Soft Palate Pleomorphic Adenoma of a Minor Salivary Gland: An Unusual Presentation.

Approximately 10% of pleomorphic adenomas occur in the minor salivary glands with the palate being the most common site. Pleomorphic adenomas account for the majority of palatal tumours; however, minor salivary gland tumours have a higher risk of malignancy compared to tumours of the major salivary glands, so appropriate diagnostic evaluation should be prompt. We present a case of a 52-year-old man with a longstanding history of a soft palate pleomorphic adenoma which required excision under general anaesthetic via a mandibular swing approach. As well as the surgical approach to access this tumour; this case is unique as it is the largest soft palate pleomorphic adenoma reported in the literature. We discuss the appropriate preoperative investigations and airway considerations for this patient, as well as the factors to consider when planning operative management of palatal tumours.

Ring and peg electrodes for minimally-Invasive and long-term sub-scalp EEG recordings.

OBJECTIVE: Minimally-invasive approaches are needed for long-term reliable Electroencephalography (EEG) recordings to assist with epilepsy diagnosis, investigation and more naturalistic monitoring. This study compared three methods for long-term implantation of sub-scalp EEG electrodes. METHODS: Three types of electrodes (disk, ring, and peg) were fabricated from biocompatible materials and implanted under the scalp in five ambulatory ewes for 3months. Disk electrodes were inserted into sub-pericranial pockets. Ring electrodes were tunneled under the scalp. Peg electrodes were inserted into the skull, close to the dura. EEG was continuously monitored wirelessly. High resolution CT imaging, histopathology, and impedance measurements were used to assess the status of the electrodes at the end of the study. RESULTS: EEG amplitude was larger in the peg compared with the disk and ring electrodes (p<0.05). Similarly, chewing artifacts were lower in the peg electrodes (p<0.05). Electrode impedance increased after long-term implantation particularly for those within the bone (p<0.01). Micro-CT scans indicated that all electrodes stayed within the sub-scalp layers. All pegs remained within the burr holes as implanted with no evidence of extrusion. Eight of 10 disks partially eroded into the bone by 1.0mm from the surface of the skull. The ring arrays remained within the sub-scalp layers close to implantation site. Histology revealed that the electrodes were encapsulated in a thin fibrous tissue adjacent to the pericranium. Overlying this was a loose connective layer and scalp. Erosion into the bone occurred under the rim of the sub-pericranial disk electrodes. CONCLUSIONS: The results indicate that the peg electrodes provided high quality EEG, mechanical stability, and lower chewing artifact. Whereas, ring electrode arrays tunneled under the scalp enable minimal surgical techniques to be used for implantation and removal.

Ex vivo biomechanical comparison of barbed suture and standard polypropylene suture for acute tendon laceration in a canine model.

OBJECTIVES: Evaluate performance and resistance to gap formation of a non-absorbable, barbed, monofilament suture, in comparison with a non-absorbable, smooth, monofilament polypropylene suture, in two different suture patterns: three-loop pulley (3LP) and modified Bunnell-Mayer (BM). SAMPLE SIZE: Seventy-two medium-sized cadaveric superficial digital flexor muscle tendon units. METHODS: After manual transection and suture repair, individual specimens were placed in an electromechanical tensile testing machine and tested to monotonic failure using tensile ramp loading. Video data acquisition allowed evaluation of failure mode and quantification of gap formation. RESULTS: Incidence of gap formation between tendon ends was significantly greater in tenorrhaphies repaired with barbed suture compared to those repaired with smooth polypropylene. Use of a 3LP suture pattern caused significantly less gapping between tendon ends when compared to the BM pattern. CONCLUSION: Smooth polypropylene suture was consistently superior in load performance than a unidirectional barbed suture. The 3LP pattern was more resistant than a BM pattern at preventing gap formation. CLINICAL SIGNIFICANCE: Smooth polypropylene should be recommended over barbed unidirectional suture for use in canine tendinous repair to provide increased resistance to gap formation. The 3LP is superior to the BM suture pattern, requiring significantly more force to cause tenorrhaphy gap formation and failure, which may translate to increased accrual of repair site strength and tendinous healing in clinical situations.

A partial hearing animal model for chronic electro-acoustic stimulation.

OBJECTIVE: Cochlear implants (CIs) have provided some auditory function to hundreds of thousands of people around the world. Although traditionally carried out only in profoundly deaf patients, the eligibility criteria for implantation have recently been relaxed to include many partially-deaf patients with useful levels of hearing. These patients receive both electrical stimulation from their implant and acoustic stimulation via their residual hearing (electro-acoustic stimulation; EAS) and perform very well. It is unclear how EAS improves speech perception over electrical stimulation alone, and little evidence exists about the nature of the interactions between electric and acoustic stimuli. Furthermore, clinical results suggest that some patients that undergo cochlear implantation lose some, if not all, of their residual hearing, reducing the advantages of EAS over electrical stimulation alone. A reliable animal model with clinically-relevant partial deafness combined with clinical CIs is important to enable these issues to be studied. This paper outlines such a model that has been successfully used in our laboratory. APPROACH: This paper outlines a battery of techniques used in our laboratory to generate, validate and examine an animal model of partial deafness and chronic CI use. MAIN RESULTS: Ototoxic deafening produced bilaterally symmetrical hearing thresholds in neonatal and adult animals. Electrical activation of the auditory system was confirmed, and all animals were chronically stimulated via adapted clinical CIs. Acoustic compound action potentials (CAPs) were obtained from partially-hearing cochleae, using the CI amplifier. Immunohistochemical analysis allows the effects of deafness and electrical stimulation on cell survival to be studied. SIGNIFICANCE: This animal model has applications in EAS research, including investigating the functional interactions between electric and acoustic stimulation, and the development of techniques to maintain residual hearing following cochlear implantation. The ability to record CAPs via the CI has clinical direct relevance for obtaining objective measures of residual hearing.

Cochlear implantation for chronic electrical stimulation in the mouse.

The mouse is becoming an increasingly attractive model for auditory research due to the number of genetic deafness models available. These genetic models offer the researcher an array of congenital causes of hearing impairment, and are therefore of high clinical relevance. To date, the use of mice in cochlear implant research has not been possible due to the lack of an intracochlear electrode array and stimulator small enough for murine use, coupled with the difficulty of the surgery in this species. Here, we present a fully-implantable intracochlear electrode stimulator assembly designed for chronic implantation in the mouse. We describe the surgical approach for implantation, as well as presenting the first functional data obtained from intracochlear electrical stimulation in the mouse.

Sinonasal bony changes in nasal polyposis: prevalence and relationship to disease severity.

BACKGROUND: Nasal polyposis is characterised by opacification of the nasal cavities, paranasal sinuses and ostiomeatal complexes on computed tomography scanning. Sinonasal bony changes have been reported as disease sequelae. OBJECTIVES: To assess the prevalence of sinonasal bone expansion, erosion and thickening in patients with nasal polyposis, and to correlate disease severity with the prevalence of bony changes. METHODS: A retrospective radiological study was conducted comprising pre-operative computed tomography scans of 104 patients with nasal polyposis and scans of 44 age- and gender-matched individuals (control group) without sinonasal disease. Lund­Mackay scores and bony changes were quantified. RESULTS: Ninety-three per cent of the study group scans showed sinonasal bony change, with no changes in the control group. Radiological severity of nasal polyposis correlated positively with the prevalence of bony changes (rs = 0.31; p < 0.01). CONCLUSION: Sinonasal bony changes were common in the study group. This highlights the importance of pre- and intra-operative imaging, which can help to prevent intra-operative complications. As bony changes may mimic invasive disease, the importance of histological assessment of polyps is emphasised.

Labeled vs actual concentration of bleaching agents.

The purpose of this study was to determine if the actual concentration of bleaching agents available in four different countries were the same as the label indicated and within the recommendations of the International Standard on Tooth Whitening. The method recommended for assaying peroxide by the United States Pharmacopeia was used to determine concentrations. All products in the United States and China were within the standard when products were tested immediately upon delivery at testing sites. One product in Saudi Arabia and three products in Brazil had greater than 30% concentration loss. Three of 24 products in the United States did not meet the International Standard when they were tested at month of expiration.

Kinematic analysis of the pelvic limbs of healthy dogs during stair and decline slope walking.

OBJECTIVES: To evaluate range of motion (ROM) of the pelvic limb in healthy dogs descending stairs compared with decline slope walking. METHODS: Reflective spheres were placed on the skin over the joints of the right pelvic limb of seven adult, hound-type dogs with no clinical signs of orthopaedic or neurologic disease. Five trials of stair and ramp descent of each dog were recorded using four 60 Hz digital infrared cameras. Two-dimensional kinematic data were collected as dogs walked down stairs and on a continuous decline of equivalent slope. Maximum and minimum joint angles and ROM were calculated for the coxofemoral, femorotibial and tibiotarsal joints. RESULTS: Stair descent resulted in significantly greater femorotibial flexion and tibiotarsal flexion and extension compared with continuous slope descent. Significantly greater ROM was achieved in the coxofemoral, femorotibial and tibiotarsal joints during stair descent. CLINICAL SIGNIFICANCE: Compared with a continuous slope, stair descent achieves greater ROM in the pelvic limbs of dogs. Stair descent may be a useful therapeutic exercise to improve ROM in dogs with musculoskeletal disease of the pelvic limb, and ramp descent may be easier for dogs with limited motion of pelvic limb joints.

The p75 neurotrophin receptor protects primary auditory neurons against acoustic trauma in mice.

In the adult rodent inner ear, p75NTR is weakly expressed in primary auditory neurons (PANs) and cochlear Schwann cells. When the organ of Corti is damaged during trauma, its expression dramatically increases. It is unclear what role p75NTR plays under these conditions. Characterisation of p75NTR mutant mice reveals that altering genetic backgrounds can differentially affect the survival of PANs in mutant mice. To conclusively elucidate the physiological role of p75NTR in the cochlea, we challenged wild type (p75NTR +/+) and mutant (p75NTR -/-) mice with an acoustic trauma at 130 dB SPL, 10 kHz for 2 h. This produces a permanent auditory threshold shift >40 dB SPL, damages the organ of Corti and causes secondary degeneration of PANs. After exposure, mice were maintained for 3-9 weeks. Interestingly, survival of PANs in p75NTR -/- mice was significantly compromised in all time-points when compared to wild type mice: 15% reduction after 3 weeks (n = 6), 32% reduction after 6 weeks (n = 6) and 26% reduction after 9 weeks (n = 6-8). Therefore, our data do not support a role of p75NTR as a death inducer in PANs but show its crucial role in protecting PANs.

Melioidosis and the vacuum-assisted closure device: a rare cause of a discharging neck wound, and a new approach to management.

OBJECTIVE: We report a case of melioidosis presenting as a discharging neck abscess, and we describe the use of a vacuum-assisted closure device in its management. METHOD: We report the case of a 44-year-old, Afro-Caribbean woman with melioidosis. We also present the results of a literature search using the search terms 'melioidosis', 'Burkholderia pseudomallei' and 'vacuum-assisted closure device'. RESULTS: Microbiological analysis identified the causative organism as being the bacterium Burkholderia pseudomallei, and its antimicrobial sensitivities to imipenem and ciprofloxacin. A vacuum-assisted closure device was used to manage the patient's melioidosis of the neck; we believe this is the first report of such treatment. CONCLUSIONS: Melioidosis is rare in the UK and western world; however, exposure can occur during travel to endemic areas. We therefore draw attention to this infection as part of the differential diagnosis of a neck abscess. We propose the use of vacuum-assisted closure devices as useful adjuncts to the management of discharging neck wounds.

Efficacy of solifenacin in patients with severe symptoms of overactive bladder: a pooled analysis.

BACKGROUND: The efficacy of antimuscarinic drug therapy in patients who have more severe symptoms of overactive bladder (OAB) at baseline has not been evaluated thoroughly. OBJECTIVE: This analysis determined the effects of solifenacin in patients with severe OAB symptoms at baseline. METHODS: All randomized, placebo-controlled phase III studies of solifenacin were pooled to determine the effects in patients with severe OAB symptoms at baseline. In these studies, patients were randomized to treatment with placebo or solifenacin 5 or 10 mg once daily. Baseline severity was defined according to the number of incontinence episodes/24 h, number of urgency episodes/24 h, and micturition frequency/24 h. The proportion of patients with restoration of continence, resolution of urgency, and normalization of micturition frequency at endpoint was determined. Mean change from baseline to endpoint in the number of episodes/24 h for incontinence, urgency, and micturition, and in the volume voided/micturition were assessed. Comparisons of change from baseline to endpoint were done with analysis of covariance (ANCOVA), and comparisons of percentage change from baseline to endpoint were based on van Elteren's test. RESULTS: Results from four multinational phase III studies of solifenacin with 2848 patients were pooled. The proportion of patients with restoration of continence, resolution of urgency, and normalization of micturition frequency at endpoint was significantly greater with solifenacin than with placebo among patients with severe OAB at baseline. Solifenacin 5 and 10 mg were significantly (p < 0.05) more effective than placebo for reductions in the number of episodes of incontinence, urgency, and micturition, and for the increase in volume voided/micturition among most subgroups of patients who were highly symptomatic at baseline (incontinence, urgency, or micturitions). CONCLUSION: Solifenacin was significantly more effective than placebo for patients with severe symptoms of OAB. The significant and consistent response was observed for all endpoints with solifenacin 10 mg and for most endpoints with solifenacin 5 mg using different definitions of baseline disease severity, and supports the overall effectiveness of solifenacin in highly symptomatic patients.

Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder.

PURPOSE: In this phase 3 trial we assessed the efficacy of solifenacin 5 mg and 10 mg daily in patients with symptoms related to overactive bladder. In addition, we assessed the safety and acceptability of solifenacin. MATERIALS AND METHODS: The study was a multicenter, multinational, randomized, double-blind, placebo controlled trial. Patients were randomized to 12-week once daily treatment with solifenacin 5 mg, solifenacin 10 mg or placebo. The primary efficacy variable was changed from baseline to study end point in mean number of micturitions per 24 hours. Secondary efficacy variables included changes from baseline in mean number of urgency, nocturia and incontinence episodes per 24 hours, and mean volume voided per micturition. RESULTS: Compared with changes obtained with placebo (-1.59), micturitions per 24 hours were statistically significantly decreased with solifenacin 5 mg (-2.37, p = 0.0018) and solifenacin 10 mg (-2.81, p = 0.0001). A statistically significant decrease was observed in the number of incontinence episodes with both solifenacin doses (5 mg, p = 0.002 and 10 mg, p = 0.016). This effect was also seen for episodes of urge incontinence (5 mg, p = 0.014 and 10 mg, p = 0.042). Of patients reporting incontinence at baseline, fully 50% achieved continence after treatment with solifenacin. Episodes of nocturia were statistically significantly decreased in patients treated with solifenacin 10 mg (-0.71, -38.5%) versus placebo (-0.52, -16.4%, p = 0.036). Episodes of urgency were statistically significantly reduced with solifenacin 5 mg (-2.84, -51%, p = 0.003) and solifenacin 10 mg (-2.90, -52%, p = 0.002). Mean volume voided per micturition was statistically significantly increased with both solifenacin doses (p = 0.0001). Treatment with solifenacin was well tolerated. Dry mouth, mostly mild in severity, was reported in 7.7% of patients receiving solifenacin 5 mg and 23% receiving solifenacin 10 mg (vs 2.3% with placebo). CONCLUSIONS: In this study treatment with solifenacin 5 mg and 10 mg once daily significantly improved all the major symptoms of overactive bladder including frequency, urgency and incontinence. Solifenacin 10 mg also decreased the frequency of nocturia. Solifenacin therapy was associated with a favorable tolerability profile and a low incidence of dry mouth, especially at the 5 mg starting dose.

Scope of linear estimators of tidal and occluded volumes using thoracoabdominal indications of breathing movement coordination.

The basic theory for respiratory inductive plethysmography (RIP) applications was re-examined, refined and tested. A realistic model of the RIP interpretation of respiratory mechanics related tidal volumes (VT) to a linear combination of ribcage and abdomen movements. Lissajous plots of asynchronous thoracoabdominal movements revealed their net effect equivalent to the superposition of synchronous and antipathetic respiration modes at right angles, along the principal axes specific to the combined motion. Predictors of relative changes in VT, degree of asynchrony and volume thus being occluded were developed via least squares estimation theory, with an optional validation facility. The approach enabled clinically adequate analysis of 452 h of RIP data from 29 postoperative patients. Correct identification of only seven complete apnoeas in 111 incidences of obstruction during periodic, variable, asynchronous or paradoxical natural breathing was substantiated via non-invasive airflow monitoring. The modelling helped clarify RIP limitations--the possibility of misleading indications from obese or abnormal physiques or movement artefacts degrading its otherwise nearly optimal performance. Nevertheless, our uncalibrated predictors had better theoretical basis, improved reliability and more convenient practical utility than the traditional approach of calibrating RIP by spirometry prior to non-invasive monitoring and identifying and classifying apnoeas.

Potential research participants' views regarding researcher and institutional financial conflicts of interest.

BACKGROUND: Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants. METHODS: The authors surveyed potential research participants over the internet, using the Harris Interactive Chronic Illness Database. A potential research participant was defined by: (1) self report of diagnosis by a health care professional and (2) willingness to participate in clinical trials. Email invitations were sent to 20 205 persons with coronary artery disease, breast cancer, or depression; a total of 6363 persons were screened; of these, 86% or 5478 met inclusion criteria and completed the survey. The outcome measures were respondents' ratings on: importance of knowing conflict of interest information, whether its disclosure ought to be required, and its effect on willingness to participate-across seven widely discussed scenarios of financial conflicts of interest (ranging from commercial funding to equity ownership). RESULTS: Majority responded that knowing conflict of interest information was "extremely" or "very" important; a larger majority felt financial conflicts of interest should be disclosed as part of informed consent (64% to 87%). In all seven scenarios, a majority was still willing to participate but in some scenarios a sizable minority would be wary of participation. Respondents were more wary of individual than institutional conflicts of interest. Illness group and sociodemographic factors had modest effects and did not affect the main trends. CONCLUSIONS: The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants.

Duloxetine vs placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trial.

OBJECTIVES: To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women. PATIENTS AND METHODS: The study included 458 women aged 27-79 years enrolled in a double-blind, placebo-controlled trial. The patients with predominantly SUI were identified using a validated clinical algorithm. They were randomly assigned to receive placebo (231) or duloxetine 40 mg twice daily (227) for 12 weeks. The primary outcome variables included the incontinence episode frequency (IEF) and the Incontinence Quality of Life (I-QOL) questionnaire. Van Elteren's test was used to analyse the percentage changes in IEF where the stratification variable was weekly baseline IEF (IEF < 14 and > or = 14). Analysis of covariance was used to analyse I-QOL scores. RESULTS: The mean baseline IEF was 18.4/week; 55% of patients had a baseline IEF of > or = 14. There was a significantly greater median decrease in IEF with duloxetine with placebo (54% vs 40%, P = 0.05), with comparable significant improvements in quality of life (I-QOL score increases of 10.3 vs 6.4, P = 0.007). The improvements with duloxetine were associated with significantly greater increases in voiding intervals than with placebo (20.4 vs 8.5 min, P < 0.001). The placebo response was 10.7% and 12.5% higher than those reported in two European and North American phase 3 trials. This may have been related to more patients being naïve for incontinence management in the current trial. Discontinuation rates for adverse events were 1.7% for placebo and 17.2% for duloxetine (P < 0.001), with nausea being the most common reason for discontinuation (3.1%); it was the most common adverse event with duloxetine, but was mild or moderate in most (81%), did not worsen in any patient and resolved within 7 days in 60% and within 1 month in 86% of continuing patients; 88% of women who experienced nausea while taking duloxetine completed the trial. CONCLUSIONS: These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America.

Clinical efficacy of tolterodine with or without a simplified pelvic floor exercise regimen.

OBJECTIVES: To investigate whether the combination of tolterodine plus (Tp) a simple pelvic floor muscle exercise (PFME) program would provide improved treatment benefits compared with tolterodine alone (Ta) in patients with symptoms of overactive bladder (OAB). METHODS: After a 1-2 week run-in period, 480 patients with symptoms of urinary frequency (> or =8 micturitions/24 hr), urgency, and urge incontinence (> or =1 episode/24 hr), were randomized to receive tolterodine 2 mg bid with or without a simple PFME program for 24 weeks in this multinational study. Treatment efficacy was assessed by comparing the change from baseline in 3-day micturition diary recordings. RESULTS: After 24 weeks' treatment, in the Ta group the urgency episodes reduced from mean of 4.1 to 1.5 (83% reduction) while in the Tp group the urgency episodes reduced from 4.2 to 2.1 (78.7% reduction). Mean incontinence episodes per day decreased from 3.21 (standard deviation (SD) 3.4) to 0.95 (SD 1.9) in Ta group and from 3.44 (SD 3.4) to 1.25 (SD 2.7) in the Tp group. Similarly, the number of micturition/24 hr were significantly reduced, from 12.78 to 9.20 (27.3% reduction) in the Ta group and from 11.87 to 9.29 (23% reduction) in the Tp group. There was an improvement in the patients' perception of urinary symptoms in 85.9% of patients on Ta and 81.7% patients on Tp PFME. There were no statistically significant differences between the groups with regard to any of the outcome parameters. CONCLUSIONS: Tolterodine therapy for 24 weeks results in significant improvement in urgency, frequency, and incontinence, however, no additional benefit was demonstrated for a simple PFME program.

Doses to fetal and maternal organs from intravenous 59FeCl3 or 57CoCl2.

Doses from intravenous intakes of 59Fe or 57Co chloride during pregnancy were estimated. Near term fetal organ doses were derived via the MIRDOSE3 newborn phantom, with mean dose/cumulated activity (S) values rescaled for compatibility with near term fetus whole body S. A detailed in vivo biodistribution database provided indications of residence times in important maternal and fetal organs. 59Fe doses to the fetus whole body from early to late pregnancy were 7-11 mGy MBq(-1) (8.5-14.3 mSv MBq(-1)), similar to that to the mother. Doses to near term fetal spleen (59 mGy MBq(-1)), liver (36), and red marrow (9) were similar or higher than to the mother. 57Co doses to fetus whole body from early to late pregnancy were 0.7-3.3 mGy MBq(-1) (2.5-8.2 mSv MBq(-1)), similar or higher than to the mother. Doses to near term fetal small intestine (34 mGy MBq(-1)). liver (4.7) and red marrow (2.7) were similar or higher than to the mother.