Maryland Paid Clinical Trials

Given the limited long-term effectiveness of traditional weight loss methods, bariatric surgery is increasingly becoming the preferred option for sustained weight loss. With the ascendancy of the laparoscopic approach, the two most common procedures are the Roux-en-Y gastric bypass (RYGB) and the vertical sleeve gastrectomy (VSG). Because bariatric surgery decreases nutrient intake through restriction, malabsorption, or both, and given that obese patients are often malnourished even before surgery, postoperative micronutrient deficiency, particularly of iron, can be a serious complication and difficult to treat. Iron deficiency anemia has been reported to be as high as 49% in the post-bariatric surgical patient. The current standard for correcting iron deficiency anemia in the post-operative bariatric surgical patient is oral iron supplements. However, oral iron therapy is known for its caustic effects on the gastric mucosa causing gastric irritation, nausea, epigastric discomfort and constipation. These debilitating symptoms lead to poor adherence and lower long and short-term efficacy. Furthermore, iron absorption from oral iron supplements when taken with food in patients with low iron stores ranges from 2 to 13% and without food 5 to 28%. An alternative and more effective method of iron replenishment is the use of intravenous iron. A litany of published trials, without contradiction, show marked superiority of intravenous iron in improving hemoglobin concentrations and iron parameters when compared to historical controls. Nonetheless, the current recommendations of the American Society of Metabolic and Bariatric Surgery nutritional guidelines, state that oral iron supplementation for IDA is the recommended first line of treatment. Studies are lacking that compare the efficacy of oral versus intravenous (IV) iron therapy for the treatment of IDA in the post-bariatric surgical patient. The aim of our study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of IDA in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures. The primary outcome will be determined at 6 weeks of treatment with a follow-up at 12 months after treatment. Non-responders at 6 weeks after treatment may, if they qualify (based on inclusion/exclusion criteria), have an open-label IV iron treatment and will be followed with the same evaluations used after the first IV iron treatments. Read Less

The primary purpose of the PCOS Indirect and Intangible Economic Buren study is to estimate the economic costs of having PCOS in terms of quality of life and work productivity. The population will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS. This study is a sub-study of The PCOS Challenge Study. Read Less

Spinocerebellar ataxias (SCA) are genetic neurological diseases that cause imbalance, poor coordination, and speech difficulties. There are different kinds of SCA and this study will focus on types 1, 2,3, and 6 (SCA 1, SCA 2, SCA 3 , also known as Machado-Joseph disease and SCA 6). The diseases are rare, slowly progressive, cause increasingly severe neurological difficulties and are variable across and within genotypes. The purpose of this research study is to bring together a group of experts in the field of SCA for the purpose of learning more about the disease. The research questions are: How does your disease progress over time? What are the best ways to measure the progression? Do some genes, other than the gene that is abnormal in your disease, have any effect on the way the disease behaves? This is a nationwide study and we expect that 800 patients will participate all over the USA. The participants will be in the study for an indeterminate period of time. Study visits will be done every 6 or 12 months depending on the participating site. Read Less

NTS-104 TRIS will be administered as a single intravenous dose to healthy subjects at doses of 0.8, 4, 8 and 16 mg/kg in 4 Cohorts. Each cohort of 8 subjects will begin with dosing 2 sentinel subjects with one being given the investigational product and one the placebo. If no safety issues arise, dosing the remaining subjects in the cohort will begin. A Safety Review Committee will review the safety and pharmacokinetic data before approving escalation to the next dose level. Read Less

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study. Read Less

The purpose of the study is to test effectiveness of donepezil to improve wound healing in patients with diabetic wounds that have not healed with standard treatment. Read Less

Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort. Read Less

RGX-314 is being developed as a novel, potential one-time gene therapy treatment for the treatment of diabetic retinopathy, a chronic and progressive complication of diabetes mellitus. Diabetic retinopathy (DR) is a sight-threatening disease characterized in the early stages by neuronal and vascular dysfunction in the retina, and later by neovascularization that leads to further deterioration of functional vision. Despite the availability of current treatments, diabetic retinopathy remains the leading cause of vision loss in working-age adults, those between the ages of 20 and 74. Existing treatment with anti-VEGF agents, although shown to be effective, are limited by short therapeutic half-lives, which then require frequent intravitreal injections over the patient's lifetime, resulting in increased risk of associated adverse events and significant treatment burden. Due to the burden of treatment, patients often do not closely adhere to treatment regimens and experience sub-optimal outcomes and a decline in vision. RGX-314 is being developed as a potential one time treatment for diabetic retinopathy, which may deliver advantages over conventional treatments, such as potentially providing a longer duration of therapeutic effect and intervening at an earlier stage of the disease. Read Less

The investigators will perform follow-up on 250 of 500 cases recruited into the ROSE study of cases with deep and lobar intracerebral hemorrhage to perform advanced neuroimaging at 12-24 months post stroke, and evaluations of motor and cognitive function at baseline, 6 months after baseline, and 12 months after baseline to determine predictors of recovery, progressive cognitive or functional impairment. The investigators propose to leverage the recruitment, DNA, RNA-seq and baseline advanced neuroimaging cohort of ROSE to obtain long-term neuroimaging and identical assessments longitudinally to address critical questions regarding the progressive decline of patients 12 to 24 months post intracerebral hemorrhage (ICH) with long term cognitive follow-up to 36 months on average. This proposal would represent the largest, and longest advanced neuroimaging and RNA-sequencing evaluation after ICH to date. Read Less

The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit. Read Less

With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. The goal of the "Speech Perception and High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm. In the present study neural (as measured by pupillometry and magnetoencephalography) and behavioral changes of speech-in-noise perception from pretest to posttest will be examined in older adults (age 65 - 85 years) assigned to one of three training groups: 1) Active Control Group: sessions of watching informational videos, 2) Auditory Training Group: sessions of auditory training listening to one of two speakers in everyday scenarios (e.g., driving directions) and needing to recall what one speaker said in the previous sentence, and 3) Auditory-cognitive training group: identical to the auditory training group, except participants will be asked to remember information from two previous sentences. Changes in speech-in-noise perception will be examined for the three groups of older adults and gains will be compared to a control group of young, normal hearing adults (18-30 years) that is not part of the clinical trial and will not undergo any training. Read Less

This is a descriptive study assessing the feasibility of using VR rehabilitation with unilateral (or bilateral) impairment of the arm, wrist and or hand resulting in reduced range of motion, dexterity, and/or strength of the hand. Read Less