bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase III Randomized Study Comparing Docetaxel Plus Trastuzumab With Vinorelbine Plus Trastuzumab As First-Line Therapy of Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: The HERNATA Study
Authors: Andersson Michael , Lidbrink Elisabeth , Bjerre Karsten , Wist Erik , Enevoldsen Kristin , Jensen Anders B. , Karlsson Per , Tange Ulla B. , Sørensen Peter G. , Møller Susanne , Bergh Jonas , Langkjer Sven T. 
Published: December 2010

Purpose To evaluate docetaxel or vinorelbine, both with trastuzumab, as first-line therapy of human epidermal growth factor receptor 2–positive advanced breast cancer. Patients and Methods Patients naive to chemotherapy for advanced disease were randomly assigned to docetaxel 100 mg/m2 day 1 or vinorelbine 30 to 35 mg/m2 on days 1 and 8, both combined with trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance dose) on day 1 every 3 weeks. The primary end point was time to progression (TTP). Results A total of 143 patients were randomly allocated to docetaxel, and 141 patients were assigned to vinorelbine. The median TTP for docetaxel and vinorelbine respectively was 12.4 months versus 15.3 months (hazard ratio [HR] = 0.94; 95% CI, 0.71 to 1.25; P = .67), median overall survival was 35.7 months versus 38.8 months (HR = 1.01; 95% CI, 0.71 to 1.42; P = .98), and the 1-year survival rate was 88% in both arms. Median time to treatment failure for study chemotherapy was 5.6 months versus 7.7 months (HR = 0.50; 95% CI, 0.38 to 0.64; P < .0001). The investigator-assessed overall response rate among 241 patients with measurable disease were 59.3% in both arms. More patients in the docetaxel arm discontinued therapy due to toxicity (P < .001). Significantly more treatment-related grade 3 to 4 febrile neutropenia (36.0% v 10.1%), leucopenia (40.3% v 21.0%), infection 25.1% v 13.0%), fever (4.3% v 0%), neuropathy (30.9% v 3.6%), nail changes (7.9% v 0.7%), and edema (6.5% v 0%) were reported with docetaxel. Conclusion The study failed to demonstrate superiority of any drug in terms of efficacy, but the vinorelbine combination had significantly fewer adverse effects and should be considered as an alternative first-line option.
Immunosuppressive Therapy for Patients With Myelodysplastic Syndrome: A Prospective Randomized Multicenter Phase III Trial Comparing Antithymocyte Globulin Plus Cyclosporine With Best Supportive Care—SAKK 33/99
Authors: Passweg Jakob R. , Giagounidis Aristoteles A.N. , Simcock Mathew , Aul Carlo , Dobbelstein Christiane , Stadler Michael , Ossenkoppele Gert , Hofmann Wolf-Karsten , Schilling Kristina , Tichelli André , Ganser Arnold 
Published: December 2010

Purpose Immunosuppressive treatment is reported to improve cytopenia in some patients with myelodysplastic syndrome (MDS). Combined antithymocyte globulin (ATG) and cyclosporine (CSA) is most effective in patients with immune-mediated marrow failure. Patients and Methods This trial was designed to assess the impact of immunosuppression on hematopoiesis, transfusion requirements, transformation, and survival in patients with MDS randomly assigned to 15 mg/kg of horse ATG for 5 days and oral CSA for 180 days (ATG+CSA) or best supportive care (BSC), stratified by treatment center and International Prognostic Scoring System (IPSS) risk score. Primary end point was best hematologic response at 6 months. Eligible patients had an Eastern Cooperative Oncology Group performance status of ≤ 2 and transfusion dependency of less than 2 years in duration. Results Between 2000 and 2006, 45 patients received ATG+CSA (median age, 62 years; range, 23 to 75 years; 56% men) and 43 patients received BSC (median age, 65 years; range, 24 to 76 years; 81% men). IPSS score was low, intermediate-1, intermediate-2, high, and not evaluable in eight, 24, seven, one, and five patients on ATG+CSA, respectively, and eight, 25, five, zero, and five patients on BSC, respectively. Refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess of blasts (RAEB) -I, RAEB-II, and hypoplastic disease were present in 21, six, nine, zero, and nine patients on ATG+CSA, respectively, and 18, eight, 11, two, and four patients on BSC, respectively. By month 6, 13 of 45 patients on ATG+CSA had a hematologic response compared with four of 43 patients on BSC (P = .0156). Two-year transformation-free survival (TFS) rates were 46% (95% CI, 28% to 62%) and 55% (95% CI, 34% to 70%) for ATG+CSA and BSC patients, respectively (P = .730), whereas overall survival (OS) estimates were 49% (95% CI, 31% to 66%) and 63% (95% CI, 42% to 78%), respectively (P = .828). Conclusion This open-label randomized phase III trial demonstrates that ATG+CSA treatment seems to be associated with hematologic response in a subset of patients without apparent impact on TFS and OS.
Electrolyte-balanced heparin in blood gas syringes can introduce a significant bias in the measurement of positively charged electrolytes
Authors: van Berkel Miranda , Scharnhorst Volkher 
Published: December 2010

Abstract

Background: Heparin binds positively charged electrolytes. In blood gas syringes, electrolyte-balanced heparin is used to prevent a negative bias in electrolyte concentrations. The potential pre-analytical errors introduced by blood gas syringes are largely unknown. Here, we evaluate electrolyte concentrations in non-anticoagulated blood compared with concentrations measured in electrolyte-balanced blood gas syringes.

Methods: Venous blood was collected into plain tubes. Ioni-zed calcium, potassium, sodium and hydrogen ions were analyzed directly using a blood gas analyzer and the remaining blood was collected into different blood gas syringes in random order: Preset (Becton Dickinson), Monovette (Sar-stedt) and Pico 50-2 (Radiometer).

Results: Ionized calcium and sodium concentrations were significantly lower in blood collected in Becton Dickinson and Sarstedt syringes compared to non-heparinized (NH) blood. The mean bias exceeded biological variation-based total allowable error, which in most cases leads to clinically misleading individual results. In contrast, ionized calcium concentrations in blood collected in Pico 50-2 syringes were identical to values obtained from NH blood. Sodium showed a minor, yet statistically significant, bias.

Conclusions: Despite the fact that blood gas syringes now contain electrolyte-balanced heparin, one should be aware of the fact that these syringes can introduce pre-analytical bias in electrolyte concentrations. The extent of the bias differs between syringes.
A new tool in the field of in-vitro diagnosis of allergy: preliminary results in the comparison of ImmunoCAP© 250 with the ImmunoCAP© ISAC
Authors: Gadisseur Romy , Chapelle Jean-Paul , Cavalier Etienne 
Published: December 2010

Abstract

Background: The ImmunoCAP© ISAC allows for the determination of specific immunoglobulin E (IgE) against 103 recombinant or purified allergen components in a single analytical step. The aim of our study was to perform a comparison of the specific IgE results measured with the microarray method to those obtained using the traditional method of ImmunoCAP©.

Methods: We selected 86 clinically relevant patients on the basis of their specific IgE for recombinant allergens (ImmunoCAP© 250, Phadia). Also, we selected two patients with a high total IgE to evaluate the non-specific binding of IgE. All samples were screened with the ImmunoCAP© ISAC. Then, we compared the 555 specific IgE antibodies results provided by ImmunoCAP© ISAC with the specific IgE levels obtained with ImmunoCAP© 250.

Results: We observed that 82 of the 384 results found to be positive with ImmunoCAP© were negative with ISAC© (concordance 78.65%). Of 171 negative results obtained with ImmunoCAP©, 11 were positive with ISAC© (concordance 93.57%). No non-specific binding was observed.

Conclusions: Our results show that the ImmunoCAP© ISAC has good analytical performance when compared with the ImmunoCAP© 250 method. We did not observe any non-specific binding. However, better sensitivity for some clinically relevant allergen components, such as rPru p 3 is needed.
Serum hepcidin-25 in comparison to biochemical markers and hematological indices for the differentiation of iron-restricted erythropoiesis
Authors: Thomas Christian , Kobold Uwe , Thomas Lothar 
Published: December 2010

Abstract

Background: Biochemical markers have problems in distinguishing iron deficiency anemia (IDA) from anemia of chronic disease (ACD), and the combined state of iron-restricted erythropoiesis (IRE) with ACD (ACD/IRE). We investigated the extent to which hepcidin-25, a potential marker for the evaluation of iron metabolism, enables the differentiation of the states above, and to assess its correlation with convential markers of iron deficiency.

Methods: One hundred and fifty-five patients with anemia were classified as having IDA, ACD or ACD/IRE using clinical findings, biochemical markers and hematological indices. The diagnostic performance of hepcidin-25 alone or in combination with the reticulocyte hemoglobin content (CHr) was evaluated using receiver-operating characteristic curve analysis and multivariate analysis. Hepcidin-25 was determined using an isotope-dilution micro-HPLC-tandem mass spectrometry method.

Results: Hepcidin-25 correlated with biochemical markers of iron deficiency but not with hematological indices. Use of a hepcidin-25 cut-off of ≤4 nmol/L allowed the differentiation of IDA from ACD and ACD/IRE, but not the discrimination of ACD from ACD/IRE in patients with severe inflammation. Furthermore, the discrimination of ACD/IRE from ACD required the combination with CHr.

Conclusions: Hepcidin-25 is primarily an indicator for decreased body iron levels, but not for IRE. The combination of hepcidin-25 with CHr in a diagnostic plot (hepcidin-25 plot) might be useful for the differentiation of ACD from ACD/IRE and IDA.
Determination of oxidative and occupational stress in palliative care workers
Authors: Casado Ángela , Castellanos Alberto , López-Fernández Ma Encarnación , Ruiz Rocío , Imedio Eulalia López , Castillo Carmen , Fernández-Nieto Ana María 
Published: December 2010

Abstract

Background: In previous work, we demonstrated that some occupational workers in stressful conditions can have increases in several markers of oxidative stress when compared to other workers. We investigated two antioxidant enzymes, superoxide dismutase (SOD) and catalase (CAT) activities, and malondialdehyde (MDA) concentrations, according to demographics, lifestyle and occupational parameters in palliative care unit workers, and analyzed the relationship with occupational burnout.

Methods: Fifty-two palliative care unit workers and 50 gender- and aged matched healthy individuals as controls were surveyed. Spectrophotometric and high-pressure liquid chromatography methods were used for biochemical determinations.

Results: No significant variation with respect to gender were detected with respect to SOD and CAT activities, MDA concentrations or occupational burnout. MDA concentrations increased with age in controls and palliative care unit workers, and we observed significant differences in MDA between controls and palliative care unit workers for all age groups. Significant variation in MDA concentrations were detected between unmarried (287.22±8.31 nmol/mg hemoglobin) and married individuals (317.18±6.24 nmol/mg hemoglobin), but not with respect to divorced individuals (288.41±5.64 nmol/mg hemoglobin). Significant differences were detected between smokers and non-smokers for SOD, CAT and MDA, but not for alcohol, coffee, tea or cola consumption. Significant differences were seen in MDA concentrations between those who frequently practice some kind of sport (280.59±7.62 nmol/mg hemoglobin) and those who never practice any kind of sport (299.12±8.09 nmol/mg hemoglobin), and between those who frequently ate fruit and greens (291.05±8.11 nmol/mg hemoglobin) and those who never eat fruit and greens (316.31±7.42 nmol/mg hemoglobin). SOD activity and MDA concentrations are higher in palliative care workers who work the evening and night shifts (p<0.01), and these workers also show significantly higher levels of stress.

Conclusions: Our findings suggest that oxidative stress, occupational stress and occupational burnout levels are similar in men and women. Occupational stress increases oxidative stress levels probably as a response to increased generation of reactive oxygen species. Working during the evening and night shifts increases oxidative levels and burnout levels.
„Versprechungen“ der Verwaltung – Zusagen, Zusicherungen und ähnliche behördliche Erklärungen
Authors: Hebeler Timo , Schäfer Björn 
Published: December 2010

Abstract
Im deutschen Verwaltungsrecht gibt es unterschiedliche Arten von behördlichen Erklärungen, die hier unter der – nicht rechtstechnisch, sondern deskriptiv zu verstehenden – Bezeichnung »Versprechungen der Verwaltung« zusammengefasst und im Einzelnen dargestellt werden. Das gemeinsame Moment dieser behördlichen Erklärungen besteht darin, dass die Verwaltung zwar bereits gegenwärtig handelt, dieses Handeln aber – zumindest wenn man es im größeren Kontext betrachtet – noch nicht abschließend ist, sondern auf weiteres Tätigwerden in der Zukunft gerichtet ist und dieses zukünftige Tätigwerden entweder vorbereitet, teilweise bereits regelt oder sonstwie beeinflusst. Rechtlich können diese behördliche Erklärungen sehr unterschiedlich zu bewerten sein.
StR Der strafprozessuale Tatbegriff
Authors: Steinberg Georg , Stam Fabian 
Published: December 2010

Abstract
So wie die materiellrechtliche Konkurrenzlehre (§§ 52 ff. StGB) für das Verständnis des materiellen Strafrechts eine Schlüsselstellung einnimmt – weshalb die insoweit oft festzustellende studentischerseits geübte Vernachlässigung unverzeihlich ist! –, ist der prozessuale Tatbegriff ein wichtiger Schlüssel für das Verständnis des Strafprozessrechts im Ganzen. Deshalb, aber auch als möglicher Gegenstand der »Prozessualen Zusatzfrage« in der Examensklausur, ist der prozessuale Tatbegriff unbedingt »examensrelevant« und sollte daher in seinen Grundzügen beherrscht werden.
Er wird im folgenden in zwei Schritten knapp erläutert. Zunächst wird skizziert, welche konkreten Folgen sich aus dem Vorliegen einer oder mehrerer Taten in den verschiedenen Abschnitten des Strafverfahrens ergeben. Sodann wird der prozessuale Tatbegriff präziser definiert mit Blick auf Grenzfälle, nämlich darauf, dass er vom materiellrechtlichen Tatbegriff (§§ 52 ff. StGB) in einigen wichtigen Konstellationen abweicht. Abschließend wird kurz auf die (wachsende) Bedeutung des Tatbegriffs im europarechtlichen Kontext eingegangen.
Examensklausur Schwerpunktbereich Arbeitsrecht Europarechtswidrige Kündigungsfrist, Verwirkung des Widerspruchsrechts und gegenläufige betriebliche Übung
Authors: Jacobs Matthias , Krois Christopher 
Published: December 2010

Abstract
Der nachstehende Fall wurde im Wintertrimester 2009 als fünfstündige Examensklausur für den Schwerpunktbereich Arbeit, Wirtschaft und Soziales an der Bucerius Law School (Hamburg) gestellt. Der erste Teil problematisiert unter anderem die vom EuGH im Januar 2010 konstatierte Europarechtswidrigkeit von § 622 II 2 BGB sowie aktuelle Fragen des Betriebsübergangs, insbesondere die Verwirkung des Widerspruchsrechts. Der zweite Teil behandelt die Zulässigkeit der gegenläufigen betrieblichen Übung nach der Schuldrechtsreform.
Pictura & Nomenclatura. Zur Wissensvermittlung in Wort und Bild in der Sachgruppenlexikographie des 17. Jahrhundert
Authors: Müller Peter O. 
Published: December 2010

Abstract
Onomasiological dictionaries, in which the vocabulary is arranged primarily according to thematic groups, played a major role within early modern lexicography. They were used in particular as travel vocabularies in order to procure a useful stock of basic terms while abroad and also belonged to prevalent modes of teaching in the humanistic school system, especially in elementary instruction. During the second half of the 17th century a lasting change of knowledge transfer inside this type of dictionary occurred by including illustrations which permeate not only Johann Amos Comenius' Orbis sensualium pictus but also Johann Georg Seybold's Teutsch-Lateinisches Wörterbüchlein. Both works will be conceptually explicated against the background of traditional topical lexicography and it will be shown that in both works, which mark the starting point of the history of the pictorial dictionary in the German-speaking parts, different semantic purposes of illustrations correlates with distinct vocabulary-picture-relations.
Semantik, Pragmatik und Wörterbuchform in einsprachigen Wörterbüchern
Authors: Wiegand Herbert Ernst 
Published: December 2010

Abstract
This paper looks at a question that has up to now not yet been put, namely which textual dictionary structure elements with which features, by the use of which the user can find semantic and pragmatic knowledge within an article can systematically be differentiated. In order to do this the following four dictionary structure elements are introduced: items, item texts, functional item additions and item symbols. Then the dictionary structure elements for enabling knowledge regarding meaning are treated by means of examples, e.g. different types of items giving the meaning, different types of items giving semantically related expressions, different types of pragmatically enriched items giving the paraphrase of meaning, etc. Finally, the dictionary structure elements enabling pragmatic knowledge are discussed, e.g. different types of diasystematic labelling items and pragmatic labelling symbols. In conclusion, a brief perspective is given on the relevant approach to meaning.
A Fiber Optic Sensored Triaxial Testing Device
Authors: Lee Jui-Ting , Tien Kai-Cheng , Te Ho Yen , Huang An-Bin 
Published: December 2010

Abstract
The physical quantities involved in a triaxial testing device have mostly been monitored with electric sensors. These sensors are currently subject to short circuit when submerged under water and electromagnetic interference (EMI). Waterproofing and EMI noise filtration have often been a challenge to the triaxial test set-up. These drawbacks can be substantially minimized when using optic fiber sensors. The optic fiber Bragg grating (FBG) sensors have the additional advantage of being partially distributive where multiple sensors can share the same signal transmission line. Taking advantage of these unique capabilities, the authors explored the possibility of converting all pressure/force and linear displacement transducers in a triaxial testing device into FBG based sensors. A series of shearing tests on unsaturated and saturated soil specimens were carried out using the new FBG sensored triaxial testing device. In most cases, the measurement of physical quantities was paired with electric sensors so that the results can be compared. This paper describes the principles of the individual FBG sensor designs and demonstrates their applications in triaxial testing.
Improving the Condensation Resistance of Fenestration by Considering Total Building Enclosure and Mechanical System Interaction
Authors: Nelson Peter E. , Totten Paul E. 
Published: December 2010

Abstract
Many condensation problems at fenestration are related to the adjacent building components the system interacts with. This includes adjacent cladding and wall systems, structural systems used for the connection of the fenestration, and interaction with the building’s mechanical system. We will discuss how the condensation resistance of windows and curtain walls can be greatly improved by aligning the thermal elements in the wall with the thermal aspects of the windows (such as thermal breaks), how air leakage at window systems can increase the volume of condensation, and how thermal bridges adjacent to the fenestration can have a significant impact on the overall performance. We will discuss how Winter time cold air flow from adjacent wall cavities can cause elements at window or curtain wall surrounds (sill, jambs, and head) to condense when they would not otherwise. Thermal improvements through the application of carefully applied and designed insulation systems will also be discussed, as over insulating in some cases can exasperate the condensation problems by further isolating the systems from heat sources. We will discuss the relationship between the heating source position and distance from the window or curtain wall system. The discussion in this paper will be mostly related to Winter time condensation. We will use examples to show (1) how thermal breaks, like rubber and plastic shims below the windows, can disassociate the window from heat loss to colder large thermal wall masses and improve performance; (2) how elements like spandrel panels and shadow boxes can have condensation due to air leakage into the shadow box and proposed solutions for these elements to reduce their condensation risk; (3) how interior curtains, furniture, and interior furnishings can block heat flow and cause condensation; (4) how the two-dimensional thermal analysis can be used to evaluate the condensation potential and evaluate possible solutions; (5) the results of infrared thermography used to evaluate both condensation problems and evaluate the solutions; (6) the importance of long-term data logging and monitoring of the results; and (7) the review of options for reducing condensation occurrences through passive (heat fin and insulation) and active (heat trace) means.
Kinetics and Mechanism of Oxidation of Gabapentin (Neurontin) Anion by Alkaline Diperiodatonickelate(IV) — A Free Radical Intervention
Authors: Hiremath Mallikarjuna I. , Nandibewoor Sharanappa T. 
Published: December 2010

Abstract
The kinetics of oxidation of gabapentin (Neurontin) (GP) by diperiodatonickelate(IV) (DPN) in aqueous alkaline medium was studied spectrophotometrically. The reaction is first order with respect to [DPN] and is an apparent less than unit order, each in [GP] and [alkali] under the experimental conditions. Reaction rate increases with increase in ionic strength and in solvent polarity of the medium. Addition of reaction products has no effect on the reaction rate. A mechanism involving the formation of a complex between the oxidant and substrate has been proposed. The products are identified by spot test, IR and NMR studies. The reaction constants involved in the mechanism were evaluated. There is a good agreement between the observed and calculated rate constants under varying experimental conditions. The activation parameters with respect to the slow step of scheme were evaluated and discussed.