Publications by authors named "H A Bradley"
Introduction: Weight-banded trofinetide dosing improved physician- and caregiver-rated efficacy measures and had acceptable tolerability in patients aged 2‒4 years (DAFFODIL study) and 5‒20 years (LAVENDER study) with Rett syndrome (RTT). Selection of weight-banded dosing regimens for these studies was based on population pharmacokinetic (popPK) modeling and exposure simulations. This study applied an updated popPK model to confirm steady-state trofinetide exposures achieved in DAFFODIL patients were within target range.
View Article and Find Full Text PDFIntroduction: Oral trofinetide administered using a body weight-banded dosing regimen was approved in the US for the treatment of Rett syndrome (RTT) in patients aged ≥ 2 years. This approval was principally based on efficacy and safety findings of the phase 3 LAVENDER study in girls and women aged 5-20 years with RTT and extended to younger children aged 2-4 years with supporting data from the DAFFODIL study. Weight-banded dosing regimens were selected based on early clinical population pharmacokinetic (popPK) modeling and different scenario simulations.
View Article and Find Full Text PDFPurpose/background: One-fifth of women experience antenatal depression. Untreated antenatal depression is associated with increased risk of adverse birth outcomes. This study investigated the effect of broad-spectrum micronutrients (BSM; vitamins and minerals), used to treat antenatal depression (NUTRIMUM trial), on birth outcomes.
View Article and Find Full Text PDFArticle Synopsis
- - The study aimed to evaluate the effects of the COVID-19 pandemic on the health of people who inject drugs (PWID) using a collaborative data-sharing model established in 2021, which pooled data from multiple studies across North America.
- - Researchers analyzed data on various health indicators (like substance use treatment and mental health conditions) over four different time periods: pre-pandemic, early-pandemic, mid-pandemic, and late-pandemic, involving 6,213 PWID participants.
- - The results showed minimal changes in health indicators throughout the pandemic, suggesting stability possibly due to policy adjustments and resilience in support services for PWID, highlighting the potential of the data-sharing model for better health insights.
Objective: This study applies predictive analytics to identify patients at risk of missing appointments at a novel post-discharge clinic (PDC) in a large academic health system. Recognizing the critical role of appointment adherence in the success of new clinical ventures, this research aims to inform future targeted interventions to increase appointment adherence.
Materials And Methods: We analyzed electronic health records (EHRs) capturing a wide array of demographic, socio-economic, and clinical variables from 2168 patients with scheduled appointments at the PDC from September 2022 to August 2023.