Pulmonary, Critical Care, and Sleep Medicine

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. A Study to Evaluate Ultrasound-guided Erector Spinae Plane Blocks

   Rochester, Minn.

   The purpose of this study is to to demonstrate the feasibility of performing ultrasound-guided erector spinae plane blocks in the Emergency Department (ED) and Intensive Care Unit (ICU).

2. Developing Interventions for Healthy Sleep in Native American Families

   Rochester, Minn.

   The purpose of this study is to gather information on sleep duration and sleep patterns in Native American families.

3. Study to Compare Electrical and Ultrasonographic Evaluation of the Phrenic Nerve-Diaphragm Neuromuscular Junction (NMJ) Function

   Jacksonville, Fla.

   The purpose of this study is to ensure technical success in the treatment of assessing diaphragmatic neuromuscular junction (NMJ) function of the diaphragm in normal patients.

4. Development of Potential COVID-19 Vaccine and Serological Assay

   Rochester, Minn.

   Our group has explored the use of genomic RNA/phage display libraries derived from primary human malignant melanoma cells as a means of identifying antibody detectable targets on cancer cells (cancer vaccines or antibody guided therapeutics).  In this approach, we isolate and affinity-column immobilize the IgG fraction from patient serum before and after immune therapy for melanoma, and expose the immobilized antibodies to bacteriophage expressing approximately 2x109 overlapping cDNA sequences of paired (same patient derived plasma and cancer cells) melanoma genomic RNA.  Phage, expressing melanoma cDNA express the proteins/peptides on their capsid are “recognized” by the immobilized antibodies are retained in the column, and subsequently eluted for DNA sequencing.  Comparison of the DNA profiles of the eluted phage using pre-immunotherapy and post-immunotherapy patient sera will reveal emergence of new antibodies (post-immunotherapy gain of antibodies) against proteins of potential interest for melanoma targeting.  In the current proposal, we hypothesize that reacting COVID serum from patients that have recovered from COVID infection and compare to non-infected self-serum (if available) and control healthy volunteer serum (available in our lab) may identify protein targets that have developed as a result of the COVID infection and could be useful in the development of a COVID vaccine as well as a serologic test for anti-COVID immunity. 

5. A Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection

   Jacksonville, Fla., Rochester, Minn.

   The purpose of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints.

6. An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed participation to BOSTON-1 and BOSTON-2 studies

   Jacksonville, Fla.

   The purpose of this study is to assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

   Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

7. A Study to Evaluate Wellness Coaching for Caregivers of Thoracic Transplant Candidates

   Rochester, Minn.

   The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

   Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

   Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, and affect.

8. Bentracimab (PB2452) in Ticagrelor-treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure

   Jacksonville, Fla.

   The purpose of this study is evaluate the reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. Approximately 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. 

9. Early Identification of Pulmonary Coccidioidomycosis

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to identify, recruit, and enroll patients with community-acquired pneumonia (CAP) to collect their blood, sputum, urine, and a nasopharyngeal swab for specimen storage. The study also aims to develop a biomarker assay to detect circulating antigen in patients infected with Coccidioides.

10. A Study to Evaluate the Effectiveness and Safety of an Amikacin Liposome Inhalation Suspension-based Regimen in Adults with Nontuberculous Mycobacterial Lung Infection

    Rochester, Minn., Jacksonville, Fla.

    The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.