Clinical Trials

The purpose of this study is to develop a screening method to provide early detection of HPV-associated Oropharyngeal Squamous Cell Carcinoma (OSCC).

The purpose of this study is to collect clinical data, serial blood samples for plasma, serum, DNA and RNA extraction, and a single time blood sample for peripheral blood monocytes for the preparation of stem cell lines and lymphocytes for the preparation of lymphoblastoid cell lines. There will also be a single time skin biopsy sample for tissue examination and preparation of skin fibroblasts from patients who have familial or sporadic ALS, ALS-FTD or similar neurodegenerative motor neuron disorders, and are participating in NINDS funded research projects in the Mayo Clinic ALS Center.

This will be a prospective study of patients with IBD at Mayo Clinic initially in Jacksonville with possible subsequent extension to other Mayo sites.  We will evaluate the immunogenicity of commercially available COVID-19 vaccines and compare vaccine response among the groups based on their immunosuppressive regimens.  We will divide the immunosuppressive regimens into presumed high vaccine responders Group A and presumed low vaccine responders Group B. We will also assess for adverse reactions to the vaccine and compare with the reported rates in the clinical trials that led to approval of these vaccines.

The purpose of this research study is to understand the views and experiences of Non-Hispanic Black women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk and research participation.

This is a qualitative interview study. Study participation involved talking on the phone or videoconference (e.g., Zoom) for about 1 - 1 1/2 hours with a researcher.

to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.

Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year, 40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die do so before reaching the hospital. Most commonly, SAH results from rupture of an intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public health problem with high lethality. Current estimates are that ruptured aortic aneurysm kills 13,000 Americans each year. Screening efforts have effectively lowered mortality from aortic aneurysm rupture but a high proportion of those who die did not have a diagnosis of aortic aneurysm prior to rupture.

The relationship between intracranial and aortic aneurysm has long been recognized, but poorly quantified. Recent genome-wide association studies (GWAS) provide a molecular biological evidence for a shared pathophysiology. The chromosome 9p21 locus confers increased risk for both intracranial aneurysms and aortic aneurysms. These GWAS data, along with linkage data for other susceptibility loci, indicate that individuals and families harboring one type of aneurysm may be at especially increased risk of the other.

The rationale for this project is that opportunistic screening for abdominal aortic aneurysms (AAA) may be warranted in patients who present with aneurysmal subarachnoid hemorrhage. This study is meant to see if the yield of screening in this population is too low to justify its routine use. The investigators plan to systematically screen for AAA in all cases of aSAH presenting to MCH for treatment. If no individual out of 81 consecutively screened cases of aSAH has evidence of AAA, then the investigators can have strong confidence that there is a less than 5% chance of finding an AAA in the patient population.

In this study, we will examine the potential side effects experienced after receiving the new hepatitis B vaccine (Heplisav-B) in patients with ulcerative colitis or Crohn's disease. This new vaccine has been found to be more effective than the existing vaccine Engerix in people without ulcerative colitis or Crohn's disease. It is now the standard of practice vaccine that we use in the Mayo gastroenterology and liver practice. The most common side effects include pain, redness, swelling, fatigue, fever and headache. We would also like to determine if there was any worsening of the patient's underlying inflammatory bowel disease.

Part 1

Given these findings and recommendations, members of the Gastroenterology and Infectious Disease department feel that the Heplisav-B vaccine should be the preferred vaccine for patients with IBD and chronic liver disease. In this study, we aim to collect data on patients who receive this vaccine on whether they experience any adverse effects or any worsening of their bowel or liver disease. We also aim to collect data regarding the effectiveness of vaccination by measuring post-vaccination antibody titers at 1 month after vaccination. The goal of this is to confirm that patients have achieved immunity after vaccination. This is consistent with best-practice guidelines and CDC recommendations in immunosuppressed persons.

Part 2:

According to the 2022 Center for CDC guidelines for Hepatitis B vaccination in immunocompromised adults, persons found to have antibody titer concentration <10 mIU/ml (indicating non-immunity) after completion of a primary vaccine series should be revaccinated [6]. Accordingly, in the case of non-immunity after the standard 2-dose Heplisav-B series, we aim to give an additional dose of Heplisav-B and re-measure antibody titers at 1 month in order to evaluate effectiveness. This is consistent with best-practice and CDC guidelines in immunosuppressed patients that have not responded to the primary vaccination series. To this point, the CDC guidelines for Hepatitis B vaccination in immunocompromised adults state that a larger vaccine dose or additional vaccine doses may be necessary in this patient population [6]. Immunity to Hepatitis B through vaccination in patients with inflammatory bowel disease and chronic liver disease is crucial due to high risk of morbidity.

Part 3:

As a continuation of the above, we aim to perform immunological testing to observing T cell response to Heplisav-B vaccination. The goal is to measure if there are any differences in T cell response depending on certain immunosuppressive medications that the patient is taking for their IBD.

Study summary:

The overall plan for this study is to conduct qualitative interviews among 40 family members of patients who have been hospitalized in a coma. Subjects for this study will be recruited by local site P.I.s from intensive care units at the following 18 U.S. centers:

All interviews will be conducted virtually via video conferencing by study staff at the Yale School of Medicine and Massachusetts General Hospital. All study activities following the interviews, including data analysis and manuscript writing, will take place at the Yale School of Medicine and Massachusetts General Hospital. We expect this study to be completed by December 31, 2021.

Hypothesis, Aims, purpose, or objectives and Background:

(Include relevant experience, gaps in current knowledge, preliminary data, etc.): 

The purpose of this study is to conduct semi-structured qualitative interviews with caregivers of severely acute brain-injured, incapacitated patients in order to understand specific aspects of their caregiving experience (i.e., emotional coping styles, expectations and understanding of illness, challenges, perceptions of caregiving) and gather information about their preferences for a future psychosocial support intervention (e.g., content, delivery mode [in person vs. secure live video mode], timing). Data from these qualitative interviews will be used to help develop a resiliency-based psychosocial support intervention for caregivers in the future.

The purpose of this study is to evaluate new and complementary analytical MS technologies to identify and define the metabolic biomarkers for lung cancer.

The purpose of this study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).