Georgia Paid Clinical Trials

The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization Read Less

Minoritized populations face mutually reinforcing levels of structural disadvantage that contribute to poor health. Despite recognition that social and economic stratification, environmental conditions, and policy are critical determinants of health disparities, there has been limited effort in expanding interventions beyond the individual level to disrupt systemic causes of health. This is in part due to the challenges of describing how racism and discrimination have become systematized over time and across place.68 Studies that do examine SRD and health and well-being, focus on one level of SRD at a time, rather than examining multiple levels simultaneously. Also, the measurement of SRD at all levels has not been very detailed and more research is needed on the nuances of these experiences (e.g., frequency, timeframe, intensity). Finally, there is a need for more prospective longitudinal studies, as most research to date has been cross-sectional. In addition to comprehensively examining the four SRD levels, the current study will examine these multi- level predictors of SRD simultaneously, longitudinally, and across two sites to identify targets for multi-level interventions that will be more likely to be effective and sustainable. Read Less

Adding cottonseed oil to the diet has been shown to improve cholesterol profiles and other markers of chronic disease risk in both healthy and at-risk adults. However, CSO has only been tested in the context of high-fat diets. The goal of this clinical trial is to learn about the health effects of lower amounts of cottonseed oil (CSO) added to the diet in adults at increased risk for cardiovascular disease. The main questions it aims to answer are: * How do different amounts of CSO in the diet affect fasting cholesterol profiles and markers of liver function? * How do different amounts of CSO in the diet affect fasting and post-meal markers of lipid metabolism (i.e. triglycerides) and glycemic control (i.e. blood sugar and insulin)? * How do different amounts of CSO in the diet affect fasting and post-meal markers of chronic disease risk factors such as oxidative stress, inflammation, coagulation potential, and appetite control? Participants will be asked to: * Consume provided breakfast shakes and snacks daily for 28-days. * Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials. * Attend two longer (5.5 h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO LOW, CSO MID, CSO HIGH, and Control groups (receiving a mixture of oils) to see if lower doses of CSO in the diet impart the same health benefits as previously shown with high doses of CSO. Read Less

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). Read Less

This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo. Read Less

This research project will explore negative symptoms of schizophrenia, such as motivational deficits, by examining the relationship between inflammation and reward-related brain regions. To accomplish this, we will administer a single infusion of either the anti-inflammatory medication infliximab or placebo (n=10 per group) to patients with high inflammation. This study is important because schizophrenia can be a chronic and debilitating neuropsychiatric disorder and negative symptoms are some of the most difficult aspects of schizophrenia associated with worst functional outcomes. These symptoms do not typically respond to antipsychotic therapies, and as such, there are no current medications to treat negative symptoms. Read Less

The goal of the Phase 3a part of this clinical trial is to determine the optimal dose that will be used in the Phase 3b part of this clinical trial. The goal of the Phase 3b part is to assess the efficacy of SNP-ACTH (1-39) Gel relative to rituximab in patients with primary membranous nephropathy (PMN) at month 24. Read Less

The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Preterm born infants are at high risk for neurosensory impairments and developmental delays. In the NICU, infants are often deprived of infant-directed parental speech because of numerous challenges to parental visitation, resulting in reduced differentiation of speech sounds, altered brain structure and poor language outcomes. The study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier equipped with a sensor for suck pressure/timing, connected to a speaker that delivers mother's voice. The study will test the hypothesis that there will be a greater response difference between speech sounds on EEG, for infants receiving the suck-contingent mother's voice intervention than for infants hearing the same amount of non-contingent mother's voice from a speaker device. Read Less

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK) Read Less

Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set. These women will be enrolled from annual screening population and diagnostic workup population. The enrolled patient will undergo KBCT scans within 4 weeks of her screening or diagnostic mammography exam and before breast biopsy occurs if biopsy is needed. Read Less

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems. Read Less

The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children. PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner. One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice. Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings. If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world. Read Less