The purpose of this study is to perform a comprehensive research assessment of children and adolescents who meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for Bipolar Disorder (BD) , offspring of a parent with BD, and healthy controls (HC), to obtain blood samples and saliva samples from each subject to allow the evaluation for BD biomarkers and genetic information, to notify participants about future research studies they may qualify for , to recommend follow-up with an outpatient provider if needed and to use magnetic resonance imaging (MRI) (structural MRI and diffusion tensor imaging) to investigate brain structures and relevant pathways associated with mood and behavioral regulation, conversion from softer forms of the BD spectrum (BD-NOS) to harder forms (BD-I and BD-II) and possible early identification.

Type: Observational [Patient Registry]

Start Date: Dec 2022

open study

Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes vitamin K antagonist (VKA), is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. This clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to investigate whether transcranial direct-current stimulation (tDCS) will engage reward-related brain circuitry, more specifically the uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus accumbens (NAcc) regions. Also to evaluate whether the changes in the fractional anisotropy (FA) of the UF tract are associated with changes of clinical symptoms of anhedonia and finally to investigate the moderation role of simulated electric fields (EFs) in an association between FA of the UF and symptoms of anhedonia.

Type: Interventional

Start Date: Oct 2022

open study

The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively

Type: Interventional

Start Date: Sep 2021

open study

The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD.

Type: Observational [Patient Registry]

Start Date: Jun 2016

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 purpose of this study is to measure the evidence-based intervention's (EBIs) impact on patient safety and efficiency, to assess the EBIs implementation by measuring acceptability, appropriateness, cost, fidelity, penetration, and sustainability and to identify the facilitators and barriers that influence the degree of implementation of these EBIs.

Type: Interventional

Start Date: Jan 2024

open study

This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, cardiometabolic indices, and non-calcified plaque (NCP) in the coronary arteries (assessed by coronary CT angiography, CCTA). This trial will be enrolled at UCSF and UCLA. Collaborators at Massachusetts General Hospital (MGH) will serve as the core facility for imaging.

Type: Interventional

Start Date: Mar 2023

open study

The purpose of the study is to assess a culinary curriculum in persons with substance use disorder who are receiving medication assisted therapy and who are in recovery residences in Texas. The curriculum has the goal of increasing nutritional knowledge and confidence in cooking skills.

Type: Interventional

Start Date: Aug 2025

open study

This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures. Researchers aim to determine the maximum tolerated dose (MTD) of TLC590 via Safety Monitoring Committee (SMC). The study evaluates TLC590 in bunionectomy, laparoscopy-assisted open ventral hernia repair, breast augmentation, abdominoplasty, and total knee arthroplasty models. Additionally, it determines the relative bioavailability of TLC590 to ropivacaine injection.

Type: Interventional

Start Date: Sep 2024

open study

The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.

Type: Interventional

Start Date: May 2023

open study

VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window.

Type: Observational

Start Date: Jun 2022

open study

The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects. The MDBP is one of the world's largest leukodystrophy biorepositories, having enrolled nearly 2,000 affected individuals since it was launched over a decade ago. Researchers working in the biorepository hope to use these materials to uncover new genetic etiologies for various leukodystrophies, develop biomarkers for use in future clinical trials, and better understand the natural history of these disorders. The knowledge gained from these efforts may help improve the diagnostic tools and treatment options available to patients in the future.

Type: Observational [Patient Registry]

Start Date: Dec 2016

open study

The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant).

Type: Interventional

Start Date: Jul 2025

open study

The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.

Type: Interventional

Start Date: Apr 2021

open study

The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.

Type: Interventional

Start Date: Aug 2024

open study

The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.

Type: Interventional

Start Date: Sep 2023

open study

The purpose To determine the diagnostic potential of various biological markers in blood and cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs). Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository study enrolling all patients diagnosed with pancreatic cyst and undergoing the cyst aspiration. Procedures to be used Blood Sample Cyst Fluid Sample Data Collection: Medical Record Number Demographics (age, sex, gender, race) Contact information History of alcohol use and IV and other recreational drugs and narcotics use/abuse Medication history Past hospitalizations, diagnoses, and treatment Physical examination findings Imaging data of abdominal and chest regions, including and not limited to ultrasonography, magnetic resonance imaging (MRI), computed tomography (CT) Future admissions, diagnoses, treatment including histopathological findings of resected specimens and blood reports End of study data: clinical progression of disease, cyst size, wall thickening, calcification, communication with pancreatic duct, string sign, cytology, immunohistochemical findings, assay levels of lipase, amylase CEA (carcinoembryonic antigen), carbohydrate antigen19-9 (CA 19-9), and other biomarkers. Risks and potential benefits The risks associated with this study are slight discomfort or bruising from the blood sampling and the possible loss of confidentiality if the patient data or information is inadvertently disclosed outside of this study. The patient will not receive any additional benefit from the study aside from those received as part of routine standard of care. Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may benefit other patients with Pancreatic Cyst Lesions in the future.

Type: Observational [Patient Registry]

Start Date: May 2015

open study

The purpose of this study is to compare CBT VR exposure + VR social skills treatment to CBT Imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (SA), to identify characteristics associated with benefitting from the CBT-VR treatment and to assess acceptability and feasibility of the VR intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.

Type: Interventional

Start Date: Nov 2024

open study

Harris Health System is currently participating, along with two other partners, GoldiFresh Inc., and Brighter Bites, in a cross-sector collaborative home delivery-based Produce Prescription Program (PPRx) pilot initiative that provides consistent access to healthy food plus nutrition education to Medicaid-eligible pregnant women in Harris County, TX, deemed to be at high risk of adverse pregnancy or birth outcomes. The objectives of this study are two-fold: (a) to examine utilization of food basket contents and improvements in diet quality in this home delivery based PPRx program, and (b) to evaluate if and the extent to which utilization of food basket contents outcomes improves with support from an interactive AI-based conversational agent to convert food into healthy meals.

Type: Interventional

Start Date: Jul 2024

open study

Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records. Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.

Type: Observational

Start Date: Jul 2024

open study

An international randomized trial to test the primary hypothesis that perioperative tight blood pressure management reduces a composite of major perfusion-related complications (myocardial injury, stroke, non-fatal cardiac arrest, Stage 2-3 acute kidney injury, deep or organ-space infection, sepsis, and death) in the 30 days after major non-cardiac surgery. The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management).

Type: Interventional

Start Date: Jul 2021

open study

The purpose of this study is to To determine the effect of warm and humidified (WH) carbon dioxide (CO2) on post-operative pain/analgesia requirement in patients undergoing laparoscopic bariatric surgery.

Type: Interventional

Start Date: May 2023

open study

The purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students.

Type: Interventional

Start Date: Apr 2022

open study

Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

Type: Interventional

Start Date: May 2021

open study