University of Maryland, Baltimore

The primary study objective is to determine the efficacy of pregabalin administered orally for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The secondary objective is to assess the safety and tolerability of pregabalin in participants with alcohol use disorder and co-occurring posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The investigators will utilize a large and diverse sample of African-Americans that includes both genders and individuals with different types of trauma. All participants will receive standardized bi-weekly Brief Behavioral Compliance Enhancement Treatment (BBCET).

Type: Interventional

Start Date: Sep 2016

open study

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

open study

At the current time there is no effective disease modifying therapy for diabetic neuropathy (DN). The proposed study design employs a quantifiable early measure of DN, intraepidermal nerve fiber density (IENFD), allowing for accurate assessment of actual nerve fiber density. Preclinical data supports the use of Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) as a potential therapy for diabetic neuropathy. Phase I data indicates safety in humans. This study seeks to investigate the use of Niagen® (NR) as a potential treatment for diabetic neuropathy in subjects with type 2 diabetes mellitus or impaired glucose tolerance over a 6 month period. The endpoint measures in addition to the IENFD with determine changes in clinical and electrophysiological outcomes, quality of life and biochemical measures.

Type: Interventional

Start Date: Jan 2019

open study

Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia. Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS) activity. What is unknown is whether fluoxetine can also enhance SNS responses and also override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS responses during exercise.

Type: Interventional

Start Date: Oct 2012

open study

Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To date no studies appear to have investigated the effects of differing levels of hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The specific aim of our study will be to determine the effects of differing levels of hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.

Type: Interventional

Start Date: Jul 2015

open study

In a double-blinded, randomized, parallel controlled design, patients with schizophrenia spectrum disorder will be exposed to active or sham repetitive transcranial magentic stimulation (TMS) which was guided by functional magnetic resonance image (MRI). Smoking reduction/cessation and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

Type: Interventional

Start Date: May 2018

open study

Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activity during hospitalization (e.g., mobility,bathing, dressing) has a positive impact on older adults including prevention of functional decline, less pain, less delirium, less BPSD, fewer falls, shorter length of stay and decreased unplanned hospital readmissions. Despite known benefits, physical activity is not routinely encouraged and older hospitalized patients spend over 80% of their acute care stay in bed. Challenges to increasing physical activity among older patients with ADRD include environment and policy issues (e.g., lack of access to areas to walk); lack of knowledge among nurses on how to evaluate, prevent and manage delirium and BPSD; inappropriate use of tethers; beliefs among patients, families, and nurses that bed rests helps recovery and prevents falls; and lack of motivation/willingness of patients to get out of bed. To increase physical activity and prevent functional decline while hospitalized we developed Function Focused Care for Acute Care (FFC-AC-EIT) for patients with ADRD. Implementation of FFC-AC-EIT changes how care is provided by having nurses teach, cue, and help patients with ADRD engage in physical activity during all care interactions. FFC-AC-EIT was developed using a social ecological model, social cognitive theory and the Evidence Integration Triangle. It involves a four-step approach that includes: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families. The purpose of this study is to test the efficacy of FFC-AC-EIT within 12 hospitals in Maryland and Pennsylvania randomized to FFC-AC-EIT or Function Focused Care Education Only (EO) with 50 patients recruited per hospital (total sample 600 patients). Aim 1 will focus on efficacy at the patient level based primarily on physical activity, function, and participation in function focused care, and secondarily on delirium, BPSD, pain, falls, use of tethers, and length of stay; and all of these outcomes (except length of stay and tethers) along with emergency room visits, re-hospitalizations and new long term care admissions at 1, 6 and 12 months post discharge; and at the unit level the aim is to evaluate the impact of FFC-AC-EIT on policies and environments that facilitate function and physical activity at 6, 12 and 18 months post implementation. Hospitals randomized to FFC-AC-EIT will be compared with those randomized to Function Focused Care Education Only (EO). Aim 2 will evaluate the feasibility, based on treatment fidelity (delivery, receipt, enactment)136, and relative cost and cost savings of FFC-AC-EIT versus EO. Findings will address several prioritized areas of research: a focus on ADRD; improving physical function; and training of hospital staff and will demonstrate efficacy of an approach to care for patients with ADRD that can be disseminated and implemented across all acute care facilities.

Type: Interventional

Start Date: Oct 2020

open study

This is a randomized, placebo-controlled dose-escalation study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.

Type: Interventional

Start Date: Oct 2019

open study

Multiple Sclerosis (MS) is an autoimmune disorder of the central nervous system. In MS, inflammation is known to attack areas of the brain, spinal cord, and optic nerves; resulting in disability. Current MRI technology provides an adequate view of the impact of MS on the "white matter" of the brain, which contains many of the connections between neurons. Quantification of lesions in the white matter due to MS are a standard part of clinical trials and clinical care in MS. However, it has long been known that MS not only can affect the white matter, but also the "gray matter," which contains the majority of the nerve cells in the brain and can cause inflammation in the meninges (the protective tissue that surrounds the brain and spinal cord). Autopsy studies have shown that the inflammation seen in the meninges is driven by a B-cells, a subset of white blood cells and that meningeal inflammation may be responsible for damage to the gray matter of the brain. Ocrelizumab is a new treatment for multiple sclerosis. This medication works by targeting and destroying circulating B-cells. It is thought that this may reduce the level of meningeal inflammation in patients with multiple sclerosis. By reducing meningeal inflammation, this medication may result in less damage to the gray matter and subsequently less disability in MS patients. In this study, the investigators will evaluate the use of a method on 7 tesla (7T) MRI to identify inflammation in the meninges as a potential predictor of response to ocrelizumab treatment for multiple sclerosis. Further, the investigators will evaluate if this MRI technique can be used to monitor the long-term effect of the medication on meningeal inflammation and the development of damage to the gray matter of the brain.

Type: Observational

Start Date: Sep 2018

open study

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Type: Interventional

Start Date: Dec 2019

open study

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

Type: Interventional

Start Date: Oct 2020

open study

This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.

Type: Interventional

Start Date: Nov 2018

open study

The Wellness Champions for Change (WCC) study aims to reduce pediatric obesity among students who attend schools in Maryland by training teacher and student-led wellness teams to increase opportunities for physical activity and healthy eating at school. The study uses a cluster randomized design to allocate 6 schools (3 elementary, 3 middle) in 5 school systems to one of 3 arms: "A" (teacher and student training), "B" (teacher training only), and "C") (delayed teacher training/control). Approximately 36 3rd/6th graders and their caregivers ("evaluation cohort"), 15 4th/7th graders ("student leaders"), and 20 teachers from each school will be recruited in the spring before the intervention. All schools will identify a teacher "Wellness Champion" who will coordinate intervention activities. In "A" and "B" schools, wellness champions will attend a training to learn how to build a wellness team and create more opportunities for students to make healthy choices. In "A" schools, student leaders ("Student Wellness Champions") will meet weekly during lunch with a health educator to receive training as peer leaders and help the Wellness Champion with wellness initiatives. Student leaders in "B" and "C" schools will receive a monthly general Adolescent Health Curriculum. To assess the impact of the teacher and student-led interventions, the evaluation cohort will be followed for 2.5 years, with measures including: anthropometry (height/weight), 7-day accelerometry (physical activity), and validated questionnaires to assess healthy eating. Student leaders will be followed for 1.5 years to assess the impact of their participation, with measures including: anthropometry, 7-day accelerometry, validated questionnaires to assess healthy eating, and validated questionnaires and focus groups to assess leadership/advocacy skills. Teachers will complete validated questionnaires to investigate their perceptions of the school environment, classroom practices, and role modeling skills. Prior to data collection and analysis, participants will be assigned an identification number, and all documents linking participant information to identification numbers will be locked/ password-protected.

Type: Interventional

Start Date: May 2017

open study

Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-Randomized and MAC cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-randomized cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Type: Interventional

Start Date: Jun 2018

open study

Background: While the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support. This can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies. Purpose: Examine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well. This effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU. In addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty.

Type: Observational [Patient Registry]

Start Date: Sep 2014

open study

Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to develop a mechanistically based therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral balance function through protective stepping to prevent falls. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. Age-related declines in lateral balance function result from neuromuscular and biomechanical limitations in hip abductor-adductor muscle power generation. This study will test whether these impairments can be improved with high-velocity hip muscle resistance power training that will be more effective than conventional resistance strength training.

Type: Interventional

Start Date: Sep 2019

open study

Stroke is the leading cause of long-term disability in the U.S. Individuals with hemiparesis due to stroke often have difficulty bearing weight on their legs and transferring weight from one leg to the other. The ability to bear weight on the legs is important during functional movements such as rising from a chair, standing and walking. Diminished weight transfer contributes to asymmetries during walking which commonly leads to greater energy expenditure. Moreover, deficits in bearing weight on the paretic leg contribute to lateral instability and are associated with decreased walking speed and increased risk of falling in individuals post-stroke. These functional limitations affect community participation and life quality. Thus, restoring the ability to bear weight on the legs, i.e., limb loading, is a critical goal for rehabilitation post-stroke. The purpose of this research is to identify the impairments in neuromechanical mechanisms of limb loading and determine whether limb loading responses can be retrained by induced forced limb loading.

Type: Interventional

Start Date: Feb 2019

open study

Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney disease (ADPKD) have opened up possibilities of new therapies to prevent disease progression. High quality clinical investigations in patients with ADPKD, however, pose significant challenges to investigators including limited access to patients with ADPKD,insufficient guidance by experienced investigators and lack of resources to conduct these studies. The Polycystic Kidney Disease Research Clinical and Translational Core (P30) aims to establish an infrastructure that will assist investigators in designing and conducting highest quality clinical and translational research focused on a diverse group of patients with ADPKD. Objective 1: To establish a Mid-Atlantic cohort of ADPKD patients (N=250) with baseline clinical phenotyping performed at the General Clinical Research Unit of the University of Maryland School of Medicine. Objective 2: To establish a state-of-the-art biobank of specimens from the ADPKD cohort including serum, plasma,urine and DNA. Objective 3: To develop a collaborative network of physicians and practices in the Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer patients for future studies and trials. Objective 4: To establish a web-based registry of ADPKD patients in the Mid-Atlantic area.

Type: Observational [Patient Registry]

Start Date: Mar 2013

open study

Severe and refractory pain after acute injury is a known-risk factor for chronic opioid use disorder. In this study, the investigators will use Virtual Reality (VR) immersion as a non-pharmacological adjunct to treat pain associated with acute traumatic injuries, including traumatic brain injury. The investigators hypothesize that VR therapy will decrease pain and reduce opioid use in patients with acute traumatic injuries, including TBI.

Type: Interventional

Start Date: Sep 2020

open study

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Type: Interventional

Start Date: Aug 2018

open study

INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.

Type: Observational

Start Date: Dec 2017

open study

This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB.

Type: Interventional

Start Date: Oct 2018

open study

The purpose of this study is to explore the long-term outcomes, durability of effect, and real world treatment patterns in participants previously participating in the Phase 3 oral cladribine in first clinical demyelinating event(ORACLE MS) and Oral Cladribine in participants with relapsing remitting multiple sclerosis, extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.

Type: Interventional

Start Date: Aug 2019

open study

For tablets to be absorbed, the drug must dissolve after being swallowed. Drugs with low solubility sometimes require the inert ingredients in tablets to help the drug dissolve after being swallowed. This study uses itraconazole as an example drug with low solubility. Itraconazole tablets with different inert ingredients and manufacturing will be administered to healthy volunteers to see if the different inert ingredients and manufacturing impact drug absorption.

Type: Interventional

Start Date: Feb 2020

open study

The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

Type: Interventional

Start Date: Nov 2020

open study