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Children and clinical trials

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https://www.readbyqxmd.com/read/27907034/budget-impact-of-long-acting-insulin-analogues-the-case-in-brazil
#1
Fernanda O Laranjeira, Everton Nunes da Silva, Maurício G Pereira
BACKGROUND: Long-acting insulin analogues for type 1 diabetes (T1D) treatment have been available on the Brazilian market since 2002. However, the population cannot access the analogues through the public health system. OBJECTIVE: To estimate the incremental budget impact of long-acting insulin analogues coverage for T1D patients in the Brazilian public health system compared to NPH insulin. METHODS: We performed a budget impact analysis of a five-year period...
2016: PloS One
https://www.readbyqxmd.com/read/27906719/diagnosis-of-cardiac-surgery-associated-acute-kidney-injury-from-functional-to-damage-biomarkers
#2
Wim Vandenberghe, Jorien De Loor, Eric A J Hoste
PURPOSE OF REVIEW: Acute kidney injury (AKI) occurs in up to 30% after cardiac surgery and is associated with adverse outcome. Currently, cardiac surgery-associated acute kidney injury (CSA-AKI) is diagnosed by Kidney Disease: Improving Global Outcomes criteria based on creatinine and urine output. To detect and treat AKI earlier, various biomarkers have been evaluated. This review addresses the current position of the two damage biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and [TIMP-2] [IGFBP7] in clinical practice...
November 30, 2016: Current Opinion in Anaesthesiology
https://www.readbyqxmd.com/read/27905678/a-phase-i-ii-trial-of-at9283-a-selective-inhibitor-of-aurora-kinase-in-children-with-relapsed-or-refractory-acute-leukemia-challenges-to-run-early-phase-clinical-trials-for-children-with-leukemia
#3
B Vormoor, G J Veal, M J Griffin, A V Boddy, J Irving, L Minto, M Case, U Banerji, K E Swales, J R Tall, A S Moore, M Toguchi, G Acton, K Dyer, C Schwab, C J Harrison, J D Grainger, D Lancaster, P Kearns, D Hargrave, J Vormoor
Aurora kinases regulate mitosis and are commonly overexpressed in leukemia. This phase I/IIa study of AT9283, a multikinase inhibitor, was designed to identify maximal tolerated doses, safety, pharmacokinetics, and pharmacodynamic activity in children with relapsed/refractory acute leukemia. The trial suffered from poor recruitment and terminated early, therefore failing to identify its primary endpoints. AT9283 caused tolerable toxicity, but failed to show clinical responses. Future trials should be based on robust preclinical data that provide an indication of which patients may benefit from the experimental agent, and recruitment should be improved through international collaborations and early combination with established treatment strategies...
December 1, 2016: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/27904616/effect-of-folic-acid-and-metformin-on-insulin-resistance-and-inflammatory-factors-of-obese-children-and-adolescents
#4
Elham Hashemi Dehkordi, Farnaz Sattari, Abolfazl Khoshdel, Karamali Kasiri
BACKGROUND: Considering the increasing trend of obesity, especially in developing countries such as Iran, and the role of inflammatory factors and insulin resistance (IR) in the occurrence of obesity-related complications as well as the safety of some agents such as folic acid and metformin, this clinical trial was designed to investigate the effect of metformin and folic acid on inflammatory factors and IR among obese children. MATERIALS AND METHODS: In this randomized, double-blind, controlled clinical trial study, sixty obese children aged 6-12 years were enrolled...
2016: Journal of Research in Medical Sciences: the Official Journal of Isfahan University of Medical Sciences
https://www.readbyqxmd.com/read/27904542/the-effect-of-brushing-with-a-soft-toothbrush-and-distilled-water-on-the-incidence-of-ventilator-associated-pneumonia-in-the-intensive-care-unit
#5
Khadijeh Nasiriani, Fakhri Torki, Mohammad Hossein Jarahzadeh, Fahimeh Rashidi Maybodi
BACKGROUND: Ventilator-associated pneumonia (VAP) is a common nosocomial infection, which results in longer hospitalization, increased treatment costs, and higher mortality rates. One major cause of VAP is colonization and microaspiration of oropharyngeal secretions following the formation of dental plaque, which is due to poor oral hygiene and failure to mechanically remove these microorganisms from the teeth. This study was conducted to determine the effect of brushing teeth with distilled water on the incidence of VAP in patients admitted to intensive care unit (ICU)...
2016: Tanaffos
https://www.readbyqxmd.com/read/27903788/treatment-of-adenoviral-acute-respiratory-distress-syndrome-using-cidofovir-with-extracorporeal-membrane-oxygenation-case-series-and-literature-review
#6
Minhyeok Lee, Seulgi Kim, Oh Jung Kwon, Ji Hye Kim, Inbeom Jeong, Ji Woong Son, Moon Jun Na, Yoo Sang Yoon, Hyun Woong Park, Sun Jung Kwon
Adenovirus infections are associated with respiratory (especially upper respiratory) infection and gastrointestinal disease and occur primarily in infants and children. Although rare in adults, severe lower respiratory adenovirus infections including pneumonia are reported in specific populations, such as military recruits and immunocompromised patients. Antiviral treatment is challenging due to limited clinical experience and lack of well-controlled randomized trials. Several previously reported cases of adenoviral pneumonia showed promising efficacy of cidofovir...
November 30, 2016: Journal of Intensive Care Medicine
https://www.readbyqxmd.com/read/27903593/respiratory-syncytial-virus-infection-detection-and-new-options-for-prevention-and-treatment
#7
REVIEW
Cameron Griffiths, Steven J Drews, David J Marchant
Respiratory syncytial virus (RSV) infection is a significant cause of hospitalization of children in North America and one of the leading causes of death of infants less than 1 year of age worldwide, second only to malaria. Despite its global impact on human health, there are relatively few therapeutic options available to prevent or treat RSV infection. Paradoxically, there is a very large volume of information that is constantly being refined on RSV replication, the mechanisms of RSV-induced pathology, and community transmission...
January 2017: Clinical Microbiology Reviews
https://www.readbyqxmd.com/read/27903282/start-now-a-comprehensive-skills-training-programme-for-female-adolescents-with-oppositional-defiant-and-conduct-disorders-study-protocol-for-a-cluster-randomised-controlled-trial
#8
Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M Freitag, Robert L Trestman, Christina Stadler
BACKGROUND: In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands...
December 1, 2016: Trials
https://www.readbyqxmd.com/read/27901353/can-new-chemical-therapies-improve-the-management-of-multiple-sclerosis-in-children
#9
Emanuele D'Amico, Aurora Zanghì, Francesco Patti
Pediatric multiple sclerosis (MS) may represent up to 10% of all MS cases. Establishing the diagnosis of MS in a child is complicated by the limited diagnostic criteria and the possibility of significant overlap with acute disseminated encephalomyelitis. Areas covered: This review puts in perspective the potential possibilities given by new pharmacological agents in pediatric MS; focusing on the unmet needs in terms of research development in this field. Expert Opinion: The treatment landscape of MS has dramatically changed in the last 5 years...
November 30, 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27900529/effectiveness-of-pit-and-fissure-sealants-bonded-with-different-adhesive-systems-a-prospective-randomized-controlled-trial
#10
Gizem Erbas Unverdi, Stephan Atilla Atac, Zafer Cavit Cehreli
OBJECTIVES: To evaluate and compare the clinical retention of a resin-based fissure sealant placed with an intermediate layer of etch-and-rinse (ER) or self-etch (SE) adhesives. MATERIALS AND METHODS: Two hundred twenty-eight sealants were placed in 57 children with previously unsealed, caries-free permanent first molars, employing a split-mouth design. The teeth were randomized into four groups (n = 57 teeth/groups) according to the adhesive system placed under the tested sealant (Delton FS+; Dentsply)...
November 30, 2016: Clinical Oral Investigations
https://www.readbyqxmd.com/read/27899082/interventions-to-improve-gross-motor-performance-in-children-with-neurodevelopmental-disorders-a-meta-analysis
#11
Barbara R Lucas, Elizabeth J Elliott, Sarah Coggan, Rafael Z Pinto, Tracy Jirikowic, Sarah Westcott McCoy, Jane Latimer
BACKGROUND: Gross motor skills are fundamental to childhood development. The effectiveness of current physical therapy options for children with mild to moderate gross motor disorders is unknown. The aim of this study was to systematically review the literature to investigate the effectiveness of conservative interventions to improve gross motor performance in children with a range of neurodevelopmental disorders. METHODS: A systematic review with meta-analysis was conducted...
November 29, 2016: BMC Pediatrics
https://www.readbyqxmd.com/read/27898605/initial-results-of-a-safety-and-feasibility-study-of-auditory-brainstem-implantation-in-congenitally-deaf-children
#12
Eric P Wilkinson, Laurie S Eisenberg, Mark D Krieger, Marc S Schwartz, Margaret Winter, Jamie L Glater, Amy S Martinez, Laurel M Fisher, Robert V Shannon
OBJECTIVE: To determine the safety and feasibility of the auditory brainstem implant (ABI) in congenitally deaf children with cochlear aplasia and/or cochlear nerve deficiency. STUDY DESIGN: Phase I feasibility clinical trial of surgery in 10 children, ages 2 to 5 years, over a 3-year period. SETTING: Tertiary children's hospital and university-based pediatric speech/language/hearing center. INTERVENTION(S): ABI implantation and postsurgical programming...
November 24, 2016: Otology & Neurotology
https://www.readbyqxmd.com/read/27898175/interventions-for-promoting-participation-in-shared-decision-making-for-children-with-cancer
#13
REVIEW
Imelda Coyne, Dónal P O'Mathúna, Faith Gibson, Linda Shields, Edith Leclercq, Greg Sheaf
BACKGROUND: This is an update of the Cochrane systematic review of shared decision-making (SMD) making published in 2013. Children's rights to have their views heard in matters that affect their lives are now well established since the publication of the UN Convention treaty (1989). Children with cancer generally prefer to be involved in decision-making and consider it important that they have the opportunity to take part in decision-making concerning their health care, even in end-of-life decisions...
November 29, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27896933/feasibility-and-clinical-integration-of-molecular-profiling-for-target-identification-in-pediatric-solid-tumors
#14
Thomas Pincez, Nathalie Clément, Eve Lapouble, Gaëlle Pierron, Maud Kamal, Ivan Bieche, Virginie Bernard, Paul Fréneaux, Jean Michon, Daniel Orbach, Isabelle Aerts, Hélène Pacquement, Franck Bourdeaut, Irene Jiménez, Estelle Thébaud, Caroline Oudot, Cécile Vérité, Sophie Taque, Cormac Owens, François Doz, Christophe Le Tourneau, Olivier Delattre, Gudrun Schleiermacher
BACKGROUND: The role of tumor molecular profiling in directing targeted therapy utilization remains to be defined for pediatric tumors. We aimed to evaluate the feasibility of a sequencing and molecular biology tumor board (MBB) program, and its clinical impact on children with solid tumors. PROCEDURE: We report on a single-center MBB experience of 60 pediatric patients with a poor prognosis or relapsed/refractory solid tumors screened between October 2014 and November 2015...
November 29, 2016: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/27896811/measuring-changes-of-manual-ability-with-abilhand-kids-following-intensive-training-for-children-with-unilateral-cerebral-palsy
#15
Yannick Bleyenheuft, Andrew M Gordon, Eugène Rameckers, Jean-Louis Thonnard, Carlyne Arnould
AIM: ABILHAND-Kids is a parent-reported questionnaire measuring manual ability in children with cerebral palsy (CP). Its psychometric properties have been established, with the exception of responsiveness, which is examined here. METHOD: In this cohort study, 98 children (46 males, 52 females; range 6-19y, mean 11y, standard deviation [SD] 3.3y) with unilateral CP underwent three assessments of upper extremity function: at baseline (T1); after 80 to 90 hours of intensive training (T2); and at follow-up (T3)...
November 29, 2016: Developmental Medicine and Child Neurology
https://www.readbyqxmd.com/read/27894435/pediatric-appendicitis
#16
REVIEW
Rebecca M Rentea, Shawn D St Peter
Appendicitis is one of the most common surgical pathologies in children. It can present with right lower quadrant pain. Scoring systems in combination with selective imaging and surgical examination will diagnose most children with appendicitis. Clinical pathways should be used. Most surgical interventions for appendicitis are now almost exclusively laparoscopic, with trials demonstrating better outcomes for children who undergo index hospitalization appendectomies when perforated. Nonoperative management has a role in the treatment of both uncomplicated and complicated appendicitis...
February 2017: Surgical Clinics of North America
https://www.readbyqxmd.com/read/27893955/using-a-patient-centered-outcome-measure-to-test-methylphenidate-versus-placebo-in-children-with-autism-spectrum-disorder
#17
Lawrence Scahill, Karen Bearss, Rena Sarhangian, Christopher J McDougle, L Eugene Arnold, Michael G Aman, James T McCracken, Elaine Tierney, Scott Gillespie, Valentina Postorino, Benedetto Vitiello
OBJECTIVES: Parent rating scales are commonly used to evaluate change in clinical trials. Despite advantages, these measures may not capture parental impression of the child's most salient problems. We examine the use of parent target problems (PTPs) in a randomized trial of methylphenidate (MPH) in children with autism spectrum disorder and symptoms of attention-deficit/hyperactivity disorder. METHODS: This multisite, 4-week, randomized crossover trial compared three dose levels (low, medium, and high) of MPH with placebo...
November 28, 2016: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/27893880/protective-prevention-effects-on-the-association-of-poverty-with-brain-development
#18
Gene H Brody, Joshua C Gray, Tianyi Yu, Allen W Barton, Steven R H Beach, Adrianna Galván, James MacKillop, Michael Windle, Edith Chen, Gregory E Miller, Lawrence H Sweet
Importance: This study was designed to determine whether a preventive intervention focused on enhancing supportive parenting could ameliorate the association between exposure to poverty and brain development in low socioeconomic status African American individuals from the rural South. Objective: To determine whether participation in an efficacious prevention program designed to enhance supportive parenting for rural African American children will ameliorate the association between living in poverty and reduced hippocampal and amygdalar volumes in adulthood...
November 28, 2016: JAMA Pediatrics
https://www.readbyqxmd.com/read/27893870/associations-between-hydration-status-intravenous-fluid-administration-and-outcomes-of-patients-infected-with-shiga-toxin-producing-escherichia-coli-a-systematic-review-and-meta-analysis
#19
Silviu Grisaru, Jianling Xie, Susan Samuel, Lisa Hartling, Phillip I Tarr, David Schnadower, Stephen B Freedman
Importance: The associations between hydration status, intravenous fluid administration, and outcomes of patients infected with Shiga toxin-producing Escherichia coli (STEC) remain unclear. Objective: To determine the relationship between hydration status, the development and severity of hemolytic uremic syndrome (HUS), and adverse outcomes in STEC-infected individuals. Data Sources: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials via the OvidSP platform, PubMed via the National Library of Medicine, CINAHL Plus with full text, Scopus, Web of Science, ClinicalTrials...
November 28, 2016: JAMA Pediatrics
https://www.readbyqxmd.com/read/27889809/reversal-of-type-2-diabetes-in-youth-who-adhere-to-a-very-low-energy-diet-a-pilot-study
#20
Megan L Gow, Louise A Baur, Nathan A Johnson, Chris T Cowell, Sarah P Garnett
AIMS/HYPOTHESIS: The aim of the study was to investigate whether a very-low-energy diet (VLED) is a feasible and acceptable treatment option for type 2 diabetes in children and adolescents, and whether adherence can lead to rapid weight loss, reversal of type 2 diabetes and reduced liver fat as seen in adult studies. METHODS: Eight participants with type 2 diabetes and obesity, aged 7-16 years, non-medicated (n = 1) or treated with metformin (n = 7) and in some cases insulin (n = 3), followed a VLED (<3360 kJ/day) for 8 weeks, then transitioned to a hypocaloric diet (∼6300 kJ/day) that they followed to 34 weeks...
November 26, 2016: Diabetologia
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