INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

Background The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials. Methods In this context, we have developed a Master Protocol, based on the “backbone” of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow. Discussion The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers

Food habits and trophic niche overlap of the badger Meles meles L. and the red fox Vulpes vulpes L. in a Mediterranean coastal area

Volume: 50Start Page: 226End Page: 23

Food habits and trophic niche variation of the red fox Vulpes vulpes (L. 1758) in a Mediterranean coastal area

The flexible social organisation of the Red fox and its ability to adapt readily to environmental changes allow this Canid to survive, and often to establish flourishing populations, in a variety of environments. Therefore it is hard to draw general conclusions on many aspects of its biology, the parameters of which tend to vary locally. In particular, a thorough knowledge of its food habits and of their variation throughout the year is mandatory for any study on habitat use and pattern of distribution of this Canid (Macdonald, 1983). There have been few studies of the food habits of the Red fox in southern Europe (e.g. Amores, 1975; Braiia & Del Campo, 1980; Rau et al. , 1985, for Spain ; Reynolds, 1979, for S. France ; Leinati et al. , 1960; Macdonald et al. , 1980 ; Ciampalini & Lovari, 1985 ; Pandolfi & Marcon, 1985, for ltaly). While most of the studies were conducted in mountain regions, only Reynolds (1979), Rau et al. (1985) and Ciampalini & Lovari (1985) studied the diet of the Fox in coastal areas. Two of these studies were undertaken to assess potential competition with the Spanish Lynx Lynx pardina in the Coto Doiiana, S. Spain (Rau et al. , 1985), and with the Badger Meles meles in an area south of the mouth of the Ombrone river, Grosseto province, ltaly (Ciampalini & Lovari, 1985). While the dietary niches of the Lynx and the Fox showed little overlap, if any, the Badger diet was found to be very similar to that of the Fox. The Spanish study was carried out in a dense Mediterranean scrub and a wetland area. The ltalian study was done in a variety of habitats to give an overall picture of the food habits of the Fox

Photo-lithological map of the southern flank of the Tindouf Basin (Western Sahara)

This paper examines the potential to map surface geology by applying specific enhancement techniques to Landsat 7 ETM+ imagery, resulting in false color composite images, which were interpreted and then validated during a field campaign. The study area is located on the southern flank of the Tindouf Basin (Western Sahara), and it is noted that there is a general lack of bibliographic data due both to the region's remote location and to its difficult political situation. A number of photo-lithological units were mapped within the Proterozoic basement and the sedimentary succession of the Tindouf Basin incisively contributing to the knowledge of the geological setting of this area. © 2012 Andrea Ciampalini, Francesca Garfagnoli, Benedetta Antonielli, Chiara Del Ventisette and Sandro Moretti

Il Muscolo Gran Dorsale Ruotato ed Innervato nel Trattamento dei Sarcomi delle Parti Molli della Spalla

Il Muscolo Gran Dorsale Ruotato ed Innervato nel Trattamento dei Sarcomi delle Parti Molli della Spall

Transvaginal echocystourethrography

The anatomo-physiologic appearances of female urination obtained with a new ultrasonographic technique is illustrated. The technique is performed using an intravisceral linear probe positioned in the vagina and a special chair which allows the urination in physiological position; at the same time the urination is videorecorded. The results, compared with X-Ray cystourethrography, enabled us to show the normal aspects (both dynamic and morphologic) and several pathologic aspects. Basing upon the direction of the urethra, it is possible to establish the change of the position of the floor and the neck bladder, which are often responsible of stress incontinence. The Authors stress the relative simplicity and noninvasiveness of the echographic technique. X-Ray radiation aren't used: this test is particularly advisable to study the urination disease of women in fertile-age