Introduction: Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. Several studies have demonstrated the beneficial effects of antithrombin replacement in patients with preeclampsia. Here, we describe the study protocol of KOUNO-TORI (KW-3357 randOmized, mUlti-center, double-bliNd, placebO-controlled phase 3 sTudy in patients with early Onset pReeclampsIa) to evaluate recombinant human antithrombin gamma (rhAT-gamma) for the treatment of early-onset severe de novo preeclampsia.
Material And Methods: Patients with early-onset severe de novo preeclampsia who are ≥24 to <32 weeks pregnant at the time of registration and have an antithrombin activity of ≤100% at screening are included. The target population is selected based on a reanalysis of the data of a previous plasma-derived antithrombin phase 3 study. Primary endpoint is the prolongation of pregnancy from the initiation of rhAT-gamma treatment to the pregnancy termination. Secondary endpoints include gestational age in terms of achievement of 32- and 34-weeks'gestation, and gestational age in terms of achievement of 28 weeks' gestation for patients enrolled at <28 weeks' gestation. Maternal, fetal, and neonatal outcomes will be assessed.
Discussion: As we have selected a specifically defined target population based on reanalysis of data of a previous plasma-derived antithrombin phase 3 study, the results of our study are expected to provide efficacy and safety data concerning rhAT-gamma treatment in Japanese patients. This study could help identify an effective novel treatment for such patients with early-onset severe preeclampsia for whom appropriate treatment is unavailable.
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http://dx.doi.org/10.1016/j.cct.2021.106490 | DOI Listing |
Importance: Childhood maltreatment (CM) is associated with the early onset of psychiatric and medical disorders and accelerated biological aging.
Objective: To identify types of maltreatment and developmental sensitive periods that are associated with accelerated adult brain aging.
Design: Participants were mothers of infants recruited from the community into a study assessing the effects of CM on maternal behavior, infant attachment, and maternal and infant neurobiology.
Schizophr Res Cogn
June 2025
University Department of Child and Adolescent Psychiatry, Children's Hospitals of NICE CHU-Lenval, Nice, France.
Objective: To conduct a systematic review of neurocognitive dysfunctions in patients with childhood-onset schizophrenia (COS), a neuropsychiatric disorder that occurs before age 13 and is rarer and more severe than adult-onset schizophrenia.
Method: A search was made in the PubMed database. Sixty-seven studies (out of 543) which analyzed Intellectual Quotient (IQ), attentional, memory and executive functions were selected by two independent researchers.
Front Pediatr
January 2025
Division of Neonatology, Department of Pediatrics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand.
Background: Multisystem inflammatory syndrome in neonates (MIS-N) is a rare condition thought to be associated with prenatal exposure to maternal severe acute respiratory syndrome coronavirus 2 infection. This immune-mediated hyperinflammation has been described in neonates with multiorgan dysfunction, including cardiopulmonary, encephalopathy, coagulopathy, and vascular complications. However, renovascular complications in MIS-N are rare.
View Article and Find Full Text PDFBMC Public Health
January 2025
Statistics, Brigham Young University, Provo, 84602, Utah, USA.
Background: Bullying, encompassing physical, psychological, social, or educational harm, affects approximately 1 in 20 United States teens aged 12-18. The prevalence and impact of bullying, including online bullying, necessitate a deeper understanding of risk and protective factors to enhance prevention efforts. This study investigated the key risk and protective factors most highly associated with adolescent bullying victimization.
View Article and Find Full Text PDFDermatol Ther (Heidelb)
January 2025
Department of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", "Sapienza" University of Rome, Polo Pontino, 04100, Latina, Italy.
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus and a relapsing course, affecting approximately 25% of children and 4-7% of adults. This study evaluated the efficacy, safety, and quality-of-life impact of tralokinumab, a humanized monoclonal antibody targeting interleukin-13 (IL-13), in treating moderate-to-severe AD in a real-world setting, with a focus on different AD phenotypes.
Methods: An observational cohort of 30 adults treated with tralokinumab for ≥ 16 weeks was analyzed.
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