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Children and clinical trials

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https://www.readbyqxmd.com/read/29040598/effect-of-metformin-on-vascular-function-in-children-with-type-1-diabetes-a-12-month-randomized-controlled-trial
#1
Jemma J A Anderson, Jennifer J Couper, Lynne C Giles, Catherine E Leggett, Roger Gent, Brian Coppin, Alexia S Peña
Context: Children with type 1 diabetes have vascular dysfunction preceding atherosclerosis. Early interventions are needed to reduce cardiovascular disease. Objective: To evaluate the effect of metformin on vascular function in type 1 diabetes children. Design: 12 month double blind, randomized, placebo-controlled trial. Setting: Tertiary pediatric diabetes clinic. Participants: 90 type 1 diabetes children(8-18 years), above 50th percentile body mass index (BMI)...
October 9, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29039999/treatment-and-survival-of-childhood-neuroblastoma-evidence-from-a-population-based-study-in-the-united-states
#2
Dairmuid Coughlan, Matthew Gianferante, Charles F Lynch, Jennifer L Stevens, Linda C Harlan
BACKGROUND: Childhood neuroblastoma describes a heterogeneous group of extracranial solid tumors, that are treated per risk profile. We sought to describe treatment patterns and survival using population-based data from throughout the United States. MATERIALS AND METHODS: Using the National Cancer Institute (NCI)'s Patterns of Care data, we analyzed treatment provided to newly diagnosed, histologically confirmed neuroblastoma patients in 2010 and 2011, registered to one of 14 Surveillance, Epidemiology, and End Results (SEER) cancer registries...
October 17, 2017: Pediatric Hematology and Oncology
https://www.readbyqxmd.com/read/29034782/the-comparative-epidemiology-of-pediatric-severe-sepsis
#3
Mary E Hartman, Mohammed J Saeed, Kimberly N Powell, Margaret A Olsen
OBJECTIVE: To determine whether the coding strategies used to identify severe sepsis in administrative data sets could identify cases with comparable case mix, hospitalization characteristics, and outcomes as a cohort of children diagnosed with severe sepsis using strict clinical criteria. METHODS: We performed a retrospective cohort study using data from 2005 to 2011 from the New York and Florida State Inpatient Databases, available from the US Healthcare Cost and Utilization Project...
January 1, 2017: Journal of Intensive Care Medicine
https://www.readbyqxmd.com/read/29034009/a-multicenter-randomized-study-of-decitabine-as-epigenetic-priming-with-induction-chemotherapy-in-children-with-aml
#4
Lia Gore, Timothy J Triche, Jason E Farrar, Daniel Wai, Christophe Legendre, Gerald C Gooden, Winnie S Liang, John Carpten, David Lee, Frank Alvaro, Margaret E Macy, Carola Arndt, Philip Barnette, Todd Cooper, Laura Martin, Aru Narendran, Jessica Pollard, Soheil Meshinchi, Jessica Boklan, Robert J Arceci, Bodour Salhia
BACKGROUND: Decitabine is a deoxycytidine nucleoside derivative inhibitor of DNA-methyltransferases, which has been studied extensively and is approved for myelodysplastic syndrome in adults but with less focus in children. Accordingly, we conducted a phase 1 multicenter, randomized, open-label study to evaluate decitabine pre-treatment before standard induction therapy in children with newly diagnosed AML to assess safety and tolerability and explore a number of biologic endpoints. RESULTS: Twenty-four patients were fully assessable for all study objectives per protocol (10 in Arm A = epigenetic priming induction, 14 in Arm B = standard induction)...
2017: Clinical Epigenetics
https://www.readbyqxmd.com/read/29033302/the-antimicrobial-susceptibility-of-helicobacter-pylori-in-strains-isolated-from-children-in-israel
#5
Nina Pastukh, Avi Peretz, Diana Brodsky, Natlya Isakovich, Maya Azrad, Avi On
BACKGROUND: Helicobacter pylori is a pathogen that causes inflammation in the gastric mucosa, and may lead to a peptic ulcer, perforation, or malignancy. Children are at risk of contracting H. pylori and developing subsequent morbidity. In children, diagnosis and management are difficult and merit a different approach than with adults. OBJECTIVE: To describe resistance rates of H. pylori to antibiotics such as amoxicillin, tetracycline, clarithromycin, metronidazole, levofloxacin, and Rifampicin...
October 12, 2017: Journal of Global Antimicrobial Resistance
https://www.readbyqxmd.com/read/29033034/antimicrobial-resistance-among-children-in-sub-saharan-africa
#6
REVIEW
Phoebe C M Williams, David Isaacs, James A Berkley
Antimicrobial resistance is an important threat to international health. Therapeutic guidelines for empirical treatment of common life-threatening infections depend on available information regarding microbial aetiology and antimicrobial susceptibility, but sub-Saharan Africa lacks diagnostic capacity and antimicrobial resistance surveillance. We systematically reviewed studies of antimicrobial resistance among children in sub-Saharan Africa since 2005. 18 of 1075 articles reviewed met inclusion criteria, providing data from 67 451 invasive bacterial isolates from inconsistently defined populations in predominantly urban tertiary settings...
October 9, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29033032/ring-vaccination-with-rvsv-zebov-under-expanded-access-in-response-to-an-outbreak-of-ebola-virus-disease-in-guinea-2016-an-operational-and-vaccine-safety-report
#7
Pierre-Stéphane Gsell, Anton Camacho, Adam J Kucharski, Conall H Watson, Aminata Bagayoko, Severine Danmadji, Natalie E Dean, Abdourahamane Diallo, Abdourahmane Diallo, Honora Djidonou, Moussa Doumbia, Godwin Enwere, Elizabeth S Higgs, Thomas Mauget, Diakite Mory, Ximena Riveros, Fofana Thierno Oumar, Alhassane Toure, Andrea S Vicari, Ira M Longini, W J Edmunds, Ana Maria Henao-Restrepo, Marie Paule Kieny, Sakoba Kéïta
BACKGROUND: In March, 2016, a flare-up of Ebola virus disease was reported in Guinea, and in response ring vaccination with the unlicensed rVSV-ZEBOV vaccine was introduced under expanded access, the first time that an Ebola vaccine has been used in an outbreak setting outside a clinical trial. Here we describe the safety of rVSV-ZEBOV candidate vaccine and operational feasibility of ring vaccination as a reactive strategy in a resource-limited rural setting. METHODS: Approval for expanded access and compassionate use was rapidly sought and obtained from relevant authorities...
October 9, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29031582/validation-of-a-shortened-version-of-the-children-s-eating-behavior-questionnaire-and-associations-with-bmi-in-a-clinical-sample-of-latino-children
#8
Alma I Behar, Noe C Crespo, Melawhy L Garcia, Guadalupe X Ayala, Nadia Campbell, Lisa M Shadron, John P Elder
OBJECTIVE: To examine the validity of the Children's Eating Behavior Questionnaire (CEBQ) through the associations of its 3 subscale scores (food responsiveness, slowness in eating, and satiety responsiveness) with body mass index (BMI). DESIGN: Cross-sectional study of baseline data from a clinic-based obesity prevention and control randomized controlled trial. PARTICIPANTS: Latino pediatric patients (n = 295) aged 5-11 years from a federally qualified health center in San Diego County, CA, with BMI percentiles ranging from 75...
October 11, 2017: Journal of Nutrition Education and Behavior
https://www.readbyqxmd.com/read/29030411/global-shortage-of-neonatal-and-paediatric-antibiotic-trials-rapid-review
#9
Georgina Thompson, Charlotte I Barker, Laura Folgori, Julia A Bielicki, John S Bradley, Irja Lutsar, Mike Sharland
OBJECTIVES: There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. METHODS: Studies were identified using key word searches of the ClinicalTrials...
October 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/29030176/physiologically-based-pharmacokinetic-modeling-of-disposition-and-drug-drug-interactions-for-valproic-acid-and-divalproex
#10
Todd M Conner, Vahagn C Nikolian, Patrick E Georgoff, Manjunath P Pai, Hasan B Alam, Duxin Sun, Ronald C Reed, Tao Zhang
Valproic acid (VPA) is an older first-line antiepileptic drug with a complex pharmacokinetic (PK) profile, currently under investigation for several novel neurologic and non-neurologic indications. Our study objective was to design and validate a mechanistic model of VPA disposition in adults and children; and evaluate its predictive performance of drug-drug interactions (DDIs). This study expands upon existing physiologically based pharmacokinetic (PBPK) models for VPA by incorporating UGT enzyme kinetics and an advanced dissolution, absorption, and metabolism (ADAM) model for extended-release (ER) formulation...
October 10, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29029938/dengvaxia-sensitizes-seronegatives-to-vaccine-enhanced-disease-regardless-of-age
#11
Scott B Halstead
During a large scale clinical efficacy trial of the Sanofipasteur live-attenuated tetravalent dengue vaccine (Dengvaxia), features of hospitalized disease accompanying dengue infections in placebo recipients were closely similar to those in vaccinated children. However, the age specific hospitalization curves for these two populations differed. The curve for children vaccinated at ages 2-16 years closely resembled the 1981 age specific hospitalization rate curve for Cuban children infected with DENV 2 who were sensitized by a prior DENV 1 infection...
October 10, 2017: Vaccine
https://www.readbyqxmd.com/read/29029798/effect-of-intravenous-ondansetron-on-qtc-interval-in-children-with-gastroenteritis
#12
Robert J Hoffman, Khalid Alansari
BACKGROUND: The potential for ondansetron to cause QT prolongation and fatal dysrhythmia is well-reported, including a 2011 FDA report on the topic. Few clinical trials evaluating this phenomenon in the ED setting exist, and only one is pediatric. OBJECTIVE: We have sought to determine the effect of a standardized dose of intravenous ondansetron on the QTc duration of children under 14years of age treated for gastroenteritis-associated vomiting in a pediatric ED...
October 4, 2017: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/29029679/investigating-habituation-to-premonitory-urges-in-behavior-therapy-for-tic-disorders
#13
David C Houghton, Matthew R Capriotti, Lawrence D Scahill, Sabine Wilhelm, Alan L Peterson, John T Walkup, John Piacentini, Douglas W Woods
Behavior therapy is effective for Persistent Tic Disorders (PTDs), but behavioral processes facilitating tic reduction are not well understood. One process, habituation, is thought to create tic reduction through decreases in premonitory urge severity. The current study tested whether premonitory urges decreased in youth with PTDs (N = 126) and adults with PTDs (N = 122) who participated in parallel randomized clinical trials comparing behavior therapy to psychoeducation and supportive therapy (PST). Trends in premonitory urges, tic severity, and treatment outcome were analyzed according to the predictions of a habituation model, whereby urge severity would be expected to decrease in those who responded to behavior therapy...
November 2017: Behavior Therapy
https://www.readbyqxmd.com/read/29029629/effects-of-age-and-gender-on-reference-levels-of-biomarkers-comprising-the-pediatric-renal-activity-index-for-lupus-nephritis-p-rail
#14
Michael R Bennett, Qing Ma, Jun Ying, Prasad Devarajan, Hermine Brunner
BACKGROUND: Systemic Lupus Erythematosus (SLE) is a multisystem autoimmune disease that disproportionately effects women and children of minorities. Renal involvement (lupus nephritis, or LN) occurs in up to 80% of children with SLE and is a major determinant of poor prognosis. We have developed a non-invasive pediatric Renal Activity Index for Lupus (p-RAIL) that consists of laboratory measures that reflect histologic LN activity. These markers are neutrophil gelatinase associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), monocyte chemotactic protein (MCP-1), adiponectin (APN), ceruloplasmin (CP) and hemopexin (HPX)...
October 13, 2017: Pediatric Rheumatology Online Journal
https://www.readbyqxmd.com/read/29029518/meta-analysis-of-the-clinical-characteristics-and-prognostic-relevance-of-notch1-and-fbxw7-mutation-in-t-cell-acute-lymphoblastic-leukemia
#15
Rong-Bin Liu, Jian-Gui Guo, Tian-Ze Liu, Cheng-Cheng Guo, Xin-Xiang Fan, Xiao Zhang, Wei-Han Hu, Xiu-Yu Cai
The NOTCH1 signaling pathway is crucial for T-cell development, and NOTCH1 and/or FBXW7 mutations are frequently detected in T-cell acute lymphoblastic leukemia (T-ALL). We performed a systematic review and meta-analysis of 18 randomized controlled trials (RCTs) to assess the prognostic impact of mutations in the NOTCH1 pathway. After retrieving relevant articles from PubMed, EMBASE, and the Cochrane Library, we investigated overall survival (OS) and event-free survival (EFS) with hazard ratios (HRs) using fixed-effects or random-effects models and conducted subgroup analyses based on population and mutation status...
September 12, 2017: Oncotarget
https://www.readbyqxmd.com/read/29029393/intermittent-treatment-with-farnesyltransferase-inhibitor-and-sulforaphane-improves-cellular-homeostasis-in-hutchinson-gilford-progeria-fibroblasts
#16
Diana Gabriel, Dinah Dorith Shafry, Leslie B Gordon, Karima Djabali
Hutchinson-Gilford progeria syndrome (HGPS) is a rare genetic condition associated with mutations in the LMNA gene. This disease recapitulates some aspects of normal aging, such as hair loss, thin skin, joint stiffness, and atherosclerosis. The latter leads to heart attack or stroke that causes death at an average age of 14.6 years in children with HGPS. The typical LMNA mutation results in the production of a truncated prelamin A protein, progerin, that remains permanently farnesylated and abnormally associated with the nuclear envelope...
September 12, 2017: Oncotarget
https://www.readbyqxmd.com/read/29028980/influenza-among-young-children-in-bangladesh-clinical-characteristics-and-outcomes-from-a-randomized-clinical-trial
#17
Elizabeth Rotrosen, K Zaman, Jodi Feser, Justin R Ortiz, Doli Goswami, Amina Tahia Sharmeen, Mustafizur Rahman, Kristen D C Lewis, Md Ziaur Rahman, Burc Barin, W Abdullah Brooks, Kathleen M Neuzil
Background: Influenza causes substantial morbidity in children worldwide, although influenza vaccine is seldom used in low-resource settings. More information on the clinical presentation of influenza and the efficacy of vaccine is needed to inform policy. Methods: In 2013 we conducted a randomized, placebo-controlled clinical trial of live attenuated influenza vaccine (LAIV) in children aged 24-59 months in Bangladesh (N = 1761). If participants met prespecified specimen collection criteria, we collected nasopharyngeal washes for testing by singleplex reverse-transcription polymerase chain reaction (RT-PCR) for laboratory-confirmed influenza virus infection (LCI)...
October 6, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29028159/serologically-diagnosed-acute-human-bocavirus-1-infection-in-childhood-community-acquired-pneumonia
#18
Amanda C Nascimento-Carvalho, Ana-Luisa Vilas-Boas, Maria-Socorro H Fontoura, Man Xu, Tytti Vuorinen, Maria Söderlund-Venermo, Olli Ruuskanen, Cristiana M Nascimento-Carvalho
AIM: To assess the role of human bocavirus 1 (HBoV1) as a causative agent of non-severe community-acquired pneumonia (CAP) in children. METHODS: Patients aged 2-59 months with non-severe CAP (respiratory complaints and radiographic pulmonary infiltrate/consolidation) attending a University Hospital in Salvador, Brazil were enrolled in a prospective cohort. From 820 recruited children in a clinical trial (ClinicalTrials.gov NCT01200706), nasopharyngeal aspirate (NPA), and acute and convalescent serum samples were obtained from 759 (92...
October 13, 2017: Pediatric Pulmonology
https://www.readbyqxmd.com/read/29028128/diagnostic-accuracy-of-magnetic-resonance-imaging-hepatic-proton-density-fat-fraction-in-pediatric-nonalcoholic-fatty-liver-disease
#19
Michael S Middleton, Mark L Van Natta, Elhamy R Heba, Adina Alazraki, Andrew T Trout, Prakash Masand, Elizabeth M Brunt, David E Kleiner, Edward Doo, James Tonascia, Joel E Lavine, Wei Shen, Gavin Hamilton, Jeffrey B Schwimmer, Claude B Sirlin
We assessed the performance of magnetic resonance imaging (MRI) proton density fat fraction (PDFF) in children to stratify hepatic steatosis grade before and after treatment in the Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease in Children (CyNCh) trial, using centrally-scored histology as reference. Participants had multi-echo 1.5T or 3T MRI on scanners from three manufacturers. Of 169 enrolled children, 110 (65%) and 83 (49%) had MRI and liver biopsy at baseline and at end-of-treatment (EOT; 52-weeks), respectively...
October 13, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29027824/a-computable-phenotype-for-asthma-case-identification-in-adult-and-pediatric-patients-external-validation-in-the-chicago-area-patient-outcomes-research-network-capricorn
#20
Majid Afshar, Valerie G Press, Rachel G Robison, Abel N Kho, Sindhura Bandi, Ashvini Biswas, Pedro C Avila, Harsha Vardhan Madan Kumar, Byung Yu, Edward T Naureckas, Sharmilee M Nyenhuis, Christopher D Codispoti
OBJECTIVE: Comprehensive, rapid, and accurate identification of patients with asthma for clinical care and engagement in research efforts is needed. The original development and validation of a computable phenotype for asthma case identification occurred at a single institution in Chicago and demonstrated excellent test characteristics. However, its application in a diverse payer mix, across different health systems and multiple electronic health record vendors, and in both children and adults was not examined...
October 13, 2017: Journal of Asthma: Official Journal of the Association for the Care of Asthma
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