162 matching studies

Sponsor Condition of Interest
Platelet Bioenergetics in TBI
Kevin Hatton Brain Injuries, Traumatic
This is a prospective study enrolling 5 patients with a diagnosis of traumatic brain injury (TBI) without polytrauma and 5 patients with TBI with polytrauma admitted to the University of Kentucky (UK) Chandler Medical Center to evaluate differences in platelet bioenergetics in... expand

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

Type: Observational

Start Date: Feb 2020

open study

Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
Rachel Miller Cancer
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... expand

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

Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
Phillip Gribble Ankle Sprains
The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower... expand

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

Type: Interventional

Start Date: Nov 2019

open study

Therapy in Amyotrophic Lateral Sclerosis (TAME)
University of Kansas Medical Center Amyotrophic Lateral Sclerosis Frontal Temporal Dementia
The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction with riluzole, can slow down the disease progression of patients with ALS including potentially improving their neuropsychiatric changes, as well as determine if serum biomarkers can... expand

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

Type: Interventional

Start Date: Nov 2018

open study

Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Craig Rush Methamphetamine Use Disorder
This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods. expand

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

Type: Interventional

Start Date: Sep 2019

open study

Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
Craig Rush Alcohol Use Disorder
This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods. expand

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

Type: Interventional

Start Date: Sep 2018

open study

Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a...
Advanced Bionics Hearing Loss Partial Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural... expand

The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

Type: Interventional

Start Date: Apr 2014

open study

Fixed-Dose Trial in Early Parkinson's Disease (PD)
Cerevel Therapeutics, LLC Parkinson Disease
The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD. expand

The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

Type: Interventional

Start Date: Dec 2019

open study

Down Syndrome Clinical Trials - Study of Alzheimer's Disease in Down Syndrome
LuMind IDSC Foundation Alzheimer's Disease in Down Syndrome
This is an observational, multi-center, longitudinal cohort study to characterize adults with DS ages 25 years and above enrolled at specialized care centers. The aim is to assess changes in cognition, behavior, function and health over approximately 32 months. Blood will be... expand

This is an observational, multi-center, longitudinal cohort study to characterize adults with DS ages 25 years and above enrolled at specialized care centers. The aim is to assess changes in cognition, behavior, function and health over approximately 32 months. Blood will be collected for the development of plasma AD biomarkers useful in the DS population.

Type: Observational

Start Date: Jun 2019

open study

HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections...
Inflammatix Respiratory Tract Infections Urinary Tract Infections Intra-Abdominal Infections Skin and Soft Tissue Infection Sepsis
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause. expand

This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause.

Type: Observational

Start Date: Feb 2020

open study

Suvorexant and Cocaine
William Stoops Cocaine Use Disorder
The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also... expand

The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on cocaine 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: Jul 2019

open study

A Study of Suboptimally Controlled Participants Previously Taking Injectable Disease-modifying Drugs...
EMD Serono Research & Development Institute, Inc. Multiple Sclerosis
To evaluate the effectiveness and safety of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any... expand

To evaluate the effectiveness and safety of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable DMD approved in the United States (US) for RMS in a real-world setting.

Type: Observational

Start Date: May 2019

open study

Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
Allena Pharmaceuticals Enteric Hyperoxaluria
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria. expand

The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

Type: Interventional

Start Date: Aug 2019

open study

Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid...
Kristin Ashford Smoking Cessation
This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation,... expand

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

Type: Interventional

Start Date: Dec 2018

open study

A Prospective Clinical Study of Phenylketonuria (PKU)
BioMarin Pharmaceutical Phenylketonurias
This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study. expand

This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study.

Type: Observational

Start Date: Oct 2019

open study

Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
Aman Chauhan Large-Cell Neuroendocrine Carcinoma
PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC). The hypothesis is that HG-NEC (excluding small cell carcinoma) can be segregated based on mutational analysis and... expand

PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC). The hypothesis is that HG-NEC (excluding small cell carcinoma) can be segregated based on mutational analysis and that next generation sequencing (NGS)-based assignment of therapy is feasible and will potentially improve the outcomes.

Type: Interventional

Start Date: Nov 2020

open study

A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant...
Amplyx Pharmaceuticals BK Virus Infection
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus. expand

This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.

Type: Interventional

Start Date: Aug 2020

open study

CERAMENT™| Bone Void Filler Device Registry
BONESUPPORT AB Orthopedic Disorder
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use. expand

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

Sodium Watchers Program - Hypertension
Misook L. Chung Hypertension
Hypertensive adults are a vulnerable population at high risk of developing cardiovascular disease. Despite the many interventions tested to reduce hypertension, it remains a major risk factor that is not appropriately managed in the population. Prior dietary interventions... expand

Hypertensive adults are a vulnerable population at high risk of developing cardiovascular disease. Despite the many interventions tested to reduce hypertension, it remains a major risk factor that is not appropriately managed in the population. Prior dietary interventions were successful on reduction of sodium intake, but the changes were not maintained after the end of the intervention. We propose that changing patients' salt taste preference and including family members will produce long-term changes in sodium intake and blood pressure. The Sodium Watchers Program (SWaP) proposed in this study is designed to improve adherence to a sodium restricted diet through education and self-care strategies for gradual taste adaptation to low salt foods. The purpose of this pilot is to test short-term effects of the SWaP intervention on adherence to the sodium restricted diet, blood pressure, salt taste preference, and dietary patterns in hypertensive adults. A total of 30 hypertensive adults will be randomly assigned to the intervention (n=20) or control group (n=10). The intervention group will receive 16-weeks of education and booster sessions remotely using a video conferencing program on mini-iPads. All participants will collect a 24-hour urine specimen for sodium excretion and complete assessments of blood pressure, salt taste preference testing using salt concentration solutions, and dietary pattern using VioScreen Food Frequency Questionnaire at baseline and post intervention at 4-months. Data will be analyzed using repeated measures analysis of variance.

Type: Interventional

Start Date: Sep 2019

open study

Randomized Controlled Trial for Ankle Fracture Pain Control
University of Massachusetts, Worcester Ankle Fractures
This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures. expand

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

Type: Interventional

Start Date: Jan 2020

open study

Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
University of Kentucky Pain, Neuropathic Complex Regional Pain Syndromes Phantom Limb Pain Spinal Cord Injuries
This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain. expand

This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.

Type: Interventional

Start Date: Jun 2012

open study

Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
University of Kentucky Stroke Hemiparesis
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation... expand

Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

Type: Interventional

Start Date: Nov 2018

open study

Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
University of Alabama at Birmingham Acute Kidney Injury
This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care. expand

This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.

Type: Interventional

Start Date: Oct 2020

open study

AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Columbia University Stroke
Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban... expand

Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

Type: Interventional

Start Date: Jan 2018

open study

A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian...
Vascular Biogenics Ltd. operating as VBL Therapeutics Recurrent Platinum Resistant Ovarian Cancer
The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer. expand

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Type: Interventional

Start Date: Dec 2017

open study