Photodynamic topical antimicrobial therapy for infected foot ulcers in patients with diabetes: a randomized,double-blind,placebo-controlled study—the D.A.N.T.E (Diabetic ulcer Antimicrobial New Topical treatment Evaluation) study

This study was designed to assess the antimicrobial effect and tolerability of a single dose of a photo-activated gel containing RLP068 in the treatment for infected foot ulcers in subjects with diabetes. A randomized, double-blind, parallel series, placebo-controlled phase IIa trial was performed with three concentrations of RLP068 (0.10, 0.30, and 0.50 %), measuring total and pathogen microbial load on Day 1 (before and 1 h after topical gel application and photoactivation with 689 nm red light), on Days 3, 8, and 15, as add-on to systemic treatment with amoxicillin and clavulanic acid. Blood samples were also drawn 1, 2, and 48 h after administration for the assessment of systemic drug absorption. The trial was performed on 62 patients aged ≥18 years, with type 1 or type 2 diabetes and infected foot ulcer, with an area of 2–15 cm² and a maximum diameter ≤4.6 cm. A dose-dependent reduction in total microbial load was observed (?1.92 ± 1.21, ?2.94 ± 1.60, and ?3.00 ± 1.82 LogCFU/ml for 0.10, 0.30, and 0.50 % RPL068 vs. ?1.00 ± 1.02 LogCFU/ml with placebo) immediately after illumination, with a progressive fading of the effect during follow-up. No safety issues emerged from the analysis of adverse events. Systemic absorption of RLP068 was negligible. Photodynamic antimicrobial treatment with RLP068 of infected diabetic foot ulcers is well tolerated and produces a significant reduction in germ load. Further clinical trials are needed to verify the efficacy of this approach as add-on to systemic antibiotic treatment.     

Bowel Sonoelastography in Patients with Crohn's Disease: A Systematic Review

Sonoelastography is an ultrasound-based method for evaluating the biological properties of a target tissue. It is commonly used in the diagnosis of liver and thyroid disease, but recently its use for monitoring the characteristics of bowel wall in patients affected by Crohn's disease (CD) has been proposed. Our aim was a systematic review of the use of sonoelastography in patients with CD. An initial database search retrieved 32 possible articles. On initial screening, 7 articles, concerning a total of 129 patients and 154 lesions of the small and large bowel, were finally included in the review. The age range varied between 6 and 53 y, and disease duration ranged between 1 and 623?mo. We collected data on the examinations performed (type and time), bowel area considered and parameters evaluated. All authors found that elastography correlates well with the degree of fibrosis, as wall strain significantly decreases in segments affected by fibrotic stenosis. Even though the endpoints proposed in the various articles are relatively inhomogeneous and scarcely comparable, we found that sonoelastography is a promising tool in the evaluation of patients with CD as it can differentiate inflammatory and fibrotic strictures in small case series.     

Cerebral mapping in subjects suffering from migraine with aura

Cerebral mapping of the spontaneous electroencephalographic activity was performed in 31 subjects suffering from migraine with aura and the results were compared with those of a matched control group. All the patients were examined during the interictal period. While traditional visual interpretation of EEG records was negative in all but five cases (16.1%) spectral analysis showed an asymmetry in alpha total power over the posterior regions in 13 cases (41.9%) and an asymmetry in alpha band peak frequency in 17 (54.8%). By means of cerebral mapping and statistical significance probability mapping we were able to demonstrate a significant increase in alpha total power in 13 cases (41.9%) and a regional increase in delta and theta total power in 20 cases (64.5%). In comparison with the control group, the migraine patients showed a widespread increase in slow activity (theta and delta) mostly over the temporal regions.     

Randomized controlled study of an oral jaw-positioning appliance for the treatment of obstructive sleep apnea in children with malocclusion.

To evaluate the clinical usefulness and tolerability of an oral jaw-positioning appliance in the treatment of obstructive sleep apnea syndrome in children, we studied 32 patients (mean age, 7.1 +/- 2.6 yr; 20 males) with symptoms of obstructive sleep apnea, malocclusion, and a baseline apnea index > 1 event/h. A group of 19 subjects was randomly assigned to a 6-mo trial of an oral appliance; the remainder acted as control subjects. At baseline and after the trial all patients underwent physical examination, a standard polysomnography, and orthodontic assessment. A modified version of the Brouillette questionnaire related to obstructive sleep apnea symptoms was administered to parents before and after the trial and a clinical score was calculated. Of the 32 subjects enrolled, 4 treated subjects and 5 control subjects were lost to follow-up. Polysomnography after the trial showed that treated subjects all had significantly lower apnea index (p < 0.001) and hypopnea index values (p < 0.001) than before the trial, whereas in untreated control subjects these values remained almost unchanged. Clinical assessment before and after treatment showed that in 7 of the 14 subjects (50%) the oral appliance had reduced (a fall of at least 2 points in the respiratory score) and in 7 had resolved the main respiratory symptoms, whereas untreated patients continued to have symptoms. In conclusion, treatment of obstructive sleep apnea syndrome with an oral appliance in children with malocclusion is effective and well tolerated.     

Synthesis and 13C NMR characterization of ethylene glycol/terephthalic acid/hydroxybenzoic acid copolyesters

Copolyesters of terephthalic acid, p-hydroxybenzoic acid and ethylene glycol were prepared by high-temperature melt polycondensation, starting from different hydroxybenzoic acid derivatives. Methyl p-hydroxybenzoate monomers having the hydroxyl either free, etherified with ethylene glycol or esterified with terephthalic acid were used. The chemical structure of the copolyesters obtained was characterized by means of ¹³C NMR spectroscopy, and chemical shifts were assigned to the respective carbons. The investigation clearly indicates that oxybenzoate units are quantitatively present in the polymer as etherified (on the hydroxyl group) and esterified (on the carboxylic group) with ethylene glycol. Similar analyses were performed on intermediate products formed after the transesterification stage. They point out that at this stage the hydroxyl group is free when starting from methyl p-hydroxybenzoate, while a noticeable amount of ether is already present when starting from the monomer esterified with terephthalic acid. A reaction scheme encompassing these results and based on the competition between esterification and etherification process of the phenolic hydroxyl is put forward.     

Pulse Pressure: An Independent Predictor of Coronary and Stroke Mortality in Elderly Females from the General Population

The aim of this paper is to evaluate whether pulse pressure is an independent risk factor for coronary and stroke mortality in 3282 subjects (1281 males and 2001 females) aged ≥65 years, taking part in the CArdiovascular STudy in the Elderly (CASTEL). After dividing subjects into tertiles of pulse pressure, adjusted relative risk (RR) and confidence intervals (CI) for 14-year coronary and stroke mortality was evaluated for each tertile. Among females, coronary mortality rate was 2.7% in the first tertile of pulse pressure, 4.7% in the second (RR 1.38, 95% CI [1.15-2.66]) and 6.2% in the third (RR 2, CI [1.20-3.51]). Stroke mortality was 3.6%, 4.1% (RR 1.23, CI [1.02-2.23]) and 8.3% (RR 2.27, CI [1.37-3.74]), respectively. This trend was recognizable in normotensive, borderline and sustained hypertensive women, where mortality increased with rising pulse pressure. No relationship was found between pulse pressure and mortality in males. In elderly women, pulse pressure was a good predictor of coronary and stroke mortality, even superior to the label of hypertension. No matter how any given pulse pressure level was obtained, it was more predictive of both coronary and cerebrovascular mortality than belonging to a normo- or hypertensive category.