Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

ABSTRACT: BACKGROUND: Chronic headache (headache [GREATER-THAN OR EQUAL TO] 15 days/month for at least 3 months) affects 2--5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH) can be identified by using the Severity of Dependence Scale (SDS). A "brief intervention" scheme (BI) has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI) scheme to be used for MOH in primary care. METHODS: A double-blinded cluster randomised parallel controlled trial (RCT) of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. DISCUSSION: There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication withdrawal method. To our knowledge this is the first RCT of structured non-pharmacological MOH treatment in primary care. Results may hold the potential of offering an instrument for treating MOH patients in the general population by GPs. Trial registration ClinicalTrials.gov identifier: NCT01314768.     

Application of the finite-element method to simulation of damage to the human skull as a consequence of missile impact on a multi-layered composite crash helmet

Finite-element analysis is a powerful technique which could be applicable to the study of a wide range of circumstances where the frame and/or the vital organs of the body are subjected to extreme loading conditions. This paper reports the results of an exploratory investigation in which the performance of a crash helmet in protecting the skull from an impacting load is modelled. The immediate objective is to show how a typical crash helmet design of glass-reinforced plastic (GRP) outer casing with quasi-foam-like liner can, with a suitable choice of material properties, attenuate the transfer of energy from the impacting mass such that the damage intensity to the skull is minimized. A simplified structure for both helmet and skull shape is adopted and the skull is modelled as being supported on an elastic foundation. The material properties used are representative rather than being accurately matched to experimentally determined ones. Several aspects of the modelling technique are worthy of particular note: the simulation of material anisotropy by means of multiple reinforcement layers with varying orientation, the use of dashpot elements for energy attenuation and the incorpotation of multipoint constraint between the skull and the helmet lining to ensure integrity of the model with correct stiffness matrix values and allowing independent monitoring of all stress levels at the mating interface region. The results of the modelling show that the specific limited objectives can be met but also indicate how vitally important information could be obtained from similar but more detailed studies which included representative modelling of the body organs and skeleton.     

Early father-infant skin-to-skin contact and its effect on the neurodevelopmental outcomes of moderately preterm infants in China: study protocol for a randomized controlled trial

Background

Skin-to-skin contact (SSC) is an evidence-based intervention that benefits low birth weight /preterm infants. However, China’s health institutional policy inhibits parents from visiting their baby in the neonatal intensive care unit (NICU). In addition, the Chinese traditional postpartum behavioral practice of confining women to home raises barriers to mother-infant contact. Thus, to shorten the duration of parent-infant separation, father-infant SSC is considered a possible alternative. This study determines whether it is safe to perform father-infant SSC in the NICU and investigates how paternal SSC affects outcomes compared with traditional care (TC) for moderately preterm infants.

Methods/design

A randomized controlled trial will be used to investigate the effects of paternal-infant SSC in NICU wards in China. Preterm infants born at a gestational age in the range of 32⁰–34⁶?weeks with a birth weight >?1500?g will be eligible. A simple random sampling method will be used to allocate infants to the SSC group (n =?25) or the TC group (n =?25). After medical stability, infants in the SSC group will be provided SSC by fathers for one hour every day until discharged from hospital. The primary outcome is neurodevelopmental measures, specifically salivary cortisol and Premature Infant Pain Profile (PIPP) during hospitalization. At 40?weeks of corrected age, infants will be assessed using the Infant Neurological International Battery (INFANIB) and neuroimaging. Secondary outcomes include infants’ physiological stability during SSC and throughout hospitalization and state observation at discharge. The fathers’ mental health will be assessed with the State-Trait Anxiety Inventory (STAI) 1?day to 3?days after the infant’s admission to the NICU and at discharge. Father-infant attachment will be evaluated at 4 and 6?months after the infants’ discharge, measured by the Paternal Postnatal Attachment Scale (PPAS). Statistical analyses will be conducted using a two-sided significance level of 0.05.

Discussion

The effects of paternal-infant SSC on moderately preterm infants will be assessed. The data gathered in this study may have important implications for medical practice and policy in the NICU regarding the care methods of premature infants in China.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-IOR-1701274. Registered on 20 September 2017. Retrospectively registered.

     

Feasibility of guided cognitive behaviour therapy (CBT) self-help for childhood anxiety disorders in primary care

Anxiety disorders in childhood are common, disabling and run a chronic course. Cognitive behaviour therapy (CBT) is effective but expensive and trained therapists are scarce. Guided self-help treatments may be a means of widening access to treatment. This study aimed to examine the feasibility of guided CBT self-help in primary care for childhood anxiety disorders, specifically in terms of therapist adherence, patient and therapist satisfaction and clinical gain.Participants were children aged between five and 12 years referred to two primary child and adolescent mental health services (PCAMHSs) in Oxfordshire, UK, who met diagnostic criteria for a primary anxiety disorder. Of the 52 eligible children, 41 anxious children were assessed for anxiety severity and interference before and after receiving CBT self-help delivered via a parent (total therapy time = five hours) by primary mental health workers (PMHWs). Therapy sessions were rated for treatment adherence and parents and PMHWs completed satisfaction questionnaires after treatment completion. Over 80% of therapy sessions were rated at a high level of treatment adherence. Parents and PMHWs reported high satisfaction with the treatment. Sixty-one percent of the children assessed no longer met the criteria for their primary anxiety disorder diagnosis following treatment, and 76% were rated as 'much'/'very much' improved on the Clinical Global Impression-Improvement (CGI-I) scale. There were significant reductions on parent and child report measures of anxiety symptoms, interference and depression. Preliminary exploration indicated that parental anxiety was associated with child treatment outcome. The findings suggest that guided CBT self-help represents a promising treatment for childhood anxiety in primary care.     

From PMTCT to a more comprehensive AIDS response for women: a much-needed shift

Half of the 33.2 million people living with HIV today are women. Yet, responses to the epidemic are not adequately meeting the needs of women. This article critically evaluates how prevention of mother-to-child transmission (PMTCT) programs, the principal framework under which women's health is currently addressed in the global response to AIDS, have tended to focus on the prevention of HIV transmission from HIV-positive women to their infants. This paper concludes that more than ten years after their inception, PMTCT programs still do not successfully ensure the adequate treatment, care and support of HIV-infected women. Of particular concern is the continued widespread use of single-dose nevirapine despite World Health Organization recommendations to employ more effective combination therapies that do not potentially jeopardize women's future treatment outcomes. In response, the article calls for a more comprehensive approach that places women's health needs at the centre of AIDS responses. This is critical in settings where the pandemic is generalized and there is a push to greatly expand PMTCT programs, as a more effective and equitable way of meeting the needs of women in the context of HIV. Without such a comprehensive approach, women will continue to be impacted disproportionately by the pandemic, and current strategies for prevention, including PMTCT, and treatment will not be as effective and responsive as they need to be.     

Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial

ABSTRACT: BACKGROUND: Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best practice model that applies major elements of case management, including patient education, can improve antithrombotic management in primary health care in terms of reducing major thromboembolic and bleeding events. METHODS: This 24-month cluster-randomized trial will be performed in 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, health care assistants and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, health care assistants will be trained in case management and will use the Coagulation-Monitoring-List (Co-MoL) to regularly monitor patients. Patients will receive information (leaflets and a video), treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment-as-usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization, and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients' assessment of chronic illness care, self-reported adherence to medication, general practitioners' and health care assistants' knowledge, patients' knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012. Recruitment of eligible patients will start in July 2012. Assessment will occur at three time points: baseline (T0), follow-up after 12 (T1) and after 24 months (T2). DISCUSSION: The efficacy and effectiveness of individual elements of the intervention, such as antithrombotic interventions, self-management concepts in orally anticoagulated patients and the methodological tool, case-management, have already been extensively demonstrated. This project foresees the combination of several proven instruments, as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment.     

Frontal plagiocephaly: synostotic, compensational, or deformational.

Plagiocephaly is a term commonly used to describe congenital forehead asymmetry. Sixty patients with frontal plagiocephaly were evaluated retrospectively and separated into three types: synostotic (N = 24), compensational (N = 3), and deformational (N = 33). Categorization of frontal plagiocephaly as synostotic or deformational was reliably made by physical examination, focusing on the supraorbital rims, nasal root, ears, and malar eminences. Other anatomic parameters useful in the differential diagnosis included chin point, palpebral fissures, and facial height. This study documented that birth histories were similar for synostotic and deformational frontal plagiocephalic infants. However, other deformational anomalies were more common in deformational frontal plagiocephalic infants, whereas malformations had an equal incidence in deformational and synostotic frontal plagiocephalic infants. Torticollis was an associated finding in 64 percent of infants with deformational frontal plagiocephaly; almost all were ipsilateral. In contrast, head tilt, usually to the contralateral side, was noted in 14 percent of patients with synostotic frontal plagiocephaly. Female preponderance was noted in both synostotic (79 percent) and deformational (76 percent) frontal plagiocephaly. Left-sided involvement was seen in 73 percent of patients with deformational frontal plagiocephaly and in 46 percent of patients with synostotic frontal plagiocephaly. Premature pelvic descent, in the left occipital anterior position, may account for the high incidence of left-sided deformational plagiocephaly and ipsilateral torticollis.     

Different screening strategies (single or dual) for the diagnosis of suspected latent tuberculosis: a cost effectiveness analysis

Background

Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI) and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals.

Methods/Design

BE WELL is a 2-arm parallel randomized clinical trial (RCT) of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324) are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m², and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke). The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical activity level and nutrient intake) and moderators (e.g., socio-demographic characteristics and comorbidities) of the intervention effects also will be examined.

Discussion

This RCT holds considerable potential for illuminating the nature of the obesity-asthma relationship and advancing current guidelines for treating obese adults with asthma, which may lead to reduced morbidity and mortality related to the comorbidity of the two disorders.

Trial registration

NCT00901095     

Comparing the effectiveness of copper intrauterine devices available in Canada. Is FlexiT non-inferior to NovaT when inserted immediately after first-trimester abortion? Study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: We describe the rationale and protocol for a randomized noninferiority controlled trial (RCT) to determine if the Flexi-T380(+) copper intrauterine contraceptive device (IUD) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use, NovaT-200, when placed immediately after a first-trimester abortion. METHODS: Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380(+) IUD, a device for which no current evidence on expulsion or effectiveness rates is available, or the Nova-T200 IUD, the only other brand of copper IUD available in Canada at the time of study initiation. The primary outcome measure is IUD expulsion rate at 1 year. Secondary outcomes include: pregnancy rate, method continuation rate, complication rates (infection, perforation), and satisfaction with contraceptive method. A non-intervention group of consenting women choosing a range of other post-abortion contraception methods, including no contraception, will be included for comparison of secondary outcomes. Web-based contraception satisfaction questionnaires, clinical records, and government-linked health administrative databases will be used to assess primary and secondary outcomes. DISCUSSION: The RCT design, combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry, and hospital records, offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada, in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options. We highlight considerations of design, implementation, and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion.Trial registrationClinicalTrials.gov Identifier NCT01174225.     

Randomised controlled trial to evaluate early discharge scheme for patients with stroke.

OBJECTIVE: To assess the clinical effectiveness of an early discharge policy for patients with stroke by using a community based rehabilitation team. DESIGN: Randomised controlled trial to compare conventional care with an early discharge policy. SETTING: Two teaching hospitals in inner London. SUBJECTS: 331 medically stable patients with stroke (mean age 71) who lived alone and were able to transfer independently or who lived with a resident carer and were able to transfer with help. INTERVENTIONS: 167 patients received specialist community rehabilitation for up to 3 months after randomisation. 164 patients continued with conventional hospital and community care. MAIN OUTCOME MEASURES: Barthel score at 12 months. Secondary outcomes measured impairment with motoricity index, minimental state examination, and Frenchay aphasia screening test; disability with the Rivermead activity of daily living scales, hospital anxiety and depression scale, and 5 m walk; handicap with the Nottingham health profile; carer stress with caregiver strain index and patient and carer satisfaction. The main process measure was length of stay after randomisation. RESULTS: One year after randomisation no significant differences in clinical outcomes were found apart from increased satisfaction with hospital care in the community therapy group. Length of stay after randomisation in the community therapy group was significantly reduced (12 v 18 days; P < 0.0001). Patients with impairments were more likely to receive treatment in the community therapy group. CONCLUSIONS: Early discharge with specialist community rehabilitation after stroke is feasible, as clinically effective as conventional care, and acceptable to patients. Considerable reductions in use of hospital beds are achievable.     

Management of craniosynostosis

Learning Objectives: After studying this article, the participant should be able to: 1. Review the etiopathogenesis of craniosynostosis and craniofacial anomalies. 2. Develop a basic understanding of the clinical manifestations and diagnosis of craniofacial anomalies. 3. Describe the surgical principles of managing craniosynostosis and craniofacial anomalies.Craniosynostosis, or the premature closure of calvarial sutures, results in deformed calvaria at birth. Although the etiology of craniosynostosis is currently unknown, animal experiments and a recent interest in molecular biology point toward interplay between the dura and the underlying brain. This interaction occurs by means of a local alteration in the expression of transforming growth factor, MSX2, fibroblast growth factor receptor, and TWIST. The fused suture restricts growth of the calvaria, thus leading to a characteristic deformation, each associated with a different type of craniosynostosis. Uncorrected craniosynostosis leads to a continuing progression of the deformity, and in some cases, an elevation of intracranial pressure. Clinical examination should include not only an examination of the skull but also a general examination to rule out the craniofacial syndromes that accompany craniosynostosis. Because deformational plagiocephaly, or plagiocephaly without synostosis, occurs secondary to sleeping in the supine position during the early perinatal period, the physician should be aware of this abnormality. Treatment for deformational plagiocephaly is conservative when compared with treatment for craniosynostosis, which requires surgery. Appropriate investigations should include genetic screening, radiologic examination with a computerized tomographic scan, and neurodevelopmental analysis. Surgical intervention should be performed during infancy, preferably in the first 6 months of postnatal life, to prevent the further progression of the deformity and possible complications associated with increased intracranial pressure. The principles of surgical intervention are not only to excise the fused suture but also to attempt to normalize the calvarial shape. Long-term follow-up is critical to determine the effect of the surgical outcome.     

Yoga for Essential Hypertension: A Systematic Review

Background

Yoga is thought to be effective for health conditions. The article aims to assess the current clinical evidence of yoga for Essential hypertension (EH).

Strategy

MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library were searched until June, 2013. We included randomized clinical trials testing yoga against conventional therapy, yoga versus no treatment, yoga combined with conventional therapy versus conventional therapy or conventional therapy combined with breath awareness. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards.

Results

A total of 6 studies (involving 386 patients) were included. The methodological quality of the included trials was evaluated as generally low. A total of 6 RCTs met all the inclusion criteria. 4 of them compared yoga plus conventional therapy with conventional therapy. 1 RCT described yoga combined with conventional therapy versus conventional therapy combined with breath awareness. 2 RCT tested the effect of yoga versus conventional therapy alone. 1 RCT described yoga compared to no treatment. Only one trial reported adverse events without details, the safety of yoga is still uncertain.

Conclusions

There is some encouraging evidence of yoga for lowering SBP and DBP. However, due to low methodological quality of these identified trials, a definite conclusion about the efficacy and safety of yoga on EH cannot be drawn from this review. Therefore, further thorough investigation, large-scale, proper study designed, randomized trials of yoga for hypertension will be required to justify the effects reported here.     

Evaluation of the head-helmet sliding properties in an impact test

The scalp plays a crucial role in head impact biomechanics, being the first tissue involved in the impact and providing a sliding interface between the impactor and/or helmet and the skull. It is important to understand both the scalp-skull and the scalp-helmet sliding in order to determine the head response due to an impact. However, experimental data on the sliding properties of the scalp is lacking. The aim of this work was to identify the sliding properties of the scalp using cadaver heads, in terms of scalp-skull and scalp-liner (internal liner of the helmet) friction and to compare these values with that of widely used artificial headforms (HIII and magnesium EN960). The effect of the hair, the direction of sliding, the speed of the test and the normal load were considered. The experiments revealed that the sliding behaviour of the scalp under impact loading is characterised by three main phases: (1) the low friction sliding of the scalp over the skull (scalp-skull friction), (2) the tensioning effect of the scalp and (3) the sliding of the liner fabric over the scalp (scalp-liner friction). Results showed that the scalp-skull coefficient of friction (COF) is very low (0.06 ± 0.048), whereas the scalp-liner COF is 0.29 ± 0.07. The scalp-liner COF is statistically different from the value of the HIII-liner (0.75 ± 0.06) and the magnesium EN960-liner (0.16 ± 0.026). These data will lead to the improvement of current headforms for head impact standard tests, ultimately leading to more realistic head impact simulations and the optimization of helmet designs.     

A multi-centre randomized controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person's quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. METHODS: Multi-centre parallel group individually randomised controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to 4 months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented. DISCUSSION: This study protocol describes a pragmatic randomised controlled trial that will hopefully provide robust evidence of the benefit of outdoor mobility interventions after stroke for clinicians working in the community. The results will be available towards the end of 2012.     

(Cost)-effectiveness of a multi-component intervention for adults with epilepsy: study protocol of a Dutch randomized controlled trial (ZMILE study)

Background

In patients with epilepsy, poor adherence to anti-epileptic drugs has been shown to be the most important cause of poorly controlled epilepsy. Furthermore, it has been noted that the quality of life among patients with epilepsy can be improved by counseling and treatments aimed at increasing their self-efficacy and concordance, thus stimulating self-management skills. However, there is a need for evidence on the effectiveness of such programs, especially within epilepsy care. Therefore, we have developed a multi-component intervention (MCI) which combines a self-management/education program with e-Health interventions. Accordingly, the overall objective of this study is to assess the (cost)-effectiveness and feasibility of the MCI, aiming to improve self-efficacy and concordance in patients with epilepsy.

Methods

A RCT in two parallel groups will be conducted to compare the MCI with a control condition in epilepsy patients. One hundred eligible epilepsy patients will be recruited and allocated to either the intervention or control group. The intervention group will receive the MCI consisting of a self-management/education program of six meetings, including e-Health interventions, and will be followed for 12 months. The control group will receive care as usual and will be followed for 6 months, after which patients will be offered the possibility of participating in the MCI. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) process evaluation. The primary outcome will be self-efficacy. Secondary outcomes include adherence, side effects, change in seizure severity & frequency, improved quality of life, proactive coping, and societal costs. Outcome assessments will be done using questionnaires at baseline and after 3, 6, 9, and 12 months (last two applicable only for intervention group).

Discussion

In times of budget constraints, MCI could be a valuable addition to the current healthcare provision for epilepsy, as it is expected that higher concordance and self-efficacy will result in reduced use of healthcare resources and an increased QOL. Accordingly, this study is aimed helping patients to be their own provider of health care, shifting epilepsy management from professionals to self-care by patients equipped with appropriate skills and tools.

Trial registration number

NTR4484.

     

Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639

ABSTRACT: BACKGROUND: Coronary artery disease remains the dominant cause of mortality in developed countries. While platelets have been recognized to play a pivotal role in atherothrombosis, the ideal antiplatelet regime after coronary artery surgery remains elusive.The evolution of CABG has presently moved beyond technical improvements to involve modulation of pharmacologic management designed to improve patient outcomes. The aim of this trial will be to test the hypothesis that the addition of clopidogrel to patients with documented postoperative aspirin resistance will reduce the incidence of major cardiovascular events. METHODS: Patients scheduled for isolated coronary artery surgery will be eligible for the study. Patients in whom postoperative multiple electrode aggregometry documents aspirin resistance will be randomized into two groups. The control group will receive 300 mg of aspirin. The dual antiplatelet group will receive 75 mg of clopidogrel in addition to 300 mg of aspirin. Patients will be followed for 6 months. Major adverse cardiac and cerebrovascular events (death from any cause, myocardial infarction, stroke, hospitalization due to cardiovascular pathology) as well as bleeding events will be recorded. DISCUSSION: This will be the first trial that will specifically address the issue of dual antiplatelet therapy in patients undergoing coronary artery surgery who have been found to be aspirin resistant. In the event that the addition of clopidogrel proves to be beneficial in this subset of surgical patients, this study could significantly impact their future antiplatelet management.This randomized controlled trial has been registered at the ClinicalTrials.gov website (Identifier NCT01159639).     

The iceman under pressure (Part I): A description of skull deformations due to 5100 years of glacial action

Due to its long deposition in the glacier, the 'Iceman' (an ice-mummy from the Hauslabjoch) has been deformed, notably its skull. We introduce various comparative methods that describe these deformations, assuming they can be ascribed--to a large extent--to glacial action. While pressure is a scalar, the deformations must be described via a 2-tensor strain field (which can be represented by a matrix function value at every point throughout the skull). In this paper, we present the assumed deformations in numerous graphical forms and, furthermore, the limitations in interpretation--including an estimate of statistical variability--that can be revealed by this analysis. These methods, although describing the results of glacial action and implying a 2-tensor strain field (which will be presented in a subsequent paper), do not permit a straightforward reconstruction of the original, underformed skull. These methods have wider applications to the general problem of deformation.     

Cancer of the Nasopharynx

Of 75 consecutive patients with nasopharyngeal cancer treated at UCLA Center for Health Sciences, 42 were eligible for long-term study. Fourteen (33 percent) survived five years, and one survived ten years. Since the management of nasopharyngeal cancer is primarily irradiation, a well-planned aggressive treatment program using supravoltage therapy is recommended. In spite of cranial nerve involvement or skull erosion, radiation therapy occasionally may offer long term control of the disease.