Ongoing Trials at UTHealth

DERMATOLOGIC (SKIN disorders)

  • Acne Study
    A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
    Clinical Research Nurse: Rhea Elliott, NP
    E-mail: Rhea.e.elliott@uth.tmc.edu
    Phone: 713-500-8280
    Study Coordinator: Maria Lopez
    E-mail: maria.d.lopez@uth.tmc.edu
    Phone: 713-500-8266
    Sub-Investigator: Daniel Grabell, MD
    E-mail: Daniel.a.grabell@uth.tmc.edu 
    Phone: 713-500-8278
    Principal Investigator: Adelaide A. Hebert, MD
    for more information - clinicaltrials.gov

    Target Population: Moderate to Severe Acne

  • Acne Study for Children
    An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris
    Clinical Research Nurse: Rhea Elliott, NP
    E-mail: Rhea.e.elliott@uth.tmc.edu
    Phone: 713-500-8280
    Study Coordinator: Maria Lopez
    E-mail: maria.d.lopez@uth.tmc.edu
    Phone: 713-500-8266
    Sub-Investigator: Daniel Grabell, MD
    E-mail: Daniel.a.grabell@uth.tmc.edu 
    Phone: 713-500-8278
    Principal Investigator: Adelaide A. Hebert, MD
    for more information - clinicaltrials.gov

    Target Population: Children with Moderate to Severe Acne who are between age 9 to <12 years of age
  • Hyperhidrosis Study
    A Phase 2a Study to Evaluate the Clinical Effect, Pharmacokinetics, Safety and Tolerability of Topically Applied Umeclidinium in Subjects With Primary Palmar Hyperhidrosis
    Clinical Research Nurse: Rhea Elliott, NP
    E-mail: Rhea.e.elliott@uth.tmc.edu
    Phone: 713-500-8280
    Study Coordinator: Maria Lopez
    E-mail: maria.d.lopez@uth.tmc.edu
    Phone: 713-500-8266
    Sub-Investigator: Daniel Grabell, MD
    E-mail: Daniel.a.grabell@uth.tmc.edu 
    Phone: 713-500-8278
    Principal Investigator: Adelaide A. Hebert, MD
    for more information - clinicaltrials.gov

    Target Population: Patients with Palmar Hyperhidrosis
  • Psoriasis Study for Children
    A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing with DFD-01 versus Diprolene® (augmented betamethasone dipropionate) Lotion, 0.05% in Adolescent Subjects with Moderate to Severe Plaque Psoriasis
    Clinical Research Nurse: Rhea Elliott, NP
    E-mail: Rhea.e.elliott@uth.tmc.edu
    Phone: 713-500-8280
    Study Coordinator: Maria Lopez
    E-mail: maria.d.lopez@uth.tmc.edu
    Phone: 713-500-8266
    Sub-Investigator: Daniel Grabell, MD
    E-mail: Daniel.a.grabell@uth.tmc.edu 
    Phone: 713-500-8278
    Principal Investigator: Adelaide A. Hebert, MD
    for more information - clinicaltrials.gov

    Target Population: Children with psoriasis who are at least 12 years of age and no more than 16.9 years of age

  • Psoriasis Study for Children
    A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety, Efficacy, Systemic Exposure, and Pharmacodynamics of Calcipotriene Foam, 0.005%, Versus Vehicle Foam in Pediatric Subjects (Ages 2 to 11 Years) with Plaque Psoriasis
    Clinical Research Nurse: Rhea Elliott, NP
    E-mail: Rhea.e.elliott@uth.tmc.edu
    Phone: 713-500-8280
    Study Coordinator: Maria Lopez
    E-mail: maria.d.lopez@uth.tmc.edu
    Phone: 713-500-8266
    Sub-Investigator: Daniel Grabell, MD
    E-mail: Daniel.a.grabell@uth.tmc.edu 
    Phone: 713-500-8278
    Principal Investigator: Adelaide A. Hebert, MD
    for more information - clinicaltrials.gov

    Target Population: Children with psoriasis who are at least 2 years of age and no more than 11 years of age

  • Psoriasis Study for Children
    A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Calcipotriene Foam, 0.005%, Applied Under Maximal-Use Conditions in Adolescent Subjects (Ages 12 to 16 Years) with Plaque Psoriasis
    Clinical Research Nurse: Rhea Elliott, NP
    E-mail: Rhea.e.elliott@uth.tmc.edu
    Phone: 713-500-8280
    Study Coordinator: Maria Lopez
    E-mail: maria.d.lopez@uth.tmc.edu
    Phone: 713-500-8266
    Sub-Investigator: Daniel Grabell, MD
    E-mail: Daniel.a.grabell@uth.tmc.edu 
    Phone: 713-500-8278
    Principal Investigator: Adelaide A. Hebert, MD
    for more information - clinicaltrials.gov

    Target Population: Children with psoriasis who are at least 12 years of age and no more than 15.9 years of age
  • Psoriasis study
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-Resistant Pruritus Associated with Atopic Dermatitis
    Clinical Research Nurse: Rhea Elliott, NP
    E-mail: Rhea.e.elliott@uth.tmc.edu
    Phone: 713-500-8280
    Study Coordinator: Maria Lopez
    E-mail: maria.d.lopez@uth.tmc.edu
    Phone: 713-500-8266
    Sub-Investigator: Daniel Grabell, MD
    E-mail: Daniel.a.grabell@uth.tmc.edu 
    Phone: 713-500-8278
    Principal Investigator: Adelaide A. Hebert, MD
    for more information - clinicaltrials.gov

    Target Population: Patients 18 years of age and older with chronic pruritus associated with atopic dermatitis

GASTROINTESTINAL / HEPATITIS

  • Recurrent Clostridium Difficile Infection
    Study Coordinator: 713-442-1220
    Principal Investigator: Herbert L. Dupont, MD

    Study Overview: The Program for Restoration of Intestinal Microbata is conducting clinical trials for patients with recurrent clostridium difficile infection.

    Target Population: Individuals with at least 3 documented recurrences of CDI in the past year inclusive of the recurrent CDI episode or at least 2 episodes of severe CDI resulting in hospitalization, a positive C. difficile toxin test report for most recent CDI (within last 60 days) and at least 2 positive additional C. difficile test reports; and who have completed at least 2 rounds of standard-of-care antibiotic (vancomycin or fidaxomicin) therapy

HEART & VASCULAR

  • ALLSTAR
    Coordinator Name: Deborah Barr
    E-mail: deborah.d.barr@uth.tmc.edu
    Phone: 713-500-6598
    Principal Investigator: H.V. Anderson, MD
    for more information – clinicaltrials.gov

    Study Overview: The ALLSTAR Study will evaluate the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells (Stem Cells) in Patients With an Anterior Heart Attack and Ischemic Left Ventricular Dysfunction.

    Target Population: Patients with previous heart attack (within 1 month – 12 months of study treatment)

  • Century Health
    Coordinator Name: Catey Carter, RN 
    E-mail: catharine.v.carter@uth.tmc.edu 
    Phone: 713-500-5200 
    E-mail: ms.century@uth.tmc.edu 
    Phone: 713-500-5200 
    Principal Investigator: K. Lance Gould, MD
    for more information - clinicaltrials.gov
    or  http://www.uth.tmc.edu/pet/century-study/

  • COAPT Trial
    Coordinator Name: Rhonda Patterson
    E-mail: rhonda.s.patterson@uth.tmc.edu
    Phone: 713-500-6550
    Principal Investigator: Richard Smalling. MD
    for more information – clinicaltrials.gov

    Study Overview: The purpose of the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in high surgical risk subjects.

    Target Population: Patients with Mitral Valve Regurgitation

  • PARTNER II Trial
    Coordinator Name: Susan Davidson
    E-mail: susan.l.davidson@uth.tmc.edu
    Phone: 713-500-5219
    Coordinator Name: Belinda Metts
    E-mail: belinda.j.metts@uth.tmc.edu
    Phone: 713-500-5219
    Principal Investigator: Richard Smalling, MD
    for more information – clinicaltrials.gov

    Study Overview: The purpose of this research study is to study the safety and effectiveness of the Edwards SAPIEN XT™ Transcatheter Heart Valve (THV) and associated delivery systems (transfemoral, transapical and transaortic), which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

    Target Population: Patients with severe aortic stenosis
  • The SECRET of CHF
    Coordinator Name: Deborah Barr
    E-mail: deborah.d.barr@uth.tmc.edu 
    Phone: 713-500-6598
    Principal Investigator: Prakash Balan, MD
    for more information – clinicaltrials.gov

    Study Overview: The SECRET of CHF Study will evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy.

    Target Population: Patients admitted to the hospital with heart failure and volume overload
  • Sentinel Study
    Coordinator Name: Belinda Metts
    E-mail: belinda.j.metts@uth.tmc.edu
    Phone: 713-500-5219
    Principal Investigator: Richard Smalling, MD
    for more information – clinicaltrials.gov

    Study Overview: The Sentinel Study is a randomized controlled trial that will assess the safety and efficacy of the Claret Medical Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR) compared to the TAVR standard of care (without embolic protection).

    Target Population: Patients with severe aortic stenosis who are undergoing TAVR

HEMODIALYSIS

  • Heparin-bonded versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts
    Coordinator Name: Samuel Leake
    E-mail: Samuel.S.Leake@uth.tmc.edu 
    Phone: 713-486-5120
    Principal Investigator: Kristofer Charlton-Ouw, MD
    for more information - clinicaltrials.gov

HIV

HYPERTENSION

  • Determination of Genetics in Childhood Onset Hypertension 
    Coordinator Name: Josephine Turner
    Phone: 713-704-4137
    Email: Josephine.Turner@uth.tmc.edu
    Coordinator Name: Cary Warner
    Phone Number: 713-704-3743
    Principal Investigator: Monesha Gupta, MD

NEUROLOGIC

  • RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy
    Coordinator Name: (Leigh) Beth Latham, PhD 
    E-mail: Leigh.B.Latham@uth.tmc.edu
    Phone: 832-325-7107
    Principal Investigator: Raja Mehanna, MD

for more information – clinicaltrials.gov

  • Enroll-HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
    Coordinator Name: (Leigh) Beth Latham, PhD
    E-mail: Leigh.B.Latham@uth.tmc.edu 
    Phone: 832-325-7107
    Principal Investigator: Erin Furr-Stimming, MD

for more information – clinicaltrials.gov

  • Aseptic Meningoencephalitis in Adults 
    Coordinator Name: Monika Ruscheinsky 
    E-mail: monika.ruscheinsky@uth.tmc.edu   
    Phone: 713-704-0825 
    Principal Investigator: Rodrigo Hasbun, MD, MPH

  • ASSIST: Acute Stroke and Spleen Size 
    Coordinator Name: Jennifer Garrett, RN
    E-mail: Jennifer.M.Garrett@uth.tmc.edu
    Phone: 713-500-7183 
    Principal Investigator: Sean Savitz, MD

  • Human Epilepsy Project
    Coordinator Name: Kara Kime
    E-mail: Kara.L.Kime@uth.tmc.edu
    Phone: 713-500-7070
    Principal Investigator: Robert Knowlton, MD
    for more information - http://humanepilepsyproject.org/

  • A Prospective, Open-label Study of the Structure and Function of the Retina in Adult Patients with Refractory Complex Partial Seizures Treated with Vigabatrin (Sabril®)
    Coordinator Name: Kara Kime
    E-mail: Kara.L.Kime@uth.tmc.edu
    Phone: 713-500-7070
    Principal Investigator: Jeremy Slater, MD
    for more information - clinicaltrials.gov

  • VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia
    Coordinator Name: Kara Kime
    E-mail: Kara.L.Kime@uth.tmc.edu
    Phone: 713-500-7070
    Principal Investigator: Jeremy Slater, MD
    for more information - clinicaltrials.gov

PEDIATRIC SURGERY

  • A Randomized Pilot Trial of Dilute Povidone-iodine Irrigation vs No Irrigation for Children with Acute, Perforated Appendicitis 
    Coordinator Name: Tiffany G. Ostovar-Kermani, MD, MPH
    E-mail: pvitrial@gmail.comtiffany.g.ostovarkermani@uth.tmc.edu
    Phone: 713-570-6238, 713-500-7481
    Principal Investigator: KuoJen Tsao, MD
    for more information - clinicaltrials.gov

PSYCHIATRY

  • Autism Spectrum Disorders and Symptoms of ADHD 
    Coordinator Name: Rosleen Mansour 
    E-mail: Rosleen.Mansour@uth.tmc.edu 
    Phone: 713-486-2591  
    Principal Investigator: Deborah A. Pearson, PhD
    for more information - clinicaltrials.gov

  • A Double-blind Randomized Placebo-controlled Study of Aspirin and N-acetyl Cysteine as Adjunctive Treatments for Bipolar Disorder Patients
    Coordinator Name: Danielle Spiker
    E-mail: danielle.e.spiker@uth.tmc.edu
    Phone: 713-486-2627
    Coordinator Name: Lindsay Brewer
    E-mail: lindsay.d.harris@uth.tmc.edu
    Phone: 713-486-2527
    Principal Investigator: Jair C. Soares, MD

  • Schizophrenia Study for Adults (Ages: 18-35): A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment with Aripiprazole Once Monthly and Treatment as Usual on Effectiveness in First Episode and Early Phase Illness in Schizophrenia
    Coordinator Name: Danielle Spiker
    E-mail: utpsychosisresearch@uth.tmc.edu
    Phone: 713-486-2839
    Principal Investigator: Raymond Cho, MD, MSc

Study Overview: The purpose of this research study is to compare standard treatment to treatment with the medication, aripiprazole, that is taken only once each month. Study participants at other centers will receive once monthly aripiprazole and participants at this center will receive the care the center usually provides. At the end of the study, we will compare how well participants at the two types of sites did in order to determine if participants receiving the medication once a month had less days in the hospital and had better health outcomes. All participants at this center will receive the care this center usually provides.

for more information – clinicaltrials.gov

  • Schizophrenia Cognition Study for Adults (Ages: 18-50): Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia
    Coordinator Name: Cristin Rodriguez
    E-mail: utpsychosisresearch@uth.tmc.edu
    Phone: 713-486-2839
    Principal Investigator: Raymond Cho, MD, MSc

Study Overview: This is an interventional study, meaning this research will evaluate health-related outcomes and there may be a direct benefit to participants. As part of this study, we are studying tDCS and its effect on cognitive symptoms and brain function in schizophrenia and schizoaffective disorder. Involvement will last approximately 2 months, including assessment sessions, tDCS sessions (2 daily 30min sessions over 5 consecutive days), four sessions of EEG testing, and MRI sessions (for some participants). 

for more information – clinicaltrials.gov

  • Neuroimaging Study of Brain Oscillations in Psychosis (Ages: 18-50)
    Coordinator Name: Cristin Rodriguez
    E-mail: utpsychosisresearch@uth.tmc.edu
    Phone: 713-486-2839
    Principal Investigator: Raymond Cho, MD, MSc

Study OverviewThe purpose of this research is to study the brain mechanisms of memory, attention and perception, using magnetoencephalography (MEG), to learn more about the characteristics of people who suffer from schizophrenia and schizoaffective disorder. MEG is a brain imaging technique that measures the electrical activity of the brain. As part of this study, MEG will be recorded while the participant views various images and/or perform simple tasks, MRI will be collected to localize brain activity, and both clinical and cognitive assessments will be conducted.  

PULMONARY

  • Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program (PAH QuERI Ext)
    Coordinator Name: Kristi Morin, RN, BSN
    E-mail: Kristi.l.baysinger@uth.tmc.edu 
    Phone: 713-500-6851
    Principal Investigator: Bela Patel, MD
    for more information - clinicaltrials.gov

  • Trial of the Early Combination of Oral Treprostinil With a PDE-5 Inhibitor or ERA in Subjects With Pulmonary Arterial Hypertension (FREEDOM-Ev)
    Coordinator Name: Kristi Morin, RN, BSN
    E-mail: Kristi.l.baysinger@uth.tmc.edu 
    Phone: 713-500-6851
    Principal Investigator: Bela Patel, MD

REPRODUCTIVE

 

SCLERODERMA

  • Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
    Coordinator Name: Ann Saulino, RN
    E-mail: Ann.R.Saulino@uth.tmc.edu 
    Phone: 713-500-7118
    Additional Contact: Kristi Morin, RN, BSN
    E-mail: Kristi.l.baysinger@uth.tmc.edu 
    Phone: 713-500-6851
    Principal Investigator: Maureen Mayes, MD, MPH
    for more information - clinicaltrials.gov

SLEEP

  • Rapid Eye Movement Sleep Behavior Disorder & Parkinson's 
    Coordinator Name: Vicki Ephron, RN 
    E-mail: Vicki.J.Ephron@uth.tmc.edu 
    Phone: 713-500-7073 
    Principal Investigator: Mya C. Schiess, MD
    for more information - clinicaltrials.gov

SUBSTANCE ABUSE

  • Cocaine Use Treatment Research Studies
    Clinical Trial of Citalopram in Cocaine Dependence
    Coordinator: Jessica Vincent
    E-mail: Jessica.N.Vincent@uth.tmc.edu
    Phone: 713-486-2803
    Principal Investigator: Joy M. Schmitz, PhD
    Cognitive-enhancing DA Medications for Cocaine Dependence
    Coordinator: Jessica Vincent
    E-mail: Jessica.N.Vincent@uth.tmc.edu
    Phone: 713-486-2803
    Principal Investigator: Joy M. Schmitz, PhD
    PPAR Gamma Agonist Treatment for Cocaine Dependence
    Coordinator: Jessica Vincent
    E-mail: Jessica.N.Vincent@uth.tmc.edu
    Phone: 713-486-2803
    Principal Investigator: Ponnada Narayana, PhD

  • PTSD & Substance Use Treatment Study
    Trial of a Novel Treatment for Posttraumatic Stress and Substance Dependence
    Coordinator: Jessica Vincent
    E-mail: Jessica.N.Vincent@uth.tmc.edu
    Phone: 713-486-2803
    Principal Investigator: Anka Vujanovic, PhD

  • Marijuana Study
    Effects of Buspirone on Mood and Attention in Marijuana Users
    Coordinator: Isabela Chapa
    E-mail: Isabela.E.Chapa@uth.tmc.edu
    Phone: 713-486-2794
    Coordinator: Jessica Vincent
    E-mail: Jessica.N.Vincent@uth.tmc.edu
    Phone: 713-486-2803
    Principal Investigator: Scott Lane, PhD

WEIGHT LOSS

  • Text Messaging for Weight Loss in Primary Care Patients
    Coordinator Name: Landrus Burress
    E-mail: Landrus.Burress@uth.tmc.edu
    Phone: 713-500-7904
    Principal Investigator: Kevin O. Hwang, MD
    for more information - clinicaltrials.gov 

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS | ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu

last modified October, 2013
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