Search Results

To evaluate 3 year progression free survival (PFS) rate of high-risk neuroblastoma patients after treatment with a tandem consolidation of Thiotepa/ Cyclophosphamide and PBSC rescue followed by Carboplatin/Etoposide/ Melphalan (CEM) and PBSC rescue, as compared to historical controls of a single CEM consolidation course with PBSC rescue.

Holly Franceen - hfrancee@umn.edu

This is a prospective study aimed at quantifying walking and balance in normal pressure hydrocephalus (NPH) patients in the clinical setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of ventriculoperitoneal shunt (VPS) on walking and balance among NPH patients. Thus, our objectives are: Aim 1: We will demonstrate the use of quantitative kinematic data on NPH patients pre-lumbar drain, post-lumbar drain and post-VPS in order to assess the predictive value of CSF removal on gait and balance. Aim 2: We will demonstrate the use of objective, neuropsychological data on NPH patients pre-lumbar drain, post-lumbar drain and post-VPS in order to assess the predictive value of CSF removal on cognition 3. We will demonstrate the use of objective, physical therapy data on NPH patients pre-lumbar drain, post-lumbar drain and post-VPS in order to assess the predictive value of CSF removal on therapeutic intervention in terms of walking and balance measures.

Thomas Lisko - tlisko@umn.edu

A single-center, single-arm, non-interventional natural history study to evaluate the longitudinal clinical course, functional outcome measures, and candidate biomarkers for individuals with DNA repair disorders, including Cockayne syndrome (CS), xeroderma pigmentosum (XP), and trichothiodystrophy (TTD).

Seth Stafki - stafk006@umn.edu

We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.

Claire McDonald - mcdo1202@umn.edu

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 22-70 years old with Medicare or Medicare Advantage insurance.

Interventional Psychiatry Lab Study - ipl@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)

Greg Lee - glee413@umn.edu

The primary objective is to estimate overall survival (OS) at 3 years post-transplant for patients who received the radiation free preparative regimen.

Veronika Bachanova - bach0173@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 purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.

tenkfs STUDY - tenkfs@umn.edu

The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes

Lydia Golden - golde406@umn.edu

This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.

Ali Stockness - nicho656@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 head and neck cancers.

Smoking Alcohol Study - smoking-alcohol@umn.edu

This trial is a two-part study (Part A and Part B) of adults with primary membranous nephropathy, ages 18-75 inclusive. Part A is an open-label, PK phase to compare belimumab exposure between participants who have “low” proteinuria (≥ 4 to < 8 g/day) and “high” proteinuria (≥ 8 g/day) at Visit -1. Part B is a prospective, randomized, phase II, double-blind, placebo-controlled, multicenter clinical trial in adults with primary MN. Part B will commence after the analysis of the PK data in Part A.

Patrick Nachman - pnachman@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).

Melanie Farinella - crawl027@umn.edu

1.1 Purpose: This protocol will carry out Aim 2 (Experiments 1 and 3) of Udall Project 2, leveraging the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over 4 weeks).

Kristin Garland - garl0038@umn.edu

Currently, there are no approved treatment options for pediatric subjects with proteinuric kidney conditions. The study will look at the safety, efficacy, and pharmacokinetic (PK)trial in children ≥1 to <18 years treated for up to 108 weeks with the drug sparsentan.

Anael Kuperwajs Cohen - kuper029@umn.edu

This is a registry study. The Cardiac Sarcoidosis Consortium (CSC) is an international, multicenter partnership among physicians and allied professionals at major medical centers with the unifying purpose to learn more about cardiac sarcoidosis through collaborative research.

Maddy Chopp - chopp015@umn.edu

The objectives of this study are to assess the following: - Incidence of sustained donor engraftment at day 42 post transplant - Incidence of transplant related mortality (TRM) at day 100 - Overall survival at day 100 and 1 year - Acute GVHD after this second transplant at day 100 and 6 months - Chronic GVHD after this second transplant at day 12 and 24 months

Timothy Krepski - tkrepsk1@fairview.org

This is a long-term registry is designed to collect data on hypophosphatasia (HPP) to better understand the condition and learn more about the disease, how patients feel about living with HPP and effect of HPP on the patients wellbeing and health. The study will look at participant’s medical records and health questionnaires about the health status of patients. This study collects observational data from clinical care and does not involve any treatment for HPP or administration of medication for HPP.

Kyriakie Sarafoglou - saraf010@umn.edu

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.

Mandi DeGrote - carl1032@umn.edu

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Nest Lab Study - nestlab@umn.edu

In this protocol, we will enroll pediatric, adolescent and adult patients diagnosed with adrenoleukodystrophy (ALD). These patients will include probands diagnosed by newborn screening and their relatives subsequently diagnosed, as well other patients who are diagnosed with ALD due to other presenting signs and symptoms and subsequently were confirmed to have ALD. We will ask consenting subjects to provide a medical history (with verification via medical records), to participate in a semi-annual health survey and provide consent to collect biospecimens. The overarching goal of this work is to engage with families affected by ALD and to assemble a resource of clinical, medical, and biological data that will allow of to better understand the natural history of ALD, and how this is affected by newborn screening. The initial focus will be on patients within Minnesota, but participation will be open to any family interested in the study, as this will be web-based. This registry and biobank, together with other research conducted in tandem, will possibly provide information describing the natural history of ALD and outcomes with interventions. It is anticipated that the data collected will further our understanding of the natural history of the disease, basic biology of adrenoleukodystrophy, diagnosis and outcomes. Ultimately, this research may lead to new avenues for early diagnosis and development of safer and more effective therapies for ALD.

Rachael Eye - eye00002@umn.edu

The purpose of this study is to measure levels of blood and brain chemicals related to oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher disease (GD1) to see if these levels are altered by GD1. We will also examine if there is a change in these blood and brain chemicals after participants begin taking oral N-acetylcysteine (NAC), which is available both as a prescription medication and a natural product that has antioxidant and anti-inflammatory effects.

Reena Kartha - rvkartha@umn.edu

This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HSCT. While it will primarily be applied for the treatment of non-malignant diseases (NMD), on occasion it may be used to treat patients with malignant disorders as well.

Teresa Bekkala - tkivist1@fairview.org

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Beiqing Wu - wu000948@umn.edu

This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.

Williams Dobyns - wbdobyns@umn.edu

This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures. Randomized, controlled trials have demonstrated that stimulation of the anterior nucleus of the thalamus (ANT) suppresses seizures. The central hypothesis tested here will be that PSD measured in the ANT will correlate with seizure frequency and stimulation settings that suppress broadband activity will result in lower seizure rates.

Robert McGovern - rmcgover@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

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, and with non-drinkers to identify DNA damage that might be important to cancer formation. We also want to understand how alcohol can affect the bacteria in our mouths and how that might impact oral DNA damage.

Alcohol Study - alcohol-study@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.

Schallmo Lab Study - schallmolab@umn.edu