Search Clinical Trials
Sponsor Condition of Interest |
---|
Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and1
Francis Farhadi
Spinal Cord Stimulation
Electric Stimulation Therapy
Traumatic Spinal Cord Injury
Cervical Myelopathy
The study will be a non-randomized, non-blinded pilot study to analyze the safety and
feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The
aim is to include 30 total patients, 10 patients in each of 3 groups:
1. Non-traumatic spinal cord injury (ntSCI) with d1 expand
The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups: 1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention. 2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury. Type: Interventional Start Date: Oct 2024 |
Creating VIP Corps to Reduce Maternal Deaths
Ann Coker
Maternal Morbidity and Mortality
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 complem1 expand
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 |
Reinforcing Effects of Marijuana and Opioids
Shanna Babalonis, PhD
Marijuana Use
Opioid Use
The primary goals of this study are to examine 1) marijuana modulation of oxycodone
self-administration and 2) oxycodone modulation of marijuana self-administration, under
controlled conditions and across a range of doses for each drug. expand
The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug. Type: Interventional Start Date: Aug 2023 |
A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
Century Therapeutics, Inc.
R/R CD19-Positive B-Cell Malignancies
Indolent Non-Hodgkin Lymphoma
Aggressive Non-Hodgkin Lymphoma
ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety,
pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or
refractory cluster of differentiation (CD)19-positive B-cell malignancies. expand
ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies. Type: Interventional Start Date: Jan 2023 |
tDCS and Inhibitory Control in PTSD
Gopalkumar Rakesh
Post Traumatic Stress Disorder
Large samples (~2,000/yr) of adult undergraduate students at a large southern university
will be pre-screened via the University of Kentucky SONA System (IRB#43626) to identify
and recruit adult female participants who report a history of IPV and probable PTSD to
participate in a one-day lab study.1 expand
Large samples (~2,000/yr) of adult undergraduate students at a large southern university will be pre-screened via the University of Kentucky SONA System (IRB#43626) to identify and recruit adult female participants who report a history of IPV and probable PTSD to participate in a one-day lab study. After completing an IRB-approved informed consent, participants will complete a brief psychiatric diagnostic interview and a battery of questionnaires. They will then complete three blocks of the Stop Signal Task (SST). Participants will be randomized (double-blind, stratified by PTSD diagnosis and psychotropic medication use) to receive 15-min of active or sham multifocal tDCS targeting the rIFG. tDCS will be delivered offline for 11.5-mins after block 1 of the SST and online for 3.5-mins during block 2 of the SST. Sham stimulation will be identical to active tDCS, but electrical current will only be ramped in/out at the beginning and end of the 15-mins. The third block of the SST will be completed after tDCS. Lastly, participants will complete a pictorial trauma-related symptom provocation task. Participants will be compensated with course credit. Type: Interventional Start Date: Oct 2023 |
A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participant1
Kowa Research Institute, Inc.
Fuchs Endothelial Corneal Dystrophy
A study to assess the safety and efficacy of K-321 in participants with FECD after
descemetorhexis. expand
A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis. Type: Interventional Start Date: Mar 2023 |
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
AtriCure, Inc.
Ischemic Stroke
Systemic Embolism
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority
trial. The objective of this trial is to evaluate the effectiveness of left atrial
appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial
embolism in subjects undergoing cardiac1 expand
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. Type: Interventional Start Date: Jan 2023 |
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Francis Farhadi
Spondylolisthesis
Spinal Stenosis
Degenerative Disease
Establish a data repository of patients who have undergone single, two-, or three-level
lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System. expand
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 |
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Philip Kern
Pre-diabetes
Obesity
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 will1 expand
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 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
Bevacizumab Treatment For Type 1 ROP
Jaeb Center for Health Research
Retinopathy of Prematurity
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and
has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in
these severe cases. Also unknown is the timing and extent of peripheral retinal
vascularization after low-dose bevacizumab1 expand
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I. Type: Interventional Start Date: May 2022 |
Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI
Sam Tyagi
Descending Aortic Dissection
Postoperative Pain
Thoracoabdominal Aortic Aneurysm
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). expand
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 |
Healthy Recovery After Trauma Study
Christal L Badour
Stress Disorders, Post-Traumatic
Shame
Guilt
Sexual Assault and Rape
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., 2011 expand
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 |
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Sympto1
HELP for NOWS Consortium
Neonatal Opiate Withdrawal Syndrome
This clinical trial will help us learn more about how to best care for babies with
Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have
tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that
have NOWS need medicine. Doctors have two ways1 expand
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today: 1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper. 2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given. We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS. Type: Interventional Start Date: Mar 2024 |
Precision Lung Cancer Survivorship Care Intervention
Jerod L Stapleton, PhD
Lung Cancer
Pulmonary Neoplasm
Neoplasms, Lung
Neoplasms, Pulmonary
Neoplasm, Pulmonary
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. T1 expand
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 |
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Microvention-Terumo, Inc.
Wide Neck Bifurcation Intracranial Aneurysms
A prospective, multicenter, single arm, interventional study. The target patient
population for this study are adult subjects with WNBAs of the anterior and posterior
intracranial circulation. The primary effectiveness outcome of the study is adequate
intracranial aneurysm occlusion on the 1 year a1 expand
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory. Type: Interventional Start Date: Aug 2022 |
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures At High Risk1
Major Extremity Trauma Research Consortium
Post Operative Surgical Site Infection
The overall objective is to compare the effect of Vancomycin and Tobramycin powder
combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation
infections of tibial plateau and tibial pilon fractures at high risk of infection
(collectively considered the "study injuries"). expand
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries"). Type: Interventional Start Date: May 2021 |
Neuroblastoma Maintenance Therapy Trial
Giselle Sholler
Neuroblastoma
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/1 expand
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 |
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive1
ImmunoGen, Inc.
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and
efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with
platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate
receptor-alpha (FRα) expression. expand
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. Type: Interventional Start Date: Dec 2022 |
Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
Brian W. Noehren
Femoral Fracture
Tibial Fractures
The purpose of this study is to evaluate speed high intensity interval training (HIIT)
walking program following an orthopedic trauma. expand
The purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma. Type: Interventional Start Date: Mar 2022 |
Role of the Sympathetic Nervous System in Rosacea
Kristen Metzler-Wilson
Rosacea
Rosacea is a common skin disorder which causes facial redness and inflammation in about
16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are
stressors that affect the sympathetic ("fight or flight") portion of the nervous system,
and a recent pilot study suggests there1 expand
Rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. This project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea. Type: Interventional Start Date: May 2019 |
Prospective Analysis of Spinal Epidural Abscess
University of Kentucky
Spinal Epidural Abscess
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 clinica1 expand
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 |
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
Hartmut Malluche, MD
Age-Related Osteoporosis
Osteoporosis affects 24.5% of women over 65 and results in fracture-related hospital
admissions exceeding those of heart attacks, strokes and breast cancer combined. Current
treatment options do not account for differences between age-related and estrogen
deficiency related osteoporosis, because of1 expand
Osteoporosis affects 24.5% of women over 65 and results in fracture-related hospital admissions exceeding those of heart attacks, strokes and breast cancer combined. Current treatment options do not account for differences between age-related and estrogen deficiency related osteoporosis, because of the need for bone biopsies for determination. This study will establish a paradigm-shifting individualized treatment protocol for age-related osteoporosis and a non-invasive method for its determination, thereby reducing the major health problems and enormous burden on society and the elderly related to this disease. Type: Interventional Start Date: Mar 2022 |
Telehealth Delivered Physical Rehabilitation for an Ankle Sprain
Kyle Kosik
Ankle Sprains
Telerehabilitation
Analgesic, Opioid
Analgesics, Non-narcotic
Anti-Inflammatory Agents, Non-Steroidal
A vast majority (75-85%) of ankle sprain patients treated in emergency departments (ED)
receive pain medication and are not referred for physical rehabilitation. Therefore,
purpose of this study is to increase access to the standard of care for an ankle sprain
by provide patients with physical reha1 expand
A vast majority (75-85%) of ankle sprain patients treated in emergency departments (ED) receive pain medication and are not referred for physical rehabilitation. Therefore, purpose of this study is to increase access to the standard of care for an ankle sprain by provide patients with physical rehabilitation delivered through telehealth. The purpose of this study includes compare a 2-week telehealth intervention to the usual care for treating 1) subjective function; 2) physical impairments; 3) medication consumption; and 4) patient-perceived barriers. The central hypothesis is participants receiving the 2-week telehealth intervention will 1) have less pain and disability; 2) improve balance and ankle range of motion; 3) consume less medication; and 4) reports positive feedback compared to the usual care group. Type: Interventional Start Date: Jan 2021 |
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well1
Regeneron Pharmaceuticals
Follicular Lymphoma (FL)
This study is researching an experimental drug called odronextamab, referred to as study
drug. The study is focused on participants with previously untreated follicular lymphoma.
Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with
follicular lymphoma that has come back a1 expand
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on quality-of-life and ability to complete routine daily activities Type: Interventional Start Date: Nov 2023 |
- Previous
- Next