bluuebunny/crossref_metadata_2025_split huggingface dataset:
A phase 1 randomized, placebo-controlled study to investigate potential interactions between ASP8062, a positive allosteric modulator of the GABAB receptor, and morphine in recreational opioid users
Authors: Ito Mototsugu , Walzer Mark , Blauwet Mary Beth , Spence Anna , Heo Nakyo , Kelsh Debra , Blahunka Paul , Erdman Jay , Alsharif Mohamad Nour , Marek Gerard J 
Published: April 2023

Background: Recent increases in opioid use and subsequent opioid use disorder are a major public health crisis in the United States. Aims: This phase 1 randomized, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics (PKs) of ASP8062, a γ-aminobutyric acid B receptor-positive allosteric modulator, with and without administration of morphine in participants who used opioids recreationally. Methods: Participants were randomly assigned (2:1) to daily dosing with ASP8062 25 mg or placebo on days 1–10. On day 10, all participants received morphine as a single oral dose of 45 mg; assessments were performed on days 11–16. The primary end point was safety, evaluated as the nature, frequency, and severity of adverse events, and end-tidal CO2 levels. PK end points were a secondary outcome measure. Results: A total of 24 participants (aged 21–54 years) received ASP8062 ( n = 16) or placebo ( n = 8). There were no deaths or serious adverse events leading to treatment discontinuation during the study. Most adverse events were mild, with numerically lower absolute number of adverse events reported with ASP8062 plus morphine versus placebo plus morphine. ASP8062 plus morphine did not increase respiratory depression, potential drug abuse- or withdrawal-related adverse events. There were no significant PK interactions. Conclusions: In this phase 1 study, we did not observe any unexpected safety signals or notable PK interactions with concomitant morphine administration. These data suggest a potentially low risk for an increase in drug abuse- or withdrawal-related adverse events or respiratory distress in participants exposed to ASP8062 and morphine.
The study of self-regulating α-TCP based composite by micro/nano scaled silk fibroin and α-CSH on physicochemical and biological properties of bone cement
Authors: Song Yaping , Zhao Liqin , Niu Baolong , Zhao Hongyun , Hu Yinchun , Wei Yan , Huang Di , Wang Tongxin , Lian Xiaojie 
Published: April 2023

A novel self-hardening α-tricalcium phosphate (α-TCP) bone cement complexed with different content of α-calcium sulfate hemihydrate (α-CSH) and micrometer hydroxyapatite mineralized silk fibroin (HA-SF) using micro/SF as curing liquid has been investigated in this work, which was capable of tunable setting time, degradation, mechanical property and ability to anti-washout. After addition 0 ∼ 25% α-CSH to the α-TCP cement with SFFs as curing liquid, it shortened the setting time of the modified composite to 10 ∼ 30 min. Furthermore, the addition of SFFs improved the compressive strength of the composite from 5.41 MPa to 9.44 MPa. The composites with both Na2HPO4 and SFFs as curing liquid showed good anti-collapse performance. The weight loss ratio of bone cement was −0.18 ∼ 12.08% in 4 weeks when the content of α-CSH in α-TCP/α-CSH was between 0 ∼ 25 wt%. During the degradation of α-CSH, the amorphous α-TCP were deposited as hydroxyapatite to formed a plate-like products on the surface of composite. Compared to the composite with Na2HPO4 solution as the curing liquid, alkaline phosphatase (ALP) activity of the composites using SFFs as curing liquid were maintained at high levels on the 14th day especially when the Ca/P ratio was 1.7. This study provides a theoretical basis for the regeneration of bone defects guided by bone cement materials.
Impact of follow-up adherence on disease activity in childhood-onset systemic lupus erythematosus (cSLE)
Authors: Nelson Meghan Corrigan , Mosley Colleen , Villacis-Nunez D Sofia , Rouster-Stevens Kelly , Thakral Amit 
Published: April 2023

Background/Purpose: Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease, with a potential for significant disease damage, morbidity, and mortality. In comparison to the adult population, childhood-onset SLE (cSLE) tends to be more aggressive given the higher preponderance of renal and neuropsychiatric disease and increased disease activity. There is a paucity of literature examining relationship between disease activity, rheumatology follow-up visits, and health care utilization. The objective of this study is to determine whether adherence with outpatient clinic visits would affect disease activity in patients with childhood-onset systemic lupus erythematosus (cSLE). Methods 41 children <18 years of age at time of diagnosis with SLE who met Systemic Lupus International Collaborative Clinics (SLICC) criteria and not evaluated in clinic within the previous 120-day period were identified as eligible for inclusion. Patients were continuously searched between December 2021 and July 2022 for eligibility evaluation. Through retrospective chart review, we assessed disease activity (SLE Disease Activity Index) at the last clinic visit. The patients were stratified into two cohorts of lower and higher disease activity, with SLE disease activity index (SLEDAI) ≤ 3 and SLEDAI ≥ 4, respectively. Descriptive statistics and Willcox Rank Sum (numerical variables) and Fisher’s test (categorical variables) were used to compare these two groups. Results Clinical, epidemiological, and serological data were compared between the two groups, with observed statistically significant differences to include current use of high dose prednisone associated with higher SLEDAI scores ( p = 0.019). In nonparametric analysis, time to follow-up ( p < 0.001), hospitalizations ( p = 0.017), and Emergency Department visits (ED) ( p < 0.001) were found to be associated with higher SLEDAI scores. Conclusion Our findings suggest that cSLE patients with higher disease activity are at risk for increased health care utilization with respect to ED visits as well as hospitalizations in the setting of follow-up nonadherence. While further studies are required to enhance our understanding of this association, this links the importance of disease-related outcome and routine outpatient visits in this particularly vulnerable patient population.
Comparison of the Correlation Between Coagulation Indices and Rivaroxaban Concentrations
Authors: Wu Tingting , Wu Shuyi , Li Meijuan , Zhang Jinhua 
Published: April 2023

Background: Rivaroxaban has predictable pharmacokinetics and pharmacodynamics. However, monitoring rivaroxaban concentrations should be provided for special patients with hepatic insufficiency, high bleeding risk, and high thrombotic risk. Objective: This study aimed to correlate chromogenic anti-Xa assay, prothrombin time (PT), activated partial thromboplastin time (APTT), thromboelastogram reaction time (TEG R-time), and rivaroxaban concentration measured by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) (MS-Riva). Methods: Peripheral venous blood was collected from recruited patients 30 minutes before and 2 to 4 hours after drug administration. High-performance liquid chromatography-tandem mass spectrometry and chromogenic anti-Xa assay measured rivaroxaban concentration. Different assays were compared by Pearson correlation coefficient and Bland-Altman analysis. Results: A total of 104 patients with 191 plasma were included in the study. Overall analysis shows that chromogenic anti-Xa assay, PT, APTT, and TEG R-time strongly correlated with MS-Riva ( r = 0.986; r = 0.884; r = 0.741; r = 0.739; P < 0.001). Rivaroxaban peak concentration detected by HPLC-MS/MS (MS-peak) showed a very strong correlation with the chromogenic anti-Xa assay ( r = 0.977, P < 0.001) and moderate correlation with PT, APTT, and TEG R-time ( r = 0.670; r = 0.571; r = 0.481, P < 0.001). Rivaroxaban trough concentration detected by HPLC-MS/MS (MS-trough) correlated strongly with the chromogenic anti-Xa assay ( r = 0.884, P < 0.001), weakly with APTT ( r = 0.313; P = 0.043), and not significantly with PT and TEG R-time ( P = 0.140; P = 0.341). Conclusion and Relevance: High-performance liquid chromatography-tandem mass spectrometry/MS is the preferred choice for monitoring peak and tough concentrations, followed by anti-Xa, while PT is only suitable for peak concentrations. This study can help the clinicians to better adjust the medication regimen and reduce the risk of recurrence of thrombosis as well as the risk of bleeding.
Open Reduction and Internal Fixation of the Posterior Malleolus Fragment in Ankle Fractures Improves the Patient-Rated Outcome: A Systematic Review
Authors: Miksch Rainer Christoph , Herterich Viktoria , Barg Alexej , Böcker Wolfgang , Polzer Hans , Baumbach Sebastian Felix 
Published: April 2023

Background: The best treatment strategy for fractures to the posterior malleolus (PM) is still intensively debated. The aim of this systematic review was to compare the patient-rated outcome following open reduction and internal fixation (ORIF) for fractures of the PM to either closed reduction using AP screws (CRIF) or no treatment in bi- or trimalleolar ankle fractures. Methods: Systematic literature research (MEDLINE (PubMed), CINAHL, Scopus, Central and EMBASE) according to the PICOS and PRISMA guidelines. Eligible were studies comparing the outcome following ORIF to any other treatment strategy for fractures to the posterior malleolus in isolated bi- or trimalleolar ankle fractures. Results: Twelve studies were eligible for a qualitative analysis and 6 for a quantitative analysis. Overall, a considerable heterogeneity among the studies was observed. The most commonly used outcome score was the American Orthopaedic Foot & Ankle Society ankle-hindfoot score (AOFAS). The final follow-up ranged from 12 to 160 months. Four studies compared ORIF to CRIF of the PM. The quantitative analysis revealed significantly better AOFAS scores for ORIF (90.9 vs 83.4 points; P < .001; I2 = 0%). Three studies compared ORIF to untreated PM fragment. The quantitative analysis again revealed superior AOFAS scores for ORIF (92.0 vs 82.5 points; P < .001; I2 = 99%). A similar trend was observed for the Ankle Fracture Scoring System and American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire scores as well as the quality of reduction. Conclusion: Despite a considerable heterogeneity, the data available point to a superior outcome following ORIF for fractures to the PM when compared to CRIF or no treatment.
A systems approach to multilingual language attitudes: A case study of Montréal, Québec, Canada
Authors: Feng Ruo Ying , Tiv Mehrgol , Kutlu Ethan , Gullifer Jason W. , Palma Pauline , O’Regan Elisabeth , Vingron Naomi , Doucerain Marina M. , Titone Debra 
Published: April 2023

Purpose: People are shaped holistically by dynamic and interrelated individual and social-ecological systems. This perspective has been discussed in the context of varied aspects of bilingual experiences, namely language acquisition and development. Here, we applied a Systems Framework of Bilingualism to language attitudes, which may be especially responsive to social-ecological influences. Methodology: One hundred twenty-three French–English bilingual adults ( Mage = 21.20, SD = 3.21) completed self-report questionnaires on demographic information and their attitudes toward languages. A subset of these bilinguals ( n = 73) completed a social network survey. Data and analysis: We used language-tagged social network analysis and geospatial demographic analysis to examine the role of individual characteristics (i.e., first language), interpersonal language dynamics (i.e., person-to-person interactions), and ecological language dynamics (i.e., neighborhood language exposure). Findings and Conclusions: At an individual level, we found that bilinguals’ language background (i.e., first language) predicted attitudes of solidarity toward a language (i.e., whether a language is associated with personal identity and belongingness). When considering sociolinguistic layers of influence, we found that bilinguals’ social network and neighborhood-level language exposure jointly predicted their attitudes of solidarity toward a language, as well as their attitudes toward the protection of minority languages. Originality: While most studies have examined language experience in a unidimensional nature, the present study investigated multilingual language attitudes by considering multiple systems within a social-ecological framework. Implications: Taken together, the results suggest that several interrelated interpersonal and ecological systems are associated with language attitudes, which could have important implications for planning future language policies in multilingual societies such as Montréal.
Optional or optimal? off-label stenting for intracranial atherosclerotic stenosis: A scoping review
Authors: Zhao Zhongyu , Liang Wenzhao , Yan Lei , Zhang Kai , Kong Huijing , Mang Jing 
Published: April 2023

Background Intracranial atherosclerotic stenosis is a major cause of ischemic stroke. In addition to the Wingspan stent system, several self-expanding stents have been used off-label to treat intracranial atherosclerotic stenosis lesions. The purpose of this review is to assess the existing data on the off-label use of self-expanding stents in intracranial atherosclerotic stenosis, to highlight methodological limitations in current study designs, and thus providing strategies and precautions for clinical practice. Methods The PubMed, EMBASE, and the Cochrane Library databases were systematically searched for relevant articles published up to April 2022. In addition to the meta analysis of Enterprise, Neuroform EZ and closed cell stent respectively, we used a narrative synthesis to summarize and discuss the appropriate strategies and precautions for the use of each stent. Results We identified 17 studies (1091 patients with 1124 lesions) reporting 6 types of off-label self-expanding stents. The most common endpoints reported were incidence of short-term complications (range: 0–15.8%, median: 3.8%), long-term complications (range: 0–12.0%, median: 0%). Potential risks include infeasibility of stenting hard lesions or tortuous vessels, stent migration, and in-stent thrombosis. Less is known about the conditions that are appropriate for an optimal stent (e.g., open-cell, close-cell, hybrid cell). There was considerable heterogeneity across studies with regards to study populations and study designs. Conclusions The potential risks and benefits should be carefully considered when using off-label stents for intracranial atherosclerotic stenosis, particularly given the current evidence power. As a potential option for the Wingspan stent, based on device's approval only, a tailored approach with lesion-specific devices could be beneficial in certain patients.
Worsening of anemia increases the risks of complications and prolonged length of stay following revision total shoulder arthroplasty
Authors: Grovu Radu , Quan Theodore , Wei Chapman , Das Avilash , Nguyen Andrew , Tabaie Sean , Zimmer Zachary R 
Published: April 2023

Background There are no studies currently in the literature that assesses complications following revision total shoulder arthroplasty (TSA) in patients with varying severity of anemia. The purpose of this study was to determine the impact of preoperative anemia severity on postoperative complications following revision TSA. Methods Patients undergoing revision TSA from 2013 to 2019 were queried in a national database. Based on previous studies’ definitions of anemia, three subgroups were stratified: patients without anemia (hematocrit >36% for women, hematocrit >39% for men), patients with mild anemia (hematocrit 33% to 36% for women, hematocrit 33% to 39% for men) and patients with moderate to severe anemia (hematocrit <33% for both women and men). In this analysis, patient demographics, comorbidities, and postoperative complications were compared between the three groups. Results Of 1559 total patients undergoing revision TSA, 1178 patients (75.6%) did not have anemia, 255 (16.3%) had mild anemia, and 126 (8.1%) had moderate/severe anemia. Following adjustment on multivariate analysis, patients with mild anemia were more likely to have postoperative transfusion and extended length of stay compared to non-anemic patients. Patients with moderate/severe anemia were at increased risk of postoperative transfusion, sepsis, extended length of stay, and reoperation compared to non-anemic patients. Discussion From mild anemia to moderate/severe anemia, there was a stepwise increase in the risk of postoperative complications. Our study showed that there is clinical value in the preoperative correction of anemia for these patients as it relates to complications and hospital stay. Level of Evidence III.
Promoting Chinese Students’ Creative Performance Through Collaborative Reasoning
Authors: Ma (马淑风) Shufeng , Zhou (周茜楠) Qiannan , Li (李亚光) Yaguang , Chen (陈森宇) Senyu 
Published: April 2023

Purpose Creativity is highly valued by modern society; however, in China, there is a major challenge in creating school-based curricula or courses that promote students’ creativity. This study introduced an interactive learning format called Collaborative Reasoning (CR). The goal was to investigate whether CR would improve a student's ability to generate creative ideas. Design/Approach/Methods The data comprised 474 seventh graders from eight classes in a rural middle school in northern China. The eight classes were randomly assigned to two conditions: Four classes participated in CR discussions, and the remaining four classes were taught via teacher-directed Chinese reading classes. After participating in the CR discussions, students completed a Realistic Presented Problem test that was designed to evaluate their creative performance. Findings The results indicated that compared to the control students, CR students generated more effective solutions (fluency) and proposed a greater variety of solutions (flexibility) to three realistic problems. The solutions proposed by the CR students were more unique (novelty) and more useful in real-life situations (usefulness) than those proposed by the control group. Originality/Value Providing abundant opportunities for the exchange of ideas in a social context can boost students’ performance in creative problem-solving.
Treatment of C5 Palsy: An International Survey of Peripheral Nerve Surgeons
Authors: Lubelski Daniel , Hersh Andrew M. , Feghali James , Sciubba Daniel M. , Witham Timothy , Bydon Ali , Theodore Nicholas , Belzberg Allan J. 
Published: April 2023

Study Design International survey. Objectives C5 palsy (C5P) is a neurological complication affecting 5-10% of patients after cervical decompression surgery. Most cases improve with conservative treatment; however, nearly 20% of patients may be left with residual deficits. Guidelines are lacking on C5P management and timing of surgical intervention. Therefore, we sought to survey peripheral nerve surgeons on their management of C5P. Methods An online survey was distributed centered around a patient with C5P after posterior cervical decompression and fusion. Questions included surgeon demographics, diagnostic modalities, and timing and choice of operation. Responses were summarized and the chi-squared and Kruskal-Wallis H tests were used to examine differences across specialties. Results A total of 154 surgeons responded to the survey, of which 59 (38%) indicated that they manage C5P cases. Average time prior to operating was 4.5 ± 2.2 months for complete injuries and 6.6 ± 3.2 months for partial injuries, with neurosurgeons significantly more likely to wait longer periods for complete ( P = .01) and partial injuries ( P = .03). Foraminotomies were selected by 19% of surgeons, while 92% selected nerve transfers. Transfer of the ulnar nerve to the musculocutaneous nerve was the most common choice (81%), followed by transfer of the radial nerve to the axillary nerve (58%). Conclusion Consensus exists among peripheral nerve surgeons on the use of nerve transfers for surgical treatment in cases with severe motor weakness failing to improve. Most surgeons advocate for early intervention in complete injuries. Disagreement concerns the type of nerve transfer employed, timing of surgery, and efficacy of foraminotomy.
Efficacy of Platelet-Rich Plasma for Chronic Lateral Ankle Instability After Modified Broström-Gould surgery: A Randomized, Single-Blinded, Prospective Controlled Trial
Authors: Sabaghzadeh Amir , Zarei Kurdkandi Hooshmand , Ebrahimpour Adel , Biglari Farsad , Jafari Kafiabadi Meisam 
Published: April 2023

Background: Modified Broström-Gould (MBG) surgery is frequently used for chronic lateral ankle instability (CLAI). However, conventional postoperative management (CPOM) due to prolonged immobilization may have adverse effects on tendons, ligaments, and joints, causing stiffness. This prospective, randomized controlled trial aimed to determine outcomes among patients randomized to receive CPOM plus ultrasonography-guided triple injections of leukocyte-rich platelet-rich plasma (LR-PRP) compared to patients who receive only CPOM after MBG surgery. Methods: The present study included 40 patients with symptomatic CLAI who were candidates for the MBG surgery. The patients were randomized into 2 groups of 20, the control and PRP groups. In the PRP group, patients were injected with 3 doses of LR-PRP solution using ultrasonographic guidance. In the first injection, 2 mL of LR-PRP was injected near the injury site, and in the second and third injections, 4 mL of LR-PRP was injected in the tibiotalar joint. All patients received a short leg splint for 2 weeks, followed by 4 weeks in a walking boot. The primary outcome measure was the visual analog scale (VAS), and the secondary outcome measures were the American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale and ankle total range of motion (total ROM). The assessment was performed at baseline and 3 and 6 months after surgery. Results: The mean VAS and AOFAS scores improved significantly in both groups 6 months after surgery ( P < .001). However, the PRP group did not significantly improve in VAS or AOFAS scores compared with the control group. No clinically significant difference was observed between the 2 groups regarding the total ROM scores at month 3. Conclusion: The application of LR-PRP after MBG surgery did not show any superior clinical or functional improvement over CPOM. Level of Evidence: Level II, prospective randomized trial.