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Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU

This study will be a prospective analysis of a post-operative transplant cohort in the PICU to determine whether using magnesium sulfate as an analgesic adjuvant can decrease overall opiate requirement in this patient population. It will indirectly also look at opiate-induced side effects, effects on overall PICU course, and applicability/safety of a magnesium infusion in pediatric patients. It is well known that post-operative analgesia in children is one of many challenges faced by surgeons and intensivists, both due to the invasiveness of procedures as well as the biopsychosocial variance in these populations. TPIAT (total pancreatectomy and islet autotransplantation) and liver transplant patients at our institute have protocols designed for their management, part of which includes continuous opiate dosing, other adjuvants (such as tylenol, ketorolac, ketamine), and sometimes paravertebral nerve blocks. All of these medications, despite their benefits, come with their own unique side effect profile. Opiates remain no stranger to this, in addition to a distinct growing shortage nationwide. Magnesium sulfate has been cited as a potential source of adjuvant analgesia by its action on the NMDA receptor. Pediatric populations where magnesium has shown potential analgesic benefit include post-tonsillectomy, post-osteotomy (cerebral palsy), post-operative scoliosis repair, sickle cell, and hsevere headache management. Literature also supports use in adult populations, which includes more expansive operative cohorts. Added benefit of magnesium is its overall safety profile (symptoms not present until levels significantly above normal indices), cost-effectiveness, and incidental overall prevalence of hypomagnesemia within PICU populations. We plan to implement a magnesium therapy protocol to all of our liver and TPIAT transplant children in the pediatric ICU with dosing that has been used both efficaciously (in comparison to available adult data) and safely (in comparison to other pediatric studies). This will be done via a bolus dose in the operating room followed by infusion dosing for the next 48 hours. Magnesium levels will be checked serially to ensure they remain below toxic levels. We will track opiate dosage metrics throughout their post-operative ICU admission, as well as other secondary outcomes listed elsewhere. The control will be a retrospective chart review of the same primary and secondary outcome measures from previous post-transplant patients in this PICU. The study protocol has been approved by the U.S Food & Drug Administration, which will also be involved in monitoring of the study.

Gwenyth Fischer
fisch662@umn.edu
All
3 Years to 18 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04812028
STUDY00005974
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Inclusion Criteria:
Experimental Group:
•Be scheduled for and receive a liver transplant or total pancreatectomy and islet cell autotransplantation Control Group:
•Received a liver transplant or total pancreatectomy and islet cell autotransplantation.
Exclusion Criteria:
Experimental Group:
• Pregnant or unwilling to abstain from sex if not practicing birth control during participation in the study.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Known allergic reactions to components of the MgSO4
• History of heart block or myasthenia graves in past medical history.
• Presence of cardiac pacemaker
• Any patient with preoperative creatinine level > 1.5x upper limit of normal. Control Group:
• Any patient who had filed as research-exempt (opt-out of research previously).
• Any patient with preoperative creatinine level > 1.5x upper limit of normal.
Drug: Magnesium sulfate
Postoperative Pain
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University of Minnesota — Minneapolis, Minnesota Lexie Goertzen - (lexieg@umn.edu)

Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery

Cole Bennett
bennettc@umn.edu
All
18 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04776954
STUDY00012072
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Inclusion Criteria:

•Undergoing elective renal transplantation
Exclusion Criteria:

• Previous surgery involving organ transplantation or nephrectomy. These patients are at higher risk of blood loss, making temperature regulation subject to more variables outside our control.
• End stage renal disease with decreased or no urine output from normal. Bladder temperature will not be valid in these patients.
• Previous upper extremity amputations
• Ongoing sepsis or other infection
• Thyroid dysfunction
• Emergency surgery
• Refusal of consent to participate in study
• Pregnancy
Device: Forced Air Warming System, Device: Resistive Blanket Warming System
Surgery, Temperature Change, Body
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University of Minnesota — Minneapolis, Minnesota

Study on Hypoallergenic Hair Dye

Permanent hair dyes are commonly used in over-the-counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well-known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of PPD with less allergy potential.

Paul Bigliardi
pbigliar@umn.edu
All
18 Years to 90 Years old
This study is NOT accepting healthy volunteers
NCT04772482
STUDY00012094
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Inclusion Criteria:

•Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)
Exclusion Criteria:

• Use of oral immunosuppressive, anti-inflammatory and chemotherapy medications, particularly corticosteroids for at least 1 month before testing.
• Immunocompromised patient (e.g. Cancer, Diabetes mellitus, medication, Immunodeficiency, radiation therapy)
• History of acute hepatitis, chronic liver disease or end stage liver disease.
• History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
• Use of illicit drugs within the past 6 months prior to study start and/or opioid use disorder.
• Pregnancy as established by questionnaire
Diagnostic Test: Sensitivity Patch Testing
Contact Dermatitis, Allergy, Dermatitis, Dermatitis
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University of Minnesota — Minneapolis, Minnesota Paul Bigliardi, MD

Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks

This study will examine the effects of non-invasive, transcranial electric stimulation (TES) on neural activity during a cognitive task or rest using invasive recordings in patients undergoing phase II epilepsy monitoring.

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04680481
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Inclusion Criteria:
1. the patient can consent for themselves; 2. the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation; 3. age 18+ years old;
Exclusion Criteria:
1. diminished capacity to consent;
Device: Transcranial alternating current stimulation
Working Memory
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University of Minnesota — Minneapolis, Minnesota Ivan Alekseichuk, PhD - (ialeksei@umn.edu)

Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.

Christine Conelea
cconelea@umn.edu
All
12 Years to 21 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04578912
STUDY00010519
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Inclusion Criteria:

• 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. Tics must not be due to a medical condition or the direct physiological effects of a substance.
• 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 or equal to 70
• English fluency to ensure comprehension of study measures and instructions.
• Right-handed
Exclusion Criteria:

• Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or participants of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician
• Inability to undergo MRI.
• Left handedness.
• Active suicidality.
• Previous diagnosis of psychosis or cognitive disability.
• Substance abuse or dependence within the past year.
• Concurrent psychotherapy focused on tics.
• Neuroleptic/antipsychotic medications.
• Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT), Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Continuous Theta Burst Stimulation (cTBS)
Tic Disorders, Tics, Tic, Motor, Tic Disorder, Childhood, Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence
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University of Minnesota — Minneapolis, Minnesota Christine Conelea, PhD

Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)

All
11 Years to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04562688
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Inclusion Criteria:
1. Potential participant is between the age of 11 and 18 (inclusive) at the time of consent. 2. Potential participant has a clinical diagnosis of Autism Spectrum Disorder (ASD), as confirmed by medical/clinical records or standardized assessments/interviews (e.g., Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) or Autism Diagnostic Interview
•Revised (ADI-R)). 3. Potential participant has an IQ Score > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) or a comparable measure in medical/clinical records. 4. Potential participant has normal or corrected to normal vision (20/20 or better; self/parent-reported. 5. Potential participant has normal hearing (self/parent-reported). 6. Potential participant is a fluent English speaker, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician, to ensure reasonable neuropsychological results on key assessments. 7. Potential participant has adequate sensorimotor capacity to perform the intervention and study activities, including visual capacity adequate to read from a computer screen or mobile device at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer, based on participant and/or parent/legal guardian self-report and as determined by the screening clinician and/or study team. 8. Potential participant must be clinically stable as a result of therapy or medication regimen for 4 weeks prior to enrolling into the study. 9. Potential participant has reliable access to the internet.
Exclusion Criteria:
1. Potential participant has history of psychotic disorders and/or seizure disorder and/or seizure episodes within the last 2 years. 2. Potential participant has a motor/perceptual handicap that prevents digital device use, as determined by the screening clinician and/or study team. 3. Potential participant has problems in performing assessments or comprehending or following spoken instructions, as determined by the screening clinician and/or study team. 4. Potential participant has medical illnesses/genetic syndromes deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, ongoing chemotherapy or other cancer treatment. 5. Potential participant has a history of head trauma, traumatic brain injury, or other neurological disorder that impairs cognition 6. Potential adult participant scores less than a 14 (75%) on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). Please note, this criteria applies only to adult participants, age 18, at the time of screening.
Other: CICADAS and then PEERS, Other: PEERS + CICADAS and then no-contact, Other: PEERS + Active Comparator and then no-contact
Autism Spectrum Disorder
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University of Minnesota — Minneapolis, Minnesota Megan DuBois - (canlab@umn.edu)

Outpatient Treatment of SARS-CoV-2 With Ivermectin, Fluvoxamine, and Metformin (COVID-19)

1) Determine whether metformin can prevent ED utilization for Covid-19 disease in persons with SARS-CoV-2 infection; 2) Determine whether metformin is effective post-exposure prophylaxis of SARS-CoV-2 infection in persons with close contact to someone with SARS-CoV-2 infection

Carolyn Bramante
bramante@umn.edu
All
30 Years to 85 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04510194
STUDY00011393
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Inclusion Criteria:

• Positive laboratory test for active SARS-CoV-2 viral infection based on local laboratory standard (i.e. +PCR) within 3 days of randomization.
• No known history of confirmed SARS-CoV-2 infection
• BMI >= 25kg/m2 by self-report height/weight or >= 23kg/m2 in patients who self-identify in South Asian or Latinx background.
• Willing and able to comply with study procedures (i.e. swallow pills)
• Has an address and electronic device for communication
• GFR>45ml/min within 2 weeks for patients >75 years old, or with history of heart, kidney, or liver failure.
Exclusion Criteria:

• Hospitalized, for COVID-19 or other reasons.
• Symptom onset greater than 7 days before randomization (symptoms not required for inclusion).
• Immune compromised state (solid organ transplant, bone marrow transplant, AIDS, on high dose steroids)
• Hepatic impairment (Child-Pugh B and C) or other condition that, in the opinion of the investigator, would affect safety
• Inability to obtain informed consent
• Enrollment in another blinded Randomized Controlled Trial for COVID-19
• Already received an effective (FDA approved/EUA*) therapy for COVID-19 (currently monoclonal antibody treatment)
• Alcohol use disorder
• Other unstable medical condition or combination of home medications that in the view of the PI make it unsafe for the individual to participate
• History of severe kidney disease i.e.: 1. Stage 4 or 5 CKD, or Estimated Glomerular Filtration Rate (eGFR) of < 45ml/min/1.73 m2 2. Other kidney disease that in the opinion of the investigator would affect clearance
• Unstable heart failure (Stage 3 or 4 heart failure)
• Allergic reaction to metformin, fluvoxamine, or ivermectin in the past
• Bipolar disease: individuals who report they have bipolar disorder or are taking medication for bipolar disorder (lithium, valproate, high-dose antipsychotic), unless the investigator concludes that the risk for mania is unlikely
• Current loa loa or onchocerciasis infection
• Typhoid, BCG, or cholera vaccination within the 14-days or 3 days after Medication Exclusions:
• Cimetidine, hydroxychloroquine, insulin, sulfonylurea, dolutegravir, patiromer, ranolazine, tafenoquine.
• Rasagiline, selegiline, or monoamine oxidase inhibitors, linezolid, methadone
• Duloxetine, methylene blue
• Tizanidine, ramelteon, sodium picosulfate
• Alosetron, agomelatine, bromopride, dapoxetine, tamsimelteon, thioridazine, urokinase, pimozide The following medications may not need to be excluded when dose for that individual is considered alongside the low dose of fluvoxamine being used and other medications being used. The PI or site PI may review and decide if the patient should be excluded from the fluvoxamine arms: 1. Taking SSRIs, SNRIs, or tricyclic antidepressants, unless these are at a low dose such that a study investigator concludes that a clinically significant interaction with fluvoxamine (ie either serotonin syndrome or TCA overdose) is unlikely (examples: participant takes escitalopram but only at 10mg daily; that dose plus 100mg fluvoxamine would be insufficient to cause serotonin syndrome; or, participant takes amitriptyline but only at 25mg nightly; even if fluvoxamine inhibits its metabolism, it would be an insufficient dose to cause QTc prolongation or problematic side effects). Risk Class C, monitor therapy. 2. Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 20% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs). Risk Class C, monitor therapy 3. Participants taking theophylline, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine) will be reviewed with a study investigator and excluded unless the investigator concludes that the risk to the participant is low (this would be unlikely; example: participant takes clozapine only as needed and is willing to avoid it for the 14 days of the study). 4. Patients will be advised that there is a small risk that the following substances will be affected by fluvoxamine, but that significant effects are not likely at the low dose being used: caffeine, nicotine, melatonin. Risk Class C, monitor therapy 5. Taking warfarin-also known as Coumadin, NSAIDs, and Aspirin (rationale: increased risk of bleeding), phenytoin (rationale: fluvoxamine inhibits its metabolism), clopidogrel (rationale: fluvoxamine inhibits its metabolism from pro-drug to active drug which raises risk of cardiovascular events), and St John's wort (rationale: fluvoxamine + St John's wort are considered contraindicated because of the risk of serotonin syndrome) Risk C, monitor therapy.
Drug: Metformin, Drug: Placebo, Drug: Fluvoxamine, Drug: Ivermectin
Covid19, SARS-CoV Infection
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University of Minnesota — Minneapolis, Minnesota Carolyn Bramante, MD, MPH - (covidout@umn.edu)

Poke and a Placebo

The purpose of the study is to discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure. The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. One script will contain the wording “Poke and a burn” prior to subcutaneous local anesthetic administration for the epidural placement and one will contain “this is numbing medication, which will make the rest of the procedure go easier”. There will be no difference in the epidural placement, medications, or the rest of the script. After the procedure the patient will be asked to circle their responses to three questions regarding the epidural experience.

Aaron Berg
bergx831@umn.edu
Female
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04497220
STUDY00010360
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Inclusion Criteria:

• pregnancy
• requesting an epidural for the first time
Exclusion Criteria:

• previous epidural (either for labor or for surgery)
• BMI greater than 40 kg/m^2
• previous lumbar spine surgery
• inability to speak English
• a history of chronic pain or are on chronic opioids
• a history of opioid drug abuse
Behavioral: Negative Connotation Langauge, Behavioral: Positive Connotation Language
Anesthesia
Epidural Anesthesia (labor)
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University of Minnesota — Minneapolis, Minnesota Candace Nelson - (nelso377@umn.edu)

Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

This study will enroll adults who are currently in a methadone treatment program and clinically stable in a randomized, double-blind, transcranial direct current stimulation (tDCS) intervention (active or sham) trial study. The primary study aim seeks to examine whether pairing non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) with cognitive training, as a therapeutic intervention can enhance cognition and reduce relapse rates in opioid use disorder. The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder.

All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04495673
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Inclusion Criteria:

• Current diagnosis of opioid use disorder
• Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable.
• Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder
• Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use.
• Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
• Head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
• Any contraindications for tDCS or MRI scanning (tDCS contraindication: actively receiving treatment for seizures or epilepsy; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
• Current active psychosis or mania
• Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis)
• Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
• Current stimulant use disorder (need to be free of stimulant use for at least 1 month)
• History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies
• incarceration
Device: Transcranial Direct Current Stimulation (tDCS), Device: Sham Transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive Training
Opioid-Related Disorders, Heroin Dependence, Morphine Dependence
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University of Minnesota — Minneapolis, Minnesota Lisa Keacher - (keach003@umn.edu)

Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women

Manda Keller-Ross
kell0529@umn.edu
Female
35 Years to 70 Years old
This study is also accepting healthy volunteers
NCT04439370
STUDY00004979
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Inclusion Criteria:

• Aged 35-49 or 50-70 years of age who experienced premature (<40) or early (≤45) menopause
• Premenopausal 35-49 years of age
• Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
• Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of >30 mIU/mL
Exclusion Criteria:

• Current nicotine/tobacco use within the past six months
• Are diabetic or asthmatic
• Have diagnosed significant carotid stenosis
• Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
• Have existing metabolic or endocrine abnormities
• Take any heart/blood pressure medications that are determined to interfere with study outcomes
• IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
• Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
• Are pregnant or breastfeeding
Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA), Diagnostic Test: Baroreflex sensitivity testing, Diagnostic Test: Sympathoexcitatory Maneuvers, Diagnostic Test: Blood tests
Hypertension, Menopause, Premature, Menopause, Blood Pressure
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University of Minnesota — Minneapolis, Minnesota Manda Keller-Ross, PhD, DPT, PT - (kell0529@umn.edu)

Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (Exergames)

The purpose of this study is to examine the efficacy of a new low-cost Virtual Reality Cognitive Training (VRCT) combined with concurrent cycling intervention called exergame on improving cognition in at-risk community-dwelling older adults at risk for Alzheimer's disease and dementia. We will conduct this study in two phases: Phase I (Feasiblity Testing)aims: Aim1. Develop a prototype exergame that supports integrated, concurrent cycling and VRCT. Aim 2. Examine the feasibility of the exergame in older adults at risk for AD. Phase II (Effect Testing) aims: Aim 1. Develop a fully-featured version of the VRCT aspect of the exergame. Aim 2. Determine the efficacy of the exergame in older adults at risk for AD using an RCT. We hypothesize that cognitive improvement will be greatest for exergame subjects followed by cycling subjects, and least in control subjects. Aim 3. Assess the distraction effect of the concurrent VRCT in exergame on gains in aerobic fitness. We hpothesize that exergame subjects will achieve similar gains in aerobic fitness to cycling only subjects (difference is < 1 standard deviation).

All
65 Years and over
N/A
This study is also accepting healthy volunteers
NCT04311736
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Inclusion Criteria:
1. Cognitive complaint (defines as answering yes to the question "Do you feel that your memory or thinking skills have gotten worse recently within the last 2 years?"); 2. Not engaging in aerobic exercise or cognitive training >2 days/week, 30 minutes a session in the past 3 months; 3. Age 65 years and older; 4. Written consent. 5. Medical clearance to participate in a supervised exercise program
Exclusion Criteria:
1. Resting heart rate > 100 or <50 beats/min with symptoms; 2. Dementia or mild cognitive impairment (self-report, diagnosis, or scoring <26 on the Telephone Interview for Cognitive Status; 3. Evidence that cognitive decline or memory complaints were caused by underlying neurological or psychiatric disorder or chemical dependency as determined by primary health care provider; 4. Current enrollment in another intervention study; 5. ACSM contraindications to exercise or other factors that make exercise impossible or unsafe.
Behavioral: Exergame, Behavioral: Cycling, Behavioral: Stretching
Mild Cognitive Impairment, Exercise Training
mild cognitive impairment, cognitive decline, aerobic exercise, physical exercise, exercise training, cognitive exercise, cognitive games, virtual reality
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University of Minnesota — Minneapolis, Minnesota Russell L Spafford, MS - (spaff010@umn.edu) Dereck L Salisbury, PhD - (salis048@umn.edu)

Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity

In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribe meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.

Aaron Kelly
kelly105@umn.edu
All
12 Years to 18 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04298203
STUDY00008743
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Inclusion Criteria:

• Severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• Age 12 to < 18 years of age at enrollment (screening) and Tanner stage >/= 2
Exclusion Criteria:

• Diabetes (type 1 or 2)
• Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide, lorcaserin, and/or combination naltrexone/bupropion
Drug: Phentermine-Topiramate, Dietary Supplement: Meal Replacement Therapy, Other: Placebo
Obesity
Childhood, Adolescent
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University of Minnesota — Minneapolis, Minnesota

Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants

Study design: Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neuro development in preterm infants. Aim 1: Characterize differences in preterm pain responses between MBI and controls.The objective of this aim is to understand the behavioral processes of MBI on pain in preterm infants by comparing the PIPP and EEG pain responses in the MBI and control cohorts. Aim 2: Identify differences between MBI and controls in preterm brain maturation and early neurodevelopment.The objective of this aim is to explore biological mechanisms of MBI on preterm brain maturation and neurodevelopment using electroencephalography (EEG) and event related potentials (ERPs).

Sonya Wang
sgwang@umn.edu
All
28 Weeks to 32 Weeks old
N/A
This study is also accepting healthy volunteers
NCT04286269
STUDY00008369
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Inclusion Criteria:

• Preterm infant born at 30 weeks (+/- 2 weeks)
• Medically stable
Exclusion Criteria:

• Treatment for major organ system disease
• Significant neurological disorder including, but not limited to, abnormal neurological examination, neonatal abstinence syndrome, intraventricular hemorrhage, seizures, meningitis, or congenital brain malformations
• Scalp lesions affecting EEG placement
Other: Music Based Intervention, Other: Sham Treatment
Preterm Birth, Pain
Music Based Intervention, Preterm Infant Pain Profile
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University of Minnesota — Minneapolis, Minnesota Sonya Wang, MD - (sgwang@umn.edu)

Prolonged Daily Fasting as a Viable Alternative to Caloric Restriction in At-Risk Obese Humans

It is an interventional trial examining the effect of dietary intervention (TRE: eight hour eating window with ad libitum intake, CR: caloric restriction by 15%, non-TRE: unrestricted control group) in humans. Purpose: Obesity is reaching epidemic proportions, affecting 36% of the adult population in the United States. There is intense interest in dietary management to treat obesity and its associated complications. The first line of obesity treatment is caloric restriction (CR), although recidivism is common. For moderate CR, attrition rates of 20% are often reported, therefore weight loss options beyond CR are urgently needed.

Lisa Chow
chow0007@umn.edu
All
18 Years to 65 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04259632
STUDY00008545
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Inclusion Criteria:

• BMI ≥30 and ≤ 55 kg/m^2
• Own a smartphone compatible with the myCircadianClock (mCC) phone application
• Self-reported habitual wakening between 5-9 am
• Self reported sleep duration of 6-9 hours
• Self reported absence of known sleep apnea
• Weight must be stable [+/- 5 pounds] for at least 3 months prior to the study
• Eating window (time between 1st food intake and last food take) ≥14 hours using mCC
• Insulin resistance based on HOMA-IR≥ 2.5 from screening visit results
• Able to understand English
Exclusion Criteria:

• Use of beta-blockers or medications known to affect weight, such as thiazolidinedione (TZD), insulin, glucagon-like peptide (GLP)-1 agonists, phentermine, or sibutamine
• Shift work (i.e. working from 11pm to 7am)
• Clinically significant medical issues (diabetes, cardiovascular disease, uncontrolled pulmonary disease)
• A history of abnormal laboratory results, such as hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5)
• MRI contraindication (metal in body, claustrophobia)
• Eating window < 12 hours per day
• Unable to consistently document food intake using the mCC app (need at least 2 eating occasions> 6 hours apart on a given day for at least 50% of days)
• Pregnancy
• Illiteracy
• Concern for active eating disorder per screening questionnaire
• Self-reported eating disorder or history of eating disorder
Behavioral: Time Restricted Eating (TRE), Behavioral: Caloric Restriction (CR)
Obesity
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University of Minnesota — Minneapolis, Minnesota Lisa S Chow, MD - (endores@umn.edu)

Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat

This study is one of three studies on an NIH-funded project addressing the effectiveness of parents in buffering children and adolescents from the physiological and brain responses to stress. This study uses MRI scanning to measure the brain response to social evaluative stress (giving a speech and doing math problems in front of a panel of judges) as well as the impact of the presence of various social partners (no one, researcher, or parent) in buffering the physiological and brain responses to social evaluative stress.

All
11 Years to 14 Years old
N/A
This study is also accepting healthy volunteers
NCT04211155
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Inclusion Criteria:

• sufficient vision to complete assent and study procedures
• sufficient hearing to complete assent and study procedures
• sufficient language skills to provide verbal and written assent
Exclusion Criteria:

• Premature birth (less than 37 weeks)
• congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
• Autism Spectrum Disorders
• history of serious medical illness (e.g., cancer, organ transplant)
• youth taking systemic glucocorticoids
• youth taking beta-adrenergic medications
• diagnoses of psychiatric illness, seizure disorder or other neurological disorders
• contraindications for MRI (implanted medical device; presence of non-removal metal in or on the body, including piercings, orthodontic braces or certain permanent retainers)
• known pregnancy
• tattoos
• history of significant claustrophobia
Other: Questionnaires, Other: MRI
Social Stress, Adolescent Behavior
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University of Minnesota — Minneapolis, Minnesota Bonny Donzella - (donzella@umn.edu)

Post-contracture Release Radiation for Dupuytren's Disease

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04122313
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Inclusion Criteria:

• Diagnoses of Dupuytren's disease
• English-speaking
Exclusion Criteria:

•Patients with Dupuytren's disease who are not currently seeking treatment
Other: Evaluation of Dupuytren's Disease Treatment
Dupuytren's Disease, Dupuytren Contracture, Dupuytren Disease of Palm and Finger, Dupuytren Disease of Finger, Dupuytrens Contracture of Both Hands, Dupuytren's Disease of Palm of Right Hand, Dupuytren's Disease of Palm of Left Hand, Dupuytren Contracture of Right Palm, Dupuytren Contracture of Left Palm, Dupuytren's Contracture Left, Dupuytren's Contracture Right
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University of Minnesota — Minneapolis, Minnesota Kathryn Dusenbery, MD - (dusen001@umn.edu)

Enhanced Spatial Targeting in ECT Utilizing FEAST

Twenty ECT eligible TRD patients will receive a course of FEAST with up to 12 sessions (including titration) in an open trial design. Sessions 2,3 and 4 will be cross-randomized between ‘typical’ FEAST electrode configuration, the same electrode placement but a reversed polarity of current flow (RP FEAST) and the reverse electrode configuration FEAST (RC FEAST). Electrophysiological markers of the induced seizure will be captured with a 6-lead EEG placed over bilateral frontal, temporal and parietal lobes.

Ziad Nahas
znahas@umn.edu
All
18 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04099342
STUDY00006734
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Inclusion Criteria:

• Diagnosis of major depressive disorder using mini-7 to derive RDC; DSM-IV
• Pretreatment HRSC score greater than or equal to 18
• ECT indicated by physician evaluation
• Willing and capable of providing informed consent as determined by physician evaluation
Exclusion Criteria:

• History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder as determined by mini-7; rapid cycling defined as greater than or equal to four episodes in past year
• History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) determined by physician evaluation and medical history
• Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation
• Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy determined by physician evaluation
• Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. determined by physician evaluation
• ECT in the past six months determined by physician evaluation and medical history
• Pregnancy as determined by urine pregnancy test and clinical interview
Device: FEAST RC, Device: FEAST, Device: FEAST RP
Treatment Resistant Depression
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University of Minnesota — Minneapolis, Minnesota Ziad Nahas, MSCR - (znahas@umn.edu)

Bupropion for the Prevention of Postpartum Smoking Relapse

Our central hypothesis is that bupropion will prevent postpartum smoking relapse among women who quit smoking during pregnancy. To explore this hypothesis, we will conduct a two-arm, double-blind, placebo-controlled randomized clinical trial using rigorous, validated and reproducible methods that will be implemented by a team of experienced investigators who are familiar with this population. We will enroll pregnant women (n=230) who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization. Intervention adherence will be confirmed quantitatively via high-performance liquid chromatography using biological samples. The implications of this novel study, pursued by a highly skilled and productive team, will directly advance the current state of the science by expanding on the role of a known pharmacotherapy within this highly vulnerable population. Further, should our central hypothesis be supported, the dissemination of this intervention is clinically applicable, relevant and maybe immediately pursued.

Sharon Allen, PhD
allen001@umn.edu
Female
18 Years to 40 Years old
Phase 4
This study is also accepting healthy volunteers
NCT04098874
STUDY00007684
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Inclusion Criteria:

• Ability to provide informed consent
• Age 18 to 40 years old
• Stable health
• 7-day point prevalence abstinence demonstrated at randomization
• Lifetime history of at least 100 cigarettes smoked
• Quit smoking during the current pregnancy
• Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
• Uncomplicated delivery
• Denies plans to become pregnant again during the trial.
• Full-term delivery ≥ 37 weeks gestation
• Home within 10 days of delivery
Exclusion Criteria:

• Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• Current use of cessation aids (e.g., varenicline, NRT)
• Current use of illicit drugs or alcohol dependence
• Current use of antidepressant medication
• Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
• Medications & conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6)
• Family history of seizures or seizure disorder
• Maternal use of medications that lower seizure threshold
• Newborn with an elevated risk of seizure
Drug: Bupropion Extended Release Oral Tablet, Drug: Placebo oral tablet
Postpartum Smoking Relapse
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University of Minnesota — Minneapolis, Minnesota Sharon Allen, MD

Cf-DNA Assay During Treatment of Acute Rejection

Arthur Matas, MD
matas001@umn.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04019353
STUDY00005393
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Inclusion Criteria:

• Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction.
Exclusion Criteria:

• <1 months post-transplant
• >12 months post-transplant
Genetic: cf-DNA Collection
Kidney Transplant Failure and Rejection, Kidney Transplant, Complications, Kidney Transplant Rejection, Transplant, Complication, Rejection, Transplant Dysfunction
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University of Minnesota — Minneapolis, Minnesota Arthur Matas, MD - (matas001@umn.edu)

SMART Use of Medication for the Treatment of Adolescent Severe Obesity (SMART)

This is a single site, 2-staged sequential multiple assignment randomized trial (SMART) that will systematically examine: 1) the optimal timing (12- versus 24 weeks) for identifying non-responders to lifestyle modification therapy (LSMT) before starting adjunct pharmacotherapy with phentermine and 2) for non-responders to LSMT+phentermine, the relative effect of adding topiramate to LMST+phentermine versus switching to LSMT+topiramate monotherapy. All participants will receive a total of 48 weeks of intervention.

Claudia Fox
lusc0001@umn.edu
All
12 Years to 17 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04007393
STUDY00006824
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Inclusion Criteria:

• Provision of signed and dated informed assent form;
• Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• BMI >/= 1.2 times the 95th percentile or BMI >/= 35 Kg/m2, whichever is lower;
• Tanner stage >/= 2;
• Male or female, aged 12-17 at time of consenting;
• For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation;
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion Criteria:

• Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension;
• Diabetes (type 1 or 2);
• Presence of cardiac pacemaker;
• Current or recent (<6 months prior to enrollment) use of weight loss medication(s);
• Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months;
• Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants;
• Seizure disorder (other than infantile febrile seizure);
• Previous bariatric surgery;
• Recent initiation of change in dose (< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s);
• Tobacco use
• History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency;
• Unstable depression or anxiety that has required hospitalization in the past year;
• Any history of suicide attempt;
• Suicidal ideation or self-harm within 12 months prior to enrollment;
• Bicarbonate < 18 mmol/L;
• Creatinine > 1.2 mg/dL;
• History of cholelithiasis;
• History of nephrolithiasis;
• Untreated thyroid disorder;
• Hyperthyroidism;
• Breastfeeding
Behavioral: Lifestyle Modification Therapy (LSMT), Drug: Phentermine Pill, Drug: Topiramate Pill
Adolescent Obesity
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University of Minnesota — Minneapolis, Minnesota Claudia Fox, MD - (lusc0001@umn.edu) Nina Jacobs - (njacobs@umn.edu)

Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens

Dorothy Hatsukami
hatsu001@umn.edu
All
18 Years and over
Phase 2
This study is also accepting healthy volunteers
NCT03978117
STUDY00003508
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Inclusion Criteria:

• Adult Male or female. Participants can be smokers or non-smokers
• In good physical health
• In stable and good mental health
• Not using any medications that may affect the Nrf2 pathway
• Women who are not pregnant or nursing or planning to become pregnant
• Participants have provided written informed consent to participate in the study
Exclusion Criteria:

• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
• Vital signs outside of the allotted range
• Not willing to abstain from eating cruciferous vegetables during the course of the study
Dietary Supplement: Freeze dried Powder, Dietary Supplement: Placebo Preparation
Healthy
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University of Minnesota — Minneapolis, Minnesota Hanna Vanderloo, RN, MSN

Low Sulfur Fecal Transplant for Ulcerative Colitis

This study is a pilot randomized controlled clinical trial examining how fecal microbiota transplant (FMT) given by capsules can change the bacteria and inflammation in people with active ulcerative colitis (UC). We will look at global changes of bacterial composition while on FMT versus those not on FMT. We are examining some specific groups of bacteria that are related to sulfate reduction. Will will measure the changes of sulfate reducing bacteria over time and among those who get better and those who don't. Overall, we aim to determine if we can alter the microbiota in UC towards a healthy, more diverse microbiota resembling the donor using capsule FMT material.

Byron Vaughn
bvaughn@umn.edu
All
18 Years to 89 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT03948919
STUDY00005279
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Inclusion Criteria:

• Able and willing to provide consent
• English speaking
• Diagnosis of ulcerative colitis based on typical clinical-histopathic diagnosis
• Diagnosis of ulcerative colitis > 3 months
• Active disease on endoscopy (endoscopic Mayo subscore ≥ 1)
• Evidence of inflammation extending beyond a minimum of 20cm
• Any ongoing ulcerative colitis therapy must be at stable doses for 4 weeks prior to study and remain stable over the course of the study
Exclusion Criteria:

• Extensive bowel resection
• Presence of ileostomy or colostomy
• Suspicion of ischemic colitis, radiation colitis or microscopic colitis
• Diagnosis of Crohn's disease
• Diagnosis of per-anal fistula or abscess
• Adenomatous polyps that have not been removed
• Use of pre or probiotics within 30 days of randomization
• Pregnancy
• Severe food allergies
• End stage liver disease or cirrhosis
• An absolute neutrophil count < 500 cell/µL
• Life expectancy < 6 months
Drug: Fecal microbiota, Other: Placebo
Ulcerative Colitis
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University of Minnesota — Minneapolis, Minnesota Byron Vaughn - (skunkel@umn.edu)

The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

Rachel Vogel
isak0023@umn.edu
Female
18 Years and over
This study is NOT accepting healthy volunteers
NCT03921658
STUDY00005451
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Inclusion Criteria:

• Age ≥18
• Ability to read and write in English
• women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
• Treatment plan includes chemotherapy
• Able to provide written voluntary consent before performance of any study related procedure.
• Cohort 1 only: within 2 years of completing initial chemotherapy treatment
• Cohort 2 only: prior to starting chemotherapy
Exclusion Criteria:

• Inability to provide informed written consent
• Previous exposure to chemotherapy
• Life expectancy < 3 months or in hospice care or nursing home
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
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University of Minnesota — Minneapolis, Minnesota Rachel I Vogel, PhD - (isak0023@umn.edu)

Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1 (MINUTES)

All
18 Years to 60 Years old
N/A
This study is also accepting healthy volunteers
NCT03896425
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Inclusion Criteria:
1. Ability to provide consent and comply with study procedures. 2. Age 18
•60 years old. 3. Estimated IQ range within the range: 70 ≤ IQ ≤ 115. 4. No Serious and Persistent Mental Illness (SPMI) or addictive disorder diagnosis as measured by the MINI (Mini International Neuropsychiatric Interview), or sleep disorder; 5. Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.
Exclusion Criteria:
1. Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV). 2. Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).
Device: Transcranial direct current stimulation (tDCS)
Transcranial Direct Current Stimulation, Healthy
tDCS, cognitive training, functional connectivity, non-invasive brain stimulation
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University of Minnesota — Minneapolis, Minnesota Kelvin Lim, MD - (kolim@umn.edu)

Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)

Chronic pancreatitis affects as many as 1 in every 2,500 persons and is associated with incapacitating pain, frequent hospitalization and risk of narcotic dependence. This is a debilitating disease with limited treatment options; afflicted patients are often young or middle aged adults. The health and economic costs of pancreatitis are great. One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the patient’s pancreas is removed (eliminating the source of the pain) and the patient’s islets, which produce insulin and other important hormones, are harvested from the pancreas and transplanted into the liver thru the portal vein. This procedure is limited by the number of islets removed in the disease pancreas, and problems with the islets functioning normally in the liver. We propose a pilot study to evaluate outcomes when a portion of the islets are placed in an omental pouch (in fatty tissue of the abdomen) to evaluate safety and islet function using this alternative site.

Gregory Beilman
beilman@umn.edu
All
18 Years to 68 Years old
N/A
This study is also accepting healthy volunteers
NCT03779139
STUDY00003956
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Inclusion Criteria:
1. Age 18-68 2. Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approved for pancreatectomy and IAT at U of MN are reviewed by a multi-disciplinary committee including surgeons, gastroenterologists specializing in pancreatic disease, a pain specialist psychologist, and endocrinologist to confirm the diagnosis of chronic pancreatitis and candidate suitability for surgery. 3. Able to provide informed consent
Exclusion Criteria:
1. Pre-Existing diabetes mellitus fasting blood glucose>115mg/dl, or hemoglobin A1c level >6.0% because these are all evidence of inadequate beta-cello mass. 2. Use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin. 3. ALT or AST>2.5 times the upper limit of normal (ULN). Bilirubin>ULN, unless due to benign diagnosis such as Gilbert's. 4. Any of the following hematologic abnormalities: server anemia (hemoglobin <10 g/dL), thrombocytopenia (<150/mm3), or neutropenia(<1.0 x 109/L). 5. Current use or expected use of oral or injected corticosteroids, or any mediation likely to affect glucose tolerance. However, use of hydrocortisone for physiologic replacement, or use of any topical, inhaled or intranasal glucocorticoid is permitted. 6. Current or expected use of any other immunosuppressive agent. 7. Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin, enoxaparin), or any history of pulmonary embolism. 8. For females, plans to become pregnant or unwillingness to use birth control for the study duration. 9. Inability to comply with the study protocol. 10. Untreated psychiatric illness that may interfere with ability to give informed consent, or other developmental delay or neurocognitive disorder that impairs with a patient's ability to consent on their own behalf. 11. Any other medical condition that , in the opinion of the investigator, may interfere wit the patient's ability to successfully and safely complete the trial.
Procedure: Intrahepatic islets and islets in the omental pouch, Procedure: Intrahepatic islets alone, Other: Normal Volunteers
Chronic Pancreatitis, Diabetes Mellitus, Islet Cell Transplantation
total pancreatectomy with islet autotransplant
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University of Minnesota — Minneapolis, Minnesota Greg Beilman - (beilm001@umn.edu)

PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant

PRI-VENT FSGS is a phase III, multicenter, randomized, open label, clinical trial to test the hypothesis that plasmapheresis plus rituximab prior to kidney transplantation can prevent recurrent FSGS in children and adults.

Priya Verghese
pverghes@umn.edu
All
1 Year to 40 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03763643
STUDY00004388
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In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age 1-40 years at the time of kidney transplant 2. Biopsy proven diagnosis of primary FSGS or minimal change disease 3. History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia) 4. First kidney transplant or second kidney transplant with a history of recurrent FSGS in the first transplant 5. The patient (if ≥18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if <18 years old will be required per local IRB requirements. 6. Negative urine pregnancy test prior to randomization (for females who are post-menarche). 7. Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab. An individual who meets any of the following criteria will be excluded from participation in this study: 1. Known genetic cause of FSGS 2. Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.) 3. 4. Received rituximab within 1 year prior to transplant 5. Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins 6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies 7. Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit. 8. Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer) 9. ANC < 1.5 x 103 10. Hemoglobin: < 8.0 gm/dL 11. Platelets: < 100,000/mm 12. AST or ALT >2.5 x Upper Limit of Normal at the local institution's laboratory 13. History of drug, alcohol, or chemical abuse within 6 months prior to screening visit. 14. Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential 15. Concomitant malignancies or previous malignancies 16. History of psychiatric disorder that would interfere with normal participation in this protocol 17. History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease) 18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 19. Inability to comply with study and follow-up procedures
Drug: Rituximab, Drug: Placebo, Procedure: Plasmapheresis
Focal Segmental Glomerulosclerosis
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University of Minnesota — Minneapolis, Minnesota Michelle Rheault - (rheau002@umn.edu)

Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg

The primary goal of this study is to investigate the qualitative and quantitative effects of SRP with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load. A randomized controlled clinical trial of a control (scaling and root planing)(SRP)) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned. Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period. Specific Aim 2: Assess serum and GCF biomarkers of inflammation, including cytokines as noted above in both control (SRP) and test group (SRP with minocycline HCL microspheres, 1 mg).

Michelle Arnett
marnett@umn.edu
All
18 Years and over
Phase 4
This study is also accepting healthy volunteers
NCT03762915
STUDY00004876
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Inclusion Criteria:

• Male and Female
• At least 21 years of age
• ADA Class III-IV Chronic Periodontitis
• Scaling and Root Planing (SRP) or localized SRP
• A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant)
Exclusion Criteria:

• Unable to comply with study protocol
• Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months
• Cigarette use within the last year
• ≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
• Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)
• Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular disease (ASVD) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization
• Have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes HbA1c > 7, HIV, etc.)
• Tetracycline allergy
• Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists, cyclosporin, warfarin, or NSAIDS)
Drug: minocycline HCl microspheres
SRP, Minocycline HCl Microspheres, Biomarkers
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University of Minnesota — Minneapolis, Minnesota Danna R Hickey, RDH, MSDH

Laryngeal Vibration for Spasmodic Dysphonia (SD-VTS)

A 2 x group (treatment/sham) design with two subgroups (high/low intensity training). The treatment SD group will receive effective vibro-tactile stimulation (VTS) at 100Hz frequency and the sham SD group will receive ineffective VTS at 5Hz stimulation frequency for a total training period of 8 weeks. Each group will be divided into two sub-groups – a low intensity and a high-intensity training group. The subgroups will cross-over after 4 weeks of training. There is no healthy control group included in this protocol.

All
18 Years to 75 Years old
N/A
This study is also accepting healthy volunteers
NCT03746509
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Inclusion Criteria:

• diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection
Exclusion Criteria:

• abductor SD
• patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD
Device: Laryngeal Vibration (Treatment), Device: Laryngeal Vibration (Comparator)
Spasmodic Dysphonia
Dystonia, Spasmodic dysphonia, Laryngeal dystonia
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University of Minnesota — Minneapolis, Minnesota Divya Bhaskaran, PhD - (bhas0021@umn.edu) Naveen Elangovan, Ph.D. - (naveen@umn.edu)

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Sayeed Ikramuddin
ikram001@umn.edu
All
40 Years to 67 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03587831
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Inclusion Criteria:
1. Age 40 to 67 years at eligibility visit. 2. At least one of the following: A) Liver biopsy within 6 months preceding enrollment consistent with non-alcoholic fatty liver disease with a NAFLD Activity Score ≥4 B) Diagnosed with type 2 diabetes mellitus or prediabetes for at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c< 9% and NOT requiring insulin 3. Body Mass Index (BMI): 35.0-50.0 kg/m2 at eligibility visit 4. Willingness to accept random assignment to either treatment group 5. All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study 6. Expect to live or work within approximately two-hours traveling time from the study clinic for the duration of the one-year trial 7. Evidence of liver fat present in the baseline MR images 8. Suitable for liver biopsy using the percutaneous approach 9. Willingness to comply with the follow-up protocol and successful completion of the run-in (described below) 10. Written informed consent
Exclusion Criteria:
1. Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months. 2. Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. 3. Pulmonary embolus or thrombophlebitis in the past six months. 4. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years. 5. Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy. 6. Serum creatinine >1.5 mg/dL. 7. Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than twice the upper limit of normal. Elevated INR. 8. Alcohol intake more than one drink or >20 grams per day 9. History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. 10. Gastric or duodenal ulcer in the past six months. 11. History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment). 12. Previous organ transplantation. 13. Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. 14. Currently pregnant or nursing, or planning to become pregnant in the next two years. 15. History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years. 16. Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. 17. Brief psychological evaluation recommendation that individual not continue in the study. 18. Current participation in a conflicting research protocol. 19. Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. 20. Serum c-peptide <1.0 ng/ml post prandial. 21. Exclusions may also be made at the discretion of the attending physician or the eligibility committee. 22. Contraindication to MRI scanning. MRI contraindications are assessed during initial eligibility review as well as on the day of scanning using the standard safety screening form. 23. Individuals that require the trans-jugular approach for liver biopsy 24. Gastroesophageal reflux disease requiring medications. History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus. Any history of dysphagia. 25. More than 2 cups of coffee per day 26. NAS fibrosis score > 3
Procedure: Vertical Sleeve Gastrectomy, Behavioral: Lifestyle Modification Counseling
NASH - Nonalcoholic Steatohepatitis
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University of Minnesota — Minneapolis, Minnesota Sara Eischen - (bengt008@umn.ed) Mary Farnsworth - (ewigx005@umn.edu)

Recurrent Hypoglycemia in Type 1 Diabetes (Aim 1)

This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics (T1D) following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH at a fourth clamp. Participant glycemic variability for ~2 weeks and activity/sleep for ~1 week before the induction of IAH will be monitored as these factors have been shown to alter responses to HG.

Elizabeth Seaquist
seaqu001@umn.edu
All
18 Years to 65 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03410277
STUDY00002192
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Inclusion Criteria:

• Type 1 diabetes diagnosed on clinical or laboratory grounds
• Diabetes duration 2
•30 years
• Hemoglobin A1C <8.5%
Exclusion Criteria:

• Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires
• Pregnant or plan to become pregnant during the study period
• Uncontrolled hypertension (blood pressure > 145/95 mmHg at screening)
• Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
• Proliferative retinopathy
• Impaired kidney function (GFR < 45)
• History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias
• Current substance abuse
• Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician
• Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs
Other: Experimental hypoglycemia
Diabetes Mellitus, Type 1
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University of Minnesota — Minneapolis, Minnesota Elizabeth R Seaquist, MD - (studydiabetes@umn.edu)