Houston, TX Paid Clinical Trials

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham). Read Less

This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer. The primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK, RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected. Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. We estimate we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents. The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. For patients not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. This initiative will be correlated with various clinical outcomes. Prespecified clinical data will be collected for correlation with these circulating biomarkers. Read Less

The PI and the research team developed the New York University (NYU) Electronic Patient Visit Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO) for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. The study aims to advance the science of cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported monitoring system for patients with HNC in real-world settings and identify implementation strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings. The study hypothesis is that participants assigned to the ePVA arm will have better swallowing, taste and smell, and social function than participants assigned to usual care arm at 4 weeks after completing radiation therapy. Read Less

The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects. Read Less

The goal of the GWIT Study is to assess whether growth hormone replacement therapy is a safe and effective treatment for veterans with Gulf War Illness (GWI) and adult growth hormone deficiency (AGHD). The main questions the study aims to answer are: 1. Is growth hormone effective at reducing fat in the trunk of the body and symptoms of GWI among veterans with GWI and growth hormone deficiency? 2. Do the results of the study suggest there is merit in pursuing a larger trial to examine the efficacy of growth hormone as a treatment for growth hormone deficiency among veterans with Gulf War Illness? To determine eligibility for the study, veterans will be asked to complete several assessments including questionnaires, blood tests, and a scan of the brain. Participants who qualify for the study will receive recombinant human growth hormone for 6-months. A body composition scan will be performed at Day1, Day 90, and Day 180 of the intervention. Questionnaires and cognitive tests will also be collected before and after the trial. Read Less

The overall objective of this proposal is to develop and utilize a multicenter UM registry that will, in a longitudinal fashion, capture prospective data in order to characterize the natural history of UM and provide data that will be used to support the development of novel therapies for this disease. The care of patients with UM requires a multi-disciplinary team of physicians that commonly requires the involvement of both radiation oncology and interventional radiology, and is typically directed by an ophthalmologic oncologist at time of initial diagnosis of primary disease. Overall management is transitioned to a medical oncologist when distant recurrence is identified. In the case that a patient presents with metastasis at the time of diagnosis, a medical oncologist typically directs overall management. The management of surveillance for the development of metastasis following the treatment of primary disease is variable and, if performed at all, is managed by either an ophthalmologic oncologist or medical oncologist. Thus, the successful development of a registry that aims to capture the data regarding the full natural history of UM requires a collaborative effort including leaders from both the UM ophthalmologic oncology and medical oncology fields. To this end, the investigators have built an initial consortium of key ophthalmologic oncology and medical oncology leaders from multiple major UM centers in the United States. Read Less

Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat. Read Less

The purpose of Fluid Loading Countermeasures is to determine how the volume of blood and of plasma (liquid part of blood) change during a normal day, how these are affected by drinking an additional amount of fluid either as water and salt tablets (as astronauts do) or an electrolyte beverage (similar to but tastes saltier than Gatorade®), and how altering the timing at which the additional fluid is consumed affects blood and plasma volume. This study observes how blood volume changes over \~9 hours of the day during 4 separate visits in healthy participants. During 1 visit participants will drink a small amount of water throughout the visit. During the other 3 study visits participants will drink the small amount of water plus either more water with salt tablets or an electrolyte solution. Consuming the additional fluids is called "fluid loading". This study is meant to simulate the food and fluid consumption of astronauts on landing day. The goal of this study is to determine the magnitude of plasma volume change that occurs with each condition of the protocol. (ICF 1.1, 3.1) Read Less

The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma. Read Less

The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs), Read Less

This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG. Read Less

Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ. Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier. There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain. The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases. Read Less