Clinical Trials

The purpose of this study is to obtain sufficient fresh kidney tissue from patients with history of kidney stones or without a history of kidney stones to perform assay transposase accessible chromatin (ATAC), cellular indexing of transcriptomes and epitomes (CITE), and RNA expression and protein (REAP) sequencing studies on fresh, snap frozen versus paraffin embedded samples.  Differential expression of renal interstitial cells, genes and encoded proteins will be confirmed by flow cytometry, qPCR, and immunofluorescence/immunohistochemistry respectively.  In addition, random urine and plasma/serum will be biobanked for biomarker studies to correlate with findings in the kidney tissue.

The purpose of this study is to understand the metabolic differences that exist between women with and without Gestational Diabetes Mellitus (GDM) 12 months following pregnancy to help us clarify why women with GDM are at higher risk of type 2 diabetes.

This is a prospective observational cohort study assessing baseline and short-term changes in patient-reported outcomes and physical activity in patients with fibrotic interstitial lung disease (f-ILD). Primary endpoints will be the prevalence and extent of anxiety and depression at baseline and over time (6 months) with focused exploration of predictive and modifying covariables, and extent of physical activity at baseline and over time (6 months) and its impact on self-reported quality of life. All patients with f-ILD seen at Mayo Clinic Rochester will be enrolled by telephonic or in-person screening, and formally consented before enrollment. Measurements of symptom burden, psychologic and emotional health, and respiratory-related quality of life will be assessed with 9 standardized questionnaires, provided to participants electronically through an crypted REDCap link. Physical activity will be measured using the Actigraph GT3X-BT, a standardized research activity monitor worn on the wrist continuously for seven days. Mean steps per day and mean minutes of sedentary and moderate activity time will be serve as quantifiable physical activity endpoints. Baseline demographics, f-ILD disease subtype and duration, pulmonary function testing, radiologic findings, medical comorbidities, and social determinants of health will be obtained and followed over the 6 month period, in conjunction with repeated questionnaire and physical activity measures at enrollment, 3, and 6 months. Statistical analysis will involve descriptors of symptom burden, emotional and psychological wellbeing, and health-related quality at baseline and over time, as stratified by a prior subgroups or covariables. Particular focus will be on the extent and severity of anxiety and depression and any correlating or modifying variables, as assessed by multivariable logistic regression or predictive modeling with elastic net. Similar descriptors of physical activity extent and change over time correlating with baseline or changes in clinical, demographic, or patient-reported outcomes will also be pursued. For modeling and covariable adjustment, 250-300 participants will be enrolled to allow adjustment for up 10 variables for each outcome.    

To learn in patients’ own words how they were educated on chemotherapy side effects, what aspects of that education were most helpful, and what aspects could be done better (and why).

The purpose of this study is to determine the extent to which patients who survive severe drug eruptions suffer long-term end organ damage and experience decreased quality of life and psychological distress

The purpose of this study is to identify sex-specific risk factors for musculoskeletal injury in active-duty service members, to determine the effect of musculoskeletal injury on resiliency in female and male service members, and to explore field based physiologic and biomechanical data captured using remote monitoring technology to assess musculoskeletal injury risk and recovery.

Hypertension (HTN) is the leading cause of cardiovascular diseases worldwide and is highly modifiable using pharmacologic and nonpharmacologic therapies.  Results from the Systolic Blood Pressure Intervention Trial (SPRINT) suggest that intensive blood pressure control to <120/80 vs. <140/90 is associated with reduced cardiovascular events and death for patients with high cardiovascular disease risk.  However, less than 50% of Americans achieve even marginal blood pressure control <140/90.  The prevalence of uncontrolled hypertension is even higher in the homeless population, which suffers from limited access to healthcare, poor nutrition, chronic stress, substance abuse and lack of consistent medication adherence.  Additional outreach support may be necessary to improve blood pressure (BP) control and reduce cardiovascular risk in this vulnerable population.  

The purpose of this project is to improve blood pressure control among a cohort of homeless and underserved patients over a 6 month period. Our target group is already participating in the Sulzbacher Center's protocol with the National Hypertension Control Initiative (NHCI), an evidence-based community program with the goal to reduce high blood pressure, in under-resourced neighborhoods.  We aim to enhance patient education on HTN and enroll eligible patients in an additional pillbox initiative to improve medication adherence.  The protocol will be as follows: 

Adult patients (aged > 18 years) with hypertension, who receive primary care and cardiovascular care through the Sulzbacher Clinic in Jacksonville, FL will be eligible for participation. Participants will be screened for hypertension during regular vital sign checks in clinic triage.  Patients with known hypertension on BP medications and those found to have hypertension (BP > 130/80) during triage will be educated on the details of the study and the risks and benefits of enrollment. Patients will be given oral informed consent, which will highlight that there is no financial benefit for enrollment and that participants may withdraw from the study at any point.    Patients who offer oral informed consent will be enrolled.  

Following enrollment, patients will receive a BP cuff and be instructed on how to use it, as is already being copmleted as part of the Sulzbacher's NHCI protocol. They will be asked to keep a BP log and to bring their log to follow-up visits. They will be prescribed antihypertensives as indicated by routine clinical care.  Pharmacological management of hypertension will be made per the discretion of the visit provider (Sulzbacher and/or Mayo Clinic advance practice provider or physician).  For the current study, BP medications will then be placed in a 1 month pill box on the day of enrollment and refilled at each subsequent visit.  Compliance will be measured by pill counts remaining in their box at each follow-up visit and self-reported adherence at follow-up. Follow-up visits will be conducted as dictated by routine medical care, and prescription refills with pill box will be supplied monthly in person.  Patients will be educated on pharmacological and nonpharmacological therapies for BP management by research staff and the visit provider.  

The primary outcomes measured will be medication compliance and percentage of patients with hypertension control at 1 month and 6 months.  We aim to improve compliance by 10% and to improve the percentage of patients with BP < 130/80 by more than 10% above baseline.  

The purpose of this study is to evaluate the experiences of patients with ME/CFS and Long COVID as related to paced activity via an online, narrative-based questionnaire in order to further elucidate its role in management of this debilitating condition. 

Update 10/8/24: In the next phase of this study, the results of the aforementioned questionnaire are applied to developing materials that will be used to update our Fibromyalgia & ME/Chronic Fatigue Sydndrome treatment program. A pre- and post- cohort of 30 patients each will be evaluated to assess differences in outcomes based on these changes.

The purpose of this study is to establish a pool of healthy blood donors who will regularly participate in our research studies of human immunity. In most cases, the blood needs to be freshly drawn. Thus, we propose to draw blood on an as needed, ongoing basis. These studies will lead to a better understanding of the immune response to tumors, infectious agents and self. This, in turn, will aid in the design of new strategies to preserve health and treat disease.

This research study is being done to determine if a low vitamin D level and mammographic density may be risk factors for developing breast cancer.