bluuebunny/crossref_metadata_2025_split huggingface dataset:
Collecting Long-Term Outcomes in Population-Based Cancer Registry Data: The Case of Breast Cancer Recurrence
Authors: Morgan Eileen , O'Neill Colette , Bardot Aude , Walsh Paul , Woods Ryan R. , Gonsalves Lou , Hawkins Sinéad , Nygård Jan F. , Negoita Serban , Ramirez-Pena Esmeralda , Gelmon Karen , Siesling Sabine , Cardoso Fatima , Gralow Julie , Soerjomataram Isabelle , Arnold Melina 
Published: October 2024

PURPOSE
Cancer recurrence is an important long-term outcome of cancer survivors that is often not routinely collected and recorded by population-based registries. In this study, we review population-based studies to determine the current availability, landscape, and infrastructure of long-term outcomes, particularly metastatic recurrence, in women initially diagnosed with nonmetastatic breast cancer (MBC).

METHODS
We reviewed the literature to identify studies that used population-based registry data to examine the distribution of metastatic recurrence in women diagnosed with non-MBC. Data on outcomes and methods of ascertainment were extracted. Registry infrastructure including sources and funding was also reviewed.

RESULTS
A total of 23 studies from 11 registries in eight countries spanning Europe, North America, and Oceania were identified and included in the review. Most studies were retrospective in nature and collected recurrence data only for ad hoc studies rather than as part of their routine registration. Definition of recurrence and data sources varied considerably across studies: the cancer-free time interval between the start of follow-up and risk window ranged from the diagnosis of primary tumor (n = 7) to 6 months from diagnosis (n = 1); the start of follow-up differed between initial diagnosis (n = 16) and treatment (n = 7).

CONCLUSION
Cancer surveillance should encompass outcomes among survivors for research and monitoring. Studies are underway, but more are needed. Cancer registries should be supported to routinely collect recurrence data to allow complete evaluation of MBC as an outcome to be conducted and inform health care providers and researchers of the prognosis of both nonmetastatic and metastatic patients with breast cancer.
Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer
Authors: Swiecicki Paul L. , Yilmaz Emrullah , Rosenberg Ari Joseph , Fujisawa Takao , Bruce Justine Yang , Meng Changting , Wozniak Michele , Zhao Yongyun , Mihm Michael , Kaplan Jason , Gorla Seema , Geiger Jessica L. 
Published: October 2024

PURPOSE

Despite advances in immunotherapy, unresectable recurrent/metastatic head and neck cancer (HNC) carries a poor prognosis, and effective treatments are needed. As nectin-4 is widely expressed in HNC, enfortumab vedotin (EV), a nectin-4–directed antibody-drug conjugate, was explored in HNC in EV-202 (ClinicalTrials.gov identifier:
NCT04225117
).

METHODS
This open-label, multicohort, phase II study evaluated intravenous EV 1.25 mg/kg on days 1, 8, and 15 of each 28-day cycle. In the HNC cohort, eligible patients had recurrent/metastatic HNC and had received platinum-based therapy for locally advanced/metastatic disease and a PD-1/PD-L1 inhibitor. The primary end point was investigator-assessed confirmed objective response rate (ORR) per RECIST version 1.1. Secondary end points were investigator-assessed duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS); overall survival (OS); and safety.

RESULTS
The primary analysis included 46 patients; all received EV (median follow-up, 9.3 months). Most patients (52.2%) had ≥3 previous lines of systemic therapy in the metastatic setting. Confirmed ORR was 23.9%, DCR was 56.5%, and median DOR was not reached (median DOR was 9.4 months at a later data cutoff [median follow-up, 11.3 months]). Median PFS and OS were 3.9 and 6.0 months, respectively. Treatment-related adverse events (TRAEs) occurring in >20% of patients were alopecia (28.3%), fatigue (26.1%), and peripheral sensory neuropathy (23.9%). Sixteen patients (34.8%) experienced grade ≥3 TRAEs; anemia and decreased neutrophil count occurred in ≥1 patient (both n = 2; 4.3%).

CONCLUSION
EV demonstrated antitumor activity in heavily pretreated HNC. Safety was consistent with the known safety profile of EV; no new safety signals were identified. These data support further evaluation of EV for advanced HNC not amenable to definitive local therapy.
Advances in Vulvar Cancer Biology and Management
Authors: Chehade Rania , Jerzak Katarzyna J. , Tavanger Farideh , Plotkin Anna , Gien Lilian T. , Leung Eric , Mackay Helen 
Published: October 2024

PURPOSE
Vulvar squamous cell carcinoma (VSCC), a rare gynecologic malignancy, has been rising in incidence. Molecular classification on the basis of human papilloma virus (HPV) and tumor protein 53 (p53) status has identified three clinically distinct subtypes, but we still treat all VSCCs the same. Here, we review molecular classification of VSCC, outline treatment landscape, and highlight potential for targeted therapies in advanced VSCC.

DESIGN
We conducted a comprehensive review of the literature on treatment of advanced VSCC with particular focus on the implications of molecular stratification on the basis of HPV and p53 status on the treatment landscape of advanced VSCC.

RESULTS
Incorporation of HPV and p53 status in locoregional treatment decision making has the potential to advise (de)escalation strategies. The role of immunotherapy, alone and in combination, requires further exploration particularly earlier in the course of the disease. In advanced stages, potential for targeted therapies in VSCCs include inhibitors of vascular endothelial growth factor, endothelial growth factor receptor, cell cycle, and DNA damage response, particularly in HPV-negative (HPV–) VSCCs. Targeting the phosphoinositide 3 kinase/mammalian target of rapamycin pathway is attractive in HPV-positive and HPV–/p53 wildtype VSCCs. Trials incorporating antibody-drug conjugates (eg, trophoblast cell-surface antigen 2, human epidermal growth factor receptor 2) should be considered, and basket trials in perineal squamous cell cancers are warranted. Preclinical models are limited and should be expanded to inform trial design.

CONCLUSION
Like other rare cancers, vulvar cancer lags behind in the identification and optimization of precision medicine strategies. Molecular-based preclinical models and rationally designed clinical trials, incorporating high-quality translational studies, are urgently required. These trials will require international collaboration to ensure feasibility and improvement of outcomes for women diagnosed with this disease.
Willingness of Women at Increased Risk of Breast Cancer to Participate in Prevention Trials
Authors: Mastrogiacomo Cecilia N. , Courtepatte Alexa , Moyer Anne , Preece Christina , Thompson Patricia , Stopeck Alison 
Published: October 2024

PURPOSE
The factors affecting women's willingness to participate (WTP) in breast cancer (BC) prevention trials are poorly understood. This study aimed to identify the characteristics of interventions associated with a higher WTP among high BC risk women.

METHODS
Women who self-identified as being at an increased risk of BC were recruited to a cross-sectional study of WTP in BC prevention trials. Responses were dichotomized into more willing (a lot and moderately) and less willing (some, a little, and not at all), and responses were compared by patient characteristics and intervention type.

RESULTS

Of 143 participants, 81.2% (116) completed ≥30% of a Likert-type scale questionnaire on WTP in various intervention types for BC prevention. Overall, WTP in BC prevention studies was high, with 82.7% more willing, including 69.0% and 70.7%, respectively, for unspecified physical activity and dietary interventions. WTP differed significantly by the duration of diet-based and physical activity behavior change interventions: decreasing with 12- versus 3-month diet-based interventions (
P
< .0001) and decreasing for 1 hour versus 30 minutes of low-intensity exercise/day (
P
< .0001). For interventions involving medication, only 18.1% expressed being more willing to participate, and WTP decreased significantly when side effects were presented. WTP was influenced by BC risk gene mutation status, with WTP among gene carriers higher compared with nongene carriers (52.6%
v
30.2%,
P
= .018).

CONCLUSION
WTP in BC prevention trials was the highest for women with known genetic risk and for interventions involving a behavior change. Medications with side effects had the lowest WTP. For behavior change, WTP was negatively influenced by intervention duration beyond a few months, indicating that individual perception of BC risk and inconvenience strongly influence WTP.
Efficacy of Cytoreg in the treatment of diabetic foot disease
Authors: Carrillo Darío , Villasana Katiusca , Torres Geizon , Dugarte Leonardo , Pozo Lewis , Bauta William , Jiménez William 
Published: October 2024

Objective: Complications from diabetic foot wounds, including bacterial infection, ulceration and gangrene, are major causes of hospitalisation and are responsible for 85% of amputations in patients with diabetes. Given that orally administered investigational therapeutic Cytoreg (Cytorex de Venezuela SA, Venezuela), a defined aqueous mixture of hydrofluoric, hydrochloric, sulfuric, phosphoric, citric and oxalic acids, has been shown to increase levels of arterial blood oxygen in a Wistar rat model, oral and oral+topical Cytoreg were tested on patients with diabetic foot ulcers (DFUs) under a humanitarian, compassionate-use protocol. Method: All patients received oral Cytoreg (5.0 ml concentrate in fruit juice) for 30 days; half also received weekly wound washing with Cytoreg concentrate in isotonic saline (1:50 volume/volume) (oral+topical group). In addition to standard clinical observations, wounds were monitored against the Saint Elian checklist system for the diabetic foot. Results: A total of 10 patients took part in the study. Complete wound closure was observed in 4/5 patients in the oral+topical group; in the remaining patient, necrotic and fibrin tissues on the wound edges were eliminated. Half (2/4) of the patients receiving oral-only Cytoreg experienced complete wound closure; one patient in this group was removed prematurely because of an unrelated illness and was not replaced. During the study, no significant differences were observed between groups in either the oxygen saturation of the affected tissues or in insulin and glycaemia levels (p<0.05). Significant increases in arterial haemoglobin and arterial oxygen partial pressure (p<0.05) were observed, and significant decreases were measured in the levels of glycosylated haemoglobin, aspartate aminotransferase, glutamic-pyruvic transaminase, creatine and urea (p<0.05). Conclusion: The results of this study justify an expanded clinical study for the treatment of DFUs with Cytoreg.
A new portable negative pressure wound therapy device: a prospective study investigating clinical outcomes
Authors: Rose Victoria , Haram Nadine Hachah , Gallala Sarah 
Published: October 2024

Objective: Closed surgical incision sites at high risk of complications, and with exudate or leakage, are increasingly being managed with closed incision negative pressure wound therapy (ciNPWT) to reduce tissue stress and increase the force necessary to disrupt the incision. This study was undertaken to investigate the performance and safety of a canister-based, single-use NPWT (suNPWT) system when used on closed surgical incision sites. Method: The investigation was designed as a prospective, open, non-comparative, multicentre study aimed at confirming the safety and performance attributes of the suNPWT system when applied to low-to-moderately exuding closed surgical incisions. The primary performance measure was the wound remaining closed from baseline to the last follow-up visit on day 14. Secondary performance measures included: wound and periwound condition; wear time of the system; product consumption; adherence to therapy; and patients’ pain progress. Details of adverse events were also collected. Results: Some 35 patients were recruited. The closed surgical incisions responded well to treatment with the tested suNPWT system. All wounds remained closed throughout the investigation. Consistent with other studies of ciNPWT reporting low infection rates, the current study observed either no or low exudation in 90.4% of wounds at the final visit, together with absence of surgical site infection. Pain severity levels were low, both at dressing change and during delivery of negative pressure. No serious adverse device events were reported. Conclusion: In this study, the suNPWT system supported the healing of closed surgical incisions with no safety concerns relating to its use.
Spinal cord stimulation combined with exercise in patients diagnosed with persistent spinal pain syndrome. Study protocol for a randomized control trial
Authors: Vicente-Mampel J. , Falaguera-Vera F. , Sánchez-Poveda D. , Hernández-Zaballos F. , Martinez-Soler M. , Blanco-Giménez P. , Sanchez-Montero F. J. 
Published: October 2024

Introduction
Administration of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in PSPS-T2 patients.

Methods/Materials
A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study has been registered at Clinicaltrial.gov (NCT06272539). Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.7 (partial η2 = 0.70, α = .05, power = 0.95), resulting in a total of 40 patients. Assuming a 30% dropout rate, 52 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception.
Exploring the interplay between Porphyromonas gingivalis KGP gingipain, herpes virus MicroRNA-6, and Icp4 transcript in periodontitis: Computational and clinical insights
Authors: Yadalam Pradeep Kumar , Neelakandan Anila , Arunraj Rex , Anegundi Raghavendra Vamsi , Ardila Carlos M. 
Published: October 2024

Background
Porphyromonas gingivalis, a major pathogen in periodontitis, produces KGP (Lys-gingipain), a cysteine protease that enhances bacterial virulence by promoting tissue invasion and immune evasion. Recent studies highlight microRNAs’ role in viral latency, potentially affecting lytic replication through host mechanisms. Herpes virus (HSV) establishes latency via interactions between microRNA-6 (miRH-6) and the ICP4 transcription factor in neural ganglia. This suggests a potential link between periodontitis and HSV-induced latency. This study aims to identify and validate the insilico inhibitory interaction of P. gingivalis KGP with ICP4 transcripts and correlate the presence of viral latency-associated transcript micro-RNA-6 with periodontitis.

Methods
Computational docking analysis was performed to investigate the potential interaction between ICP4 and KGP gingipain. The binding energy and RMSD ligand values were calculated to determine the interaction’s strength. Ten patients with recurrent clinical attachment loss despite conventional therapy were included in the clinical study. Subgingival tissue samples were collected post-phase I therapy, and HSV microRNA-6 presence was detected via polymerase chain reaction and confirmed through gel electrophoresis.

Results
Computational docking identified the ICP4-KGP gingipain complex with the lowest binding energy (-288.29 kJ mol^1) and an RMSD ligand of 1.5 Angstroms, indicating strong interaction potential. Gel electrophoresis confirmed miRH-6 presence in all samples.

Conclusion
The identification of miRNA-6 in periodontitis patients and the strong interaction potential between P. gingivalis KGP gingipain and ICP4 transcripts indicate a possible link between bacterial virulence factors and viral latency dynamics in periodontal tissues. These results highlight the complex interplay between oral pathogens, viral microRNAs, and host immune responses in periodontitis.
Using Phosphatidylethanol as an Adjunct to Self-Reported Alcohol Use Improves Identification of Liver Fibrosis Risk
Authors: Murnane Pamela M. , Afshar Majid , Chamie Gabriel , Cook Robert L. , Ferguson Tekeda , Haque Lamia Y. , Jacobson Karen R. , Justice Amy C. , Kim Theresa W. , Khalili Mandana , Krupitsky Evgeny , McGinnis Kathleen A. , Molina Patricia , Muyindike Winnie R. , Myers Bronwyn , Richards Veronica L. , So-Armah Kaku , Stewart Scott , Sulkowski Mark S. , Tien Phyllis C. , Hahn Judith A. 
Published: October 2024

INTRODUCTION:
Accurate assessment of alcohol use informs prevention and management of liver disease. We examined whether phosphatidylethanol (PEth, an alcohol metabolite) blood concentrations are associated with liver fibrosis risk independently of self-reported alcohol use, among persons with and without HIV.

METHODS:
We pooled individual-level data from 12 studies from the United States, Russia, Uganda, and South Africa with PEth, Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), and fibrosis-4 (FIB-4) measurements. We conducted mixed-effects logistic regression of the relationship between PEth and AUDIT-C as continuous variables (after checking linearity), with high FIB-4 (≥2.67). We divided PEth (range 0–1,000) by 83.3 to put it on the same scale as AUDIT-C (0–12) to directly compare odds ratios. Adjusted models included sex, race/ethnicity, age, body mass index, HIV, and virologic suppression status.

RESULTS:
Among 4,644 adults, the median age was 49 years (interquartile range [IQR]: 40–55), 998 (21%) were female, and 3,520 (76%) were living with HIV, among whom 2,386 (68%) were virologically suppressed. Median PEth was 13 ng/mL (IQR: <8–132.0) and median AUDIT-C was 3 (IQR: 1–6); 554 (12%) had high FIB-4. The adjusted odds ratios per 83.3 ng/mL difference in PEth and one-unit difference in AUDIT-C with high FIB-4 were 1.15 (95%CI: 1.08–1.22) and 1.03 (95%CI: 1.00–1.07), respectively. Findings were similar when PEth and AUDIT-C were treated as categorical variables.

DISCUSSION:
PEth was independently associated with high FIB-4, with a larger odds ratio than that of the association of AUDIT-C. The use of PEth may improve identification of alcohol use and liver fibrosis prevention and management.
Hybrid Endoscopic Submucosal Dissection for Isolated Gastric Metastasis of Renal Cell Carcinoma
Authors: Alomari Ahmad , Obri Mark , Aldroubi Basel , Khan Muhammad Zarrar , Chaudhary Ammad , Althunibat Ismail , Piraka Cyrus , Zuchelli Tobias 
Published: October 2024

ABSTRACT
Metastasis to the stomach is a rare occurrence, especially from renal cell carcinoma (RCC). We report a case of a 76-year-old man with a history of RCC, in remission for 11 years postnephrectomy, who presented with gastrointestinal symptoms, was found to have a 2 cm gastric mass confirmed as metastatic RCC. Endoscopic submucosal dissection was attempted, but due to the hypervascular nature of the mass, a hybrid endoscopic submucosal dissection was performed, achieving complete resection. Follow-up at 7 months showed no recurrence, highlighting the potential for endoscopic treatment options for isolated gastric metastasis, despite the lack of specific guidelines.
Supply Chain Environmental Uncertainty, Competitive Advantage, and Operational Performance in Manufacturing Industry
Authors: Hatani La , Rommy Nursaban , Usman  
Published: October 2024

Goal: This study investigates the impact of Supply Chain Environmental Uncertainty (SCEU) on competitive advantage and operational performance in manufacturing companies. The mediating role of competitive advantage and the moderating role of supply chain environmental uncertainty in the relationship between competitive advantage and operational performance were examined.
Design/ Methodology/ Approach: This paper used quantitative approach to confirm the conceptual model. Data was collected through questionnaires from directors/operational managers in 121 large and medium-scale manufacturing companies in Southeast Sulawesi Indonesia. The analysis employs Generalized Structured Component Analysis (GSCA) to test the direct, mediating, and moderating effects of supply chain environmental uncertainty.
Results: The findings demonstrate a significant positive influence of supply chain environmental uncertainty on competitive advantage and operational performance. However, competitive advantage does not significantly affect operational performance. The study reveals that competitive advantage is perfect mediator between supply chain environmental uncertainty and operational performance, while supply chain environmental uncertainty is a moderating predictor between competitive advantage and operational performance.
Practical Implications: The research has implications for manufacturing company managers adapting to supply chain environmental uncertainty through supplier, customer, and technology considerations. It emphasizes the importance of adapting to supply chain environmental uncertainty to enhancing competitive advantage and operational performance in the manufacturing industry. Efforts to improve operational performance and strategically integrate competitive advantage should consider the business environment, including suppliers, customers, and technology.
Limitations: This research is limited to large and medium-scale manufacturing industries, hindering generalization to other industries, particularly small-scale ones. Additionally, researchers can consider additional contextual factors such as supply chain integration, supply chain agility, and total quality management.
Originality/Value: This study expands the theoretical framework of supply chain environmental uncertainty, competitive advantage, and operational performance through empirical testing of a theoretical model. The findings support the proposed model's validity and highlight the mediation role of competitive advantage and supply chain environmental uncertainty, providing a reference for future theory development and model building.
Envy and Ressentiment
Authors: Seibert Christoph 
Published: October 2024

Abstract
This article is about the connection between envy and ressentiment. Both are understood as emotional strategies for dealing with desire. Ressentiment is understood as the perpetuation and radicalization of a strong form of envy. Lacan’s mirror stage as well as Nietzsche’s and Scheler’s theories of ressentiment serve as a frame of reference for the development of this thesis.