bluuebunny/crossref_metadata_2025_split huggingface dataset:
A pilot trial of autologous tumor infiltrating lymphocytes (lifileucel, LN-144) for patients with asymptomatic melanoma brain metastases.
Authors: Betof Warner Allison , Postow Michael A. , Panageas Katherine , Smithy James William , Schoenfeld Adam Jacob , Wolchok Jedd D. , Shoushtari Alexander Noor 
Published: June 2023

TPS9606 Background: Melanoma brain metastases (MBM) are a leading cause of morbidity and mortality for patients with advanced melanoma. Modern systemic therapies are insufficient at controlling MBM, and median overall survival (OS) for pts with MBM is < 1 year. Adoptive T cell therapy using tumor infiltrating lymphocytes (TIL) has demonstrated efficacy in advanced melanoma. Lifileucel (LN-144), an autologous TIL product, was recently shown to be safe and effective for patient with PD-1 refractory melanoma. Patients with active MBM were excluded from lifileucel trials to date. Methods: This single-center pilot trial (NCT05640193) is enrolling up to 10 pts with asymptomatic MBM from non-uveal melanoma to receive lifileucel. Patients must have ≥1 intracranial lesion measuring 5-30mm visible on MRI to be used as a target lesion for modified (m)RECIST measurement, progression on prior anti-PD-1 therapy (with or without anti-CTLA-4), progression on targeted therapy if BRAF V600E/K-mutated), ECOG PS ≤1, ≥1 resectable lesion(s) (≥1.5 cm), recovered from prior surgery/anticancer treatment-related AEs (grade ≤1). Patients are not eligible if they have symptomatic MBM and/or require corticosteroids of ≥10 mg/day of prednisone or equivalent. Lifileucel is generated from resected tumor in a centralized GMP process. The regimen includes nonmyeloablative lymphodepletion, lifileucel infusion, and a short course of high-dose IL-2. The primary endpoint is feasibility, defined as ≥7/10 patients who undergo tumor harvest receiving lifileucel infusion. Secondary endpoints are safety, feasibility of manufacturing lifileucel in patients with MBM, and brain metastasis response rate (BMRR) per mRECIST 1.1. Exploratory endpoints include overall objective response rate by mRECIST 1.1, best extracranial response rate, intracranial progression-free survival (PFS), overall PFS, OS. Extensive correlative analyses of peripheral blood mononuclear cells, plasma, tumors, and cerebrospinal fluid are planned to better understand MBM growth, treatment resistance, and response of the central nervous system to lifileucel. Clinical trial information: NCT05640193 .
Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non–Small-Cell Lung Cancer
Authors: Riely Gregory J. , Smit Egbert F. , Ahn Myung-Ju , Felip Enriqueta , Ramalingam Suresh S. , Tsao Anne , Johnson Melissa , Gelsomino Francesco , Esper Raymond , Nadal Ernest , Offin Michael , Provencio Mariano , Clarke Jeffrey , Hussain Maen , Otterson Gregory A. , Dagogo-Jack Ibiayi , Goldman Jonathan W. , Morgensztern Daniel , Alcasid Ann , Usari Tiziana , Wissel Paul , Wilner Keith , Pathan Nuzhat , Tonkovyd Svitlana , Johnson Bruce E. 
Published: June 2023

PURPOSE The combination of encorafenib (BRAF inhibitor) plus binimetinib (MEK inhibitor) has demonstrated clinical efficacy with an acceptable safety profile in patients with BRAFV600E/K-mutant metastatic melanoma. We evaluated the efficacy and safety of encorafenib plus binimetinib in patients with BRAFV600E-mutant metastatic non–small-cell lung cancer (NSCLC). METHODS In this ongoing, open-label, single-arm, phase II study (ClinicalTrials.gov identifier: NCT03915951 ), patients with BRAFV600E-mutant metastatic NSCLC received oral encorafenib 450 mg once daily plus binimetinib 45 mg twice daily in 28-day cycles. The primary end point was confirmed objective response rate (ORR) by independent radiology review (IRR). Secondary end points included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival, time to response, and safety. RESULTS At data cutoff, 98 patients (59 treatment-naïve and 39 previously treated) with BRAFV600E-mutant metastatic NSCLC received encorafenib plus binimetinib. Median duration of treatment was 9.2 months with encorafenib and 8.4 months with binimetinib. ORR by IRR was 75% (95% CI, 62 to 85) in treatment-naïve and 46% (95% CI, 30 to 63) in previously treated patients; median DOR was not estimable (NE; 95% CI, 23.1 to NE) and 16.7 months (95% CI, 7.4 to NE), respectively. DCR after 24 weeks was 64% in treatment-naïve and 41% in previously treated patients. Median PFS was NE (95% CI, 15.7 to NE) in treatment-naïve and 9.3 months (95% CI, 6.2 to NE) in previously treated patients. The most frequent treatment-related adverse events (TRAEs) were nausea (50%), diarrhea (43%), and fatigue (32%). TRAEs led to dose reductions in 24 (24%) and permanent discontinuation of encorafenib plus binimetinib in 15 (15%) patients. One grade 5 TRAE of intracranial hemorrhage was reported. Interactive visualization of the data presented in this article is available at the PHAROS dashboard ( https://clinical-trials.dimensions.ai/pharos/ ). CONCLUSION For patients with treatment-naïve and previously treated BRAFV600E-mutant metastatic NSCLC, encorafenib plus binimetinib showed a meaningful clinical benefit with a safety profile consistent with that observed in the approved indication in melanoma.
Patient-Reported Outcomes During and After Treatment for Locally Advanced Rectal Cancer in the PROSPECT Trial (Alliance N1048)
Authors: Basch Ethan , Dueck Amylou C. , Mitchell Sandra A. , Mamon Harvey , Weiser Martin , Saltz Leonard , Gollub Marc , Rogak Lauren , Ginos Brenda , Mazza Gina L. , Colgrove Brian , Chang George , Minasian Lori , Denicoff Andrea , Thanarajasingam Gita , Musher Benjamin , George Thomas , Venook Alan , Farma Jeffrey , O'Reilly Eileen , Meyerhardt Jeffrey A. , Shi Qian , Schrag Deborah 
Published: June 2023

PURPOSE The standard of care for locally advanced rectal cancer in North America is neoadjuvant pelvic chemoradiation with fluorouracil (5FUCRT). Neoadjuvant chemotherapy with fluorouracil and oxaliplatin (FOLFOX) is an alternative that may spare patients the morbidity of radiation. Understanding the relative patient experiences with these options is necessary to inform treatment decisions. METHODS PROSPECT was a multicenter, unblinded, noninferiority, randomized trial of neoadjuvant FOLFOX versus 5FUCRT, which enrolled adults with rectal cancer clinically staged as T2N+, cT3N–, or cT3N+ who were candidates for sphincter-sparing surgery. Neoadjuvant FOLFOX was given in six cycles over 12 weeks, followed by surgery. Neoadjuvant 5FUCRT was delivered in 28 fractions over 5.5 weeks, followed by surgery. Adjuvant chemotherapy was suggested but not mandated in both groups. Enrolled patients were asked to provide patient-reported outcomes (PROs) at baseline, during neoadjuvant treatment, and at 12 months after surgery. PROs included 14 symptoms from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Additional PRO instruments measured bowel, bladder, sexual function, and health-related quality of life (HRQL). RESULTS From June 2012 to December 2018, 1,194 patients were randomly assigned, 1,128 initiated treatment, and 940 contributed PRO-CTCAE data (493 FOLFOX; 447 5FUCRT). During neoadjuvant treatment, patients reported significantly lower rates of diarrhea and better overall bowel function with FOLFOX while anxiety, appetite loss, constipation, depression, dysphagia, dyspnea, edema, fatigue, mucositis, nausea, neuropathy, and vomiting were lower with 5FUCRT (all multiplicity adjusted P < .05). At 12 months after surgery, patients randomly assigned to FOLFOX reported significantly lower rates of fatigue and neuropathy and better sexual function versus 5FUCRT (all multiplicity adjusted P < .05). Neither bladder function nor HRQL differed between groups at any time point. CONCLUSION For patients with locally advanced rectal cancer choosing between neoadjuvant FOLFOX and 5FUCRT, the distinctive PRO profiles inform treatment selection and shared decision making.
Does the Type of Chronic Heart Failure Impact In-Hospital Outcomes for Aortic Valve Replacement Procedures?
Authors: Mubashir Talha , Zaki John , Yeong An Sin , Salas De Armas Ismael A. , Liang Yafen , Markham Travis , Feng Han , Akay Mehmet H. , Nascimbene Angelo , Akkanti Bindu , Williams George W. , Zasso Fabricio , Aponte Maria Patarroyo , Gregoric Igor D. , Kar Biswajit 
Published: June 2023

Abstract

Background
This study assessed in-hospital outcomes of patients with chronic systolic, diastolic, or mixed heart failure (HF) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).

Methods
The Nationwide Inpatient Sample database was used to identify patients with aortic stenosis and chronic HF who underwent TAVR or SAVR between 2012 and 2015. Propensity score matching and multivariate logistic regression were used to determine outcome risk.

Results
A cohort of 9,879 patients with systolic (27.2%), diastolic (52.2%), and mixed (20.6%) chronic HF were included. No statistically significant differences in hospital mortality were noted. Overall, patients with diastolic HF had the shortest hospital stays and lowest costs. Compared with patients with diastolic HF, the risk of acute myocardial infarction (TAVR odds ratio [OR], 1.95; 95% CI, 1.20–3.19; P = .008; SAVR OR, 1.38; 95% CI, 0.98–1.95; P = .067) and cardiogenic shock (TAVR OR, 2.15; 95% CI, 1.43–3.23; P < .001; SAVR OR, 1.89; 95% CI, 1.42–2.53; P ≤ .001) was higher in patients with systolic HF, whereas the risk of permanent pacemaker implantation (TAVR OR, 0.58; 95% CI, 0.45–0.76; P < .001; SAVR OR, 0.58; 95% CI, 0.40–0.84; P = .004) was lower following aortic valve procedures. In TAVR, the risk of acute deep vein thrombosis and kidney injury was higher, although not statistically significant, in patients with systolic HF than in those with diastolic HF.

Conclusion
These outcomes suggest that chronic HF types do not incur statistically significant hospital mortality risk in patients undergoing TAVR or SAVR.
Increased Plasma Non–High-Density Lipoprotein Levels and Poor Coronary Collateral Circulation in Patients With Stable Coronary Artery Disease
Authors: Sivri Fatih , Öztürk Ceyhan Banu 
Published: June 2023

Abstract

Background
This study investigated the relationship between coronary collateral circulation (CCC) and non–high-density lipoprotein cholesterol (non–HDL-C) in patients with stable coronary artery disease (CAD). Coronary collateral circulation plays a critical role in supporting blood flow, particularly in the ischemic myocardium. Previous studies show that non–HDL-C plays a more important role in the formation and progression of atherosclerosis than do standard lipid parameters.

Methods
A total of 226 patients with stable CAD and stenosis of more than 95% in at least 1 epicardial coronary artery were included in the study. Rentrop classification was used to assign patients into group 1 (n = 85; poor collateral) or 2 (n = 141; good collateral). To adjust for the observed imbalance in baseline covariates between study groups, propensity-score matching was used. Covariates were diabetes, Gensini score, and angiotensin-converting enzyme inhibitor use.

Results
In the propensity-matched population, the plasma non–HDL-C level (mean [SD], 177.86 [44.0] mg/dL vs 155.6 [46.21] mg/dL; P = .001) was statistically higher in the poor-collateral group. LDL-C (odds ratio [OR], 1.23; 95% CI, 1.11–1.30; P = .01), non–HDL-C (OR, 1.34; 95% CI, 1.20–1.51; P = .01), C-reactive protein (OR, 1.21; 95% CI, 1.11–1.32; P = .03), systemic immune-inflammation index (OR, 1.14; 95% CI, 1.05–1.21; P = .01), and C-reactive protein to albumin ratio (OR, 1.11; 95% CI, 1.06–1.17; P = .01) remained independent predictors of CCC in multivariate logistic regression analysis.

Conclusion
Non–HDL-C was an independent risk factor for developing poor CCC in stable CAD.
Is the Roman Catholic Church in the Philippines Turning Dark Green? Catholic Bishops Conference of the Philippines’ Environmentalism from Anti-Mining to Climate Crisis Response
Authors: Peracullo Jeane C. 
Published: June 2023

Abstract
The article examines whether the Catholic Bishop’s Conference of the Philippines (CBCP) has become “dark green.” It explores CBCP’s pastoral letters on environmental issues from 1988 to 2019. Using the framework outlined by Bron Taylor in Dark Green Religion: Nature, Spirituality, and the Planetary Future, I argue that there are shifts in the environmental consciousness of the Catholic Bishops, as evident in the pastoral letters. Since 1988, the Catholic Bishops Conference of the Philippines has exhibited a reliable commitment to environmentalism and its prophetic mission amidst various environmental challenges.
Meaning-Making Mechanisms on the Boundary between Religion and Sports
Authors: Graff-Kallevåg Kristin , Stålsett Sturla Johan 
Published: June 2023

Abstract
What characterises religious meaning-making on the boundary between church and sports? Drawing on Sanne F. Akkerman and Arthur Bakker’s theory about boundary crossing, this article analyses religious meaning-making in sermons from Christian services in the context of international sports events. The article demonstrates that potential learning mechanisms at this boundary are more effective when not only seeking harmonious coordination and legitimisation but also bringing out differences and confrontation.
My Body is Where I Exist: Poverty, Disability, and Embodied Resistance as a Theology of Practice
Authors: Radford Wren 
Published: June 2023

Abstract
This paper explores embodiment as a locus for theological practices of addressing socio-economic inequality, focusing particularly on the intersections of disability and poverty. Engaging the work of Sharon Betcher and Mayra Rivera, the paper explores the relationship between spirit and flesh, and highlights the need for theologies to engage with and learn from unruly, excluded bodies. The paper constructs three poetic accounts from a collaborative project with UK activists to highlight embodied practices of navigating and resisting inequality, and the creative, sensory knowledges necessary for developing critiques of oppressive systems.
El mito tecnológico. Una lectura a propósito de la crítica de Franz Hinkelammert al neoliberalismo
Authors: Moreno Gómez Jaime Alexander 
Published: June 2023

Este artículo tiene como objetivo, plantear el concepto de la tecnología como mito, y por lo tanto como un espacio mítico, lugar de enunciación desde donde el ser humano establece la comprensión que tiene de la realidad que le corresponde vivir, y así, plantea su actuar sobre ella. Para ello se presenta brevemente y a manera de barrunto una introducción de un análisis de la coyuntura vivida con la pandemia del Covid-19, que servirá para contextualizar la urgencia de reflexionar sobre el tema central, y que además permitirá bosquejar la conclusión de este escrito. Luego se abordará el problema planteado desde la propuesta económico-teológica del pensador crítico Franz Hinkelammert, quien a lo largo de su obra ha presentado, de manera implícita, un análisis sobre el tema de la tecnología, y quien desarrolla radicalmente la concepción de la tecnología como un mito de la modernidad. Hacer este acercamiento nos obligará a recorrer las reflexiones que este mismo pensador tiene sobre la racionalidad económica perfecta, así mismo que sobre la concepción de la economía que emergió con la revolución industrial y que se radicaliza tras las subsiguientes revoluciones que se plantean en esa línea. A lo largo de este desarrollo argumental nos veremos en la obligación de pasar por otros conceptos clave de la propuesta de Hinkelammert, como el de ideología liberal y su concepción de concepto límite. El de mala infinitud que viene desde la lectura que nuestro autor hace de Hegel. Y por supuesto el concepto de mito y espacio mítico, así como el de tecnología y su vínculo con el imaginario social de progreso que es impuesto dentro de la racionalidad económica y social del sistema-mundo imperante.
Direct calibration of indenter tip geometry by optical surface topography measuring instruments
Authors: Maculotti Giacomo , Kholkhujaev Jasurkhuja , Genta Gianfranco , Galetto Maurizio 
Published: June 2023

AbstractInstrumented indentation test (IIT) is a depth-sensing hardness test allowing nano- to macro-mechanical characterisation of surface mechanical properties. Indenter tip geometry calibration allows nano-scale characterisation, overcoming the limits of conventional hardness tests. Calibration is critical to ensure IIT traceability and applicability for quality verification in manufacturing processes. The accuracy and precision of IIT are mainly affected by the indenter tip geometry calibration. State-of-the-art indenter tip geometry calibration reports either direct calibration by AFM, which is highly expensive and unpractical for industry, or indirect calibration methods, which are less accurate, precise and robust. This work proposes a practical, direct calibration method for IIT indenter tip geometry by optical surface topography measuring instruments. The methodology is complemented by uncertainty evaluation. The proposed approach is applied to Berkovich and Vickers indenters and its advantages are proven in terms of accuracy and precision of mechanical characterisation on metallic and ceramic material.
Graphical abstract
DESIGN SIMULATION TO PASS TESTS FOR ACCEPTANCE AS DEFINED IN PREN 14363 OR UIC518
Authors: Fisher B. , Menssen R. , Markova O. , Kovtun H. 
Published: June 2023

It is necessary to investigate the behavior of the rail crew using computer simulations to be sure that the newly designed and developed rail crew successfully pass the acceptance tests. The evaluation of the effect of changes of various parameters allows optimising the dimensions and design parameters.In the work the necessary simulation options for the evaluation of the dynamic characteristics of crew are described in details. It is shown what parameters determine the accuracy of the solution of the task.
THE INFLUENCE OF CARS ACQUISITION PARAMETERS ON THEIR IDLE HOURS ON MARSHALLING YARD
Authors: Muzykina H. I. , Bolvanovska T. V. , Zhorova Ye. M. 
Published: June 2023

This paper is devoted to the problem of accumulating the train sets at a sorting station. An analysis of three specific processes of accumulating the train sets has been performed taking into consideration their varieties. The calculation formulas for wagon-hours of such an accumulating according to each scheme are given. The dependence between the train set accumulation parameter and the quantity of wagons in the train set that is departing from a station has been determined. It has been also determined the influence of the above mentioned parameter on the duration of lost time of wagons at a sorting station.
Retrospective Investigation of Viral Hepatitis Seroprevalence in Patients Admitted at the Outpatient Clinics of Internal Medicine
Authors: KULA Atay Can , CEKEN Nihan , DURAN Hülya 
Published: June 2023

ABSTRACT
Aim: Viral hepatitis agents include Hepatitis B and Hepatitis C virus, which cause an important public health problem due to serious complications. Patients examined at the outpatient clinics of internal medicine are among main risk groups, as they have concomitant diseases and undergo various procedures. We aimed to investigate retrospectively the seroprevalence of viral hepatitis in outpatients in internal medicine in our region.
Material and Methods: HBsAg and Anti-HCV parameters, and demographic data such as age and gender of patients admitted at the outpatient clinics of internal medicine at our hospital between January 2017 and July 2022 were retrospectively evaluated, with HBV-DNA and HCV-RNA levels of those who showed reactivity.
Results: HBsAg test results of 2618 patients and Anti-HCV test results of 2943 patients were obtained in this study. The mean age of patients with HBsAg tests was 34.2±15.7, and mean age of patients with Anti-HCV test was 34.3±15.7 years. HBsAg reactivity rate was 0.9%; and the mean age of patients showing reactivity was 47.7±14.4 years. Anti-HCV reactivity rate was %0.1, with a mean age of 52.6±21.3 years. Both HBsAg and Anti-HCV reactivity was not present at the same patient in our study.
Conclusion: Early diagnosis of Hepatitis B and Hepatitis C viruses decrease the risk of developing complications, easing treatment processes and decreasing the risk of contagion. Thus, increasing use of screening tests as part of preventive medicine is very important.
The role of the De Ritis ratio in acute cholecystitis: a retrospective observational study
Authors: GÜRLEVİK Ercan , AKÇA Hatice Şeyma , AKÇA Muhammed Tahir , AKÇA Hilal 
Published: June 2023

Aim
Our study aimed to evaluate the relationship between the De-Ritis ratio and prognosis and mortality in patients diagnosed with cholecystitis.
Materials and Methods
This retrospective observational study was conducted on patients diagnosed with acute cholecystitis who presented to the emergency medical clinic of XXX Hospital between June 1, 2020, and January 1, 2022. The Statistical Package for Social Sciences (SPSS) software (v.20; Chicago, IL, USA) was used for all statistical analyses. All results with p < 0.05 were considered statistically significant.
Results
In our study, 174 patients were included, and 50.6% of our patients were women. The mean age was 59.0 (43.2 to 71.8). A total of 2.29% of our patients died. No statistically significant relationship was found between AST, ALT, CRP, albumin, and the De-Ritis ratio and mortality (p=0.584, p=0.533, p=0.517, p=0.07, p=0.399, respectively). When mortality rates in operated patients were examined, no statistically significant correlation was found between AST, ALT, CRP, albumin, and De-Ritis rates and mortality (p=0.248, p=0.315, p=0.451, p=0.183, p=0.688, respectively)
Conclusion
To the best of our knowledge, no study has examined the relationship between cholecystitis and the De-Ritis ratio. De-Ritis ratio is not used as a prognostic marker in patients with cholecystitis.