bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cutaneous Adverse Events in Chronic Hepatitis C Patients Treated With New Direct-Acting Antivirals
Authors: Patel Parth , Malik Kunal , Krishnamurthy Karthik 
Published: July 2015

Background: Direct-acting antivirals (DAAs) are known to present with additional dermatological events over pegylated-interferon/ribavirin (Peg-IFN/RBV). Objective: A systematic review and meta-analysis was conducted to assess the incidence/risk of cutaneous adverse events (AEs) for simeprevir, sofosbuvir, ABT450/r-ombitasvir, dasabuvir, ledipasvir, daclatasvir, and asunaprevir. Methods: The databases searched included PubMed, Clinicaltrials.gov, and Clinicaloptions.com. Data on telaprevir and boceprevir were obtained from a previous study. Results: The incidences of cutaneous AEs were 34.3% (95% CI 18.4%-54.8%) for the old DAAs + Peg-IFN/RBV, 22.0% (95% CI 17.9%-26.8%) for the new DAAs + Peg-IFN/RBV, 9.8% (95% CI 8.6%-11.2%) for the DAAs + RBV, and 3.8% (95% CI 2.4%-6.1%) for DAAs only. Simeprevir + Peg-IFN/RBV was associated with an increased relative risk over Peg-IFN/RBV; RR = 1.319 (95% CI 1.026-1.697). Conclusion: Dermatological events are still an important issue for many of the new DAAs. Appropriate monitoring, management, and patient education are needed to minimize AEs and achieve HCV cure.
Abnormal cerebellar functional MRI connectivity in patients with paediatric multiple sclerosis
Authors: Cirillo Sara , Rocca Maria A , Ghezzi Angelo , Valsasina Paola , Moiola Lucia , Veggiotti Pierangelo , Amato Maria P , Comi Giancarlo , Falini Andrea , Filippi Massimo 
Published: July 2015

Objectives: We investigated resting state functional connectivity (RSFC) of the cerebellar dentate nuclei in paediatric MS patients and its correlations with clinical, neuropsychological and structural MRI measures. Methods: RSFC analysis was performed using a seed-region correlation approach and SPM8 from 48 paediatric MS patients and 27 matched healthy controls. Results: In both groups, dentate nuclei RSFC was significantly correlated with RSFC of several cerebellar and extra-cerebellar brain regions. Compared with healthy controls, paediatric MS patients had reduced RSFC between the right dentate nuclei and the bilateral caudate nuclei and left thalamus as well as increased RSFC between the right dentate nuclei and the left precentral and postcentral gyri. Cognitively impaired patients showed a reduced RSFC between the dentate nuclei and bilateral regions located in the parietal, frontal and temporal lobes. Decreased RSFC was correlated with longer disease duration and higher T2 lesion volumes, whereas increased RSFC correlated with shorter disease duration, lower T2 lesion volume and a better motor performance. Conclusions: Modifications of cerebellar RSFC occur in paediatric MS and are influenced by the duration of the disease and brain focal lesions. Decreased RSFC may reflect early maladaptive plasticity contributing to cognitive impairment.
Combined analysis of global and compartmental brain volume changes in early multiple sclerosis in clinical practice
Authors: Pichler A , Khalil M , Langkammer C , Pinter D , Bachmaier G , Ropele S , Fuchs S , Enzinger C , Fazekas F 
Published: July 2015

Background: The extent and clinical significance of brain volume changes in different phases of multiple sclerosis (MS) is still under discussion. Objective: To determine the rate of global and compartmental brain volume changes in patients with a clinically-isolated syndrome (CIS) compared to patients with definite MS, by long-term follow-up and as a predictor of conversion to MS in a routine clinical setting. Methods: We investigated 120 patients (63 CIS and 57 MS) at baseline and after a mean follow-up period of 43 months, including detailed clinical examination and 3-Tesla magnetic resonance imaging (MRI). Our imaging analyses comprised the normalized brain volume (NBV), cortical grey matter (cGMV) and white matter (WMV) volumes using SIENA/X, the percentage of brain volume change (PBVC) using SIENA and the change in the volume of the thalami (TV) and basal ganglia (BGV). We also determined the amount and change of T2-lesion load (T2-LL). Results: At baseline, all the brain volume metrics, except cGMV, were significantly lower; and the T2-LL was significantly higher, in patients with MS rather than CIS. During the follow-up, only the PBVC was higher in MS ( p = 0.008) and this difference was driven by converters from CIS to MS. Quartiles of PBVC did not allow us to predict conversion to MS, but were associated with the degree of disability. Conclusions: PBVC is the most sensitive marker of progressing atrophy and a higher PBVC was generally associated with more active disease; however, it did not serve to predict the course of MS on an individual basis, in this study.
Radiological differentiation of optic neuritis with myelin oligodendrocyte glycoprotein antibodies, aquaporin-4 antibodies, and multiple sclerosis
Authors: Ramanathan Sudarshini , Prelog Kristina , Barnes Elizabeth H , Tantsis Esther M , Reddel Stephen W , Henderson Andrew PD , Vucic Steve , Gorman Mark P , Benson Leslie A , Alper Gulay , Riney Catherine J , Barnett Michael , Parratt John DE , Hardy Todd A , Leventer Richard J , Merheb Vera , Nosadini Margherita , Fung Victor SC , Brilot Fabienne , Dale Russell C 
Published: July 2015

Background: Recognizing the cause of optic neuritis (ON) affects treatment decisions and visual outcomes. Objective: We aimed to define radiological features of first-episode demyelinating ON. Methods: We performed blinded radiological assessment of 50 patients presenting with first-episode myelin oligodendrocyte glycoprotein (MOG) antibody-associated ON (MOG-ON; n=19), aquaporin-4 (AQP4) antibody-associated ON (AQP4-ON; n=11), multiple sclerosis (MS)-associated ON (MS-ON; n=13), and unclassified ON ( n=7). Results: Bilateral involvement was more common in MOG-ON and AQP4-ON than MS-ON (84% vs. 82% vs. 23%), optic nerve head swelling was more common in MOG-ON (53% vs. 9% vs. 0%), chiasmal involvement was more common in AQP4-ON (5% vs. 64% vs. 15%), and bilateral optic tract involvement was more common in AQP4-ON (0% vs. 45% vs. 0%). Retrobulbar involvement was more common in MOG-ON, whereas intracranial involvement was more common in AQP4-ON. MOG-ON and AQP4-ON had longer lesion lengths than MS-ON. The combination of two predictors, the absence of magnetic resonance imaging brain abnormalities and a higher lesion extent score, showed a good ability to discriminate between an autoantibody-associated ON (MOG or AQP4) and MS. AQP4-ON more frequently had severe and sustained visual impairment. Conclusion: MOG-ON and AQP4-ON are more commonly bilateral and longitudinally extensive. MOG-ON tends to involve the anterior optic pathway, whereas AQP4-ON the posterior optic pathway.
Flow cytometric analysis of T cell/monocyte ratio in clinically isolated syndrome identifies patients at risk of rapid disease progression
Authors: Nemecek Andrea , Zimmermann Hilga , Rübenthaler Johannes , Fleischer Vinzenz , Paterka Magdalena , Luessi Felix , Müller-Forell Wibke , Zipp Frauke , Siffrin Volker 
Published: July 2015

Background: Multiple sclerosis is a chronic inflammatory central nervous system disease diagnosed by clinical presentation and characteristic magnetic resonance imaging findings. The role of cerebrospinal fluid (CSF) analysis has been emphasized in particular in the context of differential diagnosis in patients with a first episode suggestive of multiple sclerosis. Objective: We investigated here the potential additional value of analysis of CSF cellularity by fluorescence activated cell sorting (FACS) in the setting of a routine diagnostic work-up in our inpatient clinic. Methods: CSF cells from back-up samples from patients with suspected chronic inflammatory central nervous system disorder were analyzed by FACS and correlated with clinical data, magnetic resonance imaging findings and oligoclonal band status. Results: We found distinct changes of T cell/monocyte (CD4/CD14) and B cell/monocyte (CD20/CD14) ratios between clinically isolated syndrome (CIS)/multiple sclerosis and other neurologic diseases or other inflammatory neurologic diseases. In particular, patients with a rapid transition from CIS to multiple sclerosis had an elevated CD4/CD14 ratio. A subgroup analysis showed diagnostic value of CD4/CD8 ratio in the differential diagnosis of CIS/multiple sclerosis to neurosarcoidosis. Conclusion: The diagnostic and prognostic accuracy of autoimmune neuroinflammatory diseases can be improved by FACS analysis of CSF cells.
Personality traits predict perceived health-related quality of life in persons with multiple sclerosis
Authors: Zarbo Ignazio Roberto , Minacapelli Eleonora , Falautano Monica , Demontis Silvia , Carpentras Giovanni , Pugliatti Maura 
Published: July 2015

Background: Personality traits can affect health-related quality of life (HRQoL) in different disorders. In multiple sclerosis (MS), personality traits can determine patients’ willingness to take on more risky treatment options, predispose to neuropsychiatric symptoms and affect coping strategies. Objectives: We investigated the role of personality traits as possible predictors of HRQoL in a large cohort of persons with MS (PwMS). Methods: In total, 253 consecutively recruited PwMS were screened for intellectual deficits with Raven Colour Progressive Matrices (RCPM), state anxiety with STAI-X1 and major depression on a clinical basis. PwMS’ self-perceived mental and physical health status was measured with the 36-Item Short Form Health Survey (SF-36), and the personality profile with the Eysenck Personality Questionnaire (EPQ-R). The correlation between HRQoL and personality traits was investigated by means of analysis of variance, adjusting for possible confounders. Results: Of the 253 MS patients, 195 (F:M=2.75), aged 41.7±10.2 years were included in the analysis. The variance of SF-36 mental and physical composite score was largely explained by extraversion and neuroticism. Conclusions: Our data confirm that PwMS’ HRQoL is largely influenced by personality traits, which may therefore act as predictors of perceived quality of life and should be included in clinical and experimental settings focusing on HRQoL.
A two-dimensional biased coin design for dual-agent dose-finding trials
Authors: Sun Zhichao , Braun Thomas M 
Published: July 2015

Background: Given the limited efficacy observed with single agents, there is growing interest in Phase I clinical trial designs that allow for identification of the maximum tolerated combination of two agents. Purpose: Existing parametric designs may suffer from over- or under-parameterization. Thus, we have designed a nonparametric approach that can be easily understood and implemented for combination trials. Methods: We propose a two-stage adaptive biased coin design that extends existing methods for single-agent trials to dual-agent dose-finding trials. The basic idea of our design is to divide the entire trial into two stages and apply the biased coin design, with modification, in each stage. Results: We compare the operating characteristics of our design to four competing parametric approaches via simulation in several numerical examples. Under all simulation scenarios we have examined, our method performs well in terms of identification of the maximum tolerated combination and allocation of patients relative to the performance of its competitors. Limitations: In our design, stopping rule criteria and the distribution of the total sample size among the two stages are context-dependent, and both need careful consideration before adopting our design in practice. Efficacy is not a part of the dose-assignment algorithm, nor used to define the maximum tolerated combination. Conclusion: Our design inherits the favorable statistical properties of the biased coin design, is competitive with existing designs, and promotes patient safety by limiting patient exposure to toxic combinations whenever possible.
Daytime intragastric acid control: post hoc analyses of esomeprazole 20 mg and over-the-counter proton-pump inhibitors
Authors: Katz Philip , Kahrilas Peter J. , Johnson David A. , Lind Tore , Röhss Kerstin , Traxler Barry , Hugo Vincent , Dent John 
Published: July 2015

Objectives: In mild gastroesophageal reflux disease, which accounts for the great majority of cases, the major burden of reflux occurs during daytime hours, after food intake. The aim of these analyses was to evaluate intragastric pH control during the typical 14-hour daytime awake period by proton-pump inhibitors (PPIs) given at over-the-counter (OTC) dosages. Methods: In one double-blind and three open-label, randomized, crossover studies, intragastric pH was monitored for 24 hours on day 5 of treatment. The 24-hour data have been reported previously. Post hoc analyses reassessed these studies for the 14-hour daytime period, comparing esomeprazole 20 mg with currently available OTC PPIs omeprazole, pantoprazole (not available in the US) and lansoprazole. Results: Subjects maintained intragastric pH >4 for a significantly greater mean percentage of the 14-hour daytime period with esomeprazole 20 mg compared with any of the PPI comparators at OTC dosages. Geometric mean ratios (95% confidence intervals) for esomeprazole 20 mg versus the comparators were: 1.45 (1.14–1.85; p = 0.003) versus omeprazole 20 mg; 2.50 (2.01–3.11; p < 0.0001) versus pantoprazole 20 mg; and 1.69 (1.46–1.97; p < 0.0001) and 1.89 (1.05–3.37; p = 0.03) versus lansoprazole 15 mg. A greater proportion of subjects had better pH control with esomeprazole than with the other PPIs (range: 69–97%). Conclusions: Across the 14-hour daytime period, esomeprazole 20 mg once daily given 30 minutes before breakfast for 5 days provided acid control for a significantly greater average proportion of time versus the PPI comparators omeprazole, pantoprazole and lansoprazole at currently available OTC dosages.
Management of inflammatory bowel disease with oral serum-derived bovine immunoglobulin
Authors: Shafran Ira , Burgunder Patricia , Wei David , Young Hayley E. , Klein Gerald , Burnett Bruce P. 
Published: July 2015

Introduction: The clinical effect of oral serum-derived bovine immunoglobulin/protein isolate (SBI) on symptom and disease management in patients with inflammatory bowel disease (IBD) is reported in this retrospective case series. Methods: A single-center, retrospective chart review of IBD patients [ N = 45; Crohn’s disease (CD), n = 38 and ulcerative colitis (UC), n = 7] with limited to no response to traditional pharmaceutical therapies in controlling symptoms was performed after providing SBI (5 g/day) for nutritional support. Patients were contacted at least monthly to assess response to SBI for symptom management measured by a Likert scale (0 = none; 1 = minimal; 2 = moderate; 3 = significant; 4 = complete). Analysis of variance (ANOVA) was performed on response to therapy based on patient characteristics (age, gender, race) and IBD diagnosis. A multivariate ordered logistical regression model was performed to determine the odds ratio in overall disease management between week 1 and week 12. Finally, the overall group response and percent improvement to SBI was determined over 12 weeks. Results: The odds ratio from the regression model demonstrated that IBD patients were 2.8 times more likely to report clinical improvement in symptom scores with the addition of SBI to their therapeutic regimens [95% confidence interval (CI) 1.266–6.016, p = 0.011]. Disease management was not significantly associated with age, gender, race or disease state. The percentage of patients reporting a response to SBI therapy at week 1 was 49% which increased to 76% after 12 weeks with the fraction of responders gaining significant symptom improvement doubling during the same time period (9% versus 20%). Overall, this group of IBD patients showed increased, steady response to SBI therapy between week 1 and 12 with no reported side effects. Conclusion: These results suggest that SBI improves clinical management of IBD patients who are not fully managed on traditional therapies. SBI should be considered for the nutritional support of IBD regardless of disease activity, location, phenotype, duration, or complexity.
Restorative Design Features for Hospital Staff Break Areas
Authors: Nejati Adeleh , Shepley Mardelle , Rodiek Susan , Lee Chanam , Varni James 
Published: July 2015

Objectives: The study investigated the main restorative components of staff break areas in healthcare facilities, by assessing usage patterns, verbal/visual preferences, and perceived restorative qualities of specific design features found in break areas for hospital staff. Background: Nurses are extremely important to the healthcare industry, and maintaining the quality of nursing care is a central concern for healthcare administrators. While healthcare leaders are concerned about improving nurses’ satisfaction, performance, and job retention, they may overlook the importance of respite for nurses and underestimate the value of designing staff break areas to maximize their restorative potential. Methods: A multi-method approach combined qualitative explorations (focused interviews and narrative survey questions) with quantitative measurements (discrete survey questions and a visual ranking of break-room spaces), and the results were compared and triangulated. Results: It was found that staff break areas are more likely to be used if they are in close proximity to nurses’ work areas, if they have complete privacy from patients and families, and if they provide opportunities for individual privacy as well as socialization with coworkers. Having physical access to private outdoor spaces (e.g., balconies or porches) was shown to have significantly greater perceived restorative potential, in comparison with window views, artwork, or indoor plants. Conclusions: The results of this empirical study support the conclusion that improvements in the restorative quality of break areas may significantly improve nurses’ satisfaction and stress reduction, potentially leading to improved care for the patients they serve.
Detection and Measurement of Unhealthy, Environment-Derived Aerosol Materials in an Emergency Department
Authors: Choi Bryan Y. , Kobayashi Leo , Pathania Shivany , Miller Courtney B. , Locke Emma R. , Stearns Branden C. , Hudepohl Nathan J. , Patefield Scott S. , Suner Selim , Williams Kenneth A. , Machan Jason T. , Jay Gregory D. 
Published: July 2015

Objective: To measure unhealthy aerosol materials in an Emergency Department (ED) and identify their sources for mitigation efforts. Background: Based on pilot findings of elevated ED particulate matter (PM) levels, investigators hypothesized that unhealthy aerosol materials derive from exogenous (vehicular) sources at ambulance receiving entrances. Methods: The Aerosol Environmental Toxicity in Healthcare-related Exposure and Risk program was conducted as an observational study. Calibrated sensors monitored PM and toxic gases at Ambulance Triage Exterior (ATE), Ambulance Triage Desk (ATD), and control Public Triage Desk (PTD) on a 3/3/3-day cycle. Cassette sampling characterized PM; meteorological and ambulance traffic data were logged. Descriptive and multiple linear regression analyses assessed for interactions between aerosol material levels, location, temporal variables, ambulance activity, and meteorological factors. Results: Sensors acquired 93,682 PM0.3, 90,250 PM2.5, and 93,768 PM5 measurements over 366 days to generate a data set representing at least 85.6% of planned measurements. PM0.3, PM2.5, and PM5 mean counts were lowest in PTD; 56%, 224%, and 223% higher in ATD; and 996%, 200%, and 63% higher in ATE, respectively (all p < .001). Qualitative analyses showed similar PM compositions in ATD and ATE. On multiple linear regression analysis, PM0.3 counts correlated primarily with location; PM2.5 and PM5 counts correlated most strongly with location and ambulance presence. PM < 2.5 and toxic gas concentrations at ATD and PTD patient care areas did not exceed hazard levels; PM0.3 counts did not have formal safety thresholds for comparison. Conclusions: Higher levels of PM were linked with ED ambulance areas, although their health impact is unclear.
Noise Levels in Patient Rooms and at Nursing Stations at Three VA Medical Centers
Authors: Hill Jennifer N. , LaVela Sherri L. 
Published: July 2015

Objectives: To conduct an assessment of sound, dB(A) levels, in two areas of the hospital: patient rooms and nurse stations using sound meters (SMs). Background: The World Health Organization (WHO) recommends sound levels of 35 dB(A) during the day and 30 dB(A) during the night; however, many hospitals exceed these recommended levels. Assessing post-occupancy sound levels enables hospital administrators and healthcare workers to identify whether interventions to improve sound levels are needed. Methods: Sound assessments were conducted at three healthcare facilities in both patient rooms and nursing stations, and we include information on facility characteristics. An Amprobe SM-20A Sound Level Meter was placed for a 24-hr period and recorded decibel levels every 8 min. These sound levels were averaged for each hour for reporting purposes. Averages as well as highest and lowest readings are reported for both daytime (8 a.m.–10 p.m.) and nighttime (10 p.m.–8 a.m.) for each facility. Results: All three sites are considered urban and are classified with the highest complexity level (1a). Average daytime measurements for patient rooms and their corresponding nurses stations were as follows: Site A—63 dB(A)/56 dB(A), Site B—52 dB(A)/55 dB(A), and Site C—42 dB(A)/59 dB(A). Average nighttime measurements for patient rooms and nurses stations were Site A—62 dB(A)/55 dB(A), Site B—48 dB(A)/55 dB(A), and Site C—42 dB(A)/60 dB(A). Conclusion: Our findings, considered independently and collectively, showed that facilities in this study exceeded the WHO-recommended sound levels for patient rooms of 35 dB(A) during daytime and 30 dB(A) during nighttime. Research has reported negative patient outcomes, for example, decreased satisfaction, sleep disturbance, and higher incidence of rehospitalization in patients staying in areas with higher noise levels.
From Laboratory Research to a Clinical Trial
Authors: Michels Harold T. , Keevil C. William , Salgado Cassandra D. , Schmidt Michael G. 
Published: July 2015

Objective: This is a translational science article that discusses copper alloys as antimicrobial environmental surfaces. Bacteria die when they come in contact with copper alloys in laboratory tests. Components made of copper alloys were also found to be efficacious in a clinical trial. Background: There are indications that bacteria found on frequently touched environmental surfaces play a role in infection transmission. Methods: In laboratory testing, copper alloy samples were inoculated with bacteria. In clinical trials, the amount of live bacteria on the surfaces of hospital components made of copper alloys, as well as those made from standard materials, was measured. Finally, infection rates were tracked in the hospital rooms with the copper components and compared to those found in the rooms containing the standard components. Results: Greater than a 99.9% reduction in live bacteria was realized in laboratory tests. In the clinical trials, an 83% reduction in bacteria was seen on the copper alloy components, when compared to the surfaces made from standard materials in the control rooms. Finally, the infection rates were found to be reduced by 58% in patient rooms with components made of copper, when compared to patients' rooms with components made of standard materials. Conclusions: Bacteria die on copper alloy surfaces in both the laboratory and the hospital rooms. Infection rates were lowered in those hospital rooms containing copper components. Thus, based on the presented information, the placement of copper alloy components, in the built environment, may have the potential to reduce not only hospital-acquired infections but also patient treatment costs.