Search Results
Prevalence of "funky" urine in lower urinary tract reconstruction utilizing bowel or catheter-based bladder management
This study is about improving our ability to characterize the prevalence of “funky” urine (i.e., urine with an abnormal odor, color, or appearance) in adults with either (1) a history of lower urinary tract reconstruction utilizing bowel and/or (2) catheter-based bladder management. We also aim to determine the frequency with which such patients receive antibiotic treatment for presumed urinary tract infections (UTIs). This may help us better understand how to help patients avoid unnecessary treatment with antibiotics.
• people who have catheter-based bladder management including an indwelling catheter (urethral or suprapubic, or a channel) or do intermittent clean catheterization OR
• have lower urinary tract reconstruction utilizing bowel including Ileal conduit, neobladder, bladder augmentation, or a catheter channel
• willing to share mobile phone number and use this for contact with the study team
Testing ACL Reconstruction Outcome PredicTions (TAROT)
The purpose of this study is to see how accurately orthopaedic surgeons predict outcomes for people who have an anterior cruciate ligament (ACL) reconstruction. Patients will be asked to complete post-surgery surveys about occurrence of side effects, return to activity, reoperation, and satisfaction with the surgery at 4 months, 2 years, and 5 years.
• patients undergoing primary ACLR (anterior cruciate ligament reconstruction) at the University of Minnesota, Tria and CentraCare.
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)
PEPN2415; A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD1390 (NSC# 852149, IND# 172675) when Combined with Focal Radiation in Pediatric Patients with High Grade Glioma
The primary purpose of this study is to define the recommended Phase 2 dose of AZD1390 when given in combination with radiation for pediatric supratentorial and infratentorial high-grade gliomas. The toxicities, safety profile and pharmacokinetic profile of AZD1390 in this setting will also be assessed.
• For the dose escalation phase, patients must be ≥ 12 months and < 18 years of age at the time of study enrollment.
• For the disease expansion phase, patients must be ≥ 12 months and < 22 years of age at the time of study enrollment.
• Patients with newly diagnosed primary High-Grade Glioma, Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma who are eligible to receive 54-59.4 Gy fractionated radiation at 1.8 Gy/day.
• Patients must have had histologic verification of malignancy at original diagnosis except in patients with DIPG.
• Patients who are pregnant or breast-feeding.
• Patients who are currently receiving another investigational drug.
• Patients receiving prior therapy for any cancer diagnosis (including radiation) is not allowed with the exception of surgery and/or corticosteroids.
• Patients who are currently receiving other anti-cancer agents are not eligible with the exception of corticosteroids.
• Anti-GVHD agents post-transplant: Patients who are receiving anti-graft-versus-host disease post bone marrow transplant.
Proteomics of Post-Operative Complications in Patients undergoing CABG
This study aims to identify independent blood-based risk factors for postoperative complications and near-term events among patients undergoing CABG surgery. In particular, this study will be using proteomics, the study of all proteins produced by the cells found in blood, as well as genetic analysis to identify potential predictive markers of postoperative complications. We will collect blood samples from before and after surgery. This study does not involve any medical treatment other than the one prescribed by your doctor, nor does it involve any additional medical procedures.
• Undergoing CABG procedure at MHealth Fairview hospital
• 45-80 years of age
• high risk patient as determined by the Society of Thoracic Surgeons (STS) Risk Assessment Score after designated number of patients have been included (study staff will review)
Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Perception of Affordances in Children with and without developmental coordination disorder
This study looks at perceptual abilities in healthy children and children with significant movement difficulties, a condition called developmental coordination disorder (DCD). The study involves a single session of using virtual reality (VR) to look at catching skills. This will help us to better understand movement difficulties in children so we can design programs to support them.
• children aged 11-17 years old with and without movement difficulties
• medical, behavioral, neurological or psychiatric conditions that prevent them from doing fine and gross motor activities
• children who are unable to communicate in English
Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies
This study will provide the most accurate and reliable estimates to date on disease progression and clinical events in evolving chronic pancreatitis. We also hope to develop from the results of this study some lab tests that will help us with early diagnosis of chronic pancreatitis and also to discover any genetic factors that may affect your chances of developing chronic pancreatitis.
• diagnosis of chronic pancreatitis.
• N/A
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58) (EF-41)
The current study aims at testing the efficacy of concomitant temozolomide, Optune and pembrolizumab compared to concomitant temozolomide, Optune and placebo, following preclinical and clinical evidence demonstrating the potential augmentation of the immune response against glioblastoma under this regimen.
• new diagnosis of Glioblastoma (GBM)
• recovered from surgery (if done)
• completed standard adjuvant chemoradiotherapy or radiotherapy (RT) with TMZ chemotherapy
• may be to do physically strenuous activity but able to walk able to carry out work of a light or sedentary nature, e.g., light house work, office work
• on stable or decreasing dose of corticosteroids
• received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137)
• diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• known additional malignancy that is progressing or has required active treatment within the past 3 years
A Phase 2, Randomized, Multicenter, Basket Study of Vosoritide in Children with Turner Syndrome, Short Stature Homeobox-Containing Gene Deficiency, and Noonan Syndrome with Inadequate Growth During or After Human Growth Hormone Treatment
This study is enrolling children with Turner syndrome, SHOX deficiency, or Noonan syndrome to evaluate the safety and effect of 3 doses of a study drug, vosoritide.The study will look at growth over a 6 month period of time. The study will also look at how well the the study drug works (efficacy) and its safety at the therapeutic dose up until the child reaches their final adult height.
• Males >= 3 years old to < 11 years old
• Females >= 3 years old to < 10 years old
• Genetically confirmed diagnosis of Turner syndrome, SHOX deficiency or Noonan Sydrome
• Have been receiving continuous human growth hormone treatment of short stature associated with their condition for a minimum of 1 year
• Diagnosis of another systemic disease or condition that may cause short stature
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Female Subjects with Androgenetic Alopecia
The research study will compare VDPHL01 with placebo (no active ingredient) to learn about the safety and how VDPHL01 works for women who have androgenetic alopecia (AGA). AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens resulting in hair loss. VDPHL01 is an extended release (ER) oral (taken by mouth) form of minoxidil.
• women
• 18-65 years of age
• mild to moderate Androgenetic Alopecia (AGA)
• history of organ transplant
• history of heart disease ~use of minoxidil ~use of GLP-1
Vasomotor symptoms of menopause and cardiovascular disease: What is the link?
Study to examine the physiological responses that occur during a hot flush in postmenopausal women
• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ≥ 35 kg/m2
Eye gaze patterns during audiovisual speech perception and natural conversation
The purpose of this research is to better understand how listeners take advantage of visual cues to support speech perception during conversations. Experiments will characterize these gaze strategies, describe how they vary with hearing ability and conversational context, and examine how differences in gaze behavior relate to listening effort during conversation.
• Be fluent in English
• Have normal or corrected-to-normal vision
• Have normal hearing OR Use a hearing aid
• Any vision disorders
• Cochlear implant
• Single-sided deafness
A Study to Determine the Prevalence and Clinical Characteristics Associated With PKD1 Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic disease which causes cysts to form in the kidneys. Over time as the cysts grow, the kidneys are not able to function the way they should, and may eventually lead to kidney failure. Certain people have a higher risk of developing ADPKD due to their genetic makeup. This study seeks to understand how often different types of PKD1/2 variations occur and the symptoms of ADPKD that people with PKD1/2 variants have. No study drug or devices will be administered.
• adults age 18-65
• pediatric patients age 12-17
• diagnosis of Autosomal dominant polycystic kidney disease (ADPKD)
• history of solid organ or bone marrow transplantation or nephrectomy
• ongoing renal replacement therapy or planning to start renal replacement therapy <12 months from the Genotyping Visit
Evaluation of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) resistance in the tumor tissue of Non-small cell lung cancer (NSCLC) patients
This study is about discovering how Non-small cell lung cancer becomes resistant to EGFR TKI targeted therapy in order to predict and prevent this cancer from not responding to treatment.
• Age 18-85 years
• confirmed advanced adenocarcinoma of the lung
• identified EGFR mutation
• treatment with osimertinib
• radiation or other drug treatments other than osimertinib
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
COgnitive STrategies in Early Psychosis 1
This study is about decision making in psychosis spectrum disorders, like schizophrenia. We will study how a single dose of a study agent called modafinil changes how people complete computer tasks and changes how the brain functions. We hope to improve our understanding of psychosis to help people in the future.
• 18 to 35 years old
• speak English as primary language
• major medical diagnosis such as neurological disorder, kidney, heart, liver disease
• people who are pregnant, breastfeeding, or planning to become pregnant
• have a diagnosis or immediate family history of a psychotic, bipolar, or autism spectrum disorder
• study staff will review additional criteria
A Phase 1, Open-label, Ascending Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Recombinant Human Heparan N-Sulfatase (rhHNS, GC1130A) Via Intracerebroventricular Access Device in Patients with Sanfilippo Syndrome Type A (MPS IIIA).
The purpose of the study is to see if GC1130A, delivered directly to the central ventricle of the brain is safe and tolerable as a means of treating the neurologic disease in MPS 3A.
• documented MPS IIIA diagnosis
• ≥ 24 months and ≤ 72 months of age
• significant non-MPS IIIA related central nervous system impairment
• previous complication from intraventricular drug administration
• contraindications for MRI scans and for neurosurgery
• received treatment with any investigational drug or a device intended as a treatment for MPS IIIA within 30 days
• received a hematopoietic stem cell or bone marrow transplant or received gene therapy
A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.
• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease (Le-Na)
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
• diagnosis of Gaucher Disease
• hematological cancer or other uncontrolled medical conditions
Reducing Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback at Family Meals
We are doing this study to learn about how we can best educate families about things that affect the health of children including eating together and cooking. If you agree to be in this study, you, your child, and your family will be randomly (by chance) put into one of three groups (Group 1, Group 2 or Group 3). Each group will receive a different type of education on childhood health.
• child 5-10 years old
• have a sibling who lives in the home with the child
• live in the Twin Cities Metro area
• speak English or Spanish
• child with medically necessary dietary restrictions (e.g., feeding tube)
• child is developmentally unable to participate in the study
ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)
This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.
ASSESS ALL ALS Study
We are doing this research to collect a wide range of samples, clinical information, and measurements that will be used for future research into ALS and related neurological diseases. Participants will be asked to complete 7 in-person study visits and monthly remote self-assessment activities. Access to a personal device (computer and/or smartphone or tablet) that is connected to the internet is needed to complete the monthly remote activities.
• diagnosis of Amyotrophic Lateral Sclerosis (ALS) by a physician
• 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
• for HEALTHY participants: no diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS), no family history ALS/Frontotemporal Dementia (FTD) in a close family member** unless the participant has previously tested negative for the known causative ALS genes, and 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
• see link to clinicaltrials.gov
• cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days of starting the study,
• clinically significant unstable medical condition
Sleep Outcomes with DBS Therapy in Parkinson's Disease and Dystonia
The objective of this study is to describe how activation of distinct pathways in and around the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS) surgery targeting these structures.
• at least 21 years old
• existing or planned 7T brain imaging
• surgery at UMN to implant DBS system planned as part of routine clinical care (or has already occurred, as long as the first programming session is at least 2 weeks away)
• other significant neurological disorder
• history of dementia
• complications after surgery
• women who are pregnant
Udall P1A4
Through this research, the study staff hopes to better understand how DBS works and to define the optimal site in the brain for DBS treatment for Parkinson’s Disease. You will be asked to come for one study visit where you will perform some physical and mental tasks while on and temporarily off your medications and DBS treatment. Participation in this research study will take 7-8 hours.
• at least 10 years old
• diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia
• implanted Deep Brain Stimulator (DBS)
• have a 7T MRI
• history of dementia
• women who are pregnant or breastfeeding
• other exclusion criteria (study staff will review)
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.
• diagnosis of Essential Tremor (ET)
• age 21 or older
• will receive a Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
• 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
Vestibular and Cortical Contributions to Transitions in Freezing of Gait and Parkinson's Disease
This study will examine the brain activation associated with the transition between movements in Parkinson’s disease, and if these changes are related to the development of problems with moving (like freezing of gait) and thinking. We will look at brain activity associated with the vestibular (inner ear) and cortical (surface of the brain) systems. People with Parkinson’s disease (especially people with freezing of gait) sometimes have difficulty initiating changes in movement types, such as going from standing to walking, turning, or switching between slow and fast repetitive movements. The difficulty in movement transitions may be associated with an overactive vestibular system (inner ear) or cortical system. In each experiment in this study, we expect about 20-25 participants with Parkinson’s disease and freezing of gait, 20-25 participants with Parkinson’s without freezing of gait, and 20-25 control participants
• 40 to 80 years old
• diagnosis of idiopathic PD with and without freezing gait
• able to walk independently without the use of an assistive device (e.g. cane) for 50 meters (about 160 feet)
• for HEALTHY OLDER ADULTS: 40 to 80 years old, able to walk independently without a cane or walker and able to perform complex activities of daily living independently
• any musculoskeletal disorder that affects the ability to stand or walk
• history of musculoskeletal disorders that significantly affect movement of lower limbs
• uncorrected visual impairment
• history of visual and/or vestibular conditions
• moderate to severe hearing impairment
• women who are pregnant
• study staff will discuss additional exclusion criteria
Imaging Core Aim 2, and Udall Project 2 Aim 2
We are conducting this research to try to find a better way of treating Parkinson's disease, specifically postural instability and gait disturbances (PIGD) by looking at certain brain characteristics using 3T magnetic resonance imaging (MRI.) We think we could discover how to make DBS more effective for such things as postural gait instability and other symptoms of PD. Participants will be asked to come to our research location, walk on a treadmill, and have a 3T MRI.
• at least 21 years old
• already have a MRI-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson’s disease
• able to speak English
• women who are pregnant
• extreme claustrophobia
• unable to have a MRI
Mechanisms and effects of pallidal deep brain stimulation on levodopa resistant motor signs in Parkinson's disease; Udall Project 2, Aim 2
We hope to identify patterns in the brain that may be related to symptoms of PD, such as problems with walking. We are also testing different stimulation settings to see if they might be more effective than the settings that are currently used for treatment. This research may aid in our understanding of PD and how to treat it more effectively with DBS.
• receiving DBS therapy in for treatment of Parkinson's Disease (PD)
• implanted with Medtronic Percept DBS system
• at least 3 months since initial activation of the DBS
• musculoskeletal disorders that significantly affect the ability to perform the motor tasks
• dementia or cognitive impairment
• other significant neurological disorders
• post-operative complications or adverse effects of the DBS stimulation