Efficacy and safety of the Betamethasone valerate 0.1% plaster in mild-to-moderate chronic plaque psoriasis: a randomized, parallel-group, active-controlled, phase III study

Corticosteroids are a versatile option for the treatment of mild-to-moderate psoriasis due to their availability in a wide range of potencies and formulations. Occlusion of the corticosteroid is a widely accepted procedure to enhance the penetration of the medication, thereby improving its effectiveness. Betamethasone valerate (BMV) is a moderately potent corticosteroid that is available as a cream, ointment, and lotion. A ready-to-use occlusive dressing, which provides a continuous sustained release of BMV, has been developed for the treatment of psoriasis.

Removable dentures with implant support in strategic positions followed for up to 8 years

PURPOSE: The aim of this study was to analyze prosthetic maintenance in partially edentulous patients with removable prostheses supported by teeth and strategic implants. MATERIALS AND METHODS: Sixty patients with removable partial prostheses and combined tooth-implant support were identified within the time period from 1998 to 2006. One group consisted of 42 patients (planned group) with a reduced residual dentition and in need of removable partial dentures (RPDs) or overdentures in the maxilla and/or mandible. They were admitted consecutively for treatment. Due to missing teeth in strategic important positions, one or two implants were placed to improve symmetrical denture support and retention. The majority of residual teeth exhibited an impaired structural integrity and therefore were provided with root copings for denture retention. A few vital teeth were used for telescopic crowns. The anchorage system for the strategic implants was selected accordingly. A second group of 18 patients (repair group) wearing RPDs with the loss of one abutment tooth due to biologic or mechanical failure was identified. These abutment teeth were replaced by 21 implants, and patients continued to wear their original prostheses. The observation time for planned and repair groups was 12 months to 8 years. All patients followed a regular maintenance schedule. Technical or biologic complications with supporting teeth or implants and prosthetic service were registered regularly. RESULTS: Three maxillary implants were lost after loading and three roots with copings had to be removed. Biologic problems included caries and periodontal/peri-implant infection with a significantly higher incidence in the repair group (P < .05). Technical complications with the dentures were rather frequent in both groups, mostly related to the anchorage system (matrices) of root copings and implants. Maintenance and complications were observed more frequently in the first year after delivery of the denture than in the following 3 years (P < .05). No denture had to be remade. CONCLUSIONS: The placement of a few implants allows for maintaining a compromised residual dentition for support of RPDs. The combination of root and implant support facilitates treatment planning and enhances designing the removable denture. It also proves to be a practical rescue method. Technical problems with the anchorage system were frequent, particularly in the first year after delivery of the dentures.

A new method to measure higher visual functions in an immersive environment

BACKGROUND: Higher visual functions can be defined as cognitive processes responsible for object recognition, color and shape perception, and motion detection. People with impaired higher visual functions after unilateral brain lesion are often tested with paper pencil tests, but such tests do not assess the degree of interaction between the healthy brain hemisphere and the impaired one. Hence, visual functions are not tested separately in the contralesional and ipsilesional visual hemifields. METHODS: A new measurement setup, that involves real-time comparisons of shape and size of objects, orientation of lines, speed and direction of moving patterns, in the right or left visual hemifield, has been developed. The setup was implemented in an immersive environment like a hemisphere to take into account the effects of peripheral and central vision, and eventual visual field losses. Due to the non-flat screen of the hemisphere, a distortion algorithm was needed to adapt the projected images to the surface. Several approaches were studied and, based on a comparison between projected images and original ones, the best one was used for the implementation of the test. Fifty-seven healthy volunteers were then tested in a pilot study. A Satisfaction Questionnaire was used to assess the usability of the new measurement setup. RESULTS: The results of the distortion algorithm showed a structural similarity between the warped images and the original ones higher than 97%. The results of the pilot study showed an accuracy in comparing images in the two visual hemifields of 0.18 visual degrees and 0.19 visual degrees for size and shape discrimination, respectively, 2.56° for line orientation, 0.33 visual degrees/s for speed perception and 7.41° for recognition of motion direction. The outcome of the Satisfaction Questionnaire showed a high acceptance of the battery by the participants. CONCLUSIONS: A new method to measure higher visual functions in an immersive environment was presented. The study focused on the usability of the developed battery rather than the performance at the visual tasks. A battery of five subtasks to study the perception of size, shape, orientation, speed and motion direction was developed. The test setup is now ready to be tested in neurological patients.

Seals and the Need for more Deference to Vienna by WTO Adjudicators

This paper asks how World Trade Organization (WTO) panels and the Appellate Body (AB) take public international law (PIL) into account when interpreting WTO rules as a part of international economic law (IEL). Splendid isolation of the latter is not new; indeed it is intended by the negotiators of the Understanding on the Settlement of Disputes (DSU). At the same time, the Vienna Convention on the Law of Treaties (VCLT) is quite clear when it provides the general rules and the supplementary means of treaty interpretation. Despite such mandatory guidance, WTO adjudicators (when given a choice and assuming they see the conflict) prefer deference to WTO law over deference to Vienna and take a dogmatic way out of interpretation quandaries. The AB and panels make abundant reference to Vienna, though less so to substantive PIL. Often times, however, they do so simply in order to buttress their findings of violations of WTO rules. Perhaps tellingly, however, none of the reports in EC – Seals contains even a single mention of VCLT, despite numerous references to international standards addressing indigenous rights and animal welfare. In the longer term, and absent a breakthrough on the negotiation front, this pattern of carefully eschewing international treaty law and using PIL just for the sake of convenience could have serious consequences for the credibility and acceptance of the multilateral trading system. Following the adage ‘negotiate or litigate’ recourse to WTO dispute settlement increases when governments are less ready to make treaty commitments commensurate with the challenges of globalisation. This is true even for ‘societal choice’ cases on the margins of classic trade disputes. We will argue here that it is precisely for cases such as these that VCLT and PIL should be used more systematically by panels and the AB. Failing that, instead of building bridges for more coherent international regulation, WTO adjudicators could burn those same bridges which the DSU interpretation margin leaves open for accomplishing their job which is to find a ‘positive solution’. Worse, judicial incoherence could return to WTO dispute settlement like a boomerang and damage the credibility and thus the level of acceptance of the multilateral trading system per se.

[Only a denture sore? Causes of a possible denture sore from a maxillary complete denture]

This case presentation documents the treatment sequence of a 74 years old patient who complained about a sore spot of the palatal mucosa underneath the complete denture. The intraoral examination revealed a dark spot, redness and swelling of the mucosa around this spot and halitosis. The mucosa exhibited a perforation of 3 x 10 mm in diameter. A radiographic 3-D picture showed an impacted canine tooth, which was partly covered by the palatal bone. Firstly the denture base was relieved and the swelling gradually disappeared. Then a biopsy was taken for histological analysis to exclude any malignant process. In local anesthesia the tooth was extracted, which exhibited a deep carious lesion of the entire crown. After surgery a visible collapse of the jaw crest was observed. During a period of two months the denture was relined with a soft material to improve its fit and to enhance the healing process. With a final rebasement, the existing denture could be adapted again and the patient continued to wear it.

Compression hosiery for occupational leg symptoms and leg volume: a randomized crossover trial in a cohort of hairdressers

OBJECTIVE: Occupational leg symptoms are highly prevalent in the general population and impair the psychic state of health. We investigated hairdressers, a cohort exposed to prolonged standing during work, in a randomized crossover trial. We hypothesized that hairdressers wearing low-strength compression hosiery would benefit from less leg volume increase and discomfort. METHODS: One hundred and eight hairdressers were randomized to wear medical compression stockings (MCS; 15-20 mmHg) in a crossover study. The effect of MCS on symptoms and on lower leg volume was compared with no compression treatment. Symptoms were assessed with a comprehensive questionnaire, categorized using factor analysis with varimax rotation and correlated with leg volume changes. RESULTS: Wearing MCS reduced the symptom score for pain and feelings of swelling (range 0-4) by an average of 0.22 (12%, P < 0.001). Sleep disturbance, feeling of unattractive legs and depressiveness improved with MCS compared with no MCS. Subjects initially obliged to refrain from wearing stockings showed a significant decrease of pain and feelings of swelling as well (by 0.10 [6%], P = 0.015). Wearing MCS was associated with a decrease of lower leg volume by an average of 19 mL (P < 0.001), with preference in older hairdressers (P < 0.001). The effects of wearing MCS on symptoms and on leg volume were not correlated with each other. CONCLUSIONS: Individuals working in a standing profession experience leg pain, feelings of swelling, heaviness and various other disturbing feelings. These symptoms can be alleviated by wearing low-strength MCS.

Physiological correlates of aesthetic perception of artworks in a museum

Arts experts are commonly skeptical of applying scientific methods to aesthetic experiencing, which remains a field of study predominantly for the humanities. Laboratory research has however indicated that artworks may elicit emotional and physiological responses. Yet, this line of aesthetics research has previously suffered from insufficient external validity. We therefore conducted a study in which aesthetic perception was monitored in a fine-art museum, unrestricting to the viewers’ freedom of aesthetic choice. Visitors were invited to wear electronic gloves through which their locomotion, heart rate and skin conductance were continuously recorded. Emotional and aesthetic responses to selected works of an exhibition were assessed using a customized questionnaire. In a sample of 373 adult participants, we found that physiological responses during perception of an artwork were significantly related to aesthetic-emotional experiencing. The dimensions ‘Aesthetic Quality’, ‘Surprise/Humor’, ‘Dominance’ and ‘Curatorial Quality’ were associated with cardiac measures (heart rate variability, heart rate level) and skin conductance variability. This is first evidence that aesthetics can be statistically grounded in viewers’ physiology in an ecologically valid environment, the art gallery, enhancing our understanding of the effects of artworks and their curatorial staging.

[Radiation exposure in (90)Y-Zevalin therapy: results of a prospective multicentre trial]

AIM of this study was the assessment of the radiation exposure from preparation and application of (90)Y-Zevalin, the measurement of the dose rate at the patient, the exposure of family members as well as the determination of the activity concentration in urine of patients. METHODS: Overall data from 31 therapeutic administrations carried out in four institutions were evaluated. During preparation and application of (90)Y-Zevalin the finger exposures of radiochemists, technicians, and physicians were measured. The dose rate of the patient was measured immediately after radioimmunotherapy. In patients treated in a nuclear medicine therapy unit, urine was collected over a two day period and the corresponding activity was determined. Family members of outpatients were asked to wear a dosimeter over a seven day period. RESULTS: During the preparation we found a maximum skin dose of 6 mSv at the average, and during application of 3 mSv, respectively. After administration of (90)Y the dose rate was 0.4 +/- 0.1 microSv/h at 2 m distance. Urine measurements yielded a cumulated 24 h excretion of 3.9 +/- 1.4% and 4.4 +/- 1.4% within 48 h, respectively, that is equivalent to 43 +/- 18 and 50 +/- 20 MBq of (90)Y, respectively. Family members received a radiation exposure of 40 +/- 14 microSv over seven days. CONCLUSION: During preparation and application of (90)Y-Zevalin appropriate radiation shielding is necessary. For family members as well as nursing staff no additional special radiation protection measures beyond those being common for other nuclear medicine procedures are necessary.

[Titanium-alloy vs. CoCr-alloy in removable prosthodontics--a clinical study]

Different types of titanium-alloys instead of CoCr-alloys have been tested as material for the framework of removable partial dentures (RPD). Adequate casting and processing techniques have been developed which enable to fabricate frameworks of complex designs and the problem limits porosity. This opened new possibilities for the use of titanium-alloys with improved properties (E-module). The aim of this study was to summarise the use of titanium in removable prosthodontics and to evaluate prospectively the use of the Ti6A17Nb-alloy for RPDs in a small group of patients. Two identically designed RPDs from CoCr-alloy (remanium GM 800+) and Ti6A17Nb-alloy (girotan L) were produced for ten patients. They had to wear each RPD during six months, first the CoCr-RPD and then the Ti6A17Nb-RPD. A questionnaire (visual analogue scale = VAS) was completed by the patients after one, three and six months of function for each RPD. Prosthetic complications and service needed were recorded. After the end of the entire observation period of twelve months, the patients remained with the Ti6A17Nb-RPD and answered the questionnaire after another six months. All parameters regarding the design of the RPDs were positively estimated by the dentist. Minimal, not significant differences were noted by the patients concerning comfort, stability and retention (VAS). Clinically, no differences in technical aspects or regarding biological complications were observed after six-months periods. The Ti6A17Nb-alloy (girotan L) for the framework of RPDs was judged by patients and professionals to be equivalent to RPDs made from CoCr-alloy. No differences in material aspects could objectively be observed. The Ti6A17Nb-alloy can be beneficial for patients with allergies or incompatibility with one or several components of the CoCr-alloy.

Within-subject comparison of two rigid bar designs connecting two interforaminal implants: patients' satisfaction and prosthetic results

BACKGROUND: There is evidence for the superiority of two-implant overdentures over complete dentures in the mandible. Various anchorage devices were used to provide stability to overdentures. The aim of the present study was to compare two designs of a rigid bar connecting two mandibular implants. MATERIALS AND METHODS: Completely edentulous patients received a new denture in the maxilla and an implant-supported overdenture in the mandible. They were randomly allocated to two groups (A or B) with regard to the bar design. A standard U-shaped bar (Dolder bar) was used connecting the two implants in a straight line. For comparison, precision attachments were soldered distal to the bar copings. Group A started the study with the standard bar (S-bar), while group B started with the attachment-bar (A-bar). After 3 months, they had to answer a questionnaire (visual analogue scale [VAS]); then the bar design was changed in both groups. After a period of another 3 months, the patients had to answer the same questions; then they had the choice to keep their preferred bar. Now the study period was extended to another year of observation, and the patients answered again the same questionnaire. In vivo force measurements were carried out with both bar types at the end of the test periods. The prosthetic maintenance service carried out during the 6-month period was recorded for both bar types in both groups. Statistical analysis as performed with the SPSS statistical package (SPSS Inc., Chicago, IL, USA). RESULTS: Satisfaction was high in both groups. Group B, who had entered the study with the attachment bar, gave slightly better ratings to this type for four items, while in group A, no differences were found. At the end of the 6-month comparison period, all but one patient wished to continue to wear the attachment bar. Prosthetic service was equal in groups A and B, but the total number of interventions is significantly higher in the attachment bar. Force patterns of maximum biting were similar in both bar designs, but exhibited significantly higher axial forces in the attachment bar. CONCLUSIONS: Both bar designs provide good retention and functional comfort. High stability appears to be an important factor for the patients' satisfaction and oral comfort. Rigid retention results in a higher force impact and appears to evoke the need for the retightening of occlusal screws, resulting in more maintenance service.

Finite element 3D reconstruction of the pulmonary acinus imaged by synchrotron X-ray tomography

The alveolated structure of the pulmonary acinus plays a vital role in gas exchange function. Three-dimensional (3D) analysis of the parenchymal region is fundamental to understanding this structure-function relationship, but only a limited number of attempts have been conducted in the past because of technical limitations. In this study, we developed a new image processing methodology based on finite element (FE) analysis for accurate 3D structural reconstruction of the gas exchange regions of the lung. Stereologically well characterized rat lung samples (Pediatr Res 53: 72-80, 2003) were imaged using high-resolution synchrotron radiation-based X-ray tomographic microscopy. A stack of 1,024 images (each slice: 1024 x 1024 pixels) with resolution of 1.4 mum(3) per voxel were generated. For the development of FE algorithm, regions of interest (ROI), containing approximately 7.5 million voxels, were further extracted as a working subunit. 3D FEs were created overlaying the voxel map using a grid-based hexahedral algorithm. A proper threshold value for appropriate segmentation was iteratively determined to match the calculated volume density of tissue to the stereologically determined value (Pediatr Res 53: 72-80, 2003). The resulting 3D FEs are ready to be used for 3D structural analysis as well as for subsequent FE computational analyses like fluid dynamics and skeletonization.

Management of infusion reactions in clinical trials and beyond: the US and EU perspectives

Monoclonal antibodies have expanded our cancer-fighting armamentarium in both the United States and Europe. While in general, monoclonal antibodies are well tolerated and do not have significant overlapping side effects with traditional cytotoxic agents, severe infusion reactions (IRs)--sometimes severe enough to be life threatening--have been reported. The pathophysiology of severe infusion reactions associated with monoclonal antibodies is poorly understood, but mechanisms are beginning to be elucidated. Geographic differences in the incidence of IRs have become apparent. Understanding the risk, recognizing the signs and symptoms, and being ready to promptly manage severe IRs are key for the clinician to avoid unnecessarily discontinuing these effective anticancer agents and prevent potentially tragic consequences for their patients. To date, clinical trials have incorporated monoclonal antibodies into combinations with standard cytotoxic regimens; it is expected that in time clinical trials will be testing promising new combinations utilizing multiple targeted agents, resulting in improved toxicity profiles and efficacy for cancer patients.

Practical handling of AIO admixtures - Guidelines on Parenteral Nutrition, Chapter 10

All-in-one admixtures (AIO-admixtures) provide safe, effective and low-risk PN (parenteral nutrition) for practically all indications and applications. Water, energy (carbohydrates and lipids), amino acids, vitamins and trace elements are infused together with PN either as industrially-manufactured AIO admixtures provided as two- or three-chamber bags (shelf life usually more than 12 months) completed with electrolytes and micronutrients where appropriate or as individually compounded ready-to-use AIO admixtures (compounding, usually prepared by a pharmacy on either a daily or weekly basis and stored at 2-8 degrees C). Physico-chemical and microbial stability of an AIO admixture is essential for the safety and effectiveness of patient-specific PN, and its assurance requires specialist pharmaceutical knowledge. The stability should be documented for an application period of 24 (-48) hours. It is advisable to offer a limited selection of different PN regimes in each hospital. For reasons of drug and medication safety, PN admixtures prepared for individual patients must be correctly labelled and specifications for storage conditions must also be followed during transport. Monitoring is required where applicable. Micronutrients are usually administered separately to AIO admixtures. In case compatibility and stability have been well documented trace elements and/or combination preparations including water-soluble or water-soluble/fat soluble vitamin supplements can be added to PN admixtures under strict aseptic conditions. AIO admixtures are usually not used as vehicles for drugs (incompatibilities).

A simple asthma prediction tool for preschool children with wheeze or cough

BACKGROUND Many preschool children have wheeze or cough, but only some have asthma later. Existing prediction tools are difficult to apply in clinical practice or exhibit methodological weaknesses. OBJECTIVE We sought to develop a simple and robust tool for predicting asthma at school age in preschool children with wheeze or cough. METHODS From a population-based cohort in Leicestershire, United Kingdom, we included 1- to 3-year-old subjects seeing a doctor for wheeze or cough and assessed the prevalence of asthma 5 years later. We considered only noninvasive predictors that are easy to assess in primary care: demographic and perinatal data, eczema, upper and lower respiratory tract symptoms, and family history of atopy. We developed a model using logistic regression, avoided overfitting with the least absolute shrinkage and selection operator penalty, and then simplified it to a practical tool. We performed internal validation and assessed its predictive performance using the scaled Brier score and the area under the receiver operating characteristic curve. RESULTS Of 1226 symptomatic children with follow-up information, 345 (28%) had asthma 5 years later. The tool consists of 10 predictors yielding a total score between 0 and 15: sex, age, wheeze without colds, wheeze frequency, activity disturbance, shortness of breath, exercise-related and aeroallergen-related wheeze/cough, eczema, and parental history of asthma/bronchitis. The scaled Brier scores for the internally validated model and tool were 0.20 and 0.16, and the areas under the receiver operating characteristic curves were 0.76 and 0.74, respectively. CONCLUSION This tool represents a simple, low-cost, and noninvasive method to predict the risk of later asthma in symptomatic preschool children, which is ready to be tested in other populations.

Swallowing Activity Assessed by Ambulatory Impedance-pH Monitoring Predicts Awake and Asleep Periods at Night

INTRODUCTION: Voluntary muscle activity, including swallowing, decreases during the night. The association between nocturnal awakenings and swallowing activity is under-researched with limited information on the frequency of swallows during awake and asleep periods. AIM: The aim of this study was to assess nocturnal swallowing activity and identify a cut-off predicting awake and asleep periods. METHODS: Patients undergoing impedance-pH monitoring as part of GERD work-up were asked to wear a wrist activity detecting device (Actigraph(®)) at night. Swallowing activity was quantified by analysing impedance changes in the proximal esophagus. Awake and asleep periods were determined using a validated scoring system (Sadeh algorithm). Receiver operating characteristics (ROC) analyses were performed to determine sensitivity, specificity and accuracy of swallowing frequency to identify awake and asleep periods. RESULTS: Data from 76 patients (28 male, 48 female; mean age 56 ± 15 years) were included in the analysis. The ROC analysis found that 0.33 sw/min (i.e. one swallow every 3 min) had the optimal sensitivity (78 %) and specificity (76 %) to differentiate awake from asleep periods. A swallowing frequency of 0.25 sw/min (i.e. one swallow every 4 min) was 93 % sensitive and 57 % specific to identify awake periods. A swallowing frequency of 1 sw/min was 20 % sensitive but 96 % specific in identifying awake periods. Impedance-pH monitoring detects differences in swallowing activity during awake and asleep periods. Swallowing frequency noticed during ambulatory impedance-pH monitoring can predict the state of consciousness during nocturnal periods