This is a prospective, observational multicenter study to collect blood from patients with mucopolysaccharidosis type IH (MPS-IH) undergoing laronidase therapy and a stem cell transplant.

Paul Orchard - orcha001@umn.edu

The goal of this study is to better understand how drinking alcohol may lead to oral cancers. Acetaldehyde, a chemical formed when the body breaks down alcohol, is believed to play an important role. This study will measure acetaldehyde and DNA damage levels in the mouth of participants after a low dose of alcohol. The levels will be compared between three groups, all having different degrees of risk for developing oral cancer, in order to identify DNA damage that might be crucial to cancer formation.

Alcohol Study - alcohol-study@umn.edu

This purpose of this study is to identify a safe dose level for the study drug, E7777, when given with standard tisagenlecleucel therapy (also known by its brand name, Kymriah, is an immunotherapy that is made from the participants own blood cells) in participants with Diffuse Large B-Cell Lymphoma (DLBCL). Up to three dose levels of E7777 will be tested.

Eric Homan - homa0030@umn.edu

Feasibility study to test our overall hypothesis that time restricted eating (TRE) presents a viable alternative to caloric restriction for improving glycemic measures and reducing weight in overweight/obese patients with metformin-only treated Type 2 diabetes (T2DM).

SFS3 Study - seefoodstudy@umn.edu

This is a randomized, active-controlled, parallel-group, double-blind Phase II trial, of oral restorative microbiota therapy (RMT) or placebo combined with intravenous (IV) durvalumab (MEDI4736) plus tremelimumab and chemotherapy in patients with treatment naïve advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC). The primary objectives include: -To evaluate the efficacy of restorative microbiota therapy (RMT) in combination with durvalumab and tremelimumab plus chemotherapy compared with placebo in combination with durvalumab and tremelimumab plus chemotherapy using PFS per RECIST 1.1 as assessed by the investigator -To evaluate the safety and feasibility of restorative microbiota therapy (RMT) in combination with durvalumab and tremelimumab plus chemotherapy in patients with untreated advanced or metastatic adenocarcinoma non-small cell lung cancer (NSCLC)

Amit Kulkarni - kulkarni@umn.edu

The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

Julie Longman - longm021@umn.edu

Arteriovenous fistulas are a type of arteriovenous malformation whereby blood is shunted directly from the arterial system to the venous system, bypassing the capillary bed. Dural arteriovenous fistulas (dAVFs) are a rare type of acquired intracranial vascular malformation consisting of a pathologic shunt located within the dura mater of the brain. 1 These lesions have been categorized by Awad et al 2, Borden et al 3, and Cognard et al 4 according to their locations and patterns of venous drainage. Dural arteriovenous fistulas (dAVFs) can be observed anywhere on the dural layer meninges of the cranium and spine. This condition accounts for 10-15% of all intracranial arteriovenous malformations diagnosed. 5 These fistulas can be congenital or acquired diseases. When observed as acquired diseases, they are most often encountered in males between the age of 50 and 60 years old. DAVFs present with a wide spectrum of symptoms or none at all, and come with varying range of risk of clinical sequalae. A thorough evaluation of the anatomy and venous drainage is crucial to determining the best treatment strategy. Acute presentation with intracranial hemorrhage occurs in up to 65% of patients, and patients with a previous intracranial hemorrhage may have up to a 35% risk of another neurologic event within 2 weeks. 6 Endovascular embolization has become the primary treatment approach for DAVFs. The goal of endovascular therapy is to achieve complete obliteration of the fistulous point between the feeding arteries and the draining veins. This can be safely accomplished by occluding the draining veins, which often results in complete closure of the lesion, unlike in cerebral arteriovenous malformations. The PHIL® device is a non-adhesive liquid embolic agent comprised of a Triiodophenol-(lactide-co-glycolide) acrylate and hydroxyethyl methacrylate (HEMA) co-polymer dissolved in DMSO (dimethyl sulfoxide). An iodine component is chemically bonded to the co-polymer to provide a radiopacifier element during fluoroscopic visualization. The PHIL® Liquid Embolic System consists of a sterile, pre-filled, 1.0 mL syringe of PHIL® liquid embolic, a sterile, prefilled 1.0 mL syringe of DMSO, and microcatheter hub adaptors. Intracranial dAVFs may produce a wide variety of symptoms. Individual risk is evaluated by a precise analysis of the venous drainage. The decision to treat is based on this analysis. Treatment strategy is decided by a multidisciplinary neurovascular team and must consider the individual risk of each dAVF. Embolization is, in most cases, proposed as the first treatment option and often succeeds to obtain a complete and definitive cure of the dAVF. Surgery may be required in some locations or in the case of embolization failure. Radiosurgery is rarely indicated because it is not always efficient and because of the time required for shunt obliteration and the risk of bleeding in this period. Liquid embolics have distinct characteristics that make them a principle treatment option in the obliteration of dAVFs. They can flow through complex vascular structures so that the surgeon does not need to target the catheter to every single vessel. 10 There is little choice available in the US market for the liquid embolic treatment of dAVF. Currently, nBCA (TRUFILL n-Butyl Cyanoacrylate, Cordis) and Onyx (Medtronic) are the only liquid embolic agents available. Both are approved by FDA for presurgical embolization of cerebral arteriovenous malformations. However, they have been used off-label for dAVFs. This use demonstrates the unmet medical need for the patients suffering with dAVFs. The aim of this study is to evaluate the use of PHIL in the management of intracranial dural AVFs.

Nonye Harcourt - harco002@umn.edu

This study is intended to determine the clinical benefit of tabelecleucel (EBV-specific cytotoxic T-lymphocytes) in subjects with EBV-associated diseases.

Eric Homan - homa0030@umn.edu

The purpose of the study is to compare quality of life (QOL), adherence, insulin resistance, body composition and efficacy of LAGH to DGH in children with GHD.

Brad Miller - mille685@umn.edu

To evaluate the ability to achieve high-level donor hematopoietic engraftment (defined as neutrophil recovery by Day +42 post-transplant and ≥ 80% donor cells on the myeloid fraction of peripheral blood at Day +100 post-transplant) using related and unrelated BM, PBSC, or UCB grafts following a reduced intensity conditioning regimen based on targeted-exposure busulfan, fludarabine +/- serotherapy in patients with inherited metabolic disorders and severe osteopetrosis.

Timothy Krepski - tkrepsk1@fairview.org

This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-55 years old with Medicare or Medicare Advantage insurance.

Interventional Psychiatry Lab Study - ipl@umn.edu

Evaluate the efficacy of treatment with bb1111 (also known as LentiGlobin BB305 Drug Product for Sickle Cell Disease) in subjects with sickle cell disease (SCD).

Danielle Jin - zhuxx003@umn.edu

The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices and are considered non-investigational. The primary endpoint is cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.

Timothy Krepski - tkrepsk1@fairview.org

We are studying a new medication, namilumab, given to treat Chronic Pulmonary Sarcoidosis. We are looking at the effectiveness, how well the drug is tolerated, and the side effects that occur. For the first part of the study, some people will receive the namilumab; the others will receive an inactive (placebo) drug. In the second part of the study, everyone may receive the namilumab.

UMN Sarcoidosis Research Group Study - umnsarc@umn.edu

The purpose of this study to examine the effects of cigarette smoking and drinking alcohol on the formation of DNA damage in the mouth. The overall goal is to identify DNA damage that may be important to the development of cancer.

Laura Garcia Pimentel - garci970@umn.edu

This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.

Shannon Jannatpour - sjannatp@umn.edu

The primary objective of this study is to determine the optimal dose of VIC-1911 when given in combination with standard immunosuppressive therapy in adult patients undergoing myeloablative stem cell transplantation.

Janine Delage - jdelage@umn.edu

This is an open-label, multi-center, single arm, Phase 1/2 study to evaluate the safety, PK, PD, and efficacy of quizartinib administered in combination with fludarabine and cytarabine (FLA) (Re-Induction Cycles 1 and 2) chemotherapy for re-induction, with optional consolidation chemotherapy, and as a single agent continuation therapy (after optional, but strongly encouraged, HSCT per standard of care), in pediatric relapsed/refractory AML subjects aged ≥1 month old to <18 years old (and young adults up to 21 years old) with FLT3-ITD mutations.

Allison Fullenkamp - fulle631@umn.edu

We are looking at the effectiveness of adding an immunotherapy drug, pembrolizumab, to usual treatment for people who have salivary gland cancer that can’t be treated with surgery or radiation. The cancer must be androgen receptor positive.

Manish Patel - patel069@umn.edu

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.

Alycia Lape-Krawczynski - lape0021@umn.edu

The purpose of this study is to better understand how switching from smoking to the use of electronic cigarettes (e-cigarettes) may change users’ exposures to various harmful chemicals. Your participation will also help us to understand how nicotine that is present in e-cigarettes is taken in and modified by your body.

Andrew Egbert - egber014@umn.edu

The purpose of the study is to demonstrate the safety and effectiveness of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure. This study is prospective, multi-center, dual-arm with 2:1 study vs. control pool allocation ratio, pivotal study designed to evaluate the safety and effectiveness of the BioVentrix Revivent TC System for treatment of Left Ventricular (LV) Antero-Septal Aneurysms/Scars in Patients with Symptomatic Heart Failure. Patients will be selected for enrollment by a Heart Team at each clinical site that will be minimally composed of a heart failure specialist, an Interventional cardiologist, and a cardiac surgeon, one of whom is the site PI. The Heart Team will guide patient selection by pre-procedural agreement of the entire heart team regarding anatomic suitability and eligibility prior to selection of the patient by the Study PI. The Heart Team will optimize procedural performance (joint Interventionalist and cardiac surgical participation), and provide optimal and equivalent Guideline Directed Medical Therapy for residual or ongoing heart failure symptoms in test (post-procedural) and control group patients as determined by the heart failure specialist and referring physician

Julie Dicken - dicke022@umn.edu

This is a single center phase I and II study which is designed to initially assess the safety, and later the efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing only conservative presurgical management. This study will consist of two phases, each with a 1 month preprocedural evaluation, day of treatment and 30 day follow up period for the first 10 participants and 6 month for the remaining 40 participants. 10 participants will be enrolled for the first phase, and 40 participants will be enrolled for the second phase at the University of Minnesota Medical Center. Enrollment is expected to take up to 6 months for each phase of the study. The collection of data will be accomplished by utilizing a clinical research team that will assess the efficacy and safety. Efficacy assessments will include; Joint injection intervals, MRI, X-ray, joint aspiration / serologies and patient questionnaires evaluating joint pain. Safety assessments include participant and investigator reported adverse events, vital signs, (blood pressure, heart rate, temperature), and physical exam.

Connie Dale - dalex179@umn.edu

This is a single center, open label, Phase I clinical trial of bioactive curcumin with high phenolic extra virgin olive oil (HP-EVOO) to treat cutaneous neurofibromas (cNF) in Neurofibromatosis, type 1 (NF1) patients (aged 18 years or older).

Pavlina Sverak - svera004@umn.edu

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.

Boris Winterhoff - bwinterh@umn.edu

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

Kelly Ryberg - rybe0010@umn.edu

The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumors.

Allison Fullenkamp - fulle631@umn.edu

To determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin, and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature.

Douglas Yee - yeexx006@umn.edu

The proposed research will measure and compare differences in visual performance and associated neural processing in participants who do or do not experience Visual Snow Syndrome, using a series of well-established psychophysical and imaging paradigms.

Samantha Montoya - monto112@umn.edu

In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribe meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.

Nina Jacobs - njacobs@umn.edu