Dallas, TX Paid Clinical Trials

Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work. Read Less

A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma. Read Less

This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo. Read Less

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Read Less

This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting. Read Less

This evaluation uses a formative approach and a descriptive design with repeated measures to assess the efficacy of a Continuous Quality Improvement (CQI) Process to improve services delivered by the Family Champions Project (FCP). The FCP delivers education-based services-TYRO Leadership and Core Communication curricula-with funding from the Office of Family Assistance to low-income fathers and mothers to promote healthy family relationships and economic stability in their households. TYRO Leadership and Core Communication are adapted from the TYRO suite of curricula that were developed by the RIDGE Project, and they are designed to improve the relationships of families affected by the incarceration of a parent and the economic stability of their households. Participants must be at least 18 years of age with a child no older than 24 years and have no open criminal cases (cases can be deferred). Evaluation activities are carried out by Midwest Evaluation and Research (MER) and assess the extent to which our CQI Process is a feasible approach to improve outputs and the outcomes that might be associated with them for an education-based service delivery effort like the FCP. Specifically, study results from formative evaluation will inform practitioners in the field of HMRE about the viability of using a CQI Process like ours to achieve full implementation and provide some evidence about its capacity to improve outcomes. Formative evaluation not only assesses experiences of the CQI Team and front-line service staff while implementing our CQI Process, but also pays attention to the timing and other specifics of any performance interventions that occur over the 5-year project. As a result, performance interventions present opportunities to conduct a series of mini studies to descriptively evaluate CQI Team efforts to improve implementation of the FCP. Performance trends that improve after an intervention indicate the CQI Team was likely successful to more fully implement outputs which should result in a positive effect on retention rates and, in turn, short term outcomes if we assume a sound theory of change for the FCP is depicted in the logic model. Read Less

This impact evaluation aims to determine if the addition of 10 hours of domestic violence prevention programming is effective at improving outcomes among those program participants who are randomly assigned to the treatment group. Both study groups will receive standard TYRO Champion Dads services (the TYRO Dads and TYRO Core Communication evidence-based curricula, plus support services), but only the treatment group will be offered the additional Ray of Hope curriculum hours focused on mitigating risk factors related to domestic violence. Read Less

CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care. Read Less

This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to: Identify the recommended dose of AC676 that can be given safely to participants Evaluate the safety profile of AC676 Evaluate the pharmacokinetics of AC676 Evaluate the effectiveness of AC676 Read Less

This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months. Read Less

ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. Four types of solid tumor cancers will be profiled including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) and pancreatic cancer. Healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for CRC and healthy individuals at low risk for CRC. Risk assessment will be based on family history or past neoplastic findings during CRC screening. Data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. Stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment. Currently enrolling the CRC, high risk, and low risk cohorts. Subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. Approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during Standard of Care (SOC) screening colonoscopy or retained surgical tissue from colectomy. Electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. In select cases, stool and blood samples will be collected beyond 2 years. Read Less

This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM). Read Less