bluuebunny/crossref_metadata_2025_split huggingface dataset:
A post hoc analysis of the effect of viloxazine extended-release capsules on learning and school problems in children and adolescents with attention-deficit/hyperactivity disorder
Authors: Faraone Stephen V. , Gomeni Roberto , Hull Joseph T. , Busse Gregory D. , Melyan Zare , Rubin Jonathan , Nasser Azmi 
Published: September 2021

AbstractImprovement in attention-deficit/hyperactivity disorder (ADHD) symptoms vs. placebo was reported in a series of pediatric clinical trials of viloxazine extended-release capsules (viloxazine ER; Qelbree™). This post hoc analysis of those studies evaluated the effect of viloxazine ER on learning and school problems (LSPs). We used data from four Phase 3 placebo-controlled trials of 100–600 mg/day viloxazine ER (N = 1354; 6–17 years of age). LSPs were evaluated using the School domain of the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P-S) and the Learning Problems content scale of the Conners 3rd Edition-Parent Short Form (C3PS-LP) at baseline and end of study (≥ Week 6). ADHD symptoms were assessed weekly using the ADHD Rating Scale 5th Edition. The analyses were performed using the general linear mixed model with participant as a random effect. The responder analyses were performed using the Chi-square test. Viloxazine ER demonstrated significantly greater improvements in WFIRS-P-S (p < 0.0001) and C3PS-LP (p = 0.0113) scores vs. placebo. The response rate for the WFIRS-P-S was significantly greater for viloxazine ER vs. placebo (p = 0.001), and the number needed to treat (NNT) was 10.3 (effect size 0.7). Conversely, response rates for C3PS-LP did not differ between groups (p = 0.9069). In addition to ADHD symptoms improvement demonstrated in previous studies, viloxazine ER significantly reduced LSPs in pediatric subjects with ADHD. The responder analyses and NNT estimates indicate that a substantial number of children and adolescents with ADHD treated with viloxazine ER improved in clinically assessed LSPs.
Prevalence and factors related to sleep apnoea in ankylosing spondylitis
Authors: Wiginder Adrian , Sahlin-Ingridsson Carin , Geijer Mats , Blomberg Anders , Franklin Karl A. , Forsblad-d’Elia Helena 
Published: September 2021

Abstract
An increased prevalence of obstructive sleep apnoea (OSA) has been suggested in patients with ankylosing spondylitis (AS) in a few controlled studies. We aimed to study the prevalence of OSA compared to controls and to investigate if disease-related and non-disease-related factors were determinants of OSA in AS patients. One hundred and fifty-five patients with AS were included in the Backbone study, a cross-sectional study that investigates severity and comorbidities in AS. Controls were recruited from the Swedish CArdioPulmonary bioImage Study. To evaluate OSA, the participants were asked to undergo home sleep-monitoring during one night’s sleep. For each AS patient 45–70 years old, four controls were matched for sex, age, weight, and height. OSA was defined as an apnoea-hypopnoea index (AHI) ≥ 5 events/hour. Sixty-three patients with AS were examined with home sleep-monitoring, and 179 controls were matched with 46 patients, 45–70 years. Twenty-two out of 46 (47.8%) patients with AS vs. 91/179 (50.8%) controls had OSA (AHI ≥ 5 events/hour), P = 0.72. No differences in the sleep measurements were noted in AS patients vs. controls. In logistic regression analysis adjusted for age and sex, higher age, higher BMI, and lesser chest expansion were associated with the presence of OSA in the 63 AS patients. In the current study, patients with AS did not have a higher prevalence of OSA compared to matched controls. AS patients with OSA had higher BMI, were older, and had lesser chest expansion because of more severe AS compared to patients without OSA.

Key points

• Patients with ankylosing spondylitis did not have a higher prevalence of obstructive sleep apnoea versus matched controls.

• Patients with ankylosing spondylitis and obstructive sleep apnoea were older and had higher body mass index versus patients without obstructive sleep apnoea.

• Patients with ankylosing spondylitis and obstructive sleep apnoea had lesser chest expansion versus patients without obstructive sleep apnoea.
Real-world safety and effectiveness of nivolumab in Japanese patients with unresectable advanced or recurrent gastric/gastroesophageal junction cancer that has progressed after chemotherapy: a postmarketing surveillance study
Authors: Yamaguchi Kensei , Boku Narikazu , Muro Kei , Yoshida Kazuhiro , Baba Hideo , Tanaka Shinji , Akamatsu Ayumi , Sano Takeshi 
Published: September 2021

Abstract
Background
This postmarketing surveillance study evaluated the real-world safety and effectiveness of nivolumab as salvage (after ≥ 2 lines) therapy in Japanese patients with unresectable advanced or recurrent gastric/gastroesophageal junction (G/GEJ) cancer.

Methods
This multicenter, observational study was conducted at 158 centers in Japan. Patients with unresectable advanced or recurrent G/GEJ cancer were registered between Nov 1, 2017, and Oct 31, 2018, and observed for 6 months after treatment initiation with nivolumab. Correlation of background characteristics with treatment-related adverse events (TRAEs) and tumor response was explored.

Results
Overall, 654 patients were registered (safety analysis set, n = 650; effectiveness analysis set, n = 636; response evaluation set, n = 516). The incidences of all TRAEs and grade ≥ 3 TRAEs were 31.5 and 11.2%, respectively. TRAEs significantly correlated with the absence of peritoneal metastasis; C-reactive protein level < 1; prior G/GEJ cancer surgery; and past or concomitant pulmonary, thyroid, or renal disease (each p < 0.05). The incidence of TRAEs was significantly lower in patients with higher Glasgow prognostic scores (p < 0.05). No new safety signals were observed. Complete response, partial response, stable disease, and progressive disease were observed in 1.2, 10.1, 27.1, and 58.3% of the response evaluation set, respectively. Patients aged ≥ 65 years (13.9 vs 5.3%, p = 0.0083) and ≥ 75 years (18.8 vs 9.2%, p = 0.0036) showed a higher response rate than their younger counterparts.

Conclusions
The real-world safety and effectiveness of nivolumab as salvage (after ≥ 2 lines) therapy in Japanese patients with unresectable advanced or recurrent G/GEJ cancer were consistent with those observed in the phase 3 ATTRACTION-2 study.
Comparison of inulin clearance with 2-h creatinine clearance in Japanese pediatric patients with renal disease: open-label phase 3 study of inulin
Authors: Uemura Osamu , Ishikura Kenji , Kamei Koichi , Hamada Riku , Yamamoto Masaki , Gotoh Yoshimitsu , Fujita Naoya , Sakai Tomoyuki , Sano Takafumi , Fushimi Masahiko , Iijima Kazumoto 
Published: September 2021

Abstract
Background
There is no approved dosage and administration of inulin for children. Therefore, we measured inulin clearance (Cin) in pediatric patients with renal disease using the pediatric dosage and administration formulated by the Japanese Society for Pediatric Nephrology, and compared Cin with creatinine clearance (Ccr) measured at the same time. We examined to what degree Ccr overestimates Cin, using the clearance ratio (Ccr/Cin), and confirmed the safety of inulin in pediatric patients.

Methods
Pediatric renal disease patients aged 18 years or younger were enrolled. Inulin (1.0 g/dL) was administered intravenously at a priming rate of 8 mL/kg/hr (max 300 mL/hr) for 30 min. Next, patients received inulin at a maintenance rate of 0.7 × eGFR mL/min/1.73 m2 × body surface area (max 100 mL/hr) for 120 min. With the time the maintenance rate was initiated as a starting point, blood was collected at 30 and 90 min, while urine was collected twice at 60-min intervals. The primary endpoint was the ratio of Ccr to Cin (Ccr/Cin).

Results
Inulin was administered to 60 pediatric patients with renal disease; 1 patient was discontinued and 59 completed. The primary endpoint, Ccr/Cin, was 1.78 ± 0.52 (mean ± standard deviation). Regarding safety, five adverse events were observed in four patients (6.7%); all were non-serious. No adverse reactions were observed in this study.

Conclusions
The results in this study on the dosage and administration of inulin showed that inulin can safely and accurately determine GFR in pediatric patients with renal disease.

ClinicalTrials.gov identifier
NCT03345316.
A Study of Gene Expression, Structure, and Contractility of iPSC-Derived Cardiac Myocytes from a Family with Heart Disease due to LMNA Mutation
Authors: Mehrabi Mehrsa , Morris Tessa A. , Cang Zixuan , Nguyen Cecilia H. H. , Sha Yutong , Asad Mira N. , Khachikyan Nyree , Greene Taylor L. , Becker Danielle M. , Nie Qing , Zaragoza Michael V. , Grosberg Anna 
Published: September 2021

AbstractGenetic mutations to the Lamin A/C gene (LMNA) can cause heart disease, but the mechanisms making cardiac tissues uniquely vulnerable to the mutations remain largely unknown. Further, patients with LMNA mutations have highly variable presentation of heart disease progression and type. In vitro patient-specific experiments could provide a powerful platform for studying this phenomenon, but the use of induced pluripotent stem cell-derived cardiomyocytes (iPSC-CM) introduces heterogeneity in maturity and function thus complicating the interpretation of the results of any single experiment. We hypothesized that integrating single cell RNA sequencing (scRNA-seq) with analysis of the tissue architecture and contractile function would elucidate some of the probable mechanisms. To test this, we investigated five iPSC-CM lines, three controls and two patients with a (c.357-2A>G) mutation. The patient iPSC-CM tissues had significantly weaker stress generation potential than control iPSC-CM tissues demonstrating the viability of our in vitro approach. Through scRNA-seq, differentially expressed genes between control and patient lines were identified. Some of these genes, linked to quantitative structural and functional changes, were cardiac specific, explaining the targeted nature of the disease progression seen in patients. The results of this work demonstrate the utility of combining in vitro tools in exploring heart disease mechanics.
Evaluation of the URGOnight Tele-neurofeedback Device: An Open-label Feasibility Study with Follow-up
Authors: Krepel Noralie , Egtberts Tommy , Touré-Cuq Emma , Bouny Pierre , Arns Martijn 
Published: September 2021

AbstractSMR neurofeedback shows potential as a therapeutic tool for reducing sleep problems. It is hypothesized that SMR neurofeedback trains the reticulo-thalamocortical-cortical circuit involved in sleep-spindle generation. As such, strengthening this circuit is hypothesized to reduce sleep problems. The current study aims to investigate the effectiveness of a home-based device that uses SMR neurofeedback to help reduce sleep problems. Thirty-seven participants reporting sleep problems received the SMR neurofeedback-based program for 40 (n = 21) or 60 (n = 16) sessions. The Pittsburgh Sleep Quality Index (PSQI) and Holland Sleep Disorders Questionnaire (HSDQ) were assessed at baseline, session 20, outtake, and follow-up (FU). Actigraphy measurements were taken at baseline, session 20, and outtake. Significant improvements were observed in PSQI Total (d = 0.78), PSQI Sleep Duration (d = 0.52), HSDQ Total (d = 0.80), and HSDQ Insomnia (d = 0.79). Sleep duration (based on PSQI) increased from 5.3 h at baseline to 5.8 after treatment and 6.0 h. at FU. No effects of number of sessions were found. Participants qualified as successful SMR-learners demonstrated a significantly larger gain in sleep duration (d = 0.86 pre-post; average gain = 1.0 h.) compared to non-learners. The home-based SMR tele-neurofeedback device shows the potential to effectively reduce sleep problems, with SMR-learners demonstrating significantly better improvement. Although randomized controlled trials (RCTs) are needed to further elucidate the specific effect of this device on sleep problems, this is the first home-based SMR neurofeedback device using dry electrodes demonstrating effectiveness and feasibility.
Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: Results of a single-center, multi-arm phase Ib study
Authors: Thein Kyaw Z. , Karp Daniel D. , Tsimberidou Apostolia , Gong Jing , Sulovic Selma , Shah Jatin , Milton Denái R. , Hong David S. , Janku Filip , McQuinn Lacey , Stephen Bettzy A. , Colen Rivka , Carter Brett W. , Yap Timothy A. , Piha-Paul Sarina A. , Fu Siqing , Meric-Bernstam Funda , Naing Aung 
Published: September 2021

Summary

Background. Carboplatin and paclitaxel (CT) is one of the standard chemotherapy regimens used in various tumor types. Preclinical models have suggested that selinexor, a first-in-class oral potent selective inhibitor of nuclear export Exportin-1, and CT exerts antitumor activity in multiple malignancies. Methods. This was a single-center, multi-arm phase Ib study utilizing a “basket type” expansion. CT and selinexor was employed as one of the 13 parallel arms. Advanced relapsed/refractory solid tumors following standard therapy or where the addition of selinexor to standard regimens deemed appropriate, were eligible. Results. Of 13 patients treated, 12 patients were evaluable for response. The most common cancers were breast (n = 4), esophageal (n = 2), ovarian (n = 2) and non-small cell lung cancers (n = 2). All 13 patients had at least one treatment-related adverse events (TRAEs) and the most common were neutropenia (85%), leukopenia (85%), thrombocytopenia (85%), anemia (69%), nausea (54%), vomiting (46%), and fatigue (46%). One patient at 60 mg QW experienced DLT with grade 3 nausea and vomiting lasting 3 days. Unconfirmed partial response (uPR) was observed in 3 patients; one patient each with esophageal, breast, and ovarian cancer. One patient with esophageal adenocarcinoma had confirmed PR, however, was discontinued from the study due to clinical progression. Five patients achieved stable disease (SD). Disease control rate was 8%. Majority of patients (77%), including two patients who had uPR, had prior exposure to carboplatin and/or paclitaxel. Time-to-treatment failure (TTF) ranged from 1 to 153 weeks. Conclusion. The RP2D of selinexor was 60 mg QW in combination with CT. The combination conferred viable clinical activity with durable objective responses which should further be explored in tumor types for which CT is used as standard of care. Trial information. ClinicalTrials.gov Identifier: NCT02419495. Sponsor(s): Karyopharm Therapeutics. (Trial registration: NCT02419495. Registered 14 April 2015, https://clinicaltrials.gov/ct2/show/NCT02419495).
From Inter-Racial Solidarity to Action: Minority Linked Fate and African American, Latina/o, and Asian American Political Participation
Authors: Chan Nathan Kar Ming , Jasso Francisco 
Published: September 2021

AbstractRecent literature in race, ethnicity, and politics has assessed how minority linked fate, defined as “the idea that ethnoracial minorities might share a sense of commonality that extends beyond their particular ethnoracial group to other ethnoracial groups (Gershon et al., in Politics Groups Identities 7(3):642–653, 2019),” shapes attitudes toward descriptive representation and support for coalition building. However, scholarship has yet to examine the influence of minority linked fate on political participation. We argue that similar to those who view the interests of co-ethnics as a proxy for their individual interests, Latina/os, Asian Americans, and African Americans who express linked fate with a more expansive minority community are more likely to take political action. This political participation results from senses of obligation to and solidarity with other racial minorities outside of their own. Results from the 2016 Collaborative Multiracial Post-Election Survey show that controlling for conventional measures of linked fate, minority linked fate is associated primarily with more system-challenging modes of political activity for Latina/os, Asian Americans, and African Americans. We conclude by positioning minority linked fate as a complementary heuristic to traditional notions of intra-racial linked fate and note how shared inter-racial linked fate informs our understanding of recent political activism among people of color.
IonFlow: a galaxy tool for the analysis of ionomics data sets
Authors: Iacovacci J. , Lin W. , Griffin J. L. , Glen R. C. 
Published: September 2021

Abstract
Introduction
Inductively coupled plasma mass spectrometry (ICP-MS) experiments generate complex multi-dimensional data sets that require specialist data analysis tools.

Objective
Here we describe tools to facilitate analysis of the ionome composed of high-throughput elemental profiling data.

Methods
IonFlow is a Galaxy tool written in R for ionomics data analysis and is freely accessible at https://github.com/wanchanglin/ionflow. It is designed as a pipeline that can process raw data to enable exploration and interpretation using multivariate statistical techniques and network-based algorithms, including principal components analysis, hierarchical clustering, relevance network extraction and analysis, and gene set enrichment analysis.

Results and Conclusion
The pipeline is described and tested on two benchmark data sets of the haploid S. Cerevisiae ionome and of the human HeLa cell ionome.
Anti-thrombotics and their impact on inpatient epistaxis management: a tertiary centre experience
Authors: Donaldson Gavin , Goh Kwee Yen , Tiwari Puneet , Maini Sangeeta , Ram Bhaskar , Dwivedi Raghav C. 
Published: September 2021

Abstract
Introduction
Epistaxis represents a massive burden upon NHS resources. Despite being an extremely common reason for emergency ENT admissions, there remains significant variation in its management. Although the evidence base is continually growing, there appears to be a lack of guidance towards managing anti-coagulants and anti-platelet medications and identifying patient-specific outcomes in this setting. Epistaxis has long been associated with a multitude of risk factors but none have shown consistent, direct correlation.

Materials and methods
We aimed to identify if the use of anti-thrombotic medication was associated with a longer length of hospital admission or conferred a higher requirement for nasal packing, re-packing, surgery or re-admission. We conducted a retrospective analysis of 100 consecutive adult patients admitted over a 6-month period. Statistical analysis was conducted using SPSS software.

Results
Sixty-five percent of patients were taking anti-thrombotic medication. The variability of admission INR values in those taking warfarin did not relate with any outcome measure. There was no statistical difference between patients taking anti-thrombotic medication and those who do not, with regards to our primary outcome measures. Re-admission rates within 28 days were found to be 13%, with anti-thrombotic medication use and pre-existing cardiovascular disease recognised as commonly encountered risk factors. Three percent of patients required surgical intervention. Eight percent of patients required re-packing, with a Rapid Rhino chosen in all instances.

Conclusion
The use of anti-thrombotic medication is not associated with increased morbidity or increased rate of complications. Anti-thrombotic usage and more than one medical co-morbidity increase the risk of re-admission within 28 days.
Joint computation offloading and deployment optimization in multi-UAV-enabled MEC systems
Authors: Chen Zheyi , Zheng Hongqiang , Zhang Jianshan , Zheng Xianghan , Rong Chunming 
Published: September 2021

AbstractThe combination of unmanned aerial vehicles (UAVs) and mobile edge computing (MEC) technology breaks through the limitations of traditional terrestrial communications. The effective line-of-sight channel provided by UAVs can greatly improve the communication quality between edge servers and mobile devices (MDs). To further enhance the Quality-of-Service (QoS) of MEC systems, a multi-UAV-enabled MEC system model is designed. In the proposed model, UAVs are regarded as edge servers to offer computing services for MDs, aiming to minimize the average task response time by jointly optimizing UAV deployment and computation offloading. Based on the problem definition, a two-layer joint optimization method (PSO-GA-G) is proposed. First, the outer layer utilizes a Particle Swarm Optimization algorithm combined with Genetic Algorithm operators (PSO-GA) to optimize UAV deployment. Next, the inner layer adopts a greedy algorithm to optimize computation offloading. The extensive simulation experiments verify the feasibility and effectiveness of the proposed PSO-GA-G. The results show that the PSO-GA-G can achieve a lower average task response time than the other three baselines.
Luxury in Germany: Sick Cars and Healthy Bodies
Authors: Biehl Brigitte 
Published: September 2021

AbstractThe car is one of the few luxury items that historically is widely accepted in Germany, the land of “discreet consumption.” This contribution draws on social science research, includes writings on popular culture, and presents examples from people and their cars in the media that give evidence of how luxury is increasingly emotionally charged, enriched, and negotiated. Cars were status symbols in Germany as a divided nation, with people in West Germany driving a Mercedes and people in the East driving a Trabant. Today, German rappers praise their “sick” cars, and paradox Bio Germans shield their luxury body in an expensive SUV. These examples illustrate luxury consumption that aesthetically and narratively links identities to cultural heritage. The media discourse reflects the symbolic and also the increasingly affective nature of luxury, while healthy “luxury” bodies remain in a competition for limited resources in a social context.
Treatment Options for Massive Irreparable Rotator Cuff Tears
Authors: Kucirek Natalie K. , Hung Nicole J. , Wong Stephanie E. 
Published: September 2021

AbstractPurpose of ReviewMassive irreparable rotator cuff tears present a significant challenge to the orthopedic surgeon. No single treatment, particularly among joint-preserving options, has been shown to be superior. The purpose of this review is to discuss recent advances in the treatment of massive irreparable rotator cuff tears, including partial repair with and without graft augmentation, interposition grafts, superior capsule reconstruction, subacromial balloon spacers, tendon transfer, and reverse total shoulder arthroplasty. We will also offer guidance on surgical indications based on our clinical experience.Recent FindingsPartial repair may offer reasonable clinical improvement for patients with lower preoperative function despite high re-tear rates. Additionally, several types of interposition grafts have shown promising short-term results and may outperform repair alone. Subacromial balloon spacers may lead to clinical improvement, especially in patients without glenohumeral osteoarthritis or pseudoparalysis, and recently received FDA approval for use in the USA. Superior capsule reconstruction is a technically demanding procedure that appears to produce excellent short-term results particularly when performed at high volume, but long-term studies in heterogeneous study groups are needed. Tendon transfers improve function by restoring force coupling in the shoulder, offering a promising option for younger patients. Reverse total shoulder arthroplasty (RTSA) is a reliable option for treatment of irreparable cuff tears in elderly patients with lower functional demands.SummaryIrreparable cuff tears remain a difficult condition to treat. Recommended treatment for younger patients without glenohumeral osteoarthritis is particularly controversial. For older patients with low-demand lifestyles and glenohumeral osteoarthritis, RTSA is an effective treatment option. For all discussed procedures, patient selection appears to play a critical role in clinical outcomes.