bluuebunny/crossref_metadata_2025_split huggingface dataset:
Current status and perspectives of interventional clinical trials for brain metastases: analysis of ClinicalTrials.gov
Authors: Tini Paolo , Marampon Francesco , Giraffa Martina , Bucelli Samira , Niyazi Maximilian , Belka Claus , Minniti Giuseppe 
Published: April 2023

Abstract
Background
The management of brain metastases (BM), the major cause of cancer morbidity and mortality, is becoming an emerging area of interest. Surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS), have historically been the main focal treatments for BM. However, the introduction of innovative targeted- and immune-based therapies is progressively changing the paradigm of BM treatment, resulting in an increase in clinical trials investigating new therapeutic strategies.

Methods
Using ClinicalTrials.gov, the largest clinical trial registry with over 400,000 registered trials, we performed an analysis of phase II and phase III ongoing trials evaluating different systemic therapies, radiotherapy (RT), and surgery given alone or in combination in patients with BM.

Results
One hundred sixty-eight trials, 133 phase II and 35 phase III; the largest part having primarily the curative treatment of patients with BM from lung cancer, breast cancer and melanoma, were selected. One hundred sixty-three trials used systemic therapies. One hundred thirteen used tyrosine kinase inhibitors, more frequently Osimertinib, Icotinib and Pyrotinib, 50 used monoclonal antibodies, more frequently Trastuzumab, Pembrolizumab, Nivolumab, 20 used conventional chemotherapies whilst no oncological active drugs were used in 6 trials. Ninety-six trials include RT; 54 as exclusive treatment and 42 in combination with systemic therapies.

Conclusion
Systemic targeted- and/or immune-based therapies, combined or not with RT, are increasingly used in the routine of BM treatment. SRS is progressively replacing WBRT. All these trials intend to address multiple questions on the management of patients with BMs, including the recommended upfront treatment for different cancer histologies and the optimal timing between systemic therapies and radiation regarding brain control and neurocognitive outcome and quality of life.
Efficacy of concurrent chemoradiotherapy alone for loco-regionally advanced nasopharyngeal carcinoma: long-term follow-up analysis
Authors: Xu An-An , Miao Jing-Jing , Wang Lin , Li An-Chuan , Han Fei , Shao Xun-Fan , Mo Zhi-Wen , Huang Shao-Min , Yuan Ya-Wei , Deng Xiao-Wu , Zhao Chong 
Published: April 2023

Abstract
Background
To analysis the clinical outcomes of concurrent chemoradiotherapy (CCRT) alone based on 10-year results for loco-regionally advanced nasopharyngeal carcinoma (LANPC), so as to provide evidence for individualized treatment strategy and designing appropriate clinical trial for different risk LANPC patients.

Methods
Consecutive patients with stage III-IVa (AJCC/UICC 8th) were enrolled in this study. All patients received radical intensity-modulated radiotherapy (IMRT) and concurrent cisplatin chemotherapy (CDDP). The hazard ratios (HRs) of death risk in patients with T3N0 was used as baseline, relative HRs were calculated by a Cox proportional hazard model to classify different death risk patients. Survival curves for the time-to-event endpoints were analyzed by the Kaplan–Meier method and compared using the log-rank test. All statistical tests were conducted at a two-sided level of significance of 0.05.

Results
A total of 456 eligible patients were included. With 12-year median follow-up, 10-year overall survival (OS) was 76%. 10-year loco-regionally failure-free survival (LR-FFS), distant failure-free survival (D-FFS) and failure-free survival (FFS) were 72%, 73% and 70%, respectively. Based on the relative hazard ratios (HRs) of death risk, LANPC patients were classified into 3 subgroups, low-risk group (T1-2N2 and T3N0-1) contained 244 patients with HR < 2; medium-risk group (T3N2 and T4N0-1) contained 140 patients with HR of 2 – 5; high-risk group (T4N2 and T1-4N3) contained 72 patients with HR > 5. The 10-year OS for patients in low-, medium-, and high-risk group were 86%, 71% and 52%, respectively. Significantly differences of OS rates were found between each of the two groups (low-risk group vs. medium-risk group, P < 0.001; low-risk group vs. high-risk group, P < 0.001; and medium-risk group vs. high-risk group, P = 0.002, respectively). Grade 3–4 late toxicities included deafness/otitis (9%), xerostomia (4%), temporal lobe injury (5%), cranial neuropathy (4%), peripheral neuropathy (2%), soft tissue damage (2%) and trismus (1%).

Conclusions
Our classification criteria demonstrated that significant heterogeneity in death risk among TN substages for LANPC patients. IMRT plus CDDP alone maybe suitable for low-risk LANPC (T1-2N2 or T3N0-1), but not for medium- and high-risk patients. These prognostic groupings provide a practicable anatomic foundation to guide individualized treatment and select optimal targeting in the future clinical trials.
Is the traction table necessary to treat femoral fractures with intramedullary nailing? A meta-analysis
Authors: He Yu-kun , Wang Yi-chong , Li Feng-feng 
Published: April 2023

AbstractBackgroundThe traction table is generally used in femoral intramedullary nailing surgery. Recently, some published studies have shown that the same or better treatment effects can be gotten without a traction table. It remains no consensus on this issue.MethodsThe Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline was applied in this study. We searched PubMed, Embase, Web of Science, and Cochrane Library databases for eligible studies. The random-effect model was used to calculate the standardized mean difference (SMD) and risk ratios with 95% CIs. Trial sequential analysis (TSA) was performed to verify the results.ResultsThe pooled estimates of seven studies, including 266 cases each in the manual traction group and traction table group, indicated that manual traction could shorten operative time [SMD, − 0.77; 95% CI (− 0.98, − 0.55);P < 0.00001] and preoperative set-up time [SMD, − 2.37; 95% CI (− 3.90, − 0.84);P = 0.002], but it would not reduce intraoperative blood loss volume and fluoroscopy time. No statistical difference was found in their fracture healing time, postoperative Harris scores, and malunion rate. The use of a Traction repositor could reduce the set-up time [SMD, − 2.48; 95% CI (− 4.91, − 0.05);P < 0.00001].ConclusionsCompared with manual traction, the traction table in femoral intramedullary nailing surgery lengthened operative time and preoperative set-up time. At the same time, it did not show significant advantages in reducing blood loss volume and fluoroscopy time, or improving prognosis. In clinical practice, the optimal surgical plan must be made on a case-by-case basis to avoid unnecessary traction table use.
Practical considerations for determination of scapular internal rotation and its relevance in reverse total shoulder arthroplasty planning
Authors: Siegert Paul , Meraner Dominik , Pokorny-Olsen Alexandra , Akgün Doruk , Korn Gundobert , Albrecht Christian , Hofstaetter Jochen G. , Moroder Philipp 
Published: April 2023

Abstract
Background
Scapulothoracic orientation, especially scapular internal rotation (SIR) may influence range of motion in reverse total shoulder arthroplasty (RTSA) and is subjected to body posture. Clinical measurements of SIR rely on apical bony landmarks, which depend on changes in scapulothoracic orientation, while radiographic measurements are often limited by the restricted field of view (FOV) in CT scans. Therefore, the goal of this study was (1) to determine whether the use of CT scans with a limited FOV to measure SIR is reliable and (2) if a clinical measurement could be a valuable alternative.

Methods
This anatomical study analyzed the whole-body CT scans of 100 shoulders in 50 patients (32 male and 18 female) with a mean age of 61.2 ± 20.1 years (range 18; 91). (1) CT scans were rendered into 3D models and SIR was determined as previously described. Results were compared to measurements taken in 2D CT scans with a limited FOV. (2) Three apical bony landmarks were defined: (the angulus acromii (AA), the midpoint between the AA and the coracoid process tip (C) and the acromioclavicular (AC) joint. The scapular axis was determined connecting the trigonum scapulae with these landmarks and referenced to the glenoid center. The measurements were repeated with 0°, 10°, 20°, 30° and 40° anterior scapular tilt.

Results
Mean SIR was 44.8° ± 5.9° and 45.6° ± 6.6° in the 3D and 2D model, respectively (p < 0.371). Mean difference between the measurements was 0.8° ± 2.5° with a maximum of 10.5°. Midpoint AA/C showed no significant difference to the scapular axis at 0° (p = 0.203) as did the AC-joint at 10° anterior scapular tilt (p = 0.949). All other points showed a significant difference from the scapular axis at all degrees of tilt.

Conclusion
2D CT scans are reliable to determine SIR, even if the spine is not depicted. Clinical measurements using apical superficial scapula landmarks are a possible alternative; however, anterior tilt influenced by posture alters measured SIR.
FMRP binds Per1 mRNA and downregulates its protein expression in mice
Authors: Tang Xiangrong , Zhang Jing , Li Xin , Hu Ying , Liu Dengfeng , Li Jia-Da , Lu Renbin 
Published: April 2023

AbstractFMRP, an RNA-binding protein, has previously shown to be involved in regulation of circadian rhythms in flies and mice. However, the molecular mechanism remains elusive. Here we demonstrate that core circadian component Per1 mRNA was a target of FMRP and the association leads to reduced PER1 expression. In Fmr1 KO mice, the oscillation of PER1 protein expression was significantly affected in a temporal and tissue-dependent pattern when compared to WT mice. Our work thus identified Per1 mRNA as a novel target of FMRP and suggested a potential role of FMRP in regulation of circadian function.
Autologous adipose-derived mesenchymal stem cell therapy reverses detrusor underactivity: open clinical trial
Authors: Coelho Henrique Rodrigues Scherer , Neves Silvia Cordeiro das , da Silva Menezes Jovino Nogueira , Antoniolli-Silva Andréia Conceição Milan Brochado , Oliveira Rodrigo Juliano 
Published: April 2023

Abstract
Background
Detrusor underactivity is a disease that can cause chronic urinary tract infection, urinary tract infection, urinary retention and kidney failure and has no effective treatment in traditional medicine. The present research evaluated the effects of cell therapy with adipose tissue-derived stem cells on the treatment of detrusor underactivity in men.

Methods
Nine male patients diagnosed with a clinical and urodynamic diagnosis of detrusor underactivity were evaluated and underwent two transplants via cystourethroscopy, with 2 × 106 cells/transplant, performed by intravesical injection at five points on the bladder body above the vesical trigone.

Results
Cell therapy increased the maximum flow from 7.22 ± 1.58 to 13.56 ± 1.17, increased the mean flow from 3.44 ± 0.74 to 5.89 ± 0.45, increased the urinated volume from 183.67 ± 49.28 to 304.78 ± 40.42 and reduced the residual volume in the uroflowmetry exam from 420.00 ± 191.41 to 118.33 ± 85.51; all of these changes were significant (p < 0.05). There were also significant increases (p < 0.05) in maximum flow (from 7.78 ± 0.76 to 11.56 ± 1.67), maximum detrusor pressure (from 20.22 ± 8.29 to 41.56 ± 5.75), urinary volume (from 244 ± 27.6 to 418.89 ± 32.73) and bladder contractility index (from 44.33 ± 4.85 to 100.56 ± 8.89) in the pressure flow study. Scores on the International Consultation on Incontinence Questionnaire decreased from 11.44 ± 1.43 to 3.78 ± 0.78 after cell therapy, which indicates an improvement in quality of life and a return to daily activities. No complications were observed in the 6-month follow-up after cell therapy. Before treatment, all patients performed approximately five intermittent clean catheterizations daily. After cell therapy, 7/9 patients (77.78%) did not need catheterizations, and the number of catheterizations for 2/9 patients (22.28%) was reduced to two catheterizations/day.

Conclusions
The results indicate that stem cell therapy led to improvements in voiding function. Cell therapy with adipose tissue-derived stem cells is safe and should be considered a new therapeutic option for the treatment of detrusor underactivity.
Trial registration ISRCTN, ISRCTN23909398; Registered 15 March 2021—Retrospectively registered, https://doi.org/10.1186/ISRCTN23909398
Unique iterative solution for high-order nonlinear fractional q-difference equation based on $\psi -(h,r)$-concave operators
Authors: Wang Jufang , Wang Si , Yu Changlong 
Published: April 2023

AbstractAn objective of this paper is to investigate the boundary value problem of a high-order nonlinear fractional q-difference equation. It was to obtain a unique iterative solution for this problem by means of applying a novel fixed-point theorem of $\psi -(h,r)$
ψ
−
(
h
,
r
)
-concave operator, in which the operator is increasing and defined in ordered sets. Moreover, we construct a monotone explicit iterative scheme to approximate the unique solution. Finally, we give an example to illustrate the use of the main result.
Numerical solution of system of second-order integro-differential equations using nonclassical sinc collocation method
Authors: Ghasemi Mohammad , Mohammadi Keivan , Alipanah Amjad 
Published: April 2023

AbstractIn this paper, a nonclassical sinc collocation method is constructed for the numerical solution of systems of second-order integro-differential equations of the Volterra and Fredholm types. The novelty of the approach is based on using the new nonclassical weight function for sinc method instead of the classic ones. The sinc collocation method based on nonclassical weight functions is used to reduce the system of integro-differential equations to a system of algebraic equations. Furthermore, the convergence of the method is proposed theoretically, showing that the method converges exponentially. By solving some examples, including problems with a non-smooth solution, the results are compared with other existing results to demonstrate the efficiency of the new method.
The furosemide stress test predicts the timing of continuous renal replacement therapy initiation in critically ill patients with acute kidney injury: a double-blind prospective intervention cohort study
Authors: Zhang Kun , Zhang Haohua , Zhao Chai , Hu Zhenjie , Shang Jiuyan , Chen Yuhong , Huo Yan , Zhao Congcong , Li Bin , Guo Suzhi ,   the Hebei Key Laboratory of Critical Disease Mechanism and Intervention
Published: April 2023

Abstract
Background
Continuous renal replacement therapy (CRRT) remains a crucial treatment for critically ill patients with acute kidney injury (AKI), although the timing of its initiation is still a matter of contention. Furosemide stress testing (FST) may be a practical and beneficial prediction instrument. This research was meant to examine if FST can be used to identify high-risk patients for CRRT.

Methods
This study is a double-blind, prospective interventional cohort study. For patients with AKI receiving intensive care unit (ICU) income, FST was selected with furosemide 1 mg/kg intravenous (1.5 mg/kg intravenous if a loop diuretic was received within 7 days). Urinary volume more than 200 ml at 2 h after FST was FST-responsive, less than 200 ml was FST-nonresponsive. The FST results are kept strictly confidential from the clinician, who decides whether to initiate CRRT based on laboratory testing and clinical symptoms other than the FST data. The FST data are concealed from both the patients and the clinician.

Results
FST was delivered to 187 of 241 patients who satisfied the inclusion and exclusion criteria, with 48 patients responding to the test and 139 patients not responding. 18/48 (37.5%) of the FST-responsive patients received CRRT, while 124/139 (89.2%) of the FST-nonresponsive patients received CRRT. There was no significant difference between the CRRT and non-CRRT groups in terms of general health and medical history (P > 0.05). Urine volume after 2 h of FST was considerably lower in the CRRT group than in the non-CRRT group (35 ml, IQR5-143.75 versus 400 ml, IQR210-890; P = 0.000). FST non-responders were 2.379 times more likely to initiate CRRT than FST responders (95% CI 1.644–3.443, P = 0.000). The area under the curve (AUC) for initiating CRRT was 0.966 (cutoff of 156 ml, sensitivity of 94.85%, specificity of 98.04%, P < 0.001).

Conclusion
This study demonstrated that FST is a safe and practical approach for predicting the initiation of CRRT in critically ill AKI patients.
Trial registrationwww.chictr.org.cn, ChiCTR1800015734, Registered 17 April 2018.
Patient Information Resources on Cardiovascular Health After Cancer Treatment: An Audit of Australian Resources
Authors: Diaz Abbey , McErlane Jorja , Jeon Mi Hye , Cunningham Joan , Sullivan Victoria , Garvey Gail 
Published: April 2023

PURPOSE Up to one third of patients with cancer are thought to experience adverse cardiovascular events after their cancer diagnosis and treatment. High-quality information about cancer treatment-related cardiovascular disease can prepare patients and reduce anxiety. The aim of this project was to systematically identify Australian online information resources about cardiovascular health after cancer and assess the readability, understandability, actionability, and cultural relevance for Aboriginal and Torres Strait Islander patients. METHODS We conducted systematic Google and website searches to identify potentially relevant resources. Eligibility was assessed using predefined criteria. For each eligible resource, we summarized the content and assessed readability, understandability, actionability, and cultural relevance for Aboriginal and Torres Strait Islander people. RESULTS Seventeen online resources addressing cardiovascular health after cancer were identified: three focused solely on cardiovascular health and the remaining 14 dedicated between <1% and 48% of the word count to this topic. On average, three of 12 predefined content areas were covered by the resources. Only one resource was considered comprehensive, covering eight of 12 content areas. Overall, 18% of the resources were deemed readable for the average Australian adult, 41% deemed understandable, and only 24% had moderate actionability. None of the resources were considered culturally relevant for Aboriginal and Torres Strait Islander people, with 41% addressing only one of the seven possible criteria and the remainder addressing none of the criteria. CONCLUSION This audit confirms a gap in online information resources about cardiovascular health after cancer. New resources, especially for Aboriginal and Torres Strait Islander people, are needed. The development of such resources must be done through involvement and collaboration with Aboriginal and Torres Strait Islander patients, families, and carers, through a codesign process.
Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma
Authors: Motzer Robert J. , Hutson Thomas E. , Tomczak Piotr , Michaelson M. Dror , Bukowski Ronald M. , Oudard Stéphane , Negrier Sylvie , Szczylik Cezary , Pili Roberto , Bjarnason Georg A. , Garcia-del-Muro Xavier , Sosman Jeffrey A. , Solska Ewa , Wilding George , Thompson John A. , Kim Sindy T. , Chen Isan , Huang Xin , Figlin Robert A. 
Published: April 2023

Purpose A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-α) in progression-free survival (primary end point) as first-line treatment for metastatic renal cell carcinoma (RCC). Final survival analyses and updated results are reported. Patients and Methods Seven hundred fifty treatment-naïve patients with metastatic clear cell RCC were randomly assigned to sunitinib 50 mg orally once daily on a 4 weeks on, 2 weeks off dosing schedule or to IFN-α 9 MU subcutaneously thrice weekly. Overall survival was compared by two-sided log-rank and Wilcoxon tests. Progression-free survival, response, and safety end points were assessed with updated follow-up. Results Median overall survival was greater in the sunitinib group than in the IFN-α group (26.4 v 21.8 months, respectively; hazard ratio [HR] = 0.821; 95% CI, 0.673 to 1.001; P = .051) per the primary analysis of unstratified log-rank test ( P = .013 per unstratified Wilcoxon test). By stratified log-rank test, the HR was 0.818 (95% CI, 0.669 to 0.999; P = .049). Within the IFN-α group, 33% of patients received sunitinib, and 32% received other vascular endothelial growth factor–signaling inhibitors after discontinuation from the trial. Median progression-free survival was 11 months for sunitinib compared with 5 months for IFN-α ( P < .001). Objective response rate was 47% for sunitinib compared with 12% for IFN-α ( P < .001). The most commonly reported sunitinib-related grade 3 adverse events included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%). Conclusion Sunitinib demonstrates longer overall survival compared with IFN-α plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic RCC. The overall survival highlights an improved prognosis in patients with RCC in the era of targeted therapy.
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: The ADIMOS Case-Control Study
Authors: Paccou Julien , Badr Sammy , Lombardo Daniela , Khizindar Huda , Deken Valérie , Ruschke Stefan , Karampinos Dimitrios C , Cotten Anne , Cortet Bernard 
Published: April 2023

Abstract

Context
Noninvasive assessment of proton density fat fraction (PDFF) by magnetic resonance imaging (MRI) may improve the prediction of fractures.

Objective
This work aimed to determine if an association exists between PDFF and fractures.

Methods
A case-control study was conducted at Lille University Hospital, Lille, France, with 2 groups of postmenopausal women: one with recent osteoporotic fractures, and the other with no fractures. Lumbar spine and proximal femur (femoral head, neck, and diaphysis) PDFF were determined using chemical shift-based water-fat separation MRI (WFI) and dual-energy x-ray absorptiometry scans of the lumbar spine and hip. Our primary objective was to determine the relationship between lumbar spine PDFF and osteoporotic fractures in postmenopausal women. Analysis of covariance was used to compare PDFF measurements between patient cases (overall and according to the type of fracture) and controls, after adjusting for age, Charlson comorbidity index (CCI) and BMD.

Results
In 199 participants, controls (n = 99) were significantly younger (P &lt; .001) and had significantly higher BMD (P &lt; 0.001 for all sites) than patient cases (n = 100). A total of 52 women with clinical vertebral fractures and 48 with nonvertebral fractures were included. When PDFFs in patient cases and controls were compared, after adjustment on age, CCI, and BMD, no statistically significant differences between the groups were found at the lumbar spine or proximal femur. When PDFFs in participants with clinical vertebral fractures (n = 52) and controls were compared, femoral neck PDFF and femoral diaphysis PDFF were detected to be lower in participants with clinical vertebral fractures than in controls (adjusted mean [SE] 79.3% [1.2] vs 83.0% [0.8]; P = 0.020, and 77.7% [1.4] vs 81.6% [0.9]; P = 0.029, respectively).

Conclusion
No difference in lumbar spine PDFF was found between those with osteoporotic fractures and controls. However, imaging-based proximal femur PDFF may discriminate between postmenopausal women with and without clinical vertebral fractures, independently of age, CCI, and BMD.