UK Center for Clinical and Translational Science

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 goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.

Type: Interventional

Start Date: Jan 2025

open study

The purpose of this basket study in children with Turner syndrome, SHOX deficiency, and Noonan syndrome is to evaluate the effect of 3 doses of vosoritide on growth as measured by AGV after 6 months of treatment. The long-term efficacy and safety of vosoritide at the therapeutic dose will be evaluated up to FAH.

Type: Interventional

Start Date: Nov 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 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 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

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 goal of this study is to learn if adding a game to the 6-minute walk test for children with neuromuscular disorders will increase enjoyment and motivation to complete the test.

Type: Interventional

Start Date: Feb 2026

open study

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.

Type: Interventional

Start Date: Feb 2016

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

The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness: 1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments 2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors 3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission

Type: Observational

Start Date: Oct 2022

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

The goal of this observational study is to create and rigorously evaluate a violence intervention and prevention corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students; and to develop a novel maternal injury surveillance system (MISS) to complement an existing maternal violent death registry in Kentucky.

Type: Interventional

Start Date: Sep 2023

open study

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

Type: Observational [Patient Registry]

Start Date: Feb 2022

open study

The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).

Type: Interventional

Start Date: Dec 2020

open study

The goal of this clinical trial is to learn if Bromelain Supplement works to decrease the amount of swelling or the amount of time swelling is present following jaw surgery. It will also learn about the safety of Bromelain supplement. The main questions it aims to answer are: Does Bromelain decrease facial swelling following orthognathic, or jaw, surgery? Does Bromelain supplement decrease the amount of time that patients are swollen following orthognathic, or jaw, surgery? Participants will: Take Bromelain supplement once daily for 9 days total. Take 2 days before surgery and 7 days following surgery. Keep a log of when the bromelain supplement is taken as well as another other medications. Visit the clinic with pre and post surgical protocol

Type: Interventional

Start Date: Sep 2025

open study

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.

Type: Observational

Start Date: Sep 2024

open study

The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.

Type: Interventional

Start Date: Jul 2025

open study

The goal of this clinical trial is to learn if the drug semaglutide changes markers of disease risk as it relates to weight in children ages 12-15 years old who are obese (class 2 or 3). The main questions it aims to answer are: - How do the rate of weight loss, body mass index (BMI), body composition, heart structure and function, and exercise ability interact with one another in the study population at enrollment? - How do risk markers of disease change over the study in the study participants who are given semaglutides to help with weight loss? - Are there differences in the above factors between males and females and are there key factors to help improve the outcomes? Participants will be given semaglutide for this study. During the course of the study, participants will: - have two cardiac MRI scans OR two cardiac echocardiograms (one before starting semaglutide and one around 12 months after taking the drug) - have body composition and fitness levels assessed twice (before semaglutide and around 12 months after taking it) and have urine specific gravity (USG) measured - have extra blood drawn when labs their doctor orders are already being drawn (once at the beginning of the study, once around 6 months after enrollment, and once at the end of the study) - have follow up visits with the study doctor - be asked to take a pregnancy test if they are female and have started menstruation

Type: Observational

Start Date: Jun 2025

open study