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A Study Of The Safety And Activity Of Eculizumab In Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Study Of The Safety And Activity Of Eculizumab In Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder articles that have been published worldwide.
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The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAI...
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord. At least two thirds of cases are associated with aquaporin-4 antibodies (AQP4-IgG) and complement-mediated damage to the central nervous system. In a previous small, open-label study involving patients with AQP4-IgG-positive disease, eculizumab, a terminal complement inhibitor, was shown to reduce the frequency of relapse.
Eculizumab has caused a revolution in the treatment and prognosis of atypical hemolytic uremic syndrome. Early initiation of treatment is recommended to increase chances of renal recovery.
C3 glomerulonephritis (C3GN) is a disorder of excess alternative complement activation leading to glomerular injury. Following kidney transplantation, C3GN has a high recurrence rate, and the overall prognosis is poor without treatment. However, treatment efficacy is highly variable. Eculizumab, a humanized monoclonal antibody that targets complement C5 to inhibit terminal complement activity, has emerged as a potential treatment option for C3G, although data regarding its clinical utility remains limited. ...
Natalizumab (NTZ) is very effective for treatment of relapsing-remitting multiple sclerosis (RRMS), its use is mainly limited by safety issues. Discontinuation of NTZ is associated with recurrence of disease activity (reactivation and rebound). The best strategy for subsequent therapy and the predictive factors for recurrence in such patients are areas of active research. We aimed to evaluate predictors of reactivation in a multicentric study.
Patient safety has become an important and required topic in medical education. A needs assessment showed that pediatric emergency medicine program directors were interested in a common pediatric emergency-specific safety curriculum.
Treatment with eculizumab in Shiga toxin-associated haemolytic and uraemic syndrome (STEC-HUS) remains controversial despite its increasing utilization. The aim of our study was to evaluate the outcomes of children treated with eculizumab for STEC-HUS in a single-centre matched cohort study.
While complement blockade with eculizumab is recommended as first-line therapy of atypical hemolytic uremic syndrome (aHUS), plasma exchanges (PEX) remain the chief option for anti-factor H (FH) antibody associated disease and when access to eculizumab is limited.
This phase I study investigated pharmacokinetic (PK) and pharmacodynamic (PD) profiles of natalizumab in pediatric patients with relapsing-remitting MS (RRMS).
To evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).
Inflammatory bowel disease encompasses relapsing gastrointestinal disorders commonly presenting in pediatric patients, with 25% of diagnoses made before age 20 and 4% before age 5. Considering the need for life-long surgical follow-up, a collaborative system involving both pediatric and colorectal surgeons could improve overall patient experiences. We hypothesized that cases performed in collaboration with both pediatric and adult colorectal surgeons may lead to better outcomes.
Previous studies have shown that perceptions of neighborhood safety are associated with various mental health outcomes. However, scant attention has been paid to the mediating pathways by which perception of neighborhood safety affects mental health. In addition, most previous studies have evaluated perception of neighborhood safety with questionnaires or field audits, both of which are labor-intensive and time-consuming. This study is the first attempt to measure perception of neighborhood safety using str...
This mixed-methods study aims to inform the development of a 'Park Prescription' intervention, including face-to-face counseling on physical activity and park use and providing weekly structured exercise sessions in the park to promote physical activity. Participants aged 40-65 years were recruited from regional health screening events in Singapore where they completed a questionnaire (N = 97) and consented to focus group (FG) participation (N = 16). The questionnaire assessed current park use, and the type...
Natalizumab is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). Data on clinical and imaging measures predictive of disease activity and progression during treatment is limited.
The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is approved in the Republic of Korea for use in individuals from 2 months of age. This single-arm, open-label, observational, multicenter, post-marketing study (NCT01766206) assessed the safety of MenACWY-CRM vaccine administered according to local clinical practice. A total of 3939 individuals aged 2 months-55 years provided safety data post-vaccination; the analysis was conducted on the per-protocol set (3920 participants). Solicited and unsolic...
Patient safety remains a critical issue in health care. Adverse events related to blood transfusion constitute a threat to patient safety. The aim of this study is to compare and contrast reporting trends of patient safety events that occur during the transfusion of blood components in pediatric and adult hospital care settings.
Pet ownership is associated with increased levels of physical activity (PA) in older adults. Studies have mainly focused on the association between PA and dog walking; however, broader aspects of pet ownership may influence PA. The purpose of this study was to explore the association between pet ownership and incidental and purposeful PA using a mixed methods approach. Participants' (N = 15) PA was measured for 7 days using accelerometers and diaries. Semistructured interviews explored participants' perspec...
Fusobacterium nucleatum is a common oral commensal bacterium capable of severe invasive infections. We report a case of a diffuse bilateral pneumopathy with F. nucleatum-positive blood culture successfully treated by common antibiotics in a patient receiving eculizumab for a drug-induced thrombotic microangiopathy (TMA). It is the first described case of a severe F. nucleatum-associated infection in a patient undergoing terminal complement inhibitor therapy. We suggest providing preventive dental care befor...
No oral systemic treatments are approved for pediatric psoriasis patients.
The aim of the current study is to identify key issues with utility, effectiveness, and appeal of specific electronic applications (apps) for people with mild cognitive impairment (MCI) to guide the design and development of a mobile app, which integrates physical activity and cognitive activities. Sixteen participants age ≥65 were recruited from three assisted living facilities in Alabama. Participants were observed playing a physical activity app and cognitive training app via a tablet on two separate o...
A/H5N1 influenza virus has significant pandemic potential, and vaccination is the main prophylactic measure. This phase 2, randomized, observer-blind, multicenter study evaluated the safety and immunogenicity of two MF59-adjuvanted, cell culture-derived H5N1 (aH5N1c) vaccine formulations in healthy pediatric subjects 6 months to 17 years old.
Although the majority of children are hospitalized in nonchildren's hospitals, little is known about the quality and safety of pediatric care in community hospitals.
The first administrations of a molecule to humans, so-called phase I studies of drug development, follow experimental animal studies which allow to have a first assessment of the pharmacological effects and toxicity of the molecule under development. Typically, these studies are performed in "healthy" subjects or in relapsing patients with cancer. Participants' safety is a priority. Trained professionals administer single doses, followed by repeated doses, in authorized medical centres. They allow to study ...
Randomised clinical trials (RCTs) and observational studies have reported adverse events that preclude the use of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) in the long term or in specific populations, however, little is known about the relationship between the use of DMTs and frequency of undesirable events. We aimed to conduct a systematic review and network meta-analyses (NMAs) of RCTs and observational studies to synthesise the evidence on the safety of all avail...