bluuebunny/crossref_metadata_2025_split huggingface dataset:
Uterine electromyography during active phase compared with latent phase of labor at term
Authors: Trojner Bregar Andreja , Lucovnik Miha , Verdenik Ivan , Jager Franc , Gersak Ksenija , Garfield Robert E. 
Published: November 2015

AbstractIntroductionIn a prospective study in a tertiary university hospital we wanted to determine whether uterine electromyography (EMG) can differentiate between the active and latent phase of labor.Material and methodsThirty women presenting at ≥370/7 weeks of gestation with regular uterine contractions, intact membranes, and a Bishop score <6. EMG was recorded from the abdominal surface for 30 min. Latent phase was defined as no cervical change within at least 4 h. Student's t‐test was used for statistical analysis (p ≤ 0.05 significant). Diagnostic accuracy of EMG was determined by receiver operator characteristics (ROC) analysis. The integral of the amplitudes of the power density spectrum (PDS) corresponding to the PDS energy within the “bursts” of uterine EMG activity was compared between the active and latent labor groups.ResultsSeventeen (57%) women were found to be in the active phase of labor and 13 (43%) were in the latent phase. The EMG PDS integral was significantly higher (p = 0.02) in the active (mean 3.40 ± 0.82 μV) compared with the latent (mean 1.17 ± 0.33 μV) phase of labor. The PDS integral had an area under the ROC curve (AUC) of 0.80 to distinguish between active and latent phases of labor, compared with number of contractions on tocodynamometry (AUC = 0.79), and Bishop score (AUC = 0.78). The combination (sum) of PDS integral, tocodynamometry, and Bishop score predicted active phase of labor with an AUC of 0.90.ConclusionsAdding uterine EMG measurements to the methods currently used in the clinics could improve the accuracy of diagnosing active labor.
Differences in sperm morphology in foam‐nesting leptodactyline frogs (Anura, Leptodactylidae)
Authors: Salles Natália M. E. , Zara Fernando J. , Prado Cynthia P. A. 
Published: November 2015

AbstractSperm morphology is diverse among vertebrates and is influenced by the reproductive strategies adopted by species. In anurans, sperm morphology is associated with reproductive modes and mating systems. Here, we describe the sperm morphology of 11 frog species in the genus Leptodactylus and that of Lithodytes lineatus and discuss the relationship between sperm morphology and species' mating systems. We observed two distinct sperm morphotypes among the leptodactyline species, which differed mostly in head morphology. Type I sperm had triangular head, discrete acrosome vesicle with posterior margin not clearly visible; type II sperm had elongated head, clear acrosomal vesicle with posterior margin clearly visible. These sperm types do not seem to be associated with phylogeny; instead, type II sperm was observed in all polyandrous species analysed and in species with evidences of polyandry. Moreover, sperm of all species presented tail with undulating membrane connected to the axial fibre. We suggest that differences in sperm morphology might be associated with sperm competition to what polyandrous species are subjected. However, natural history observations on polyandrous mating in some species presenting type II sperm and phylogenetic comparative studies are need to elucidate the role of mating systems in the evolution of sperm morphology in leptodactylines.
A comparison of the intrasubject variation in drug exposure between generic and brand‐name drugs: a retrospective analysis of replicate design trials
Authors: Yu Yang , Teerenstra Steven , Neef Cees , Burger David , Maliepaard Marc 
Published: November 2015

AIMSThe aim of the present study was to investigate whether differences in total and peak drug exposure upon generic substitution are due to differences between formulations or to intrasubject pharmacokinetic variability of the active substance.MethodsThe study was designed as a retrospective reanalysis of existing studies. Nine replicate design bioequivalence studies representing six drug classes – i.e. for alendronate, atorvastatin, cyclosporin, ebastine, exemestane, mycophenolate mofetil, and ropinirole – were retrieved from the Dutch Medicines Regulatory Authority.ResultsIn most studies, the intrasubject variability in total and peak drug exposure was comparable for the brand‐name [in the range 0.01–0.24 for area under the concentration–time curve (AUCt) and 0.02–0.29 for peak plasma concentration (Cmax) on a log scale] and generic (0.01–0.23 for AUCt and 0.08–0.33 for Cmax) drugs, and was comparable with the intrasubject variability upon switching between those drugs (0.01–0.23 for AUCt and 0.06–0.33 for Cmax). The variance related to subject‐by‐formulation interaction could be considered negligible (–0.069 to 0.047 for AUCt and –0.091 to 0.02 for Cmax).ConclusionIn the investigated studies, the variation in total and peak exposure seen when a patient is switched from a brand‐name to a generic drug is comparable with that seen following repeated administration of the brand‐name drug in the patient. Only the intrasubject variability seems to play a crucial and decisive role in the variation in drug exposure seen; no additional formulation‐dependent variation in exposure is observed upon switching. Thus, our data support that, for the medicines that were included in the present investigation, from a clinical pharmacological perspective, the benefit–risk balance of a generic drug is comparable with that of the brand‐name drug.
Variability of Voriconazole Trough Levels in Haematological Patients: Influence of Comedications with cytochrome P450(CYP) Inhibitors and/or with CYP Inhibitors plus CYP Inducers
Authors: Cojutti Piergiorgio , Candoni Anna , Forghieri Fabio , Isola Miriam , Zannier Maria Elena , Bigliardi Sara , Luppi Mario , Fanin Renato , Pea Federico 
Published: November 2015

AbstractVoriconazole plasma exposure greatly varies among haematological patients. The purpose of this study was to identify the magnitude of influence of comedications with CYP inhibitors and/or with CYP inhibitors plus CYP inducers on voriconazole trough level (Cmin). Voriconazole Cmin was retrospectively assessed among haematological patients who underwent therapeutic drug monitoring (TDM). Univariate and multivariate linear mixed‐effect regression analyses were performed to identify the independent predictors of normalized Cmin. Of the 83 included patients, 35 had comedications with CYP inhibitors (omeprazole or pantoprazole) and 21 with CYP inhibitors (omeprazole or pantoprazole) plus CYP inducers (methylprednisolone, dexamethasone, phenobarbital, rifampin or carbamazepine). Median Cmin value (n = 199) was 2.4 mg/L with a wide range of distribution (<0.2–13.5 mg/L). Median (IQR) normalized voriconazole Cmin value was significantly higher in the presence of CYP inhibitors (4.20 mg/L, 3.23–5.51 mg/L) than either in the absence of interacting cotreatments (2.55 mg/L, 1.54–3.47 mg/L) or in the presence of CYP inhibitors plus CYP inducers (2.16 mg/L, 1.19–3.09 mg/L). The presence of CYP inhibitors was highly significantly associated with Cmin >5.5 mg/L (OR: 23.22, 95% CI: 3.01–179.09, p = 0.003). No significant association emerged when CYP inhibitors were coadministered with CYP inducers (OR: 3.53, 95% CI: 0.36–34.95, p = 0.280). The amount of expected Cmin increase was significantly influenced by both the type and the dose of the administered proton pump inhibitor. The study highlights that the benefit from TDM of voriconazole may be maximal in those patients who are cotreated with CYP inhibitors and/or with CYP inhibitors plus CYP inducers, especially when receiving proton pump inhibitors (PPIs) at very high dosages intravenously.
Enhanced Precision in the Analysis of Randomized Trials with Ordinal Outcomes
Authors: Díaz Iván , Colantuoni Elizabeth , Rosenblum Michael 
Published: November 2015

Summary
We present a general method for estimating the effect of a treatment on an ordinal outcome in randomized trials. The method is robust in that it does not rely on the proportional odds assumption. Our estimator leverages information in prognostic baseline variables, and has all of the following properties: (i) it is consistent; (ii) it is locally efficient; (iii) it is guaranteed to have equal or better asymptotic precision than both the inverse probability-weighted and the unadjusted estimators. To the best of our knowledge, this is the first estimator of the causal relation between a treatment and an ordinal outcome to satisfy these properties. We demonstrate the estimator in simulations based on resampling from a completed randomized clinical trial of a new treatment for stroke; we show potential gains of up to 39% in relative efficiency compared to the unadjusted estimator. The proposed estimator could be a useful tool for analyzing randomized trials with ordinal outcomes, since existing methods either rely on model assumptions that are untenable in many practical applications, or lack the efficiency properties of the proposed estimator. We provide R code implementing the estimator.
Implementation of an inter‐agency transition model for youth with spina bifida
Authors: Lindsay S. , Cruickshank H. , McPherson A. C. , Maxwell J. 
Published: November 2015

AbstractBackgroundTo address gaps in transfer of care and transition support, a paediatric hospital and adult community health care centre partnered to implement an inter‐agency transition model for youth with spina bifida. Our objective was to understand the enablers and challenges experienced in the implementation of the model.MethodsUsing a descriptive, qualitative design, we conducted semi‐structured interviews, in‐person or over the phone, with 12 clinicians and nine key informants involved in implementing the spina bifida transition model. We recruited all 21 participants from an urban area of Ontario, Canada.ResultsClinicians and key informants experienced several enablers and challenges in implementing the spina bifida transition model. Enablers included dedicated leadership, advocacy, funding, inter‐agency partnerships, cross‐appointed staff and gaps in co‐ordinated care to connect youth to adult services. Challenges included gaps in the availability of adult specialty services, limited geographical catchment of adult services, limited engagement of front‐line staff, gaps in communication and role clarity.ConclusionsAlthough the transition model has realized some initial successes, there are still many challenges to overcome in transferring youth with spina bifida to adult health care and transitioning to adulthood.
Subcutaneous infusion of kisspeptin‐54 stimulates gonadotrophin release in women and the response correlates with basal oestradiol levels
Authors: Narayanaswamy Shakunthala , Jayasena Channa N. , Ng Noel , Ratnasabapathy Risheka , Prague Julia K. , Papadopoulou Deborah , Abbara Ali , Comninos Alexander N. , Bassett Paul , Bloom Stephen R. , Veldhuis Johannes D. , Dhillo Waljit S. 
Published: November 2015

SummaryBackground and objectiveKisspeptin stimulates hypothalamic GnRH secretion resulting in gonadotrophin release and has potential as a future therapeutic. Chronic subcutaneous infusion of kisspeptin via a pump (similar to an insulin pump) may provide an alternative route of administration in the future. We investigated for the first time in humans, the gonadotrophin response to subcutaneous (SC) infusions of kisspeptin‐54 in healthy women. Women are markedly more responsive to exogenous kisspeptin in the late follicular phase preovulation when oestradiol levels are naturally high. Therefore, we further investigated whether there was a correlation between baseline oestradiol levels and LH response to kisspeptin.Design and patientsA prospective, single‐blinded placebo‐controlled study. Healthy women (n = 4) received an 8‐h SC infusion of kisspeptin‐54 0·1, 0·3 or 1·0 nmol/kg/h or saline in the early follicular phase of 4 separate menstrual cycles. Gonadotrophins and oestradiol were measured every 10 min during the infusions.ResultsSC infusion of kisspeptin‐54 increased LH and FSH. The LH response to SC infusion of kisspeptin‐54 (0·3 and 1·0 nmol/kg/h) positively correlated with baseline oestradiol levels (P < 0·001). Further statistical analyses showed that in the 1·0 nmol/kg/h group, a 100pmol/l rise in baseline oestradiol was associated with a 1·0 IU/l increase in LH.ConclusionsKisspeptin administered via a SC infusion could be a viable future therapeutic route of administration for patients with infertility. Baseline oestradiol levels may be an important determinant of the gonadotrophin response to kisspeptin treatment in women and should be taken into consideration when evaluating gonadotrophin response.
Evaluation of a national reform in the Israeli child protection practice designed to improve children's participation in decision‐making
Authors: Alfandari Ravit 
Published: November 2015

AbstractA national reform of child protection practice in Israel includes the ambition of strengthening children's participation in intervention decisions carried out in formal committees, called planning, intervention and evaluation committees. A qualitative study was conducted of how well this was being achieved by following 21 case studies of families referred to the committees over 6 months. Data were collected from interviews with social workers, field observations of the committees and a document review. A systems approach was undertaken as a conceptual framework in order to allow a whole‐organizational understanding of what is happening in the field, and why. The key finding was a very limited realization of the reform's aim. Only seven children attended the committees, and they had little influence on decisions, which appears to have made them less co‐operative in implementing them. Those who did not attend rarely had their views conveyed to the committee by their social workers. The reform's lack of success is explained by being ill suited to the organizational working environment and culture. The analysis identified a number of systemic factors influencing the failure to give greater priority to children's views, including lack of skill and time, organizational messages about practice priorities and paternalistic ideology.
Important first encounter: Service user experience of pathways to care and early detection in first‐episode psychosis
Authors: Jansen Jens Einar , Pedersen Marlene Buch , Hastrup Lene Halling , Haahr Ulrik Helt , Simonsen Erik 
Published: November 2015

AbstractBackgroundLong duration of untreated psychosis is associated with poor clinical and functional outcomes. However, few systematic attempts have been made to reduce this delay and little is known of service users' experience of early detection efforts.AimWe explored service users' experience of an early detection service and transition to specialized treatment service, including pathway to care, understanding of illness and barriers to adequate assessment and treatment.MethodsIn‐depth interviews were conducted with 10 service users (median age 21, range 18–27, five males and five females) who were diagnosed with a first‐episode non‐affective psychosis and who were seen by an early detection team (TOP) and currently enrolled in a specialized early intervention service for this disorder (OPUS).ResultsStigma and fear of the ‘psychiatric system’ were reported as significant barriers to help seeking, while family members were seen as a crucial support. Moreover, the impact of traumatic events on the experience and development of psychosis was highlighted. Finally, participants were relieved by the prospect of receiving help and the early detection team seemed to create a trusting relationship by offering a friendly, ‘anti‐stigmatized’ space, where long‐term symptomatology could be disclosed through accurate and validating questioning.ConclusionsEarly detection services have two important functions. One is to make accurate assessments and referrals. The other is to instil hope and trust, and to facilitate further treatment by forming an early therapeutic alliance. The findings in this study provide important insights into the way in which early detection efforts and pathways to care are experienced by service users, with direct implications for improving psychiatric services.
Reference intervals for biochemical and haematological parameters in mature domestic donkeys (Equus asinus) in the UK
Authors: Burden F. A. , Hazell‐Smith E. , Mulugeta G. , Patrick V. , Trawford R. , Brooks Brownlie H. W. 
Published: November 2015

SummaryReference intervals (RIs) for haematology and serum biochemistry for donkeys in a temperate climate have been previously published using blood sample results from the resident population of a large donkey shelter in the UK. Periodic review of reference intervals is recommended to ensure their applicability to the patient population and changes in laboratory methods and technologies. The current study aimed to revise the previously published haematology and serum biochemistry values for the adult domestic donkey (Equus asinus) in the UK in the light of a change in analytical equipment at the Donkey Sanctuary laboratory, but also to refine the demography of the sample population with respect to age, physiology and clinical history. Clinical pathology results from 138 clinically healthy mature (4–24 years inclusive) female and castrated male donkeys selected from the resident population of the Donkey Sanctuary, were analysed retrospectively. The animals were blood sampled during the period February 2008 to June 2011 as part of a routine health screen prior to rehoming. Results for a total of 38 biochemical and haematological parameters were analysed including 3 previously unreferenced parameters in addition to those assessed in the previous study. The new reference intervals and median values show very poor transferability with recently derived reference intervals for non‐Thoroughbred horses and only limited transferability with reference intervals previously published for donkeys in the UK. Of particular note is a marked reduction in the upper reference limit for triglycerides of 2.8 mmol/l (from 4.3 mmol/l) since this parameter is used to decide when donkeys are at risk of developing hyperlipaemia. This study demonstrates the value of intermittent review of reference intervals and refinement of study populations. Notwithstanding the caution with which reference interval data from different laboratories should be compared, the lack of transferability of results between donkeys and horses highlights the importance of use of species‐appropriate reference intervals for clinical decision‐making.
A devolved model for public involvement in the field of mental health research: case study learning
Authors: Moule Pam , Davies Rosie 
Published: November 2015

AbstractBackgroundPatient and public involvement in all aspects of research is espoused and there is a continued interest in understanding its wider impact. Existing investigations have identified both beneficial outcomes and remaining issues. This paper presents the impact of public involvement in one case study led by a mental health charity conducted as part of a larger research project. The case study used a devolved model of working, contracting with service user‐led organizations to maximize the benefits of local knowledge on the implementation of personalized budgets, support recruitment and local user‐led organizations.ObjectiveTo understand the processes and impact of public involvement in a devolved model of working with user‐led organizations.DesignMultiple data collection methods were employed throughout 2012. These included interviews with the researchers (n = 10) and research partners (n = 5), observation of two case study meetings and the review of key case study documentation. Analysis was conducted in NVivo10 using a coding framework developed following a literature review.FindingsFive key themes emerged from the data; Devolved model, Nature of involvement, Enabling factors, Implementation challenges and Impact. While there were some challenges of implementing the devolved model it is clear that our findings add to the growing understanding of the positive benefits research partners can bring to complex research.ConclusionsA devolved model can support the involvement of user‐led organizations in research if there is a clear understanding of the underpinning philosophy and support mechanisms are in place.
Oxidative stress – a key emerging impact factor in health, ageing, lifestyle and aesthetics
Authors: Kandola K. , Bowman A. , Birch‐Machin M. A. 
Published: November 2015

AbstractOxidative stress is the resultant damage that arises due to redox imbalances, more specifically an increase in destructive free radicals and reduction in protection from antioxidants and the antioxidant defence pathways. Oxidation of lipids by reactive oxygen species (ROS) can damage cellular structures and result in premature cell death. At low levels, ROS‐induced oxidative stress can be prevented through the action of antioxidants, however, when ROS are present in excess, inflammation and cytotoxicity eventually results leading to cellular oxidative stress damage. Increasing evidence for the role of oxidative stress in various diseases including neurological, dermatological, and cardiovascular diseases is now emerging. Mitochondria are the principal source (90%) of ROS in the cell, with superoxide radicals being generated when molecular oxygen is combined with free electrons. Given the key role of mitochondria in the generation of cellular oxidative stress it is worth considering this organelle and the process in more detail and to provide methods of intervention.
The role of oxidative damage in poor scalp health: ramifications to causality and associated hair growth
Authors: Schwartz J. R. , Henry J. P. , Kerr K. M. , Mizoguchi H. , Li L. 
Published: November 2015

AbstractThe oxidative stress element of unhealthy scalp leads to compromised pre‐emergent hair formation and poorly formed hair as it grows. Only cosmetic solutions can minimize the impact of unhealthy hair and to achieve healthy looking and feeling hair, the scalp health must be normalized first. The objectives of this research were to both investigate whether oxidative stress was a relevant aetiological element in scalp dandruff and seborrhoeic dermatitis and whether scalp condition affects the quality of hair that grows from it. Further, this research was designed to determine whether an effective anti‐dandruff shampoo would repair and protect the scalp and pre‐emergent hair from oxidative stress. This study demonstrated that oxidative stress is an aetiological element relevant to the dandruff condition and that a potentiated ZPT shampoo effectively improves scalp condition, including a reduction in oxidative stress. The compromised hair condition associated with dandruff is concomitantly improved when the scalp condition is improved. It appears that there is a direct link between hair quality and scalp health.