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.
•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.
• 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.
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
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.
•Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)
• 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
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.
• 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)
Care Improving Cognition for ADolescents on the Autism Spectrum (CICADAS)
•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.
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
• 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.
• 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.
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.
• 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
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.
• 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.
• 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
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
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).
• Preterm infant born at 30 weeks (+/- 2 weeks)
• Medically stable
• 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
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.
• 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
• 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)
• Concern for active eating disorder per screening questionnaire
• Self-reported eating disorder or history of eating disorder
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
• history of significant claustrophobia
Post-contracture Release Radiation for Dupuytren's Disease
• Diagnoses of Dupuytren's disease
•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
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
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.
• 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.
• 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;
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
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.
• 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
• 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
• Severe food allergies
• End stage liver disease or cirrhosis
• An absolute neutrophil count < 500 cell/µL
• Life expectancy < 6 months
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
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.
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.
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.
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).
• 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)
• 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)
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.
• diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection
• abductor SD
• patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
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
• 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