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with several ocular signs of leprosy and other nonspecific and rarely seen symptoms. Uveitis is a condition that often requires a multidisciplinary team of ophthalmologists and clinicians because of the possible manifestation of an underlying systemic disease, creating a challenge for all the medical personnel involved in the management of the case.

A phase 2 trial has suggested that treatment with the melanocortin-4 receptor (MC4R) agonist setmelanotide is associated with a decrease in hunger and weight-related outcomes in participants with Bardet-Biedl syndrome (BBS) and Alström syndrome. Here, we present the study design of an ongoing, randomized, double-blind, placebo-controlled, phase 3 trial to assess the long-term efficacy and safety of setmelanotide for the treatment of obesity and hyperphagia in individuals with BBS or Alström syndrome (ClinicalTrials.gov identifier NCT03746522).

It was initially planned that ~30 participants aged ≥6 years with a clinical diagnosis of BBS or Alström syndrome would be enrolled. Participants with obesity as defined by a body mass index ≥30kg/m

(in those aged ≥16 years) or a weight >97th percentile (in those aged 6-15 years) are included. Participants are initially randomized in a 11 ratio to receive setmelanotide or placebo for 14 weeks (period 1). Following period 1, all participants receive 38 weeks of open-label treatment with setmelanotide (period 2). In each treatment period, setmelanotide is administered at 3mg once a day following completion of dose escalation. The primary endpoint is the proportion of participants aged ≥12 years achieving a clinically meaningful reduction from baseline (≥10%) in body weight after ~52 weeks (eg, following period 2). Safety and tolerability are assessed by frequency of adverse events.

This pivotal trial is designed to evaluate the efficacy and safety of setmelanotide for the treatment of obesity and hyperphagia in individuals with BBS and Alström syndrome.

Study Design, Statistical Design, Study Protocols.

Study Design, Statistical Design, Study Protocols.

Racial/ethnic and socioeconomic disparities in diabetes prevalence and management persist. Unmet basic needs such as food insecurity and unstable housing interfere with optimal diabetes self-management. Bridge to Health/Puente a la Salud is a randomized pilot trial designed to examine the feasibility of testing the effectiveness of addressing unmet basic needs via navigation services versus navigation plus diabetes self-management support (DSMS) on improving diabetes-related outcomes among racial/ethnic minority and low-income patients with uncontrolled diabetes.

We recruited and randomized 110 African American, Hispanic, and Medicaid patients (any race/ethnicity) with diabetes and recent hemoglobin A1C≥8% to one of two 6-month interventions 1) Navigation only; or 2) Navigation+DSMS. In both arms, practice-embedded patient navigators help participants navigate social services and community-based resources to address unmet basic needs. In Navigation+DSMS, participants are also assigned to a community healtorm refinements of the overall study design for the larger, randomized clinical trial.

Protocols utilizing high-sensitivity cardiac troponin (hs-cTn) assays for the evaluation of suspected acute coronary syndrome (ACS) in the emergency department (ED) have been gaining popularity across the US and the world. These protocols more rapidly rule-out ACS and more accurately identify the presence of acute myocardial injury. At this time, few randomized trials have evaluated the safety and operational impact of these assays, resulting in limited evidence to guide the use and implementation of hs-cTn in the ED.

The main study objective is to test the effectiveness of a rapid ACS rule-out pathway using hs-cTnI in safely discharging patients from the ED for whom clinical suspicion for ACS exists.

This prospective, implementation trial (n=11,070) will utilize a stepped wedge cluster randomized trial design. The design will allow for all participating sites to capture benefit from the implementation of the hs-cTnI pathway while providing data evaluating the effectiveness in providing safe and rapid evaluation of patients with clinical suspicion for ACS.

Demonstrating that clinical pathways using hs-cTnI can be effectively implemented to rapidly rule-out ACS while conserving costly hospital resources has significant implications for the care of patients with possible acute cardiac conditions in EDs across the US.

NCT04488913.

NCT04488913.The National Spinal Cord Injury Statistical Center estimates 294,000 people in the US live with a spinal cord injury (SCI), with approximately 17,810 new cases each year. Although the physical outcomes associated with SCI have been widely studied, the psychological consequences of sustaining a SCI remain largely unexplored. this website Scant research has focused on posttraumatic stress disorder (PTSD) in this population, despite prevalence estimates suggesting that up to 60% of individuals with SCI experience PTSD post-injury, compared to only 7% of the general US population. Fortunately, prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD. However, no trauma focused exposure-based therapy for PTSD (e.g. PE) has not yet been tested in a SCI population. Thus, we aim to conduct the first test of an evidence-based intervention for PTSD among patients with SCI. Adults with SCI and PTSD (N = 60) will be randomly assigned to either (1) 12-sessions of PE (2-3 sessions per week) or (2) a treatment as usual (TAU) control group who will receive the standard inpatient rehabilitation care for SCI patients. Primary outcomes will be assessed at 0, 6, 10, and 32 weeks.

Mild traumatic brain injury (mTBI) is a signature injury sustained by Veterans during recent conflicts. For some, mTBI/concussion is associated with disabling symptoms, including post-concussive headaches (PCH). However, there are limited evidence-based treatments for persistent PCH.

Investigators assessed the feasibility of design elements of a yoga-based interventional trial for PCH among Veterans, as well as the acceptability of the intervention.

This randomized controlled acceptability and feasibility trial was implemented using a waitlist-control design. Design elements of interest included an exercise run-in class; recruitment and retention strategies; and, ecological momentary assessment (EMA) modalities to track headaches and yoga practice. Veteran satisfaction regarding the intervention was also evaluated. A descriptive analysis was conducted on candidate outcomes including PCH, post-concussive symptoms, pain, and daily functioning.

Twenty-seven participants (out of 70 consented and eligible after Study Visit 1) completed each evaluation timepoint and regularly attended yoga sessions, with 89% of these Veterans reporting moderate to high levels of satisfaction with the intervention at study completion.