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Discover 11,431 clinical trials near Miami, Florida. Find research studies in your area.
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NCT03657043
This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).
NCT02993120
This is a multicenter observational cohort study with both retrospective and prospective data collection components in subjects with ASCVD. The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD.
NCT04146896
To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.
NCT00881361
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.
NCT03118375
The purpose of this study is to assess the benefit of new super-power bone-anchored hearing aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and single-sided hearing loss when they are unable to use or receive limited benefit from traditional hearing. Until recently, BAHAs were only recommended to people with up to a moderate hearing loss. New super-power BAHA processors may be able to help people who previously were not candidates for BAHAs or received limited benefit from them. The information collected in this study may lead to improved evaluation of and expanded treatment options for people considering BAHA. Different types of hearing tests will be used to compare the devices.
NCT03149484
The purpose of this research study is to learn about the hearing outcomes of children with conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.
NCT01008241
The goal of this cross-sectional study is to gain an understanding of the knowledge and attitudes regarding end of life issues and hospice care among a sample of residents of South Florida. This study is being conducted by 3rd year Osteopathic Medical Student (OMS-III)Nova Southeastern University College of Osteopathic Medicine (NSU COM) research fellow Heather Ruff as part of the research fellowship requirements. Participants will complete a paper and pencil questionnaire that measures 4 domains of interest (advanced care planning; end of life care; hospice care and death and dying) as well as demographic factors (age, marital status, education etc.). It is estimated that the survey will take 15 minutes to complete. Data will be collected anonymously, with no personal identifying information. The instructions on the questionnaire state that by completing the questionnaire, the participant is providing consent to participate in the study. We will use time and space sampling methods to recruit up to 250 participants at community venues (i.e., beaches, street corners, parks, pedestrian malls, and other public venues were people congregate) in South Florida. At each venue, we will define a specific area; persons who enter the defined area will be approached, screened for eligibility (18 years of age or older and a resident of South Florida), and if eligible, invited to participate by trained research staff. Sampling intervals will be determined by traffic flow at each venue. If a person agrees to participate they will be given a paper and pencil copy of the survey to complete on the spot. Participants will be given a token of appreciation. Data entry and data analyses will be done using Statistical Package for the Social Sciences (SPSS).
NCT03400943
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
NCT02094716
To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.
NCT03191864
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.
NCT05681689
This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples. Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System. Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.
NCT00057304
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.
NCT03510884
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins. Secondary Objectives: * To evaluate the efficacy of alirocumab versus placebo on LDL-C levels. * To evaluate the effects of alirocumab versus placebo on other lipid parameters. * To evaluate the safety and tolerability of alirocumab in comparison with placebo. * To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. * To evaluate the development of anti-alirocumab antibodies.
NCT04120116
This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
NCT02823574
A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
NCT03217136
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.
NCT03230838
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.
NCT04535167
It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.
NCT05403567
Economic and geographic barriers can limit access to rehabilitation therapies for children with cerebral palsy (CP). These barriers are magnified in developing countries like Costa Rica, where 43% of children with disabilities do not have access to basic health services. To address this accessibility gap, effective and engaging approaches are needed to motivate and support children in practicing motor therapies at home. Bootle Blast (BB) is a low-cost, movement-tracking video game that encourages upper limb (UL) exercises at home. BB is mixed-reality; using real-life objects (e.g., toys) in gameplay to target fine motor skills. It is customizable to diverse abilities and therapy goals. BB applies best practices in video game design, theories of motivation and motor learning, to optimize engagement and clinical effectiveness. This mixed-methods study will assess the feasibility of a family-centred BB home intervention among children with hemiplegic CP. The investigators will address four areas of feasibility to 1) Understand the demand for the BB intervention (i.e., expressed interest in the program), 2) Establish probable efficacy for clinical outcomes related to UL function, activity, and participation, 3) Evaluate implementation of the 8-week BB intervention and 4) Explore acceptability (e.g., participants' experiences). Fifteen children with a diagnosis of hemiplegic CP (7-17 yrs) and one of their primary caregivers will participate. This study consists of three phases, each one contributing to the development of the next one. In Phase 1 (demand), recruitment rates and percentage of children with appropriate in-home technology to play will be collected during screening. A pre-intervention interview will explore participants' expectations for the intervention. In Phase 2, study assessments will be performed via videoconference (probable efficacy). Measures will target UL activity and related participation. Children will play BB at home for 8 weeks. Computer-system logs and data from reported technical barriers will be collected (implementation). In Phase 3 parents and children will participate in a post-intervention interview to explore their experiences and perceived value of the BB program (acceptability). Worldwide, children face accessibility barriers to motor therapy services. This study will provide learnings on how therapy gaming interventions can/should be implemented to bridge accessibility gaps, engage children and improve access to care.
NCT04686383
This is a multi-center, open-label, dose-escalation, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of CAL056 mesylate in cancer patients with resistant or refractory solid tumors.