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Clinical Trials

Once researchers have discovered a new treatment, clinical trials take it to the next level. A clinical trial is conducted to determine whether a new drug or treatment is safe and effective. These studies rely on patients who volunteer to participate.

Thanks to clinical trials and volunteers, there are better ways to treat and prevent diseases. Those who participate in clinical trials can play an active role in their own healthcare, gain access to new research treatments, and help provide a cure for others in the future. Every participant is screened for certain characteristics and optimal health to ensure safety.

Want to contribute to medical research by participating in a clinical trial? These are the current studies being conducted at UT Health Northeast:

  • Cancer

    Cancer Preventative Clinical Trials

    In the following studies, physicians and scientists analyze samples of body fluids and/or tissue to determine if they can identify nontoxic strategies to prevent cancer.

    IRB 995

    The goal of this clinical research study is to create a research bank for use in future research related to cancer and/or biomarkers. Biomarkers are found in the blood and may be related to lung cancer risk and detection. This is a multicenter study to establish a biospecimen repository from a cohort of current and former smokers who meet the criteria for low dose helical computed tomography (LDCT) screening established by the National Comprehensive Cancer Network (NCCN) as a result of the positive findings from the National Lung Screening Trial (NLST).

    For more information, please contact:

    Jay Shoemaker
    (903) 877-5455
    email: jay.shoemaker@uthct.edu

    Cancer Treatment Clinical Trials

    These studies enroll participants diagnosed with cancer with the goal of identifying new methods to treat the disease. The trials may ask the participant to undergo surgery, take medication, and/or receive radiation therapy as part of the study. Additionally, the collection of blood or other body fluids, as well as imaging of the body to determine treatment response may be involved.

    IRB 945

    A study comparing two different combinations of chemotherapy in the treatment of metastatic breast cancer in patients who have received two or more prior regimens of chemotherapy.

    IRB 970

    The purpose of this research study is to find out what effects, both good and bad, an experimental drug called Entinostat has on breast cancer patients, when given together with the standard hormonal drug treatment, Exemestane.

    For more information, please contact:

    Benji Hawkins, CCRC
    (903) 877-5831
    email: benji.hawkins@uthct.edu

  • Cardiology/Heart

    IRB 926

    This study is a global registry looking at patients who are newly diagnosed with Atrial Fibrillation and at risk for stroke. Patients who receive a certain anticoagulant will be followed for two years, clinic visits occurring at 3, 6, 12, and 24 months from time of enrollment. This study does not provide a treatment for atrial fibrillation.

    IRB 927

    This study is seeking to enroll subjects with known peripheral arterial disease (PAD). The study will be looking at the use of ticagrelor versus Clopidogrel treatment in the prevention of cardiovascular events such as heart attack. The anticipated patient participation is 27 months.

    IRB 982

    This study is being done in patients who are 40 years of age or older, who have been hospitalized for at least 3 days for an acute medical illness who have other risk facts for VTE (venous thromboembolism- a condition that included deep vein thrombosis and pulmonary embolism).

    IRB 1012

    This study is looking for patients with type 2 diabetes and cardiovascular disease (disease of the heart and/or blood vessels), whose blood sugar levels are not well controlled with their current treatment(s).

    For more information, please contact:

    Benji Hawkins, CCRC
    (903) 877-5831
    email: benji.hawkins@uthct.edu

    IRB 966

    This is a prospective registry study to discover the treatment patterns and outcomes of newly diagnosed patients with atrial fibrillation with at least one additional risk factor for stroke in real-life practice.

    For more information, please contact:

    Jay Shoemaker
    (903) 877-5455
    email: jay.shoemaker@uthct.edu

    IRB 989

    This is a registry is to learn more about doctor prescribed cholesterol lowering medications using the current and previous health guidelines. Participants will be asked to complete a survey about their heart disease and lipid lowering medications and provide a blood sample.

    For more information, please contact:

    Lilly Garza
    (903) 877-5435
    email: elizabeth.garza@uthct.edu

  • Pulmonary/Lung

    Alpha-1 Rare Lung

    IRB 953

    A study assessing the safety and efficacy of weekly intravenous Alpha­1-proteinase Inhibitor in patients with pulmonary emphysema due to Alpha1-antitrypsin deficiency.

    IRB 1002

    The purpose of this research study is to find out if subjects with Alpha 1 have any differences in the symptoms and side effects they may experience when they receive the study drug with a higher particle number or with a lower particle number, as well as how their immune system may react to the study drug.

    IRB 1007

    Subjects previously diagnosed with alpha-1 antitrypsin deficiency (AATD) and emphysema are being enrolled to test a new experimental drug, Hyaluronic Acid Inhalation Solution to evaluate the possible treatment of Emphysema in AATD patients.

    For more information, please contact:

    Jan Hoeft, RN, CCRC
    (903) 877-5518
    email: janice.hoeft@uthct.edu

    Asthma

    IRB 987

    The purpose of the study is to evaluate the efficacy and safety of Tralokinumab in reducing oral corticosteroid use in adults and adolescents with oral corticosteroid dependent asthma.

    IRB 1000

    This study is being done to test the safety and effectiveness of a new study drug, administered by subcutaneous injections (i.e. injections beneath the skin) in adult subjects with severe asthma.

    For more information, please contact:

    Jay Shoemaker
    (903) 877-5455
    email: jay.shoemaker@uthct.edu

    Bronchiectasis

    IRB 967

    The purpose of this research study is to assess how effective the study drug is, compared to inactive substance, in managing chronic lung infections such as P. aeruginosa in subjects with non-Cystic Fibrosis bronchiectasis by evaluating the time to first pulmonary exacerbation.

    For more information, please contact:

    Rebekah Hibbard, CCRC
    (903) 877-8246
    email: rebekah.hibbard@uthct.edu

    IRB 974

    The purpose of this research study is to evaluate patients with bronchiectasis and/or Non-Tuberculosis Mycobacterium (NTM) and looking at associations related to estrogen, such as breast cancer.

    For more information, please contact:

    Lilly Garza, CCRC
    (903) 877-5435
    email: elizabeth.garza@uthct.edu

    COPD

    IRB 977

    The purpose of the study is to evaluate the efficacy and safety of Benralizumab (MEDI-563) in patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with a history of COPD exacerbations.

    For more information, please contact:

    Jay Shoemaker
    (903) 877-5455
    email: jay.shoemaker@uthct.edu

    IRB 963

    This study is to evaluate the effect of the study drug on cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD.

    For more information, please contact:

    Jay Shoemaker
    (903) 877-5455
    email: jay.shoemaker@uthct.edu

    Cystic Fibrosis

    IRB 973

    The purpose of this study is to test an experimental drug in adults and children with CF to determine if the study drug helps lung function, reduces CF symptoms, decreases the number of hospitalizations, decreases the use of antibiotics, improver overall quality of life and safety.

    IRB 988

    The purpose of this research study is to learn more about the safety and effects of the combination of study drug in subjects with CF.

    For more information, please contact:

    Rebekah Hibbard, CCRC
    (903) 877-8246
    email: rebekah.hibbard@uthct.edu

    Mycobacterium Avium Complex (MAC)

    IRB 986

    The purpose of this research study is to test the effectiveness and safety of an experimental drug in patients with lung infection due to Mycobacterium avium complex (MAC) who have a history of failing to improve on standard treatments.

    For more information, please contact:

    Rebekah Hibbard, CCRC
    (903) 877-8246
    email: rebekah.hibbard@uthct.edu