Gainesville, FL Paid Clinical Trials

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 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

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

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

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers. Read Less

In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Read Less

The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). This is a retrospective and prospective, multicenter, US/OUS, observational data registry. Read Less

With this prospective double-blinded, placebo controlled clinical trial we hypothesize that immediate (post-injury) intervention with Fluoxetine will prevent/mitigate the development of negative psychiatric symptomology such as PTSD and depression for victims of bodily trauma. We also hypothesize that immediate use of Fluoxetine will decrease subjects' pain, pain interference and opioid use without changing our standard of care post-injury pain medication regimen. Enrolled subjects will be randomized to Fluoxetine or placebo at their index hospitalization. Read Less

The purpose of this study is to evaluate the safety and efficacy of narsoplimab in pediatric patients with thrombotic microangiopathies (TMA) following hematopoietic stem cell transplant (HSCT). Read Less

The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators. Another goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study. Read Less

This study will use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating mindfulness-based interventions into physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment. First, researchers will develop a manual for training physical therapists to provide mindfulness-based interventions to patients with chronic musculoskeletal pain and long-term opioid treatment. Next, the researchers will evaluate the competency of physical therapists to provided mindfulness-based interventions after being randomized to one of 3 different mindfulness training arms. Patients scheduled for physical therapy with the randomized physical therapists will be invited to enroll in the study. These patients will be asked to complete a variety of patient reported outcomes including self-reported average pain and the the amount of prescription opioid pain medication taken. Read Less