University of Texas Medical Branch

The goal of this clinical trial is to compare oxytocin infusion rates for induction and augmentation of labor in nulliparous women. The main question[s] it aims to answer are: - Does a high dose oxytocin infusion protocol affect length of induction to delivery interval? - Does a high dose oxytocin infusion protocol affect mode of delivery? - Does a high dose oxytocin infusion protocol affect maternal and neonatal outcomes? Participants will be randomized to either low- or high-dose oxytocin groups: - The low dose group will receive an infusion to start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. The maximum rate of infusion is 40 milli-units/min. - The high dose group will receive an infusion to start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min.

Type: Interventional

Start Date: Apr 2023

open study

This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squamous cell cancer of the head and neck.

Type: Interventional

Start Date: Jul 2022

open study

This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals age 0-25 years who will enter the cohort with and without SARS-CoV-2 infection at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without PASC symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and participants will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptoms will be reported by participants or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.

Type: Observational

Start Date: Mar 2022

open study

This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.

Type: Interventional

Start Date: Nov 2015

open study

The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders.

Type: Observational

Start Date: Nov 2010

open study

The Aim of the study is to determine endometrial/myometrial spillage during total laparoscopic hysterectomy with manual morcellation.

Type: Observational

Start Date: Aug 2023

open study

Heart failure (HF) remains one of the most common causes of hospitalization with high morbidity and mortality, and its worldwide prevalence is increasing. Despite notable progress in outcomes for HF the rate of early rehospitalization for HF (re-HHF) remains high, especially in the first 30 days. The rate of 30-day HF rehospitalization in the claims databases of the USA and in worldwide randomized clinical trials is 20-25% and 5-10% respectively. In patients with bilateral leg edema, the presence of CHF (congestive heart failure) as the factor causing or worsening local leg swelling should be evaluated. Application of local leg compression can be considered in stable CHF patients without decompensated heart function (NYHA Class I and II) for both CHF-related edema treatment and for treatment of concomitant diseases leading to leg swelling occurrence. Current literature does not have recommendations on the routine use of lower limb compression in leg swelling related to end stage heart disease and advanced, decompensated heart failure. Potential benefits of applying medical compression in more severe classes of CHF (NYHA Class III and IV) would need to be evaluated by further randomized clinical studies to determine which cohort of patients would benefit most from lower limb compression, as well as to choose the safest and most efficient compression protocol for these patients. The AIM of this study is to improve the clinical outcome of patients admitted with exacerbation of heart failure with associated volume overload. The primary objectives are: 1) diminish the duration of hospitalization of CHF patients; 2) decrease the incidence of rehospitalization from CHF exacerbation and 3) prevent local complications associated with prolonged lower extremity edema. The investigators hypothesize that the application of local compression to bilateral lower extremities, when added to guideline-based therapy for CHF exacerbation, will improve overall clinical outcome in patients at the University of Texas Medical Branch (UTMB). If our intervention is proven to be beneficial, it could lead to a significant reduction in nationwide hospitalization costs associated with heart failure.

Type: Interventional

Start Date: Apr 2022

open study

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®). To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution. The immune response is how the body's cells, tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. This study is seeking participants who are: - male or female infants who are 2 months of age, - infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and, - said to be healthy by the study doctor There are three groups in this study. All participants will be assigned to one of the three groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study. The first 400 people who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1. Once 400 people have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3. Half the participants in Group 3 will receive PG4 in the second solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Groups 3 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.

Type: Interventional

Start Date: Jul 2024

open study

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

Type: Interventional

Start Date: Dec 2023

open study

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

Type: Observational

Start Date: Mar 2017

open study

The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.

Type: Interventional

Start Date: Sep 2024

open study

The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction

Type: Interventional

Start Date: Feb 2023

open study

This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

Type: Interventional

Start Date: Jul 2020

open study

The purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (LFU) that may or may not help healing.

Type: Interventional

Start Date: Jul 2024

open study

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

Type: Interventional

Start Date: Jan 2021

open study

This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.

Type: Observational

Start Date: Dec 2020

open study

This phase II trial studies how well olaparib works in treating patients with bladder cancer and other genitourinary tumors with deoxyribonucleic acid (DNA)-repair defects that has spread to other places in the body (advanced or metastatic) and usually cannot be cured or controlled with treatment. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing.

Type: Interventional

Start Date: Nov 2020

open study

This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is in a class of drugs called antineoplastic agents. It blocks the ability of a cell to repair damage to its DNA and may kill cancer cells. It may also help some anticancer drugs work better. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill cancer cells. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving TRC102 in combination with usual care treatment may be more effective than usual care treatment alone in stabilizing and lengthening survival time in patients with stage III non-squamous NSCLC.

Type: Interventional

Start Date: Dec 2022

open study

Objectives: This protocol addresses the first phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted for the larger, comparative study. In this initial development phase, our prototype patient decision aid will be updated to reflect current guidelines about lung cancer screening. The updated aid will then be pilot-tested in a new sample of patients. In addition, several of the study measures will be refined and further developed in preparation for the larger study. The specific aims of the measures and decision aid development phase of this project are as follows: Update the aid to reflect current screening guidelines and refine the aid via cognitive testing with patients/smokers; and pilot test the updated aid for acceptability with patients/smokers. Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new measure with patients/smokers, and evaluate the reliability of the new measure in a sample patients/smokers.

Type: Observational

Start Date: Jul 2014

open study

A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.

Type: Interventional

Start Date: Aug 2018

open study

The research will find out if using portable ultrasound devices by nurses can make it quicker to get babies from 24 to 32 weeks on the doppler monitor.

Type: Interventional

Start Date: Oct 2023

open study

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

Type: Interventional

Start Date: Sep 2021

open study

The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.

Type: Interventional

Start Date: Jul 2021

open study

The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.

Type: Interventional

Start Date: Jul 2021

open study

The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.

Type: Interventional

Start Date: Apr 2024

open study