
Search Results
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.
• 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
• 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
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.
• 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
• 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
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.
• 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
• 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
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.
• at least 14 years old
• diagnosis of spina bifida
• able to effectively communicate in English
• reconstructive surgery or urinary diversion in the last 3 months
• admitted to the hospital admission in the last month
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.
• 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
A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) (IDEAL)
The purpose of this research study is to determine if seladelpar (study drug) is effective at normalizing the disease marker alkaline phosphatase in subjects with PBC who are currently on ursodeoxycholic acid (UDCA) treatment or intolerant to UDCA. This will be done by looking at changes in blood tests. This research study is also measuring whether seladelpar makes itching (pruritus) better. This will be done using information about itching that subjects enter on a device or app on their phone.
• 18 to 75 years old
• taking Ursodeoxycholic Acid (UDCA) for 12 months prior to screening (with stable dose for more than 3 months before starting the study) OR unable to take UDCA (last dose of UDCA greater than 3 months before starting the study)
• study staff will review additional inclusion and exclusion criteria
• other chronic liver diseases
• drinking more than 2 drinks per day in women and 3 drinks per day in men, or unable to quantify alcohol intake reliably
• history of cancer diagnosed or treated, active or within 2 years, or ongoing evaluation for cancer; squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ are allowed (if treated)
• women who are pregnant or plan to become pregnant, or are breastfeeding
A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer
The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.
• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
HM2024-11: A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLATUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA
The purpose of this study is to compare the efficacy and safety of glofitamab, a novel cluster of differentiation (CD) 20/CD3 bispecific antibody, in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola‑R‑CHP) versus Pola‑R‑CHP in patients with previously untreated CD20-positive large B-cell lymphoma (LBCL).
• 18 to 80 years old
• have not received any treatment for Large B-Cell Lymphoma
• 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
• prior solid organ transplantation
• history of significant cardiovascular disease
• current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• clinically significant liver disease
• chronic hepatitis B infection, hepatitis C, or HIV
Geniculate Artery Embolization
Osteoarthritis (OA) is a leading cause of disability and chronic pain that reduces physical activity and daily activities. In this clinical research study, the goal is to learn more about geniculate artery (located in the knee) embolization (GAE) treatment to see if it will reduce pain as well as stiffness and difficulty performing daily activities caused by knee OA and if it can be performed safely.
• 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
• 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
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.
• 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
• 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
Effects of tobacco and nicotine cessation on biomarkers
This study will bank biological samples (cells from mouth, urine, blood, saliva) to investigate the effects of quitting smoking or vaping on different markers in the body.
• 21 years of age or older
• in good health
• smokes cigarettes daily
• willing to abstain from smoking for 15 days
• marijuana use
PREVENT ALL ALS
Individuals who are carriers of ALS causative gene variants have an increased lifetime risk of developing ALS or a related disorder, Frontotemporal Dementia (FTD). We are doing this research to collect a wide range of biofluid samples, clinical information, and other health and wellbeing information to look for measurable differences that will help us understand how and when the body changes in response to ALS causative gene variants.
• first-degree relative of a known carrier of any Amyotrophic Lateral Sclerosis (ALS) causative gene1 (regardless of whether ALS or Frontotemporal Dementia FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and/or FTD in a family with a "compelling family history" of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members. A "compelling family history" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.
• access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)
• evidence of neurological signs or symptoms concerning for ALS of FTD
• significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days (about 3 months)
• clinically significant, unstable medical condition
Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People with Chronic Temporomandibular Disorder (TMD) Pain (TMD)
This study is about how pain affects drinking behaviors in people with chronic temporomandibular disorder (TMD).
• 21+ years of age, with a valid ID
• Fluent in English
• Report drinking ≥ 2 days/week
• Women must report ≥1 drink/day on average over the last 6 months.
• Men must report ≥2 drink/day on average over the last 6 months
• Diagnosis of TMD, myalgia, TMJ, or a combination
• Have a smartphone with Internet
• History of any psychotic disorder, current major depression, substance use disorder or current alcohol use disorder
• Serious medical illness
• Under-controlled hypertension or diabetes or neurological disease
• Impaired cognitive function
• Women who are pregnant breastfeeding, or intending to become pregnant
• Loss of sensation in lower legs or physical inability to complete study tasks
• Positive drug screening
• Medications that contraindicate alcohol use
• Comparison group: Chronic pain & TMD
MT2019-01: Adrenoleukodystrophy National Registry Study (ALD) and Biobank
The purpose of this research to enhance our understanding of adrenoleukodystrophy ALD and study biospecimens such assaliva, blood, urine and stool to identify potential biomarkers for early identification of dise. We invite people who have or are at risk to have ALD, including females who are known or at risk carriers of the mutation for ALD, to help us learn more.
• age 0 to 100
• patient or family member diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation
• patient or family member with known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• living in the United States and territories
• have undergone BMT or other cellular therapy
• not fluent in English who are unable to consent in-person
• people who are unable to read or write
REFORM-HF. REducing Fluid Overload using Renal Independent systeM in Heart Failure Patients (REFORM-HF)
This research study is designed to evaluate a new treatment approach for patients with chronic heart failure. This study will assess the effectiveness and safety of a new medical device, the AquaPass system, in managing the accumulation of fluids in the body that persists despite standard medical treatment. The purpose of this study is to understand if the use of the AquaPass System with medication treatment results in increased fluid removal compared to only regular medication treatment.
• diagnosis of heart failure NYHA Class II, III who is congested and not responding to usual treatment such as 80mg of lasix (or another diuretic) per day
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• acute worsening of heart failure needing care in the ICU
• arrhythmia, infection, or other medical condition that is causing acute illness
• lower body skin problems (open wounds, ulcers, infections)
• severe peripheral artery disease
• women who are pregnant, breast feeding, or planning to get pregnant during the study period
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.
• 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
• 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
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.
• 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
• 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
Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients receiving Neoadjuvant Chemotherapy with Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer who are Folate Receptor positive
The purpose of the study is to document the feasibility of undergoing surgery for cancer after receiving 3 cycles of neoadjuvant chemotherapy carboplatin and mirvetuximab soravtansine as first-line treatment in patients with advanced-stage ovarian cancer that are Folate Receptor alpha positive.
• confirmed high grade serous epithelial ovarian cancer
• stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy (before surgery)
• strenuous activity may be restricted but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 4 months after the last dose
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• previously treated with a systemic anti-cancer therapy
• low-grade serous, endometrioid, clear cell, or mucinous cancer
• women who have active or chronic corneal (eye) disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision
• history of hepatitis B or C infection or human immunodeficiency virus (HIV) infection
• women who are pregnant or breastfeeding
• history of other cancer within 3 years prior
• significant heart, lung, liver disease
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.
• 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
• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
MT2012-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
The primary purpose of this study is to record outcomes and patient characteristics in the Cancer Center’s and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• up to 50 years old
• diagnosis of immunodeficiency or histiocytic disorder
• see link to clinicaltrials.gov for complete inclusion criteria
• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
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) .
• 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
• previous diagnosis of psychosis or cognitive disability
• substance abuse or dependence within the past year
• neuroleptic/antipsychotic medications
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.
• ages 12-17
• neurodevelopmental disorder (e.g. intellectual disability, severe autism)
• major medical and/or neurological illness
A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) (FIRST-308)
The main purpose of this study is to learn how well tinengotinib works and how safe tinengotinib is compared with the study doctor’s choice of chemotherapy treatment. The purpose of Part A of the study will be to determine the best dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and how safe it is compared with the study doctor’s choice of treatment.
• adenocarcinoma of biliary origin (bile ducts) that can't be surgically removed or is metastatic (spread to other areas of the body)
• cancer has FGFR2 fusion/rearrangement gene status
• received at least one line of prior chemotherapy and one FDA approved FGFR inhibitor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received two or more FGFR inhibitors, either approved or investigational drugs
• brain or central nervous system (CNS) metastases
• presence of another cancer that requires treatment
• uncontrolled hypertension (blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite treatment with antihypertensive medications)
Research Evaluating Vagal Excitation and Anatomical Links
We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.
• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
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.
• age 20 - 50
• right handed
• no major psychiatric illness
• claustrophobia
• any metal or devices in the body (e.g., pace makers, aneurysm clips etc.)
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).
• 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
• patients with a history of bilateral Wilms tumor
• patients with any uncontrolled, intercurrent illness
• female patients who are pregnant or breastfeeding
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.
• 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
• 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
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.
• 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
• 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
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection
We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.
• 18 to 75 years old
• having surgery for diverticulitis or sigmoid colon cancer
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant -receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
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.
• 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
• 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)