UK Center for Clinical and Translational Science

Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients

Type: Interventional

Start Date: Dec 2020

open study

This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.

Type: Interventional

Start Date: Aug 2025

open study

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery. Participants will: Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months. Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug. Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.

Type: Interventional

Start Date: Mar 2025

open study

This study aims to determine how flywheel-based inertial training (FIT) implemented according to principles of velocity-based training (VBT) and High-Intensity Interval Training (HIIT) affects disuse-induced physical de-conditioning including loss of voluntary muscle strength, aerobic capacity, and balance regulation.

Type: Interventional

Start Date: Oct 2024

open study

The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.

Type: Interventional

Start Date: Dec 2023

open study

Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections. This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope.

Type: Observational

Start Date: Nov 2017

open study

This study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months. There is a 3/4 (or 75%) chance that a participant will receive an active cannabis dose in the study. There is a 1/4 (or 25% chance) that a participant will receive a placebo dose (meaning a blank dose/no cannabis/no active drug). The goals of this study are to determine 1) the safety and tolerability of cannabis in individuals with cancer and 2) if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting, appetite, pain, sleep, and quality of life.

Type: Interventional

Start Date: Jun 2025

open study

This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.

Type: Interventional

Start Date: May 2023

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

The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults. Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.

Type: Interventional

Start Date: May 2025

open study

Electroconvulsive therapy (ECT) is one of the most efficacious treatments available for treatment-resistant depression (TRD). Although a maintenance ECT protocol exists, multiple barriers limit its use for long-term use. These barriers include procedure tolerability, cognitive side effects, financial burden, and unreliable social support to accompany patients for these treatments. On the other hand, a different modality of noninvasive neuromodulation called transcranial magnetic stimulation (TMS) can be performed in the outpatient setting and does not need anesthesia. The likelihood of cognitive adverse effects with TMS is much lower than with ECT. Our clinical question encompasses piloting a maintenance TMS regimen to maintain remission in treatment-resistant major depressive disorder. This will be a patient-preference clinical trial, with patients offered the choice to initiate maintenance TMS versus maintenance ECT after their index ECT sessions for treatment-resistant depression. There will be no randomization or placebo involved in this study.

Type: Interventional

Start Date: Apr 2025

open study

ME&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. ME&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.

Type: Interventional

Start Date: Jan 2024

open study

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

Type: Interventional

Start Date: Jul 2024

open study

Hereditary spastic paraplegia (HSP) is a rare neurological condition that causes stiffness, weakness, and difficulty walking due to damage in the nerves that control movement. This study will test whether a noninvasive form of spinal cord stimulation, called transcutaneous spinal cord stimulation (tSCS), can improve walking and reduce muscle stiffness in adults with HSP. In this study, participants will receive tSCS twice a week for 8 weeks. The stimulation is delivered through self-adhesive electrodes placed on the skin over the lower back and does not require surgery. Each session will last about one hour. After the treatment period, participants will be followed for an additional 8 weeks without stimulation to see whether any improvements are maintained. Researchers will measure walking speed, walking endurance, muscle stiffness, and overall disease severity. Additional tests will explore changes in bladder and bowel function and muscle strength.

Type: Interventional

Start Date: Mar 2026

open study

Stroke, severe brain injury, uncontrolled seizures and brain infections are the most common life-threatening neurological illnesses in the world with an estimated combined annual hospital management cost of up to 44 billion dollars. Seizures and infections are common complications following acute neurological illnesses and contribute significantly to poor outcomes if not promptly treated with appropriately dosed anti-seizure medications and antibiotics, respectively. Limited research suggested that many of those patients present with a phenomenon called augmented renal clearance (ARC) or, in other words, enhanced kidney function. ARC may have a significant influence on how medications are removed from the body potentially resulting in insufficient doses and treatment failure. Therefore, patients with ARC require higher medication doses; however, ARC is largely undetected using kidney assessment methods currently used in practice. In addition, it is not clear how medications should be dosed in those with ARC. The majority of ARC research has not focused on patients with life-threatening neurological illnesses. Thus, clinicians are likely under-dosing vital medications in those patients, and completely unaware. There is an immediate need to address the gap in knowledge. Therefore, this research aims to characterize the phenomenon of ARC in patients with life-threatening neurological illnesses through identifying the frequency, duration, contributing factors and clinical impact of ARC. Adult patients admitted to the neurosciences intensive care unit for life-threatening neurological illnesses will be enrolled in the study. Urine and blood samples wil be collected from participants to determine the presence of ARC and identify its contributing factors. In addition, blood samples will be collected from participants treated with select antibiotics and anti-seizure medications to determine their concentration and propose dose adjustment in those with ARC. This research is expected to improve the care of patients with life-threatening neurological illnesses through efficient identification and monitoring of patients exhibiting ARC facilitating timely medication dosage optimization. Furthermore, recommendations of optimal doses of commonly used medications in patients with ARC would improve the likelihood of treatment success with potential to improve patients' health and wellbeing.

Type: Observational

Start Date: Oct 2021

open study

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are: 1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine? 2. Does one treatment lead to better overall clinical outcomes than the other? Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly. Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care. No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.

Type: Observational [Patient Registry]

Start Date: Dec 2025

open study

The goal of this clinical trial is to help learn about the safety and feasibility of hepatic artery infusion chemotherapy for those who have colorectal liver metastases, both resectable and unresectable, or unresectable intrahepatic cholangiocarcinoma. The main questions it aims to answer are: - safety and feasibility of installing a pump that deliveries chemotherapy to the hepatic artery (the blood vessel that supplies blood to the liver) - help learn more about the safety of patients having pump refills at home or a local clinic versus having it routinely done at the hospital Participants will have surgery to install a pump which is a standard surgical procedure. After surgery, participants will select to either receive treatment at the hospital facility or with a community oncologist that will provide cancer care to participants close to home, rather than in a large hospital or academic medical center. The main treatment on study will last about 3-4 months.

Type: Interventional

Start Date: Jan 2026

open study

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

Type: Interventional

Start Date: Dec 2024

open study

The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. The project involves a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes.

Type: Interventional

Start Date: Aug 2024

open study

This is a prospective study involving all patients treated at the University of Kentucky for spinal epidural abscess over a 2-year period. Based on ongoing referrals of patients with SEA, we expect that 200 patients will be enrolled during this time window. We propose to study all available clinical, pathological, radiological, and socioeconomic data of patients diagnosed with a spinal infection with or without a history of drug abuse over this study period. All patients' charts will be prospectively reviewed starting at the time of presentation for a period of 1 year.

Type: Observational

Start Date: Jul 2022

open study

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.

Type: Interventional

Start Date: Dec 2021

open study

The overarching hypotheses of this protocol are that (1) persistent brain glutamate changes induced by chronic opioid use will exacerbate use of cocaine during opioid physical dependence and withdrawal and (2) n-acetylcysteine (NAC) will ameliorate glutamatergic dysregulation, and thus will reduce both opioid and cocaine demand. These hypotheses will be tested with two specific aims. Specific Aim 1. Determine the reinforcing effects of cocaine in individuals with comorbid opioid and cocaine use disorder with physiological dependence on opioids during NAC maintenance. All subjects will be maintained on oral hydromorphone. They will also be randomly assigned to receive placebo or oral NAC (2.4 g/day), stratified by sex. After dose stabilization, experimental sessions will be conducted in which subjects complete hypothetical cocaine purchase tasks during opioid maintenance and opioid withdrawal. The hypotheses are: 1) cocaine purchasing will be greater during opioid withdrawal and 2) NAC maintenance will attenuate cocaine purchasing across opioid maintenance and withdrawal periods. Specific Aim 2. Evaluate glutamate functionality during periods of opioid maintenance and withdrawal in individuals with comorbid opioid and cocaine use disorder and physiological dependence on opioids during NAC maintenance. Subjects will undergo magnetic resonance spectroscopy to evaluate brain glutamate changes as a function of opioid maintenance/withdrawal state and NAC maintenance. The hypotheses are: 1) glutamate levels will be elevated during opioid withdrawal and 2) NAC maintenance will ameliorate elevated glutamate levels.

Type: Interventional

Start Date: Dec 2022

open study

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Type: Interventional

Start Date: Dec 2020

open study

Mental contamination-an internal experience of dirtiness evoked in the absence of physical contact with an external source-has been linked to the development and maintenance of posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD symptom clusters (particularly those of intrusive reexperiencing, negative cognitions/mood, and arousal/reactivity; Brake et al., 2019; Fergus & Bardeen, 2016). Additionally, trauma-related mental contamination has been linked to a number of negative posttraumatic emotions such as shame, guilt, disgust, and anger (Fairbrother & Rachman, 2004; Radomsky & Elliott, 2009) Despite clear and consistent links between mental contamination and problematic posttraumatic outcomes following sexual trauma, there is a dearth of research investigating how existing or promising new interventions for PTSD impact mental contamination. Cognitive Processing Therapy (CPT) is an efficacious and effective 12-session manualized cognitive-behavioral intervention for PTSD that is considered a gold-standard empirically-supported treatment for PTSD that is recommended by the American Psychological Association (APA, 2017). In addition to PTSD symptom improvement, CPT has also demonstrated benefit for improving feelings of shame and guilt, which are often seen among individuals with trauma-related mental contamination (Nishith et al., 2005; Resick et al., 2002, 2008). Cognitive reappraisal, a primary technique employed in CPT, involves challenging one's view of an emotionally-eliciting situation to alter its emotional impact (Gross & John, 2003). However, some investigators have suggested that cognitive reappraisal may be less effective in targeting moral emotions such as shame, guilt, and self-disgust that are based on an individual's standards and virtues (Finlay, 2015). Self-compassion (SC; i.e., self-directed care and kindness; forgiveness; and feelings of common humanity; Neff, 2003) has been proposed as an alternative method for addressing trauma-related shame and preliminary evidence suggests a 6-session self-compassion intervention may have benefit for reducing both PTSD symptoms and trauma-related shame (Au et al., 2017). Given the centrality of shame, guilt, and self-disgust to the experience of mental contamination, and the fact that mental contamination often arises in response to experiences involving moral violation or betrayal (Millar et al., 2016; Rachman, 2010), a SC intervention for PTSD may also offer promise as a standalone or adjunctive intervention for reducing trauma-related mental contamination. A test of these interventions for their impact on reducing trauma-related mental contamination is needed. The current study will use Single Case Experimental Design to isolate and evaluate the effects of CPT and SC in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma. Aims: 1) explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 12-sessions of CPT or 6-sessions of a SC intervention; 2) evaluate whether presentation of either treatment first yields differences in symptom reduction for PTSD and/or mental contamination symptoms; 3) evaluate whether the addition of the alternative module will enhance reductions in PTSD symptoms and mental contamination; 4) evaluate if such reductions are maintained during follow-up. Visual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.

Type: Interventional

Start Date: Sep 2020

open study