Fort Worth, TX Paid Clinical Trials

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. Read Less

The objective of this study is to assess the efficacy, safety, and pharmacokinetics of NBI-921352 as adjunctive therapy for seizures in subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE). Read Less

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened. Read Less

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue. Read Less

Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction. Read Less

The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes. Read Less

Compared to the general population, individuals from underserved communities are more likely to receive low quality end-of-life care and unwanted, costly and burdensome treatments due in part to a lack of advance care planning (ACP; the process of discussing wishes for end-of-life care with loved ones/clinicians and documenting them in advance directives). This study will use existing, trusted, and respected social networks to evaluate two conversation-based tools intended to engage underserved individuals in discussions about end-of-life issue and motivate them to carry out ACP behaviors. Through this study, investigators will learn how best to engage underserved populations in ACP so as to: 1) increase the likelihood that patients from underserved communities will receive high-quality end-of-life care; 2) address health disparities related to end-of-life treatments; and 3) reduce unnecessary suffering for patients and their families. Read Less

The prevalence of underage alcohol use continues to be a public health concern. Numerous studies have reported associations between teen drinking tendencies and parental attitudes and beliefs, parental awareness of teen drinking, parental monitoring and the quality of the parent-teen relationship and communication. The extensive work in this area has resulted in parent-based intervention (PBI) efforts to prevent or reduce adolescent alcohol use. Several independent studies have indicated that teens whose parents received a PBI reported less alcohol use and fewer alcohol-related consequences. Despite these strengths, one major limitation of PBI is that they do not currently take into account the large role that social networking sites (SNS) use plays in adolescents' lives and in relation to their alcohol use. Most (90%) adolescents are on SNS, and their Facebook, Instagram, and Twitter profiles include alcohol content. Thus, adolescents are making and exposed to SNS alcohol displays and these displays are associated with high-risk drinking cognitions and alcohol use. As such, the investigators propose to develop and refine an interactive PBI designed to reduce high-risk SNS cognitions (i.e. attitudes and norms), alcohol use, and negative consequences among adolescents. To achieve study aims, the investigators propose an iterative process of focus groups in order to develop and refine the interactive PBI to be delivered in the pilot study with 1 and 6-month follow-up among 100 parent/teen dyads. The objective of this R34 application is to establish feasibility and acceptability of the newly developed interactive PBI that focuses on the role of SNS in adolescent alcohol use as well as to determine preliminary effect sizes for future studies. Determining an efficacious way to reduce alcohol use and high-risk alcohol display cognitions affords future research the opportunity to make use of social network-based interventions, thus the proposed research has great potential to serve as a catalyst for future research. Read Less

To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults. Read Less

This study will assess the safety and efficacy of increasing doses of narazaciclib (ON 123300) in combination with the standard daily dose (2.5mg) of letrozole in patients with Recurrent Metastatic Low-grade Endometrioid Endometrial Cancer and other Gynecologic Malignancies. Read Less

The Empowering Students Project is an evaluation of the effectiveness of a psychoeducational program for adolescents, intended to help youth build healthy relationship skills while supporting positive socioemotional development and promoting successful transition to young adulthood. Read Less

A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196) Read Less