bluuebunny/crossref_metadata_2025_split huggingface dataset:
Blood Pressure and Cardiorenal Outcomes With Finerenone in Chronic Kidney Disease in Type 2 Diabetes
Authors: Ruilope Luis M. , Agarwal Rajiv , Anker Stefan D. , Filippatos Gerasimos , Pitt Bertram , Rossing Peter , Sarafidis Pantelis , Schmieder Roland E. , Joseph Amer , Rethemeier Nicole , Nowack Christina , Bakris George L. ,   on behalf of the FIDELIO-DKD Investigators
Published: October 2022

Background:
Chronic kidney disease is frequently associated with hypertension and poorly controlled blood pressure can lead to chronic kidney disease progression. Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, significantly improves cardiorenal outcomes in patients with chronic kidney disease and type 2 diabetes. This analysis explored the relationship between office systolic blood pressure (SBP) and cardiorenal outcomes with finerenone in FIDELIO-DKD trial (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease).

Methods:

Patients with type 2 diabetes, urine albumin-to-creatinine ratio 30 to 5000 mg/g, and estimated glomerular filtration rate of 25 to <75 mL/min per 1.73 m
2
receiving optimized renin-angiotensin system blockade, were randomized to finerenone or placebo. For this analysis, patients (N=5669) were grouped by baseline office SBP quartiles.

Results:

Finerenone reduced office SBP across the baseline office SBP quartiles, including patients with baseline office SBP of >148 mm Hg. Overall, patients with lower baseline office SBP quartile and greater declines from baseline in SBP were associated with better cardiorenal outcomes. The risk of primary kidney and key secondary cardiovascular composite outcomes was consistently reduced with finerenone versus placebo irrespective of baseline office SBP quartiles (
P
for interaction 0.87 and 0.78, respectively). A time-varying analysis revealed that 13.8% and 12.6% of the treatment effect with finerenone was attributed to the change in office SBP for the primary kidney composite outcome and the key secondary cardiovascular outcome, respectively.

Conclusions:
In FIDELIO-DKD, cardiorenal outcomes improved with finerenone irrespective of baseline office SBP. Reductions in office SBP accounted for a small proportion of the treatment effect on cardiorenal outcomes.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02540993.
Multiclass characterization of frontotemporal dementia variants via multimodal brain network computational inference
Authors: Gonzalez-Gomez Raul , Ibañez Agustín , Moguilner Sebastian 
Published: October 2022

Abstract
Characterizing a particular neurodegenerative condition against others possible diseases remains a challenge along clinical, biomarker, and neuroscientific levels. This is the particular case of frontotemporal dementia (FTD) variants, where their specific characterization requires high levels of expertise and multidisciplinary teams to subtly distinguish among similar physiopathological processes. Here, we used a computational approach of multimodal brain networks to address simultaneous multiclass classification of 298 subjects (one group against all others), including five FTD variants: behavioral variant FTD, corticobasal syndrome, nonfluent variant primary progressive aphasia, progressive supranuclear palsy, and semantic variant primary progressive aphasia, with healthy controls. Fourteen machine learning classifiers were trained with functional and structural connectivity metrics calculated through different methods. Due to the large number of variables, dimensionality was reduced, employing statistical comparisons and progressive elimination to assess feature stability under nested cross-validation. The machine learning performance was measured through the area under the receiver operating characteristic curves, reaching 0.81 on average, with a standard deviation of 0.09. Furthermore, the contributions of demographic and cognitive data were also assessed via multifeatured classifiers. An accurate simultaneous multiclass classification of each FTD variant against other variants and controls was obtained based on the selection of an optimum set of features. The classifiers incorporating the brain’s network and cognitive assessment increased performance metrics. Multimodal classifiers evidenced specific variants’ compromise, across modalities and methods through feature importance analysis. If replicated and validated, this approach may help to support clinical decision tools aimed to detect specific affectations in the context of overlapping diseases.
Assessing Stakeholder Engagement for Outcomes-Based Research Among Patients With Chronic Rhinosinusitis and Asthma: A Survey-Based Investigation
Authors: Gill Amarbir S. , Shipman Paige , Beswick Daniel M. , Howe Heather , Alt Jeremiah A. 
Published: October 2022

Background: Despite significant morbidity, there remains a critical need for prospective analyses to investigate the impact of comorbid chronic rhinosinusitis (CRS) with asthma (CRSwA) on patient centered outcomes. The objective of this study was to ascertain critical stakeholder feedback from patients that could inform future study design based on patient preferences, in an effort to optimize patient enrollment. Methods: A prospective, descriptive study was performed in order to determine the importance of various factors on CRSwA treatment among critical stakeholders. A Likert-scale survey highlighting various aspects of treatment of CRSwA and elucidating patient enthusiasm for clinical enrollment was constructed and prospectively administered to patients with CRSwA. A univariate analysis was instituted to understand the significance of the different trial design preferences. Results: Survey responses were collected from a total of 17 patients with CRSwA. With Likert scores >4/5, responses indicated significant stakeholder interest in research focused on understanding symptom triggers, including the impact of air quality and allergens. Importantly, the highest mean scores noted were for studies focused on improving (1) overall quality of life (4.8/5) and (2) lung function (4.8/5). Patients appeared least interested in participation in a randomized trial, whereas the greatest support was communicated for a purely observational trial ( P = .08). Conclusion: Patients with CRSwA demonstrate enthusiasm for participation in research that focuses on improving patient centered outcomes—specifically quality of life and lung function. Stakeholder feedback also indicates a preference for observational study design over randomized control trials.
Postoperative Outcomes in Pediatric Septoplasty
Authors: Benyo Sarah , Moroco Annie E. , Saadi Robert A. , Patel Vijay A. , King Tonya S. , Wilson Meghan N. 
Published: October 2022

Objective: Identify risk factors and perioperative morbidity for pediatric patients undergoing septoplasty. Methods: The American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) database was retrospectively queried to identify patients who underwent septoplasty (CPT 30520) for a diagnosis of deviated nasal septum (ICD J34.2) from 2018 to 2019. Outcomes analyzed include patient demographics, medical comorbidities, surgical setting, operative characteristics, length of stay, and postoperative outcomes. Results: A total of 729 children were identified. Median age at time of surgery was 15.8 years, with most patients (82.8%) >12 years of age; no significant association was identified between age at time of surgery and adverse surgical outcomes. Overall, postoperative complications were uncommon (0.6%), including readmission (0.4%), septic shock (0.1%), and surgical site infection (0.1%). A history of asthma was found to be a significant risk factor for postoperative complications ( P = .035) as well as BMI ( P = .028). Conclusion: The 30-day postoperative complications following pediatric septoplasty in children reported in the NSQIP-P database are infrequent. Special considerations regarding young age, complex sinonasal anatomy, and surgical technique remain important features in considering corrective surgery for the pediatric nose and certainly warrant further investigation in subsequent studies.
Comparison of A1c Reduction, Weight Loss, and Changes in Insulin Requirements With Addition of GLP-1 Agonists vs SGLT-2 Inhibitors in Patients Using Multiple Daily Insulin Injections
Authors: Wehrman Gunther , Halton Micah , Riveland Brynn , Potter Emily , Gaddy Melinda 
Published: October 2022

Objective: To determine whether Glucagon-Like Peptide 1 (GLP-1) agonists or Sodium Glucose Transporter 2 (SGLT-2) inhibitors result in greater A1c reduction, weight loss, and reduction of insulin requirements in veterans using multiple daily doses of insulin. Methods: This retrospective, single-site, cohort study included patients of VA Eastern Kansas Health Care System with a diagnosis of Type II Diabetes utilizing multiple daily dose insulin and an SGLT-2 inhibitor or GLP-1 agonist. SAS Enterprise Guide was utilized to complete a multivariate analysis of variance to evaluate all outcomes. Key Findings: 150 patients met selection criteria. The GLP-1 group averaged a .65% reduction in A1c compared to a 1.05% reduction in the SGLT-2 group (P = .1397). The Basal insulin dose was reduced by 5.5 units in the GLP-1 group vs 2.45 units in the SGLT-2 group (P = .3132), and 7.12 units vs 8.14 units respectively for short-acting insulin (P = .8170). The resulting weight reduction was 4.1 Kg in the GLP-1 group compared to 3.6 Kg in the SGLT-2 group (P = .6993). Conclusion: The results suggest there is not a statistically significant difference in changes to A1c, insulin requirements, or weight after 1 year of treatment with an SGLT-2 vs GLP-1 in patients using multiple daily insulin injections.
Management of chemotherapy-induced febrile neutropenia and use of granulocyte colony-stimulating factor in patients with soft tissue or bone sarcoma
Authors: Mazzaro Raphaele Teixeira , Vaz Mahanna Vanzeler , Badin Rebeka Caribé , Bernardina Eliza Dalla , Manaças Liliane Rosa Alves 
Published: October 2022

Introduction Febrile neutropenia, an oncological complication related to myelosuppressive chemotherapy, can lead to unplanned hospitalization, morbidity, mortality, and changes in the oncological therapeutic plan. The present study aimed (1) to determine the prevalence of chemotherapy-induced febrile neutropenia requiring hospitalization and the use of granulocyte colony-stimulating factor and (2) to evaluate its consequences for the oncological treatment of patients with soft tissue or bone sarcomas. Methods This is a cross-sectional and retrospective study (January 2018 to December 2019) carried out in a reference oncology hospital in the Brazilian public health system. Inpatients diagnosed with chemotherapy-induced febrile neutropenia, older than the age of 18 years, and treated with granulocyte colony-stimulating factor were included in the study. Results Twenty-nine chemotherapy-induced febrile neutropenia events were identified, involving 25 patients. Among the febrile neutropenia events, 90% were grade 4, and 59% occurred during palliative chemotherapy. Among patients with febrile neutropenia, 31% had arterial hypertension or/and diabetes mellitus comorbidities, 34% had infectious skin sites, such as compression ulcers and tumor wounds, and 31% had infections with defined etiologic agents. Treatment of hospitalized patients was performed with cefepime in combinations or alone (97%) and filgrastim. The outcomes related to chemotherapy-induced febrile neutropenia were chemotherapy dose reduction (31%), chemotherapy cycle delays (21%), chemotherapy treatment suspension (17%), deaths (7%), and other associated complications (10%). Granulocyte colony-stimulating factor prophylaxis was prescribed in 72.41% of febrile neutropenia events. The frequency of febrile neutropenia concerning total chemotherapy cycles was 2.15%. Conclusion Even with granulocyte colony-stimulating factor prophylaxis, an overall prevalence of 2.15% of febrile neutropenia associated with hospitalization was observed, causing negative outcomes in chemotherapy treatment of patients.
Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Motor Impairment and Function After Chronic Ischemic Stroke: Subgroup Analysis of the Randomized, Blinded, Pivotal, VNS-REHAB Device Trial
Authors: Dawson Jesse , Engineer Navzer D. , Cramer Steven C. , Wolf Steven L. , Ali Rushna , O’Dell Michael W. , Pierce David , Prudente Cecília N. , Redgrave Jessica , Feng Wuwei , Liu Charles Y. , Francisco Gerard E. , Brown Benjamin L. , Dixit Anand , Alexander Jen , DeMark Louis , Krishna Vibor , Kautz Steven A. , Majid Arshad , Tarver Brent , Turner Duncan L. , Kimberley Teresa J. 
Published: October 2022

Background Vagus Nerve Stimulation (VNS) paired with rehabilitation improved upper extremity impairment and function in a recent pivotal, randomized, triple-blind, sham-controlled trial in people with chronic arm weakness after stroke. Objective We aimed to determine whether treatment effects varied across candidate subgroups, such as younger age or less injury. Methods Participants were randomized to receive rehabilitation paired with active VNS or rehabilitation paired with sham stimulation (Control). The primary outcome was the change in impairment measured by the Fugl–Meyer Assessment Upper Extremity (FMA-UE) score on the first day after completion of 6-weeks in-clinic therapy. We explored the effect of VNS treatment by sex, age (≥62 years), time from stroke (>2 years), severity (baseline FMA-UE score >34), paretic side of body, country of enrollment (USA vs UK) and presence of cortical involvement of the index infarction. We assessed whether there was any interaction with treatment. Findings The primary outcome increased by 5.0 points (SD 4.4) in the VNS group and by 2.4 points (SD 3.8) in the Control group ( P = .001, between group difference 2.6, 95% CI 1.03-4.2). The between group difference was similar across all subgroups and there were no significant treatment interactions. There was no important difference in rates of adverse events across subgroups. Conclusion The response was similar across subgroups examined. The findings suggest that the effects of paired VNS observed in the VNS-REHAB trial are likely to be consistent in wide range of stroke survivors with moderate to severe upper extremity impairment.
Effect of Comorbidities on Outcomes of Infrapopliteal Angioplasty in Patients with Chronic Limb-Threatening Ischemia
Authors: Vivekanand Vivekanand , Motukuru Vishnu , Kolalu Sumanthraj , Rangaswamy Girija Kempaiah , Jain Piyushkumar 
Published: October 2022

Objective: This subgroup analysis aimed to evaluate the effect of comorbidities on infrapopliteal angioplasty outcomes in patients with chronic limb-threatening ischemia (CLTI). Methods: This was an observational study evaluating eligible CLTI patients aged >18 years who underwent infrapopliteal angioplasty between April 2014 and May 2017 at a tertiary care center. Subgroup analyses were based on (1) baseline glycated hemoglobin (HbA1c ≤6.5% vs >6.5%), (2) presence/absence of chronic kidney disease (CKD), and (3) control of lipid parameters. Results: A total of 231 patients with 332 infrapopliteal vessels were treated. While diabetes was prevalent in all participants, hypertension, coronary artery disease, and CKD were reported in 76.6%, 46.3%, and 25.5% of patients at baseline, respectively. The overall technical success rate was 84.4%, and the patency rate at 6 months was 82.04%. Patency at 6 months, wound healing, in-line flow, and complete plantar arch formation were numerically higher in patients with HbA1c ≤6.5% versus >6.5%, but all comparisons were nonsignificant. According to multivariable analysis, the odds of wounds not healing was 2.38 times higher (odds ratio [OR] = 2.4, 95% confidence interval [CI]: 1.2 to 4.5) and developing plantar arch was 5.88 times higher (OR = 5.9, 95% CI: 1.3 to 25) among patients with CKD compared with patients without CKD. Conclusions: The 6-month outcomes of infrapopliteal angioplasty may be better in patients with controlled versus uncontrolled glycemic levels. Control of lipid parameters may not have a significant influence on outcomes, especially in patients on statin therapy. The short-term outcomes may be similar in patients with and without CKD.
Cross-sectional and longitudinal relationships between cardiorespiratory fitness and health-related quality of life in primary school children in England: the mediating role of psychological correlates of physical activity
Authors: Solera-Sanchez A , Christian DL , Beltran-Valls MR , Adelantado-Renau M , Martin-Smith R , MacDonald MJ , Tyler R , Fairclough SJ 
Published: October 2022

Aims: The aims were (1) to analyse the cross-sectional and longitudinal associations between children’s cardiorespiratory fitness (CRF) and health-related quality of life (HRQoL) and (2) to examine whether these associations were mediated by physical activity self-efficacy and physical activity enjoyment. Methods: This study involved 383 children (10.0 ± 0.5 years) recruited from 20 primary schools in northwest England. Data were collected on two occasions 12 weeks apart. The number of laps completed in the 20-m Shuttle Run Test was used as the CRF indicator. HRQoL was assessed using the KIDSCREEN-10 questionnaire. Physical activity self-efficacy and enjoyment were assessed with the social-cognitive and Physical Activity Enjoyment Scale questionnaires, respectively. Linear mixed models with random intercepts (schools) assessed associations between CRF and HRQoL cross-sectionally, and longitudinally. Boot-strapped mediation procedures were performed, and indirect effects (IE) with 95% confidence intervals (CI) not including zero considered as statistically significant. Analyses were adjusted for sex, time of the year, socioeconomic status, waist-to-height ratio, maturation, and physical activity. Results: CRF was cross-sectionally associated with HRQoL (β = 0.09, 95% CI = 0.02, 0.16; p = .015). In the longitudinal analysis, CRF at baseline was associated with HRQoL at 12 weeks after additionally controlling for baseline HRQoL (β = 0.08, 95% CI = 0.002; p = .15, p = .045). Cross-sectionally, physical activity self-efficacy and enjoyment acted individually as mediators in the relationship between CRF and HRQoL (IE = 0.069, 95% CI = 0.038; p = .105 and IE = 0.045, 95% CI = 0.016; p = .080, respectively). In the longitudinal analysis, physical activity self-efficacy showed a significant mediating effect (IE = 0.025, 95% CI = 0.004; p = .054). Conclusion: Our findings highlight the influence of CRF on children’s psychological correlates of physical activity and their overall HRQoL.
Continuous EEG monitoring detects nonconvulsive seizure and Ictal-Interictal Continuum abnormalities in moderate to severe ICANS following systemic CAR-T therapy
Authors: Satyanarayan Sammita , Spiegel Jay , Hovsepian Dominic , Markert Matthew , Thomas Reena , Muffly Lori , Miklos David , Graber Kevin , Scott Brian J. 
Published: October 2022

Background and Purpose Immune Cell Effector Associated Neurotoxicity Syndrome (ICANS) is common amongst patients receiving CD19 targeted Chimeric Antigen Receptor T-cell (CAR-T) therapy. The purpose of this study is to characterize the incidence of seizures and ictal-interictal continuum (IIC) abnormalities in patients with ICANS. Methods Retrospective review of consecutive patients treated with axicabtagene ciloleucel (axi-cel) for recurrent high-grade systemic lymphoma at Stanford Medical Center between 2/2016-6/2019. Electronic medical records (EMR) were reviewed for clinical features, treatment information, EEG data, CRS (cytokine release syndrome)/ICANS severity, and clinical outcomes. Results Fifty-six patients met inclusion criteria. 85.7% of patients developed CRS, and 58.9% developed ICANS. Twenty-eight patients had EEG monitoring, of whom 26 had ICANS. Median duration of EEG monitoring was 30 hours (range .5-126 hours). Four patients (7.1%) had seizures (1 patient had a clinical generalized seizure, 2 patients had clinical and nonconvulsive seizures, and 1 patient had an isolated non-convulsive seizure). Ictal-interictal continuum abnormalities were common, of which generalized periodic discharges (GPDs) with triphasic morphology and GPDs with epileptiform morphology were most frequently seen. Generalized periodic discharges with triphasic wave morphology were found across Grade 2-3 peak ICANS severity, however the majority (86%) of patients with epileptiform GPDs had Grade 3 peak ICANS severity. Conclusions Among patients receiving axi-cel, seizure occurred in 7.1% of the total cohort, representing 12% of patients with ICANS. Ictal-interictal continuum abnormalities are also seen in patients with ICANS, most commonly GPDs. 75% of patients with seizures had nonconvulsive seizures supporting the use of continuous video EEG monitoring in this population.
Recognition of Obesity and Perceptions of Weight Loss Management in Patients With Chronic Kidney Disease: A Retrospective Cross-Sectional Study
Authors: Chiu Michael , Moist Louise , Al-Jaishi Ahmed , Jain Arsh K. 
Published: October 2022

Background: Obesity is, directly and indirectly, linked to the progression of chronic kidney disease (CKD). However, nephrologists’ recognition of obesity and willingness to address and manage obesity are unknown. Objectives: The aim of this article is to investigate if obesity is recognized and documented in the clinical encounter and to examine nephrologists’ perceptions of obesity and comfort with weight loss management. Design: We conducted a 2-part study. Part I used a retrospective chart review and part II used an anonymous online survey of practicing nephrologists (n = 14) in our center. Setting: The study took place in the Multi-care Kidney Clinic (MCKC) at London Health Sciences Centre in London, Ontario, Canada. Patients: In part I, we conducted a retrospective chart review of 10 random patients with advanced CKD and obesity (body mass index [BMI] > 30 kg/m2) from each of the nephrologists between January and December 2019. Methods: In part I, charts were assessed for documentation of obesity and/or a treatment plan (lifestyle counseling, pharmacologic intervention, and specialist referral). In part II, a survey completed by the nephrologists explored their current experience and perceptions of obesity and comfort with weight loss management. Responses were ranked on a 5-point Likert scale. Results: In all, 140 patient charts were reviewed. The median age was 69 (interquartile range [IQR] = 60-77) years, estimated glomerular filtration rate (eGFR) was 17 (IQR = 12-20) ml/min/1.73 m2, weight was 99 (IQR = 90-116) kg, and BMI was 36 (IQR = 33-40) kg/m2. Obesity with a BMI was documented in 36 (26%) charts, and only 2 (1%) documented a weight loss plan, which only included non-pharmacologic strategies. There were 13 survey responses (93% response rate). All nephrologists agreed that obesity negatively affects the health of patients with CKD. Twelve (92%) reported discussing obesity with patients, but none felt that they had time to treat it. All reported discussions of obesity would evoke a negative patient response, while 5 (38%) thought patients actually want to discuss obesity. Regarding treatment, 8 (62%) nephrologists felt comfortable with non-pharmacologic treatment, but only 1 respondent was comfortable with pharmacologic treatments. Twelve (92%) nephrologists thought patients should be referred to a specialist. Limitations: There was limited generalizability as this was a single center study. The BMI may reflect hypervolemia rather than body mass. Conclusion: In our study, nephrologists rarely document and manage obesity in patients with advanced CKD, despite their perception of treatment benefits. Improved outcomes of obesity management for patients with CKD will require increased knowledge and clinical tools to efficiently address obesity with patients.