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Discover 23,284 clinical trials near Maryland. Find research studies in your area.
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NCT03197688
The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.
NCT03153111
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.
NCT00381641
This phase II trial studies how well sunitinib malate works in treating patients with thyroid cancer that did not respond to iodine I 131 (radioactive iodine) and cannot be removed by surgery. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
NCT05726058
The goal of this clinical trial is to investigate the use of an FDA-cleared retinal blood flow imaging instrument called the XyCAM RI and XyCAM FC (Vasoptic Medical, Inc., Columbia, MD) in glaucoma management. The main question it aims to answer are: * Can the investigators use blood flow to discriminate between eyes with early-stage glaucoma and variable-matched controls? * Can the investigators validate that the XyCAM FC simultaneously captures both stereo fundus photography and ocular blood flow monitoring? Participants will be * measured for their blood pressure, heart rate, height, and weight * dilated with tropicamide * imaged using the XyCAM RI, fundus photography, optical coherence tomography, and standard automated perimetry * imaged using the XyCAM RI while inhaling 100% oxygen through a mask
NCT03707158
The Kids FACE FEARS (Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services) is a large-scale, streamlined, pragmatic Randomized Controlled Trial (RCT) evaluating Therapist-Led CBT (telehealth, office-based, or hybrid) vs. Guided Online Cognitive-Behavioral Therapy (CBT) for the treatment of elevated child and adolescent anxiety. Families will be recruited from pediatric health centers serving primarily racial/ethnic minority youth in urban, suburban, and semi-rural regions. Services will be offered in English and Spanish. Patient-centered outcomes will be evaluated across a one-year follow-up period. To compare the effectiveness of the two treatment comparators, investigators will analyze the reports of caregivers, youth, and therapists, as well as independent evaluators who are not informed of each child's treatment assignment. Primary outcomes will focus on family-rated anxiety severity and impairment, treatment responder and remission status rated by independent evaluators, family-perceived effectiveness, and treatment satisfaction. Secondary analyses will examine additional outcomes, predictors of varied outcomes across different subgroups of youth, and facilitators and barriers to treatment implementation. Caregivers, patients, providers, and other key stakeholders will be actively engaged throughout all aspects of the research.
NCT04804033
The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
NCT02276872
This was a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who were (1) transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin therapy; or (3) not currently receiving prostacyclin therapy.
NCT05547165
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.
NCT03754933
Primary Objective: The primary objective of the study is to evaluate the safety of repeat administration of a dose level of Ad/PNP plus fludarabine phosphate (F-araAMP) which demonstrated anti-tumor activity in patients with advanced head and neck cancer in a completed phase I study. Secondary Objective: The secondary objective is to evaluate the antitumor activity of repeat administration of Ad/PNP plus F-araAMP. FDA Office of Orphan Drugs Division is a source of funding for the overall project.
NCT05458024
The main objective of this study is to determine whether the administration of a single dose of Vitamin D in the Emergency Department following a motor vehicle collision can improve musculoskeletal pain severity as well as reduce musculoskeletal pain outcome disparity between Blacks and White following a motor vehicle collision. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy (response to study drug, ability to reduce racial disparity in pain outcomes). This data can be used to adequately power a larger randomized controlled trial to fully assess efficacy.
NCT04376827
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
NCT03871829
The purpose of this study is to compare the efficacy (rate of very good partial response \[VGPR\] or better as best response as defined by the International Myeloma Working Group \[IMWG\] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.
NCT04420754
The purpose of this study is to assess the safety and tolerability and determine the recommended Phase 2 dose of AIC100 Chimeric Antigen Receptor (CAR) T cells in patients with relapsed/refractory poorly differentiated thyroid cancer and anaplastic thyroid cancer, including newly diagnosed.
NCT05261191
Study CP-MGD020-01 is a phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination with MGD014 in persons with HIV-1 (PWH) on antiretroviral therapy (ART). The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of the study drugs. The study consists of 3 parts (Part 1A, Part 1B, and Part 2). The participant's standard of care ART regimen is continued throughout the study period. MGD020 is a bispecific DART® molecule that binds CD3 and gp41 subunit of HIV-1 envelope. MGD014 is a bispecific DART® molecule that binds CD3 and gp120 subunit of HIV-1 envelope. These DART molecules redirect CD3+ T lymphocytes to kill HIV-1-infected CD4+ T cells. Part 1A evaluates groups of participants given a single dose of MGD020. A 2-week safety period is observed prior to escalation to the next dose level. Dose escalation continues until either the maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined. Part 1B begins after the end of Part 1A. Part 1B evaluates groups of participants given a single dose of the MGD020 MTD or MAD from Part 1A and a fixed dose of of MGD014. The first group will be treated with a single dose of MGD020, at a dose determined to be one dose lower than the single-agent MTD/MAD from Part 1A, and a single 300 mcg/kg dose of MGD014. Dose escalation proceeds until either the MTD or MAD is determined. Part 2 begins after the end of Part 1B. Part 2 is a multi-dose expansion group. Each participant will receive the MTD or MAD of MGD020 from Part 1B and a fixed dose of MGD014 from Part 1B, administered every 2 weeks (Q2W) for 3 combination doses over 4 weeks. Up to 6 participants may be enrolled in Part 2.
NCT05825898
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population \>75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR. What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.
NCT00740103
CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).
NCT05256771
Multi-center, three-arm, randomized, evaluator-blinded study of electrical muscle stimulation (EMS) and/or 1064 nm diode laser, pulsed electromagnetic field (PEMF) and vacuum assisted radio frequency (RF) using the Venus Bliss Max for fat reduction, body contouring and aesthetic improvement.
NCT05782296
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
NCT01968187
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.
NCT03692715
This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.
