A MIXED METHODS SINGLE-GROUP SINGLE-CENTER FEASIBILITY STUDY OF A FOOD RESPONSE AND ATTENTION TRAINING TO REDUCE UNHEALTHY DIETARY INTAKE AND PROMOTE WEIGHT LOSS IN RACIALLY AND ETHNICALLY DIVERSE PATIENTS WITH OBESITY
Over 40% of American adults have obesity, with a higher prevalence for racial/ethnic minorities such as Hispanic (47%) and non-Hispanic Black/African American populations (46.8%), increasing their cardiovascular disease risk. Most behavioral interventions do not target attention bias that may be driving food intake, and this may limit their effectiveness. Attention bias to unhealthy foods describes the automatic processes by which these foods capture attention, and activate the brain’s reward system. During computer-based food response training, people can learn to counteract this attention bias by repeatedly inhibiting their responses to unhealthy foods. Afterward, people devalue these foods, experience fewer cravings, and reduce their food intake, binge eating symptoms, and weight. Food response training may be particularly beneficial for people with low inhibitory control who, by definition, demonstrate decreased ability to suppress task-irrelevant behaviors. Food response training has promise as a novel weight-loss treatment, yet most studies to date have taken place in laboratory settings with students. Thus, it is unclear whether findings are generalizable to diverse patient populations and within clinical settings. Using a mixed-methods approach, this study aims to determine the acceptability and feasibility of a food response training intervention among racially and ethnically diverse patients with obesity and elevated cardiovascular disease. We will conduct a single group pre-post study to examine the acceptability and feasibility of the food response training intervention and 12-week outcomes (i.e., dietary intake, weight, and blood pressure). We will also conduct individual interviews with a subset of patients to examine patients’ perceptions of the food response training intervention. We also explore if the effects of the food response training intervention on reduced dietary intake and weight will be stronger for patients who score low on the inhibitory self-control scale. Food response training is a novel and potentially scalable weight-loss intervention that may help diverse patients with obesity to consume healthy foods, lose weight, and improve their cardiovascular health.
A Modular Open-label Phase I/II Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies
EP0031-101 is an interventional, modular, multi-arm, multi-centre, open-label Phase I/II study to investigate the safety, tolerability, PK, and PD of EP0031, to determine the RP2D of EP0031, and todetermine preliminary efficacy of EP0031 in defined patient populations with RET-altered malignancies.The design consists of a core study protocol and individual Modules, as follows:? Module A: Monotherapy dose escalation and RP2D optimisation in patients with RETaltered solid tumours (including a paired biopsy cohort)? Module B: Dose-expansion cohorts will be opened to further explore the safety andtolerability and provide preliminary efficacy data in selected patient populations withRET-altered tumours? Module C: Further dose expansion and initial efficacy investigation in patients who haveprogressed following first-generation SRI therapy
A Multi-Center Observational Study Assessing the Utility of an Immune Cell Function Assay in a Cardiac Sarcoid Population
Sarcoid is an autoimmune disease that can be found in any and every organ system. The greatest degree of morbidity and mortality comes from cardiac involvement where it can lead to sudden cardiac death, heart block, and heart failure. The basics of the treatment for cardiac sarcoid include appropriate preventative treatment for ventricular arrhythmias, guideline directed medical treatment for heart failure, and immunosuppression to decrease active cardiac inflammation. The amount of immunosuppression and with which medication is of expert opinion. Using PET scan, we can help assess for successful suppression of the disease, but often 2nd or 3rd line treatments are required after initial therapy strategy is deemed insufficient. As of now, there are no predictors of who will fail initial treatment. For this study, there are three different hypotheses. First, we suspect the baseline Immuknow tertile (low, medium, high) will correlate with the rate of response to first line immunosuppression with low being more likely than the combined medium/high grouping to be responsive on first clinically indicated PET follow up. Second, that a subsequent decrease in ImmuKnow grade, for those that start in the medium or high range, will be predictive of resolution of inflammation on cardiac PET. Lastly, we would like to assess whether an intermediate ImmuKnow assay, drawn at 1 month, would be predictive of response at 3 month follow up.The study population will include adults with a clinical or histological diagnosis of cardiac sarcoidosis found to have active inflammation on cardiac PET scan who are not currently on immunosuppressive therapy. This should be their first time undergoing treatment for cardiac sarcoid (i.e. not with disease recurrence). This will give us a uniform patient population that will not have effects of prior immunosuppression as to their response to current treatment, and not possibly already have treatment failure. We will also be storing biologic samples for future analysis. We believe that a change in the immunophenotype of an individual in response to treatment will be the hallmark of successful immunosuppression. We will be using these samples to assess this in the future.
A Multi-Center Phase 2/3 Randomized Double-Blind Placebo-Controlled Parallel- Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare
This is a multi-center Phase 2/3 randomized, double-blind, placebo-controlled,parallel-group safety and efficacy study with a 7-day period of IMP treatment conducted insubjects with an acute gout flare.
A Multi-Center Prospective Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis (ENDEAVOUR-UC)
The purpose of this research study is to observe the effectiveness of Etrasimod (Velsipity®) in adults with moderately to severely active ulcerative colitis (UC). The study consists of 52-weeks of follow-up from etrasimod initiation and an additional 28-day safety follow-up period.
A MULTI-CENTER PROSPECTIVE NON-RANDOMIZED PIVOTAL TRIAL EVALUATING THE SAFETY AND EFFECTIVENESS OF THE POLYMOTION HIP RESURFACING SYSTEM
This research study is being conducted to evaluate the safety and effectiveness of an investigational device, the Polymotion Hip Resurfacing System.
A Multi-Center Prospective Observational Study of Patients with Neuroinflammatory Disease
Patients meeting inclusion criteria for the study will be prospectively enrolled and followed over time to evaluate clinical variables and the natural history of these disorders. Additionally, we will analyze patient electroencephalograms, brain imaging studies, and collect blood, spinal fluid, tissue, and other biospecimens when available, for future biomarker, immunophenotyping, and genetic analyses.
A Multi-Center Prospective Registry to Evaluate the Continued Safety and Effectiveness of Arthrex Products used for Knee Sports Medicine Repair and Reconstruction
The study is being done to evaluate the effectiveness and safety profile of Arthrex knee products when used as standard of care for repair or reconstruction of soft tissues of the knee such as ligaments, tendons, or the meniscus.
A multi-center randomized blinded controlled study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval System (EXPANDER-2)
The Urocross Expander System is indicated for the treatment of lowerurinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia(BPH) in men = 45 years old, and while implanted in the prostaticurethra.The Urocross Expander Implant is indicated for an indwell duration of 6months, after which it is retrieved under visualization, using the UrocrossRetrieval Sheath and a commercially available compatible grasper usedduring urological procedures.The Urocross Retrieval Sheath is indicated for use to retrieve theUrocross Expander Implant using a compatible flexible cystoscope andcompatible graspers commonly used during urological procedures.
A Multi-centered Double-blind Randomized Placebo-controlled Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients with Multiple System Atrophy
The study is evaluating the safety and effectiveness of "TEV-56286" to treat multiple system atrophy (MSA). The total duration of participation is just over one year.