Aurora, CO Paid Clinical Trials

This will be prospective study of patients with knee effusion associated with degenerative osteoarthritis or symptomatic primary total knee arthroplasty that undergo therapeutic joint arthrocentesis. The diagnosis of knee osteoarthritis will be based on knee radiographs (including AP, Rosenburg view, lateral and Merchant views) read and interpreted by one of our clinical providers (PA, Fellow or Surgeon). Patients with at least Grade II Kellgren and Lawrence changes or higher will be included in the osteoarthritis group. Patients in the arthroplasty group must have had a primary total knee arthroplasty without infection (as determined by knee aspirate) to be included. Patients will be clinically evaluated at the time of their visit for presence of a knee effusion using a stroke test and graded on a 5-point scale (zero, trace, 1+, 2+, or 3+) which has shown good interrater reliability. Patients with a mild to severe effusion (1+ to 3+) will considered for the study. Patients having significant pain associated with their effusion will be offered a therapeutic arthrocentesis as part of their treatment plan discussion. This is a pre-post test design in which outcome measures will be collected immediately pre-arthrocentesis and immediately post arthrocentesis. Additionally, there will be an optional 7-10 follow up visit where outcomes measures will be collected again, should the participant choose to return to this visit. Read Less

Age-related hearing loss, presbycusis, affects up to 50% of American adults. There are two main causes for presbycusis: 1) Progressive death of hair cells in the inner ear, and 2) Central hearing loss, or the reduced ability to decipher the sound source of interest from other competing sounds in a multi-source complex environment. The first cause is better understood and treatment options, such as hearing aids and cochlear implants, are available. However, central hearing loss is not as well understood and there is not a treatment available at this time. This study aims to advance our understanding of central hearing loss by evaluating the abilities of younger and older listeners in two primary outcome measures: to 1) neurologically process sound stimuli and 2) focus on conversational speech in the presence of spatially-separated competing background noise. A test using Auditory Brainstem Responses (ABR) will be used to evaluate the brain's response to clicking sounds. This study will assess all waveform data, but will focus particularly on wave III. Sentence in noise tests will be used to assess each subject's ability to process speech in noisy situations. Both the ABR and sentence in noise tests are non-invasive and are commonly used in audiology practices to diagnosis and treat a variety of audiological pathologies. Read Less

This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease. There will be no limit on prior use of endocrine therapy including aromatase inhibitors, tamoxifen and fulvestrant, given a documented clinical benefit of elacestrant in this setting. Read Less

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts. Read Less

An external tunneled central venous access device (CVAD) is a small plastic tube that is tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require a tunneled CVAD are some of the sickest patients we encounter and include oncology, hematology, and gastrointestinal (intestinal failure) patients. These patients are heavily reliant on their tunneled CVAD, which can be a lifeline for long-term administration of chemotherapeutics, IV medications, blood product transfusions, antibiotics, enteral nutrition, blood draws and fluids. Unfortunately, nearly 30% of pediatric external tunneled CVADs fail prior to the completion of treatment. External tunneled CVAD failures lead to unnecessary morbidity and mortality, interruption of medical therapy, and the added costs and risks associated with additional procedural complications. It is hypothesized that a newly designed securement method for external tunneled central venous access devices (CVAD) will reduce catheter-related complications and increase patient, parent and provider satisfaction, compared to the current standard of care, which is a clear transparent film dressing over the catheter exit site. A 20 patient, prospective clinical trial is proposed to address the following specific aims, which will determine if the securement device: Is rated by patients, parents and providers as easy to apply and comfortable for users Reduces CVAD-related complications, such as delayed healing of the tract, catheter-related infections, and episodes of catheter dislodgement Improves the quality of life for patients and their parents Is preferred over the standard, clear transparent dressing alone Requires any design modifications to improve performance and/or comfort of the device Read Less

Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in subjects with relapsed or refractory metastatic colorectal cancer. Read Less

The aim of this study is to compare the outcomes, ease of use, and cost of the Werewolf FLOW50 device to the institutional standard of care which is does not include the use of electrocautery devices during anterior cruciate ligament reconstruction (ACLR) surgery in patients 12-18 years of age using a randomized control trial design. The investigators hypothesize that a lower proportion of participants who undergo ACLR and are randomized to the Werewolf FLOW50 procedure will experience post-operative arthrofibrosis compared to those randomized to standard of care (control group). Read Less

This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical repair of single-sided inguinal hernias. The researchers hypothesize that when given the autonomy to return to activity at the patient's discretion, convalescence will decrease in comparison to a control group given specific precautions to refrain from lifting and strenuous activity. Specific aims include differences in convalescence and surgical outcomes for each group, i.e. rates of complications, hernia recurrence, physical activity assessments pre and postop, and quality of life outcomes. Read Less

The primary objectives of this study are to establish exercise training as a novel intervention to treat Long COVID and characterize the cardiorespiratory and autonomic physiology in these patients to precisely characterize mechanisms contributing to this syndrome. Read Less

Eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, is a clinical and financial burden to patients if left untreated. Often the natural history of the disease includes development of fibrosis and stricturing of the esophagus, acute food impactions, unplanned emergency room visits, and invasive procedures such as endoscopy. Currently there are no Food and Drug Administration (FDA) approved medications for the treatment of EoE. As such, pharmacologic options approved for use in asthma are used for treatment of EoE and include proton pump inhibitors and swallowed topical steroids. These medications are prescribed chronically as EoE is considered a lifelong disease. Chronic administration of exogenous steroids, when given in inhaled or systemic preparations, can lead to adrenal insufficiency (AI). AI is seen in 7.8% of patients receiving chronic inhaled steroids and 48.7% of patients receiving chronic systemic steroids. The administration of steroids in EoE is unique, as patients typically swallow topical preparations of the drug. The risk of secondary AI from taking swallowed topical steroids is currently unknown, as there has been no study in an adult population assessing this risk as a primary endpoint. Pediatric studies of patients with EoE have shown the risk of AI from swallowed topical steroids to be 5-10%. Based on the risk of AI with inhaled steroids (7.8% prevalence) and the prevalence of AI from swallowed topical steroids in pediatric populations (5-10%), we hypothesize that the risk with swallowed topical steroids is >5%. This could warrant consideration of screening given the potentially serious consequences of undiagnosed AI. To address this hypothesis, this project aims to define the prevalence of developing AI in adults with EoE taking swallowed topical steroids and compare that prevalence to a similar control population of adults with EoE who are taking proton pump inhibitors. Read Less

To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls. Read Less

Decades of research have established that providing repeated exposure to new foods is the most robust strategy for promoting children's acceptance of new foods (1). However, there is little guidance on how best to translate this recommendation into everyday family life about how often to introduce children to new foods. We propose to conduct a proof-of-concept randomized trial that will evaluate three different schedules of repeated exposure to a novel vegetable, which will help to identify the optimal "pacing" of repeated exposure to promote children's acceptance (i.e., intake) of new vegetables. Here we define "pacing" as how often (every day, every few days, etc.) and across what interval of time (days, weeks, months) repeated exposure is effective for infants to learn to accept a novel food. Read Less