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489 recruiting in FL
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A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics

Glaucoma, Suspect ยท Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System ยท Congenital Coloboma of the Optic Nerve

The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.

Fort Lauderdale, FL5โ€“8 yrsAll genders
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Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy

Acute Ischemic Stroke AIS

The purpose of this clinical trial is to study the two main types of approaches used in stroke thrombectomy and to investigate if one approach is more effective than the other, as this is currently not known. This study will be conducted in adults who have been diagnosed with an acute ischemic stroke and who are undergoing a thrombectomy for the treatment of their stroke. The main questions it aims to answer are: * Does the use of a balloon guide catheter versus a conventional guide catheter lower the time needed to restore blood flow in the blocked vessel in the brain * To help researchers better understand the technical, clinical, and procedural outcomes associated with using a balloon guide catheter versus a conventional guide catheter in stroke thrombectomy Participants will be asked to * Share their medical history and imaging data that is collected as part of their routine medical care * Undergo a mechanical thrombectomy as part of their routine medical care * Answer some questions about their neurological functioning at 3 months (90 days) post hospitalization

Tampa, FL18+ yrsAll genders
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Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

Atherosclerotic Cardiovascular Disease ยท Overweight ยท Obesity

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Boca Raton, Edgewater +more, FL45โ€“99 yrsAll genders
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Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

Atrial Fibrillation (AF)

The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMapยฎ) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults. Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).

Clearwater, Jacksonville +more, FL22+ yrsAll genders
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Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Multiple Myeloma

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Orlando, Tampa, FL18+ yrsAll genders
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Responses to Backward Walking Training Post-Stroke

Stroke

Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. The investigators have previously established the effectiveness of a backward walking training program to improve gait and balance in post-stroke Veterans. To best serve Veterans in this era of personalized medicine, there is a current need to determine the appropriate training dose as well as which post-stroke Veterans would most benefit. This study addresses both needs as it will 1) test responses to two different doses (18 vs. 27 sessions) of backward walking training and 2) assess brain activity, measured by magnetic resonance imaging, before and after training intervention to determine its ability to predict rehabilitation response as well as brain mechanisms of behavioral change.

Gainesville, Jacksonville, FL18โ€“90 yrsAll genders
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HIIT Following Breast Cancer Chemotherapy

Breast Cancer

Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.

Gainesville, FL18โ€“85 yrsWomen
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The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment

Pregnant Individuals ยท Aneuploidy ยท Down Syndrome (Trisomy 21)

The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of prenatal invasive diagnostic testing or postnatal genetic and clinical diagnosis of the resulting neonate. This is a prospective study of pregnant individuals.

Sarasota, FLAll agesWomen
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Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

Stroke, Acute ยท Ischemic Stroke, Acute ยท Hemorrhagic Stroke

Most stroke patients are initially evaluated at the closest hospital but some need to be transferred to a hospital that can provide more advanced care. The "Door-In-Door-Out" (DIDO) process at the first hospital can take time making transferred patients no longer able to get the advanced treatments. This study will help hospitals across the US "stand up" new ways to evaluate stroke patients, decide who needs to be transferred, and transfer them quickly for advanced treatment.

Miami, FL18+ yrsAll genders
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Improving Veteran Referral to Cardiac Rehabilitation

Cardiovascular Disease ยท Cardiac Rehabilitation

This study will test whether the Veterans Cardiac Rehabilitation Referral Program (VCR2P) improves cardiac rehabilitation participation by studying 816 Veterans across three VA medical centers in Nashville, Dallas, and Gainesville over 12 months. The trial compares referral rates from the 6 months before implementing the program to 6 months after, using a "before and after" design since randomization would be impractical. The study will measure whether the program increases the proportion of eligible Veterans who receive cardiac rehabilitation referrals and whether more Veterans actually attend rehabilitation sessions. Additionally, focus groups with physicians, nurses, and Veterans will identify what helps or hinders the program's success, providing essential insights for expanding this intervention to other VA facilities nationwide if it proves effective.

Gainesville, FL18+ yrsAll genders
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)

Systemic Sclerosis ยท Idiopathic Inflammatory Myopathies ยท Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.

Gainesville, Miami +more, FL18โ€“75 yrsAll genders
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360โ„ข Catheter and Afferaโ„ข Mapping and Ablation System (Horizon 360)

Paroxysmal AF

The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.

Naples, FL18โ€“80 yrsAll genders
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External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial

Severe Traumatic Brain Injury ยท Intracranial Hypertension

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.

Gainesville, FL18โ€“65 yrsAll genders
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Supporting Health in Veterans With Heart Failure

Heart Failure

This study will test the effectiveness of a culturally-sensitive, telephone-based, tailored problem-solving intervention to improve physical and mental health in Veterans with heart failure (HF). Veterans will be recruited from VA clinics throughout the United States. As a component of this study, Veterans will partner with a registered nurse for a 12-week telehealth program that includes 8 telephone sessions. Follow-up data will be collected at 3-months (post intervention) and 6-, 12-, and 18-months to examine sustainability of intervention effect.

Gainesville, FL18+ yrsAll genders
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