Pozzilli, Italy
Pozzilli, Italy

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Mulligan N.,University of California at San Diego | Schalkwijk S.,Radboud University Nijmegen | Best B.M.,University of California at San Diego | Colbers A.,Radboud University Nijmegen | And 34 more authors.
Frontiers in Pharmacology | Year: 2016

Background: The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women. Methods: IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women. Intensive steady-state 12-h pharmacokinetic profiles were performed from 2nd trimester through postpartum. Etravirine was measured at two labs using validated ultra performance liquid chromatography (detection limits: 0.020 and 0.026 mcg/mL). Results: Fifteen women took etravirine 200 mg twice-daily. Etravirine AUC0-12 was higher in the 3rd trimester compared to paired postpartum data by 34% (median 8.3 vs. 5.3 mcg*h/mL, p = 0.068). Etravirine apparent oral clearance was significantly lower in the 3rd trimester of pregnancy compared to paired postpartum data by 52% (median 24 vs. 38 L/h, p = 0.025). The median ratio of cord blood to maternal plasma concentration at delivery was 0.52 (range: 0.19-4.25) and no perinatal transmission occurred. Conclusion: Etravirine apparent oral clearance is reduced and exposure increased during the third trimester of pregnancy. Based on prior dose-ranging and safety data, no dose adjustment is necessary for maternal health but the effects of etravirine in utero are unknown. Maternal health and infant outcomes should be closely monitored until further infant safety data are available. Clinical Trial registration: The IMPAACT protocol P1026s and PANNA study are registered at ClinicalTrials.gov under NCT00042289 and NCT00825929. © 2016 Mulligan, Schalkwijk, Best, Colbers, Wang, Capparelli, Moltó, Stek, Taylor, Smith, Hidalgo Tenorio, Chakhtoura, van Kasteren, Fletcher, Mirochnick, Burger and on behalf of the PANNA Network and the IMPAACT 1026s Study Teams.


Romano M.R.,University of Bari | Biagioni F.,IRCSS | Carrizzo A.,IRCSS | Lorusso M.,Ecclesiastical Authority Regional General Hospital Miulli | And 14 more authors.
Experimental Eye Research | Year: 2014

The study was designed to investigate the effects of a new ophthalmic solution containing 0.05% vitamin B12 0.05% on corneal nerve regeneration in rats after corneal injury. Eyes of anesthetized male Wistar rats were subjected to corneal injury by removing the corneal epithelium with corneal brush (Algerbrush). After the epithelial debridement, the right eye of each animal received the instillation of one drop of the ophthalmic solution containing vitamin B12 0.05% plus taurine 0.5% and sodium hyaluronate 0.5% four time per day for 10 or 30 days. Left eyes were used as control and treated with solution containing taurine 0.5% and sodium hyaluronate 0.5% alone following the same regimen. Fluorescein staining by slit-lamp and morphological analysis was used to determine corneal wound healing. Immunohistochemistry, immunoblot and confocal microscopy were used to examine corneal re-innervation. Slit-lamp and histological analyses showed that re-epithelization of the corneas was accelerated in rats treated with vitamin B12. A clear-cut difference between the two groups of rats was seen after 10 days of treatment, whereas a near-to-complete re-epithelization was observed in both groups at 30 days. Vitamin B12 treatment had also a remarkable effect on corneal re-innervation, as shown by substantial increased in the expression of neurofilament 160 and β-III tubulin at both 10 and 30 days. The presence of SV2A-positive nerve endings suggests the presence of synapse-like specialized structures in corneal epithelium of the eye treated with vitamin B12. Our findings suggest that vitamin B12 treatment represents a powerful strategy to accelerate not only re-epithelization but also corneal re-innervation after mechanical injury. © 2014 Elsevier Ltd.


Galluzzi C.,IRCSS | Bureca I.,IRCSS | Guariglia C.,IRCSS | Guariglia C.,University of Rome La Sapienza | Romani C.,Aston University
Neuropsychologia | Year: 2015

Research on aphasia has struggled to identify apraxia of speech (AoS) as an independent deficit affecting a processing level separate from phonological assembly and motor implementation. This is because AoS is characterized by both phonological and phonetic errors and, therefore, can be interpreted as a combination of deficits at the phonological and the motoric level rather than as an independent impairment. We apply novel psycholinguistic analyses to the perceptually phonological errors made by 24 Italian aphasic patients. We show that only patients with relative high rate (>10%) of phonetic errors make sound errors which simplify the phonology of the target. Moreover, simplifications are strongly associated with other variables indicative of articulatory difficulties - such as a predominance of errors on consonants rather than vowels -but not with other measures - such as rate of words reproduced correctly or rates of lexical errors. These results indicate that sound errors cannot arise at a single phonological level because they are different in different patients. Instead, different patterns: (1) provide evidence for separate impairments and the existence of a level of articulatory planning/programming intermediate between phonological selection and motor implementation; (2) validate AoS as an independent impairment at this level, characterized by phonetic errors and phonological simplifications; (3) support the claim that linguistic principles of complexity have an articulatory basis since they only apply in patients with associated articulatory difficulties. © 2015 The Authors.


Corona G.,Critics Territorial Unit of Oncology and Palliative Care | Dinardo F.,COOPERATIVES Auxilium | Bochicchio G.B.,IRCSS
Nutritional Therapy and Metabolism | Year: 2011

One of the issues noted during home palliative treatments is the staggering amount of patients with poor venous access due to the "butchered" state of their arms caused by previous intravenous therapies or attempts at therapies. The aim of the present work was to demonstrate the feasibility of home placement of peripherally inserted central catheters and midline catheters in aged bedridden patients who cannot be taken to hospital. The patients were chosen on the basis of a codified procedure which took into account their clinical condition (such as mobility level and Karnofsky index) as well as the hygienic conditions of their homes. In a three-year period, 150 successful insertions were performed at home in patients aged over 80 (97 women and 53 men) affected by various diseases and in need of continuous infusion therapy, parenteral nutrition, or blood transfusions. One hundred eleven patients had peripherally inserted central catheters and 39 midline catheters. The basilic vein was used in 99 cases. Cancer was the most frequent underlying condition (63 patients) followed by Alzheimer disease (37 patients), whereas the need for infusion therapy was the most frequent indication (129 patients). The mean duration was 41 days (50 for peripherally inserted central catheters and 15 for midline catheters). Death was the most frequent reason for catheter removal, followed by involuntary removal. Twelve complications occurred, with thrombosis being the most frequent, followed by infections and catheter malfunctioning. Based on these findings, it can be concluded that age does not affect the outcome of home placement of peripherally inserted central catheters and midline catheters. Moreover, the home is the ideal place to carry out peripherally inserted central catheter and midline insertion because undesirable hospitalization is avoided. Finally, these devices are able to improve quality of life in patients aged over 80, although this specific issue needs further investigation. The ratio between the use of peripherally inserted central catheters and/or midlines versus the use of traditional peripheral cannulas for venous access was 1:14 in the authors' personal series (6106 days of catheters in situ). This should prompt more use of peripherally inserted central catheters and midline catheters, given the more favorable cost-effectiveness ratio. © 2011 SINPE-GASAPE.


PubMed | University of Rome La Sapienza, Aston University and IRCSS
Type: | Journal: Neuropsychologia | Year: 2015

Research on aphasia has struggled to identify apraxia of speech (AoS) as an independent deficit affecting a processing level separate from phonological assembly and motor implementation. This is because AoS is characterized by both phonological and phonetic errors and, therefore, can be interpreted as a combination of deficits at the phonological and the motoric level rather than as an independent impairment. We apply novel psycholinguistic analyses to the perceptually phonological errors made by 24 Italian aphasic patients. We show that only patients with relative high rate (>10%) of phonetic errors make sound errors which simplify the phonology of the target. Moreover, simplifications are strongly associated with other variables indicative of articulatory difficulties - such as a predominance of errors on consonants rather than vowels -but not with other measures - such as rate of words reproduced correctly or rates of lexical errors. These results indicate that sound errors cannot arise at a single phonological level because they are different in different patients. Instead, different patterns: (1) provide evidence for separate impairments and the existence of a level of articulatory planning/programming intermediate between phonological selection and motor implementation; (2) validate AoS as an independent impairment at this level, characterized by phonetic errors and phonological simplifications; (3) support the claim that linguistic principles of complexity have an articulatory basis since they only apply in patients with associated articulatory difficulties.


Consalvi S.,IRCSS | Sandona M.,IRCSS | Sandona M.,University of Rome La Sapienza | Saccone V.,IRCSS
Stem Cells International | Year: 2016

In the context of regenerative medicine, based on the potential of stem cells to restore diseased tissues, epigenetics is becoming a pivotal area of interest. Therapeutic interventions that promote tissue and organ regeneration have as primary objective the selective control of gene expression in adult stem cells. This requires a deep understanding of the epigenetic mechanisms controlling transcriptional programs in tissue progenitors. This review attempts to elucidate the principle epigenetic regulations responsible of stem cells differentiation. In particular we focus on the current understanding of the epigenetic networks that regulate differentiation of muscle progenitors by the concerted action of chromatin-modifying enzymes and noncoding RNAs. The novel exciting role of exosome-bound microRNA in mediating epigenetic information transfer is also discussed. Finally we show an overview of the epigenetic strategies and therapies that aim to potentiate muscle regeneration and counteract the progression of Duchenne Muscular Dystrophy (DMD). © 2016 Silvia Consalvi et al.


PubMed | University of Rome La Sapienza and IRCSS
Type: | Journal: Stem cells international | Year: 2016

In the context of regenerative medicine, based on the potential of stem cells to restore diseased tissues, epigenetics is becoming a pivotal area of interest. Therapeutic interventions that promote tissue and organ regeneration have as primary objective the selective control of gene expression in adult stem cells. This requires a deep understanding of the epigenetic mechanisms controlling transcriptional programs in tissue progenitors. This review attempts to elucidate the principle epigenetic regulations responsible of stem cells differentiation. In particular we focus on the current understanding of the epigenetic networks that regulate differentiation of muscle progenitors by the concerted action of chromatin-modifying enzymes and noncoding RNAs. The novel exciting role of exosome-bound microRNA in mediating epigenetic information transfer is also discussed. Finally we show an overview of the epigenetic strategies and therapies that aim to potentiate muscle regeneration and counteract the progression of Duchenne Muscular Dystrophy (DMD).

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