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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

105 Study Matches

A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

CCS - test OnCore size limitation

Status: Recruiting
Contact(s):

Amanda Garcia - garc0276@umn.edu

Age: 18 years and over
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 27034
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Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Conditions: Cancer, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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State Representation in Early Psychosis (STEP)

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.

Status: Recruiting
Contact(s):

STEP Study - stepstudy@umn.edu

Principal Investigator: Sophia Vinogradov
Age: Not specified
Phase: NA
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 29914
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Inclusion Criteria:

• able to speak and write English
• 15 to 40 years old
• diagnosis of schizophrenia, schizoaffective disorder, psychosis, bipolar disorder with psychosis, or major depressive disorder with psychosis, with psychotic symptoms starting in the past 5 years
• no hospitalizations and on stable doses of medications for the past one month or more
• For healthy volunteers without a mental health diagnosis: will match on age, sex, etc. to people enrolled in the study.
Exclusion Criteria:

• currently pregnant
• history of neurological disorder
• previous head injury with loss of consciousness
• currently suicidal or has attempted suicide in the past 6 months
Conditions: Mental Health & Addiction
Keywords: Psychosis, Schizoaffective Disorder, Schizophrenia
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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)

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

Status: Recruiting
Contact(s):

Boris Winterhoff - bwinterh@umn.edu

Principal Investigator: Boris Winterhoff
Age: 18 years and over
Phase: PHASE1
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 36844
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Inclusion Criteria:

• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
Exclusion Criteria:

• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Solid Tumor, Endometrial Cancer, NSCLC, Ovarian Cancer
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A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients with Locally Advanced or Metastatic Solid Tumours

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.

Status: Recruiting
Contact(s):

Douglas Yee - yeexx006@umn.edu

Principal Investigator: Douglas Yee, MD
Age: 18 years and over
Phase: PHASE1
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 34662
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Inclusion Criteria:

• advanced solid tumor that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy
• restricted in strenuous activity but can walk and is able to do light work e.g., light house work, office work
• contact study staff for additional requirements
Exclusion Criteria:

• inability to perform the required imaging procedures (e.g., inability to lay flat during scan time)
• uncontrolled brain metastasis
• history of organ transplantation, including stem cell transplantation
• other significant medical or mental health diagnosis (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Solid Tumors
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Characterization of spleen motion and anatomy using imaging and sensors

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).

Status: Recruiting
Contact(s):

Spleen Imaging Study - spleenimagingstudy@gmail.com

Principal Investigator: Hubert Lim
Age: 18 years and over
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 35044
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Inclusion Criteria:

• at least 18 years old
Exclusion Criteria:

• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
Conditions: Digestive & Liver Health
Keywords: Imaging, Spleen
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Transdiagnostic Cognitive Biomarkers

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.

Status: Recruiting
Contact(s):

Gabby Hernandez - hern0245@umn.edu

Principal Investigator: David Darrow
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 32102
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Inclusion Criteria:

• all participants must be adults 18 years or older
• diagnosis of chronic pain that isn't controlled with oral pain medication OR
• diagnosis of major depression OR
• healthy volunteers
Exclusion Criteria:

• unable to have TMS due to metallic hardware (such as cochlear implants, deep brain stimulator, medication pumps)
• history of seizures or epilepsy
• unable to have a MRI
• unable to complete tasks associated with study
• women who are pregnant
• non-English speaking
• blindness
• healthy volunteers may not have a diagnosis of chronic pain or depression
Conditions: Brain & Nervous System, Mental Health & Addiction
Keywords: Depression, chronic pain, pain, MRI, TMS
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I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)

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.

Status: Recruiting
Contact(s):

Douglas Yee - yeexx006@umn.edu

Principal Investigator: Douglas Yee, MD
Age: 18 years and over
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 38844
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Inclusion Criteria:

• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
Exclusion Criteria:

• other medical or mental health diagnosis that would limit compliance with study requirements
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2
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MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

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

Status: Recruiting
Contact(s):

Eric Homan - homa0030@umn.edu

Principal Investigator: Joseph Maakaron
Age: Not specified
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 33603
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Inclusion Criteria:

• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
Exclusion Criteria:

• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
Conditions: Cancer, Infectious Diseases
Keywords: Clinics and Surgery Center (CSC), Epstein-Barr Virus (EBV)
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MT2020-27: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphomas

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.

Status: Recruiting
Contact(s):

Eric Homan - homa0030@umn.edu

Principal Investigator: Veronika Bachanova, MD
Age: 18 years and over
Phase: PHASE1
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 31795
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Inclusion Criteria:

• diagnosis of a relapse or refractory large B cell lymphoma, for which treatment with Kymriah is planned
• received two or more lines of systemic therapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of child bearing age must use birth control for 30 days following completion of treatment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• CNS involvement by malignancy
• eye disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an eye exam as part of screening
• additional exclusion criteria (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Diffuse Large B Cell Lymphoma, DLBCL, High-grade B-cell Lymphoma
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MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or azer-cel), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

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.

Status: Recruiting
Contact(s):

Maura Arneson - arnes294@umn.edu

Principal Investigator: Joseph Maakaron
Age: 18 years and over
Phase: PHASE1
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 29217
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Inclusion Criteria:

• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
Exclusion Criteria:

• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
Conditions: Cancer
Keywords: Non-Hodgkin Lymphoma
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Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111

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.

Status: Recruiting
Contact(s):

Manish Patel - patel069@umn.edu

Principal Investigator: Manish Patel
Age: 18 years and over
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 20371
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Inclusion Criteria:

• at least 18 years old
• locally advanced, recurrent, or metastatic salivary gland carcinoma that is not amenable to curative surgery or radiation
• tumor is androgen receptor-positive
• unable to do physically strenuous activity but can walk and is able to do work of a light nature, such as house work or office work
• prior chemotherapy, radiation, or surgery as part of curative intent therapy are allowed
• any number of prior lines of systemic therapy are permitted as long as it did not include anti-androgen therapy or immune checkpoint blockade
• men and women of child bearing age must agree to use contraception during the treatment period and for at least 8 months after the last dose of study treatment
• contact study staff for additional requirements
Exclusion Criteria:

• received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
• received prior androgen deprivation therapy
• pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the first visit through 120 days after the last dose of trial treatment.
• additional cancer that is progressing or has required active treatment within the past 2 years
• contact study staff for additional exclusion criteria
Conditions: Cancer
Keywords: Salivary Gland Carcinoma, Clinics and Surgery Center (CSC)
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MT2019-06: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.

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).

Status: Recruiting
Contact(s):

Danielle Jin - zhuxx003@umn.edu

Principal Investigator: Ashish Gupta
Age: Not specified
Phase: PHASE3
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 25197
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Inclusion Criteria:

• must be 2 to 50 years old
• diagnosis of Sickle Cell Disease
• weigh a minimum of 6 kg (13.2 pounds)
• treated and followed for at least the past 24 months
• experienced at least 4 protocol-defined VOEs in the past 24 months
• experienced HU failure at any point in the past or must have intolerance to HU
• female and male subjects of childbearing potential agree to use 1 method of highly effective contraception from starting the study to at least 6 months after drug product infusion.
Exclusion Criteria:

• if allogeneic hematopoietic stem cell transplantation (allo-HSCT) is medically appropriate and a willing, human leukocyte antigen (HLA)-matched related hematopoietic stem cell donor is available
• unable to receive a transfusion
• prior allogeneic transplant or gene therapy
• prior or current malignancy or immunodeficiency disorder, except cured tumors such as squamous cell carcinoma of the skin
• women who are pregnant or breast feeding
• additional exclusion criteria (study staff will review)
Conditions: Blood Disorders
Keywords: SCD, Sickle Cell Disease
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HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

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.

Status: Recruiting
Contact(s):

Marie Hu - hu000322@umn.edu

Principal Investigator: Marie Hu
Age: 18 years and over
Phase: PHASE1
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 36122
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Inclusion Criteria:

• diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-Cell Non-Hodgkin Lymphoma (B-NHL)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab
• stem cell transplant within 60 days prior to start of study drug
• Human immunodeficiency virus (HIV) seropositive
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: B-Cell Non-Hodgkin Lymphoma, B-NHL, Clinics and Surgery Center (CSC)
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Geniculate Artery Embolization

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.

Status: Recruiting
Contact(s):

Deb Mailand - mailand@umn.edu

Principal Investigator: Reza Talaie
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 25754
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Inclusion Criteria:

• osteoarthritis of the one knee with symptoms that have not improved after at least 3 months of treatment such as PT, injection, medications,
• partial knee replacement and total knee arthroplasty are not currently options (may be in the future)
• 40-70 years of age
Exclusion Criteria:

• weight greater than 250 pounds
• smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• diabetic with A1C greater than 9%
• advanced peripheral arterial disease
Conditions: Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Keywords: Clinics and Surgery Center (CSC), Osteoarthritis
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RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial

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.

Status: Recruiting
Contact(s):

Beiqing Wu - wu000948@umn.edu

Principal Investigator: Byron Vaughn
Age: Not specified
Phase: PHASE4
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 35143
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Inclusion Criteria:

• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:

• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Crohn's disease
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Targeting Family Meal Quality and Quantity to Reduce Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback

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.

Status: Recruiting
Contact(s):

Jerica Berge - jberge@umn.edu

Principal Investigator: Jerica Berge
Age: Up to 18 years old
Phase: NA
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 20261
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Inclusion Criteria:

• Child 5-10 years old
• Have a sibling who lives in the home with the child
• Live in the Metro area
• Speaks English or Spanish
Conditions: Children's Health, Prevention & Wellness
Keywords: family, family meals, nutrition, primary care
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Cardiac Sarcoidosis Consortium

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.

Status: Recruiting
Contact(s):

Julie Dicken - dicke022@umn.edu

Principal Investigator: Henri Roukoz
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 16347
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Inclusion Criteria:

• People who have been diagnosed with Cardiac sarcoidosis (CS)
• History of ventricular tachycardia or fibrillation
• Ventricular arrhythmias treated medically or with an implanted device
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), ablation, cardiac ablation, Cardiac sarcoidosis, Ventricular Tachycardia
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Lifestyle Counseling and Medication for Adolescent Weight Management (QUEST)

This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI (primary efficacy endpoint) and body fat and greater improvements in cardiometabolic risk factors and quality of life compared to intensive behavioral counseling at 56 weeks.

Status: Recruiting
Contact(s):

Nina Jacobs - njacobs@umn.edu

Principal Investigator: Aaron Kelly
Age: Up to 18 years old
Phase: PHASE2
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 33826
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Inclusion Criteria:

• ages 12-17
• BMI greater than or equal to the 95th percentile for age and sex
Exclusion Criteria:

• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
Conditions: Children's Health, Diabetes & Endocrine
Keywords: Obesity, Overweight, weight loss
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Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity

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.

Status: Recruiting
Contact(s):

Nina Jacobs - njacobs@umn.edu

Principal Investigator: Aaron Kelly
Age: Up to 18 years old
Phase: PHASE2
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 28574
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Inclusion Criteria:

• severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• 12 to less than 18 years of age at enrollment
• female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
Exclusion Criteria:

• diabetes (type 1 or 2)
• current or recent (< six months prior to enrollment) use of anti-obesity medication(s) (use of naltrexone or bupropion alone is not an exclusion)
• previous metabolic/bariatric surgery
• current use of a stimulant medication
• history of glaucoma
• current or recent (<14 days) use of monoamine oxidase inhibitor
• history of treatment with growth hormone
• history of bulimia nervosa
• major psychiatric disorder
• any history of active suicide attempt
• history of suicidal ideation or self-harm within the previous 30 days
• current pregnancy or plans to become pregnant during study participation
• current tobacco use
• history of cardiac, endocrine, kidney disease (study staff will review)
Conditions: Children's Health, Diabetes & Endocrine
Keywords: Clinics and Surgery Center (CSC), Obesity, overweight, weight loss
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MT2013-31:Allogeneic Hematopoietic Cell Transplantation for Inherited Metabolic Disorders and Severe Osteopetrosis following Conditioning with Busulfan (Therapeutic Drug Monitoring), Fludarabine +/- ATG

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.

Status: Recruiting
Contact(s):

Paul Orchard - orcha001@umn.edu

Principal Investigator: Paul Orchard
Age: Not specified
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 16279
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Inclusion Criteria:

• up to 55 years old
• diagnosis of an Inherited Metabolic Disorders (IMD)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• uncontrolled bacterial, fungal or viral infections including HIV
• women who are pregnant
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Allogeneic Hematopoietic Cell Transplantation, IMD, Inherited metabolic disorders, osteopetrosis
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Biomechanical Mechanisms of Soft Tissue Deformation during the Volleyball Spike

No current studies have examined in vivo glenohumeral kinematics during the overhead volleyball spike despite the high prevalence of spike-related shoulder pain. The extreme shoulder positions achieved by volleyball players during the spike motion may contribute to unique deformations that could result in structural change or pathology of the rotator cuff and long head biceps tendons. The purpose of this study is to determine the extent to which GH kinematics differ between SAB and a simulated volleyball spike at a self-selected position of ball contact.

Status: Recruiting
Contact(s):

Aaron Hellem - hell0255@umn.edu

Principal Investigator: Paula Ludewig
Age: 18 years and over
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 38485
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Inclusion Criteria:

• 18 to 35 years old
• played at least 2 years of high school varsity-level volleyball and/or play competitive volleyball at the club level or NCAA D3/NAIA level or above
• have no shoulder pain that has resulted in removal from, or cessation of volleyball participation in the past 6 months
• have a negative clinical screening exam
• fluent in English
Exclusion Criteria:

• any injuries, impairments, or pain of the hitting arm that limits participation in volleyball
• shoulder pain related to the cervical spine
• history of trauma and/or surgery of the hitting shoulder
• currently pregnant.
Conditions: Bone, Joint & Muscle
Keywords: athlete, shoulder, spike mechanics, Volleyball
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Brain Mechanisms of Qigong for Neuropathic Pain Relief in Adults with Spinal Cord Injury

The researchers aim to prove that Qigong practice can result in reduced or relieved neuropathic pain, improved mood, life satisfaction, self-efficacy, enjoyment to move, and community integration; and decreased fear of movement, use of medication or health care services for adults with spinal cord injury.

Status: Recruiting
Contact(s):

Ann Van de Winckel - avandewi@umn.edu

Principal Investigator: Ann Van de Winckel
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 32582
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Inclusion Criteria:

• 18 to 75 years old
• spinal cord injury (SCI) at least 3 months ago
• medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
• highest level of below-level SCI-related neuropathic pain >3 on the numeric pain rating scale.
Exclusion Criteria:

• unable to have a MRI (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder; cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent the participant from following directions or from learning
• ventilator dependent
• pregnant or plans to become pregnant during study
• inability to perform kinesthetic imagery
Conditions: Brain & Nervous System
Keywords: SCI, Spinal Cord Injury
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MT2021-29: Evaluation of intravenous laronidase pharmacokinetics before and after hematopoietic cell transplantation in patients with mucopolysaccharidosis type IH

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.

Status: Recruiting
Contact(s):

Paul Orchard - orcha001@umn.edu

Principal Investigator: Silvia Illamola
Age: Up to 18 years old
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 35782
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Inclusion Criteria:

• between 0 to 3 years of age
• meet protocol specific eligibility criteria for allogeneic HCT for MPS IH
• planning to receive laronidase both pre and post-transplant in an inpatient setting as part of standard-of-care treatment. Virtually all patients with MPSIH being considered for transplantation at the University of Minnesota are already receiving enzyme infusions, and it is standard practice to continue to give enzyme infusions to 8 weeks post-transplant. Therefore, participation will not modify the treatment course
Exclusion Criteria:

• patient's parent/ legal guardians are unable to provide informed consent.
Conditions: Rare Diseases, Cancer
Keywords: Hematopoietic Cell Transplantation
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Humanitarian Use Device: Medtronic DBS Therapy for Dystonia (HDE #H020007) (Dystonia IRB)

Humanitarian Use device application for DBS therapy for dystonia

Status: Recruiting
Contact(s):

Kelly Ryberg - rybe0010@umn.edu

Principal Investigator: Jerrold Vitek
Age: 7 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 19733
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Inclusion Criteria:

• 7 to 99 years old
• diagnosed with chronic, intractable (drug refractory) primary dystonia determined by a neurologist or neurosurgeon
Exclusion Criteria:

• patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist
• patients who have not had an adequate trial of medical or non-surgical treatment
Conditions: Brain & Nervous System
Keywords: DBS, Deep Brain Stimulation, Dystonia
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Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core

The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.

Status: Recruiting
Contact(s):

Kelly Brown - ksbrown@umn.edu

Principal Investigator: Scott Cooper
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 19364
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Inclusion Criteria:

• age 21 years and older
• diagnosis of Parkinson's disease
• candidate for DBS
Exclusion Criteria:

• diagnosis of dementia
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulation, Parkinson's Disease
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Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery "Frail Heart" Study

We are looking at measures of frailty (including an assessment questionnaire and other data from the medical record) and the relationship to outcomes from cardiac or vascular surgery. The questionnaire will take about 10 minutes to complete and we will contact you by phone once every three months for one year after your surgery.

Status: Recruiting
Contact(s):

Frail Heart Study - frailheart@umn.edu

Principal Investigator: Tjorvi Perry
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 29874
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Inclusion Criteria:
People who are having any of the following heart surgery procedures:
• thoracic aortic surgery
• coronary artery bypass graft surgery
• Aortic valve replacement
• Mitral valve replacement or repair
• Tricuspid valve replacement or repair
• Pulmonary valve replacement
• Infective endocarditis surgery
• Open and interventional abdominal aortic revascularization
Exclusion Criteria:

• People who have liver cirrhosis
• People who aren't able to make independent health care decisions
Conditions: Heart & Vascular
Keywords: FRAIL, Abdominal Aortic Surgery, Cardiac Surgery, Coronary Artery Bypass, Heart Valve Replacement
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Visual Perception in Visual Snow Syndrome

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.

Status: Recruiting
Contact(s):

Schallmo Lab Study - schallmolab@umn.edu

Principal Investigator: Michael-Paul Schallmo
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 36444
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Inclusion Criteria:

• Between 18 - 60 years old
• Good general physical health
• No history of other neurological disorders or problems
• Fluent in English
Conditions: Vision & Eyes
Keywords: Visual snow, visual snow syndrome
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MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

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.

Status: Recruiting
Contact(s):

Holly Franceen - hfrancee@umn.edu

Principal Investigator: Ashish Gupta
Age: Not specified
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 16776
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Inclusion Criteria:

• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Conditions: Cancer
Keywords: Neuroblastoma
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Mechanisms and effects of pallidal deep brain stimulation on levodopa resistant motor signs in Parkinson's disease; Udall Project 2, Aim 2

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).

Status: Recruiting
Contact(s):

Kristin Garland - garl0038@umn.edu

Principal Investigator: Colum MacKinnon
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 37325
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Inclusion Criteria:

• receiving DBS therapy in for treatment of Parkinson's Disease (PD)
• implanted with Medtronic Percept DBS system
• at least 3 months since initial activation of the DBS
Exclusion Criteria:

• musculoskeletal disorders that significantly affect the ability to perform the motor tasks
• dementia or cognitive impairment
• other significant neurological disorders
• post-operative complications or adverse effects of the DBS stimulation
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson Disease
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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study

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.

Status: Recruiting
Contact(s):

Kelly Ryberg - rybe0010@umn.edu

Principal Investigator: Colum MacKinnon
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 19448
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Inclusion Criteria:

• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
Exclusion Criteria:

• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson's Disease, PD
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