bluuebunny/crossref_metadata_2025_split huggingface dataset:
Retrospective analysis of a surgical innovation using the IDEAL framework: radical cystectomy with epidural anaesthesia
Authors: Gerullis Holger , Ecke Thorsten H. , Barski Dimitri , Bantel Carsten , Weyland Andreas , Uphoff Jens , Jansen Thomas , Wawroschek Friedhelm , Winter Alexander 
Published: February 2017

Objectives To retrospectively analyse experience of radical cystectomy using spinal/epidural anaesthesia and to classify this method using the IDEAL criteria. Methods Data from patients who had undergone radical cystectomy using spinal/epidural anaesthesia were evaluated retrospectively, focusing on clinical data, intraoperative and perioperative parameters and postoperative complications. Current literature reporting on this technique was reviewed and, together with the present study, evaluated according to the IDEAL recommendations. Results Three male patients aged 66–79 years who had undergone radical cystectomy with epidural anaesthesia were identified. The operating time ranged from 159–261 min and only minor complications occurred. Between 2013 and 2015, three published studies reported experiences with radical cystectomy with epidural/spinal anaesthesia; one was prospective and two were retrospective in nature and they included a total of 55 patients. According to the IDEAL classification, the present study corresponds to stage 1 (idea) and overall the surgical technique can be ranked as stage 2a (development). Conclusions Radical cystectomy with epidural anaesthesia is feasible and applicable for those who are not fit for general anaesthesia. The present study confirmed the functional results of this technique, which can be classified as IDEAL stage 2a on the basis of published studies.
Using Acute Performance on a Comprehensive Neurocognitive, Vestibular, and Ocular Motor Assessment Battery to Predict Recovery Duration After Sport-Related Concussions
Authors: Sufrinko Alicia M. , Marchetti Gregory F. , Cohen Paul E. , Elbin R.J. , Re Valentina , Kontos Anthony P. 
Published: February 2017

Background: A sport-related concussion (SRC) is a heterogeneous injury that requires a multifaceted and comprehensive approach for diagnosis and management, including symptom reports, vestibular/ocular motor assessments, and neurocognitive testing. Purpose: To determine which acute (eg, within 7 days) vestibular, ocular motor, neurocognitive, and symptom impairments predict the duration of recovery after an SRC. Study Design: Cohort study (prognosis); Level of evidence, 2. Methods: Sixty-nine patients with a mean age of 15.3 ± 1.9 years completed a neurocognitive, vestibular/ocular motor, and symptom assessment within 7 days of a diagnosed concussion. Patients were grouped by recovery time: ≤14 days (n = 27, 39.1%), 15-29 days (n = 25, 36.2%), and 30-90 days (n = 17, 24.6%). Multinomial regression was used to identify the best subset of predictors associated with prolonged recovery relative to ≤14 days. Results: Acute visual motor speed and cognitive-migraine-fatigue symptoms were associated with an increased likelihood of recovery times of 30-90 days and 15-29 days relative to a recovery time of ≤14 days. A model with visual motor speed and cognitive-migraine-fatigue symptoms within the first 7 days of an SRC was 87% accurate at identifying patients with a recovery time of 30-90 days. Conclusion: The current study identified cognitive-migraine-fatigue symptoms and visual motor speed as the most robust predictors of protracted recovery after an SRC according to the Post-concussion Symptom Scale, Immediate Post-concussion Assessment and Cognitive Testing, and Vestibular/Ocular Motor Screening (VOMS). While VOMS components were sensitive in identifying a concussion, they were not robust predictors for recovery. Clinicians may consider particular patterns of performance on clinical measures when providing treatment recommendations and discussing anticipated recovery with patients.
Commonly Consumed Foods
Authors: Ayogu Rufina , Edeh Raphael , Madukwe Edith , Ene-Obong Henrietta 
Published: February 2017

Background: Commonly consumed foods may be nutritionally inadequate. Schoolchildren may be at risk of undernutrition as a result of this. Objective: To assess the nutrient and energy values of commonly consumed foods and determine their contributions to the recommended nutrient intakes (RNIs) of schoolchildren (6-15 years). Methods: List of commonly consumed foods was obtained through focus group discussions with parents of schoolchildren. Ninety randomly selected schoolchildren were visited at home on 3 consecutive days (2 weekdays and 1 weekend day) during which their portion sizes of these foods were obtained. Aliquots of these foods were collected, wrapped in polyethylene bags, and kept frozen until analysis. The samples were analyzed using standard methods. Percentage contributions of the nutrients to RNI were calculated. Data were analyzed by descriptive statistics. Results: Results per 100 g showed that Pentaclethra macrophylla ( akpaka) sauce had the highest moisture (76.91%), ash (6.9%), iron (13.51%), and vitamin A (44.0 retinol equivalent [RE]). Steamed bambara groundnut pudding ( okpa) had the highest protein (15.08%). Maize + pigeon pea ( ayaraya oka) had the highest fat (15.76%). Tomato stew proved superior in carbohydrate (28.15%) and energy (194.6 kcal). Pterocarpus soyauxii ( oha) soup contained the highest fiber (4.13%). Yam + pigeon pea ( ayaraya ji) had the highest zinc (4.97 mg). Contributions to RNI were protein (5.0%-134.0%), carbohydrate (0.6%-9.9%), energy (4.9%-38.8%), iron (1.5%-168.8%), vitamin A (0.0%-18.7%), and zinc (1.2%-166.0%). Conclusion: Most foods did not meet one-third of the schoolchildren’s RNI for vitamin A, zinc, iron, protein, carbohydrate, and energy. Nutrition education on nutrient adequacy is recommended.
Economic Examination of Cefoperazone Therapy
Authors: Jacobs Jake , Wyant Susan 
Published: February 2017

Medical records of 1137 patients from 35 hospitals were reviewed to examine the total cost of care for patients receiving cefoperazone as initial therapy compared to a control group receiving alternative agents. The direct costs of care measurable through a retrospective review of patient records were examined, including the cost of antibiotic acquisition, drug administration, laboratory testing, and room and board. Results of a regression analysis show that cefoperazone as initial therapy is associated with lower costs for all factors studied except acquisition cost. Antibiotic acquisition averaged $24 per patient mora for the cefoperazone group (p < 0.01). However, for cefoperazone patients drug administration was $63 less (p <0.0001), laboratory testing costs averaged $9 less (p = 0.22), and costs associated with room and board charges were $80 less (p = 0.40). Total costs averaged $3073 per cefoperazone patient and $3228 per control patient (p = 0.20). These data suggest that the previously accepted definitions of antimicrobial costs (i.e., cost per gram, cost per dose, cost per day) may no longer be adequate in this era of cost containment. In order to make sound clinical decisions with lowest total costs, practitioners should identify how and where costs are incurred.
Using a Hand-Held Spirometer as a Monitoring Tool in Chronic Theophylline Therapy
Authors: Mikhail May N. , Catania Patrick N. 
Published: February 2017

This study evaluates the use of a hand-held spirometer (pocket spirometer, Buhl type) in monitoring pulmonary function as a part of a homebased pharmacokinetic service for patients with respiratory disease. To calibrate the spirometer and determine its accuracy, six healthy volunteers were trained in its use by the pharmacist. Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were determined for each volunteer once a month for six months, The T test for the presence of outliers showed no statistical difference at p <0.05. Seven patients on chronic therapy with theophylline derivatives for respiratory problems were randomly referred by their physicians to the pharmacokinetic service. The pharmacist counseled each patient and measured FVC and FEV1 once a month for six months. The ratio, (FEV1:FVC) x 100, was calculated for each patient before and after steady-state serum level determination and dosage adjustment. The mean value for this ratio was 45.1 before pharmacokinetic intervention and 57.5 after intervention. Using the Student's t-test, these results were significant (p < 0.05). The correlation coefficient was calculated to determine if a correlation existed between the increase in the ratio and the increase in serum theophylline levels. Serum levels were ordered before and after intervention for five of the seven patients receiving pharmacokinetic intervention. The change in serum levels vs. change in the ratio was associated with a correlation coefficient of 0.718. Monitoring pulmonary function may be a useful adjunct for the pharmacist who provides pharmacokinetic counseling to patients with respiratory disease, but expanded studies are needed to judge the value of routine spirometric measurements on homebased patients.
Compatibility and Stability of Clindamycin Phosphate-Aminoglycoside Combinations Within Polypropylene Syringes
Authors: Zbrozek Arthur S. , Marble Dwight A. , Bosso John A. , Bair Jan N. , Townsend Raymond J. 
Published: February 2017

The stability and compatibility of clindamycin phosphate admixed separately with gentamicin sulfate, tobramycin sulfate, and amikacin sulfate in polypropylene syringes under specific storage conditions were studied. In duplicate syringes, clindamycin phosphate 900 mg was admixed with sterile NaCl 0.9% 1 ml and with either gentamicin sulfate 120 mg, tobramycin sulfate 120 mg, or amikacin sulfate 750 mg. In duplicate polypropylene syringes, control solutions of clindamycin phosphate and each aminoglycoside were prepared separately and stored under the same conditions. The clindamycin control consisted of clindamycin phosphate 900 mg in 6 ml. The gentamicin and tobramycin controls consisted of gentamicin sulfate and tobramycin sulfate 120 mg in 3 ml plus 1 ml of sterile NaCl 0.9%. The amikacin control consisted of amikacin sulfate 750 mg in 3 ml plus 1 ml of sterile NaCl 0.9%. Drug concentrations were determined at the time of preparation and 1, 4, 8, 12, 24, and 48 hours thereafter. Aminoglycosides were assayed by fluorescence polarization immunoassay and clindamycin was assayed by high performance liquid chromatography. Visual inspections and pH determinations of each combination and control solution were performed at each assay time. For the clindamycin, gentamicin, tobramycin, and amikacin control solutions, changes in concentration were within ten percent of the original concentration. Concentrations of clindamycin and gentamicin when admixed together also remained within ten percent of the original concentration. Similar results were found with concentrations of clindamycin and amikacin when admixed together. Tobramycin and clindamycin formed a lasting precipitate upon initial contact when admixed under the study conditions.
The Drug Approval Process and the Information it Provides
Authors: Myers Ann , Moore Steven R. , Hartzema Abraham G. , Porta Miquel S. , Tilson Hugh H. 
Published: February 2017

By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A brief history on the legislation regarding the FDA's responsibility in the drug approval area is discussed along with recent regulations, legislation, and FDA initiatives aimed at improving the drug approval process. Specific information that can be released to the public upon request is also discussed. This paper is limited to the regulation of drugs; somewhat different regulations govern the review and regulation of biological products and abbreviated new drug applications.
Evaluation of the Potential for Drug Interactions With Patiromer in Healthy Volunteers
Authors: Lesko Lawrence J. , Offman Elliot , Brew Christine Taylor , Garza Dahlia , Benton Wade , Mayo Martha R. , Romero Alain , Du Mond Charles , Weir Matthew R. 
Published: February 2017

Introduction: Patiromer is a potassium-binding polymer that is not systemically absorbed; however, it may bind coadministered oral drugs in the gastrointestinal tract, potentially reducing their absorption. Methods: Twelve randomized, open-label, 3-period, 3-sequence crossover studies were conducted in healthy volunteers to evaluate the effect of patiromer (perpetrator drug) on absorption and single-dose pharmacokinetics (PK) of drugs (victims) that might be commonly used with patiromer. Subjects received victim drug alone, victim drug administered together with patiromer 25.2 g (highest approved dose), and victim drug administered 3 hours before patiromer 25.2 g. The primary PK endpoints were area under the curve (AUC), extrapolated to infinity (AUC0-∞), and maximum concentration ( Cmax). Results were reported as 90% confidence intervals (CIs) about the geometric mean AUC0-∞ and Cmax ratios with prespecified equivalence limits of 80% to 125%. Results: Overall, 370 subjects were enrolled, with 365 receiving ≥1 dose of patiromer; 351 subjects completed the studies and all required treatments. When coadministered with patiromer, the 90% CIs for AUC0-∞ remained within 80% to 125% for 9 drugs (amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil, and warfarin). The AUC0-∞ point estimate ratios for levothyroxine and metformin with patiromer coadministration were ≥80%, with the lower bounds of the 90% CIs at 76.8% and 72.8%, respectively. For ciprofloxacin, the point estimate for AUC0-∞ was 71.5% (90% CI: 65.3-78.4). For 8 of 12 drugs, point estimates for Cmax were ≥80% with patiromer coadministration; for ciprofloxacin, clopidogrel, metformin, and metoprolol, the point estimates were <80%. When patiromer was administered 3 hours after each victim drug, the 90% CIs for AUC0-∞ and Cmax for each drug were within the prespecified 80% to 125% limits. Conclusion: For 9 of the 12 drugs coadministered with patiromer, there were no clinically significant drug–drug interactions. For 3 drugs (ciprofloxacin, levothyroxine, and metformin), a 3-hour separation between patiromer and their administration resulted in no clinically significant drug–drug interactions.
Revisiting cognitive reserve and cognition in multiple sclerosis: A closer look at depression
Authors: Patel Viral P , Walker Lisa AS , Feinstein Anthony 
Published: February 2017

Background: The protective effect of cognitive reserve (CR) on cognition in people with multiple sclerosis (PwMS) has been well described. Objective: To explore the relationship between aspects of CR, namely, leisure pursuits and depression. Methods: In a cross-sectional study, a sample of 155 PwMS and 115 healthy controls (HC) underwent cognitive testing with the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery. Leisure activity was retrospectively recorded using the Leisure Activity Scale (LAS). Depression was assessed using the Hospital Anxiety and Depression Scale. Results: PwMS demonstrated greater decreases in leisure activity over time compared to the HC group, particularly in the past year ( p < 0.001). Here, depression accounted for 17% of the variance in determining the level of leisure activity ( p < 0.001). Premorbid IQ and leisure activity within the past year emerged as significant predictors of information processing speed, learning, memory and executive function. After controlling for depression, the influence of leisure activity on cognition was insignificant. Conclusion: Depression can cause significant changes in behaviour which can influence indices of CR, such as leisure pursuits. Successfully treating depression may lead to a more active lifestyle thereby offsetting in part the cognitive burden of disease.
Impact of a telemedicine eICU cart on sepsis management in a community hospital emergency department
Authors: Machado Shana M , Wilson Erika H , Elliott John O , Jordan Kim 
Published: February 2017

Introduction Intensivist involvement for patients with sepsis is associated with decreased complications and mortality, and lower hospital resource utilization, but few studies have evaluated outcomes for patients exposed to electronic intensive care unit (eICU) telemedicine sepsis management in the emergency department (ED). In this study, we assess whether eICU cart exposure in the ED improved compliance with components of the 2010 Surviving Sepsis Campaign bundles, length of stay (LOS), disposition and hospital costs. Methods An institutional review board-approved, retrospective cohort study was completed on patients with confirmed sepsis who presented to our ED from July 2010 through February 2013. Results Of 711 patient ED encounters, 314 cases met criteria for analysis (95 exposed and 219 non-exposed). Patient cohorts had similar demographics and comorbid International Classification of Diseases, Ninth Edition (ICD-9) diagnoses. The exposed cohort received antibiotics more quickly (122.3 minutes ±83.3 versus 163.4 minutes ±204.4, p = 0.043) and were more likely to have lactic acid levels drawn within six hours (98.9% vs. 90%, p = 0.019). The exposed cohort had a shortened ED LOS (in days) 0.08 ± 0.28 versus 0.16 ± 0.37, p = 0.036. Hospital LOS, disposition and death were similar in both cohorts. Total hospital costs for the exposed cohort were lower and less variable (US$19,713 ± 16,550 vs. US$24,364 ± 25068), but this was not significant ( p = 0.274). Discussion Our findings suggest that in individuals with confirmed sepsis, ED exposure to a telemedicine-based eICU cart impacted adherence to aspects of the Surviving Sepsis Campaign recommended bundle, but did not impact overall survival and medical costs.
Treatment of Vesicovaginal Fistulas With Autologous Cell Injections—A Randomized Study in an Animal Model
Authors: Jepsen Marianne S. , Sellathurai Jeeva , Conti Alessandro , Schrøder Henrik D. , Lund Lars 
Published: February 2017

Purpose: To evaluate the effect of autologous satellite cell and smooth muscle cell transplantation on vesicovaginal fistulas in a randomized controlled study by comparing the proportion of fistula closure and tissue composition between the 2 groups. Materials and Methods: Eight pigs underwent surgery to establish an experimental induced fistula. One pig was excluded due to insufficient weight gain. Seven pigs were randomized to receive either an injection of satellite cells and smooth muscle cells or no treatment. Cells were isolated from abdominal skeletal muscle and bladder smooth muscle, cultured in vitro, and marked with bromodeoxyuridine. Cell purity, growth kinetics, and differentiation potential were determined. Cells were injected around the fistula using a cystoscope. Five weeks after the injection of cells, the fistula area was examined macroscopically and histologically. Results: The isolated satellite cell population consisted of 76.6% neural cell adhesion molecule positive cell and the smooth muscle cell population of 88.6% α-smooth muscle actin positive cells. All pigs had a persisting fistula before treatment. One of the 4 vesicovaginal fistulas was closed 5 weeks after injection of satellite cells and smooth muscle cells compared to none in the control group. No histological differences in the tissue composition between the 2 groups were observed and no bromodeoxyuridine-labeled cells were detected around the fistula tissue in the histological examination. Conclusion: We established an animal model with a persisting clinical and histological confirmed vesicovaginal fistula. The study indicated that there might be an effect on vesicovaginal fistula closure using an injection of satellite cells/smooth muscle cells and alginate gel.
Diagnostic Validity Comparison Between Criteria Based on CSF Alzheimer’s Disease Biomarkers
Authors: Blanco-Cantó Maria Empar , Monge-Argilés J. A. , Pérez-Cejuela C. , Badía C. , Gabaldón L. , Muñoz-Ruíz C. , Sánchez-Payá J. , Gasparini-Berenguer R. , Leiva-Santana C. 
Published: February 2017

Aim: To compare the diagnostic validity of NIA-AA criteria, for AD CSF biomarkers, with our own new criteria. Materials and Methods: Between 2008 and 2011, 170 patients with Mild Cognitive Impairment (MCI) were included. CSF levels of Aβ1-42, T-tau, P-tau181, and ratios of T-tau/Aβ1-42 and P-tau181/Aβ1-42 were analyzed. In our criteria, we considered 3 or more abnormal variables indicative of a high likelihood of MCI due to AD. Results: After a clinical follow-up of 4.5 ± 1.2 years, 44 patients remained stable, 95 developed AD, 15 other forms of dementia, 7 died and 9 received other diagnoses. Using the NIA-AA criteria and our own criteria, the diagnostic validity of the CSF biomarkers was 58% versus 85%, specificity 84% versus 72%, PPV 82% versus 79% and NPV 61% versus 79%. Conclusion: The inclusion of the ratios in diagnostic criteria increases sensitivity and NPV for the diagnosis of MCI due to AD.
Causes of peripheral cytopenia in hepatitic cirrhosis and portal hypertensive splenomegaly
Authors: Lv Yunfu , Yee Lau Wan , Wu Hongfei , Han XiaoYu , Gong Xiaoguang , Liu Ning , Yue Jie , Li Qingqing , Li YeJuan , Deng Jie 
Published: February 2017

The clinical data of 183 patients with hepatitic cirrhosis and portal hypertensive splenomegaly complicated by peripheral cytopenia were retrospectively analyzed to investigate the causes of peripheral cytopenia, as well as the proportion of the causes in these patients. All patients underwent splenectomy. Before operation, these patients had one or more types of peripheral cytopenia (cumulative cytopenia: 390 patient-times). After splenectomy, blood counts in 79.2% (309/390) returned to normal, while in 15.9% (62/390) they increased but failed to reach to normal levels, and in 4.9% (19/390) they became lower than before the operations. For the last group of patients ( n = 19), long-term follow-up showed that blood counts returned to normal in five patients. In other words, in 80.5% [(309 + 5)/390 or 314/390] of patient-times, the peripheral cytopenia was due to hypersplenism, in 15.9% it was due to a combination of factors, and in 3.6% [14/390] it had nothing to do with the hypersplenism. Thus, hypersplenism is a major cause, but not the only cause, of peripheral cytopenia in patients with hepatic cirrhosis and portal hypertensive splenomegaly, and splenectormy is an effective treatment for these patients.Impact statementFor a long time, the development of peripheral cytopenias as a complication to cirrhotic portal hypertension has been attributed to hypersplenism; however, this has never been fully demonstrated. Dameshek summarized that hypersplenism should be diagnosed by the presence of four conditions: (a) mono- or multi-lineage peripheral cytopenias; (b) compensatory hyperplasia of bone marrow; (c) splenomegaly; and (d) correction of cytopenias after splenectomy. We retrospectively analyzed the clinical data from 183 surgical patients, and found that 80.5% of peripheral cytopenias was caused by hypersplenism, 16% by a combination of factors, and 3.5% by other factors unrelated to hypersplenism. As the first quantitative findings in this field, our results verify that hypersplenism is a major, but not exclusive, cause of peripheral cytopenias, and provides important clinical evidence for investigating the cause of peripheral cytopenias.