All Clinical Trials

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

The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin. The target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis. Read Less

The main questions it aims to answer are: 1. Does completing a standard assessment increase the detection of chemotherapy induced taste changes compared with usual care (no assessment)? What TA are experienced? Are there any patterns in TA symptom occurrence based on age, sex, race/ethnicity, cancer type, chemotherapy agent, etc. 2. Do patients take action to deal with the TA? What strategies are used? Do patients in the intervention group use the assessments to select interventions? 3. Do the interventions lessen TA symptoms and maintain food intake? Is the treatment (in-depth assessment and education) more effective in lessening the intensity of TA than usual care? Which level of assessment is needed to support symptom management to reduce symptom severity? Participants will: Complete baseline assessment before starting their initial chemotherapy infusion (all patients) Participate in baseline patient education based on assigned intervention (usual care vs. treatment) Engage in TA management between chemotherapy infusion clinic visits based on education Visit the clinic for chemotherapy infusions as scheduled; Complete TA assessments and reporting based on intervention; Work with nurse coaches to answer questions and help with the intervention. Complete study data collection on the 4th chemotherapy cycle (but continue intervention) Complete final data collection at 6 months Read Less

The Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in skeletally mature patients with degenerative disc disease and instabilities at one or more levels of the spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have described the use of conduit cages in interbody fixation procedures, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, and instabilities at one to multilevel contiguous levels between C2-T1 and 1-2 contiguous levels between L2-S1 of the spine with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis and spondylodesis. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any. Read Less

Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep. Read Less

This is a double blind active placebo controlled clinical trial for individuals within an inpatient setting with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms. Read Less

Clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo. Read Less

Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging. The primary study objective of MOCHA is to develop an accurate and reliable assessment algorithm for determining neurologic prognosis in patients initially unconscious (no eye opening, GCS-M\<6 and not following commands) post-cardiac arrest, using multiple prognostic modalities at standardized time points. Read Less

The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization. Read Less

The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are: * does remote temperature monitoring reduce the number of days spent inpatient * what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring * the number of billable CPT codes that will be generated by providing remote temperature monitoring Researchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient. Patients will * wear the thermometer for the duration of their participation in the study * have their temperature monitored continuously * receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician * respond to texts or calls from remote monitors when an alert is triggered Read Less

Background: Current techniques used to measure the health and function of a person s nerves and muscles are generally effective, but they do have limits. Researchers are looking for ways to improve the ability to observe nerves and muscles and how they function in this natural history protocol. Objective: To study the use of ultrasound (sound waves) to learn more about nerves and muscles. Eligibility: Healthy adults, aged 18 and older, with no history of stroke, nerve or muscular disorders, or spine surgery are also needed. A smaller population of adults aged 18 and older who have a neuromuscular disorder or show symptoms of nerve or muscle disorder will also be evaluated. Design: Participants will be screened with a medical record review. Participants will have up to 5 outpatient clinic visits. Most participants will have 1 or 2 visits. Visits will last for less than 3-4 hours each. During each visit, participants will give a brief medical history and have a physical exam. Participants will have ultrasounds to get pictures and measurements of their nerves and muscles. Gel will be applied to their skin. A probe will be placed on the skin surface. Sound waves sent through the probe will be used to create pictures. Participants may have nerve conduction studies. Wires will be taped to the skin surface near a muscle or nerve in the arm or leg. The nerve will be stimulated with a small electric current that feels like a rubber band flick. The response will be recorded through the wires. Read Less

180 young adult vapers who are not current smokers will participate in a baseline functional magnetic resonance imaging (fMRI) experiment, prospectively linked to a 1-year randomized controlled trial. Baseline fMRI tasks will probe critical neurocognitive markers with high potential to account for individual differences in nicotine use prognosis and responsiveness to anti-vaping public service announcements (PSAs). Participants will be assigned randomly to a survey-only control condition, or one of two intervention orders, Regular PSA then Flavor PSA, and Flavor PSA then Regular PSA (n=60 each) in a 1-year counterbalanced crossover design. Every week intervention groups will receive anti-vaping PSAs either do not specifically address harms associated with vaping flavors (regular PSAs) or PSAs with a theme focusing on the harms of flavored vape products (flavor PSAs). Participants of the intervention groups will switch PSA exposure condition after 6 months. Their evaluations of the PSAs will be assessed with brief weekly online surveys. The links to the weekly online surveys will be sent via e-mail and text which allow them to access the surveys using any device with an internet browser. During the survey, the PSA of that week will first be displayed to PSA groups (n=120), followed by a query to provide message evaluation. Afterward, the survey questions will also assess their e-cigarette, cigarette, other tobacco use, and nicotine dependence, during the past week. The control group (n=60) will complete the surveys without viewing PSAs. In-person assessments at 3, 6, 9, and 12 months will biochemically confirm nicotine exposure. Read Less