bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of anticoagulation control and outcomes between usual medical care and pharmacist-led anticoagulation service in ambulatory patients taking warfarin at tertiary hospital in Ethiopia: a quasi-experimental study
Authors: Tadesse Tamrat Assefa , Gebremedhin Amha , Yadeta Dejuma , Chelkeba Legese , Fenta Teferi Gedif 
Published: June 2024

Abstract
Background
We aimed to compare anticoagulation control and outcomes between usual medical care (UMC) and pharmacist-led anticoagulation services (PLAS) in patients receiving warfarin at the Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia.

Methods
A quasi-experimental study was conducted, including 350 (66.7%) and 175 (33.3%) patients from the UMC and PLAS groups, respectively, from 525 patients. The time in therapeutic range (TTR) was determined using the Rosendaal method, with a TTR ≥ 65% set as the cut-off for optimal anticoagulation. The two-sample Wilcoxon rank-sum (Mann–Whitney U) test was used to compare continuous variables between groups. Categorical variables were compared between groups using Pearson’s chi-square test or Fisher’s exact test. Logistic regression and negative binomial regression analyses were conducted to identify the factors associated with suboptimal TTR and secondary outcomes, respectively, at the p values < 0.05, and 95% confidence interval (CI).

Results
Compared with the UMC group, the patients in the PLAC group showed a significantly higher median (IQR) TTR [60.89% (43.5–74.69%) vs. 53.65% (33.92–69.14%), p < 0.001]. A significantly higher optimal TTR (≥ 65%) was achieved in the PLAC group (41.7% vs. 31.7%) than in the UMC group (p = 0.002). The odds of having a poor TTR were reduced by 43% (AOR = 0.57, 95% CI = 0.36–0.88, p = 0.01) among patients in the PLAC group compared to those in the UMC group. There were no statistically significant differences in the secondary outcomes between the groups, except for all-cause emergency visits (p = 0.003). The incidence of bleeding events decreased by 3% (IRR = 0.97, 95% CI = 0.96–0.99, p < 0.001) for every increase in INR monitoring frequency. The incidence of thromboembolic events increased by a factor of 15.13 (IRR = 15.13, 95% CI = 1.47–155.52, p = 0.02) among patients with a high-risk CHA2DS2-VASc score compared with those with a moderate score.

Conclusion
Patients in the PLAC group had a significantly higher median TTR than those in the UMC group did. There were no statistically significant differences in the secondary outcomes between the groups, except for fewer all-cause emergency department visits in the PLAC group.
Effects of a Preseason Neuromuscular Training Program vs. an Endurance-Dominated Program on Physical Fitness and Injury Prevention in Female Soccer Players
Authors: Belamjahad Ali , Tourny Claire , Jebabli Nidhal , Clark Cain C. T. , Laher Ismail , Hackney Anthony C. , Granacher Urs , Zouhal Hassane 
Published: June 2024

Abstract
Background
The pre-season preparatory period is considered key for optimizing the physical fitness levels needed to withstand congested match periods and preventing injuries during the regular soccer season. This study contrasted the effects s of neuromuscular training (NMT) versus an endurance-dominated training (ET) program conducted during the preseason on measures of physical fitness and injury occurrence in female soccer players.

Methods
Twenty-four female soccer players aged 17.0 ± 1.3 years from a professional soccer club participated in this study. Players were randomly assigned to NMT (n = 12) or ET (n = 12) groups according to their playing position. The preseason intervention program lasted six weeks, with three weekly sessions with a duration of 45–60 min per session. Exercises in the NMT group included muscle strengthening exercises, plyometrics, agility and dynamic stability exercises, while the ET group practiced a traditional pre-season training program consisting of running and sprinting exercises, fartlek, and high-intensity interval training. The training volumes were similar in the two study groups. Anthropometric measurements, physical fitness tests (i.e., linear and change-of-direction speed, muscle strength and power tests) and the overall injury rate per 1000 h of exposure (training, match) were recorded throughout the season.

Results
No between group differences were found at pre (T1). Significant group-by-time interactions were observed for the 5, 10, and 30-m linear sprint speed tests (p < 0.001, 2.16 < d < 2.58), the T-test (p = 0.024, d = 1.03), the squat (p < 0.001, d = 4.04), and the countermovement jump test (p < 0.001, d = 2.21), the Loughborough soccer passing test (LSPT) (p = 0.019, d = 1.08), and the 1-RM back squat test (p < 0.001, d = 2.53). Post-hoc tests indicated that NMT provided larger improvements for SJ, CMJ, 1-RM back squat, the 5-m sprint, 10-m sprint, 30-m sprint, T-test and LSPT compared to ET (1.07 > d > 2.77). The injury rate across the season was significantly lower in the NMT (5.1/1000 h exposure) compared to ET (11.8/1000 h exposure) (p = 0.014).

Conclusions
The findings support that six-weeks of preseason NMT versus ET induced larger performance improvements, and significantly reduced injury occurrence in elite female soccer players.
Different deployments of attentional breadth selectively predict UFOV task performance in older adults
Authors: Wyche Nicholas J. , Edwards Mark , Goodhew Stephanie C. 
Published: June 2024

AbstractThe Useful Field of View task (UFOV) is a strong and reliable predictor of crash risk in older drivers. However, while the functional domain of attention is clearly implicated in UFOV performance, the potential role of one specific attentional process remains unclear: attentional breadth (the spatial extent of the attended region around the point of visual fixation). The goal of the present study was to systematically test the role of two distinct aspects of attentional breadth, maintaining a specific breadth of attention and resizing the attended region, in UFOV performance. To this end, 135 older adults completed the UFOV and modified Navon tasks to measure their efficiency in maintaining, contracting, and expanding the breadth of attention. We then examined individual-difference associations between these aspects of attentional breadth deployment and UFOV performance. We found that performance on UFOV Subtask 2 was associated with efficient contraction of attentional breadth (i.e., resizing the attended region to a smaller area), while Subtask 3 performance was associated with the efficiency of expanding attentional breadth (i.e., resizing the attended region to a larger area). The selectivity of these relationships appears to implicate these specific deployments of attentional breadth in how people complete the task, as it suggests that these relationships are not simply attributable to shared variance in a broader domain of cognitive functioning. The implications of these results for our understanding of UFOV, as well as future research directions that test the relative contributions of different cognitive processes in predicting task performance, are discussed.
Unusual presentation of lung cancer in young patient: case report
Authors: El Sayed Tamer Awad , Abd El Gawad Taha Taha 
Published: June 2024

AbstractThis case report describes the diagnostic journey of a 35-year-old patient presenting with interstitial lung disease (ILD). The patient underwent a bronchoscopy, which revealed the presence of cancer. This case highlights the importance of considering malignancy as a potential cause of ILD, even in younger patients, and emphasizes the role of bronchoscopy in the diagnostic process.
BEAT-SC: A randomized phase III study of bevacizumab or placebo in combination with atezolizumab and platinum-based chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC).
Authors: Ohe Yuichiro , Han Baohui , Nishio Makoto , Watanabe Satoshi , Ren Xiubao , Murakami Shuji , Yang Nong , Okamoto Isamu , Li Gaofeng , Katakami Nobuyuki , Liu Xianling , Nogami Naoyuki , Nakagawa Yuki , Hayashi Morihiko , Nanki Toshihiro , Qian Chunyu , Yamamoto Nobuyuki 
Published: June 2024

8001 Background: Atezolizumab combined with carboplatin and etoposide is approved as first-line treatment for patients with ES-SCLC, based on results from the Phase I/III IMpower133 trial (NCT02763579). The VEGF inhibitor bevacizumab (bev) is approved for the treatment of many tumor types and has synergistic effects when combined with atezolizumab, as demonstrated by the Phase III IMpower150 study (NCT02366143) in non-small cell lung cancer. BEAT-SC (jRCT2080224946) is evaluating the efficacy and safety of bev combined with atezolizumab and platinum-based chemotherapy in patients with ES-SCLC from Japan and China. Here, we report the primary analysis for progression-free survival (PFS) and the first interim analysis for overall survival (OS) from BEAT-SC. Methods: Eligible patients had measurable ES-SCLC, were aged ≥20 y (≥18 y for patients from China), had an ECOG performance status of 0 or 1 and had no prior systemic treatment for ES-SCLC. Patients were randomized 1:1 to receive 4 cycles (21 days/cycle) of induction therapy with bev combined with atezolizumab + cisplatin or carboplatin + etoposide (ACE) or placebo combined with ACE, followed by maintenance therapy with bev + atezolizumab or placebo + atezolizumab, respectively. The primary endpoint was investigator-assessed PFS (INV-PFS). Key secondary endpoints included OS and safety. Results: The ITT population comprised 333 patients with a median age of 65.0 y; 82.6% of the patients were male, 57.7% were from China, 91.8% received carboplatin and 87.6% were current or former smokers. At data cutoff (June 30, 2023; median follow-up, 10.2 mo), median INV-PFS was 5.7 mo for bev + ACE vs 4.4 mo for placebo + ACE (HR, 0.70; 95% CI: 0.54, 0.90; P=0.0060; 2-sided α boundary=0.05). Median OS was 13.0 mo for bev + ACE vs 16.6 mo for placebo + ACE (HR, 1.22; 95% CI: 0.89, 1.67; P=0.2212; 2-sided α boundary=0.0079). Among the safety analysis population (n=330), bev + ACE was well-tolerated and treatment-related adverse events (TRAEs) were generally similar between treatment arms (Table). Conclusions: BEAT-SC met its primary endpoint, demonstrating that the addition of bev to ACE significantly increased PFS vs placebo + ACE. OS data were immature at the first interim OS analysis, and the numerical OS improvement of bev + ACE was not shown vs placebo + ACE; OS follow-up will continue. No new safety signals were observed. Clinical trial information: jRCT2080224946 . [Table: see text]
A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091).
Authors: Liu Hui , Qiu Bo , Zhao Yuanyuan , He Wen-zhuo , Feng Weineng , Zeng Weijing , Jia Jun , Meng Fanjun , Wang DaQuan , Liu FangJie , Guo JinYu , Zou YingYi , Guo SuPing , Wu YingJia , Luo QiaoTing , Li Ji-Bin , Yang Yunpeng , Xia Liang-Ping , Zhang Li 
Published: June 2024

8008 Background: Enhancing clinical outcomes in resectable non-small cell lung cancer (NSCLC) has been associated with neoadjuvant or perioperative administration of nivolumab. However, the efficacy and safety of consolidation nivolumab versus observation following neoadjuvant chemotherapy plus nivolumab, hypofractionated radiotherapy and concurrent chemotherapy (hypo-CCRT) in patients with unresectable stage III NSCLC remain underexplored. Methods: Conducted as a randomized, multi-center, phase 2 trial in patients with unresectable stage IIIA-C NSCLC, this study enrolled individuals aged 18 to 75 with an ECOG performance status of 0 or 1. Neoadjuvant therapy consisted of docetaxel, cisplatin, and nivolumab (360mg every 3 weeks for 2 cycles), followed by hypo-CCRT. Patients without disease progression or G2+ pneumonitis after hypo-CCRT were randomly assigned to receive nivolumab (360 mg every 3 weeks for up to 12 months) or undergo observation. Randomization factors included age, sex, smoking history, and EGFR mutation status. The primary endpoint was progression-free survival (PFS) from randomization, with preplanned analysis results reported herein. The trial is registered with ClinicalTrials.gov, NCT04085250. Results: Between Dec 3rd, 2019, and Aug 18th, 2023, 264 patients underwent neoadjuvant therapy, 242 received hypo-CCRT, and 172 were randomly assigned to nivolumab consolidation (n = 86) or observation (n = 86) post hypo-CCRT. At the January 31, 2024, data cutoff, the median follow-up for all randomized patients was 22.8 months. Nivolumab consolidation exhibited significantly longer PFS compared to observation (median not reached vs. 12.2 months [95% CI 6.2-18.1]; hazard ratio 0.49 [95% CI 0.31-0.79], p = 0.002). The 12-month and 18-month PFS rates were 72.6% and 64.8% in the consolidation group, contrasting with 52.5% and 42.3% in the observation group. Grade 3-4 nonhematological adverse events occurred in 14.0% (37/264) during neoadjuvant therapy and hypo-CCRT. Following randomization, grade 3-5 adverse events occurred in 7.0% (6/86) with consolidation (G3 pneumonitis, 2.3%; G5 pneumonitis, 1.2%; G3 proximal bronchial tree toxicity, 3.5%) and 4.6% (4/86) with observation (G3 pneumonitis, 2.3%; G3 proximal bronchial tree toxicity, 2.3%). Conclusions: Consolidation with nivolumab after neoadjuvant chemotherapy plus nivolumab and hypo-CCRT demonstrates effectiveness and tolerability for patients with unresectable stage III NSCLC. Extended follow-up is essential for confirming these findings. Clinical trial information: NCT04085250 .
ALK testing patterns in early-stage non-small cell lung cancer: A real-world evidence study.
Authors: Leal Ticiana , Sussell Jesse , Ngiam Celina , Zhang Qing , Majda Thomas , Sheinson Daniel , Ogale Sarika , Bara Ilze , Schulze Katja , Porter Jason 
Published: June 2024

8074 Background: Comprehensive biomarker testing in advanced non-small cell lung cancer (aNSCLC) is standard of care, but disparities exist. As new clinical data emerge in early disease (eNSCLC), the set of actionable lung driver mutations (LDMs) and therefore the testing landscape in that setting will change. In particular, following the results of the ALINA trial, therapies that target ALK fusions are anticipated to become part of routine treatment of eNSCLC in 2024.This study thus sought to identify the factors associated with receipt of timely ALK testing in eNSCLC, prior to this shift. Methods: We retrospectively analyzed patients with resected stage I-IIIa NSCLC diagnosed between 2018-2023 using the expanded nationwide (US-based) de-identified Flatiron Health EHR-derived database; data were consolidated from approximately 280 US cancer clinics (≅800 sites of care), using natural language processing with machine learning (ML) to extract patient characteristics. The primary endpoint was ALK testing results (by any modality) within 90 days of initial diagnosis. We used multivariable logistic regression to assess the association between clinico-demographic characteristics and likelihood of testing. Results: The sample contained 21,982 stage I-IIIa patients. Of these, 6,685 (30%) were tested within 90 days, and 15,297 (70%) were not. Patients were more likely to be tested within 90 days if they were diagnosed in more recent years (2023 vs. 2018 odds ratio (OR) 2.12); had no history of smoking (OR 1.21); had highest socioeconomic status (SES) quintile (OR vs. lowest SES 1.14); had more advanced disease (stage IIIa vs. stage I OR 2.43); or were treated in a community setting (OR vs. academic 1.13), all p < 0.05. Patients with Medicare insurance (OR vs. commercial insurance 0.89, p = 0.014) or squamous histology (OR vs. non-squamous 0.46, p < 0.01) were less likely to be tested. There were no significant differences between black and white patients (OR 0.91, p = 013). Conclusions: In this real-world analysis of patients diagnosed between 2018-2023 most patients did not have testing within 90 days of diagnosis. Our data show variation in the baseline probability of testing with respect to clinico-demographic factors. Given that barriers to testing persist in aNSCLC, this suggests that once ALK inhibitors become part of routine care in eNSCLC, some groups might be less likely to be tested and therefore to receive efficacious targeted treatment. Preemptive measures such as education of patients, providers, payers, and policy makers could help prevent disparities from emerging.
Integration of circulating tumor DNA and metabolic parameters for outcome prediction in unresectable locally advanced non-small cell lung cancer.
Authors: Wu Leilei , Zhang Zhenshan , Sun Xiaojiang , Yan Yujie , Jiang Chenxue , Zhu Yaoyao , Yaping Xu 
Published: June 2024

8080 Background: An effective biomarker to direct precise consolidation treatment after CRT is still lacking. Circulating tumor DNA (ctDNA) molecular residual disease (MRD) following curative-intent treatment strongly predicts recurrence in multiple tumor types, but whether further treatment can improve outcomes in patients with MRD remains unclear. Hereby, we applied CAPP-Seq ctDNA analysis to plasma samples collected before and after definitive chemoradiotherapy (CRT) or radiotherapy (RT) in unresectable LA-NSCLC. Methods: A total of 62 unresectable LA-NSCLC patients were prospectively enrolled, providing 62 baseline and 49 post-definitive CRT/RT plasma samples. All patients underwent a PET/CT scan at baseline and 33 patients received a mid-treatment PET/CT scan upon reaching a RT dose of 40Gy/20f during therapy. These 33 patients were randomly assigned to either receive or not receive adaptive dose-escalated RT. A group of patients who received immune checkpoint inhibitor (ICI) consolidation after CRT/RT was compared with patients who were ctDNA-/high △TMTV post-treatment. Results: ctDNA was detected at baseline in 44 (71.0%) patients. Pre-treatment ctDNA concentration was significantly correlated with TMTV (p = 0.004) and TLG (p = 0.010). Baseline ctDNA detection and concentration were not able to differentiate patients with varying treatment responses or predict survival. However, patients with undetectable ctDNA and low TMTV exhibited significantly better PFS (p = 0.024). One month after completing CRT or RT, ctDNA was detected in 25 (47.2%) patients. While the concentration of circulating free DNA (cfDNA) remained relatively stable (p = 0.652), both the mean ctDNA Variant Allele Frequency (VAF) (p = 0.002) and ctDNA concentration (p = 0.043) showed a significant decrease. Patients with undetectable ctDNA post-treatment exhibited significantly longer PFS and OS. A lower ∆TMTV was significantly associated with longer PFS and OS. Compared to the non-response group, the response group exhibited significantly lower change in △SUVmax (p = 0.024), with a trend towards lower change in TMTV, although not significant (p = 0.064). Compared with the matched 30 patient receiving ICI consolidation, those with negative ctDNA and high △TMTV after CRT demonstrated significantly better PFS (p = 0.042) and OS (p = 0.039). Conclusions: Baseline ctDNA combined with TMTV can enhance the predictive ability for survival. Post-CRT ctDNA and △TMTV possess strong prognostic capabilities. Patients who are ctDNA- and with high △TMTV may be exempt from ICI consolidation therapy.
Results of a phase III clinical trial with anti-PDL1 treatment in combination with chemotherapy for extensive stage small cell lung cancer.
Authors: Lu Shun , Dai Xiang Rong , Li Benjamin Xiaoyi , Chen Zhiwei 
Published: June 2024

8095 Background: In China, small cell lung cancer (SCLC) accounts for over 15% of lung cancers. The morbidity of SCLC has been continuously increasing. SCLC is invasive, fast-growing cancer that distinctly differs from other cancers. Approximately 70% of cases present with metastasis at diagnosis and the median overall survival rate is about 8 to 11 months with a 5-year survival rate of less than 5%. Although being sensitive to chemotherapy and radiotherapy, SCLC patients are liable to relapse and often present with drug resistance. Here we study the combination of Socazolimab, an anti-PDL1 antibody, carboplatin and etoposide to treat extensive stage small cell lung cancer. Methods: The study is a randomized, double-blinded, placebo-controlled multicenter Phase III clinical trial. Patients who have extensive-stage SCLC are eligible to the trial. Patients are randomly assigned to the study group (Socazolimab + carboplatin + etoposide) or control group (placebo + carboplatin + etoposide) at 1:1 ratio, with a treatment cycle of every 3 weeks. There are 4 cycles of chemotherapy followed by Socazolimab or placebo alone until termination events occurred or for up to 2 years. The primary endpoint is overall survival (OS). The major secondary endpoint is progression free survival (PFS). Results: There were a total of 498 patients recruited for the study with average age of 61.9 amount which 449 patients were diagnosed with stage IV SCLC. All the analysis was based on intent-to-treat (ITT). The median baseline performance status score was 1.0. The median OS of study group and control group are 13.90 months (95% CI: 12.22-15.34) and 11.58 months (95% CI: 10.64-12.81) respectively, with a P-value of 0.0316. The 24 month survival rate of study group and control group are 20.7% (95% CI:14.8-27.3) and 5.9 %(95% CI: 0.8-18.9). The median PFS of the two groups are 5.55 months (95% CI:5.06-5.82) and 4.37 months (95% CI: 4.27-4.70) with a P-value < 0.0001. The treatment related adverse event were similar in both groups. Conclusions: These results show that Socazolimab plus chemotherapy continued to provide clinically meaningful improvements in OS for patients with extensive stage small cell lung cancer. Clinical trial information: NCT04878016 .