Gainesville, FL Paid Clinical Trials

A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest. Read Less

The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures. Read Less

This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning. Read Less

Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation. Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice. Read Less

People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved. Read Less

The goal of this clinical trial is to learn about the mechanisms by which minocycline effect blood pressure in individuals with treatment-resistant hypertension. The main questions it aims to answer are: * To what extent does minocycline lower blood pressure and are these effects different across races? * Are such blood pressure effects mediated through changes in gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or some combination of these? Participants will be randomly assigned to treatment with minocycline or placebo, treated daily for 3 months, to evaluate these questions. Read Less

The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery. Read Less

Daily patient participation is critical to the successful, life-saving delivery of radiotherapy. There is very little in the literature describing the best way to prepare patients to give optimal participation. This study aims to look at an already-prepared conversion of patient instruction materials and measure whether the improvement in clarity and specificity produces the desired changes in patient decision-making and emotional comfort. Read Less

This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems. Read Less

BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial with a sequential parallel comparison design (SPCD) of bilateral pterygopalatine fossa (PPF) injections with 20mg ropivacaine + 4mg dexamethasone (active, PPF-block) compared to saline (placebo) for headache in survivors of aneurysmal subarachnoid hemorrhage (SAH), while monitoring intracranial arterial mean flow velocities with transcranial Doppler (TCD) peri-intervention (intervention = PPF-injections: active or placebo) Read Less

There are three main objectives of the protocol. First, we will evaluate the added clinical- and cost- effectiveness of parent-targeted motivational aids (reminder/recall and phone-based MI) alone and when combined with community-targeted healthcare access assistance beyond the effects of clinician-targeted training. Second, we will estimate the differential effectiveness of the implementation strategies by patient-level factors (age, race/ethnicity, sex, distance from home to clinic, social vulnerability). Third, we will measure moderation of implementation strategy effectiveness by clinic-level factors (HPV vaccination priority, resources, clinic visit types, scheduling practices, and implementation success). Within 11 rural North Central Florida counties, we will evaluate the layering of evidence-based implementation strategies that progressively addressing clinician, parent, and healthcare access barriers faced by rural communities on HPV vaccination rates among 9- to 12-year-olds. To best address our main question of whether layering complementary strategies continues to increase effects on HPV vaccination, we will test our hypotheses with a three-arm cluster randomized study design of nested strategies. The proposed nested study design optimizes evaluation, causal inference, and scientific rigor by putting the maximum number of clinics towards addressing the layering of strategies. Randomization will occur at the clinic level. All clinics will receive implementation strategy A: clinician-targeted recommendation training. A random 20 of 30 of clinics will also receive facilitation of parent-targeted motivational aids (B) for an implementation strategy package of A+B. Finally, a random half of the clinics who receive A+B will also receive community-targeted healthcare access (C) for a total implementation strategy package of A+B+C. This equates to a three-arm cluster randomized trial in which 10 clinics receive clinician- targeted recommendation training alone (A), 10 clinics receive clinician-targeted recommendation training and parent-targeted motivational aids (A+B), and 10 clinics receive clinician-targeted recommendation training, parent-targeted motivational aids, and community-targeted healthcare access (A+B+C). Read Less

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial. Read Less