Σάββατο 12 Ιανουαρίου 2019

A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

Condition:   Marburg Virus Disease Interventions:   Drug: galidesivir;   Drug: placebo Sponsors:   BioCryst Pharmaceuticals;   National Institute of Allergy and Infectious Diseases (NIAID) Recruiting (Source: ClinicalTrials.gov)

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Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the " RITUXIMAB 3 " Trial

Condition:   Autoimmune Diseases Interventions:   Drug: Rituximab;   Drug: corticosteroids'therapy Sponsor:   University Hospital, Rouen Not yet recruiting (Source: ClinicalTrials.gov)

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A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

Condition:   Marburg Virus Disease Interventions:   Drug: galidesivir;   Drug: placebo Sponsors:   BioCryst Pharmaceuticals;   National Institute of Allergy and Infectious Diseases (NIAID) Recruiting (Source: ClinicalTrials.gov)

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Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the " RITUXIMAB 3 " Trial

Condition:   Autoimmune Diseases Interventions:   Drug: Rituximab;   Drug: corticosteroids'therapy Sponsor:   University Hospital, Rouen Not yet recruiting (Source: ClinicalTrials.gov)

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Severe infantile epileptic encephalopathy associated with D-glyceric aciduria: report of a novel case and review

We describe a male patient from a consanguineous Arab family with infantile onset of DGA, characterized by profound psychomotor retardation, progressive microcephaly, intractable seizures, cortical blindness and deafness. Consecutive brain MR imaging showed an evolving brain atrophy, thinning of the corpus callosum and diffuse abnormal white matter signals. Whole exome sequencing identified the homozygous missense variant in theGLYCTK gene [c.455  T >  C, NM_145262.3], which affected a highly conserved leucine residue located at a domain of yet unknown function of the enzyme [p.Leu152Pro, NP_660305]. In silico analysis of the variant supported its pathogenicity. A review of the 15 previously reported patients, together with the current one, con firms a clear association between DGA...

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Effect of Bone Marrow-Derived Mesenchymal Stem Cells on Cochlear Function in an Experimental Rat Model.

Authors: Mittal R, Ocak E, Zhu A, Perdomo MM, Pena SA, Mittal J, Bohorquez J, Eshraghi AA Abstract Mesenchymal stem cell (MSC) therapy is an emerging treatment modality for various human diseases. Although induced pluripotent stem cells have been explored for the restoration of hearing, the potential of MSCs as a therapeutic strategy for various cochlear insults is not precisely known. MSCs possess anti-inflammatory, anti-apoptotic and neuroprotective properties, making them an attractive target for the treatment of inner ear disorders such as hair cell damage in response to inflammation. Most of the previous studies have used immunosuppression or the complex surgical techniques to deliver stem cells into the cochlea. However, no information is available regarding the biocompatibil...

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TGF β-1 and WNT signaling pathways collaboration associated with cochlear implantation trauma-induced fibrosis.

This study explores and highlights the collaboration between the TGF-β1 and WNT pathways in the trauma-initiated fibrotic process within the implanted cochlea. WNT signaling is involved in the development of the inner ear and therefore a potential target in hair cell regeneration therapies. However, in light of our observations from the current study, manipulation of the WNT pathway by gene therapeutic techniques in the pathological ear seems a very complex process with an increased risk of inducing excessive fibrosis thereby compromising the efficacy of implant function. This article is protected by copyright. All rights reserved. PMID: 30632705 [PubMed - as supplied by publisher] (Source: Anatomical Record)

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Bone marrow stromal cells accelerate hearing recovery via regeneration or maintenance of cochlear fibrocytes in mouse spiral ligaments.

This article is protected by copyright. All rights reserved. PMID: 30632312 [PubMed - as supplied by publisher] (Source: Anatomical Record)

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Degeneration of saccular hair cells caused by MITF gene mutation

Waardenburg syndrome (WS) is the consequence of an inherited autosomal dominant mutation which causes the early degeneration of intermediate cells of cochlear stria vascularis (SV) and profound hearing loss. P... (Source: Neural Development)

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://bit.ly/2RoXdnB

Severe infantile epileptic encephalopathy associated with D-glyceric aciduria: report of a novel case and review

We describe a male patient from a consanguineous Arab family with infantile onset of DGA, characterized by profound psychomotor retardation, progressive microcephaly, intractable seizures, cortical blindness and deafness. Consecutive brain MR imaging showed an evolving brain atrophy, thinning of the corpus callosum and diffuse abnormal white matter signals. Whole exome sequencing identified the homozygous missense variant in theGLYCTK gene [c.455  T >  C, NM_145262.3], which affected a highly conserved leucine residue located at a domain of yet unknown function of the enzyme [p.Leu152Pro, NP_660305]. In silico analysis of the variant supported its pathogenicity. A review of the 15 previously reported patients, together with the current one, con firms a clear association between DGA...

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://bit.ly/2RusNAA

Effect of Bone Marrow-Derived Mesenchymal Stem Cells on Cochlear Function in an Experimental Rat Model.

Authors: Mittal R, Ocak E, Zhu A, Perdomo MM, Pena SA, Mittal J, Bohorquez J, Eshraghi AA Abstract Mesenchymal stem cell (MSC) therapy is an emerging treatment modality for various human diseases. Although induced pluripotent stem cells have been explored for the restoration of hearing, the potential of MSCs as a therapeutic strategy for various cochlear insults is not precisely known. MSCs possess anti-inflammatory, anti-apoptotic and neuroprotective properties, making them an attractive target for the treatment of inner ear disorders such as hair cell damage in response to inflammation. Most of the previous studies have used immunosuppression or the complex surgical techniques to deliver stem cells into the cochlea. However, no information is available regarding the biocompatibil...

MedWorm Message: If you are looking to buy something in the January Sales please visit TheJanuarySales.com for a directory of all the best sales in the UK. Any income gained via affiliate links keeps MedWorm running.



from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://bit.ly/2ChypDC

TGF β-1 and WNT signaling pathways collaboration associated with cochlear implantation trauma-induced fibrosis.

This study explores and highlights the collaboration between the TGF-β1 and WNT pathways in the trauma-initiated fibrotic process within the implanted cochlea. WNT signaling is involved in the development of the inner ear and therefore a potential target in hair cell regeneration therapies. However, in light of our observations from the current study, manipulation of the WNT pathway by gene therapeutic techniques in the pathological ear seems a very complex process with an increased risk of inducing excessive fibrosis thereby compromising the efficacy of implant function. This article is protected by copyright. All rights reserved. PMID: 30632705 [PubMed - as supplied by publisher] (Source: Anatomical Record)

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://bit.ly/2RoXdE7

Bone marrow stromal cells accelerate hearing recovery via regeneration or maintenance of cochlear fibrocytes in mouse spiral ligaments.

This article is protected by copyright. All rights reserved. PMID: 30632312 [PubMed - as supplied by publisher] (Source: Anatomical Record)

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://bit.ly/2CjainX

Degeneration of saccular hair cells caused by MITF gene mutation

Waardenburg syndrome (WS) is the consequence of an inherited autosomal dominant mutation which causes the early degeneration of intermediate cells of cochlear stria vascularis (SV) and profound hearing loss. P... (Source: Neural Development)

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader http://bit.ly/2RoXdnB

Surgical site infections after parotidectomy: management and benefits of an antibiotic prophylaxis protocol.

Related Articles

Surgical site infections after parotidectomy: management and benefits of an antibiotic prophylaxis protocol.

Acta Otorhinolaryngol Ital. 2018 Dec 29;:

Authors: Meccariello G, Montevecchi F, D'Agostino G, Zeccardo E, Al-Raswashdeh MFH, De Vito A, Vicini C

Abstract
The use of perioperative prophylactic antibiotics in uncontaminated head and neck surgery is still controversial. The aim of this study was to assess the efficacy of an institutional antibiotic prophylactic protocol in preventing surgical site infection after parotidectomy. The medical charts of 448 patients who underwent parotidectomy were reviewed. Patients were divided in two groups according the use of perioperative administration of intravenous cefazolin or post-operative week course of antibiotics. Surgical site infection was registered in 29 (6.5%) cases, 16 (5.7%) within the group before the application of protocol and 13 (7.9%) within the antibiotic prophylaxis protocol group. The univariate and multivariate logistic regression analyses showed that predictors for surgical site infection were the amount of drain output ≥ 50 ml in the first post-operative 24 hours (OR: 4.86; 1.59-14.82 95% CI; p < 0.01) and history of a previous parotid acute infection (OR: 13.83; 5.31-36 95% CI; p < 0.01). The majority of post-surgical infections (82%) were treated with intravenous antibiotic therapy. The remnants were treated surgically. Perioperative antibiotic treatment is recommended for patients undergoing parotid gland surgery and intravenous antibiotics during the post-operative course are highly suggested in case of history of previous acute parotid infection and drain output ≥ 50 ml in first 24 hours.

PMID: 30632521 [PubMed - as supplied by publisher]



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Surgical site infections after parotidectomy: management and benefits of an antibiotic prophylaxis protocol.

Related Articles

Surgical site infections after parotidectomy: management and benefits of an antibiotic prophylaxis protocol.

Acta Otorhinolaryngol Ital. 2018 Dec 29;:

Authors: Meccariello G, Montevecchi F, D'Agostino G, Zeccardo E, Al-Raswashdeh MFH, De Vito A, Vicini C

Abstract
The use of perioperative prophylactic antibiotics in uncontaminated head and neck surgery is still controversial. The aim of this study was to assess the efficacy of an institutional antibiotic prophylactic protocol in preventing surgical site infection after parotidectomy. The medical charts of 448 patients who underwent parotidectomy were reviewed. Patients were divided in two groups according the use of perioperative administration of intravenous cefazolin or post-operative week course of antibiotics. Surgical site infection was registered in 29 (6.5%) cases, 16 (5.7%) within the group before the application of protocol and 13 (7.9%) within the antibiotic prophylaxis protocol group. The univariate and multivariate logistic regression analyses showed that predictors for surgical site infection were the amount of drain output ≥ 50 ml in the first post-operative 24 hours (OR: 4.86; 1.59-14.82 95% CI; p < 0.01) and history of a previous parotid acute infection (OR: 13.83; 5.31-36 95% CI; p < 0.01). The majority of post-surgical infections (82%) were treated with intravenous antibiotic therapy. The remnants were treated surgically. Perioperative antibiotic treatment is recommended for patients undergoing parotid gland surgery and intravenous antibiotics during the post-operative course are highly suggested in case of history of previous acute parotid infection and drain output ≥ 50 ml in first 24 hours.

PMID: 30632521 [PubMed - as supplied by publisher]



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Predicting locally advanced rectal cancer response to neoadjuvant therapy with 18 F-FDG PET and MRI radiomics features

Abstract

Purpose

Pathological complete response (pCR) following neoadjuvant chemoradiotherapy or radiotherapy in locally advanced rectal cancer (LARC) is reached in approximately 15–30% of cases, therefore it would be useful to assess if pretreatment of 18F-FDG PET/CT and/or MRI texture features can reliably predict response to neoadjuvant therapy in LARC.

Methods

Fifty-two patients were dichotomized as responder (pR+) or non-responder (pR-) according to their pathological tumor regression grade (TRG) as follows: 22 as pR+ (nine with TRG = 1, 13 with TRG = 2) and 30 as pR- (16 with TRG = 3, 13 with TRG = 4 and 1 with TRG = 5). First-order parameters and 21 second-order texture parameters derived from the Gray-Level Co-Occurrence matrix were extracted from semi-automatically segmented tumors on T2w MRI, ADC maps, and PET/CT acquisitions. The role of each texture feature in predicting pR+ was assessed with monoparametric and multiparametric models.

Results

In the mono-parametric approach, PET homogeneity reached the maximum AUC (0.77; sensitivity = 72.7% and specificity = 76.7%), while PET glycolytic volume and ADC dissimilarity reached the highest sensitivity (both 90.9%). In the multiparametric analysis, a logistic regression model containing six second-order texture features (five from PET and one from T2w MRI) yields the highest predictivity in distinguish between pR+ and pR- patients (AUC = 0.86; sensitivity = 86%, and specificity = 83% at the Youden index).

Conclusions

If preliminary results of this study are confirmed, pretreatment PET and MRI could be useful to personalize patient treatment, e.g., avoiding toxicity of neoadjuvant therapy in patients predicted pR-.



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Predicting locally advanced rectal cancer response to neoadjuvant therapy with 18 F-FDG PET and MRI radiomics features

Abstract

Purpose

Pathological complete response (pCR) following neoadjuvant chemoradiotherapy or radiotherapy in locally advanced rectal cancer (LARC) is reached in approximately 15–30% of cases, therefore it would be useful to assess if pretreatment of 18F-FDG PET/CT and/or MRI texture features can reliably predict response to neoadjuvant therapy in LARC.

Methods

Fifty-two patients were dichotomized as responder (pR+) or non-responder (pR-) according to their pathological tumor regression grade (TRG) as follows: 22 as pR+ (nine with TRG = 1, 13 with TRG = 2) and 30 as pR- (16 with TRG = 3, 13 with TRG = 4 and 1 with TRG = 5). First-order parameters and 21 second-order texture parameters derived from the Gray-Level Co-Occurrence matrix were extracted from semi-automatically segmented tumors on T2w MRI, ADC maps, and PET/CT acquisitions. The role of each texture feature in predicting pR+ was assessed with monoparametric and multiparametric models.

Results

In the mono-parametric approach, PET homogeneity reached the maximum AUC (0.77; sensitivity = 72.7% and specificity = 76.7%), while PET glycolytic volume and ADC dissimilarity reached the highest sensitivity (both 90.9%). In the multiparametric analysis, a logistic regression model containing six second-order texture features (five from PET and one from T2w MRI) yields the highest predictivity in distinguish between pR+ and pR- patients (AUC = 0.86; sensitivity = 86%, and specificity = 83% at the Youden index).

Conclusions

If preliminary results of this study are confirmed, pretreatment PET and MRI could be useful to personalize patient treatment, e.g., avoiding toxicity of neoadjuvant therapy in patients predicted pR-.



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The Diagnostic Performance of Ultrasonography and Computed Tomography in Differentiating Superficial from Deep Lobe Parotid Tumors

Abstract

Objectives

To validate and compare ultrasound (US) versus computed tomography (CT) criteria in the localization of superficial/deep lobe tumors of the parotid gland.

Design and Setting

This was a retrospective study of diagnostic tests performed from January 2008 to June 2017.

Participants

We included adult patients who were referred for a neck ultrasonography examination due to parotid tumors, and who subsequently underwent parotid surgery.

Main outcome measures

We assessed the location of parotid tumors, comparing the minimum fascia–tumor distance (MFTD) criterion on an US with eight CT criteria. We analyzed receiver operating characteristic (ROC) curves of the MFTD for malignant, benign, and all parotid tumors, and compared the accuracy, sensitivity, and specificity of the optimal MFTD with those of CT anatomical criteria.

Results

A total of 166 parotid tumors were included. The mean (SD) MFTD in superficial lobe tumors was significantly shorter than that of deep lobe tumors (1.2 [0.7] vs 2.8 [1.9] mm, effect size: 1.84; 95% CI, 1.27 to 2.41). The areas under the ROC curve were 0.63 for malignant tumors and 0.88 for benign tumors. The optimal MFTD cut point was 2.4 mm for the 154 benign parotid tumors and the accuracy, sensitivity, and specificity were 90%, 80% and 91%, respectively. For the 136 benign parotid tumors that underwent CT examination, three criteria had an accuracy of over 90% (FNline, tMasseter and Conn's arc), but the sensitivities were all below 50%.

Conclusions

MFTD is more feasible for benign tumors than for malignant tumors for the localization of parotid tumors. For benign parotid tumors, US is enough to guide operations.

This article is protected by copyright. All rights reserved.



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Computerised tomography in the investigation of otalgia of unknown origin; our experience in 100 patients

Abstract

Otalgia is a common presenting symptom in the specialty of ENT. In its primary form it is caused by conditions and diseases affecting the outer, middle or inner ear structures, thus giving rise to pain and discomfort around the ear itself. However, in its secondary form (referred), pain can be remote from the source and thus provide greater diagnostic challenge due to the possibility of occult disease that is not well visualised.

This article is protected by copyright. All rights reserved.



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