Impact of residual disease after "unplanned excision" of primary localized adult soft tissue sarcoma of the extremities: evaluation of 452 cases at a single Institution.

BACKGROUND: Soft tissue sarcomas are often inappropriately excised; it is, however, still a matter of debate whether the presence of residual disease in the re-excision specimen can affect patients' prognosis. The aim of this study is to investigate the impact of re-excision after unplanned surgery of primary soft tissue sarcomas (STS) of the extremities. PATIENTS AND METHODS: We retrospectively evaluated 452 adults with grade 2-3, localized STS (349 primary and 103 unplanned excisions). RESULTS: In the re-excision group, a full 43% of the patients had residual tumor. The re-excision group achieved a significantly better outcome in terms of sarcoma-specific survival (SS) (p = 0.002), local recurrence (LR) (p = 0.004) and distant metastasis (DM) (p = 0.028). Residual tumor was associated with a higher risk of DM (p = 0.005). CONCLUSION: We confirm that unplanned surgery does not compromise patients' prognosis; scar re-excision guarantees at least the same SS, LR and DM rates compared to STS primarily treated in a referral center. Routine use of radiation therapy after re-excision could improve local control. Distant metastases seem to be negatively affected by the presence of residual tumor, and therefore, the use of CT in deep and large STS is suggested. The main goal is to avoid unplanned surgery by referring suspected lumps (especially deep, large, increasing in size) to a specialist center.

Start-up procedures and analysis of heavy metals inhibition on methanogenic activity in EGSB reactor.

The effectiveness of operating an industrial UASB reactor, treating wastewater from the beer industry, with flows containing heavy metals was evaluated. A pilot-scale UASB reactor, already used to simulate the industrial reactor, was unsuccessfully employed. An easy start-up was obtained arranging it as an EGSB reactor. Considerations about this modification are reported. The effects of Cu(II), Ni(II) and Cr(III) ions on the anaerobic activity were analyzed by measurements of methane production rate and COD removal. The employed biomass was the sludge of the industrial UASB reactor, while a solution of ethanol and sodium acetate with COD of 3000 mg/L and a heavy metal concentration of 50 mg/L were continuously fed. Experimental results proved higher biomass sensitivity for copper and much slighter for nickel and chromium. Moreover, copper inhibition has been demonstrated to be less significant if a metal-free feed was provided to the system before copper addition.

Supercritical antisolvent precipitation of nimesulide: preliminary experiments.

The purpose of this preliminary study was to investigate the physico-chemical properties of nimesulide precipitated by continuous supercritical antisolvent (SAS) from different organic solvents like acetone, chloroform and dichloromethane at 40 degrees C and 80, 85 and 88 bar, respectively. Scanning electron microscopy, differential scanning calorimetry, X-Ray diffractometry and in vitro dissolution tests were employed to study how the technological process and the solvent nature would affect the final product. SAS-processed nimesulide particles showed dramatic morphological change in crystalline structure if compared to native nimesulide, resulting in needle and thin rods shaped crystals. The solid state analysis showed that using chloroform or dichloromethane as a solvent the drug solid state remained substantially unchanged, whilst if using acetone the applied method caused a transition from the starting form I to the meta-stable form II. So as to identify which process was responsible for this result, nimesulide was further precipitated from the same solvent by conventional evaporation method (RV-sample). On the basis of this comparison, the solvent was found to be responsible for the re-organization into the different polymorphic form and the potential of the SAS process to produce micronic needle shaped particles, with an enhanced dissolution rate if compared to the to the pure drug, was ascertained. Finally, the stability of the nimesulide form II, checked by DSC analysis, was ruled on over a period of 15 months.

Preparation of theophylline-hydroxypropylmethylcellulose matrices using supercritical antisolvent precipitation: a preliminary study.

Several controlled release systems of drugs have been elaborated using a supercritical fluid process. Indeed, recent techniques using a supercritical fluid as a solvent or as an antisolvent are considered to be useful alternatives to produce fine powders. In this preliminary study, the effect of Supercritical Anti Solvent process (SAS) on the release of theophylline from matrices manufactured with hydroxypropylmethylcellulose (HPMC) was investigated. Two grades of HPMC (HPMC E5 and K100) as carriers were considered in order to prepare a sustained delivery system for theophylline which was used as a model drug. The characterization of the drug before and after SAS treatment, and the coprecipitates with carriers, was performed by X-ray Diffraction (XRD) and Differential Scanning Calorimetry (DSC). The dissolution rate of theophylline, theophylline-coprecipitates, and matricial tablets prepared with coprecipitates were determined. The physical characterizations revealed a substantial correspondence of the drug solid state before and after supercritical fluid treatment while drug-polymer interactions in the SAS-coprecipitates were attested. The dissolution studies of the matrices prepared compressing the coprecipitated systems showed that the matrices based on HPMC K100 were able to promote a sustained release of the drug. Further, this advantageous dissolution performance was found to be substantially independent of the pH of the medium. The comparison with the matrices prepared with untreated substances demonstrated that matrices obtained with SAS technique can provide a slower theophylline release rate. A new mathematical model describing the in vitro dissolution kinetics was proposed and successfully tested on these systems.

Characterisation of nimesulide-betacyclodextrins systems prepared by supercritical fluid impregnation.

The purpose of this study was to apply the supercritical CO(2) impregnation process for preparing solvent-free nimesulide (NMS)-betacyclodextrins (BCD) association systems with enhanced drug dissolution rate. Several drug-to-carrier molar ratios were tested (1:1; 1:2.5; 1:3.5) at different conditions of temperatures (40, 100, and 130 degrees C) and pressures (140, 190 or 220 bar). The physical and morphological characterisation of the systems using powder X-ray diffraction, thermal analysis, diffuse reflectance Fourier transform-infrared spectroscopy and scanning electron microscopy was carried out to understand the influence of this technological process on the physical status of single components and binary systems and to detect possible interactions between drug and carrier. These analyses provided no evidence of a complete inclusion of NMS in the carrier but the existence of interactions between drug and carrier together with a partial dehydration of the BCD and the formation of drug crystallites with lower melting point and heat of fusion than the native NMS. These phenomena were more intense when severe conditions of pressure and temperature (220 bar and 130 degrees C) were used during impregnation trials and when the amount of BCD augmented in the systems. These activated solid state of the impregnated systems promoted an enhancement of drug dissolution rate that, in keeping with the results of the physical characterisation, was function of the process conditions and BCD content.

Study of the solid state of carbamazepine after processing with gas anti-solvent technique.

The purpose of this study was to investigate the influence of supercritical CO2 processing on the physico-chemical properties of carbamazepine, a poorly soluble drug. The gas anti-solvent (GAS) technique was used to precipitate the drug from three different solvents (acetone, ethylacetate and dichloromethane) to study how they would affect the final product. The samples were analysed before and after treatment by scanning electron microscopy analysis and laser granulometry for possible changes in the habitus of the crystals. In addition, the solid state of the samples was studied by means of X-ray powder diffraction, differential scanning calorimetry, diffuse reflectance Fourier-transform infrared spectroscopy and hot stage microscopy. Finally, the in vitro dissolution tests were carried out. The solid state analysis of both samples untreated and treated with CO2, showed that the applied method caused a transition from the starting form III to the form I as well as determined a dramatic change of crystal morphology, resulting in needle-shaped crystals, regardless of the chosen solvent. In order to identify which process was responsible for the above results, carbamazepine was further precipitated from the same three solvents by traditional evaporation method (RV-samples). On the basis of this cross-testing, the solvents were found to be responsible for the reorganisation into a different polymorphic form, and the potential of the GAS process to produce micronic needle shaped particles, with an enhanced dissolution rate compared to the RV-carbamazepine, was ascertained.

Individual differences in the capacity limitations of visuospatial short-term memory: research on sighted and totally congenitally blind people.

The study of visuospatial imagery processes in totally congenitally blind people makes it possible to understand the specific contribution of visual experience for imagery processes. We argue that blind people may have visuospatial imagery processes, but they suffer from some capacity limitations. Similar, although smaller, limitations and individual differences may be found in sighted people. Visuospatial imagery capacity was explored by asking people to follow an imaginary pathway through either two- or three-dimensional matrices of different complexity. The blind appear to use specific visuospatial processes in this task (Experiments 2 and 3), but they have difficulty with three-dimensional matrices; sighted people have no such difficulty with three-dimensional matrices (Experiment 1). On the other hand, when a three-dimensional pattern exceeded sighted capacity, the blind and sighted showed similar patterns of errors. Subsequent analyses suggested that both visuospatial processes and verbal mediation were used.