Search Clinical Trials
Thank you for your interest in research at UTMB! Taking part in research is one way to be part of tomorrow’s healthcare discoveries. UTMB is always looking for volunteers just like you so that our researchers can better understand how to prevent, diagnose, and treat diseases. Everyone is needed. Both healthy volunteers and people with health conditions can help us answer important questions that impact the health of our communities. Ready to start searching for a study to be involved with? • Enter a health condition or leave it blank if you are looking to join any study as a healthy volunteer • Enter your gender and age • Click “View Results” • Click on the study titles for information • Click on the “Contact/Details” tab to get information for contacting the study team
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Patient-Centered Hearing Aid Trial
Northwestern University
Hearing Aids
Hearing Loss
Satisfaction and benefit from hearing aids fit using two patient self fit methods will be
compared against those fit using audiology-based best practices. Individuals between the ages
of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit... expand
Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting. Type: Interventional Start Date: Dec 2020 |
Microbial Determinants of Dementia Risk in Type 2 Diabetics of Mexican Descent
The University of Texas Medical Branch, Galveston
Diabetes
Type 2 diabetes (T2D) predisposes individuals to neurodegeneration and dementia, including
Alzheimer's Disease (AD); yet the link between metabolic and neurodegenerative disorders
remains unknown. Here, the investigators will study a well-defined human population with
increased... expand
Type 2 diabetes (T2D) predisposes individuals to neurodegeneration and dementia, including Alzheimer's Disease (AD); yet the link between metabolic and neurodegenerative disorders remains unknown. Here, the investigators will study a well-defined human population with increased prevalence and early onset of both T2D and AD, individuals of Mexican descent living in South Texas. The study will begin to explore the possibility that disruption of the structure of the bacterial community residing in the gut in type 2 diabetic individuals of Mexican descent living in South Texas is directly related to the increased prevalence of early onset AD in this population. In this study, the investigators will perform gene sequencing on DNA isolated from fecal samples to identify and compare the populations of bacteria living in individuals with T2D versus non-diabetic controls. The investigators will analyze the findings to determine if the community structure of the gut microbiome of individuals of Mexican descent with T2D is significantly altered compared to that of non-diabetics within the same population. The investigators' findings could lead to the identification of early indicators of dementia onset as well as novel therapies for treating metabolic and neurodegenerative diseases. Type: Observational Start Date: Jan 2021 |
Starting a Testosterone and Exercise Program After Hip Injury
Washington University School of Medicine
Hip Fracture
Frailty
Sarcopenia
This study is a randomized controlled double-blinded multi-center clinical trial enrolling
female hip fracture patients who are 65 and older. It will compare the effects of six months
of supervised exercise training combined with daily topical testosterone gel, to six months... expand
This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older. It will compare the effects of six months of supervised exercise training combined with daily topical testosterone gel, to six months of supervised exercise and inactive gel, and to Enhanced Usual Care. Out of nine participants, 4 will receive topical testosterone gel and a supervised exercise training program; 4 will receive topical inactive gel and a supervised exercise training program; and 1 will receive a home exercise program. All participants will receive nutritional counseling, and calcium and vitamin D supplements. Type: Interventional Start Date: Sep 2017 |
Endocrine, Metabolic and Microbiome Influence on the Post COVID-19 Syndrome
The University of Texas Medical Branch, Galveston
Covid19
The aim of this study is characterize the endocrine, metabolic and microbiomes of patients
with post-COVID syndrome.
expand
The aim of this study is characterize the endocrine, metabolic and microbiomes of patients with post-COVID syndrome. Type: Observational Start Date: May 2021 |
Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
The University of Texas Medical Branch, Galveston
Traumatic Brain Injury
Fatigue
Cognitive Impairment
COVID-19
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of
SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation
test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI)... expand
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period. Type: Interventional Start Date: Aug 2018 |
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses
of prototype and variant (alone or in combination) vaccine candidates in previously
vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2)... expand
This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to inform on how to shift the immune response to cover new variants as they emerge. A randomized open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18 years of age and older, who are in a stable state of health, has received a complete authorized/approved vaccine series (primary series + booster either with homologous or heterologous vaccine products) >/ = 16 weeks prior to enrollment. Subjects will be stratified by i) age (18-64 years and >/= 65 years of age) and ii) history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will target a goal of approximately 45% of each of the variant vaccine arms to be in older adults (>/= 65 years of age) and approximately 20% to have had confirmed COVID-19.The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination. Type: Interventional Start Date: Mar 2022 |
Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of...
The University of Texas Medical Branch, Galveston
Prediabetic State
Gestational Weight Gain
Hypertension
Overweight or Obesity
Nearly half of women have obesity and/or hypertension (HTN). Specific to women, pregnancy
creates a vulnerable window for excess gestational weight gain (GWG), exacerbating
intergenerational risks for obesity, HTN, type 2 diabetes (T2D), and cardiovascular disease
(CVD) across... expand
Nearly half of women have obesity and/or hypertension (HTN). Specific to women, pregnancy creates a vulnerable window for excess gestational weight gain (GWG), exacerbating intergenerational risks for obesity, HTN, type 2 diabetes (T2D), and cardiovascular disease (CVD) across the lifespan. Healthy lifestyles are the first-line recommendations for prevention and treatment of overweight/obesity, HTN, T2D, and CVD. The Diabetes Prevention Program (DPP) is a well-established, Centers for Disease Control and Prevention (CDC)-led public health program focusing on healthy lifestyle changes and is effective at reducing 5-7% of body weight, lowering risks for T2D. Interestingly, research investigating the DPP as a lifestyle intervention for other chronic conditions (i.e., overweight/obesity and HTN) is lacking, demonstrating a missed opportunity. The aim of this study is to determine the initial effects of the first 6-months and after receiving the full 12-months of the virtual DPP compared to the DPP expanded with a CDC-approved HTN prevention component (DPP+) on physical activity, diet, weight, and CVD risk factors in 30 prediabetic women (18-45 years old) with a history of excess GWG, overweight/obesity, and HTN. Participants will be recruited through University of Texas Medical Branch (UTMB) community-based clinics using Epic. The Participants will be randomized into 2 groups (DPP and DPP+) and guided through the 12-month virtual DPP or DPP+ program using UTMB DPP personnel. Type: Interventional Start Date: Jun 2022 |
Understanding the Long-term Impact of COVID on Children and Families
NYU Langone Health
SARS-CoV-2 Infection
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... expand
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 |
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger...
Merck Sharp & Dohme LLC
Papillomavirus Infections
Coronavirus Disease (COVID-19)
The primary hypothesis is that concomitant administration of the first doses of 9vHPV vaccine
and 2-dose regimen of mRNA-1273 vaccine induces noninferior geometric mean titers (GMTs) of
antibodies to each of the 9vHPV vaccine types at 4 weeks postdose 2 of 9vHPV vaccine AND... expand
The primary hypothesis is that concomitant administration of the first doses of 9vHPV vaccine and 2-dose regimen of mRNA-1273 vaccine induces noninferior geometric mean titers (GMTs) of antibodies to each of the 9vHPV vaccine types at 4 weeks postdose 2 of 9vHPV vaccine AND noninferior geometric mean concentrations (GMCs) of SARS-CoV-2 spike protein-specific binding antibody at 4 weeks Postdose 2 of mRNA-1273 vaccine, compared with the corresponding postdose 2 GMTs/GMCs induced by a 2-dose regimen of 9vHPV vaccine and mRNA-1273 vaccine, where the first doses of each are administered nonconcomitantly. Type: Interventional Start Date: Mar 2022 |
Efficacy and Safety of MK-1654 in Infants (MK-1654-004)
Merck Sharp & Dohme LLC
Respiratory Syncytial Virus Infection
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study
are to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants.
It is hypothesized that MK-1654 will reduce the incidence of respiratory syncytial virus... expand
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants. It is hypothesized that MK-1654 will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo. Type: Interventional Start Date: Apr 2021 |
Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal...
Alliance for Clinical Trials in Oncology
Colorectal Adenocarcinoma
This phase III trial studies how well vitamin D3 given with standard chemotherapy and
bevacizumab works in treating patients with colorectal cancer that has spread to other parts
of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and
teeth.... expand
This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab). Type: Interventional Start Date: Sep 2019 |
CanGaroo® Registry Study
Aziyo Biologics, Inc.
Arrhythmias, Cardiac
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope
During their CIED Implantation
expand
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation Type: Observational [Patient Registry] Start Date: May 2021 |
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic...
Mirum Pharmaceuticals, Inc.
Intrahepatic Cholestasis of Pregnancy
The purpose of this clinical research study is to evaluate the efficacy, safety and
tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of
pregnancy (ICP) and elevated serum bile acid concentrations.
expand
The purpose of this clinical research study is to evaluate the efficacy, safety and tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of pregnancy (ICP) and elevated serum bile acid concentrations. Type: Interventional Start Date: Jan 2021 |
InterStim Micro Post Market Clinical Follow-up Study
MedtronicNeuro
Overactive Bladder
Fecal Incontinence
Non-obstructive Urinary Retention
Post-market clinical follow-up for continued assessment of safety and performance to confirm
long-term outcomes of the InterStim Micro System for sacral neuromodulation.
expand
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation. Type: Interventional Start Date: Aug 2020 |
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary...
Alliance for Clinical Trials in Oncology
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema
in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse
mapping may help to preserve the lymph node drainage system around the breast so as to
prevent... expand
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery. Type: Interventional Start Date: May 2019 |
Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery
Southwest Oncology Group
Bladder Carcinoma
This phase III trial studies how well nutrition therapy works in improving immune system in
patients with bladder cancer that can be removed by surgery. Improving nutrition before and
after surgery may reduce the infections and other problems that sometimes occur after
surgery.... expand
This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery. Type: Interventional Start Date: Feb 2019 |
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV...
Alliance for Clinical Trials in Oncology
Brain and Central Nervous System Tumors
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as temozolomide, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. It is not yet known whether giving
radiation... expand
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma. Type: Interventional Start Date: Sep 2009 |
Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
The University of Texas Medical Branch, Galveston
PPROM
Respiratory Distress Syndrome in Premature Infants
The purpose of this study is to determine if a repeat course of betamethasone given to
pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's
length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity... expand
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition. Type: Interventional Start Date: Nov 2016 |
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Duke University
Lactating Women on Select DOI
Breastfed Infants of Mothers on Select DOI
Over half of women in the US who are breastfeeding their infants take prescription drugs. You
are being asked to participate in this study because you are breastfeeding your infant and
are currently taking, as part of your medical care, at least one of the drugs we are
studying.... expand
Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants. Type: Observational Start Date: Oct 2018 |
Treatment of ppROM With Erythromycin vs. Azithromycin Trial
The University of Texas Medical Branch, Galveston
Preterm Premature Rupture of Membranes (PPROM)
Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This
pregnancy complication is a major contributor to preterm births and results in neonatal
morbidity and mortality. The current standard of care for PPROM subjects between the
gestational... expand
Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This pregnancy complication is a major contributor to preterm births and results in neonatal morbidity and mortality. The current standard of care for PPROM subjects between the gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do not tolerate this regimen over the course of 7 days. In addition, there is a national shortage of erythromycin, and published expert opinion proposed to use a second-generation macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The investigators' working hypothesis is that there is no measurable difference in the primary outcome between the group randomized to the azithromycin regimen versus the group randomized to the erythromycin regimen. Type: Interventional Start Date: Feb 2017 |
Longitudinal Study of the Porphyrias
Icahn School of Medicine at Mount Sinai
Acute Porphyrias
Cutaneous Porphyrias
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.
expand
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 |
Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm
This phase Ib trial studies side effects and best dose of copanlisib and olaparib when given
together with durvalumab, and how well they work in treating patients with solid tumors that
have spread to other places in the body (metastatic) or cannot be removed by surgery
(unresectable).... expand
This phase Ib trial studies side effects and best dose of copanlisib and olaparib when given together with durvalumab, and how well they work in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. 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. Giving combinations of copanlisib and olaparib or copanlisib, olaparib, and durvalumab may work better in treating patients with solid tumors compared to usual treatments such as surgery, radiation, or other chemotherapy drugs. Type: Interventional Start Date: Aug 2019 |
Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
The University of Texas Medical Branch, Galveston
Operative Time
Wound Heal
Despite the high numbers of cesareans being performed, scientific evidence behind which
surgical techniques are best remains uncertain. Our objective is to determine if subcuticular
absorbable staples improve operative time and wound cosmetics.
expand
Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics. Type: Interventional Start Date: Nov 2021 |
Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
The University of Texas Medical Branch, Galveston
Blood Loss
Postpartum hemorrhage is a well-known complication of delivery and the leading cause of
maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly
collected as a means to assess or base treatment for blood loss. The Hemi device is a
point-of-care... expand
Postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly collected as a means to assess or base treatment for blood loss. The Hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. The ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose of this study is to compare the hematocrit of vaginal blood using the Hemi device with standard venipuncture. Type: Observational Start Date: Oct 2021 |
Intrathecal Morphine Microdose Method Sensory Changes
The University of Texas Medical Branch, Galveston
Analgesic Drug Dependence
Sensory Disorders
Chronic Pain
Following the retrospective study on the effectiveness of the microdose method of intrathecal
morphine therapy, the investigators are interested in measuring the sensory changes at 4 time
points during the microdose method. The microdose method involves weaning the patient off... expand
Following the retrospective study on the effectiveness of the microdose method of intrathecal morphine therapy, the investigators are interested in measuring the sensory changes at 4 time points during the microdose method. The microdose method involves weaning the patient off oral opioids and maintaining an opioid-free period prior to initiating a very low opioid dose in intrathecal therapy. The microdose method is a standard of care. The study involves measuring sensory changes to hot, cold, and pressure. Data collection will be performed at regularly scheduled clinic visits, examining range of doses, pain scores,dose escalations, quantifiable psychosocial factors ( not captured in previous retrospective study), and changes in sensory thresholds. Type: Interventional Start Date: Oct 2018 |