Florida Paid Clinical Trials

The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi. Read Less

Anxiety disorders are the most common form of psychopathology, and frequently begin in childhood, resulting in lifelong impairment. Increased brain activity after making mistakes, as reflected by the error-related negativity (ERN), is observed in people with anxiety disorders, even before disorder onset. The ERN is therefore of great interest as a potentially modifiable risk factor for anxiety. However, methodological issues can make the ERN difficult to measure. Increased brain activity in response to a balance disturbance, as reflected by the balance N1, resembles the ERN, but does not share its methodological issues. The investigators' preliminary data demonstrate that the balance N1 and the ERN are associated in amplitude in adults, suggesting they may depend on the same brain processes. The balance N1 has never been investigated in individuals with anxiety disorders, but it increases in amplitude within individuals under anxiety-inducing environmental contexts. Further, balance and anxiety are related in terms of brain anatomy, daily behavior, disorder presentation, and response to treatment. The present investigation will measure the ERN and the balance N1 in children (ages 9-12) with anxiety disorders, and further, how these brain activity measures change in response to a brief, 45-minute, computerized psychosocial intervention that was developed to reduce reactivity to errors, and has been shown to reduce the ERN. The investigators will recruit approximately 80 children with anxiety disorders, half of whom will be randomly assigned to the active intervention condition. The other half will be assigned to an active control condition, consisting of a different 45-minute computerized presentation. Participants assigned to the control condition can access the computerized intervention after participation in the study. The purpose of this investigation is to test the hypothesis that the balance N1 and the ERN will be reduced to a similar extent after the intervention, to demonstrate that these brain responses arise from shared brain processes. Transfer of the effect of the psycho-social intervention to the balance N1 would provide insight into prior work demonstrating that balance training can alleviate anxiety in young children, and well-documented benefits of psychotherapy to balance disorders. Collectively, these data may guide the development of multidisciplinary interventions for the prevention and treatment of anxiety disorders in children. Read Less

The rapid increase of electronic nicotine delivery systems (ENDS) use by young people in the US and their potential to harm health, cause addiction, and serve as a risk for cigarette smoking or dual-use is alarming. The epidemic of ENDS use among young people in the US has been associated with the rise in popularity of ENDS products that are very efficient in delivering high doses of nicotine to users. Therefore, the investigators propose to study the effects of nicotine reduction (NR) on young ENDS users as a potential regulatory strategy to reduce the addictiveness and use of ENDS. The proposed studies are directly responsive to research priories identified by the FDA and specified in this RFA under Addiction; studying the "Impact of changes in tobacco product characteristics (e.g. nicotine formulation) on dependence". This project aims to provide an overview of this project's rationale significance divided into 1) scientific rationale and regulatory implications; 2) the need to respond to the rising trend of ENDS use among young people in the US; 3) the importance of reducing the addictiveness of ENDS; 4) the strength of our clinical and analytical lab approach for regulatory purposes; and 5) the strengths and weaknesses in the rigor of prior research about NR for ENDS. Read Less

This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole. Read Less

Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303. Read Less

International retrospective observational cohort study aimed to describe a molecular classification for NMZL. Read Less

Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression. Read Less

The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm. Read Less

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing. Read Less

The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain. The main question aims to compare a group taking active treatment and a group taking a look-alike substance containing no active treatment. All participants will answer questions on Day 1, before treatment, and on 7-day after treatment, about: * Amount and quality of pain * Interference with physical activity * Interference with sleep Read Less

The PANTHERS (Parents And iNfants Together in Home-based Early Remote Services) Projects is a study funded by the National Institute of Child Health and Human Development to evaluate the efficacy and maintenance of a remote home-based preventive intervention, the Infant Behavior Program (IBP), to decrease behavior problems in infants from high-risk families. All families will participate in five remote evaluations in their home, and families will also receive 6 remote treatment sessions of either the IBP or the EPPC. All participant procedures will be conducted remotely. Read Less

The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy. Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms. * Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment. * Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment. * Arm 3 participants will receive daily hedgehog pathway inhibitor only. Read Less