Louisville, KY Paid Clinical Trials

The primary aims of this study are to compare, after 4 months, the clinical and histologic results of a combination demineralized/mineralized putty allograft vs. synthetic calcium phosphosilicate (CPS) putty alloplast graft utilization in socket preservation procedures. A regenerative tissue matrix membrane will be used to cover each graft lying below the flap. Read Less

24 patients will be treated with a coronally positioned tunnel with AlloDerm RTM with or without the addition of Enamel Matrix Derivative to compare the baseline and 6-month changes in recession defect coverage, clinical attachment levels, amount of keratinized tissue width, and soft tissue thickness. Read Less

This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements. The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients following high energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or ligamentous injury with resultant instability requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2 week, 16 week, 1 year, and 2 year) time points. Read Less

This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy. Read Less

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life. Read Less

The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures. Read Less

Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy. Read Less

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy. Read Less

GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time, regardless of whether any treatment was given or not. If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up. Read Less

Patients with the symptoms of generalized GI dysmotility, including gastroparesis, are sometimes refractory to available medications, devices and other interventions/ Some of these patients have serologic and/or endo organ abnormalities and findings consistent with autoimmune neuropathies, primarily involving the GI tract. These disorders have been known as autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), among other terms. Some patients respond to intravenous immunoglobulin (IVIG) and this study, which is an observational clinical series, documents the patients, their findings and standardized responses to therapy with IVIG. Read Less

The evaluation of the foregut, the esophagus and stomach, has come a long way over the past two decades, and continues to experience exciting discoveries in the clinical evaluation of foregut physiology. Assessing esophageal peristalsis has relied for the past several decades on High Resolution Manometry (HRM), however it has recently become known that even though HRM is an extremely effective tool, that there are certain subsets of patients in which additional information is required. Additionally, the assessment of esophageal reflux disease has relied on pH impedance for the last two decades. However, this procedure requires a catheter to be passed through a nostril and remain in place for at least 24 hours. Novel techniques, already FDA approved, including EndoFLIP for esophageal peristalsis and mucosal integrity (MI) for reflux disease, have emerged as time-of-endoscopy assessments. Both involve the placement of a balloon through the scope at time of upper endoscopy (standard first line assessment for both dysphagia and reflux symptoms) and are quick and pose little-to-no additional risk or discomfort for patients. However, data regarding normal esophageal parameters are poorly defined for both EndoFLIP and MI. Additionally, EndoFLIP has increasingly been used to assess the pylorus, and scarce data exists there regarding how a tool originally envisioned for esophageal assessment can be used more distally in the GI tract. We will recruit healthy, asymptomatic volunteers to undergo testing with MI and FLIP (esophageal and pyloric). The data obtained will help establish the benchmark from which assessments can be made in patients. Read Less

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction. Read Less