bluuebunny/crossref_metadata_2025_split huggingface dataset:
A single-center retrospective review of the impact of cryotherapy on peripheral neuropathy scores in patients with breast cancer who received chemotherapy with a taxane-based treatment regimen.
Authors: Huffman Deanna , Primeaux Austin , Helm Elizabeth Reilly , Chen Lily Zhiying , Mason Joseph , Guzman-Arevalo Rafael , Chapple Andrew G , Loch Michelle Marie 
Published: July 2024

e24106 Background: Taxanes are a class of chemotherapy frequently used for neoadjuvant and adjuvant treatment of breast cancer. While effective, taxane use is not without adverse effects, the most well-known being chemotherapy-induced peripheral neuropathy (CIPN). As CIPN is dose-related, it can lead to dose reductions and interruptions in therapy that may be detrimental to the patient. Cryotherapy has been used as a prevention strategy, but its efficacy remains unclear. Methods: We performed a retrospective review of the cryotherapy program in our center. Included patients had breast cancer of any stage treated with a taxane in the neoadjuvant or adjuvant setting. All patients were offered cryotherapy at the time of their treatment and were separated into cohorts whether they opted in or out (“cryotherapy” and “non cryotherapy,” respectively). Neuropathy scores were collected by nursing staff via survey and scaled from 0-4. Patient demographics and neuropathy scoring were compared between the “cryotherapy” and “non cryotherapy” cohorts. Results: In total, 41 patients were included. Nearly half of patients in each cohort experienced neuropathy, 10 patients (41.7%) treated with cryotherapy and 8 patients (47.1%) without cryotherapy use. Younger age (46.5 years vs 57 years, p = 0.060), and patients using Medicaid (35.3% vs 75.0%, when compared to all other insurance types, p = 0.023) predicted cryotherapy use. Use of paclitaxel also predicted cryotherapy used when compared to docetaxel (76.0% and 31.2%, respectively, p = 0.009). There was not a significant difference in predicted neuropathy score between the cohorts (Adjusted Multiplicative Effect = .81, 95% CI = .34-1.96, p = .645). Conclusions: Our data did not suggest that the use of cryotherapy could predict lower neuropathy scores, but our study suffered from small sample size and short-duration of follow-up. Additional large, randomized trials with standard neuropathy scoring scales are needed to better evaluate the efficacy of cryotherapy in prevention of CIPN for breast cancer patients receiving taxane-based therapy.
DEFENDOR: Real-world evidence of primary prolonged G-CSF prophylaxis by empegfilgrastim for relative dose intensity compliance in patients with solid tumors—The final analysis.
Authors: Snegovoy Anton , Kononenko Inessa , Radyukova Irina , Orlova Svetlana , Starostina Tatiyana , Sultanbaev Alexander Valerievich , Dubovichenko Daria , Dergunov Alexander , Saydullaeva Alexandra , Repina Nadezhda , Gronskaya Yulia , Rossokha Elena , Sorokina Irina , Prosianikova Oksana 
Published: July 2024

e24109 Background: Myelosuppression management under chemotherapy (CT) is crucial for maintaining the relative dose intensity (RDI) of therapy and ensuring effective treatment of patients with solid tumors (ST). RDI > 85% is associated with better overall survival for the most ST. Granulocyte colony stimulating factors (G-CSF) have been the standard of care for the prevention of chemotherapy-induced neutropenia (CIN). Here we present the final results of a multicenter prospective observational post-marketing study of safety and efficacy of pegylated G-CSF Extimia (INN: empegfilgrastim, JSC BIOCAD) in pts with ST who receive cytotoxic therapy. Methods: The primary endpoint was the RDI of CT courses (4-8 cycles per course are allowed) with empegfilgrastim support. RDI was calculated for each single agent in the chemotherapy-based (CTb) regimen and for the CTb regimen in total. Extimia (7,5 mg) was administered subcutaneously once per chemotherapy cycle. Results: The study included 3218 pts with various tumor types across 41 centers in Russia. 3217 (99.97%) pts received at least one dose of the study drug. 2663 (82.8%) pts were included in the RDI assessment population per protocol. The average age of pts was 56.9 (18–84) y.o. Individuals aged ≥65 y.o accounted for almost one third of all pts. RDI ≥ 85% was achieved in 2415 (90.7%) pts (Table 1). 1447 (54.3%) pts have at least one FN risk factor whereas age ≥ 65 years is the most common (763/2663 (28.6%) pts). 91.5% RDI was registered in pts < 65 y.o and 88.7% RDI - in pts ≥ 65 y.o. Neutropenia was reported in 19 (0.7%) cases as a reason of RDI decrease. Grade 3-4 AEs were recorded in 74 (1.8%) cases in 59 pts whereas neutropenia (n = 22), anemia (n = 8) and diarrhea (n = 6) were the most common (CTCAE (v. 5.0)). Conclusions: Primary prolonged G-CSF prophylaxis by empegfilgrastim allows effectively maintaining RDI across various tumor types (TT) and treatment groups in pts with ST in routine clinical practice. Clinical trial information: NCT0481144 . [Table: see text]
Quantifying the risk of hypocalcemia in individuals treated with cabozantinib.
Authors: Murthy Anirudh 
Published: July 2024

e24110 Background: Cabozantinib, a potent inhibitor for multiple receptor-tyrosine kinases, has been approved for the treatment of various advanced cancers. The risks of all-grade and high-grade hypocalcemia have been noted in many clinical trials. We have conducted an up-to-date systematic review and meta-analysis of clinical trials using single agent cabozantinib to assess the overall risk of hypocalcemia. Methods: We systematically identified relevant English-language studies primarily from PubMed and Clinicaltrials.gov (up to March 2023), covering phase I to phase III trials using cabozantinib in cancer patients. Studies with patients assigned to single agent cabozantinib with available data on hypocalcemia were included. We employed fixed-effects or random-effect models depending on study heterogeneity to calculate the incidence and relative risk of hypocalcemia. Results: A total of nineteen studies were included for analysis. The overall incidence of all-grade hypocalcemia with cabozantinib was 15.0% (95% CI: 9.0-21.0%), with a high-grade (grade 3 or 4) incidence of 2.0% (95% CI: 1.0-3.0%). Significant variability was observed among different tumor types (p < 0.001), ranging from 45.0% in multiple myeloma to 2.0% in hepatocellular carcinoma and colorectal cancer. In comparison with placebo, cabozantinib significantly increased the risk of hypocalcemia with an RR of 1.75 (95% CI: 0.96-2.53, p < 0.001). However, when compared to prednisone, cabozantinib showed a non-significant risk reduction of 0.30 (95% CI: -0.20-0.79, p = 0.24). Furthermore, cabozantinib did not elevate the risk of hypocalcemia compared to other chemotherapeutic agents (everolimus, paclitaxel, and sunitinib). Conclusions: Patients undergoing cabozantinib treatment face an increased risk of hypocalcemia, with variations observed across different tumor types. Proactive measures can be implemented to prevent or mitigate hypocalcemia during cabozantinib therapy. Additionally, monitoring vulnerable patient populations is essential to optimize clinical care and enhance overall outcomes.
Cardiotoxicity in patients with breast cancer after modern therapy.
Authors: Xu Xiaocao , Lester-Coll Nataniel Hernan , Mari Mikaela-joy , Dittus Kim , Li Puyao 
Published: July 2024

e24117 Background: Breast cancer survivors are at increased risk of adverse cardiac events (ACE). Many patient and treatment characteristics, including the use of radiation, anthracyclines, and anti-HER2 therapy, have been reported to affect the rate of ACE. Most prior studies evaluated patients treated with older techniques and therapies, and examined only ischemic events as an endpoint. We report the incidence and risk factors associated with a range of ACE in patients receiving modern systemic and radiation treatments. Methods: Retrospective review identified 235 women with breast cancer who received definitive treatment including radiation between 2017-2023. Coronary artery calcifications (CAC) were defined as density in the heart with ≥130 HU on simulation CT. Event free survival estimates were calculated by Kaplan-Meier method. Uni- and multivariate analyses (MVA) were performed by Cox proportional hazards model. Median follow-up was 3.9 years (range, 0.8-6.9). Results: Patient characteristics are listed in table 1. At 4 years, ACE-free survival was 91.6%. Sixty-six patients had ACE, including arrhythmias (n = 21), valvular disease (17), acute coronary syndrome (9), ventricular dysfunction (20), and pericarditis (1). On MVA, radiation mean heart dose (MHD) > 4 Gy [HR 2.8, 95%CI 1.05-7.5, p = 0.04] and presence of CAC [HR 2.5, 1.2-5.2, p = 0.017] were independently associated with increased ACE. Endocrine therapy was associated with decreased risk (HR 0.4, 0.2-0.8, p = 0.012). Smoking (p = 0.88), hypertension (p = 0.97), diabetes (p = 0.52), treatment with chemotherapy (p = 0.89) including anthracyclines (p = 0.43), treatment with anti-HER2 therapy (p = 0.53), and radiation field (p = 0.65) were not significantly related to ACE in this limited cohort. A subset of patients participated in oncology rehab (n = 43) and there was no clear association with decreased ACE (p = 0.96) in in an exploratory analysis. Conclusions: The rate of ACE is low with modern therapy, even when accounting for a full spectrum of ACE. Consistent with prior studies, we found that higher MHD and CAC are independently associated with ACE, including previously under-reported ACE. Treatment with endocrine therapy was associated with fewer ACE. In this limited cohort with shorter-term follow up, hypertension, diabetes, smoking, and treatment with anthracyclines and anti-HER2 therapy were not associated with ACE, suggesting that these may be less important risk factors. [Table: see text]
Comparison of prophylactic effects for chemotherapy-induced neutropenia between same-day vs next-day administration of pegteograstim in chemotherapy regimen composed of day 1 intensive myelosuppressive agent: A randomized phase III trial (CONCISE, KCSG PC22-11).
Authors: Park Kwonoh , Oh Sang-Bo , Hong Yun Jeong , Huh Seok Jae , Kim Il-Hwan , Shin Seong-Hoon 
Published: July 2024

TPS12149 Background: Administration of peg-GCSF 24 to 72 hours after chemotherapy is usually recommended. Next-day administration (after 24 hours) resulted in fewer duration of Gr4 chemotherapy-induced neutropenia (CIN) and decreased severity of CIN than same-day (within 4 hours). However, patients sometimes receive same-day Peg-GCSF for the sake of convenience. In addition, a few prior studies showed that the same-day method is comparable or superior to the next-day in preventing CIN, especially in regimens that include day 1 myelosuppressive agents. Thus, we aim to test hypothesis that same-day administration of pegteograstim, a new formulation of peg-GCSF, is non-inferior to next-day administration in terms of Gr4 CIN duration. Methods: This study is a randomized, multicenter, open-label, investigator-initiated phase 3 study. Patients with adjuvant/neoadjuvant or 1st palliative chemotherapy comprising intensively myleosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled. The patients are assigned to the same-day arm or the next-day arm in a 1:1 ratio. Randomizations are stratified according to number of CIN risk (1 vs ≥2), setting (perioperative vs palliative), and interval (2- vs 3-week). In the same-day, pegteograstim 6 mg is SC injected within 4 hrs after chemotherapy, while 24-36 hrs in the next-day. CBC test is performed daily from day 5 to 9 during the cycle 1. From cycle 2 to 4, treatments are performed in accordance with general practice, including checking for febrile neutropenia (FN), dose intensity, and safety. The primary endpoint is duration of Gr4 CIN (during cycle 1), and secondary endpoints include incidence of Gr 3-4 CIN (cycle 1), severity of CIN (cycle 1), time to recovery ANC 1000/㎕ (cycle 1), incidence of FN, CIN-related dose delay, and dose intensity. In order to verify non-inferiority of 0.6 days of Gr4 CIN duration, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each arm. We are currently recruiting patients (since Nov 2022). Clinical trial information: KCT0007694 .
Guard 01: A randomized, multicentre, controlled trail on the prophylactic use of efbemalenograstim alfa for concurrent chemo-radiotherapy induced neutropenia.
Authors: Chen Yuanyuan , Li QiWen , Chen Chunyan , Ouyang Yi , Chen Ming 
Published: July 2024

TPS12155 Background: Concurrent chemo-radiotherapy plays a crucial role in the treatment of various advanced-stage malignant tumors. However, it is often associated with significant hematologic toxicity, especially leukopenia and neutropenia, which may lead to treatment interruptions, reduced efficacy, and even severe infections. Efbemalenograstim alfa is a novel long-acting recombinant human granulocyte colony stimulating factor (rhG-CSF) combined of an immunoglobulin (Ig) G2-Fc fragment and two rhG-CSF molecules. Although efbemalenograstim alfa has been confirmed to be effective in the prevention of chemotherapy induced neutropenia by a number of clinical studies, its prophylactic efficacy during concurrent chemo-radiotherapy was seldom investigated. Guard-01 is aimed to evaluate the effectiveness and safety of primary preventive use of efbemalenograstim alfa in concurrent chemo-radiotherapy. Methods: This study is a multicenter, open-label, randomized, controlled clinical trial involving 120 patients who are planned to receive definitive concurrent chemo-radiotherapy with non-small cell lung cancer, small cell lung cancer, esophageal cancer, nasopharyngeal carcinoma, head and neck squamous cell carcinoma, or cervical cancer. Patients will be randomized into efbemalenograstim alfa arm or control arm in a 1:1 ratio on the first day of the first concurrent chemo-radiotherapy cycle. The stratification factor is chemotherapy regimen of the patients. Approximately 48 (±4) hours after the completion of each chemotherapy cycle, patients in the efbemalenograstim alfa arm will receive efbemalenograstim alfa (20 mg per dose, subcutaneous injection) for prevention. Patients in the control arm will receive rhG-CSF (5 μg/kg/day) when the absolute neutrophil count (ANC) is less than 1.0×109/L, and treatment will be discontinued when ANC reaches ≥5×109/L. The primary endpoint is the incidence of grade ≥3 neutropenia (ANC<1.0×109/L) during concurrent chemo-radiotherapy. The trial is opened in November 2023 and will be conducted in 8 hospitals with the aim of recruiting 120 evaluable patients (4 patients are recruited untilled 29-Jan-2024). Clinical trial information: ChiCTR2300077504.
Cohesin composition and dosage independently affect early development in zebrafish
Authors: Labudina Anastasia A. , Meier Michael , Gimenez Gregory , Tatarakis David , Ketharnathan Sarada , Mackie Bridget , Schilling Thomas F. , Antony Jisha , Horsfield Julia A. 
Published: July 2024

ABSTRACT
Cohesin, a chromatin-associated protein complex with four core subunits (Smc1a, Smc3, Rad21 and either Stag1 or 2), has a central role in cell proliferation and gene expression in metazoans. Human developmental disorders termed ‘cohesinopathies’ are characterized by germline variants of cohesin or its regulators that do not entirely eliminate cohesin function. However, it is not clear whether mutations in individual cohesin subunits have independent developmental consequences. Here, we show that zebrafish rad21 or stag2b mutants independently influence embryonic tailbud development. Both mutants have altered mesoderm induction, but only homozygous or heterozygous rad21 mutation affects cell cycle gene expression. stag2b mutants have narrower notochords and reduced Wnt signaling in neuromesodermal progenitors as revealed by single-cell RNA sequencing. Stimulation of Wnt signaling rescues transcription and morphology in stag2b, but not rad21, mutants. Our results suggest that mutations altering the quantity versus composition of cohesin have independent developmental consequences, with implications for the understanding and management of cohesinopathies.
Export activity of enterprises: a case study of a border region
Authors: Zabielska Izabela 
Published: July 2024

Motivation: Enterprises, especially SMEs, are the backbone of the Polish economy. Their desire to develop makes them decide, among other things, to export. Particularly those located in border regions, are a challenge for the economic cohesion and economic activation of these areas. The openness of the border and the prevailing economic relations between neighbouring countries are of vital importance here. This peculiarity of the border location and the potential of the border regions of Eastern Poland (peripheral and economically underdeveloped), as well as the still existing research gap in this area justifies, among other things, taking up the topic.Aim: Identification and assessment of the state of export activity of Polish companies, with particular emphasis on the sector of small and medium-sized enterprises located in the border region.Results: The research carried out (empirical — primary and secondary — identifying the level of export activity by region in terms of quantity and value) into the dynamics and level of export activity by border regions — shows significant differentiation. This differentiation is influenced, inter alia, by the location and different historical and political conditions of the neighbours. Poland’s accession to the EU in 2004 and joining the Schengen area in 2007 resulted in completely different opportunities for the development of export activity in regions located on Poland’s western border (e.g. with Germany and thus within the European Union) than in regions located on Poland’s north-eastern border (e.g. with the Kaliningrad Oblast of the Russian Federation, where the state border is at the same time the EU border in the eastern part of Europe). This peculiarity results in the fact that there is still a lack of compact, homogeneous studies on the export activity of enterprises, especially SMEs, in relation to border regions. This is certainly still an existing research gap.
CORRUPTION, GOVERNMENT’S ECONOM-IC PERFORMANCE AND INSTITUTIONAL TRUST IN THE MENA REGION
Authors: KOUBAA Salah 
Published: July 2024

Motivation: Countries in the MENA region are perceived as highly corrupt. They are struggling to achieve clear results against corruption. Unfortunately, no country has reached a significant improvement on the Corruption Perceptions Index (CPI) published by Transparency International in 2021. The United Arab Emirates and Qatar are the top performers in the Region. The former was ranked 69 out of 100, the latter 63 out of 100. Libya (17/100), Yemen (16/100), and Syria (13/100) awfully damaged by the war are the worst. The state-of-the-art impacts trust at the national level and the performance of public institutions as well.

Aim: This paper aims to study the relationship between corruption and trust, and its impact on public economic performance in the MENA region. It is based on the data provided by Arabbarometer, 2018-2019. Our sample includes 8215 individuals located in 12 countries in that region. To test all our hypotheses simultaneously, we have used the structural equation modeling method with SmartPLS software. The latent variable of the research model – corruption, fighting corruption, and economic performance of the government- all of them are used as a reflective measurement. However, trust is included in the model as a formative measurement.

Results:
The findings show that trust in public institutions, measured by a formative scale, is negatively impacted by the level of corruption (-0,36). It also depends on the efforts made by the state to fight corruption in public agencies and institutions (0,37). Trust is one of the most important components of social capital. The performance of public policies is highly correlated to the level of trust between public administration and individuals. The government’s economic performance depends on the level of that trust (0,341), the efforts made to fight corruption (0,173), and public corruption (-230). All hypotheses are significant at 1%.
impact of lifestyle interventions targeting physical activity and healthy diet on treatment of Obstructive Sleep Apnea (OSA)
Authors: Lipska Julia , Hamerska Laura , Hamerska Julia , Bocianiak Bogumił , Antczak Joanna , Kajka Anna , Fenrych Urszula , Wojtczak Karolina , Skupińska Olga , Ruta Damian 
Published: July 2024

Introduction and purpose: Obstructive Sleep Apnea Syndrome (OSAS) is a worldwide prevalent sleep-related medical condition characterised by upper airway collapse, leading to hypoxia and hypercapnia. Excess body weight is the risk factor of OSAS. Lifestyle interventions, particularly targeting weight loss, have emerged as potential management strategies for OSAS. The purpose of this review is to compile the information about the effectiveness of different forms of lifestyle interventions in the treatment of OSA.
Brief description of the state of knowledge:
While CPAP remains the current “gold standard” treatment of Obstructive Sleep Apnea, it’s not always well-tolerated. Consequently, lifestyle interventions such as dietary modifications, exercise programs, and behavioural therapies have emerged as important components in the management of this disease. The research has shown that these strategies not only reduce the severity of OSA but also improve quality of life.
Summary: Lifestyle interventions, including dietary modifications, exercise programs, and behavioral therapies targeting weight loss, have demonstrated promising results in reducing the severity of obstructive sleep apnea (OSA) and alleviating associated symptoms. However, further large-scale, long-term studies are necessary to validate their efficacy and understand their broader impact on OSA management.
Ginger (Zingiber officinale) - A Beneficial Effect on Health and Physical Activity
Authors: Popławska Natalia Aleksandra , Śliz Justyna , Skorupska Marta , Czeczotka Magdalena Joanna , Woźniak Krzysztof 
Published: July 2024

Introduction:
Ginger (Zingiber officinale) is a member of the Zingiberaceae plant family and is indigenous to Southeast Asia. It has been widely utilized as an herbal remedy in numerous nations and is known for its beneficial properties, such as anti-inflammatory, antioxidant, and anti-apoptotic effects. Ginger is commonly consumed for its various health benefits, including alleviating coughs, reducing pain, addressing nausea, aiding digestion, and exhibiting analgesic and anti-inflammatory effects. Recently, research has begun to uncover the potential benefits of ginger on physical activity and athletic performance.
Materials and methods:
A comprehensive examination of scientific and medical literature was performed using the PubMed and Google Scholar databases. The search terms employed were: "ginger," "ginger anticancer," "ginger anti-inflammatory," and "ginger antiemetic."
Conclusion:
Ginger, scientifically known as Zingiber officinale, is a widely utilized herb with various biological effects including anti-inflammatory, antioxidant, anticancer, and antibacterial properties primarily attributed to four phenolic compounds: gingerols, shogaols, paradols, and zingerone. Notably, 6-shogaol, an active ingredient in ginger, shows promise as a natural anticancer product with potential therapeutic benefits. Also, several scientific studies have indicated that ginger supplementation may lead to reduced muscle soreness, improved endurance performance, and decreased inflammation in response to intense physical activity.