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Discover 17,468 clinical trials near Dallas, Texas. Find research studies in your area.
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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.
NCT00667823
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
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.
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.
NCT05644353
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.
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.
NCT01384630
This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the end of the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.
NCT01474798
This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.
NCT03153137
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
NCT02846532
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram \[mg\] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram \[mg/kg\]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.
NCT04494360
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
NCT06025877
There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related\_conditions/mild-cognitive-impairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related\_conditions/mild-cognitive-impairment. Accessed August 16, 2022).
NCT04035226
The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).
NCT04376827
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
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.
NCT04767919
The decision to use standard percutaneous nephrolithotomy (PCNL) versus mini-percutaneous nephrolithotomy (MIP) has been a subject of much debate in the urological community. The investigators propose a randomized controlled trial to compare the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. The results of this study will help guide the decision making regarding these two procedures in the US population and provide further insight into the utility and safety of these procedures. A cost analysis will be performed, and it is hypothesized that the reusable components of the Storz MIP set will result in lower costs of the mini-PCNL procedure compared to standard PCNL.
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).
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.
NCT02060721
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
NCT04362592
The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.
