bluuebunny/crossref_metadata_2025_split huggingface dataset:
New garment proposal for prevention of spreading Gram-negative bacteria resistant to carbapenem antibiotic class under hospital settings
Authors: Nogueira Frederico , Gomes Ana P , Gouveia Isabel C 
Published: December 2017

Sensitive skin diseases, including atopic dermatitis, skin inflammation and bedsores, leave patients vulnerable under hospital setting. It is important for the development of a hospital gown with “soft hand” properties and at the same time as a protector against nosocomial infections. Klebsiella pneumoniae has developed resistance to antibiotics in the carbapenem antibiotic class, known as carbapenem-resistant K. pneumoniae (CRKP). CRKP is resistant to nearly all antibiotics and can kill up to 50% of infected patients. This work consisted in the development of a washable recycled silk fibroin-based gown covalently linked with an amino acid l-Cysteine(l-Cys), focused on prevention of K. pneumoniae establishment, proliferation and spreading to community, for use under hospital settings. With the growing problem of resistance to antibiotics and few new therapies on the horizon, gowns adsorbed with L-Cys show to function as a barrier to the establishment and proliferation of microorganisms, providing user protection from infectious disease. This gown was knitted at a rectilinear needle loom with a Jersey knit structure. Then it was cross-linked with l-Cys, subjected to laundry, and subsequently characterized by energy-dispersive X-ray spectroscopy, Fourier transform infrared spectroscopy, contact angle, free energy of adhesion, scanning electron microscopy and transmission electron microscopy. Results presented a bactericidal effect against K. pneumoniae of 94.92% after three rinses and 88.88% after five washing cycles, with the few adhered bacteria with an altered and compromised morphology.
Use of an android phone application for automated text messages in international settings: A case study in an HIV clinical trial in St. Petersburg, Russia
Authors: Forman Leah S , Patts Gregory J , Coleman Sharon M , Blokhina Elena , Lu John , Yaroslavtseva Tatiana , Gnatienko Natalia , Krupitsky Evgeny , Samet Jeffrey H , Chaisson Christine E 
Published: December 2017

Background/aims: Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings. Methods: To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St. Petersburg, Russia (Zinc for HIV disease among alcohol users—a randomized controlled trial in the Russia Alcohol Research Collaboration on HIV/AIDS cohort). The application is downloaded once onto an Android study phone. When it is time for the text message reminders to be sent, study personnel access the application on a local phone, which in turn accesses the existing clinical trial database hosted on a US web server. The application retrieves a list of participants with the following information: phone number, whether a message should be received at that time, and the appropriate text of the message. The application is capable of storing multiple outgoing messages. With a few clicks, text messages are sent to study participants who can reply directly to the message. Study staff can check the local phone for incoming messages. The SMSMessenger application uses an existing clinical trial database and is able to receive real-time updates. All communications between the application and server are encrypted, and phone numbers are stored in a secure database behind a firewall. No sensitive data are stored on the phone, as outgoing messages are sent through the application and not by messaging features on the phone itself. Messages are sent simultaneously to study participants, which reduces the burden on local study staff. Costs and setup are minimal. The only local requirements are an Android phone and data plan. Conclusion: The SMSMessenger technology could be modified to be applied anywhere in the world, in any language, script, or alphabet, and for many different purposes. The novel application of this existing low-cost technology can improve the usefulness of text messaging in advancing the goals of international clinical trials.
Characteristics and trends of clinical trials funded by the National Institutes of Health between 2005 and 2015
Authors: Gresham Gillian K , Ehrhardt Stephan , Meinert Jill L , Appel Lawrence J , Meinert Curtis L 
Published: December 2017

Background The National Institutes of Health is one of the largest biomedical research agencies in the world. Clinical trials are an important component of National Institutes of Health research efforts. Given the recent updates in National Institutes of Health trial reporting requirements, more information regarding the current state of National Institutes of Health–funded clinical trials is warranted. The objective of this analysis was to describe characteristics and trends of clinical trials funded by the National Institutes of Health over time and by Institutes and Centers of the National Institutes of Health. Methods Interventional studies funded by the National Institutes of Health and registered in ClinicalTrials.gov between 2005 and 2015 were included in the analysis. Trials were identified from the 27 March 2016 Clinical Trials Transformation Initiative Aggregate Analysis of ClinicalTrials.gov database. A descriptive analysis of trials by year and National Institutes of Health Institute/Center was performed. Results There were 12,987 National Institutes of Health–funded clinical trials registered between 2005 and 2015. There were 1,580, 1,116, and 930 trials registered in 2005, 2010, and 2015, respectively. The majority were early-development trials (phases 0, 1, or 2; 53%), randomized (61%), and single-center (63%). Trial demographics have remained unchanged over time. Median trial sample size was 64 (interquartile range 29–192) with 10% of trials enrolling ≥500 participants. Most trials were completed within 5 years of enrollment start (69%). Trial characteristics varied considerably across National Institutes of Health Institutes and Centers. Results were reported under the assumptions that most National Institutes of Health–funded trials are registered in ClinicalTrials.gov and that trials are being registered completely and accurately. Conclusion In conclusion, there has been a decline in the number of trials being funded over time, explained in part by a relatively constant budget, increases in trial costs, or other factors that cannot be quantified. National Institutes of Health–funded trials are relatively small and tend to be single-centered. There are substantial differences in the number and types of trials done by Institutes and Centers within the National Institutes of Health.
Effects of Structured Versus Unstructured Self-Monitoring of Blood Glucose on Glucose Control in Patients With Non-insulin-treated Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials
Authors: Mannucci Edoardo , Antenore Alessandro , Giorgino Francesco , Scavini Marina 
Published: December 2017

Background: The use of self-monitoring of blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes is debated. Meta-analyses of randomized clinical trials (RCTs) suggest a small reduction of HbA1c in patients using SMBG, without considering potential confounders, such as SMBG regimen and use of SMBG data to adjust diabetes medications. Methods: A meta-analysis was performed including RCTs in patients with non-insulin-treated type 2 diabetes, with an intervention of ≥24 weeks and HbA1c as the primary endpoint, to verify the effect of SMBG (vs no monitoring), structured SMBG (vs unstructured), and of SMBG-driven therapy adjustments. Results: In RCTs (n = 8) comparing SMBG with no SMBG (1277 and 1072 patients, respectively), SMBG reduced HbA1c by −0.17% (95% CI −0.25 to −0.09%, P < .003). The reduction in HbA1c was greater in RCTs (n = 3) in which SMBG data were used to adjust diabetes medications (HbA1c decrease: −0.3% [95% CI −0.49 to −0.1%]) than in RCTs (n = 6) where SMBG data were not used for this purpose (HbA1c decrease: −0.1% [95% CI −0.2 to 0.0%]) ( P < .005). In the RCTs comparing structured and unstructured SMBG (757 and 750 patients, respectively), in which structured SMBG data were also used to adjust diabetes medications, the HbA1c difference between groups at study end was −0.27% (95% CI −0.49 to −0.04%, P < .018). Conclusions: In RCTs performed in non-insulin-treated patients with type 2 diabetes, SMBG is associated with a significant, although small, reduction in HbA1c. HbA1c reduction was greater with structured SMBG and when structured SMBG data were used to adjust diabetes therapy.
Comparative Effectiveness of Structural versus Regulatory Protein Gene Transfer on Articular Chondrocyte Matrix Gene Expression
Authors: Shi Shuiliang , Wang Congrong , Chan Albert , Kirmani Kashif , Eckert George J. , Trippel Stephen B. 
Published: December 2017

Objective The production of extracellular matrix is a necessary component of articular cartilage repair. Gene transfer is a promising method to improve matrix biosynthesis by articular chondrocytes. Gene transfer may employ transgenes encoding regulatory factors that stimulate the production of matrix proteins, or may employ transgenes that encode the proteins themselves. The objective of this study was to determine which of these 2 approaches would be the better choice for further development. We compared these 2 approaches using the transgenes encoding the structural matrix proteins, aggrecan or type II collagen, and the transgene encoding the anabolic factor, insulin-like growth factor I (IGF-I). Methods We transfected adult bovine articular chondrocytes with constructs encoding type II collagen, aggrecan, or IGF-I, and measured the expression of type II collagen ( COL2A1) and aggrecan ( ACAN) from their native genes and from their transgenes. Results IGF-I gene ( IGF1) transfer increased the expression of the native chondrocyte COL2A1 and ACAN genes 2.4 and 2.9 times control, respectively. COL2A1 gene transfer did not significantly increase COL2A1 transcripts, even when the transgene included the genomic COL2A1 regulatory sequences stimulated by chondrogenic growth factors. In contrast, ACAN gene transfer increased ACAN transcripts up to 3.4 times control levels. IGF1, but not ACAN, gene transfer increased aggrecan protein production. Conclusion Taken together, these results suggest that the type II collagen and aggrecan production required for articular cartilage repair will be more effectively achieved by genes that encode anabolic regulatory factors than by genes that encode the matrix molecules themselves.
Misdiagnosis: CNS Erdheim–Chester disease mimicking CLIPPERS
Authors: Berkman Jillian , Ford Caleb , Johnson Emily , Malow Beth A , Aulino Joseph M 
Published: December 2017

Introduction Chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS) is an inflammatory central nervous system (CNS) disorder with particular involvement of the pons. Diagnostic criteria include a range of clinical symptoms related to the underlying brainstem pathology, visible with magnetic resonance imaging (MRI). MRI findings include the appearance of punctuate and curvilinear gadolinium enhancement ‘peppering’ the pons. We discuss a patient presenting with clinical and radiographic characteristics of CLIPPERS who was diagnosed with Erdheim–Chester disease (ECD). Case report A 52-year-old male presented with 2 years of progressive spasticity, dysarthria, and gait instability. Initially, he was diagnosed with Parkinson’s disease at an outside hospital, based on tremor, rigidity, and gait instability; however, he failed to improve with a trial of levodopa. Brain MRI showed small enhancing parenchymal nodules coalescing in the central pons, but also affecting the cerebellum and cerebellar peduncles, with more punctate enhancing lesions in the cerebral lobar subcortical white matter. When the patient’s response to steroids was inadequate, further imaging was done, revealing perinephric processes. Subsequent biopsy revealed ECD. Conclusions A review of the literature for cases of CLIPPERS demonstrated a subset of patients later found to have various malignancies involving the CNS. This case report uses the patient’s unique radiographic and clinical presentation to demonstrate the importance of the exclusion criteria within the CLIPPERS diagnostic requirements and stresses red flags suggestive of alternative diagnoses. This distinction is of high importance when differentiating a relatively benign process such as CLIPPERS from more malignant diseases.
A single institution’s experience with using dabigatran, rivaroxaban and warfarin for prevention of thromboembolism in atrial fibrillation
Authors: Chan Li Xin , Wong Yee May , Chia Pow-Li , Kek Zhen Liang 
Published: December 2017

Background: Although non-vitamin K antagonist oral anticoagulants (NOACs) are approved for stroke prevention in atrial fibrillation (AF) patients, their use in the local clinical setting has not been well studied. This study aims to evaluate the clinical outcomes of dabigatran, rivaroxaban and warfarin in a tertiary hospital in Singapore. Methods: This is a retrospective cohort study with one-year follow-up. A total of 383 patients recruited between June 2011 and December 2014 were studied. Incidents of stroke, systemic embolism and clinically relevant bleeding events were compared between dabigatran, rivaroxaban and warfarin. Results: Stroke rates were 5.47% per year with warfarin, 7.27% per year with dabigatran (HR=1.32; 95% CI 0.48−3.64; p=0.591) and 2.76% per year with rivaroxaban (HR=0.49; 95% CI 0.14−1.69; p=0.261). The warfarin group had significantly higher incidence of minor bleeding (62.4% vs 3.64% for dabigatran vs 13.79% for rivaroxaban; p<0.001), major bleeding (3.91% for warfarin, 0.91% for dabigatran, 0% for rivaroxaban; p=0.028) and other adverse events (51.18% for warfarin, 3.64% for dabigatran, 8.28% for rivaroxaban; p<0.001). Incidence of dyspepsia was higher in both NOAC groups compared to warfarin (0% for warfarin, 7.27% for dabigatran, 5.52% for rivaroxaban; p=0.003). Conclusion: Stroke and venous thromboembolism rates after one year were comparable among dabigatran, rivaroxaban and warfarin. Warfarin was associated with more bleeding and adverse events while both NOACs were associated with higher rates of dyspepsia. Further study is needed to assess the clinical benefit of NOACs in the Singaporean population.
Improved risk stratification of patients with acute coronary syndromes using a combination of hsTnT, NT-proBNP and hsCRP with the GRACE score
Authors: Klingenberg Roland , Aghlmandi Soheila , Räber Lorenz , Gencer Baris , Nanchen David , Heg Dik , Carballo Sebastian , Rodondi Nicolas , Mach François , Windecker Stephan , Jüni Peter , von Eckardstein Arnold , Matter Christian M , Lüscher Thomas F 
Published: December 2017

Background: Clinical scores and biomarkers improve risk stratification of patients with acute coronary syndromes. However, little is known about their value in patients referred for coronary angiography. Methods: Consecutive patients admitted at four Swiss university hospitals with a diagnosis of acute coronary syndrome were enrolled into the SPUM-ACS Biomarker Cohort between 2009 and 2012. Patients were followed at 30 days and 1 year with assessment of adjudicated events including all-cause mortality and the composite of all-cause mortality or non-fatal recurrent myocardial infarction. Results: Events and biomarkers were analysed in 1892 patients (52.4% with ST-segment elevation myocardial infarction, 43.3% with non-ST-segment elevation myocardial infarction and 4.3% with unstable angina). Death at 30 days occurred in 35 patients (1.9%) and at 1 year in 80 patients (4.3%). The choice of troponin assay (conventional versus high sensitivity) to calculate the Global Registry of Acute Coronary Events (GRACE) score did not affect risk prediction. The prognostic accuracy of the GRACE score was improved when combined with three individual biomarkers including high sensitivity troponin T (hsTnT), N-terminal-pro B-type natriuretic peptide (NT-proBNP) and high sensitivity C-reactive protein (hsCRP) to yield a 9% increment (C-statistic 0.73–>0.82) for the discrimination of short-term risk for all-cause mortality. In contrast, the novel biomarkers placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFlt-1) and the ratio sFlt-1/PlGF did not improve risk stratification. Conclusions: In patients with acute coronary syndrome referred for coronary angiography, combinations of biomarkers including hsTnT, NT-proBNP and hsCRP with the GRACE score enhanced risk discrimination. Clinical Trials Registration: NCT01000701
Increased mortality risk in diabetic patients discharged from hospital with insulin therapy after an acute myocardial infarction: Data from the FAST-MI 2005 registry
Authors: Bataille Vincent , Ferrières Jean , Danchin Nicolas , Puymirat Etienne , Zeller Marianne , Simon Tabassome , Carrié Didier 
Published: December 2017

Background: Merits of insulin use for diabetes treatment in patients with advanced atherosclerosis are debated. This observational study conducted in diabetic patients after an acute myocardial infarction aimed to assess whether insulin prescription at discharge (IPD) was related to all-cause mortality during follow-up. Methods: Subjects were diabetic patients admitted in intensive- or coronary-care units for acute myocardial infarction (consecutively recruited in 223 centres in France) and discharged alive from the hospital, with or without an IPD. Vital status after five years was obtained and the relationship between insulin prescription at discharge and survival was studied. Results: Overall, 1221 diabetic patients were discharged alive and 38% had an IPD. Factors independently related to IPD were female gender, hospitalization in a public hospital, duration of diabetes, HbA1c level, smoking, peripheral artery disease, history of coronary heart disease and Killip class. After adjustment, IPD was independently related to all-cause mortality after five years of follow-up (adjusted hazard ratio = 1.72 (1.42–2.09), p<0.001). This increased mortality in subjects with IPD was also observed in propensity matched analyses, when subjects actually treated or actually not treated with insulin at discharge were compared in two groups matched on their computed probability of having had insulin prescribed. Conclusions: Insulin was preferably prescribed in seriously affected patients, regarding diabetes and cardiovascular risk. However, insulin prescription at discharge was associated with increased all-cause mortality after extensive adjustments for confounders. These results suggest possible intrinsic harmful effects of insulin in high-risk diabetic patients after myocardial infarction.
Multivessel versus culprit lesion only percutaneous coronary intervention in cardiogenic shock complicating acute myocardial infarction: A systematic review and meta-analysis
Authors: de Waha Suzanne , Jobs Alexander , Eitel Ingo , Pöss Janine , Stiermaier Thomas , Meyer-Saraei Roza , Fuernau Georg , Zeymer Uwe , Desch Steffen , Thiele Holger 
Published: December 2017

Background: Early revascularisation of the culprit lesion is the therapeutic cornerstone in cardiogenic shock complicating acute myocardial infarction. The optimal management of additional non-culprit lesions is unclear. This systematic review and meta-analysis aims to summarise current evidence on the comparison of immediate multivessel percutaneous coronary intervention (MV-PCI) or culprit lesion only PCI with possible staged revascularisation (C-PCI) in patients with cardiogenic shock complicating acute myocardial infarction. Methods: Medical literature databases were screened to identify analyses comparing MV-PCI with C-PCI in patients with cardiogenic shock complicating acute myocardial infarction and multivessel coronary artery disease. In absence of randomised trials, 10 cohort studies were included in the current meta-analysis. The primary outcome of short-term mortality was assessed at hospital discharge or 30 days after hospital admission. Secondary outcomes were long-term mortality as well as myocardial re-infarction, stroke, acute renal failure, and bleeding at short-term follow-up. Results: Of 6051 patients, 1194 (19.7%) received MV-PCI and 4857 (80.3%) C-PCI. Short-term mortality was 37.5% in patients undergoing MV-PCI compared with 28.8% in C-PCI patients (risk ratio 1.26, 95% confidence interval 1.12–1.41, p=0.001). Long-term mortality ( p=0.77), myocardial re-infarction ( p=0.77), stroke ( p=0.12), acute renal failure ( p=0.17) and bleeding ( p=0.53) did not differ significantly between the two revascularisation groups. Conclusions: Results of this first meta-analysis on the interventional management of patients with cardiogenic shock complicating acute myocardial infarction and multivessel coronary artery disease do not support MV-PCI over C-PCI. However, possible treatment selection bias in the individual studies must be taken into account.
Influence of Gender on Health-Related Quality of Life and Disability at 1 Year After Surgery for Thoracolumbar Burst Fractures
Authors: Maior Tiberiu , Ungureanu Gheorghe , Kakucs Cristian , Berce Cristian , Petrushev Bobe , Florian Ioan-Stefan 
Published: December 2017

Study Design: Case series. Objective: Thoracolumbar burst fractures (TLBF) are the most frequent type of spinal fractures. Approximately half of the patients are neurologically intact and their treatment is still debatable. Gender could influence outcome after surgical procedures, but this is still unclear in patients sustaining a spinal fracture. The aim of this study was to investigate how gender influences health-related quality of life (HRQOL) and disability in patients operated on for TLBF. Methods: We identified 44 neurologically intact patients from a consecutive series of patients treated surgically for a single-level traumatic burst fracture (AOSpine Subaxial Classification System A3) in the thoracolumbar transition area (Th12-L2). At 1 year after surgery, they were evaluated using the SF-36v2 questionnaire to assess HRQOL and Oswestry Disability Index (ODI) questionnaire to evaluate disability. Results: Male patients scored higher in each item of the SF-36v2, with significant differences ( P < .05) for Physical Function (PF), Bodily Pain (BP), and Social Function (SF). Male patients also had lower disability scores. Overall ODI score had a strong correlation with Physical Function, Role-Physical, Bodily Pain, Vitality, Mental Health, and overall Physical Component Summary (PCS) of the SF-36 in women, but only with Physical Function, Role-Physical, Role-Emotional, and PCS in men. Conclusions: In this study, male patients reported better outcomes at 1 year after surgery for TLBF than women. Disability strongly correlated with the overall HRQOL, physical and mental health in women, but not in men. We found gender-related differences favoring men after surgical interventions for spinal fractures.