keyword
https://read.qxmd.com/read/38494842/establishment-of-rws-guidance-reflecting-contributions-of-china-to-regulatory-science
#21
JOURNAL ARTICLE
Jun Wang, Jie Chen, Jun Zhao, Ying Wu, Xiaona Xin, Pingyan Chen
China's accession to the ICH has accelerated the advancement of its regulatory science. To foster innovation and improve the efficiency of pharmaceutical research and development, the China National Medical Products Administration (NMPA) encourages the use of real-world evidence (RWE) to support drug regulatory decision-making and has constructed a series of real-world study (RWS) related guidance, reflecting the contribution of the NMPA to the field of RWS in drug clinical development. Based on the four guidelines on RWE, real-world data (RWD), RWS design and protocol development, and communication with regulatory authorities, the guidance has been extended to more specific clinical applications, such as oncology, rare diseases, pediatric drugs, and traditional Chinese medicine...
March 17, 2024: Journal of Biopharmaceutical Statistics
https://read.qxmd.com/read/38494492/development-and-validation-of-predictive-models-for-myopia-onset-and-progression-using-extensive-15-year-refractive-data-in-children-and-adolescents
#22
JOURNAL ARTICLE
Jing Zhao, Yanze Yu, Yiming Li, Feng Li, Zhe Zhang, Weijun Jian, Zhi Chen, Yang Shen, Xiaoying Wang, Zhengqiang Ye, Chencui Huang, Xingtao Zhou
BACKGROUND: Global myopia prevalence poses a substantial public health burden with vision-threatening complications, necessitating effective prevention and control strategies. Precise prediction of spherical equivalent (SE), myopia, and high myopia onset is vital for proactive clinical interventions. METHODS: We reviewed electronic medical records of pediatric and adolescent patients who underwent cycloplegic refraction measurements at the Eye & Ear, Nose, and Throat Hospital of Fudan University between January 2005 and December 2019...
March 17, 2024: Journal of Translational Medicine
https://read.qxmd.com/read/38494391/technological-advances-in-pediatric-epilepsy-surgery
#23
JOURNAL ARTICLE
Michael E Baumgartner, Liming Qiu, Lucas R Philipp, Kathleen Galligan, Casey Halpern, Benjamin C Kennedy
No abstract text is available yet for this article.
March 16, 2024: Current Problems in Pediatric and Adolescent Health Care
https://read.qxmd.com/read/38493896/recovery-of-measles-containing-and-hpv-vaccine-ordering-post-covid-19-pandemic-trends-by-public-vs-private-funding-source-urbanicity-and-state-united-states-january-2018-december-2022
#24
JOURNAL ARTICLE
Yoonjae Kang, Seth Meador, Carla Black, Tara Vogt
OBJECTIVE: To assess recovery in childhood and adolescent vaccine ordering since initial declines in 2020 due to COVID-19 pandemic-related disruptions. METHODS: Using vaccine ordering data provided by Merck & Co., Inc., Rahway, NJ, USA, the number of measles-containing vaccine doses ordered each month in the U.S. during January 1, 2020-May 31, 2022 were compared to doses ordered during the corresponding month in 2018 and human papillomavirus (HPV) vaccine doses ordered during January 1, 2020-December 31, 2022 were compared to corresponding month in 2019...
March 15, 2024: Preventive Medicine
https://read.qxmd.com/read/38493878/anisocytosis-as-a-possible-predictor-of-low-cardiac-output-syndrome-in-children-undergoing-mitral-valve-surgery
#25
JOURNAL ARTICLE
Michał Sobieraj, Tomasz Urbanowicz, Anna Olasińska-Wiśniewska, Marcin Gładki, Michał Michalak, Krzysztof J Filipiak, Anita Węclewska, Alicja Bartkowska-Śniatkowska, Andrzej Tykarski, Waldemar Bobkowski, Marek Jemielity
PURPOSE: Mitral valve surgery in children involves correcting congenital and acquired pathologies, with a reported mortality rate of 0.9%. Low cardiac output syndrome (LCOS) is a serious complication with the incidence of 20-25%. The aim of the study was to estimate possible prognostic factors of LCOS in children undergoing mitral valve procedure. MATERIAL AND METHOD: This single-center retrospective analysis enrolled children aged <18 years who underwent mitral valve surgery during 24 year period...
March 15, 2024: Advances in Medical Sciences
https://read.qxmd.com/read/38493394/contraception-initiation-in-the-emergency-department-adolescent-perspectives
#26
JOURNAL ARTICLE
Tara Ketterer, Erin Sieke, Jungwon Min, Maria Quidgley-Martin, Romina L Barral, Aletha Akers, Amber Adams, Elizabeth Miller, Melissa K Miller, Cynthia Mollen
PURPOSE: The purpose of this study was to identify factors affecting contraceptive intention and behavior among adolescent females in the pediatric Emergency Department. METHODS: We conducted a qualitative interview study nested within a larger prospective cohort study examining adolescent contraceptive counseling for females ages 15-18 years at-risk of unintended pregnancy presenting to the pediatric Emergency Department. Interviews were conducted in a subset of participants...
March 15, 2024: Journal of Adolescent Health
https://read.qxmd.com/read/38493326/clinical-characteristics-etiology-and-outcomes-of-hypothermia-in-well-appearing-children-referred-to-the-emergency-department
#27
JOURNAL ARTICLE
Lea Ohana Sarna, Dina Qaraen Saloni, Mevaseret Avital, Naama Pines, Itai Gross, Giora Wieser, Saar Hashvya
BACKGROUND: Hypothermia, as a sign of serious bacterial infection (SBI) in children and infants older than 90 days is poorly characterized, especially in the post-pneumococcal vaccine era. OBJECTIVES: To assess the prevalence of SBI in children and infants presenting to the pediatric emergency department (PED) with reported or documented hypothermia. METHODS: Retrospective data analysis was conducted of all well-appearing children aged 0-16 years who presented with a diagnosis of hypothermia at two tertiary PEDs from 2010 to 2019...
March 2024: Israel Medical Association Journal: IMAJ
https://read.qxmd.com/read/38493024/college-health-centers-an-update-on-medical-issues
#28
JOURNAL ARTICLE
Ariel Tassy Nunez
College health centers are an important source of health care for large numbers of young adults throughout the country. With 16.9 million students enrolled in 2023 in post-secondary institutions in the United States, the potential impact that health centers at these institutions have is significant. Late adolescence and early adulthood is a particularly vulnerable stage of both cognitive and psychosocial development, and college health centers that provide comprehensive medical and mental-health care play an important role in providing comprehensive care for this age group...
March 15, 2024: Current Problems in Pediatric and Adolescent Health Care
https://read.qxmd.com/read/38492332/structural-and-organizational-determinants-of-the-capacity-for-covid-19-testing-and-diagnoses-in-children-insights-from-the-2009-influenza-and-covid-19-pandemics
#29
JOURNAL ARTICLE
Yusuke Okubo, Kazuhiro Uda
BACKGROUND: This study explored factors associated with testing and diagnoses for children with COVID-19 at the hospital level and investigated whether the capacity of testing and diagnoses during the 2009 influenza pandemic was associated with that during COVID-19 pandemic. METHODS: In this observational study, we analyzed data obtained from the Japan Medical Data Center database, comprising 4906 medical facilities and 1.7 million infectious disease-related visits among children aged <20 years in 2020-2021...
March 15, 2024: Respiratory Investigation
https://read.qxmd.com/read/38491726/a-young-girl-with-acute-encephalopathy-who-presented-with-status-epilepticus-following-a-flu-like-illness
#30
JOURNAL ARTICLE
Noora Mohamed Saqr Aljalahma, Raafat Hammad Seroor Jadah
BACKGROUND Acute necrotizing encephalopathy of childhood (ANEC) is a rare form of acute encephalopathy in children that is characterized by rapid and progressive deterioration in the patient's clinical condition. Our aim in reporting the case is to highlight the importance of early diagnoses and aggressive early management of ANEC to achieve a better outcome. We report the case of a 5-year-old girl who presented with acute progressive encephalopathy with bilateral symmetrical thalamic involvement and brainstem lesion proceeded by a flu-like illness...
March 16, 2024: American Journal of Case Reports
https://read.qxmd.com/read/38490819/improving-health-equity-and-outcomes-for-children-and-adolescents-the-role-of-school-based-health-centers-sbhcs
#31
JOURNAL ARTICLE
Khalida Itriyeva
School-based health centers (SBHCs) provide a critical point of access to youth in low-resource communities. By providing a combination of primary care, reproductive health, mental health, vision, dental, and nutrition services, SBHCs improve the health, wellbeing, and academic achievement of the students they serve. SBHCs operate in collaboration with schools and community primary care providers to optimize the management of chronic health conditions and other health concerns that may result in suboptimal scholastic achievement and other quality of life measures...
March 14, 2024: Current Problems in Pediatric and Adolescent Health Care
https://read.qxmd.com/read/38490772/pediatric-intubations-in-a-semiurban-helicopter-emergency-medicine-service-a-retrospective-review
#32
JOURNAL ARTICLE
Sarah Morton, Sinead Keane, Matt O'Meara
OBJECTIVE: Although a small proportion of helicopter emergency medical service (HEMS) missions are for pediatric patients, it is recognized that children do present unique challenges. This case series aims to evaluate the intubation first-pass success rate in HEMS pediatric patients for both medical and trauma patients in a UK semiurban environment. METHODS: A retrospective review of the computerized records system was performed from January 1, 2015, to July 31, 2022, at 1 UK HEMS...
2024: Air Medical Journal
https://read.qxmd.com/read/38490252/design-and-implementation-of-a-didactic-curriculum-in-a-large-neonatal-perinatal-medicine-fellowship-program-a-single-center-experience
#33
JOURNAL ARTICLE
Shanmukha Mukthapuram, Beth Ann Johnson, Cara Slagle, John Erickson, Beena D Kamath-Rayne, Jennifer M Brady
OBJECTIVE:  Although the Accreditation Council for Graduate Medical Education and American Board of Pediatrics (ABP) provide regulations and guidance on fellowship didactic education, each program establishes their own didactic schedules to address these learning needs. Wide variation exists in content, educators, amount of protected educational time, and the format for didactic lectures. This inconsistency can contribute to fellow dissatisfaction, a perceived poor learning experience, and poor attendance...
March 15, 2024: American Journal of Perinatology
https://read.qxmd.com/read/38490241/evaluation-of-cerebral-autoregulation-of-oxygen-by-nirs-method-during-postnatal-transition-period-in-term-and-late-preterm-newborns-without-resuscitation-requirement
#34
JOURNAL ARTICLE
Omer Ertekin, Mehmet Buyuktiryaki, Sehribanu Isik, Nilufer Okur, Serife Suna Oguz
BACKGROUND: Pulse oximetry is commonly used to monitor arterial oxygen saturation and heart rate during the transition period and reference intervals have been determined. However, the effect of the change in arterial oxygen saturation on tissue oxygenation does not seem to be the same. So, a non-invasive method for monitoring cerebral or regional tissue oxygenation will be potentially useful for vulnerable infants. This study aims to evaluate the effectiveness of cerebral autoregulation in the first 10 min after delivery in term and late preterm newborns without resuscitation requirement...
February 7, 2024: Journal of Tropical Pediatrics
https://read.qxmd.com/read/38489828/the-longitudinal-reciprocal-relationships-of-tooth-brushing-behaviors-between-underserved-children-and-their-caregivers
#35
JOURNAL ARTICLE
Romano Endrighi, Michelle Henshaw, William G Adams, Erin Montion, Hannah Park, Belinda Borrelli
BACKGROUND: Tooth brushing is effective in preventing early childhood caries. However, it is unclear how children's and caregiver's tooth brushing are reciprocally related. PURPOSE: The current study investigated whether the longitudinal relationships between children and caregiver tooth brushing are moderated by a caregiver-targeted child oral health intervention and caregiver depression. METHODS: Secondary analysis of a randomized clinical trial that tested whether caregiver-targeted oral health text messages (OHT) outperformed child wellness text messages (CWT) on pediatric dental caries and oral health behaviors (n = 754, mean child age = 2...
March 15, 2024: Annals of Behavioral Medicine: a Publication of the Society of Behavioral Medicine
https://read.qxmd.com/read/38489811/pediatric-brain-tumors-in-sub-saharan-africa-a-systematic-review-and-meta-analysis
#36
JOURNAL ARTICLE
Arsene Daniel Nyalundja, Ulrick Sidney Kanmounye, Claire Karekezi, Tsegazeab Laeke, Nqobile Thango, James A Balogun
OBJECTIVE: Brain tumors are a global problem, leading to higher cancer-related morbidity and mortality rates in children. Despite the progressive though slow advances in neuro-oncology care, research, and diagnostics in sub-Saharan Africa (SSA), the epidemiological landscape of pediatric brain tumors (PBTs) remains underestimated. This study aimed to systematically analyze the distribution of PBT types in SSA. METHODS: Ovid Medline, Global Index Medicus, African Journals Online, Google Scholar, and faculty of medicine libraries were searched for literature on PBTs in SSA published before October 29, 2022...
March 15, 2024: Journal of Neurosurgery. Pediatrics
https://read.qxmd.com/read/38489726/flexible-nailing-pushing-the-indications-for-diametaphyseal-lower-extremity-fractures
#37
JOURNAL ARTICLE
Gregory Benes, Jessica Schmerler, Andrew B Harris, Adam Margalit, Rushyuan Jay Lee
Elastic stable intramedullary nailing (ESIN) has been shown to be an effective form of surgical management for lower-extremity diametaphyseal fractures in pediatric patients, but studies are limited because ESIN treatment for these fractures is relatively uncommon. We sought to determine whether ESIN can be used effectively in the most distal or proximal short-segment forms of these fractures. We queried the electronic medical record system at Johns Hopkins Hospital using Current Procedural Terminology codes for femur and tibia fractures treated with ESIN in patients under 18 years old between January 2015 and October 2022...
March 15, 2024: Medicine (Baltimore)
https://read.qxmd.com/read/38489714/lipid-emulsion-treatment-for-local-anesthetic-systemic-toxicity-in-pediatric-patients-a-systematic-review
#38
JOURNAL ARTICLE
Soo Hee Lee, Sunmin Kim, Ju-Tae Sohn
BACKGROUND: Local anesthetic systemic toxicity (LAST) is rare, but fatal; the current widely used treatment is lipid emulsion (LE). The goal of this study was to analyze and review case reports on LE treatment for LAST in pediatric patients. METHODS: We performed a systematic review using case reports on LE treatment for LAST in pediatric patients, searching PubMed and Scopus databases to March 2023 using the following keywords: ("local anesthetic toxicity" OR "local anesthetic systemic toxicity" OR LAST") AND ("newborn" OR "infant" OR "child" OR "children" OR "adolescent" OR "pediatric") AND ("lipid emulsion" OR "Intralipid")...
March 15, 2024: Medicine (Baltimore)
https://read.qxmd.com/read/38489703/fitness-for-use-of-retrospective-multicenter-electronic-health-records-to-conduct-outcome-analysis-for-pediatric-ulcerative-colitis
#39
JOURNAL ARTICLE
Zhu Wang, Xing Song, Lemuel R Waitman, Jeffrey S Hyams, Lee A Denson
The use of electronic health records has garnered interest as an approach for conducting innovative outcome research and producing real-world evidence at a reduced cost compared to traditional clinical trials. The study aimed to evaluate the utility of deidentified EHR data from a multicenter research network to identify characteristics associated with treatment escalation (TE) in newly diagnosed pediatric ulcerative colitis patients. EHR data (01/2010-12/2021) from 13 Midwest healthcare systems (Greater Plains Collaborative) were collected for pediatric ulcerative colitis patients...
March 15, 2024: Medicine (Baltimore)
https://read.qxmd.com/read/38489698/the-incidence-and-risk-factors-of-secondary-epilepsy-after-viral-encephalitis-in-children-a-10-year-single-center-retrospective-analysis
#40
JOURNAL ARTICLE
Yang Hu, Bo Huang, Mengsha Zhu, Suzhen Sun, Guiying Zhang
Secondary epilepsy is a common concomitant disease of viral encephalitis (VE) in children. However, the risk factors for secondary epilepsy after VE remain debated. The aim of this study was to perform a 10-year single-center retrospective analysis to investigate the incidence and risk factors of secondary epilepsy after VE in children. A total of 8691 patients suffered from VE in our hospital between December 2011 and February 2022 were included. The patients were divided into control group (Group C) and epilepsy group (Group E) according to whether they followed secondary epilepsy...
March 15, 2024: Medicine (Baltimore)
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