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Healthy Volunteer

What is this?
A volunteer subject with no known significant health problems who participates in research to test a new drug, device or intervention. These volunteers are recruited to serve as controls for patient groups. Healthy volunteers receive the same test, procedure, or drug the patient group receives.

Study phase

What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Search Results 1-10 of 48 for Pulmonary hypertension

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  1. A Study of Alveolar-Capillary Recruitment as a Screening and Tracking Tool for Patients with Pulmonary Arterial Hypertension

    Scottsdale/Phoenix, AZ, Rochester, MN

    A Study of Alveolar-Capillary Recruitment as a Screening and Tracking Tool for Patients with Pulmonary Arterial Hypertension

    • Location:

      Observational

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to determine if non-invasive measurement of blood flow to the lungs and the movement of gas from the lungs to the blood stream at rest and in response to low to moderate intensity exercise can be used as an assessment tool to allow for earlier detection and monitoring of individuals with pulmonary-arterial hypertension, and the response to drug treatments.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information

    Scottsdale/Phoenix, Ariz.

    Closed for enrollment
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 14-009439
      • Scottsdale/Phoenix, Arizona: 14-009439

    • Sponsor Protocol Number:

      14-009439

  2. A Study of Macitentan in Pulmonary Hypertension After Left Ventricular Assist Device Implantation

    Scottsdale/Phoenix, AZ

    A Study of Macitentan in Pulmonary Hypertension After Left Ventricular Assist Device Implantation

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to evaluate the effect of macitentan 10 mg on pulmonary vascular resistance as compared to placebo in subjects with pulmonary hypertension after left ventricular assist device (LVAD) implantation

     

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Scottsdale/Phoenix, Ariz.

    Open for enrollment

    		View complete study & contact information
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    • Site IRB:

      • Scottsdale/Phoenix, Arizona: 15-008912

    • NCT ID:

      NCT02554903

    • Sponsor Protocol Number:

      AC-055-205

  3. A Study of Levosimendan in Pulmonary Hypertension (PH) with Heart Failure (HF) and Preserved Left Ventricular Ejection Fraction (pEF) Patients

    Rochester, MN

    A Study of Levosimendan in Pulmonary Hypertension (PH) with Heart Failure (HF) and Preserved Left Ventricular Ejection Fraction (pEF) Patients

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to evaluate for safety and effectiveness weekly, open-label doses of levosimendan over extended use in patients with pulmonary hypertension with heart failure and preserved left ventricular ejection fraction (PH-HFpEF).

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 18-010329

    • NCT ID:

      NCT03624010

    • Sponsor Protocol Number:

      TNX-LVO-05

  4. Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil

    Rochester, MN

    Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      III
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 18-002201

    • NCT ID:

      NCT03399604

    • Sponsor Protocol Number:

      18-002201

  5. Vascular Diseases Biorepository

    Rochester, MN

    Vascular Diseases Biorepository

    • Location:

      Observational

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The eventual goal of this study is to identify genetic and proteomic markers that may influence susceptibility to vascular diseases including peripheral arterial disease, pulmonary hypertension, carotid artery stenosis, arterial aneurysmal disease, fibromuscular dysplasia, congenital heart disease and other less common diseases that affect the blood vessels.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 08-008355

    • Sponsor Protocol Number:

      08-008355

  6. United States Pulmonary Hypertension Scientific Registry (USPHSR)

    Rochester, MN

    United States Pulmonary Hypertension Scientific Registry (USPHSR)

    • Location:

      Observational

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of the United States Pulmonary Hypertension Scientific Registry (USPHSR) will be to promote a greater understanding of PAH in an era of genetic discoveries, the study of the physical make up of individual people, and new treatments through education and collaborative assessment of information among pulmonary hypertension (PH) centers throughout the U.S. The development of a national USPHSR Registry will be an important element for advancement of the understanding of PAH and improvement of the care of patients who suffer from this life threatening disorder.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 16-006159

    • Sponsor Protocol Number:

      16-006159

  7. Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

    Jacksonville, FL, Rochester, MN

    Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II/III
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Jacksonville, Fla.

    Closed for enrollment

    		View complete study & contact information

    Rochester, Minn.

    Closed for enrollment
    Print study details

    • Site IRB:

      • Jacksonville, Florida: 16-002642
      • Rochester, Minnesota: 16-002642

    • NCT ID:

      NCT02630316

    • Sponsor Protocol Number:

      RIN-PH-201

  8. A Study to Evaluate Whether or Not Selexipag is Effective and Safe in Patients with Chronic Thromboembolic Pulmonary Hypertension when the Disease is Inoperable or Persistent/Recurrent After Surgery

    Jacksonville, FL

    A Study to Evaluate Whether or Not Selexipag is Effective and Safe in Patients with Chronic Thromboembolic Pulmonary Hypertension when the Disease is Inoperable or Persistent/Recurrent After Surgery

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      III
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to assess the effectiveness and safety of selexipag in subjects with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH).

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Jacksonville, Fla.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Jacksonville, Florida: 19-000875

    • NCT ID:

      NCT03689244

    • Sponsor Protocol Number:

      AC-065B302

  9. Pulmonary Vascular Complications of Liver Disease-2

    Rochester, MN

    Pulmonary Vascular Complications of Liver Disease-2

    • Location:

      Observational

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to determine if certain genes, hormones, or other factors predict the risk of developing lung vessel disease in patients with liver disease and whether they determine outcome.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 12-007715

    • Sponsor Protocol Number:

      12-007715

  10. A Study to Evaluate Cardiopulmonary Complications in Systemic Sclerosis

    Rochester, MN

    A Study to Evaluate Cardiopulmonary Complications in Systemic Sclerosis

    • Location:

      Observational

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to assess whether our not the percentage of pulmonary related vascular structures (PRVS) determined by the quantitative CT (Q-CT) tool CALIPER is a novel measure that can be used for the early detection of pulmonary vascular remodeling in patients with SSc.  pulmonary related vascular structures

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 19-001310

    • Sponsor Protocol Number:

      19-001310
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