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Clinical application of magnetic resonance elastography in pediatric neurological disorders
Magnetic resonance elastography is a relatively new, rapidly evolving quantitative magnetic resonance imaging technique which can be used for map**...
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Patient engagement in clinical trial design for rare neuromuscular disorders: impact on the DELIVER and ACHIEVE clinical trials
BackgroundEngaging individuals living with disease in drug development and regulatory processes leads to more thoughtful and sensitive trial designs,...
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Evolution of clinical and translational advances in the management of pediatric arteriovenous malformations
Arteriovenous malformations (AVMs) represent one of the most challenging diagnoses in pediatric neurosurgery. Until recently, the majority of AVMs...
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Approaches for Discussing Clinical Trials with Pediatric Oncology Patients and Their Families
Purpose of ReviewThis manuscript aims to describe evidence-based best practices to guide clinicians in communicating with pediatric patients and...
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Cardiac Magnetic Resonance Imaging to Determine Single Ventricle Function in a Pediatric Population is Feasible in a Large Trial Setting: Experience from the Single Ventricle Reconstruction Trial Longitudinal Follow up
The Single Ventricle Reconstruction (SVR) Trial was a randomized prospective trial designed to determine survival advantage of the modified...
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Completeness and accuracy of digital charting vs paper charting in simulated pediatric cardiac arrest: a randomized controlled trial
ObjectivesTo determine if data collected through digital charting are more complete and more accurate compared to traditional paper-based charting...
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The Cure SMA Clinical Trial Experience Survey: A Study of Trial Participant Perspectives on Clinical Trial Management and Patient-Centric Management Practices
IntroductionUnderstanding clinical trial experiences can illuminate opportunities to optimize trial design and management, with potential benefits...
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The Investigational Clinical Center: a clinical-supportive and patient-centered trial unit model. Ten years of experience through normal and pandemic times of a large pediatric trial center in Italy
Evidence-based medicine relies on appropriately designed, conducted and reported clinical trials (CTs) to provide the best proofs of efficacy and...
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Bayesian adaptive design for pediatric clinical trials incorporating a community of prior beliefs
BackgroundPediatric population presents several barriers for clinical trial design and analysis, including ethical constraints on the sample size and...
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Randomized controlled open-label trial to evaluate prioritization software for the secondary triage of patients in the pediatric emergency department
BackgroundThe continual increase in patient attendance at the emergency department (ED) is a worldwide health issue. The aim of this study was to...
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Pediatric biobanks to enhance clinical and translational research for children
Including children in biomedical research is an argument for continual reflection and practice refinement from an ethical and legal standpoint....
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Comparing the Effectiveness of a Clinical Decision Support Tool in Reducing Pediatric Opioid Dose Calculation Errors: PediPain App vs. Traditional Calculators – A Simulation-Based Randomised Controlled Study
Wrong dose calculation medication errors are widespread in pediatric patients mainly due to weight-based dosing. PediPain app is a clinical decision...
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Open versus Closed Suctioning Among Mechanically Ventilated Pediatric Patients: A Randomised Control Trial
ObjectivesTo compare the difference in efficacy of closed tracheal suction system (CTSS) to open tracheal suction system (OTSS) in reducing incidence...
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Comparisons of fentanyl and sufentanil on recovery time after inguinal hernia repair in children: a randomized clinical trial
BackgroundInguinal hernia repair is a common pediatric procedure. We studied postoperative recovery times in children undergoing laparoscopic...
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Initial dysnatremia and clinical outcomes in pediatric traumatic brain injury: a multicenter observational study
PurposeWe aimed to investigate the association between initial dysnatremia (hyponatremia and hypernatremia) and in-hospital mortality, as well as...
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Use of a real-time risk-prediction model to identify pediatric patients at risk for thromboembolic events: study protocol for the Children’s Likelihood Of Thrombosis (CLOT) trial
BackgroundPediatric patients have increasing rates of hospital-associated venous thromboembolism (HA-VTE), and while several risk-prediction models...
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Hemodynamic Responses to Recorded Maternal Voice Among Sedated Children in the Pediatric Intensive Care Unit: An Open-Label Randomized Controlled Trial
ObjectiveTo assess the effect of maternal audiotaped voice on clinical parameters of sedated children.
MethodsA randomized controlled trial was...
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Impact of tight glycemic control and hypoglycemia after pediatric cardiac surgery on neurodevelopmental outcomes at three years of age: Findings from a randomized clinical trial
BackgroundStudies examining the impact of randomization As per standard instruction, city is required for affiliations; however, this information is...
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Avelumab Dose Selection for Clinical Studies in Pediatric Patients with Solid Tumors
Background and ObjectiveA phase I/II trial evaluated the safety, antitumor activity, and pharmacokinetics of avelumab (anti-PD-L1 antibody) in...
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Early clinical trial unit tumor board: a real-world experience in a national cancer network
PurposeEarly clinical trials are the first step into clinical therapies for new drugs. Within the six Bavarian university-based hospitals (Augsburg,...