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365 Study Matches

Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

Michael Todd
18 years and over
This study is NOT accepting healthy volunteers
STUDY00002808
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Inclusion Criteria:

• scheduled to undergo any elective surgical procedure under general anesthesia in the MHealth East Bank operating rooms
• administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated
Exclusion Criteria:

• procedure is being done as an emergency
• procedure occurring in the evening or weekend
Brain & Nervous System
Anesthesia
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Synergistic Enteral Regimen for Treatment of the Gangliosidoses (SYNER-G) (Syner-G)

The Syner-G regimen research study seeks to evaluate the use of a combination of a medication called miglustat and a ketogenic diet for treatment of the gangliosidoses to learn if this combination will provide improved clinical outcomes compared to what we currently know about the natural course of the disease.

Jeanine Jarnes
Up to 18 years old
This study is NOT accepting healthy volunteers
1311M46101
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Inclusion Criteria:

• no more than 17 years old
• documented infantile or juvenile gangliosidosis disease
Exclusion Criteria:

• severe kidney disease
• females who are pregnant or breast feeding
• females who are post puberty who are unwilling to use highly effective birth control
Rare Diseases
GM1 Gangliosidoses, GM2 Gangliosidoses, Sandhoff Disease, Tay-Sachs Disease
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Biomarkers of Exposure and Effect in SREC Users

The purpose of this study is to better understand how switching from smoking to the use of electronic cigarettes (e-cigarettes) may change users’ exposures to various harmful chemicals. Your participation will also help us to understand how nicotine that is present in e-cigarettes is taken in and modified by your body.

Irina Stepanov
18 years and over
This study is also accepting healthy volunteers
STUDY00002033
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Inclusion Criteria:
Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine; Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product; Biochemically confirmed regular smoking status by a NicAlert test level of 6; Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group); No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures); Subjects are in good physical health (no unstable medical condition); Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse); Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes; Women who are not pregnant or nursing or planning to become pregnant; Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Exclusion Criteria:
Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes; Currently using nicotine replacement or other tobacco cessation products; Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data; Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional); Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional); Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional; Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once; Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once; Pregnant or breastfeeding; Failure to agree to take adequate protection to avoid becoming pregnant during the study; Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): Systolic BP greater than or equal to 160 mm/hg Diastolic BP greater than or equal to 100 mm/hg Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) Heart rate greater than or equal to 105 bpm Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) Expired air carbon monoxide (CO) level greater than 80 ppm; Self-reported allergies to propylene glycol or vegetable glycerin; Adverse reactions when previously using electronic cigarettes; Household member enrolled in the study concurrently; Unable to read for comprehension or completion of study documents; Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Prevention & Wellness
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Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes.  Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014879
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Inclusion Criteria:

• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC), fatty liver, gastrectomy, sleeve, sleeve gastrectomy, weight loss
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RANDOMIZED NON-INFERIORITY TRIAL COMPARING OVERALL SURVIVAL OF PATIENTS MONITORED WITH SERUM TUMOR MARKER DIRECTED DISEASE MONITORING (STMDDM) VERSUS USUAL CARE IN PATIENTS WITH METASTATIC HORMONE RECEPTOR POSITIVE HER-2 NEGATIVE BREAST CANCER

This study is looking at how well serum tumor markers work to monitor people who have hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. We want to see if using the markers (from a blood sample) is as good as using scans to monitor disease.

Nicole Hartung
18 years and over
This study is NOT accepting healthy volunteers
MMCORC021
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Inclusion Criteria:

• diagnosis of hormone receptor positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative, metastatic (M1) breast cancer
• receiving or plan to receive first-line systemic treatment for metastatic disease
• no other prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five years
Exclusion Criteria:

• known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia
• known brain leptomeningeal metastases
• must not be pregnant
Cancer
Breast Cancer, Breast Cancer, Tumor Markers, Metastatic Breast Cancer
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A Phase 3 open-label, controlled, randomised, multi-centre trial comparing imlifidase and standard-of-care with standard-of-care alone in the treatment of severe anti-GBM antibody disease (Goodpasture disease) (GOOD-IDES-02)

The purpose of the trial is to evaluate the effect and safety of imlifidase when given to participants with antiGBM disease (also called Goodpasture disease). We will study if the addition of imlifidase to the standard of care treatment results in a better effect without causing unacceptable side effects compared to standard of care alone.

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016584
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Inclusion Criteria:

• Anti-GBM antibodies constituting an indication for Plasma exchange (PLEX)
• presence of blood or sediment in urine
Exclusion Criteria:

• diagnosis of anti-GBM disease made more than 14 days ago
• women who are pregnant or breast feeding
• additional exclusion criteria (study staff will review)
Rare Diseases, Kidney, Prostate & Urinary
Anti-Glomerular Basement Membrane Disease, Good Pasture Syndrome, Goodpasture Syndrome
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Site for ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

We are continuing to study the SARS-CoV-2 coronavirus and the evolving new variants. We are looking at drugs that have Food and Drug Administration (FDA) approval for other uses. The goal is to determine if these drugs can make participants who get the coronavirus feel better faster and reduce death and hospitalizations.

Carolyn Bramante
18 years and over
This study is NOT accepting healthy volunteers
SITE00001271
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Inclusion Criteria:

• at least 30 years old
• confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days before starting study
• two or more current symptoms of acute infection for no more than 7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion Criteria:

• current or recent (within 10 days of starting study) hospitalization for COVID-19 infection
• current or planned participation in another interventional trial to treat COVID-19 (study physician will review)
• current or recent use (within the last 14 days) of study drug or study drug/device combination
COVID-19, Infectious Diseases
Primary Care, COVID, COVID-19

Comparison of normothermia maintenance between resistive blanket and forced air warming systems in renal transplant surgery

The maintenance of normal body temperature is important for all patients undergoing anesthesia to maintain important body functions. To help patients maintain normal body temperature during the surgery, a warming device is used. This study will compare the effectiveness of a resistive blanket warming device to the standard of care forced air warming device.

Cole Bennett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012072
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Inclusion Criteria:

• having a kidney transplant (not an emergency surgery)
Exclusion Criteria:

• previous organ transplantation or nephrectomy
• diagnosis of end stage renal disease with decreased or no urine output
• previous upper extremity amputation
• sepsis or other infection
• women who are pregnant
Kidney, Prostate & Urinary
Kidney transplant
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MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)

The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.

Veronika Bachanova, MD
Not specified
This study is NOT accepting healthy volunteers
1611M99805
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Inclusion Criteria:

• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
Cancer
Clinics and Surgery Center (CSC), Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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Assessing Usability of Tools to Access Pericardial Space in Simulator

This study is designed to assess the usability of tools to access the pericardial space for delivery of conductive pacing leads to the pericardium using a modified Seldinger technique. A prototype thoracic access port tool or an EndoPath trocar will used to complete a series of short tasks involving accessing the pericardial space in a simulator doll.

Bradley Clark
STUDY00018417
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SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) Trial (SHARP)

We are studying the effectiveness of a new procedure to treat people who have episodes of acute pancreatitis with pancreas divisum. Of the participants, half will receive the new procedure called endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic spincterotomy (miES) the other half with receive only ERCP. We will monitor outcomes for at least eighteen months.

Martin Freeman
18 years and over
This study is NOT accepting healthy volunteers
SITE00000387
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Inclusion Criteria:

• at least 18 years old
• two or more episodes of acute pancreatitis, with one occurring in the last 24 months
• there is no certain explanation for recurrent acute pancreatitis
Exclusion Criteria:

• prior minor papilla therapy (endoscopic or surgical)
• other causes of pancreatitis (study staff will review)
• regular use of opioid medication for abdominal pain for the past three months
Digestive & Liver Health
Clinics and Surgery Center (CSC), ERCP, Pancreatitis
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COG AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors (P3BEP)

This trial is an open label, randomized, stratified 2-arm Australian-led multicenter phase 3 clinical trial undertaken in two stages. Participants (age >= 11 years and <= 45 years) with intermediate and poor-risk metastatic germ cell tumors will be randomized into either a “standard BEP” group or “accelerated BEP” group. Participants will be assigned to the two treatment arms in a 1:1 ratio and evaluated weekly, and then for 5 years after completing the study to assess the long-term effects of the chemotherapy. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00000331
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Inclusion Criteria:

• between 11 years and 45 years old
• confirmed germ cell tumour (non-seminoma or seminoma) OR Exceptionally raised tumour markers (AFP equal or greater than 1000ng/mL and/or HCG equal or greater than 5000 IU/L)
• primary arising in testis, ovary, retro-peritoneum, or mediastinum
• metastatic disease or non-testicular primary
• see link to clinicaltrials.gov for completed Inclusion/Exclusion criteria
Exclusion Criteria:

• other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
• significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
• peripheral neuropathy equal or greater than grade 2 or clinically significant sensorineural hearing loss or tinnitus
Cancer
Germ Cell Tumor
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Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)

Dereck Salisbury
18 years and over
STUDY00001135
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Inclusion Criteria:
-65 years and older
• diagnosis of Mild Cognitive Impairment
• live in the community
• English speaking
• adequate vision
• physician confirms that exercise is safe
• stable on drugs affecting cognitive and psychological status
• able to have a MRI
Exclusion Criteria:

• resting heart rate less than 50 or greater than 100
• additional medical or mental health diagnosis (study staff will review)
• enrolled in another intervention study related to cognitive improvement
Brain & Nervous System, Community Health
cognitive decline, memory complaint, mild cognitive impairment
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MT2013-06C : Treatment of graft Failure after HSCT

Troy Lund
1404M49341
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Inclusion Criteria:
Patients with primary or secondary graft failure, as defined below, may receive a second transplant: Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant. Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery. Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood. Recipients should have acceptable organ function defined as: Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments. Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal Cardiac: left ventricular ejection fraction > 40%
Exclusion Criteria:
Uncontrolled infection at the time of transplant. Patients with Fanconi Anemia or other DNA breakage syndromes.
Clinics and Surgery Center (CSC)
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Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults with Prediabetes

We are looking at how an 8-week exercise program of walking for 30-45 minutes 3 times/week affects the body. This study is for people who are prediabetic and overweight or obese. We will compare the exercise group to a group that didn’t participate in the exercise to see if there are differences in gut microbes, body measurements, and blood work.

Mark Pereira
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009136
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Inclusion Criteria:

• 30-64 years old
• classified as overweight or obese with BMI greater than 25 kg/m2
• physician diagnosed as pre-diabetic or HbA1c value of 5.7 - 6.4% obtained during study screening
• currently exercise less than 100 minutes per week
• physically able to exercise
• no antibiotics taken for at least 45 days
• weight has been stable for the last 6 months (less than 10% change)
• willing to maintain current diet and exercise levels unless changed by the study
Exclusion Criteria:

• current gastrointestinal illness
• taking metformin or other medications for high blood sugar
• history of bariatric surgery
• pregnant or breast feeding
Diabetes & Endocrine
Prediabetes, elevated blood glucose, impaired glucose, blood sugar, obesity, Hemoglobin A1c, exercis
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A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

We are studying the addition of a drug to the treatment for people who have triple-negative breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells. Some people will receive the current treatment and others will have the current treatment with carboplatin added. The results of the two treatments will be compared.

Edward Greeno, M.D.
18 years and over
This study is NOT accepting healthy volunteers
MMCORC003
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Inclusion Criteria:

• breast tumor must have been determined to be estrogen receptor (ER)-and progesterone receptor (PgR)-negative
• tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative
• surgery (mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy) completed no more than 60 days from enrollment
Exclusion Criteria:

• T4 tumors including inflammatory breast cancer
• clinical or radiologic evidence of metastatic disease
• previous history of invasive breast cancer or DCIS in the same breast
• Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
Cancer
Breast Cancer, Breast Cancer, Triple Negative Breast Cancer
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Prospective quantitative kinematic assessment of patients with normal pressure hydrocephalus

The purpose of this research is to better understand balance and walking in patients with normal pressure hydrocephalus. Balance and walking problems in patients with normal pressure hydrocephalus do not respond well to the typical medication treatments. This research study uses small wearable devices that attach to your clothing and can measure your body’s location while performing walking and balance tests.

Robert McGovern, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00010297
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Inclusion Criteria:
People who are suspected of having Normal Pressure Hydrocephalus (NPH) and scheduled to have inpatient admission for a trial lumbar drain
Exclusion Criteria:

• People who have dementia of sufficient severity to impair their ability to make health-care decisions
• People who have other types of Parkinson's Disease
• People who are unable to stand without help
Brain & Nervous System
Normal pressure hydrocephalus, Hydrocephalus, Balance, Incontinence, Dementia
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Kinematic signatures of postural instability and gait in Parkinson Disease

This is a prospective study aimed at quantifying walking and balance in Parkinson's Disease patients in the clinical setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of deep brain stimulation (DBS) frequency in patients who already have DBS systems in place. Thus, our objectives are: 1. Develop an anonymized database of quantitative postural responses and gait of PD patients. 2. Develop software that can quantify the postural response and gait of PD participants using only standard video camera footage. 3. Test the effectiveness of bilateral high and low frequency STN-DBS on the postural responses and gait of PD patients using the portable motion capture system. 4. We will passively record thalamic LFPs from patients with Medtronic Percept DBS devices while the DBS is OFF, set to low frequency, and set to high frequency.

Robert McGovern, MD
18 years and over
This study is also accepting healthy volunteers
STUDY00005877
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Inclusion Criteria:

• People diagnosed with Parkinson's disease, with or without implanted Deep Brain Stimulator (DBS). May be at any age of disease progression.
• Healthy adults of similar age to participants who have Parkinson's Disease and are enrolled in the study.
Exclusion Criteria:
People who have dementia of sufficient severity to impair their ability to make health-care decisions for themselvess
Brain & Nervous System
Parkinson's, Parkinson's Disease, Deep Brain Stimulator, DBS
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Geniculate Artery Embolization

Osteoarthritis (OA) is a leading cause of disability and chronic pain that reduces physical activity and daily activities. In this clinical research study, the goal is to learn more about geniculate artery (located in the knee) embolization (GAE) treatment to see if it will reduce pain as well as stiffness and difficulty performing daily activities caused by knee OA and if it can be performed safely.

Reza Talaie
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006202
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Inclusion Criteria:

• osteoarthritis of the one knee with symptoms that have not improved after at least 3 months of treatment such as PT, injection, medications,
• partial knee replacement and total knee arthroplasty are not currently options (may be in the future)
• 40-70 years of age
Exclusion Criteria:

• weight greater than 250 pounds
• smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• diabetic with A1C greater than 9%
• advanced peripheral arterial disease
Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Clinics and Surgery Center (CSC), Osteoarthritis
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Bupropion for the Prevention of Postpartum Smoking Relapse

Currently, more than half of all women who are able to quit smoking cigarettes during pregnancy start smoking again within six months after they give birth. We want to find out if the drug bupropion (a commercially-available medicine) can help women who quit smoking during pregnancy to continue not smoking after they give birth. All study visits can be completed either in-person or virtually.

Sharon Allen, PhD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007684
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Inclusion Criteria:

• age 18 to 40
• lifetime history of smoking at least 100 cigarettes, quit smoking during current pregnancy
• uncomplicated delivery, at least 37 weeks gestation
• home within 10 days of delivery
• don't want to start smoking again
Exclusion Criteria:

• currently use other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• currently use cessation aids
• currently use illicit drugs or alcohol dependence
• taking an antidepressant
• family history of seizures or seizure disorder
Mental Health & Addiction, Women's Health
postpartum, smoking, smoking cessation
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Use of Continuous Wave Doppler to assess Vascular Malformations in Pediatric Dermatology

The aim of our study is to look at blood flow in various tumors and irregularities located in blood vessels using a handheld continuous wave doppler. Correct and efficient diagnosis of vascular anomalies (outside of what is expected to happen in blood vessels) in pediatric patients will help determine a treatment plan. Blood flow in vascular anomalies has not been well described in the past.

Sheilagh Maguiness
Not specified
This study is NOT accepting healthy volunteers
STUDY00012200
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Inclusion Criteria:

• less than 21 years old
• have a vascular anomaly such as Arteriovenous malformations (AVM), Capillary malformations (CM), Venous malformations (VM), Lymphatic malformations (LM), Pyogenic granuloma (PG), Infantile hemangioma (IH), or Congenital hemangioma (CH)
• being treated at University of MN pediatric dermatology outpatient clinic or the multidisciplinary vascular anomalies clinic
Exclusion Criteria:

• history of any prior surgical, radiologic, medications for treatment (including oral or topical beta blocking agents)
Dermatology (Skin, Hair & Nails)
Vascular Anomalies
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Long COVID Ultrasound Trial

This research is being performed to study whether an investigational ultrasound treatment of the spleen can reduce the symptoms of Long COVID by reducing inflammation in the body. Ultrasound is widely used in human medicine because it is designed to be safe, non-invasive, and painless. The same kind of ultrasound that is used for imaging (for example, to visualize babies in utero) may be able to treat Long COVID.

Farha Ikramuddin
18 years and over
STUDY00020251
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Inclusion Criteria:

• 18 to 65 years old
• diagnosis of COVID-19 within one year of starting the study, documented by a positive test in which there is evidence in the medical records, physical or photographic evidence, or a note in the medical records from a medical professional documenting that they were positive for COVID-19
• symptoms present for 12 or more weeks including fatigue and one or more of: a. Myalgia b. General aches/pains c. Joint pain d. Cognitive dysfunction (brain fog)
Exclusion Criteria:

• history of intubation or admission to ICU to treat COVID-19
• pre-existing lung conditions such as chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or severe asthma
• women who are pregnant
• history of coronary artery disease (CAD) or stroke
• history of smoking
• any non-marijuana drug abuse history within 30 days
• history of alcohol abuse: greater than 2 drinks a day for men and 1 drink for females
• participant does not speak English
• additional medical and mental health diagnosis (study staff will review)
COVID-19
Covid, Long Covid
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TMS x DPX

We will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while we are measuring the change in brain function with EEG. Please fill out the linked screening questionnaire to determine if you are eligible.

Alik Widge
18 years and over
This study is also accepting healthy volunteers
STUDY00019156
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Inclusion Criteria:

• age 18 to 65
Exclusion Criteria:

• diagnosed with a psychiatric disorder
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of, or recent withdrawal from, medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or have an implanted medical device
Mental Health & Addiction
cognition, EEG, rTMS
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A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)

One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.

Gregory Beilman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003956
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Inclusion Criteria:

• age 18- 68
• scheduled for a total pancreatectomy and IAT at University of Minnesota
Exclusion Criteria:

• diabetes mellitus fasting blood glucose greater than 115mg/dl, or hemoglobin A1c level greater than 6.0%
• 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
• other medical or mental health diagnosis (study staff with review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Diabetes Mellitus, Islet Cell Transplantation
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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation (CLASP II TR)

The goal of this trial is to evaluate the safety and effectiveness of the PASCAL System with optimal medical therapy (OMT) compared to OMT alone in participants with symptomatic severe tricuspid regurgitation. We are studying this in patients who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve).

Marat Yanavitski
18 years and over
This study is NOT accepting healthy volunteers
SITE00001026
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Inclusion Criteria:

• at least 18 years old
• symptoms of severe tricuspid valve regurgitation in spite of medical treatment
Exclusion Criteria:

• untreated coronary artery disease, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
• women who are pregnant, breastfeeding, or planning pregnancy within the next 12 months
• other significant medical diagnosis (study team will review)
Heart & Vascular
Heart Valve, TAVR, Transcatheter Valve Repair System, tricuspid valve
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Self-Weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot

This study will test whether adding in daily weighing (5-7 days per week) is helpful in weight loss. In adults, it has been found to be helpful to have individuals who are obese to be more successful with their weight loss efforts if they weigh themselves at home every day. We want to see if this could be helpful in children as well. This research will last for about 12 weeks (3 months).

Carolyn Bramante
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00012679
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Inclusion Criteria:

• aged 12 to <18 years
• BMI at the 95th percentile or greater
• weight loss or maintenance determined as the treatment goal by PWMC provider
Exclusion Criteria:

• any unhealthy weight control behaviors
• participation in other PWMC study
• developmental delay
• diagnosis that might cause weight fluctuations in weight
• severe anxiety or depression
Children's Health
children's health, obesity, weight, weight management
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Lifestyle Counseling and Medication for Adolescent Weight Management (QUEST)

This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI and body fat and greater improvement in cardiometabolic factors and quality of life compared to intensive behavioral counseling at 56 weeks.

Aaron Kelly
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00012932
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Inclusion Criteria:

• ages 12-17
• BMI greater than or equal to the 95th percentile for age and sex
Exclusion Criteria:

• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
Diabetes & Endocrine, Children's Health
Obesity, Overweight, weight loss
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Assess Pituitary Function in COVID-19 Patients and Correlate Results with Clinical Symptoms Fatigue

We are studying hormone levels and fatigue of people who have recently had COVID-19. Participants will complete questionnaires and have blood drawn to determine hormone levels. Participants who are experiencing high levels of fatigue or who have abnormal hormone levels will complete questionnaires and have blood drawn every three months for a year. We are hoping to determine how COVID-19 affects hormone levels and the pituitary gland, which is responsible for releasing hormones.

Takako Araki
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014212
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Inclusion Criteria:

• People who have COVID-19 documented with a positive SARS-CoV-2 test.
Exclusion Criteria:

• People with pituitary abnormalities diagnosed prior to the diagnosis of COVID-19.
• People receiving hormone replacement therapy, including thyroid hormone, estrogen replacement, (including oral contraceptives), testosterone, or growth hormone.
• People who are on active treatment with oral, topical, inhaled, or injectable corticosteroids (injection within 4 weeks of screening)
• People who have current and continuous (> 3 months) opioid use
• People who are not able to complete study procedures necessary for the study, such as an early morning blood draw.
COVID-19, Diabetes & Endocrine, Infectious Diseases
COVID, COVID-19, Fatigue
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Intermittent Pneumatic Compression with and without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL (INTERCEDE)

The purpose of this study is to establish whether the device, intermittent pneumatic compression (IPC), both with and without walking exercise, can improve the ability to walk and prevent decline in the ability to walk for people with PAD. Intermittent pneumatic compression consists of blood pressure cuffs that are wrapped around the lower legs (below the knees) that inflate three times per minute. These cuffs may improve blood flow to the lower legs and feet.

Diane Treat-Jacobson
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013094
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Inclusion Criteria:

• diagnosis of Peripheral Artery Disease (PAD) based on specific criteria that study staff will review
Exclusion Criteria:

• above or below-knee amputation
• wheelchair-bound
• currently have a foot ulcer on bottom of foot or ongoing infection of the toes, foot, or lower extremity
• walking is limited by a symptom other than PAD
• major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months
• already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months)
• non English speaking
• BMI greater than 45kg/M2
• major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness (study staff will review)
Heart & Vascular
peripheral arterial disease, cocoa, intercede, pad, peripheral artery disease, prove
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Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

We are studying brain mechanisms related to chronic temporomandibular disorder (TMD) pain. We are looking at brain structural and functional characteristics that can potentially explain why some people experience persistent pain in their jaws for months or years. We will compare this to information we get from people who do not experience TMD pain. We expect that this new knowledge will improve our understanding of this chronic pain condition and help us develop better treatments.

Estephan Moana-Filho
18 years and over
This study is also accepting healthy volunteers
STUDY00013924
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Inclusion Criteria:

• Female participants only (biological sex)
• Age between 18-65 years
• Pain-free participants OR
• Chronic jaw pain ( > 3 months)
Exclusion Criteria:

• Certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia)
• Any MRI contraindications (examples: metal implants, claustrophobia)
• Being left-handed only
Bone, Joint & Muscle, Brain & Nervous System, Dentistry
Chronic Jaw Pain, Functional Brain Imaging, Sensory Testing, Temporomandibular Disorders
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