Search Results
Antimicrobial Stewardship Community Awareness and Acceptance in Minnesota
This is a community-based study engaging diverse Minnesota adults aged >=18 years. The goal is to understand the public's acceptance and awareness of antimicrobial resistance and stewardship efforts and subsequently look at electronic educational methodology to increase antimicrobial stewardship public engagement.
A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)
The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.
• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (AFFINITY)
The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome.
• Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
• age 18-70 years for patients in the DKD cohort
• receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks
• there are different requirements for each diagnosis category & study staff will review these
• current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy
• history of kidney transplantation or other organ transplantation
• except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months
• blood pressure above 150 mmHg systolic or 95 mmHg diastolic
• history of heart failure or a previous hospital admission for fluid overload.
• history of liver disease
• hemoglobin below 9 g/dL or blood transfusion for anemia within the past 3 months.
• cancer in the past 5 years (except nonmelanoma skin cancer and curatively treated cervical carcinoma in situ)
• women who are pregnant, breastfeeding, or intend become pregnant during the study
• recently received an investigational agent -clinically significant unstable or uncontrolled medical condition (study staff will review)
Impact of Inflammatory Bowel Disease and IBD-related Surgery on Female Fertility: A Prospective Registry
This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.
• age 18-45 years
• diagnosis of inflammatory bowel disease (IBD)
• not currently pregnant or trying to get pregnant
• desire to become pregnant within the next 12 months (may become pregnant while in the study)
• prior pelvic surgery, including surgery of the cervix, ovary, uterus or fallopian tubes
• known female sterility
• known male infertility factors in partner
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes. Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.
• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Mechanisms of a Dynamic Stability Approach
If you have been referred to occupational therapy for thumb carpometacarpal osteoarthritis and you are 18 years or older, you are eligible for this study. Arthritis is the leading cause of disability in the United States, with an estimated 25.6 million Americans affected by osteoarthritis (OA) of the hand. Thumb carpometacarpal osteoarthritis (thumb carpometacarpal (CMC) joint osteoarthritis) is the most common and limiting form of hand osteoarthritis, causing chronic pain, weakness, reduced joint movement, and difficulty carrying out common daily tasks. The purpose of this research study is to find out if an 8-week dynamic stability program can help people with a range of CMC OA severity and symptoms. Dynamic stability (DS) is a new occupational therapy program that uses a series of exercises to strengthen specific muscles around the thumb CMC joint. By strengthening these muscles, the DS approach aims to reduce joint pain, delay further damage, and improve function and participation in daily activities. If you enroll, we expect that you will be in this research study for 9 weeks, for a total of about 15 hours of participation. During the study, you will participate in: 4 occupational therapy (OT) study visits (about 60 minutes each), a home exercise program (15-20 minutes/day) for 8 weeks and, 2 assessment visits (Baseline, and week 9) where we will using Computerized Tomography, a type of X-ray, and ultrasound to take measures of your affected joint and have you complete questionnaires related to pain and disability.
• Thumb Carpometacarpal (CMC) Osteoarthritis confirmed by xray
• referred to occupational therapy for treatment of thumb CMC osteoarthritis
• cortisone treatments to the affected thumb within the prior three months
• hand rehabilitation within the past six months
• thumb CMC joint replacement
• diagnosis of inflammatory arthritis
Defining Clinical Endpoints in LGMD (GRASP-01-001)
The purpose of this study to learn more about Limb Girdle Muscular Dystrophy by measuring how muscles change over a twelve-month period. Our clinical evaluator will test muscle strength and participants will be asked to complete a series of questionnaires to find out how Limb Girdle impacts daily activities. This information will help plan future studies and drug development for people with LGMD.
• 4 to 65 years of age
• diagnosis of Muscular Dystrophy with weakness in either a limb-girdle pattern, or in a arm or leg
• confirmed mutation in ANO5, CAPN3, DYSF, DNAJB6 or SGCA-G.
• bleeding disorder, platelet count less than 50,000, or currently taking an anticoagulant.
• women who are pregnant
• other illness that would interfere clinical trial (study staff will review)
Evaluate the perspectives of cancer survivor patients and caregivers on using an intrathecal drug delivery system as a continuum of pain management care using a qualitative study.
Targeted medication delivery near the spinal cord (intrathecal pump) may be offered for cancer pain treatment in carefully selected patients. Prior studies showed an improved functional status reduction in oral medications and their side effects. Cancer survivors receiving intrathecal pump treatment for pain are eligible to participate in the research and share their stories. After consenting, a interview (45 minutes by zoom) will be conducted before and after the treatment to improve our understanding of patient perceptions of pain treatment with an intrathecal pump.
• cancer survivors with pain for more than 3 months duration who may benefit from intrathecal pump treatment for pain
• people who are not eligible for treatment with an intrathecal pump
GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.
• at least 18 years old
• able to tolerate giving a blood specimen of up to 60 cc
• willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• people who have untreated colon cancer OR have previously removed adenomas, OR have a family history of colon cancer OR have a current positive screening stool test in the past 12 months that hasn't been evaluated
• Healthy Controls: have no history of finding polyps, no family history, or negative colorectal cancer screening test (if performed) within past 12 months
• people who have had surgery, radiation, or chemotherapy for their current colorectal cancer or any other cancer
• history or clinically active Inflammatory Bowel Disease
• HIV or chronic active viral hepatitis
• history of cancer in the past 3 years (except minor skin, cervical, or endometrial)
• active chemotherapy or radiation treatment for any purpose
Phase II Multi-Institutional Study of Low-Dose (2Gy x 2) Palliative Radiotherapy in the Treatment of Symptomatic Bone metastases from Multiple Myeloma
There is no consensus on the radiation dose required to relieve the pain from bone lesions from multiple myeloma. Usually, patients receive between 10 and 12 radiation treatments to achieve pain relief. But a shorter course of radiotherapy may be more effective. This study will evaluate whether pain relief can be achieved using only 1 or 2 radiation treatments, which will be delivered to a painful bone lesion. Your study doctor will decide whether you receive 1 or 2 treatments. The total amount of radiation you will receive will be the same whether it is done in one or two treatment sessions.
• diagnosis of multiple myeloma
• painful bone metastasis that has been confirmed by a xray
• may have had any number of prior chemotherapy/immunotherapy regimens
• at least able to walk and do all selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for additional requirements
• received prior radiation therapy or prior palliative surgery to the bone lesion that is causing pain
• pathologic fracture or impending fracture at the area of the bone lesion causing pain
• women who are pregnant
• additional criteria apply (study staff will review)
Neuroplasticity in REM Sleep Behavior Disorder
REM sleep behavior disorder may predict the eventual symptom development of Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy. This occurs over years to decades and the sleep disorder may hide other typical symptoms and result in a delay in diagnosis. We are studying the changes in the brain over two years. We will do high field MRI’s (7T) and other tests of neurological function of people who have REM sleep disorder and people who don’t have this disorder (matched for age and sex).
• Diagnosis of isolated iRBD confirmed by sleep study
• Able to walk independently without the use of an assistive device (e.g., cane) for at least 50 meters.
• 21 to 75 years old
• Diagnosis of Dementia
• History of musculoskeletal disorders that significant affect movement of lower or upper limbs
• Other significant neurological disorders
• Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.
• Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).
• Untreated sleep-disordered breathing
• Pregnant women
Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease
This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The study entails 2 visits over a 3-month period. On enrollment, participants will be scheduled for the 2 visits, during which fasting blood samples will be collected.
• ages 18 to 80
• healthy volunteers without any known diagnosis
• hematological cancer or other uncontrolled medical conditions
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
Fully Automated Motion-corrected MR Spectroscopy in Human Brain and Spinal Cord
The goal of this proposal is to develop fully automated, high performance, motion-corrected MRS sequences for the brain and spinal cord, that are also easy to share (no additional external hardware needed) with other institutions and easy to use.
• Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
• Pregnancy
• Claustrophobia
• Inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Diabetes that has been diagnosed within the past 3 months (diabetes is OK if it is stably controlled (per participant report of either HbA1c <7.0 or stable control for at least 3 months))
• Hearing loss sufficient to prevent communication via telephone
• Weight > 250 and BMI > 35.
• Uncontrolled high blood pressure (>170/100) or working with doctor to stabilize blood pressure
• Severe lung, liver, kidney or heart disease of other major organ failure.
• Head size > 23.25 inches
COMPARE: Expanding first-line options for depression and matching treatments to patients: hatha yoga vs. behavioral therapy
We are studying treatment options for people who have depression. One group will practice hatha yoga and the other will have behavioral therapy. All treatments are done virtually via telehealth (computer) with no in person clinic visits.
• Symptoms of depression
• Able to read English or Spanish
• Live in states of NC, MA, MN, or RI
• Bone fracture or joint surgery in the past 6 months
• Unable to walk
• Severe heart failure or lung disease
• Engaged in yoga practice or psychotherapy more than once in the past 4 weeks
• Currently pregnant
• Active suicidal or manic symptoms
Neural and Behavioral Markers of the Temporal Dynamics of Language Planning and Phonological Working Memory Processes in Persons Who Stutter
This is a study of persons who do and do not stutter between ages 7 and 65 years. This study is trying to figure out how attention skills influence memory, language, and speech fluency skills.
• age 7 through 65 years
• remaining eligibility will be determined based on response to an intake survey
COG ARST2031: A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)
his phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. Cyclophosphamide is in a class of medications called alkylating agents. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work by slowing or stopping the growth of cancer cells in the body. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.
Physical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF) (REHAB-HFpEF)
The purpose of this research study is to assess the effect of a physical rehabilitation program for people admitted to the hospital with a diagnosis of heart failure. After completing baseline tests, participants will be randomly assigned to one of two study groups. Randomization means that you are put into a group by chance. (It is like flipping a coin.) You will have an equal chance of being placed into either group. Participants are assigned to a rehabilitation intervention (treatment) group, or to the attention control group, that will receive usual care.
• at least 60 years old
• in the hospital for at least 24 hours to treat acute heart failure
• heart failure episode included symptoms getting worse and the need to add or increase drugs to treat it
• able to walk 4 meters (13 feet) with or without a cane or walker when the study starts
• discharge to an independent living situation
• acute heart attack in the past 3 months, or planned intervention in the next 6 months
• severe valve disease
• advanced kidney disease with dialysis planned in the next 6 months
• dementia
• already actively exercising at least 30 minutes at a time, twice a week for the past 6 weeks
Neural mechanisms of early visual dysfunction in psychosis
The purpose of this study is to look at symptoms, thoughts, and behaviors related to the way a person sees the world. This is called visual perception. This study will also look at brain function. We will study these things in people with and without psychosis. People with psychosis see the world differently than others. For example, they may experience hallucinations. We are interested in understanding how differences in the way people see the world relate to brain circuits. This project will use visual and behavioral experiments, EEG, and Magnetic Resonance Imaging (MRI) to look at how visual perception is different in people with and without psychosis. This research study has three visits lasting 2-4 hours each. We expect that these visits will take place over 2-3 months, depending on your availability and preferences.
• 18-60 years old
• normal or corrected-to-normal vision
• current diagnosis of schizophrenia or schizoaffective disorder
• claustrophobia
• current substance dependence (other than nicotine)
• any vision problem (e.g. strabismus/crossed eyes, lazy eye, color blindness)
• current or past diagnosis of bipolar I disorder
teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) (teleABLE)
We are exploring ways to increase physical activity after stroke using a web-based rehabilitation program. The purpose of this study is to adapt the Activating Behavior for Lasting Engagement (ABLE) program using video visits so people with stroke can participate from home.
• experienced a stroke in the last 12 months
• currently spend at least 6 hours per day sitting
• access to a device for virtual video visits
Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
• preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
• mother is 18 to 45 years of age at the time of delivery
• mother's BMI between 18.5 to 40 kg/m^2 before pregnancy or at first trimester
• preterm babies with significant health issues at birth
• mothers: a) alcohol consumption >1 drink per week or any tobacco use during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
MT-2018-20: COG AALL1631 - International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients (> 1 year and < 21 years) with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
• >= 1 year (365 days) and =< 21 years at ALL diagnosis
• Diagnosis: Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or molecular methodologies. OR
• Diagnosis: ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABLclass fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA.
• see link to clinicaltrials.gov for complete Inclusion Criteria
• known history of chronic myelogenous leukemia (CML)
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Down syndrome
• patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease (NPC-QIC)
• up to 15 months old
• newborns diagnosed with HLHS or other univentricular condition
• intended to undergo Norwood procedure
Enhanced Spatial Targeting in ECT Utilizing Focally Electrically-administered Seizure Therapy (FEAST)
The purpose of this study is to look at a different type of electroconvulsive therapy (ECT) that may reduce negative side effects while still providing relief from symptoms of major depression.
• age 22 to 90
• diagnosis of major depression
• ECT recommended for treatment
• other psychiatric diagnosis such as schizophrenia, schizoaffective disorder, other psychosis
• history of neurological illness -alcohol or substance abuse or dependence in the past year
• ECT in the past six months
Quantifying the Individual Heterogeneity of Presentation and Symptoms of Cognitive Impairment in Long COVID
This questionnaire and cognitive task study is being done to learn how different activities, like exercise, sleep, and stress, may affect symptoms of long COVID. We also want to know how symptoms may fluctuate over different times during the day and over several weeks. The study will take about 4 weeks to complete and will be done remotely.
• able to speak English
• have access to a compute with internet access
• history of having COVID-19
• continue to experience symptoms of long COVID-19 such as fatigue, "brain fog", trouble sleeping, headaches, etc.
• never tested positive for COVID-19
The DART Study
We are interested in learning more about how Transcranial Magnetic Stimulation (TMS) and ketamine affect depressive symptoms. We are most interested in learning how anhedonia (lacking pleasure in life) is changed by these treatments. Patients who have been diagnosed with treatment-resistant depression (TRD) and who are also scheduled to receive ketamine or Transcranial Magnetic Stimulation (TMS) are being recruited for this study. We are looking to enroll a second group of participants into a healthy control group who have not been diagnosed with a psychiatric disorder. This group will have a single 60 minute visit in which computer tasks and surveys will be completed while wearing an electroencephalogram (EEG) head cap to record brain activity.
• criteria for healthy volunteers: age 18 or older and able to read English
• diagnosis or history of depression, bipolar disorder, Generalized Anxiety Disorder, or other psychiatric conditions.
Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Psilocybin is the perception-altering drug found in ‘magic mushrooms’ and we want to learn more about visual perception in people taking psilocybin and how these relate to brain functions. Participants will be given an investigational study drug during 2 visits and asked to come in for a total of 7 study visits. Participants will also be required to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.
• 25-65 years of age
• have at least a high school education (GED ok) and able to speak and write English
• experience taking psilocybin
• in good physical and mental health with BMI between 20.0 and 28.0 kg/M2
• have someone who can drive to study sessions at the University of MN
• live within 1 hour driving distance of the University of MN
• agree not to use any recreational drugs while in the study ( for example, hallucinogens, ketamine, and marijuana)
• current or past history of a mental health issue
• currently taking any prescription medications on a daily basis, except birth control pills
• pregnant or breast feeding
• can't have a MRI
Composur, A Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Patients with Overactive Bladder
This study will evaluate treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with vibegron for the treatment of OAB in the context of real-world clinical practice.
• diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• symptoms of OAB for at least 3 months
• specific previous treatments for OAB (study staff will review)
• neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• women who are pregnant or breast feeding or planning to become pregnant
Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults with Prediabetes
We are looking at how an 8-week exercise program of walking for 30-45 minutes 3 times/week affects the body. This study is for people who are prediabetic and overweight or obese. We will compare the exercise group to a group that didn’t participate in the exercise to see if there are differences in gut microbes, body measurements, and blood work.
• 30-64 years old
• classified as overweight or obese with BMI greater than 25 kg/m2
• physician diagnosed as pre-diabetic or HbA1c value of 5.7 - 6.4% obtained during study screening
• currently exercise less than 100 minutes per week
• physically able to exercise
• no antibiotics taken for at least 45 days
• weight has been stable for the last 6 months (less than 10% change)
• willing to maintain current diet and exercise levels unless changed by the study
• current gastrointestinal illness
• taking metformin or other medications for high blood sugar
• history of bariatric surgery
• pregnant or breast feeding
PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.