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Showing "Companies Paediatric Extensions 2016 Many Firms Miss Trial" PubMed Articles 1–25 of 8,100+

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.

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...

Setting up and running a paediatric emergency department in a hospital in Malawi: 15 years on.

Paediatric emergency care is not recognised as a specialty in many countries in Africa but is being practised increasingly. Setting up a paediatric emergency care unit takes time and often involves trial and error. Here we describe the start of the paediatric emergency department in Blantyre, Malawi, a low-income country and how it has continued to evolve over 15 years, in the hope that our experience will inform and assist others who are already developing their own emergency unit or wishing to do so.

New-generation full-spectrum endoscopy versus standard forward-viewing colonoscopy: a multicenter, randomized, tandem colonoscopy trial (J-FUSE Study).

Although colonoscopy is the criterion standard for detection of colorectal adenomas, some adenomas are missed. Full-spectrum endoscopy (FUSE) allows for observation with a 330° angle of view, which is expected to decrease the miss rate. However, no consensus has been reached regarding the superiority of FUSE over standard forward-viewing colonoscopy (SFVC) for detection of adenomas; we therefore compared new-generation FUSE and SFVC regarding colorectal adenoma miss rate (AMR) in this, the first reported r...


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...

Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey.

The key role played by research nurses in coordinating clinical trials in a paediatric setting has developed in line with increasing complexities of trial design. A questionnaire-based survey was conducted to investigate the training of research nurses involved in paediatric trials across Europe, to identify potential training needs and compare roles across specialties and countries.

Minimally Invasive Spinal Surgery for Adult Spinal Deformity.

The purpose of this review is to present the current techniques and outcomes of adult spine deformity (ASD) surgery using the minimally invasive spine surgery (MISS) approach. We performed a systemic search of PubMed for literature published through January 2018 with the following terms: "minimally invasive spine surgery," "adult spinal deformity," and "degenerative scoliosis." Of the 138 items that were found through this search, 57 English-language articles were selected for full-text review. According to...

Teaching paediatric basic life support in medical schools using peer teaching or video demonstration: A prospective randomised trial.

The outcome of children with an out-of-hospital cardiac arrest is still poor, but bystander cardiopulmonary resuscitation can increase survival and minimise severe neurological sequelae. While teaching basic life support is standardised in emergency medicine classes, paediatric basic life support (PBLS) in neonates and toddlers is under-represented in paediatric curricula during university education. The appropriate mixture of E-learning and peer teaching lessons remains controversial in teaching paediatric...

Paediatric acute care: Highlights from the Paediatric Acute Care-Advanced Paediatric Life Support Conference, Gold Coast, 2017.

The Paediatric Acute Care Conference is an annual conference organised by APLS Australia to advance paediatric acute care topics for clinicians in pre-hospital medicine, EDs, acute paediatrics, intensive care and anaesthesia. The Conference 2017 was held at Surfers Paradise, Queensland. We provide a summary of some of the presentations.

Biopharmaceutical Optimization in neglected diseases for paediatric patients by applying the provisional paediatric Biopharmaceutical Classification System.

Unavailability and lack of appropriate, effective and safe formulations are common problems in paediatric therapeutics. Key factors such as swallowing abilities, organoleptic preferences and dosage requirements determine the need of for optimization of formulations. The provisional Biopharmaceutics Classification System can be used in paediatric formulation design as a risk analysis and optimization tool. The objective of this study was to classify six neglected tropical diseases drugs following a provision...

A 22-year follow-up reveals a variable disease severity in early-onset facioscapulohumeral dystrophy.

To assess the long-term natural course of early-onset facioscapulohumeral dystrophy (FSHD), which is important for patient management and trial-readiness, and is currently lacking.

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 ...

A database linking Chinese patents to China's census firms.

To meet researchers' increasing interest in the fast growing innovation activities taking place in China, we match patents filed with China's State Intellectual Property Office to firms covered in China's Census. China has experienced a strong growth in patent filings over the past two decades, and has since 2011 become the world's top patent filing country. China's Census database covers about one million unique manufacturing firms from 1998-2009, representing the broad Chinese economy. We design data pars...

Immunizations under sedation at a paediatric hospital in Melbourne, Australia from 2012-2016.

Sedation for immunizations is of particular importance in a subset of paediatric patients with anxiety disorders, needle phobia, developmental or behavioural disorders. The Royal Children's Hospital (RCH) Melbourne offers a unique immunization under sedation service for these patients. We aimed to evaluate the number and types of patients using inpatient sedation for immunizations, distraction and sedation techniques used, and outcomes of these procedures.

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...

Evaluation of knowledge of students in paediatric dentistry concerning cardiopulmonary resuscitation skills in children.

The study evaluated the theoretical knowledge and practical ability of students in paediatric dentistry concerning basic life support (BLS) and cardiopulmonary resuscitation (CPR) in children and babies.

Drug Companies' Liability for the Opioid Epidemic.

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.

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...

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).

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 ...

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

Observational pre-post study showed that a quality improvement project reduced paediatric antibiotic prescribing rates in primary care.

This study assessed the effectiveness of a quality improvement project that aimed to promote more considered antibiotic prescribing in paediatric primary care. Method This was an observational pre-post study that used patient-level prescribing data from the Emilia-Romagna region of Italy to monitor indicators from 2005 to 2016. Multilevel interventions and activities started in 2007 and these included developing guidelines and updates, disseminating evidence, audits and feedback, public information campaign...

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