bluuebunny/crossref_metadata_2025_split huggingface dataset:
New insights into the paradox between smoking and the risk of SARS-CoV-2 infection (COVID-19): Insufficient evidence for a causal association
Authors: Kramer Iris , Zhu Yinjie , Van Westen-Lagerweij Naomi A. , Dekker Louise H. , Mierau Jochen O. , Croes Esther A. 
Published: July 2024

Aims: Previous studies have reported a ‘smoker’s paradox’, where people who smoke appear to be protected against Severe Acute Respiratory Syndrome CoronaVirus-2 (SARS-CoV-2) infection (COVID-19). This conflicts with well-established evidence that people who smoke are generally more vulnerable to respiratory infections. In this study, we aimed to validate the association between smoking and SARS-CoV-2 infection in a general Dutch population, and to evaluate the evidence underlying the possible causal relationship between smoking and SARS-CoV-2 infection by applying a modern adaptation of the Bradford Hill criteria. Methods: In total, 57,833 participants from the Lifelines Cohort Study were included in the analysis. Smoking status, including never smoker, current smoker, and former smoker, was derived from the Lifelines general assessment between 2014 and 2017, while SARS-CoV-2 infection status was derived from an additional COVID-19 questionnaire from 2021 to 2022. Logistic regressions were used for the association between smoking status and infection status. The adapted Bradford Hill’s criteria, including the strength of association (including an analysis of plausible confounding), plausibility, temporality and study design suitability, were applied to evaluate the existing literature. Results: We found, compared with never smokers, an increased risk of SARS-CoV-2 infection for former smokers (odds ratio (OR)=1.07, 95% confidence interval (CI)=1.01–1.13), but a reduced risk for current smokers (OR=0.85, 95% CI=0.79–0.92), after adjusting for several relevant covariates. However, we discerned a possible explanation of the smoker’s paradox since we observed that current smokers were more likely to be non-responders to the COVID-19 questions and, more importantly, these non-responders were more likely to have other established risk factors for SARS-CoV-2 infection. Conclusions: There is insufficient evidence to suggest that smoking protects against SARS-CoV-2 infection. According to the adapted Bradford Hill’s criteria, we observed a high inconsistency between study results, a high possibility for residual confounding and no clear evidence for biological plausibility. Future studies should include linkage with the confirmed testing results from national healthcare registries to mitigate avoidable bias.
Endovascular Treatment for Renal Vein Embolism by a Renal Calculus After Percutaneous Nephrolithotomy
Authors: Riguetti-Pinto Cristina Ribeiro , Virgini-Magalhães Carlos Eduardo , Carvalho Marchon Lívia Ramos , de Araujo Fernando Augusto Peixoto , Alves Machado Henrique , Rodrigues Neto Eduardo de Oliveira , de Araújo-Gomes Cristiane Ferreira , Fagundes Felipe Borges 
Published: July 2024

Purpose: This report presents the endovascular strategies adopted to treat a kidney calculus venous embolism after percutaneous nephrolithotomy and the versatility of endovascular techniques to manage even the most unexpected renovascular complications after urological intervention. According to the literature available in PubMed, Cochrane, SciELO, and Science.gov repositories, this is the first case to our knowledge of renal vein calculus embolism as a complication of percutaneous treatment of kidney stones. Case Report: A 62-year-old woman underwent percutaneous nephrolithotomy to treat a left kidney 2.8-cm staghorn calculi. The stone cracked, leaving a residual fragment in the ureteropelvic junction. Abdominal computed tomography revealed a 0.9-mm extrarenal calculus located inside the left retroaortic renal vein. Calculus was captured using a basket catheter system through a 6F 45-cm sheath positioned in the left common femoral vein (CFV) and accessed by dissection to safely conclude the calculus extraction by venous cut down. The patient was asymptomatically discharged 48 hours after the endovascular procedure, under a rivaroxaban anticoagulation regimen, with no symptoms or renal function impairment until the 6 months of follow-up. Conclusion: The endovascular strategy proposed in this case was effective for calculus rescue and venous flow restoration. Clinical Impact This case reinforces the adaptability of endovascular therapy in an unexpected scenario. A potentially life-threatening extremely rare adverse event following a common urological procedure could be treated with minimally invasive hybrid treatment, preserving renal function and maintaining venous vascular patency. This report may add a discussion of procedures to manage similar events and bring to the literature a possible strategy to solve the problem.
iPREDICT: proof-of-concept study to develop a predictive model of changes in asthma control
Authors: Castro Mario , Zavod Merrill , Rutgersson Annika , Jörntén-Karlsson Magnus , Dutta Bhaskar , Hagger Lynn 
Published: July 2024

Background: The individualized PREdiction of DIsease Control using digital sensor Technology (iPREDICT) program was developed for asthma management using digital technology. Devices were integrated into daily lives of patients to establish a predictive model of asthma control by measuring changes from baseline health status with minimal device burden. Objectives: To establish baseline disease characteristics of the study participants, detect changes from baseline associated with asthma events, and evaluate algorithms capable of identifying triggers and predicting asthma control changes from baseline data. Patient experience and compliance with the devices were also explored. Design: This was a multicenter, observational, 24-week, proof-of-concept study conducted in the United States. Methods: Patients (⩾12 years) with severe, uncontrolled asthma engaged with a spirometer, vital sign monitor, sleep monitor, connected inhaler devices, and two mobile applications with embedded patient-reported outcome (PRO) questionnaires. Prospective data were linked to data from electronic health records and transmitted to a secure platform to develop predictive algorithms. The primary endpoint was an asthma event: symptom worsening logged by patients (PRO); peak expiratory flow (PEF) < 65% or forced expiratory volume in 1 s < 80%; increased short-acting β2-agonist (SABA) use (>8 puffs/24 h or >4 puffs/day/48 h). For each endpoint, predictive models were constructed at population, subgroup, and individual levels. Results: Overall, 108 patients were selected: 66 (61.1%) completed and 42 (38.9%) were excluded for failure to respond/missing data. Predictive accuracy depended on endpoint selection. Population-level models achieved low accuracy in predicting endpoints such as PEF < 65%. Subgroups related to specific allergies, asthma triggers, asthma types, and exacerbation treatments demonstrated high accuracy, with the most accurate, predictive endpoint being >4 SABA puffs/day/48 h. Individual models, constructed for patients with high endpoint overlap, exhibited significant predictive accuracy, especially for PEF < 65% and >4 SABA puffs/day/48 h. Conclusion: This multidimensional dataset enabled population-, subgroup-, and individual-level analyses, providing proof-of-concept evidence for development of predictive models of fluctuating asthma control.
Long-term outcomes and predictors of vedolizumab persistence in ulcerative colitis
Authors: Gros Beatriz , Ross Hannah , Nwabueze Maureen , Constantine-Cooke Nathan , Derikx Lauranne A. A. P. , Lyons Mathew , O’Hare Claire , Noble Colin , Arnott Ian D. , Jones Gareth-Rhys , Lees Charlie W. , Plevris Nikolas 
Published: July 2024

Background: Long-term vedolizumab (VDZ) outcomes in real-world cohorts have been largely limited to 1-year follow-up, with few bio-naïve patients or objective markers of inflammation assessed. Objectives: We aimed to assess factors affecting VDZ persistence including clinical, biochemical and faecal biomarker remission at 1, 3 and 5 years. Design: We performed a retrospective, observational, cohort study. Methods: All adult inflammatory bowel disease (IBD) patients who had received VDZ induction for ulcerative colitis (UC)/IBD-unclassified (IBDU) were included. Baseline phenotype and follow-up data were collected via a review of electronic medical records. Results: We included 290 patients [UC n = 271 (93.4%), IBDU n = 19 (6.6%)] with a median time on VDZ of 27.6 months (interquartile range: 14.4–43.2). At the end of follow-up, a total of 157/290 (54.1%) patients remained on VDZ. The median time to discontinuation was 14.1 months (7.0–23.3). Previous exposure to ⩾1 advanced therapy, steroid use at baseline and disease extension (E3 and E2 versus E1) were independent predictors for worse VDZ persistence. Clinical remission (partial Mayo < 2) was 75.7% (171/226), 72.4% (157/217) and 70.2% (127/181) at years 1, 3 and 5, respectively. Steroid use during maintenance VDZ therapy occurred in 31.7% (92/290), hospitalization in 15.5% (45/290) and surgery in 3.4% (10/291). The rate of serious adverse events was 1.2 per 100 patient-years of follow-up. Conclusion: VDZ effectiveness appears enduring with favourable long-term safety profile. VDZ persistence was influenced by previous exposure to biologics/small molecules, disease distribution and steroid use at baseline in our study.
Cost-effectiveness analysis of 11 pharmacotherapies for recurrent glioblastoma in the USA and China
Authors: Xu Yanan , Xu Boya , Guan Haijing , Zhao Zhigang 
Published: July 2024

Background: Several studies have systematically assessed the efficacy and safety of progressive or recurrent glioblastoma multiforme (GBM). However, the discernible limitations of efficacy and the elevated costs of interventions instigate an investigation into the cost-effectiveness of these treatments. Objectives: This study aimed to evaluate cost-effectivenesses of 11 pharmacotherapeutic interventions for recurrent GBM from the perspective of healthcare payers in the United States (US) and China. Design: A model-based pharmacoeconomic evaluation. Methods: A partitioned survival model was employed to evaluate the cost-effectiveness of 11 distinct drug-based treatments. The clinical efficacy and safety data were obtained from a network meta-analysis, while the medical expenditure and health utility were primarily derived from published literature. One-way sensitivity analyses, scenario analyses, and probabilistic sensitivity analyses (PSA) were performed to scrutinize the impact of potential uncertainties to ensure the robustness of the model. The primary endpoint was the incremental cost-effectiveness ratio. Results: Among the therapeutic interventions evaluated, lomustine emerged as the cheapest option, with costs amounting to $78,998 in the United States and $30,231 in China, respectively. Regorafenib displayed the highest quality-adjusted life years at 0.475 in the United States and 0.465 in China. The one-way sensitivity analyses underscored that drug price was a key factor influencing cost-effectiveness. Both scenario and PSA consistently demonstrated that, considering the willingness-to-pay thresholds, lomustine was a cost-effective treatment with probability of more than 94%. Conclusion: In comparison to the alternative antitumor agents, lomustine was likely to be a cost-effective option for relapsed GBM patients from the perspective of healthcare payers in both the United States and China.
A pooled analysis of clinical outcome in driver-gene negative non-small cell lung cancer patients with MET overexpression treated with gumarontinib
Authors: Yu Yongfeng , Dong Wen , Shi Yanxia , Wu Rong , Yu Qitao , Ye Feng , Zhou Chengzhi , Dong Xiaorong , Li Xingya , Li Yongsheng , Li Zhen , Wu Lin , Pan Yueyin , Shen Hong , Wu Dehua , Xu Zhongyuan , Wu Jinsheng , Xu Nong , Qin Yanru , Zang Aimin , Zhang Jingdong , Zhou Jianya , Zhang Xiaotao , Zhao Yanqiu , Li Fugen , Wang Huizhen , Liu Qi , Han Zhenyong , Li Jin , Lu Shun 
Published: July 2024

Background: MET overexpression represents the most MET aberration in advanced non-small-cell lung cancer (NSCLC). However, except MET exon 14 ( METex14) skipping mutation was recognized as a clinical biomarker, the role of MET overexpression as a predictive factor to MET inhibitor is not clear. Objectives: The purpose of the pooled analysis is to explore the safety and efficiency of gumarontinib, a highly selective oral MET inhibitor, in drive-gene negative NSCLC patients with MET overexpression. Design and methods: NSCLC patients with MET overexpression [immunohistochemistry (IHC) ⩾3+ as determined by central laboratory] not carrying epidermal growth factor receptor mutation, METex14 skipping mutation or other known drive gene alternations who received Gumarontinib 300 mg QD from two single arm studies were selected and pooled for the analysis. The efficacy [objective response rate (ORR), disease control rate (DCR), duration of response, progression-free survival (PFS) and overall survival (OS)] and safety [treatment emergent adverse event (TEAE), treatment related AE (TRAE) and serious AE (SAE) were assessed. Results: A total of 32 patients with MET overexpression were included in the analysis, including 12 treatment naïve patients who refused or were unsuitable for chemotherapy, and 20 pre-treated patients who received ⩾1 lines of prior systemic anti-tumour therapies. Overall, the ORR was 37.5% [95% confidence interval (CI): 21.1–56.3%], the DCR was 81.3% (95% CI: 63.6–92.8%), median PFS (mPFS) and median OS (mOS) were 6.9 month (95% CI: 3.6–9.7) and 17.0 month (95% CI: 10.3–not evaluable), respectively. The most common AEs were oedema (59.4%), hypoalbuminaemia (40.6%), alanine aminotransferase increased (31.3%). Conclusion: Gumarontinib showed promising antitumour activity in driver-gene negative locally advanced or metastatic NSCLC patients with MET overexpression, which warranted a further clinical trial. Trial registration: ClinicalTrials.gov identifier: NCT03457532; NCT04270591.
Efficacy of ferric carboxymaltose or darbepoetin alfa for chemotherapy-induced anemia in patients with esophagogastric or pancreaticobiliary cancer: a retrospective comparative study
Authors: Cho Minkwan , Park Eunkyung , Lee Yong-Pyo , Kim Hongsik , Park Hee Sue , Kim Hee Kyung , Yang Yaewon , Kwon Jihyun , Hyeong Lee Ki , Han Hye Sook 
Published: July 2024

Background: Esophagogastric and pancreaticobiliary cancers are associated with chronic blood loss, poor nutrition, and surgical interventions that interfere with iron absorption. Patients with these cancers often have a higher incidence of chemotherapy-induced anemia (CIA) than patients with other malignancies. Objectives: To investigate the efficacy of intravenous iron or erythropoietin-stimulating agents (ESA) for CIA treatment in patients with esophagogastric or pancreaticobiliary cancer. Design: Retrospective, comparative chart review of patients with esophagogastric or pancreaticobiliary cancer who received ferric carboxymaltose (FCM), or darbepoetin alfa (DA), and myelosuppressive chemotherapy at Chungbuk National University Hospital between June 2018 and December 2022. Methods: To assess the efficacy of FCM or DA over time, data on hemoglobin (Hb) levels were collected from the time of administration of FCM or DA (baseline) until 6 months post-baseline, when available. Results: In total, 214 patients (124 in the FCM and 90 in the DA group) were included in the analysis. The FCM group had a higher maximum Hb level and Hb changes for 3 months (mean ± standard deviation) following FCM or DA administration from baseline than the DA group (11.3 ± 1.5 versus 10.9 ± 1.2 g/dL, p = 0.02 and 2.0 ± 1.4 versus 1.5 ± 1.1 g/dL, p = 0.004, respectively). The FCM group had a higher proportion of Hb responders than the DA group (83.9% versus 68.9%, p = 0.013). Based on multivariable analysis, only the CIA treatment group was a significant factor for Hb response (odds ratio = 2.06, 95% confidence interval = 1.05–4.06, p = 0.036). Conclusion: Both FCM and DA are effective, and FCM showed a higher Hb response than DA for CIA treatment in patients with esophagogastric or pancreaticobiliary cancer. Therefore, further randomized controlled trials should determine the optimal treatment for CIA in patients with these cancers undergoing myelosuppressive chemotherapy.
Analysis of surgical complexity and short-term prognostic indicators in NSCLC patients: neoadjuvant targeted therapy versus neoadjuvant chemoimmunotherapy
Authors: Wang Kun , Yi Hang , Lv Zhuoheng , Jin Donghui , Fu Li , Mao Yousheng 
Published: July 2024

Background: Neoadjuvant therapy improves survival benefits in patients with locally advanced non-small cell lung cancer but increases tissue density, presenting challenges for surgeons. Objectives: To compare the differences in surgical complexity and short-term prognostic outcomes between neoadjuvant targeted therapy (NTT) and neoadjuvant chemoimmunotherapy (NCI). Design/methods: This study enrolled 106 patients underwent curative surgery after neoadjuvant therapy between January 2020 and December 2023 at the National Cancer Center of China. Differences in surgical complexity and short-term prognostic outcomes between the two neoadjuvant therapy cohorts were evaluated. The pathological indicators such as pathological response rate and lymph node upstaging/downstaging were then analyzed. Results: In total, 33 patients underwent NTT and 73 underwent NCI preoperatively. Patients who received NTT showed a higher minimally invasive surgery rate (84.8% versus 53.4%, p < 0.01), shorter operative time (144 versus 184 min, p < 0.01), lower conversion rate (3.3% versus 17.8%, p = 0.03), less postoperative drainage (day 3: 140 versus 200 mL, p = 0.03), and lower incidence of postoperative complications including arrhythmias (6.1% versus 26%, p = 0.02). The pathological response rate in the NTT and NCI groups was 70% and 75%, respectively, with the latter group showing a higher complete pathological response rate. The two groups had no significant differences in major pathological response and lymph node pathological response rate. Conclusion: Patients who received NTT presented fewer surgical challenges for surgeons and had better surgical outcomes than those who received NCI therapy, with comparable pathological response rates between the two cohorts. Accordingly, NTT is the preferred induction regimen for patients harboring mutation status.
Unlocking Potential: Personalized Lifestyle Therapy for Type 2 Diabetes Through a Predictive Algorithm-Driven Digital Therapeutic
Authors: Kannenberg Swantje , Voggel Jenny , Thieme Nils , Witt Oliver , Pethahn Kim Lina , Schütt Morten , Sina Christian , Freckmann Guido , Schröder Torsten 
Published: July 2024

Background: We present a digital therapeutic (DTx) using continuous glucose monitoring (CGM) and an advanced artificial intelligence (AI) algorithm to digitally personalize lifestyle interventions for people with type 2 diabetes (T2D). Method: A study of 118 participants with non–insulin-treated T2D (HbA1c ≥ 6.5%) who were already receiving standard care and had a mean baseline (BL) HbA1c of 7.46% (0.93) used the DTx for three months to evaluate clinical endpoints, such as HbA1c, body weight, quality of life and app usage, for a pre-post comparison. The study also included an assessment of initial long-term data from a second use of the DTx. Results: After three months of using the DTx, there was an improvement of 0.67% HbA1c in the complete cohort and −1.08% HbA1c in patients with poorly controlled diabetes (BL-HbA1c ≥ 7.0%) compared with standard of care ( P < .001). The number of patients within the therapeutic target range (< 7.0%) increased from 38% to 60%, and 33% were on the way to remission (< 6.5%). Patients who used the DTx a second time experienced a reduction of −0.76% in their HbA1c levels and a mean weight loss of −6.84 kg after six months ( P < .001) compared with BL. Conclusions: These results indicate that the DTx has clinically relevant effects on glycemic control and weight reduction for patients with both well and poorly controlled diabetes, whether through single or repeated usage. It is a noteworthy improvement in T2D management, offering a non-pharmacological, fully digital solution that integrates biofeedback through CGM and an advanced AI algorithm.
Dynamic loading response of an additively produced bio-inspired nacre structure with foam and acrylic filling
Authors: Adithya RN , Ganapathy Sakthi Balan , Sakthivel Aravind Raj , Sultan Mohamed Thariq Hameed , Shahar Farah Syazwani 
Published: July 2024

Numerous structures gain inspiration from nature and have been effectively incorporated into different applications such as automobiles and airplanes. In order to effectively withstand impact loads and achieve efficient energy absorption, it is necessary to incorporate appropriate structures along with suitable filler materials. This study examines the energy absorption capacities of a nacre structured core with foam filling at the central nacre cell cavities, as well as an acrylic filling at the top and bottom sides, under low velocity impacts. The design of experiments involved identifying and varying three important design parameters which influence the energy absorption behavior of the composites. Subsequently, fillers were incorporated and the specimens were subjected to drop weight testing. The composite material exhibited minimal deformations while absorbing a maximum energy of 40.87 J. Therefore, it proved that this composite could withstand dynamic impact loads in the absence of fiber face sheets, and adhesion between the PLA-carbon fiber and acrylic fill was also improved under these conditions. The higher energy absorption behavior was obtained due to the intermittent force transfer in the transverse direction due to the presence of the cross webs on the top and bottom of the composite plate. The alternate arrangement of the hard and flexible materials in the composite leads to the suppression of the stress step by step which results in high energy absorption behavior. In order to achieve optimal energy absorption with minimized deformations, the core structure must possess a nacre wall thickness of 2 mm with double cross web design.