Pulmonary, Critical Care, and Sleep Medicine

Below are current clinical trials.

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

1. Synucleinopathies

   Rochester, Minn.

   The goals of the study are to prospectively evaluate clinical and laboratory biomarkers of multiple system atrophy and Parkinson’s disease at early clinical disease, at a premotor stage (PAF), and even at a prodromal stage (RBD).

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. PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the safety, tolerability, and effectiveness of PRA023 in subjects with Systemic Sclerosis (SSc) with diffuse cutaneous disease and Interstitial Lung Disease (ILD). 

5. Evaluation of the Effects of Caffeine, Via the ACE2 Receptor, on Clinical Severity of COVID-19 Disease

   Jacksonville, Fla.

   The purpose of this study is to assess levels of caffeine intake among patients who tested positive for COVID-19 infection and compare that to disease severity.

6. 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.

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. Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

   Rochester, Minn.

   REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.

   The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.

   The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.

9. Safety and Durability of Sirolimus for Treatment of LAM

   Rochester, Minn., Jacksonville, Fla.

   The MIDAS study aims to follow women with LAM who are currently taking, have previously failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or everolimus as part of their clinical care.

10. Donor-Specific Cell Free DNA Monitoring of Thoracic Allografts

    Rochester, Minn., Jacksonville, Fla.

    The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.