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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.

430 Study Matches

PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA

The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.

Principal Investigator: Frank Ondrey
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001771
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Inclusion Criteria:

• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: Clinics and Surgery Center (CSC), Oral Leukoplakia
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Feasibility Study of Resection and GammaTile® Followed by Concomitant External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ in Newly Diagnosed Glioblastoma (GBM). (GESTALT)

The purpose of this research study is to evaluate the safety of GammaTile in combination with the Stupp Protocol for the treatment of newly diagnosed Glioblastoma. A GammaTile (GT) is an FDA cleared device used to provide radiation therapy following the removal of a brain tumor. GT are small (2cm x 2cm x 0.4cm) collagen squares/tiles that contain sources of radiation that look like grains of rice. The doctor will place tiles containing the radiation sources in the cavity left after surgically removing the brain tumor. They do not need to be removed as the collagen tiles will be absorbed by the body and the radiation sources can be left in place. The Stupp Protocol includes External Beam Radiation (EBRT) in combination with Temozolomide (TMZ) which is a chemotherapy drug. EBRT uses external beams to deliver radiation to the cavity left after surgical removal of a brain tumor. After the completion of EBRT/TMZ cycle additional treatment with TMZ will continue for 6 months.

Principal Investigator: Lindsey Sloan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001565
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Inclusion Criteria:

• newly diagnosed Glioblastoma (GBM)
• plan for surgery to excise the tumor
• cares for self; unable to carry on normal activity or work
• able to understand English or Spanish
• men and women of childbearing potential must be willing to use contraception throughout the study and for men for up to 3 months after completing treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known to have a IDH mutation glioma by prior biopsy
• previous chemotherapy or radiotherapy to the head or neck region
• prior invasive cancer (except non-melanoma skin cancer, cervical cancer in situ) unless disease free for a minimum of 2 years
• contraindication to MRI or CT
• women who are pregnant or breast feeding
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), GBM, Glioblastoma
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Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry (IPF/ILD-PRO)

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.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1408M52921
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Inclusion Criteria:

• at least 30 years old
• new diagnosis of Idiopathic Pulmonary Fibrosis (IPF) -diagnosis of a non-IPF Interstitial Lung Disease (ILD) of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis
Exclusion Criteria:

• Cancer, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
• currently waiting for lung transplantation
• currently enrolled in a clinical trial
Conditions: Respiratory System
Keywords: Clinics and Surgery Center (CSC), Idiopathic Pulmonary Fibrosis (IPF) Interstitial Lung Disease
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Comparison of motor and sensory thresholds for sacral neuromodulation

Participants in this research study are people who are considering or already receiving therapy using sacral nerve modulation (a treatment that sends electrical impulses to nerves in the lower back). In this research we are measuring brief responses to stimulation that is delivered using this therapy. With our research we are hoping to improve the therapy in the future. We expect that people would be in this research study for only a 20 minutes.

Principal Investigator: Nissrine Nakib
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020299
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Inclusion Criteria:

• has an implanted sacral neuromodulation device for control of urinary or pelvic symptoms, or plans to have one implanted
• has the ability provide signal (verbal or otherwise) regarding sensory or motor responses to stimulation delivery
• geographically available and is willing to come to the University for follow up visits and testing
Exclusion Criteria:

• women who are pregnant
• diagnosis of a bleeding disorder or coagulopathies
• any abnormality of the urinary tract including the bladder, ureters or kidneys
• has had any invasive or surgical intervention involving the kidneys, bladder, urethra, rectum or vaginal wall within the last 6 months
Conditions: Kidney, Prostate & Urinary
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Bladder Management Patient Reported Outcomes for Young Adults with Spina Bifida

The purpose of this study is to determine how different bladder management methods affect the quality of life for young people with spina bifida. We hope to find out if certain bladder management methods are associated with a better quality of life. This information could help doctors make better treatment decisions and counsel young people living with spina bifida.

Principal Investigator: Sean Elliott
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024162
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Inclusion Criteria:

• at least 14 years old
• diagnosis of spina bifida
• able to effectively communicate in English
Exclusion Criteria:

• reconstructive surgery or urinary diversion in the last 3 months
• admitted to the hospital admission in the last month
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC)
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MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Principal Investigator: Ashish Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1601M82901
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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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MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022432
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Inclusion Criteria:

• able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Large B-cell lymphoma (LBCL) or Mantle Cell Lymphoma (MCL)
• cancer has recurred or not responded to at least 2 prior lines of treatment
• willing to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of medication
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• prior allogeneic stem cell transplant
• Autologous stem cell transplant within 6 months
• Auto-immune disease or condition requiring systemic immunosuppressant therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• significant cardiac disease including heart failure or arrhythmia
• history of a stroke in the past 6 months
• history of another active cancer in the past 3 years
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: LBLC, Mantle Cell Lymphoma (MCL), Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
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Ten Thousand Families Study

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.

Principal Investigator: Jen Poynter
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00000877
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Inclusion Criteria:

• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Conditions: Cancer, Microbiota, Prevention & Wellness
Keywords: Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS, D2D
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Neural Correlates of Goal Prioritization and Conscientiousness

This research will use neuroimaging to study the brain systems involved in prioritizing goals effectively, as well as testing whether variation in those systems is associated with the personality trait conscientiousness, which reflects organization, self-discipline, and industriousness and predicts important health and other life outcomes.

Principal Investigator: Colin DeYoung
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019311
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Inclusion Criteria:

• age 20 - 50
• right handed
• no major psychiatric illness
Exclusion Criteria:

• claustrophobia
• any metal or devices in the body (e.g., pace makers, aneurysm clips etc.)
Conditions: Brain & Nervous System
Keywords: Brain imaging, Personality
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Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)

Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.

Principal Investigator: Beth Thielen
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00019522
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Inclusion Criteria:

• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
Exclusion Criteria:

• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
Conditions: Community Health, Infectious Diseases, Respiratory System
Keywords: germs, infection, respiratory illness, RSV, virus
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Senolytics To slOw Progression of Sepsis

Researchers hope that using Fisetin, an antioxidant, will reduce inflammation in the body caused by sepsis, which could help your body and organs have more time to recover. Placebo in this study will be something that looks similar to the study treatment, but does not contain any active drug. Everyone will receive 4 pills, but your group will determine how many of the pills are Fisetin. Researchers will look at the potential effects Fisetin or placebo has on inflammation in the body and how sick participants are at 7 days and 28 days.

Principal Investigator: Michael Puskarich
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001869
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Inclusion Criteria:

• Age 65 or older
• Primary diagnosis of acute infection
• Expected length of hospital stay at least 48 hours
Exclusion Criteria:

• No acute infection
• Known hypersensitivity or allergy to Fisetin
• Not admitted to hospital
• Enrolled in another Sepsis clinical trial
Conditions: Infectious Diseases
Keywords: Fisetin, Sepsis
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MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)

The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.

Principal Investigator: Veronika Bachanova, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1611M99805
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Inclusion Criteria:

• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

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.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006945
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Inclusion Criteria:

• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
Exclusion Criteria:

• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Conditions: Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Chronic Depression, Depression
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Coordinated Reset Deep Brain Stimulation for Essential Tremor

This study is for people who have essential tremor and will be receiving the Boston Scientific Vercise Genus deep brain stimulation (DBS) system. We are studying the possibility that a kind of deep brain stimulation called "coordinated reset" stimulation (CR-DBS) will be more effective than current DBS treatment for essential tremor. We expect that participants will be in this research study for about 9 to 11 months.

Principal Investigator: Jing Wang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018050
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Inclusion Criteria:

• diagnosis of Essential Tremor (ET)
• age 21 or older
• will receive a Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
Exclusion Criteria:

• history of musculoskeletal disorders that affect movement of the limbs or gait
• history of dementia or cognitive impairment
• significant psychiatric disease
• on medication that could cause tremor
• women who are pregnant
• prior brain surgery
Conditions: Brain & Nervous System
Keywords: Essential Tremor, ET
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Bupropion for the Prevention of Postpartum Smoking Relapse

Currently, more than half of all women who are able to quit smoking cigarettes during pregnancy start smoking again within six months after they give birth. We want to find out if the drug bupropion (a commercially-available medicine) can help women who quit smoking during pregnancy to continue not smoking after they give birth. All study visits can be completed either in-person or virtually.

Principal Investigator: Sharon Allen, PhD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007684
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Inclusion Criteria:

• age 18 to 40
• lifetime history of smoking at least 100 cigarettes, quit smoking during current pregnancy
• uncomplicated delivery, at least 37 weeks gestation
• home within 10 days of delivery
• don't want to start smoking again
Exclusion Criteria:

• currently use other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• currently use cessation aids
• currently use illicit drugs or alcohol dependence
• taking an antidepressant
• family history of seizures or seizure disorder
Conditions: Mental Health & Addiction, Women's Health
Keywords: postpartum, smoking, smoking cessation
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Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

This study will enroll children aged 6 to 12 years who have difficulty in maintaining a healthy weight and see if the medication Vyvanse may help them to reduce their weight.

Principal Investigator: Claudia Fox
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019097
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Inclusion Criteria:

• children 6 to 12 years old
• severe obesity defined as BMI greater than or equal to 1.2 times the 95th percentile
• failed attempt of lifestyle therapy
Exclusion Criteria:

• significant congenital or structural heart disease or arrhythmia
• hypertension
• history of chemical dependency
• Diabetes mellitus (type 1 or 2)
• current or recent ( less than 3 months ago) use of anti-obesity medication(s)
• additional medical or mental health conditions (study staff will review)
Conditions: Children's Health, Diabetes & Endocrine
Keywords: healthy weight, Obesity
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Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1): Potential Use of Antioxidant/Anti-inflammatory Medications

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.

Principal Investigator: James Cloyd
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1506M74581
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Inclusion Criteria:

• 18 years or older
• diagnosis of Type 1 Gaucher's Disease (GD1) who are medically stable
• on a stable medication therapy for 2 years, or if dosage or drug has been changed it has been at least 6 months and condition is stable
Exclusion Criteria:

• women who are pregnant or breast feeding
• asthma that is currently being treated
• unable to have a MRI scan
Conditions: Rare Diseases
Keywords: Gaucher disease
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COG AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

This phase II trial studies how well combination chemotherapy works in treating patients (≤ 30 years old) with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).This trial may help doctors find out what effects, good and/or bad, regimen UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT)and regimen ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001038
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Inclusion Criteria:

• patients must be =< 30 years old at study enrollment
• patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor and have received an initial risk assignment showing DAWT or patients with relapsed favorable histology Wilms tumor
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• patients with a history of bilateral Wilms tumor
• patients with any uncontrolled, intercurrent illness
• female patients who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Kidney Wilms Tumor, Wilms tumors
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A randomized, double-blind, placebo- controlled study of LMN-201 for prevention of C. difficile infection recurrence (RePreve)

This study is recruiting people who have developed an infection of the lower intestine (the colon) by bacteria called Clostridioides difficile (abbreviated C. difficile or C. diff). The standard treatment for this infection is with antibiotics, but in some people, the infection keeps coming back. The purpose of this research is to test whether an investigational drug can prevent a return of the infection. We want to make sure LMN-201 is safe when used as part of standard of care for C. diff, and we want to see if we can improve treatment and reduce re-infection.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022202
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Inclusion Criteria:

• diagnosis of Clostridioides Difficile Infection (CDI) defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency and a positive stool C. difficile toxin B immunoassay and no other likely explanation for diarrhea
• able to take oral medication and willing to adhere to the study medication
• have access to a mobile smartphone
• women and men of reproductive potential must use of highly effective contraception during study participation and for an additional 4 weeks after the end of study drug administration
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• violent diarrhea from C. difficile colitis
• Underlying gastrointestinal disorder characterized by diarrhea such as chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, etc.
• women who are pregnant, trying to get pregnant or breast feeding
Conditions: Infectious Diseases
Keywords: C-Diff, CDI, Clostridioides Difficile Infection
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Computational Modeling of Tic Change Trajectories in Tourette Syndrome

We are looking for participants who have tics. We would like to measure your tics before, during and after a course of Comprehensive Behavioral Intervention for Tics (CBIT) .

Principal Investigator: Brianna Wellen
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021987
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Inclusion Criteria:

• age 12-17
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months
• at least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only)
• full scale IQ greater than 80
Exclusion Criteria:

• previous diagnosis of psychosis or cognitive disability
• substance abuse or dependence within the past year
• neuroleptic/antipsychotic medications
Conditions: Brain & Nervous System
Keywords: Tics, Tourette Syndrome

Creativity Camp Study

This study explores how engaging in creative activities may be helpful for mental health and wellbeing in adolescents. Study participants will attend eight sessions (over two weeks) of Creativity Camp which involves a range of different kinds of arts activities. Participants will also complete a series of questionnaires, interviews, and other assessments to assess the potential benefits of the camp. We have previously shown that Creativity Camp is effective for reducing depression symptoms and improving well-being in adolescents with depression.

Principal Investigator: Kathryn Cullen
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00014280
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Inclusion Criteria:

• ages 12-17
Exclusion Criteria:

• neurodevelopmental disorder (e.g. intellectual disability, severe autism)
• major medical and/or neurological illness
Conditions: Children's Health, Mental Health & Addiction
Keywords: Adolescents, Arts, Creativity
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A novel partial-enteral nutrition protocol to improve nutrition status of adult patients experiencing a Crohn's disease flare and starting new immunologic therapy

The purpose of this study is to evaluate if a partial enteral nutrition diet, with a pea protein plant-based oral nutrition supplement (ONS; Kate Farms Peptide 1.5), combined with the Inflammatory bowel disease - Anti-Inflammatory Diet (IBD-AID) improves the nutritional intake of adult patients experiencing a CD flare initiating immunologic therapy compared to standard of care. Standard of care for patients experiencing a CD flare is commonly characterized by prescription of a low fiber diet and either lack of oral nutrition supplementation or use of an animal protein based supplement.

Principal Investigator: Byron Vaughn
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013936
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Inclusion Criteria:

• 18 years and older
• diagnosis of moderate to severe Crohn's Disease (CD) as defined by physician
• starting new advanced therapy
Exclusion Criteria:

• short bowel syndrome
• ileostomy or colostomy
• use of pre or probiotic supplements within last 14 days
• active implanted medical devices (cardiac pacemaker, defibrillator)
• pregnancy
• other serious medical conditions (study staff will review)
Conditions: Digestive & Liver Health
Keywords: Crohn's Disease (CD)
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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.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011895
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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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MT2023-38 Monitoring of Immune Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies

The purpose of this research is to collect and store specimens and information about the recovery of the immune system following a stem cell transplant (HCT) or immunotherapy to treat a cancer or blood disease. Samples from many people are being collected and stored so they can be used for research now and in the future.

Principal Investigator: Jeffrey Miller, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021493
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Inclusion Criteria:

• planning to have a Hematopoietic Cell Transplant (HCT), gene therapy or other cell therapy or immunotherapy
• allogeneic related donors
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cell therapy, gene therapy, HCT, Hematopoietic Cell Transplant, immunotherapy
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A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1) (PRIOH-1)

The purpose of this research study is to look at the safety and effectiveness of pritelivir given orally (by mouth for a maximum of 42 days) for people with an impaired immune system who have recurrent lesions caused by the form of HSV that does respond to treatment with acyclovir.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020605
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Inclusion Criteria:

• at least 16 years old
• immunocompromised or body is unable to fight off infection
• have lesions that can been seen in order to determine if they are healing
• willing to use highly effective birth control
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history or current evidence of gastrointestinal malabsorption
• on hemodialysis for any reason and end stage renal disease (ESRD)
• women who are pregnant or breastfeeding
• unable to communicate with study staff
Conditions: Rare Diseases, Infectious Diseases
Keywords: Clinics and Surgery Center (CSC), Herpes, Herpes Simplex Virus, HSV Infection
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BEGIN-OB-19: A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN) (BEGIN)

This is a study of highly effective CFTR modulators and their impact in children with CF on endocrine growth factors, the gut microbiome, respiratory microbiome, liver and pancreatic function, lung function, sweat chloride, and inflammatory markers.

Principal Investigator: Elissa Downs
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00000975
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Inclusion Criteria:

• For Part A: less than 5 years of age at the first study visit
• For Part B: participated in Part A OR less than 6 years of age at the first study visit, CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy and physician intends to prescribe ivacaftor or elexacaftor/tezacaftor/ ivacaftor
• Documented diagnosis of Cystic Fibrosis (CF)
Exclusion Criteria:

• use of ivacaftor or elexacaftor/tezacaftor/ ivacaftor within the 180 days
• use of an investigational drug within 28 days prior to first study visit
• use of chronic oral corticosteroids within the 28 days prior to first study visit
Conditions: Rare Diseases
Keywords: Cystic Fibrosis
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MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.

Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021781
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Inclusion Criteria:

• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), Acquired Amegakaryocytic Thrombocytopenia, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, SA
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CONQUER Protocol Number 001: COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER)

The purpose of this study is to develop a cohort of patients with early scleroderma, and to collect data on clinical outcomes, radiological tests, laboratory tests and to obtain biological specimens for testing.We hope to explore medical care and the impact of SSc on patients' daily lives through various questionnaires that will be collected during study participation. By looking at all of the areas mentioned, we hope to find out information about SSc that will help treat future patients, develop new treatments, and work towards a cure.

Principal Investigator: Jerry Molitor
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014622
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Inclusion Criteria:

• at least 18 years old
• have a diagnosis of systemic sclerosis
• less than 5 years from onset of first symptom attributed to systemic sclerosis
Exclusion Criteria:

• cognitive impairment that interferes with ability to participate in the study
• unable to speak, read, and write English
Conditions: Arthritis & Rheumatic Diseases
Keywords: Clinics and Surgery Center (CSC), Scleroderma
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Increasing HPV vaccination coverage among pediatric, adolescent, and young adult (PAYA) cancer survivors: A multilevel intervention

The purpose of this research is to test the efficacy of different interventions to increase vaccination against human papillomavirus (HPV). Survivors of childhood, adolescent and young adult cancers are at increased risk of developing HPV-associated secondary cancers, but have lower HPV vaccination coverage compared to the general population. Interventions which are found to be successful in this study will be incorporated into future survivorship care to improve adherence to recommend preventive healthcare practices. All research procedures will be conducted remotely (e.g. online).

Principal Investigator: Deanna Teoh
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013006
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Inclusion Criteria:

• current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic
• seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder
• survivor of childhood cancer (diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age
• at least 6 months post-treatment (current treatment for graft-versus-host disease allowed)
• no previous HPV vaccination or incomplete HPV vaccination
• people who are unsure of their HPV vaccination status and are unable to find vaccination records (study staff will review)
Exclusion Criteria:

• previously completed HPV vaccination series
• unable to read and write in English
• pregnant or plans to become pregnant in the next year
• currently receiving treatment for cancer or hematologic disorder or plan for treatment in next 12 months
• immediate hypersensitivity reaction to any vaccine component (study staff will review)
Conditions: Cancer, Children's Health
Keywords: Clinics and Surgery Center (CSC), cancer survivors, HPV, vaccination
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An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

We’re studying disitamab vedotin to find out what its side effects are and if it works for urothelial cancer when given with pembrolizumab. We want to see if these drugs work better together than the available approved treatments.

Principal Investigator: Gautam Jha
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018433
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Inclusion Criteria:

• confirmed locally advanced unresectable or metastatic urothelial cancer (UC) including that originating from the renal pelvis, ureters, bladder, or urethra
• able to receive cisplatin- or carboplatin-containing chemotherapy
• 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.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history of or active autoimmune disease that has required systemic treatment in the past 2 years
• prior solid organ or bone marrow transplantation
• pleural effusion or ascites with symptoms or requiring symptomatic treatment
Conditions: Cancer
Keywords: Urothelial Carcinoma
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