bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessing the bioequivalence of analogues of endogenous substances (‘endogenous drugs’): considerations to optimize study design
Authors: Dissanayake Sanjeeva 
Published: November 2009

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The complexities of assessing the bioequivalence of endogenous drugs are recognised.• The FDA have published guidelines regarding the evaluation of levothyroxine and potassium chloride bioequivalence, whilst other authors have documented specific strategies to counter biases inherent in biostudies of endogenous drugs.• A consolidated consideration of valid methods to optimise the design of such studies is however lacking. WHAT THIS STUDY ADDS • This paper is to the author's knowledge the first summarising various key approaches used to assess the bioequivalence of endogenous drugs, and to propose a series of recommendations for studies in this field.BACKGROUND Assessment of the bioequivalence of generic versions of certain reference drugs is complicated by the presence of endogenous levels of said compounds which cannot be distinguished from externally derived compound levels following drug administration. If unaccounted for, the presence of endogenous compound biases towards equivalence in bioequivalence studies of these drugs. Bioequivalence assessments may be complicated further as disposition of the exogenous analogue can be subject to various endogenous processes resulting in nonlinear pharmacokinetics. To overcome these inherent biases a number of different strategies have been employed.AIMS To critically review methods used to overcome confounding biases in bioequivalence studies of ‘endogenous’ drugs.METHODS A literature search of the EMBASE and PubMed databases was performed.RESULTS The following strategies were identified: ablation/modulation of baseline endogenous substance levels; recruitment of ‘substance‐deficient’ populations; restriction of dietary intake of the relevant substance; standardization of conditions with the potential to affect relevant homeostatic mechanisms; correction for baseline substance levels; and administration of supra‐therapeutic drug doses.CONCLUSIONS On the basis of this review key study design concepts, intended to optimize the design of future bioequivalence studies of these so‐called ‘endogenous drugs’, are described. The dual stable isotope method, which could be used in a specific context, is also discussed.
Insertion and management of percutaneous veno‐venous bypass cannula for liver transplantation: a reference for transplant anesthesiologists
Authors: Sakai Tetsuro , Gligor Silviu , Diulus John , McAffee Richard , Wallis Marsh J. , Planinsic Raymond M. 
Published: November 2009

Sakai T, Gligor S, Diulus J, McAffee R, Marsh JW, Planinsic RM. Insertion and management of percutaneous veno‐venous bypass cannula for liver transplantation: a reference for transplant anesthesiologists. Clin Transplant 2009 DOI: 10.1111/j.1399‐0012.2009.01145.x © 2009 John Wiley & Sons A/S.Abstract:  Surgical advances using the retrohepatic caval preservation technique in liver transplantation (LT) has significantly decreased the need for veno‐venous bypass (VVB). However, VVB still remains a viable adjunct of LT. The venous return cannula has traditionally been inserted using a cut‐down technique via the axillary vein, but this technique carries significant risks for lymphorrhea, infection, or nerve damage. Since 2001, our institution has routinely used VVB in adult LT surgery. Percutaneous insertion of an internal jugular venous return cannula is performed by the attending anesthesiologist. The aim of this report is to describe the method of insertion and management of a percutaneous veno‐venous return cannula in the internal jugular vein during LT. In‐depth detail as well as video clips will provide a reference for LT centers wishing to apply this method in their practice.
Filamentous fungi found on foundress queens of leaf‐cutting ants (Hymenoptera: Formicidae)
Authors: Rodrigues A. , Silva A. , Bacci Jr M. , Forti L. C. , Pagnocca F. C. 
Published: November 2009

AbstractQueens of the leaf‐cutting ant species Atta laevigata and Atta capiguara were collected soon after their mating flight and maintained in the laboratory until death. Ant corpses showing signs of contamination by insect pathogenic fungi were selected for fungal identification. Filamentous fungi such as Beauveria bassiana and Paecilomyces lilacinus actively sporulated in the ant’s corpses. This is the first report of the latter fungus on reproductives of leaf‐cutting ants. The fact that queens may acquire filamentous fungi including saprophytic and potential insect pathogens after their mating event is especially interesting regarding the impacts of such microbes on the establishment of a new nest.
Emergency department performance at a small rural hospital: An independent in‐depth review
Authors: Tescher Paul , Chen Tony Mengxi 
Published: November 2009

AbstractObjectives:  This study aims to provide a retrospective review of the recent performance of the emergency department of Cobram District Hospital, a small rural hospital located on the border of Victoria and New South Wales. Design:  Retrospective review. Setting:  Small rural accident and emergency department. Intervention:  All available data collected from the emergency department from the previous three financial years (July 2005 to June 2008) were compiled onto a computerised spreadsheet and analysed by two independent investigators. Main outcome measures:  Key performance indicators, including time for patient to be seen by a doctor and frequency of patient presentations to the emergency department. Results:  Cobram District Hospital has fewer than 5000 patients presenting to the emergency department each year. 12 p.m. to 12 a.m. accounts for 69% of all presentations, with three notable time periods that experience most presentations. Life‐threatening emergencies represented <3% of all presentations to the emergency department. Patients in triage categories 1–3 did not met Australasian triage scale (ATS)‐suggested time for maximum waiting timing, while categories 4 and 5 well exceeded ATS standards.Conclusion:  The small size and lack of dedicated emergency department staff place restrictions on the ability of an unfunded rural hospital to match the performance of major metropolitan emergency departments. ATS guidelines should be revised to improve clarity and reflect the different performance capabilities between metropolitan and rural centres.
Mapping oncology services in regional and rural Australia
Authors: Underhill Craig , Bartel Rebecca , Goldstein David , Snodgrass Helen , Begbie Stephen , Yates Patsy , White Kate , Jong Kathy , Grogan Paul 
Published: November 2009

AbstractObjective:  To map clinical oncology services in regional and rural Australia. Design and setting:  A self‐administered survey was sent to 161 regional hospitals administering chemotherapy (RHAC) in Australia. RHAC were categorised by state, Hospital Peer Group and the Australian Standard Geographical Classification (ASGC) Remoteness Areas classification. Main outcome measure(s):  Survey data provided percentage and aggregate figures about availability of medical, radiation and surgical oncologists, chemotherapy nurses, breast cancer nurses, palliative care physicians and allied health professionals according to remoteness and state. Chemotherapy prescribing practices, adherence to occupational health and safety guidelines and availability of multidisciplinary clinics were also explored. Results:  A 98% survey completion rate was achieved. Significant deficiencies in service provision were identified in RHAC. Only 21% of RHAC reported a resident medical oncology service, 7% had a radiation oncology unit, and 6% had a resident surgical oncologist. Only 24% of RHAC reported a dedicated palliative care specialist and 39% identified a dedicated oncology counselling service. Other issues included administration of chemotherapy by nurses outside a recognised facility or by nurses without recognised oncology training, limited availability of funded breast care nurses and lack of multidisciplinary clinics. Conclusion:  Survey data highlight marked cancer service deficiencies in rural and regional Australia. It is not unreasonable to conclude that these deficiencies might contribute to poorer outcomes for cancer patients living in these areas. The results suggest the need for short‐ and long‐term measures to improve access to best‐practice cancer services for patients living in regional, rural and remote areas of Australia.
Clinical manifestations and survival of patients with hepatocellular carcinoma and cardiac metastasis
Authors: Liu Yu‐Chun , Ho Yi‐Lwun , Huang Guan‐Tarn , Chen Ding‐Shinn , Sheu Jin‐Chuan , Chen Chien‐Hung 
Published: November 2009

AbstractBackground and Aim:  Antemortem diagnosis of hepatocellular carcinoma (HCC) with cardiac metastasis is uncommon. To clarify the clinical manifestation and survival of HCC patients with cardiac metastases, we initiated the present study.Methods:  We retrospectively analyzed 48 HCC patients with metastases into cardiac cavity diagnosed antemortem. The baseline clinical characteristics, echocardiogram, treatment modality and the outcome data were collected.Results:  The most common symptoms of cardiac metastasis included asymptomatic in 19 cases (39.5%), bilateral lower leg edema in 18 cases (37.5%) and exertional dyspnea in 15 cases (31.3%). The median and mean survival times from the time of diagnosis of cardiac metastasis were 102 days and 161 days, respectively. Compared with another cohort of 48 patients with age‐, gender‐, and stage‐matched HCC patients without cardiac metastasis, the median survival in the cardiac metastasis group was similar to the control group (68 days) (P = 0.67). The cause of death was HCC in 29, hepatic failure in seven, multiple organ failure in four, gastrointestinal bleeding in three, sepsis in two, pulmonary embolism in one, respiratory failure in one, and acute myocardial infarction in one.Conclusions:  Hepatocellular carcinoma patients with cardiac metastases were in the advanced stages. These patients had limited survival from the diagnosis of cardiac metastases. The most common cause of death was related to HCC per se or the underlying liver disease. Only a few patients expired because of cardiac metastases.
Do we need an ‘in‐house’ neutralization assay for confirmation of hepatitis B surface antigen? Answers from a tertiary care hospital in India
Authors: Fletcher Gnanadurai J , Gnanamony Manu , David Joel , Ismail Ashrafali M , Subramani Thenmozhi , Abraham Priya 
Published: November 2009

AbstractBackground and Aims:  Hepatitis B surface antigen (HBsAg) is an important serological marker for diagnosis of hepatitis B virus (HBV) infection. Commercial kits for detection of HBsAg emphasize confirmation by neutralization assays. In this study, we have standardized an ‘in‐house’ neutralization test for HBsAg confirmation.Methods:  Among 6684 HBsAg‐positive samples, 615 were subjected to an ‘in‐house’ HBsAg neutralization test (NT). Of these, 91 (100%) high‐reactive samples (optical density [OD] 1.000–3.000) and 286 (93%) of 289 low‐reactive samples (OD < 1.000) were neutralized, and 235 (100%) grey‐zone reactive samples were ‘in‐house’ NT negative. Eighty‐four samples of varying reactivities that were tested by the ‘in‐house’ NT were compared with a commercial NT (AxSYM, Abbott).Results:  The ‘in‐house’ NT showed an excellent agreement (κ = 0.83, P < 0.001) with the commercial confirmatory assay. The sensitivity, specificity, positive and negative predictive values were 90%, 94%, 96% and 87%, respectively.Conclusion:  The enzyme immunoassay‐based ‘in‐house’ HBsAg neutralization assay is a feasible alternative to the commercial HBsAg confirmatory assay. This technique is easily adaptable, cost‐effective and reliable for the confirmation of HBsAg in a low resource setting, enhancing the overall quality of HBsAg screening.
TRANS‐WORLD: DEBATING THE PLACE AND BORDERS OF PLACES IN THE AGE OF TRANSNATIONALISM
Authors: ERNSTE HUIB , VAN HOUTUM HENK , ZOOMERS ANNELIES 
Published: November 2009

ABSTRACTIn this introductory contribution to this special issue of TESG, we want to question the usual way of conceptualising places and borders in the debate about transnationalism. We argue, that in studies of transnationalism, on the one hand the idea of nation‐states as spatial containers is overcome, but on the other hand also reproduces the same spatial containers. Instead we suggest the use of the term ‘trans‐world’ to avoid any connotation suggesting spatial containers. In this framework, places and borders are instead seen as multi‐dimensional and dynamic concepts which can be applied to almost any kind of relationships transgressing and reconfiguring borders and places at all scales. The papers which follow this introduction show how in particular situations and contexts, these transgressing and reconfiguring activities can be conceptualised in very different ways.
POWER OF BORDERS AND SPATIALITY OF TRANSNATIONALISM: A STUDY OF CHINESE‐OPERATED TOURISM BUSINESSES IN EUROPE
Authors: LEUNG MAGGI W.H. 
Published: November 2009

ABSTRACTThis paper examines the spatiality of transnationalism and meanings of borders as displayed in the tourism business sector operated by Chinese migrants in Europe. Drawing upon empirical research conducted from 1999 to 2002 and from 2006 to 2007, it will illustrate how Chinese migrants practise transnationalism and transculturality in their entrepreneurial activities. Instead of serving simply as a bridge between their two home economies, migrants engaged in the tourism sector are active and innovative agents in crossing and redrawing the borders of different geo‐cultural spheres they are embedded in, producing modified tourism landscapes that suit the desire of their compatriot travellers. An examination of the spatiality of their business networks also suggests that transnationalism and diaspora studies should go beyond focusing only on ties between the sending and receiving societies. Furthermore, an analysis of the interactions among members of this business community from different places will exemplify the power of borders in the Chinese diaspora.
THEOLOGY, EVOLUTION, AND THE HUMAN MIND: HOW MUCH CAN BIOLOGY EXPLAIN?
Authors: Haught John F. 
Published: November 2009

Abstract.Evolutionary biology contributes much to our present understanding of life, and it promises also to deepen our understanding of human intelligence, ethics, and even religion. For some scientific thinkers, however, Darwin's science seems so impressive that it now supplants theology altogether by providing the ultimate explanation of all manifestations of life, not only biologically but also metaphysically. By focusing on human intelligence as an emergent aspect of nature this essay examines the question of whether theology can still have an explanatory role to play alongside biology in attempts to understand mind.
Prognostic factors for cure following treatment of onychomycosis
Authors: Sigurgeirsson B 
Published: November 2009

AbstractObjective  To examine if host baseline factors and week 24 mycology results are associated with mycological and clinical cure in patients with onychomycosis treated with oral terbinafine.Design  Open pilot study to determine prognostic factors in the treatment of onychomycosis.Setting  Outpatient dermatology clinic.Patients  A total of 199 patients from the Icelandic arm of a trial comparing continuous terbinafine with intermittent terbinafine in onychomycosis were recruited for additional observation.Main outcome measures  Mycological, clinical and complete cure of the target toenail 72 weeks after treatment was initiated.Results  Patients with matrix involvement or slow nail growth were less likely to reach mycological, clinical and complete cure. Lateral involvement affected complete and mycological cure rates negatively. Patients with a dermatophytoma were less likely to reach mycological cure. Patients with a history of prior infection, men and older patients were less likely to reach clinical cure. Positive culture at 24 weeks affected mycological and clinical cure at 72 weeks negatively.Limitations  Only patients treated with terbinafine were considered.Conclusions  Several host‐related factors at baseline and positive culture at 24 weeks had negative effects on cure of onychomycosis 72 weeks after treatment was initiated. This finding merits a large study on prognostic outcome factors in onychomycosis.
No association between nickel allergy and reporting cosmetic dermatitis from mascara or eye shadow: a cross‐sectional general population study
Authors: Thyssen JP , Linneberg A , Menné T , Nielsen NH , Johansen JD 
Published: November 2009

AbstractBackground  In theory, all pigmented make‐up products may contain metal allergens including nickel. Eyelid dermatitis has previously been observed among nickel allergic dermatitis patients following exposure to nickel containing mascara and eye shadow. However, an association between nickel eyelid dermatitis and nickel in make‐up products remains controversial.Objective  This cross‐sectional patch test study investigated whether the frequency of self‐reported cosmetic dermatitis from mascara or eye shadow use was higher among nickel allergic Danish women than women without nickel allergy.Methods  In 2006, a total of 1843 18–69 year old women completed a postal questionnaire including questions on cosmetic dermatitis and were patch tested with nickel sulphate. Data were analysed by logistic regression analyses and associations were expressed as odds ratios (ORs) with 95% confidence intervals (CIs).Results  The prevalence of nickel allergy was similar among women who reported cosmetic dermatitis from eye shadow or mascara and among women who did not report such symptoms. Cosmetic dermatitis was positively associated with self‐reported atopic dermatitis and age.Conclusion  Overall, no association between having nickel allergy and reporting cosmetic dermatitis from mascara or eye shadow use was found in the general population. This does not exclude a causal relationship in selected cases.
ORIGINAL ARTICLE: Teaching methods and curriculum models used in Finland in the education of students diagnosed with having severe/profound intellectual disabilities
Authors: Kontu Elina K. , Pirttimaa Raija A. 
Published: November 2009

Accessible summary

To find out what models for educational planning and which methods are currently in use with severely intellectually disabled students in Finland.
Teaching praxis is based on small child’s normal psychological development and behavioral analytic tradition.

SummaryTen years ago children diagnosed as having severe/profound intellectual disabilities were allowed to attend and study in Finnish comprehensive schools. The nationwide intensive developmental work for creating a curriculum for this group of students began earlier, in the 1980s.The aim of this study was to discover what types of models of curriculums and which teaching methods are currently in use. The reason for this was the lack of recent research in this area, and the current strong emphasis on developing quality education for this group which continues to be focused away from segregated systems. The findings of this survey indicated that the most widely used principle for planning teaching directed at this group of students is based on normal psychological development of a young child. Of all teaching methods used the most popular ones were categorized as sensory and environmental enrichment and stimulation. Another large group of teaching methods was discovered to be based on behavior analysis.
Fitness Among Individuals with Early Childhood Deafness: Studies in Alumni Families from Gallaudet University
Authors: Blanton Susan H. , Nance Walter E. , Norris Virginia W. , Welch Katherine O. , Burt Amber , Pandya Arti , Arnos Kathleen S. 
Published: November 2009

SummaryThe genetic fitness of an individual is influenced by their phenotype, genotype and family and social structure of the population in which they live. It is likely that the fitness of deaf individuals was quite low in the Western European population during the Middle Ages. The establishment of residential schools for deaf individuals nearly 400 years ago resulted in relaxed genetic selection against deaf individuals which contributed to the improved fitness of deaf individuals in recent times. As part of a study of deaf probands from Gallaudet University, we collected pedigree data, including the mating type and the number and hearing status of the children of 686 deaf adults and 602 of their hearing siblings. Most of these individuals had an onset of severe to profound hearing loss by early childhood. Marital rates of deaf adults were similar to their hearing siblings (0.83 vs. 0.85). Among married individuals, the fertility of deaf individuals is lower than their hearing siblings (2.06 vs. 2.26, p = 0.005). The fitness of deaf individuals was reduced (p = 0.002). Analysis of fertility rates after stratification by mating type reveals that matings between two deaf individuals produced more children (2.11) than matings of a deaf and hearing individual (1.85), suggesting that fertility among deaf individuals is influenced by multiple factors.
Art and the theatre of mind and body: how contemporary arts practice is re‐framing the anatomo‐clinical theatre
Authors: Ingham Karen 
Published: November 2009

AbstractThe correspondences and disparities between how artists and anatomists view the body have historically been a source of creative collaboration, but how is this imaginative interdisciplinarity sustained and expressed in a contemporary context? In this review I suggest that contemporary artists engaging with the body, and the corresponding biomedical and architectural spaces where the body is investigated, are engendering innovative and challenging artworks that stimulate new relationships between art and anatomy. Citing a number of examples from key artists and referencing some of my own practice‐based research, I posit that creative cross‐fertilization provokes a discourse between mediated public perceptions of disease, death and the disposal of morbid remains, and the contemporary reality of biomedical practice. This is a dialogue that is complex, rich and diverse, and ultimately rewarding for both art and anatomy.