bluuebunny/crossref_metadata_2025_split huggingface dataset:
Climate therapy: Developing a climate change charter for Cancer Trials Ireland (CTI).
Authors: O'Reilly Seamus , Weadick Catherine , Murphy Lucy , Kivlehan Patrick , Clayton-Lea Angela , Mulroe Eibhlin 
Published: June 2024

e23214 Background: Climate change is a threat to human existence. Healthcare is the 5th leading cause of CO2 emissions globally, while clinical trials generate the equivalent of half the CO2 emissions of Denmark. Consequently, both enterprises represent significant, potentially modifiable, causes of climate change. In response to this climate toxicity (PMID 36773799), CTI launched the National Green Cancer Clinical Trials Initiative in 2022. A climate charter, which was to consist of a living document of actionable areas, was commissioned by the CTI board to implement them. Methods: Carbon footprint touch points of CTI’s activity on climate change were identified such as travel, procurement, energy use, financial management. An online scoping review of existing academic and non-academic sustainability initiatives, funding agency and national policy documents, peer reviewed and grey literature sources was conducted using the terms climate change and sustainability. Action points were categorised and collated. No exemplar climate charters for clinical trial organisations were identified in the search. Results: 5 pillars of interaction with sustainability initiatives were evident. These were education, engagement, empowerment, embedding, and emphasising. These pillars related to 8 themes for climate smart involvement by CTI staff and members. Personal commitment to sustainability at an individual level eg dietary choices, EU climate pact participation. Trial design and management eg sustainability assessment & integration into protocols Recycling and waste management at central office and sites. Energy and water use eg optimise computing infrastructure, prioritise low carbon sources. Procurement and contracts eg promote green purchasing, integrate environmental and social sustainability clauses in contracts, sustainability assessment of financial services including pensions Meetings and conferences eg prioritising virtual meetings, select conference venues and accommodation with environmental certs. Commuting and business travel. Outreach eg, to University partners, trainees, network with Green Trial groups. Conclusions: The climate charter provides a structure to facilitate sustainability integration at CTI. This living document registers existing activities, highlights areas for engagement, facilitates horizon scanning and outreach to emerging initiatives, empowers staff , and demonstrates an organisational commitment to climate smart, clinical trial conduct.
Independent validation of 30-day emergency department visit after initial chemotherapy A-PROACCT model.
Authors: Maroney Thomas T. , He Yusen , Dhannapuneni Srujankumar , Shah Nikita C. , Laughlin Amy Iarrobino , Dvorak Tomas 
Published: June 2024

e23243 Background: This study assessed model performance and, more importantly, the clinical usefulness of the PROACCT model created by Grant et al. (JAMA, 2019), refined as A-PROACCT by Stein et al. (JOP, 2023) with data from Orlando Health. The predictive performance of models anticipating acute care events within thirty days (ACE30) of initial chemotherapy administration (ICA) were evaluated. Methods: Stein et al. models classified high-risk patients as those whose model output risk score was at or above the 90th percentile. They studied 5153 ICAs between July and November of 2021, of which 559 (10.8%) had an ACE30. Their first model used drug category, age group, ED visits and hospitalizations in the prior year, and cancer type, and had sensitivity (Sen), specificity, (Spec), C-Statistic (C-Stat), and positive predictive value (PPV) of 0.28, 0.93, 0.79 and 0.18 respectively. Their second model added insurance category, number of anti-cancer agents, race, and BMI category and reported Sen, Spec, C-Stat, and PPV of 0.30, 0.94, 0.80 and 0.23 respectively. Of the high-risk patients, 33.6% and 34.1% had an ACE30 respectively. Of the low-risk patients, 8.3% and 8.1% had an ACE30 respectively. Our data were propagated through the two models. Results: Between February of 2012 and April 2021, Orlando Health had 15,483 distinct patient visits with ICAs. Overall, 2046 (13.2%) had an ACE30. Model one had Sen, Spec, C-Stat, and PPV of 0.19, 0.92, 0.65 and 0.27 respectively. Model two had Sen, Spec, C-Stat, and PPV of 0.19, 0.91, 0.65 and 0.25 respectively. Both models had an accuracy of 0.82. This demonstrated our data fit the Stein model. Of the 1460 ICAs identified as high-risk by model one, 387 (26.5%) had an ACE30, and of the 14,023 ICAs identified as low-risk, 1659 (11.8%) had an ACE30. Of the 1549 ICAs identified as high-risk by model two, 393 (25.4%) had an ACE30, and of the 13,934 ICAs identified as low-risk, 1653 (11.9%) had an ACE30. The difference of ACE30 rates between high risk and low risk groups were statistically significant (p < 0.0001) in both models. This demonstrated both models were clinically useful in identifying chemotherapy patients at high risk of acute care events. Conclusions: These models allowed for clinically relevant stratification of patients into meaningful high-risk and low-risk groups (26.5% vs 11.8% with our data) for risk of acute care events within 30 days of initial chemotherapy administration. Nevertheless, only 26.5% of these high-risk patients actually had an acute care event within thirty days of initial chemotherapy administration. Further research is needed to improve the precision of identifying high-risk patients, by potentially adding more clinical variables, using alternative sampling methods, and employing nonlinear and more complex machine learning methodologies.
Breaking the bad news of cancer: Exploring patient-doctor communication among clinical oncologists in Nigeria.
Authors: Okoye Ifeoma , Otene Samuel , Aniarodo Agnes , Ejoh Denise Uzoma , Okwor Vitalis Chukwuemeka , Akin-Odanye Elizabeth Oluwatoyin , Sarimiye Foluke , Nnamani Amaka , Okwu Gloria C. , Onyemah Tobenna , Okolie Tochukwu J. , Odo Obinna , Udeh Kingsley , Agha Agha A. , Chidebe Runcie C. W. 
Published: June 2024

e23251 Background: Nigeria ranks top on the incidence of cancer as well as on cancer-related deaths in Africa with an estimated 72,000 cancer-related deaths and 124,000 incidences annually. Cancer patients in this population, report some of the worst patient outcomes. Previous studies have explored several systems and patient-level factors responsible for the high cancer mortality, and poor outcomes. The process of breaking the ‘bad’ news of cancer to patients by the clinical oncologists in Nigeria has remained an understudied area. This study aims to explore the process of breaking the ‘bad’ news of cancer to patients by clinical oncologists (COs) in Nigeria. Methods: Participants ( N = 24) were clinical oncologists who treat and care for cancer patients in Nigeria. We used a semi-structured interview for the data collection. All the data were managed using Dedoose and used grounded theory for the data analysis. Results: Five themes were identified: (1) the process of breaking the ‘bad’ news is overwhelming, (2) COs need training on patient-doctor communication, (3) every process of breaking the bad news should be unique (4) patients should be the primary focus and (5) clinical workload is affecting the capacity of CO in breaking the ‘bad’ news. Conclusions: The findings show that there is a need for a more robust patient engagement and navigation program focused on empowering patients to ask the right questions. There is a need for the government to explore ways of reducing clinical workload among COs.
Refining the 30-day emergency department visit after initial chemotherapy administration A-PROACCT model.
Authors: He Yusen , Maroney Thomas T. , Dhannapuneni Srujankumar , Shah Nikita C. , Laughlin Amy Iarrobino , Dvorak Tomas 
Published: June 2024

e23253 Background: This study attempted to address limitations in the A-PROACCT model developed by Stein et al. (JOP, 2023) to predict the rate of acute care events within 30 days (ACE30) of initial chemotherapy administration (ICA). The four most important predictors were drug category (immunotherapy), cancer type (gastrointestinal), age group ( < 40), and BMI category (underweight). Only linear relationships were considered. For patients for whom an ACE30 was predicted by their first and second models, only 0.18 and 0.23 actually had an ACE30, a low positive predictive value (PPV). We attempted to improve the PPV with advanced modeling techniques. Methods: Using Orlando Health data between February of 2012 and April 2021, random sampling was used to split the dataset into training (10,838) and validation (4645). For the training data, resampling was employed to obtain a balanced quota, equal observations followed by an ACE30 and not followed by an ACE30. We included only variables used in Stein (drug category, age group, ED visits and hospitalizations in the prior year, cancer type, insurance category, number of anti-cancer agents, race, and BMI category). Logistic regression with L1-penalty, XGBoost (a non-linear nonparametric tree-based algorithm to account for nonlinear relationships), and artificial neural networks were used to develop and evaluate predictive models. Different sampling methods (bootstrap and SMOTE) as well as cuff-off thresholds for high-risk groups were tested. Results: Based on evaluation with validation data set, the best performing approach was an XGBoost model with SMOTE resampling in the training data. The four most important predictors were ED visits in the prior year, payor category (self-insured), cancer type (genitourinary) and hospitalization in past year. This model reported a PPV of 0.27. Many other combinations of methodologies described above were performed, and the PPV varied between 0.19 to 0.27. Of the 282 ICAs identified as high-risk by the best model, 76 (27.0%) had an ACE30. Of the 4346 ICAs identified as low-risk, 533 (12.3%) had an ACE30. The differences between high risk and low risk ACE30 rates were statistically significant (p < 0.0001). In comparison, using Stein et al. models with our data reported a PPV of 0.27 and 0.25 which are basically at the same level of our best trained model. Conclusions: Using the variables included in A-PROACCT and a variety of machine learning models, advanced sampling methodologies and threshold cut-off limits, the best results were similar to those obtained using basic logistic regression. This suggests improvement in predicting acute care events following chemotherapy administration need to incorporate more extensive multimodal data, such as vital signs, performance status, patient reported outcomes, socioeconomic factors, laboratory and radiology results, remote patient monitoring and wearable device data.
First-line pembrolizumab for lung cancer in a Spanish real-world study.
Authors: Burgos Amparo , Calleja Teresa , Ibáñez Cristina , Valencia Carmen María , Orallo Claudia , Titos Jose Carlos , Conde David , Diaz Sacramento , Matilla Belén , Lizeaga Garbiñe , Sánchez Carmen , Marin Pozo Juan Francisco , Jimenez Silvia , Jiménez Inmaculada , Díez Raúl , Garrido Margarita , Larrosa María , Martinez Maria Jose , Moreno Estela , Campelo Rosario Garcia 
Published: June 2024

e23268 Background: KEYNOTE (KN) 024 trial showed that pembrolizumab significantly improves progression free survival (PFS) and overall survival (OS) in patients with previously untreated advanced non-small cell lung cancer (NSCLC) with a PD-L1 expression ≥ 50% without EGFR/ALK alterations. The main aim of this study is to report the outcomes (PFS and OS) of pembrolizumab in a real life setting. Methods: Multicenter retrospective study in 42 Spanish hospitals. Inclusion period: 01/2016 – 07/2020; cut-off date: 31/12/2021. Demographic, clinical and treatment-related data were retrospectively obtained from patients’ medical files. Statistical analysis was carried out using descriptive metrics and survival analysis techniques (Kaplan-Meier, log-rank test, Cox regression). Results: In our cohort of 1005 patients, 74.5% were males, mean age was 66.4 ± 9.7 and mean BMI 25.6 ± 4.6. The majority were current (35.6%) or former smokers (56.6%), with 11 % of patients with ECOG ≥ 2. Patients with a non squamous histology were 79.5% and 95.2% were classified as IV stage (30.3% had hepatic and/or brain metastases, 49.3% had ≥ 2 metastatic sites). Pembrolizumab dose was mainly fixed (83.1% of patients), while the number of treatment cycles was highly variable. 31.8% received concurrent radiotherapy, while previous corticoid (PCE), antibiotic and proton pump inhibitors (PPI) exposure were 18.2%, 7.7% and 40.7% respectively. With a median follow-up of 6.3 months, median OS and PFSwere 19 (95%CI: 16.2 – 21.3) and 8.7 (95%CI: 7.2 – 10.1) months. Several variables were associated with PFS and OS after univariate survival analysis. Age and previous antibiotic exposure were associated to worse OS but not to PFS. Multivariate analysis showed that ECOG ≥2 (HR 2.7 95%CI 2-3.5) and previous PPI exposure (HR 1.3 95%CI 1.1-1.6) were predictors of poor outcome. Conclusions: In our cohort, pembrolizumab showed lower OS and similar PFS than KN 024. Our results confirm that poor PS (ECOG) is a negative predictive factor for effectiveness. [Table: see text]
Trends in survival in solid malignancies with synchronous brain metastases: A population-based study.
Authors: Sharma Parth , Miller Tayla , Mahadevia Himil , Fatima Ifrah , Sharma Priyanka , Cheng An-Lin , Shrestha Anuj 
Published: June 2024

e23299 Background: Brain metastasis in solid malignancies at diagnosis has a poor prognosis. Improvements in the treatment of solid malignancies and advancements in neuroimaging techniques have led to increased incidence of brain metastases. In our study, we examined survival outcomes in patients diagnosed with brain metastasis at the time of diagnosis of primary malignancy at four different sites in the year groups 2010 to 2014 and 2015 to 2020. Methods: Surveillance, Epidemiology, and End Results (SEER) Program 17 registry (November 2022 submission) database was analyzed for four primary sites of cancer based on their high propensity to develop brain metastases- lung and/or bronchus, breast, kidney and/or renal pelvis, and melanoma. Patients diagnosed with malignancy during autopsy or via death certificate and patients with incomplete survival data were excluded. R 4.3.1 software was used for all the analyses. Kaplan-Meier method was used for 2-year survival rate and overall survival analyses. Cox regression analysis was used for hazard ratios (HR). Results: A total of 29,056 and 37,437 cases were identified across the four cancer groups during the period 2010-2014 (Group 1) and 2015-2020 (Group 2), respectively. Lung and/or bronchus tumors comprised the majority of the cases (n = 58,324). 14,811 patients in Group 1 and 18,703 patients in Group 2 received chemotherapy. 8,741 patients in Group 1 and 12,533 patients in Group 2 received radiotherapy. In all the cancers combined, the median survival time in Group 1 was 4 months, and in Group 2 was 5 months. Patients in Group 2 had significantly better survival outcomes than Group 1 (HR:0.81, 95% CI:0.78-0.83, p < 0.001). Table 1 outlines the 2-year survival rates with overall survival p-value. Conclusions: Modest improvement in survival was found in patients diagnosed with synchronous brain metastases during 2015-2020 compared to patients diagnosed in 2010-2014. This slight improvement could be attributed to the improved systemic therapies for cancer, like immunotherapy, as well as advanced local therapy options for brain metastases, although the data for immunotherapy use is unavailable in the SEER database. Overall, the prognosis of synchronous brain metastases remains poor in both groups. Further studies and brain metastases inclusive clinical trials are warranted to improve outcomes in this population. [Table: see text]
ECOG-ACRIN EAZ171: Prospective Validation Trial of Germline Predictors of Taxane-Induced Peripheral Neuropathy in Black Women With Early-Stage Breast Cancer
Authors: Schneider Bryan P. , Zhao Fengmin , Ballinger Tarah J. , Garcia Sofia F. , Shen Fei , Virani Shamsuddin , Cella David , Bales Casey , Jiang Guanglong , Hayes Lisa , Miller Nadia , Srinivasiah Jayanthi , Stringer-Reasor Erica M. , Chitalia Ami , Davis Andrew A. , Makower Della F. , Incorvati Jason , Simon Melissa A. , Mitchell Edith P. , DeMichele Angela , Miller Kathy D. , Sparano Joseph A. , Wagner Lynne I. , Wolff Antonio C. 
Published: June 2024

PURPOSE Black women experience higher rates of taxane-induced peripheral neuropathy (TIPN) compared with White women when receiving adjuvant once weekly paclitaxel for early-stage breast cancer, leading to more dose reductions and higher recurrence rates. EAZ171 aimed to prospectively validate germline predictors of TIPN and compare rates of TIPN and dose reductions in Black women receiving (neo)adjuvant once weekly paclitaxel and once every 3 weeks docetaxel for early-stage breast cancer. METHODS Women with early-stage breast cancer who self-identified as Black and had intended to receive (neo)adjuvant once weekly paclitaxel or once every 3 weeks docetaxel were eligible, with planned accrual to 120 patients in each arm. Genotyping was performed to determine germline neuropathy risk. Grade 2-4 TIPN by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 was compared between high- versus low-risk genotypes and between once weekly paclitaxel versus once every 3 weeks docetaxel within 1 year. Patient-rated TIPN and patient-reported outcomes were compared using patient-reported outcome (PRO)–CTCAE and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity. RESULTS Two hundred and forty of 249 enrolled patients had genotype data, and 91 of 117 (77.8%) receiving once weekly paclitaxel and 87 of 118 (73.7%) receiving once every 3 weeks docetaxel were classified as high-risk. Physician-reported grade 2-4 TIPN was not significantly different in high- versus low-risk genotype groups with once weekly paclitaxel (47% v 35%; P = .27) or with once every 3 weeks docetaxel (28% v 19%; P = .47). Grade 2-4 TIPN was significantly higher in the once weekly paclitaxel versus once every 3 weeks docetaxel arm by both physician-rated CTCAE (45% v 29%; P = .02) and PRO-CTCAE (40% v 24%; P = .03). Patients receiving once weekly paclitaxel required more dose reductions because of TIPN (28% v 9%; P < .001) or any cause (39% v 25%; P = .02). CONCLUSION Germline variation did not predict risk of TIPN in Black women receiving (neo)adjuvant once weekly paclitaxel or once every 3 weeks docetaxel. Once weekly paclitaxel was associated with significantly more grade 2-4 TIPN and required more dose reductions than once every 3 weeks docetaxel.
Algebraic solution and thermodynamic properties for the one- and two-dimensional Dirac oscillator with minimal length uncertainty relations
Authors: Dagoudo Léonie , Dossa Finagnon Anselme , Avossevou Gabriel Yves Hugues 
Published: June 2024

Abstract
We study the quantum characteristics of the Dirac oscillator within the framework of Heisenberg's generalized uncertainty principle. This principle leads to the appearance of a minimal length of the order of the Planck length. Hidden symmetries are identified to solve the model algebraically. The presence of the minimal length leads to a quadratic dependence of the energy spectrum on the quantum number n, implying the hard confinement property of the system. Thermodynamic properties are calculated using the canonical partition function. The latter is well determined by the method based on Epstein's zeta function. The results reveal that the minimal length has a significant effect on the thermodynamic properties.
Navigating Complexities: Vitamin D, Skin Pigmentation, and Race
Authors: Singh Ospina Naykky , Diaz-Thomas Alicia , McDonnell Marie E , Demay Marie B , Pittas Anastassios G , York Elizabeth , Corrigan Maureen D , Lash Robert W , Brito Juan P , Murad M Hassan , McCartney Christopher R 
Published: June 2024

Abstract
Vitamin D plays a critical role in many physiological functions, including calcium metabolism and musculoskeletal health. This commentary aims to explore the intricate relationships among skin complexion, race, and 25-hydroxyvitamin D (25[OH]D) levels, focusing on challenges the Endocrine Society encountered during clinical practice guideline development. Given that increased melanin content reduces 25(OH)D production in the skin in response to UV light, the guideline development panel addressed the potential role for 25(OH)D screening in individuals with dark skin complexion. The panel discovered that no randomized clinical trials have directly assessed vitamin D related patient-important outcomes based on participants' skin pigmentation, although race and ethnicity often served as presumed proxies for skin pigmentation in the literature. In their deliberations, guideline panel members and selected Endocrine Society leaders underscored the critical need to distinguish between skin pigmentation as a biological variable and race and ethnicity as socially determined constructs. This differentiation is vital to maximize scientific rigor and, thus, the validity of resulting recommendations. Lessons learned from the guideline development process emphasize the necessity of clarity when incorporating race and ethnicity into clinical guidelines. Such clarity is an essential step toward improving health outcomes and ensuring equitable healthcare practices.
Gut Microbiome Alterations Accompany Metabolic Normalization Following Bariatric Surgery in ROHHAD Syndrome
Authors: Granato Alessandra , Ryan Paul M , Wong Anthony , Hamilton Jill K , Danska Jayne S 
Published: June 2024

Abstract
Rapid onset obesity with hypoventilation, hypothalamic, and autonomic dysregulation (ROHHAD) syndrome in childhood is characterized by abrupt onset weight gain and dysautonomia with variable neuroendocrine involvement. In the absence of definitive disease-modifying therapies, the primary management strategy remains symptom control. This case report describes the first successful correction of obesity, dysautonomia, and metabolic derangement in a patient with ROHHAD following Roux-en-Y gastric bypass. Anthropometrics, metabolic profiling, and stool microbiome composition were assessed in a longitudinal fashion. In the 48-month period following surgery, the patient body mass index (BMI) reduced by 9.5 kg/m2 and metabolic status improved, evidenced in weaning of insulin, and improved glycated hemoglobin, lipid profile, and hepatic enzymes. Chronic diarrhea resolved after surgery and prior to significant weight loss. Evaluation of stool bacterial composition and biomass demonstrated shifts in absolute abundance and taxonomic composition in longitudinal samples following surgery. This case demonstrates the potential efficacy of bariatric surgery in correcting the metabolic disruption of ROHHAD syndrome, producing long-term changes in gut microbiome composition and biomass.