bluuebunny/crossref_metadata_2025_split huggingface dataset:
Strategies for Postmarketing Surveillance of Drugs and Devices in Patients with ESRD Undergoing Dialysis
Authors: Vardi Moshe , Yeh Robert W. , Herzog Charles A. , Winkelmayer Wolfgang C. , Setoguchi Soko , Charytan David M. 
Published: August 2013

Summary
The lack of evidence on the effectiveness and safety of interventions in chronic dialysis patients has been a subject of continuing criticism. New technologies are often introduced into the market without having specifically studied or even included patients with advanced kidney disease. Therefore, the need to generate valid effectiveness and safety data in this vulnerable subpopulation is of utmost importance. The US Food and Drug Administration has recently placed an increased focus on safety surveillance, and sponsors must now meet this additional postmarketing commitment. In patients with ESRD, the unique data collection environment in the United States allows for creative and efficient study designs to meet the needs of patients, providers, and sponsors. The purpose of this manuscript is to review the methodological and practical aspects of the different options for postmarketing study design in this field, with critical appraisal of their advantages and disadvantages.
Evaluation of calcium, phosphorus, and selected trace mineral status in commercially available dry foods formulated for dogs
Authors: Gagné Jason W. , Wakshlag Joseph J. , Center Sharon A. , Rutzke Michael A. , Glahn Raymond P. 
Published: August 2013

Abstract
Objective—To evaluate concentrations of calcium, phosphorus, zinc, iron, copper, manganese, and selenium in several commercially available dry dog foods and compare these with current Association of American Feed Control Officials (AAFCO) recommendations for maintenance of healthy dogs.
Design—Descriptive study.
Sample—45 over-the-counter dry foods formulated for maintenance of healthy dogs (ie, maintenance foods) and 5 therapeutic dry foods formulated for dogs with hepatic or renal disease.
Procedures—Mineral concentrations were measured via inductively coupled plasma mass spectrometry or inductively coupled plasma atomic emission spectroscopy and compared with AAFCO-recommended minimum and maximum values.
Results—Most (39/45) maintenance foods were in compliance with AAFCO recommendations for all mineral concentrations evaluated. Calcium concentration was > 7. 1 g/1,000 kcal of metabolizable energy (ME) in 4 of 45 maintenance foods, and phosphorus concentration was > 4.6 g/1,000 kcal ME in 3 of these; 2 maintenance foods contained < 34 mg of zinc/1,000 kcal ME. These values were not within AAFCO-recommended ranges. Calcium-to-phosphorus ratio in foods formulated for dogs with renal disease was above, and copper concentration in foods formulated for dogs with hepatic disease was below, recommended ranges for healthy dogs.
Conclusions and Clinical Relevance—Calcium concentrations exceeded recommended limits in some maintenance foods labeled for all life stages, underscoring the need to feed diets appropriately formulated for specific life stages, particularly for large- and giant-breed puppies. Studies investigating the bioavailability of minerals are necessary before firm recommendations can be made.
Evaluation of short-term outcome after lung lobectomy for resection of primary lung tumors via video-assisted thoracoscopic surgery or open thoracotomy in medium- to large-breed dogs
Authors: Mayhew Philipp D. , Hunt Geraldine B. , Steffey Michele A. , Culp William T. N. , Mayhew Kelli N. , Fuller Mark , Johnson Lynelle R. , Pascoe Peter J. 
Published: August 2013

Abstract
Objective—To describe clinicopathologic features of dogs that underwent lung lobectomy for resection of primary lung tumors via video-assisted thoracoscopic surgery (VATS) or open thoracotomy (OT) and to compare short-term outcomes for dogs following these procedures.
Design—Retrospective cohort study.
Animals—46 medium- to large-breed dogs with primary lung tumors.
Procedures—Medical records of dogs that underwent a lung lobectomy via VATS (n = 22) or OT (24) for resection of primary lung tumors between 2004 and 2012 were reviewed. Dogs were included if they weighed > 10 kg (22 lb) and resection of a primary lung tumor was confirmed histologically. Tumor volumes were calculated from preoperative CT scans where available. Surgical time, completeness of excision, time in the ICU, indwelling thoracic drain time, postoperative and total hospitalization time, incidence of major complications, and short-term survival rate were evaluated.
Results—VATS was performed with a 3-port (n = 12) or 4-port (10) technique and 1-lung ventilation (22). In 2 of 22 (9%) dogs, VATS was converted to OT. All dogs survived to discharge from the hospital. There were no significant differences between the VATS and OT groups with regard to most variables. Surgery time was significantly longer for VATS than for OT (median, 120 vs 95 minutes, respectively).
Conclusions and Clinical Relevance—In medium- to large-breed dogs, short-term outcomes for dogs that underwent VATS for lung lobectomy were comparable to those of dogs that underwent OT. Further studies are required to evaluate the effects of surgical approach on indices of postoperative pain and long-term outcomes.
Molecular structures of metalmacrocyclic chelates of 3d-elements formed at template synthesis in the ion M(II)- thiooxamide-guanidine-formaldehyde quaternary systems
Authors: Mikhailov Oleg , Chachkov Denis , Grigorieva Olga 
Published: August 2013

Abstract
Using density functional theory (DFT) at the OPBE/TZP level, the calculation of the geometric parameters of the molecular structures of M(II) (5456)macrotetracyclic complexes with a tetradentate macrocyclic ligand with (NNNN)-coordination of donor centers, resulting from template reactions in M(II)- thiooxamide- guanidine-formaldehyde quaternary systems, where M= Mn, Fe, Co, Ni, Cu, Zn was performed. The calculation of the molecular structure of this “template” ligand itself was also carried out. The values of the bond lengths, bond and torsion angles in the resulting complexes are presented. The values of the standard enthalpy, entropy and Gibbs free energy of formation of these compounds were also calculated.
Effects of mechanical activation on structure and photocatalytic properties of ZnO powders
Authors: Gancheva Maria , Iordanova Reni , Dimitriev Yanko , Avdeev Georgi , Iliev Tzvetoslav 
Published: August 2013

Abstract
Zinc oxide (ZnO) was mechanically activated in air using a planetary ball mill using varying milling speeds and time. The obtained samples were analyzed by X-ray diffraction analysis (XRD), scanning electron microscopy (SEM) and UV-Vis diffusion reflectance spectroscopy. The photocatalytic activity of the mechanically treated ZnO powders were investigated in the reaction of Malachite Green (MG) degradation in aqueous solution under UV-light irradiation. A decrease in the crystallite size (from 90 to 10 nm) accompanied by an increase of microstrains and lattice parameters were established applying different milling speeds. The agglomeration of the particles was observed by SEM analysis. The absorption spectra of the initial and mechanically activated ZnO samples show shifting of the band position from 360 to 330 nm, which can be related to decrease in the crystalline size. The ZnO powders activated at lower milling speeds (for shorter time intervals) exhibit highest photocatalytic activity.
Chemical modification and characterization of poly(ethylene terephthalate) surfaces for collagen immobilization
Authors: Drobota Mioara , Persin Zdenka , Zemljic Lidija , Mohan Tamiselvan , Stana-Kleinschek Karin , Doliska Ales , Bracic Matej , Ribitsch Volker , Harabagiu Valeria , Coseri Sergiu 
Published: August 2013

Abstract
The functionalization of poly(ethylene terephthalate) (PET) surface films by reactions with multifunctional amines such as triethylenetetramine (TETA), and tetraethylenepentamine (TEPA) was investigated. For the functionalization of PET films surface we used a new way of treatment, a “sandwich model”. Physical-chemical properties of functionalized PET films were analysed. Qualitative and quantitative determination of the introduced amine groups were examined by means of Fourier Transform Infrared Attenuated Total Reflexion (FTIR — ATR), X-ray photoelectron spectroscopy (XPS), and potentiometric titration. Gained wetting properties were determined by using contact angle measurements and thoroughly analysed by acid-base approach. In addition, surface topography was investigated by atomic force microscopy (AFM). The amount of the introduced amino groups after TETA incorporation has been found to be two times higher as compared to TEPA. Wetting properties were significantly improved after aminolysis. Surface free energy was higher for PET — TETA treated film than that observed for PET — TEPA treated which is in accordance with titration results. The collagen immobilization onto PET treated films was evidenced by using AFM and subsequently by using XPS.
Intramedullary spinal capillary hemangiomas: clinical features and surgical outcomes
Authors: Wu Liang , Deng Xiaofeng , Yang Chenlong , Xu Yulun 
Published: August 2013

Object
Intramedullary capillary hemangiomas are exceedingly rare lesions in the spinal cord, and have been previously reported in the literature as case reports. The authors review their experience in 5 surgically treated patients with intramedullary capillary hemangiomas and discuss the clinical features, radiological findings, and surgical outcomes.

Methods
Clinical and imaging data of 5 patients with intramedullary spinal capillary hemangiomas treated at a single institution were retrospectively analyzed.

Results
There were 4 men and 1 woman, and their ages ranged from 18 to 63 years (mean 47.2 years). The thoracic cord was affected in 4 patients, and the cervicothoracic cord in 1 patient. Four patients underwent a gross-total resection. One patient initially underwent a subtotal removal and then underwent a second surgery due to enlargement of the residual lesion. Long-term neurological function was improved in all patients and MRI showed no tumor recurrence.

Conclusions
Capillary hemangiomas should be considered in the differential diagnosis of intramedullary spinal vascular lesions. Complete resection is the treatment of choice for these lesions. When total resection cannot be achieved, subtotal or even partial removal of the tumor is advised and repeat removal of the lesion is indicated when residual tumor regrowth is associated with neurological deterioration.
Decline in Serum 25 Hydroxyvitamin D Levels in HIV–Hbv-Coinfected Patients after Long-Term Antiretroviral Therapy
Authors: Avihingsanon Anchalee , Apornpong Tanakorn , Ramautarsing Reshmie A , Ubolyam Sasiwimol , Tangkijvanich Pisit , Ananworanich Jintanat , Lange Joep MA , Matthews Gail , Lewin Sharon R , Ruxrungtham Kiat ,   HIV-NAT 105 study team
Published: August 2013

Background Vitamin D insufficiency plays an important role in the development of fibrosis in chronic liver disease. Methods This was a cross-sectional study from Thailand. Liver fibrosis was assessed by transient elastography. Serum 25 hydroxyvitamin D (25[OH]D)<30 ng/ml was defined as hypovitaminosis D. 25(OH)D was assessed prior to and following tenofovir disoproxil fumarate (TDF). Factors related to 25(OH)D levels were determined by logistic regression analysis. Results A total of 158 HIV–HBV-coinfected patients (32% female, median age 43 years) were included. Overall, liver disease was mild with 13.4% having a fibrosis score (FS) of 7.1–14 kPa and 2% with a FS>14 kPa. Median (IQR) duration on TDF was 5 years (4–7). The median estimated glomerular filtration rate was 96.9 ml/min/1.73 m2. The median (IQR) serum 25(OH)D levels prior to and following TDF were 24.8 ng/ml (21.3–30.6) and 22.8 ng/ml (18.0–27.7), respectively; P≤0.001). The proportion of patients with hypovitaminosis D significantly increased from 72.2% (95% CI 64.7, 78.6) prior to TDF to 84.2% (95% CI 77.7, 89.0) after taking TDF ( P=0.01). Factors associated with hypovitaminosis D by multivariate analysis were female sex (adjusted OR 3.8, 95% CI 1.1, 13.7; P=0.038) and duration of antiretroviral therapy (ART)>5 years (OR 3.3, 95% CI 1.2, 8.8; P=0.017). Vitamin D levels were not associated with significant liver fibrosis. Conclusions Although our HIV–HBV-coinfected patients live in the tropics, there was a high prevalence of hypovitaminosis D, especially in female patients and those receiving prolonged ART. Since HIV–HBV-coinfection requires long-term use of the HBV-active drug, TDF, which can also contribute to bone loss, routine vitamin D assessment and supplementation as necessary should be considered.
Evaluation of Four Tenofovir-Containing Regimens as First-Line Treatments in Cameroon and Senegal: The Anrs 12115 Dayana Trial
Authors: Landman Roland , Koulla-Shiro Sinata , Sow Papa Salif , Ngolle Maguy , Diallo Mahamadou-Baila , Guèye Ndèye Fatou Ngom , Le Moing Vincent , Eymard-Duvernay Sabrina , Benalycherif Aïda , Charpentier Charlotte , Peytavin Gilles , Delaporte Eric , Girard Pierre-Marie ,   the DAYANA Study Group
Published: August 2013

Background The aim of the present study was to determine appropriate tenofovir-based regimens meriting evaluation in large-scale randomized trials among sub-Saharan African patients. Methods This was a randomized open-label 96-week prospective pilot study evaluating four first-line regimens: tenofovir/emtricitabine/nevirapine (group 1), tenofovir/ lopinavir/ritonavir (group 2), tenofovir/emtricitabine/zidovudine (group 3) and tenofovir/emtricitabine/efavirenz (group 4) in antiretroviral-naive, HIV-1-infected patients in Senegal and Cameroon. The primary end point was defined as an HIV-1 RNA viral load <50 copies/ml (study detection limit) at week 16 in ≥50% of patients using intention-to-treat analysis. Results At baseline, 119 patients included were 34% male, had a median plasma viral load of 5.4 log10 copies/ml and median CD4+ T-cell count of 200 cells/mm3 (range 53–358). The primary end point was achieved for groups 1, 3 and 4 (58% [ n=31], 62% [ n=29] and 53% [ n=30], respectively), but not for group 2 (38% [ n=29]). At week 96, undetectable HIV-1 RNA had been achieved in 74% of patients in group 1, 38% in group 2, 72% in group 3 and 73% in group 4. Patients with detectable HIV-1 RNA at week 16 were more likely to have baseline HIV-1 RNA≥100,000 copies/ml (adjusted OR 5.56, 95% CI 1.72, 16.67). HIV mutations associated with protease inhibitor resistance emerged in three patients, all of whom were in group 2. Anaemia occurred in two group 3 patients and was the only serious treatment-related adverse event. Conclusions Three efficient and safe tenofovir-based triple regimens were identified; the two-drug regimen (tenofovir/lopinavir/ritonavir) did not achieve the protocol-defined virological threshold of efficacy.
L'irréductibilité de la souveraineté territoriale
Authors: Maulin Éric 
Published: August 2013

Cet article affirme l’irréductibilité de la souveraineté territoriale. L’auteur considère que les discours sur la mondialisation sont avant tout des discours prospectifs sur un monde annoncé comme inéluctable, mais qu’en fait, la raison d’État sanctuarise le territoire national. Si l’évolution liée à la mondialisation peut affecter la nature de l’État, elle n’en change pas le principe de son existence souveraine ; d’autant que seule la souveraineté du peuple garantit le principe démocratique.
La voie juridique vers l'indépendance d'un territoire espagnol
Authors: Perez-Calvo Alberto 
Published: August 2013

Cet article étudie les possibilités de sécession de communautés autonomes dans le cadre de la constitution espagnole. En évoquant les distinctions entre « peuple » et « nationalités » dans la constitution, la question du référendum, ainsi que la révision de la constitution, l’auteur conclut à l’impossibilité de faire reconnaître la sécession dans le cadre constitutionnel espagnol actuel. Il ajoute que dans le cadre juridique européen, l’indépendance entraînerait la sortie de l’Union européenne de l’État sécessionnaire.
Les dettes publiques sont-elles souveraines ?
Authors: Dévoluy Michel 
Published: August 2013

La perte de souveraineté financière des États au cours des trente dernières années n’est pas due pour l’essentiel à l’absence de rigueur budgétaire. Elle résulte avant tout de trois mouvements de fond : la financiarisation des dettes publiques, la conversion libérale des politiques fiscales et, pour ce qui concerne spécifiquement l’Europe, la mise sous tutelle des budgets nationaux. La crise n’a fait qu’accélérer cette tendance. Le chemin de la reconquête d’une autonomie financière exige des États qu’ils s’émancipent du paradigme néolibéral. Les membres de la zone euro doivent remplir une condition supplémentaire : s’engager résolument vers une Europe fédérée.
Towards a Europeanisation of French Mediterranean Politics?
Authors: Martins Verónica 
Published: August 2013

L’analyse de l’européanisation de la politique française en Méditerranée constitue le thème principal de cet article qui aborde également la dynamique du couple franco-allemand en politique étrangère. En considérant simultanément les relations bilatérales à travers trois Présidents de la République et la politique méditerranéenne de la France au niveau européen, il est possible d’observer que les deux dimensions co-existent et que la politique étrangère française est tombée dans une « dépendance au sentier » particulièrement marquée pour le Maghreb, alors que la politique envers la Turquie semble s’améliorer. L’européanisation se vérifie dans ses deux dimensions : ‘bottom-up’ où la France se présente particulièrement comme un ‘policy-shaper’ et un ‘policy supporter’ et ‘top down’ où elle assume la forme d’une ‘absorption’ dans laquelle la logique européenne, orientée par l’Allemagne, a contré les projets de ‘refrancisation’ de la politique européenne.
L'Envie : récits, mythes et psychanalyse
Authors: Wassef Olfat 
Published: August 2013

Résumé L’être humain est confronté dès sa naissance à la frustration et, de ce fait, au sentiment d’envie. Les religions ici citées ont mis en place des lois et des règles visant à maîtriser ce sentiment. Les récits, contes et mythes ont illustré la façon dont l’envieux cherche à ravir à l’envié sa place ou ses biens. La clinique psychothérapeutique nous enseigne les différentes issues trouvées par les sujets en proie au sentiment d’envie : le refoulement, la projection, le phantasme ou la sublimation.
Modulation of Inflammasome-Mediated Pulmonary Immune Activation by Type I IFNs Protects Bone Marrow Homeostasis during Systemic Responses to Pneumocystis Lung Infection
Authors: Searles Steve , Gauss Katherine , Wilkison Michelle , Hoyt Teri R. , Dobrinen Erin , Meissner Nicole 
Published: August 2013

Abstract
Although acquired bone marrow failure (BMF) is considered a T cell–mediated autoimmune disease, possible innate immune defects as a cause for systemic immune deviations in response to otherwise innocuous infections have not been extensively explored. In this regard, we recently demonstrated an important role of type I IFNs in protecting hematopoiesis during systemic stress responses to the opportunistic fungal pathogen Pneumocystis in lymphocyte-deficient mice. Mice deficient in both lymphocytes and type I IFN receptor (IFrag−/− mice) develop rapidly progressing BMF due to accelerated bone marrow (BM) cell apoptosis associated with innate immune deviations in the BM in response to Pneumocystis lung infection. However, the communication pathway between lung and BM eliciting the induction of BMF in response to this strictly pulmonary infection has been unclear. In this study, we report that absence of an intact type I IFN system during Pneumocystis lung infection not only causes BMF in lymphocyte-deficient mice but also transient BM stress in lymphocyte-competent mice. This is associated with an exuberant systemic IFN-γ response. IFN-γ neutralization prevented Pneumocystis lung infection–induced BM depression in type I IFN receptor–deficient mice and prolonged neutrophil survival time in BM from IFrag−/− mice. IL-1β and upstream regulators of IFN-γ, IL-12, and IL-18 were also upregulated in lung and serum of IFrag−/− mice. In conjunction, there was exuberant inflammasome-mediated caspase-1 activation in pulmonary innate immune cells required for processing of IL-18 and IL-1β. Thus, absence of type I IFN signaling during Pneumocystis lung infection may result in deregulation of inflammasome-mediated pulmonary immune activation, causing systemic immune deviations triggering BMF in this model.
A Pilot Study of Concurrent Lead and Cotinine Screening for Childhood Tobacco Smoke Exposure: Effect on Parental Smoking
Authors: Joseph Anne , Murphy Sharon , Thomas Janet , Okuyemi Kolawole S. , Hatsukami Dorothy , Wang Qi , Briggs Anna , Doyle Brandon , Winickoff Jonathan P. 
Published: August 2013

Purpose. To investigate whether a biomarker screening approach for tobacco smoke exposure (TSE) conducted concurrently with lead screening at well-child visits would increase parental smoking cessation and implementation of home smoking restrictions. Design. Observational, quasi-experimental. Setting. Pediatric clinic in Minneapolis, Minnesota. Subjects. Eighty parents who smoked and their children presenting for well-child visits. Intervention. Children in the intervention group had serum cotinine measured with lead screening. Laboratory results were sent to providers and parents and a counselor proactively contacted parents to offer an eight-session telephone intervention to help parents stop smoking. The comparison group, a historical control, received usual care. Measures. Parental smoking, engagement in tobacco treatment, and home and car smoking policies 8 weeks later. Analysis. Mean/standard deviation for continuous data or frequency/percentage for categorical data. Results. Eighty-four percent of eligible parents agreed to have their child tested for TSE along with lead testing. Measurable cotinine was identified in 93% of children. More parents in the intervention group received tobacco treatment than in the comparison group (74% vs. 0%) and more parents reported 7-day point-prevalent abstinence from smoking at 8 weeks (29% vs. 3%). Conclusion. These data demonstrate the feasibility of adding cotinine measurement to routine well-child lead screening to document TSE in small children. Data suggest providing this information to parents increases engagement in tobacco treatment and prompts smoking cessation.