics, and clinical outcome according to the modified Rankin scale.

Results
A total of 181 children with arterial ischemic stroke were identified. Angiography descriptions were available in 133 children and demonstrated LVOs in 28 (21.1%) of these. Fourteen children with LVOs underwent MT and 14 were treated conservatively. Thirteen of 14 (92.9%) children treated with MT achieved successful reperfusion. Periprocedural complications were observed in 2 children, including 1 child who developed symptomatic intracerebral hemorrhage <24 hours from MT. Long‐term outcome was poor (modified Rankin scale score 3–6) in 7 out of 14 (50.0%) children with LVOs treated conservatively and 5 out of 14 (35.7%) children treated with MT. When limiting analysis to MT procedures performed within 24 hours from stroke onset, a poor outcome was observed in 3 out of 11 (27.3%) children treated with MT. Outcome did not differ significantly between treatment groups.

Conclusion
This nationwide study demonstrates that MT is feasible and apparently safe to use in children. Among children with LVOs, outcome tended to be better for those treated with MT than those treated conservatively, but outcome did not differ significantly between groups, likely due to small sample sizes.
0. Introduction
Authors: Richter Michael , Rubinstein Ariel 
Published: April 2024

The stage on which this book's plots are set is a model called an economy. The model captures situations in which each agent in a society chooses an alternative and there exists a fundamental tension between the agents' personal desires and society-wide feasibility constraints. The chapter includes many examples of economies.
A candidate for an equilibrium includes two components:
(i) A profile of choices - one choice for each agent.
(ii) A specification of certain parameters that systematically influence either agents' choice problems or their preference relations.
In equilibrium, agents make individually optimal choices, and the parameters restrict their choice sets to be compatible, in the sense that the resulting profile of choices is feasible.
We provide an overview of the equilibrium concepts we study in the book. They are classified into two groups. In the choice group, each agent's choice set depends on a price-like equilibrium parameter, but not on the equilibrium profile of choices. In the deviation group, an equilibrium is a profile of choices which is immune to any single agent's deviation from his prescribed alternative to any other alternative in a set determined by the equilibrium parameters.
1. Equilibrium in the Jungle
Authors: Richter Michael , Rubinstein Ariel 
Published: April 2024

The standard economic approach treats economic activity as voluntary: all involved parties do whatever they do of their own free will. However, life is not just a series of voluntary actions. An agent might use power to seize assets from others or to force others to do things against their will. Economic Theory typically ignores the use of power as a driver of social activity.
This chapter follows Piccione and Rubinstein (2007) which introduces a model of a society referred to as the jungle, in which economic transactions are governed only by coercion. The model consists of a set of agents with exogenous preferences over a set of assets and a power ordering of the agents. Power means that a stronger agent is able to take things away from a weaker agent without the weaker agent's consent.
A jungle equilibrium is a feasible allocation of the assets such that no agent wishes to take assets from an agent (or agents) weaker than himself. We will apply versions of the concept to the housing economy (Shapley and Scarf (1974)) and to the division economy. Throughout, we will deal with standard issues, such as: existence, uniqueness and the fundamental theorems of welfare.
2. The Permissible and the Forbidden
Authors: Richter Michael , Rubinstein Ariel 
Published: April 2024

Following Richter and Rubinstein (2020), we analyze an equilibrium concept based upon social norms: the Y-equilibrium. A Y-equilibrium is a set of permissible alternatives and a profile of choices, one for each agent, such that:
(i) each agent's choice is optimal from among the permissible alternatives;
(ii) the profile of choices is feasible; and
(iii) the set of permissible alternatives is maximal in the sense that there is no superset of permissible alternatives from which a profile satisfying (i) and (ii) can be found.
By this definition, two forces make a permissible set unstable: The first modifies the permissible set in the case that the profile of (intended) choices is not feasible, while the second loosens restrictions on the permissible set as long as a new profile of optimal choices is feasible. We also consider a variant of this concept where we require that the permissible set is convex.
We study the Y-equilibria of a variety of examples and prove existence theorems, “welfare” theorems and a structure theorem when the set of alternatives is Euclidean.