LLukas22/scidocs huggingface dataset:
Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Purpose.With this publication a subcommittee of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) makes recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules. Methods. This subcommittee was comprised of 10 members representing Pharmaceutical, Biotechnology, and the contract research organization industries from the United States, Canada, and Europe. Each section of this consensus document addresses a specific analytical performance characteristic or aspect for validation of a LBA. Within each section the topics are organized by an assay's life cycle, the development phase, pre-study validation, and in-study validation. Because unique issues often accompany bioanalytical assays for macromolecules, this document should be viewed as a guide for designing and conducting the validation of ligand binding assays. Results. Values of ±20% (25% at the lower limit of quantification [LLOQ]) are recommended as default acceptance criteria for accuracy (% relative error [RE], mean bias) and interbatch precision (%coefficient of variation [CV]). In addition, we propose as secondary criteria for method acceptance that the sum of the interbatch precision (%CV) and the absolute value of the mean bias (%RE) be less than or equal to 30%. This added criterion is recommended to help ensure that in-study runs of test samples will meet the proposed run acceptance criteria of 4-6-30. Exceptions to the proposed process and acceptance criteria are appropriate when accompanied by a sound scientific rationale. Conclusions. In this consensus document, we attempt to make recommendations that are based on bioanalytical best practices and statistical thinking for development and validation of LBAs.
A prospective comparison of integrated FDG-PET/contrast-enhanced CT and contrast-enhanced CT for pretreatment imaging of advanced epithelial ovarian cancer.

OBJECTIVE
The use of tumor debulking surgery in the management of epithelial ovarian cancer (EOC), which is often disseminated in the peritoneal cavity at the time of diagnosis, has a significant impact on prognosis. We compared (18)F-fluorodeoxyglucose (FDG) positron emission tomography/contrast-enhanced computed tomography (PET/CT) to contrast-enhanced CT for the detection of dissemination into the abdominal cavity preventing successful primary debulking surgery.


METHODS
Forty-one women with EOC underwent preoperative whole-body low-dose FDG-PET/CT followed by diagnostic high dose contrast-enhanced CT scan, and the results were compared with systematically recorded surgical findings as a reference standard. Both site-based and patient-based analyses were conducted.


RESULTS
FDG-PET/CT was superior to conventional CT for the detection of carcinomatosis in subdiaphragmatic peritoneal surfaces (p=0.020) and in the bowel mesentery (p=0.001). Patient-based analysis of upper abdominal areas requiring extensive surgical procedures showed no significant differences between the two imaging methods. The sensitivity of PET/CT and CT was poor in certain areas of the peritoneal cavity (64% vs. 27% in the small bowel mesentery and 65% vs. 55% in the right upper abdomen). Extra-abdominal disease spread was detected by PET/CT in 32 patients and by CT in 25 patients.


CONCLUSIONS
PET/CT was not superior to CT for the detection of intra-abdominal disease spread. Patients with suspected EOC should be referred for upfront radical surgery regardless of the results of preoperative imaging studies. PET/CT is more effective for the detection of extra-abdominal disease than CT, but the clinical significance of this finding is unclear.
Enhancing IT governance practices: A model and case study of an organization's efforts

For many organizations, Information Technology (IT) enabled business initiatives and IT infrastructure constitute major investments that, if not managed properly, may impair rather than enhance the organization's competitive position. Especially since the advent of Sarbanes–Oxley (SOX), both management and IT professionals are concerned with design, implementation, and assessment of IT governance strategies to ensure that technology truly serves the needs of the business. Via an in-depth study within one organisation, this research explores the factors influencing IT governance structures, processes, and outcome metrics. Interview responses to open-ended questions indicated that more effective IT governance performance outcomes are associated with a shared understanding of business and IT objectives; active involvement of IT steering committees; a balance of business and IT representatives in IT decisions; and comprehensive and well-communicated IT strategies and policies. IT governance also plays a prominent role in fostering project success and delivering business value. © 2007 Elsevier Inc. All rights reserved.
Reply to the comment formation of molecular hydrogen in the bimolecular self-reaction of hydroperoxyl radicals in the gas phase

The analysis made by chemists working in the liquid phase is not in disagreement with the conclusions drawn by Sahetchian, Heiss, and Rigny. It seems interesting to the authors on discussions as well as experiments, particularly to establish the reality of the title reaction at ambient temperature.
Treatment and outcome of vaseline-induced sclerosing lipogranuloma of the penis.

OBJECTIVES
To study the treatment and short-term outcome of 16 consecutive cases of sclerosing lipogranuloma of penis developing after Vaseline inoculation for penile augmentation.


METHODS
After Vaseline inoculation, patient pain was related mainly to erection and severe phimosis. At surgical reconstruction complete and radical excision of the involved penile skin was performed, followed by skin substitution from the existing, saved coat of the penis. In most cases the stored, uninvolved inner preputial skin was used; less frequently scrotal flaps and in the least-favorable cases penis embedment in the scrotum was applied for coverage of the penis.


RESULTS
All 16 patients were cured, no matter how long after self-injection vaselinoma developed or which kind of surgery was performed. Histopathologic evaluation revealed different findings according to the time elapsed after Vaseline injection.


CONCLUSIONS
Early detection of patients with Vaseline penile augmentation and urgent surgery are essential because the best esthetic and functional results can be achieved in the acute period; this is when granuloma does not involve the subdermal but only the subcutaneous layer and local penile flaps can most commonly be used for reconstruction.
Social network analysis: developments, advances, and prospects

This paper reviews the development of social network analysis and examines its major areas of application in sociology. Current developments, including those from outside the social sciences, are examined and their prospects for advances in substantive knowledge are considered. A concluding section looks at the implications of data mining techniques and highlights the need for interdisciplinary cooperation if significant work is to ensue.
2011 Compendium of Physical Activities: a second update of codes and MET values.

PURPOSE
The Compendium of Physical Activities was developed to enhance the comparability of results across studies using self-report physical activity (PA) and is used to quantify the energy cost of a wide variety of PA. We provide the second update of the Compendium, called the 2011 Compendium.


METHODS
The 2011 Compendium retains the previous coding scheme to identify the major category headings and specific PA by their rate of energy expenditure in MET. Modifications in the 2011 Compendium include cataloging measured MET values and their source references, when available; addition of new codes and specific activities; an update of the Compendium tracking guide that links information in the 1993, 2000, and 2011 compendia versions; and the creation of a Web site to facilitate easy access and downloading of Compendium documents. Measured MET values were obtained from a systematic search of databases using defined key words.


RESULTS
The 2011 Compendium contains 821 codes for specific activities. Two hundred seventeen new codes were added, 68% (561/821) of which have measured MET values. Approximately half (317/604) of the codes from the 2000 Compendium were modified to improve the definitions and/or to consolidate specific activities and to update estimated MET values where measured values did not exist. Updated MET values accounted for 73% of all code changes.


CONCLUSIONS
The Compendium is used globally to quantify the energy cost of PA in adults for surveillance activities, research studies, and, in clinical settings, to write PA recommendations and to assess energy expenditure in individuals. The 2011 Compendium is an update of a system for quantifying the energy cost of adult human PA and is a living document that is moving in the direction of being 100% evidence based.
The Patient Care Monitor-Neutropenia Index: development, reliability, and validity of a measure for chemotherapy-induced neutropenia.

PURPOSE/OBJECTIVES
To provide an initial evaluation of the psychometric properties of the Patient Care Monitor 1.0 Revised-Neutropenia Index (PCM-N), a symptom-based assessment tool designed to measure health-related quality-of-life (HRQOL) changes associated with chemotherapy-induced neutropenia.


DESIGN
Known-groups methodology and self-report instrument validation.


SETTING
A large community oncology practice in Memphis, TN.


SAMPLE
424 patients with cancer in four samples.


METHODS
All patients in the first three samples were assessed at baseline of chemotherapy administration and at a point analogous to midcycle. The fourth sample underwent a cross-sectional evaluation of the ability of the PCM-N to distinguish patients with febrile neutropenia, severe afebrile neutropenia, and no neutropenia.


MAIN RESEARCH VARIABLES
PCM-N score, grade of neutropenia, and febrile status.


FINDINGS
Internal consistency reliability and factor analysis supported the single additive scale structure of the 13 items of the PCM-N. The PCM-N demonstrated good known-groups validity and was able to distinguish patients with grades 3-4 neutropenia from those with grades 0-2. The tool also was able to distinguish patients with febrile neutropenia, severe afebrile neutropenia, and no neutropenia. Receiver operating characteristic analyses provided a psychometrically based threshold score.


CONCLUSIONS
The PCM-N is a reliable and valid instrument sensitive to changes in HRQOL associated with moderate-to-severe chemotherapy-induced neutropenia.


IMPLICATIONS FOR NURSING
Nurses can use the PCM-N as a rapid and cost-effective tool for monitoring symptoms of neutropenia in patients with cancer.
Telugu to English Translation using Direct Machine Translation Approach

The motivation behind working on a translation system from Telugu to English were based on the principles that a) There are many translation systems for translating from English to Indian languages but very few for vice versa. Telugu is a language that exhibits very strong phrasal, word and sentence structures next to Sanskrit, which makes the work organized on one hand but complex in handling on the other. This work demonstrates one such machine translation (MT) system for translating simple and moderately complex sentences from Telugu to English. b) Of the many MT approaches, the direct MT is used for translation between similar or nearly related languages. However, the direct MT has been used in this work for conversion from Telugu to English, which is quite complex compared to other Indian languages. The purpose of using direct MT for development of such a tool was to have the flexibility in usage, keeping it simple, look for rapid development and primarily to have better accuracy than all the known system. c) There are very large numbers of elisions/ inflection rules in Telugu requiring complex morphs, like those in Sanskrit. A large number of rules for handling inflections were to be developed along with the grammar rules. The outcomes were compared with Google Translator, a publicly available translation web based system. The outcomes were found to be much better, as much as 90 percent more accurate. This work shall bring forth deeper insights into Telugu MT research. KeywordsMachine translation (MT), direct MT, Telugu to English, natural language processing (NLP), elisions, inflections.
Random Graph Isomorphism

Abstract. A straightforward linear time canonical labeling algorithm is shown to apply to almost all graphs (i .e. all but o(2 (2 >) of the 2 t 1 graphs on n vertices) . Hence, for almost all graphs X, any graph Y can be easily tested for isomorphism to X by an extremely naive linear time algorithm . This result is based on the following : In almost all graphs on n vertices, the largest n 0 .15 degrees are distinct . In fact, they are pairwise at least n0 .03 apart .
Biomechanical energy harvesting from human motion: theory, state of the art, design guidelines, and future directions

Biomechanical energy harvesting from human motion presents a promising clean alternative to electrical power supplied by batteries for portable electronic devices and for computerized and motorized prosthetics. We present the theory of energy harvesting from the human body and describe the amount of energy that can be harvested from body heat and from motions of various parts of the body during walking, such as heel strike; ankle, knee, hip, shoulder, and elbow joint motion; and center of mass vertical motion. We evaluated major motions performed during walking and identified the amount of work the body expends and the portion of recoverable energy. During walking, there are phases of the motion at the joints where muscles act as brakes and energy is lost to the surroundings. During those phases of motion, the required braking force or torque can be replaced by an electrical generator, allowing energy to be harvested at the cost of only minimal additional effort. The amount of energy that can be harvested was estimated experimentally and from literature data. Recommendations for future directions are made on the basis of our results in combination with a review of state-of-the-art biomechanical energy harvesting devices and energy conversion methods. For a device that uses center of mass motion, the maximum amount of energy that can be harvested is approximately 1 W per kilogram of device weight. For a person weighing 80 kg and walking at approximately 4 km/h, the power generation from the heel strike is approximately 2 W. For a joint-mounted device based on generative braking, the joints generating the most power are the knees (34 W) and the ankles (20 W). Our theoretical calculations align well with current device performance data. Our results suggest that the most energy can be harvested from the lower limb joints, but to do so efficiently, an innovative and light-weight mechanical design is needed. We also compared the option of carrying batteries to the metabolic cost of harvesting the energy, and examined the advantages of methods for conversion of mechanical energy into electrical energy.
Convergent Evolution: Gene Sharing by Eukaryotic Plant Pathogens

Oomycetes and filamentous parasitic fungi are plant pathogens that have undergone convergent evolution. A recent study has shown that these microbial eukaryotes have exchanged metabolic genes, which might explain some of their phenotypic similarities.
Traumatic asphyxia: a rare syndrome in trauma patients

A 6-year-old boy was admitted to the emergency department (ED) suffering from petechiae and purpura on his face caused by a farming accident. He got his T-shirt caught in a rotating shaft at the back of a tractor. The T-shirt wrapped around his thorax and compressed him. He did not lose his consciousness during the incident. His score on the Glasgow Coma Scale was 15 and his initial vital signs were stable upon arrival at the ED. On physical examination, diffuse petechiae and purpura were noted on the face and neck although there was not any sign of the direct trauma (Figs. 1 and 2). The patient denied suffering head trauma. Examination for abdominal and thoracic organ injury was negative. Traumatic asphyxia is a rare condition presenting with cervicofacial cyanosis and edema, subconjunctival hemorrhage, and petechial hemorrhages of the face, neck, and upper chest that occurs due to a compressive force to the thoracoabdominal region [1]. Although the exact mechanism is controversial, it is probably due to thoracoabdominal compression causing increased intrathoracic pressure just at the moment of the event. The fear response, which is characterized by taking and holding a deep breath and closure of the glottis, also contributes to this process [1, 2]. This back pressure is transmitted ultimately to the head and neck veins and capillaries, with stasis and rupture producing characteristic petechial and subconjunctival hemorrhages [2]. The skin of the face, neck, and upper torso may appear blue-red to blue-black but it blanches over time. The discoloration and petechiae are often more prominent on the eyelids, nose, and lips [3]. In patients with traumatic asphyxia, injuries associated with other systems may also accompany the condition. Jongewaard et al. reported chest wall and intrathoracic injuries in 11 patients, loss of consciousness in 8, prolonged confusion in 5, seizures in 2, and visual disturbances in 2 of 14 patients with traumatic asphyxia [4]. Pulmonary contusion, hemothorax, pneumothorax, prolonged loss of consciousness, Int J Emerg Med (2009) 2:255–256 DOI 10.1007/s12245-009-0115-x
Substrate effect on texturized microstructures in NiCr thin films

Abstract NiCr thin films with a composition of 40at.%Ni and 60at.%Cr have been sputter deposited on stainless steel and glass substrates. The microstructure and composition have been analysed by scanning electron microscopy, Rutherford-backscattering spectroscopy, X-ray diffraction and transmission electron microscopy. Evidence is found of the metastable σ phase and of the two terminal solid solutions α-Cr and γ-Ni. The microstructure is characterized by a cubic close-packed lattice alternating with a hexagonal one within the same grains, resulting in a stacking fault presence. Evidence is found that the films have a fibre texture with the axis tilted 20° with respect to the surface normal and that different substrates induce different fibre axis orientations: (111) for the stainless steel substrate and (110) for the glass one. This characteristic could be interpreted in terms of different relative concentrations of the two terminal solid solutions due to the different substrate temperature during thin film deposition.
In-hospital treatment of obstructive sleep apnea during decompensation of heart failure.

BACKGROUND
Treatment of obstructive sleep apnea (OSA) in outpatients with systolic heart failure improves cardiac function. We evaluated the impact of immediate inpatient diagnosis and treatment of OSA in hospitalized patients with acutely decompensated heart failure (ADHF) on in-hospital cardiac outcomes.


METHODS
A pilot randomized controlled trial was conducted in an academic heart hospital. Patients with ADHF underwent an attended in-hospital sleep study within 2 days of hospital admission to establish the diagnosis of sleep-disordered breathing. The participants were 46 consecutive patients with ADHF who had OSA (apnea-hypopnea index [AHI], >or= 15 events per hour). Participants were randomly assigned to either the intervention arm (n = 23), with in-hospital treatment of OSA using auto-adjusting positive airway pressure along with standard treatment of ADHF, or to the control arm (n = 23), in which they received only standard treatment for ADHF. The primary outcome was the change in left ventricular ejection fraction (LVEF) 3 nights postrandomization.


RESULTS
The change in LVEF from baseline to 3 days postrandomization in the intervention arm was significantly superior to that of the control group. The difference in LVEF improvement was 4.6% (p = 0.03). LVEF increased in the intervention group by 4.5% (SE, 1.7%). The LVEF change in the control arm was--0.3% (SE, 1.5%). The difference in LVEF improvement between the two groups persisted after adjustment for baseline LVEF, type of cardiomyopathy, BMI, AHI, and sex.


CONCLUSIONS
An approach of early identification and in-hospital treatment of OSA in patients with ADHF is feasible and resulted in improvement in systolic function. The impact of this approach on out-of-hospital outcomes requires further investigation.


TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00701038.
Protocol for a block randomised controlled trial of an intervention to improve heart failure care.

AIM
To describe the design of a randomised controlled trial conducted to evaluate a culturally tailored, nurse-led educational intervention.


BACKGROUND
Self-care strategies are critical to improving health outcomes in heart failure. The family unit is crucial in collectivist cultures, but little is known about involving the family in the self-care of patients with heart failure.


DISCUSSION
Involving the family in the self-care of heart failure is a novel approach. To the authors' knowledge, no one has evaluated it using a randomised controlled trial.


CONCLUSION
A valid comparison of outcomes between the control group and the intervention group involved in the study was provided in this trial. The chosen design, randomised controlled trial, enabled the assessment of the intervention.


IMPLICATIONS FOR PRACTICE
The application of a family self-care intervention in a collectivist culture was shown to improve clinical and quality outcomes of patients with heart failure. Considering the individual and the community needs is vital in improving these outcomes.
The Next Big Thing: Web Services Collaboration

In this paper, we introduce the lifecycle of a Web services solution that consists of Web services modeling, development, deployment, publishing, as well as discovery, composition and collaboration, plus monitoring and analytical control. Then some research and development challenges of building a Web services solution in the context of Web services solution lifecycle are described. Especially, we present an emerging Web services research direction, namely, Web services collaboration, followed by a few major research issues associated with facilitating extended business collaboration using Web services and semantic annotation.
A Theory of the Firm Only a Microeconomist Could Love

Although agency theory dominates corporate governance research, its behavioral assumptions stand in direct competition to the worldviews held by most organizational scholars. In this article, the author argues that it is high time for organizational scholars to stop deferring to economists and start to develop their own governance theories, for which their conceptual base is far better suited.