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International workshop: what is needed to ensure outcome measures for Rett syndrome are fit-for-purpose for clinical trials? June 7, 2023, Nashville, USA.
Trials
December 2024
School of Medicine Depts of Pediatrics, Neurology and Pharmacology, Children's Hospital Colorado/University of Colorado, 12800 E 19th, MS8102, Aurora, CO, 80045, USA.
Introduction: The clinical, research and advocacy communities for Rett syndrome are striving to achieve clinical trial readiness, including having fit-for-purpose clinical outcome assessments. This study aimed to (1) describe psychometric properties of clinical outcome assessment for Rett syndrome and (2) identify what is needed to ensure that fit-for-purpose clinical outcome assessments are available for clinical trials.
Methods: Clinical outcome assessments for the top 10 priority domains identified in the Voice of the Patient Report for Rett syndrome were compiled and available psychometric data were extracted.
Preoperative factors predicting outcomes in patients with suspected perihilar cholangiocarcinoma referred for curative resection- a single-center 10-year experience.
Langenbecks Arch Surg
December 2024
Department of Surgery and Transplantation, Centre for Cancer and Organ Diseases, Rigshospitalet, 2100, Copenhagen, Denmark.
Purpose: Perihilar cholangiocarcinoma (pCCA) is a rare malignancy requiring resection of extrahepatic bile ducts with or without hepatectomy. Prognostic models for post-operative outcomes in pCCA are unusable in pre-operative decision-making as most are based on post-operative variables. Additionally, no pre-operative models include futile laparotomy or benign hilar stenosis (BHS) as possible outcomes.
View Article and Find Full Text PDFPredictors of biochemical remission after transsphenoidal surgery in a large cohort of acromegaly patients.
Pituitary
December 2024
Computational Neuroscience Outcomes Center, Harvard Medical School, Boston, Massachusetts, USA.
Purpose: The objective of this study was to characterize the clinical characteristics and factors predictive of biochemical remission in patients with symptomatic acromegaly undergoing transsphenoidal surgery (TSS) at an academic tertiary care center, as defined by the 2022 Acromegaly Consensus Conference guidelines.
Methods: In this single institution, longitudinal, retrospective study, a large cohort of 158 patients with a preoperative diagnosis of acromegaly undergoing surgery at a large, academic, tertiary care center were examined. We excluded 38 patients as IGF-1 testing was performed less than 12 weeks postoperatively.
Population Pharmacokinetics of Ledipasvir/Sofosbuvir in Pediatric Patients: Impact of Acute Lymphoblastic Leukemia.
Clin Ther
December 2024
Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Purpose: The pharmacokinetic (PK) profile of direct-acting antivirals, namely ledipasvir/sofosbuvir (LDV/SOF), might be altered in patients with acute lymphoblastic leukemia (ALL), affecting the optimum dose needed for hepatitis C virus treatment. Limited data are available evaluating the population PK of LDV/SOF and SOF metabolite GS-331007. We aimed to study whether ALL could affect population PK parameters of LDV, SOF, and the SOF major metabolite GS-331007 in hepatitis C virus-infected children, develop and validate a predictive PK model of LDV/SOF disposition in this special population, and identify their explained and unexplained sources of variability.
View Article and Find Full Text PDFIdentifying Paediatric Populations with Increased Risk for Oropharyngeal Dysphagia in Acute and Critical Care Settings: A Scoping Review.
Dysphagia
December 2024
School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.
Dysphagia is common in hospitalised children. Clarity regarding its prevalence is required to direct service needs. This review reports oropharyngeal dysphagia prevalence in children admitted to acute and/or critical care, following acute illness, medical or surgical intervention.
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