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Σάββατο 26 Ιανουαρίου 2019

Neural Switch Asymmetry in Feature-Based Auditory Attention Tasks

Abstract

Active listening involves dynamically switching attention between competing talkers and is essential to following conversations in everyday environments. Previous investigations in human listeners have examined the neural mechanisms that support switching auditory attention within the acoustic featural cues of pitch and auditory space. Here, we explored the cortical circuitry underlying endogenous switching of auditory attention between pitch and spatial cues necessary to discern target from masker words. Because these tasks are of unequal difficulty, we expected an asymmetry in behavioral switch costs for hard-to-easy versus easy-to-hard switches, mirroring prior evidence from vision-based cognitive task-switching paradigms. We investigated the neural correlates of this behavioral switch asymmetry and associated cognitive control operations in the present auditory paradigm. Behaviorally, we observed no switch-cost asymmetry, i.e., no performance difference for switching from the more difficult attend-pitch to the easier attend-space condition (P→S) versus switching from easy-to-hard (S→P). However, left lateral prefrontal cortex activity, correlated with improved performance, was observed during a silent gap period when listeners switched attention from P→S, relative to switching within pitch cues. No such differential activity was seen for the analogous easy-to-hard switch. We hypothesize that this neural switch asymmetry reflects proactive cognitive control mechanisms that successfully reconfigured neurally-specified task parameters and resolved competition from other such "task sets," thereby obviating the expected behavioral switch-cost asymmetry. The neural switch activity observed was generally consistent with that seen in cognitive paradigms, suggesting that established cognitive models of attention switching may be productively applied to better understand similar processes in audition.



http://bit.ly/2R90hiL

Kimura’s Disease: A Diagnostic and Therapeutic Challenge

Abstract

Kimura's disease, also known as Eosinophilic Granuloma, is a rare chronic condition seen mainly in Oriental population. It presents with subcutaneous nodules, lymphadenopathy, salivary gland hypertrophy with peripheral eosinophilia and raised serum IgE levels; rarely renal involvement may also be present. Its etiology mainly remains unknown. We present a case series of two patients. Our first case is a middle aged female which presented with a parotid swelling, mimicking a parotid neoplasm. Further investigations revealed associated intra-parotid and cervical lymphadenopathy. An excisional biopsy in the form of Superficial Parotidectomy with lymph node excision was done. Histopathological examination of the excised specimen revealed it to be a case of Kimura's disease. Our second case, a young adult, presented with a gradually increasing post-auricular swelling. Preliminary investigations in this case pointed towards Kimura's disease. Excision biopsy of the lesion was done. Histopathological studies confirmed the diagnosis for the same. Both the patients are under our regular follow up and remain disease-free at a follow up of 1 year and 8 months respectively.



http://bit.ly/2HqWP3e

An Immunohistochemical Study of HIF-1 Alpha in Oral Epithelial Dysplasia and Oral Squamous Cell Carcinoma

Abstract

To evaluate and compare the expression of HIF-1 Alpha (HIF-1α) in oral epithelial dysplasia (OED) and various grades of Oral squamous cell carcinoma (OSCC). 30 cases each of OEDand OSCC were stained with HIF-1α antibody. Quantification of HIF-1α positive cellswas carried out and the data was statistically analysed. The mean % HIF-1α labeling index (HIF-1α LI) increased significantly from mild OED (32.11%), moderate OED (55.07%), to severe OED (64.58%). There was a statistically significant increase in the expression of HIF-1α as grades of OED increased. The mean HIF-1α LI % in well differentiated OSCC was 46.3%, Moderately differentiated OSCC—76.31% and Poorly differentiated OSCC—89.9%. The mean HIF-1α LI was found to increase with increasing grades of OSCC which was statistically significant (P < 0.05). Further a comparison of mean HIF-1α LI in OED with different histologic grades of OSCC by Independent samples t test was performed. We found statistically significant difference between OED and moderately differentiated OSCC and OED and poorly differentiated OSCC (P = 0.000). Progressive increase in expression of HIF-1α was noted from OED to OSCC. It can be postulated that epithelial dysplastic lesions with increased HIF-1α expression are at greater risk of malignant transformation, suggesting that the expression of HIF-1α is an early event in oral carcinogenesis.



http://bit.ly/2S4Uq2r

To Be Cautious or Not: Tension Pneumothorax After First Tracheostomy Tube Exchange

Abstract

Tracheostomy tube change is a relatively common procedure once a tracheo-cutaneous tract matures. Regular tracheostomy tube changes prevent the formation of granulation tissue and reduce bacterial colonization (Yaremchuk and Yaremchuk in Laryngoscope 113(1):1–10, 2003). However, serious complications such as subcutaneous emphysema, loss of airway and mediastinitis, can occur if the tube exchange is performed inappropriately. We present a rare association of tension pneumothorax following a tracheostomy tube exchange in a 50-year-old patient who underwent tracheotomy 3 days back. The patient was successfully managed conservatively with chest tube and supportive care.



http://bit.ly/2RWz3R1

Evaluation of Quality of Life and Pattern of Improvement of Bronchial Asthma in Chronic Rhinosinusitis Patients Treated by Functional Endoscopic Sinus Surgery

Abstract

Chronic inflammatory disorders of the upper airways are extremely prevalent and have a major impact on public health. Sinusitis and bronchial asthma are closely interrelated diseases and sinusitis is known to influence bronchial asthma in its severity and chronicity. Causal relationships have been proposed but not yet proved. The relationship between sinusitis and asthma is academically interesting and has important diagnostic and therapeutic implications. The present study is designed to evaluate the efficacy of functional endoscopic sinus surgery done as treatment for chronic rhinosinusitis on bronchial asthma patients, in terms of quality of life and pattern of improvement. Objectives of the study were to determine whether bronchial asthma and quality of life improved after functional endoscopic sinus surgery. This was an open labelled randomised control trial, done at ENT Department of Medical College, Thiruvananthapuram. Those in Group A underwent functional endoscopic sinus surgery and group B patients were given only medicines as per standard protocol. All of them received asthma treatment depending on asthma attacks and severity and followed up at specific intervals. Quality of life status and pattern of improvement of bronchial asthma among these patients were evaluated. Patients of chronic rhinosinusitis treated by functional endoscopic sinus surgery showed significant improvement in the mean asthma symptom score, asthma medication use score, pulmonary function test results, and quality of life assessment scores. Functional endoscopic sinus surgery could be considered early in the natural course of chronic rhinosinusitis with concomitant bronchial asthma.



http://bit.ly/2FHHo58

Leiomyosarcoma of Mandible: A Diagnostic Dilemma; Case Report and Review of Literature

Abstract

Leiomyosarcoma and its pleomorphic variant are rare entities in the head and neck region. Since they usually present as slow growing, discrete firm, and non-ulcerated painless mass, they seem to be deceptively benign and are thus misdiagnosed. Histopathological and immunohistochemical studies are the ways of getting a definitive diagnosis. Till date surgery has been the primary treatment but effectiveness of radiotherapy/chemotherapy is still questionable. Here, we describe a case of leiomyosarcoma in mandible along with discussion about the ways of diagnosis, its differentiation with its pleomorphic variant and their managements.



http://bit.ly/2CxPUQ7

Complications of Paediatric Cochlear Implantation in the Population of Uttarakhand

Abstract

Cochlear implants surgery is now routinely done at this center. Complications which have been experienced in cochlear implant surgery at our center are discussed, as a detailed knowledge about the complications and their early anticipation can save an expensive device and most importantly patients morbidity. To discuss the complications of the paediatric cochlear implantation in the population of Uttarakhand. The total of 60 patients were included in this study (age group 1–5 years) who had undergone the cochlear implantation surgery between Sept. 2015 and Sept. 2016. These patients were regularly monitored and followed up for 1 year. All the surgeries were performed by same team of surgeons. Rate of minor complications is 8.33% (reversible facial nerve paresis, injury to chorda tympani nerve, local skin reaction, perilymph gussher) and major complications is 5% (implant rejection and flap necrosis). The various complications should be closely monitored by the surgeon so that these can be avoided.



http://bit.ly/2RDtXd5

Suitable Alternative for Human Cadaver Temporal Bone Dissection: Comparative Micro Ear Anatomy of Cattle, Pig and Sheep with Human

Abstract

The study was undertaken to compare the micro ear anatomy of three commonly available animal models which are expected to have similar anatomy to human and to find out suitable model among them as an alternative for human cadaver temporal bone dissection. This is an observational study of comparison of micro ear anatomy of the three animal models with human. Decapitated heads of cattle, pig and sheep were collected from slaughter houses, soft tissues along with brain were removed and preserved in commercially available formalin preservative. CT scan was taken for the three specimens and 3D reconstructions were done. Each specimen was subjected to micro dissection and the anatomical features were studied and compared with human. Among the three animal models sheep is found to be an ideal model for a beginner because of ease of exposure of bone, very thin cortical bone, and no cellularity, good exposure of all the middle ear structures and similar interrelations of middle ear structures with human. Pig may not be an ideal model because of abundant fatty soft tissues, thick periosteum very narrow space occupied by the middle ear, difficulty in accessing cellularity small fragile ossicular chain and overhanging facial nerve.



http://bit.ly/2FMC6ES

A Study on Deep Neck Space Infections

Abstract

Deep neck space infections (DNSI) are serious diseases that involve several spaces in the neck. These are commonly seen in low socioeconomic group with poor oral hygiene, and nutritional disorders. These are bacterial infections originating from the upper aerodigestive tract. The incidence of this disease was relatively high before the advent of antibiotics. Treatment of DNSI includes antibiotic therapy, airway management and surgical intervention. Management of DNSI is traditionally based on prompt surgical drainage of the abscess followed by antibiotics or nonsurgical treatment using appropriate antibiotics in the case of cellulitis. This study was conducted to investigate the age and gender, clinical symptoms, site involved, etiology, co-morbidities, bacteriology, complications and outcomes in the patients of DNSI. A prospective study of deep neck space infections was conducted during the period July 2017 to July 2018 on the patients who attended the outpatient department and were admitted as inpatient in Safdarjung hospital, New Delhi. 40 Cases with DNSI all ages and both genders were included in the study. Patients who didn't require surgical intervention to drain pus were excluded. All parameters including age, gender, co-morbidities, presentation, site, bacteriology, complications, and investigations were studied. Due to advent of antibiotics, deep neck space infections are in decreasing trend. The common age group found to be affected is in 2nd and 3rd decade in our study. Out of all deep neck space infections, submandibular space infections were common (37.5%) followed by peritonsillar infections (12.5%). Infection of deep neck space remains fairly common and challenging disease for clinicians. Prompt recognition and treatment of DNSI are essential for an improved prognosis. Odontogenic and tonsillopharyngitis are the commonest cause. Key elements for improved results are the prompt recognition and early intervention. Special attention is required to high-risk groups such as diabetics, the elderly and patients with underlying systemic diseases as the condition may progress to life-threatening complications.



http://bit.ly/2FFiwLh

Teaching Ear Examination Skill to Undergraduate Students Using Check List

Abstract

For examination of ear, proper illumination is a pre requisite. Diseases related to ear may lead to altered sense of hearing and may affect normal balance system. If students are taught to examine ear using a check list, they may perform better. To teach ear examination to undergraduate students using a check list. Total 50 undergraduate students of M.B.B.S. attending E.N.T. clinic in Chirayu Medical College and Hospital were included in the study. They were given enrolment no. 1 to 50 and were divided into two groups. Group 1, enroll. no. 1 to 25 and group 2, enroll. no. 26 to 50. Group 1 was taught using check list and the Group 2 was taught without use of checklist. Both the groups were evaluated using check list. The group B students were again taught, using check list and were again evaluated using check list. Use of check list showed that there was statistically significant improvement in learning by students using check list in group 1 students compared to group 2 students who were taught without use of check list. The group 2 students also had improvement on evaluation, after they were taught using check list. Study suggests that use of check list for ear examination skill to undergraduate students has significant role and students learn better than when taught without use of checklist. Inclusion of checklist for teaching ear examination to undergraduate students may be considered.



http://bit.ly/2FLzHKp

Early Intratympanic Methylprednisolone in Sudden SNHL: A Frequency-wise Analysis

Abstract

Sudden sensorineural hearing loss is a dire medical emergency which must be treated at the earliest to get better long term hearing results. Our study aims to determine the efficacy of intratympanic steroid (Methylprednisolone) on auditory outcomes in patients of sudden sensorineural hearing loss and study the relation between time of onset of hearing loss to start of therapy and frequency-wise recovery of hearing loss. A prospective cohort clinical study with 33 patients with sudden hearing loss of 30 dB or more were treated with the intratympanic injection of methylprednisolone and the effect of the drug was observed. In this study, 33 patients with sudden onset (unilateral or bilateral) of hearing loss were treated with intratympanic methylprednisolone. The duration at which the drug was administered and the age of the participants was taken into consideration. Main outcome measures included audiometry results at low, medium and high hearing loss frequencies. The specific frequency at which the hearing improvement took place was tabulated. It was observed that hearing improved significantly if the steroid is injected within the first 4 days of onset (p < 0.05) at all the frequencies. A gain of 15 dB or more was achieved in more than 78% patients after injecting methylprednisolone intratympanically. A statistically significant association was found between recovery rate and frequency of hearing loss with patients showing greater improvement at low hearing loss frequency in comparison to mid and high frequencies (p < 0.05). The drug efficacy does not change with the age of the patient.



http://bit.ly/2RVKxnH

Reconstructive Ladder for Transoral Resections of Oropharyngeal Cancers

Abstract

Purpose of Review

Transoral robotic surgery (TORS) now offers extended reach and capability to the head and neck oncologic surgeon, but in doing so, provides a reconstructive dilemma. The objective of this manuscript is to discuss the most recent advances and options available after resection with TORS.

Recent Findings

The latest research provides a common framework for surgeons to classify the type of oropharyngeal defect. A variety of reconstructive options described include secondary intent, modifications to existing local and regional flaps, and advances utilizing robotic assistance in free flap reconstruction.

Summary

There exists a multitude of reconstructive options with appropriate considerations for a stepwise approach based on patient-specific factors, surgeon capability, and the extent of the oropharyngeal defect. Just as robotic resection extends the capability in extirpation, it is now being used to refine free flap inset in the appropriate case.



http://bit.ly/2G0G0tU

Technical Challenges in Temporal Bone Paraganglioma Surgery: a Clinical Review

Abstract

Purpose of the Review

Temporal bone paragangliomas have always presented the otologist with their ultimate challenge. Surgical management is difficult, dangerous and demanding. It is also often associated with increased cranial nerve deficits and decreased quality of life for the patient. Management protocols for patients with temporal bone paragangliomas are changing as a result of advances in knowledge and technical developments. Multi-disciplinary care is now recommended for most patients with surgical intervention becoming restricted for the most difficult tumours.

Recent Findings

Previously considered unresponsive or resistant to radiotherapy, recent experiences using stereotactic radiosurgery techniques suggest that this is not correct. Tumour growth can be halted in some and slowed down in others. Advances in molecular medicine have defined a number of paraganglioma predisposition syndromes. Recognition of these syndromes is essential. Paragangliomas are now considered to be pioneer models of genetic-based personalised medical care.

Summary

This review aims to define the best current management plan for paragangliomas arising in, or involving, the temporal bone. It alerts surgeons to critical phases of surgical technique.



http://bit.ly/2FRV7Xj

Consumer Technology for Sleep-Disordered Breathing: a Review of the Landscape

Abstract

Purpose of Review

The consumer market for devices that quantify sleep is quickly evolving. We conducted a review of the consumer technology available for sleep disorders, including its potential and limitations to screen obstructive sleep apnea (OSA).

Recent Findings

There are many commercial devices claiming to objectively measure sleep, but only a few are tested rigorously in research. We critically review the technology available, including its overall ability to provide objective measures of sleep (total sleep time (TST), sleep efficiency (SE), sleep latency (SL), wake after sleep onset (WASO)), and to estimate apnea-hypopnea indexes in OSA patients.

Summary

Although consumer devices performed similarly to standard actigraphy, they still overestimated TST and SE, and underestimated WASO and SL. Biomotion sensors and mattress-based devices showed potential for use as an OSA screening tool. However, research in the sleep-disordered breathing (SDB) population is limited, needs further external validation, and should be implemented in the course of multiple days.



http://bit.ly/2G2Pdle

Drug-Induced Sleep Endoscopy as a Tool for Surgical Planning

Abstract

Purpose of Review

To review whether drug-induced sleep endoscopy (DISE) aids in obstructive sleep apnea surgical planning, if it changes the initial proposal, and if so, does it contribute to increased surgical success or unnecessary morbidity?

Recent Findings

A DISE and surgical outcomes multicenter cohort study (n = 275) reported no association for surgical outcomes with velopharyngeal and epiglottic collapse. Oropharyngeal and tongue base collapse on the other hand were associated with lower odds of surgical response.

Summary

DISE changes surgical planning mainly in regard to the approach of the tongue base and epiglottis, as these structures usually do not collapse in the awake state. The decision of velopharyngeal surgery usually does not change, as the vast majority demonstrate velopharyngeal collapse in DISE. Whether DISE increases or not, surgical success is controversial, with conflicting published data. However, poorer surgical outcomes have been associated with velopharyngeal concentric, oropharyngeal lateral wall, and tongue base collapse.



http://bit.ly/2FP5RFP

Clinical Outcomes in OSA—SLEEP GOAL—a More Holistic Approach

Abstract

Purpose of Review

Obstructive sleep apnea (OSA) is a systemic disease that is due to a narrow upper airway that collapses and obstructs during sleep, which results in frequent nocturnal hypoxemia, sympathetic overdrive, tachycardia, nocturnal hypertension, and oxidative metabolic stress. Symptoms include unrefreshed sleep, daytime tiredness, loss of memory, irritability, lack of concentration, poor work productivity, poor quality of life (QOL), mood swings, and even depression. This upper airway disorder can lead to systemic diseases such as hypertension, cardiovascular events, myocardial infarct, and fatal arrhythmias.

Recent Findings

The standard diagnostic test for OSA is commonly assumed to be the overnight polysomnography (PSG); however, it is widely known that there is discordance between the levels of AHI (apnea–hypopnea index) used to denote outcomes/success of therapy and real-world clinical outcomes such as QOL, patient perception of disease, cardiovascular measures, and/or survival.

Summary

Hence, the use of a single parameter AHI is inadequate and unrealistic; sleep specialists need more holistic and less biased parameters to assess treatment outcomes. Some of these parameters include snoring level, sleep satency, execution time, Epworth Sleepiness Scale, blood pressure, gross weight (BMI), oxygen duration below 90%, AHI, and QOL scores.



http://bit.ly/2G3jRv1

Frictional Keratosis, Contact Keratosis and Smokeless Tobacco Keratosis: Features of Reactive White Lesions of the Oral Mucosa

Abstract

White lesions of the oral cavity are quite common and can have a variety of etiologies, both benign and malignant. Although the vast majority of publications focus on leukoplakia and other potentially malignant lesions, most oral lesions that appear white are benign. This review will focus exclusively on reactive white oral lesions. Included in the discussion are frictional keratoses, irritant contact stomatitis, and smokeless tobacco keratoses. Leukoedema and hereditary genodermatoses that may enter in the clinical differential diagnoses of frictional keratoses including white sponge nevus and hereditary benign intraepithelial dyskeratosis will be reviewed. Many products can result in contact stomatitis. Dentrifice-related stomatitis, contact reactions to amalgam and cinnamon can cause keratotic lesions. Each of these lesions have microscopic findings that can assist in patient management.



http://bit.ly/2U9yVL4

A Rare Presentation of Inflammatory Myofibroblastic Tumor in the Nasolabial Fold

Inflammatory myofibroblastic tumor (IMT) is a benign lesion that occurs most frequently in the soft tissues and viscera. In the head and neck region, the tumor has been reported to occur in the orbit, tongue, nasopharynx, larynx, and paranasal sinuses and the central nervous system. Despite being a benign lesion, it exhibits infiltrative and destructive behaviours, making histopathological examination necessary to confirm the diagnosis. We report the case of a 38-year-old female presented with a right nasolabial fold mass, which was confirmed histologically to be an IMT. Surgical excision of the mass was achieved through a sublabial approach with an uneventful postoperative period. To the best of our knowledge, this is the first reported case of an IMT in the nasolabial fold.

http://bit.ly/2AX43X8

A Case of Respiratory Epithelial Adenomatoid Hamartoma (REAH) in a Patient with History of Radiation Exposure

Respiratory epithelial adenomatoid hamartomas (REAHs) are becoming a more commonly recognized otolaryngologic tumor and are often misdiagnosed as inverted papilloma. Here, we present such a case in a patient with history of previous radiation exposure. Otolaryngologists and pathologists should be aware of the mucinous histological appearance of REAH to help differentiate from other growths. Given our patient's history, an association between REAH and previous radiation exposure is worth consideration.

http://bit.ly/2Dppt0Y

VideoEndocrinology™ New Open Access Video

Parapharyngeal Dissection for Papillary Thyroid Cancer
Justin Tran, Mark Zafereo 

The post VideoEndocrinology™ New Open Access Video appeared first on American Thyroid Association.



http://bit.ly/2T4XFEg

Effects of continuous and intermittent parathyroid hormone administration on midpalatal suture expansion in rats

Publication date: Available online 25 January 2019

Source: Archives of Oral Biology

Author(s): Jianru Yi, Li Mei, Xue Li, Wei Zheng, Yu Li, Zhihe Zhao

Abstracts
Objectives

The aim of this study was to investigate the effects of continuous parathyroid hormone (cPTH) and intermittent parathyroid hormone (iPTH) on bone formation and bone resorption in midpalatal suture during maxillary expansion.

Methods

Forty-eight male SD rats were randomly divided into four groups (n = 12 each), including the control, the expansion (E), the E + cPTH, and the E + iPTH. A thermosensitive controlled-release hydrogel was synthesized for cPTH administration. All animals were sacrificed after seven days. Microcomputed tomography, histochemical staining and real-time PCR were used to investigate the bone remodeling of midpalatal suture. Serum chemistry was adopted to evaluate the systemic condition of experimental animals.

Results

The suture width was increased by the expansion, and further elevated by cPTH and iPTH administration. Both regimes improved bone volume fraction and trabecular thickness of suture bone region. Moreover, both cPTH and iPTH decreased SOST expression and enhanced the expression of β-catenin and Col-I. cPTH increased RANKL expression, inhibited OPG expression, and resulted in an increment of osteoclasts, while iPTH had no influence on osteoclastogenesis. The serum calcium concentration was enhanced by PTH administration.

Conclusion

Both cPTH and iPTH promote midpalatal suture expansion by enhancing bone formation, probably via SOST downregulation and the resulting β-catenin activation. Our results demonstrated that PTH administration may have potential to be an adjunctive approach for maxillary expansion treatment.



http://bit.ly/2ROJAOX

Corrigendum to “Long-term survival and late toxicities of elderly nasopharyngeal carcinoma (NPC) patients treated by high-total- and fractionated-dose simultaneous modulated accelerated radiotherapy with or without chemotherapy” [Oral Oncol. 89 (2019) 40–47]

Publication date: Available online 26 January 2019

Source: Oral Oncology

Author(s): Jingjing Miao, Lin Wang, Manyi Zhu, Weiwei Xiao, Haijun Wu, Muping Di, Yuqing Huang, Shaomin Huang, Fei Han, Xiaowu Deng, Xiang Guo, Chong Zhao



http://bit.ly/2RecqTv

Reprint of Long-term survival and late toxicities of elderly nasopharyngeal carcinoma (NPC) patients treated by high-total- and fractionated-dose simultaneous modulated accelerated radiotherapy with or without chemotherapy

Publication date: Available online 25 January 2019

Source: Oral Oncology

Author(s): Jingjing Miao, Lin Wang, Manyi Zhu, Weiwei Xiao, Haijun Wu, Muping Di, Yuqing Huang, Shaomin Huang, Fei Han, Xiaowu Deng, Xiang Guo, Chong Zhao

Abstract
Background

To analyse the survival and late toxicities of elderly nasopharyngeal carcinoma (NPC) patients treated by intensity-modulated radiotherapy (IMRT) with the high-total- and fractionated-dose simultaneous modulated accelerated radiation therapy (SMART) boost technique and to identify the effect of concurrent chemotherapy for these patients.

Methods

Two hundred and fifty-four elderly patients (age ≥ 60.0) with newly diagnosed non-metastatic NPC were retrospectively analysed. Statistical analyses were performed using the SPSS software program.

Results

The actual mean total and fractionated doses delivered to the gross tumour volume of the nasopharynx (GTVnx) were 74.55 Gy and 2.49 Gy, respectively. The 5-year locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), disease-specific survival (DSS) and overall survival (OS) of the whole cohort were 93.0%, 85.7%, 83.2% and 74.1%, respectively. No grade 4 acute or late radiotherapy-induced toxicities were observed. Of 247 patients with stage II–IVb disease, 89 patients received radiotherapy (RT) alone, and 158 patients received concurrent chemoradiotherapy (CCRT), and the 5-year LRRFS, DMFS, DSS and OS of the RT-alone group vs. the CCRT group were 94.0% vs. 92.2%, 83.5% vs. 86.2%, 81.8% vs. 83.1% and 74.0% vs. 72.8% (all P > 0.05), respectively. Multivariate analyses showed that CCRT was not an independent predictor for LRRFS, DMFS, DSS and OS (all P > 0.05).

Conclusion

High-total- and fractionated-dose SMART boost IMRT could obtain a satisfactory long-term outcome with mild late toxicity in elderly NPC patients. The role of CCRT needs to be further studied to optimize the treatment strategy and improve the overall survival.



http://bit.ly/2Wt5lT4

Health-related quality of life in patients with cleft palate: reproducibility, responsiveness and construct validity of the Dutch version of the VELO questionnaire

Publication date: Available online 26 January 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Laura Bruneel, Cassandra Alighieri, Sofie De Smet, Kim Bettens, Marc De Bodt, Kristiane Van Lierde

Abstract
Objectives

Recently, the Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) questionnaire, which evaluates the impact of speech and swallowing difficulties on health-related quality of life (HRQoL) in patients with VPI (Skirko et al., 2012), was translated to Dutch (Bruneel et al., 2017). The purpose of this study was to evaluate the reproducibility, responsiveness and construct validity of this Dutch version of the questionnaire.

Methods

To evaluate the reproducibility, 50 parents and 14 children with cleft palate re-completed the questionnaire after two weeks. Thirty-five parents and 8 children with cleft palate completed the VELO questionnaire after one year for the evaluation of the responsiveness. The correlation between age and the VELO questionnaire (construct validity), and the internal consistency (Cronbach's α) were re-determined based on the responses of 73 parents and 24 children.

Results

Based on descriptive statistics, results of the Wilcoxon signed rank-test, and the absolute (SEM) and relative (ICC) consistency, the questionnaire showed good reproducibility. VELO scores did not significantly differ after one year, neither when performing separate analyses for the intervention (speech therapy) and the non-intervention group. Correlations indicated higher HRQoL, as perceived by the parents, with increasing age. The reverse was the case for the report. Cronbach's α showed excellent internal consistency for both reports.

Conclusions

The VELO questionnaire showed good reproducibility and internal consistency. Moreover, results reconfirmed the age effect on VELO scores. To understand the implications of the results regarding the questionnaire's responsiveness, future research should focus on the identification of factors influencing the patient's evolution in HRQoL.



http://bit.ly/2Rhmdbq

Complete Polysomnographic Parameters In Infants With Severe Laryngomalacia Prior To And After Supraglottoplasty. A Pilot Study

Publication date: Available online 26 January 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Cortes María Cristina, Villamor Perla, González C. de la Torre, Álvarez-Neri Hiram

Abstract
Introduction

Laryngomalacia is the most common congenital laryngeal anomaly. Because of supraglottic prolapse, laryngomalacia may be associated with obstructive sleep apnea (OSA) and sleep disturbances. The effects of OSA and sleep disorders in children include failure to thrive, cognitive and behavioral disturbances, cardiovascular compromise, and an association with sudden infant death syndrome.

Objective

To evaluate the presence of OSA and sleep disturbances in children with severe laryngomalacia through complete nocturnal polysomnography, as well as to establish the effects of supraglottoplasty in each of the polysomnographic parameters.

Results

Nine infants with severe laryngomalacia were included, all with a complete polysomnographic study prior to and after supraglottoplasty. The average age was 5.5 months. All patients presented an Apnea-Hypopnea Index (AHI) within the range of severe OSA. After supraglottoplasty, a significant reduction in AHI was found, from 34.87±20.34 to 9.44±5.28 after surgery (p: 0.022). Additionally, sleep efficiency had a significant increase, from 21.4% to 56.29% of total sleep time (p: 0.0013). All patients presented a significant decrease in obstructive apnea episodes (p <0.0001), as well as in hypopnea episodes (p: 0.0154). The mean and minimum peripheral oxygen saturation (SpO2) had a significant increase after supraglottoplasty from 88.2% to 94.09% (p: 0.0002), and from 81.01% to 89.33% (p <0.0001), respectively.

Conclusion

Polysomnography (PSG) may provide better surgical sustenance in infants with severe laryngomalacia and OSA, as well as, serving as a monitoring tool of success. However, the surgical decision should not be reduced to polysomnographic results, and a good history and examination remain as the fundamental criteria.



http://bit.ly/2WnR7D1

Simulation-based education to improve emergency management skills in caregivers of tracheostomy patients

Publication date: Available online 25 January 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Kara Prickett, Anita Deshpande, Heather Paschal, Dawn Simon, Kiran B. Hebbar

Abstract
Introduction

Children with tracheostomies are medically complex and may be discharged with limited and variably trained home nursing support. When faced with emergencies at home, caregivers must often take the lead role in management, and many lack experience with troubleshooting these emergencies prior to initial discharge.

Methods

A high-fidelity simulation-based tracheostomy education program was designed using a programmable mannequin (Gaumard HAL S3004 one-year-old pediatric simulator). At the conclusion of our standard education program, caregivers completed three simulation scenarios: desaturation, mucus plugging, and dislodgement. A trained simulation facilitator graded performance. A self-assessment tool was used to analyze comfort with emergency management at the beginning of training, before and after simulation. Caregivers rated confidence using a 10 cm visual analog scale. All participants completed a post-simulation debriefing session.

Results

39 caregivers completed all three scenarios and returned pre- and post-simulation self-assessments. Mean scores from the caregiver self-assessments increased for all three scenarios, with mean increases of 9.0 mm for desaturation, 16 mm for mucus plugging, and 10 mm for decannulation. Two patterns of responses emerged: caregivers with progressive increase in confidence through training, and caregivers who initially rated confidence highly, and had confidence decrease as the complexity of true emergency management became apparent. All participants found the simulations to be realistic and helpful.

Discussion

High-fidelity simulation training allows for realistic exposure to trach-related emergencies. Many caregivers overestimate their ability to handle emergencies and gain important insight through simulation.

Implications for Practice

Identification of skills and knowledge gaps prior to discharge allows for targeted re-education in emergency management.



http://bit.ly/2RebXkd

An update of spectrum and frequency of GJB2 mutations causing hearing loss in the south of Iran: A literature review

Publication date: Available online 25 January 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Mahbobeh koohiyan, Amirhossein Ahmadi, Farideh koohian, Shahrzad Aghaei, Beheshteh Amiri, Morteza Hashemzadeh-Chaleshtori

Abstract
Objective

Mutations in the GJB2 gene are a major cause of autosomal recessive non-syndromic HL (ARNSHL) in many populations. Previous studies have estimated the average frequency of GJB2 mutations to be between 16-18% in Iran, but would vary among different ethnic groups. Here, we have taken together and reviewed results from our three previous publications and data from search other published mutation reports to provide a comprehensive collection of data for GJB2 mutations and HL in the south of Iran.

Methods

In all, 447 unrelated families were included and analyzed for the prevalence and type of the GJB2 gene mutations.

Results

Totally, the frequency of GJB2 mutations was found to be 11.5% in the southern provinces studied which is significantly lower than that identified in Northern populations of Iran, and also a southwest to southeast Iranian gradient in the frequency of GJB2 mutations is suggested.

Conclusions

This study highlights the importance of establishing prevalence, based on the local population for screening and diagnostic programs of live births in Iran.



http://bit.ly/2WiS2UZ

Audiometric Findings in Children with Unilateral Enlarged Vestibular Aqueduct

Publication date: Available online 25 January 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Robert J. Macielak, Jameson K. Mattingly, Ursula M. Findlen, Aaron C. Moberly, Prashant S. Malhotra, Oliver F. Adunka

Abstract
Objective

To evaluate the prevalence of bilateral hearing loss in children with unilateral enlarged vestibular aqueduct (EVA) at a single institution.

Methods

A retrospective case review was performed at a tertiary care pediatric referral center involving children with radiologic findings of unilateral EVA and normal labyrinthine anatomy of the contralateral ear diagnosed via CT and/or MRI. The main outcome measure of interest is the number of patients with unilateral EVA who were diagnosed with bilateral hearing loss.

Results

Sixty-one pediatric patients were identified. The mean audiometric follow-up was 48.2 months (0-150). Three (4.9%) patients with unilateral EVA were noted to have bilateral hearing loss, and this rate was not significantly different (p=1.0) from the rate reported in a comparison group of patients with contralateral hearing loss (6.0%) without an EVA. The pure-tone average (defined as the average dB HL at 500, 1000, 2000, and 4000 Hz) in the group with bilateral hearing loss was 31.3 dB HL in the better hearing ear and 79.6 dB HL in the worse hearing ear, with the difference being statistically significant (p=0.02). In the unilateral EVA patients without contralateral hearing loss (n=56, 91.8%), the PTA was 9.4 dB HL in the better hearing ear and 51.9 dB HL in the worse hearing ear, with the difference being statistically significant (p<0.001). Two patients (3.3%) with unilateral EVA were found to have hearing within normal limits bilaterally. The EVA was ipsilateral to the worse hearing ear in all cases.

Conclusion

The prevalence of bilateral hearing loss in children with unilateral EVA appears to be low. Specifically, it may be no different than the rate of contralateral hearing loss in children with unilateral hearing loss without an EVA. The present report is somewhat different than the previously described prevalence in the literature. This difference could be related to the imaging type and diagnostic criteria used, the patients included, the source of the identified patents, and the overall population of patients studied.



http://bit.ly/2ReleIZ

Are pediatricians and otolaryngologists well prepared to identify early signs of vertical facial growth?

Publication date: Available online 25 January 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Christian Calvo-Henríquez, Silvia Martins-Neves, Ana Faraldo-García, Alberto Ruano-Ravina, Sofía Rocha, Miguel Mayo-Yáñez, Gabriel Martinez-Capoccioni

Abstract
BACKGROUND

The prevalence of vertical facial growth is very high in the developed world. Most authors agree that mouth breathing is its main cause. Even though care is mainly conducted by odontologists, the professionals who first see these patients are pediatricians and otolaryngologists. The objective of this study is to analyze the ability of pediatricians and otolaryngologists to identify early signs of vertical facial growth among children.

METHODS

60 participant aged 4.1-13.7 years were analyzed subjectively by 9 otolaryngologists, 9 pediatricians and two specialists in dentofacial orthopedics. They were also assessed objectively with cephalometric analysis.

RESULTS

Otolaryngologists showed 34.78% sensitivity, 92.86% specificity and 48.33% efficiency. Pediatricians showed 13.04% sensitivity, 100% specificity and 33.33% efficiency. Using a linear regression model compared against the objective measurements we found a weak positive correlation both for otolaryngologists and pediatricians.

CONCLUSION

The sensitivity was very low for both groups. We believe it is of paramount importance to increase the awareness and the ability of otolaryngologists and pediatricians to recognize signs of disrupt facial growth.



http://bit.ly/2Wt5hCO

The role of unilateral nasal inspiratory peak flow in nasal obstruction‐ a study of seventy patients undergoing septorhinoplasty surgery

Abstract

Nasal Inspiratory Peak Flow (NIPF) poorly correlates with subjective patient reported outcomes (PROMs) following functional septorhinoplasty.

The aim of this study is to determine whether unilateral NIPF correlates with PROMs.

The study demonstrates significant improvement in objective and subjective measurements post septorhinoplasty surgery in seventy patients.

There was weak correlation between improvements in bilateral NIPF when compared with changes in the NOSE score.

Whilst unilateral NIPF does not correlate with subjective outcome scores, it is still a useful measure in assessing nasal patency and in patient education.

This article is protected by copyright. All rights reserved.



http://bit.ly/2DzijY3

Association study of cell cycle proteins and human papillomavirus in laryngeal cancer in Chinese Population

Abstract

Objective

To investigate the role of human papillomavirus (HPV) in laryngeal squamous cell carcinoma (LSCC) and analyze the relationship between HPV and the expression of cell cycle‐related proteins.

Design

The study consisted of LSCC between 2005 and 2011 in Tongren Hospital. Clinical data such as age, sex, smoking/ alcohol consumption and TNM stage were collected. HPV DNA and cell cycle‐related proteins were assessed in terms of clinical features.

Setting

Single center study.

Participants

A total of 332 LSCC patients were included in the study.

Main outcome measures

The presence of genotype‐specific HPV DNA was evaluated using PCR‐RDB in formalin‐fixed paraffin‐embedded tissues. All samples were also evaluated for p16INK4A, p21WAF1/CIP1, P53, Cyclin D1, and Ki67 immunohistochemical staining by tissue microarray.

Results

HPV DNA was detected in 45 of 332 (13.55%) patients with LSCC, with HPV‐16 being the predominant genotype. The presence of HPV‐16 DNA was significantly associated with basaloid squamous cell carcinoma and cystic lymph node metastasis (P < 0.05). Of the 332 patients 36 (10.84%) were scored as p16INK4A positivity, and they were more likely to be female (P < 0.05). Cyclin D1‐positivity and p21WAF1/CIP1‐positivity were observed in 60.24% (200/332)and 40.66%(135/332), respectively. In 114 cases (34.33%), LSCCs had moderate‐ to ‐strong p53 accumulation, which was correlated with TNM stage (P < 0.05). HPV‐16 DNA was correlated with p16INK4A, and manifested a higher Ki‐67 labeling index and p21WAF1/CIP1 expression than HPV‐16‐negative tumors (P < 0.05). No relationship was observed between Cyclin D1or P53 expression and HPV‐16 infection (P > 0.05).

Conclusion

HPV DNA was detected in 13.55% patients with LSCC, with HPV‐16 being the predominant genotype and it was correlated with p16INK4A, and manifested a higher Ki‐67 labeling index and p21WAF1/CIP1 expression than HPV‐16‐negative tumors.

This article is protected by copyright. All rights reserved.



http://bit.ly/2UiMSqa

The infraorbital artery: From descriptive anatomy to mucosal perforator flap design

Abstract

Background

The terminal and perforating branches of the infraorbital artery (IOA) are poorly described. Its anatomical situation and mucosal component could provide an interesting donor site for mucosal reconstruction. The aims of the following study were to establish an anatomical description and to assess the feasibility of mucosal perforator flaps for eyelid and nasal reconstruction.

Methods

Twenty‐three fresh cadaver hemifaces were studied in order to perform an IOA anatomical classification by recording the artery's characteristics, its course, number, type, and diameter of terminal branches. We also examined the feasibility of local flaps for facial reconstruction.

Results

We highlighted five different types of courses. All cadavers had at least one superior vestibular branch with a caliber of ≥0.4 mm. A pedicled flap arising from the vestibular branch was raised in all dissections.

Conclusion

The vestibular perforator flap based on the IOA seems to be a reliable flap in reconstruction of mucosal defects.



http://bit.ly/2TftjiB

Tumor implantation following percutaneous endoscopic gastrostomy insertion for head and neck and oesophageal cancer: Review of the literature

Abstract

Background

Because of publication bias, there is uncertainty about the true incidence of tumor seeding or implantation in patients with head and neck or oesophageal cancer undergoing percutaneous endoscopic gastrostomy (PEG) insertion.

Methods

In order to obtain a more reliable estimate of risk, a systematic review was undertaken. Randomized or non‐randomized studies and case reports were identified by electronic searching. A risk of bias assessment was carried out for each study.

Results

Ninety‐eight cases from 74 published case reports and 1 unpublished case were identified. Synchronous distant metastases were present in 37%. Analysis of case series (6192 patients) considered to carry a moderate risk of bias suggests an incidence of seeding after PEG insertion of 0.32%. Studies carrying a lower risk of bias indicate a risk of seeding closer to 1 in 2000.

Conclusion

The true risk of seeding after PEG insertion is probably less than 1 in 1000.



http://bit.ly/2B5fVqh

Detection of laryngeal carcinoma in the U.S. elderly population with gastroesophageal reflux disease

Abstract

Background

An association is suggested between gastroesophageal reflux disease (GERD) or laryngopharyngeal reflux (LPR) and malignancy of the larynx in elderly patients in the United States. Early detection with flexible fiberoptic laryngoscopy (FFL) or CT remains poorly defined.

Methods

The Surveillance, Epidemiology, and End Results (SEER)‐Medicare linked database was queried from 2003 to 2011.A case‐cohort design evaluated patients aged 66 and older with a diagnosis of GERD and/or LPR for the occurrence of FFL or CT within 6 months of the exposure diagnosis.

Results

Of a total 156 426 Medicare beneficiaries, the relative risk of early cancer diagnosis with FFL was 14.61(95% confidence interval [CI], 13.59‐15.70), corresponding to a number needed to detect (NND) a case of cancer of 13(95% CI, 13‐14). The relative risk of an early cancer diagnosis with CT was 31.83 (95% CI, 29.57‐34.26), with a NND of 5 (95% CI, 5‐5).

Conclusions

Early FFL and CT are associated with a higher likelihood of laryngeal cancer diagnosis in elderly individuals with a diagnosis of reflux. Screening trials are necessary to establish this relationship.



http://bit.ly/2ROBeqz

Clinical Trials News

Mon Jan 07, 2019 00:00
Clinical Trials Survey
Would you like to help improve the clinical research experience for patients? We are interested in your opinion about reporting your symptoms for clinical trials. Please click the link below to complete this short, 5-minute survey. Your anonymous responses will be used for research purposes to better understand how to improve patient care. Complete the survey and provide your email address to be entered to win a $100 Visa gift card! Thank you for taking the time to provide your opinion.
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Thu Jan 24, 2019 17:33
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Thu Jan 24, 2019 16:05
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Thu Jan 24, 2019 14:30
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Thu Jan 24, 2019 13:59
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Thu Jan 24, 2019 13:17
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Thu Jan 24, 2019 11:20
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PBR - Clinical Trials News
Thu Jan 24, 2019 13:17
ChemoCentryx Announces Withdrawal of Phase II-Based Conditional Marketing Authorisation (CMA) Application for ANCA-Associated Vasculitis in Europe, Phase III Advocate Trial Data Release Planned for Q4 2019
ZURICH & MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Regulatory News: ChemoCentryx, Inc. and Vifor Fresenius Medical Care Renal Pharma Ltd., a company of Vifor Pharma Group, today announced that in light of the upcoming availability of data from the pivotal Phase III ADVOCATE trial – the largest controlled trial in active anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis) – they have decided to withdraw the application for Conditional Marketing Authorisation (CM
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 08:00
Gossamer Bio Announces Commencement of Initial Public Offering
SAN DIEGO--(BUSINESS WIRE)--Gossamer Bio, Inc., a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") in connection with the commencement of a proposed initial public offering of its common stock. Gossamer Bio is offering 14,375,000 sha
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 00:24
Advaxis' Phase 3 AIM2CERV Study Placed on Partial Clinical Hold by FDA Related to CMC Requests
PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced receipt of notification from the U.S. Food and Drug Administration (FDA) that the Company's ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) has been placed on partial clinical
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 23:05
Ironwood Pharmaceuticals Initiates Phase 1 Trial of IW-6463, the First CNS-penetrant sGC Stimulator to Enter Clinical Trials
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) today announced the initiation of a Phase 1 study evaluating IW-6463 in healthy volunteers. IW-6463 is an orally administered central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator that is being developed for the treatment of serious and orphan CNS disorders. Data from the Phase 1 study are expected in the second half of 2019. "The initiation of this Phase 1 study with IW-6463 marks an im
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Wed Jan 23, 2019 23:01
Vedanta Biosciences Announces Publication in Nature of Seminal Research Revealing A New Mechanism of Human Microbiota-Driven Antitumor Immunity Involving Induction of IFNy+ CD8+ T Cell Accumulation in the Gut and Tumors
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences announced a publication in Nature that revealed a newly discovered mechanism underlying antitumor immunity.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 20:07
Modulated Imaging Raises $7M in Series B Funding
IRVINE, Calif.--(BUSINESS WIRE)--Modulated Imaging has raised $7 million in Series B funding to fund the commercialization of its Clarifi technology and clinical studies.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 19:30
Vascular Dynamics Names Prof. Martin Rothman Chief Medical Officer
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--World-renowned interventional cardiologist Martin Rothman has been named chief medical officer at VDI.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 19:05
Redx gets regulatory nod to restart RXC004 clinical trial
An oral porcupine inhibitor, RXC004 has been designed to target the Wnt signaling pathway. The early-stage trial of the small molecule drug was temporarily stopped in March 2018 The post Redx gets regulatory nod to restart RXC004 clinical trial appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 17:43
U.S. Patent Office Issues CEL-SCI Two Patents for Its LEAPS Vaccine Platform Technology
VIENNA, Va.--(BUSINESS WIRE)--U.S. patent office issues CEL-SCI two patents for its LEAPS vaccine platform technology.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 16:20
Medidata Joins the World Economic Forum
NEW YORK--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/MDSO?src=hash" target="_blank"gt;#MDSOlt;/agt;--Medidata (NASDAQ:MDSO) today announced that it has entered into a three-year strategic collaboration with the World Economic Forum. The company becomes a Partner Member Associate and will participate in the WEF System Initiative focused on Shaping the Future of Health and Healthcare. The initiative has a goal of transforming the continuum of care – from prevention to diagnosis, treatment,...
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 15:30
Ferring Pharmaceuticals appoints Sophie Opdyke to lead its new U.S. oncology division
PARSIPPANY, N.J.--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/Ferring?src=hash" target="_blank"gt;#Ferringlt;/agt;--Sophie Opdyke, Pharm.D., MBA, will be responsible for building the Ferring Pharmaceuticals (U.S.) oncology division
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 15:25
InGeneron Expands Development Pipeline with Two Osteoarthritis Programs
HOUSTON--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/backpain?src=hash" target="_blank"gt;#backpainlt;/agt;--InGeneron expands development pipeline with two studies for chronic backpain and wrist osteoarthritis, setting focus on orthopedic indications.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 15:00
BridgeBio Pharma Closes $299.2 Million Financing Round to Support Its Efforts to Target Genetic Disease at the Source
PALO ALTO, Calif.--(BUSINESS WIRE)--BridgeBio Pharma, a clinical-stage biopharmaceutical company focused on genetic diseases, today announced a new financing round of $299.2 million. The round was co-led by existing investors KKR and Viking Global Investors. Other existing investors participating included Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital, and Hercules Capital; and they were joined by new investors Sequoia Capital, and a blue-chip long-term investor. The financing wil
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Wed Jan 23, 2019 15:00
Talee Bio Announces $4.5 Million Award from the Cystic Fibrosis Foundation to Advance Development of Two Gene Therapy Product Candidates
PHILADELPHIA--(BUSINESS WIRE)--Talee Bio, Inc., a development stage biopharmaceutical company focused on developing gene therapy treatments for cystic fibrosis, today announced agreements with the Cystic Fibrosis Foundation (CF Foundation) to fund the preclinical development of two mutation-agnostic gene therapy product candidates, TL-101 and TL-102. The CF Foundation committed up to $4.5 million to expedite the development of both product candidates for all people with cystic fibrosis, and par
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Wed Jan 23, 2019 14:00
Sage Therapeutics Appoints Elizabeth Barrett and George Golumbeski to Board of Directors
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the addition of Elizabeth (Liz) Barrett and George Golumbeski, Ph.D., to the company's board of directors. "We are extremely pleased to add these two experienced executives to Sage's board of directors. As Sage continues to advance its programs in development, adding an executive
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 14:00
Triumvira Announces Build out of Senior Management Team with Addition of Industry-Experienced Professionals in R&D and Business Development
AUSTIN, Texas & HAMILTON, Ontario--(BUSINESS WIRE)--Triumvira appoints Andreas Bader as Senior Vice President of Research & Development and Joshua Carle as Vice President of Business Development.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 14:00
New Study Shows Supplementation with Nicotinamide Riboside (NR) During Breastfeeding Yields Measurable, Lasting Benefits to Mothers and Offspring in Animal Model
LOS ANGELES--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/Breastfeeding?src=hash" target="_blank"gt;#Breastfeedinglt;/agt;--Supplementation with unique B3 vitamin nicotinamide riboside confers significant and enduring physiological benefits to mouse mothers and offspring.
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Wed Jan 23, 2019 13:30
Idiopathic Pulmonary Fibrosis Report - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019-2021 - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Idiopathic Pulmonary Fibrosis - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering. Idiopathic Pulmonary Fibrosis - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019" report provides comprehensive insights about marketed and Phase III products for Idiopathic Pulmonary Fibrosis . The report includes information of marketed products including their product des
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 13:24
EC approves Blincyto in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL
The approval was based on data from the Phase 2 BLAST study in frontline and relapsed/refractory ALL, the largest prospective trial for MRD-positive ALL ever conducted. BLINCYTO, a The post EC approves Blincyto in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 11:52
Rocket Pharmaceuticals announces clearance of IND for RP-A501 gene therapy for Danon disease
RP-A501 is the Company's first adeno-associated viral vector (AAV)-based gene therapy for the treatment of Danon disease that is in development under a collaboration with the University of The post Rocket Pharmaceuticals announces clearance of IND for RP-A501 gene therapy for Danon disease appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 11:52
GSK closes acquisition of Tesaro for $5.1bn
Tesaro acquisition will enable GSK to strengthen its pharmaceutical business; and expand its pipeline and commercial capability in oncology. Tesaro president and COO Dr Mary Lynne Hedley said: The post GSK closes acquisition of Tesaro for $5.1bn appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 11:52
UroGen Pharma Announces Proposed Public Offering of Ordinary Shares
NEW YORK--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that it intends to offer and sell $150 million of its ordinary shares in an underwritten public offering. The company also intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of ordinary shares sold in the offering at the pu
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 23:01
LabCorp Named to FORTUNE Magazine's 2019 List of 'World's Most Admired Companies,' Making the Annual List for the Second Consecutive Year
BURLINGTON, N.C.--(BUSINESS WIRE)--LabCorp® (NYSE: LH), a leading global life sciences company, today announced that it has been named to FORTUNE magazine's 2019 List of World's Most Admired Companies, making the annual list for the second consecutive year. The annual survey, conducted by FORTUNE and Korn Ferry, a global organizational consulting firm, is given to top executives, directors, and financial analysts to identify the companies that enjoy the strongest reputations within their indust
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 17:35
Gamida Cell and Be The Match BioTherapies® Announce Strategic Collaboration
BOSTON & MINNEAPOLIS--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24GMDA&src=ctag" target="_blank"gt;$GMDAlt;/agt;--Gamida Cell and Be The Match BioTherapies® announced a collaboration to improve outcomes for patients undergoing bone marrow transplantation.
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Tue Jan 22, 2019 15:30
Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for BAT1806, a Proposed Biosimilar of Actemra® (Tocilizumab)
GUANGZHOU, China--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/arthritis?src=hash" target="_blank"gt;#arthritislt;/agt;--Bio-Thera Solutions announces the initiation of a Phase III clinical trial for BAT1806, a proposed biosimilar of Actemra® (Tocilizumab).
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Tue Jan 22, 2019 15:08
LabConnect Announces Global Sample Processing Network
SEATTLE--(BUSINESS WIRE)--LabConnect is pleased to announce a new service: LabConnect's global sample processing network (GSPN).
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:00
Seattle Genetics to Host Conference Call and Webcast Discussion of Fourth Quarter and Full Year 2018 Financial Results on February 7, 2019
BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it will report its fourth quarter and full year 2018 financial results on Thursday, February 7, 2019 after the close of financial markets. Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows: LIVE access on Thursday, February 7, 20191:30 p.m. Pacific Time / 4
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:00
Rainier Therapeutics Announces Oral Abstract Presentation on Fierce 21 Phase 2 Trial of Vofatamab in Metastatic Urothelial Cell Carcinoma (Bladder Cancer) at the 2019 ASCO Genitourinary Cancers Symposium
SAN LEANDRO, Calif.--(BUSINESS WIRE)--Data from ongoing P2 trial of Rainier's FGFR3-targeted antibody vofatamab to be presented at 2019 ASCO Genitourinary Cancers Symposium Feb 14 in SF
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:00
Resumen: Gore presenta en Europa la endoprótesis para aorta torácica adaptable GORE® TAG® con perfiles reducidos
FLAGSTAFF, Arizona--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) ha introducido hoy perfiles reducidos para los diámetros más utilizados de la endoprótesis para aorta torácica adaptable GORE® TAG® con el sistema de CONTROL ACTIVO. El perfil reducido permite a los médicos realizar reparaciones endovasculares torácicas (TEVAR) en pacientes con vasos más pequeños donde el acceso es difícil y la anatomía aórtica es tortuosa, lo que amplía la disponibilidad de la endoprótesis para aorta
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Tue Jan 22, 2019 14:47
Samenvatting: Gore introduceert GORE® TAG® Conformable Thoracic Stent Graft met gereduceerde profielen in Europa
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) introduceerde vandaag gereduceerde profielen voor de meest gebruikte diameters van de GORE® TAG® Conformable Thoracic Stent Graft met ACTIVE CONTROL System. Het gereduceerde profiel stelt artsen in staat om TEVAR uit te voeren bij patiënten met kleinere vaten waar de toegang moeilijk is en de aorta anatomie kronkelig is, waardoor de beschikbaarheid van Gore's thoracale stenttransplantaat wordt uitgebreid naar een groter
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:47
Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease
WILMINGTON, Del.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24INCY&src=ctag" target="_blank"gt;$INCYlt;/agt;--Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:30
Data Presented at LINC Confirm the Safety and Effectiveness of Zilver® PTX®
BLOOMINGTON, Ind.--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/cookmedical?src=hash" target="_blank"gt;#cookmedicallt;/agt;--Today at the Leipzig Interventional Course (LINC), Cook Medical participated in significant discussion about the use of paclitaxel to treat patients suffering from PAD. Through several presentations to meeting attendees, data supported the use of paclitaxel-coated devices to help the more than 200 million1 patients globally who are fighting the disease. "We believe...
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:10
Aurinia Announces Voclosporin Ophthalmic Solution Demonstrates Statistically Superior Efficacy Versus Restasis® in a Phase 2 Head-to-Head Study for the Treatment of Dry Eye Syndrome
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced positive results for its exploratory Phase 2 head-to-head study evaluating the efficacy, safety and tolerability of voclosporin ophthalmic solution (VOS 0.2%) versus Restasis®(cyclosporine ophthalmic emulsion 0.05%) for the treatment of dry eye syndrome (DES). Both drugs were shown to be well-tolerate
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Tue Jan 22, 2019 14:00
Concert Pharmaceuticals Completes Enrollment of 12 mg Cohort in Phase 2a Trial of CTP-543 in Alopecia Areata
LEXINGTON, Mass.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24CNCE&src=ctag" target="_blank"gt;$CNCElt;/agt; lt;a href="https://twitter.com/hashtag/AlopeciaAreata?src=hash" target="_blank"gt;#AlopeciaAreatalt;/agt;--Concert completed enrollment in its Phase 2a trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata.
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:00
Immunochina Raises $20.4 Million USD in Series C Financing
BEIJING--(BUSINESS WIRE)--Beijing-based Immunochina Pharmaceuticals today announced the closing of its $140 million RMB Series C financing (approximately $20.4 million in US Dollars). This financing will enable the company to expand its GMP-grade manufacturing capabilities while continuing clinical trials for its lead IM19 product targeting B-Cell Acute Lymphoblastic Leukemia (B-ALL) and Non Hodgkin's Lymphoma, as well as advancing the development of its pipeline targeting multiple solid and li
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:00
Aplastic Anemia - Pipeline Insight, 2019 - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Aplastic Anemia - Pipeline Insight, 2019" drug pipelines report has been added to ResearchAndMarkets.com's offering. This report offers comprehensive Insight of the pipeline (under development) therapeutics scenario and growth prospects across Aplastic Anemia development. The report provides detailed coverage of the pipeline landscape for this mechanism of action, equipped with data from multiple sources with complete pipeline analysis by developmental stage, assoc
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Tue Jan 22, 2019 13:40
Cluster Headache Syndrome - Pipeline Insight, 2019 - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Cluster Headache Syndrome - Pipeline Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering. This report offers comprehensive Insight of the pipeline (under development) therapeutics scenario and growth prospects across Cluster Headache Syndrome development. The report provides detailed coverage of the pipeline landscape for this mechanism of action, equipped with data from multiple sources with complete pipeline analysis by developmental
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 13:34
TC BioPharm creates allogeneic cell banks for CAR-T cancer therapy products
GLASGOW, Scotland--(BUSINESS WIRE)--TC BioPharm (TCB), a developer of CAR-T immuno-oncology products, including Gamma Delta T (GDT) cell therapies, today announced it has completed formulation of its first allogeneic GDT cell banks. The T cell banks provide TCB with core technology to develop a deep portfolio of next-generation CAR-T products directed against a wide variety of different cancer types, both hematological and solid tumors. The project was supported by funding from the European Uni
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Tue Jan 22, 2019 12:55
Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial
Publication date: Available online 21 January 2019Source: Contemporary Clinical TrialsAuthor(s): Heather M. Johnson, Lisa Sullivan-Vedder, KyungMann Kim, Patrick E. McBride, Maureen A. Smith, Jamie N. LaMantia, Jennifer T. Fink, Megan R. Knutson Sinaise, Laura M. Zeller, Diane R. LauverAbstractYoung adults (18–39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension...
ScienceDirect Publication: Contemporary Clinical Trials
Tue Jan 22, 2019 13:13
EC approves Vertex's CF treatment Orkambi for children aged two to five years
The label extension has been granted to treat the most common form of CF based on data from a phase 3 open-label safety study in 60 patients. According The post EC approves Vertex's CF treatment Orkambi for children aged two to five years appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Tue Jan 22, 2019 12:25
Nash's NASH NP-160 shows repeated positive results in second pre-clinical study
In addition, a second compound, NP-135 was identified as an additional lead. Both NP-135 and NP-160 are one of a number of already approved compounds that Nash has The post Nash's NASH NP-160 shows repeated positive results in second pre-clinical study appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Tue Jan 22, 2019 12:25
Global Clinical Trials 2007-2018: Current Trends and Recent Advancements - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Global Clinical Trials - Current Trends and Recent Advancement" report has been added to ResearchAndMarkets.com's offering. "Global Clinical Trials Current Trends and Recent Advancement", provides an in-depth assessment of the current trends in the number of clinical trials globally, Top 10 therapy area, geography wise clinical trials, YOY clinical trials in top 10 therapy area. An overview of clinical guidelines reforms has also been provided to show how regulator
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 11:17
PredictImmune Confirms Canadian Patent Grant
CAMBRIDGE, England--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/IBD?src=hash" target="_blank"gt;#IBDlt;/agt;--PredictImmune confirm Canadian patent grant which covers PredictImmune's intellectual property relating to methods for predicting autoimmune disease
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 11:00
PCI announces further investment in infrastructure for packaging of controlled substances
PCI has extended onsite controlled substance storage at its US commercial packaging locations in Philadelphia, PA and Rockford, IL, and will undertake further expansions as demand increases for The post PCI announces further investment in infrastructure for packaging of controlled substances appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Tue Jan 22, 2019 12:25
Wren Therapeutics Completes £18 Million Series A Financing
CAMBRIDGE, United Kingdom--(BUSINESS WIRE)--Wren Therapeutics ("Wren"), a biopharmaceutical company focused on drug discovery and development for protein misfolding diseases, today announces it has completed a Series A financing round. The company, formally founded in 2016, raised a total of £18 million from an international syndicate led by The Baupost Group with participation from LifeForce Capital and a number of high net worth individual investors. Protein molecules form the machinery that
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 09:30
EMMAC Life Sciences PLC: Acquisition of a Majority Interest in Medalchemy, a GMP Certified Laboratory, in Alicante Spain
LONDON--(BUSINESS WIRE)--EMMAC, the European independent medical cannabis company, is pleased to announce the acquisition of a majority interest in Medalchemy, a fully-licensed GMP certified laboratory in Alicante, Spain. Medalchemy, a technology-based manufacturing company located on the premises of the University of Alicante, has more than a decade of experience in the research, development and manufacture of active pharmaceutical ingredients (APIs) and has submitted license applications to i
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 09:00
Updated Analysis of Pivotal Study Reveals: Proactive, High Dosage of Venofer® Significantly Reduces Risk of Death or Major Cardiovascular Events in Haemodialysis Patients
ZURICH--(BUSINESS WIRE)--Re-analysis of pivotal study reveals: Proactive, High DOSAGE OF venofer®...
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 08:00
Ferring, Rebiotix and Karolinska Institutet Extend Collaboration to Research Next Generation of Microbiome Treatments
SAINT-PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals and Karolinska Institutet announced today a five-year extension of their collaboration to explore the potential of the human microbiome in reproductive medicine and women's health and gastroenterology. The collaboration brings together specialist expertise from Karolinska Institutet in early stage research, Rebiotix Inc. (acquired by Ferring in 2018), a late-stage clinical microbiome company, and Ferring's therapeutic area and co
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 08:00
Proteus Digital Health Launches Digital Oncology Medicines to Improve Patient Outcomes
January 17, 2019 – REDWOOD CITY, Calif. and MINNEAPOLIS, Minn. – Proteus Digital Health®, Inc., Fairview Health Services, and University of Minnesota Health announced today that for the first time cancer patients are using digital...
Drugs.com - Clinical Trials
Thu Jan 17, 2019 22:01
Two Positive Phase III studies of Tafenoquine for the Radical Cure of Plasmodium vivax Malaria Published in The New England Journal of Medicine
London UK; Philadelphia US; Geneva Switzerland - January 16, 2019 -- GSK and Medicines for Malaria Venture (MMV) today announced the publication of positive results from two phase III studies of single-dose tafenoquine for the radical cure...
Drugs.com - Clinical Trials
Wed Jan 16, 2019 23:01
vTv Therapeutics Announces Publication of Comprehensive Data in Science Translational Medicine Detailing the Discovery and Clinical Development of TTP399, including Results of Phase 2 AGATA Study
HIGH POINT, N.C.--(BUSINESS WIRE)--Jan. 16, 2019-- vTv Therapeutics Inc. (Nasdaq: VTVT) today announced the publication of a paper in Science Translational Medicine showcasing the discovery and development of TTP399, an investigational, oral, small...
Drugs.com - Clinical Trials
Wed Jan 16, 2019 22:01
Amgen Makes All Repatha (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price
THOUSAND OAKS, Calif., Jan. 7, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that as part of the Company's commitment to improve patient affordability for an innovative biologic medicine for people with high cholesterol who are at...
Drugs.com - Clinical Trials
Mon Jan 07, 2019 22:01
Gore führt GORE® TAG® Conformable Thoracic Stent Graft mit reduzierten Profilen für die Vermarktung in Europa ein
FLAGSTAFF, Arizona--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) meldete heute die Markteinführung reduzierter Profile für die am häufigsten verwendeten Durchmesser von GORE® TAG® Conformable Thoracic Stent Graft mit ACTIVE CONTROL System. Das reduzierte Profil ermöglicht es den Ärzten, bei Patienten mit kleineren Blutgefäßen eine thorakale endovaskuläre Aortenreparatur (TEVAR) durchzuführen, wenn der Zugang anspruchsvoll und die Aorta gewunden ist, um auf diese Weise die Einsatzmö
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Mon Jan 21, 2019 22:37
Gore lance sur le marché européen GORE® TAG®, une endoprothèse thoracique conformable à profils réduits
FLAGSTAFF, Arizona--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) a présenté aujourd'hui des profils réduits des diamètres les plus couramment utilisés de l'endoprothèse thoracique conformable implantable GORE® TAG® dotée du système ACTIVE CONTROL. La réduction du profil permet aux médecins de procéder à une procédure TEVAR (réparation endovasculaire des anévrismes de l'aorte thoracique) chez les patients dont les vaisseaux sont étroits et difficiles d'accès et l'anatomie aortique t
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 19:30
Riassunto: Gore lancia in Europa lo stent graft toracico conformabile GORE® TAG® con profili ridotti
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) ha oggi lanciato profili ridotti per i diametri più comunemente utilizzati dello stent graft toracico conformabile GORE® TAG® con sistema ACTIVE CONTROL. Il profilo ridotto consente al personale medico di eseguire trattamenti endovascolari dell'aorta toracica (TEVAR) nei pazienti con vasi sanguigni più piccoli, di difficile accesso e con anatomia aortica tortuosa, ampliando la disponibilità dello stent graft toracico di
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 16:18
Antibe Therapeutics Receives Approval to Initiate Part Two of Phase 2B Dose-Ranging, Efficacy Study for ATB-346
TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Receives Approval to Initiate Part Two of Phase 2B Dose-Ranging, Efficacy Study for ATB-346
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 14:00
Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label extension for ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation, the most common form of the disease. "Today's approval by the European Commission brings us one step closer to our goal of bringing treatment to all people living with CF," said Reshma K
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Mon Jan 21, 2019 11:00
Gore Introduces GORE® TAG® Conformable Thoracic Stent Graft with Reduced Profiles in Europe
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--Gore Introduces GORE® TAG® Conformable Thoracic Stent Graft with Reduced Profiles in Europe
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 10:00
Promentis Pharmaceuticals commences phase 2 studies for SXC-2023 targeting Glutamatergic mechanism
Promentis is developing SXC-2023 along with other compounds that engage System xc-, a central nervous system target addressing glutamatergic imbalance and oxidative stress, to treat trichotillomania and other The post Promentis Pharmaceuticals commences phase 2 studies for SXC-2023 targeting Glutamatergic mechanism appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Mon Jan 21, 2019 12:58
Kyn Therapeutics, Celgene partner on immuno-oncology therapies development
The collaboration will combine the immuno-oncology expertise and pipeline of Kyn Therapeutics with the capabilities of Celgene in development and commercialization of drugs in areas of high unmet The post Kyn Therapeutics, Celgene partner on immuno-oncology therapies development appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Mon Jan 21, 2019 09:02
Lilly's second immune-oncology candidate using Zymeworks' Azymetric platform to start clinical trials
In accordance with Zymeworks' 2014 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$8.0 million for Lilly's submission of an IND application for The post Lilly's second immune-oncology candidate using Zymeworks' Azymetric platform to start clinical trials appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Mon Jan 21, 2019 12:58
SanBio: Addition of a Cerebral Hemorrhage Program for SB623 Regenerative Cell Medicine
TOKYO--(BUSINESS WIRE)--At a meeting held today, the Board of Directors of SanBio Co., Ltd. (hereinafter, the "Company") resolved to add a program for treatment of chronic motor deficit from cerebral hemorrhage as a new indication for SB623, a regenerative cell medicine developed by the Group. (Hereinafter, the "Group" refers to two companies, SanBio Co., Ltd., and SanBio, Inc.) 1. Details of the Decision As part of its mission to introduce new therapeutic drugs for the central nervous system,
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 02:05
Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers
Publication date: Available online 19 January 2019Source: Contemporary Clinical TrialsAuthor(s): Richard I. Stein, Jaime R. Strickland, Rachel G. Tabak, Ann Marie Dale, Graham A. Colditz, Bradley A. EvanoffAbstractWeight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus,...
ScienceDirect Publication: Contemporary Clinical Trials
Sun Jan 20, 2019 13:44