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00:31 EDT 26th September 2018 | BioPortfolio

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

The inherent risks associated with newly traded biopharmaceutical firms.

Here, we provide a comprehensive study related to the risks of all biopharmaceutical firms going public in the USA between 1996 and 2015. We found 355 firms that met our requirements for being in the sector that focuses on creating drugs for humans. Collectively, these firms spent approximately US$86.9 billion on research and development (R&D) during this time. They also lost approximately US$69.3 billion in combined net income. We also examine the delisting of these firms from a public market, their number...

High-Deductible Health Plan Enrollment Increased From 2006 To 2016, Employer-Funded Accounts Grew In Largest Firms.

Over the past decade, employers have increasingly turned to high-deductible health plans (HDHPs) to limit health insurance premium growth. We used data from private-sector establishments for 2006 and 2016 from the Medical Expenditure Panel Survey-Insurance Component to examine trends in HDHP enrollment and heterogeneity in HDHPs by firm size. We studied insurance plan offerings along the following dimensions: whether employers fund accounts to help defray employees' out-of-pocket health care spending, the a...

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.

DKG Certification of Paediatric Cancer Centres.

The new certification module will continue to foster the development of interdisciplinary networks and a centralised commitment to high quality of care in paediatric oncology. The new module was initiated in a joint venture of the German Society of Paediatric Oncology and Haematology (GPOH) and the German Cancer Society (DKG) in 2016. The comprehensive Catalogue of Requirements is based on the directive for paediatric oncology by the Federal Joint Committee (G-BA) and has been successfully implemented into ...

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.

Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?

Ethics guidelines emphasise that research should be acceptable to the people invited to take part. However, acceptability is subjective and dependent on context, complicating its assessment and use as an ethical standard. This paper examines the concept of acceptability in relation to parents' perspectives on a paediatric vaccine trial in Malawi. We examined decisions on participation and experiences of the trial through interviews with parents in 41 households invited to enrol their children and participan...

FDG PET in response evaluation of bulky masses in paediatric Hodgkin's lymphoma (HL) patients enrolled in the Italian AIEOP-LH2004 trial.

We present the results of an investigation of the role of FDG PET in response evaluation of bulky masses in paediatric patients with Hodgkin's lymphoma (HL) enrolled in the Italian AIEOP-LH2004 trial.

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...

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.

Chapter 4 Demography of the UK Paediatric Renal Replacement Therapy Population in 2016.

What is new in paediatric uveitis?

The aim of this study was to summarize the demographics and causes of paediatric uveitis and to discuss the latest treatment options for noninfectious paediatric uveitis.

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 ...

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.

Components of an Occupational Safety and Health Communication Research Strategy for Small- and Medium-Sized Enterprises.

The majority of the global labor force works in firms with fewer than 50 employees; firms with fewer than 250 employees make up 99% of workplaces. Even so, the lack of extensive or comprehensive research has failed to focus on occupational safety and health communication to these small- and medium-sized enterprises (SMEs). Given that the magnitude of all occupational safety and health (OSH) morbidity, mortality, and injury disproportionately occurs in businesses with fewer than 250 employees, efforts to com...

Validity Evidence for Direct Observation of Procedural Skills in Paediatric Gastroscopy.

Direct observation of procedural skills (DOPS) are competence-assessment tools in endoscopy. Formative paediatric gastroscopy DOPS were implemented into the UK curriculum in 2016 but lack validity evidence; we aimed to assess validity evidence using a recognised contemporary validity framework.

Effect of visual distraction on children's anxiety during dental treatment: a crossover randomized clinical trial.

This was to evaluate the effect of visual distraction on anxiety of children during dental treatment.

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.

Inducements by Pharmaceutical Companies: The Elephant in the Room.

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.

Incidence of peri-operative paediatric cardiac arrest: Influence of a specialised paediatric anaesthesia team.

Peri-operative critical events are still a major problem in paediatric anaesthesia care. Access to more experienced healthcare teams might reduce the adverse event rate and improve outcomes.

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