Search Results

CCS - test OnCore size limitation

Amanda Garcia - garc0276@umn.edu

In the first phase of the study, participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews and questionnaires about their life experiences and mental health, and they will have an EEG and fMRI while completing computerized tasks. The second phase of the study is optional. In this phase, participants will test one of two forms of computerized cognitive training, or brain games. They will be asked to complete 10 hours of training over a 3-6 week period. After the training period is over, they will have two sets of follow up visits, one right after the training period and one five months later. At these appointments, participants will complete the same activities done in the first phase of this study, including the interviews, questionnaires, and imaging (fMRI and EEG) combined with computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.

STEP Study - stepstudy@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 is an early study of a new drug, called [225Ac]-FPI-1434, to treat solid tumors that have not responded to usual treatment. We are testing different doses of the drug and looking at how well it works for treating the cancer and side effects that occur.

Douglas Yee - yeexx006@umn.edu

This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).

Spleen Imaging Study - spleenimagingstudy@gmail.com

The overall objective of this study is to determine the feasibility of identifying transdiagnostic biomarkers of cognitive function mediated by neuromodulation of the dorsolateral prefrontal cortex that are translatable across disease groups in order to more accurately phenotype clusters of cognitive dysfunction. Completing behavioral paradigms with electrophysiology and TMS is a challenging frontier. This study focuses on the feasibility of such an endeavor for those with chronic pain or depression as well as healthy controls.

Gabby Hernandez - hern0245@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

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

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

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.

Maura Arneson - arnes294@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

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

This protocol aims to characterize the safety and tolerability of loncastuximab tesirine in combination with gemcitabine, lenalidomide, polatuzumab vedotin, or umbralisib, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for any of the combinations in subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This project aims to address the resistance mechanisms to single agent therapies and enhance efficacy by engaging different targets, in synergistic or additive manner.

Marie Hu - hu000322@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.

Deb Mailand - mailand@umn.edu

The proposed study is an individual three-arm randomized controlled tiled aimed at utilizing state-of-the-art intervention methods to examine whether increasing the quality and the quantity of family meals reduces childhood obesity.

Jerica Berge - jberge@umn.edu

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 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.

Julie Dicken - dicke022@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

The main purpose of this study is to check how safe the study drug is and how well your body handles taking it. The study will also check: • if the study drug works to improve your kidney function • whether the study drug has an impact on your daily life • the amount of the study drug in your blood over a period of time (called pharmacokinetics)

Anael Kuperwajs Cohen - kuper029@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 treatment guideline for allogeneic hemapoetic stem cell transplant (HSCT) in patients with primary immune deficiencies. Endpoints include time to engraftment, incidence of graft failure, incidence of chimerism at 100 days, 6 months, and 1 year; incidence of acute GVHD at 100 days and chronic GVHD at 6 months and 1 year; incidence of transplant related mortality at 6 months and incidence of disease free survival and overall survival at 6 months. All endpoints will be abstracted from routine data collected by the BMT Database.

Christen Ebens - ebens012@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

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

Veronika Bachanova - bach0173@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

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

This is a Phase 1/2 multicenter, open-label study to evaluate palbociclib in combination with either irinotecan (IRN) and temozolomide (TMZ) or topotecan (TOPO) and cyclophosphamide (CTX) chemotherapy in children, adolescents and young adults with recurrent or refractory solid tumors. The study consists of a non- randomized Phase 1 portion for recurrent or refractory solid tumors followed by potential non- randomized tumor specific cohort(s) and a randomized, Phase 2 portion for recurrent or refractory EWS.

Allison Fullenkamp - fulle631@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

MM - Study 3 of 6 - Expedited Study

Interventional Psychiatry Lab Study - ipl@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.

Smoking Alcohol Study - smoking-alcohol@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