Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
•Undergoing elective renal transplantation
• 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
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.
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.
• 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
• 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)
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.
• pregnancy
• requesting an epidural for the first time
• 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
Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement
3.1 Primary Endpoint/Event/Outcome: We will characterize right ventricular function based on pressure-volume loop, pulmonary artery catheter and transesophageal echocardiographic parameters after LVAD implantation. Specifically, we will collect the following from the high-fidelity conductance catheter placed in the right ventricle; ● Stroke volume, heart rate, ejection fraction, cardiac output, end-systolic pressure and volume, end-diastolic pressure and volume, right ventricular dP/dt, and stroke work We will collect the following from the pulmonary artery catheter; ● Cardiac output, right atrial pressure, right ventricular systolic and diastolic (early and late) pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, and central venous blood saturation We will collect the following from the transesophageal echocardiography; ● “Eyeball” method for assessing right ventricular function, tricuspid annular plane systolic excursion (TAPSE), fractional area change (FAC), tissue Doppler-derived right ventricular systolic excursion velocity S’, portal vein flow
•Patients undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center
• Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
• Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
• Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
• Patients unable to consent to participating in the study
• Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery.
Geniculate Artery Embolization for Osteoarthritis
• Unilaterally dominant symptomatic osteoarthritis (bilateral radiographic OA will not exclude)
• Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee)
• Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
• Patients who are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure
• Patients who are willing to comply with regular follow up during the 12 month follow-up period
• Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
• Patients with WOMAC Score >=6 in at least 2 categories
• Patients with a weight >250 pounds
• Patients with advanced peripheral arterial disease (resting ABI <= 0.9)
• Patients with known significant peripheral arterial disease precluding common femoral catheterization
• Patients who do smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• Patients with diabetes who have a hemoglobin A1C of >9%
• Patients who have undergone previous lower extremity embolization
• Patients with uncontrolled emotional disorders per patient medical history
• Patients with chronic pain syndrome or currently under a pain contract
• Patients with anatomic variants involving the lower extremities which would increase the risk of non-target embolization
• Patients with renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis.
• Patients with an abnormal INR (>1.5).
• Patients with a platelet count <50x109/L.
• Patients who are currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
• Patients with a known severe allergy to iodine which cannot be adequately pre-medicated
• Patients who are pregnant or intend to become pregnant within 6 months of the procedure
• Patients with a contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
• Patients with a life expectancy <60 months
• Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
• Patients with contraindications to medical and physical rehabilitative treatments of OA
• Patients with known advanced atherosclerosis
• Patients with known current or previous lower extremity fistula
• Patients with rheumatoid arthritis or seronegative arthropathies
• Patients with prior ipsilateral knee surgery.
• Patients with WOMAC Pain Scale < 6
• Patients having received more than one steroid injection in the affected joint or an injection in the affected joint within 3 months of screening
Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
• 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
• 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
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).
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.
• 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
• 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
Community-based Exercise Following Revascularization for PAD
The primary aim of this new clinical trial is to evaluate whether community-based structured exercise therapy, which could be accessible and easily disseminated, adds benefit to patients with peripheral artery disease (PAD) undergoing revascularization to improve their function and cardiovascular health.
• Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb
• Patients with focal and/or diffuse peripheral artery disease
• Bilateral Revascularization patients will also be included
• Ability to participate in an exercise program
• Lower extremity amputation(s) which interfere(s) with walking on the treadmill
• Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
• PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis).
• Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
• Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
• Individuals who have had a myocardial infarction within 3 months prior to screening
• Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
• Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
• Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening. Patients can be reconsidered for study inclusion following a 1-month washout period
• Poorly controlled diabetes defined as glycated hemoglobin >12%
• Abnormal results of blood work not conducive to safely participate in an exercise trial (e.g., anemic, electrolyte abnormalities)
• Inability to speak English
• Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
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.
• 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
• 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
Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
Supervised exercise training (SET) improves functioning and quality of life for patients with peripheral artery disease (PAD). However, these programs have primarily been conducted in research settings, thus the physical activity that patients complete in real-world settings (urban and rural hospitals) is unknown. The proposed project will use a novel smartphone app called Daynamica, to summarize patients activity patterns and also to enhance patient-study staff communication and subsequently improve PAD patient health outcomes.
• Diagnosis of atherosclerotic PAD and referred to hospital-based SET
• Ability to complete an evaluation of physical function and walk on a treadmill
• Resting ankle-brachial index (ABI) of ≤0.90 or stenosis ≥50% in a peripheral vessel or those with lifestyle limiting vascular-related claudication
• Those with a resting ABI of 0.91-0.99 (borderline) who have completed an exercise-ABI assessment with a >20% drop compared to resting values
• Those with ABI >1.40 who have had an abnormal toe-brachial index of ≤0.70
• Lower extremity amputation(s) which interfere(s) with walking on the treadmill.
• Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
• PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
• Females who are pregnant
• Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
• Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
• Individuals who have had a myocardial infarction within 3 months prior to screening
• Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
• Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
• Poorly controlled diabetes defined as glycated hemoglobin >12%
• Abnormal results of blood work not conducive to safely participating in an exercise trial (e.g., anemic, electrolyte abnormalities)
• Inability to speak English
• Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Post-contracture Release Radiation for Dupuytren's Disease
• Diagnoses of Dupuytren's disease
• English-speaking
•Patients with Dupuytren's disease who are not currently seeking treatment
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.
• 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
• 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
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.
• 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
• 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
Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy (ICP Waveform)
• Must be able to sit still and fix their eyes on a target in the VO objective.
• ICP participants must have an inserted ICP probe for clinical purposes.
• Diagnosis of glaucoma, retinopathy or head tremor.
Cf-DNA Assay During Treatment of Acute Rejection
• Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction.
• <1 months post-transplant
• >12 months post-transplant
Hepatic Energy Fluxes in NASH and NAS Patients
• Age 18 to 67 years at eligible visit
• Diagnosed with NASH with a total NAS ≥ 3 including a ballooning score of at least 1, or non-NASH/NAFLD with a total NAS ≤3, or Diagnosed with T2DM or prediabetes, HbA1c< 8% , or CAP score greater than or equal to 248 on Fibroscan
• Body Mass Index (BMI) 30.0-55.0 kg/m2 at eligibility visit
• Willingness to accept surgical intervention after an individual seminar session
• All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all patients enrolled in the study
• Expect to live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
• Willingness to comply with the follow-up protocol and successful completion of the run-in
• Written informed consent
• Suitable for liver biopsy using the percutaneous approach
• Vulnerable populations will not be targeted for inclusion, but those noted in section 9.1 may be allowed to participate provided they met all of the inclusion and none of the exclusion criteria.
• Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
• Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
• Cardiac stress test indicating that surgery or IMM would not be safe.
• Pulmonary embolus or thrombophlebitis in the past six months
• Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
• Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
• Serum creatinine >1.5 mg/dL.
• 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 2.5 the upper limit of normal. Elevated INR.
• Alcohol intake more than one drink or >20 grams per day
• History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
• Gastric or duodenal ulcer in the past six months.
• History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
• Previous organ transplantation.
• Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, or cirrhosis
• Currently pregnant or nursing, or planning to become pregnant in the next two years.
• History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
• Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
• Depression A CESD score more than 17 and a psychologist determination that the patient is not a good fit for surgery.
• Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
• 12-lead EKG indicating that surgery would not be safe.
• Serum c-peptide <1.0 ng/ml post prandial.
• Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
• Contraindication to MRI scanning. MRI contraindications are assessed by MR technologists on the day of scanning using a standard safety screening form.
• History of endoscopy demonstrating esophagitis or Barretts changes in the esophagus. Any history of dysphagia.
• Treatment with drugs associated with nonalcoholic fatty liver disease (amiodarone, methotrexate, oral glucocorticoids at doses greater than 5 mg/day, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, valproic acid) for more than 4 weeks within the last 2 months prior to the initial screening.
• Treatment with pioglitazone or high-dose vitamin E (>400 IU/day) within the last 2 months prior to the initial screening.
Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens
• 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
• 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
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
• 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
• Inability to provide informed written consent
• Previous exposure to chemotherapy
• Life expectancy < 3 months or in hospice care or nursing home
Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients (ANAPOD)
The Westmed Inc Anapod system used a humidified warming unit that is located within the anesthesia breathing circuit. The manufacturer has supported studies to evaluate the performance of the Anapod Humi-Therm Heated Humidification System Breathing Circuit in adult subjects. But while the system is being used nationwide in pediatric populations, there have been no studies in pediatrics, nor studies evaluating its performance compared to another well-established warming method (i.e. forced-air warming blanket).
•Pediatric patients undergoing elective, scheduled dental procedures at Masonic Children's hospital requiring general anesthesia with endotracheal intubation, anticipated to last 1-6 hours or longer
• Parent refusal of consent
• Patient refusal of assent (if applicable)
• Additional procedures (combined procedures) that involve other specialties besides dentists and other parts of the patient's body other than the oral cavity.
• History of diseases associated with temperature dysregulation (active hyperthyroidism, dysautonomia, osteogenesis imperfecta, history of malignant hyperthermia)
• Patients that will not be intubated for the procedure
Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1 (MINUTES)
•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.
Green Exercise for Cancer - Creating Opportunities for Survivors (GECCOS)
• Survivors of childhood cancer or hematopoietic cell transplantation for non-malignant diseases
• Between the ages of 13 and 30
• Able to speak English
• More than 3 months out from the completion of cancer treatment and/or 6 months out from hematopoietic cell transplantation with no evidence of recurrent or residual cancer
• Must be off of all immune suppressing therapies
• Anyone not meeting the inclusion criteria
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.
Neuromodulation and Cognitive Training in Opioid Use Disorder
Patients will receive 20 minutes of continuous stimulation of either active or sham transcranial direct current stimulation every day for five consecutive days. This will allow investigation to whether the pairing of dorsolateral prefrontal corex stimulation and cognitive flexibility training can enhance functional connectivity between dorsolateral prefrontal corex and nucleaus accumbens, assisting with treatment for opioid use disorder.
• 20 abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
• This 28-day program provides a supervised environment to treat individuals with OUD in which patients receive random drug screenings. Lodging Plus has 50 beds and admits an average of 20 patients per week and about 50% of patients admitted have a diagnosis of opioid use disorder.
• Ability to provide written consent and comply with study procedures, meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for OUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on opioid use. Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study. Vulnerable populations will not be included.
• Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
• A 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: history of seizures; 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)
• DSM-V criteria for psychiatric disorder, may have a lifetime diagnosis of depression
• Presence of a condition that would render study measures difficult or impossible to administer or interpret
• Age outside the range of 18 to 60
• Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
• Clinical evidence for Wernicke-Korsakoff syndrome
• Nicotine use will be recorded.
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.
Spectroscopic Magnetic Resonance Imaging of Glioma (MEGA-PRESS)
The primary objective of this study is to develop and test new Magnetic Resonance Imaging methods that can improve characterization of brain cancer (Glioma) and facilitate improved clinical care of these patients. Develop better spectroscopic techniques to characterize brain tumors through measurement of 2HG concentration at the clinically relevant field strength of 3 T. Reliable and robust detection of the presence of 2 hydroxyglutarate (2HG) as well as studies of the associated physiologic consequences 2HG accumulation can fundamentally alter clinical decision making in the treatment of these patients.
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.
• Type 1 diabetes diagnosed on clinical or laboratory grounds
• Diabetes duration 2
•30 years
• Hemoglobin A1C <8.5%
• 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
Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke (AFAS)
• Females and males ages 18-99 years of age
• People with stroke who are medically stable with one or more ischemic or
• hemorrhagic stroke(s)
• left or right hemiplegia
• willing and able to attend a one-time behavioral testing session
• willing and able to sign consent to participate
• able to hear, read and comprehend instructions given during the study
• English speaking (or willing to work with a (student) translator)
• cognitive impairment (Mini-mental State Exam-brief version, <13/16)
• contractures in the tested arm that would hinder testing arm movements
• adults lacking capacity to consent
• severe neglect, aphasia, apraxia
• other medical conditions that preclude participation
Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)
Gaucher disease is the most common lysosomal storage disorder due to a mutation in the lysosomal enzyme, glucocerebrosidase. There is increasing evidence that oxidative stress and/or inflammation contribute to the pathophysiology. In order to evaluate oxidative stress and/or inflammation in patients with Gaucher disease, we will analyze a series of blood biomarkers and correlate them with currently used diagnostic biomarkers of this condition. We will determine oxidative stress and/or inflammation related biomarkers in whole blood and/or plasma in adult subjects with Gaucher disease. Fifteen milliliter blood sample will be collected during three independent visits over a period of approximately 3 months. These samples will be processed to separate plasma from red blood cells and frozen until assays are performed. Standardized immunoassay methods and LC/MS based methods will be adopted to assay a series of biomarkers in these samples. These data will be correlated with currently used diagnostic biomarkers.