bluuebunny/crossref_metadata_2025_split huggingface dataset:
Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?
Authors: Holbein M. E. Blair , Berglund Jelena P. , Weatherwax Kevin , Gerber David E. , Adamo Joan E. 
Published: January 2015

AbstractPurposeThe Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access.MethodsFDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared.ResultsThe FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight.ConclusionThe FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements.
Synthetic cannabinoid withdrawal: A new demand on detoxification services
Authors: Macfarlane Vicki , Christie Grant 
Published: January 2015

AbstractIntroduction and AimsSynthetic cannabinoid dependence and withdrawal are not well described in the literature. We aimed to report on the characteristics and treatment course of clients attending a detoxification service for support with synthetic cannabinoid withdrawal in Auckland, New Zealand.Design and MethodsA retrospective audit of electronic and paper files for clients presenting for treatment in association with problematic synthetic cannabinoid use between May 2013 and May 2014 was conducted. Demographic information, reported synthetic cannabinoid use, other substance use, reported adverse effects, withdrawal symptoms and treatment information were recorded using a piloted template. Descriptive statistics were used to summarise the characteristics of the audit sample.ResultsIn the 12 month period, 47 people presented to detoxification services reporting problems withdrawing from synthetic cannabinoids. Twenty clients were admitted for medical management within an inpatient setting. Coexisting substance dependence apart from nicotine dependence was low. The most common withdrawal symptoms were agitation, irritability, anxiety and mood swings. Withdrawal symptoms were managed with diazepam and quetiapine.Discussion and ConclusionsThe harm associated with use of synthetic cannabinoids has had a direct impact on the utilisation of specialist alcohol and drug services in Auckland, New Zealand. Many clients with synthetic cannabinoid withdrawal symptoms required intensive support including medication and admission to an inpatient detoxification unit. Clients withdrawing from synthetic cannabinoids were the third largest group of clients admitted to inpatient detoxification services in Auckland, New Zealand, between May 2013 and May 2014. [Macfarlane V, Christie G. Synthetic cannabinoid withdrawal: A new demand on detoxification services. Drug Alcohol Rev 2015;34:147–53]
Avifaunal disarray: quantifying models of the occurrence and ecological effects of a despotic bird species
Authors: Thomson James R. , Maron Martine , Grey Merilyn J. , Catterall Carla P. , Major Richard E. , Oliver Damon L. , Clarke Michael F. , Loyn Richard H. , Davidson Ian , Ingwersen Dean , Robinson Doug , Kutt Alex , MacDonald Michael A. , Mac Nally Ralph 
Published: January 2015

AbstractAimStrongly interacting species have disproportionately large ecological effects relative to their abundances or biomass. We previously developed two conceptual models that described how one such strong interactor, the Australian bird the noisy miner Manorina melanocephala: (1) establishes resident high‐density and hyperaggressive colonies and (2) in doing so, affects other biota and ecosystem processes. Here, we evaluate parts of those models relating to noisy miner habitat preferences and effects on bird assemblages using data from across the geographical range of the miner.LocationEastern Australia.MethodsAvian‐assemblage data were compiled for 2 128 survey transects (distributed over > 1.3 × 106 km2) and were linked to variables reflecting productivity, local habitat structure and landscape context. Predictors were chosen based on the models, although detailed data for some variables were unavailable at such large scales. We used hierarchical Bayesian models that included observation models to account for different survey effort coupled with potentially nonlinear, spatially‐explicit process models.ConclusionsNoisy miner densities increased with proximity to forest edges (higher densities on forest edges and open sites), in low rainfall areas, and in vegetation dominated by trees with blade‐shaped rather than needle‐shaped leaves. The presence of noisy miners at even relatively small densities (> 0.6 individuals ha−1) depressed both species richness and the abundances of smaller (< 63 g) bird species, by 50% on average. There were positive associations between densities of noisy miners and the abundance and richness of larger‐bodied (> 63 g) bird species. In areas with higher mean rainfall, the associations between noisy miners and small‐ and large‐bird species were more negative and less positive, respectively.
Vegetation resurvey is robust to plot location uncertainty
Authors: Kopecký Martin , Macek Martin 
Published: January 2015

AbstractAimResurveys of historical vegetation plots are increasingly used for the assessment of decadal changes in plant species diversity and composition. However, historical plots are usually relocated only approximately. This potentially inflates temporal changes and undermines results.LocationTemperate deciduous forests in Central Europe.MethodsTo explore whether robust conclusions can be drawn from resurvey studies despite location uncertainty, we compared temporal changes in species richness, frequency, composition and compositional heterogeneity between exactly and approximately relocated plots. We hypothesized that compositional changes should be lower and changes in species richness should be less variable on exactly relocated plots, because pseudoturnover inflates temporal changes on approximately relocated plots.ResultsTemporal changes in species richness were not more variable, and temporal changes in species composition and compositional heterogeneity were not higher on approximately relocated plots. Moreover, the frequency of individual species changed similarly on both plot types.Main conclusionsThe resurvey of historical vegetation plots is robust to uncertainty in original plot location and, when done properly, provides reliable evidence of decadal changes in plant communities. This provides important background for other resurvey studies and opens up the possibility for large‐scale assessments of plant community change.
Testing the co‐invasion hypothesis: ectomycorrhizal fungal communities onAlnus glutinosaandSalix fragilisin New Zealand
Authors: Bogar Laura M. , Dickie Ian A. , Kennedy Peter G. 
Published: January 2015

AbstractAimIt has been proposed that co‐invasion with ectomycorrhizal (EM) fungi is a common mechanism by which non‐indigenous trees overcome symbiont limitation, yet virtually all prior evidence has come from a single plant family, the Pinaceae. We tested the co‐invasion hypothesis by examining theEMfungal communities associated with a specialized host,Alnus glutinosa(black alder), and a generalist host,Salix fragilis(crack willow), in New Zealand, where both trees are invasive. We aimed to find out if these two hosts, which often co‐occur on invaded riverbanks, (1) were forming novelEMfungal associations in New Zealand and (2) had potential to facilitate each other through sharedEMfungi.LocationNew Zealand.MethodsWe collected root tip samples from both host plants at riparian sites on the North Island and South Island and usedDNAsequence‐based identification to characterizeEMfungal communities.ResultsBoth trees relied upon exoticEMfungi from their indigenous ranges and did not associate with any known endemic New ZealandEMfungi.Alnushad highly similar communities on both islands, while theSalixcommunities were distinct. AllEMfungi on South IslandAlnuswere also present on South IslandSalix, while North IslandSalixdid not substantially shareEMfungal associates withAlnus.Main conclusionsOverall, our study indicates that plant hosts with specialized and more generalistEMfungal communities can both successfully invade new habitats with non‐indigenousEMfungi. While there may be some potential for facilitation between these twoEMplants hosts via shared non‐indigenous fungi, this outcome was context specific. Our findings suggest that the specificity of fungal mutualists is not a major barrier to the spread of invasive plants and cannot be taken as evidence an introduced plant will not become invasive.
High levels of anomalous self‐experience are associated with longer duration of untreated psychosis
Authors: Haug Elisabeth , Øie Merete , Andreassen Ole A. , Bratlien Unni , Nelson Barnaby , Melle Ingrid , Møller Paul 
Published: January 2015

AbstractAimTo investigate the relationship between anomalous self‐experiences and duration of untreated psychosis in a sample of patients with first‐episode schizophrenia spectrum disorders.MethodsAnomalous self‐experiences were assessed by means of the Examination of Anomalous Self‐Experience manual in 55 patients referred to their first adequate treatment for schizophrenia. Diagnoses, symptom severity, functioning and childhood trauma were assessed using the Structured Clinical Interview for the Positive and Negative Syndrome Scale, Premorbid Adjustment Scale, Social Functioning Scale and Childhood Trauma Questionnaire. Substance misuse was measured with the Drug Use Disorder Identification Test, and alcohol use was measured with the Alcohol Use Disorder Identification Test. Duration of untreated psychosis was measured in accordance with a standardized procedure.ResultsHigh levels of anomalous self‐experiences are significantly associated with longer duration of untreated psychosis, an association which held after correcting for other variables associated with long duration of untreated psychosis.ConclusionsThe field of early detection in psychosis is in need of additional clinical perspectives to make further progress. Improved understanding and assessment of anomalous self‐experiences may help clinicians to detect these important phenomena and provide earlier help, and thus reduce treatment delay.
Mare and foal survival and subsequent fertility of mares treated for uterine torsion
Authors: Spoormakers T. J. P. , Graat E. A. M. , ter Braake F. , Stout T. A. E. , Bergman H. J. 
Published: January 2015

SummaryReasons for performing studyPrevious surveys have reported that mare and foal survival after correction of uterine torsion (UT) varies from 60 to 84% and from 30 to 54%, respectively. Furthermore, resolution via a standing flank laparotomy (SFL) has been associated with better foal, but not mare, survival.ObjectivesTo compare the success of SFL with other correction methods (e.g. midline or flank laparotomy under general anaesthesia; correction per vaginam).Study designRetrospective analysis of clinical records.MethodsData on correction technique, stage of gestation, degree of rotation, survival and subsequent fertility for 189 mares treated for UT at 3 equine referral hospitals in The Netherlands during 1987–2007 were analysed.ResultsMean stage of gestation at diagnosis was 283 days (range 153–369 days), with the majority of UTs (77.5%) occurring before Day 320 of gestation. After correction of UT, 90.5% of mares and 82.3% of foals survived to hospital discharge, between 3 and 39 days later, and to foaling. Multivariable logistic regression indicated that correction method and stage of gestation at UT affected survival of foals and mares. For foals, survival was 88.7% after SFL compared with 35.0% after other methods (P = 0.001). When UT occurred at <320 days, 90.6% of foals survived, compared with 56.1% at ≥320 days (P = 0.007). For mare survival, an interaction between stage of gestation and correction method was detected (P = 0.02), with higher survival after SFL (97.1%) than other methods (50.0%) at <320 days of gestation (P<0.01). When UT occurred at ≥320 days, mare survival did not differ between techniques (76.0 vs. 68.8%; P = 0.6). Of 123 mares that were bred again, 93.5% became pregnant; fertility did not differ between mares treated by SFL (93.9%) and other techniques (87.5%; P = 0.9).ConclusionsStanding flank laparotomy is the surgical technique of choice for resolving uncomplicated equine UT (i.e. with no coexisting gastrointestinal lesions) except when the stage of gestation exceeds 320 days.
Quantitative motor unit action potential analysis of supraspinatus, infraspinatus, deltoideus and biceps femoris muscles in adultRoyalDutch sport horses
Authors: Jose‐Cunilleras E. , Wijnberg I. D. 
Published: January 2015

SummaryReasons for performing studyReference values for quantitative electromyography (QEMG) in shoulder and hindlimb muscles of horses are limited.ObjectivesTo determine normative data onQEMGanalysis of supraspinatus (SS), infraspinatus (IS), deltoideus (DT) and biceps femoris (BF) muscles.Study designExperimental observational study and retrospective case series.MethodsSeven adult healthyRoyalDutch sport horses underwent quantitative motor unit action potential analysis of each muscle using commercial electromyography equipment. Measurements were made according to published methods. One‐wayANOVAwas used to compare quantitative motor unit action potential variables between muscles, withpost hoctesting according toBonferroni, with significance set at P<0.05. TheQEMGand clinical information from horses with lower motor neuron disorders (n = 7) or myopathy (n = 4) were summarised retrospectively.ResultsThe 95% confidence intervals of duration, amplitude, phases, turns, area and size index of quantitative motor unit action potential were 8.7–10.4 ms, 651–867 μV, 3.2–3.7, 3.7–4.7, 1054–1457 μV·ms and 1.1–1.5 forSS, 9.6–11.0 ms, 779–1082 μV, 3.3–3.7, 3.8–4.7, 1349–2204 μV·ms and 1.4–1.9 forIS, 6.0–9.1 ms, 370–691 μV, 2.9–3.7, 2.8–4.5, 380–1374 μV·ms and 0.3–1.3 forDTand 5.7–7.8 ms, 265–385 μV, 2.7–3.2, 2.6–3.1, 296–484 μV·ms and 0.2–0.5 forBF, respectively. Mean duration, amplitude, number of phases and turns, area and size index were significantly (P<0.01) higher inSSandISthan inDTandBFmuscles. In addition, 4 of 7 normal horses had >15% polyphasic motor unit action potentials inSSandISmuscles.ConclusionsDifferences between muscles should be taken into account when performingQEMGin order to be able to distinguish normal horses from horses with suspected neurogenic or myogenic disorders. These normal data provide the basis for objectiveQEMGassessment of shoulder and hindlimb muscles. Quantitative electromyography appears to be helpful in diagnosing neuropathies and discriminating these from myopathies.
Patient evaluation of service quality in government homeopathic hospitals in West Bengal, India: a cross‐sectional survey
Authors: Koley Munmun , Saha Subhranil , Singh Arya Jogendra , Choubey Gurudev , Ghosh Aloke , Deb Das Kaushik , Ganguly Subhasish , Dey Samit , Ghosh Shubhamoy , Nag Goutam , Ali Swaif , Saha Sangita , Bhattacharyya Kajal , Singh Rakesh 
Published: January 2015

AbstractBackgroundService quality (SQ) is the perceived difference between expectation and performance along the quality dimensions. It is central to the process of continuous quality improvement; however, SQ has rarely been studied in homeopathic hospital settings.ObjectiveTo examine the quality of service provided by four government homeopathic hospitals in West Bengal, India.MethodsIn this cross‐sectional survey, 644 patients from a systematically selected sample were invited to complete a modified Bengali SERVQUAL instrument (a quality management framework comprising 22 items with four‐point Likert scale response sets descending from 4=strongly agree to 1=strongly disagree). The SQ expectation and perception scores were generated across five dimensions: reliability, responsiveness, empathy, assurance and tangibles. Service‐quality gaps were then analysed.ResultsMean differences between patient perceptions and expectations of SQ revealed statistically significant gaps (P<0.0001) across all five dimensions and all 22 individual items of the survey. Multiple regression found residence significantly (P<0.001) influenced perceived quality gaps. The questionnaire used in this study showed promising psychometrics, including acceptable internal consistency (Cronbach's alpha ≥ 0.6) and item‐corrected total correlations (ICC; Pearson's r >0.3).ConclusionThe services patients received at various homeopathic hospitals in West Bengal, India, did not meet patient expectations across the five domains of SERVQUAL. This gap needs to be addressed through focused improvement efforts.
Developing environmental flow recommendations for freshwater mussels using the biological traits of species guilds
Authors: Gates Kiza K. , Vaughn Caryn C. , Julian Jason P. 
Published: January 2015

Summary

North American freshwater mussels (Unionidae) are a diverse and imperilled fauna that are very sensitive to flow alterations. Previous attempts to develop environmental flows for mussels have struggled to accommodate their varied habitat requirements and complex life histories.

We review what is known about the habitat requirements of mussels, how they can vary among species within a community, and how this variation influences the effectiveness of different environmental flow methodologies.

We propose a trait‐based environmental flow method that addresses the needs of mussel guilds differentiated by their thermal tolerances and reproductive strategies. Used previously for fish, plants and macroinvertebrates, the guild approach groups species by traits and identifies flow requirements of guilds as opposed to entire communities.

We apply the guild approach to the mussel fauna of the Kiamichi and Little Rivers in south‐eastern Oklahoma, U.S.A., and illustrate how changes in the hydrograph can be made to better meet the seasonal flow needs of differing mussel guilds and their host fish.

The guild environmental flow method can provide flow recommendations that cater to the life history and habitat requirements represented within diverse mussel communities. In addition, the method can be adapted among regions where trait data are available or combined with rating models that estimate trait data for understudied species.
Potassium: a neglected nutrient in global change
Authors: Sardans Jordi , Peñuelas Josep 
Published: January 2015

AbstractAimPotassium (K) is the second most abundant nutrient in plant photosynthetic tissues after nitrogen (N). Thousands of physiological and metabolic studies in recent decades have established the fundamental role of K in plant function, especially in water‐use efficiency and economy, and yet macroecological studies have mostly overlooked this nutrient.MethodsWe have reviewed available studies on the content, stoichiometry and roles of K in the soil–plant system and in terrestrial ecosystems. We have also reviewed the impacts of global change drivers on K content, stoichiometry and roles.ConclusionsThe current literature indicates that K, at a global level, is as limiting as N and phosphorus (P) for plant productivity in terrestrial ecosystems. Some degree of K limitation has been seen in up to 70% of all studied terrestrial ecosystems. However, in some areas atmospheric K deposition from human activities is greater than that from natural sources. We are far from understanding the K fluxes between the atmosphere and land, and the role of anthropogenic activities in these fluxes. The increasing aridity expected in wide areas of the world makes K more critical through its role in water‐use efficiency. N deposition exerts a strong impact on the ecosystem K cycle, decreasing K availability and increasing K limitation. Plant invasive success is enhanced by higher soil K availability, especially in environments without strong abiotic stresses. The impacts of other drivers of global change, such as increasing atmospheric CO2 or changes in land use, remain to be elucidated. Current models of the responses of ecosystems and carbon storage to projected global climatic and atmospheric changes are now starting to consider N and P, but they should also consider K, mostly in arid and semi‐arid ecosystems.
Steroid minimization immunosuppression protocol using basiliximab in adult living donor liver transplantation for hepatitis C virus‐related cirrhosis
Authors: Hibi Taizo , Shinoda Masahiro , Itano Osamu , Obara Hideaki , Kitago Minoru , Abe Yuta , Yagi Hiroshi , Tanaka Masayuki , Hoshino Ken , Fujino Akihiro , Kuroda Tatsuo , Kawachi Shigeyuki , Tanabe Minoru , Shimazu Motohide , Kitagawa Yuko 
Published: January 2015

AimRecent randomized trials have failed to prove the benefit of steroid‐free immunosuppression in liver transplantation for hepatitis C virus (HCV)‐related cirrhosis. Furthermore, there is a lack of data on the use of basiliximab in living donor liver transplantation (LDLT). This pilot study evaluated the safety and efficacy of a steroid minimization protocol using basiliximab compared with standard immunosuppression.MethodsA single center, prospective cohort analysis was conducted to compare two immunosuppression regimens in adult recipients who underwent LDLT for HCV since 2004: calcineurin inhibitor/mizoribine/basiliximab (the St− group) and calcineurin inhibitor/mizoribine/steroid (the St+ group). Study end‐points were rejection rates, recurrent HCV, patient survival and other adverse events up to 2 years after transplantation.ResultsA total of 27 consecutive patients were enrolled. Transplantation characteristics were similar between the two groups (14 St− and 13 St+) except ABO incompatible cases being more common in the St+ group. Rejection rates, recurrent HCV, patient survival, fibrosis stage and new‐onset diabetes mellitus at 2 years were comparable between the two groups. ABO incompatibility did not affect short‐ and long‐term outcomes. Nine St− and seven St+ recipients underwent interferon and ribavirin therapy for recurrent HCV, with a sustained virological response rate of 33% and 29%, respectively.ConclusionA steroid minimization protocol with basiliximab in adult LDLT for HCV is safe and affords equivalent rejection rates compared with standard immunosuppression. However, no significant differences are observed with respect to recurrent HCV, patient survival and metabolic complications.