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A Study of Baricitinib (LY3009104) in Children With COVID-19
Eli Lilly and Company
Covid19
Corona Virus Infection
The purpose for this study is to determine if the study drug baricitinib is effective and
safe in hospitalized pediatric participants with Coronavirus disease 2019 (COVID -19) and to
confirm the dose.
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The purpose for this study is to determine if the study drug baricitinib is effective and safe in hospitalized pediatric participants with Coronavirus disease 2019 (COVID -19) and to confirm the dose. Type: Interventional Start Date: Dec 2021 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score...
NRG Oncology
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy.... expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy
The University of Texas Medical Branch, Galveston
Pelvic Organ Prolapse
The purpose of this study is to compare operative time, patient reported outcomes, surgical
complications, and surgical outcomes between the tunneling versus dissection technique during
robotic assisted sacrocolpopexy (RA SCP).
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The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (RA SCP). Type: Interventional Start Date: Aug 2023 |
A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute...
Biogen
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab)
compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus
Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and
the... expand
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B]. Type: Interventional Start Date: Sep 2022 |
Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
Canadian Cancer Trials Group
Breast Cancer
The purpose of this study is to compare the effects on low risk breast cancer receiving usual
care that includes regional radiation therapy, with receiving no regional radiation therapy.
Researchers want to see if not giving this type of radiation treatment works as well at... expand
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back. Type: Interventional Start Date: Oct 2018 |
Understanding the Burn Wound Microbiome: Comparing Traditional Wound Cultures to Next Generation Sequencing...
The University of Texas Medical Branch, Galveston
Microbial Colonization
Burns
The purpose of this investigation is to better understand the wound microbiome in burn wounds
and the role it plays in outcomes and complications related to treatment.
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The purpose of this investigation is to better understand the wound microbiome in burn wounds and the role it plays in outcomes and complications related to treatment. Type: Observational [Patient Registry] Start Date: Nov 2022 |
Measuring Relative Afferent Pupillary Defect
The University of Texas Medical Branch, Galveston
Relative Afferent Pupil Defect (RAPD)
The goal of this prospective reliability study is to test the effectiveness of a commercially
available, off-the-shelf virtual reality head-mounted display (VR HMD) and machine learning
(ML) algorithms in detecting Relative Afferent Pupillary Defect (RAPD) in a group of subjects... expand
The goal of this prospective reliability study is to test the effectiveness of a commercially available, off-the-shelf virtual reality head-mounted display (VR HMD) and machine learning (ML) algorithms in detecting Relative Afferent Pupillary Defect (RAPD) in a group of subjects with known RAPD and another group with no known RAPD. The main questions it aims to answer are: - Does the use of the VR HMD and ML to replace the standard of care swinging flashlight test provide a more reliable and objective pupil measurement to detect RAPD? - Can RAPD be detected by the VR HMD and ML algorithms at an earlier stage than the standard of care swinging light test? Participants will be asked to undergo the standard of care swinging flashlight test, have their pupils manually measured, then have the test repeated using the VR HMD and ML. Researchers will compare the measurements taken manually, following the standard of care swinging light test and those recorded by the VR HMD and ML to help answer the above questions. Type: Interventional Start Date: May 2023 |
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
The University of Texas Medical Branch, Galveston
Opioid Withdrawal
Analgesia
The purpose of the study is to find out how a stimulation device worn on the ear works. This
device is thought to stimulate nerves in the area around the ear to change the signals in the
brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The... expand
The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The investigator will also investigate changes in the way each participant perceive sensations of pressure and heat. The participant will be asked to reduce the amount of pain medication that they take. Then, the participant will spend several days and nights in the Clinical Research Center at UTMB (University of Texas Medical Branch) in Galveston. During that time, the participant will be monitored for withdrawal symptoms and will receive either active (e.g., "real") brain stimulation or sham (e.g., "fake") brain stimulation for two days (four hours each day). At two times over the course of the study (before and after ear stimulation treatment), the participant will complete questionnaires about their pain score and how they are feeling, sensory testing, and will undergo magnetic resonance imaging (MRI) of their brain. The investigator will collect the following information from the participant's medical record: age, gender, medication history, medical diagnoses, recent vital signs, past doctor visits or hospital stays, and results of urine drug tests. Participation in this study will last approximately four days, and the participant will stay in the Clinical Research Center. Type: Interventional Start Date: May 2023 |
Viral Mucosal Reprogramming
The University of Texas Medical Branch, Galveston
Asthma
Allergic Rhinitis
Cat Allergy
Healthy
This is a mechanistic, controlled, open-label, single-site study to evaluate the effects of
RG-RV16 inoculation on airway mucosal gene expression and airway remodeling in 25 healthy
controls (HC), in 25 allergic rhinitis subjects (AR) with cat dander allergy, and in 25
allergic... expand
This is a mechanistic, controlled, open-label, single-site study to evaluate the effects of RG-RV16 inoculation on airway mucosal gene expression and airway remodeling in 25 healthy controls (HC), in 25 allergic rhinitis subjects (AR) with cat dander allergy, and in 25 allergic asthmatic subjects (AA) with cat dander allergy. Three groups (HC, AR, and AA) will undergo screening to establish clinical history, will undergo pulmonary function testing (spirometry), and will have blood drawn for clinical characterization (IgE, , ImmunoCAP, CBC and differential), and for assessing the presence of existing neutralizing antibody against RV16. Only those who meet criteria will be permitted to continue into the interventional and run-out phases of the study. Type: Interventional Start Date: Apr 2023 |
Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy
The University of Texas Medical Branch, Galveston
Pregnancy Related
Iron Deficiency Anemia of Pregnancy
The target population for our study is pregnant women in the first or second trimester with a
diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be
obtained by person to person contact. Eligible participants will be randomized to receive
either... expand
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation. Type: Interventional Start Date: Oct 2020 |
Prevalence of Malnutrition and/or Sarcopenia at Hospital Admission
The University of Texas Medical Branch, Galveston
Malnutrition
Sarcopenia
The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at
admission to the hospital in older adults.
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The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at admission to the hospital in older adults. Type: Observational Start Date: Feb 2015 |
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for...
National Cancer Institute (NCI)
Clear Cell Renal Cell Carcinoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Neoplasm in the Lymph Nodes
Metastatic Malignant Neoplasm in the Soft Tissues
Metastatic Malignant Neoplasm in the Viscera
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab
followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by
nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread
to other... expand
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body. Type: Interventional Start Date: May 2019 |
Antibacterial-coated Sutures at Time of Cesarean
The University of Texas Medical Branch, Galveston
Surgical Site Infection
Surgical Wound Infection
Cesarean Section; Infection
Cesarean Section Complications
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections
after a number of surgical procedures, but none of the previous trials included cesarean
delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces... expand
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery. Type: Interventional Start Date: Jan 2018 |
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Children's Oncology Group
Ganglioneuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with newly
diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from
patients with cancer in the laboratory may help doctors identify and learn more about
biomarkers related... expand
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. Type: Observational Start Date: Nov 2000 |
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000...
The University of Texas Health Science Center, Houston
Vitamin D Deficiency
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to
usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and
indicators of likely or plausible effects of vitamin D supplementation on the function or
structure... expand
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are <28 weeks gestational age (GA) or <1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed). Type: Interventional Start Date: Feb 2023 |
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
The University of Texas Medical Branch, Galveston
Immunization
HPV Infection
Human Papillomavirus
The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine
among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response.
Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked
to... expand
The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination. Type: Interventional Start Date: Jan 2023 |
Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
NYU Langone Health
SARS-CoV2 Infection
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of
individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying
stages before and after infection. Individuals with and without SARS-CoV-2 infection and with... expand
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and subjects 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 symptom screen will be reported by subjects 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: Oct 2021 |
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression...
Agendia
Breast Cancer
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,... expand
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. Type: Observational [Patient Registry] Start Date: Apr 2017 |
Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
Stryker Neurovascular
Aneurysm, Intracranial
The primary objective of this study is to evaluate the safety and effectiveness of the
Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial
aneurysms measuring ≤ 12 mm and located on the ICA or its branches
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The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches Type: Interventional Start Date: Jul 2020 |
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
Infant Bacterial Therapeutics
Necrotizing Enterocolitis
IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to
placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.
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IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis. Type: Interventional Start Date: Jul 2019 |
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
Pfizer
COVID-19
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which
contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its
safety, and the extent to which side effects can be tolerated for treatment of pregnant women... expand
The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19. This study is seeking participants who: - are expecting a healthy baby and are in their second or third trimester pregnancy and have mild or moderate COVID-19 - are not pregnant and have mild or moderate COVID-19. All participants in this study will take Paxlovid by mouth every 12 hours for 5 days. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe. All participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date. During this time, participants will have 7to 8 visits and, if pregnant, a visit at delivery. Around 2 to 3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). The other 5 visits may be done over the phone, unless in-person visit is necessary as decided by the doctor. Blood samples will be collected on the first 4 to 5 study visits (and at other study visits, if necessary). Type: Interventional Start Date: Jun 2022 |
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Sanofi
Chronic Obstructive Pulmonary Disease
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of
action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and
current smokers with COPD, aged 40 to 70 years.
This study consists of participants who... expand
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: - 4-week screening period - 12-week treatment period - 20-week followup period Type: Interventional Start Date: May 2022 |
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
NRG Oncology
Stage III Colon Cancer
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients
based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon
cancer.
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This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Type: Interventional Start Date: Mar 2022 |
Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
The University of Texas Medical Branch, Galveston
Atrophy of Muscle Due to Disuse
Rehabilitation
This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral leg
disuse (Phase 1), immediately followed by 14 days of bilateral leg rehabilitation (Phase 2).
The investigators will recruit cohorts of healthy middle-aged men and women to address their... expand
This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral leg disuse (Phase 1), immediately followed by 14 days of bilateral leg rehabilitation (Phase 2). The investigators will recruit cohorts of healthy middle-aged men and women to address their aims: - Demonstrate the sex-specific effects of skeletal muscle disuse (Phase 1) - Identify key molecular determinates of susceptibility of skeletal muscle atrophy (Phase 1) - Map the early, sex-specific molecular time-course of rehabilitation (Phase 2) - Determine if disused and healthy muscle respond similarly to exercise (Phase 2) Healthy, middle-age men and post-menopausal women (50-65 years) will be recruited from the greater Houston/Galveston area. This under-represented research demographic demonstrate few negative metabolic or phenotypic signs of advanced age, but are at increased risk of being hospitalized and experiencing accelerated loss of lean mass and muscle function that parallels a much older population. The goal of this study is to characterize phenotypic and molecular skeletal muscle changes in middle-aged men and women during critical periods of disuse and rehabilitation and ultimately direct the development of targeted and effective prevention and treatment strategies. Type: Interventional Start Date: Aug 2021 |
Effect of Oral Cimetidine in the Protoporphyrias
Amy K. Dickey, M.D.
Erythropoietic Protoporphyria
X-linked Protoporphyria
Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) result from genetic
defects of heme biosynthesis that cause life-long, painful cutaneous sensitivity to light.
The objective of this study is to determine the efficacy and safety of oral cimetidine
administration... expand
Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) result from genetic defects of heme biosynthesis that cause life-long, painful cutaneous sensitivity to light. The objective of this study is to determine the efficacy and safety of oral cimetidine administration for treatment of the protoporphyrias. Efficacy will be based on protoporphyrin levels, photosensitivity, and quality of life questionnaires. Funding Source- FDA OOPD Type: Interventional Start Date: Jun 2022 |
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