Introduction: Despite a high prevalence of retained bullet fragments (RBFs) after firearm related injury (FRI) there is limited data on the full spectrum of their consequences, particularly the psychological impacts on those injured. Further, the experiences of FRI survivors with RBFs are missing from existing literature. The objective of this study was to explore the psychological impacts of RBFs on individuals who have experienced recent FRI.
View Article and Find Full Text PDFDelayed-release and extended-release methylphenidate (DR/ER-MPH), the first stimulant predicted to be absorbed primarily in the colon, demonstrated significant improvements in attention-deficit/hyperactivity disorder (ADHD) symptoms and functional impairment from awakening until evening versus placebo in clinical trials. The clinical significance of these improvements was explored post hoc by examining response and remission thresholds as well as safety in the context of dose optimization. Data from the open-label, treatment-optimization phase of a phase 3 study of DR/ER-MPH in children (aged 6-12 years) with ADHD, as diagnosed by criteria and enrolled between July 2015 and March 2016, were analyzed.
View Article and Find Full Text PDFObjective: The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior-Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful.
Method: Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression-Improvement (CGI-I) = 1 and CGI-I ≤ 2.
Inadequately controlled symptoms and associated impaired functioning have a significant negative impact on caregivers of children with attention-deficit/hyperactivity disorder (ADHD). This study aimed to assess the impact of evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH) treatment on caregiver strain, measured by the Caregiver Strain Questionnaire (CGSQ), and present psychometric analyses assessing the reliability and validity of the CGSQ, its ability to detect change (responsiveness), and to derive responder definitions. The CGSQ was an exploratory efficacy endpoint in a phase 3, 3-week, randomized, double-blind, multicenter, placebo-controlled, forced-dose titration trial of DR/ER-MPH in children aged 6-12 years with ADHD (NCT02520388).
View Article and Find Full Text PDFPurpose: HLD200 is the first evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH) designed to delay initial release of MPH and provide treatment effects throughout the day and into the evening for individuals with attention-deficit/hyperactivity disorder (ADHD). Because DR/ER-MPH is uniquely absorbed in the colon, it cannot be substituted for other ADHD medications on a milligram-per-milligram basis. To provide clinicians with a target dose range for DR/ER-MPH when transitioning patients from a prior ADHD medication, dose conversion ratios (DCRs) between prior medication doses and optimized doses of DR/ER-MPH were determined post hoc from a pivotal Phase III study of children (aged 6-12 years) with ADHD.
View Article and Find Full Text PDFLittle is known about how perceptions of government affects women's views of violence against women. This qualitative study examines women's perceptions of violence against women laws and trust in the health and legal sector response in São Paulo State, Brazil. Thirty interviews with female residents of Santo André, 18 years and older, were audio recorded, transcribed, coded, and analyzed for themes using MAXQDA12 software.
View Article and Find Full Text PDFObjective: Children with attention-deficit/hyperactivity disorder (ADHD) frequently manifest behavioral difficulties in the morning prior to school and in the afternoons and evenings. We sought to establish norms for 2 time-specific measures of functioning: the Before School Functioning Questionnaire (BSFQ) and the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R), which includes Morning (AM) and Evening (PM) subscales.
Methods: The normative online survey of a representative US sample of 1,200 primary caregivers of children and adolescents aged between 6 and 17 years was conducted in June 2016.
Health care providers (HCPs) who directly interact with women play a critical role in intimate partner violence (IPV) prevention and response. The aim of this study was to identify the structural and interpersonal barriers to IPV response among HCPs working in public health clinics in Santo André, Brazil. Eligible participants included all HCPs providing direct care to individuals at three public health clinics.
View Article and Find Full Text PDFJ Child Adolesc Psychopharmacol
February 2020
HLD200, a once-daily, evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH), was designed to provide therapeutic effect beginning upon awakening and lasting into the evening. This pivotal, randomized, double-blind, multicenter, placebo-controlled, phase 3 trial assessed improvements in functional impairment across the day using multiple validated measures tailored for different settings and time of day in children (6-12 years) with attention-deficit/hyperactivity disorder (ADHD). Following a 6-week, open-label titration of DR/ER-MPH to an optimal dose (20, 40, 60, 80, or 100 mg/day) and dosing time (8:00 PM ±1.
View Article and Find Full Text PDFObjectives: HLD200, an oral, once-daily, evening-dosed, delayed-release, and extended-release methylphenidate (DR/ER-MPH), was designed to provide efficacy from the early morning, throughout the day, and into the evening to individuals with attention-deficit/hyperactivity disorder. The objectives were to evaluate DR/ER-MPH pharmacokinetic (PK) properties in healthy adults, including dose proportionality, food effect, the potential of accumulation using multiple-dose modeling, and bioavailability compared to an immediate-release MPH (IR MPH).
Methods: Three open-label, single-dose, crossover studies were conducted, all with a 7-day washout between treatments.
Introduction Published national guidelines on chronic obstructive pulmonary disease (COPD) highlight the importance of oxygen therapy, bronchodilators, corticosteroids, and appropriate antibiotics during acute exacerbations of COPD (AECOPD). We wished to assess how the implementation of local COPD guidelines affects emergency department (ED) staff awareness, knowledge, the use of such guidelines, and patient outcomes, including treatment failure and rates of return to the ED. Methods This study was conducted at a tertiary hospital ED.
View Article and Find Full Text PDFObjective: Evening-dosed HLD200 is a delayed-release and extended-release methylphenidate (DR/ER-MPH) formulation consisting of uniform, dual-layered microbeads with an inner drug-loaded core. DR/ER-MPH is designed to delay the initial release of drug by 8-10 hours, and thereafter, provide a controlled, extended drug release to target onset of effect upon awakening that lasts into the evening. This phase 3 study evaluated the safety and efficacy of DR/ER-MPH on symptoms and temporal at-home functional impairment in children with attention-deficit/hyperactivity disorder (ADHD).
View Article and Find Full Text PDFObjective: Current extended-release (ER) formulations of psychostimulants used for treatment of attention-deficit/hyperactivity disorder (ADHD) provide an extended duration of ADHD symptom control; however, the onset of efficacy can be protracted and variable, leaving the early morning untreated. The primary objective was to characterize the single-dose pharmacokinetics and tolerability of HLD200, an evening-dosed, delayed-release (DR) and ER formulation of methylphenidate (MPH), in healthy adults and in adolescents and children with ADHD.
Methods: The pharmacokinetics and tolerability of a single, oral evening dose of HLD200 (54 mg) were evaluated in two single-center open-label studies: the first in healthy adults (n = 12) and the second in adolescents (n = 18) and children (n = 11) with ADHD.
Objective: Children with ADHD frequently manifest behavioral difficulties in the morning prior to school. We sought to assess the reliability and validity of the Daily Parent Rating of Evening and Morning Behavior Scale, Revised (DPREMB-R) morning score as a measure of morning behaviors impaired by ADHD.
Method: We used data from a clinical trial of HLD200 treatment in pediatric participants with ADHD to address our objectives.
Parents' decisions about human papillomavirus (HPV) vaccine for sons may be influenced by potentially protecting sons' future female partners from HPV. We sought to identify characteristics of parents likely to consider future partner protection in vaccine decisions, and to determine if parents likely to consider future partners in vaccine decisions had greater intention to vaccinate. We performed a cross-sectional survey of parents with sons in a pediatric clinic in 2010.
View Article and Find Full Text PDFWomen of color (WOC) are at increased risk of dying from HIV/AIDS, a disparity that may be partially explained by the care barriers they face. Based in a health care disparity model and the socio-ecological framework, the objective of this study was to identify the barriers and facilitators to HIV care at three points along the HIV continuum: HIV testing, entry/early care, and engagement. Two focus groups (n=11 women) and 19 semi-structured interviews were conducted with HIV-positive WOC in an academic medical setting in North Carolina.
View Article and Find Full Text PDFThis is an interesting paper of a 4 cm posttraumatic pseudolipoma on the back of the neck of an adult man who has participated in "tar barrel rolling" since adolescence. To the best of our knowledge, this is the first case of a pseudolipoma to be reported in the literature in association with tar barreling.
View Article and Find Full Text PDFThe EXPLORE study evaluated a behavioral intervention to prevent HIV seroconversion among men who have sex with men (MSM). The present ancillary study enrolled 345 EXPLORE participants at one study site (Boston) and assessed high-risk sexual behavior with other EXPLORE participants. It also assessed sexual intentions across other EXPLORE participants, HIV-negative individuals, and unknown HIV serostatus partners.
View Article and Find Full Text PDFDA release in the nucleus accumbens (NAcc) is a critical substrate mediating locomotor behavior. Cholecystokinin (CCK) is co-localized with dopamine (DA) in up to 90% of mesolimbic DA neurons. We have previously shown that while CCKA receptor antagonists generally do not affect locomotor behaviors, systemic administration of a CCKA receptor antagonist attenuates amphetamine (AMPH)-induced locomotion in animals previously treated chronically with AMPH, suggesting that chronic stimulant pretreatment may sensitize CCK systems.
View Article and Find Full Text PDFAdherence to antiretroviral therapy is critical for treatment success. Antiretroviral therapy typically requires multiple pills at multiple dosing times. To address this, we tested the feasibility, utility, and efficacy of a customizable reminder system using pagers, which were programmed using web-based technology, to increase and maintain proper adherence in patients with pre-existing adherence problems.
View Article and Find Full Text PDFRationale: The potentiation of the acoustic startle response (ASR) by stimuli associated with aversive events is mediated via the amygdala and is used as an index of "anxiety" and "fear". In laboratory animals, cholecystokinin(B) (CCK(B)) agonists increase anxiety and fear and activation of amygdala CCK(B) receptors potentiates ASR. Additionally, antagonism of CCK(B) receptors attenuates fear-potentiated ASR.
View Article and Find Full Text PDFPsychopharmacology (Berl)
August 2000
Rationale: Repeated administration of psychostimulants such as amphetamine (AMPH) produces an enduring augmentation of their locomotor effects. Previous research suggests that this phenomenon, termed sensitization, is related to changes within the mesolimbic dopamine (DA) system.
Objectives: The present experiments were designed to investigate the contribution of endogenous cholecystokinin (CCK), a neuropeptide co-localized with DA in the mesolimbic system, to the development (experiment 1) and the expression (experiment 2) of locomotor sensitization to AMPH.
Psychopharmacology (Berl)
January 2000
Rationale: Previous studies have shown that individual differences in oral sucrose consumption are predictive of the psychomotor and dopamine (DA) stimulant properties of amphetamine in rats.
Objectives: The present experiment was designed to examine the relationship between sucrose feeding and the reinforcing properties of amphetamine using the intravenous (i.v.
Psychopharmacology (Berl)
December 1999
Rationale: The mesolimbic dopamine (DA) system is implicated in psychostimulant drug self-administration. The neuropeptide cholecystokinin (CCK) is co-localised with DA and inhibits nucleus accumbens (NAcc) DAergic neurotransmission via CCKB receptors.
Objectives: The present experiment was designed to examine the effects of intra-NAcc CCKB receptor stimulation on fixed-ratio (FR) amphetamine self-administration.
Pharmacol Biochem Behav
January 1999
These studies investigated whether endogenous activation of CCK(A) receptors mediates the expression of amphetamine (AMP)-induced locomotor activity. In Experiment 1, locomotor activity was assessed in rats pretreated with the CCK(A) antagonist devazepide (0.001, 0.
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