UK Center for Clinical and Translational Science

Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.

Type: Observational

Start Date: Mar 2018

open study

The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The objective will be to compare adverse event rates for patients in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to rates from the previous IDE trial (G050208).

Type: Observational [Patient Registry]

Start Date: Nov 2015

open study

This is a substudy (Part 2) of a larger two-part clinical trial including both observational and therapeutic (interventional) cohorts to assess the progression free survival ratio of patients treated with a targeted therapy based on genomic analysis results and recommendation by the Markey Cancer Center Molecular Tumor Board (MCC MTB).

Type: Interventional

Start Date: Apr 2017

open study

This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.

Type: Observational

Start Date: Jan 2018

open study

Acute lung injury (ALI) and the more severe manifestation, acute respiratory distress syndrome (ARDS) describe syndromes of acute onset, bilateral, inflammatory pulmonary infiltrates and impaired oxygenation. ARDS/ALI are a continuum of disease which results in a life threatening, rapidly progressive illness and occurs in critically ill patients. Recent reports in the Journal of the American Medical Association (JAMA) highlight the significant public health impact ARDS/ALI has on the critically ill population in that despite robust research efforts, these illnesses continue to be under diagnosed, under treated, and continue to have a high mortality rate (≥ 40% of all confirmed diagnoses). The estimates for ARDS/ALI incidence vary due to inconsistencies with proper diagnosis and lack of valid biomarkers of disease; however, it is expected that anywhere from 20-50% of patients on mechanical ventilation will develop this disease. Previous work by our group has shown that sphingolipids play a multifaceted role in lung inflammation. Sphingolipid are a class of bioactive lipids that play a role in cellular processes such as apoptosis, cell migration, and adhesion. Ceramide is one species of sphingolipid the investigators have examined in both man and mouse. Our laboratory has shown that ceramide is up-regulated in pulmonary inflammation in mouse models of pneumonitis and is elevated in the exhaled breath condensate of mechanically ventilated patients at risk for ARDS/ALI. Our work coupled with the work of others highlighting a role for ceramide in chronic obstructive pulmonary disease (COPD), surfactant dysfunction, and infectious disease make ceramide a logical candidate biomarker that warrants further investigation. To our knowledge, there are no studies examining the role of ceramide as a biomarker in ARDS/ALI. Thus, our overarching hypothesis is that ceramide is elevated in the lungs of patients who develop ARDS/ALI. This lipid dysregulation accounts for the pathophysiology seen in this disease and may be a potential pharmacologic target for clinical treatment. Thus the purpose of this exploratory research is to maximize existing specimens to further evaluate ceramide as a biomarker for acute lung injury.

Type: Observational

Start Date: Apr 2019

open study

The Corazón de la Familia study is a randomized controlled trial to examine the effects of a novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health workers, the family-focused intervention engages two members of a family in an educational program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a randomized controlled trial using a 2-group design and compare the short-term and long-term impact of the family-focused active intervention to an individual-focused control condition on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will examine outcomes of participants in the family-focused intervention to determine how each family member's engagement in healthy lifestyle behaviors and level of support for the other family member's engagement in healthy lifestyle behaviors affects their own and their partner's outcomes.

Type: Interventional

Start Date: Oct 2017

open study

Health disparities have been documented in same-sex partnered women, including higher rates of cardiovascular disease, Type 2 diabetes, cancers, and mental health disorders. Higher rates of smoking, substance use, and obesity are behavioral risk factors that contribute to these chronic health problems. Living in rural areas with fewer social supports and less access to culturally sensitive healthcare services may also contribute to health disparities in sexual minorities. Their stigmatized identity is linked to minority stress, a well-documented social determinant of health behaviors and outcomes. Coping responses are an important couple-level mechanism that link stigma-related (minority) stress and health in same-sex couples. Relationship education (RE) programming is a potentially effective approach to increasing positive dyadic-level coping skills that support health. In a sample of 40 female same-sex couples, investigators will test the hypothesis that couples who complete newly revised, web-based RE modules that target health-related coping responses to stigma-related stress will report immediate (post-intervention) and persistent (3-month follow up) positive effects on their relationship quality (e.g., positive communication and problem-solving, relationship satisfaction, perceived partner support), stigma-related coping behaviors, and health (e.g., reduced substance use, depression/anxiety, physical health symptoms). This intervention represents one of the first efforts to test the effects of a culturally appropriate web-based relationship education tool that specifically targets health-related coping behaviors in rural female same-sex couples, a stigmatized, high-risk, under-researched and under-resourced population.

Type: Interventional

Start Date: Jun 2019

open study

This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy. Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky.

Type: Interventional

Start Date: Mar 2019

open study

Treatment of recurrent oligometastatic prostate cancer may be enhanced by the addition of Hydroxychloroquine to the current treatment regimens. Potential benefits of Hydroxychloroquine include delayed disease progression and delayed initiation of androgen deprivation therapy (ADT), thus lessening morbidity, distressing side effects, and improving functioning and quality of life in men with recurrent prostate cancer. Building on prior research at Markey, patients recently diagnosed with recurrent oligometastatic prostate cancer will be approached about participating in this study. Per standard of care, these patients undergo either surgery or radiation, in addition participants of this clinical trial will also receive Hydroxychloroquine (400 mg per day, oral medication) for 3 months. It is expected that a participant will exhibit a 50% increase of tumor suppressor PAR-4, as well as few, if any, negative side effects from Hydroxychloroquine.

Type: Interventional

Start Date: Dec 2019

open study

Three pieces of information lead to the basis for this study: 1. Individuals with Type-2 diabetes commonly develop peripheral neuropathy. 2. Increased production of the hormone amylin occurs in individuals who have Type-2 diabetes. 3. Aggregations of amylin was found in the peripheral vasculature of rats that overexpressed human amylin. The purpose of this study is to determine whether a correlation exists between the amount of amylin present in the upper extremities of human subjects with Type-2 diabetes and the extent to which symptoms of peripheral neuropathy are expressed in those subjects. The investigators will be testing this by initially collecting blood and skin biopsy samples from subjects, followed by measuring patient sensation and pain responses to heat, cold, and pressure in the upper extremities.

Type: Observational

Start Date: Feb 2018

open study

This is a prospective study enrolling 5 patients with a diagnosis of traumatic brain injury (TBI) without polytrauma and 5 patients with TBI with polytrauma admitted to the University of Kentucky (UK) Chandler Medical Center to evaluate differences in platelet bioenergetics in the populations. Additionally, five healthy subjects will be recruited to the control group.

Type: Observational

Start Date: Feb 2020

open study

The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is that clonidine will effectively treat drug withdrawal manifestations in neonates.

Type: Interventional

Start Date: Dec 2017

open study

This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails. This study will compare people in a re-entry health linkage intervention with people who will get overdose education in jail. Everyone will take part in follow-up surveys after release. Participants will be assigned to one of the two groups by chance based on when they are released from jail and when their county is randomly chosen to start the project.By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C, and overdose education to people leaving rural jails will reduce substance use and related harms.

Type: Interventional

Start Date: Nov 2019

open study

The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.

Type: Interventional

Start Date: Dec 2018

open study

Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.

Type: Interventional

Start Date: Jan 2016

open study

Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences.

Type: Observational

Start Date: Mar 2010

open study

This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy. Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery.

Type: Observational [Patient Registry]

Start Date: Aug 2012

open study

Primary Objective • To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable cancers Secondary Objectives - To determine if short-term treatment with TVB-2640 decreases cancer cell proliferation. - To examine other biological endpoints and determine if TVB-2640 inhibits cell survival signaling and lipid biogenesis. - To perform comprehensive metabolomic analysis in tumor tissues to identify metabolic alterations induced by TVB-2640 treatment. - To correlate FASN levels in tumor with metabolic and biological endpoints to determine if FASN inhibition has more pronounced effects in patients with increased expression.

Type: Interventional

Start Date: Jan 2017

open study

The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates of re-injury and improved health. This will address the identified needs for evidence-support and reintegration strategies to improve understanding of the management of patient rehabilitation strategies throughout the rehabilitation process following neuromusculoskeletal injury. The project will validate an innovative rehabilitation approach while providing metrics of success using a variety of clinical and innovative markers.

Type: Interventional

Start Date: Nov 2019

open study

The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Type: Interventional

Start Date: Jul 2016

open study

This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation, which is standard cessation counseling from the provider plus additional cessation support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants will receive standard tobacco cessation from their provider. The project will also determine the economic impact of the B-EPIC intervention on healthcare expenditures.

Type: Interventional

Start Date: Dec 2018

open study

The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction with riluzole, can slow down the disease progression of patients with ALS including potentially improving their neuropsychiatric changes, as well as determine if serum biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS. Funding Source: FDA-OPD

Type: Interventional

Start Date: Nov 2018

open study

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Type: Interventional

Start Date: Jul 2016

open study

This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.

Type: Interventional

Start Date: Sep 2019

open study

It is unknown whether early modulation of inflammatory cytokines is associated with improved patient outcomes, reduced narcotic requirements in orthopaedic patient population, and improved patient subjective pain after hospital discharge. Preliminary animal and clinical studies have shown correlation between elevated blood cytokine concentrations during the acute phase of trauma and the development of post-traumatic complications. Early administration of nonsteroidal anti-inflammatory drug (NSAID) in animals significantly reduced inflammatory profiles, improved pulmonary edema, and enhanced arteriole vasoconstriction in response to hemorrhage. The ability to modify post-traumatic physiologic response via short-term administration of a non-steroidal anti-inflammatory drug (NSAID) may lead to improved patient outcome. In addition, given the current landscape for opioid epidemic in the United States, alternative non-opioid pain management during acute trauma has the potential to reduce opioid consumption and represents a pivotal component of multimodal analgesia strategy. By doing this study, the investigators hope to learn how to provide the best care for all patients in the state of Kentucky. Patient participation in this research will last about 1 year.

Type: Interventional

Start Date: Feb 2019

open study