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https://www.readbyqxmd.com/read/28213598/informing-efficient-randomised-controlled-trials-exploration-of-challenges-in-developing-progression-criteria-for-internal-pilot-studies
#1
Kerry N L Avery, Paula R Williamson, Carrol Gamble, Elaine O'Connell Francischetto, Chris Metcalfe, Peter Davidson, Hywel Williams, Jane M Blazeby
OBJECTIVES: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28209419/a-safety-and-pharmacokinetic-dosing-study-of-glucagon-like-peptide-2-in-infants-with-intestinal-failure
#2
David L Sigalet, Mary E Brindle, Dana Boctor, Bryan Dicken, Viona Lam, Lily Sia Lu, Elaine de Heuvel, Bolette Hartmann, Jens J Holst
BACKGROUND & AIMS: Glucagon-like peptide 2 (GLP-2) analogues are approved for adults with intestinal failure (IF), but no studies have included infants. This study examined the pharmacokinetics (PK), safety, and nutritional effects of GLP-2 in infants with IF. METHODS: With parental consent (Health Canada Protocol:150,979), parenteral nutrition (PN)-dependent infants were treated with 5-20-μg/kg/day GLP-2 for 3days (phase 1), and if tolerated continued for 42days (phase 2)...
January 29, 2017: Journal of Pediatric Surgery
https://www.readbyqxmd.com/read/28157808/improved-clinical-performance-and-teamwork-of-pediatric-interprofessional-resuscitation-teams-with-a-simulation-based-educational-intervention
#3
Elaine Gilfoyle, Deanna A Koot, John C Annear, Farhan Bhanji, Adam Cheng, Jonathan P Duff, Vincent J Grant, Cecilia E St George-Hyslop, Nicole J Delaloye, Afrothite Kotsakis, Carolyn D McCoy, Christa E Ramsay, Matthew J Weiss, Ronald D Gottesman
OBJECTIVES: To measure the effect of a 1-day team training course for pediatric interprofessional resuscitation team members on adherence to Pediatric Advanced Life Support guidelines, team efficiency, and teamwork in a simulated clinical environment. DESIGN: Multicenter prospective interventional study. SETTING: Four tertiary-care children's hospitals in Canada from June 2011 to January 2015. SUBJECTS: Interprofessional pediatric resuscitation teams including resident physicians, ICU nurse practitioners, registered nurses, and registered respiratory therapists (n = 300; 51 teams)...
February 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28152086/nnktt120-an-anti-inkt-cell-monoclonal-antibody-produces-rapid-and-sustained-inkt-cell-depletion-in-adults-with-sickle-cell-disease
#4
Joshua J Field, Elaine Majerus, Kenneth I Ataga, Elliot P Vichinsky, Robert Schaub, Robert Mashal, David G Nathan
: Invariant NKT (iNKT) cells can be activated to stimulate a broad inflammatory response. In murine models of sickle cell disease (SCD), interruption of iNKT cell activity prevents tissue injury from vaso-occlusion. NKTT120 is an anti-iNKT cell monoclonal antibody that has the potential to rapidly and specifically deplete iNKT cells and, potentially, prevent vaso-occlusion. We conducted an open-label, multi-center, single-ascending-dose study of NKTT120 to determine its pharmacokinetics, pharmacodynamics and safety in steady-state patients with SCD...
2017: PloS One
https://www.readbyqxmd.com/read/28145828/an-industry-update-what-is-new-in-the-field-of-therapeutic-delivery-this-month
#5
Elaine Harris
The present industry update covers the period of 1-30 November 2016, with information sourced primarily from company press releases, regulatory and patent agencies, scientific literature and various news websites. There was positive news on the clinical trials front for both EyeNovia and Glaxo SmithKline, but this month also saw Innocol release disappointing Phase IIb results for its Cogenzia product. In regulatory news, it was announced that the US FDA indicated that EyeGate may use the 510(k) De Novo Path for their device, the Ocular Bandage Gel...
January 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28137792/cardiac-autonomic-regulation-and-repolarization-during-acute-experimental-hypoglycemia-in-type-2-diabetes
#6
Elaine Chow, Alan Bernjak, Emma Walkinshaw, Alexandra Lubina-Solomon, Jenny Freeman, Ian A Macdonald, Paul J Sheridan, Simon R Heller
Hypoglycemia is associated with increased cardiovascular mortality in trials of intensive therapy in type 2 diabetes (T2DM). We previously observed an increase in arrhythmias during spontaneous prolonged hypoglycemia in T2DM patients. Our aim was to examine changes in cardiac autonomic function and repolarization during sustained experimental hypoglycemia.Twelve adults with T2DM and eleven age, BMI-matched nondiabetic controls underwent paired hyperinsulinemic clamps separated by 4 weeks. Glucose was maintained at euglycemia (6...
January 30, 2017: Diabetes
https://www.readbyqxmd.com/read/28135804/the-interaction-between-equipoise-and-logistics-in-clinical-trials-a-case-study
#7
Meredith G Warshaw, Vincent J Carey, Elizabeth J McFarland, Liza Dawson, Elaine Abrams, Ann Melvin, Lee Fairlie, Hans Spiegel, Jonathan Jay, Allison L Agwu
INTRODUCTION: Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. BACKGROUND: Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28134053/what-is-the-value-of-conducting-a-trial-of-r-tpa-for-the-treatment-of-mild-stroke-patients
#8
Gregory F Guzauskas, Er Chen, Deepa Lalla, Elaine Yu, Darren Tayama, David L Veenstra
Background The Phase IIIb, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS) trial will assess r-tPA in ischemic stroke patients who present with mild deficits (i.e. mild stroke). Aims To assess PRISMS's societal value in clarifying the optimal care for patients with mild ischemic stroke. Methods A value of information (VOI) decision model was developed to compare the outcomes of mild stroke patients treated vs...
February 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28130430/involvement-of-fathers-in-pediatric-obesity-treatment-and-prevention-trials-a-systematic-review
#9
REVIEW
Philip J Morgan, Myles D Young, Adam B Lloyd, Monica L Wang, Narelle Eather, Andrew Miller, Elaine M Murtagh, Alyce T Barnes, Sherry L Pagoto
CONTEXT: Despite their important influence on child health, it is assumed that fathers are less likely than mothers to participate in pediatric obesity treatment and prevention research. OBJECTIVE: This review investigated the involvement of fathers in obesity treatment and prevention programs targeting children and adolescents (0-18 years). DATA SOURCES: A systematic review of English, peer-reviewed articles across 7 databases. Retrieved records included at least 1 search term from 2 groups: "participants" (eg, child*, parent*) and "outcomes": (eg, obes*, diet*)...
February 2017: Pediatrics
https://www.readbyqxmd.com/read/28129748/the-speed-of-increasing-milk-feeds-a-randomised-controlled-trial
#10
Jane Abbott, Janet Berrington, Ursula Bowler, Elaine Boyle, Jon Dorling, Nicholas Embleton, Edmund Juszczak, Alison Leaf, Louise Linsell, Samantha Johnson, Kenny McCormick, William McGuire, Tracy Roberts, Ben Stenson
BACKGROUND: In the UK, 1-2% of infants are born very preterm (<32 weeks of gestation) or have very low birth weight (<1500 g). Very preterm infants are initially unable to be fed nutritional volumes of milk and therefore require intravenous nutrition. Milk feeding strategies influence several long and short term health outcomes including growth, survival, infection (associated with intravenous nutrition) and necrotising enterocolitis (NEC); with both infection and NEC being key predictive factors of long term disability...
January 28, 2017: BMC Pediatrics
https://www.readbyqxmd.com/read/28117679/the-potential-of-targeting-ribosome-biogenesis-in-high-grade-serous-ovarian-cancer
#11
REVIEW
Shunfei Yan, Daniel Frank, Jinbae Son, Katherine M Hannan, Ross D Hannan, Keefe T Chan, Richard B Pearson, Elaine Sanij
Overall survival for patients with ovarian cancer (OC) has shown little improvement for decades meaning new therapeutic options are critical. OC comprises multiple histological subtypes, of which the most common and aggressive subtype is high-grade serous ovarian cancer (HGSOC). HGSOC is characterized by genomic structural variations with relatively few recurrent somatic mutations or dominantly acting oncogenes that can be targeted for the development of novel therapies. However, deregulation of pathways controlling homologous recombination (HR) and ribosome biogenesis has been observed in a high proportion of HGSOC, raising the possibility that targeting these basic cellular processes may provide improved patient outcomes...
January 20, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28116988/efficacy-of-home-based-visuomotor-feedback-training-in-stroke-patients-with-chronic-hemispatial-neglect
#12
Stéphanie Rossit, Christopher S Y Benwell, Larissa Szymanek, Gemma Learmonth, Laura McKernan-Ward, Elaine Corrigan, Keith Muir, Ian Reeves, George Duncan, Philip Birschel, Margaret Roberts, Katrina Livingstone, Hazel Jackson, Pauline Castle, Monika Harvey
Hemispatial neglect is a severe cognitive condition frequently observed after a stroke, associated with unawareness of one side of space, disability and poor long-term outcome. Visuomotor feedback training (VFT) is a neglect rehabilitation technique that involves a simple, inexpensive and feasible training of grasping-to-lift rods at the centre. We compared the immediate and long-term effects of VFT vs. a control training when delivered in a home-based setting. Twenty participants were randomly allocated to an intervention (who received VFT) or a control group (n = 10 each)...
January 24, 2017: Neuropsychological Rehabilitation
https://www.readbyqxmd.com/read/28103809/dietary-treatment-of-crohn-s-disease-perceptions-of-families-with-children-treated-by-exclusive-enteral-nutrition-a-questionnaire-survey
#13
Vaios Svolos, Konstantinos Gerasimidis, Elaine Buchanan, Lee Curtis, Vikki Garrick, Jacqueline Hay, Susan Laird, Joanna Munro, Daniel R Gaya, Richard K Russell, Richard Hansen
BACKGROUND: Diet is strongly associated with the aetiology of Crohn's Disease (CD) and exclusive enteral nutrition (EEN) is the primary induction treatment in paediatric CD. This study explored opinions around the use of EEN and alternative novel, solid food-based diets (SFDs) expressed by paediatric patients with CD, previously treated with EEN and their parents. METHODS: This anonymous questionnaire surveyed families of CD patients treated with EEN over 1 year...
January 19, 2017: BMC Gastroenterology
https://www.readbyqxmd.com/read/28093194/effects-of-neuromuscular-electrical-stimulation-during-hemodialysis-on-peripheral-muscle-strength-and-exercise-capacity-a-randomized-clinical-trial
#14
Ana Karla Vieira Brüggemann, Carolina Luana Mello, Tarcila Dal Pont, Deborah de Camargo Hizume Kunzler, Daniel Fernandes Martins, Franciane Bobinski, Wellington Pereira Yamaguti, Elaine Paulin
OBJECTIVE: To evaluate the effects of neuromuscular electrical stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on physical function and inflammation markers in patients with chronic kidney disease (CKD). DESIGN: Randomized clinical trial SETTING: Hemodialysis clinic. PARTICIPANTS: 51 CKD patients were randomized into blocks of four by means of opaque envelopes. They were divided into a group of high frequency and intensity neuromuscular electrical stimulation (HG) and a group of low frequency and intensity neuromuscular electrical stimulation (LG)...
January 13, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/28089709/objective-assessment-of-dietary-patterns-by-use-of-metabolic-phenotyping-a-randomised-controlled-crossover-trial
#15
Isabel Garcia-Perez, Joram M Posma, Rachel Gibson, Edward S Chambers, Tue H Hansen, Henrik Vestergaard, Torben Hansen, Manfred Beckmann, Oluf Pedersen, Paul Elliott, Jeremiah Stamler, Jeremy K Nicholson, John Draper, John C Mathers, Elaine Holmes, Gary Frost
BACKGROUND: Accurate monitoring of changes in dietary patterns in response to food policy implementation is challenging. Metabolic profiling allows simultaneous measurement of hundreds of metabolites in urine, the concentrations of which can be affected by food intake. We hypothesised that metabolic profiles of urine samples developed under controlled feeding conditions reflect dietary intake and can be used to model and classify dietary patterns of free-living populations. METHODS: In this randomised, controlled, crossover trial, we recruited healthy volunteers (aged 21-65 years, BMI 20-35 kg/m(2)) from a database of a clinical research unit in the UK...
January 12, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28086958/biofeedback-interventions-for-people-with-cerebral-palsy-a-systematic-review-protocol
#16
Alexander MacIntosh, Nicolas Vignais, Elaine Biddiss
BACKGROUND: Cerebral palsy is a life-long disability that affects motor control and activities of daily living. Depending on the type of cerebral palsy, some individuals may have trouble performing tasks with one or both of their arms and/or legs. Different strategies exist to help develop motor capacity. Biofeedback therapy is a commonly applied rehabilitation strategy. In biofeedback therapy, information about the motor behavior while completing a task is given back to the individual to help improve their performance...
January 13, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28072562/a-systematic-review
#17
Sarah Drejet, Stacey Halum, Matthew Brigger, Elaine Skopelja, Noah P Parker
Objectives (1) To systematically identify studies evaluating the use of intralesional cidofovir or bevacizumab as an adjunct in adult recurrent respiratory papillomatosis, determine disease severity and functional outcomes, and assess study quality. (2) To compare outcomes between the 2 adjuncts. Data Sources Ovid Medline, EMBASE, Scopus, and Clinical-Trials.gov . Review Methods Data sources were systematically searched. A priori inclusion and exclusion criteria were instituted. Quality was evaluated with the Newcastle-Ottawa Quality Assessment Scale...
January 1, 2017: Otolaryngology—Head and Neck Surgery
https://www.readbyqxmd.com/read/28056877/antenatal-care-trial-interventions-a-systematic-scoping-review-and-taxonomy-development-of-care-models
#18
Andrew Symon, Jan Pringle, Soo Downe, Vanora Hundley, Elaine Lee, Fiona Lynn, Alison McFadden, Jenny McNeill, Mary J Renfrew, Mary Ross-Davie, Edwin van Teijlingen, Heather Whitford, Fiona Alderdice
BACKGROUND: Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research...
January 6, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28055065/effect-of-fish-oil-supplementation-and-aspirin-use-on-arteriovenous-fistula-failure-in-patients-requiring-hemodialysis-a-randomized-clinical-trial
#19
Ashley B Irish, Andrea K Viecelli, Carmel M Hawley, Lai-Seong Hooi, Elaine M Pascoe, Peta-Anne Paul-Brent, Sunil V Badve, Trevor A Mori, Alan Cass, Peter G Kerr, David Voss, Loke-Meng Ong, Kevan R Polkinghorne
Importance: Vascular access dysfunction is a leading cause of morbidity and mortality in patients requiring hemodialysis. Arteriovenous fistulae are preferred over synthetic grafts and central venous catheters due to superior long-term outcomes and lower health care costs, but increasing their use is limited by early thrombosis and maturation failure. ω-3 Polyunsaturated fatty acids (fish oils) have pleiotropic effects on vascular biology and inflammation and aspirin impairs platelet aggregation, which may reduce access failure...
February 1, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/28032810/active-classrooms-a-cluster-randomised-controlled-trial-evaluating-the-effects-of-a-movement-integration-intervention-on-the-physical-activity-levels-of-primary-school-children
#20
Rosemarie Martin, Elaine Murtagh
DESIGN: A cluster randomized controlled trial was conducted to assess the effectiveness of the 'Active Classrooms' intervention, which integrates movement into academic lessons, on the moderate-to-vigorous physical activity levels (MVPA) of primary school children during classtime and throughout the school day. METHODS: Ten classroom teachers and their students aged 8-12 years were recruited and randomized into the 'Active Classrooms' intervention group (n=131students, n=5teachers) or a delayed-treatment controlled group (n=117students, n=5teachers)...
December 29, 2016: Journal of Physical Activity & Health
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