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A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Amgen
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
The primary objective of this study is to evaluate the long-term safety of avacopan in
participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). expand
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Type: Interventional Start Date: Feb 2024 |
Mobile Apps for Preschool Parents (MAPP) Study
Pamela Hull
Obesity, Childhood
Nutrition, Healthy
Physical Inactivity
Sleep, Inadequate
The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the
effectiveness of two mobile applications for parents of preschool aged children: 1) an
app focused on child and family nutrition and wellness, and 2) an app focused on parents
reading to their children. expand
The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the effectiveness of two mobile applications for parents of preschool aged children: 1) an app focused on child and family nutrition and wellness, and 2) an app focused on parents reading to their children. Type: Interventional Start Date: Aug 2024 |
Ankle Instability Using Foot Intensive Rehabilitation
Matthew Hoch
Ankle Injuries
Ankle Sprains
The overall objective of this study is to examine the effects of a 6-week foot-intensive
rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI
symptoms, sensorimotor function, and self-reported disability in CAI patients. expand
The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients. Type: Interventional Start Date: Oct 2021 |
A Precision Medicine Approach to Target Engagement for Emotion Regulation
Matthew Southward
Emotional Regulation
Depression
Anxiety
Borderline Personality Disorder
Obsessive-Compulsive Disorder
The proposed study is designed to first test whether teaching people personalized or
standardized emotion regulation skills leads to greater decreases in daily negative
emotion intensity. Second, using data from an initial sample, the investigators will
prospectively assign an independent sample of1 expand
The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions. Type: Interventional Start Date: Sep 2023 |
A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refr1
Novartis Pharmaceuticals
Lupus Erythematosus, Systemic
Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene
autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in
patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis
(LN). expand
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN). Type: Interventional Start Date: Sep 2024 |
Impact of Plant Diet for Diabetes Prevention
Jean L. Fry
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
The primary purpose of this study is to determine the sex-specific metabolic and
molecular response, among adults with prediabetes, when moving from a Western Diet to
plant-based diet. expand
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet. Type: Interventional Start Date: Oct 2024 |
Hyperbaric Oxygen Brain Injury Treatment Trial
Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial. expand
The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Type: Interventional Start Date: Jun 2018 |
Suvorexant and Alcohol
University of Kentucky
Alcohol Use Disorder
This research will translate findings from preclinical research and provide the initial
clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other
alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study
will also provide basic science1 expand
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans. Type: Interventional Start Date: Jun 2024 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Janssen Research & Development, LLC
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory
Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:
- can a dose of JNJ-90009530 be determined that is safe and well tolerated by
patients.
- will JNJ-90009530 help patients1 expand
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: - can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients. - will JNJ-90009530 help patients achieve a response and for how long? Type: Interventional Start Date: Nov 2023 |
Cocaine and Zolmitriptan
William Stoops
Cocaine Use Disorder
Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT
resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some
of these receptor subtypes have been implicated in the abuse-related effects of cocaine,
including its primary reinforcing effe1 expand
Cocaine potently inhibits the reuptake of serotonin (5-HT). Increased synaptic 5-HT resulting from this reuptake inhibition activates multiple 5-HT receptor subtypes. Some of these receptor subtypes have been implicated in the abuse-related effects of cocaine, including its primary reinforcing effects (i.e., cocaine taking behavior). 5-HT1b receptors, which are autoreceptors on 5-HT nerve endings that regulate 5-HT release and heteroreceptors that also mediate other neurotransmitter release, play a particularly important role in cocaine effects, likely because they are highly expressed in the mesocorticolimbic system. The 5-HT1b system displays profound dysregulation during both active cocaine use and abstinence. Initial preclinical research showed that selective 5-HT1b agonists enhanced the reinforcing and locomotor effects of cocaine during ongoing cocaine administration, but subsequent research showed that these agents robustly attenuated reinstatement of cocaine- and cue-primed cocaine seeking behavior. These findings have been replicated in rigorously conducted studies using multiple schedules of reinforcement and negative sucrose reinforcement controls across laboratories. Notably, though, these preclinical studies used compounds not approved for use in humans, hindering translation. Recently published data show that zolmitriptan, a commercially available selective 5-HT1b agonist migraine medication, also selectively attenuates the reinforcing and other abuse-related effects of cocaine, regardless of stage of use (i.e., ongoing or extinguished cocaine self-administration). Although a robust preclinical literature supports the premise that 5-HT1b activation reduces a number of cocaine-associated behaviors (e.g., self-administration, cocaine seeking), this area remains unstudied in humans. The overarching goal of this project is to advance these promising preclinical findings, specifically those with zolmitriptan, to a clinical population, thereby demonstrating that the 5-HT1b system plays a key role in the effects of cocaine in humans Type: Interventional Start Date: Oct 2021 |
Evaluation of K9 in Subjects with Thyroid Eye Disease (TED)
Peter Timoney
Thyroid Eye Disease
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in
healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with
active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one
time or for up to 4 weeks. Particip1 expand
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one time or for up to 4 weeks. Participants will have blood drawn and/or complete eye exams and questionnaires. The planned duration of this study is 6 weeks. Type: Interventional Start Date: Nov 2024 |
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
The purpose of this trial is to generate clinical evidence related to key performance
outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder
Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are
randomized and imaging collected at all foll1 expand
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint. Type: Interventional Start Date: Jan 2023 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurren1 expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jun 2022 |
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Agains1
Regeneron Pharmaceuticals
Diffuse Large B-cell Lymphoma (DLBCL)
This study is researching an experimental drug called odronextamab, referred to as study
drug, when used in combination with chemotherapy. The study is focused on patients with
diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called
"previously untreated"). Patients with DLB1 expand
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.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 in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. 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 when combined with chemotherapy - 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: Dec 2023 |
CSTOP Now! Child Sex Trafficking Stops with You
Ann Coker
Child Sex Trafficking
Focus: Intervention & prevention of child commercial sexual exploitation or trafficking
(CST) In Kentucky, familial SU/D increases risk of CST.
Primary goal: Implement and evaluate effectiveness of multi-level bystander-informed
program (CSTOP Now!) aimed at Kentucky public middle schools for staf1 expand
Focus: Intervention & prevention of child commercial sexual exploitation or trafficking (CST) In Kentucky, familial SU/D increases risk of CST. Primary goal: Implement and evaluate effectiveness of multi-level bystander-informed program (CSTOP Now!) aimed at Kentucky public middle schools for staff. Type: Interventional Start Date: Sep 2023 |
Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)
Ophirex, Inc.
Snakebite
Envenoming, Snake
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed
to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of
IV varespladib followed by transition to the oral dosage form, varespladib-methyl,
concurrently with SOC, in participant1 expand
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes. Note: Funding Source - FDA-OOPD Type: Interventional Start Date: May 2023 |
Spinal Cord Injury Neuroprotection With Glyburide
University of Kentucky
Acute Spinal Cord Injury
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective
agent in patients with acute cervical or thoracic traumatic spinal cord injury. expand
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury. Type: Interventional Start Date: Jul 2022 |
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin,1
Novartis Pharmaceuticals
Extensive Stage Small Cell Lung Cancer
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in
combination with carboplatin, etoposide and atezolizumab in this setting and to assess
preliminary efficacy of this combination treatment versus the combination of carboplatin,
etoposide, and atezolizumab.The stud1 expand
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type. Type: Interventional Start Date: Jul 2022 |
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
Penumbra Inc.
Deep Vein Thrombosis
DVT
The objective of this study is to demonstrate the safety and efficacy of the Indigo
Aspiration system for percutaneous mechanical thrombectomy in a population presenting
with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. expand
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. Type: Interventional Start Date: Sep 2021 |
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Impulse Dynamics
Heart Failure
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized,
single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of
care. Patients to be included will have NYHA functional class III symptoms and a left
ventricular ejection fraction of 251 expand
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45% Type: Observational [Patient Registry] Start Date: Jan 2020 |
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
C. R. Bard
Open Midline Laparotomy
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at
the time of midline fascial closure compared to primary suture closure in preventing a
subsequent incisional hernia in subjects at risk for incisional hernia after open midline
laparotomy surgery. expand
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery. Type: Interventional Start Date: Dec 2019 |
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Zachary Warriner
Rib Fractures
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy
versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and
oral outpatient) alone for patients with multiple rib fractures. The objective of this
study is to analyze the effect of c1 expand
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications. Type: Interventional Start Date: Dec 2024 |
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
Ellipses Pharma
Advanced Solid Tumor
The aim of this study is to assess the safety, side effects and effectiveness of EP0031
in patients with advanced RET-altered malignancies expand
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies Type: Interventional Start Date: Sep 2022 |
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Nuwellis, Inc.
Heart Failure (for Example, Fluid Overload)
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of
adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop
diuretics in patients with worsening heart failure (HF) and fluid overload. expand
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload. Type: Interventional Start Date: Jun 2022 |