Georgia Paid Clinical Trials

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

This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated. Read Less

This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests. The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes. Read Less

This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase. Read Less

This trials studies communication issues in patient and provider discussions about immunotherapy. The goal of this study is to describe where patients have heard about immunotherapy, what the participants understand about it, how physicians and other healthcare workers describe immunotherapy, and how educational videos may support patient knowledge about immunotherapy. Read Less

A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI). Read Less

The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are: * Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible. * What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge. Read Less

This study investigates the neural mechanisms causally involved in how people navigate through their immediately visible environment (e.g., walking around one's bedroom flawlessly and effortlessly, not bumping into the walls or furniture). To investigate whether particular neural mechanisms are causally involved in "visually-guided navigation", repetitive transcranial magnetic stimulation (rTMS) is used to temporarily disrupt the functioning of particular brain regions in healthy adults while they are shown simple visual stimuli of places (e.g., bedrooms, kitchens, and living rooms) and asked to perform simple computer tasks or to complete simple behavioral tasks. Read Less

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer. Read Less

Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP. Read Less

The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation. Read Less

This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy. Read Less