Unilateral soft palate palsy secondary to blunt neck trauma: a case report.

Unilateral soft palate paralysis is rare. No cases of unilateral soft palate paralysis with associated velopharyngeal insufficiency (VPI) secondary to minor blunt neck trauma have been reported to date. This case details the presentation of a man with isolated unilateral soft palate paralysis and associated velopharyngeal insufficiency following a collision with an opponent when playing soccer.

Gastrostomy insertion in head and neck cancer patients: a 3 year review of insertion method and complication rates.

Patients with head and neck cancer who have resection, radiotherapy, chemoradiotherapy, or a combination of these require nutritional support to be implemented before treatment, and this may involve insertion of a prophylactic gastrostomy feeding tube. The aim of this study was to compare the use and complication rates of percutaneous endoscopic gastrostomy (PEG) and radiologically inserted gastrostomy (RIG) in these patients at a tertiary referral centre. We retrospectively reviewed gastrostomy data forms completed by nutritional support nursing staff over a recent 34-month period, which included information on method of insertion, 30-day postoperative serious and minor complications, and mortality. A total of 110 patients had prophylactic insertion of a gastrostomy (21 PEG, 89 RIG) over the study period. In the first 12 months 13 (31%) PEG feeding tubes were placed but in the last 12 months none were inserted using an endoscopic approach. Serious complications occurred with 2 (10%) PEG and 12 (13%) RIG; the most common cause was accidental removal of the tube (n=13, 12%). Minor complications of peristomal infection, leakage, or blockage of the tube occurred in 6 (5%) gastrostomies. No patients died during the study period. In recent years, and in the absence of recommended guidelines, there has been an increase in the elective insertion of RIG in patients with head and neck cancer. Serious complications for both methods of insertion in this study are comparable with similar reports. However, with RIG there is a high rate of tubes becoming dislodged with the potential for serious consequences. The most appropriate method to insert a gastrostomy tube in patients with head and neck cancer remains unclear.

Identification of largemouth bass virus in the introduced Northern Snakehead inhabiting the Chesapeake Bay watershed.

The Northern Snakehead Channa argus is an introduced species that now inhabits the Chesapeake Bay. During a preliminary survey for introduced pathogens possibly harbored by these fish in Virginia waters, a filterable agent was isolated from five specimens that produced cytopathic effects in BF-2 cells. Based on PCR amplification and partial sequencing of the major capsid protein (MCP), DNA polymerase (DNApol), and DNA methyltransferase (Mtase) genes, the isolates were identified as Largemouth Bass virus (LMBV). Nucleotide sequences of the MCP (492 bp) and DNApol (419 pb) genes were 100% identical to those of LMBV. The nucleotide sequence of the Mtase (206 bp) gene was 99.5% identical to that of LMBV, and the single nucleotide substitution did not lead to a predicted amino acid coding change. This is the first report of LMBV from the Northern Snakehead, and provides evidence that noncentrarchid fishes may be susceptible to this virus.

Improvements in multi-joint leg function following chronic eccentric exercise.

Previous authors have reported that chronic eccentric cycling facilitates greater changes in multi-joint leg function (hopping frequency, maximum jumping height) compared with concentric cycling. Our purpose was to evaluate changes in leg spring stiffness and maximum power following eccentric and concentric cycling training. Twelve individuals performed either eccentric (n=6) or concentric (n=6) cycling for 7 weeks (3 sessions/week) while training duration progressively increased. Participants performed trials of submaximal hopping, maximal counter movement jumps, and maximal concentric cycling to evaluate leg spring stiffness, maximum jumping power, and maximum concentric cycling power respectively, before and 1 week following training. Total work during training did not differ between eccentric and concentric cycling (126 ± 15-728 ± 91 kJ vs 125 ± 10-787 ± 76 kJ). Following training, eccentric cycling exhibited greater changes in k(leg) and jumping P(max) compared with CON(cyc) (10 ± 3% vs -2 ± 4% and 7 ± 2% vs -2 ± 3%, respectively, P=0.05). Alterations in CON(cyc) P(max) did not differ between ECC(cyc) (1035 ± 142 vs 1030 ± 133 W) and CON(cyc) (1072 ± 98 vs 1081 ± 85 W). These data demonstrate that eccentric cycling is an effective method for improving leg spring stiffness and maximum power during multi-joint tasks that include stretch-shortening cycles. Improvements in leg spring stiffness and maximum power would be beneficial for both aging and athletic populations.

OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine.

OBJECTIVE: To assess the effects of treatment with onabotulinumtoxinA (Botox, Allergan, Inc., Irvine, CA) on health-related quality of life (HRQoL) and headache impact in adults with chronic migraine (CM). METHODS: The Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program (PREEMPT 1 and 2) included a 24-week, double-blind phase (2 12-week cycles) followed by a 32-week, open-label phase (3 cycles). Thirty-one injections of 5U each (155 U of onabotulinumtoxinA or placebo) were administered to fixed sites. An additional 40 U could be administered "following the pain." Prespecified analysis of headache impact (Headache Impact Test [HIT]-6) and HRQoL (Migraine-Specific Quality of Life Questionnaire v2.1 [MSQ]) assessments were performed. Because the studies were similar in design and did not notably differ in outcome, pooled results are presented here. RESULTS: A total of 1,384 subjects were included in the pooled analyses (onabotulinumtoxinA, n = 688; placebo, n = 696). Baseline mean total HIT-6 and MSQ v2.1 scores were comparable between groups; 93.1% were severely impacted based on HIT-6 scores ≥60. At 24 weeks, in comparison with placebo, onabotulinumtoxinA treatment significantly reduced HIT-6 scores and the proportion of patients with HIT-6 scores in the severe range at all timepoints including week 24 (p < 0.001). OnabotulinumtoxinA treatment significantly improved all domains of the MSQ v2.1 at 24 weeks (p < 0.001). CONCLUSIONS: Treatment of CM with onabotulinumtoxinA is associated with significant and clinically meaningful reductions in headache impact and improvements in HRQoL. CLASSIFICATION OF EVIDENCE: This study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.

The clients' perspective--do military uniform and rank impact on the therapeutic relationship between military mental health clients and clinicians.

OBJECTIVE: To measure the perception of military mental health clients of the impact of wearing military uniform on the therapeutic relationship between client and clinician and to ascertain if uniform and rank is perceived as a barrier. METHOD: A brief questionnaire was distributed to Departments of Community Mental Health to be disseminated to their mental health clients to measure their responses. RESULTS: 282 responses from mental health clients were collected over a 30 day period regarding the impact that military uniform makes to the therapeutic relationship with the clinician. 63% (n = 178) regarded uniform as negatively influencing their relationship with the clinician, 37% (n = 104) responded that it did not. 39% (n = 111) believed rank to be a barrier, whereas 61% (n = 171) did not believe it affected the relationship. CONCLUSION: The majority of military mental health clients regard the wearing of uniform as negative to the therapeutic relationship and a significant minority have similar feelings about rank. Military mental health practitioners should consider the impact of these results on the therapeutic relationship with military patients.

Dietary supplements and military operations: caution is advised.

We describe the case of a 32-year-old soldier who presented with acute organic psychosis during an operational tour to Iraq. This was precipitated by excessive consumption of caffeine coupled with additional use of oral nutritional stimulants. Her biochemical profile was compounded by the additional use of exogenous creatine. We present a brief overview of the issue of exercise supplementation and highlight some of the potential problems and clinical issues surrounding their use. This has important implications for both serving soldiers and the wider medical community.

Continuous exposure to infectious pancreatic necrosis virus during early life stages of rainbow trout, Oncorhynchus mykiss (Walbaum).

Rainbow trout, Oncorhynchus mykiss (Walbaum), were exposed continuously to infectious pancreatic necrosis virus (IPNV) at 0, 10(1), 10(3) or 10(5) plaque forming units (pfu) L(-1) of water to estimate the effects of chronic IPNV exposure on early life stages. Fish density averaged 35 fish L(-1) (low density) or 140 fish L(-1) (high density), and the tank flow rate was 250 mL(-1) min. Virus exposure began at 6 days before hatch and continued until fish were 44 days old. Cumulative per cent mortality, analysis of survival and hazard functions, and discrete-time event analysis were used to explore the patterns of survival and mortality. In eggs and fish exposed to IPNV, mortality significantly greater than in the 0 pfu L(-1) exposure did not occur until IPNV concentration was 10(5) pfu L(-1) at low fish density and 10(3) pfu IPNV L(-1) at high fish density. These results suggest that in the natural aquatic environment, where rainbow trout densities are likely to be considerably lower than in this study, mortality resulting from infection with IPNV will very likely not occur when ambient concentrations of virus are < or =10(3) pfu IPNV L(-1). In aquaculture rearing units, trout density is likely to be as high or higher than the densities used in this study. Therefore, continuous inputs of virus at concentrations greater than 10(1) pfu L(-1) may result in IPN epidemics in aquaculture facilities.

The operational mental health consequences of deployment to Iraq for UK Forces.

UK Forces are currently engaged in high tempo, high intensity operations in both Iraq and Afghanistan. Concern has been raised about the impact of current operations upon the mental health of Service personnel. Using data gathered from deployed Field Mental Health Teams, a random sample of UK based non-deployed Community Mental Health Teams and services dedicated to mobilising, de-mobilising and to de-mobilised Reserve Forces, this paper explores the current mental health burden for UK Forces. At present, operationally related psychological disorders do not appear to be a substantial concern for Regular Forces, although for the minority that suffer such problems they are both distressing and of occupational relevance. Proportionately there are more mobilised Reserve Forces seeking help for mental health problems than Regular Forces on operations, but the overall burden that they currently place upon the Defence Mental Health Services is small. There is at present no evidence of an epidemic of mental health problems amongst either Regular or Reserve Forces veterans of the Op TELIC deployment, however, this may change in the future given the evolving nature and fluctuating intensity of operational activity.

The symptoms and recognition of post-traumatic stress reactions.

The three most common clinical sequelae of trauma have been outlined above. However, the vast majority of cases will produce a normal reaction, which would not fulfil any of the diagnostic criteria. Overall, therefore, clinically significant traumatic responses are rare in the military environment, and for the most part short lived. For the conditions that are not self-limited, there are effective treatment options available which will be outlined later in this series.

Do military uniform and rank impact on the therapeutic relationship between military mental health clients and clinicians?

OBJECTIVE: to measure the perceptions of military staff of the impact of wearing military uniform on the therapeutic relationship with mental health clients. METHOD: a brief questionnaire was distributed to all military clinicians in Departments of Community Mental Health to measure their attitudes. RESULTS: there was a 67.9% (n=70) response rate regarding the impact of uniform on the therapeutic relationship. 20% of responses were positive, 31% negative, 37% mixed and 12% gave no answer. CONCLUSION: there was no clear pre-existing literature on this issue. Overall, the wearing of uniform appeared to be perceived positively positive. There is a need to assess clients' points of view in future studies.

Development of a subunit vaccine for infectious pancreatic necrosis virus using a baculovirus insect/larvae system.

Various attempts to develop a vaccine against infectious pancreatic necrosis virus (IPNV) have not yielded consistent results. Thus, at present, no commercial vaccine is available that can be used with confidence to immunize fry of salmon and trout. We generated a cDNA clone of the large genome segment A of an IPNV Sp strain and expressed all structural protein genes in insect cells and larvae using a baculovirus expression system. Green fluorescent protein was also coexpressed as a reporter molecule. High yields of IPNV proteins were obtained and the structural proteins self assembled to form virus-like particles (VLPs). We tested the immunogenicity of the putative VLP antigen in immersion vaccine experiments (two concentrations) in rainbow trout (Oncorhynchus mykiss) fry, and by intraperitoneal immunisation of Atlantic salmon (Salmo salar) pre-smolts using an oil adjuvant formulation. Rainbow trout were challenged by immersion using either the Sp or the VR-299 strain of IPNV two or three weeks post-vaccination, while Atlantic salmon were bath challenged with Sp strain after two months, after parr-smolt transformation. In the rainbow trout fry challenged two weeks post-immunization, cumulative mortality rates three weeks post challenge were 14 % in the fry that had received the highest dose versus 8 % in the control groups. No indication of protection was seen in repeated trials using a lower dose of antigen and challenge three weeks post-immunisation. The cumulative mortality rate of intraperitoneally immunised Atlantic salmon post-smolts four weeks post challenge was lower (56%) than in the control fish (77%), showing a dose-response pattern.

Op Telic--a field mental health team in the general support medical setting.

The recent conflict in the Gulf saw the large-scale deployment of Field Mental Health Teams (FMHT), in support of 1 UK Division and its constituent brigades. This article describes the activities and findings from a FMHT deployed alongside a General Support Medical Regiment covering the divisional rear area. The rate of psychiatric casualties was much lower than anticipated, but the expected bias towards less experienced personnel and reservists was noted. The article covers all stages of the operation from pre-deployment training, reception, staging and onward integration, operations, redeployment and homecoming, describing the core activities of the FMHT at each stage.

Validation of fermentation processes.

The ability to prepare consistent biopharmaceutical products depends extensively on possession of banked and characterized cell substrates and on development of production processes which can be validated. While the attributes that define cell characterization have been extensively detailed by ICH and the regulatory agencies in the past decade, little has been specified regarding process validation for biological processes. The extent to which validation concepts can be applied to biological processes varies depending on the nature of the process, the nature of the product, and the level of knowledge regarding the relationship between process parameters and product quality. Expectations concerning the rigour of the validation programme should be adjusted accordingly. There is no single approach that is appropriate for all processes and products. At a minimum, there should be an attempt to define which process parameters are critical, and to focus the attention of validation efforts on these parameters.

Medical device regulation for manufacturers.

Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. Health Canada also requires that medical device manufacturers maintain distribution records to ensure that devices can be traced to the source and consumers can be contacted successfully in the event that a device is recalled. Medical devices exported from Canada must be compliant with the regulations of the country of import. The Canadian Medical Device Regulations were based on the Medical Device Directives of the European Union thus facilitating approval of Canadian devices for the European market. The United States Food and Drug Administration has separate and distinct requirements for safety and quality of medical devices. While effort has been made to facilitate approval and trade of Canadian medical devices in the United States and the European Union, obtaining approval from multiple regulatory bodies can result in increased device development time and cost. The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices.