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https://www.readbyqxmd.com/read/28925064/improving-realism-in-clinical-trial-simulations-via-real-world-data
#1
EDITORIAL
Holly Kimko, Kwan Lee
Simulation validity depends on how well sampling distributions used reflect real-patient characteristics, such as drug adherence, disease progression, and pharmacologic handling in the body. We challenge the current use of growth charts from nondisease-specific pediatrics in simulations for drug development. Complementary use of data from clinical trials and the real-world is expected to achieve a more realistic representation of clinical outcomes for decisions in drug development, regulatory approval, and health technology assessment...
September 19, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28914546/defibrotide-an-oligonucleotide-for-sinusoidal-obstruction-syndrome
#2
May T Aziz, Payal P Kakadiya, Samantha M Kush, Kylie Weigel, Denise K Lowe
OBJECTIVE: To review the efficacy and safety of defibrotide as well as its pharmacology, mechanism of action, pharmacokinetics (PK), drug-drug interactions, dosing, cost considerations, and place in therapy. DATA SOURCES: A PubMed search was performed through August 2017 using the terms defibrotide, oligonucleotide, hepatic veno-occlusive disease (VOD), sinusoidal obstruction syndrome (SOS), and hematopoietic cell transplantation (HCT). Other data sources were from references of identified studies, review articles, and conference abstracts plus manufacturer product labeling and website, the Food and Drug Administration website, and clinicaltrials...
September 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28883017/nf%C3%AE%C2%BAb-signaling-in-alveolar-rhabdomyosarcoma
#3
Megan M Cleary, Atiya Mansoor, Teagan Settelmeyer, Yuichi Ijiri, Katherine J Ladner, Matthew N Svalina, Brian P Rubin, Denis C Guttridge, Charles Keller
Alveolar rhabdomyosarcoma (aRMS) is a pediatric soft tissue cancer commonly associated with a chromosomal translocation that leads to the expression of a Pax3:Foxo1 or Pax7:Foxo1 fusion protein, the developmental underpinnings of which may give clues to its therapeutic approaches. In aRMS, the NFκB-YY1-miR-29 regulatory circuit is dysregulated, resulting in repression of miR-29 and loss of the associated tumor suppressor activity. To further elucidate the role of NFκB in aRMS, we first tested 55 unique sarcoma cell lines and primary cell cultures in a large-scale chemical screen targeting diverse molecular pathways...
September 1, 2017: Disease Models & Mechanisms
https://www.readbyqxmd.com/read/28874164/radiation-free-cmr-diagnostic-heart-catheterization-in-children
#4
Kanishka Ratnayaka, Joshua P Kanter, Anthony Z Faranesh, Elena K Grant, Laura J Olivieri, Russell R Cross, Ileen F Cronin, Karin S Hamann, Adrienne E Campbell-Washburn, Kendall J O'Brien, Toby Rogers, Michael S Hansen, Robert J Lederman
BACKGROUND: Children with heart disease may require repeated X-Ray cardiac catheterization procedures, are more radiosensitive, and more likely to survive to experience oncologic risks of medical radiation. Cardiovascular magnetic resonance (CMR) is radiation-free and offers information about structure, function, and perfusion but not hemodynamics. We intend to perform complete radiation-free diagnostic right heart catheterization entirely using CMR fluoroscopy guidance in an unselected cohort of pediatric patients; we report the feasibility and safety...
September 6, 2017: Journal of Cardiovascular Magnetic Resonance
https://www.readbyqxmd.com/read/28866891/integration-of-hypnosis-into-pediatric-palliative-care
#5
Stefan J Friedrichsdorf, Daniel P Kohen
At least 8 million children would need specialized pediatric palliative care (PPC) services annually worldwide, and of the more than 42,000 children and teenagers dying annually in the United States, at least 15,000 children would require PPC. Unfortunately, even in resource-rich countries the majority of children dying from serious advanced illnesses are suffering from unrelieved, distressing symptoms such as pain, dyspnea, nausea, vomiting, and anxiety. State of the art treatment and prevention of those symptoms requires employing multi-modal therapies, commonly including pharmacology, rehabilitation, procedural intervention, psychology, and integrative modalities...
June 27, 2017: Annals of Palliative Medicine
https://www.readbyqxmd.com/read/28851284/anesthetic-management-of-a-pediatric-patient-with-electron-transfer-flavoprotein-dehydrogenase-deficiency-etfdh-and-acute-appendicitis-case-report-and-review-of-the-literature
#6
Emmanuel Lilitsis, Elisavet Astyrakaki, Evaggelos Blevrakis, Sofia Xenaki, George Chalkiadakis, Emmanuel Chrysos
BACKGROUND: Mitochondria are the energy producing organelles practically in every human cell except erythrocytes. Indeed mitochondria are widespread in high energy requiring organs like brain, heart and muscles. Currently there are no clinical trials supporting with clear evidence which is the most suitable surgical or anesthetic management of a patient with known mitochondrial disease presenting with surgical disorders. This condition poses possible hazardous problems to the medical attention of those patients...
August 29, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28843460/safety-threats-during-the-care-of-infants-with-hypoglycemic-seizures-in-the-emergency-department-a-multicenter-simulation-based-prospective-cohort-study
#7
Barbara M Walsh, Sandeep Gangadharan, Travis Whitfill, Marcie Gawel, David Kessler, Robert A Dudas, Jessica Katznelson, Megan Lavoie, Khoon-Yen Tay, Melinda Hamilton, Linda L Brown, Vinay Nadkarni, Marc Auerbach
BACKGROUND: Errors in the timely diagnosis and treatment of infants with hypoglycemic seizures can lead to significant patient harm. It is challenging to precisely measure medical errors that occur during high-stakes/low-frequency events. Simulation can be used to assess risk and identify errors. OBJECTIVE: We hypothesized that general emergency departments (GEDs) would have higher rates of deviations from best practices (errors) compared to pediatric emergency departments (PEDs) when managing an infant with hypoglycemic seizures...
August 23, 2017: Journal of Emergency Medicine
https://www.readbyqxmd.com/read/28840947/the-conceptualization-of-childhood-in-north-american-pediatric-dentistry-texts-a-discursive-case-study-analysis
#8
Nora Makansi, Franco A Carnevale, Mary Ellen Macdonald
BACKGROUND: In recent year, conceptions of childhood have been evolving towards an increased recognition of children as active agents, capable of participating in the determination of their wellbeing. In pediatric dentistry, the extent to which these conceptions are being discursively endorsed is not well known. AIM: The aim of this investigation was to examine the discursive construction of childhood in seminal North American pedagogical dentistry materials. DESIGN: We conducted a qualitative discourse analysis of a sample of prominent texts using a sociological discourse analysis approach...
August 25, 2017: International Journal of Paediatric Dentistry
https://www.readbyqxmd.com/read/28837801/pharmacologic-and-nonpharmacologic-treatment-for-acute-cough-associated-with-the-common-cold-chest-expert-panel-report
#9
Mark A Malesker, Priscilla Callahan-Lyon, Belinda Ireland, Richard S Irwin
BACKGROUND: Acute cough associated with the common cold (CACC) causes significant impairment in quality of life. Effective treatment approaches are needed for CACC. We conducted a systematic review on the management of CACC to update the recommendations and suggestions of the CHEST 2006 guideline on this topic. METHODS: This systematic review of randomized controlled trials (RCTs) asked the question: Is there evidence of clinically relevant treatment effects for pharmacologic or nonpharmacologic therapies in reducing the duration/severity of acute CACC? Studies of adults and pediatric patients with CACC were included and assessed for relevance and quality...
August 22, 2017: Chest
https://www.readbyqxmd.com/read/28831924/management-of-antiepileptic-treatment-after-epilepsy-surgery-practices-and-problems
#10
Guido Rubboli, Anne Sabers, Peter Uldall, Kristina Malmgren
BACKGROUND: Although epilepsy surgery is a recognized treatment option for drug-resistant epilepsies since several decades, the management of antiepileptic drugs (AEDs) after successful surgery still remains one of the most difficult and unsolved therapeutic challenges. Indeed, no systematic controlled trials have been specifically conducted so far and no consensus or standardized guidelines regarding postsurgical drug discontinuation policy and procedures are available. METHODS: In this paper, we aim to provide an updated overview on the the present knowledge on this topic, which is based mainly on retrospective studies reporting practices used in individual centers...
August 22, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28831753/pharmacological-management-of-restless-legs-syndrome-and-periodic-limb-movement-disorder-in-children
#11
Geoffrey Rulong, Thomas Dye, Narong Simakajornboon
Restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) are under-recognized sleep disorders in children and adolescents. Several recent epidemiological studies have shown that RLS and PLMD are common in the pediatric population, and if left untreated, may lead to cardiovascular and neurocognitive consequences. Therefore, early diagnosis and intervention may help preventing long-term consequences. The management of RLS and PLMD in children involves both non-pharmacologic and pharmacologic approaches...
August 22, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28830790/increased-delivery-of-chemotherapy-to-the-vitreous-by-inhibition-of-the-blood-retinal-barrier
#12
Guillem Pascual-Pasto, Nagore G Olaciregui, Javier A W Opezzo, Helena Castillo-Ecija, Maria Cuadrado-Vilanova, Sonia Paco, Ezequiel M Rivero, Monica Vila-Ubach, Camilo A Restrepo-Perdomo, Montserrat Torrebadell, Mariona Suñol, Paula Schaiquevich, Jaume Mora, Guillermo F Bramuglia, Guillermo L Chantada, Angel M Carcaboso
Treatment of retinoblastoma -a pediatric cancer of the developing retina- might benefit from strategies to inhibit the blood-retinal barrier (BRB). The potent anticancer agent topotecan is a substrate of efflux transporters BCRP and P-gp, which are expressed at the BRB to restrict vitreous and retinal distribution of xenobiotics. In this work we have studied vitreous and retinal distribution, tumor accumulation and antitumor activity of topotecan, using pantoprazole as inhibitor of BCRP and P-gp. We used rabbit and mouse eyes as BRB models and patient-derived xenografts as retinoblastoma models...
August 19, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28817401/challenges-in-the-anesthetic-management-of-ambulatory-patients-in-the-mri-suites
#13
Jasper Deen, Yzabel Vandevivere, Peter Van de Putte
PURPOSE OF REVIEW: MRI is becoming an indispensable diagnostic tool. The need for prolonged motion-free periods has substantially increased the need for deep sedation or anesthesia in a challenging environment. This review summarises recent literature with respect to pharmacological sedative strategies, nonpharmacological alternative approaches, airway management and safety issues in the ambulatory setting. RECENT FINDINGS: Most literature researches the pediatric patient population...
August 16, 2017: Current Opinion in Anaesthesiology
https://www.readbyqxmd.com/read/28814263/acute-pain-management-in-hospitalized-children
#14
Ria Dancel, Edmund Allen Liles, Darren Fiore
BACKGROUND: Acute pain in hospitalized pediatric patients is prevalent. Recent shifts in the paradigm of pediatric acute pain management focus less on reliance on opioids, due to their adverse side effects and risk of dependence, and more on multimodal pain management. OBJECTIVE: We sought to review the most recent studies on acute pain management in hospitalized pediatric patients. METHODS: We searched the Cochrane Database and PubMed for articles published in the past five years regarding the treatment of acute pain in pediatric patients focusing on large randomized or quasi-randomized control trials, cohort trials, and meta-analyses...
August 16, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/28806766/sublingual-immunotherapy-slit-for-house-dust-mites-does-not-prevent-new-allergen-sensitization-and-bronchial-hyper-responsiveness-in-allergic-rhinitis-children
#15
Jae Hyun Lim, Jin Youp Kim, Doo Hee Han, Chul Hee Lee, Seung-No Hong, Jee Hye Wee, Sue K Park, Chae-Seo Rhee
INTRODUCTION: The aim of this study is to identify the effects of sublingual immunotherapy (SLIT) on immunologic parameters and bronchial-hyper-responsiveness in children with allergic rhinitis to house-dust mite (HDM), through long-term follow-up cohort. METHODS: Among the Allergic Rhinitis Cohort Study for Kids, pediatric patients who visited the hospital for rhinitis symptoms and proven allergy to HDM through skin prick test were studied. In this cohort, 37 patients received SLIT more than 3-years (SLIT group), and 184 patients received only pharmacologic therapy (non-SLIT group) were included in this study...
2017: PloS One
https://www.readbyqxmd.com/read/28804210/efficacy-and-safety-of-alogliptin-in-a-pediatric-patient-with-maturity-onset-diabetes-of-the-young-type-1
#16
Ryosuke Tonouchi, Yusuke Mine, Masako Aoki, Misako Okuno, Junichi Suzuki, Tatsuhiko Urakami
The first-line pharmacological treatment for patients with maturity-onset diabetes of the young type 1 (MODY1) and maturity-onset diabetes of the young type 3 (MODY3) are sulfonylureas (SUs) or insulin. However, several reports have suggested the possibility of using incretin-associated drugs, including dipeptidyl-peptidase-4 (DPP-4) inhibitors, for the treatment of patients with these types of MODY. Here we report a case of a pediatric patient with MODY1 who was successfully treated with a DPP-4 inhibitor, alogliptin...
2017: Clinical Pediatric Endocrinology: Case Reports and Clinical Investigations: Official Journal of the Japanese Society for Pediatric Endocrinology
https://www.readbyqxmd.com/read/28782468/induced-pluripotent-stem-cells-as-a-model-for-therapy-personalization-of-pediatric-patients-disease-modeling-and-drug-adverse-effects-prevention
#17
Elena Genova, Marco Pelin, Katsunori Sasaki, Yue Fengming, Gaetana Lanzi, Stefania Masneri, Alessandro Ventura, Gabriele Stocco, Giuliana Decorti
Understanding the biological and molecular processes underlying human pathologies is fundamental in order to develop innovative approaches to treat or prevent them. Among the technologies that could provide innovative disease models, induced pluripotent stem cells (iPSCs) is one of the most promising. Indeed, one application of iPSCs technology is personalized disease modeling. These cells, obtained by reprogramming patients' cells collected from accessible tissues, have the unique capability to differentiate, under an adequate stimulus, into any human cell type...
August 4, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28777308/key-challenges-in-the-search-for-innovative-drug-treatments-for-special-populations-converging-needs-in-neonatology-pediatrics-and-medical-genetics
#18
Stuart MacLeod
The explosion of knowledge concerning the interplay of genetic and environmental factors determining pathophysiology and guiding therapeutic choice has altered the landscape in pediatric clinical pharmacology and pharmacy. The need for innovative research methods and design expertise for small clinical trials to be undertaken in sparse populations has been accentuated. At the same time, shortfalls in critical human resources represent a key challenge, especially in low- and middle-income countries where the need for new research and education directions is greatest...
August 4, 2017: Children
https://www.readbyqxmd.com/read/28772100/catastrophic-epilepsies-of-childhood
#19
MacKenzie A Howard, Scott C Baraban
The tragedy of epilepsy emerges from the combination of its high prevalence, impact upon sufferers and their families, and unpredictability. Childhood epilepsies are frequently severe, presenting in infancy with pharmaco-resistant seizures; are often accompanied by debilitating neuropsychiatric and systemic comorbidities; and carry a grave risk of mortality. Here, we review the most current basic science and translational research findings on several of the most catastrophic forms of pediatric epilepsy. We focus largely on genetic epilepsies and the research that is discovering the mechanisms linking disease genes to epilepsy syndromes...
July 25, 2017: Annual Review of Neuroscience
https://www.readbyqxmd.com/read/28753596/inhibition-of-i%C3%AE%C2%BAb%C3%AE-nf%C3%AE%C2%BAb-signaling-prevents-lps-induced-il1%C3%AE-expression-without-increasing-apoptosis-in-the-developing-mouse-lung
#20
Sarah McKenna, Brittany Butler, Laurie Jatana, Sankar Ghosh, Clyde J Wright
BackgroundThe pro-inflammatory consequences of IL1β expression contribute to the pathogenesis of bronchopulmonary dysplasia. Selectively targeting Lipopolysaccharide (LPS)-induced IκBβ/NFκB signaling attenuates IL1β mRNA expression in macrophages. Whether targeting IκBβ/NFκB signaling affects the anti-apoptotic gene expression, a known consequence of global LPS-induced NFκB inhibition, is unknown.MethodsMacrophages (RAW 264.7, bone marrow-derived macrophage) were assessed for LPS-induced IL1β mRNA/protein expression, anti-apoptotic gene expression, cell viability (trypan blue exclusion), and activation of apoptosis (caspase-3 and PARP cleavage) following pharmacologic and genetic attenuation of IκBβ/NFκB signaling...
August 23, 2017: Pediatric Research
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