All Clinical Trials

The purpose of this project is to conduct an impact evaluation of the Conjoint Behavioral Consulting (CBC) intervention under real-world conditions as an IES Efficacy Replication trial. CBC is a family-school partnership intervention proven efficacious for children with serious emotional and behavior problems. The investigation will conduct a systematic efficacy replication of CBC to identify important process and context variables in need of attention prior to a CBC effectiveness study. School-based specialists (SBSs) will implement CBC and will be responsible for working directly with parents and teachers who have a student with or at risk for severe emotional disturbance, with more implementation support (i.e., non-routine conditions) than would be expected under routine conditions to ensure adequate fidelity of implementation. The research questions examine the impact of CBC, when implemented by SBSs, on student, parent, and teacher outcomes, as well its effect on mediational pathways. In addition, the research team will gather stakeholder feedback in focus groups to provide information about factors that stakeholders perceive as impeding or promoting CBC adoption, implementation, and sustainability. Read Less

Social skills interventions are sometimes used to treat the social impairments of higher-functioning children with autism spectrum disorder (hfASD; without intellectual disability). Despite the recognized need for such treatments, few children with hfASD receive social interventions. Efforts to develop and implement school social interventions have been hindered by barriers during the school day (e.g., lack of resources, staffing, training, and time). As such, there is a need for feasible and effective social interventions that can be delivered by non-professional (paraprofessional) school staff in school settings including after-school programs. The purpose of this study is to test the feasibility and initial efficacy of an after-school social intervention delivered by paraprofessionals in school settings for children with hfASD. Children will be randomly assigned to the social intervention group or a no-treatment control (waitlist) group. The intervention will be delivered by paraprofessionals four days per week (90 minutes per session) over eight weeks during the children's after-school program conducted at their schools. Sessions include social skills groups, social recreational games to practice skills, and behavioral reinforcement to strengthen learning. Feasibility will be assessed via implementation fidelity (accuracy), parent and child satisfaction ratings, and attendance and attrition rates. Outcomes will test the intervention effect on a child test of social-cognition, parent ratings of social skills and ASD symptoms, and behavioral coding of social competence by naïve raters during unstructured game play. Child outcome measures will be completed for both the social intervention group and no-treatment control (waitlist) group immediately prior to (pretest) and following (posttest) the eight-week intervention, and children initially assigned to the social intervention will also complete the assessments three months later (follow-up). Children assigned to the no-treatment control (waitlist) group will receive the social intervention after the intervention group completes the social intervention. Read Less

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD). Read Less

Background and Significance: In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown. Specific Aims of Research Project: 1. To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center. 2. To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models. Read Less

Atrial fibrillation is a type of irregular heartbeat that is common after having heart surgery. There may be many different reasons why some people get atrial fibrillation after their heart surgery. These reasons may include that a person is older or that he/she is taking certain types of medications before surgery. Genes may also be a reason. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Some people may have genes that make it more likely for them to get atrial fibrillation after their heart surgery. This research project is being done to find out if the cells of people who develop atrial fibrillation after heart surgery are different from the cells in people who do not develop atrial fibrillation after surgery. Read Less

Proton therapy is a limited medical resource that is more expensive than conventional x-ray therapy. To correctly measure the success of proton therapy in treating different conditions, it is important to check a patient's health status after their treatment is finished. Checking on the progress of patients over many years (called long-term follow-up) is needed because the long-term effects of proton therapy are not well known. Read Less

This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples. Future analysis of these samples can potentially help investigators to better categorize groups of patients, understand the underlying etiology of these pathologies, identify markers that are associated with favorable or poor outcomes, and track changes that occur during the natural course of the disease or with treatment. This is a prospective observational study which will use samples from such patients to create this library which can be used to explore these questions in the future. Read Less

Renuva is allograft adipose matrix commonly used as a filler in cosmetic procedures. The investigators are studying this material as an injectable in the vocal fold to treat glottic insufficiency. Currently, many products can be used as an injectable in the vocal fold to correct glottic insufficiency such as carbomethycellulose, hyaluronic acid, collagen derivatives and calcium hydroxyapatite amongst others. An ideal injectable would not impair the fibroelastic property of the vocal fold tissues and would integrate within the tissue of the vocal fold. Since Renuva has the property of stimulating adipogenesis by using growth factor and collagen, the investigators believe it could represent a good option in terms of safety and efficacy for vocal fold augmentation. This study will assess the safety and efficacy of Renuva as a vocal fold injectable to treat glottic insufficiency. Read Less

The objective of this pilot study is to determine whether obesity and metabolic syndrome are in fact synergistic in relation to airway nitric oxide (NO) biology. To do so, the investigators want to determine how obesity and the metabolic syndrome relate to metabolism in bronchial airway epithelial cells and the nasal epithelium. Read Less

The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for a minimum of 3 years and up to 5 years for recurrence. Read Less

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation. This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years Read Less

The objective is to better identify suspicious breast lesions that need to be biopsied for malignancy in women currently recommended for biopsy. The long-term goal is to reduce unnecessary biopsies and increase biopsy yield. To do this, the investigators have developed an innovative way to use FDA-approved breast imaging protocols to acquire multispectral images to measure the composition of suspicious breast lesions. The central hypothesis is that breast tissue composition in combination with analysis of morphological and textural tissue characteristics on digital breast tomosynthesis (DBT) imaging will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone. Read Less