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Showing "Companies Paediatric Extensions 2016 Many Firms Miss Trial" PubMed Articles 1–25 of 7,900+

Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.

Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless granted a waiver. We aimed to evaluate the availability of paediatric trial results from studies required under the Paediatric Regulation for new medicines authorised in the EU.

Clinical trial simulations in paediatric oncology: A feasibility study from the Innovative Therapies for Children with Cancer Consortium.

Paediatric dose-finding studies are challenging to perform due to ethical reasons, the limited number of available patients and restricted number of blood samples. In certain cases, the adult pharmacokinetic (PK) exposure can be used as target for dose finding in paediatrics. The aim of this study was to investigate the performance of a paediatric phase I dose-finding clinical trial in silico.

Medical malpractice web advertising: a qualitative, cross-sectional analysis of plaintiff medical malpractice firms in Suffolk County, Massachusetts.

Medical malpractice plaintiff firms play a central role in the prosecution of malpractice claims. There have been limited studies on the online advertising practices of plaintiff medical malpractice firms. The Martindale-Hubbell directory was used to identify all plaintiff medical malpractice firms in Suffolk County, Massachusetts. Each firm's website was individually mined for relevant data. Thirty-one unique medical malpractice law firms were identified. Seventy-seven percent of law firms advertised award...

QuickStats: Percentage* of Children and Teens Aged 6-17 Years Who Missed >10 Days of School in the Past 12 Months Because of Illness or Injury,(†) by Serious Emotional or Behavioral Difficulties Status(§) and Age Group - National Health Interview Survey, 2014-2016(¶).

During 2014-2016, children aged 6-17 years whose parent or guardian indicated the child had serious emotional or behavioral difficulties (EBDs) were almost four times as likely to miss >10 days of school because of illness or injury compared with children without serious EBDs (13.4% compared with 3.5%). Among children with serious EBDs, those aged 6-10 years were less likely (8.0%) to miss >10 days of school compared with children aged 11-14 years (15.6%) and children aged 15-17 years (19.5%). Among childre...

Estimating risk propagation between interacting firms on inter-firm complex network.

We derive a stochastic function of risk propagation empirically from comprehensive data of chain-reaction bankruptcy events in Japan from 2006 to 2015 over 5,000 pairs of firms. The probability is formulated by firm interaction between the pair of firms; it is proportional to the product of α-th power of the size of the first bankrupt firm and β-th power of that of the chain-reaction bankrupt firm. We confirm that α is positive and β is negative throughout the observing period, meaning that the probabil...


This study examines the kerma-area product (PKA) levels from paediatric cardiac catheterisations at a major Children's Hospital over three different time periods in order to gain an understanding of the causation of dose variations over time and to present a model for dose reduction. A retrospective review of 1245 paediatric procedural records was undertaken. This cohort consisted of patients that were catheterised over a period from November 2007 to July 2009, October 2009 to November 2011 and January 2016...

Zika Virus Disease in Children in Colombia, August 2015 to May 2016.

Children are considered a potentially vulnerable population for Zika virus infection. However, data on paediatric Zika virus infection are sparse.

Corrigendum to "Randomized, proof-of-concept trial of low dose naltrexone for patients with breakthrough symptoms of major depressive disorder on antidepressants" J. Affect. Disord. 208 (2017, Jan. 15) 6-14, doi: 10.1016/j.jad.2016.08.029, Epub 2016 Oct. 1.

Paediatric surgical services in remote northern Australia: an integrated model of care.

Surgical services for children in the Northern Territory of Australia are routinely performed by general surgeons with specific paediatric training, supported by paediatric surgeons. In Australasia, indications for appropriate transfer of elective routine surgery in children to tertiary paediatric surgical centres have been contentious. To transfer all elective paediatric cases from rural locations would have significant social and financial consequences for families and the health system. This study review...

Novel Proteins that Regulate Cell Extension Formation in Fibroblasts.

Cell extensions are critical structures that enable matrix remodeling in wound healing and cancer invasion but the regulation of their formation is not well-defined. We searched for new proteins that mediated cell extension formation over collagen by tandem mass tagged mass spectrometry analysis of purified extensions in 3T3 fibroblasts. Unexpectedly, importin-5, ENH isoform 1b (PDLIM5) and 26S protease regulatory subunit 6B (PSMC4) were more abundant (>10-fold) in membrane-penetrating cell extensions than ...

Ethnic differences in maternal near miss.

To evaluate the association between ethnic differences and the occurrence of maternal near miss (MNM) in the Amazon and Northeast regions of Brazil.

Systematic review of pharmacogenomics and adverse drug reactions in paediatric oncology patients.

Many paediatric patients with cancer experience significant chemotherapy side effects. Predisposition to drug reactions is governed by single nucleotide polymorphisms (SNPs). We performed a systematic review of the literature from 2006 through 2016. Outcomes of interest included patient characteristics, cancer type drug of interest, genes investigated, toxicity identified and genetic polymorphisms implicated. The primary toxicities studied were neurotoxicity cardiotoxicity, osteonecrosis, and thromboembolis...

Prospective Incidence of Paediatric Inflammatory Bowel Disease in New Zealand in 2015: Results from the PINZ Study.

The global incidence of paediatric inflammatory bowel disease (IBD) is increasing. Much of the evidence attesting to this has arisen from North America and Europe. There is a relative paucity of information on the epidemiology of paediatric IBD in the Southern Hemisphere. This study aimed to document the prospectively-collected incidence of paediatric IBD in New Zealand in 2015.

Multi-centre emergency department study found that paracetamol and ibuprofen were inappropriately used in 83% and 63% of paediatric cases.

The Pain Practice in Italian Paediatric Emergency Departments assessed how appropriately analgesic drugs were being used by Italian clinicians, based on national paediatric pain guidelines.

Review of the phenotype of early-onset generalised progressive dystonia due to mutations in KMT2B.

In 2016, two research groups independently identified microdeletions and pathogenic variants in the lysine-specific histone methyltransferase 2B gene, KMT2B in patients with early-onset progressive dystonia. KMT2B-dystonia (DYT28) is emerging as an important and frequent cause of childhood-onset progressive generalised dystonia and is estimated to potentially account for up to 10% of early-onset generalised dystonia. Herein, we review variants in KMT2B associated with dystonia, as well as the clinical pheno...

Drug Companies' Liability for the Opioid Epidemic.

Predictive Indicators to Identify High-Risk Paediatric Febrile Neutropenia in Paediatric Oncology Patients in a Middle-Income Country.

To validate a clinical risk prediction score (Ammann score) to predict adverse events (AEs) in paediatric febrile neutropenia (FN).

Paediatric Zika - Beyond Pregnant Women.

Pragmatic criteria of the definition of neonatal near miss: a comparative study.

The objective of this study was to test the validity of the pragmatic criteria of the definitions of neonatal near miss, extending them throughout the infant period, and to estimate the indicators of perinatal care in public maternity hospitals.

In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir.

The palatability of a new paediatric formulation of valaciclovir was assessed in children and their parents: non-inferiority of the new paediatric formulation (test formulation) compared to the reference formulation was investigated.

Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries.

Despite the coordinated efforts by several stakeholders to speed up access to HIV treatment for children, development of optimal paediatric formulations still lags 8 to 10 years behind that of adults, due mainly to lack of market incentives and technical complexities in manufacturing. The small and fragmented paediatric market also hinders launch and uptake of new formulations. Moreover, the problems affecting HIV similarly affect other disease areas where development and introduction of optimal paediatric ...

Evaluating firms' R&D performance using best worst method.

Since research and development (R&D) is the most critical determinant of the productivity, growth and competitive advantage of firms, measuring R&D performance has become the core of attention of R&D managers, and an extensive body of literature has examined and identified different R&D measurements and determinants of R&D performance. However, measuring R&D performance and assigning the same level of importance to different R&D measures, which is the common approach in existing studies, can oversimplify th...

2015-2016 Influenza Season in an Irish Regional Paediatric Unit: Importance of Influenza Vaccination Highlighted.

Business cycles' correlation and systemic risk of the Japanese supplier-customer network.

This work aims to study and explain the business cycle correlations of the Japanese production network. We consider the supplier-customer network, which is a directed network representing the trading links between Japanese firms (links from suppliers to customers). The community structure of this network is determined by applying the Infomap algorithm. Each community is defined by its GDP and its associated business cycle. Business cycle correlations between communities are estimated based on copula theory....

The detection of rotavirus in paediatric oncology patients with diarrhoea: the impact of rotavirus vaccine.

We reviewed seven year's data to examine stool testing for rotavirus in patents treated on a regional Paediatric Oncology Unit before and after the introduction of UK-wide rotavirus immunisation in July 2013. The prevalence of rotavirus positivity has diminished since the introduction of rotavirus immunisation, with 21 of 416 positive samples between 2010 and 2012, but only one positive test out of 122 samples in 2015 and 2016. Based on these results, we suggest there is very little utility for routine rota...

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