Gainesville, FL Paid Clinical Trials

This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10\^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo. Read Less

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi \&; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Read Less

Our long-term goal is to reduce stress and improve sickle cell disease (SCD) pain control with less opioid use through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We Support (YCWS). Americans living with SCD suffer recurrent episodes of acute and chronic pain, both of which are exacerbated by stress. Building on the successes of our prior formative studies, we now propose a well-designed, appropriately powered study to test efficacy of YCWS on outcomes (pain intensity, stress intensity, opioid use) in adults with SCD. We propose to recruit 170 adults for a randomized controlled trial of the short-term (8 weeks) and long-term (6 months) effects of YCWS on outcomes (pain, stress, and opioid use). Stratified on worst pain intensity (\<=5; \>5), we will randomly assign patients to groups: 85 to Control (Self-monitoring of outcomes + alerts/reminders), and 85 to Experimental (Self-monitoring of outcomes + alerts/reminders + use of YCWS \[RDE + Support\]). We will ask participants to report outcomes daily. During weeks 1-8, we will send system-generated alerts/reminders to both groups via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the patient does not enter data after 24 hours, study support staff will contact him/her for data entry trouble-shooting (both groups) and YCWS use (experimental). We will time stamp and track participants' online activities to understand the study context and conduct exit interviews on acceptability of the staff and system-generated support. We will analyze data using mixed-effects regression models (short-term, long-term) to account for repeated measurements over time and utilize machine learning to construct and evaluate models predictive of outcomes. Specific aims are: Aim 1: To determine the short-term effects of YCWS. Aim 2: To determine the long-term effects of YCWS. Aim 3 (exploratory): Using machine learning, to develop and evaluate models that predict patient outcomes based on their group assignment and on their personal (e.g., self-efficacy, sex, education, family income, computer experience, etc.,) and environmental characteristics (e.g., distance from care, quality of cell connection, etc.). Read Less

The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks. Read Less

This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration. Participants will be enrolled in one of 2 parts: * In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants * In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants and investigators will be masked to dose. After receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5. Read Less

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Read Less

Retinitis pigmentosa (RP) is an inherited retinal degeneration caused by one of several mistakes in the genetic code. Such mistakes are called mutations. The mutations cause degeneration of rod photoreceptors which are responsible for vision in dim illumination resulting in night blindness. After rod photoreceptors are eliminated, gradual degeneration of cone photoreceptors occurs resulting in gradual constriction of side vision that eventually causes tunnel vision. Oxidative stress contributes to cone degeneration. N-acetylcysteine (NAC) reduces oxidative stress and in animal models of RP it slowed cone degeneration. In a phase I clinical trial in patients with RP, NAC taken by month for 6 months caused some small improvements in two different vision tests suggesting that long-term administration of NAC might slow cone degeneration in RP. NAC Attack is a clinical trial being conducted at many institutions in the US, Canada, Mexico, and Europe designed to determine if taking NAC for several years provides benefit in patients with RP. Read Less

This phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called human epidermal growth factor receptor 2 (HER2). Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Adding neratinib to trastuzumab deruxtecan may be able to shrink cancer with a change in the HER2 gene. Read Less

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome \[ASyS\]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/. Read Less

Processing sweet corn may impact digestibility and, therefore, glycemic response following consumption. The primary aim of this study is to assess the glycemic index of various sweet corn products and varieties. An exploratory aim is to assess hunger/satiety scores following sweet corn intake. Read Less

Premature infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 168 VLBW infants for 4 weeks following birth. Read Less

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection. Read Less